Blood pump device and method for manufacturing blood pump

文档序号：216699 发布日期：2021-11-09 浏览：14次中文

阅读说明：本技术 血液泵浦装置及制造血液泵浦的方法 (Blood pump device and method for manufacturing blood pump ) 是由依哈德·史库汪门透由希·吐佛丹尼尔·格楼兹曼于 2014-03-13 设计创作，主要内容包括：本发明公开一种血液泵浦装置及制造血液泵浦的方法,包含辨认一受验者罹患选自于：心功能不全、充血性心脏衰竭、肾脏血流减少、肾脏血管阻力增加、高血压及肾功能不全所组成的一族群的一情况。因应上述情况,通过在所述受验者的肾脏静脉(32)内放入一血液泵浦(150)且激活叶轮以使从所述肾脏静脉汲取血液到所述受验者的一腔静脉(26),来减少在所述受验者的一肾脏静脉之内的血压。本发明也描述多种其他应用。(The invention discloses a blood pump device and a method for manufacturing the blood pump, comprising the following steps of identifying a subject suffering from: cardiac insufficiency, congestive heart failure, decreased renal blood flow, increased renal vascular resistance, hypertension and renal insufficiency. In response, blood pressure within a renal vein (32) of the subject is reduced by placing a blood pump (150) within the renal vein and activating the impeller to draw blood from the renal vein into a vena cava (26) of the subject. Numerous other applications are also described.)

1. A blood pumping device characterized by: comprises the following steps:

an impeller, comprising:

a impeller frame comprising a proximal portion and a distal portion and at least two helical elongate elements wound from the proximal portion to the distal portion; and

a film of material attached to the at least two helical elongate elements such that the helical elongate elements with the material attached thereto define blades of the impeller,

The film of material is an elastomer shaped to define a hollow central cavity therethrough.

2. A blood pumping apparatus as defined in claim 1, wherein: further comprising an axial support passing through the hollow central cavity and configured to support the impeller.

3. A blood pumping apparatus as defined in claim 1, wherein: the at least two helical elongate elements comprise three helical elongate elements that wind from the proximal portion to the distal portion, and wherein the material is connected to the three helical elongate elements such that each helical elongate element and the material connected thereto define a respective blade of the impeller.

4. A method of manufacturing a blood pump, comprising: comprises the following steps:

an impeller is manufactured by the steps of:

attaching an elastomeric material to a structure defining a plurality of helical elongate elements such that the plurality of helical elongate elements and the material attached thereto define blades of the impeller; and

shaping the material such that the material defines a hollow central cavity therethrough.

5. The method of claim 4, wherein: further comprising: inserting an axial support through the hollow central cavity, the axial support configured to support the impeller.

6. The method of claim 4, wherein: the structure defines three helical elongate elements and attaching the material to the structure includes attaching the material to the three helical elongate elements such that each helical elongate element having the material attached thereto defines a respective blade of the impeller.

7. The method of claim 4, wherein: attaching the material to a structure defining the plurality of helical elongate elements comprises:

immersing at least a portion of the structure in the material while the material is in a liquid state;

drying the material while the material is supported by the plurality of helical elongate elements; and

during drying of the material, the structure is rotated about its longitudinal axis so as to form a thin film of material having a substantially uniform thickness.

8. The method of claim 7, wherein: the material comprises silicone, and wherein drying the material comprises curing the silicone.

9. The method of claim 4, wherein: manufacturing the impeller further includes forming the structure by:

Cutting a tube such that the cut tube defines a structure having a first end portion and a second end portion at a proximal end and a distal end of the structure, the first end portion and the second end portion being interconnected by a plurality of elongate elements; and

causing, at least in part, by axially compressing the structure, the plurality of elongated elements to radially expand and form at least two helical elongated elements.

10. The method of claim 9, wherein: causing the plurality of elongated elements to radially expand and form the plurality of helical elongated elements further comprises: twisting the structure.

11. A blood pump, comprising: comprises the following steps:

a blood seepage prevention sleeve;

at least one support structure configured to connect a first end and a second end of the sleeve to a blood vessel of a subject; and

a pump configured to draw blood from an exterior of the sleeve to a location in fluid communication with an interior of the sleeve.

12. A blood pump as defined in claim 11, wherein: the pump is configured to perform ultrafiltration on the blood.

13. A blood pump as defined in claim 11, wherein: the pumping arrangement is configured to anchor the structure to the vessel by causing the vessel to circumferentially compress at least a portion of the structure.

14. A blood pump as defined in claim 11, wherein:

the structure comprises a stent configured to define a plurality of widened ends thereof, widened relative to a central portion of the stent, and

the sleeve comprises a sleeve connected to the holder,

the sleeve defines a plurality of flared ends thereof coupled to the plurality of widened ends of the support, at least one of the flared ends of the sleeve being configured to act as a valve by at least partially separating the widened end of the support to which it is coupled in response to pressure applied to the flared end of the sleeve.

15. A blood pump as defined in claim 11, wherein:

the support structure includes a spiral support member disposed around the sleeve, and

a distal portion of the blood pump is configured to be guided to fit around the exterior of the sleeve using the helical support.

16. A blood pump as defined in claim 11, wherein:

the support structure comprises a spiral portion of the blood pump disposed around the sleeve and configured to support the sleeve, an

The pump is configured to draw blood from the exterior of the sleeve by drawing blood into the plurality of access holes of the pump defined by the helical portion of the blood pump.

17. A blood pump according to any of claims 11 to 14, wherein:

said sleeve being configured to define a plurality of flared ends thereof and a narrow central portion between said flared ends; and

the structure comprises a scaffold configured to define:

a sleeve-supporting stent configured to define a plurality of widened ends thereof, and a narrowed central portion between said plurality of widened ends which are narrower than said plurality of widened ends of said stent, said sleeve connecting said sleeve-supporting stent of said stent; and

a vessel-wall-support stent is connected to the narrow central portion of the sleeve-support stent and projects radially therefrom.

18. A blood pump as defined in claim 17, wherein: the pump is configured to draw blood from between an exterior of the sleeve and an interior wall of the vessel by being placed between the exterior of the sleeve and the vessel-wall-supporting stent.

19. A blood pump according to any of claims 11 to 16, wherein: the structure is configured to separate blood within a renal vein of the subject into a compartment separate from blood flow within a vena cava of the subject by connecting a downstream end of the sleeve to a wall of the vena cava at a first location downstream of all renal veins of the subject and by connecting an upstream end of the sleeve to a wall of the vena cava at a second location upstream of all renal veins of the subject.

20. A blood pump as defined in claim 19, wherein: the sleeve is configured to connect to the vena cava for less than one week, and the pumping is configured to operate for less than one week.

21. A blood pump as defined in claim 19, wherein: the pumping is configured to reduce blood pressure within a plurality of renal veins of the subject by drawing blood.

22. A blood pump as defined in claim 19, wherein: the pump is configured to draw blood from the compartment to a location within the vena cava.

23. A blood pump as in claim 22, wherein: the pump is configured to draw blood from the compartment to a location within the vena cava upstream of the sleeve.

24. A blood pump as in claim 22, wherein: the pump is configured to draw blood from the compartment to a location within the vena cava downstream of the sleeve.

25. A blood pump according to any of claims 11 to 16, wherein: the sleeve is configured to define an opening through which the pump is insertable.

26. A blood pump as in claim 25, wherein: the opening has a diameter of between 2 mm and 10 mm.

27. A blood pump as in claim 25, wherein: the opening is sized to form a seal around the pump.

28. A blood pump according to any of claims 11 to 16, wherein: also included is a pump-receiving sleeve projecting from the blood-leakage-prevention sleeve, the pump-receiving sleeve configured to receive the pump inserted through the exterior of the blood-leakage-prevention sleeve.

29. A blood pump as in claim 28, wherein: an inner diameter of the pump-receiving sleeve is between 2 mm and 10 mm.

30. A blood pump as in claim 28, wherein: the pump-receiving sleeve is sized to form a seal around the pump.

31. An apparatus, characterized by: comprises the following steps:

a stent configured for placement within a vessel at a placement location of the stent; and

a pump configured to anchor the stent to the vessel at the placement location by causing the vessel to circumferentially compress at least a portion of the stent by applying a suction force within the vessel.

32. The apparatus of claim 31, wherein: the vessel comprises a blood vessel having a predetermined diameter at the placement location, and the stent comprises a stent having a diameter less than the predetermined diameter.

33. An apparatus, characterized by: comprises the following steps:

a stent configured for placement within a blood vessel, the stent configured to define a plurality of widened ends thereof, widened relative to a central portion of the stent; and

a blood-impermeable sleeve connected to the stent,

34. An apparatus, characterized by: comprises the following steps:

a blood seepage prevention sleeve defining a plurality of flared ends thereof and a narrow central portion located between the flared ends; and

a stent configured for placement within a vessel, the stent configured to define:

a sleeve-supporting stent configured to define a plurality of widened ends thereof and a narrowed central portion located between said widened ends which are narrower than said widened ends of said stent, said sleeve connecting said sleeve-supporting stent of said stent; and

a vessel-wall-support stent is connected to the narrow central portion of the sleeve-support stent and projects radially therefrom.

35. The apparatus of claim 34, wherein: also included is a blood pump configured to draw blood from between an exterior of the sleeve and an interior wall of the blood vessel by being placed between the exterior of the sleeve and the vessel-wall-supporting stent.

36. The apparatus of claim 34, wherein: a diameter of the narrow central portion of the sleeve is between 8 mm and 35 mm.

37. The apparatus of claim 34, wherein: a maximum diameter of the flared ends of the sleeve is between 10 mm and 45 mm.

38. The apparatus of claim 34, wherein: a ratio of a maximum diameter of the flared ends of the sleeve to a diameter of the narrow central portion of the sleeve is in the range of 1.1: 1 and 2: 1.

39. The apparatus of claim 34, wherein: a maximum diameter of the vessel-wall-support stent is between 10 mm and 50 mm.

40. The apparatus of any one of claims 34 to 39, wherein: the ratio of a maximum diameter of said wall-support stent to a diameter of said narrow central portion of said sleeve-support stent is in the range of 1.1: 1 and 5: 1.

41. The apparatus of claim 40, wherein: the ratio is greater than 1.5: 1.

42. the apparatus of any one of claims 34 to 39, wherein: a length of the sleeve is greater than 6 millimeters.

43. The apparatus of claim 42, wherein: the length of the sleeve is less than 80 millimeters.

44. The apparatus of claim 42, wherein: a length of each of the plurality of flared ends of the sleeve is greater than 3 millimeters.

45. The apparatus of claim 44, wherein: the length of each of the plurality of flared ends of the sleeve is less than 40 millimeters.

46. The apparatus of claim 42, wherein: a length of the narrow central portion of the sleeve is greater than 3 millimeters.

47. The apparatus of claim 46, wherein: the length of the narrow central portion of the sleeve is less than 70 millimeters.

48. A device for use with a blood vessel of a subject, comprising: the device includes:

an occluding member configured for placement within one of said blood vessels, said occluding member having an occluding condition wherein said occluding member occludes said blood vessel and a non-occluding condition wherein said occluding member does not occlude said blood vessel;

A vascular pump configured to:

drawing blood in a downstream direction from a location in fluid communication with an upstream side of the occlusion; and

drawing blood into a blood vessel of the subject on a downstream side of the occlusion, the drawing of the blood into the blood vessel being performed in a manner to maintain the occlusion in an occluded state thereof.

49. The apparatus of claim 48, wherein: the blood pump is configured to perform ultrafiltration on the blood prior to drawing the blood into a blood vessel of the subject.

50. The apparatus of claim 48, wherein: the occlusion is configured to be placed within the blood vessel for less than one week, and the pump is configured to draw blood into the blood vessel for less than one week.

51. The apparatus of claim 48, wherein: the occlusion is configured to be placed within the blood vessel for more than one week, and the pump is configured to draw blood into the blood vessel for less than one week.

52. The apparatus of any one of claims 48 to 51, wherein: the pumping is arranged to be carried out in the manner in which the drawing of the blood into the blood vessel of the subject maintains the occlusion in the occlusive state thereof by drawing the blood into the blood vessel of the subject, such that the hydrodynamic pressure of the blood drawn into the blood vessel of the subject maintains the occlusion in the occlusive state thereof.

53. The apparatus of claim 52, wherein: the occlusion comprises a valve having a plurality of valve leaflets, and the pump is configured to draw the blood into the blood vessel of the subject such that the hydrodynamic pressure of the blood maintains the occlusion in its occluded state by drawing the blood into the blood vessel of the subject such that the blood drawn into the blood vessel of the subject directly impacts a plurality of downstream sides of the plurality of valve leaflets.

54. The apparatus of claim 53, wherein: the valve is configured such that:

in response to blood pressure on an upstream side of the valve leaflets exceeding pressure on the downstream side of the valve leaflets, blood flows in an antegrade direction between cusps of the valve leaflets and an inner wall of the blood vessel, an

In response to blood pressure on the downstream side of the plurality of valve leaflets exceeding pressure on the upstream side of the plurality of valve leaflets, the valve closes by the plurality of prongs of the plurality of valve leaflets contacting the inner wall of the blood vessel.

55. The apparatus of claim 53, wherein: the pumping is configured to reduce a plurality of blood clots at the plurality of valve leaflets by flushing the plurality of valve leaflets by drawing the blood into a blood vessel of the subject such that the blood drawn into the blood vessel of the subject directly impacts a plurality of downstream sides of the plurality of valve leaflets.

56. The apparatus of claim 53, wherein: the device is used in conjunction with an anticoagulant, and wherein the pump is configured to draw the anticoagulant along with the blood drawn into the blood vessel of the subject such that the anticoagulant directly impacts the valve leaflets.

57. The apparatus of claim 53, wherein: also included is a balloon configured to maintain portions of the valve leaflets in contact with a wall of the blood vessel by being inflated.

58. The apparatus of claim 53, wherein: also included is a slit tube configured for insertion into the blood vessel through portions of the slit tube between the slits that are radially expanded outward and configured to maintain portions of the valve leaflets in contact with a wall of the blood vessel.

59. The apparatus of claim 53, wherein: the blood pump is configured to connect to the valve, the blood pump includes a plurality of output holes at the blood vessel of the subject by drawing the blood, and the plurality of output holes are configured such that when the blood pump is connected to the valve, the plurality of output holes direct the blood toward the plurality of downstream sides of the plurality of valve leaflets.

60. The apparatus of claim 53, wherein: the blood pump is configured to be connected to the valve, the blood pump including a blood pumping conduit defining a radial projection concavely curved therefrom toward a distal end of the conduit, the radial projection configured such that when the blood pump is connected to the valve, the radial projection directs blood drawn into the blood vessel toward the plurality of valve leaflets.

61. The apparatus of claim 53, wherein: the blood pump is configured to connect to the valve, the blood pump includes a plurality of output holes through which the blood is drawn into the blood vessel of the subject, and the plurality of output holes are disposed on the blood pump such that the plurality of holes are adjacent to a plurality of seats of the plurality of valve leaflets when the blood pump is connected to the valve.

62. The apparatus of claim 61, wherein: the plurality of output holes are disposed on the blood pump such that when the blood pump is connected to the valve, the plurality of output holes are adjacently disposed to a location along a plurality of lengths of the plurality of valve leaflets that is midway between the plurality of prongs of the plurality of leaflets and the plurality of bases of the plurality of leaflets.

63. A device for use with a blood vessel of a subject, the device comprising:

a blood pump configured to draw blood in a downstream direction through the blood vessel into the pump; and

a valve comprising a plurality of rigid portions thereof configured to connect the valve to the blood vessel, the valve configured to connect to a distal portion of the blood pump and prevent blood from flowing through the valve in a retrograde direction.

64. The apparatus of claim 63, wherein: the valve also includes a plurality of resilient valve leaflets connected to the plurality of rigid portions of the valve.

65. An apparatus, characterized by: comprises the following steps:

an artificial valve comprising a plurality of resilient valve leaflets and a rigid valve support, the valve leaflets being connected to the valve support such that:

In response to pressure on a first side of the valve leaflets exceeding pressure on a second side of the valve leaflets, the leaflets open by separation of the cusps of the valve leaflets from the rigid support, and

in response to the blood pressure on the second side of the plurality of valve leaflets exceeding the pressure on the first side of the plurality of valve leaflets, the valve closes by the plurality of prongs of the plurality of valve leaflets contacting the rigid scaffold.

66. An apparatus, characterized by: comprises the following steps:

a blood pump, comprising:

a tube;

a first one-way valve and a second one-way valve disposed at the proximal and distal ends of the tube, respectively;

a membrane connected to the interior of the tube to divide the tube into a first compartment in fluid communication with the valves and a second compartment not in fluid communication with the valves; and

a pumping mechanism configured to pump fluid through the tube by increasing and progressively decreasing the size of the first compartment by moving the membrane relative to the tube.

67. The apparatus of claim 66, wherein: the tube includes a support, and a material disposed on the support.

68. The apparatus of claim 66, wherein: the occlusion is configured to be placed within the blood vessel for less than one week.

69. The apparatus of claim 66, wherein: one of the valves is configured to prevent backflow of blood from the tube into the blood vessel, and a second of the valves is configured to prevent backflow of blood from the blood vessel into the tube.

70. The apparatus of any one of claims 66 to 69, wherein: the blood pump is configured to be placed within a renal vein of a subject and to draw blood in a downstream direction from the renal vein to a vena cava of the subject.

71. The apparatus of claim 70, wherein: the blood pump is configured to occlude a return flow of blood from the vena cava to the renal vein.

72. A device for use with a first vein of a subject, the first vein being a branch of a second vein and forming a junction with the second vein, the device comprising: the device includes: a catheter configured to be placed within the first vein, a distal end of the catheter configured to draw blood in a downstream direction through the first vein and into the catheter; and

A stoma-covering umbrella disposed around the outside of the catheter and configured to be placed over the second vein at the confluence, a stoma at the confluence from a location within the second vein being covered by the stoma-covering umbrella such that the umbrella prevents backflow of blood from the second vein to the first vein.

73. The apparatus of claim 72, wherein: by drawing the blood, the catheter is configured to cause the aperture-covering umbrella to become a seal against a wall of the second vein surrounding the aperture.

74. The apparatus of claim 72, wherein: when in an open configuration, the aperture-covering umbrella has a diameter of more than 6 millimeters.

75. The apparatus of any one of claims 72 to 74, wherein: the first vein comprises a renal vein of the subject, and the second vein comprises a vena cava of the subject, and wherein the catheter is configured to draw blood by drawing blood in a downstream direction from the renal vein.

76. The apparatus of claim 75, wherein: covering, from a location within the vena cava, an aperture at a confluence of the renal vein and the vena cava with the aperture-covering umbrella, the aperture-covering umbrella configured to prevent backflow of blood from the vena cava to the renal vein.

77. An apparatus, characterized by: comprises the following steps:

a conduit;

a pumping mechanism configured to draw fluid into a distal end of the catheter; and

an aperture-covering umbrella disposed about said conduit, said umbrella having a diameter of at least 6 millimeters when in an open configuration.

78. The apparatus of claim 77, wherein: said diameter of said aperture-covering umbrella is between 10 mm and 20 mm.

79. The apparatus of claim 77, wherein: said diameter of said aperture-covering umbrella is between 15 mm and 25 mm.

Technical Field

Some applications of the present invention generally relate to medical devices. In particular, some applications of the invention relate to devices or methods relating to the placement of a pump in the kidney of one or more subjects.

Background

It is common for cardiac dysfunction or congestive heart failure to progress to renal insufficiency, which in turn leads to the development or worsening of the symptoms of congestive heart failure. Typically, systolic and/or diastolic cardiac insufficiency causes systemic venous congestion that produces pressure that increases the renal veins and spaces. The increase in pressure is caused by an increase in fluid retention (fluid retention) by the body due to both renal insufficiency and renal neuroendocrine activation, both of which typically develop as a result of the increased renal venous and interstitial pressure. The resulting fluid retention causes the development or worsening of congestive heart failure by overloading a volume of blood at the heart and/or by increasing systemic resistance. Similarly, it is common for renal insufficiency and/or renal neurohormonal activation to progress to cardiac insufficiency and/or congestive heart failure. In cardiac insufficiency and/or congestive heart failure leading to renal dysfunction and/or renal neurohormonal activation, or in renal dysfunction and/or renal neurohormonal activation leading to cardiac dysfunction and/or congestive heart failure, each dysfunction leads to an exacerbation in the other dysfunction, this pathophysiological cycle being called cardiorenal syndrome.

Increasing renal venous pressure has been shown experimentally to result in azotemia, and a decrease in glomerular filtration rate, renal blood flow, urine volume, and sodium excretion. It has also been shown to increase plasma renin and aldosterone, and protein excretion. Venous congestion can also promote anemia by three different routes: a decrease in erythropoietin production in the kidney, blood dilution by fluid retention, and inflammatory reactions lead to a decrease in gastrointestinal iron uptake.

Mechanistically, increasing renal venous pressure may cause intracapsular pressure, and subsequent interstitial peritubular pressure may rise. Increased pressure around the tubules may affect tubular function (reduce sodium excretion) and reduce glomerular filtration by increasing the pressure in Bowman capsule.

In patients with heart failure, increased renal venous pressure can result not only from increased pressure in the central vein (right atrium), but also from intra-abdominal fluid accumulation (ascites) directly exerting pressure on the kidneys. Reducing intra-abdominal pressure in patients with heart failure by removing fluid (e.g., by puncture, and/or ultrafiltration) has been shown to reduce plasma creatinine levels.

Particularly in heart failure patients, increased venous return caused by activation of the "leg muscle pump" during physical activities such as walking may raise systemic venous pressure and may cause return to the renal vein.

Increased venous return from activation such as walking may cause systemic venous pressure, particularly the resulting venous return of the "leg muscle pump" during physical activity in heart failure patients, and may lead to reflux into the renal veins.

Disclosure of Invention

In accordance with certain applications of the present invention, to provide acute treatment for a subject suffering from cardiac insufficiency, congestive heart failure, low renal blood flow, high renal vascular resistance, hypertension and renal insufficiency, a blood pump comprises an impeller placed within a renal vein of a subject and activated to draw blood from the renal vein to a vena cava of the subject. For example, the impeller may be placed in the subject's renal veins for a period of more than one hour (e.g., more than one day), less than one week (e.g., less than four days), and/or between one hour and one week (e.g., between one day and four days).

The pump is generally configured to draw blood in a downstream direction to reduce pressure in the renal veins. Typically, perfusion (perfusion) of the kidney is increased due to a reduction in pressure in the renal veins caused by the draw of the blood in the downstream direction. This, in turn, may result in a pressure rise in the plurality of renal veins relative to the pressure in the plurality of renal veins immediately after the start of the draw due to the increased blood flow into the renal veins. Typically, even after an increase in perfusion of the kidney, the pumping arrangement maintains the pressure in the kidney vein at a lower value compared to the pressure in the kidney vein before the start of the draw.

Typically, the subject's renal vein is protected from damage by the impeller by placing a hood within the renal vein and surrounding the impeller, the hood separating a wall of the renal vein from the impeller. For some applications, the cover and the impeller are coupled to one another by a coupling mechanism, such that the impeller becomes radially compressed in response to the cover becoming radially compressed, such that the cover maintains separation between the wall of the renal vein and the impeller

According to some applications, to provide acute treatment to a subject suffering from cardiac insufficiency, congestive heart failure, low renal blood flow, high renal vascular resistance, hypertension and renal insufficiency, a pump and an occlusion (e.g., a valve) are placed within the renal vein of the subject. For example, the pump and the occlusion may be placed within the subject's renal vein for a period of more than one hour (e.g., more than one day), less than one week (e.g., less than four days), and/or between one hour and one week (e.g., between one day and four days).

The occlusion is configured to occlude the renal vein at an occlusion. The pump is configured to draw blood in a downstream direction from a location upstream of the flow-through occlusion element to a location downstream of the flow-through occlusion element. In doing so, the pump reduces the pressure within the renal vein. The occlusion is configured to protect the renal vein from backflow of blood from the vena cava into the renal vein.

Typically, perfusion of the kidney is increased due to a reduction in pressure in the renal veins caused by the draw of the blood in the downstream direction. This, in turn, may result in a pressure rise in the plurality of renal veins relative to the pressure in the plurality of renal veins immediately after the start of the draw due to the increased blood flow into the renal veins. Typically, the pumping arrangement maintains the pressure in the renal veins at a lower value even after an increase in perfusion of the kidney, compared to the pressure in the renal veins before the start of the pumping.

According to some applications of the present invention, a blood-impervious sleeve is placed within the vena cava of the subject such that a downstream end of the sleeve is connected to the wall of the vena cava at a first location downstream of all of the renal veins of the subject and such that an upstream end of the sleeve is connected to the wall of the vena cava at a second location upstream of all of the renal veins of the subject. Typically, a connecting structure, such as a rigid connecting structure (e.g., a stent), is configured to connect the upstream and downstream ends of the sleeve to the vena cava.

A pump draws blood from a location outside of the sleeve to a location in fluid communication with the interior of the sleeve (e.g., a location within the vena cava upstream or downstream of the sleeve). Thus, the pump draws blood outside the subject's renal veins and into the subject's vena cava. The sleeve prevents backflow of blood from the vena cava to the plurality of renal veins.

There is therefore provided, in accordance with certain applications of the present invention, a method, comprising:

identifying a subject suffering from a disease selected from: cardiac insufficiency, congestive heart failure, decreased renal blood flow, increased renal vascular resistance, hypertension and renal insufficiency; and

in response, blood pressure within a renal vein of the subject is reduced by placing an impeller within the renal vein of the subject and activating the impeller to draw blood from the renal vein into a vena cava of the subject.

For some applications, the step of activating the impeller to draw blood from the renal vein to the vena cava comprises: increasing a rate of blood flow from the renal vein into the vena cava without causing a substantial change in a direction of the blood flow relative to a direction of blood flow from the renal vein into the vena cava when the pump is not activated.

For some applications, the step of activating the impeller to draw blood from the renal vein to the vena cava comprises: activating the impeller to draw blood directly from the renal vein to a portion of the vena cava adjacent to the renal vein.

For some applications, the step of activating the impeller to draw blood from the renal vein to the vena cava comprises: activating the impeller to draw blood from the renal vein into the vena cava without moving blood from a venous system of the subject into a non-venous container.

For some applications, the step of placing the impeller within the renal vein comprises: the subject's renal vein is protected from the impeller by placing the impeller into the renal vein and having a hood surrounding the impeller that separates an inner wall of the renal vein from the impeller.

For some applications, the step of placing the impeller with the hood within the renal vein comprises: positioning the impeller within the renal vein and positioning the shroud around the impeller, the shroud and the impeller engaging one another via an engagement mechanism so that the impeller becomes axially elongated in response to the shroud becoming radially compressed so that the shroud maintains separation between the wall of the renal vein and the impeller.

There is also provided, in accordance with certain embodiments of the present invention, apparatus comprising:

an impeller, comprising:

a impeller frame comprising a proximal portion and a distal portion and a plurality of helical elongate elements wound from the proximal portion to the distal portion; and

a material connecting the plurality of helical elongate elements such that the plurality of helical elongate elements having the material attached thereto define at least one blade of the impeller.

For some applications, the impeller comprises: a biocompatible impeller configured for insertion into a blood vessel of a subject.

For some applications, the plurality of elongated elements comprises: a plurality of helical ribbons.

For some applications, at least one of the helical elongate elements has a variable pitch, the pitch of the at least one of the helical elongate elements varying along a length of the helical elongate element.

For some applications, the impeller is configured to be placed within a blood vessel of a subject and draw blood through the blood vessel by rotation relative to the blood vessel, the device further comprising a radially expandable shroud configured to be disposed between the impeller and an inner wall of the blood vessel and to separate the inner wall of the blood vessel from the impeller.

For some applications, the proximal portion and the distal portion include: a proximal ring and a distal ring.

For some applications, at least one of the proximal portion and the distal portion defines a notch at an edge thereof, the notch configured to facilitate attachment of the material to the plurality of helical elongate elements.

For some applications, the impeller further comprises: a plurality of sutures tied around the plurality of helical elongate elements, the plurality of sutures configured to facilitate attachment of the material to the plurality of helical elongate elements.

For some applications, the plurality of helical elongate elements comprises: three helical elongate elements, wound from the proximal portion to the distal portion.

For some applications, a length of each of the plurality of helical elongate elements, measured along a longitudinal axis of the impeller, is greater than 5 millimeters when the impeller is in its non-limiting configuration. For some applications, the length of each of the plurality of helical elongate elements, measured along a longitudinal axis of the impeller, is less than 14 millimeters when the impeller is in its non-limiting configuration.

For some applications, a span width of the impeller in a direction perpendicular to a longitudinal axis of the impeller is greater than 8 millimeters when the impeller is in its non-limiting configuration. For some applications, the cross-width of the impeller is greater than 10 millimeters. For some applications, the cross-width of the impeller is less than 15 millimeters. For some applications, the cross-width of the impeller is less than 12 millimeters.

For some applications, the plurality of helical elongate elements comprises: two helical elongate elements, wound from said proximal portion to said distal portion.

For some applications, the radius of each of the two helical elongate elements is within 20% of the other. For some applications, the two helical elongate elements each have a radius similar to the other. For some applications, the pitch of each of the two helical elongate elements is within 20% of the other. For some applications, the pitch of each of the two helical elongate elements is similar to the other. For some applications, the longitudinal axes of each of the two helical elongated elements are parallel to each other and to a longitudinal axis of the impeller.

For some applications, the material comprises: a continuous film of material supported by the plurality of helical elongate elements.

For some applications, each of the plurality of helical elongate elements defines more than one-eighth of a winding of a helix. For some applications, each of the plurality of helical elongate elements defines less than one-half of a winding of a helix.

For some applications:

The plurality of helical elongate elements defining a proximal end and a distal end thereof;

the plurality of helical elongate elements configured to support the material between the proximal and distal ends of the plurality of helical elongate elements; and

the impeller does not include any additional support to support the material located between the proximal and distal ends of the plurality of helical elongate elements.

For some applications, the impeller is configured such that rotational motion is imparted from the proximal portion of the impeller to the distal portion of the impeller substantially only through the plurality of helical elongate elements of the impeller.

For certain applications, the impeller is configured to be radially compressible to a smaller diameter by not including any additional support for supporting the material between the proximal and distal ends of the plurality of helical elongated elements than if the impeller included any additional support for supporting the material between the proximal and distal ends of the plurality of helical elongated elements.

For some applications, the impeller is configured to be more flexible by not including any additional support for supporting the material located between the proximal and distal ends of the plurality of helical elongate elements, than if the impeller included any additional support for supporting the material located between the proximal and distal ends of the plurality of helical elongate elements.

For some applications, by not including any additional support for supporting the material between the proximal and distal ends of the plurality of helical elongated elements, the impeller is configured to enable a predetermined amount of force required to axially elongate the impeller to be less than would be required if the impeller included any additional support for supporting the material between the proximal and distal ends of the plurality of helical elongated elements.

According to some applications of the invention there is additionally provided a method comprising the steps of:

an impeller is manufactured by the steps of:

cutting a tube such that the cut tube defines a structure having a first end portion and a second end portion at a proximal end and a distal end of the structure, the first end portion and the second end portion being interconnected by a plurality of elongate elements;

causing the plurality of elongated elements to radially expand and form a plurality of helical elongated elements by axially compressing the structure; and

attaching a material to the plurality of helical elongate elements such that the plurality of helical elongate elements having the material attached thereto define at least one blade of the impeller.

For some applications, the step of cutting the tube comprises: laser cutting the tube.

For some applications, the step of manufacturing the impeller comprises: a biocompatible impeller is fabricated for insertion into a blood vessel of a subject.

For some applications, the step of radially expanding the plurality of elongated elements and forming a plurality of helical elongated elements comprises: providing at least one of said plurality of elongated elements with a variable pitch, said pitch of said at least one of said plurality of elongated elements varying along a length of said helical elongated element.

For some applications, cutting the tube such that the cut tube defines a structure, the step of having a first end portion and a second end portion at a proximal end and a distal end of the structure comprising: the tube is cut such that the cut tube defines a structure having a first loop and a second loop at a proximal end and a distal end of the structure.

For some applications, the step of cutting the tube further comprises: forming a notch in an edge of at least one of the first end portion and the second end portion, the notch configured to facilitate attachment of the material to the plurality of helical elongate elements.

For some applications, the method further comprises: tying a plurality of sutures around the plurality of helical elongate elements, the plurality of sutures configured to facilitate attachment of the material to the plurality of helical elongate elements.

For some applications, the step of cutting the tube comprises: cutting the tube so that the cut tube defines a structure having a first end portion and a second end portion at a proximal end and a distal end of the structure, the first end portion and the second end portion being interconnected by three elongated elements, and wherein the step of causing the plurality of elongated elements to radially expand and form a plurality of helical elongated elements comprises: forming the plurality of elongated elements into three helical elongated elements.

For some applications, the step of cutting the tube comprises: the tube is cut such that the structure has a length measured along a longitudinal axis of the structure of greater than 15 millimeters in the absence of axial compression applied to the structure. For some applications, the step of cutting the tube comprises: the tube is cut such that the length of the structure measured along a longitudinal axis of the structure is less than 25 millimeters in the absence of axial compression applied to the structure. For some applications, the step of cutting the tube comprises: the tube is cut such that each of the plurality of elongated elements has a length measured along a longitudinal axis of the structure that is greater than 14 millimeters in the absence of axial compression applied to the structure. For some applications, trimming the tube comprises: cutting said tube such that said length of each of said plurality of elongated elements measured along a longitudinal axis of said structure is less than 22 millimeters in the absence of axial compression applied to said structure.

For some applications, the step of axially compressing the structure comprises: axially compressing the structure such that the structure defines a length measured along a longitudinal axis of the structure that is greater than 8 millimeters. For some applications, the step of axially compressing the structure comprises: axially compressing the structure such that the structure defines the length measured along the longitudinal axis of the structure to be less than 18 millimeters. For some applications, axially compressing the structure comprises: axially compressing the structure such that each of the plurality of elongated elements defines a length measured along a longitudinal axis of the structure that is greater than 5 millimeters. For some applications, axially compressing the structure comprises: axially compressing the structure such that the length of each of the plurality of elongated elements measured along the longitudinal axis of the structure is less than 14 millimeters.

For some applications, the step of axially compressing the structure comprises: axially compressing the structure such that a cross-width of the structure in a direction perpendicular to a longitudinal axis of the structure is greater than 8 millimeters. For some applications, the step of axially compressing the structure comprises: axially compressing the structure such that the cross-width of the structure is greater than 10 millimeters. For some applications: the step of axially compressing the structure comprises: axially compressing the structure such that the cross-width of the structure is greater than 15 millimeters. For some applications, the step of axially compressing the structure comprises: axially compressing the structure such that the cross-width of the structure is less than 12 millimeters.

For some applications, the step of attaching the material to the plurality of helical elongate elements comprises: impregnating at least a portion of the structure into the material when the material is in its liquid state, and drying the material when the material is supported by the plurality of helical elongate elements. For some applications, the step of drying the material comprises: curing the material.

For some applications, the step of cutting the tube comprises: cutting the tube such that the cut tube defines a structure having a first end portion and a second end portion at a proximal end and a distal end of the structure, the first end portion and the second end portion being interconnected by two elongated elements, and wherein the step of radially expanding the plurality of elongated elements and forming a plurality of helical elongated elements comprises: forming the plurality of elongated elements into two helical elongated elements.

For some applications, the step of drying the material while supported by the plurality of helical elongated elements comprises: forming the material into a continuous film between the plurality of spiral-shaped elongated elements, the continuous film being supported by the plurality of spiral-shaped elongated elements.

For some applications, trimming the tube comprises: cutting the tube such that the cut tube defines a structure having a first end portion and a second end portion at a proximal end and a distal end of the structure, the first end portion and the second end portion being interconnected by two elongated elements, and wherein the step of radially expanding the plurality of elongated elements and forming a plurality of helical elongated elements comprises: forming the plurality of elongated elements into two helical elongated elements.

For some applications, the step of forming the plurality of elongated elements into two helical elongated elements comprises: causing both of two helical elongated elements formed by said plurality of elongated elements to start at said first end portion and end at said second end portion, said plurality of helical elongated elements having a radius similar to the other. For some applications, the step of forming the plurality of elongated elements into two helical elongated elements comprises: causing both of two helical elongated elements formed by said plurality of elongated elements to start at said first end portion and end at said second end portion, the radius of said plurality of helical elongated elements being within 20% of the other.

For some applications, the step of forming the plurality of elongated elements into two helical elongated elements comprises: causing both of two helical elongated elements formed by said plurality of elongated elements to start at said first end portion and end at said second end portion, said plurality of helical elongated elements having a pitch similar to the other. For some applications, the step of forming the plurality of elongated elements into two helical elongated elements comprises: causing both of two helical elongated elements formed by said plurality of elongated elements to start at said first end portion and end at said second end portion, the pitch of said plurality of helical elongated elements being within 20% of the other.

For some applications, the step of forming the plurality of elongated elements into two helical elongated elements comprises: forming the plurality of elongated elements into two helical elongated elements having longitudinal axes parallel to each other and to a longitudinal axis of the impeller.

For some applications, the step of forming the plurality of elongated elements into two helical elongated elements comprises: forming said plurality of elongated elements into two helical elongated elements, each of said helical elongated elements defining more than one eighth of a winding of a helix. For some applications, the step of forming the plurality of elongated elements into two helical elongated elements comprises: forming said plurality of elongated elements into two helical elongated elements, each of said helical elongated elements defining less than one-half of a winding of a helix.

For some applications, the step of cutting the tube comprises: cutting the tube such that the cut tube defines a structure having a first loop and a second loop at a proximal end and a distal end of the structure, and such that the first end and the second end of each of the plurality of elongated elements are disposed at an angle to each other relative to the circumference of the first loop and the second loop, the angle being greater than 50 degrees. For some applications, the step of cutting the tube comprises: the tube is cut such that the first and second ends of each of the plurality of elongated elements are disposed at an angle to each other with respect to the circumference of the first and second rings, the angle being greater than 70 degrees. For some applications, the step of cutting the tube comprises: the tube is cut such that the first and second ends of each of the plurality of elongated elements are disposed at an angle to each other with respect to the circumference of the first and second rings, the angle being greater than 90 degrees.

For some applications, the step of cutting the tube comprises: cutting the tube such that the cut tube defines a structure having a first loop and a second loop at a proximal end and a distal end of the structure, and such that the first end and the second end of each of the plurality of elongated elements are disposed at an angle to each other relative to the circumference of the first loop and the second loop, the angle being less than 180 degrees. For some applications, the step of cutting the tube comprises: the tube is cut such that the first and second ends of each of the plurality of elongated elements are disposed at an angle to each other with respect to the circumference of the first and second rings, the angle being less than 150 degrees. For some applications, the step of cutting the tube comprises: the tube is cut such that the first and second ends of each of the plurality of elongated elements are disposed at an angle to each other with respect to the circumference of the first and second rings, the angle being less than 110 degrees.

For some applications, the step of attaching the material to the plurality of helical elongate elements comprises: connecting the material to the plurality of elongated elements such that the material located between the proximal and distal ends of the plurality of helical elongated elements is supported by the plurality of helical elongated elements without any additional support located between the proximal and distal ends of the plurality of helical elongated elements to support the material.

For some applications, the step of connecting the material to the plurality of helical elongate elements without any additional support between the proximal and distal ends of the plurality of helical elongate elements to support the material comprises: configuring the impeller such that rotational motion is imparted from the proximal end portion of the impeller to the distal end portion of the impeller substantially only through the plurality of helical elongate elements of the impeller.

For some applications, the step of connecting the material to the plurality of helical elongate elements without any additional support between the proximal and distal ends of the plurality of helical elongate elements to support the material comprises: configured, the impeller is radially compressible to a smaller diameter than if the impeller included an additional support for supporting the material between the proximal and distal ends of the plurality of helical elongate elements.

For some applications, the step of connecting the material to the plurality of helical elongate elements without any additional support between the proximal and distal ends of the plurality of helical elongate elements to support the material comprises: configured to be more flexible than if the impeller included an additional support for supporting the material between the proximal and distal ends of the plurality of helical elongated elements.

For some applications, the step of connecting the material to the plurality of helical elongate elements without any additional support between the proximal and distal ends of the plurality of helical elongate elements to support the material comprises: configuring said impeller such that a predetermined amount of force required to axially elongate said impeller is less than would be required if said impeller included an additional support positioned between said proximal and distal ends of said plurality of helical elongated elements for supporting said material.

According to some applications of the present invention, there is also provided an apparatus comprising:

an impeller configured to draw a fluid by rotation in a radially expanded configuration thereof;

A radially expandable shroud disposed about said impeller so as to separate said impeller from an inner surface of said shroud in a radially expanded configuration of said impeller and said shroud; and

an engagement mechanism configured to engage the impeller relative to the shroud, such that the engagement mechanism axially elongates the impeller in response to the shroud becoming radially compressed to maintain the impeller separated from the inner surface of the shroud.

For some applications:

said shroud and said impeller defining an axially elongated configuration thereof, said shroud being configured to receive said impeller within said shroud when in said shroud axially elongated configuration, with said impeller in its axially elongated configuration; and

the cover comprises a plurality of struts, at least some of the struts comprising: portions thereof that undulate at least when the cover is in the radially expanded configuration of the cover;

a degree of co-deflection of the plurality of undulations of the plurality of struts when the cover is in its radially expanded configuration is greater than a degree of co-deflection of the plurality of undulations of the plurality of struts when the cover is in its axially elongated configuration.

For some applications, the engagement mechanism is configured to allow rotation of the impeller while the shroud is maintained in a rotationally fixed position.

For some applications, the engagement mechanism is configured to axially elongate the impeller by imparting longitudinal movement of the impeller caused by longitudinal movement of the shroud in response to the shroud becoming radially compressed.

For some applications, the impeller comprises: a biocompatible impeller configured to be placed within a blood vessel and rotated to draw blood through the blood vessel, and wherein the cover is configured to be disposed between the impeller and an inner wall of the blood vessel and to separate the blood vessel wall from the impeller.

For some applications, the cover comprises: a plurality of struts configured to define a plurality of cells, and wherein the cover is configured to separate the vessel wall from the impeller even if the vessel wall protrudes through a cell of the cover.

For some applications:

said impeller being connected to said shroud such that a longitudinal axis of said impeller is aligned with a longitudinal axis of said shroud; and

the cover defines a central portion thereof having a generally cylindrical shape, an outer surface of the cover at the generally cylindrical portion of the cover being parallel to the longitudinal axis of the cover.

For some applications, the impeller is configured to be placed in a blood vessel and rotated to draw the blood through the blood vessel, and wherein the cover is configured to be disposed between the impeller and an inner wall of the blood vessel and to separate the inner wall of the blood vessel from the impeller.

For some applications, the cover is configured to radially expand within the blood vessel such that the outer surface of the cover at the substantially cylindrical portion of the cover engages the inner wall of the blood vessel, the cover thereby becoming oriented within the blood vessel such that the longitudinal axis of the cover is parallel to a local longitudinal axis of the blood vessel.

According to some applications of the invention, there is additionally provided a method comprising:

placing within a blood vessel of a subject:

an impeller configured in a radially expanded configuration thereof for drawing blood through said blood vessel by rotation; and

a radially expandable shroud disposed about said impeller;

radially expanding said shroud and said impeller within said vessel such that said impeller is separated from an inner wall of said vessel by said shroud;

Said impeller being engaged relative to said shroud so as to be axially elongated in response to said shroud becoming radially compressed to maintain said impeller spaced from said inner wall of said blood vessel; and

a control unit is operated to draw blood through the blood vessel by rotating the impeller.

For some applications, the vessel comprises: a renal vein, and wherein the step of operating the control unit to draw blood through the blood vessel comprises: operating the control unit to draw blood away from a kidney and toward a vena cava of the subject.

For some applications, the method further comprises operating the control unit to:

measuring pressure within the blood vessel of the subject at a first location within the blood vessel upstream of the impeller and at a second location within the blood vessel downstream of the impeller; and

controlling rotation of the impeller in response to the pressure measured at the first and second locations.

For some applications:

the step of placing said cover and said impeller within said vessel comprises: placing said shroud and said impeller within said vessel when said shroud and said impeller are in their axially elongated configuration; and when said shroud is in its axially elongated configuration, said shroud receives said impeller within said shroud while said impeller is in its axially elongated configuration;

The cover comprises a cover defining a plurality of posts, at least some of the posts comprising: portions thereof that undulate at least when the cover is in the radially expanded configuration of the cover; and

the step of radially expanding the cover comprises: radially expanding the cover such that a degree of co-deflection of the plurality of undulations of the plurality of struts becomes greater than a degree of co-deflection of the plurality of undulations of the plurality of struts when the cover is in its axially elongated configuration.

For some applications, the step of operating the control unit to rotate the impeller: including operating the control unit to rotate the impeller while the cover is maintained in a rotationally fixed position.

For some applications, the cover comprises: a plurality of struts configured to define a plurality of cells, and wherein radially expanding the cover comprises: separating the vessel wall from the impeller even though the vessel wall protrudes through a cell of the mask by radially expanding the mask.

For some applications:

the step of placing the impeller and the cover into the vessel comprises: placing said impeller and said shroud in said blood vessel, said impeller coupled to said shroud such that a longitudinal axis of said impeller is aligned with a longitudinal axis of said shroud;

Said cover comprising a cover defining a central portion thereof having a generally cylindrical shape, an outer surface of said cover at said generally cylindrical portion of said cover being parallel to said longitudinal axis of said cover; and

the step of radially expanding the cover within the vessel comprises: radially expanding said cover within said blood vessel such that said outer surface of said cover at said generally cylindrical portion of said cover engages said inner wall of said blood vessel, said cover thereby becoming oriented within said blood vessel such that a longitudinal axis of said cover is parallel to a local longitudinal axis of said blood vessel.

For some applications:

said vessel having a predetermined diameter in the absence of said cover;

the step of radially expanding the cover comprises: widening a portion of the blood vessel such that a diameter of the portion of the blood vessel is greater than the predetermined diameter; and

the step of radially expanding the impeller comprises: radially expanding the impeller such that a cross-width of the impeller is at least as large as the predetermined diameter.

For some applications, the method further comprises: operating the control unit to:

Measuring flow through the blood vessel; and

controlling rotation of the impeller in response to the measured flow.

For some applications, the step of operating the control unit to measure flow through the blood vessel comprises: the control unit is operated to measure blood flow by a heat flow sensor disposed within a housing configured such that a direction of blood flow through the housing is substantially parallel to a local longitudinal axis of the blood vessel.

According to some applications of the present invention, there is also provided an apparatus comprising:

a radially expandable impeller configured to draw a fluid by rotation in a radially expanded configuration thereof;

a radially expandable shroud disposed about said impeller such that in a radially expanded configuration of said impeller and said shroud, said impeller is spaced from an inner surface of said shroud;

the impeller is connected with the cover so that a longitudinal axis of the impeller is aligned with a longitudinal axis of the cover; and

For some applications:

said shroud and said impeller defining an axially elongated configuration thereof, said shroud being configured to receive said impeller within said shroud when said shroud is in its axially elongated configuration, while said shroud is in its axially elongated configuration; and

the cover comprises a plurality of struts, at least some of the struts comprising: portions thereof that undulate at least when the cover is in the radially expanded configuration of the cover,

For some applications:

the impeller defining a proximal ring and a distal ring at a proximal end and a distal end, respectively;

said mask defining a proximal ring and a distal ring at a proximal end and a distal end, respectively;

the impeller is formed by:

said proximal rings of both said impeller and shroud being placed on a first support member so that said proximal rings of both said impeller and shroud are in alignment with each other; and

Said distal rings of both said impeller and said shroud being placed on a second support in such a way that said distal rings of both said impeller and said shroud are aligned with each other;

to connect said shroud such that said longitudinal axis of said impeller is aligned with said longitudinal axis of said shroud.

For some applications, the apparatus further comprises: an engagement mechanism configured to engage the impeller relative to the shroud such that the engagement mechanism axially elongates the impeller in response to the shroud becoming radially compressed, thereby maintaining the impeller spaced from the inner surface of the shroud.

For some applications, the engagement mechanism is configured to allow rotation of the impeller when the cover is maintained in a rotationally fixed position.

For some applications, the engagement mechanism is configured to axially elongate the impeller by imparting longitudinal motion of the impeller caused by longitudinal motion of the shroud in response to the shroud becoming radially compressed.

For some applications, the impeller is a biocompatible impeller configured to be placed within a blood vessel and rotated to draw blood through the blood vessel, and wherein the shroud is configured to be disposed between the impeller and an inner wall of the blood vessel and separate the blood vessel wall from the impeller.

For some applications, the impeller is a biocompatible impeller configured to be placed within a blood vessel and draw blood through the blood vessel by rotation, and wherein the shroud is configured to be disposed between the impeller and an inner wall of the blood vessel, separating the blood vessel wall from the impeller.

According to some applications of the present invention, there is also provided a method comprising:

placing within a blood vessel of a subject:

an impeller configured in a radially expanded configuration to draw blood through the vessel by rotation; and

A radially expandable shroud disposed about said impeller, said impeller coupled to said shroud such that a longitudinal axis of said impeller is aligned with a longitudinal axis of said shroud, and said shroud defining a central portion having a generally cylindrical shape with an outer surface of said shroud at said generally cylindrical portion of said shroud being parallel to said longitudinal axis of said shroud;

radially expanding the mask within the vessel such that:

separating said impeller from an inner wall of said blood vessel by said shroud; and

said outer surface of said cover at said generally cylindrical portion of said cover being attached to said inner wall of said blood vessel, said cover thereby becoming oriented within said blood vessel such that a longitudinal axis of said cover is parallel to a local longitudinal axis of said blood vessel; and

a control unit is operated to draw blood through the blood vessel by rotating the impeller.

For some applications, the method further comprises: operating the control unit to:

Controlling rotation of the impeller in response to the pressure measured at the first and second locations.

For some applications:

said vessel having a predetermined diameter in the absence of said cover;

the step of radially expanding the cover comprises: widening a portion of the blood vessel such that a diameter of the portion of the blood vessel is greater than the predetermined diameter; and

the step of radially expanding the impeller comprises: radially expanding the impeller such that a cross-width of the impeller is at least as large as the predetermined diameter.

For some applications, the method further comprises: operating the control unit to:

measuring flow through the blood vessel; and

controlling rotation of the impeller in response to the measured flow.

For some applications, the step of operating the control unit to measure flow through the blood vessel comprises: operating the control unit to measure blood flow through a heat flow sensor disposed within a housing configured such that blood flow through the housing is in a direction substantially parallel to the local longitudinal axis of the blood vessel.

According to some applications of the present invention, there is also provided an apparatus comprising:

A radially expandable impeller configured to draw a fluid by rotation in a radially expanded configuration thereof; and

a radially expandable shroud disposed about said impeller so as to space said impeller from an inner surface of said shroud in a radially expanded configuration of said impeller and said shroud;

said shroud and said impeller defining an axially elongated configuration thereof, said shroud being configured to receive said impeller within said shroud when said shroud is in its axially elongated configuration while said impeller is in its axially elongated configuration;

the cover comprises a plurality of struts, at least some of the struts comprising: portions thereof that undulate at least when the cover is in the radially expanded configuration of the cover; and

For some applications, for each of the plurality of struts including the plurality of undulating portions, the strut is configured to:

A shortest distance from a first longitudinal end of said strut to a second longitudinal end of said strut when said cover is in its axially elongated configuration; for the

A shortest distance from a first longitudinal end of said strut to a second longitudinal end of said strut when said cover is in its radially expanded configuration;

the ratio of the two is more than 1.05: 1.

for some applications, the ratio is less than 1.4: 1. for some applications, the ratio is greater than 1.15: 1. for some applications, the ratio is greater than 1.2: 1.

for some applications, the apparatus further comprises: an engagement mechanism configured to engage the impeller relative to the shroud, whereby the impeller is axially elongated to maintain the impeller spaced from the inner surface of the shroud in response to the shroud becoming radially compressed.

For some applications, the engagement mechanism is configured to allow rotation of the impeller when the cover is maintained in a rotationally fixed position.

For some applications:

said shroud and said impeller being biocompatible, said shroud and said impeller being configured for insertion between a blood vessel when said impeller is disposed within said shroud and when said shroud and said impeller are in said axially elongated configuration thereof;

the impeller is configured to radially expand within the blood vessel to draw blood through the blood vessel by rotation; and

the shroud is configured to expand radially within the vessel and is disposed between the impeller and an inner wall of the vessel to separate the inner wall of the vessel from the impeller.

For some applications, the plurality of struts of the cover are configured to define a plurality of cells, and wherein the cover is configured to separate the vessel wall from the impeller even if the vessel wall protrudes through a cell of the cover.

For some applications:

the impeller is connected with the cover so that a longitudinal axis of the impeller is aligned with a longitudinal axis of the cover; and

For some applications, the impeller is biocompatible and is configured to be placed within a blood vessel and draw blood through the blood vessel by rotation, and wherein the shroud is configured to be disposed between the impeller and an inner wall of the blood vessel, separating the blood vessel wall from the impeller.

For some applications, the cover is configured to radially expand in the blood vessel such that the outer surface of the cover at the substantially cylindrical portion of the cover engages the inner wall of the blood vessel, the cover thereby becoming oriented inwardly of the blood vessel such that the longitudinal axis of the cover is parallel to a local longitudinal axis of the blood vessel.

According to some applications of the invention, there is additionally provided a method comprising:

placing within a blood vessel of a subject:

an impeller configured to draw blood through the blood vessel by rotation in a radially expanded configuration thereof; and

a radially expandable shroud disposed about said impeller, said shroud defining a plurality of struts, said positioning step being performed by: when said shroud and said impeller are in their axially elongated configurations, and when said shroud is in its axially elongated configuration, housing said impeller within said shroud while said impeller is in its axially elongated configuration;

Radially expanding the shroud and the impeller within the vessel such that the shroud and the impeller are in their radially expanded configuration and the impeller is separated from an inner wall of the vessel by the shroud; and

operating a control unit to draw blood through the blood vessel by rotating the impeller,

the cover comprises a plurality of struts, at least some of the struts comprising: at least portions of said cover that undulate when in said radially expanded configuration of said cover,

For some applications, the method further comprises: operating the control unit to:

Measuring pressure within the blood vessel of the subject at a first location within the blood vessel upstream of the impeller and at a second location within the blood vessel downstream of the impeller; and

controlling rotation of the impeller in response to the pressure measured at the first and second locations.

For some applications:

said vessel having a predetermined diameter in the absence of said cover;

the step of radially expanding the cover comprises: widening a portion of the blood vessel such that a diameter of the portion of the blood vessel is greater than the predetermined diameter; and

the step of radially expanding the impeller comprises: radially expanding the impeller such that a cross-width of the impeller is at least as large as the predetermined diameter.

For some applications, the step of radially expanding the cover comprises: radially expanding the mask such that, for each of the plurality of struts comprising the plurality of undulations:

a shortest distance from a first longitudinal end of said strut to a second longitudinal end of said strut when said cover is in its axially elongated configuration; for the

A shortest distance from a first longitudinal end of said strut to a second longitudinal end of said strut when said cover is in its radially expanded configuration;

The ratio of the two is more than 1.05: 1.

for some applications, the step of radially expanding the cover comprises: radially expanding the mask such that, for each of the plurality of struts including the plurality of undulations, the ratio is less than 1.4: 1. for some applications, the step of radially expanding the cover comprises: radially expanding the cover such that, for each of the plurality of struts including the plurality of undulations, the ratio is greater than 1.15: 1. for some applications, the step of radially expanding the cover comprises: radially expanding the cover such that, for each of the plurality of struts including the plurality of undulations, the ratio is greater than 1.2: 1.

for some applications, the method further comprises: operating the control unit to:

measuring flow through the blood vessel; and

controlling rotation of the impeller in response to the measured flow.

According to some applications of the present invention, there is also provided a method comprising:

placing a radially expandable structure within a blood vessel of a subject, the blood vessel having a predetermined diameter in the absence of the radially expandable structure;

widening a portion of the blood vessel by expanding the radially expandable structure within the portion of the blood vessel to cause a diameter of the portion of the blood vessel to be greater than the predetermined diameter;

placing an impeller within said portion of said blood vessel, said impeller comprising a plurality of impeller blades, a cross-width of said plurality of impeller blades being at least equal to said predetermined diameter; and

a control unit is operated to draw blood through the blood vessel by rotating the impeller relative to the blood vessel.

For some applications, the step of expanding the radially expandable structure comprises: expanding a radially expandable shroud disposed about said impeller to separate said impeller from an inner wall of said vessel via said shroud.

For some applications, the method further comprises: operating the control unit to:

controlling rotation of the impeller in response to the pressure measured at the first and second locations.

For some applications, the method further comprises: operating the control unit to:

measuring flow through the blood vessel; and

controlling rotation of the impeller in response to the measured flow.

For some applications, the step of operating the control unit to measure flow through the blood vessel comprises: operating the control unit to measure blood flow through a thermal flow sensor disposed within a housing configured such that a direction of blood flow through the housing is substantially parallel to the local longitudinal axis of the blood vessel.

For some applications, the step of widening the portion of the blood vessel comprises: widening the portion of the blood vessel by expanding the radially expandable structure within the portion of the blood vessel such that the diameter of the portion of the blood vessel is greater than 105% of the predetermined diameter. For some applications, the step of widening the portion of the blood vessel comprises: widening the portion of the blood vessel by expanding the radially expandable structure within the portion of the blood vessel such that the diameter of the portion of the blood vessel is greater than 115% of the predetermined diameter. For some applications, the portion of the blood vessel is widened by expanding the radially expandable structure within the portion of the blood vessel to cause the diameter of the portion of the blood vessel to be greater than 125% of the predetermined diameter.

There is also provided, in accordance with certain embodiments of the present invention, apparatus comprising:

a blood pump configured to draw blood through a blood vessel of a subject, the blood pump comprising:

an elongated member; and

an impeller disposed at a distal end of the elongate member and configured to draw blood through the blood vessel by rotation;

a heat flow sensor configured to measure the flow of the drawn blood, the heat flow sensor comprising an upstream temperature sensor, a heating element, and a downstream temperature sensor, sequentially disposed along a portion of a length of the elongated element,

the elongated member includes a housing configured to receive the heat flow sensor and configured such that a direction of blood flow through the housing is substantially parallel to a local longitudinal axis of the blood vessel.

For some applications, the housing comprises: a portion of an outer surface of the elongated member configured to define a groove therein, wherein the upstream temperature sensor, the heating element, and the downstream temperature sensor are sequentially disposed along the groove.

For some applications, a ratio of a length of the groove to a width of the groove is greater than 4: 1.

For some applications, the apparatus further comprises: a cover is coupled to the elongated member and positioned to cover the thermal sensor.

For some applications, the housing comprises: a housing disposed on an outer surface of the elongated member, wherein the upstream temperature sensor, the heating element, and the downstream sensor are sequentially disposed along an interior of the housing.

For some applications, the housing comprises: a compressible tube disposed on the outer surface of the elongate member.

For some applications, a ratio of a length of the housing to a width of the housing is greater than 4: 1. for some applications, a ratio of a length of the housing to a height of the housing is greater than 4: 1.

according to some applications of the invention, there is additionally provided a method comprising:

placing a blood pump into a blood vessel of a subject, the blood pump comprising:

an elongated member; and

an impeller disposed at a distal end of the elongate member;

operating a control unit to measure the flow of the drawn blood using a heating element and a heat flow sensor, wherein the heat flow sensor comprises an upstream temperature sensor, a heating element and a downstream temperature sensor disposed sequentially along a portion of a length of the elongated member;

The elongated member comprises a housing configured to receive the heat flow sensor and configured to direct a flow of blood through the housing in a direction substantially parallel to a local longitudinal axis of the blood vessel; and

operating the control unit to draw blood through the blood vessel by rotating the impeller at least partially in response to the measured flow.

According to some applications of the present invention, there is also provided an apparatus comprising:

a pump configured to draw a fluid, the pump comprising:

an elongated member; and

an impeller disposed at a distal end of the elongated member and configured to draw the fluid by rotation;

a heat flow sensor configured to measure a flow rate of the fluid drawn, the heat flow sensor comprising an upstream temperature sensor, a heating element, and a downstream temperature sensor disposed sequentially along a portion of a length of the elongated element,

the elongated member includes a housing configured to receive the heat flow sensor and configured such that a direction of flow of the fluid through the housing is substantially parallel to a local longitudinal axis of the elongated member.

For some applications, the housing comprises: a portion of an outer surface of the elongated member is configured to define a groove therein, wherein the upstream temperature sensor, the heating element, and the downstream sensor are sequentially disposed along the groove.

For some applications, a ratio of a length of the groove to a width of the groove is greater than 4: 1.

for some applications, the apparatus further comprises: a cover is coupled to the elongated member and is configured to cover the thermal sensor.

For some applications, the housing comprises: a housing disposed on an outer surface of the elongated member, wherein the upstream temperature sensor, the heating element, and the downstream temperature sensor are sequentially disposed along an interior of the housing.

For some applications, the housing comprises: a compressible tube disposed on the outer surface of the elongate member.

according to some aspects of the present invention, there is also provided a method for use with a plurality of tributary veins providing a main vein, comprising:

mechanically separating blood in the plurality of veins into a compartment separate from blood flow in the main vein; and

controlling blood flow from the plurality of veins to the main vein by drawing blood from the compartment to the main vein.

For some applications, the method further comprises: performing ultrafiltration on the drawn blood.

For some applications it is desirable to have,

the step of separating the plurality of veins comprises:

placing a blood-impervious sleeve and a helical support member disposed around said sleeve into said main vein, an

Using the helical support to connect the sleeve to a wall of the main vein; and

the step of drawing blood from the compartment to the main vein comprises: using the helical support to guide a distal portion of a blood pump into the compartment and using the blood pump to draw the blood.

For some applications:

the step of separating the plurality of veins comprises:

placing a blood-impermeable sleeve and a spiral portion of a blood pump disposed around said sleeve into said main vein, an

Connecting the sleeve to a wall of the main vein: and

the step of drawing blood from the compartment to the main vein comprises: drawing blood into a plurality of access holes of the blood pump defined by the spiral portion of the blood pump.

For some applications:

the step of separating blood in the plurality of veins into a compartment separate from blood flow in the main vein comprises: separating blood in a plurality of renal veins of the subject into a compartment separate from blood flow in a vena cava of the subject by placing an anti-bleeding sleeve into the vena cava of the subject such that a downstream end of the sleeve is connected to a wall of the vena cava at a first location downstream of the vena cava of the subject and such that an upstream end of the sleeve is connected to the wall of the vena cava at a second location upstream of the vena cava of the subject; and

The step of drawing blood from the compartment to the main vein comprises: a pump is operated to draw blood from the compartment to a location in fluid communication with an interior of the sleeve.

For some applications, the step of drawing blood from the compartment comprises: drawing blood in a downstream direction through the plurality of renal veins.

For some applications, the step of placing the sleeve within the vena cava comprises: placing said sleeve in said vena cava for less than one week, and operating said pump comprises: the pump was operated for less than one week.

For some applications, the method further comprises: identifying the subject as having a disease selected from: a subject in a condition selected from the group consisting of cardiac insufficiency, congestive heart failure, decreased renal blood flow, increased renal vascular resistance, hypertension and renal insufficiency, and operating said pump comprising: in response to identifying the subject as suffering from the condition, reducing blood pressure within a plurality of renal veins of the subject by operating the pump.

For some applications, the step of placing the sleeve within the vena cava of the subject comprises: anchoring the sleeve to the vena cava by circumferentially compressing at least a portion of the sleeve by operating the pump.

For some applications, the step of operating the pump to draw blood from the compartment to the location in fluid communication with an interior of the sleeve comprises: operating the pump to draw blood from the compartment to a location of the vena cava upstream of the sleeve.

For some applications, the step of placing the sleeve into the vena cava comprises: placing within the vena cava:

a stent configured to define widened upstream and downstream ends thereof, widened relative to a central portion of the stent, an

A blood-impervious sleeve connected to said stent, said sleeve defining flared upstream and downstream ends thereof connected to said widened upstream and downstream ends of said stent, respectively; and

connecting the stent to the vessel such that:

in response to the blood pressure being greater on a first side of at least one of the flared ends of the sleeve than on a second side of the at least one flared end of the sleeve, blood flows between an outer side of the at least one flared end of the sleeve and an inner wall of the blood vessel, an

In response to the blood pressure on the first side of the at least one flared end of the sleeve being less than on the second side of the at least one flared end of the sleeve, the at least one flared end of the sleeve occludes blood flow between the outside of the at least one flared end of the sleeve and the inner wall of the blood vessel by contacting the inner wall of the blood vessel.

For some applications, the step of placing the sleeve into the vena cava comprises: placing within the vena cava:

a sleeve configured to define a plurality of flared ends thereof, and a narrow central portion located between the flared ends; and

a stent configured to define:

a sleeve-supporting stent configured to define a plurality of widened ends thereof and a narrowed central portion between said widened ends which is narrower than said widened ends of said stent, said sleeve connecting said sleeve-supporting stent of said stent; and

a vessel-wall-support stent connected to the stenotic central portion of the sleeve-support stent and radially protruding from the sleeve-support stent.

For some applications, the step of drawing blood from the compartment comprises: drawing blood from a location between an outside of the sleeve and an inner wall of the vena cava.

For some applications, the method further comprises: the pump is insertable through an opening in the sleeve to insert the pump into the compartment.

For some applications, the step of inserting the pump through the opening comprises: the pump is inserted through an opening having a diameter between 2 mm and 10 mm.

For some applications, the step of inserting the pump through the opening comprises: the pump is inserted through the opening such that the opening forms a seal around the pump.

For some applications, the method further comprises inserting the pump into the compartment through a pump-receiving sleeve projecting from the sleeve.

For some applications, the step of inserting the pump into the compartment through the pump-receiving sleeve comprises: the pump is inserted into the compartment through a pump-receiving sleeve having a diameter between 2 mm and 10 mm.

For some applications, the step of inserting the pump into the compartment through the pump-receiving sleeve comprises: inserting the pump through the pump-receiving sleeve into the compartment such that the pump-receiving sleeve forms a seal around the pump.

According to some applications of the present invention, there is also provided an apparatus comprising:

a blood seepage prevention sleeve;

at least one support structure configured to connect a first end and a second end of the sleeve to a blood vessel of a subject; and

a pump configured to draw blood from an exterior of the sleeve to a location in fluid communication with an interior of the sleeve.

For some applications, the pump is configured to perform ultrafiltration on the blood.

For some applications, the pumping arrangement is configured to anchor the structure to the vessel by causing the vessel to circumferentially compress at least a portion of the structure.

For some applications it is desirable to have,

the structure comprises a stent configured to define a plurality of widened ends thereof, widened relative to a central portion of the stent, and

the sleeve comprises a sleeve connected to the bracket,

For some applications:

the support structure includes a spiral support member disposed around the sleeve, and

a distal portion of the blood pump is configured to be guided to fit around the exterior of the sleeve using the helical support.

For some applications:

the support structure comprises a spiral portion of the blood pump disposed around the sleeve and configured to support the sleeve, an

The pump is configured to draw blood from the exterior of the sleeve by drawing blood into the plurality of access holes of the pump defined by the helical portion of the blood pump.

For some applications:

said sleeve being configured to define a plurality of flared ends thereof and a narrow central portion between said flared ends;

the structure comprises a scaffold configured to define:

a sleeve-supporting stent configured to define a plurality of widened ends thereof, and a narrowed central portion between said widened ends which are narrower than said widened ends of said stent, said sleeve connecting said sleeve-supporting stent of said stent; and

A vessel-wall-support stent is connected to the narrow central portion of the sleeve-support stent and projects radially therefrom.

For some applications, the pumping arrangement is configured to draw blood from between an exterior of the sleeve and an interior wall of the vessel by being placed between the exterior of the sleeve and the vessel-wall-supporting stent.

For some applications, the structure is configured to separate blood within a renal vein of the subject into a compartment separate from blood flow within a vena cava of the subject, by connecting a downstream end of the sleeve to a wall of the vena cava at a first location downstream of all of the renal veins of the subject, and by connecting an upstream end of the sleeve to a wall of the vena cava at a second location upstream of all of the renal veins of the subject.

For some applications, the sleeve is configured to connect to the vena cava for less than one week, and the pumping is configured to operate for less than one week.

For some applications, the pumping is configured to reduce blood pressure within a plurality of renal veins of the subject by drawing blood.

For some applications, the pump is configured to draw blood from the compartment to a location within the vena cava.

For some applications, the pump is configured to draw blood from the compartment to a location within the vena cava upstream of the sleeve.

For some applications, the pump is configured to draw blood from the compartment to a location within the vena cava downstream of the sleeve.

For some applications, the sleeve is configured to define an opening through which the pump is insertable.

For some applications, the opening has a diameter between 2 mm and 10 mm.

For some applications, the opening is sized to form a seal around the pump.

For some applications, the device further includes a pump-receiving sleeve protruding from the blood-leakage prevention sleeve, the pump-receiving sleeve configured to receive insertion of the pump through the exterior of the blood-leakage prevention sleeve.

For some applications, an inner diameter of the pump-receiving sleeve is between 2 mm and 10 mm.

For some applications, the pump-receiving sleeve is sized to form a seal around the pump.

According to some applications of the invention, there is additionally provided a method comprising:

placing a stent in a blood vessel at a placement location of the stent; and

anchoring the stent at least partially to the vessel at the placement location by causing the vessel to circumferentially compress at least a portion of the stent by applying a suction force within the vessel.

For some applications, the vessel comprises a blood vessel having a predetermined diameter at the placement location, and the step of placing the stent in the blood vessel comprises placing the stent having a diameter less than the predetermined diameter in the blood vessel.

For some applications, the step of circumferentially compressing the vessel against at least a portion of the stent comprises: by over-sizing the stent to reduce the anchoring of the stent to the vessel to a degree relative to if the vessel was not anchored around at least the portion of the stent.

According to some applications of the present invention, there is also provided an apparatus comprising:

a stent configured for placement within a vessel at a placement location of the stent;

For some applications, the vessel comprises a blood vessel having a predetermined diameter at the placement location, and the stent comprises a stent having a diameter less than the predetermined diameter.

According to some applications of the invention, there is additionally provided an apparatus comprising:

a stent configured for placement within a blood vessel, the stent configured to define a plurality of widened ends thereof, widened relative to a central portion of the stent; and

a blood-impermeable sleeve connected to the stent,

According to some applications of the present invention, there is also provided a method comprising:

placing within a blood vessel of a subject:

a stent configured to define widened upstream and downstream ends thereof, widened relative to a central portion of the stent, an

Connecting the stent to the vessel such that:

The at least one flared end of the sleeve occludes blood flow between the outside of the at least one flared end of the sleeve and the inner wall of the blood vessel by contacting the inner wall of the blood vessel in response to the blood pressure being less on the first side of the at least one flared end of the sleeve than on the second side of the at least one flared end of the sleeve.

According to some applications of the invention, there is additionally provided an apparatus comprising:

a blood seepage prevention sleeve defining a plurality of flared ends thereof and a narrow central portion located between the flared ends; and

a stent configured for placement within a vessel, the stent configured to define:

A vessel-wall-support stent is connected to the narrow central portion of the sleeve-support stent and projects radially therefrom.

For some applications, the device further comprises a blood pump configured to draw blood from between an exterior of the sleeve and an interior wall of the blood vessel by being placed between the exterior of the sleeve and the vessel-wall-supporting stent.

For some applications, a diameter of the narrow central portion of the sleeve is between 8 mm and 35 mm.

For some applications, a maximum diameter of the flared ends of the sleeve is between 10 mm and 45 mm.

For some applications, a ratio of a maximum diameter of the flared ends of the sleeve to a diameter of the narrow central portion of the sleeve is in the range of 1.1: 1 and 2: 1.

For some applications, a maximum diameter of the vessel-wall-supporting stent is between 10 mm and 50 mm.

For some applications, a ratio of a maximum diameter of the wall-support stent to a diameter of the narrow central portion of the sleeve-support stent is in the range of 1.1: 1 and 5: 1. For some applications, the ratio is greater than 1.5: 1.

For some applications, a length of the sleeve is greater than 6 millimeters. For some applications, the length of the sleeve is less than 80 millimeters. For some applications, a length of each of the plurality of flared ends of the sleeve is greater than 3 millimeters. For some applications, the length of each of the plurality of flared ends of the sleeve is less than 40 millimeters. For some applications, a length of the narrow central portion of the sleeve is greater than 3 millimeters. For some applications, the length of the narrow central portion of the sleeve is less than 70 millimeters.

According to some applications of the invention, there is additionally provided a method comprising:

placing within a blood vessel of a subject:

a blood seepage prevention sleeve defining a plurality of flared ends thereof and a narrow central portion located between the flared ends; and

a stent configured to define:

a vessel-wall-supporting stent connected to the narrow central portion of the sleeve-supporting stent and radially protruding therefrom; and

Connecting the stent to the vessel by supporting the wall of the vessel such that the vessel-wall-supporting stent of the stent remains open to the vessel, and the sleeve-supporting stent supports the sleeve within the vessel.

For some applications, the method further comprises drawing blood from a location between an outside of the sleeve and an inner wall of the vena cava by placing a pump between the outside of the sleeve and the vessel-wall-supporting stent.

For some applications, the step of placing the sleeve within the vessel comprises: placing said sleeve into said blood vessel, said narrow central portion of said sleeve having a diameter of between 8 mm and 35 mm.

For some applications, the step of placing the sleeve within the vessel comprises: placing said sleeve into said blood vessel, said flared ends of said sleeve having a maximum diameter of between 10 mm and 45 mm.

For some applications, the step of placing the sleeve within the vessel comprises: the step of placing the sleeve into the vessel comprises placing the sleeve into the vessel with a maximum diameter of the flared ends of the sleeve and a diameter of the narrow central portion of the sleeve between 1.1:1 and 2: 1.

For some applications, the step of placing the sleeve within the vessel comprises: placing said sleeve into said vessel, a maximum diameter of said wall-support scaffold and a diameter of said narrow central portion of said sleeve-support scaffold being between 1.1:1 and 5: 1. For some applications, the step of placing the sleeve within the vessel comprises: placing said sleeve into said vessel, said ratio being greater than 1.5: 1.

for some applications, the step of placing the sleeve within the vessel comprises: placing said sleeve into said blood vessel, said sleeve having a length greater than 6 mm. For some applications, the step of placing the sleeve within the vessel comprises: placing said sleeve into said blood vessel, said length of said sleeve being less than 80 millimeters. For some applications, the step of placing the sleeve within the vessel comprises: placing the sleeve into the vessel, a length of each of the plurality of flared ends of the sleeve being greater than 3 millimeters. For some applications, the step of placing the sleeve within the vessel comprises: placing said sleeve into said blood vessel, said length of each of said plurality of flared ends of said sleeve being less than 40 millimeters. For some applications, the step of placing the sleeve within the vessel comprises: placing said sleeve into said blood vessel, said narrow central portion of said sleeve having a length greater than 3 mm. For some applications, the step of placing the sleeve within the vessel comprises: placing said sleeve into said blood vessel, said length of said narrow central portion of said sleeve being less than 70 millimeters.

According to some aspects of the present invention, there is also provided a method of operating a blood pump disposed in a blood vessel of a subject, the method comprising:

placing an occluding member within said blood vessel, said occluding member having an occluding state in which said occluding member occludes said blood vessel and a non-occluding state in which said occluding member does not occlude said blood vessel;

drawing blood in a downstream direction from a location in fluid communication with an upstream side of the occlusion;

drawing blood into a blood vessel of the subject on a downstream side of the occlusion,

the drawing of the blood into the blood vessel of the subject is carried out in a manner that maintains the occlusion in an occlusion state in which the occlusion occludes the blood vessel.

For some applications, the method further comprises performing ultrafiltration on the blood prior to drawing the blood into the location of the blood vessel of the subject.

For some applications, the step of placing the occlusion element within the vessel comprises: placing the occlusion member in the blood vessel for less than one week, and drawing the blood comprises drawing the blood into the blood vessel for less than one week. For some applications, the step of placing the occlusion element within the vessel comprises: placing the occlusion member in the blood vessel for more than one week, and drawing the blood comprises drawing the blood into the blood vessel for less than one week.

For certain applications, the method further comprises identifying the subject as suffering from a disease selected from the group consisting of: a subject in a condition selected from the group consisting of cardiac insufficiency, congestive heart failure, decreased renal blood flow, increased renal vascular resistance, hypertension and renal insufficiency, said blood vessel comprising a renal vein of said subject, and the step of drawing blood in said downstream direction from said location on said upstream side in fluid communication with said occluding member comprises: in response to identifying that the subject is afflicted with the condition, reducing blood pressure within a renal vein of the subject by drawing the blood in the downstream direction.

For some applications, the step of drawing the blood into the blood vessel of the subject to maintain the occlusion in the occluding state thereof comprises: drawing the blood into the blood vessel of the subject such that the hydrodynamic pressure of the blood drawn into the blood vessel of the subject maintains the occlusion in its occluded state.

For some applications, the step of placing the occlusion element within the vessel comprises: the step of placing a valve having a plurality of valve leaflets within the blood vessel and drawing the blood into the blood vessel of the subject such that the hydrodynamic pressure of the blood drawn into the blood vessel of the subject maintains the occluding member in its occluded state comprises: drawing the blood into a blood vessel of the subject such that the blood drawn into the blood vessel of the subject directly impacts a plurality of downstream sides of the plurality of valve leaflets.

For some applications, the step of placing the valve within the vessel comprises: the step of placing the valve in the vessel comprises placing the valve in the vessel such that:

In response to blood pressure on the downstream side of the plurality of valve leaflets exceeding pressure on the upstream side of the plurality of valve leaflets, the valve occludes retrograde blood flow by the plurality of prongs of the plurality of valve leaflets contacting the inner wall of the blood vessel.

For some applications, the step of drawing the blood into the blood vessel of the subject such that the blood drawn into the blood vessel of the subject directly impacts downstream sides of the plurality of valve leaflets includes reducing blood clots at the plurality of valve leaflets by flushing the plurality of valve leaflets.

For some applications, the method further comprises: drawing an anticoagulant (anticoagulant) along with the blood drawn into the subject's blood vessel such that the anticoagulant directly impacts the plurality of valve leaflets.

For some applications, the step of placing the valve within the vessel comprises: maintaining portions of the valve leaflets in contact with a wall of the blood vessel by inflating a balloon.

For some applications, the step of placing the valve within the vessel comprises: maintaining portions of the plurality of valve leaflets in contact with a wall of the blood vessel by radially outwardly expanding portions of a slit tube (slit tube).

For some applications, the step of drawing the blood to impinge the blood directly on downstream sides of the plurality of valve leaflets comprises: drawing the blood into a blood vessel of the subject through a plurality of apertures configured to direct the blood toward the plurality of downstream sides of the plurality of valve leaflets.

For some applications, the step of drawing the blood to impinge the blood directly on downstream sides of the plurality of valve leaflets comprises: drawing the blood into the blood vessel of the subject through a pumping conduit configured to define a radial protrusion concavely curved therefrom toward a distal end of the conduit, the radial protrusion configured to direct blood drawn into the blood vessel toward the plurality of valve leaflets.

For some applications, the step of drawing the blood to impinge the blood directly on downstream sides of the plurality of valve leaflets comprises: drawing the blood into a blood vessel of the subject at a plurality of bases adjacent to the plurality of valve leaflets through a plurality of apertures.

For some applications, the step of drawing the blood to impinge the blood directly on the downstream sides of the plurality of valve leaflets comprises: drawing the blood into the blood vessel of the subject through a plurality of apertures disposed adjacent to a location along a plurality of lengths of the plurality of valve leaflets midway between the plurality of cusps of the plurality of leaflets and the plurality of bases of the plurality of valve leaflets.

According to some aspects of the present invention, there is also provided a device for use with a blood vessel of a subject, the device comprising:

an occluding member configured for placement within one of said blood vessels, said occluding member having an occluding state in which said occluding member occludes said blood vessel and a non-occluding state in which said occluding member does not occlude said blood vessel;

a vascular pump arrangement for:

drawing blood in a downstream direction from a location in fluid communication with an upstream side of the occlusion, an

Drawing blood into a blood vessel of the subject on a downstream side of the occlusion, the pumping being configured to cause the drawing of the blood into the blood vessel to be carried out in a manner that maintains the occlusion in an occluded state thereof.

For some applications, the blood pump is configured to perform ultrafiltration on the blood prior to drawing the blood into a blood vessel of the subject.

For some applications, the occlusion is configured to be placed within the blood vessel for less than one week, and the pumping is configured to draw blood into the blood vessel for less than one week. For some applications, the occlusion is configured to be placed within the blood vessel for more than one week, and the pumping is configured to draw blood into the blood vessel for less than one week.

For some applications, the pumping is configured to be carried out in the manner of maintaining the occlusion in the occlusion state by drawing the blood into a blood vessel of the subject such that the hydrodynamic pressure of the blood drawn into the blood vessel of the subject maintains the occlusion in the occlusion state.

For some applications, the occlusion includes a valve having a plurality of valve leaflets, and the pumping is configured to draw the blood into the subject's blood vessel such that the hydrodynamic pressure of the blood maintains the occlusion in its occluded state by drawing the blood into the subject's blood vessel such that the blood drawn into the subject's blood vessel directly impacts downstream sides of the plurality of valve leaflets.

For some applications, the valve is configured such that:

For some applications, the pumping is configured to reduce a plurality of blood clots at the plurality of valve leaflets by flushing the plurality of valve leaflets by drawing the blood into the blood vessel of the subject such that the blood drawn into the blood vessel of the subject directly impinges a plurality of downstream sides of the plurality of valve leaflets.

For some applications, the device is used in conjunction with an anticoagulant, and the pump is configured to draw the anticoagulant along with the blood drawn into the blood vessel of the subject such that the anticoagulant directly impacts the valve leaflets.

For some applications, the device further comprises a balloon configured to maintain portions of the valve leaflets in contact with a wall of the blood vessel by being inflated.

For some applications, the device further comprises a slit tube configured to be inserted into the blood vessel through portions of the slit tube between the slits that are radially expanded outward and to maintain portions of the valve leaflets in contact with a wall of the blood vessel.

For some applications, the blood pump is configured to connect to the valve, the blood pump includes a plurality of output apertures at the blood vessel of the subject by drawing the blood, and the plurality of output apertures are configured such that when the blood pump is connected to the valve, the plurality of output apertures direct the blood toward the plurality of downstream sides of the plurality of valve leaflets.

For some applications, the blood pump is configured to be connected to the valve, the blood pump including a blood pump conduit defining a radial projection concavely curved therefrom toward a distal end of the conduit, the radial projection configured such that when the blood pump is connected to the valve, the radial projection directs blood drawn into the blood vessel toward the plurality of valve leaflets.

For some applications, the blood pump is configured to connect to the valve, the blood pump includes a plurality of output holes through which the blood is drawn into the blood vessel of the subject, and the plurality of output holes are disposed on the blood pump such that when the blood pump is connected to the valve, the plurality of holes abut the plurality of seats of the plurality of valve leaflets.

For some applications, the plurality of output holes are disposed on the blood pump such that when the blood pump is connected to the valve, the plurality of output holes are adjacently disposed to a location along a plurality of lengths of the plurality of valve leaflets that is midway between the plurality of prongs of the plurality of valve leaflets and the plurality of bases of the plurality of valve leaflets.

According to some aspects of the present invention, there is also provided a device for use with a blood vessel of a subject, the device comprising:

a blood pump configured to draw blood in a downstream direction through the blood vessel into the pump; and

a valve comprises rigid portions thereof configured to connect the valve to the blood vessel, the valve configured to connect to a distal portion of the blood pump and prevent blood from flowing through the valve in a retrograde direction.

For some applications, the valve further comprises a plurality of resilient valve leaflets attached to the plurality of rigid portions of the valve.

According to some applications of the invention, there is additionally provided a method comprising:

providing an artificial valve defining a plurality of valve leaflets; and

placing the valve in a blood vessel such that:

According to some applications of the present invention, there is also provided an apparatus comprising:

an artificial valve comprising a plurality of resilient valve leaflets and a rigid valve support, the valve leaflets being connected to the valve support such that:

in response to pressure on a first side of the valve leaflets exceeding pressure on a second side of the valve leaflets, the leaflets open by separation of the cusps of the valve leaflets from the rigid support, and

According to some applications of the invention there is additionally provided an apparatus comprising:

a blood pump, comprising:

a tube;

the first one-way valve and the second one-way valve are respectively arranged at the near end and the far end of the pipe;

a pumping mechanism configured to pump fluid through the tube by increasing and gradually decreasing the size of the first compartment by moving the membrane relative to the tube.

For some applications, the tube comprises a stent, and a material disposed on the stent.

For some applications, the occlusion is configured to be placed within the blood vessel for less than one week.

For some applications, one of the valves is configured to prevent backflow of blood from the tube into the blood vessel, and a second of the valves is configured to prevent backflow of blood from the blood vessel into the tube.

For some applications, the blood pump is configured to be placed within a renal vein of a subject and to draw blood in a downstream direction from the renal vein to a vena cava of the subject.

For some applications, the blood pump is configured to occlude a return flow of blood from the vena cava to the renal vein.

According to some applications of the invention there is additionally provided a method comprising:

connecting a tube to an inner wall of a blood vessel of a subject,

first and second directional valves disposed at the proximal and distal ends of the tube, respectively, an

A membrane connected to the interior of the tube to divide the tube into a first compartment in fluid communication with the valves and a second compartment not in fluid communication with the valves; and

Operating a pumping mechanism to pump fluid through the tube by increasing and progressively decreasing the size of the first compartment by moving the membrane relative to the tube.

For some applications, the tube comprises a stent and material disposed on a stent, and the step of connecting the tube to the inner wall of the vessel comprises connecting the stent and the material to the inner wall of the vessel.

For some applications, the step of connecting the tube to the inner wall of the blood vessel comprises: connecting the tube to the inner wall of the blood vessel for less than one week.

For some applications, the step of operating the pumping mechanism comprises: operating the pumping mechanism such that one of the plurality of valves prevents backflow of blood from the tube into the blood vessel and a second of the plurality of valves prevents backflow of blood from the blood vessel into the tube.

For some applications, the step of connecting the tube to the inner wall of the blood vessel comprises: connecting the tube to an interior wall of a renal vein of a subject, and operating the pumping mechanism comprises: blood is drawn in a downstream direction from the renal vein to a vena cava of the subject.

For some applications, the step of connecting the tube to the inner wall of the blood vessel comprises: occluding backflow of blood from the vena cava to the renal vein.

For certain applications, the method further comprises identifying the subject as suffering from a disease selected from the group consisting of: a subject in a condition selected from the group consisting of cardiac insufficiency, congestive heart failure, decreased renal blood flow, increased renal vascular resistance, hypertension and renal insufficiency, and operating said pump comprising: in response to identifying the subject as suffering from the condition, reducing blood pressure within the subject's renal vein by operating the pump to draw blood from the renal vein to the vena cava in the downstream direction.

According to some applications of the present invention, there is also provided a method comprising:

operating a pump to draw blood in a downstream direction through a first vein that is a branch of a second vein and forms a confluence with the second vein; and

by covering a small hole at the confluence with a small hole-covering umbrella provided in the second vein, backflow of blood from the second vein to the first vein is avoided.

For some applications, the step of operating the blood pump comprises: performing ultrafiltration on the drawn blood.

For some applications, the small bore covering umbrella comprises: when in an open configuration, an aperture-covering umbrella has a diameter in excess of 6 millimeters, and the step of covering the aperture with the umbrella comprises covering the aperture with the umbrella having a diameter in excess of 6 millimeters.

For some applications, the step of operating the blood pump comprises making the stoma-covering umbrella a seal against a wall of the second vein surrounding the stoma.

For some applications, the first vein comprises a renal vein of the subject, and the second vein comprises a vena cava of the subject, and the step of drawing blood in the downstream direction comprises: blood is drawn from the renal vein in a downstream direction toward the vena cava.

For some applications, the step of avoiding backflow of blood from the second vein to the first vein comprises avoiding backflow of blood from the vena cava to the renal vein.

For some applications, the method further comprises: identifying the subject as having a disease selected from: a subject in a condition selected from the group consisting of cardiac insufficiency, congestive heart failure, decreased renal blood flow, increased renal vascular resistance, hypertension and renal insufficiency, and operating said pump comprising: in response to identifying the subject as suffering from the condition, reducing blood pressure within the subject's renal vein by operating the pump to draw blood from the renal vein to the vena cava in the downstream direction.

According to some aspects of the present invention, there is also provided a device for use with a first vein of a subject, the first vein being a branch of and merging with a second vein, the device comprising:

a catheter configured to be placed within the first vein, a distal end of the catheter configured to draw blood in a downstream direction through the first vein and into the catheter; and

a stoma-covering umbrella disposed around the outside of the catheter and configured to be placed over the second vein at the confluence, a stoma at the confluence from a location within the second vein being covered by the stoma-covering umbrella such that the umbrella prevents backflow of blood from the second vein to the first vein.

For some applications, the catheter is configured to cause the orifice-covering umbrella to be a seal against a wall of the second vein surrounding the orifice by drawing the blood.

For some applications, the aperture-covering umbrella has a diameter of more than 6 millimeters when in an open configuration.

For some applications, the first vein comprises a renal vein of the subject, and the second vein comprises a vena cava of the subject, and the catheter is configured to draw blood by drawing blood from the renal vein in a downstream direction.

For some applications, the aperture at a confluence of the renal vein and the vena cava is covered from a location within the vena cava by the aperture-covering umbrella, which is configured to prevent backflow of blood from the vena cava to the renal vein.

According to some applications of the present invention, there is also provided an apparatus comprising:

a conduit;

a pumping mechanism configured to draw fluid into a distal end of the catheter; and

an aperture-covering umbrella disposed about said conduit, said umbrella having a diameter of at least 6 millimeters when in an open configuration.

For some applications, the diameter of the aperture-covering umbrella is between 10 mm and 20 mm. For some applications, the diameter of the aperture-covering umbrella is between 15 mm and 25 mm.

According to some applications of the present invention, there is additionally provided a method of measuring flow in a blood vessel, comprising:

occluding the vessel with an occlusion member;

drawing blood from an upstream side of the occlusion to a downstream side of the occlusion;

measuring blood pressure on the upstream and downstream sides of the occlusion;

modulating the draw to equalize pressure on the downstream side of the occlusion to pressure on the upstream side of the occlusion;

Measuring a flow rate of blood through the pump when the pressure on the downstream side of the occlusion is equal to the pressure on the upstream side of the occlusion;

assigning the measured flow rate as a baseline flow rate; and

subsequently, a flow rate of blood through the pump relative to the baseline flow rate is measured.

For some applications, the method further comprises, in response to specifying the baseline flow rate, specifying a baseline measurement of the subject's vascular resistance, and then measuring the subject's vascular resistance relative to the baseline vascular resistance.

The invention will be more fully understood from the following detailed description of various embodiments thereof, taken in conjunction with the accompanying drawings, in which:

drawings

FIGS. 1A-B are schematic illustrations of the right heart of a healthy subject during diastole and systole, respectively;

figure 1C shows a set of graphs of central venous flow rate distribution and central venous pressure distribution for a healthy subject relative to the subject's electrocardiogram cycle (ECG cycle);

2A-B are schematic illustrations of the right heart of a subject suffering from congestive heart failure during diastole and systole, respectively;

Figure 2C shows a set of graphs of the subject's central venous flow rate distribution and central venous pressure distribution for congestive heart failure relative to the subject's electrocardiogram cycle (ECG cycle);

figure 3A is a schematic of blood backflow towards the plurality of kidneys of the subject suffering from congestive heart failure;

figure 3B shows a set of graphs of the central venous flow rate profile and renal venous pressure profile of the subject suffering from congestive heart failure, relative to the subject's electrocardiographic cycle;

figure 4A is a schematic illustration of a pump and an obturator placed in the left and right renal veins of a subject suffering from congestive heart failure, in accordance with certain applications of the present invention;

figure 4B is a set of graphs showing the central venous flow rate profile and renal venous pressure profile of the subject suffering from congestive heart failure, after placement of a blood pump within the left and right renal veins of the subject and activation of the blood pump, relative to the electrocardiographic cycle of the subject, according to some applications of the present invention;

FIGS. 5A-D are schematic illustrations of a reversing valve disposed around a blood pumping catheter in accordance with certain implementations of the invention;

FIGS. 6A-G are schematic illustrations of configurations of the blood pumping catheter used with the reversing valve according to some applications of the present invention;

FIGS. 7A-B are schematic illustrations of a blood pumping catheter and a non-reversing valve disposed within the renal vein when the non-reversing valve is in its closed and open states, respectively, in accordance with certain implementations of the invention;

FIGS. 8A-B are schematic illustrations of fields of view of a blood pump according to some applications of the present invention;

FIGS. 9A-D are schematic illustrations of stages of an operating cycle of the blood pump of FIGS. 8A-B, in accordance with certain applications of the present invention;

figures 10A-D are schematic illustrations of a sleeve configured to occlude blood flow from the vena cava of a subject to renal veins of the subject according to some implementations of the invention;

figures 10E-F are schematic illustrations of connecting a sleeve to the vena cava of a subject using a helical support configured to occlude blood flow from the vena cava to renal veins of the subject, according to some applications of the present invention;

figure 10G is a schematic view of a sleeve connected to a spiral-type blood pumping catheter, the sleeve and the blood pumping catheter configured to occlude blood flow from the vena cava of a subject to renal veins of the subject, in accordance with certain applications of the present invention;

Figures 11A-C are schematic illustrations of a blood-pumping catheter placed within a renal vein of a subject such that a small hole-covering umbrella surrounding the exterior of the catheter covers the small hole at the confluence between the subject's vena cava and the renal vein, in accordance with certain applications of the present invention;

FIGS. 12Ai-ii and 12B-E are schematic illustrations of a blood pump including an impeller disposed within a radially expandable cover, in accordance with certain applications of the present invention;

FIGS. 13A-D are schematic illustrations of stages in a method of manufacturing an impeller for a blood pump, in accordance with certain applications of the present invention;

14A-B are schematic illustrations of a plurality of sutures tied around a portion of a stent of an impeller in accordance with certain applications of the present invention;

FIG. 15 is a schematic view of an impeller for use in a blood pump according to some applications of the present invention;

FIGS. 16A-B are schematic illustrations of a three-bladed impeller for a blood pump according to some applications of the present invention;

FIG. 17 is a radially expandable cover for use with an impeller-based blood pump in accordance with certain implementations of the present invention;

18Ai-18Aiii are schematic illustrations of various views and/or configurations of a support of an impeller according to some applications of the present invention;

18Bi-18Biii are views and/or configurations of a support of an impeller according to some applications of the present invention, the impeller support of FIGS. 18Bi-18Biii being configured to define a plurality of blades that extend a greater cross-section than the plurality of blades of the impeller support depicted in FIGS. 18Ai-18 Aiii;

FIG. 18C is a schematic view of a radially expanding covering including struts with undulations thereof, according to certain applications of the present invention;

FIG. 18D is a schematic illustration of side views of radially expanded masks according to some applications of the present invention;

FIGS. 19A-B are schematic illustrations of an impeller shroud configuration to define a generally cylindrical central portion without any force being applied to the shroud in accordance with certain applications of the present invention;

FIG. 20 is a schematic view of an impeller hood configured for placement within a blood vessel such that the diameter of a portion of the blood vessel is more expanded relative to the diameter of the portion of the blood vessel without the impeller hood, in accordance with certain applications of the present invention;

figure 21A is a schematic illustration of impeller-based blood pumps inserted through the femoral vein of a subject into the left and right renal veins of a subject according to some applications of the present invention;

Figure 21B is a schematic illustration of impeller-based blood pumps inserted into the left and right renal veins of a subject through the subclavian vein of the subject, in accordance with certain implementations of the invention;

FIGS. 22Ai-ii, 22Bi-ii, and 22Ci-ii are schematic illustrations of a heat flow sensor and a housing that houses the heat flow sensor in accordance with certain applications of the present invention; and

fig. 23 is a graph showing the results of the experiments performed on a pig using an impeller-based blood pump, according to some applications of the present invention.

Detailed Description

Referring now to fig. 1A-B, there is shown a schematic representation of a healthy subject's heart during diastole and systole, respectively. As shown in figure 1A, during diastole, blood flows from the Right Atrium (RA) 20 of the subject to the Right Ventricle (RV) 22 of the subject. As shown in fig. 1B, during systole, the tricuspid valve 24, which separates the right ventricle from the right atrium, closes as the right atrium draws blood toward the lung of the subject. During contraction of the long axis of the right ventricle, the right atrium fills with blood from the vena cava 26, which expands to draw blood into the right atrium.

Figure 1C shows a set of graphs of the central venous flow rate distribution and central venous pressure distribution for a healthy subject relative to the subject's ecg cycle. The flow rate profile is characterized by a biphasic forward flow (biphasic forward flow) with flow during systole being greater than during diastole. Typically, there is a small amount of reverse flow AR during atrial contraction. The central venous pressure distribution is characterized by a relatively low pressure that exceeds the duration of the cardiac cycle, with the A-wave (e.g., the pressure during atrial systole) generally being greater than the V-wave (V-wave) (e.g., the pressure during systole).

Reference is now made to fig. 2A-B, which are schematic illustrations of the right heart of a subject suffering from congestive heart failure during diastole and systole, respectively. As shown in fig. 2A, blood flows from right atrium 20 to right ventricle 22 of the subject during diastole, as in the healthy heart. As shown in fig. 2B, when the high atrial pressure is delivered to the vena cava, during systole, the subject's right atrium hyperemia is shortened, causing it to increase pressure in the vena cava 26, due to the right atrium pressure being too high. In some cases (e.g., cases of ultrahigh right atrial pressure, tricuspid insufficiency, or atrial fibrillation), there may be retrograde flow of blood from the right atrium into the vena cava 26, and/or multiple branches of the vena cava, as the hyperemia in the right atrium of the subject is shortened.

Figure 2C shows a set of graphs of the central venous flow rate distribution and central venous pressure distribution of the subject suffering from congestive heart failure, relative to the electrocardiographic cycle of the subject. The flow rate profile is characterized by increased retrograde flow AR at the end of diastole, and less anterograde flow during systole than during diastole. For example, there is zero flow in some subjects, or reverse flow during contractions. The central venous pressure profile is characterized by a relatively high pressure exceeding the duration of the heart cycle, with the V-wave being higher relative to the V-wave of a particularly healthy heart and relative to the a-wave of the subject.

Reference is now made to fig. 3A, which is a schematic illustration of blood backflow through left and right renal veins 32 of the subject towards the plurality of kidneys 30 of the subject suffering from congestive heart failure. Figure 3B shows a set of graphs of the central venous flow rate profile and renal venous pressure profile of the subject suffering from congestive heart failure, relative to the electrocardiographic cycle of the subject. It is noted that the graph depicted in fig. 3B is the same as that depicted in fig. 2C, except that the pressure profile depicted in fig. 3B is of the renal veins, while the pressure profile depicted in fig. 2C is of the central venous pressure profile. As shown, the renal vein pressure distribution is equivalent to the central vein pressure distribution substantially when no device is placed within the renal vein (as is practical for some applications according to the present invention), and assuming the renal vein is at the same elevation as the central vein system. The renal venous pressure profile is characterized by a relatively high pressure exceeding the duration of the heart cycle, with the Baud classification being higher relative to a healthy heart.

Reference is now made to fig. 4A, which is a schematic illustration of a blood pump 34 and an occlusion 36 placed in the left and right renal veins 32 of a subject suffering from congestive heart failure, according to some applications of the present invention. To provide acute treatment for a subject suffering from cardiac insufficiency, congestive heart failure, low renal blood flow, high renal vascular resistance, hypertension, and renal insufficiency, the pump and the occlusion are typically placed into renal veins of the subject. For example, the pump and the occlusion may be placed within renal veins of the subject for a period of more than one hour (e.g., more than one day), less than one week (e.g., less than four days), and/or between one hour and one week (e.g., between one and four days). For certain applications, the pump and the occlusion are chronically placed into renal veins of a subject suffering from cardiac insufficiency, congestive heart failure, low renal blood flow, high renal vascular resistance, hypertension, and renal insufficiency in order to provide long-term treatment to the subject. For certain applications, a long-term treatment is administered to a subject for more than weeks, months or years, wherein the pump and the occlusion are placed intermittently in the subject's renal veins, and the subject is treated intermittently according to the techniques described herein. For example, the subject may be treated intermittently at intervals of days, weeks or months.

The occlusion is configured to occlude the renal vein at an occlusion location. The pump is configured to draw blood in a downstream direction from a location upstream of the flow-through occlusion element to a location downstream of the flow-through occlusion element. In doing so, the pump reduces the pressure within the renal vein. The occlusion is configured to protect the renal vein from backflow of blood from the vena cava into the renal vein.

Typically, perfusion of the kidney is increased due to a reduction in pressure in the renal veins caused by the draw of the blood in the downstream direction. This, in turn, may result in a pressure rise in the plurality of renal veins relative to the pressure in the plurality of renal veins immediately after the start of the draw due to the increased blood flow into the renal veins. Typically, the pumping is configured to maintain the pressure in the renal vein at a lower value even after an increase in perfusion of the kidney, as compared to the pressure in the renal vein prior to the start of the pumping. For some applications, the blood pump performs ultrafiltration on the blood of the subject in addition to reducing pressure of the renal veins of the subject, and/or increasing perfusion of the kidney of the subject.

Notably, for certain applications, the pressure reduction within the renal veins due to the draw of the blood in the downstream direction is caused, for example, by Circulation Research (Circulation Research) published in 1956 by Haddy et al, an article titled "Effect of elevation of renal vascular resistance on renal vascular resistance luminal pressure", which is incorporated herein by reference, the subject's renal venous resistance is reduced according to the described physiological mechanisms. It is further noted that increasing renal perfusion by increasing blood pressure in a plurality of renal arteries of the subject does not substantially affect the above-described physiological mechanisms.

Typically, when multiple blood pumps as described herein are used to reduce the pressure in multiple renal veins of the subject, the response by the subject is expected to be improved over administration of a diuretic to the subject due to the reduction in renal vein pressure. Thus, for some applications, a reduced diuretic dose may be administered to the subject relative to a diuretic dose administered to the subject without the techniques described herein. Alternatively, a conventional diuretic dose may be administered to the subject, but the diuretic may have a better effect on the subject due to the reduction in renal venous pressure.

High central venous pressure results in a high degree of blood pressure within the heart which, in turn, causes the subject to release Atrial Natriuretic Peptide (ANP) and B-type natriuretic peptide (BNP), both of which act as natural diuretics. In general, when multiple blood pumps as described herein are used to reduce pressure within multiple renal veins of the subject, the response by the subject is expected to be more improved than the release of the natural diuretic by the subject due to the reduced renal vein pressure. For certain applications, it is expected that the subject will release atrial and type B natriuretic peptides on a sustained basis, since the subject's central venous pressure is not reduced by the plurality of blood pumps described herein, even when the subject's renal venous pressure is reduced by the use of the plurality of blood pumps described herein. Thus, for certain applications, utilization of the plurality of blood pumps described herein may result in sustained release of atrial natriuretic peptide and B-type natriuretic peptide by the subject, and result in the effect of the aforementioned natural diuretic being greater than the effect of the diuretic when the plurality of blood pumps are not used.

For some applications, a pressure and/or flow sensor is disposed at the distal end of the catheter, and the suction pressure applied to the renal veins by the pump is modulated in response to feedback from the pressure and/or flow sensor. For example, a first pressure sensor 35 may be provided on the side of the occlusion near the kidney, and a second pressure sensor 37 may be provided on the side of the occlusion near the vena cava. When the pumping of the pump begins, the flow rate of the pumping is modulated (e.g., automatically modulated, or manually modulated) such that the pressure measured by the first sensor (indicative of the pressure at the renal veins) is the same as the pressure measured by the second sensor (indicative of the central venous pressure). When the pressure measured at the first sensor is the same as that measured at the second sensor, the pump control unit interprets the flow rate of the draw to indicate the native blood flow rate from the subject's renal vein to the subject's vena cava because the renal venous pressure is the same as the central venous pressure before the occlusion is inserted into the renal vein. For some applications, the pump control unit assigns the measured flow rate as a baseline flow rate. Subsequently, when the pump is activated to reduce the pressure at the renal veins relative to the central venous pressure, the pump control unit measures the flow rate of the drawn blood relative to the assigned baseline flow rate.

For some applications, a third sensor (e.g., a non-invasive blood pressure sensor, or an invasive blood pressure sensor) is used to measure arterial blood pressure of the subject. As described above, when the pumping of the pump begins to proceed, the flow rate of the pumping is modulated so that the pressure measured by the first sensor is the same as the pressure measured by the second sensor. When the pressure measured at the first sensor is the same as that measured at the second sensor, the pump controller determines a baseline measure of renal vascular resistance of the subject by measuring the difference between the measured arterial and venous pressures and differentiating the difference by the baseline flow rate. Subsequently, when the pump is activated to reduce the pressure within the renal vein relative to the central venous pressure, the pump control unit measures the current renal vascular resistance relative to the assigned baseline renal vascular resistance (based on the current difference between the measured arterial and venous pressures and the current flow rate).

Figure 4B is a set of graphs showing the central venous flow rate profile and renal venous pressure profile of the subject suffering from congestive heart failure, after placement of the blood pump 32 and occlusion 36 within the left and right renal veins 32 of the subject and activation of the pumps, relative to the electrocardiographic cycle of the subject, in accordance with certain applications of the present invention. The graph of renal venous pressure depicts the original venous pressure distribution in a dashed curve and depicts two curves showing the renal venous pressure after the pumps and occlusions are placed in the veins and the pumps are activated. Generally, the plurality of pumps and the plurality of occlusions are placed within the plurality of veins, and the height of the venous pressure profile after activation of the plurality of pumps is based on the rate of draw applied by the operator to the plurality of renal veins by the plurality of pumps. Thus, two curves show the renal venous pressure after the multiple pumps and the multiple occlusions are placed into the multiple veins and the multiple pumps are activated. As shown, even if the subject's central venous pressure rises, placing the plurality of pumps and the plurality of occlusions within the plurality of veins and activating the plurality of pumps substantially causes a reduction and flattening of the renal venous pressure distribution. For some applications, the renal vein pressure distribution is not completely flat because although the pump provides a certain amount of suction pressure to the plurality of renal veins throughout the duration of the subject's cardiac cycle, small periodic changes in blood pressure are transmitted through the renal capillary system into the plurality of renal veins. Alternatively, the plurality of pumps and the plurality of occlusions are placed within the plurality of veins, and the renal vein pressure profile is flattened upon activation of the plurality of pumps.

Reference is now made to fig. 5A-D, which are schematic illustrations of a reverse valve 40 disposed around a blood pumping conduit 42, in accordance with certain implementations of the present invention. The reverse valve 40 is an example of the occlusion member 36 described above with reference to fig. 4A-B, and the blood pump catheter 42 is an example of the blood pump 34 described above with reference to fig. 4A-B.

The reverse valve 40 generally includes a rigid bracket 44 configured to anchor the reverse valve to the renal vein 32. (in Figs. 5A-B, the reverse valve 40 is shown in the left renal vein, but the scope of the invention includes placing the reverse valve 40 and blood-pumping conduit 42 in the right renal vein, and as is often the case, placing the reverse valve 40 and blood-pumping conduit 42 in each of the subject's renal veins.) the reverse valve 40 may also include a plurality of valve leaflets 46. In response to blood pressure on the upstream side of the valve leaflets exceeding pressure on the downstream side of the valve leaflets, the valve leaflets are configured to open by separating the walls of the blood vessel (and generally by separating the rigid scaffold of the valve) to flow blood in an antegrade direction between cusps of the valve leaflets and an inner wall of the blood vessel. In this sense, the retrograde valve is retrograde with respect to a conventional vascular valve, with the plurality of leaflets configured to open through the plurality of cusps of the plurality of leaflets separated from one another in response to blood pressure on the upstream side of the plurality of valve leaflets exceeding pressure on the downstream side of the plurality of valve leaflets in order to allow blood flow between the plurality of leaflets. Further, a typical vascular valve is disposed within the vessel such that the valve leaflets converge toward one another in the downstream direction, whereas the leaflets 46 of the valve 40 diverge away from one another in the downstream direction, as shown in fig. 5A-B.

Fig. 5A shows the reverse valve in an open state with arrows 48 indicating blood flow in an antegrade direction between the cusps of the valve leaflets and an inner wall of the renal vein 32. Typically, when the retrograde valve 40 and blood pumping conduit 42 are placed in the renal vein and the blood pumping conduit is not activated, the valve leaflets will open to allow blood flow from the renal vein to the vena cava in response to the blood pressure in the renal vein exerting pressure on the upstream side of the valve leaflets 46.

Fig. 5B shows the reverse valve 40 in the closed state. As shown, in the closed state of the valve, the valve occludes blood flow from the renal vein to the vena cava by the plurality of cusps of a plurality of valve leaflets 46 contacting the inner wall of the renal vein at an occlusion location 49. For some applications, the plurality of cusps of the plurality of valve leaflets contact a portion of the rigid scaffold of the valve in the occluded state of the valve. Typically, the valve closes in response to the blood pressure on the downstream side of the plurality of valve leaflets exceeding the pressure on the downstream side of the plurality of valve leaflets. When the catheter blood pump is activated, the pump draws blood in a downstream direction from a location that is in flow communication with the upstream side of the valve and draws blood back into the venous system at a location that is in flow communication with a downstream side of the valve. For example, the catheter blood pump may define a plurality of inlet holes 50 that flow through an upstream side of the valve and are drawn through blood into the pump, and the catheter blood pump may further define a plurality of outlet holes 52 that are disposed to flow through the downstream side of the valve and are drawn through blood into the renal vein or the vena cava. For some applications, the catheter blood pump draws blood using an impeller disposed within a lumen 56 defined by the catheter blood pump, as shown.

For some applications, the blood-pumping conduit 42 is connected to the bracket 44 of the valve 40 prior to inserting the blood-pumping conduit 42 and valve 40 into the body of the subject. The pump is connected to the valve support such that, when placed in the renal vein, a plurality of inlet orifices 50 communicate with an upstream side of a plurality of valve leaflets 46 and a plurality of outlet orifices 52 are provided to communicate with the downstream side of the valve. For some applications, valve 40 and blood-pumping conduit 42 are inserted into the renal veins of the subject, respectively. For example, the valve may be inserted into the renal vein and the blood-pumping catheter may then be inserted through the valve so that the blood-pumping catheter becomes connected to the valve holder 44. Or the blood pumping catheter may be inserted into the renal vein and the valve may then be inserted into the renal vein and beyond the blood catheter. Typically, the blood pump and the valve support define a connection mechanism connecting the blood pump conduit to the valve support such that a plurality of inlet apertures 50 communicate with an upstream side of a plurality of valve leaflets 46 and such that a plurality of outlet apertures 52 are disposed to communicate with the downstream side of the valve.

Typically, the blood pumping conduit 42 is configured to draw blood into the renal vein in a manner that places the reverse valve 40 in an occluded state thereof and/or in a manner that maintains the reverse valve 40 in an occluded state thereof. For example, the blood pumping conduit can be configured to draw blood out of the plurality of output holes 52 in such a way that blood flow outside the plurality of output holes directly impinges the plurality of downstream sides of the plurality of valve leaflets 46 to place and/or maintain the plurality of cusps of the plurality of leaflets in contact with the inner wall of the renal vein. Thus, the hydrodynamic pressure of the blood drawn into the blood vessel of the subject places and/or maintains the cusps of the plurality of leaflets in contact with the inner wall of the renal vein. For some applications, the blood pumping conduit is structurally configured in the foregoing manner to draw blood out of the plurality of output holes, for example, in accordance with the various applications of the present invention described above and with reference to fig. 6B-D. Typically, valve 40 and blood-pumping conduit 42 are configured such that in response to the blood-pumping conduit becoming inactive (e.g., lacking power to the pump), a plurality of valve leaflets 46 will open to allow blood flow from the renal vein to the vena cava in response to applying pressure on the upstream side of the plurality of valve leaflets through blood within the renal vein of the subject.

As described above, for some applications, blood pumping conduit 42 is configured to draw blood out of output holes 52 in such a way that blood flow out of the output holes directly impinges on the downstream sides of valve leaflets 46. For some applications, drawing the blood directly against the downstream sides of the valve leaflets has an anticoagulant effect by flushing the valve leaflets with the blood drawn against the valve leaflets, and reduces the buildup of blood clots and/or tissue growth on the valve leaflets relative to drawing the blood if not directly against the valve leaflets. Alternatively or additionally, the blood pumping conduit draws an anticoagulant directly toward the plurality of leaflets, in conjunction with the blood drawn directly toward the plurality of leaflets. For some applications, a higher dose of the anticoagulant is provided to the leaflets by drawing an anticoagulant directly toward the leaflets than, for example, if the anticoagulant is systemically administered to the subject. Thus, the amount of anticoagulant administered to the subject may be reduced relative to if the anticoagulant is systemically administered to the subject, and/or the anticoagulant may be more effective in reducing tissue growth on multiple blood clots and/or at the multiple valve leaflets relative to if the anticoagulant is systemically administered to the subject. For some applications, the plurality of valve leaflets define a plurality of apertures configured to allow the flow of the anticoagulant therethrough to the plurality of upstream sides of the plurality of valve leaflets.

According to the description of fig. 5A-B, the combination of the reverse valve 40 and the blood-pumping conduit 42 is thus configured to: (a) when the blood pump is not active, the reverse valve opens in response to applying pressure on the upstream sides of the valve leaflets by blood within the renal vein, and (b) when the blood pump is active, the drawing of blood into the renal vein maintains the valve in an occluded state thereof on the downstream side of the valve leaflets 46.

Fig. 5C-D are schematic views of the multiple views of the upstream ends of the reverse valve 40 and blood-pumping catheter 42 when the valve is in its non-occluded and an occluded states, respectively. As shown in fig. 5C, when the valve is in its non-occluded state, the cusps 58 of the plurality of leaflets 46 are separated from the valve stent to allow blood flow between the cusps of the plurality of leaflets and the inner wall of the blood vessel (blood vessel not shown). It is noted that for some applications, the structure of the valve carriage is different than that depicted in fig. 5C-D. For example, the valve stent may have a structure as depicted in fig. 5A-B such that the plurality of cusps of the plurality of leaflets do not directly contact a portion of the valve stent, but contact the inner wall of the blood vessel, even when the valve is in its occluded state.

Reference is now made to fig. 6A-G, which are schematic illustrations of various configurations of the blood-pumping catheter used in conjunction with the reversing valve 40, in accordance with certain implementations of the present invention.

Fig. 6A shows a control unit 60 for controlling the drawing of the blood pumping conduit 42. According to the respective application of the present invention, the plurality of dashed boxes 62 indicate a plurality of positions of the blood pumping motor. For some applications, the blood pump motor is provided at the location indicated by box 62A, outside the subject's body, and in the vicinity of the pump control unit (e.g., within the same housing as the pump control unit). For some applications, the motor disposed outside the subject's body allows the use of a smaller diameter catheter for the blood pumping catheter than would be required if the motor were disposed within the catheter. Alternatively, the blood pumping motor is provided at the location indicated by box 62B such that when the distal end of the blood pumping catheter is provided within the renal vein 32, the motor is provided within the vena cava. For some applications, the motor disposed within the portion of the catheter located within the vena cava allows the distal portion of the catheter placed within the renal vein to be smaller than would be required if the motor were disposed within the distal portion of the catheter. Still alternatively, the blood pump motor is disposed within the distal portion of the catheter placed within the renal vein at the location indicated by box 62C. For some applications, the blood pumping motor is disposed within the vicinity of the impeller 54 (e.g., at the location indicated by box 62C in order to impart more effective rotational motion to the impeller than if the blood pumping motor were disposed at a greater distance from the impeller 54.

Fig. 6B-D are schematic views of blood pumping conduit 42 configured to draw blood out of output holes 52 in a manner that maintains reverse valve 40 in an occluded state thereof.

As shown in fig. 6B, for some applications, the plurality of output apertures are positioned such that they are positioned adjacent to the plurality of seats 64 of the plurality of valve leaflets 46 when the blood pumping conduit and the plurality of inlet apertures 50 are positioned in flow communication with the upstream side of the valve through (or connected to) the valve. For example, the plurality of output holes of the pump can be located adjacent to a location along the length of the plurality of valve leaflets that is located midway between the cusps 58 of the plurality of leaflets and the bases 64 of the plurality of leaflets. Typically, due to the placement of the plurality of outlet apertures relative to the plurality of valve leaflets, blood flowing out of the plurality of outlet apertures flows against the plurality of downstream sides of the plurality of valve leaflets 46, thereby maintaining the plurality of cusps of the plurality of leaflets in contact with the inner wall of the renal vein, e.g., thereby maintaining the valve in an occluded (closed) state.

For some applications, the blood pumping catheter is configured to define a radial projection 66 therefrom that is concave and curves toward a distal end of the catheter, as shown in fig. 6C. The curvature and placement of the projections 66 is typical such that a first end of the projections connected to the catheter is proximally placed to the plurality of output holes 52 and the other end of the radial projections is distally placed to the plurality of output holes. Typically, blood flowing out of the plurality of outlet holes is directed toward the downstream sides of valve leaflets 46 by radial projections 66, thereby maintaining the cusps of the leaflets in contact with the inner wall of the renal vein, e.g., to maintain the valve in an occluded (e.g., closed) state.

For some applications, output holes 52 are configured to direct blood at a remote location and outside the plurality of holes (e.g., toward the upstream end of the catheter pump). For example, as shown in fig. 6D, the surfaces 68 defining the plurality of holes may be curved toward the distal end of the pumping catheter. Thus, the blood flowing out of the output apertures is directed toward downstream sides of valve leaflets 46, thereby maintaining the cusps of the leaflets in contact with the inner wall of the renal vein, e.g., to maintain the valve in an occluded (e.g., closed) state.

Fig. 6E-G illustrate the retrograde valve 40 being supported within the renal vein as an alternative or additional stent 40 (such as shown in fig. 5A-D).

For some applications, the valve 40 is a three-lobed valve. Or the valve may be a two-leaflet valve, or may have more than three leaflets. The plurality of valve leaflets maintain contact with the renal veins at a plurality of commissures of the plurality of valve leaflets. Between the plurality of commissures of the plurality of valve leaflets, the plurality of cusps of the plurality of valve leaflets contact the renal vein wall when the valve is in the occluded state of the valve, and the plurality of cusps of the plurality of valve leaflets separate from the renal vein wall when the valve is in the non-occluded state of the valve to allow blood flow between the plurality of valve leaflets and the renal vein wall.

For some applications, (e.g., as shown in fig. 5A-D), the plurality of valve leaflets are coupled to a valve support 48 at the plurality of commissures of the plurality of valve leaflets, and the valve support maintains the plurality of commissures of the plurality of valve leaflets in contact with the renal vein wall. Alternatively or additionally, as shown in fig. 6E, a slit tube 72 is pushed beyond the blood-pumping catheter 42. The tube is configured such that the portions of the tube located between the plurality of slits expand radially outward when the distal end of the tube is pushed toward the distal end of the catheter. The radially expanded portions of the tube are configured to maintain the plurality of commissures of the plurality of valve leaflets in contact with the renal vein wall.

Alternatively or additionally, a balloon 74 having a star-shaped cross-section (e.g., a three-tipped star-shaped cross-section, as shown) is disposed around the portion of the blood pumping conduit 42 disposed within the valve 40. The various views of the balloon 74, the blood-pumping catheter 42 and the valve 40 are shown in fig. 6F-G. For some applications, the three-dimensional shape of the balloon, when the balloon is in its inflated state, is similar to the shape of a carambola (e.g., a star fruit). Typically, the balloon is inflated such that the balloon at the plurality of points of the star of the balloon cross-section maintains the plurality of commissures of the plurality of valve leaflets in contact with the renal vein wall.

As described herein, typically, the reverse valve 40 and blood pump conduit 42 are used to provide an acute treatment to a subject. For example, the retrograde valve and the blood pumping catheter may be placed within the subject's renal veins for a period of more than one hour (e.g., more than one day), less than one week (e.g., less than four days), and/or between one hour and one week (e.g., between one day and four days). For some applications, after the termination of the treatment, using the suture tube 72 or balloon 74 to maintain the plurality of valve junctions in contact with the renal vein wall facilitates removal of the valves from the renal veins. For example, to remove the valve from the renal vein, the suture tube may be retracted to compress the plurality of radially expanded portions of the tube and the plurality of valve leaflets are no longer maintained in contact with the renal vein wall, and/or balloon 74 may be inflated to cause the plurality of valve leaflets to be no longer maintained in contact with the renal vein wall.

Reference is now made to fig. 7A-B, which are schematic illustrations of a blood pumping catheter 42 and a non-reversing valve 80 in their closed and open states, respectively, according to some applications of the present invention. In some applications, the blood pumping catheter 42 is inserted through a non-reversing valve as an alternative to placement through a reversing valve, as shown in fig. 7A-B. The non-reversing valve 80 is an example of the blocking member 36 described above with reference to fig. 4A-B. Non-reversible valves typically include a rigid frame 82 and valve leaflets 84.

Typically, the blood pumping conduit 42 is used to draw blood in a downstream direction from a location flowing through an upstream side of the valve leaflets 84 to a location flowing through a downstream side of the valve leaflets 84, such as a location within the vena cava or a location within the renal veins. In response to the pressure on the downstream side of the plurality of valve leaflets exceeding the pressure on the upstream side of the plurality of valve leaflets, valve 80 is configured to prevent backflow of blood by the plurality of cusps 86 of the plurality of valve leaflets contacting the conduit. In response to the pressure on the upstream side of the plurality of valve leaflets exceeding the pressure on the downstream side of the plurality of valve leaflets, valve 80 is also configured to separate from the conduit through the plurality of cusps of the plurality of leaflets to allow the blood flow to traverse the valve, allowing blood to flow through the plurality of leaflets and the blood pumping conduit in the direction of arrow 88 (fig. 7A).

For some applications, a combination of a valve (e.g., a reverse valve, as shown in fig. 5A-D and 6A-G, or a non-reverse valve, as shown in fig. 7A-B) and a pump is initially used to treat the subject. Subsequently (e.g., after a period of up to more than one hour, less than one week, and/or between one hour and one week), the pump is removed from the renal vein of the subject, and the valve is left in place within the renal vein. The valve is configured to reduce pressure within the subject's renal vein by avoiding backflow of blood from the subject's renal vein into the subject's renal vein and allowing blood to flow from the subject's renal vein into the subject's renal vein, even without the pump, relative to the renal pressure within the subject's renal vein without the valve. Thus, for some applications, to provide long-term treatment of the subject, the valve is left in the renal vein even after the acute treatment of the subject (using the pump in conjunction with the valve) has terminated.

Reference is now made to fig. 8A-B, which are schematic illustrations of fields of view of a blood pump 90 according to some applications of the present invention. Pump 90 is an example of both occlusion 36 and pump 34 described above with reference to FIGS. 4A-B, since pump 90, when placed within the renal vein of the subject, is configured to both occlude the renal vein and draw blood downstream from a location on an upstream side through which the pump is circulated to a location on a downstream side through which the pump is circulated.

Pump 90 includes an outer tube 92, the outer surface of which is configured to contact the inner wall of the renal vein. Typically, the outer tube 92 comprises a stent having material (typically, a blood-impermeable material) disposed thereon. First and second one-way valves 94 and 96 are provided at respective ends of the tube, the valves allowing blood to flow into and out of the tube only in the downstream direction. A membrane 98 is connected to the interior of the tube such that the membrane separates the tube from a first compartment 100 in which the valves are fluidly connected and a second compartment 102 in which the valves are not fluidly connected. An extraction mechanism 104, such as an electromagnetically driven extraction mechanism, cyclically drives the membrane relative to the tube to cause the relative sizes of the first and second compartments to change.

Reference is now made to fig. 9A-D, which are schematic illustrations of various stages of an operating cycle of the blood pump 90 according to some applications of the present invention. Fig. 9A depicts the blood pump at an arbitrary starting point in the operating cycle of the blood pump, at which point both valve 94 and valve 96 are closed. As shown in the transition period from fig. 9A to 9B and 9B to 9C, the draw mechanism 104 moves the membrane 98 to increase the volume of the first compartment 100, such as by drawing fluid (air or saline) out of the second compartment through the draw mechanism. The increase in the volume of the first chamber reduces the pressure within the first chamber relative to the pressure on the upstream side of the first valve 94, causing valve 94 to open and blood to be drawn into the first chamber. Subsequently, the draw mechanism moves the membrane to increase the volume of the second compartment, for example, by drawing fluid into the second compartment, as shown by the transition periods from fig. 9C to 9D and 9D to 9A. The movement of the membrane causes the volume of the first compartment to decrease and the pressure in the first compartment to increase. The pressure in the first chamber causes valve 94 to close and valve 96 to open and blood flow in the first chamber to the downstream side of pump 90 is achieved.

Reference is now made to fig. 10A-D, which are schematic illustrations of an anti-bleeding sleeve 110 configured to occlude blood flow from the vena cava 26 of a subject to renal veins 32 of the subject, in accordance with some implementations of the invention. Typically, the sleeve is placed within the vena cava such that a downstream end 112 of the sleeve is attached to the wall of the vena cava at a first location 114 downstream of all renal veins of the subject (e.g., left and right renal veins in a typical subject having two renal veins), and such that an upstream end 116 of the sleeve is attached to a wall of the vena cava at a second location 118 upstream of all renal veins of the subject. Thus, the sleeve isolates the blood in the plurality of renal veins from entering a compartment that separates blood flow through the vena cava. Typically, a rigid structure, such as a stent 120 as shown, is configured to connect the upstream and downstream ends of the sleeve to the vena cava.

A pump 122 is configured to draw blood from a location external to the cartridge 110 (e.g., from the partitioned compartment) to a location in fluid communication with the interior of the cartridge (e.g., a location within the vena cava upstream or downstream of the cartridge). Thus, the pump draws blood outside of the subject's renal veins and into the subject's vena cava. The sleeve prevents backflow of blood from the vena cava into the plurality of renal veins.

For some applications, as shown, the bracket 120 defines a plurality of flared ends thereof. The sleeve 110 also defines a plurality of flared ends thereof. The flared ends of the sleeve are configured to occlude blood flow from the vena cava to the renal veins by contacting the wall of the vena cava if the pressure at the vena cava is greater than or the same as the pressure within the renal veins. For some applications, at least one of the flared ends of the sleeve is configured to act as a valve, such as by providing blood flow from outside the sleeve to the vena cava, to relieve pressure and/or a blood spill outside the sleeve. In response to blood pressure within the plurality of renal veins exceeding blood pressure within the vena cava, the flared end of the sleeve is configured to at least partially separate from the wall of the vena cava to allow the blood to flow between the outer face of the flared end of the sleeve and the inner wall of the vena cava. For some applications, the upstream and downstream ends of the sleeve are configured to act as a valve in a manner similar to that described above. Fig. 10A depicts the sleeve closing the upstream and downstream ends of the sleeve to occlude the flow of blood between the outside of the sleeve and the wall of the vena cava. Fig. 10B shows the sleeve open at the upstream and downstream ends of the sleeve to allow the blood flow from the plurality of renal veins to the vena cava, and between the exterior of the sleeve and the wall of the vena cava.

As shown in fig. 10A-B and 10D, for some applications, a pump containment sleeve 124 protrudes from the exterior of one of the flared ends of the sleeve 110 (e.g., the downstream flared end of the sleeve 110, as shown). The pump receiving sleeve is configured to facilitate insertion of the pump 122 therethrough. The pump containment sleeve is configured to form a seal around the pump so that there is minimal or zero blood flow between the exterior of the pump and the interior of the pump containment sleeve. For some applications (not shown), a seal around the outer portion of the pump is formed without the use of a pump-receiving sleeve, the flared end of the sleeve defining an opening (e.g., a hole) through which the pump is inserted, the opening being sized so that the interface between the outer portion of the pump and the flared distal end of the sleeve is sealed.

It is noted that although the pump receiving sleeve is shown as protruding from the outer portion of the flared upstream end of the sleeve, for some applications the pump is inserted through the downstream flared end of the sleeve, and the downstream flared end of the sleeve defines a pump receiving sleeve, or a bore through which the pump is inserted. In general, the scope of the invention includes inserting the plurality of blood pumps and the plurality of occlusions described herein towards the plurality of renal veins, from above the plurality of renal veins or from below the plurality of renal veins, via the plurality of renal veins through the vena cava. For example, the plurality of renal veins may be contacted by way of the vena cava in the upstream direction through the femoral vein or in the downstream direction through the jugular vein.

Depending on the application, pump 122 draws blood into the vena cava at a location upstream or downstream of the sleeve. For some applications, the pump draws the blood into the vena cava at a location downstream of the sleeve to reduce the flow of blood through the sleeve relative to if the pump draws the blood into the vena cava at a location upstream of the sleeve. For some applications, it is advantageous to reduce the blood flow through the sleeve in the manner previously described, as the sleeve acts as a resistor to blood flow through the sleeve. As described above, and as shown, for example, in fig. 10D, for some applications, when a lead 126 is provided at a location where the pump draws blood into the vena cava at a location upstream of the sleeve.

For some applications, the sleeve 110 and stent 120 are inserted into the vena cava of the subject while a guide wire 126 is disposed within the pump-receiving sleeve 124. After the anchoring sleeve 110 and stent 120 are advanced into the vena cava, the pump 122 is inserted through the pump receiving sleeve by positioning the pump outside of the guide wire.

As shown in fig. 10C, for some applications, the stent 120 is configured to define a sleeve-support stent 128 that is generally configured to conform to the shape of the sleeve. Typically, the sleeve support stent is configured to define a plurality of widened ends 130 and a narrow central portion 132 elongated between the widened ends 130, the flared ends being elongated from the ends of the narrow central portion. Further, the stent defines a vessel-wall-support stent 134 which is connected to the stenotic central portion of the sleeve-support stent and which protrudes radially outward from the sides of the stenotic central portion of the sleeve-support stent.

For some applications, drawing blood from outside the sleeve by pump 122 causes the walls of the vena cava to be drawn inward. The vessel-wall-support stent 134 supports the inner wall of the vena cava and prevents the inner wall of the vena cava from collapsing around the stenotic central portion 132 of the stent's sleeve-support stent 128. Typically, during operation of the pump, the pump head, including the plurality of holes 125 of the pump head, is disposed within the gap between the narrow central portion of the sleeve-supporting stent of the stent (which supports the sleeve) and the vessel-wall-supporting stent (which supports the wall of the vena cava).

As noted above, for some applications, blood draw from the exterior of the sleeve by pump 122 causes the walls of the vena cava to be forced by being drawn inward. For some applications, the pumping is configured to anchor stent 120 to the vena cava by forcing the vena cava around at least a portion of the stent by applying a suction to the vena cava. For some applications, as the suction force through the pump is applied to the vena cava, compression by the vena cava around at least a portion of the stent, a stent that is not substantially oversized relative to the vena cava, and/or a stent having a diameter smaller than the vena cava is anchored to the vena cava.

As noted above, typically, the sleeve-support bracket 128 is configured to generally conform to the shape of the sleeve. The sleeve and the sleeve-support stent define a narrow central portion diameter D1 (fig. 10C), and a maximum diameter D2 at the ends of the flared ends of the sleeve. For some applications, D1 is greater than 8 millimeters, less than 35 millimeters, and/or between 8 and 35 millimeters.

For some applications, D2 is greater than 10 millimeters, less than 45 millimeters, and/or between 10 and 45 millimeters. For some applications, D2: the ratio of D1 is greater than 1.1: 1. less than 2: 1. and/or a ratio of 1.1: 1 and 2: 1. For some applications, an overall length L1 of the sleeve is greater than 6 millimeters, less than 80 millimeters, and/or between 6 and 80 millimeters. For some applications, a length L2 of the flared ends of the sleeve (e.g., from a location where the sleeve begins to form a horn up to the length of the end of the sleeve) is greater than 3 millimeters, less than 40 millimeters, and/or between 3 and 40 millimeters. For some applications, a length L3 of the narrow central portion of the sleeve and the sleeve-support bracket is greater than 3 millimeters, less than 70 millimeters, and/or between 3 and 70 millimeters.

For some applications, a maximum diameter D3 of the vessel-wall-supporting stent 134 of the stent 120 is greater than 10 mm, less than 50 mm, and/or between 10 and 50 mm. For some applications, D3: a ratio of D1 greater than 1.1: 1 (e.g., greater than 1.5: 1, or greater than 2: 1), less than 5: 1. and/or a ratio of 1.1: 1 and 5: 1.

For some applications, an inner diameter D4 (fig. 10A) of pump-receiving sleeve 124 is greater than 2 mm, less than 10 mm, and/or between 2 and 10 mm. For applications in which the sleeve 110 defines an opening through which the pump 122 is inserted, the diameter of the opening through which the pump 122 is inserted is typically greater than 2 mm, less than 10 mm, and/or between 2 and 10 mm.

For some applications, pump 122 is substantially similar to catheter blood pump 42 described above, for example, with reference to fig. 5A-D. For example, as shown in fig. 10D, the blood pump may include an impeller 123 to draw blood. Blood is drawn from the renal veins into the catheter through access holes 125, which are provided between the exterior of the sleeve and the wall of the vena cava, and drawn into the vena cava through output holes 127 provided in the vena cava, for example at a location upstream of the sleeve, as illustrated in fig. 10D.

Reference is now made to fig. 10E-F, which are schematic illustrations of connecting an anti-bleeding sleeve 135 to the vena cava 26 using a helical support configured to occlude blood flow from the vena cava of the subject to renal veins 32 of the subject, in accordance with certain applications of the present invention. Depending on the application, the helical support member may be an inflatable helical support member (e.g., a helical balloon), or a helical support member made of a shape memory alloy, such as nitinol (nitinol). Typically, the spiral support is made to connect to the vena cava such that a downstream end of the spiral support connects to the wall of the vena cava at a first location 114 downstream of all renal veins of the subject (e.g., left and right renal veins in a typical subject having two renal veins), and such that an upstream end of the spiral support connects to a wall of the vena cava at a second location 118 upstream of all renal veins of the subject. Thus, the spiral-type support member separates the blood within the plurality of renal veins into a compartment outside of the sleeve that separates blood flow through the vena cava. It is worth mentioning that the sleeve 135 need not have a plurality of flared ends configured to occlude blood flow from the vena cava to the renal veins by contacting the wall of the vena cava. Conversely, as shown, the helical support may occlude the blood flow from the vena cava to the plurality of renal veins by contacting the wall of the vena cava. Alternatively, the sleeve 135 has a substantially identically shaped sleeve 110 as described above with reference to fig. 10A-D, defining a plurality of flared ends configured to contact the wall of the vena cava.

Typically, a blood pumping catheter 137 is inserted into the vena cava through a delivery device 138 (fig. 10F). As shown by the transition from fig. 10E to fig. 10F, for some applications, the blood-pumping catheter is guided into the compartment outside the sleeve by being pushed beyond the helical support. For some applications, a distal portion of the blood pumping catheter is configured to assume a helical shape automatically when pushed out of the delivery device. Alternatively, the distal portion of the blood pumping catheter is treated as assuming a helical shape by being pushed out of the helical support. Typically, the blood pumping catheter defines a plurality of access holes 139 along a majority (e.g., more than 50 percent, or more than 75 percent of the length) of the length of the distal portion of the blood pumping catheter (e.g., the portion of the blood pumping catheter that is placed within the compartment outside of the sleeve by being pushed beyond the helical support). The blood pumping catheter draws blood outside of the compartment outside of the sleeve (e.g., outside of the plurality of renal veins) into the plurality of access holes. The blood pump typically defines a plurality of output holes (not shown) configured to be disposed within the vena cava flowing through the interior of the sleeve (e.g., at a location of the vena cava upstream of the sleeve, or at a location of the vena cava downstream of the sleeve). The pump draws blood through the plurality of output holes into the vena cava.

Reference is now made to fig. 10G, which is a schematic illustration of an anti-bleeding sleeve 141 connected to a spiral blood pumping conduit 143, the sleeve and the blood pumping conduit configured to occlude blood flow from the vena cava 26 of the subject to the renal veins 32 of the subject, in accordance with some applications of the present invention. The sleeve 141 is typically configured to define a plurality of flared ends 145 thereof, as shown. Typically, sleeve 141 has a shape substantially similar to sleeve 110 described above with reference to FIGS. 10A-D, which defines a plurality of flared ends configured to contact the wall of the vena cava.

The hub 141 and blood pump catheter 143 are inserted into the vena cava via a delivery device 149. A distal end of the catheter 143 (e.g., from an insertion location through the end of the catheter inserted furthest into the subject's body) is connected to a distal end of the sleeve (e.g., a downstream end of the sleeve, as shown) at a connection location 147. The blood pumping catheter is pre-configured such that when pushed outside the distal end of the insertion device, a distal portion of the catheter assumes a helical shape disposed around the exterior of the sleeve. Typically, by assuming the helical shape, the distal portion of the catheter is axially held open to the sleeve (e.g., to avoid axial collapse of the sleeve). For some applications, a ring 151 of a shape memory alloy material (e.g., nitinol) is coupled to the proximal end of the sleeve and configured to support the proximal end of the sleeve. Typically, the blood pumping catheter defines a plurality of access holes 153 along a majority (e.g., more than 50 percent, or more than 75 percent) of the length of the distal portion of the blood pumping catheter (e.g., the helical portion of the blood pumping catheter disposed around the sleeve). The blood pumping catheter draws blood from outside the sleeve (e.g., outside the plurality of renal veins) into the plurality of access holes. Typically, the sleeve is placed within the vena cava such that a downstream end of the sleeve is connected to the wall of the vena cava at a first location 114 downstream of all renal veins of the subject (e.g., left and right kidneys in a typical subject having two renal veins), and such that an upstream end of the sleeve is connected to the wall of the vena cava at a second location 118 upstream of all renal veins of the subject. Also typically, the drawing of the blood into the plurality of access ports compresses the vena cava around the exterior of the sleeve to isolate blood within the renal veins into a compartment outside of the sleeve separated from blood flow by the vena cava.

The blood pump typically defines a plurality of output holes (not shown) configured to be disposed within the vena cava flowing through the interior of the sleeve (e.g., at a location of the vena cava upstream of the sleeve, or at a location of the vena cava downstream of the sleeve). The pump draws blood through the plurality of output holes into the vena cava.

It is noted that although in fig. 10E-G the blood pump is shown inserted from the upstream end of the sleeve to the outside of the sleeve, for some applications the blood pump is inserted from the downstream end of the sleeve to the outside of the sleeve. Generally, the scope of the present invention includes inserting the plurality of blood pumps and the plurality of occlusions described herein toward the plurality of renal veins, from above the plurality of renal veins or from below the plurality of renal veins, via the plurality of renal veins through the vena cava. For example, the plurality of renal veins may be contacted by way of the vena cava through the upstream direction from the femoral vein or through the downstream direction from the jugular vein.

Reference is now made to fig. 11A-C, which are schematic illustrations of a blood-pumping catheter 42 according to some applications of the present invention placed within a renal vein 32 of a subject such that a small hole-covering umbrella 140 disposed around the exterior of the catheter covers a small hole at a junction 142 between the vena cava 25 of the subject and the renal vein 32. It is noted that while the aperture-covering umbrella is described as an "umbrella," the scope of the present invention includes covering the apertures with any aperture-covering member configured to surround the exterior of the catheter and made of a plurality of elastic portions (e.g., a plurality of elastic tissue portions), and providing shape and structure to the plurality of rigid supports of the aperture-covering member. The orifice-covering umbrella 140 is an example of the obturator 36 described above with reference to fig. 4A-B, and the blood pump catheter 42 is an example of the blood pump 34 described above with reference to fig. 4A-B. (in FIGS. 11A-C, a stoma-covering umbrella 140 is shown covering the left renal vein stoma, but the scope of the invention includes covering the right renal vein stoma with a stoma-covering umbrella 140, and, as a typical case, placing a stoma-covering umbrella at the opening of the plurality of junctions of the vena cava and each of the left and right renal veins.)

As shown in fig. 11A-C, the blood pumping catheter 42 and the puncture-covering umbrella 140 are inserted into the vena cava 26 through an insertion device 144. During the insertion, the aperture-covering umbrella is typically in its closed state. The blood pumping catheter and the small hole-covering umbrella are pushed outside the insertion device, the small hole-covering umbrella opening in response to being pushed outside the distal end of the insertion device (fig. 11B). The orifice-covering umbrella is placed in the vicinity of the confluence 142. A blood pumping catheter is activated to draw blood through the renal vein into downstream of a plurality of access holes 50 at the distal end of the blood pumping catheter. Typically, the orifice-covering umbrella is pulled against the wall of the vena cava surrounding the orifice at confluence 142 due to the suction of the blood pump (fig. 11C).

Typically, the ostium-covering umbrella 140 occludes backflow of blood from the vena cava to the renal vein by being pushed against the wall of the vena cava surrounding the ostium at confluence 142. Also typically, when the blood pump is activated, the ostial-covering umbrella, through which the blood flow is occluded from the walls of the vena cava surrounding the ostial at confluence 142, occludes the blood flow both from the renal vein to the vena cava and from the vena cava to the renal vein due to the suction created by the blood pump. In response to pump 42 becoming inactive (e.g., due to a loss of power from the pump), umbrella allows blood to flow from the renal veins to the vena cava in the direction of arrows 146 (fig. 11B) surrounding the ostia at confluence, because when the pump is inactive, the umbrella is not occluded from the walls of the vena cava surrounding the ostia at confluence 142.

For some applications, a diameter D5 of the aperture-covering umbrella 140 is greater than 5 millimeters (e.g., greater than 10 millimeters, or greater than 20 millimeters), less than 30 (e.g., less than 25 millimeters, or less than 20 millimeters), and/or between 5 and 30 millimeters (e.g., between 10 and 20 millimeters, or between 15 and 25 millimeters) when the aperture-covering umbrella is in its open state.

Reference is now made to fig. 12Ai-ii and 12-B, which are schematic illustrations of a blood pump 150 including an impeller 152 disposed within a radially expanding impeller hood 154, in accordance with certain applications of the present invention. Fig. 12Ai and 12Aii depict various views of the blood pump 150. Referring again to fig. 12C-D, there are shown a plurality of side views of the blood pump 150 disposed within the renal vein 32 when the hood 154 is respectively disposed in radially expanded and radially compressed configurations relative thereto, in accordance with certain implementations of the present invention. Referring also to fig. 12E, there is shown a sectional view of one end of impeller 152 in combination with a cross-sectional view of a plurality of posts 204 of hood 154 and a cross-sectional view of renal vein 32, in accordance with some implementations of the present invention, when a blood pump is disposed within renal vein 32.

It is noted that the term "impeller" as used herein refers to a bladed rotor, as shown in fig. 12 Ai-E. When the bladed rotor is placed within a blood vessel (e.g., renal vein 32) and rotated, the bladed rotor functions as an impeller by virtue of the blood flowing through the blood vessel, and/or by virtue of a pressure differential created between the upstream end and the downstream end of the impeller.

For some applications, a blood pump 150 is placed in one or both of the renal veins of a subject and is used to draw blood in a downstream direction through the renal veins towards the vena cava to reduce renal vein pressure and/or enhance perfusion of the subject's kidneys.

In order to provide acute treatment to a subject suffering from cardiac insufficiency, congestive heart failure, low renal blood flow, high renal vascular resistance, hypertension, and renal insufficiency, the blood pump 150 is typically placed within a plurality of renal veins of the subject. For example, the pump may be placed within the subject's renal veins for a period of more than one hour (e.g., more than one day), less than one week (e.g., less than four days), and/or between one hour and one week (e.g., between one and four days). For certain applications, the pump is chronically placed into renal veins of a subject suffering from cardiac insufficiency, congestive heart failure, low renal blood flow, high renal vascular resistance, hypertension, and renal insufficiency in order to provide long-term treatment of the subject. For some applications, a long-term treatment is administered to a subject for more than weeks, months or years, wherein the pump is intermittently placed within the subject's renal veins, and the subject is intermittently treated according to the techniques described herein. For example, the subject may be treated intermittently at intervals of days, weeks or months.

Typically, the effect of drawing blood through the renal veins of a subject suffering from cardiac insufficiency, congestive heart failure, low renal blood flow, high renal vascular resistance, hypertension, and renal insufficiency is substantially similar to that described with reference to fig. 4B. In other words, the draw causes a decrease and flattening of the subject's renal venous pressure distribution, even if the subject's central venous pressure is elevated. The kidney pressure map depicts the original venous pressure distribution after activation of the blood pump with a curved dashed line, according to the description of fig. 4B above. Typically, the height of the venous pressure curve during the drawing of the blood through the renal veins is based on the number of the draws applied by the operator to the renal veins by the pump, as indicated by the two curved solid lines shown in fig. 4B, the plurality of curves representing a plurality of renal venous pressure profiles at various rates of draw by the blood pump 150. For some applications, as shown, the renal vein pressure distribution is not perfectly flat, as multiple cyclical changes in blood pressure are transmitted through the renal capillary system to the multiple renal veins.

Typically, perfusion of the kidney is increased due to the pressure decrease within the renal vein caused by the draw of the blood in the downstream direction by pump 150. Conversely, after the draw begins, this may cause an immediate increase in pressure within the plurality of renal veins relative to the pressure within the plurality of renal veins due to increased blood flow into the renal veins. Typically, even after the kidney perfusion is increased, the pump is configured to maintain the pressure within the kidney vein at a lower value than the pressure within the kidney vein prior to the start of the draw. For some applications, the blood pump performs ultrafiltration on the blood of the subject in addition to reducing pressure of the renal veins of the subject, and/or increasing perfusion of the kidney of the subject.

Notably, for certain applications, the pressure reduction within the renal veins due to the drawing of the blood in the downstream direction by pump 150, for example, by Circulation Research published in 1956 by black et al (Circulation Research) an article entitled "effect of elevated luminal pressure of renal vascular resistance" which is incorporated herein by reference, the subject's renal venous resistance is reduced according to the described physiological mechanisms. It is further noted that increasing renal perfusion by increasing blood pressure in a plurality of renal arteries of the subject typically does not affect the above-described physiological mechanisms.

As noted above, typically, when blood pump 150 is used to reduce pressure within a plurality of renal veins of the subject, it is expected that there will be a modification by the subject to administer diuretics to the subject due to the reduction in renal vein pressure. Thus, for some applications, a reduced diuretic dose may be administered to the subject relative to a diuretic dose administered to the subject without the techniques described herein. Alternatively, a conventional diuretic dose may be administered to the subject, but the diuretic may have a better effect on the subject due to the reduction in renal venous pressure.

High central venous pressure results in a high degree of blood pressure within the heart which, in turn, causes the subject to release Atrial Natriuretic Peptide (ANP) and B-type natriuretic peptide (BNP), both of which act as natural diuretics. Typically, when a blood pump 150 as described herein is used to reduce pressure within a plurality of renal veins of the subject, the response by the subject is expected to be more improved than the release of the natural diuretic by the subject due to the reduced renal vein pressure. For certain applications, since the subject's central venous pressure is not reduced by use of blood pump 150, even in the subject's renal venous pressure by the use of the plurality of blood pumps described herein, it is expected that the subject will release Atrial Natriuretic Peptide (ANP) and B-type natriuretic peptide (BNP) on a sustained basis. Thus, for certain applications, use of blood pump 150 as described herein may result in sustained release of Atrial Natriuretic Peptide (ANP) and B-type natriuretic peptide (BNP) by the subject, and result in the effect of the aforementioned natural diuretic being greater than the effect of the diuretic when blood pump 150 is not used.

Notably, blood pump 150 typically draws blood in a manner that enhances the rate of blood flow through the plurality of renal veins and into the vena cava, but does not cause a substantial change in the direction of the blood flow relative to the natural direction of flow through the plurality of renal veins, or from the plurality of renal veins to the vena cava (e.g., relative to blood flow drawn without the pump). That is, the pump draws blood in the downstream direction through the renal veins and then directly into the portion of the vena cava adjacent to the renal veins, rather than, for example, drawing blood from the renal veins into a different portion of veins of the subject (e.g., at an upstream location within the vena cava). Also typically, the blood pump enhances blood flow through the renal veins without removing blood from the subject's venous system into a non-venous container, such as an artificial lumen of a blood pump.

Typically, the cover 154 defines a non-stressed, radially expanded configuration in which the cover is assumed to be applied to the cover in the absence of any force, and a radially compressed configuration in which the cover is assumed to be axially elongated when the cover is in the axially extended configuration. Similarly, typically, the impeller 152 defines a non-stressed, radially-expanded configuration in which the impeller is assumed to be without any force being applied to the impeller, and a radially-compressed configuration in which the impeller is assumed to be axially elongated as the impeller is axially elongated.

Typically, during insertion of the hood 154 and impeller 152 into the renal vein of the subject, the hood and impeller are crimped by axially elongating the hood and impeller so that they become radially compressed. The hood and impeller are inserted into the renal vein while the hood and impeller are maintained in a plurality of radially compressed configurations, e.g., a catheter, by an insertion device 155. The hood and impeller are advanced out of the distal end of the insertion device into the renal vein. The shroud and the impeller automatically radially expand and axially contract in response to being pushed outside the distal end of the insertion device.

Typically, the hood 154 is configured to maintain open the interior wall of the renal vein and to separate the interior wall of the renal vein from the impeller so that the renal vein is not damaged by the impeller. Also typically, blood pump 150 includes an engagement mechanism 156 configured to engage the impeller relative to the hood. For example, as shown in fig. 12B, which depicts a cross-sectional view of the impeller and the shroud, proximal and distal bearings 250P and 250D are disposed adjacent the proximal and distal ends of impeller 152 and are configured to impart rotational motion to the impeller. Engagement mechanism 156 is disposed between a ring 202 (see fig. 17, below) disposed at the distal end of the hood and a surface of distal bearing 250P such that upon distal movement of ring 202, the ring distally urges the engagement mechanism, which in turn distally urges the distal bearing. The distal bearing is connected to a distal ring 164 of the impeller (see figures 13A-D below) such that the distal action of the distal bearing pulls the distal ring of the impeller distally, thereby axially elongating the impeller.

In response to the hood becoming radially compressed and axially elongated (e.g., in response to the renal veins exerting radial pressure on the hood), the engagement mechanism thus engages the impeller relative to the hood, the impeller being axially elongated and radially compressed. For example, as shown in the transition from fig. 12C to fig. 12D, in response to the renal veins applying pressure P to the hood 154, the hood becomes partially radially compressed, causing the hood to elongate, e.g., move in the direction of arrow 160 through the distal end of the hood. In response to the cap becoming elongated, the engagement mechanism 156 causes the impeller to become elongated. Said elongation of said impeller causes said impeller to compress radially.

The engagement mechanism 156 is typically configured so that even if a minimum at one circumferential location is at a separation S1 (fig. 12C and 12D) between the impeller and the inner surface of the cowl, a separation between the impeller and the inner surface of the cowl is maintained (e.g., the inner surfaces of the impeller and the cowl remain separated from each other) even if the cowl is radially compressed. Needless to say, even if a separation S2 between the impeller and the outer surface of the hood is minimal at a circumferential location, the engagement mechanism maintains the separation between the impeller and the outer surface of the hood (e.g., the impeller and the outer surface of the hood are still separated from each other even if the hood is radially compressed.) because the inner wall of the renal vein is supported by the outer surface of the hood, a separation S2 between the impeller and the outer surface of the hood is typically the separation between the impeller and the inner wall of the renal vein at the location where the inner wall of the renal vein is closest to the impeller. And even when the renal veins exert pressure on the mask to cause the mask to compress radially.

Notably, in response to the renal vein applying pressure P to the hood 154 and causing the hood to radially compress, the separation S1 at the inner surfaces of the impeller and the hood, and/or the separation S at the outer surfaces of the impeller and the hood, may be reduced. However, even if the shroud is radially compressed, the engagement mechanism maintains the impeller and the inner surface of the shroud spaced apart from one another. In this manner, the hood protects the renal veins from damage by the impeller even if the renal veins are compressed. It is further noted that while the interior wall of the renal vein is supported by the exterior surface of the hood, the hood typically includes a plurality of struts defining a plurality of cells, the wall of the renal vein typically projects from the plurality of cells into the hood. By maintaining a separation S1 between the impeller and the inner surface of the hood, the engagement mechanism protects the inner wall of the renal vein from being damaged by the impeller even though the inner wall of the renal vein protrudes into the hood.

When blood pump 150 is deployed within a blood vessel, such as renal vein 32, mask 154 expands relative to the interior wall of the blood vessel, e.g., the mask becomes rotationally fixed relative to the interior wall of the blood vessel. When the cover is rotationally fixed relative to the inner wall of the blood vessel, impeller 152 rotates to draw blood through the blood vessel. The engagement mechanism 156 is configured to engage the impeller with respect to the shroud such that (a) when the shroud is radially compressed, the impeller becomes radially compressed, (b) when the shroud is axially elongated, the impeller becomes axially elongated, but (c) even if the shroud is rotationally fixed in place, the impeller is able to rotate. Rotation of the distal bearing 250D within the engagement mechanism is permitted by the engagement mechanism, which is configured to permit rotation of the impeller even though the shroud is rotationally fixed in place.

Typically, to insert the cover and impeller into the vessel, the cover is placed in insertion device 155 in a crimped configuration. Typically, crimping the cover to cause the cover to assume an axially elongated configuration automatically causes the impeller to assume an axially elongated configuration because the engagement mechanism imparts the longitudinal movement of the distal end of the cover to the distal end of the impeller in the manner described above.

As shown, for example, in fig. 12C-D, pressure sensors 157 and 159 are provided on the upstream and downstream sides of blood pump 150 for some applications. When the blood pump 150 is placed in a renal vein, as shown, for example, in fig. 12C-D, the pressure measured by the upstream pressure sensor 157 indicates the blood pressure upstream of the blood pump in the renal vein, and the pressure measured by the downstream pressure sensor 159 indicates the central venous pressure. For some applications, one or more sensors 161 are also provided on the blood pump (e.g., on a downstream side of the blood pump, as shown in fig. 12C-D, or on an upstream side of the blood pump) and configured to measure one or more additional parameters, such as flow through the renal veins, and/or oxygen saturation within the renal veins. Alternatively or additionally, a heat flow sensor is used to measure flow through the renal veins. For example, a heat flow sensor 260, such as described below with reference to FIGS. 22Ai-Cii, may be used to measure flow through the renal veins of the experimenter.

Fig. 12E illustrates a plurality of struts 204 associated with the hood 154 when the blood pump 150 is disposed within the renal vein 32, in accordance with certain implementations of the invention. A cross-sectional view of the impeller 152 and a cross-sectional view of the renal vein 32. The hood and the renal veins are in a cross-sectional view in a plane perpendicular to a longitudinal axis 222 of the hood at a longitudinal position at the center of the longitudinal axis of the hood. Typically, in this position, the diameter of the hood, perpendicular to the longitudinal axis of the hood, is at its maximum. Also typically, at this location across the width of the impeller SP, perpendicular to a longitudinal axis 224 of the impeller, is also at its maximum. For some applications, the outer edge of the impeller and the inner surfaces of the struts of the shroud are minimally spaced from each other at the longitudinal location, and the outer edge of the impeller and the outer surfaces of the struts of the shroud are minimally spaced from each other at the longitudinal location.

Because the hood includes a plurality of struts 204 configured to define a plurality of cells, the hood typically allows blood to flow therethrough by allowing blood to flow through the plurality of cells defined by the hood. As shown in fig. 12E, typically, when the hood and the impeller are assumed to be in their radially expanded configurations within a vessel, such as the renal veins 32, there is a minimum separation S1 between the outer edge of the impeller and the plurality of struts 204, and a minimum separation S2 between the outer edge of the impeller and the outer surface of the plurality of struts 204 of the hood (which is also typically the minimum separation between the outer edge of the impeller and the inner wall of the vessel). Also typically, there is a space between the vanes of the impeller. Typically, even if the impeller does not actively draw blood through the blood vessel, blood can flow through the blood pump by flowing through the plurality of cells defined by the hood, and by flowing through the plurality of divisions between the impeller and the hood, through the plurality of divisions between the impeller and the vessel wall, and/or through the divisions of the plurality of vanes located at the impeller.

It is worth mentioning that the blood pump 150 typically does not comprise an occlusion member (e.g. an obturator member) to achieve the purpose of avoiding a back flow of blood through the blood pump. For some applications, when the blood pump is pumping blood in an antegrade direction, there is some retrograde flow of blood through the plurality of divisions between the impeller and the shroud, through the plurality of divisions between the impeller and the vessel wall, and/or through the divisions of the plurality of blades located on the impeller (e.g., within the vicinity of the center of the impeller). Alternatively or additionally, when the blood pump is pumping blood in a downstream direction, there is blood downstream through the plurality of divisions between the impeller and the shroud, through the plurality of divisions between the impeller and the vessel wall, and/or through the divisions between the plurality of blades of the plurality of impellers (e.g., toward the center of the impeller). Typically, whether the blood flow is in an antegrade or a retrograde direction through the regions, the blood flow through the regions reduces a likelihood that the blood will stagnate in the regions.

For some applications, a span width SP of the impeller is greater than 8 millimeters, less than 15 millimeters, and/or between 8 and 15 millimeters in a direction perpendicular to a longitudinal axis of the impeller when the impeller is in a non-stressed, radially-expanded configuration (as shown in fig. 12E). For example, the span width SP may be greater than 8 millimeters, less than 12 millimeters, and/or between 8 and 12 millimeters. Alternatively, the cross-width SP may be greater than 10 millimeters, less than 15 millimeters, and/or between 10 millimeters and 15 millimeters.

Reference is now made to fig. 13A-D, which are schematic illustrations of various stages in a method of manufacturing an impeller (e.g., bladed rotor) 152, in accordance with some implementations of the invention. For some applications, a tube 162 (e.g., a nitinol, a stainless steel, or a plastic tube) is cut (laser cut) along the dotted lines shown in fig. 13A, such that the cut tube (fig. 13B) defines a structure 165 having first and second end portions, e.g., rings 164 at ends of the structures, interconnected by a plurality (e.g., two as shown in fig. 13B, or more than two) of elongate elements 166 (e.g., elongate strips, as shown). The first and second ends of each of the plurality of elongated elements are typically disposed at an angle a (alpha) relative to each other with respect to the circumference of the plurality of loops. Typically, angle α is greater than 5 degrees (e.g., greater than 50 degrees, greater than 70 degrees, or greater than 90 degrees), less than 360 degrees (e.g., less than 180 degrees, less than 150 degrees, or less than 110 degrees), and/or between 5 and 360 degrees (e.g., between 50 and 180 degrees, between 70 and 150 degrees, or between 90 and 110 degrees).

It is noted that although a plurality of elongated members 166 are depicted and described as a plurality of strips, the scope of the present invention encompasses the use of a plurality of elongated members having other configurations, such as a plurality of elongated tubular structures, a plurality of elongated rod structures, etc., as appropriate.

The structure 165 is axially compressed, for example, by pushing the two rings toward each other to radially expand the plurality of elongated elements 166, as depicted in the transition from fig. 13B to fig. 13C. Typically, a length L4 of the structure, measured along the longitudinal axis of the structure, is greater than 15 millimeters, less than 25 millimeters, and/or between 15 and 25 millimeters prior to axial compression of the structure (e.g., in the axially elongated configuration of the structure). A length L5 of each of the plurality of elongate elements, measured along the longitudinal axis of the structure, is greater than 14 millimeters, less than 22 millimeters, and/or between 14 and 22 millimeters prior to axial compression of the structure (e.g., within the axially elongated configuration of the structure). Typically, the lengths of the impeller 154 and elongated members 166, as measured along the longitudinal axis of the impeller, are the same as lengths L4 and L5, respectively, as the impeller 152 is axially elongated. Also typically, as the impeller 152 is axially elongated, the lengths of the impeller blades 168, measured along the longitudinal axis of the impeller, are the same as L5.

Typically, the structure is arranged in the shape of the axially compressed state of the structure. Structure 165 forms the support for the impeller 152. Also typically, in the axially-compressed state of the construct, each of the plurality of elongated elements 166 of the construct 165 forms a helical shape. Each of the plurality of helical elongate elements begins at a first one of the plurality of end portions (e.g., plurality of loops 164) and terminates at the second one of the plurality of end portions (e.g., plurality of loops 164). The plurality of pitches of each of the plurality of helical elongate elements is typically within 20% of one another, the plurality of helical elongate elements typically having the same pitch as one another. For some applications, the pitch of the plurality of helical elongate elements varies along the length of the plurality of helical elongate elements. Said radius of said plurality of helical elongate elements is typically within 20% of one another and typically said plurality of helical elongate elements has the same radius as one another. For some applications, the helix defined by the two elongate elements is not symmetrical with respect to the other. The longitudinal axis of each of the plurality of helical elongate elements is typically parallel to the longitudinal axis of another of the plurality of helical elongate elements and typically parallel to the longitudinal axis of the impeller. For some applications, each of the plurality of elongated elements defines more than one-eighth of a winding of a helix and/or less than one-half of a winding of a helix, e.g., between one-eighth of a winding and one-half of a winding of a helix.

It is noted that although each of the plurality of elongated elements is described as being helical, for some applications, the plurality of elongated elements do not define an exact mathematical helix, but rather each of the plurality of elongated elements defines a generally helical shape that spirals inwardly toward a first of the plurality of end portions (e.g., rings) when axially elongated away from the first of the plurality of end portions, within a first of the plurality of end portions radially outwardly of the helical shape, and thereafter axially elongated toward the second of the plurality of end portions.

Notably, typically, the tube 162 is cut such that the angle α is as described above, to facilitate the configuration of the plurality of elongated elements 166 into the desired plurality of helical shapes. For some applications, the tube is cut so that the angle α is not as described above, and although when a shape setting process is applied to the structure 165, the plurality of elongated members 166 are configured into the desired plurality of helical shapes by twisting the structure 165. Typically, the other conditions are unchanged, when the tube 162 is cut at an angle α to reduce the pressure on the plurality of elongated elements 166 as described above, urging the configuration of the plurality of elongated elements 166 into the desired plurality of helical shapes, relative to the pressure on the plurality of elongated elements if the plurality of elongated elements were configured into the desired plurality of helical shapes without cutting the tube to achieve the angle α as described above.

Typically, a length L6 of the structure, measured along the longitudinal axis of the structure, in the axially compressed configuration of the structure is greater than 8 millimeters, less than 18 millimeters, and/or between 8 and 18 millimeters. Also typically, a length L7 of each of the plurality of elongated elements, measured along the longitudinal axis of the structure, in the axially compressed configuration of the structure is greater than 5 millimeters, less than 14 millimeters, and/or between 5 and 14 millimeters. Typically, the lengths of the impeller 154 and the plurality of elongated members 166, as measured along the longitudinal axis of the impeller, are the same as lengths L6 and L7, respectively, when the impeller 152 is in its non-stressed, radially-expanded configuration. Also typically, the lengths of the impeller blades 168, measured along the longitudinal axis of the impeller, when the impeller is in its non-stressed, radially-expanded configuration, are typically the same as L7.

After axially compressing structure 165, a material 168 (e.g., an elastic polymeric material such as silicone, polyurethane, and/or polyester) is attached to at least a portion of structure 165, such as to the plurality of helical elongate elements of structure 165. typically, material 168 is immersed within material 168 through structure 165 while material 168 is in its liquid state. for example, structure 165 may be immersed in liquid silicone, a silicone-based elastomer, and/or a different elastomer. thereafter, the material is dried (e.g., by a curing and/or a polymerization process) to form a film of the material supported by the plurality of helical elongate elements of structure 165. for some applications, techniques are used to facilitate the formation of a film on structure 165 and/or to attach the material to the plurality of helical elongate elements of structure 165, as described below. For some applications, during the drying of material 168, structure 165 is rotated about its longitudinal axis to facilitate the formation of a thin film of material 168 having a uniform thickness. For some applications, material 168 is attached to structure 168 in a manner different from that described above, such as by stitching and/or forming an elastic polymeric material into the plurality of helical elongate elements of structure 165 electrostatically (e.g., silicone, polyurethane, and/or polyester).

The helical elongate member 166 having the material attached thereto defines the impeller blades. To form impeller 152 with a single blade, as shown in fig. 13D, tube 162 is cut to define a structure defining two helical elongated elements between rings 164. (note that the impeller depicted in figure 13D may alternatively be described as a two-bladed impeller having each of these elongate elements connected thereto defining a blade, for example, in the end view of the impeller, as depicted in figure 18Ai, the portions of the impeller on respective sides of the ring 164 may each be considered a blade although, in the context of this application, an impeller comprising two helical elongate elements, as shown in figure 13D, is described as having a single blade.) for some applications, a three-bladed impeller is formed by cutting a tube 162 to define a structure, defining three elongate elements between rings 164, such that the structure defines three helical elongate elements when the structure is axially compressed, for example, as described below with reference to fig. 16A-B. Alternatively or additionally, an impeller with a different number, e.g. 4-8 blades, is used.

Typically, material 168 is coupled to structure 165 such that the material forms a continuous layer (e.g., a continuous film) between the plurality of elongated elements 166. More particularly, material 168 is typically configured to form one or more blades upon drying the material (e.g., by a curing or a polymerization process), and without the use of any equipment, such as a shaping mandrel configured to impart shape to the blades, by virtue of the material being supported by helical elongated elements 166

As depicted in fig. 13D, the impeller blades typically form a continuous film of material 168 supported by a plurality of helical elongated elements 166 that typically form the edges of the outer portions of the blades of the impeller. It is noted that typically, the impeller does not include an axial support member (e.g., a shaft) along the shaft of the impeller between the proximal and distal ends of the plurality of helical elongated elements for providing support to the film of material. More generally, the impeller typically does not include any support member (e.g., a shaft) positioned between the proximal and distal ends of the plurality of helical elongated elements to provide support for the membrane of material 168. Thus, typically, there are no support members that disrupt said continuity of said film of material provided between said plurality of helical elongated elements. Further, rotational motion is imparted from the proximal portion (e.g., proximal ring 164) of the impeller to the distal portion (e.g., distal ring 164) of the impeller by the plurality of helical elongated elements of the impeller (e.g., substantially only by the plurality of helical elongated elements), and not by an axial support member (e.g., a shaft).

During insertion of the impeller by the insertion means 155 (fig. 12Ai), the impeller is radially compressed by the axial elongated structure 165 to straighten the plurality of helical elongated elements 166. Typically, during the axial elongation of the structure 165, the film of material 168 conforms to the plurality of shape changes experienced by the plurality of helical elongated elements because no additional support members provide support to the material 168 between the proximal and distal ends of the plurality of helical elongated elements. Also typically, the absence of an axial support (e.g., a shaft) between the proximal and distal ends of the helical elongate elements facilitates radial compression of the impeller such that the maximum diameter of the impeller when the impeller is in its maximum radial compression configuration is less than that of an impeller similar to the other but including an axial support, e.g., if the impeller includes an additional support for supporting the material between the proximal and distal ends of the helical elongate elements, the impeller is configured to be radially compressible to a smaller diameter, otherwise unchanged.

For some applications, other conditions are unchanged due to the absence of an axial support (e.g., a shaft) between the proximal and distal ends of the plurality of helical elongated elements, the impeller being more resilient than an impeller similar to other aspects but including an axial support (e.g., a shaft). The impeller and the cover are typically inserted during the insertion into the renal vein by forming a plurality of acute angles relative to each other and a plurality of junctions of a plurality of blood vessels disposed at a short distance relative to each other. For example, the impeller and the hood may be passed through the femoral vein, the iliac vein, into the vena cava, and then into the renal vein. The elasticity of the impeller typically facilitates insertion of the impeller into the renal vein.

Further, the absence of an axial support member (e.g., a shaft member) between the proximal and distal ends of the helical elongated elements facilitates axial elongation of the impeller by a predetermined length using less force than is required to axially elongate an impeller including an axial support member (e.g., a shaft member) between the proximal and distal ends of the helical elongated elements by the predetermined length, as axial elongation of an impeller including an axial support member typically requires axial elongation of the axial support member (e.g., by axial telescoping of the support member). Similarly, other conditions are unchanged if a predetermined force is applied to the impeller to cause axial elongation of the impeller, the axial elongation of the impeller being greater than would be encountered with a substantially similar impeller including an axial support (e.g., a shaft) located between the proximal and distal ends of the plurality of helical elongated elements.

For certain alternative applications of the invention, the material 168 of the impeller itself is cast to facilitate the insertion of an axial support therethrough. For example, an elastomer (e.g., silicone, a silicone-based elastomer) may be used as material 168, and the elastomer may be cast to form a hollow central cavity therethrough. An axial support may be connected to the impeller by being passed through the hollow central cavity defined by the elastomer.

Reference is now made to fig. 14A-B, which are schematic illustrations of a structure 165 having a plurality of sutures 170 tied around a portion of the structure from where the impeller 152 is formed, in accordance with certain applications of the present invention. Reference is also made to fig. 15, which is a schematic illustration of an impeller 152 in accordance with some applications of the present invention.

As noted above, material 168 is typically attached to at least a portion of structure 165 when material 168 is in its liquid state, immersed within material 168 through structure 168. For example, the structure 165 may be dipped into liquid silicone. The material is then dried (e.g., by a curing and/or a polymerization process) to form a film of the material supported by the plurality of spiral-shaped elongated elements of structure 165. For some applications, to facilitate such formation of a thin film of material 168 on the structure 165, and/or to facilitate joining the material 168 to the plurality of helical elongate elements 166, a plurality of sutures 170 are tied around a portion of the structure 165. For example, the plurality of sutures may be tied around the plurality of helical elongate elements 166 of the structure 165, as shown in fig. 14A, which depicts the plurality of sutures 170 tied around the plurality of helical elongate elements 166 before the material 168 has been attached to the structure 165.

For some applications, the plurality of stitches increase the surface area of material 168 into contact when material 168 is in its liquid state. Alternatively or additionally, the surfaces of the plurality of sutures are rougher and/or porous than the plurality of elongate elements 166 (which are typically nitinol). Thus, material 168 becomes attached to the plurality of sutures, with a greater attachment strength, than the attachment between material 168 and plurality of elongated elements 166. For some applications, the sutures serve as intermediaries between a material made from the elongated elements, which typically has a relatively high stiffness (and typically nitinol), and material 168, which typically is an elastomer having a relatively low stiffness. When the material is dry, the plurality of stitches thereby enhance the strength of the connection between material 168 and plurality of helical elongate members 166. For some applications, the plurality of stitches avoid a plurality of grooves from forming between the material 168 and the plurality of helical elongate elements 166 by enhancing the strength of the connection between the material 168 and the plurality of helical elongate elements 166 during and/or after the drying of the material 168. In such manner, the plurality of stitches facilitate the formation of a continuous film of material 168 located between the plurality of helical elongate elements. Fig. 14B depicts the impeller 152 after the formation of a thin film of material 168 on the structure 165, the thin film being supported by the plurality of helical elongated elements 166 of the structure 165.

Alternatively or additionally, to facilitate the formation of a film of material 168 on the structure 165, the edges of the end portions (e.g., loops 164) of the structure 165 nearest the plurality of helical elongated elements 166 define notches 180 therein, as shown in fig. 15. As noted above, material 168 is typically attached to at least a portion of structure 165 by structure 165 dipping into material 168 when material 168 is in its liquid state. Typically, some of the liquid material enters the plurality of gaps 180 in the plurality of end portions (e.g., plurality of loops 164) such that the contact area between the material and structure is increased relative to if the plurality of end portions did not define the plurality of gaps. Thus, when the material is subsequently dried. The strength of the attachment of the material to the structure 165 is enhanced.

Reference is now made to fig. 16A-B, which are schematic illustrations of an impeller 152 defining three blades 190 according to some applications of the present invention. Typically, the three-bladed impeller 152 is fabricated using a technique substantially similar to that described above with reference to FIGS. 13A-D. However, rather than cutting the tube 162 (fig. 13A) to define two elongated elements 166 (fig. 13B), the tube 162 is cut to define three elongated elements. The tube is then axially compressed to form the plurality of elongated elements into three helical shapes, and the tube is contoured to the axially compressed configuration. Material 168 is then attached to at least a portion of structure 165. Typically, when material 168 is in its liquid state, immersed within material 168 through structure 165, the material is attached to at least a portion of structure 165. For example, the structure 165 may be dipped into liquid silicone. Typically, the material is dried (e.g., by curing, and/or polymerizing) onto the plurality of helical elongated elements such that the plurality of helical elongated elements having the material thereon form a three-bladed impeller, as shown in fig. 16A-B. It is noted that the three-bladed impeller illustrated in fig. 16A-B typically does not include an axial support (e.g., a shaft) between the proximal and distal ends of the plurality of helical elongated elements and along the axis of the impeller for providing support to the material 168. More generally, the impeller does not typically include a support (e.g., a shaft) that provides support to the material 168, except for the helical elongated elements located between the proximal and distal ends of the helical elongated elements. Further, rotational motion is imparted from the proximal portion (e.g., proximal ring 164) of the impeller to the distal portion (e.g., distal ring 164) of the impeller by the plurality of helical elongated elements of the impeller (e.g., substantially only by the plurality of helical elongated elements), and not by an axial support member (e.g., a shaft).

During insertion by the insertion means 155 (fig. 12Ai), the impeller is radially compressed by axially elongating the impeller, so as to straighten the plurality of helical elongated elements 166. Typically, during the axial elongation of the structure 165, the material 168 conforms to the plurality of shape changes experienced by the plurality of helical elongated elements because no additional support member (e.g., a shaft member) provides support to the material 168 between the proximal and distal ends of the plurality of helical elongated elements. Also typically, the absence of an axial support (e.g., a shaft) between the proximal and distal ends of the helical elongate elements facilitates radial compression of the impeller such that the maximum diameter of the impeller when the impeller is in its maximum radial compression configuration is less than that of an impeller similar to the other but including an axial support, e.g., if the impeller includes an additional support for supporting the material between the proximal and distal ends of the helical elongate elements, the impeller is configured to be radially compressible to a smaller diameter, otherwise unchanged.

For some applications, other conditions are unchanged, the impeller being more resilient than an impeller similar to other aspects but including an axial support (e.g., a shaft) due to the absence of an axial support (e.g., a shaft) located between the proximal and distal ends of the plurality of helical elongate elements. The impeller and the shroud are typically inserted during the insertion into the renal vein by forming acute angles (e.g., angles in excess of 70 degrees) relative to each other and junctions of vessels located at relatively short distances from each other. For example, the impeller and the hood may be inserted into the renal vein, through the femoral vein, the iliac vein, into the vena cava, and then into the renal vein. The elasticity of the impeller typically facilitates insertion of the impeller into the renal vein.

Further, as described above, the absence of an axial support member (e.g., a shaft member) located between the proximal and distal ends of the plurality of helical elongated elements facilitates axial elongation of the impeller by a predetermined length using less force than is required to axially elongate an impeller including an axial support member (e.g., a shaft member) located between the proximal and distal ends of the plurality of helical elongated elements by the predetermined length. Similarly, other conditions are unchanged if a predetermined force is applied to the impeller to cause axial elongation of the impeller, the axial elongation of the impeller being greater than would be encountered with a substantially similar impeller including an axial support (e.g., a shaft) located between the proximal and distal ends of the plurality of helical elongated elements.

For certain alternative applications of the present invention, the impeller's own material 168 is cast to facilitate the insertion of an axial support therethrough. For example, an elastomer (e.g., silicone, a silicone-based elastomer) may be used as material 168, and the elastomer may be cast to form a hollow central cavity therethrough. An axial support may be connected to the impeller by the hollow central cavity defined through the elastomer.

Referring now to fig. 17, a schematic diagram of a protective cover 154 for a blood pump 150 according to some embodiments of the present invention is shown. Typically, the cover includes proximal and distal rings 202. Between the proximal and distal rings, the cover includes a plurality of struts 204 configured to define a plurality of cells. For some applications, in a non-stressed, radially-expanded configuration of the mask (e.g., without any external force applied to the mask), the mask located between the proximal and distal rings defines a generally spherical or ovoid shape, as shown in fig. 17. The engagement mechanism 156 (fig. 12B) typically engages the impeller relative to the cage 154 via the plurality of rings 164 (fig. 13A-D) of the impeller, the plurality of rings 202 of the cage, and a distal bearing 250D (fig. 12B).

For some applications, a length L8 of the hood, measured along the longitudinal axis of the hood, and including the plurality of rings 202 of the hood, is greater than 17 millimeters, less than 26 millimeters, and/or between 17 and 26 millimeters when the hood 154 is in its radially expanded configuration. A length L9 of the hood measured along the longitudinal axis of the hood, and excluding the plurality of loops 202 of the hood, is greater than 12 millimeters, less than 21 millimeters, and/or between 12 and 21 millimeters. For some applications, the length of the cover, as measured along the longitudinal axis of the cover and including the plurality of loops 202 of the cover, is greater than 22 millimeters, less than 35 millimeters, and/or between 22 and 35 millimeters when the cover is axially elongated and radially compressed by being crimped (configuration not shown). Typically, for such applications, the length of the cover excluding the plurality of loops 202 of the cover is greater than 18 millimeters, less than 30 millimeters, and/or between 18 and 30 millimeters as the cover is axially elongated by being crimped (configuration not shown), measured along the longitudinal axis of the cover. For some applications, the hood 154 in its radially expanded configuration has a diameter D7 that is greater than 8 millimeters, less than 20 millimeters, and/or between 8 and 20 millimeters. For example, the diameter D7 may be greater than 8 millimeters, less than 15 millimeters, and/or between 8 millimeters and 15 millimeters. Alternatively, the diameter D7 may be greater than 13 millimeters, less than 19 millimeters, and/or between 13 millimeters and 19 millimeters.

When in a crimped configuration (e.g., axially elongated and radially compressed as the mask is in the non-compressed configuration relative to the mask), the mask is typically inserted into a blood vessel (e.g., into the renal vein). As described above, during insertion of the impeller into the vessel, the impeller is radially compressed by the axial elongate structure 165 to straighten the plurality of helical elongate elements 166. Typically, the film of material 168 conforms to the plurality of shape changes experienced by the plurality of helical elongated elements during the elongation of the impeller. Also typically, the impeller 152 is already disposed within the hood during insertion of the blood pump into the vessel. Thus, during insertion of the blood pump into the blood vessel, the impeller 150 is disposed within the hood when the hood is in its curled configuration and when the impeller is in its axially elongated configuration, wherein the plurality of helical elongate elements of the impeller are straightened. Typically, the cover automatically assumes the non-compressed, radially expanded configuration of the cover in response to being released from the insertion device positioned within the vessel. Similarly, in response to the closure and the impeller being released from the insertion device, the impeller typically automatically radially expands within the closure to assume a non-compressed, radially expanded configuration.

Reference is now made to fig. 18Ai-18Aii, which are schematic illustrations of an example of a structure 165 forming the support of the impeller 152, according to some applications of the present invention.

As indicated by the inner dashed circle 194, which is the same size in both fig. 18Ai-18Aii, the plurality of impellers depicted in each of fig. 18Ai and 18Bi are depicted as rotating to include a circular region of the same size. Thus, as indicated by the outer dashed circle 196, which is the same size in both fig. 18Ai-18Aii, the plurality of impellers depicted in each of fig. 18Ai and 18Bi are adapted to be placed within a blood vessel having a predetermined cross-sectional area to have a separation between the inner wall of the blood vessel and the impellers, as described above. (the outer dashed circle represents the cross-section of the inner wall of the vessel into which the impeller is placed). The structure 165 of the impeller depicted in fig. 18Bi-18Biii is configured such that, despite being adapted to be placed within a similarly sized blood vessel, the plurality of blades of the impeller formed by the structure span a larger cross-over area as compared to the plurality of impeller blades formed by the structure 165 depicted in fig. 18Ai-18 Aiii. In other words, when viewed from an end of the impeller (as in fig. 18Ai and 18Bi), the plurality of blades of the impeller mount illustrated in fig. 18Bi-18Biii then span a span region (e.g., a region transverse to the axis of the impeller) that is greater than the span region spanned by the plurality of blades of the impeller mount illustrated in fig. 18Ai-18 Aiii. Similarly, when viewed from one end of the impeller (as in fig. 18Ai and 18Bi), then each of the plurality of blades of the impeller bracket depicted in fig. 18Bi-18Biii defines an angle θ (theta) about the longitudinal axis of the impeller that is less than that defined by each of the plurality of blades of the impeller depicted in fig. 18Ai-18 Aiii.

Typically, and otherwise invariably, for an impeller placed within a blood vessel having a predetermined diameter, the greater the power of the blood through the vessel (and, therefore, the greater the efficiency of the impeller) at a predetermined rate of rotation of the impeller, the greater the span of the blood vessel across which the plurality of blades of the impeller are positioned (e.g., the extent of the blood is transverse to the longitudinal axis of the blood vessel). For an impeller as illustrated in fig. 18Ai-iii and 18Bi-iii, the efficiency of the impeller is typically greater, the greater the angle θ being defined by the impeller blades around each side of the longitudinal axis of the impeller. Thus, with reference to fig. 18Ai-iii and 18Bi-iii, otherwise unchanged, the impeller depicted in fig. 18Bi-iii typically draws blood more efficiently than that depicted in fig. 18 Ai-iii. However, as described in more detail below, when the impellers are axially elongated, then otherwise unchanged, an impeller defining a plurality of blades across a larger span will typically be longer than an impeller defining a plurality of blades across a smaller span.

It is noted that for some applications, a single-bladed impeller as used herein, and the value of θ (e.g., the angle defined by the blades of the impeller on each side of the longitudinal axis of the impeller) is greater than 5 degrees (e.g., greater than 50 degrees, greater than 70 degrees, or greater than 90 degrees), less than 360 degrees (e.g., less than 180 degrees, less than 150 degrees, or less than 110 degrees), and/or between 5 and 360 degrees (e.g., between 50 and 180 degrees, between 70 and 150 degrees, or between 90 and 110 degrees).

During insertion of the blood pump 150 into the blood vessel, the impeller 152 is typically disposed within the hood when the hood is in its axially elongated, crimped configuration, and when the impeller is in its axially elongated, crimped configuration. Thus, the length defined by the impeller when the impeller is in its axially elongated, curled configuration is typically less than the length of the shroud when the shroud is in its axially elongated, curled configuration. Conversely, the size of the mask is limited because the diameter of the mask in the radially expanded configuration of the mask is limited based on the size of the blood vessel into which the blood pump is to be placed.

For some applications, the hood is configured to include a plurality of struts 204 having a contoured shape to include a plurality of undulations 210, as shown in fig. 18C (which is described in more detail below). Typically, the degree of undulation of the plurality of undulations of the plurality of struts of the cover is greater when the cover is in its radially expanded configuration than when the cover is in its axially elongated configuration. For some applications, a mask having a predetermined diameter and/or distributed over its radially expanded configuration may be elongated to define a greater length when the mask is elongated, as compared to a mask having a similar diameter and/or external distribution without the inclusion of a plurality of struts having a plurality of undulations. In this manner, the shroud (a) can be longer in its axially elongated configuration (and in its radially expanded configuration, thus defining a larger cross-over area) than a shroud that does not include struts having undulations, but (b) the diameter and/or outer distribution of the shroud in its radially expanded configuration is substantially similar to the shroud that does not include the struts having undulations.

FIGS. 18Ai-18C are described in more detail below.

As noted above, the structure 165 of the impeller depicted in fig. 18Bi-18Biii is configured such that the plurality of blades of the impeller span a larger span area as compared to the plurality of impeller blades formed by the structure 165 depicted in fig. 18Ai-18 Aiii. Fig. 18Aii and 18Bii depict side views of the two examples of structures 165, and fig. 18Aiii and 18Biii depict the examples of structures 165 in the axially elongated configurations of the structures in which the helical elongated elements of the structures are flattened. As noted above, the impeller is typically in the axially elongated configuration during insertion of the blood pump 150 into the vessel, as shown in fig. 18Aiii and 18 Biii. In order for the impeller blades to span a larger span area (as shown in fig. 18 Bi), the lengths of the elongate elements 166 are typically longer compared to an impeller having blades that span a smaller span area (as shown in fig. 18 Ai). Thus, the length LB of the impeller illustrated in fig. 18Bi-18Biii is greater than the length LA of the impeller illustrated in fig. 18Ai-18Aiii when the plurality of impellers are in the plurality of axially elongated configurations thereof.

Referring now to fig. 18C, a hood 154 according to some applications of the present invention includes at least some of the struts 204 with a schematic view of the plurality of undulations 210 thereof. Reference is also made to fig. 18D, which is a schematic illustration of the side views of radially expanded masks according to some applications of the present invention, one of which contains the struts 204 with their undulations 210 (the left mask) and the other of which does not contain the struts with their undulations (the middle mask). On the right side of fig. 18D, the cover including a plurality of posts with their undulations overlies the cover not including a plurality of posts with their undulations, the plurality of posts including a plurality of undulations depicted in solid lines, and the plurality of corresponding posts of the second cover not including a plurality of undulations depicted in dashed lines. As can be seen in the portion of fig. 18D depicting the plurality of covering lids, the accommodation of a plurality of undulations within certain of the plurality of struts does not alter the outer profile of the cover. However, the plurality of undulations of the plurality of struts add length to the plurality of struts such that the total axial elongated length of the stent including the plurality of struts having the plurality of undulations is greater than the total axial elongated length of the stent not including the plurality of struts having the plurality of undulations, otherwise unchanged.

As noted above, typically, the length of the impeller is less when the impeller is in its axially elongated, curled configuration than when the shroud is in its axially elongated, curled configuration, so that the curled shroud can accommodate the axially elongated impeller. Conversely, the plurality of sizes of the hood are limited because the diameter of the hood in the radially expanded configuration of the hood is limited based on the size of the blood vessel into which the blood pump is to be placed. For masks having structures such as that shown in fig. 17, then a mask having a longer crimped length, typically expands to have a larger maximum diameter within the vessel, which is undesirable.

For some applications, a cover as depicted in fig. 18C is used in order to increase the axial elongated length of the cover without increasing the diameter of the cover when the cover is in the radially expanded state of the cover. The hood depicted in fig. 18C includes some struts, including a plurality of undulations 210. During crimping of the cover, the plurality of undulating portions are configured to become at least partially flattened out, thereby adding to the crimped length of the cover relative to if no undulations were formed in plurality of portions 210. When the cover is radially expanded within the vessel, the plurality of undulations become undulating but do not add to the diameter of the cover or otherwise alter the outer profile of the cover relative to if the plurality of undulations were straight. Thus, in general, when the cover is in its crimped configuration, the extra length provided to the cover by the plurality of undulations is not added to the diameter of the cover while the cover is expanded within the vessel.

As described above, the plurality of undulations of the plurality of struts of the mask at least partially flatten during insertion of the mask into the renal vein. The degree of undulation of the plurality of undulating portions of the plurality of struts of the mask increases when the mask assumes its radially expanded configuration within the renal vein. For some applications, for each of the plurality of struts defining the plurality of undulations, the strut is configured such that:

(a) when the cover is in its axially elongated configuration (e.g., when the undulations are at least partially flattened), the shortest distance from a first longitudinal end of the strut to a second longitudinal end of the strut,

and

(b) when the cover is in its radially expanded configuration (e.g., when the undulating portion is at the degree of undulation to which the strut is contoured), the shortest distance from the first longitudinal end of the strut to the second longitudinal end of the strut,

the ratio of the two is more than 1.05: 1, e.g. greater than 1.15: 1 or greater than 1.2: 1.

for some applications, the aforementioned ratio is less than 1.4: 1, for example, the ratio may be in the range of 1.05: 1 and 1.4: 1, between 1.15: 1 and 1.4: 1, or between 1.2: 1 and 1.4: 1.

Reference is now made to fig. 19A-B, which are schematic illustrations of an impeller hood 154 configured to define a central portion having a generally cylindrical shape in the absence of any force applied to the hood, in accordance with certain applications of the present invention. The outer surface of the cover at the substantially cylindrical portion of the cover is parallel to a longitudinal axis 222 of the cover. Fig. 19A illustrates the mask itself, and fig. 19B illustrates the mask as disposed within a blood vessel, such as the renal vein 32.

Fig. 19B depicts a hood 154 having a radial expansion within the vessel (e.g., within the renal vein 32) to anchor the hood to the vessel. As described above, by rotation within the blood vessel, the impeller 152 of the blood pump 150 (fig. 12Ai) is configured to draw blood axially through the blood vessel. Typically, to achieve efficient drawing of blood through the vessel, it is desirable that a longitudinal axis 224 of the impeller be aligned with a longitudinal axis 226 of the vessel. Also typically, the plurality of rings 164 of impeller 152 are aligned with the plurality of rings 202 of cage 154 such that the longitudinal axes of the impeller and the cage are aligned with one another. For example, as shown in fig. 12B, the longitudinal axes of the impeller and the shroud may be aligned with one another by (a) positioning the proximal rings of both the impeller and the shroud around a first support member (e.g., proximal bearing 250P) to align the proximal rings of the impeller and the shroud with one another; and (b) positioning the plurality of distal rings of both the impeller and the shroud around a second support (e.g., distal bearings 250D) to align the plurality of distal rings of the impeller and the shroud with one another.

As shown in FIG. 19B, a generally cylindrical central portion 220 of cover 154 becomes anchored to the vessel such that the longitudinal axis of the cover is aligned with the longitudinal axis of the vessel. Because the longitudinal axes of the impeller and the cover are aligned with one another, the generally cylindrical central portion 220 of the cover positions the impeller within the vessel such that the longitudinal axis of the impeller is aligned with the longitudinal axis of the vessel.

As used in this application, including in the claims, a "longitudinal axis" of a structure is the set of all centers of gravity of cross-sectional portions of the structure along the structure. The cross-sectional portions are thus locally perpendicular to the longitudinal axis, which runs along the structure. (if the structure is circular in cross-section, the multiple centers of gravity correspond to the multiple centers of the multiple circular cross-sectional portions.)

Referring now to fig. 20, there is shown an impeller hood 154 configured for placement within a blood vessel (e.g., renal vein 32) to increase the diameter of a portion of the blood vessel relative to the diameter of the blood vessel without the impeller hood. As shown in fig. 20, for some applications, the hood is configured to expand a blood vessel having a diameter D6 in the absence of the hood such that a portion of the blood vessel has a diameter greater than D6. For example, the hood may widen the blood vessel such that when the blood vessel is widened, the diameter of the blood vessel is greater than 105 percent, such as greater than 110 percent, or greater than 115 percent, of the diameter D6. For some applications, the hood widens the blood vessel such that when the blood vessel is widened, the diameter of the blood vessel is less than 125 percent of diameter D6. For example, the widened diameter may be 105-. For some applications, the impeller 152 of the blood pump 150 is configured to span a diameter at least as great as the diameter D6 of the blood vessel. Typically, all other factors being equal, the more the impeller spans the diameter, the greater the flow rate at which the impeller can draw blood through the blood vessel.

Referring now to fig. 21A, there is shown a schematic diagram of impeller-based blood pumps 150 inserted through the femoral vein 230 of a subject into the left and right renal veins 32 of a subject, according to some implementations of the present invention. It is noted that the details of the blood pump 150 are not shown in fig. 21A, but the pump is generally as described above. Typically, the multiple blood pumps are inserted into the left and right renal veins through respective catheters 155, and both the multiple catheters are inserted through the femoral vein. Alternatively (not shown), the multiple blood pumps are inserted through a single catheter that passes from a single access point to the vena cava of the subject.

Typically, the plurality of impellers of the blood pump 150 are connected to a plurality of rotors 232 that impart rotational motion to the plurality of impellers. Depending on the respective application, the plurality of applications are provided outside the subject's body (as shown) or placed within the subject's body (not shown). Typically, a finger control unit 234 and a user interface 236 are provided outside the subject's body. Typically, the control unit receives inputs from pressure sensors 157 and 159, which are located on the upstream and downstream sides of the blood pumps, as described above with reference to fig. 12C-D. When the blood pump 150 is placed in a renal vein (e.g., as shown in fig. 21A), the pressure measured by the upstream pressure sensor 157 is indicative of the blood pressure upstream of the blood pump, the pressure measured by the downstream pressure sensor 159 is indicative of the central venous pressure. For some applications, the control unit receives an input from additional sensors 161 (e.g., a flow sensor and/or an oxygen saturation sensor) provided on the blood pump (e.g., on a downstream side of the blood pump, as shown in fig. 12 Ai). Alternatively or additionally, the control unit receives an input from a heat flow sensor, such as heat flow sensor 260 described below with reference to FIGS. 22 Ai-Cii.

For some applications, the control unit 234 controls the rotation of the impeller 152 by controlling the motor 232 in response to one or more of the inputs described above. Typically, user interface 236 displays the subject's current renal venous pressure and central venous pressure based on the plurality of pressures measured by sensors 157 and 159. Typically, a user (e.g., a medical professional) inputs a target value for the subject's renal venous pressure via the user interface based on the current values of the subject's renal venous pressure and central venous pressure. In response to the above, control unit 234 controls the speed of the rotation of the impeller to draw the impeller through the renal veins and toward the vena cava at a flow rate that reduces the renal vein pressure toward the target degree, as indicated by the user. For some applications, the control unit stops the impeller from rotating in response to receiving a message from the downstream sensor 159 indicating that the central venous pressure is at the target renal venous pressure. Generally, the control unit typically controls the speed of the rotation of the impeller in response to a plurality of inputs from pressure sensors 157 and 159. For some applications, the control unit typically controls the speed of the rotation of the impeller in response to an input from additional sensors 161, and/or heat flow sensors 260 (as shown in fig. 22Ai-22 Cii).

It is noted that a "control unit" as described in this application, in the description and in the claims, includes any type of processor (e.g., a computer processor) configured to perform the actions described herein. A "user interface" includes any type of user interface configuration for receiving inputs from a user and/or providing outputs to the user. For example, the user interface may include one or more input devices (e.g., a keyboard, a mouse, a trackball, a touch screen display, a touch pad, a voice-activated interface, a smart phone, a tablet computer, and/or other types of input devices known in the art), and/or one or more output devices (e.g., a display, an audio output device, a smart phone, a tablet computer, and/or other types of output devices known in the art).

Referring now to fig. 21B, therein is shown a schematic diagram of impeller-based blood pumps 150 inserted through the subclavian vein 240 of a subject into the left and right renal veins 32 of a subject, in accordance with some implementations of the present invention. It is noted that the details of the blood pump 150 are not shown in fig. 21B, but the pump is generally as described above. Typically, the multiple blood pumps are inserted into the left and right renal veins through respective catheters, and both the multiple catheters are inserted through the femoral vein. Alternatively (not shown), the multiple blood pumps are inserted through a single catheter and then passed from a subclavian access point to the vena cava of the subject. The plurality of blood pumps 150 as shown in fig. 21B are in all other respects substantially identical to the plurality of blood pumps 150 as shown in fig. 21A, except that they are inserted through a different vein into the plurality of renal veins.

Referring now to FIGS. 22Ai-Cii, a thermal flow sensor 260 in accordance with certain implementations of the invention is shown in conjunction with blood pump 150. The heat flow sensors typically include an upstream temperature sensor 262, a downstream temperature sensor 264, and a heating element 266 disposed between the upstream and downstream temperature sensors. As shown by the plurality of flow arrows in the enlarged view of the heat flow sensor shown in fig. 22Ai, blood flows past the upstream temperature sensor to the heating element. When the blood flows beyond the heating element, the heating element heats the blood. The heated blood then flows to the downstream temperature sensor. The extent to which blood that has been heated by the heating element flows past the downstream temperature sensor is a function of the flow rate of the blood. Thus, the heat flow sensor measures a change in the temperature of the blood between the upstream and downstream temperature sensors, and determines the flow of the blood in response thereto.

As described with reference to fig. 21A-B, for some applications, the control unit controls the speed of the rotation of the impeller in response to an input from a thermal flow sensor 260. Typically, it is of interest to measure the composition of the blood flow through the renal vein in the axial direction, e.g. the axial composition (component) of the blood flow parallel to the local longitudinal axis of the renal vein, as this determines the blood flow rate away from the subject's kidney. However, due to the rotation of the impeller, blood flow downstream of the impeller typically includes multiple components rather than the axial component (e.g., rotational and multiple radial components). For some applications, the heat flow sensor is disposed within a housing 268 configured to reduce components other than the axial components (e.g., rotational and radial components) of the blood flow generally in the axial direction and relative to the blood flow through the renal veins outside the housing.

Referring now to fig. 22Ai and 22Aii, which are schematic illustrations of a cross-sectional view and a top view, respectively, of the heat flow sensor 260 and the housing 268, in accordance with certain implementations of the present invention. Typically, the impeller 152 and cap 154 of the blood pump 150 are provided at the trailing end of an elongate member 270 (e.g., a tube) of the pump. For some applications, the elongated member 270 defines a gap and the heat flow sensor is received in the gap, the outer surface of the elongated member 170 defining the gap thus comprising the housing 168. Upstream temperature sensor 262, heating element 266, and downstream temperature sensor 264 are typically positioned sequentially along the length of the gap as shown. Typically, a ratio of the length LI of the gap to a width WI of the gap is greater than 4: 1; and/or less than 8: 1, for example in the range of 4: 1 and 8: 1. The ratio of the length LI to width WI typically reduces blood flow through the gap substantially in the direction parallel to the local longitudinal axis of the renal vein (and parallel to the local longitudinal axis of the elongate member) and in a plurality of components other than the axial component (e.g., rotational and radial components) of the blood flow relative to blood flow through the renal vein outside the housing. Because the thermal sensor is housed within the notch, the heat flow sensor measures the blood flow substantially in the direction parallel to the local longitudinal axis of the renal vein (and parallel to the local longitudinal axis of the elongated element).

For some applications (not shown), a single thermistor is used to measure flow, and the single thermistor is placed within a housing, typically such that blood flow through the housing is substantially in the direction parallel to the local longitudinal axis of the renal vein (and parallel to the local longitudinal axis of the elongate member), and such that components other than the axial component (e.g., rotational and radial components) of the blood flow are reduced relative to blood flow through the renal vein outside the housing, for example using the techniques described with respect to comparing fig. 21Ai-22 Cii. For such applications, a ratio of a length of the housing to the width of the housing is typically greater than 1: 1, e.g. greater than 4: 1. and/or less than 8: 1, for example in the range of 4: 1 and 8: 1. For such applications, when a housing such as that shown in fig. 22Ci-ii is used, the ratio of the length of the housing to the height of the housing is typically greater than 1: 1, e.g. greater than 4: 1, and/or less than 8: 1, for example in the range of 4: 1 and 8: 1.

Reference is now made to fig. 22Bi and 22Bii, which are schematic illustrations of a cross-sectional view and an upper view of the heat flow sensor 260 and the housing 280, respectively, in accordance with some implementations of the invention. The housing 268 shown in fig. 22Bi-22Bii is substantially similar to that shown in fig. 22Ai-22Aii, except that the heat flow sensor shown in fig. 22Bi-ii is covered by a covering other than that received within the notch in the elongated member 5. In other aspects, the thermal sensor and housing are substantially as described with reference to fig. 22Ai-22 Aii.

Reference is now made to fig. 22Ci-22Cii, which are schematic illustrations of various cross-sectional views of a heat flow sensor 260 and housing 268, in accordance with certain implementations of the invention. For some applications, the housing 268 housing the thermal sensor 260 comprises a housing, such as a tube, connected to the outer surface of the elongated member 270 of the blood pump 150. Typically, the housing is compressible so that it can be compressed during insertion of the blood pump into the blood vessel of the subject by insertion device 155.

An upstream temperature sensor 262, a heating element 266, and a downstream degree sensor 264 are typically disposed sequentially along the length of the housing, within the housing, as shown. Typically, a ratio of a length LH of the housing to a width WH of the housing is greater than 4: 1; and/or less than 8: 1, for example in the range of 4: 1 and 8: 1. Typically, a ratio of a length LH of the housing to a height HH of the housing is greater than 4: 1; and/or less than 8: 1, for example in the range of 4: 1 and 8: 1. The ratio of length LH to width WH, and length LH to height HH is typical so that blood flow through the housing is substantially in the direction parallel to the local longitudinal axis of the renal vein (and parallel to the local longitudinal axis of the elongate element), and so that a plurality of components other than the axial component (e.g., rotational and radial components) of the blood flow are reduced relative to blood flow through the renal vein outside the housing. Because the thermal sensor is housed within the notch, the heat flow sensor measures the blood flow substantially in the direction parallel to the local longitudinal axis of the renal vein (and parallel to the local longitudinal axis of the elongated element).

It is worth mentioning that in fig. 22Cii, said inner part of the elongated element 270 is shaded for explanatory purposes. Typically, however, the elongate member 270 houses a plurality of control mechanisms for controlling the movement of the impeller 152 and the shroud 154.

The experimental results are as follows:

reference is now made to fig. 23, which is a graph illustrating the results of the experiments performed on a healthy pig using an impeller-based blood pump 150, in accordance with certain applications of the present invention. In the whole experimental process, the pressure sensor arranged in the left renal vein of the pig is used for directly measuring the left renal vein pressure of the pig. Additionally, right renal vein pressure of the pig was measured using a pressure sensor within the vena cava at the level of the renal veins. Reference levels of blood flow to the left kidney, and urine output from the left and right kidneys were also measured, and the foregoing parameters were again measured at some point during the experiment.

A balloon is inflated in the porcine vena cava at the multiple junctions between the vena cava and the left and right renal veins. The balloon is inflated to increase the blood pressure in the porcine vena cava downstream of the plurality of renal veins by partially obstructing blood flow through the vena cava downstream of the plurality of renal veins. While the balloon is inflated in the porcine vena cava, an impeller-based blood pump, as described herein, is activated to draw blood through the left porcine renal vein, although no assistance is provided to the blood flow through the right porcine renal vein. While the balloon is still inflated, the blood pump in the left renal vein is temporarily turned off for a while before being turned on again. Subsequently, the balloon within the vena cava is deflated and the blood pump is turned off.

The upper graph in fig. 23 indicates that left renal venous pressure, as measured during the experiment, is indicated by the solid curve, and right renal venous pressure, as indicated by the phantom curve. It is worth noting that for purposes of more clearly depicting the left and right renal vein pressure measurements, where the left and right renal vein pressure measurements are the same (e.g., approximately between 12: 35 and 13: 28, the two curves have been slightly separated; additionally, a number of small changes in vein pressure have been ignored; as shown, initially, during the baseline, the left and right renal vein pressures are similar to one another, approximately at 8 mm Hg. subsequently, at 13: 28, the balloon is inflated and the impeller-based blood pump is activated within the left renal vein; as a result of the balloon being inflated, the pressure within the vena cava rises, and thus the right renal vein pressure rises to approximately 22 mm Hg; only the pressure of the vena cava rises, the left renal pressure does not increase due to the draw of blood through the renal veins. At approximately 14: the blood pump in the left renal vein is turned off, and as a result, the left renal pressure rises to the level of the venous pressure in the vena cava, 10. Subsequently, at approximately 14: 40, the pump is turned on again, as a result of which the pressure in the left renal vein drops. Subsequently, at 15: 24, the balloon is deflated and the renal pressure within the vena cava, and thus the right renal vein pressure falls. These results indicate that an impeller-based blood pump as described herein can effectively reduce renal venous pressure even if the central venous pressure of a subject is elevated.

The middle graph of fig. 23 depicts the renal blood flow measured within the left renal vein. As shown, the baseline value for left renal blood flow is approximately 360 mm/min. When the balloon has been inflated in the vena cava and the blood pump is operated in the left renal vein, the renal blood flow is measured again. As shown, the left renal blood flow has risen to approximately 440 ml/min due to the drawing of the blood by the blood pump. Subsequently, when the balloon is inflated within the vena cava, and when the blood pump has been turned off, left renal blood flow is measured, and the renal blood flow has dropped to approximately 380 ml/min. Subsequently, when the blood pump has been turned back on, the left renal blood flow is measured again, and the left renal blood flow has again risen to approximately 340 ml/min. These results indicate that an impeller-based blood pump as described herein can efficiently increase renal blood flow even if the central venous pressure of a subject is elevated.

It is noted that for purposes of explanation, changes in renal blood flow between one data point and the next are shown on the graph as having occurred at a constant rate. However, the inventors speculate that the changes in renal blood flow are substantially due to the blood pump being turned on or off in the left renal vein and/or due to the inflation of the balloon in the vena cava such that a majority of the changes in renal blood flow have occurred in response to the occurrence of the events.

The lower graph of fig. 23 depicts urine volume measured at the left (indicated by the solid curve) and right (indicated by the dashed curve) kidneys of the pigs at certain times during the experiment. Notably, in general, the blood flow rate through the kidney is known to have an effect on the urine volume rate. As shown, urine production from the left and right kidneys was approximately 21 mm every 10 minutes as measured during the baseline period. Then, when the balloon is inflated in the vena cava, and when the blood pump is operating in the left renal vein, at approximately 14: the urine volume of 00 is measured. As shown, when urine production from the right kidney has decreased, urine production from the left kidney increases. These results indicate that even when central venous pressure rises, which may lead to a decrease in urine volume (as indicated by the urine volume from the right kidney), urine volume may be increased by increasing renal blood flow by drawing blood using a blood pump (as implemented in the left kidney vein).

Subsequently, at approximately 14: 35, while the balloon is still inflated in the vena cava, but while the blood pump is turned off, urine volume from the left and right kidneys is measured. At this point, urine production at the right kidney has continued to decline as urine volume from the left kidney has also declined. Subsequently, after the blood pump has been turned on again, and while the balloon of the vena cava is still inflated, the urine volume from the right kidney has stabilized at approximately 14 millimeters per 10 minutes, and 48 millimeters as the urine volume from the right kidney rises to approximately 48 millimeters per 10 minutes.

It is noted that for purposes of explanation, changes in urine production between one data point and the next are shown on the graph as having occurred at a constant rate. However, the inventors speculate that the changes in urine are substantially due to the blood pump being turned on or off in the left renal vein and/or due to the inflation of the balloon in the vena cava such that a majority of the changes in urine have occurred in response to the occurrence of the events described above.

In yet another experiment, an impeller-based blood pump as described herein was used to draw blood through the renal blood vessels of a different pig over a continuous period of three hours. During this time period, no abnormality in the incidence of thrombosis or level of hemolysis occurred. This indicates that an impeller-based blood pump as described herein may be used to increase blood flow through the kidneys of a subject, thereby reducing the pressure in the renal veins without risking abnormal levels of thrombosis and/or hemolysis. Notably, during the foregoing experiments, an anticoagulant was administered to the pigs. However, because in a typical procedure performed on a human subject using an impeller-based blood pump as described herein, the subject is administered an anticoagulant, it remains the result that an impeller-based blood pump as described herein may be used to increase the flow of blood through the renal veins of a subject, thereby reducing the pressure within the renal veins without a risk of hemolysis and/or thrombosis.

In a general case, in the above experiments, and in a number of additional experiments carried out by the inventors of the present application using blood pump 150 in a number of pigs, the following observations were made:

1. blood pump 150 is successfully deployed and retrieved in a minute or less.

2. The renal venous pressure is effectively and continuously reduced from about 20 mm hg to a predetermined target value of 8 mm hg within a varying minimum margin.

3. The increase in venous pressure within the kidney veins decreases urine volume, creatinine clearance, and sodium excretion rate in untreated kidneys, but not in the kidneys treated with blood pump 150. These results indicate that the use of the blood pump 150 has a beneficial effect on glomerular and tubular function.

4. The use of blood pump 150 preserves and restores renal blood flow, urine volume, and sodium excretion rate even when venous pressure in the vena cava rises

5. With the pressure in the renal vein held constant for more than 3 hours, the blood pump 150 successfully operates in a closed loop mode.

6. No thrombus was observed in any part of the blood pump or the catheter.

7 in the case of operating the pump over 3 hours, no clinically significant hemolysis was observed.

It is noted that although some of the pumps and/or occlusions described herein are depicted as being inserted into predetermined ones of the subject's renal veins, the scope of the invention includes inserting the pumps and occlusions into a left or right renal vein, or into two renal veins of a subject. Further, the scope of the invention includes inserting the pumps and occlusions into more than two renal veins of a subject, which may have more than two renal veins, as is the case in some people.

It is noted that although some of the pumps and/or occlusions described herein are depicted as being inserted into renal veins of the subject, the scope of the invention includes inserting pumps and occlusions into other veins of a subject, as opposed to the above. For example, to reduce venous pressure within the vein and/or to reduce pressure within an organ that draws blood from the vein (e.g., to reduce liver congestion), the reverse valve 40 (fig. 5A-D and 6A-F) may be placed within the hepatic, intestinal, or adrenal veins of a subject.

Alternatively or additionally, blood pump 90 (fig. 8A-B and 10A-D) may be placed in a hepatic vein, an intestinal vein, or an adrenal vein of a subject in order to reduce venous pressure in the vein and/or reduce pressure in an organ drawing blood from the vein (e.g., to reduce hepatic congestion). Alternatively, to reduce intracranial pressure by draining cerebrospinal fluid from the chamber, a blood pump may be placed inside the fluid-filled cavity inside the brain. Alternatively or additionally, blood pump 90 may be used as a left ventricular assist device by being placed in the subject's aorta and drawing blood away from the left ventricle. Alternatively or additionally, a blood pump 90 may be placed within the urethra to maintain the prostate of the subject open and to drain the bladder of the subject.

In general, sleeve 110 (fig. 10A-C) may be used to separate into a separate compartment from the blood flow into a main vein, the blood in multiple tributary veins supplying the main vein, and pump 122 may then be used to control the blood flow from the compartment into the main vein.

For some applications, to reduce venous pressure in the vein and/or to reduce pressure in an organ drawing blood from the vein (e.g., to reduce hepatic congestion), a stoma-covering umbrella 140 (fig. 11A-C) is used to cover a stoma at a junction between a hepatic vein, an intestinal vein, or an adrenal vein and another vein of a subject, and a blood pumping catheter is used to control the blood flow from the hepatic vein, the intestinal vein, or the adrenal vein and the other veins.

For some applications, blood pump 150 (fig. 12Ai-E) is placed within an artery supplying an outer limb to increase perfusion of the outer limb, for example, to treat a gangrene limb. Alternatively or additionally, a blood pump, such as blood pump 150, is placed within an artery, such as the descending aorta, in order to push blood away from the heart, such as to reduce afterload, and/or otherwise improve heart function.

In general, throughout the description and claims of this application, the term "proximal" and related terms, when used in reference to a device or a portion thereof, should be interpreted to refer to an end of the device or the portion thereof, when inserted into a subject's body, typically closer to a location through which the device is inserted into the subject's body. The term "distal" and related terms, when used in reference to a device or a portion thereof, should be interpreted to refer to an end of the device or the portion thereof, when inserted into a subject's body, typically farther from a location through which the device is inserted into the subject's body.

In general, in the description and claims of the present application, the term "downstream" and related terms, when used in reference to a blood vessel, or to a portion of a device configured for placement within a blood vessel, should be interpreted to refer to a location within the blood vessel, or a portion of the device, for placement at a location within the blood vessel, i.e., downstream, relative to the direction of antegrade blood flow through the blood vessel, relative to a different location within the blood vessel. The term "upstream" and related terms, when used in reference to a blood vessel, or to a portion of a device configured for placement within a blood vessel, should be interpreted to refer to a location within the blood vessel, or a portion of the device, that is intended to be placed at a location within the blood vessel, i.e., upstream, relative to the direction of antegrade blood flow through the blood vessel, relative to a different location within the blood vessel.

Thus, according to some applications of the present invention, the following inventive concepts are provided:

inventive concept 1: a method for use with a plurality of branch veins providing a main vein, comprising:

mechanically separating blood in the plurality of veins into a compartment separate from blood flow in the main vein; and

controlling blood flow from the plurality of veins to the main vein by drawing blood from the compartment to the main vein.

Inventive concept 2: the method according to inventive concept 1, further comprising: performing ultrafiltration on the drawn blood.

Inventive concept 3: according to the method of the inventive concept 1,

wherein the step of separating the plurality of veins comprises:

placing a blood-impervious sleeve and a helical support member disposed around said sleeve into said main vein, an

Using the helical support to connect the sleeve to a wall of the main vein; and

wherein the step of drawing blood from the compartment to the main vein comprises: using the helical support to guide a distal portion of a blood pump into the compartment and using the blood pump to draw the blood.

Inventive concept 4: the method according to inventive concept 1, wherein:

The step of separating the plurality of veins comprises:

placing a blood-impermeable sleeve and a spiral portion of a blood pump disposed around said sleeve into said main vein, an

Connecting the sleeve to a wall of the main vein: and

the step of drawing blood from the compartment to the main vein comprises: drawing blood into a plurality of access holes of the blood pump defined by the spiral portion of the blood pump.

Inventive concept 5: the method according to any one of inventive concepts 1-4, wherein:

The step of drawing blood from the compartment to the main vein comprises: a pump is operated to draw blood from the compartment to a location in fluid communication with an interior of the sleeve.

Inventive concept 6: the method according to inventive concept 5, wherein: the step of drawing blood from the compartment comprises: drawing blood in a downstream direction through the plurality of renal veins.

Inventive concept 7: the method according to inventive concept 5, wherein: placing said sleeve within said vena cava for less than one week, and wherein said step of operating said pump comprises: the pump was operated for less than one week.

Inventive concept 8: the method according to inventive concept 5, further comprising: identifying the subject as having a disease selected from: a subject in a condition selected from the group consisting of cardiac insufficiency, congestive heart failure, decreased renal blood flow, increased renal vascular resistance, hypertension and renal insufficiency, and operating said pump comprising: in response to identifying the subject as suffering from the condition, reducing blood pressure within a plurality of renal veins of the subject by operating the pump.

Inventive concept 9: the method according to inventive concept 5, wherein the step of placing the sleeve within the vena cava of the subject comprises: anchoring the sleeve to the vena cava by circumferentially compressing at least a portion of the sleeve by operating the pump.

Inventive concept 10: the method according to inventive concept 5, wherein: the step of operating the pump to draw blood from the compartment to the location in fluid communication with an interior of the sleeve comprises: operating the pump to draw blood from the compartment to a location of the vena cava upstream of the sleeve.

Inventive concept 11: the method according to inventive concept 5, wherein: the step of operating the pump to draw blood from the compartment to the location in fluid communication with an interior of the sleeve comprises: operating the pump to draw blood from the compartment to a location of the vena cava downstream of the sleeve.

Inventive concept 12: the method according to inventive concept 5, wherein: the step of placing the sleeve into the vena cava comprises: placing within the vena cava:

a stent configured to define widened upstream and downstream ends thereof, widened relative to a central portion of the stent, an

Connecting the stent to the vessel such that:

Inventive concept 13: the method according to inventive concept 5, wherein: the step of placing the sleeve into the vena cava comprises: placing within the vena cava:

a sleeve configured to define a plurality of flared ends thereof, and a narrow central portion located between the flared ends; and

a stent configured to define:

A vessel-wall-support stent connected to the stenotic central portion of the sleeve-support stent and radially protruding from the sleeve-support stent.

Inventive concept 14: the method according to inventive concept 13, wherein: the step of drawing blood from the compartment comprises: drawing blood from a location between an outside of the sleeve and an inner wall of the vena cava.

Inventive concept 15: the method according to inventive concept 5, further comprising: the pump is insertable through an opening in the sleeve to insert the pump into the compartment.

Inventive concept 16: the method according to inventive concept 15, wherein: the step of inserting the pump through the opening comprises: the pump is inserted through an opening having a diameter between 2 mm and 10 mm.

Inventive concept 17: the method according to inventive concept 15, wherein: the step of inserting the pump through the opening comprises: the pump is inserted through the opening such that the opening forms a seal around the pump.

Inventive concept 18: the method according to inventive concept 5, further comprising inserting the pump into the compartment through a pump-receiving sleeve protruding from the sleeve.

Inventive concept 19: the method according to inventive concept 18, wherein: inserting the pump into the compartment through the pump-receiving sleeve comprises: the pump is inserted into the compartment through a pump-receiving sleeve having a diameter between 2 mm and 10 mm.

Inventive concept 20: the method according to inventive concept 18, wherein: inserting the pump into the compartment through the pump-receiving sleeve comprises: inserting the pump through the pump-receiving sleeve into the compartment such that the pump-receiving sleeve forms a seal around the pump.

Inventive concept 21: an apparatus, comprising:

a blood seepage prevention sleeve;

at least one support structure configured to connect a first end and a second end of the sleeve to a blood vessel of a subject; and

a pump configured to draw blood from an exterior of the sleeve to a location in fluid communication with an interior of the sleeve.

Inventive concept 22: the apparatus according to inventive concept 21, wherein: the pump is configured to perform ultrafiltration on the blood.

Inventive concept 23: the apparatus according to inventive concept 21, wherein: the pumping arrangement is configured to anchor the structure to the vessel by causing the vessel to circumferentially compress at least a portion of the structure.

Inventive concept 24: according to the apparatus of the inventive concept 21,

wherein: the structure comprises a stent configured to define a plurality of widened ends thereof, widened relative to a central portion of the stent, and

the sleeve comprises a sleeve connected to the bracket,

said sleeve defining a plurality of flared ends thereof, connected to said plurality of widened ends of said support,

at least one of the flared ends of the sleeve is configured to act as a valve by at least partially separating the widened end of the stent to which it is attached in response to pressure applied to the flared end of the sleeve.

Inventive concept 25: the apparatus according to inventive concept 21, wherein:

the support structure includes a spiral support member disposed around the sleeve, and

a distal portion of the blood pump is configured to be guided to fit around the exterior of the sleeve using the helical support.

Inventive concept 26: the apparatus according to inventive concept 21, wherein:

the support structure comprises a spiral portion of the blood pump disposed around the sleeve and configured to support the sleeve, an

The pump is configured to draw blood from the exterior of the sleeve by drawing blood into the plurality of access holes of the pump defined by the helical portion of the blood pump.

Inventive concept 27: the apparatus according to any of the inventive concepts 21-24, wherein:

said sleeve being configured to define a plurality of flared ends thereof and a narrow central portion between said flared ends;

the structure comprises a scaffold configured to define:

a vessel-wall-support stent is connected to the narrow central portion of the sleeve-support stent and projects radially therefrom.

Inventive concept 28: the apparatus according to inventive concept 27, wherein: the pump is configured to draw blood from between an exterior of the sleeve and an interior wall of the vessel by being placed between the exterior of the sleeve and the vessel-wall-supporting stent.

Inventive concept 29: the apparatus according to any of the inventive concepts 21-26, wherein: the structure is configured to separate blood within a renal vein of the subject into a compartment separate from blood flow within a vena cava of the subject by connecting a downstream end of the sleeve to a wall of the vena cava at a first location downstream of all renal veins of the subject and by connecting an upstream end of the sleeve to a wall of the vena cava at a second location upstream of all renal veins of the subject.

Inventive concept 30: the apparatus according to inventive concept 29, wherein: the sleeve is configured to connect to the vena cava for less than one week, and the pumping is configured to operate for less than one week.

Inventive concept 31: the apparatus according to inventive concept 29, wherein: the pumping is configured to reduce blood pressure within a plurality of renal veins of the subject by drawing blood.

Inventive concept 32: the apparatus according to inventive concept 29, wherein: the pump is configured to draw blood from the compartment to a location within the vena cava.

Inventive concept 33: the apparatus according to inventive concept 32, wherein: the pump is configured to draw blood from the compartment to a location within the vena cava upstream of the sleeve.

Inventive concept 34: the apparatus according to inventive concept 32, wherein: the pump is configured to draw blood from the compartment to a location within the vena cava downstream of the sleeve.

Inventive concept 35: the apparatus according to any of the inventive concepts 21-26, wherein: the sleeve is configured to define an opening through which the pump is insertable.

Inventive concept 36: the apparatus according to inventive concept 35, wherein: the opening has a diameter of between 2 mm and 10 mm.

Inventive concept 37: the apparatus according to inventive concept 35, wherein: the opening is sized to form a seal around the pump.

Inventive concept 38: the device according to any of the inventive concepts 21-26, further comprising a pump-receiving sleeve protruding from the blood-leakage prevention sleeve, the pump-receiving sleeve configured to receive the pump inserted through the exterior of the blood-leakage prevention sleeve.

Inventive concept 39: the apparatus according to inventive concept 38, wherein: an inner diameter of the pump-receiving sleeve is between 2 mm and 10 mm.

Inventive concept 40: the apparatus according to inventive concept 38, wherein: the pump-receiving sleeve is sized to form a seal around the pump.

Inventive concept 41: one method comprises the following steps:

placing a stent in a blood vessel at a placement location of the stent; and

The inventive concept 42: the method according to inventive concept 41, wherein: the vessel comprises a blood vessel having a predetermined diameter at the placement location, and the step of placing the stent in the vessel comprises placing the stent having a diameter less than the predetermined diameter in the vessel.

Inventive concept 43: the method according to inventive concept 41, wherein: the step of circumferentially compressing the vessel against at least a portion of the stent comprises: by over-sizing the stent to reduce the anchoring of the stent to the vessel to a degree relative to if the vessel was not anchored around at least the portion of the stent.

Inventive concept 44: an apparatus comprising:

a stent configured for placement within a vessel at a placement location of the stent;

Inventive concept 45: the apparatus according to inventive concept 44, wherein: the vessel comprises a blood vessel having a predetermined diameter at the placement location, and the stent comprises a stent having a diameter less than the predetermined diameter.

Inventive concept 46: an apparatus comprising:

a stent configured for placement within a blood vessel, the stent configured to define a plurality of widened ends thereof, widened relative to a central portion of the stent; and

A blood-impermeable sleeve connected to the stent,

said sleeve defining a plurality of flared ends thereof, connected to said plurality of widened ends of said support,

Inventive concept 47: one method comprises the following steps:

placing within a blood vessel of a subject:

a stent configured to define widened upstream and downstream ends thereof, widened relative to a central portion of the stent, an

connecting the stent to the vessel such that:

Inventive concept 48: an apparatus comprising:

a blood seepage prevention sleeve defining a plurality of flared ends thereof and a narrow central portion located between the flared ends; and

a stent configured for placement within a vessel, the stent configured to define:

a vessel-wall-support stent is connected to the narrow central portion of the sleeve-support stent and projects radially therefrom.

Inventive concept 49: the device according to inventive concept 48, further comprising a blood pump configured to draw blood from between an exterior of the sleeve and an inner wall of the blood vessel by being placed between the exterior of the sleeve and the vessel-wall-supporting stent.

Inventive concept 50: the apparatus according to inventive concept 48, wherein: a diameter of the narrow central portion of the sleeve is between 8 mm and 35 mm.

Inventive concept 51: the apparatus according to inventive concept 48, wherein: a maximum diameter of the flared ends of the sleeve is between 10 mm and 45 mm.

Inventive concept 52: the apparatus according to inventive concept 48, wherein: a ratio of a maximum diameter of the flared ends of the sleeve to a diameter of the narrow central portion of the sleeve is in the range of 1.1: 1 and 2: 1.

Inventive concept 53: the apparatus according to inventive concept 48, wherein: a maximum diameter of the vessel-wall-support stent is between 10 mm and 50 mm.

Inventive concept 54: the apparatus according to any of the inventive concepts 48-53, wherein: the ratio of a maximum diameter of said wall-support stent to a diameter of said narrow central portion of said sleeve-support stent is in the range of 1.1: 1 and 5: 1.

Inventive concept 55: the apparatus according to inventive concept 54, wherein: the ratio is greater than 1.5: 1.

inventive concept 56: the apparatus according to any of the inventive concepts 48-53, wherein: a length of the sleeve is greater than 6 millimeters.

Inventive concept 57: the apparatus according to inventive concept 56, wherein: the length of the sleeve is less than 80 millimeters.

Inventive concept 58: the apparatus according to inventive concept 56, wherein: a length of each of the plurality of flared ends of the sleeve is greater than 3 millimeters.

Inventive concept 59: the apparatus according to inventive concept 58, wherein: the length of each of the plurality of flared ends of the sleeve is less than 40 millimeters.

Inventive concept 60: the apparatus according to inventive concept 56, wherein: a length of the narrow central portion of the sleeve is greater than 3 millimeters.

Inventive concept 61: the apparatus according to inventive concept 60, wherein: the length of the narrow central portion of the sleeve is less than 70 millimeters.

The inventive concept 62: a method, comprising:

placing within a blood vessel of a subject:

a blood seepage prevention sleeve defining a plurality of flared ends thereof and a narrow central portion located between the flared ends; and

a stent configured to define:

A vessel-wall-supporting stent connected to the narrow central portion of the sleeve-supporting stent and radially protruding therefrom; and

connecting the stent to the vessel by supporting the wall of the vessel such that the vessel-wall-supporting stent of the stent remains open to the vessel, and the sleeve-supporting stent supports the sleeve within the vessel.

Inventive concept 63: the method according to inventive concept 62, further comprising drawing blood from a location between an outside of the sleeve and an inner wall of the vena cava by placing a pump between the outside of the sleeve and the vessel-wall-supporting stent.

Inventive concept 64: the method according to inventive concept 62, wherein: the step of placing the sleeve into the vessel comprises: placing said sleeve into said blood vessel, said narrow central portion of said sleeve having a diameter of between 8 mm and 35 mm.

Inventive concept 65: the method according to inventive concept 62, wherein: the step of placing the sleeve into the vessel comprises: placing said sleeve into said blood vessel, said flared ends of said sleeve having a maximum diameter of between 10 mm and 45 mm.

The inventive concept 66: the method according to inventive concept 62, wherein: the step of placing the sleeve into the vessel comprises placing the sleeve into the vessel with a ratio of a maximum diameter of the flared ends of the sleeve to a diameter of the narrow central portion of the sleeve between 1.1:1 and 2: 1.

Inventive concept 67: the method according to inventive concept 62, wherein: the step of placing the sleeve into the vessel comprises placing the sleeve into the vessel with a maximum diameter of the vessel-wall-support stent between 10 mm and 50 mm.

Inventive concept 68: the method according to any of the inventive concepts 62-67, wherein: the step of placing the sleeve into the vessel comprises: placing said sleeve into said vessel, a maximum diameter of said wall-support scaffold and a diameter of said narrow central portion of said sleeve-support scaffold being between 1.1:1 and 5: 1.

Inventive concept 69: the method according to inventive concept 68, wherein: the step of placing the sleeve into the vessel comprises: placing said sleeve into said vessel, said ratio being greater than 1.5: 1.

Inventive concept 70: the method according to any of the inventive concepts 62-67, wherein: the step of placing the sleeve into the vessel comprises: placing said sleeve into said blood vessel, said sleeve having a length greater than 6 mm.

Inventive concept 71: the method according to inventive concept 70, wherein: the step of placing the sleeve into the vessel comprises: placing said sleeve into said blood vessel, said length of said sleeve being less than 80 millimeters.

Inventive concept 72: the method according to inventive concept 70, wherein: the step of placing the sleeve into the vessel comprises: placing the sleeve into the vessel, a length of each of the plurality of flared ends of the sleeve being greater than 3 millimeters.

Inventive concept 73: the method according to inventive concept 72, wherein: the step of placing the sleeve into the vessel comprises: placing said sleeve into said blood vessel, said length of each of said plurality of flared ends of said sleeve being less than 40 millimeters.

Inventive concept 74: the method according to inventive concept 70, wherein: the step of placing the sleeve into the vessel comprises: placing said sleeve into said blood vessel, said narrow central portion of said sleeve having a length greater than 3 mm.

Inventive concept 75: the method according to inventive concept 74, wherein: the step of placing the sleeve into the vessel comprises: placing said sleeve into said blood vessel, said length of said narrow central portion of said sleeve being less than 70 millimeters.

Inventive concept 76: a method of operating a blood pump disposed within a blood vessel of a subject, the method comprising:

drawing blood in a downstream direction from a location in fluid communication with an upstream side of the occlusion;

drawing blood into a blood vessel of the subject on a downstream side of the occlusion,

the drawing of the blood into the blood vessel of the subject is carried out in a manner that maintains the occlusion in an occlusion state in which the occlusion occludes the blood vessel.

Inventive concept 77: the method according to inventive concept 76, further comprising performing ultrafiltration on the blood prior to drawing the blood into the location of the blood vessel of the subject.

Inventive concept 78: the method according to inventive concept 76, wherein: the step of placing the occlusion member in the vessel comprises: placing the occlusion member in the blood vessel for less than one week, and drawing the blood comprises drawing the blood into the blood vessel for less than one week.

Inventive concept 79: the method according to inventive concept 76, wherein: the step of placing the occlusion member in the vessel comprises: placing the occlusion member in the blood vessel for more than one week, and drawing the blood comprises drawing the blood into the blood vessel for less than one week.

Inventive concept 80: the method according to inventive concept 76, further comprising identifying the subject as suffering from a disease selected from the group consisting of: a subject in a condition selected from the group consisting of cardiac insufficiency, congestive heart failure, decreased renal blood flow, increased renal vascular resistance, hypertension and renal insufficiency, wherein the blood vessel comprises a renal vein of the subject, and wherein the step of drawing blood in the downstream direction from the location in fluid communication with the upstream side of the occluding member comprises: in response to identifying that the subject is afflicted with the condition, reducing blood pressure within a renal vein of the subject by drawing the blood in the downstream direction.

Inventive concept 81: the method according to any of the inventive concepts 76-80, wherein: the step of drawing the blood into the blood vessel of the subject to maintain the occlusion in the occluded state thereof comprises: drawing the blood into the blood vessel of the subject such that the hydrodynamic pressure of the blood drawn into the blood vessel of the subject maintains the occlusion in its occluded state.

Inventive concept 82: the method according to inventive concept 81, wherein: the step of placing a valve having a plurality of valve leaflets within the blood vessel and drawing the blood into the blood vessel of the subject such that the hydrodynamic pressure of the blood drawn into the blood vessel of the subject maintains the occluding member in its occluded state comprises: drawing the blood into a blood vessel of the subject such that the blood drawn into the blood vessel of the subject directly impacts a plurality of downstream sides of the plurality of valve leaflets.

Inventive concept 83: the method according to inventive concept 82, wherein: the step of placing the valve in the vessel comprises placing the valve in the vessel such that:

In response to blood pressure on an upstream side of the valve leaflets exceeding pressure on the downstream side of the valve leaflets, blood flows in an antegrade direction between cusps of the valve leaflets and an inner wall of the blood vessel, an

Inventive concept 84: the method according to inventive concept 82, wherein: the step of drawing the blood into the blood vessel of the subject such that the blood drawn into the blood vessel of the subject directly impacts downstream sides of the plurality of valve leaflets includes reducing blood clots at the plurality of valve leaflets by flushing the plurality of valve leaflets.

Inventive concept 85: the method according to inventive concept 82, wherein: further comprising: drawing an anticoagulant into the blood vessel of the subject along with the blood drawn into the blood vessel of the subject such that the anticoagulant directly impacts the plurality of valve leaflets.

Inventive concept 86: the method according to inventive concept 82, wherein: the step of placing the valve into the vessel comprises: maintaining portions of the valve leaflets in contact with a wall of the blood vessel by inflating a balloon.

Inventive concept 87: the method according to inventive concept 82, wherein: the step of placing the valve into the vessel comprises: maintaining portions of the valve leaflets in contact with a wall of the blood vessel by radially outwardly expanding portions of a slit tube.

Inventive concept 88: the method according to inventive concept 82, wherein: the step of drawing the blood to directly impinge the blood on downstream sides of the plurality of valve leaflets comprises: drawing the blood into a blood vessel of the subject through a plurality of apertures configured to direct the blood toward the plurality of downstream sides of the plurality of valve leaflets.

Inventive concept 89: the method according to inventive concept 82, wherein: the step of drawing the blood to directly impinge the blood on downstream sides of the plurality of valve leaflets comprises: drawing the blood into the blood vessel of the subject through a pumping conduit configured to define a radial protrusion concavely curved therefrom toward a distal end of the conduit, the radial protrusion configured to direct blood drawn into the blood vessel toward the plurality of valve leaflets.

Inventive concept 90: the method according to inventive concept 82, wherein: the step of drawing the blood to directly impinge the blood on downstream sides of the plurality of valve leaflets comprises: drawing the blood into a blood vessel of the subject at a plurality of bases adjacent to the plurality of valve leaflets through a plurality of apertures.

Inventive concept 91: the method according to inventive concept 90, wherein: the step of drawing the blood to directly impinge the plurality of downstream sides of the plurality of valve leaflets includes: drawing the blood into the blood vessel of the subject through a plurality of apertures disposed adjacent to a location along a plurality of lengths of the plurality of valve leaflets midway between the plurality of cusps of the plurality of leaflets and the plurality of bases of the plurality of valve leaflets.

Inventive concept 92: a device for use with a blood vessel of a subject, the device comprising:

A vascular pump arrangement for:

drawing blood in a downstream direction from a location in fluid communication with an upstream side of the occlusion, an

Inventive concept 93: the apparatus according to inventive concept 92, wherein: the blood pump is configured to perform ultrafiltration on the blood prior to drawing the blood into a blood vessel of the subject.

Inventive concept 94: the apparatus according to inventive concept 92, wherein: the occlusion is configured to be placed within the blood vessel for less than one week, and the pump is configured to draw blood into the blood vessel for less than one week.

Inventive concept 95: the apparatus according to inventive concept 92, wherein: the occlusion is configured to be placed within the blood vessel for more than one week, and the pump is configured to draw blood into the blood vessel for less than one week.

The inventive concept 96: the apparatus according to any of the inventive concepts 92-95, wherein: the pumping is arranged to be carried out in the manner in which the drawing of the blood into the blood vessel of the subject maintains the occlusion in the occlusive state thereof by drawing the blood into the blood vessel of the subject, such that the hydrodynamic pressure of the blood drawn into the blood vessel of the subject maintains the occlusion in the occlusive state thereof.

Inventive concept 97: the apparatus according to inventive concept 96, wherein: the occlusion comprises a valve having a plurality of valve leaflets, and the pump is configured to draw the blood into the blood vessel of the subject such that the hydrodynamic pressure of the blood maintains the occlusion in its occluded state by drawing the blood into the blood vessel of the subject such that the blood drawn into the blood vessel of the subject directly impacts a plurality of downstream sides of the plurality of valve leaflets.

Inventive concept 98: the apparatus according to inventive concept 97, wherein: the valve is configured such that:

Inventive concept 99: the apparatus according to inventive concept 97, wherein: the pumping is configured to reduce a plurality of blood clots at the plurality of valve leaflets by flushing the plurality of valve leaflets by drawing the blood into a blood vessel of the subject such that the blood drawn into the blood vessel of the subject directly impacts a plurality of downstream sides of the plurality of valve leaflets.

The inventive concept 100: the apparatus according to inventive concept 97, wherein: the device is used in conjunction with an anticoagulant, and the pump is configured to draw the anticoagulant along with the blood drawn into the blood vessel of the subject such that the anticoagulant directly impacts the valve leaflets.

The inventive concept 101: the apparatus according to inventive concept 97, further comprising a balloon configured to maintain portions of the valve leaflets in contact with a wall of the blood vessel by being inflated.

The inventive concept 102: the device according to inventive concept 97, further comprising a slit tube configured to be inserted into the blood vessel through portions of the slit tube between the slits radially expanded outward and to maintain portions of the valve leaflets in contact with a wall of the blood vessel.

The inventive concept 103: the apparatus according to inventive concept 97, wherein: the blood pump is configured to connect to the valve, the blood pump includes a plurality of output holes at the blood vessel of the subject by drawing the blood, and the plurality of output holes are configured such that when the blood pump is connected to the valve, the plurality of output holes direct the blood toward the plurality of downstream sides of the plurality of valve leaflets.

The inventive concept 104: the apparatus according to inventive concept 97, wherein: the blood pump is configured to be connected to the valve, the blood pump including a blood pumping conduit defining a radial projection concavely curved therefrom toward a distal end of the conduit, the radial projection configured such that when the blood pump is connected to the valve, the radial projection directs blood drawn into the blood vessel toward the plurality of valve leaflets.

The inventive concept 105: the apparatus according to inventive concept 97, wherein: the blood pump is configured to connect to the valve, the blood pump includes a plurality of output holes through which the blood is drawn into the blood vessel of the subject, and the plurality of output holes are disposed on the blood pump such that when the blood pump is connected to the valve, the plurality of holes are adjacent to a plurality of seats of the plurality of valve leaflets.

The inventive concept 106: the apparatus according to the inventive concept 105, wherein: the plurality of output holes are disposed on the blood pump such that when the blood pump is connected to the valve, the plurality of output holes are adjacently disposed to a location along a plurality of lengths of the plurality of valve leaflets that is midway between the plurality of prongs of the plurality of valve leaflets and the plurality of bases of the plurality of valve leaflets.

Inventive concept 107: a device for use with a blood vessel of a subject, the device comprising:

a blood pump configured to draw blood in a downstream direction through the blood vessel into the pump; and

The inventive concept 108: the apparatus according to inventive concept 107, wherein: the valve also includes a plurality of resilient valve leaflets connected to the plurality of rigid portions of the valve.

Inventive concept 109: one method comprises the following steps:

providing an artificial valve defining a plurality of valve leaflets; and

Placing the valve in a blood vessel such that:

The inventive concept 110: an apparatus comprising:

an artificial valve comprising a plurality of resilient valve leaflets and a rigid valve support, the valve leaflets being connected to the valve support such that:

Inventive concept 111: an apparatus comprising:

a blood pump, comprising:

a tube;

the first one-way valve and the second one-way valve are respectively arranged at the near end and the far end of the pipe;

a pumping mechanism configured to pump fluid through the tube by increasing and gradually decreasing the size of the first compartment by moving the membrane relative to the tube.

The inventive concept 112: the apparatus according to inventive concept 111, wherein: the tube includes a support, and a material disposed on the support.

Inventive concept 113: the apparatus according to inventive concept 111, wherein: the occlusion is configured to be placed within the blood vessel for less than one week.

The inventive concept 114: the apparatus according to inventive concept 111, wherein: one of the valves is configured to prevent backflow of blood from the tube into the blood vessel, and a second of the valves is configured to prevent backflow of blood from the blood vessel into the tube.

The inventive concept 115: the apparatus according to any one of the inventive concepts 111-114, wherein: the blood pump is configured to be placed within a renal vein of a subject and to draw blood in a downstream direction from the renal vein to a vena cava of the subject.

The inventive concept 116: the apparatus according to any of the inventive concepts 115, wherein: the blood pump is configured to occlude a return flow of blood from the vena cava to the renal vein.

Inventive concept 117: a method, comprising:

connecting a tube to an inner wall of a blood vessel of a subject,

first and second directional valves disposed at the proximal and distal ends of the tube, respectively, an

operating a pumping mechanism to pump fluid through the tube by increasing and progressively decreasing the size of the first compartment by moving the membrane relative to the tube.

The inventive concept 118: the method according to any of the inventive concepts 117, wherein: the tube comprises a stent and material disposed on a stent, and the step of connecting the tube to the inner wall of the blood vessel comprises connecting the stent and the material to the inner wall of the blood vessel.

Inventive concept 119: the method according to any of the inventive concepts 117, wherein: the step of connecting the tube to the inner wall of the blood vessel comprises: connecting the tube to the inner wall of the blood vessel for less than one week.

The inventive concept 120: the method according to any of the inventive concepts 117, wherein: the step of operating the pumping mechanism includes: operating the pumping mechanism such that one of the plurality of valves prevents backflow of blood from the tube into the blood vessel and a second of the plurality of valves prevents backflow of blood from the blood vessel into the tube.

Inventive concept 121: the method according to any one of the inventive concepts 117-120, wherein: the step of connecting the tube to the inner wall of the blood vessel comprises: connecting the tube to an interior wall of a renal vein of a subject, and operating the pumping mechanism comprises: blood is drawn in a downstream direction from the renal vein to a vena cava of the subject.

The inventive concept 122: the method according to inventive concept 121, wherein: the step of connecting the tube to the inner wall of the blood vessel comprises: occluding backflow of blood from the vena cava to the renal vein.

Inventive concept 123: the method according to inventive concept 121, further comprising identifying the subject as suffering from a disease selected from the group consisting of: a subject in a condition selected from the group consisting of cardiac insufficiency, congestive heart failure, decreased renal blood flow, increased renal vascular resistance, hypertension and renal insufficiency, wherein the step of operating the pump comprises: in response to identifying the subject as suffering from the condition, reducing blood pressure within the subject's renal vein by operating the pump to draw blood from the renal vein to the vena cava in the downstream direction.

The inventive concept 124: one method comprises the following steps:

operating a pump to draw blood in a downstream direction through a first vein that is a branch of a second vein and forms a confluence with the second vein; and

by covering a small hole at the confluence with a small hole-covering umbrella provided in the second vein, backflow of blood from the second vein to the first vein is avoided.

The inventive concept 125: the method according to inventive concept 124, wherein: the step of operating the blood pump comprises: performing ultrafiltration on the drawn blood.

The inventive concept 126: the method according to inventive concept 124, wherein: the small hole covering umbrella comprises: when in an open configuration, an aperture-covering umbrella has a diameter in excess of 6 millimeters, and the step of covering the aperture with the umbrella comprises covering the aperture with the umbrella having a diameter in excess of 6 millimeters.

Inventive concept 127: the method according to inventive concept 124, wherein: the step of operating the blood pump comprises making the aperture-covering umbrella a seal against a wall of the second vein surrounding the aperture.

The inventive concept 128: the method according to any one of the inventive concepts 124-127, wherein: the first vein comprises a renal vein of the subject and the second vein comprises a vena cava of the subject, and wherein drawing blood in the downstream direction comprises: blood is drawn from the renal vein in a downstream direction toward the vena cava.

Inventive concept 129: the method according to inventive concept 128, wherein: the step of avoiding backflow of blood from the second vein to the first vein comprises avoiding backflow of blood from the vena cava to the renal vein.

The inventive concept 130: the method according to inventive concept 128, further comprising: identifying the subject as having a disease selected from: a subject in a condition selected from the group consisting of cardiac insufficiency, congestive heart failure, decreased renal blood flow, increased renal vascular resistance, hypertension and renal insufficiency, wherein the step of operating the pump comprises: in response to identifying the subject as suffering from the condition, reducing blood pressure within the subject's renal vein by operating the pump to draw blood from the renal vein to the vena cava in the downstream direction.

Inventive concept 131: a device for use with a first vein of a subject, the first vein being a branch of and merging with a second vein, the device comprising:

a catheter configured to be placed within the first vein, a distal end of the catheter configured to draw blood in a downstream direction through the first vein and into the catheter; and

The inventive concept 132: the apparatus according to inventive concept 131, wherein: by drawing the blood, the catheter is configured to cause the aperture-covering umbrella to become a seal against a wall of the second vein surrounding the aperture.

Inventive concept 133: the apparatus according to inventive concept 131, wherein: when in an open configuration, the aperture-covering umbrella has a diameter of more than 6 millimeters.

Inventive concept 134: the apparatus according to any one of the inventive concepts 131-133, wherein: the first vein comprises a renal vein of the subject, and the second vein comprises a vena cava of the subject, and the conduit is configured to draw blood by drawing blood from the renal vein in a downstream direction.

The inventive concept 135: the apparatus according to inventive concept 134, wherein: covering, from a location within the vena cava, an aperture at a confluence of the renal vein and the vena cava with the aperture-covering umbrella, the aperture-covering umbrella configured to prevent backflow of blood from the vena cava to the renal vein.

Inventive concept 136: an apparatus comprising:

a conduit;

A pumping mechanism configured to draw fluid into a distal end of the catheter; and

an aperture-covering umbrella disposed about said conduit, said umbrella having a diameter of at least 6 millimeters when in an open configuration.

Inventive concept 137: the apparatus according to inventive concept 136, wherein: said diameter of said aperture-covering umbrella is between 10 mm and 20 mm.

The inventive concept 138: the apparatus according to inventive concept 136, wherein: said diameter of said aperture-covering umbrella is between 15 mm and 25 mm.

Inventive concept 139: a method of measuring flow in a vessel, comprising:

occluding the vessel with an occlusion member;

drawing blood from an upstream side of the occlusion to a downstream side of the occlusion;

measuring blood pressure on the upstream and downstream sides of the occlusion;

modulating the draw to equalize pressure on the downstream side of the occlusion to pressure on the upstream side of the occlusion;

measuring a flow rate of blood through the pump when the pressure on the downstream side of the occlusion is equal to the pressure on the upstream side of the occlusion;

Assigning the measured flow rate as a baseline flow rate; and

subsequently, a flow rate of blood through the pump relative to the baseline flow rate is measured.

The inventive concept 140: the method according to inventive concept 139, further comprising assigning a baseline measurement of the subject's vascular resistance in response to assigning the baseline flow rate, and subsequently measuring the subject's vascular resistance relative to the baseline vascular resistance.

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not in the prior art.

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Blood pump device and method for manufacturing blood pump

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