阅读说明：本技术 具有可扩张和可塌缩的入口区域的血管内泵及其方法 (Intravascular pump having expandable and collapsible inlet region and method thereof ) 是由 约瑟夫·P·希金斯 马修·W·蒂尔斯特拉 本杰明·D·哈泽尔曼 马修·D·康布罗纳 特里斯坦 于 2019-07-30 设计创作，主要内容包括：本发明提供了一种血管内血液泵,其包括可以可扩张和可塌缩的壳体区域,其中该可扩张壳体区域包括泵的入口,并且其中包括入口的可扩张壳体区域的远侧直径大于可扩张壳体区域的近侧直径。可以在血管内血液泵的可扩张壳体区域与泵组件之间提供和设置不可扩张区域。(The present invention provides an intravascular blood pump comprising an expandable and collapsible housing region, wherein the expandable housing region comprises an inlet of the pump, and wherein a distal diameter of the expandable housing region comprising the inlet is larger than a proximal diameter of the expandable housing region. A non-expandable region may be provided and disposed between an expandable housing region of an intravascular blood pump and a pump assembly.)

1. A blood pump, comprising:

an impeller assembly;

a non-expandable region comprising:

a housing defining a lumen therethrough,

an inner diameter; and

an outer diameter, wherein the non-expandable region is disposed distal to and in fluid communication with the impeller assembly; and

a collapsible and expandable region disposed distal to and in fluid communication with the non-expandable region, and comprising:

a housing, the housing of the collapsible and expandable region defining a lumen therethrough,

a proximal end having an outer diameter and an inner diameter; and

a distal end having an outer diameter and an inner diameter,

wherein the collapsible and expandable region is adapted to expand to an expanded configuration, wherein an inner diameter of a distal end of the collapsible and expandable region is greater than an inner diameter of a proximal end of the collapsible and expandable region.

2. The blood pump of claim 1, wherein an outer diameter of a distal end of the collapsible and expandable region is greater than an outer diameter of a proximal end of the collapsible and expandable region.

3. The blood pump of claim 1, wherein a distal end of the collapsible and expandable region includes an inlet.

4. The blood pump of claim 1, wherein the collapsible and expandable region comprises a single region having an inner diameter that decreases from a distal end of the collapsible and expandable region to a proximal end of the collapsible and expandable region.

5. The blood pump of claim 4, wherein an inner diameter of the non-expandable region is the same as an inner diameter of a proximal end of the collapsible and expandable region.

6. The blood pump of claim 1, further comprising a flared profile distal end of the collapsible and expandable region.

7. The blood pump of claim 1, wherein the collapsible and expandable region comprises a shape memory material.

8. The blood pump of claim 7, wherein the shape memory material comprises a metal and/or a polymer.

9. The blood pump of claim 1, wherein the collapsible and expandable region is biased to expand.

10. The blood pump of claim 1, wherein the collapsible and expandable region comprises at least one of an outer profile shape from the group consisting of cylindrical, elliptical, conical, trumpet, and bell.

11. The blood pump of claim 1, wherein the collapsible and expandable region comprises a support structure comprising at least one of a stent structure and a polymer.

12. The blood pump of claim 1, wherein the collapsible and expandable region comprises an expandable stent having at least one stent unit pattern.

13. The blood pump of claim 12, wherein the expandable stent includes at least one second stent unit pattern that is different from the first stent unit pattern.

14. A blood pump, comprising:

an impeller assembly;

a non-expandable region comprising:

a housing defining a lumen therethrough;

an inner diameter, and

an outer diameter, wherein the non-expandable region is disposed distal to and in fluid communication with the impeller assembly; and

a collapsible and expandable region disposed distal to and in fluid communication with the non-expandable region, and comprising:

a housing, the housing of the collapsible and expandable region defining a lumen therethrough;

a proximal end having an outer diameter and an inner diameter;

a distal end having an outer diameter and an inner diameter;

a first region comprising a reduced inner diameter moving in a proximal direction, the first region disposed distal to and in fluid communication with the impeller assembly; and

a second region having a constant inner diameter disposed distal to and in fluid communication with the first region, wherein the second region includes a distal end defining an inlet, an

Wherein the collapsible and expandable region is adapted to expand to an expanded configuration, wherein an inner diameter of a distal end of the collapsible and expandable region is greater than an inner diameter of a proximal end of the collapsible and expandable region.

15. The blood pump of claim 14, further comprising a flared profile distal end of the collapsible and expandable region.

16. The blood pump of claim 14, wherein the collapsible and expandable region comprises a shape memory material.

17. The blood pump of claim 16, wherein the shape memory material comprises a metal and/or a polymer.

18. The blood pump of claim 14, wherein the collapsible and expandable region is biased to expand.

19. The blood pump of claim 14, wherein the collapsible and expandable region comprises at least one of an outer profile shape from the group consisting of cylindrical, elliptical, conical, trumpet, and bell.

20. The blood pump of claim 14, wherein the collapsible and expandable region comprises a support structure comprising at least one of a stent structure and a polymer.

21. The blood pump of claim 14, wherein the collapsible and expandable region comprises an expandable stent having at least one stent unit pattern.

22. The blood pump of claim 21, wherein the expandable stent includes at least one second stent unit pattern that is different from the first stent unit pattern.

23. A blood pump, comprising:

an impeller assembly;

a non-expandable region comprising:

a housing defining a lumen therethrough;

an inner diameter; and

an outer diameter, wherein the non-expandable region is disposed distal to and in fluid communication with the impeller assembly; and

a collapsible and expandable region disposed distal to and in fluid communication with the non-expandable region, and comprising:

a housing, the housing of the collapsible and expandable region defining a lumen therethrough;

a proximal end having an outer diameter and an inner diameter;

a distal end having an outer diameter and an inner diameter;

a first region comprising a reduced inner diameter moving in a proximal direction, the first region disposed distal to and in fluid communication with the impeller assembly;

a second region having a constant inner diameter disposed distal to and in fluid communication with the first region; and

a third region having a reduced inner diameter moving in a proximal direction, the third region disposed distal to and in fluid communication with the second region, wherein the third region includes a distal end having an inlet,

wherein the collapsible and expandable region is adapted to expand to an expanded configuration wherein an inner diameter of a distal end of the collapsible and expandable region is greater than an inner diameter of a proximal end of the collapsible and expandable region.

24. The blood pump of claim 23, further comprising a flared profile distal end of the collapsible and expandable region.

25. The blood pump of claim 23, wherein the collapsible and expandable region comprises a shape memory material.

26. The blood pump of claim 25, wherein the shape memory material comprises a metal and/or a polymer.

27. The blood pump of claim 23, wherein the collapsible and expandable region is biased to expand.

28. The blood pump of claim 23, wherein the collapsible and expandable region comprises at least one of an outer profile shape from the group consisting of cylindrical, elliptical, conical, trumpet, and bell.

29. The blood pump of claim 23, wherein the collapsible and expandable region comprises a support structure comprising at least one of a stent structure and a polymer.

30. The blood pump of claim 23, wherein the collapsible and expandable region comprises an expandable stent having at least one stent unit pattern.

31. The blood pump of claim 30, wherein the expandable stent includes at least one second stent unit pattern that is different from the first stent unit pattern.

Technical Field

The present invention relates to an intravascular blood pump having an expandable and collapsible inlet region.

Background

Referring to fig. 1, the human heart includes four chambers and four heart valves that facilitate the forward (antegrade) flow of blood through the heart. The chambers include the left atrium, left ventricle, right atrium, and right ventricle. The four heart valves include the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve.

The mitral valve is located between the left atrium and the left ventricle and helps control the flow of blood from the left atrium to the left ventricle by acting as a one-way valve, preventing backflow into the left atrium. Similarly, the tricuspid valve is located between the right atrium and right ventricle, while the aortic and pulmonary valves are semilunar valves located in the arteries that flow blood away from the heart. The valves are all one-way valves, with leaflets that open to allow forward (antegrade) blood flow. The normally functioning valve leaflets close under the pressure exerted by the retrograde blood flow to prevent backflow of blood (retrograde flow).

Thus, as shown, the general blood flow includes deoxygenated blood returning from the body, which is received by the right atrium via the superior and inferior vena cava, and then pumped into the right ventricle, which is controlled by the tricuspid valve. The right ventricle is used to pump deoxygenated blood via the pulmonary arteries to the lungs, where it is re-oxygenated and returned to the left atrium via the pulmonary veins.

Heart disease is a health problem with high mortality. The use of temporary mechanical blood pump devices is increasingly frequently used to provide short term acute assistance during surgery or as temporary bridge assistance to help patients to crisis. These temporary blood pumps have been developed and evolved over the years to supplement the pumping action of the heart on a short-term basis and to supplement blood flow as left or right ventricular assist devices ("LVADs"), the most commonly used devices at present.

Known temporary LVAD devices are typically delivered percutaneously (e.g., via the femoral artery) such that the LVAD inlet is located or positioned in the left ventricle and the outlet is in the ascending aorta of the patient, with the body of the device disposed across the aortic valve. One skilled in the art will appreciate that an incision may be made below the groin of the patient to enable access to the femoral artery of the patient. The physician may then translate the guidewire (followed by the catheter or delivery sheath) through the femoral artery and the descending aorta until reaching the ascending aorta. The LVAD with the attached rotating drive shaft may then be translated through a delivery catheter or sheath lumen, exposing the proximal end of the drive shaft outside the patient's body, and coupled with a prime mover (such as an electric motor) or equivalent for rotating and controlling the rotational speed of the drive shaft and associated LVAD impeller.

Temporary axial flow blood pumps generally include two types: (1) axial flow blood pumps powered by a motor integrated in a device connected to the impeller of the pump (see U.S. patent nos.5,147,388 and 5,275,580); and (2) axial flow blood pumps powered by an external motor that provides rotational torque to a drive shaft, which in turn is connected to the impeller of the pump (see U.S. patent nos.4,625,712 to Wampler and 5,112,349 to Summers, each of which is incorporated herein by reference in its entirety).

Known temporary ventricular assist devices ("VAD"), including LVAD and RVAD (right ventricular assist) devices, whether with an integrated motor or an external motor, generally include the following elements mounted within a housing, listed in order from an inflow end to an outflow end: one or more inflow holes; fixed guides, also known as flow straighteners; rotating the impeller; and a stationary diffuser and/or outflow structure; and one or more outflow apertures, as shown in the cross-sectional and cut-away views of the exemplary prior art pump and/or impeller assembly of fig. 2.

In fig. 2, the known device 2 is oriented with the inflow end (distal end) on the left side of the figure and the outflow end (proximal) on the right side, such that the incoming blood flow in the ventricle enters the device housing through one or more inflow holes (not shown), the flow being defined by the surrounding housing 14, ultimately entering the impeller/pump assembly 4. There, the incoming blood encounters the stationary guide 6 before being propelled forward by the rotating impeller 8. The blood flow can then be altered by the stationary diffuser and exit into the aorta via one or more outflow holes 10 of the housing.

Known VAD or LVAD devices also include a delivery configuration and a functional or working configuration, wherein the delivery configuration has a lower profile or smaller diameter than the functional or working configuration, thereby facilitating atraumatic delivery through the delivery sheath, among other things. In other words, the blades of the housing and/or impeller of the VAD or LVAD may be expanded to achieve a functional or working configuration and collapsed to achieve a delivery configuration in various ways. However, known devices collapse and expand the impeller blades and/or the casing, wherein a collapsible and expandable casing surrounds at least a portion of the impeller so as to be movable between an expanded or working configuration and/or require an integrated motor proximate the impeller. See, e.g., U.S. patent nos. 7,027,875; no.7,927,068; and No.8,992,163.

Known LVAD devices typically include an angled housing to accommodate the aortic arch, the angle or bend typically being in the range of 135 degrees.

The LVAD device with an integrated motor in the housing must be small enough to allow atraumatic intravascular translation and positioning in the heart. While various methods are known to collapse portions of the device (including the housing and/or impeller or components thereof, such as the blades) while in a catheter or delivery sheath, the size of the collapsing device may be limited by an integrated motor.

Further, known LVAD devices include delivery configurations in which the housing and/or impeller (e.g., blades on the impeller) may be reduced in diameter and the collapsed elements are expandable when delivered distally from a delivery catheter or sheath. These devices are limited in several respects. First, the collapsing and expanding includes at least a portion of the casing occupied by the impeller. Second, the inflow region of the housing, i.e., the region away from the rotating impeller and the stationary guide or flow straightener, includes regions that have the opportunity to optimize blood flow through the cannula or housing. Known LVAD or VAD devices cannot take advantage of this opportunity. Third, known LVAD or VAD devices include a stationary guide or flow straightener that blood encounters when entering the pump, which may lead to thrombosis and/or hemolysis, among other things. Fourth, for the reasons discussed herein, reducing the crossover profile of a VAD or LVAD device is critical, and design requirements become more difficult due to the need to run wires through or along the housing of the device, where the wires can be used to power and/or communicate with motors or sensors or other operational power components, for example. In this connection, the wires need to be profile reduced to keep the crossing profile as low as possible, and the insulation and/or spacing between adjacent conductors, where such insulation and/or spacing is necessary or desirable.

Various embodiments of the present invention address these problems, among others.

The figures and the detailed description that follow more particularly exemplify these and other embodiments of the invention.

The description of the invention and as set forth herein is illustrative and is not intended to limit the scope of the invention. The features of the various embodiments may be combined with other embodiments within the contemplation of the invention. Variations and modifications of the embodiments disclosed herein are possible, and practical alternatives to and equivalents of the various elements of the embodiments will be understood by those of ordinary skill in the art after studying this patent document. These and other variations and modifications of the embodiments disclosed herein may be made without departing from the scope and spirit of the invention.

Drawings

FIG. 1 is a cross-sectional view of a human heart;

FIG. 2 is a cross-sectional view of a prior art device;

FIG. 3 is a side cross-sectional view of one embodiment of the present invention;

FIG. 4 is a side cross-sectional view of one embodiment of the present invention;

FIG. 5 is a side cross-sectional view of one embodiment of the present invention;

FIG. 6 is a side cross-sectional view of one embodiment of the present invention;

FIG. 7 is a side cross-sectional view of one embodiment of the present invention; and

FIG. 8 is a side cross-sectional view of one embodiment of the present invention.

Detailed Description

In general, various embodiments of the present invention are directed to mechanical assist devices for pumping blood within a patient. Described herein are improved temporary LVAD or VAD blood pumps for percutaneous and intravascular delivery.

Referring now to fig. 3, an exemplary LVAD blood pump 100 is shown with inflow orifice 12 on the left side of the illustration and outflow orifice 10 on the right side of the device. The motor is shown on the proximal end of the device that is outside the patient's body and is connected to a rotary drive shaft, which in turn is connected to an impeller or rotor 8 or pump assembly. However, as is well known in the art, the motor may be located within the housing of the device itself, with the motor typically being mounted on the proximal side of the rotor 8 or impeller or pump assembly. Any of these configurations may be used with the various embodiments of the invention as described herein.

The entire length of the outer housing 14 is shown to include a relatively constant diameter from the inlet or inflow orifice 12 to the outlet or outflow orifice 10. A guidewire 16 is positioned along the exterior of the device until the entry aperture 12 is reached, where it enters the lumen of the cannula C and extends distally therefrom, as shown. Thus, the guidewire 16 does not pass through the impeller or rotor 8 or pump assembly. The configuration shown in fig. 3 may include a delivery configuration with an expandable region 102, the expandable region 102 being compressed within a guide or delivery sheath or catheter 200.

Referring generally to the figures, the device 100 may include an expandable region 102 that may be positioned away from an impeller or rotor or pump assembly such that a diameter of a housing surrounding the impeller or rotor or pump assembly does not change diameter during delivery or during rotation. In other words, the proximal non-expandable region 122 may be provided and include at least an impeller or rotor or pump assembly, and the housing surrounding the assembly does not expand or contract significantly but may be flexible. In addition, a distal non-expandable region 124 may be provided that includes at least an inlet region that includes at least the inlet aperture 12. Thus, the expandable region 102 includes a proximal end and a distal end. The proximal end of the expandable region 102 abuts or is adjacent to the distal end of the proximal non-expandable region 122, while the distal end of the expandable region 102 abuts or is adjacent to the proximal end of the distal non-expandable region 124. However, the housing H surrounding the one or more non-expandable regions 122, 124 may be flexible or pliable, but they are not configured to bias expansion.

Alternatively, the housing H of the device 100 of fig. 3 may be non-expandable.

Fig. 4 illustrates an expandable embodiment of the device 100, and shows, in phantom, the change in diameter to/from a collapsed deformed expandable region extending distally along the hollow cannula from a point distal to the end of the impeller, rotor and/or pump assembly to a point just proximal to the inlet bore to an exemplary expanded undeformed expandable region. The expandable region 102 may be expanded to a maximum undeformed diameter in the range of 12-20Fr, more preferably between 16-20 Fr. In contrast, the unexpanded region maintains a substantially fixed diameter in the range of 9 to 12 Fr.

With continued general reference to fig. 3 and 4 and the remaining figures, the device 100 may include an expandable region 102 that may be partially or fully biased to an expanded configuration, and thus include a material or structure that facilitates expansion and may be biased to expand. An exemplary configuration of the expandable region 102 may include a support structure 130 surrounded by an outer material, such as a jacket or coating or sleeve composed of an expanded plastic or polymeric material that accommodates an underlying support structure known in the art. Support structure 130 may be formed from a shape memory material, such as nitinol or the like. Other materials may include gold, tantalum, stainless steel, metal alloys, aeroalloys, and/or polymers, including polymers that expand and contract when exposed to relative heat and cold. In other instances, at least a portion of the expandable region 102 (e.g., the central expandable section 104 discussed below) may include a polymer or other material sleeve configured to allow and/or accommodate expansion and collapse, and the support structure 130 may be omitted. Fig. 4 provides a rotary drive shaft connected to the impeller assembly and which, in turn, is connected to a prime mover, such as an electric motor, located outside the patient's body. However, it should be understood that the various embodiments of the invention discussed herein may also be used in conjunction with a blood pump that includes a motor integrated into the blood pump (i.e., without an external motor). Further, as discussed above, the device 100 may include an expandable shell H or region 102, or may be non-expandable.

In many of the embodiments described herein, the expandable region 102 may comprise a single expandable region without or without distinguishing between proximal, central, and/or distal transition sections.

In general, the expandable region 102 of the present invention may include a support structure 130 surrounded by a polymer coating or jacket that is adapted for expansion and collapse of the expandable region 102.

In addition, the support structure 130 may include an expandable stent-like structure formed from a series of cells formed from interacting and/or interconnected wires and/or struts and that enables the structure (e.g., stent) to collapse and bias expand, as is known in the art. See, for example, U.S. Pat. Nos.5,776,183 to Kanesaka; U.S. Pat. No.5,019,090 to Pinchuk; tower's No.5,161,547; savin, U.S. Pat. No.4,950,227; fontaine No.5,314,472; U.S. Pat. Nos.4,886,062 and 4,969,458 of Wiktor; and Hillstead's No.4,856,516; the disclosure of each of these patents is incorporated herein by reference in its entirety.

The expandable region 102 described herein is merely exemplary and is not limiting in any respect. Thus, any expandable housing H of the blood pump device 100 is readily adaptable to various embodiments of the present invention involving insulation and/or spacing and/or contour reduction or integration of wires or conductors E within or along the blood pump housing. The expandable region 102 may also comprise a single region capable of expanding and collapsing.

Turning now to fig. 5, the expandable region 102 is disposed at a point distal to the pump assembly 122 and includes a lumen therethrough. The expandable region 102 may include three regions 1, 2, and 3. Region 1 includes a cone section having a smaller diameter at a proximal end and a larger diameter at a distal end, which may also form or define the base of the cone section. Region 2, which is arranged distal to region 1, comprises a substantially cylindrical profile shape having a diameter substantially the same as the diameter of the base of the vertebral body of region 1. Alternatively, region 2 may include a diameter at its proximal end that matches the diameter of the base of the vertebral body of region 1, then slowly increasing in diameter from proximal to distal through region 2. Zone 3 is disposed distal to zone 2 and includes a diameter increasing to a maximum diameter at its distal end, which is also the entrance of device 100. As shown, a flared or bell-shaped distal end or entrance defines the distal end of zone 3, although non-flared conical shapes may also be used for zone 3 and its distal end. Also as shown, the non-expandable region 122 may be disposed proximal to the distal end of the expandable region 102, and the non-expandable region 122 may be disposed between the impeller assembly 120 and the expandable region 102. Regions 1, 2, and 3 may also be referred to herein as first, second, and third regions, respectively.

FIG. 6 is similar to FIG. 5, but is a smaller version in diameter than the expandable region 102 of FIG. 5.

Fig. 7 includes an expandable region 102 that includes two regions, region 1 being similar to region 1 of fig. 4 and 5. Zone 2 is positioned distal to zone 1 and includes a constant diameter along its length to an inlet defined at the distal end of zone 2. The diameter of region 2 is substantially the same as the diameter of the distal end of region 1, i.e. the base of the vertebral body of region 1 is smaller than the diameter of its proximal end. Thus, the diameter of the distal end of the expandable region 102 is greater than the diameter of the distal end of the expandable region 102. As with fig. 5 and 6, the non-expandable region 122 may be disposed proximal to the distal end of the expandable region 102, and the non-expandable region 122 may be disposed between the impeller assembly 120 and the expandable region 102.

FIG. 8 provides an expandable region 102 having a single region. Thus, zone 3 provides a slowly increasing diameter moving proximally to distally away from the non-expandable region 122 to the exit at the distal end of the expandable region 102. As shown, the diameter of zone 3 increases at a rate of increase from proximal to distal to form a bell or trumpet shaped profile. Alternatively, as with fig. 5-7, region 3 in fig. 8 may include a tapered profile. Finally, as the non-expandable region 122 may be disposed proximal to the distal end of the expandable region 102, and the non-expandable region 122 may be disposed between the impeller assembly 120 and the expandable region 102.

In all illustrated cases, the expandable region 102 may also collapse upon expansion to the illustrated working configuration as described above.

Thus, the inner diameter of the expanded expandable region 102 provides a lumen defined by the expanded expandable region 102. Thus, the expandable region 102 includes an increased inner diameter and area at its distal end as compared to the inner diameter and area of the lumen defined by the expanded expandable region 102 at its proximal end and the inner diameter and area of the non-expandable region 122 and impeller assembly 120. Thus, fluid flow is optimized through the lumen of the expandable region 102, through the non-expandable region 122 and the impeller assembly 120, and ultimately through the outlet aperture. Further, as shown, the outer diameter of the distal end of the expanded expandable region 102 is greater than the outer diameter of the proximal end of the expanded expandable region 102 and the outer diameter of the non-expandable region 122. The expandable region 102, the non-expandable region 122, and the impeller assembly 120 are shown operatively connected to and in fluid communication with one another such that fluid drawn into the inlet moves through the lumen of the expandable region 102, through the lumen of the non-expandable region 122, and into the impeller assembly 120.