阅读说明：本技术 具有被加强的导管的血泵 (Blood pump with reinforced catheter ) 是由 T·西斯 F·基尔霍夫 于 2018-05-03 设计创作，主要内容包括：一种用于经皮插入的血管内血泵,包括导管(10)和附接至导管(10)的泵送装置(1)。导管(10)沿着纵向轴线延伸并且具有远端端部(11)和与远端端部(11)相反的近端端部(12)。导管(10)包括沿着导管(10)的长度在导管(10)的近端端部(11)和远端端部(12)之间纵向地连续延伸的长形的加强结构(15)。加强结构可以包含诸如镍钛诺的形状记忆材料。它可以是以线缆的形式,线缆游离地延伸经过导管的管腔,并且帮助避免或显著地减少导管中的扭结。(An intravascular blood pump for percutaneous insertion comprises a catheter (10) and a pumping device (1) attached to the catheter (10). The catheter (10) extends along a longitudinal axis and has a distal end (11) and a proximal end (12) opposite the distal end (11). The catheter (10) comprises an elongate reinforcing structure (15) extending longitudinally continuously along the length of the catheter (10) between the proximal end (11) and the distal end (12) of the catheter (10). The reinforcing structure may comprise a shape memory material such as nitinol. It may be in the form of a cable that extends freely through the lumen of the catheter and helps to avoid or significantly reduce kinks in the catheter.)

1. An intravascular blood pump for percutaneous insertion into a blood vessel of a patient, comprising a catheter (10) and a pumping device (1) attached to the catheter (10), the catheter (10) extending along a longitudinal axis and having a distal end (11) and a proximal end (12) opposite the distal end (11) along the longitudinal axis, the catheter (10) comprising an elongated reinforcing structure (15) extending continuously longitudinally along the length of the catheter (10) between the proximal end (11) and the distal end (12) of the catheter (10), wherein the reinforcing structure (15) has approximately 0.00005Nm²To about 0.01Nm²And plastic deformation does not occur if bent at a minimum bending radius of 10 mm.

2. the blood pump according to claim 1, wherein the catheter (10) has at least one lumen (13), the at least one lumen (13) extending through the catheter (10) from the proximal end (12) to the distal end (11), and the reinforcing structure (15) is provided in the lumen (13) of the catheter (10).

3. The blood pump according to claim 2, wherein the reinforcing structure (15) is free inside the lumen (13) of the catheter (10).

4. The blood pump of any of claims 1 to 3, wherein the reinforcing structure comprises at least one rod or cable (15).

5. The blood pump of any of claims 1 to 4, wherein the reinforcing structure comprises a plurality of rods or cables (15B).

6. The blood pump of claim 4 or 5, wherein the at least one rod or cable (15) is solid.

7. The blood pump according to any of claims 4 to 6, wherein the at least one rod or cable (15) has a diameter of about 0.3 to 0.6mm, preferably about 0.5 mm.

8. The blood pump according to any of claims 4 to 7, wherein a cross-section of the at least one rod or cable (15) is not rotationally symmetric, wherein the cross-section of the at least one rod or cable (15) preferably has at least two intersecting axes of symmetry.

9. The blood pump of any of claims 4 to 8, wherein the at least one rod or cable (15) is straight.

10. The blood pump of any of claims 5 to 9, wherein the plurality of rods or cables are braided.

11. The blood pump of any of claims 1 to 10, wherein the bending stiffness of the reinforcing structure (15) differs for bending of the reinforcing structure (15) in different planes.

12. The blood pump of claim 11, wherein the catheter (10) is bent in a plane, and wherein the reinforcing structure (15) has a minimum bending stiffness for bending in the plane in which the catheter (10) is bent.

13. The blood pump of any of claims 1 to 12, wherein the reinforcing structure (15) comprises a shape memory material, preferably nitinol.

14. The blood pump according to any of claims 1 to 13, wherein the reinforcing structure (15) is configured to stay in the catheter (10) during operation of the blood pump.

15. The blood pump of any of claims 1 to 13, wherein the reinforcing structure (15) is configured to be removed from the catheter (10) after placement of the blood pump in the body of a patient.

Technical Field

The present invention relates to an intravascular blood pump for percutaneous insertion into a blood vessel of a patient, comprising a catheter and a pumping device attached to a distal end of the catheter.

Background

Blood pumps for percutaneous insertion are designed to support the heart of a patient and are inserted into the heart of the patient via a blood vessel, such as the aorta or the femoral artery, through a vascular access in the skin of the patient (i.e., percutaneously) by means of a catheter. Intravascular blood pumps for percutaneous insertion typically include a catheter and a pumping device attached to the catheter. The catheter may extend along a longitudinal axis from a distal end to a proximal end, and the pumping device is attached to the catheter at an end remote from an operator, such as a surgeon. The pumping device may be inserted into the left ventricle of the patient's heart, for example, via the femoral artery and aorta by means of a catheter. A blood pump placed in the heart of a patient may also be referred to as an intracardiac blood pump.

The relatively rigid catheter carries less risk of kinking, while the soft catheter better adapts to the shape of the vessel, such as the aorta, particularly the aortic arch. However, soft catheters tend to kink due to their low stiffness, especially during insertion of the catheter. Once the catheter has been kinked, this will create a weakened location on the catheter, and it will likely be kinked again at the same location. This can be particularly problematic during operation of the blood pump. For example, the blood pump may be pushed out of the heart back into the aorta, which may cause the catheter to kink, particularly if the catheter has kinked during insertion. This may cause a sharp kink at the weakened location, which in turn leads to kinking of structures inside the catheter such as the irrigation line supplying irrigation fluid to the pumping device. The irrigation line may clog and the blood pump may fail due to increased irrigation pressure, or even complete occlusion of the irrigation line.

Disclosure of Invention

It is therefore an object of the present invention to provide an intravascular blood pump for percutaneous insertion having a catheter that can be prevented from kinking.

According to the invention, this object is achieved by a blood pump for percutaneous insertion having the features of the independent claim 1. Preferred embodiments and further developments of the invention are specified in the dependent claims thereof. Throughout this disclosure, the term "distal" will refer to a direction away from the user and toward the heart, while the term "proximal" will refer to a direction toward the user.

In accordance with the present invention, a catheter for a percutaneously inserted intravascular blood pump includes an elongated reinforcing structure that extends continuously longitudinally along the length of the catheter between the proximal and distal ends of the catheter. The reinforcing structure has about 0.00005Nm²To about 0.01Nm²Preferably about 0.0001Nm²To about 0.001Nm²More preferably about 0.0001Nm²To about 0.0005Nm²More preferably about 0.0001Nm²To about 0.0007Nm²Or about 0.00005Nm²To about 0.0004Nm²And if bent at a minimum bending radius of 10mm, no plastic deformation occurs. Thus, the catheter is reinforced by means of the elongated reinforcing structure and kinking is prevented.

In one embodiment, the reinforcing structure comprises a shape memory material. The continuous reinforcement structure of the shape memory material prevents kinking of the catheter while providing sufficient flexibility to be bendable so that the catheter can be guided through a blood vessel such as the aorta. This is caused in particular by the so-called superelastic properties of the material. Shape memory materials have temperature dependent and temperature independent properties. Shape memory is a temperature-dependent property that allows shape memory materials to have the ability to undergo deformation at one temperature and then recover their original, undeformed shape when heated above their "transition temperature". The temperature change causes a transformation of the material between the martensite and austenite phases. Superelasticity is a temperature-independent property that allows a shape memory material to have the ability to undergo mechanical deformation due to an external force applied to the shape memory material and then recover its original, undeformed shape when the external force is released. Superelasticity, also called pseudoelasticity, is caused by a transformation between the martensite and austenite phases that occurs due to an external load. Thus, these materials can be reversibly deformed to very high strains. The preferred shape memory material is nitinol.

Kinking is prevented, in particular, during percutaneous insertion of a blood pump, whereby the surgeon/cardiologist pushes a catheter through the bloodA tube. Weakened locations on the catheter are avoided so that the risk of catheter kinking during operation of the blood pump is less. However, if the catheter kinks during surgery, it will have an opportunity to bend back and the catheter can recover its shape over time. In particular, since kinking is the plastic deformation, i.e. irreversible deformation, of the catheter, whereas bending is the elastic deformation by which the catheter can return to its original shape, the reinforcing structure allows the catheter to be elastically deformed with a minimum bending radius of 10mm without plastic deformation. The bend radius is measured about the central axis of the catheter. And about 0.00005Nm²To about 0.01Nm²In combination with the bending stiffness, the reinforcing structure provides an effective avoidance of kinking or at least a significant reduction of kinking.

Bending stiffness (or bending stiffness) is the mechanical value of a reinforcing structure, depending on the material and dimensions, more specifically the product of the modulus of elasticity ("young's modulus") and the moment of inertia, which in turn depends on the cross-sectional area (size and shape). For example, typical diameters of the reinforcing cables are for example between 0.5mm and 0.6 mm. Assuming that the cable has a circular cross-sectional shape, this results in about 0.0031mm⁴To about 0.0064mm⁴The moment of inertia of. Exemplary values of the modulus of elasticity may be about 70-90GPa for austenitic nickel-titanium and about 20-45GPa for martensitic nickel-titanium. This results in an austenitic Nitinol bending stiffness of about 0.0002Nm²To about 0.0006Nm²And the flexural stiffness of the martensitic Nitinol is about 0.00006Nm²To about 0.0003Nm²。

In a preferred embodiment, the reinforcing structure is a wire having a cross-sectional shape with a diameter between 0.54mm and 0.56mm, the material of which has a modulus of elasticity between 73 and 85GPa for austenitic nitinol and between 23 and 42GPa for martensitic nitinol.

The reinforcing structure may extend along the length of the catheter, such as the distal end of the catheter, at least in areas where high bending forces may be generated, e.g. at least 20cm, preferably at least 30cm from the distal end. Preferably, the reinforcing structure extends along an area of the catheter placed within the body of the patient, such as at least 40cm from the distal end of the catheter. More preferably, the stiffening structure extends further in the region of the catheter to be manipulated by the surgeon, i.e. at least 50cm from the distal end of the catheter. Most preferably, the reinforcing structure extends along the entire length of the catheter. A typical length of a catheter for percutaneous insertion into a patient's heart via a femoral artery access (arterial or venous) may be between 100 and 150 cm. The reinforcing structure may also have a length of between 100 and 150 cm. In case the catheter is designed for insertion into the left ventricle via the subclavian or axillary artery or into the right ventricle via the jugular vein, the catheter and the reinforcement structure may have a length of between 25 and 50 cm.

The reinforcing structure may be configured to stay in the conduit during operation of the blood pump to support the conduit and prevent kinking throughout the surgical procedure and during operation of the blood pump. This may be advantageous in applications where, during operation of the blood pump, the blood pump tends to be pushed out of the heart by the motion of the heart or by the pumping action of the blood pump. In applications where there is little or no tendency to push the blood pump out of the heart, the reinforcing structure may be configured to be removed from the catheter after placement of the blood pump in the patient's body. This makes the catheter more flexible during operation of the blood pump and allows the catheter to better conform to the shape of various blood vessels, such as the aorta. This reduces contact between the inner wall of the vessel and the catheter and may also reduce the force with which the pump may push against the valve structure.

As mentioned above, the reinforcing structure preferably comprises or is made of a material having superelastic properties, in particular a shape memory material, i.e. a material having the ability to recover its original shape after having been deformed and which is resistant to permanent kinking. The shape memory material may be a shape memory alloy, preferably nitinol. In particular, nitinol exhibits superelastic properties, which help prevent kinking. However, other shape memory materials, such as polymeric materials having shape memory properties, may also be used to reinforce the structure. Carbon fiber reinforcements may also be used.

The use of a nitinol structure on the outside of a catheter is described in WO 2013/160443 a 1. The optical fiber extends through the catheter and out of the catheter to extend further along the exterior of the cannula within the nitinol tube. The optical fiber is placed within a catheter without a nitinol tube. In contrast, the present invention provides a reinforcing structure made of a shape memory material such as a nitinol rod or cable or tube that extends continuously along the length of the catheter to avoid kinking of the catheter. The reinforcing structure may be provided for the purpose of reinforcement only. In particular, the reinforcing structure is preferably separate from, i.e. not connected to, the pumping device. However, in some embodiments, the reinforcing structure may have additional functions such as a guiding or protecting function.

The catheter may have a lumen, such as at least one lumen, extending through the catheter from the proximal end to the distal end. The reinforcing structure is preferably disposed inside the lumen of the catheter. If the catheter has more than one lumen, the reinforcing structure may be provided in a lumen separate from the lumen housing other lines, such as electrical lines, irrigation lines, etc. Thus, a common catheter may be used and the reinforcement structure provided by inserting the reinforcement structure through the catheter lumen. Preferably, the reinforcing structure is substantially free floating or free, i.e. non-fixed, inside the catheter lumen. In particular, the distal end of the reinforcing structure may be free, i.e. not attached or not operatively connected to other parts of the blood pump, such as the pumping device. This enhances the flexibility of the catheter while effectively preventing kinking of the catheter, as the reinforcing structure can move and slide inside the catheter lumen as the catheter is bent to follow the shape of the vessel. This has the further effect that the flexibility of the catheter tube may have an isotropic behavior, i.e. the flexibility may be the same in any bending direction, since the reinforcement structure is not fixedly attached to one side of the catheter tube.

Alternatively, the reinforcing structure may be housed or embedded in the wall of the catheter or placed on the outer surface of the catheter, rather than inserted into the lumen of the catheter. The reinforcing structure may be fixed at least in the radial direction. It may be movable in an axial direction to be able to slide in an axial direction along the length of the catheter, for example when the catheter is bent. For example, the reinforcing structure may be secured to the outer surface of the catheter by means of any suitable attachment, such as a ring, eyelet or the like. Alternatively, the reinforcing structure may be fixed to the outer surface of the catheter along its entire length.

In one embodiment, the reinforcing structure comprises at least one rod or cable. In another embodiment, the reinforcing structure comprises a plurality of rods or cables, for example two, three, four or more rods or cables. It will be appreciated that the nature of the bending stiffness of the one or more rods or cables collectively provides the desired overall bending stiffness.

Preferably, at least one of the rod or cable is solid, preferably each of the rod or cable is solid. A solid rod is an easy and inexpensive construction for providing a reinforcing structure. In another embodiment, the rod may have a hollow cross-section, i.e. it may be tubular. In the case of a tubular rod or cable, the tube may be used, for example, to supply irrigation fluid to a blood pump. At least one rod, preferably each of the rods, may have a diameter of about 0.3 to 0.6mm, preferably about 0.54 to 0.56 mm. The diameter of the one or more rods need not be constant along the length, but may be variable to achieve variable flexibility along the length. For example, in the region of the catheter to be reinforced, one or more rods may have a larger diameter than in the region where the catheter is to be softer, or by having multiple rods acting simultaneously in that region. The variable flexibility may also be created by providing different materials along the length of the rod, or by providing a sheath to provide increased bending stiffness in the desired region. Preferably, the reinforcing structure provides greater stiffness at its proximal end (i.e. the end which is manipulated by the user and therefore may require higher bending stiffness). The distal end may have a lower bending stiffness than the proximal end to allow the catheter to be advanced into the blood vessel. For this purpose, the reinforcing structure may taper towards the distal end.

The one or more bars may have any suitable cross-sectional shape, in particular circular or other shapes, such as oval or polygonal, in particular triangular, rectangular, pentagonal, hexagonal or octagonal. It will be appreciated that one relatively thick rod may achieve the same or substantially the same effect as a plurality (such as two, three, four or more) of thinner rods. If the reinforcing structure comprises more than one rod, the rods may be braided to form a substantially solid braid or braided tube (i.e. a hollow tubular body). Depending on the number of rods, for example if three rods are braided, the solid braid may have different bending stiffness in different directions, while the braided tube may provide the same bending stiffness in each direction and may provide higher torsional stiffness.

In one embodiment, the reinforcing structure may have a non-rotationally symmetric cross-section. In particular, the cross section may have at least two, in particular two, intersecting axes of symmetry, preferably perpendicular axes of symmetry. Such a cross-section may be, for example, elliptical or rectangular. This symmetry can also be achieved by placing more than one bar next to each other, for example two bars with circular cross-section. More generally, the bending stiffness of the reinforcing structure may be different for bending of the reinforcing structure in different planes. This may be useful in navigation of the catheter. In particular, the conduit may be bent in a plane, and the stiffening structure may have a minimum bending stiffness for bending in the plane in which the conduit is bent. This means that the catheter can be bent more easily in the plane in which it is bent, while lateral bending in other planes is more difficult.

Preferably, the at least one rod or cable is straight or linear, which means that it is free of any undulations or the like, other than the curvature caused by the curvature of the catheter.

Drawings

The foregoing summary, as well as the following detailed description of embodiments, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the disclosure, reference is made to the accompanying drawings. However, the scope of the present disclosure is not limited to the specific embodiments disclosed in the drawings. In the drawings:

Fig. 1 shows a patient's heart with a blood pump inserted into the left ventricle through the aorta.

Fig. 2 schematically shows a catheter of the blood pump of fig. 1 with a reinforcing structure.

Fig. 3 to 5 schematically show a catheter with a reinforcement structure according to different embodiments.

Detailed Description

In fig. 1 a blood pump inserted into a heart H of a patient is shown. More specifically, the blood pump comprises a pumping device 1 attached to a catheter 10, the pumping device 1 being inserted into the left ventricle LV of a patient's heart H via the aorta AO (comprising the descending aorta DA and the aortic arch AA) by means of the catheter 10. The catheter 10 has a distal end 11 and a proximal end 12. The blood pump has a blood outflow 3 which is arranged outside the patient's heart H in the aorta AO and a blood inflow 2 which is in flow communication with a flow cannula 4 placed inside the left ventricle LV. An impeller (not shown) is provided in the pumping device 1 to flow blood from the blood inlet port 2 to the blood outlet port 3. At the distal end of the blood pump, a soft tip 5, such as a braid or J-tip, is arranged to assist the blood pump in being inserted into the patient's heart H without causing any damage to the surrounding tissue. Furthermore, the soft tip 5 helps to keep the soft tissue away from the blood flow inlet 2 and support the pumping device 1 against the inner wall of the left ventricle LV.

Referring now to fig. 2, a catheter 10 of the blood pump of fig. 1 is shown. The catheter 10 extends from a distal end 12 to a proximal end 11 and has a lumen 13 extending through the catheter 10. The pumping device 1 attached to the distal end 11 of the catheter 10 as shown in fig. 1 is not shown in fig. 2. The lumen 13 of the catheter 10 is bounded by a wall 14 of the catheter 10, which wall 14 may have a wall thickness of about 0.1 to 1mm, for example 0.5 mm. The catheter 10 may have an outer diameter of 2mm to 4mm, for example about 3mm (corresponding to a size of 9 French). Thus, the inner diameter of the catheter may be, for example, about 2mm (corresponding to a size of 7 French). A reinforcing structure in the form of an elongate rod 15 is disposed within the catheter lumen 13 and extends from a distal end 16 to a proximal end 17. Which extends continuously through the catheter 10 from its distal end 11 to its proximal end 12. Other structures that may extend through the catheter 10, such as irrigation lines or electrical cables, are omitted from fig. 2 for clarity.

The rod 15 is particularly made of nitinol and provides a bending stiffness sufficient to prevent kinking of the catheter 10 while allowing the catheter 10 to bend to accommodate the shape of a blood vessel such as the aorta AO, particularly the aortic arch AA. As shown in fig. 2, the rod 15 is free floating, i.e. free and not fixed inside the catheter 10, in the lumen 13 of the catheter 10. Thus, it may follow a slightly different radius of curvature than catheter 10 as it moves within catheter lumen 13. The rod 15 is also allowed to slide, in particular axially, within the lumen 13, which may be advantageous for the flexibility of the catheter 10. The distal end 16 of the rod 15 is free, in particular not attached to the pumping device 1 or a component of the pumping device 1. Both the distal and proximal ends of the rod 15, or at least one of its ends, may be protected or covered by a soft tip to avoid piercing the catheter 10 or other adjacent structure.

The rod-shaped reinforcing structure preferably has a solid cross-section, i.e. no lumen or the like extending therethrough, and may have a different cross-sectional shape.

In another embodiment (not shown), the rod may be tubular and may function as a line for flushing fluid or for supplying gas. Thus, the tubular wand may be attached to a pump or other structure requiring the presence of a fluid or gas to be delivered.

The cross-sectional shape is preferably circular or substantially circular, as shown in fig. 3. In another embodiment, the rod 15A may have a rectangular or square cross-section, as shown in FIG. 4. In yet another embodiment, a plurality of rods 15B may be provided, such as three rods 15B as shown in fig. 5. The rods 15B may be formed identically in shape and size or may be different. In another embodiment (not shown), a plurality of rods may be braided. The bending stiffness of the bars 15B amounts to the desired total bending stiffness of the reinforcing structure.

It will be appreciated that any of the reinforcing structures 15, 15A and 15B may be combined with each other. As shown in fig. 3-5, an irrigation fluid line 18 for supplying irrigation fluid to the pumping device 1 and an electrical cable 19 for supplying electrical power to the pumping device 1 may be inserted into the catheter lumen 13. The reinforcing structure 15 is particularly useful for preventing kinking of the catheter 10, which would occlude the flush line 18 and would lead to failure of the blood pump due to too high a flush pressure or interruption of lubrication.

As described above, the rod 15 may extend longitudinally through the catheter 10 in a straight manner to increase kink resistance of the catheter. The rod 15 may be inserted into the catheter 10 during insertion of the pumping device 1 into the body of a patient. The rod 15 may stay in the catheter after insertion, or may be removed to make the catheter 10 flexible and thus less traumatic to surrounding tissue.

Regardless of its shape, size and configuration, the reinforcing structure 15 comprises or is made of a shape memory material, preferably a shape memory alloy, particularly nitinol. Not only because of this material, the reinforcing structure 15 allows the catheter 10 to bend, i.e., elastically deform, at a bend radius of 10mm or less without kinking, i.e., without plastic deformation. The bend radius is measured about the central axis of the catheter. Thus, a catheter 10 having a reinforcing structure 15 made of a shape memory material, such as a catheter having a nitinol cable, provides better bending stiffness. The desired bending stiffness characteristics derive primarily from the superelastic properties of nitinol. It is important to prevent kinking of the catheter, for example to avoid blockage of the tubular lines inside the catheter.