Blood pump with reinforced catheter

Abstract

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 stiffening 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). The stiffening structure (15) may comprise a shape-memory material, such as Nitinol. It may be in the form of a wire that extends loosely through the lumen of the catheter and helps to avoid or significantly reduce kinks in the catheter.

Claims

1. An intravascular blood pump for percutaneous insertion into a patient's blood vessel, comprising: a catheter, and a pumping device attached to the catheter, the catheter extending along a longitudinal axis and having a distal end and a proximal end opposite the distal end along the longitudinal axis, the catheter comprising an elongate stiffening structure extending continuously longitudinally along a length of the catheter between the proximal end and the distal end of the catheter, wherein the stiffening structure comprises at least one rod or wire having a cross-section that is not rotationally symmetric, and wherein the stiffening structure has a minimum bending stiffness of about 0.00005 Nm.sup.2 to about 0.01 Nm.sup.2 and is not subject to plastic deformation if bent with a minimum bending radius 10 mm.

2. The blood pump of claim 1, wherein the catheter has at least one lumen that extends through the catheter from the proximal end to the distal end, with the stiffening structure being disposed in the lumen of the catheter.

3. The blood pump of claim 2, wherein the stiffening structure is loose inside the lumen of the catheter.

4. The blood pump of claim 1, wherein the stiffening structure comprises a plurality of rods or wires.

5. The blood pump of claim 1, wherein the at least one rod or wire is solid.

6. The blood pump of claim 1, wherein the at least one rod or wire is straight.

7. The blood pump of claim 4, wherein the plurality of rods or wires are braided.

8. The blood pump of claim 1, wherein the stiffening structure comprises a shape-memory material.

9. The blood pump of claim 8, wherein the shape-memory material is Nitinol.

10. The blood pump of claim 1, wherein the stiffening structure is configured to stay in the catheter during operation of the blood pump.

11. The blood pump of claim 1, wherein the stiffening structure is configured to be removed from the catheter after placement of the blood pump in a patient's body.

12. The blood pump of claim 1, wherein the cross-section of the at least one rod or wire has at least two intersecting axes of symmetry.

13. An intravascular blood pump for percutaneous insertion into a patient's blood vessel, comprising: a catheter, and a pumping device attached to the catheter, the catheter extending along a longitudinal axis and having a distal end and a proximal end opposite the distal end along the longitudinal axis, the catheter comprising an elongate stiffening structure extending continuously longitudinally along a length of the catheter between the proximal end and the distal end of the catheter, wherein the stiffening structure has a minimum bending stiffness of about 0.00005 Nm.sup.2 to about 0.01 Nm.sup.2 and is not subject to plastic deformation if bent with a minimum bending radius 10 mm, and wherein a bending stiffness of the stiffening structure varies with respect to bending of the stiffening structure in different planes.

14. The blood pump of claim 13, wherein the catheter is curved in a plane and wherein the stiffening structure has a minimum bending stiffness with respect to bending in said plane in which the catheter is curved.

15. The blood pump of claim 13, wherein the catheter has at least one lumen that extends through the catheter from the proximal end to the distal end, with the stiffening structure being disposed in the lumen of the catheter.

16. The blood pump of claim 15, wherein the stiffening structure is loose inside the lumen of the catheter.

17. The blood pump of claim 13, wherein the stiffening structure comprises a shape-memory material.

18. The blood pump of claim 17, wherein the shape-memory material is Nitinol.

19. The blood pump of claim 13, wherein the stiffening structure is configured to stay in the catheter during operation of the blood pump.

20. The blood pump of claim 13, wherein the stiffening structure is configured to be removed from the catheter after placement of the blood pump in a patient's body.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

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

(2) FIG. 1 shows a patient's heart with a blood pump inserted through the aorta into the left ventricle.

(3) FIG. 2 schematically shows the catheter of the blood pump of FIG. 1 with a stiffening structure.

(4) FIGS. 3 to 5 schematically show the catheter with a stiffening structure in accordance with different embodiments.

DETAILED DESCRIPTION

(5) In FIG. 1 is illustrated a blood pump inserted into a patient's heart H. More specifically, the blood pump comprises a pumping device 1 attached to a catheter 10 by means of which the pumping device 1 is inserted into the left ventricle LV of the patient's heart H via the aorta AO, including the descending aorta DA and the aortic arch AA. The catheter 10 has a distal end 11 and a proximal end 12. The blood pump has a blood flow outlet 3 that is disposed outside the patient's heart H in the aorta AO, while a blood flow inlet 2 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 cause the blood flow from the blood flow inlet 2 to the blood flow outlet 3. At the distal end of the blood pump, a soft tip 5, such as a pigtail or J-tip, is arranged to facilitate insertion of the blood pump into the patient's heart H without causing any harm to the surrounding tissue. Also, the soft tip 5 helps to keep soft tissue away from the blood flow inlet 2 and to support the pumping device 1 against the inner wall of the left ventricle LV.

(6) Referring now to FIG. 2, the catheter 10 of the blood pump of FIG. 1 is shown. The catheter 10 extends from the distal end 12 to the proximal end 11 and has a lumen 13 that extends through the catheter 10. The pumping device 1 which is 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 defined by a wall 14 of the catheter 10, which may have a wall thickness of about 0.1 to 1 mm, such as 0.5 mm. The catheter 10 may have an outer diameter of 2 mm to 4 mm, such as about 3 mm (corresponding to a dimension of 9 French). Accordingly, the inner diameter of the catheter may be for instance about 2 mm (corresponding to a dimension of 7 French). A stiffening structure in the form of an elongated rod 15 is disposed inside the catheter lumen 13 and extends from a distal end 16 to a proximal end 17. It extends continuously through the catheter 10 from the catheter's distal end 11 to its proximal end 12. Other structures that may extend through the catheter 10, such as a purge line or electric wire, are omitted in FIG. 2 for the sake of clarity.

(7) The rod 15 is particularly made of Nitinol and provides a bending stiffness sufficient to prevent the catheter 10 from kinking, while permitting the catheter 10 to bend to adapt to the shape of the blood vessel, such as the aorta AO, in particular the aortic arch AA. As illustrated in FIG. 2, the rod 15 is free-floating in the lumen 13 of the catheter 10, i.e. loose and not fixed inside the catheter 10. Thus, it may follow a slightly different radius of curvature than the catheter 10 while moving inside the catheter lumen 13. The rod 15 is also permitted to slide inside the lumen 13, in particular axially, 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 parts of the pumping device 1. Both, distal and proximal, ends of the rod 15 or at least one end thereof may be protected or encapsulated with a soft tip to avoid penetration into the catheter 10 or other adjacent structures.

(8) The rod-like stiffening structure preferably has a solid cross-section, i.e. no lumen or the like extending therethrough, and may have different cross-sectional shapes.

(9) In another embodiment (not shown), the rod may be tubular and may act as a line for a purge fluid or for supplying a gas. The tubular rod may, therefore, be attached to the pump or other structure that requires the presence of transported fluid or gas.

(10) 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 illustrated in FIG. 4. In still another embodiment, a plurality of rods 15B may be provided, such as three rods 15B as shown in FIG. 5. Said rods 15B may be identically formed with respect to shape and size or may be different. In another embodiment (not shown) the multiple rods may be braided. The bending stiffnesses of the rods 15B add up to the desired total bending stiffness of the stiffening structure.

(11) It will be appreciated that any of the stiffening structures 15, 15A and 15B may be combined with each other. As shown in FIGS. 3 to 5, a purge fluid line 18 for supplying a purge fluid to the pumping device 1, and an electric wire 19 for supplying electric power to the pumping device 1, may be inserted in the catheter lumen 13. The stiffening structure 15 is particularly useful for preventing the catheter 10 from kinking, which would occlude the purge line 18 and lead to failure of the blood pump because the purge pressure is too high or lubricating is interrupted.

(12) As described above a rod 15 may extend longitudinally through the catheter 10 in a straight manner to increase the catheter's resistance to kinking. The rod 15 may be inserted in the catheter 10 during insertion of the pumping device 1 into the patient. The rod 15 may stay in the catheter or may be removed to render the catheter 10 flexible after insertion, therefore less traumatic to surrounding tissue.

(13) Regardless of its shape, size and configuration, the stiffening structure 15 comprises or is made of a shape-memory material, preferably a shape-memory alloy, in particular Nitinol. Not least because of this material the stiffening structure 15 allows the catheter 10 to be bent, i.e. elastically deformed, with a bending radius of 10 mm or less without kinking, i.e. without the occurrence of plastic deformation. The bending radius is measured with respect to a central axis of the catheter. Thus, the catheter 10 with the stiffening structure 15 made of a shape-memory material, e.g. a catheter with a Nitinol wire, provides a better bending stiffness. The desired bending stiffness characteristics result mainly from the superelastic properties of the Nitinol. Preventing kinking of the catheter is important, for instance to avoid occlusion of tubular lines inside the catheter.