Catheter pump

• US 8,597,170 B2
• Filed: 01/04/2012
• Issued: 12/03/2013
• Est. Priority Date: 01/05/2011
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories), Penn State Research Foundation (Pennsylvania State University), Thoratec LLC
• Original Assignee: Penn State Research Foundation (Pennsylvania State University), Thoratec LLC
• Inventors: Walters, Daniel A., Repka, William James, Powell, Kevin J., Keenan, Richard L., Walsh, Justin M., Campbell, Robert L., McBride, Mark W.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US13/343,618
• Publication Number:
  US 20120172656A1
• Time in Patent Office: 699 Days
• Field of Search: 600/16
• US Class Current: 600/16
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2025/0006 which can be secured against axial movement, e.g. by using a locking cuff
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 60/13 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/216 including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/237 the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
• CPC Class Codes: A61M 60/411 generated by an electromotor
• CPC Class Codes: A61M 60/414 transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
• CPC Class Codes: A61M 60/806 Vanes or blades
• CPC Class Codes: A61M 60/81 Pump housings
• CPC Class Codes: A61M 60/824 Hydrodynamic or fluid film bearings
• CPC Class Codes: A61M 60/825 Contact bearings, e.g. ball-and-cup or pivot bearings
• CPC Class Codes: A61M 60/829 having a purge fluid supply
• CPC Class Codes: F16C 17/02 for radial load only
• CPC Class Codes: F16C 2202/02 Mechanical properties
• CPC Class Codes: F16C 2206/06 Composite carbon material, e.g. carbon fibre reinforced carbon (C/C)
• CPC Class Codes: F16C 2208/32 Polytetrafluorethylene [PTFE] F16C2208/58 takes precedence
• CPC Class Codes: F16C 2208/36 : Polyarylene ether ketones [PAEK], e.g. PEK, PEEK F16C2208/58 takes precedence
• CPC Class Codes: F16C 2316/18 : Pumps for pumping blood
• CPC Class Codes: F16C 33/1045 : Details of supply of the liquid to the bearing
• CPC Class Codes: F16C 33/105 : Conditioning, e.g. metering, cooling, filtering
• CPC Class Codes: F16C 33/1085 : Channels or passages to recirculate the liquid in the bearing
• CPC Class Codes: F16C 33/20 : Sliding surface consisting mainly of plastics F16C33/22 - F16C33/28 take precedence

Abstract

A heart pump and a catheter assembly therefor are provided that include a flexible catheter body having a proximal end and a distal end, the catheter body having a plurality of lumens therethrough. The catheter body can be sufficiently flexible to extend from a peripheral access to a patient'"'"'s heart. The catheter assembly can also include an impeller assembly having an impeller and a housing. The impeller assembly can be coupled with the flexible catheter body such that a tensile force applied to opposite ends of the catheter assembly enhances the security of the connection between the catheter body and the impeller assembly.

Claims

1. A catheter assembly for a heart pump, comprising

a flexible catheter body having a proximal end and a distal end and defining a plurality of lumens therethrough, the catheter body being sufficiently flexible to extend from a peripheral access to a patient'"'"'s heart;

an impeller assembly having an impeller and a housing comprising a hypotube sized to be disposed over a distal portion of the catheter body, the hypotube having at least one barb disposed distally such that the barb engages a portion of the catheter assembly disposed inward of the hypotube when tensile forces are applied to opposite ends of the catheter assembly, to enhance the security of the connection between the catheter body and the impeller assembly under such tensile forces.

2. The catheter assembly of claim 1, wherein the hypotube comprises two axial rows of barbs, each row comprising at least two barbs.

3. The catheter assembly of claim 2, wherein the at least two barbs are generally evenly distributed radially about the hypotube.

4. The catheter assembly of claim 1, wherein the at least one barb is in the shape of a rectangular flange.

5. The catheter assembly of claim 1, wherein the hypotube is generally non-expandable.

6. The catheter assembly of claim 1, wherein a proximal portion of the impeller assembly is disposed proximally over a distal length of the catheter body, proximal portion having at least one barb extending circumferentially to engage the catheter body when torsional forces are applied to an end of the catheter assembly.

7. A catheter for a heart pump, comprising

a flexible catheter body having a proximal end and a distal end and defining a plurality of lumens configured to convey an infusant therethrough, the catheter body being sufficiently flexible to extend from a peripheral access to a patient'"'"'s heart;

an impeller having a shaft and at least one blade;

a bearing housing in which the shaft is journaled for rotation; and

a coupler having a distal end configured to be coupled with the bearing housing and a proximal end configured to be coupled with the catheter body, the proximal end being disposed proximal of the distal end of the lumens of the catheter body;

wherein the catheter assembly is configured such that a first portion of the infusant flows from a distal port in a distal direction over the impeller shaft and a second portion of the infusant flows from the distal port in a proximal direction over the impeller shaft.

8. The catheter of claim 7, wherein the coupler is configured to direct infusant distally from the catheter body to the bearing housing.

9. The catheter of claim 7, wherein the coupler is configured to direct infusant proximally from the bearing housing to the shaft.

10. The catheter of claim 7, wherein the distal end of the coupler is configured to be received within the bearing housing.

11. The catheter of claim 10, wherein the proximal end of the coupler is configured to be received within the catheter body.

12. The catheter of claim 10, wherein the distal end of the coupler has a first diameter and the proximal end of the coupler has a second diameter less than the first diameter.

13. A heart pump configured to be applied percutaneously, comprising:

a catheter assembly comprising a proximal end, a distal end, and an elongate body extending therebetween, the elongate body having a drive lumen extending therethrough;

an impeller assembly comprising an impeller shaft and an impeller disposed on the impeller shaft; and

a drive shaft disposed in the drive lumen, the drive shaft having a plurality of layers;

wherein the drive shaft comprises first and second coil wire lavers wound in opposite directions.

14. The heart pump of claim 13, wherein each of the layers comprises a coil wire.

15. The heart pump of claim 13, further comprising at least one bearing coupled with the distal end of the catheter assembly and configured to hydrodynamically support the impeller assembly.

16. The heart pump of claim 13, wherein at least the portion of the elongate body forming the drive lumen comprises a material configured to resist wear and provide enhanced lubricity.

17. The heart pump of claim 13, wherein a gap between the drive shaft and a surface of the elongate body defining the drive lumen is controlled to permit lubricant flow and to minimize distortion of the drive shaft.

18. The heart pump of claim 13, wherein the impeller includes at least one impeller blade having a leading edge surface, a trailing edge surface, a first zone adjacent to the impeller shaft, and a second zone spaced radially away from the first zone, the second zone having a rounded edge spanning from the leading edges surface to the trailing edge surface.

19. The heart pump of claim 13, wherein the impeller includes at least one impeller blade having a rounding feature applied between a suction side surface and a pressure side surface at (1) a leading edge, (2) a trailing edge, and/or (3) tip edge.

20. The heart pump of claim 13, wherein the drive shaft further comprises a guidewire lumen extending therethrough.

21. A heart pump comprising

a catheter assembly comprising a proximal end, a distal end, and an elongate body extending therebetween;

an impeller assembly coupled with the elongate body and comprising an impeller shaft and an impeller disposed on the impeller shaft;

a bearing disposed between the proximal end of the impeller shaft and the distal end of the catheter assembly; and

an infusant inflow port disposed distal of the bearing and configured to direct infusant radially inwardly toward the impeller shaft.

22. The heart pump of claim 21, wherein the heart pump is configured such that when infusant is directed through the infusant inflow port, a first flow rate of infusant is provided proximally along the outer surface of the impeller shaft and a second flow rate of infusant is provided distally along the outer surface of the impeller, the first flow rate being greater than the second flow rate.

23. The heart pump of claim 21, wherein an infusant inflow channel is provided to convey infusant from the proximal end of the elongate body to the inflow port, the inflow channel being disposed at a radial position spaced from a central longitudinal axis of the elongate body, the outer surface of the impeller being disposed between the radial position of the inflow channel and the central longitudinal axis.

24. The heart pump of claim 21, wherein the bearing is a first bearing and further comprising a second bearing disposed distally of the first bearing.

25. The heart pump of claim 24, wherein the first bearing has a length greater than a length of the second bearing.

26. The heart pump of claim 24, wherein a first clearance distance is defined between the first bearing and the impeller shaft and a second clearance distance is defined between the second bearing the impeller shaft, the first clearance distance being greater than the second clearance distance.

27. The heart pump of claim 24, wherein at least one of the first and second bearings includes a material comprising PEEK.

28. The heart pump of claim 27, wherein the material comprises carbon fiber, PTFE, and graphite.

29. The heart pump of claim 27, wherein the material has a coefficient of friction in the range of from about 0.15 to about 0.3.

30. The heart pump of claim 21, further comprising a bearing housing in which the bearing is mounted, the infusant inflow port being formed in an inner wall of the bearing housing.

31. The heart pump of claim 30, comprising a plurality of inflow ports formed in the bearing housing and a plurality of channels corresponding to each inflow port, the channels being disposed at least in part within a peripheral wall of the bearing housing.

32. The heart pump of claim 31, wherein the channels are in fluid communication with a plurality of flow channels formed in an elongate body disposed proximally of the bearing housing.

33. The heart pump of claim 21, wherein the elongate body comprises a multilumen catheter having a central lumen disposed therein and a peripheral lumen disposed radially outwardly of the central lumen, the peripheral lumen being in fluid communication with the infusant inflow port.

34. The heart pump of claim 21, the heart pump is configured such that infusant directed through the inflow port lubricates the bearing and causes distal flow out of the heart pump keeping blood out of the bearing and impeller assembly.

35. The heart pump of claim 34, wherein the infusant flow causes debris to be moved away from the bearing and the impeller assembly.

36. The heart pump of claim 21, wherein at least the impeller comprises a layer disposed on a surface that is exposed to blood when the heart pump is inserted into the patient and operating, the layer is configured to enhance biocompatibility of the pump.

37. A catheter assembly for a heart pump, comprising:

a flexible catheter body having a proximal portion and a distal portion and defining one or more lumens therethrough, the catheter body having a central longitudinal axis and being configured to extend from a peripheral access to a patient'"'"'s heart; and

an impeller assembly having an impeller and a housing in which the impeller is disposed,

wherein the distal portion of the catheter body and a proximal portion of the impeller assembly are joined along a length, the distal portion of the catheter body being disposed between an overlying member of the catheter assembly and the central longitudinal axis,

wherein the distal portion of the catheter body is mechanically engaged with the overlying member by a projection of one of the catheter body and the overlying member into the other of the catheter body and the overlying member.

38. The catheter assembly of claim 37, wherein the overlying member comprises an annular member

39. The catheter assembly of claim 38, wherein the annular member comprises a portion of the impeller housing.

40. The catheter assembly of claim 39, wherein the annular member further comprises one or more barbs configured to secure the proximal portion of the impeller housing with the distal portion of the catheter body.

41. The catheter assembly of claim 39, wherein the distal portion of the catheter body comprises one or more notches positioned to engage the one or more barbs.

42. The catheter assembly of claim 38, further comprising an adhesive disposed on a surface of the distal portion of the catheter body to secure the distal portion of the catheter body to a concentrically mounted structure.

43. The catheter assembly of claim 38, further comprising a seal disposed on a surface of the distal portion of the catheter body to reduce leakage along the surface.