Impeller housing for percutaneous heart pump

• US 8,485,961 B2
• Filed: 01/04/2012
• Issued: 07/16/2013
• 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: Campbell, Robert L., Fitzgerald, Keif, Harrison, William James, Leschinsky, Boris, Mallison, Thomas M., McBride, Mark W., Roslund, Adam, Walters, Daniel A., Yuen, Phyllis
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US13/343,617
• Publication Number:
  US 20120172655A1
• Time in Patent Office: 559 Days
• Field of Search: 600/16
• US Class Current: 600/16
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• 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 60/411 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

Abstract

Disclosed herein are heart pumps that include a catheter assembly and that can be applied percutaneously. Some embodiments include a locking device that prevents components of the catheter assembly from being separated when in use. The catheter assembly can include an expandable tip. In some embodiments, the catheter assembly includes a housing having a wall structure, a portion of which can have a bulbuous shape or can be deformable. In other embodiments, the housing can be configured to reduce fluttering or deflection of the housing and/or to maintain a gap between the housing and an impeller blade disposed therein.

Claims

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

an elongate tubular member;

a hub coupled with a proximal end of the elongate tubular member;

a plurality of structural members forming a distal portion of an impeller housing;

a locking device disposed between the structural members and the hub configured to prevent the elongate tubular member from being separated from the structural members when the catheter assembly is in use.

2. The catheter assembly of claim 1, wherein the locking device comprises a barb at the distal end of the structural members and a narrow aperture channel formed at a proximal aspect of the hub, the narrow aperture channel permitting insertion of the barb and resisting retraction of the barb.

3. The catheter assembly of claim 1, wherein the hub comprises a recess formed at a proximal end thereof and further comprising a core member configured to be inserted into the recess, the catheter assembly being configured to prevent the structural members from being retracted from the core member.

4. The catheter assembly of claim 3, wherein the structural member and the core member comprises a T-shaped configuration such that a proximal narrow portion of the recess abuts and opposes retraction of a wider portion of the structural member disposed distal thereof.

5. The catheter assembly of claim 3, wherein the hub is coupled to the elongate tubular member through the core member.

6. The catheter assembly of claim 3, wherein the core member comprises a distal portion configured to securely couple with the elongate tubular member.

7. The catheter assembly of claim 6, wherein the distal portion of the core member extends distally of the hub.

8. The catheter assembly of claim 3, wherein a barrier structure is provided within the recess of the hub to separate at least a portion of the recess from a lumen within the catheter assembly.

9. The catheter assembly of claim 1, wherein the hub has an increasing outer profile along its length.

10. The catheter assembly of claim 1, wherein the hub has an elongated tapered section having a distal end disposed distally of the distal portion of the core member to provide a dilating structure.

11. The catheter assembly of claim 1, wherein the hub comprises a distal portion configured to securely couple with the elongate tubular member.

12. The catheter assembly of claim 1, wherein the locking device comprises a through-hole in the structural members configured to permit a first portion of material disposed on an inside surface of the structural member to branch through to a second portion of material disposed on an outside surface of the structural member.

13. The catheter assembly of claim 12, wherein the locking device comprises a plurality of through-holes disposed along a distal length of at least one of the structural members.

14. The catheter assembly of claim 12, wherein the locking device comprises a circular structure disposed at the distal end of the at least one of the structural members.

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

an elongate tubular member;

an expandable housing disposed at the distal end of the elongate tubular member, the expandable housing configured to house an impeller and to convey blood from an intake toward the impeller in use;

an expandable tip coupled with the distal end of the expandable housing, the expandable tip having a collapsed configuration in which a tapered profile is provided for facilitating advancement through an anatomical structure and having an expanded configuration for spacing the intake from the anatomy adjacent to where the pump is operates.

16. The catheter assembly of claim 15, further comprising a plurality of elongate arcuate structural members disposed between the expandable housing and the expandable tip, the arcuate structural members providing wide openings for blood intake into the housing.

17. The catheter assembly of claim 15, further comprising a sheath adapted to be advanced relative to the elongate tubular member to be positioned over the expandable housing and the expandable tip to maintain the tip in the collapsed configuration.

18. The catheter assembly of claim 17, wherein the tip comprises a plurality of arms having proximal portions configured with reduced thickness to engage with a sheath.

19. The catheter assembly of claim 17, wherein the tip comprises a plurality of arms coupled as their distal ends with a hub disposed around a guidewire port, the arms having proximal ends coupled with the expandable housing.

20. The catheter assembly of claim 15, wherein the expandable tip is bulbuous when in the expanded configuration.

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

an impeller shaft and an impeller blade extending from the impeller shaft;

a housing in which the impeller shaft is journaled for rotation, the housing having an elongate wall structure disposed circumferentially about the impeller blade and extending distally and proximally thereof, a distal region of the wall structure being configured to isolate a proximal region of the wall structure from deflection due to application of loads by the heart during operation of the impeller assembly within the patient.

22. The catheter assembly of claim 21, wherein the wall structure comprises a first region disposed over the impeller and a second region distal the first region, the second region having less stiffness than the first region such that loads applied within or distal of the second region produces deformation of the housing that is primarily distal of the first region.

23. The catheter assembly of claim 22, wherein the wall structure comprises a mesh structure and a coating disposed over the mesh, the mesh structure being arranged with a first stiffness in the first region and a second stiffness in the second region, the second stiffness being less than the first stiffness.

24. The catheter assembly of claim 23, wherein the mesh structure in the second region has progressively less stiffness toward the distal end of the housing.

25. The catheter assembly of claim 23, wherein the mesh structure further comprises a third region having a third stiffness that is less than the second stiffness.

26. A percutaneous heart pump, comprising:

a catheter assembly having a proximal end, a distal end, and an elongate body disposed therebetween, the elongate body configured such that the distal end can be disposed inside heart chamber of a human patient while a proximal end is disposed outside the patient,

the distal end comprising an expandable housing being configured to be insertable into a peripheral vessel in a low profile configuration and to be expanded to a larger profile within the patient;

an impeller shaft and an impeller blade extending from the impeller shaft, the impeller shaft is journaled for rotation in the distal portion of the catheter assembly;

wherein the expandable housing comprising;

an elongate wall structure disposed circumferentially about the impeller blade and extending distally and proximally thereof, the wall being configured to maintain a gap between the blade an inner surface of the wall structure within a selected range over a range of transverse loading corresponding to forces generated during systole and diastole of the heart.

27. The percutaneous heart pump of claim 26, wherein the elongate wall structure comprises a metallic mesh disposed in a fluid-tight structure, the elongate wall structure having a stiffness profile that is greatest at a longitudinal position corresponding to that of the impeller blades and being decreased distally thereof.

28. The percutaneous heart pump of claim 27, wherein the metallic mesh structure is more dense in a region corresponding to the impeller blade and is less dense distally thereof.

29. The percutaneous heart pump of claim 28, wherein the metallic mesh structure comprises circumferential rings having a greater concentration in the region corresponding to the impeller blade and is less dense distally thereof.

30. The percutaneous heart pump of claim 28, wherein the metallic mesh structure comprises circumferential rings connected by axial connectors, the axial connectors being stiffer in the region corresponding to the impeller blade and being less stiff distally thereof.

31. The percutaneous heart pump of claim 27, wherein the fluid-tight structure comprises a polymeric coating, the polymeric coating being thicker in a region corresponding to the impeller blade and is less dense distally thereof.

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

an impeller shaft and an impeller blade extending from the impeller shaft;

an impeller housing in which the impeller shaft is journaled for rotation, the housing comprising;

an inlet;

an outlet; and

an elongate wall structure disposed circumferentially about the impeller blade and extending distally and proximally thereof between the inlet and outlet, the wall structure adjacent to at least one of the inlet and the outlet being configured to maintain a bulbous shape when deployed.

33. The catheter assembly of claim 32, wherein the elongate wall structure comprises a mesh structure and a coating disposed over the mesh structure, the coating having a stiffened region adjacent the inlet to maintain a first transverse size, the transverse size of the wall structure decreasing proximally and distally of the stiffened region.

34. The catheter assembly of claim 33, wherein the stiffened region comprises an annular band of the wall structure that is thicker than the thickness of the wall structure proximal of the stiffened region.

35. The catheter assembly of claim 32, wherein the elongate wall structure comprises a mesh structure and a coating disposed over the mesh structure, the coating having a stiffened region adjacent the outlet to maintain a first transverse size and the wall structure being configured distal of the outlet to have a transverse size that is less than the first transverse size.

36. The catheter assembly of claim 32, wherein the impeller comprises a diffuser and the wall structure comprises a reinforced annular portion, a flared section extending distally of the annular portion and being disposed over a distal portion of the diffuser and a plurality of leaflets disposed proximally of the annular portion.

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

an impeller shaft and an impeller blade extending from the impeller shaft;

a housing in which the impeller shaft is journaled for rotation, the housing having an elongate wall structure disposed circumferentially about the impeller blade and extending distally and proximally thereof, the wall structure being sufficiently deformable to be displaced by ambient conditions during operation of the impeller assembly within a patient.

38. The catheter assembly of claim 37, wherein the housing is sufficiently flexible to be deflected by fluid flow generated by the impeller blade upon movement of the impeller blade toward the wall.

39. The catheter assembly of claim 38, wherein the wall comprises a plurality of struts and a covering disposed over the struts, the struts and covering being disposed circumferentially about the impeller blade.

40. The catheter assembly of claim 39, wherein the plurality of struts comprises a first strut density at an axial position corresponding to the impeller blade and a second strut density greater than the first strut density at a location proximal or distal of the location of the first density.

41. The catheter assembly of claim 39, wherein the plurality of struts comprises a first average strut thickness at an axial position corresponding to the impeller blade and a second average strut thickness greater than the first average strut thickness at a location proximal or distal of the location of the first density.

42. The catheter assembly of claim 39, wherein the covering comprises a first average thickness at an axial position corresponding to the impeller blade and a second average thickness greater than the first average thickness at a location proximal or distal of the location of the first density.

43. The catheter assembly of claim 39, wherein the plurality of struts comprises a plurality of circumferentially extending sinusoidal member.

44. The catheter assembly of claim 39, wherein the sinusoidal members are elastically deformable at least along a length extending substantially from a proximal end of the impeller blade to a distal end of the impeller blade.

45. The catheter of claim 37, wherein the housing is sufficiently flexible to be deflected to a converging or diverging configuration at an axial position upstream of an impeller inlet plane.

46. The catheter of claim 37, wherein the housing is sufficiently flexible to be deflected to a diverging configuration to produce a diffusing or deswirling effect at an axial position downstream of an impeller outlet plane.

47. An impeller assembly for a heart pump, comprising:

an impeller shaft and an impeller blade extending from the impeller shaft; and

a housing in which the impeller shaft is journaled for rotation, the housing comprising an impeller blade zone, an inlet zone, and an outlet zone, the impeller blade zone being elongate and having a substantially constant transverse size at least from proximal of the impeller blade to distal of the impeller blade;

wherein the impeller zone is disposed between the inlet zone and the outlet zone; and

wherein at least one of the inlet zone and the outlet zone is configured to reduce fluttering of the housing when the heart pump is operating.

48. The impeller assembly of claim 47, wherein the inlet zone comprises enhanced stiffness compared to the stiffness of the impeller zone.

49. The impeller assembly of claim 47, wherein the outlet zone comprises enhanced stiffness compared to the stiffness of the impeller zone.

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

an impeller shaft and an impeller blade extending from the impeller shaft;

a housing in which the impeller shaft is journaled for rotation, the housing having an elongate wall structure a portion of which is disposed circumferentially about the impeller blade and the impeller shaft, the wall structure being configured to provide a first stiffness over the impeller blade and a second stiffness greater than the first stiffness at a location proximal of the impeller blade to reduce bending of the housing proximal of the blade.

51. The catheter assembly of claim 50, wherein the wall structure comprises a first plurality of circumferential sinusoidal rings being joined by a first plurality of generally circumferentially oriented connectors to provide the first stiffness and in the and a second plurality of circumferential sinusoidal rings being joined by a second plurality of generally circumferentially oriented connectors to provide the second stiffness.