Heart assist device with expandable impeller pump

• US 9,364,593 B2
• Filed: 09/14/2012
• Issued: 06/14/2016
• Est. Priority Date: 09/17/2004
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated), Penn State Research Foundation, Thoratec LLC
• Original Assignee: Penn State Research Foundation, Thoratec LLC
• Inventors: McBride, Mark W., Boger, David A., Campbell, Robert L., Dillon, Gregory P., Hambric, Stephen A., Kunz, Robert F., Leschinsky, Boris, Mallison, Thomas M., Runt, James P., Walsh, Justin M.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US13/618,071
• Publication Number:
  US 20130066140A1
• Time in Patent Office: 1,369 Days
• Field of Search: 600 16- 18
• US Class Current: 1/1
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• 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 60/174 discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
• 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 60/414 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 60/808 specially adapted for deformable impellers, e.g. expandable impellers
• CPC Class Codes: A61M 60/824 Hydrodynamic or fluid film bearings
• CPC Class Codes: A61M 60/829 having a purge fluid supply
• CPC Class Codes: A61M 60/865 Devices for guiding or inserting pumps or pumping devices into the patient's body
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: F04D 29/181 Axial flow rotors F04D29/185 take precedence
• CPC Class Codes: F04D 29/247 elastic or self-adjusting
• CPC Class Codes: F04D 29/528 especially adapted for liquid pumps
• CPC Class Codes: F04D 29/542 Bladed diffusers fixing blades to stators F01D9/042
• CPC Class Codes: F04D 3/00 Axial-flow pumps priming or boosting F04D9/00
• CPC Class Codes: F04D 3/02 of screw type
• CPC Class Codes: F05B 2240/311 flexible or elastic
• CPC Class Codes: F05B 2280/5001 Elasticity

Abstract

An impeller includes a hub and a blade supported by the hub. The impeller has a stored configuration in which the blade is compressed so that its distal end moves towards the hub, and a deployed configuration in which the blade extends away from the hub. The impeller may be part of a pump for pumping fluids, such as blood, and may include a cannula having a proximal portion with a fixed diameter, and a distal portion with an expandable diameter. The impeller may reside in the expandable portion of the cannula. The cannula may have a compressed diameter which allows it to be inserted percutaneously into a patient. Once at a desired location, the expandable portion of the cannula may be expanded and the impeller expanded to the deployed configuration. A flexible drive shaft may extend through the cannula for rotationally driving the impeller within the patient.

Claims

1. An apparatus for inducing motion of a fluid relative to the apparatus, the apparatus comprising:

an expandable cannula having a mesh comprising an undulating pattern, the expandable cannula having a proximal portion and a distal portion and a plurality of struts, each strut of the plurality extending from the proximal portion of the expandable cannula to a non-expandable portion of the apparatus, the proximal portion of the expandable cannula being expandable, the expandable cannula and the struts arranged to facilitate recollapse of the cannula; and

an impeller positioned, at least in part, in an expandable portion of the expandable cannula, the impeller positioned distal the non-expandable portion of the apparatus.

2. The apparatus of claim 1, wherein the undulating pattern defines a circumference of the cannula.

3. The apparatus of claim 1, wherein the mesh comprises a plurality of circumferential rings.

4. The apparatus of claim 3, wherein the circumferential rings are connected by one or more connectors.

5. The apparatus of claim 4, further comprising a connector that extends between a first end connected to a side of a first circumferential ring and a second end connected to a side of a second circumferential ring.

6. The apparatus of claim 4, wherein each circumferential ring has an undulating pattern that includes a plurality of apexes pointing proximally and that defines a plurality of recesses facing distally.

7. The apparatus of claim 4, wherein the number of connectors per pair of circumferential rings decreases within the expandable cannula from a first level at a first zone adjacent to the proximal portion to a second lower level at a second zone between the first zone and the distal portion.

8. The apparatus of claim 7, wherein the number of connectors per pair of circumferential rings decreases within the expandable cannula from the second level to a third level at a third zone within the distal portion.

9. The apparatus of claim 3, wherein the circumferential rings are at least partially interleaved.

10. The apparatus of claim 3, wherein each circumferential ring includes four waves.

11. The apparatus of claim 1, wherein the expandable cannula is self-expandable.

12. The apparatus of claim 1, wherein the expandable cannula has a stored configuration and an expanded configuration, the apparatus further comprising a retainer sheath configured to hold the cannula in the stored configuration when the expandable cannula is compressed within the retainer sheath.

13. The apparatus of claim 12, wherein the expandable cannula is configured to expand into the expanded configuration from the stored configuration when the expandable cannula is urged out of the retainer sheath.

14. The apparatus of claim 13, wherein the expandable cannula in the expanded configuration has a diameter greater than 6 mm.

15. The apparatus of claim 14, wherein the expandable cannula in the expanded configuration has a diameter in a range of about 6 mm to about 7 mm.

16. The apparatus of claim 12, wherein the proximal portion of the expandable cannula is caused to collapse by advancement of a distal portion of the retainer sheath over the struts.

17. The apparatus of claim 1, wherein the mesh comprises a metal.

18. The apparatus of claim 17, wherein the mesh comprises nitinol.

19. The apparatus of claim 1, further comprising an elastic coating over at least a portion of the mesh.

20. The apparatus of claim 19, further comprising a fluid outlet defined at least in part by a proximal end of the elastic coating.

21. The apparatus of claim 1, wherein the mesh comprises the struts.

22. The apparatus of claim 21, wherein the mesh, the struts, and the non-expandable portion comprise a continuous structure.

23. The apparatus of claim 1, wherein one or more of the plurality of struts are sized and shaped to permit an outward flow of blood from the expandable cannula.

24. The apparatus of claim 1, wherein the non-expandable portion of the apparatus extends to a proximal end, wherein, during operation of the apparatus, the proximal end is disposed outside the host body.

25. The apparatus of claim 1, wherein the impeller comprises a guide wire opening therethrough and a seal at a distal end of the impeller, the seal configured to seal the guide wire opening when a guide wire is removed from the guide wire opening in the impeller.

26. The apparatus of claim 1, wherein the impeller comprises a hub and a blade extending from the hub, the blade having a proximal end at the hub and a distal end, and wherein a tip gap between the distal end of the blade and an interior surface of the expandable cannula is about 10 percent to about 50 percent of a maximum thickness of the distal end of the blade.

27. The apparatus of claim 1, wherein the impeller comprises a blade having a proximal end and a distal end, and wherein the expandable cannula has a stiffness such that, when the impeller is rotated, a tip gap between the distal end of the blade and an interior surface of the cannula is substantially constant.

28. The apparatus of claim 1, further comprising a fluid outlet to permit the flow of fluid out of the apparatus, the fluid outlet at least partially defined by the struts.

29. The apparatus of claim 1, wherein the non-expandable portion of the apparatus comprises a portion of the expandable cannula.

30. The apparatus of claim 29, wherein the non-expandable portion of the expandable cannula comprises an annular structure connected to the struts.

31. The apparatus of claim 1, wherein the plurality of struts comprises discharge struts to remove swirl velocity from discharge flow of the impeller.

32. The apparatus of claim 1, wherein the mesh comprises another plurality of struts.

33. The apparatus of claim 1, wherein the expandable cannula comprises an inlet and an outlet, the inlet and the outlet defined at least in part by the mesh.

34. The apparatus of claim 1, wherein the expandable cannula comprises a tubular portion which acts as a fluid flow duct and an outlet portion which comprises an outlet, wherein the outlet portion is tapered radially inwardly relative to the tubular portion.

35. The apparatus of claim 1, wherein the mesh comprises a plurality of first openings at a proximal portion of the expandable cannula and a plurality of second openings distal the plurality of first openings, wherein the first openings are larger than the second openings.

36. The apparatus of claim 35, further comprising an elastic coating over the second openings.

37. A heart pump comprising:

a cannula having an expandable and collapsible portion comprising a mesh, the mesh comprising a plurality of circumferential rings, wherein at least some adjacent circumferential rings are at least partially interleaved; and

an impeller positioned in the cannula.

38. The heart pump of claim 37, wherein the expandable and collapsible portion of the cannula is self-expandable.

39. The heart pump of claim 37, wherein the circumferential rings are connected by one or more connectors.

40. The heart pump of claim 39, further comprising a connector that extends between a first end connected to a side of a first circumferential ring and a second end connected to a side of a second circumferential ring.

41. The heart pump of claim 37, wherein each circumferential ring comprises a plurality of waves, and wherein each wave of the plurality of waves of two adjacent, interleaved circumferential rings at least partially overlap.

42. The heart pump of claim 37, wherein two adjacent circumferential rings at least partially overlap along a longitudinal axis of the cannula.

43. The heart pump of claim 42, further comprising a first circumferential ring and a second circumferential ring adjacent to and distal of the first circumferential ring, wherein a crest of the first circumferential ring is distal of a trough of the second circumferential ring.

44. The heart pump of claim 37, further comprising a first circumferential ring and a second circumferential ring that are at least partially interleaved, wherein the first and second circumferential rings are about the same size.

45. The heart pump of claim 37, wherein the plurality of circumferential rings are disposed on a cylindrical surface extending along the longitudinal axis of the cannula.

46. The heart pump of claim 37, wherein the impeller is disposed, at least in part, in the expandable portion of the cannula.

47. The heart pump of claim 37, further comprising an elastic coating disposed about at least a portion of the mesh.

48. The heart pump of claim 37, further comprising a retainer sheath configured to move relative to the cannula in a first direction to allow the expandable and collapsible portion to expand to the expanded configuration and in a second direction to collapse the expandable and collapsible portion.

49. The heart pump of claim 37, wherein the cannula comprises an inlet and an outlet, the inlet and the outlet defined at least in part by the mesh.

50. The heart pump of claim 37, wherein the cannula comprises a tubular portion which acts as a fluid flow duct and an outlet portion which comprises an outlet, wherein the outlet portion is tapered radially inwardly relative to the tubular portion.

51. The heart pump of claim 37, wherein the mesh comprises a plurality of first openings at a proximal portion of the cannula and a plurality of second openings distal the plurality of first openings, wherein the first openings are larger than the second openings.

52. The apparatus of claim 51, further comprising an elastic coating over the second openings.

53. A heart pump comprising:

a cannula having an expandable portion having a mesh, the mesh having a thickness and a density; and

an impeller comprising one or more blades positioned in the expandable portion of the cannula and configured to rotate in an operational configuration of the heart pump,

wherein at least one of the thickness and density of the mesh is configured such that, when the impeller rotates in the operational configuration, a tip gap between a tip of the one or more blades and an inner wall of the cannula is substantially constant.

54. The heart pump of claim 53, wherein the mesh comprises a plurality of circumferential rings.

55. The heart pump of claim 54, wherein at least some adjacent circumferential rings at least partially overlap along a longitudinal axis of the cannula.

56. The heart pump of claim 53, wherein at least one of the thickness and density of the mesh is configured such that, when the impeller rotates in the operational configuration, the expandable portion of the cannula radially deflects by a substantially constant amount.

57. The heart pump of claim 53, wherein the impeller is expandable from a stored configuration to a deployed configuration.

58. The heart pump of claim 53, further comprising an elastic coating disposed about at least a portion of the mesh.

59. The heart pump of claim 53, further comprising a retainer sheath configured to move relative to the cannula in a first direction to allow the expandable portion to expand to the expanded configuration and in a second direction to collapse the expandable portion.

60. A heart pump comprising:

a cannula having an expandable and collapsible portion comprising a mesh, the mesh comprising a plurality of circumferential rings; and

an impeller positioned in the cannula,

wherein a plane disposed orthogonal to a longitudinal axis of the heart pump intersects at least two adjacent circumferential rings.

61. The heart pump of claim 60, wherein the cannula comprises an enclosure disposed about the mesh.