Intravascular blood pumps and methods of use and manufacture

• US 10,722,631 B2
• Filed: 02/01/2019
• Issued: 07/28/2020
• Est. Priority Date: 02/01/2018
• Status: Active Grant

• Current Assignee: Shifamed Holdings, LLC
• Original Assignee: Shifamed Holdings, LLC
• Inventors: Salahieh, Amr, Saul, Tom, Esch, Brady, Kerlo, Anna, Hildebrand, Daniel, Varghai, Daniel
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US16/265,828
• Publication Number:
  US 20190328948A1
• Time in Patent Office: 543 Days
• CPC Class Codes: A61M 2207/10 Device therefor
• 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 60/139 inside the aorta, e.g. intra-aortic balloon pumps
• 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 60/804 Impellers
• CPC Class Codes: A61M 60/808 specially adapted for deformable impellers, e.g. expandable impellers
• CPC Class Codes: A61M 60/81 Pump housings
• CPC Class Codes: A61M 60/818 Bearings
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• CPC Class Codes: A61M 60/865 Devices for guiding or inserting pumps or pumping devices into the patient's body

Abstract

Devices for moving blood within a patient, and methods of doing so. The devices can include a pump portion that includes an impeller and a housing around the impeller, as well as a fluid lumen. The impeller can be activated to cause rotation of the impeller and thereby move fluid within the fluid lumen.

Claims

1. An intravascular blood pump, comprising:

a collapsible housing comprising a fluid lumen, the fluid lumen having a distal end and a proximal end;

a collapsible distal impeller axially spaced from a collapsible proximal impeller, the distal impeller having an expanded configuration and the proximal impeller having an expanded configuration, and at least a portion of each of the distal and proximal impellers disposed between the distal and proximal ends of the fluid lumen,

wherein the proximal impeller and the distal impeller are each, when in their expanded configurations and when rotated, positioned relative to the fluid lumen such that the proximal impeller is performing more than 50% of the work of the blood pump and the distal impeller is performing less than 50% of the work of the blood pump.

2. The blood pump of claim 1, wherein the blood pump does not include a vane disposed axially between the proximal and distal impellers.

3. The blood pump of claim 1, wherein the blood pump does not include a stator blade disposed axially between the proximal and distal impellers.

4. The blood pump of claim 1, wherein at least half of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

5. The blood pump of claim 4, wherein at least 50% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

6. The blood pump of claim 4, wherein at least 55% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

7. The blood pump of claim 4, wherein at least 60% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

8. The blood pump of claim 4, wherein at least 65% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

9. The blood pump of claim 4, wherein at most 90% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

10. The blood pump of claim 9, wherein at most 80% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

11. The blood pump of claim 10, wherein at most 75% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

12. The blood pump of claim 11, wherein at most 70% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

13. The blood pump of claim 11, wherein at most 65% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

14. The blood pump of claim 11, wherein at most 60% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

15. The blood pump of claim 11, wherein at most 55% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

16. The blood pump of claim 1, wherein at least half of the proximal impeller, measured along an axial length, is disposed in a flared proximal region of the fluid lumen.

17. The blood pump of claim 1, wherein the proximal impeller and the distal impeller are each, when in their expanded configurations, positioned relative to the fluid lumen such that the proximal impeller is performing more than 55% of the work of the blood pump and the distal impeller is performing less than 45% of the work of the blood pump.

18. The blood pump of claim 17, wherein the proximal impeller and the distal impeller are each, when in their expanded configurations, positioned relative to the fluid lumen such that the proximal impeller is performing more than 60% of the work of the blood pump and the distal impeller is performing less than 40% of the work of the blood pump.

19. The blood pump of claim 18, wherein the proximal impeller and the distal impeller are each, when in their expanded configurations, positioned relative to the fluid lumen such that the proximal impeller is performing more than 70% of the work of the blood pump and the distal impeller is performing less than 30% of the work of the blood pump.

20. The blood pump of claim 19, wherein the proximal impeller and the distal impeller are each, when in their expanded configurations, positioned relative to the fluid lumen such that the proximal impeller is performing about 80% of the work of the blood pump and the distal impeller is performing about 20% of the work of the blood pump.

21. A method of intravascularly pumping blood in a subject, comprising:

positioning a pump housing fluid lumen first end in a left ventricle;

positioning a distal impeller of the blood pump in the left ventricle;

positioning a proximal impeller of the blood pump in an ascending aorta;

positioning a pump housing fluid lumen second end in the ascending aorta;

positioning at least a portion of a central region of the fluid lumen across an aortic valve,

creating a flow path between the fluid lumen first end positioned in the left ventricle and the fluid lumen second end positioned in the ascending aorta such that the distal impeller and the proximal impeller can pump blood through the fluid lumen;

rotating the distal impeller and proximal impeller and thereby causing the proximal impeller to perform more than 50% of the work of the blood pump and the distal impeller to perform less than 50% of the work of the blood pump.

22. The method of claim 21, wherein the rotating step comprises rotating the distal impeller and proximal impeller and thereby causing the proximal impeller to perform more than 60% of the work of the blood pump and the distal impeller to perform less than 40% of the work of the blood pump.

23. The method of claim 21, wherein the rotating step comprises rotating the distal impeller and proximal impeller and thereby causing the proximal impeller to perform more than 70% of the work of the blood pump and the distal impeller to perform less than 30% of the work of the blood pump.

24. The method of claim 21, wherein the rotating step comprises rotating the distal impeller and proximal impeller and thereby causing the proximal impeller to perform more than 75% of the work of the blood pump and the distal impeller to perform less than 25% of the work of the blood pump.

25. The method of claim 21, wherein the rotating step comprises rotating the distal impeller and proximal impeller and thereby causing the proximal impeller to perform about 80% of the work of the blood pump and the distal impeller to perform about 20% of the work of the blood pump.

26. An intravascular blood pump, comprising:

a collapsible housing comprising a fluid lumen, the fluid lumen having a distal end and a proximal end;

a collapsible distal impeller axially spaced from a collapsible proximal impeller, the distal impeller having an expanded configuration and the proximal impeller having an expanded configuration, and at least a portion of each of the distal and proximal impellers disposed between the distal and proximal ends of the fluid lumen,

wherein the proximal impeller and the distal impeller are each, when in their expanded configurations and when rotated, positioned relative to the fluid lumen such that the proximal impeller is generating more than 50% of the pressure generated by the blood pump and the distal impeller is generating less than 50% of the pressure generated by the blood pump of the blood pump.

27. The blood pump of claim 26, wherein the blood pump does not include a vane disposed axially between the proximal and distal impellers.

28. The blood pump of claim 26, wherein the blood pump does not include a stator blade disposed axially between the proximal and distal impellers.

29. The blood pump of claim 26, wherein at least half of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

30. The blood pump of claim 29, wherein at least 50% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

31. The blood pump of claim 29, wherein at least 55% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

32. The blood pump of claim 29, wherein at least 60% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

33. The blood pump of claim 29, wherein at least 65% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

34. The blood pump of claim 29, wherein at most 90% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

35. The blood pump of claim 34, wherein at most 80% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

36. The blood pump of claim 35, wherein at most 75% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

37. The blood pump of claim 36, wherein at most 70% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

38. The blood pump of claim 36, wherein at most 65% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

39. The blood pump of claim 37, wherein at most 60% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

40. The blood pump of claim 37, wherein at most 55% of the proximal impeller, measured along an axial length, is disposed proximal to a proximal end of a substantially constant diameter portion of the fluid lumen.

41. The blood pump of claim 26, wherein at least half of the proximal impeller, measured along an axial length, is disposed in a flared proximal region of the fluid lumen.

42. The blood pump of claim 26, wherein the proximal impeller and the distal impeller are each, when in their expanded configurations, positioned relative to the fluid lumen such that the proximal impeller is generating more than 55% of the pressure of the blood pump and the distal impeller is generating less than 45% of the pressure of the blood pump.

43. The blood pump of claim 42, wherein the proximal impeller and the distal impeller are each, when in their expanded configurations, positioned relative to the fluid lumen such that the proximal impeller is generating more than 60% of the pressure of the blood pump and the distal impeller is generating less than 40% of the pressure of the blood pump.

44. The blood pump of claim 43, wherein the proximal impeller and the distal impeller are each, when in their expanded configurations, positioned relative to the fluid lumen such that the proximal impeller is generating more than 70% of the pressure of the blood pump and the distal impeller is generating less than 30% of the pressure of the blood pump.

45. The blood pump of claim 44, wherein the proximal impeller and the distal impeller are each, when in their expanded configurations, positioned relative to the fluid lumen such that the proximal impeller is generating about 80% of the pressure of the blood pump and the distal impeller is generating about 20% of the pressure of the blood pump.

46. A method of intravascularly pumping blood in a subject, comprising:

positioning a pump housing fluid lumen first end in a left ventricle;

positioning a distal impeller of the blood pump in the left ventricle;

positioning a proximal impeller of the blood pump in an ascending aorta;

positioning a pump housing fluid lumen second end in the ascending aorta;

positioning at least a portion of a central region of the fluid lumen across an aortic valve,

creating a flow path between the fluid lumen first end positioned in the left ventricle and the fluid lumen second end positioned in the ascending aorta such that the distal impeller and the proximal impeller can pump blood through the fluid lumen;

rotating the distal impeller and proximal impeller and thereby causing the proximal impeller to generate more than 50% of the pressure of the blood pump and the distal impeller to generate less than 50% of the pressure of the blood pump.