Implantable heart assist system and method of applying same

• US 7,144,365 B2
• Filed: 12/05/2003
• Issued: 12/05/2006
• Est. Priority Date: 10/09/1997
• Status: Expired due to Term

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: ORQIS Medical Corporation
• Inventors: Gharib, Morteza, Bolling, Steven F., Gaddis, Mary Lynn, Viole, Anthony J., Aldea, Gabriel
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US10/729,026
• Publication Number:
  US 20040116768A1
• Time in Patent Office: 1,096 Days
• Field of Search: 600 16- 17
• US Class Current: 600/16
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 60/117 for assisting the heart, e.g. transcutaneous or external ventricular assist devices
• 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 60/152 branching on and drawing blood from a blood vessel
• CPC Class Codes: A61M 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/232 Centrifugal pumps
• 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 60/274 the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood 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 60/569 synchronous with the native heart beat
• CPC Class Codes: A61M 60/859 Connections therefor
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body

Abstract

An extracardiac pumping for supplementing the circulation of blood, including the cardiac output, in a patient without any component thereof being connected to the patient'"'"'s heart, and method of using same. One embodiment of the extracardiac system comprises a pump configured to be implanted subcutaneously in a minimally-invasive procedure, wherein the pump can draw blood through an inflow conduit, and can discharge blood through an outflow conduit. The pump may be operated continuously or in a pulsatile fashion, synchronous with the patient'"'"'s heart, thereby potentially reducing the afterload of the heart. The conduits can be housed in a multi-lumen catheter.

Claims

1. A system for supplementing blood circulation in a patient comprising:

a pump configured to pump blood through the patient at subcardiac flow rates, said pump having an average flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy;

a conduit fluidly coupled to the pump and configured to direct blood between two locations within the patient'"'"'s vasculature wherein the blood may travel in reverse directions within the conduit, wherein the conduit further comprises;

an inflow port;

a first lumen fluidly coupled with the inflow port such that blood can be directed from the inflow port into the first lumen;

a second lumen fluidly coupled to the pump such that blood can be pumped from the pump through the second lumen;

an outflow port fluidly coupled with the second lumen such that blood can be directed from the second lumen through the outflow port;

a first cannula positioned between the pump and the first lumen; and

a second cannula positioned between the second lumen and the pump

wherein the conduit is configured such that the inflow port can be positioned at a first location within the patient'"'"'s vasculature and the outflow port can be positioned at a second location within the vasculature.

2. The system of claim 1, wherein the conduit comprises a multi-lumen catheter.

3. A system for supplementing blood circulation in a patient comprising:

a pump configured to pump blood through the patient at subcardiac flow rates, said pump having an average flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy;

a conduit fluidly coupled to the pump and configured to direct blood between two locations within the patient'"'"'s vasculatore wherein the blood may travel in reverse directions within the conduit;

a motor operatively coupled to the pump; and

a programmable controller electronically coupled to the motor and configured to control the speed of the motor and the output of the pump,

wherein the conduit is comprised of a material that is sufficiently flexible so as not to prevent the patient from being ambulatory.

4. A system for supplementing blood circulation in a patient comprising:

a pump configured to pump blood through the patient at subcardiac flow rates, said pump having an average flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy; and

a conduit fluidly coupled to the pump and configured to direct blood between two locations within the patient'"'"'s vasculature wherein the blood may travel in reverse directions within the conduit;

wherein the conduit is configured to direct blood from a first peripheral vessel to a second vessel.

5. The system of claim 4, wherein the first peripheral vessel is a femoral artery and the second vessel is the aorta.

6. The system of claim 4, wherein the conduit comprises a multi-lumen catheter.

7. The system of claim 4, wherein the pump is sized and configured to discharge blood at volumetric flow rates between about 0.1 liters/min and about 3.0 liters/min.

8. The system of claim 4, wherein the system is configured to be applied to the patient through a single cannulation site.

9. The system of claim 4, wherein the pump comprises a rotary pump.

10. The system of claim 4, wherein the conduit is comprised of a material that is sufficiently flexible so as not to prevent the patient from being ambulatory.

11. The system of claim 4, wherein the pump is configured to be implanted within the patient.

12. The system of claim 4, wherein the first peripheral vessel is a femoral artery and the second vessel is an axillary artery.

13. A system for supplementing blood circulation in a patient comprising:

a pump configured to pump blood through the patient at subcardiac flow rates, said pump having an average flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy; and

a conduit fluidly coupled to the pump and configured to direct blood between two locations within the patient'"'"'s vasculature wherein the blood may travel in reverse directions within the conduit;

wherein a first location is within a left femoral artery and a second location is in a descending aorta proximate an arterial branch.

14. The system of claim 13, wherein the second location is proximate a subclavian artery.

15. The system of claim 13, wherein the second location is proximate a mesenteric artery.

16. The system of claim 13, wherein the conduit comprises a multi-lumen catheter.

17. The system of claim 13, wherein the pump is sized and configured to discharge blood at volumetric flow rates between about 0.1 liters/min and about 3.0 liters/min.

18. A system for supplementing blood circulation in a patient comprising:

a pump configured to pump blood through the patient at subcardiac flow rates, said pump having an avenge flow rate that, during normal operation thereof is substantially below that of the patient'"'"'s heart when healthy;

a conduit fluidly coupled to the pump and configured to direct blood between two locations within the patient'"'"'s vasculature wherein the blood may travel in reverse directions within the conduit;

a motor operatively coupled to the pump; and

a programmable controller electronically coupled to the motor and configured to control the speed of the motor and the output of the pump,

wherein the pump comprises a rotary pump.

19. A system for supplementing blood circulation in a patient comprising:

a pump configured to pump blood through the patient at subcardiac flow rates, said pump having an average flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy; and

a conduit fluidly coupled to the pump and configured to direct blood between two locations within the patient'"'"'s vasculature wherein the blood may travel in reverse directions within the conduit;

wherein the pump comprises a rotary pump, and

wherein the system is configured to be applied to the patient through a single cannulation site.

20. The system of claim 19, wherein the conduit comprises a multi-lumen catheter.

21. The system of claim 19, wherein a first location of the patient'"'"'s vasculature is in a femoral artery and a second location is in the aorta.

22. The system of claim 19, wherein a first location of the patient'"'"'s vasculature is in a femoral artery and a second location is in an axillary artery.

23. The system of claim 19, wherein the pump is sized and configured to discharge blood at volumetric flow rates between about 0.1 liters/min and about 3.0 liters/min.

24. The system of claim 19, wherein the conduit is comprised of a material that is sufficiently flexible so as not to prevent the patient from being ambulatory.

25. The system of claim 19, wherein the pump is configured to be implanted within the patient.

26. A system for supplementing blood circulation in a patient comprising:

a pump configured to pump blood through the patient at subcardiac flow rates, said pump having an average flow rate that, during normal operation thereof is substantially below that of the patient'"'"'s heart when healthy; and

a conduit fluidly coupled to the pump and configured to direct blood between two locations within the patient'"'"'s vasculature wherein the blood may travel in reverse directions within the conduit;

wherein the conduit is comprised of a material that is sufficiently flexible so as not to prevent the patient from being ambulatory, and

wherein the pump is configured to be implanted within the patient.

27. The system of claim 26, wherein the conduit comprises a multi-lumen catheter.

28. The system of claim 26, wherein a first location of the patient'"'"'s vasculature is in a femoral artery and a second location is in the aorta.

29. The system of claim 26, wherein a first location of the patient'"'"'s vasculature is in a femoral artery and a second location is in an axillary artery.

30. The system of claim 26, wherein the pump is sized and configured to discharge blood at volumetric flow rates between about 0.1 liters/min and about 3.0 liters/min.

31. The system of claim 26, wherein the system is configured to be applied to the patient through a single cannulation site.

32. The system of claim 26, wherein the pump comprises a rotary pump.

33. A system for supplementing blood circulation in a patient comprising:

a pump configured to pump blood through the patient at subcardiac flow rates, said pump having an average flow rate that, during normal operation thereof;

is substantially below that of the patient'"'"'s heart when healthy; and

a conduit fluidly coupled to the pump and configured to direct blood between two locations within the patient'"'"'s vasculature wherein the blood may travel in reverse directions within the conduit;

wherein the conduit is comprised of a material that is sufficiently flexible so as not to prevent the patient from being ambulatory, and

wherein the pump comprises a rotary pump.

34. The system of claim 33, wherein the conduit comprises a multi-lumen catheter.

35. The system of claim 33, wherein a first location of the patients vasculature is in a femoral artery and a second location is in the aorta.

36. The system of claim 33, wherein a first location of the patient'"'"'s vasculature is in a femoral artery and a second location is in an axillary artery.

37. The system of claim 33, wherein the pump is sized and configured to discharge blood at volumetric flow rates between about 0.1 liters/min and about 3.0 liters/min.

38. The system of claim 33, wherein the system is configured to be applied to the patient through a single cannulation site.

39. The system of claim 33, wherein the pump is configured to be implanted within the patient.

40. A system for supplementing blood circulation in a patient comprising:

a pump configured to pump blood through the patient at subcardiac flow rates, said pump having an average flow rate that, during normal operation thereof;

is substantially below that of the patient'"'"'s heart when healthy; and

a conduit fluidly coupled to the pump and configured to direct blood between two locations within the patient'"'"'s vasculature wherein the blood may travel in reverse directions within the conduit;

wherein the conduit is comprised of a material that is sufficiently flexible so as not to prevent the patient from being ambulatory, and

wherein the conduit is configured to direct blood from a first peripheral vessel to a second vessel.

41. The system of claim 40, wherein the lint peripheral vessel is a femoral artery and the second vessel is the aorta.

42. The system of claim 40, wherein the conduit comprises a multi-lumen catheter.

43. The system of claim 40, wherein the pump is sized and configured to discharge blood at volumetric flow rates between about 0.1 liters/min and about 3.0 liters/min.

44. The system of claim 40, wherein the system is configured to be applied to the patient through a single cannulation site.

45. The system of claim 40, wherein the pump comprises a rotary pump.

46. The system of claim 40, wherein the pump is configured to be implanted within the patient.

47. The system of claim 40, wherein the first peripheral vessel is a femoral artery and the second vessel is an axillary artery.

48. A system for supplementing blood circulation in a patient comprising:

a pump configured to pump blood through the patient at subcardiac flow rates, said pump having an average flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy; and

a conduit fluidly coupled to the pump and configured to direct blood between two locations within the patient'"'"'s vasculature wherein the blood may travel in reverse directions within the conduit;

wherein the conduit is comprised of a material that is sufficiently flexible so as not to prevent the patient from being ambulatory, and wherein the conduit comprises a multi-lumen catheter.

49. The system of claim 48, wherein the pump is sized and configured to discharge blood at volumetric flow rates between about 0.1 liters/min and about 3.0 liters/min.

50. The system of claim 48, wherein a first location of the patient'"'"'s vasculature is in a femoral artery and a second location is in the aorta.

51. The system of claim 48, wherein a first location of the patient'"'"'s vasculature is in a femoral artery and a second location is in an axillary artery.

52. The system of claim 48, wherein the system is configured to be applied to the patient through a single cannulation site.

53. The system of claim 48, wherein the pump comprises a rotary pump.

54. The system of claim 48, wherein the pump is configured to be implanted within the patient.