Implantable heart assist system and method of applying same

• US 7,993,260 B2
• Filed: 11/10/2009
• Issued: 08/09/2011
• Est. Priority Date: 10/09/1997
• Status: Expired due to Fees

• Current Assignee: Thoratec LLC
• Original Assignee: Thoratec LLC
• Inventors: Bolling, Steven F.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US12/616,087
• Publication Number:
  US 20100145133A1
• Time in Patent Office: 637 Days
• Field of Search: 600/16, 600/17, 623/3.11, 623/3.13, 623/3.16, 623/3.17
• 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 methods of using same. One embodiment provides a vascular graft that has a first end that is sized and configured to couple to a non-primary blood vessel and a second end that is fluidly coupled to a pump to conduct blood between the pump and the non-primary blood vessel. An outflow conduit is also provided that has a first end sized and configured to be positioned within the same or different blood vessel, whether primary or non-primary, through the vascular graft. The outflow conduit is fluidly coupled to the pump to conduct blood between the pump and the patient. The vascular graft may be connected to the blood vessel subcutaneously to permit application of the extracardiac pumping system in a minimally-invasive procedure.

Claims

1. A method for operating a pump, comprising:

implanting minimally invasively in a patient a pump having an inlet configured to fluidly communicate with a source of blood, the pump configured to fluidly communicate with an outflow conduit to permit the pump to dispense blood into the outflow conduit; and

operating the pump at a subcardiac volumetric rate to pump blood from the inlet to the outflow conduit to supplement the patient'"'"'s circulation.

2. The method of claim 1, further comprising connecting at least one of an inflow conduit and the outflow conduit to the pump.

3. The method of claim 1, wherein at least one of an inflow conduit and the outflow conduit is pre-attached to the pump prior to implanting the pump.

4. The method of claim 1, wherein the pump is operated at a flow rate of about 3 liters/minute or less.

5. The method of claim 1, wherein the pump is implanted outside the patient'"'"'s chest cavity.

6. The method of claim 1, further comprising providing fluid communication between a distal end of an inflow conduit and a femoral artery of the patient.

7. The method of claim 1, further comprising inserting a distal end of an inflow conduit into a blood vessel to provide fluid communication between a source of blood and the pump.

8. The method of claim 1, wherein the distal end of the outflow conduit is connected to an axillary artery of the patient.

9. The method of claim 1, wherein an anastomosis connection is provided between the distal end of the outflow conduit and a subclavian artery of the patient.

10. The method of claim 1, further comprising providing fluid communication between an inflow conduit and the patient'"'"'s circulatory system by providing an anastomosis connection between the distal end of the inflow conduit and the patient'"'"'s circulatory system.

11. The method of claim 1, further comprising providing an anastomosis connection between the distal end of the outflow conduit and a peripheral blood vessel of the patient.

12. A method of operating a pump, comprising:

implanting extrathoracically and subdermally in a patient a pump configured to be coupled with an outflow conduit to permit the pump to fluidly communicate with an inlet port of the pump and the outflow conduit; and

operating the pump at a subcardiac volumetric rate to pump blood from the inlet port to the outflow conduit to supplement the patient'"'"'s circulation.

13. The method of claim 12, wherein an anastomosis connection is provided between the distal end of the outflow conduit and a subclavian artery of the patient.

14. The method of claim 12, further comprising connecting at least one of an inflow and the outflow conduit to the pump.

15. The method of claim 12, wherein at least one of an inflow conduit and the outflow conduit is pre-attached to the pump prior to implanting the pump.

16. The method of claim 12, further comprising implanting the pump in the patient'"'"'s groin area.

17. The method of claim 12, further comprising providing an anastomosis connection between the distal end of the outflow conduit and a peripheral vessel of the patient.

18. The method of claim 12, further comprising inserting a distal end of an inflow conduit into a blood vessel to provide fluid communication between a source of blood and the inlet port of pump.

19. A method for operating a pump, comprising:

implanting subcutaneously in a patient a pump to receive blood from an inlet of the pump and to dispense blood through an outflow conduit into a blood vessel of the patient; and

operating the pump at a sub-cardiac flow rate to flow blood from the inlet of the pump to the blood vessel through the outflow conduit to supplement the patient'"'"'s circulation.

20. The method of claim 19, further comprising connecting an inflow conduit to the inlet of the pump and connecting the outflow conduit to an outlet of the pump.

21. The method of claim 19, wherein at least one of an inflow conduit and the outflow conduit is pre-attached to the pump prior to the implantation procedure.

22. The method of claim 19, wherein the distal end of the outflow conduit is connected via anastomosis to the patient'"'"'s subclavian artery to direct blood flow into the aorta.

23. The method of claim 19, wherein the pump is operated at 3 liters per minute or less.

24. A pumping system for treating a patient experiencing congestive heart failure, the system comprising:

a pump configured to pump blood through the patient at subcardiac flow rates,

an inlet configured to direct blood into the pump; and

an outflow conduit configured to be fluidly coupled to the pump to direct blood from the pump to the vasculature, the outflow conduit having a first end configured to enable fluid communication between the outflow conduit and the vasculature via a blood vessel that is not directly connected to the heart;

wherein the outflow conduit is sized and configured to be implantable using a minimally-invasive surgical procedure whereby fluid communication between the outflow conduit and the vasculature may be made subcutaneously.

25. The pumping system of claim 24, wherein the pump is configured to be implanted outside the chest cavity.

26. The pumping system of claim 24, wherein the pump is configured to be implanted subcutaneously.

27. The pumping system of claim 24, wherein the pump is configured to pump blood at a rate of about 3 L/min or less.

28. The pumping system of claim 24, wherein the inlet is disposed at a distal end of an inflow conduit and wherein fluid communication between the inflow conduit and the cardiovascular system may be made subcutaneously to permit application of the inflow conduit in a minimally-invasive procedure.

29. The pumping system of claim 24, wherein the inlet is disposed at a first end of an inflow conduit to enable fluid communication with an iliac or a femoral artery.

30. The pumping system of claim 24, wherein the first end of the outflow conduit is configured to enable fluid communication with an axillary or a subclavian artery.

31. The pumping system of claim 24, wherein at least one of a first end of an inflow conduit fluidly coupled with the inlet and the first end of the outflow conduit is configured to enable fluid communication with the patient'"'"'s cardiovascular system via an anastomosis connection.

32. A device for treating a patient, comprising:

a pump configured to pump blood through the patient at subcardiac flow rates;

the pump comprising an inlet configured to permit blood to enter the pump; and

the pump having an outlet configured to be fluidly coupled with an outflow conduit to direct blood away from the pump;

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

33. The device of claim 32, further comprising:

an inflow conduit configured to couple with the inlet of the pump; and

an outflow conduit configured to couple with the outlet of the pump;

wherein at least one of the inflow and outflow conduits is adapted to be secured to a blood vessel by an anastomosis connection.

34. The device of claim 32, further comprising:

an inflow conduit configured to couple with the inlet of the pump; and

an outflow conduit configured to couple with the outlet of the pump;

wherein at least one of the inflow conduit and the outflow conduit is adapted to be percutaneously inserted into a peripheral vessel to be placed in fluid communication with a source of blood within the patient.

35. The device of claim 32, wherein the pump is adapted to be placed minimally subdermally within the patient.

36. The device of claim 32, wherein the pump is adapted to be placed extrathoracically.

37. The device of claim 32, wherein the pump is adapted to be placed outside the patient'"'"'s chest cavity.

38. The device of claim 37, wherein the pump is adapted to be placed in a patient'"'"'s groin area.

39. The device of claim 32, wherein the pump is a continuous flow pump.

40. The device of claim 32, wherein the pump is a centrifugal pump.

41. The device of claim 32, wherein the pump is an axial flow pump.

42. The device of claim 32, further comprising a minimally invasively implantable controller and power source.

43. The device of claim 32, further comprising a percutaneous line configured to extend transcutaneously between the pump and an extracorporeal power source.

44. The device of claim 32, wherein the pump is configured to operate at 3 liters per minute or less.

45. The device of claim 32, wherein the pump is a rotary blood pump.