Hydraulically actuated cardiac prosthesis and method of actuation

• US 4,369,530 A
• Filed: 05/19/1981
• Issued: 01/25/1983
• Est. Priority Date: 05/19/1981
• Status: Expired due to Fees

• Current Assignee: Foxcroft Associates, Thoratec Laboratories Corp. (Thoratec LLC)
• Original Assignee: Foxcroft Associates
• Inventors: Robinson, Thomas C., Kitrilakis, Sotiris
• Primary Examiner(s): Frinks, Ronald L.
• Application Number:
  US06/265,100
• Time in Patent Office: 616 Days
• Field of Search: 3/1.7, 128/1 D, 128/DIG. 3, 417/383, 417/388-390, 417/394, 417/395
• US Class Current: 623/3.24
• CPC Class Codes: A61M 2205/8243 by induction
• 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 60/196 replacing the entire heart, e.g. total artificial hearts [TAH]
• CPC Class Codes: A61M 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/435 with diastole or systole switching by valve means located between the blood pump and the hydraulic or pneumatic energy source
• CPC Class Codes: A61M 60/837 Aspects of flexible displacement members, e.g. shapes or materials
• CPC Class Codes: A61M 60/869 Compliance chambers containing a gas or liquid other than blood to compensate volume variations of a blood chamber
• CPC Class Codes: A61M 60/873 specially adapted for wireless or transcutaneous energy transfer [TET], e.g. inductive charging
• CPC Class Codes: A61M 60/876 Implantable batteries
• CPC Class Codes: A61M 60/88 Percutaneous cables
• CPC Class Codes: A61M 60/892 Active valves, i.e. actuated by an external force
• CPC Class Codes: A61M 60/894 Passive valves, i.e. valves actuated by the blood

Abstract

A cardiac prosthesis having a hydraulically actuated compressible blood pump. An actuation chamber adjacent the blood pump receives pulses of hydraulic actuation fluid from an actuator pump through a fluid inlet path to compress the blood pump during systole and eject blood therefrom. Between pulses the actuation fluid is permitted to drain from the actuation chamber through an outlet path into a reservoir. Discharge of fluid through the outlet path is controlled by a dump valve which is adapted to close or open the outlet path primarily in response to forces which vary as a function of the flow of actuation fluid through the fluid inlet path.

Claims

1. An implantable hydraulic actuation system for supplying motive power to a blood pumping chamber having a flexible portion comprising:

an actuation fluid reservoir;

actuation fluid pumping means in fluid communication with said reservoir for providing intermittent pulses of actuation fluid;

an actuation chamber having an actuation fluid inlet path in fluid communication with said pumping means, and a separate actuation fluid outlet path in fluid communication with said reservoir;

said actuation chamber being adapted to cause displacement of the flexible portion of said blood pumping chamber in response to changes in volume of actuation fluid in said actuation chamber; and

valve means associated with said actuation chamber adapted to close or open said actuation fluid outlet path primarily in response to forces which vary as a function of actuation fluid flow through said actuation fluid inlet path.

4. The invention of claims 1, 2 or 3 wherein said actuation fluid reservoir comprises a compliant zone defined at least in part by a flexible wall portion made from biocompatible elastomeric material.

5. The invention of claim 4 wherein said actuation fluid reservoir also includes flexible ducting leading to and from said actuation fluid pumping means and to and from said actuation chamber.

7. The invention of claims 1 or 2 wherein said actuation fluid pumping means comprises a pump and drive motor therefor.

8. The invention of claim 7 wherein said pump is a high speed, mixed flow rotary pump.

9. The invention of claim 7 wherein said drive motor is a brushless DC electric motor.

10. The invention of claim 9 further comprising means for commutating said brushless DC electric motor.

11. The invention of claim 10 wherein said means for commutating comprises back-emf control circuitry.

25. The invention of claims 1, 2 or 3 wherein said actuation chamber comprises a variable volume zone defined in part by said flexible portion of said blood pumping chamber and in part by a rigid actuation chamber housing.

26. The invention of claims 1, 2 or 3 wherein said valve means is adapted:

to close said actuation fluid outlet path at the beginning of each of said fluid pulses when sufficient flow of actuation fluid is supplied to said actuation fluid inlet path to create forces above a predetermined threshold magnitude;

to keep said actuation fluid outlet path closed during said pulses while said flow through said inlet path is sufficient to maintain said forces above said predetermined threshold magnitude; and

to open said actuation fluid outlet path at the end of said pulses when said flow through said inlet path is reduced to a value at which said forces fall below said predetermined threshold magnitude.

27. The invention of claim 26 wherein said valve means includes means for exerting a permanent bias force tending to open said actuation fluid outlet path, and the magnitude of said bias force is equal to said predetermined threshold.

28. The invention of claim 27 wherein said valve means is adapted to act in response to pressure forces created by the flow of actuation fluid through said inlet path.

29. The invention of claim 28 wherein said valve means comprises a hollow closure member having an interior in fluid communication with actuation fluid delivered by said pumping means, and movable between a closed position blocking said actuation fluid outlet path when filled with actuation fluid during fluid pulses, and an open position clear of said actuation fluid outlet path between fluid pulses.

30. The invention of claim 29 wherein said closure member comprises an expandable envelope.

31. The invention of claim 30 wherein said envelope comprises elastomeric material.

32. The invention of claim 27 wherein said valve means comprises a closure member in said fluid inlet path and movable between a closed position blocking said fluid outlet path during fluid pulses, and an open position clear of said actuation fluid outlet between fluid pulses.

33. The invention of claim 32 wherein said valve means is adapted to act in response to differential pressure forces.

34. The invention of claim 33 wherein said fluid inlet path includes at least one orifice through said closure member through which actuation fluid flows from said pumping means into said actuation chamber.

35. The invention of claim 34 wherein said closure member is hollow and has an interior in fluid communication with actuation fluid delivered by said pumping means, and said orifice is formed through the wall of said hollow closure member.

36. The invention of claim 35 wherein said closure member comprises an expandable envelope.

37. The invention of claim 36 wherein said orifice is formed through a substantially rigid wall portion of said envelope.

38. The invention of claim 37 wherein said envelope comprises elastomeric material.

39. The invention of claim 36 wherein said envelope comprises elastomeric material.

40. The invention of claim 34 further comprising means for maintaining a substantially constant pressure differential across said closure member during fluid pulses despite changes in flow rate of fluid along said fluid inlet path.

41. The invention of claim 40 wherein said means for maintaining a substantially constant pressure differential comprises at least one aperture through said closure member, and shutter means biased to substantially close said aperture, but movable to open said aperture to an extent proportional to the flow rate of fluid along said fluid inlet path.

42. The invention of claim 41 wherein said shutter means comprises a leaf spring shutter overlying said aperture.

43. The invention of claim 41 wherein said closure member is hollow and has an interior in fluid communication with actuation fluid delivered by said pumping means, and said orifice and said aperture are formed through the wall of said hollow closure member.

44. The invention of claim 43 wherein said closure member comprises an expandable envelope.

45. The invention of claim 44 wherein said orifice and said aperture are formed through a substantially rigid wall portion of said envelope.

46. The invention of claim 45 wherein said envelope comprises elastomeric material.

47. The invention of claim 44 wherein said envelope comprises of elastomeric material.

2. An implantable hydraulically actuated blood pumping system comprising:

a blood pumping chamber having a blood inlet, a blood outlet and a flexible portion;

an actuation fluid reservoir;

actuation fluid pumping means in fluid communication with said reservoir for providing intermittent pulses of actuation fluid;

an actuation chamber having an actuation fluid inlet path in fluid communication with said pumping means, and a separate actuation fluid outlet path in fluid communication with said reservoir, said actuation chamber being operatively associated with said blood pumping chamber to cause displacement of said flexible portion of said blood pumping chamber in response to changes in volume of actuation fluid in said actuation chamber; and

valve means associated with said actuation chamber adapted to close or open said actuation fluid outlet path primarily in response to forces which vary as a function of actuation fluid flow through said actuation fluid inlet path whereby said actuation chamber fills with actuation fluid and blood is expelled from said associated blood pumping chamber while said valve means is closed, and actuation fluid drains from said actuation chamber and said associated blood pumping chamber is allowed to fill with blood while said valve means is open.

23. The invention of claims 2 or 3 wherein said blood inlet and said blood outlet are provided with prosthetic valves adapted to permit the flow of blood in only one direction.

24. The invention of claims 2 or 3 wherein said blood pumping chamber comprises a variable volume zone defined in part by a flexible membrane made from biocompatible elastomeric material and in part by a rigid blood pumping chamber housing.

48. The invention of claim 2 or 3 further comprising means for applying electric power to said actuation fluid pumping means and associated control electronics in a patient having an implanted cardiac prosthesis.

49. The invention of claim 48 wherein said means for supplying electric power comprises an external primary coil inductively coupled to a subcutaneous secondary coil for transmitting electrical energy across the intact skin of said patient.

3. An implantable hydraulically actuated total cardiac prosthesis comprising:

a pair of blood pumping chambers each having a blood inlet, a blood outlet and a flexible portion;

a pair of actuation chambers each having an actuation fluid inlet path and a separate actuation fluid outlet path, one of said actuation chambers being operatively associated with one of said blood pumping chambers and the other of said actuation chambers being operatively associated with the other of said blood pumping chambers to cause displacement of the flexible portion of said blood pumping chambers in response to changes in volume of actuation fluid in their associated actuation chambers;

an actuation fluid reservoir in fluid communication with said actuation fluid outlet paths;

actuation fluid pumping means in fluid communication with said reservoir and said actuation fluid inlet paths for providing intermittent pulses of actuation fluid from said reservoir to said actuation chambers;

and

valve means associated with said actuation chambers adapted to close or open said actuation fluid outlet path primarily in response to forces which vary as a function of actuation fluid flow through said associated actuation fluid inlet path whereby said actuation chamber fills with actuation fluid and blood is expelled from said associated blood pumping chamber while said valve means is closed, and actuation fluid drains from said actuation chamber and said associated blood pumping chamber is allowed to fill with blood while said valve means is open.

6. The invention of claim 3 wherein said actuation fluid reservoir comprises a separate compliant zone associated with each of said actuation chambers, defined at least in part by a flexible wall portion made from biocompatible elastomeric material, said compliant zones communicating with each other, said pumping means and said actuation chambers by flexible ducting.

12. The invention of claim 3 wherein said actuation fluid pumping means comprises a separate pump and drive motor therefor associated with each of said actuation chambers.

13. The invention of claim 12 wherein each of said pumps is a high speed, mixed flow rotary pump.

14. The invention of claim 12 wherein each of said drive motors is a brushless DC electric motor.

15. The invention of claim 14 further comprising means for commutating said brushless DC electric motor.

16. The invention of claim 15 wherein said means for commutating comprises back-emf control circuitry.

17. The invention of claim 3 wherein said actuation fluid pumping means comprises a pump and drive motor therefor and a three-way switching valve associated with the pump outlet for alternately directing the pump output to one or the other of said actuation chambers.

18. The invention of claim 17 wherein said pump is a high speed, mixed flow rotary pump.

19. The invention of claim 17 wherein said drive motor is a brushless DC electric motor.

20. The invention of claim 19 further comprising means for commutating said brushless DC electric motor.

21. The invention of claim 20 wherein said means for commutating comprises back-emf control circuitry.

22. The invention of claim 17 wherein said three-way switching valve has a separate drive motor associated therewith.

50. A method of actuating an implantable blood pump comprising a blood pumping chamber having a blood inlet, a blood outlet, and a flexible portion, and an actuation chamber operatively associated with said blood pumping chamber having an actuation fluid inlet path, an actuation fluid outlet path and valve means associated with said actuation fluid outlet path, comprising the steps of:

(a) delivering intermittent pulses of actuation fluid to said actuation chamber through said actuation fluid inlet path; and

(b) alternately closing and opening said actuation fluid outlet path with said valve means in response to forces which vary as a function of actuation fluid flow through said actuation fluid inlet path to cause said actuation chamber to fill with actuation fluid and blood to be expelled from said blood pumping chamber while said valve means is closed, and to cause said actuation fluid to drain from said actuation chamber and blood to fill said blood pumping chamber while said valve means is open.

55. The method of claims 50, 51 or 52 wherein the steps of opening and closing of said valve means comprise utilizing the pressure forces created by the flow of actuation fluid through said actuation fluid inlet path.

56. The method of claim 55 wherein said pressure forces are differential pressure forces.

51. A method of actuating an implantable blood pump comprising a blood pumping chamber having a blood inlet, a blood outlet, and a flexible portion, and an actuation chamber operatively associated with said blood pumping chamber having an actuation fluid inlet path, an actuation fluid outlet path and valve means associated with said actuation fluid outlet, comprising the steps of:

(a) delivering intermittent pulses of actuation fluid to said actuation chamber through said actuation fluid inlet path;

(b) closing said actuation fluid outlet path with said valve means at the beginning of each fluid pulse, by supplying sufficient flow of actuation fluid through said inlet path to create forces on said valve means above a predetermined threshold magnitude;

(c) maintaining said actuation fluid outlet path closed with said valve means during each fluid pulse by continuing to supply sufficient flow of actuation fluid through said inlet path to maintain said forces at or above said predetermined threshold magnitude to cause actuation chamber to fill with actuation fluid and blood to be expelled from said blood pumping chamber during said fluid pulse; and

(d) opening said actuation fluid outlet path with said valve means at the end of each fluid pulse by reducing the flow of actuation fluid through said inlet path to cause said forces to fall below said predetermined threshold magnitude, to cause said actuation fluid to drain from said actuation chamber and blood to fill said blood pumping chamber between said fluid pulses.

52. A method of actuating an implantable total cardiac prosthesis having a pair of compressible blood pumping chambers each having a blood inlet, a blood outlet and a flexible portion, a separate actuation chamber operatively associated with each blood pumping chamber, each actuation chamber having an actuation fluid inlet path, an actuation fluid outlet path, and valve means associated with each actuation fluid outlet path, comprising the steps of:

(a) delivering intermittent pulses of actuation fluid to said actuation chambers through said actuation fluid inlet paths;

(b) alternately closing and opening the actuation fluid outlet path of said actuation chambers with said valve means in response to forces which vary as a function of actuation fluid flow through said actuation fluid inlet paths to cause said actuation chambers to fill with actuation fluid and blood to be expelled from said blood pumping chambers while said valve means is closed, and to cause said actuation fluid to drain from said actuation chambers and blood to fill said blood pumping chambers while said valve means is open.

53. The method of claim 52 wherein said total cardiac prosthesis is operated in an alternately pulsatile fashion by alternate intermittent pulses of actuation fluid to first one and then the other of said actuation chambers.

54. The method of claim 52 wherein said total cardiac prosthesis is operated in copulsatile fashion by supplying intermittent pulses of actuation fluid to both of said actuation chambers at substantially the same time.