High reliability cardiac assist system

• US 5,613,935 A
• Filed: 12/16/1994
• Issued: 03/25/1997
• Est. Priority Date: 12/16/1994
• Status: Expired due to Term

• Current Assignee: M.D. Robert Jarvik
• Original Assignee: M.D. Robert Jarvik
• Inventors: Jarvik, Robert
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US08/357,456
• Time in Patent Office: 830 Days
• Field of Search: 600/16, 607/33, 128/903, 604/151
• US Class Current: 600/16
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• 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 60/17 inside a ventricle, e.g. intraventricular balloon pumps
• 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 60/221 the blood flow through the rotating member having both radial and axial components, e.g. mixed flow pumps
• 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 60/422 the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/546 of blood flow, e.g. by adapting rotor speed
• CPC Class Codes: A61M 60/824 Hydrodynamic or fluid film bearings
• CPC Class Codes: A61M 60/825 Contact bearings, e.g. ball-and-cup or pivot bearings
• CPC Class Codes: A61M 60/833 Occluders for preventing backflow
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
• CPC Class Codes: A61M 60/873 specially adapted for wireless or transcutaneous energy transfer [TET], e.g. inductive charging
• CPC Class Codes: A61M 60/894 Passive valves, i.e. valves actuated by the blood

Abstract

A high reliability cardiac assist system is provided for permanent use. An electric motor having dual sets of coils rotates the impeller of an intraventricular axial flow pump in the preferred embodiment. The dual motor coils are powered by separate redundant battery and electronics systems configured such that if any wire breaks or if any electrical system component fails the pump will continue to run and sustain the life of the patient powered by the other electronics and battery system. High reliability pump bearings, pump structure to prevent failure due to thrombus, high reliability power cable conduits and connectors, high reliability redundant transcutaneous power transmission systems, and other sub-systems are provided which interact together in an integrated fashion to permit function for more than a decade following surgical implantation of the system without re-operation.

Claims

1. A high reliability blood pumping system comprising:

a. an electric motor having a single rotor;

b. blood pumping means actuated by the single rotor of the electric motor;

c. electric motor armature means having first and second sets of motor coils configured such that either set of coil provides sufficient electromagnetic force to rotate said rotor and actuate said blood pumping means;

d. first and second electronic power systems to respectively supply electrical energy to said first and second sets of motor coils with the proper communication timing, said first and second power systems respectively wired to said first and second sets of motor coils such that power to rotate said rotor and operate said blood pumping means may be provided by either of said first and second power systems and associated set of motor coils, wherein in the event of failure of either set of motor coils or power systems, said blood pumping means will continue to run driven by the remaining set of motor coils or power system.

2. The blood pumping system of claim 1 including monitoring and control means interconnecting said first and second power systems to permit said first power system to supply electrical energy to said second set of motor coils sufficient to operate said blood pumping means and to permit said second power system to supply electrical energy to said first set of motor coils sufficient to operate said blood pumping means, in the event of failure of either set of said motor coils or said power systems.

3. The blood pumping system of claim 1 in which said blood pumping means comprise an axial flow, mixed flow or centrifugal flow pump.

4. A high reliability cardiac assist system comprising:

a. an electrically powered blood pump;

b. dual electronics and battery systems capable of powering and controlling said blood pump, and being adapted to be implanted within a patient;

c. dual transcutaneous energy transmission systems, each having a set of coils comprised of an external transmitter coil and a receiver coil adapted to be implanted within a patient, each set capable of providing power to either of said dual implanted electronic and battery system such that one of said external transmitter coils can be removed without discontinuing power transmission by the other; and

d. an external battery system, capable of providing power to said implanted electronics and battery systems via either or both of said transcutaneous power transmission systems.

5. The high reliability cardiac assist system of claim 4 in which said blood pumping means comprise an axial flow, mixed flow or centrifugal flow pump.

6. A high reliability hydrodynamic blood pump cardiac support system utilizing residual function of the natural heart as an emergency backup comprising;

a. a hydrodynamic blood pump including inflow and outflow conduit means for connection between the left ventricle and aorta or between the right ventricle and pulmonary artery;

b. a valve in said outflow conduit means preventing back-flow into the ventricle in the event said pump stops; and

c. pump control system means adapted to vary the pump flow so as to cause said valve to close and open periodically at a frequency sufficient to prevent thrombosis due to stagnation of blood around the valve.

7. The high reliability hydrodynamic blood pump cardiac support system of claim 6 in which said blood pump is adapted to be implanted within the natural heart.

8. An electrically powered blood pump, comprising;

a. Electric motor means including stationary windings and permanent magnet rotor means;

b. Two bearings supporting both ends of said rotor means to permit rotation of said rotor means around a rotational axis thereof, one of said bearings located on the inflow side of said rotor means and the other of said bearings located on the outflow side of said rotor means, each said bearing adapted to be immersed in blood;

c. A generally tubular conduit extending through said motor windings and defining an annular blood channel between said motor windings and said permanent magnet rotor means;

d. hydrodynamic pump impeller means mounted upon said rotor means within said tubular conduit;

e. An elongated, generally conical tapered hub of said rotor means maintained within said conduit and extending from the vicinity of said impeller means to said bearing on the outflow side of said rotor means, said tapered hub having an outer surface defining an angle of taper less than or about equal to 10 degrees relative to the rotational axis; and

f. Stationary outflow stator blade means affixed to the inside of said tubular conduit and extending inward therefrom, such that said stator blade means redirects the rotational component of the blood flow produced by said impeller means towards a generally axial direction before said flow passes across the other of said bearings on the outflow side of said rotor means.

9. An axial blood pump rotor and blade structure adapted to provide optimal washing of bearings which support said rotor, comprising;

a. a housing having a generally tubular channel through which blood flows;

b. an elongated rotor mounted for rotation within said housing and having an inflow end and an outflow end;

c. first bearing support means upstream of said rotor, said first support means supporting inflow bearing means;

d. at least one pump impeller blade mounted upon said rotor and defining an inflow side and an outflow side;

e. said elongated rotor defining an elongated rotor hub disposed between said outflow side of said impeller and said outflow end of said rotor;

f. second bearing support means downstream of said rotor, said second support means supporting outflow bearing means;

g. at least one stationary outflow stator blade fixed to an inner wall of said housing through which the blood is pumped and axially located between said impeller and said outflow bearing means, said outflow stator blade configured to redirect the rotational component of the fluid flow stream exiting the impeller to a generally axially direction before the flow stream crosses said outflow bearing means; and

h. a pump flow channel within said housing comprised of the spaces between said housing, said rotor, said first and second beating support means and said inflow outflow bearings, configured such that, under the operating conditions of the pump, turbulence, flow separation, and flow stagnation sufficient to cause failure of the pump due to thrombus formation is prevented.

10. The axial flow blood pump of claim 9 in which the cross-sectional area of said pump flow channel at an upstream edge of said outflow stator blade is no more than 20% greater than the cross sectional area at said outflow side of said impeller blade.

11. The axial flow blood pump of claim 9 in which said rotor is tapered at each end to a diameter 1/3 or less than the maximum rotor diameter.

12. The axial flow blood pump of claim 9 in which said first bearing support means includes a stationary bearing sleeve at the end of an axially extending generally cylindrical post of said housing said cylindrical post being no more than 20% larger in diameter than the outside diameter of said bearing sleeve, and the axial length of said post being at least twice its diameter.

13. An apparatus for pumping blood, which comprises:

a) a housing having an inflow opening and an outflow opening, and defining a blood path for blood to flow from the inflow opening to the outflow opening;

b) a rotating member disposed within the housing and mounted for rotational movement within the blood path, the rotating member including an impeller blade for imparting pump energy to blood through the blood path;

c) a first bearing mounting the rotating member, the first bearing disposed adjacent the outflow opening;

d) a second bearing mounting the rotating member, the second bearing disposed upstream of the first bearing; and

e) an outflow stator blade disposed between the impeller blade of the rotating member and the first bearing.

14. The apparatus according to claim 13 further including a drive mechanism for imparting rotational movement to the rotating member.

15. The apparatus according to claim 14 wherein the drive mechanism includes an electric motor, the electric motor having stationary windings and a rotor magnet, the rotor magnet incorporated within the rotating member.

16. The apparatus according to claim 13 wherein the outflow stator blade is configured and dimensioned to direct blood flowing through the blood path across the first bearing.

17. The apparatus according to claim 16 wherein the rotating member has an outflow portion defining a generally tapered configuration.

18. The apparatus according to claim 16 wherein the housing member and the rotating member define a generally annular space therebetween, the blood path including the annular space.

19. The apparatus according to claim 16 further comprising a second bearing disposed adjacent the inflow opening for mounting the rotating member.

20. The apparatus according to claim 19 including an inflow stator blade extending from the housing and being disposed between the at least one impeller blade of the rotating member and the second bearing.

21. The apparatus according to claim 19 wherein the second bearing includes a tapered thrust bearing surface, the tapered thrust bearing surface cooperating with a correspondingly dimensioned thrust-bearing surface associated with the rotating member to facilitate thrust load bearing capacity of the second bearing.

22. The apparatus according to claim 21 wherein the second bearing includes a radial load supporting surface, the radial load supporting surface disposed toward the outflow opening and adapted to facilitate radial load bearing capacity of the second bearing.

23. An apparatus for pumping blood, which comprises:

a) a housing having an inflow opening and an outflow opening, and defining a blood path for blood to flow from the inflow opening to the outflow opening;

b) a rotating member disposed within the housing and mounted for rotational movement within the blood path, the rotating member including an impeller blade for imparting pump energy to blood through the blood path and having an outflow portion defining a generally streamlined tapered configuration;

c) a first bearing mounting the rotating member, the first bearing disposed adjacent the outflow opening; and

d) an outflow stator blade extending from the housing member and being configured and dimensioned to direct blood flowing through the blood path axially across the first bearing.

24. An apparatus for pumping blood, which comprises:

a) a housing having an inflow opening and an outflow opening and defining a blood path for blood to flow from the inflow opening to the outflow opening;

b) a rotating member mounted for rotational movement about a rotational axis within the blood path of the housing, the rotating member including an impeller blade for imparting pumping energy to blood passing through the blood path, the rotating member having an outflow portion defining a generally tapered configuration, the tapered configuration defining an angle of inclination with respect to the rotational axis less that than about 10°

; and

c) a drive mechanism for imparting rotational movement to the rotating member.

25. The apparatus according to claim 24 wherein the rotating member is supported for rotational movement by a first bearing disposed adjacent the outflow opening and a second bearing disposed adjacent the inflow opening.

26. The apparatus according to claim 25 wherein the outflow portion of the rotating member is disposed between the impeller blade and the second bearing.

27. An apparatus for pumping blood, which comprises:

a) a housing having an inflow opening and an outflow opening and defining a blood path for blood to flow from the inflow opening to the outflow opening;

b) a rotating member disposed within the blood path, the rotating member including an impeller blade for imparting pumping energy to blood flowing through the blood path, the rotating member supported by inflow and outflow support struts and mounted for rotational movement by a first bearing associated with the outflow support strut and a second bearing associated with the inflow support strut, the inflow support strut having an axial post extending generally axially therefrom supporting the second bearing such that the juncture of the second bearing and the rotating member is disposed along the blood path a sufficient distance beyond said inflow support strut to be away from any local area of flow stagnation downstream of the strut and thus to prevent the accumulation of thrombus at the juncture; and

c) a drive mechanism for imparting rotational movement to the rotating member.

28. The apparatus according to claim 27 wherein the rotating member has outflow and inflow bearings mounted thereto, the inflow and outflow beatings respectively mating with the first and second bearings.

29. The apparatus according to claim 28 wherein the outflow and inflow bearings each includes axial and tapered load-bearing surfaces, and wherein the first and second bearings each include corresponding axial and tapered surfaces in mating contact with the axial and tapered load bearing surfaces of the respective outflow and inflow bearings.

30. The apparatus according to claim 29 wherein the axial load bearing surfaces of the outflow and inflow bearings are remotely disposed from the rotating member with relation to the tapered load bearing surfaces.

31. The apparatus according to claim 29 wherein the tapered load bearing surfaces of the outflow and inflow bearings are remotely disposed from the rotating member with relation to the axial load bearing surfaces.

32. An apparatus for pumping blood, which comprises:

a) a housing having an inflow opening and an outflow opening and defining a blood path for blood to flow from the inflow opening to the outflow opening;

b) a rotating member disposed within the housing and mounted for rotational movement within the blood path by a station try inflow beating disposed adjacent the inflow opening and a stationary outflow bearing disposed adjacent the outflow opening, the inflow and outflow beatings each including an axial load bearing surface and tapered load bearing surfaces, the axial and tapered load bearing surfaces cooperating and mating with corresponding axial and tapered load bearing surfaces associated with the rotating member to thereby enhance thrust load bearing capacity thereof, the rotating member having an impeller blade to impart pump energy to blood along the blood path; and

c) a drive mechanism for imparting rotational movement to the rotating member.

33. The apparatus according to claim 32 wherein the rotating member has first and second rotatable bearings mounted thereto respectively mating with the stationary outflow and inflow bearings, the first and second rotatable bearings defining the axial and tapered load bearing surfaces associated with the rotating member.

34. The apparatus according to claim 32 wherein the axial load bearing surfaces of the outflow and inflow bearings are remotely disposed from the rotating member with relation to the tapered load bearing surfaces.

35. The apparatus according to claim 32 wherein the tapered load bearing surfaces of the outflow and inflow bearings are remotely disposed from the rotating member with relation to the axial load bearing surfaces.

36. An apparatus for pumping blood, which comprises:

an electric motor with a rotor;

a blood pumping member actuated by the rotor;

a first electronic and power system including a first set of motor armature coils and associated battery for powering the electric motor to rotate the rotor and actuate the blood pumping member;

a second electronic and power system including a second set of motor armature coils and associated battery for powering the electric motor to rotate the rotor and actuate the blood pumping member; and

the first electronic and power system operable simultaneously with the second electronic and power system, each of the first and second electronic and power systems capable of individually operating the electric motor to actuate the blood pumping member such that in the event of failure of either the first or second electronic and power systems, the electric motor and blood pumping member will continue to operate driven by the remaining electronic and power system.