Intraventricular artificial hearts and methods of their surgical implantation and use

• US 4,994,078 A
• Filed: 02/16/1989
• Issued: 02/19/1991
• Est. Priority Date: 02/17/1988
• Status: Expired due to Term

• Current Assignee: Jarvik Heart Incorporated
• Original Assignee: Robert K. Jarvik
• Inventors: Jarvik, Robert K.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): Willse, David H.
• Application Number:
  US07/311,921
• Time in Patent Office: 733 Days
• Field of Search: 623/3, 600/16, 417/423.12, 417/413.7, 417/423.1, 415/900
• US Class Current: 623/3.14
• 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 60/289 Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/416 transmitted directly by the motor rotor drive shaft
• CPC Class Codes: A61M 60/419 the force acting on the blood contacting member being permanent magnetic, e.g. from a rotating magnetic coupling between driving and driven magnets
• 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 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/446 the axis of both movements being parallel, e.g. roller screw actuators or cylindrical cam transmissions
• CPC Class Codes: A61M 60/476 with means converting the rotation into a translational movement of the displacement member
• CPC Class Codes: A61M 60/812 Vanes or blades, e.g. static flow guides
• CPC Class Codes: A61M 60/825 Contact bearings, e.g. ball-and-cup or pivot bearings
• CPC Class Codes: A61M 60/837 Aspects of flexible displacement members, e.g. shapes or materials
• 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 60/869 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 60/88 : Percutaneous cables
• CPC Class Codes: A61M 60/882 : Devices powered by the patient, e.g. skeletal muscle powered devices
• CPC Class Codes: A61M 60/894 : Passive valves, i.e. valves actuated by the blood
• CPC Class Codes: Y10S 415/90 : Rotary blood pump

Abstract

A method of treating heart failure is disclosed in which, without removing the damaged heart, implantation of prosthetic blood-pumping means within the natural heart sustains its function. The invention includes electrically-powered positive displacement pumps, muscle-powered pumps, and electrically-powered rotary hydrodynamic pumps sufficiently miniaturized and adopted to function within the heart. The invention also includes surgical connectors and surgical methods that permit intraventricular artificial hearts to be effectively applied.

Claims

1. An artificial heart, heart assist, or blood pumping device adapted to propel blood therethrough by means of rotary hydrodynamic fluid pumping elements, comprising:

(a) inflow and outflow means by which to connect said device to the vascular system,

(b) blood containing housing means within which a pumping mechanism is contained,

(c) minimally-hemolytic axial flow, mixed flow, or centrifugal flow rotary pump impeller means, mechanically supported and rotated by a magnetically actuated rotor,

(d) minimally-hemolytic wear-resistant blood-immersed mechanical journal bearing means supporting said rotor for rotation in a configuration such that all of the exposed junctions of the rotating and stationary components of the pumping elements are washed by high enough blood flow to prevent thrombus accumulation sever enough to cause failure of the pump, and

(e) power means and magnetic actuator means to provide force to rotate said rotor and impeller means thereby pumping the blood,

2. The device of claim 1, in which said bearing means comprise:

(a) a smooth wear-resistant wire maintained in tension to serve the function of a non-rotating shaft, and,

(b) a cylindrical rotating sleeve composed of a wear-resistant material, having an elongated hole through which said wire passes of a diameter only slightly larger than the diameter of the wire, such that only a minimal volume of blood occupies the gap between the wire and the sleeve.

3. The device of claim 1, of sufficiently small size and anatomic configuration to be implanted either within the chamber of the left ventricle, within the chamber of the right ventricle, or both, so as to produce adequate flow and pressure to replace the entire pumping function of the ventricle or ventricles in which it is implanted.

4. The device of claim 1, in which:

(a) said power means and magnetic actuator means comprise a brushless DC motor having motor windings and laminations disposed radially about an annular blood channel and having a motor rotor disposed therewithin, such that said annular blood channel passes through the gap between the motor rotor and the motor windings generally referred to as the motor "air gap",

(b) said rotary hydrodynamic pump impeller means comprise an axial or mixed flow pump impeller having a heel diameter smaller than the outside diameter of the motor rotor.

5. The device of claim 1, in which:

(a) said power means and magnetic actuator means comprise a brushless DC motor having motor windings and laminations disposed radially about said annular blood channel and having a motor rotor disposed therewithin, such that an annular blood channel passes through the gap between the motor rotor and the motor windings generally referred to as the motor "air gap",

(b) the outside diameter of the motor rotor is equal to or greater than two thirds of the inside diameter of the motor windings and laminations but not so large as to excessively obstruct said annular channel through which the blood must pass.

6. The device of claim 1, including magnetic or mechanical thrust bearing means or a combination of both.

7. The device of claim 1, in which said power and magnetic actuator means include a magnetic coupling having permanent follower magnets mounted within the rotor and having rotary outer drive magnets mounted outside the bloodstream for rotation by a motive device such that rotation of the outer drive magnets causes rotation of the follower magnets and thus rotates the rotor.

8. The device of claim 1 in which said bearing means include:

(a) a smooth wear resistant small diameter shaft;

(b) a cylindrical sleeve composed of a wear resistant material, having an elongated hole through which said shaft passes of a diameter only slightly larger than the diameter of the shaft, such that only a minimal volume of blood occupies the gap between the shaft and the sleeve.

9. The device of claim 1 in which said bearing means include mechanical wear resistant thrust bearing means having a rotating and a stationary thrust bearing surface between which a small gap exists, said gap containing blood, and said thrust bearing elements so comprised and disposed that the periphery of said gap is sufficiently well washed by the flow of blood thereacross that thrombus accumulation is prevented.

10. The device of claim 1 in which elements of said magnetic actuator means are so adapted as to provide axial forces to absorb all or part of the axial thrust load applied to said rotor as a result of rotation of the impeller within the blood and as a result of gravitational and inertial effects.

11. An artificial heart, heart assist, or blood pumping device adapted to propel blood therethrough without excessive blood damage or thrombosis by means of rotary hydrodynamic fluid pumping elements, comprising:

(a) inflow and outflow means by which to connect said device to the vascular system,

(b) blood containing housing means including a generally cylindrical tubular segment,

(c) axial flow or mixed flow rotary pump impeller means adapted to pump blood with minimal hemolysis, mechanically supported and rotated by magnetically actuated rotor means,

(d) said magnetically actuated rotor means structured to be immersed in blood within said generally cylindrical housing segment, and mechanically supported by radial bearing means in a configuration such that all of the exposed junctions of the rotating and stationary components of the pumping elements are washed by high enough blood flow to prevent thrombus accumulation severe enough to cause failure of the pump,

(e) said rotor means and said generally cylindrical segment of said housing means having therebetween an annular generally cylindrical blood channel through which flows all or part of the blood pumped by the device and across which forces to rotate the rotor are exerted magnetically, and,

(f) power means and magnetic actuator means to provide force to rotate said rotor and impeller means thereby pumping the blood.

12. The device of claim 11, in which said bearing means comprises:

(a) a smooth wear-resistant wire maintained in tension to serve the function of a non-rotating shaft, and,

(b) a cylindrical rotating sleeve composed of a wear-resistant material, having an elongated hole through which said wire passes of a diameter only slightly larger than the diameter of the wire, such that only a minimal volume of blood occupies the gap between the wire and the sleeve.

13. The device of claim 11, of sufficiently small size and anatomic configuration to be implanted either within the chamber of the left ventricle, within the chamber of the right ventricle, or both, so as to produce adequate flow and pressure to replace the entire pumping function of the ventricle or ventricles in which it is implanted.

14. The device of claim 11, in which:

(a) said power means and magnetic actuator means comprise a brushless DC motor having motor windings and laminations disposed radially about said annular blood channel and having a motor rotor disposed therewithin, such that said annular blood channel passes through the gap between the motor rotor and the motor windings generally referred to as the motor "air gap",

(b) said rotary hydrodynamic pump impeller means comprises an axial or mixed flow pump impeller having a hub diameter smaller than the outside diameter of the motor rotor.

15. The device of claim 11, in which:

(a) said power means and magnetic actuator means comprise a brushless DC motor having a motor windings and laminations disposed radially about said annular blood channel and having a motor rotor disposed therewithin, such that said annular blood channel passes through the gap between the motor rotor and the motor windings generally referred to as the motor "air gap",

(b) the outside diameter of the motor rotor is equal to or greater than two thirds of the inside diameter of the motor windings and laminations but not so large as to excessively obstruct said annular channel through which the blood must pass.

16. The device of claim 11, including magnetic or mechanical thrust bearing means or a combination of both.

17. The device of claim 11, in which said power and magnetic actuator means include a magnetic coupling having permanent follower magnets mounted within the rotor and having rotary outer drive magnets mounted outside the blood stream for rotation by a motive device such that the rotation of the outer drive magnets causes rotation of the follower magnets and thus rotates the rotor.

18. The device of claim 11 in which said bearing means include:

(a) a smooth wear resistant small diameter shaft;

(b) a cylindrical sleeve composed of a wear resistant material, having an elongated hole through which said shaft passes of a diameter only slightly larger than the diameter or the shaft, such that only a minimal volume of blood occupies the gap between the shaft and the sleeve.

19. The device of claim 11 including mechanical wear resistant thrust bearing means having a rotating and a stationary thrust bearing surface between which a small gap exists, said gap containing blood, and said thrust bearing elements so comprises and disposed that the periphery of said gap is sufficiently well washed by the flow of blood thereacross that thrombus accumulation is prevented.

20. The device of claim 11 in which elements of said magnetic actuator means are so adapted as to provide axial forces to absorb all or part of the axial thrust load applied to said rotor as a result of rotation of the impeller within the blood and as a result of gravitational and inertial effects.

21. A rotary hydrodynamic blood pump comprising:

a blood-pumping rotor including an impeller;

means to suspend the rotor for rotational motion within the bloodstream on a wire in tension that passes through a cylindrical hole in the rotor;

means to magnetically rotate the rotor within the bloodstream;

magnetic, mechanical or magnetic and mechanical thrust-bearing means to maintain the rotor in proper axial position on the wire,

configured such that all exposed junctions of the rotation and stationary components thereof are washed by high enough blood flow to prevent thrombus accumulation severe enough to cause failure of the pump.

22. The blood pump of claim 21 in which the magnetic means provided to rotate the impeller include permanent magnets of a brushless DC motor mounted within the rotor and windings of the motor mounted outside the bloodstream surrounding the rotor.

23. The blood pump as described in claim 21 in which the magnetic means to rotate the impeller include a magnetic coupling having permanent follower magnets mounted within the rotor and having rotary drive magnets mounted outside the bloodstream for rotation by a motive device such that rotation of the outer drive magnets causes rotation of the follower magnets and thus rotates the impeller.

24. The blood pump of claim 22 in which the impeller is suspended on the rotor by pins or utilizes blades such that a major portion of the bloodstream passing through the device washes across each end of the rotor to retain high flow in the vicinity where the bearing wire emerges from the rotor and thereby also prevents thrombus formation.

25. The blood pump of claim 23 in which the impeller is suspended on the rotor by pins or utilizes blades such that a major portion of the bloodstream passing through the device washes across each end of the rotor to retain high flow in the vicinity where the bearing wire emerges from the rotor and thereby also prevents thrombus formation.