Surgically implantable pump arrangement and method for pumping body fluids

• US 5,676,651 A
• Filed: 02/25/1994
• Issued: 10/14/1997
• Est. Priority Date: 08/06/1992
• Status: Expired due to Fees

• Current Assignee: General Dynamics Corporation
• Original Assignee: Electric Boat Corporation (General Dynamics Corporation)
• Inventors: Smith, James S., Pasque, Michael K., Franco, Alberto, Chapman, John H., Rosen, Marvin E., Brozek, Robert J., Slimon, Scot A., McGarvey, John J., Larson, Carl O. Jr., John, Trahan D.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US08/201,806
• Time in Patent Office: 1,327 Days
• Field of Search: 604/33, 604/52, 604/53, 604/65, 604/66, 604/67, 604/152, 604/154, 604/208, 604/890.1, 604/891.1, 600/17, 128/DIG. 12, 417/44.1, 417/259, 417/262, 417/278, 417/399, 417/401, 417/415
• US Class Current: 604/33
• 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 60/178 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 60/196 replacing the entire heart, e.g. total artificial hearts [TAH]
• 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 60/258 Piston pumps
• CPC Class Codes: A61M 60/441 generated by an electromotor
• CPC Class Codes: A61M 60/462 Electromagnetic force
• CPC Class Codes: A61M 60/554 of blood pressure
• CPC Class Codes: A61M 60/562 for making blood flow pulsatile in blood pumps that do not intrinsically create pulsatile flow
• CPC Class Codes: A61M 60/876 Implantable batteries
• CPC Class Codes: A61M 60/894 Passive valves, i.e. valves actuated by the blood
• CPC Class Codes: F16C 19/525 related to temperature and heat, e.g. insulation
• CPC Class Codes: H02K 41/031 of the permanent magnet type
• CPC Class Codes: H02K 7/14 Structural association with mechanical loads, e.g. with hand-held machine tools or fans with fan or impeller for cooling the machine H02K9/06

Abstract

In one embodiment described in the specification, a surgically implantable reciprocating pump employs a check valve as the piston, which is driven by a permanent magnet linear electric motor to assist either side of the natural heart. The pump is implanted in the aorta or pulmonary artery using vascular attachment cuffs such as flexible cuffs for suturing at each end with the pump output directly in line with the artery. The pump is powered by surgically implanted rechargeable batteries. In another embodiment, pairs of pumps are provided to replace or assist the natural heart or to provide temporary blood flow throughout the body, for example, during operations to correct problems with the natural heart.

Claims

1. A surgically implantable reciprocating pump comprising a hollow cylinder, an array of axially spaced coil windings supported by the cylinder, a piston-valve assembly positioned within the cylinder for reciprocal longitudinal movement therein, the piston-valve assembly comprising a diametral supporting ring and at least two valve leaflets supported for pivotal motion on spaced axes within the diametral support ring, permanent magnet means having axially spaced magnetic poles producing radially directed magnetic flux which cooperates with the axially spaced coil windings, the permanent magnet means fixedly attached to the piston-valve assembly for movement therewith in response to sequential energization of the coil windings in the array and means for sequentially energizing the coil windings to cause the piston-valve assembly to be drawn to the next sequentially-energized coil winding.

2. A surgically implantable reciprocating pump in accordance with claim 1 wherein the array of coil windings is disposed in uniformly spaced relation along the hollow cylinder.

3. A surgically implantable reciprocating pump in accordance with claim 2 including magnetically soft material disposed between the coil windings of the array.

4. A surgically implantable reciprocating pump in accordance with claim 3 wherein the magnetically soft material disposed between the coil windings of the array is in laminated form.

5. A surgically implantable reciprocating pump in accordance with claim 1 comprising a controller for sequentially energizing the coil windings in the array.

6. A surgically implantable reciprocating pump in accordance with claim 5 including a pacemaker connected to the controller and wherein the pump is implantable in a patient'"'"'s blood vessel and the controller synchronizes the reciprocal movement of the piston-valve with ejection of blood from a patient'"'"'s heart in response to signals provided from the pacemaker.

7. A surgically implantable reciprocating pump according to claim 5 including epicardial leads leading from the patient'"'"'s heart to the controller and wherein the controller synchronizes the reciprocation of the piston-valve with ejection of blood from the patient'"'"'s heart in response to electrocardiogram signals from the epicardial leads.

8. A surgically implantable reciprocating pump according to claim 5 including means for sensing for the array of coil windings wherein the controller synchronizes the reciprocation of the piston-valve with ejection of blood using signals sensed from the array of coil windings.

9. A surgically implantable reciprocating pump in accordance with claim 1 further comprising a stationary valve located at one end of the cylinder which permits fluid to flow only in one direction.

10. A surgically implantable reciprocating pump in accordance with claim 1 wherein the reciprocating pump has an external diameter of no more than 6 cm and a length of no more than 7.5 cm.

11. A surgically implantable reciprocating pump in accordance with claim 1 wherein the internal diameter of the hollow cylinder is substantially the same as the internal diameter of an aorta.

12. A surgically implantable reciprocating pump in accordance with claim 11 further comprising an aorta-pump connection at each end of the hollow cylinder comprising a first ring of metal and a two-part sewing ring attached at one end to the first ring of metal, the two-part sewing ring comprising an endothelial promoting outer covering and a compliant inner layer.

13. A surgically implantable reciprocating pump in accordance with claim 11 further comprising a plurality of cantilevered barbs extending from an end of the hollow cylinder, a retaining ring having recesses into which the cantilevered barbs are received and a sewing cuff for connecting the retaining ring to a blood vessel.

14. A surgically implantable reciprocating pump in accordance with claim 1 wherein the internal diameter of the hollow cylinder is substantially the same as the internal diameter of a pulmonary artery.

15. A surgically implantable reciprocating pump in accordance with claim 1 wherein the hollow cylinder comprises a substantially hard biocompatible material.

16. A surgically implantable reciprocating pump in accordance with claim 1 wherein the piston-valve assembly comprises a substantially hard biocompatible material.

17. A surgically implantable reciprocating pump in accordance with claim 1 including a coating of a non-thrombogenic biocompatible material on the internal surface of the hollow cylinder.

18. A surgically implantable reciprocating pump in accordance with claim 1 including a coating of a non-thrombogenic biocompatible material on the external surfaces of the piston-valve assembly.

19. A surgically implantable reciprocating pump in accordance with claim 17 or claim 18 wherein the non-thrombogenic biocompatible material is pyrolytic carbon.

20. A surgically implantable reciprocating pump in accordance with claim 1 wherein the hollow cylinder and piston-valve assembly comprise a substantially hard biocompatible material.

21. A method for pumping fluids in a human body comprising the steps of:

providing a surgically implantable reciprocating pump comprising a hollow cylinder with an inlet end and an outlet end, an array of coil windings supported in axially spaced relation by the hollow cylinder, means for sequentially energizing the coil windings, a piston-valve assembly slidably positioned within the hollow cylinder for longitudinal movement in response to sequential energization of the coil windings, the piston-valve assembly comprising a diametral support ring and at least two valve leaflets supported for pivotal motion inside the diametral support ring to cycle open and close in response to relative motion with respect to a fluid, and a permanent magnet arrangement having axially spaced magnet poles producing radially directed magnetic flux which cooperates with the sequentially energized coil windings and fixedly attached to the piston-valve for movement therewith;

placing the piston-valve assembly at a first end of the hollow cylinder;

introducing fluid into the hollow cylinder;

sequentially energizing the coil windings to drive the piston-valve assembly to a second end of the hollow cylinder whereby a force created by movement of the piston-valve through the fluid causes the valve leaflets to close, preventing fluid flow through the piston-valve and causing fluid to be ejected from the second end of the hollow cylinder; and

sequentially energizing the coil windings in the opposite direction to drive the piston-valve to the first end of the hollow cylinder whereby a force created by movement of the piston-valve through the fluid causes the valve leaflets to open, the sequential energization of the coil windings causing the piston to be drawn toward the energized windings when the piston is approached by the pattern of sequentially energized windings from either direction.

22. A method in accordance with claim 21 wherein the step of introducing fluid comprises introducing blood into the hollow cylinder.

23. A surgically implantable reciprocating pump comprising a hollow cylinder, an array of axially spaced coil windings supported by the cylinder having a single valve, a piston-valve assembly including the single valve and slidably positioned within the cylinder for reciprocal longitudinal movement therein, permanent magnet means including axially spaced magnetic poles producing radially directed magnetic flux which cooperates with the array of axially spaced coil windings, the permanent magnet means fixedly attached to the piston-valve assembly for movement therewith in response to sequential energization of the coil windings in the array and means for sequentially energizing the coil windings to cause the piston-valve assembly to be drawn to the next sequentially-energized coil winding.

24. A surgically implantable reciprocating pump in accordance with claim 23 wherein the valve comprises a diametral support ring and at least one valve leaflet supported for pivotal motion within the support ring.

25. A surgically implantable reciprocating pump in accordance with claim 23 wherein the array of coil windings is disposed in uniformly spaced relation along the hollow cylinder.

26. A surgically implantable reciprocating pump in accordance with claim 25 including magnetically soft material disposed between the coil windings of the array.

27. A surgically implantable reciprocating pump in accordance with claim 26 wherein the magnetically soft material disposed between the coil windings of the array is in laminated form.

28. A surgically implantable reciprocating pump in accordance with claim 23 further comprising a controller for controlling the operation of the pump by sequentially energizing the coil windings in the array.

29. A surgically implantable reciprocating pump in accordance with claim 28 including a pacemaker connected to the controller and wherein the pump is implantable in a patient'"'"'s blood vessel and the controller synchronizes the reciprocal movement of the piston-valve assembly with ejection of blood from a patient'"'"'s heart in response to signals provided from the pacemaker.

30. A surgically implantable reciprocating pump according to claim 28 including epicardial leads leading from the patient'"'"'s heart to the controller and wherein the controller synchronizes the reciprocation of the piston-valve assembly with ejection of blood from the patient'"'"'s heart in response to electrocardiogram signals from the epicardial leads.

31. A surgically implantable reciprocating pump according to claim 28 wherein the controller synchronizes the reciprocation of the piston-valve assembly with ejection of blood using signals sensed from the array of coil windings.

32. A surgically implantable reciprocating pump in accordance with claim 23 wherein the reciprocating pump has an external diameter of no more than 6 cm and a length of no more than 7.5 cm.

33. A surgically implantable reciprocating pump in accordance with claim 23 wherein the internal diameter of the hollow cylinder is substantially the same as the internal diameter of an aorta.

34. A surgically implantable reciprocating pump in accordance with claim 33 further comprising an aorta-pump connection at each end of the hollow cylinder comprising a first ring of metal and a two-part sewing ring attached at one end to the first ring of metal, the two-part sewing ring comprising an endothelial promoting outer covering and a compliant inner layer.

35. A surgically implantable reciprocating pump in accordance with claim 33 further comprising a plurality of cantilevered barbs extending from an end of the hollow cylinder, a retaining ring having recesses into which the cantilevered barbs are received and a sewing cuff for connecting the retaining ring to a blood vessel.

36. A surgically implantable reciprocating pump in accordance with claim 23 wherein the internal diameter of the hollow cylinder is substantially the same as the internal diameter of a pulmonary artery.

37. A surgically implantable reciprocating pump in accordance with claim 23 wherein the hollow cylinder comprises a substantially hard biocompatible material.

38. A surgically implantable reciprocating pump in accordance with claim 23 wherein the piston-valve assembly comprises a substantially hard biocompatible material.

39. A surgically implantable reciprocating pump in accordance with claim 23 including a coating of a non-thrombogenic biocompatible material on the internal surface of the hollow cylinder.

40. A surgically implantable reciprocating pump in accordance with claim 23 including a coating of a non-thrombogenic biocompatible material on the external surfaces of the piston-valve assembly.

41. A surgically implantable reciprocating pump accordance with claim 39 or claim 40 wherein the non-thrombogenic biocompatible material is pyrolytic carbon.

42. A surgically implantable reciprocating pump in accordance with claim 23 wherein the hollow cylinder and piston-valve assembly comprise a substantially hard biocompatible material.

43. A method for pumping fluids in a human body comprising the steps of:

providing a surgically implantable reciprocating pump comprising a hollow cylinder with an inlet end and an outlet end, an array of coil windings supported in axially spaced relation by the hollow cylinder having a single valve, a piston-valve assembly including the single valve and slidably positioned within the cylinder for longitudinal movement in response to sequential energization of the coil windings, and a permanent magnet arrangement having axially spaced magnet poles fixedly attached to the piston-valve assembly for movement therewith;

placing the piston-valve assembly at a first end of the hollow cylinder;

introducing fluid into the hollow cylinder;

sequentially energizing the coil windings to drive the piston-valve assembly to a second end of the hollow cylinder whereby a force created by movement of the piston-valve assembly through the fluid causes the valve to close, preventing fluid flow through the valve and causing fluid to be ejected from the second end of the hollow cylinder; and

sequentially energizing the coil windings in the opposite direction to drive the piston-valve assembly to the first end of the hollow cylinder whereby a force created by movement of the piston-valve assembly through the fluid causes the valve to open, the sequential energization of the coil windings being arranged to cause the piston-valve assembly to be drawn toward the energized windings when the piston-valve assembly is approached by the pattern of sequentially energized windings from either direction.

44. A method in accordance with claim 43 comprising providing a single valve having a diametral support ring and at least one valve leaflet supported for pivotal motion within the diametral support ring to provide pumping action upon reciprocating within the hollow cylinder.

45. A method in accordance with claim 43 wherein the step of introducing fluid comprises introducing blood into the hollow cylinder.