Implantable heart assist system

• US 6,299,575 B1
• Filed: 04/25/2000
• Issued: 10/09/2001
• Est. Priority Date: 10/09/1997
• Status: Expired due to Term

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: ORQIS Medical Corporation
• Inventors: Bolling, Steven F.
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US09/558,445
• Time in Patent Office: 532 Days
• Field of Search: 600/16
• US Class Current: 600/16
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 60/117 for assisting the heart, e.g. transcutaneous or external ventricular assist devices
• CPC Class Codes: A61M 60/122 Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
• 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 60/232 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 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• 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 60/569 synchronous with the native heart beat
• CPC Class Codes: A61M 60/873 specially adapted for wireless or transcutaneous energy transfer [TET], e.g. inductive charging

Abstract

An extracardiac pumping system for supplementing the circulation of blood through a patient without any component thereof being connected to the patient'"'"'s heart, and method of using same. The extracardiac system comprises a pump implanted subcutaneously at or about the patient'"'"'s groin in a minimally-invasive procedure, wherein the pump is powered by a battery, and means for charging the battery extracorporeally, wherein the pump draws blood through an inflow conduit fluidly coupled to the patient'"'"'s femoral artery via a subcutaneous anastomosis connection, and discharges blood through an outflow conduit fluidly coupled to a peripheral artery that stems from the patient'"'"'s aortic arch via a subcutaneous anastomosis connection. The pump may be operated continuously or in a pulsatile fashion, synchronous with the patient'"'"'s heart, thereby potentially reducing the pumping load on the heart.

Claims

1. A method for supplementing the circulation of blood through a patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a rotary pump to a first blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first blood vessel, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a second blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second blood vessel, wherein the step of connecting the inflow conduit to the first blood vessel comprises using an end-to-side anastomosis connection; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

2. A method for supplementing the circulation of blood through a patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a rotary pump to a first blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first blood vessel, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a second blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second blood vessel, wherein the step of connecting the inflow conduit to the first blood vessel comprises using a cannula; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

3. The method of claim 2 wherein the cannula projects into the blood vessel so as to draw blood from a point upstream of the point of blood vessel penetration.

4. A method for supplementing the circulation of blood through a patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a rotary pump to a first blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first blood vessel, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a second blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second blood vessel; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac, wherein the step of operating the pump comprises actuating the pump in a generally counterpulsating pulsatile fashion.

5. A method for supplementing the circulation of blood through a patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a rotary pump to a first blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first blood vessel, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a second blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second blood vessel; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac, wherein the step of operating the pump comprises actuating the pump in a pulsatile fashion so as to reduce the pressure at the aortic root.

6. A method for supplementing the circulation of blood through a patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a rotary pump to a first blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first blood vessel, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a second blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second blood vessel; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac, wherein the pump is actuated in a continuous fashion so as to reduce the pressure at the aortic root.

7. A method for supplementing the circulation of blood through a patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a rotary pump to a first blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first blood vessel, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a second blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second blood vessel, wherein the step of connecting the outflow conduit to the second blood vessel comprises using an end-to-side anastomosis connection; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

8. A method for supplementing the circulation of blood through a patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a rotary pump to a first blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first blood vessel, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a second blood vessel that is not a primary blood vessel with a conduit having an inner diameter no greater than about 25 millimeters using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second blood vessel, wherein the step of connecting the outflow conduit to the second blood vessel comprises using a cannula; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

9. The method of claim 8 wherein the cannula projects into the blood vessel so as to direct blood to a point downstream of the point of blood vessel penetration.

10. A method for supplementing the circulation of blood through the patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a pump to a first artery that is not the aorta or pulmonary artery with a cannula using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first artery, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a second artery that is not the aorta or pulmonary artery using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second artery; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

11. A method for supplementing the circulation of blood through the patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a pump to a first artery that is not the aorta or pulmonary artery with an end-to-side anastomosis using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first artery, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a second artery that is not the aorta or pulmonary artery using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second artery; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

12. A method for supplementing the circulation of blood through the patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a pump to a first artery that is not the aorta or pulmonary artery using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first artery, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a second artery that is not the aorta or pulmonary artery with a cannula using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second artery; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

13. A method for supplementing the circulation of blood through the patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a pump to a first artery that is not the aorta or pulmonary artery using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first artery, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a second artery that is not the aorta or pulmonary artery with an end-to-side anastomosis using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second artery; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

14. A method for supplementing the circulation of blood through the patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a pump to an axillary artery using a minimally invasive surgical procedure to permit the flow of blood to the pump from the axillary artery, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a second artery using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second artery; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

15. A method for supplementing the circulation of blood through the patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a pump to a first artery that is not the aorta or pulmonary artery using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first artery, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to an axillary artery using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the axillary artery; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

16. A method for supplementing the circulation of blood through the patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a pump to a femoral artery using a minimally invasive surgical procedure to permit the flow of blood to the pump from the femoral artery, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a second artery that is not the aorta or pulmonary artery using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second artery; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

17. A method for supplementing the circulation of blood through the patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a pump to a first artery that is not the aorta or pulmonary artery using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first artery, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a femoral artery using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the femoral artery; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

18. A method for supplementing the circulation of blood through the patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a pump to an iliac artery using a minimally invasive surgical procedure to permit the flow of blood to the pump from the iliac artery, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a second artery that is not the aorta or pulmonary artery using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second artery; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

19. A method for supplementing the circulation of blood through the patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a pump to a first artery that is not the aorta or pulmonary artery using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first artery, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to an iliac artery using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the iliac artery; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

20. A method for supplementing the circulation of blood through the patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a pump to a subdlavian artery using a minimally invasive surgical procedure to permit the flow of blood to the pump from the subclavian artery, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a second artery that is not the aorta or pulmonary artery using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second artery; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

21. A method for supplementing the circulation of blood through the patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

connecting a distal end of an inflow conduit of a pump to a first artery that is not the aorta or pulmonary artery using a minimally invasive surgical procedure to permit the flow of blood to the pump from the first artery, said pump configured to pump blood at volumetric rates that are on average subcardiac;

connecting a distal end of an outflow conduit of the pump to a subclavian artery using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the subclavian artery; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac.

22. An extracardiac pumping system for supplementing blood circulation through a patient without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a rotary pump configured to pump blood through the patient at subcardiac volumetric rates, said pump having an average flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy;

an inflow conduit having an inner diameter that is no greater than 25 millimeters fluidly coupled to the pump to direct blood to the pump from a first blood vessel that is not a primary vessel, the inflow conduit having a first end configured to couple to the first blood vessel;

an outflow conduit having an inner diameter that is no greater than 25 millimeters fluidly coupled to the pump to direct blood from the pump to a second blood vessel that is not a primary vessel, the outflow conduit having a first end configured to couple to the second blood vessel; and

at least one additional inflow conduit having a first end configured to connect to a blood vessel that is not a primary vessel.

23. An extracardiac pumping system for supplementing blood circulation through a patient without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a continuous-flow pump configured to pump blood through the patient at subcardiac volumetric rates, said pump having an average flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy;

an inflow conduit having an inner diameter that is no greater than 25 millimeters fluidly coupled to the pump to direct blood to the pump from a first blood vessel that is not a primary vessel, the inflow conduit having a first end configured to couple to the first blood vessel; and

,

an outflow conduit having an inner diameter that is no greater than 25 millimeters fluidly coupled to the pump to direct blood from the pump to a second blood vessel that is not a primary vessel, the outflow conduit having a first end configured to couple to the second blood vessel.