Implantable heart assist system

• US 6,200,260 B1
• Filed: 10/02/1998
• Issued: 03/13/2001
• Est. Priority Date: 10/09/1997
• Status: Expired due to Term

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated), Thoratec LLC
• Original Assignee: Fore Flow Corporation
• Inventors: Bolling, Steven F.
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US09/166,005
• Time in Patent Office: 893 Days
• Field of Search: 600/16, 600/17
• 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. An extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a 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 fluidly coupled to the pump to direct blood to the pump from a first peripheral blood vessel, the inflow conduit having a first end sized and configured to couple to the first peripheral blood vessel;

an outflow conduit fluidly coupled to the pump to direct blood from the pump to a second peripheral blood vessel, the outflow conduit having a first end sized and configured to couple to the second peripheral blood vessel; and

at least one additional outflow conduit having a first end configured to connect to a peripheral blood vessel;

whereby connection of the first ends of the inflow and outflow conduits to the blood vessels may be made subcutaneously to permit application of the connections in an minimally-invasive procedure.

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

a pulsatile 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 fluidly coupled to the pump to direct blood to the pump from a first peripheral blood vessel, the inflow conduit having a first end sized and configured to couple to the first peripheral blood vessel; and

,

an outflow conduit fluidly coupled to the pump to direct blood from the pump to a second peripheral blood vessel, the outflow conduit having a first end sized and configured to couple to the second peripheral blood vessel; and

a control circuit to synchronously actuate the pump so as to begin pumping during isovolumic contraction and discontinue pumping about when the aortic valve closes;

whereby connection of the first ends of the inflow and outflow conduits to the blood vessels may be made subcutaneously to permit application of the connections in an minimally-invasive procedure.

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

a 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 fluidly coupled to the pump to direct blood to the pump from a first peripheral blood vessel, the inflow conduit having a first end sized and configured to couple to the first peripheral blood vessel; and

,

an outflow conduit fluidly coupled to the pump to direct blood from the pump to a second peripheral blood vessel, the outflow conduit having a first end sized and configured to couple to the second peripheral blood vessel;

wherein the pump, inflow conduit and outflow conduit are sized and configured to be implantable using a minimally-invasive surgical procedure, and

whereby connection of the first ends of the inflow and outflow conduits to the blood vessels may be made subcutaneously to permit application of the connections in an minimally-invasive procedure.

4. The extracardiac pumping system of claim 3 further comprising an implantable battery.

5. The extracardiac pumping system of claim 4 further comprising an induction coil configured to electromagnetically couple to the battery for charging the battery following implantation of said battery and pump.

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

a 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 comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pump to direct blood to the pump from a first peripheral blood vessel, the inflow conduit having a first end sized and configured to couple to the first peripheral blood vessel; and

,

an outflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pump to direct blood from the pump to a second peripheral blood vessel, the outflow conduit having a first end sized and configured to couple to the second peripheral blood vessel;

whereby connection of the first ends of the inflow and outflow conduits to the blood vessels may be made subcutaneously to permit application of the connections in an minimally-invasive procedure.

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

a 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 fluidly coupled to the pump to direct blood to the pump from a first peripheral blood vessel, the inflow conduit having a first end sized and configured to couple to the first peripheral blood vessel;

an outflow conduit fluidly coupled to the pump to direct blood from the pump to a second peripheral blood vessel, the outflow conduit having a first end sized and configured to couple to the second peripheral blood vessel; and

,

a connector for affixing to one of the peripheral blood vessels and for connecting to one of the conduits

whereby connection of the first ends of the inflow and outflow conduits to the blood vessels may be made subcutaneously to permit application of the connections in an minimally-invasive procedure.

8. The extracardiac pumping system of claim 7, wherein the connector has a divergence of less than 90 degrees so that a majority of the blood pumped into the peripheral vessel may be directed proximally toward the heart when the system is in use.

9. An extracardiac pumping system configured to supplement the circulation of blood through a patient, the extracardiac system comprising:

an extrathoracic pump adapted to pump blood between peripheral arteries, said pump configured to be implanted extrathoracically and subcutaneously without the use of a major invasive procedure;

a pump inflow conduit connectable to a first peripheral artery; and

a pump outflow conduit connectable to a second peripheral artery, said pump outflow conduit configured to connect to the second peripheral in such a way that a majority of the blood pumped therethrough is directed proximally toward the heart,

whereby connection of the inflow and outflow conduits to the blood vessels may be subcutaneous to permit application of the connections in an minimally-invasive procedure.

10. The extracardiac pumping system of claim 9, wherein the pump is a continuous flow pump.

11. The extracardiac pumping system of claim 9, wherein the pump is actuated in a pulsatile fashion so as to reduce the hemodynamic burden on the heart.

12. An extracardiac pumping system for reducing the pumping load on the heart of a patient, said extracardiac pump configured to facilitate cardiac recovery by supplementing the circulation of blood through the patient without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a pump configured to pump blood synchronously with the patient'"'"'s heart within a range of flow rates that, during normal operation thereof, are between 0.1 and 3 liters/min., said pump being implantable at or about the patient'"'"'s groin in a minimally-invasive procedure;

an implantable battery for providing electrical power to the pump;

a controller for controlling actuation of the pump in a synchronous manner to permit pulsatile blood circulation, said controller being configured so as to be capable of actuation during systole when the aortic valve is open;

means for charging the battery extracorporeally so that the battery may be recharged without the need of a surgical procedure;

an inflow conduit having an inner diameter no greater than 25 mm, the inflow conduit configured to fluidly couple to the pump to direct blood to the pump from a peripheral artery of the patient via a subcutaneous anastomosis connection, and

an outflow conduit having an inner diameter no greater than 25 mm, the outflow conduit configured to fluidly couple to the pump to direct blood from the pump to a peripheral artery that stems from the patient'"'"'s aortic arch via a subcutaneous anastomosis connection.

13. An extracardiac pumping system for supplementing the circulation of blood 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 continuously at subcardiac rates of less than 3.0 liters/minute;

a controller for controlling actuation of the pump in a continuous manner, said controller permitting variable speed actuation;

an inflow conduit having an inner diameter no greater than 25 mm, the inflow conduit configured to fluidly couple to the pump to direct blood to the pump from a first peripheral blood vessel of the patient via a subcutaneous anastomosis connection, and

an outflow conduit having an inner diameter no greater than 25 mm, the outflow conduit configured to fluidly couple to the pump to direct blood from the pump to a second peripheral blood vessel via a subcutaneous anastomosis connection.

14. The extracardiac pumping system of claim 13, wherein said pump is implantable extrathoracically in a minimally-invasive procedure.

15. The extracardiac pumping system of claim 13, further comprising an implantable battery for providing electrical power to the pump, and means for charging the battery extracorporeally so that the battery may be recharged without the need of a surgical procedure.

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 rotary pump to a first peripheral blood vessel via a cannula in a percutaneous application with a minimally invasive surgical procedure to permit the flow of blood to the pump from the first peripheral blood vessel, said rotary 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 peripheral blood vessel via a cannula in a percutaneous application with a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second peripheral blood vessel; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system.

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 rotary pump to a first peripheral artery with a minimally invasive surgical procedure to permit the flow of blood to the pump from the first peripheral artery, said rotary 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 peripheral artery with a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second peripheral artery; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system.

18. The method of claim 17, wherein the connection between the distal end of the inflow conduit and the first peripheral blood vessel is made with a cannula.

19. The method of claim 17, wherein the connection between the distal end of the inflow conduit and the first peripheral blood vessel is made with an anastomosis connection.

20. The method of claim 17, wherein the inflow and outflow conduit distal ends are connected to a femoral artery and an axillary artery, respectively.

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 rotary pump to a first peripheral blood vessel with a minimally invasive surgical procedure to permit the flow of blood to the pump from the first peripheral blood vessel, said rotary 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 peripheral blood vessel with a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second peripheral blood vessel; and

operating said pump in copulsating fashion to perfuse blood through the patient'"'"'s circulatory system.

22. The method of claim 21, wherein the pump is controlled so as to begin actuation during isovolumic contraction.

23. 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 rotary pump to a first peripheral vein with a minimally invasive surgical procedure to permit the flow of blood to the pump from the first peripheral vein, said rotary 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 peripheral vein with a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second peripheral vein; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system.

24. 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 rotary pump to a first peripheral blood vessel with a minimally invasive surgical procedure to permit the flow of blood to the pump from the first peripheral blood vessel, said rotary 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 peripheral blood vessel with a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second peripheral blood vessel;

connecting an intervening length of conduit between the distal end of the inflow conduit and the pump; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system.

25. 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 rotary pump to a first peripheral blood vessel with a minimally invasive surgical procedure to permit the flow of blood to the pump from the first peripheral blood vessel, said rotary 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 peripheral blood vessel with a minimally invasive surgical procedure to permit the flow of blood away from the pump to the second peripheral blood vessel;

connecting an intervening length of conduit between the distal end of the outflow conduit and the pump; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system.