Implantable heart assist system and method of applying same

• US 7,513,863 B2
• Filed: 06/28/2004
• Issued: 04/07/2009
• Est. Priority Date: 10/09/1997
• Status: Expired due to Fees

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: ORQIS Medical Corporation
• Inventors: Gaddis, Mary Lynn, Viole, Anthony J., Aldea, Gabriel, Gharib, Morteza, Bolling, Steven F.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US10/878,591
• Publication Number:
  US 20040236172A1
• Time in Patent Office: 1,744 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 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 60/117 for assisting the heart, e.g. transcutaneous or external ventricular assist devices
• 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 60/178 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 60/232 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 60/569 synchronous with the native heart beat
• CPC Class Codes: A61M 60/859 Connections therefor
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body

Abstract

An extracardiac pumping system and method for using it supplement the circulation of blood, including the cardiac output, in a patient without any component thereof being connected to the patient'"'"'s heart. A battery powered pump may be implanted subcutaneously and attached to an inflow conduit fluidly coupled to a patient'"'"'s femoral artery via a subcutaneous anastomosis connection. The pump draws blood from the inflow conduit and discharges it through an outflow conduit fluidly coupled to a second peripheral artery via another subcutaneous anastomosis connection. The battery may be charged extracorporeally and the pump may be operated in either a continuous or pulsatile fashion in synchronization with the patient'"'"'s heart. The conduits can be housed in a multi-lumen catheter and a reservoir may be provided which fluidly communicates with the inflow conduits. An additional feature may keep blood traveling extracorporeally within the system at or near body temperature. The system is capable of adjusting outflow from the pump to optimize the mixing of red blood cells in the aorta and thereby enhance oxygen delivery to tissues by minimizing blood cell concentration in the center of the aorta.

Claims

1. A method for increasing perfusion in a branch artery, the method comprising:

providing fluid communication between a pump and an inflow conduit and between the pump and an outflow conduit;

fluidly coupling said inflow conduit with a first location of the vasculature using a minimally invasive surgical procedure;

advancing a distal end of the outflow conduit to a location proximate a branch artery; and

operating said pump to direct blood from the first location to the branch artery at volumetric rates that are on average subcardiac to increase perfusion through the branch artery;

wherein fluidly coupling the inflow conduit comprises fluidly coupling the inflow conduit to a first femoral artery.

2. A system for branch artery perfusion comprising:

a pump configured to pump blood through a 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 non-primary blood vessel of the vasculature of the patient; and

,

an outflow conduit fluidly coupled to the pump and configured to direct blood directly into a branch artery to maintain or enhance blood flow to an organ or tissue supplied by the branch artery, wherein the outflow conduit is configured to be insertable into a renal artery;

whereby connection of at least one of the inflow and outflow conduits to the vasculature may be made subcutaneously to permit application thereof in a minimally-invasive procedure.

3. The system of claim 2, wherein the inflow conduit defines a first lumen of a multilumen catheter and the outflow conduit defines a second lumen of the multilumen catheter.

4. The system of claim 2, wherein the outflow conduit is a cannula.

5. The system of claim 2, further comprising a cannula coupled with the outflow conduit.

6. The system of claim 2, wherein the inflow conduit is configured to couple with a femoral artery.

7. The system of claim 2, wherein the pump is configured to be implantable subcutaneously.

8. The system of claim 2, wherein the pump is capable of providing pulsatile flow.

9. The system of claim 2, wherein the pump has an average flow rate of between about 0.1 and about 3 liters per minute.

10. A system for branch artery perfusion comprising:

a pump configured to pump blood through a 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 non-primary blood vessel of the vasculature of the patient; and

,

an outflow conduit fluidly coupled to the pump and configured to direct blood directly into a branch artery to maintain or enhance blood flow to an organ or tissue supplied by the branch artery wherein the outflow conduit is configured to be insertable into a mesenteric artery;

whereby connection of at least one of the inflow and outflow conduits to the vasculature may be made subcutaneously to permit application thereof in a minimally-invasive procedure.

11. A method for increasing perfusion in a branch artery, the method comprising:

providing fluid communication between a pump and an inflow conduit and between the pump and an outflow conduit;

fluidly coupling said inflow conduit with a first location of the vasculature using a minimally invasive surgical procedure;

advancing a distal end of the outflow conduit to a location proximate a branch artery;

operating said pump to direct blood from the first location to the branch artery at volumetric rates that are on average subcardiac to increase perfusion through the branch artery; and

advancing the distal end of the outflow conduit into a renal artery.

12. The method of claim 11, further comprising operating the pump in a pulsatile manner.

13. The method of claim 12, further comprising operating the pump at an average flow rate of between about 0.1 and about 3 liters per minute.

14. A method for increasing perfusion in a branch artery, the method comprising:

providing fluid communication between a pump and an inflow conduit and between the pump and an outflow conduit;

fluidly coupling said inflow conduit with a first location of the vasculature using a minimally invasive surgical procedure;

advancing a distal end of the outflow conduit to a location proximate a branch artery;

operating said pump to direct blood from the first location to the branch artery at volumetric rates that are on average subcardiac to increase perfusion through the branch artery; and

advancing the distal end of the outflow conduit into a mesenteric artery.

15. The method of claim 14, further comprising operating the pump in a pulsatile manner.

16. The method of claim 14, further comprising operating the pump at an average flow rate of between about 0.1 and about 3 liters per minute.