Implantable heart assist system and method of applying same

• US 7,588,531 B2
• Filed: 05/03/2006
• Issued: 09/15/2009
• Est. Priority Date: 10/09/1997
• Status: Expired due to Fees

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: ORQIS Medical Corporation
• Inventors: Bolling, Steven F.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US11/417,677
• Publication Number:
  US 20060276681A1
• Time in Patent Office: 1,231 Days
• Field of Search: 600/16, 600/17, 623/3.11, 623/3.13, 623/3.16, 623/3.17
• US Class Current: 600/16
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3623 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 for supplementing the circulation of blood, including the cardiac output, in a patient without any component thereof being connected to the patient'"'"'s heart, and methods of using same. One embodiment provides a vascular graft that has a first end that is sized and configured to couple to a non-primary blood vessel and a second end that is fluidly coupled to a pump to conduct blood between the pump and the non-primary blood vessel. An outflow conduit is also provided that has a first end sized and configured to be positioned within the same or different blood vessel, whether primary or non-primary, through the vascular graft. The outflow conduit is fluidly coupled to the pump to conduct blood between the pump and the patient. The vascular graft may be connected to the blood vessel subcutaneously to permit application of the extracardiac pumping system in a minimally-invasive procedure.

Claims

1. A method for treating a patient, comprising:

providing a pump adapted to provide a flow rate of about 3 liters/minute or less, said pump having an inflow conduit and an outflow conduit;

providing fluid communication between a distal end of the inflow conduit and the patient'"'"'s circulatory system to permit the flow of blood to the pump from the patient;

connecting via anastomosis a distal end of the outflow conduit with the patient'"'"'s subclavian artery using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the subclavian artery;

implanting said pump extrathoracically and minimally subdermally beneath the skin of the patient; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at a flow rate of about 3 liters/minute or less.

2. The method of claim 1, wherein at least one of the pump, inflow conduit and outflow conduit comprise a synthetic biocompatible material selected from the group consisting of polyethylene terephthalate (PET) and polytetrafluoroethylene (PTFE).

3. The method of claim 1, wherein fluid communication is provided between the distal end of the inflow conduit and an iliac artery of the patient.

4. The method of claim 1, wherein fluid communication is provided between the distal end of the inflow conduit and a femoral artery of the patient.

5. The method of claim 1, wherein fluid communication is provided between the distal end of the inflow conduit and a vein of the patient.

6. The method of claim 1, wherein fluid communication is provided between the distal end of the outflow conduit and an axillary artery of the patient.

7. The method of claim 1, wherein an anastomosis connection is provided between the distal end of the outflow conduit and a subclavian artery of the patient.

8. The method of claim 1, wherein providing fluid communication between the inflow conduit and the patient'"'"'s circulatory system comprises providing an anastomosis connection between the distal end of the inflow conduit and the patient'"'"'s circulatory system.

9. The method of claim 1, further comprising coupling a connector with a blood vessel and coupling the distal end of the outflow conduit with the connector to provide fluid communication between the outflow conduit and the vasculature.

10. The method of claim 9, wherein the connector comprises a T-shaped fitting.

11. The method of claim 9, wherein the connector comprises a divergence configured to have a selected angle relative to the vessel to which the connector is connected.

12. A method for treating a patient, comprising:

providing a pump adapted to provide a flow rate of about 3 liters/minute or less, said pump having an inflow conduit and an outflow conduit;

providing fluid communication between a distal end of the inflow conduit and the patient'"'"'s circulatory system to permit the flow of blood to the pump from the patient;

connecting via anastomosis a distal end of the outflow conduit with a non-primary blood vessel of the patient using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the non-primary blood vessel;

implanting said pump subcutaneously; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at a flow rate of about 3 liters/minute or less.

13. The method of claim 12, wherein the distal end of the outflow conduit is connected via anastomosis to the patient'"'"'s subclavian artery to direct blood flow into the aorta.

14. The method of claim 13, further comprising providing an acute angle between the direction of flow from the outflow conduit toward the subclavian artery and the direction of flow within the subclavian artery such that blood flow from the outflow conduit is directed toward the aorta.

15. The method of claim 12, further comprising percutaneously placing in fluid communication with the patient'"'"'s circulatory system the distal end of at least one of said inflow conduit and said outflow conduit.

16. The method of claim 12, wherein said minimally invasive surgical procedure comprises a percutaneous procedure.

17. A method for treating a patient, comprising:

providing a pump adapted to provide a subcardiac volumetric flow rate, said pump having an inflow conduit and an outflow conduit;

providing fluid communication between a distal end of the inflow conduit and the patient'"'"'s circulatory system to permit the flow of blood to the pump from the patient;

connecting via anastomosis a distal end of the outflow conduit with the patient'"'"'s subclavian artery using a minimally invasive surgical procedure to permit the flow of blood away from the pump to the subclavian artery;

implanting said pump extrathoracically and minimally subdermally beneath the skin of the patient; and

operating said pump to perfuse blood through the patient'"'"'s circulatory system at a subcardiac volumetric flow rate.

18. The method of claim 17, further comprising implanting the pump in the patient'"'"'s groin area.

19. The method of claim 17, further comprising powering the pump using an extracorporeal battery.

20. The method of claim 19, further comprising attaching the extracorporeal battery to the outside of the patient.

21. The method of claim 17, further comprising implanting a battery within the patient and powering the pump with the implanted battery.

22. The method of claim 21, wherein the battery is transcutaneously rechargeable.