Implantable heart assist system and method of applying same

• US 7,591,778 B2
• Filed: 05/03/2006
• Issued: 09/22/2009
• Est. Priority Date: 10/09/1997
• Status: Expired due to Fees

• Current Assignee: TC1 LLC (Abbott Laboratories)
• Original Assignee: ORQIS Medical Corporation
• Inventors: Bolling, Steven F., Viole, Anthony, O'Leary, Shawn
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US11/417,889
• Publication Number:
  US 20060270892A1
• Time in Patent Office: 1,238 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 pumping system for supplementing blood circulation through a patient experiencing congestive heart failure without any component thereof being connected to the left ventricle of the patient, the system comprising:

a pump configured to pump blood through the patient at a rate of about 3 L/Min or less,

an inflow conduit fluidly coupled to the pump to direct blood to the pump from the cardiovascular system, the inflow conduit having a first end configured to enable fluid communication between the inflow conduit and the cardiovascular system without connection to the left ventricle of the patient; and

an outflow conduit fluidly coupled to the pump to direct blood from the pump to the vasculature, the outflow conduit having a first end configured to enable fluid communication between the outflow conduit and the vasculature via a second blood vessel that is not directly connected to the heart;

wherein at least one of the inflow conduit and the outflow conduit are sized and configured to be implantable using a minimally-invasive surgical procedure, and whereby fluid communication between the first ends of at least one of the inflow and outflow conduits and the vasculature may be made subcutaneously to permit application of the connections in a minimally-invasive procedure.

2. The pumping system of claim 1, wherein the pump is configured to be implanted extrathoracically and subcutaneously without the use of a major invasive procedure.

3. The pumping system 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).

4. The pumping system of claim 1, wherein the first end of the inflow conduit is configured to enable fluid communication between the inflow conduit and an iliac artery.

5. The pumping system of claim 1, wherein the first end of the inflow conduit is configured to enable fluid communication between the inflow conduit and a femoral artery.

6. The pumping system of claim 1, wherein the first end of the inflow conduit is configured to enable fluid communication between the inflow conduit and a vein.

7. The pumping system of claim 1, wherein the first end of the outflow conduit is configured to enable fluid communication between the outflow conduit and an axillary artery.

8. The pumping system of claim 1, wherein at least one of the first end of the inflow conduit and the first end of the outflow conduit is configured to enable fluid communication via an anastomosis connection.

9. The pumping system of claim 1, further comprising a connector coupled to the distal end of the outflow conduit and configured to fluidly couple said distal end of said outflow conduit with a blood vessel.

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

11. The pumping system 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 pumping system for supplementing blood circulation through a patient experiencing congestive heart failure without any component thereof being connected to the left ventricle of the patient, the system comprising:

a pump configured to pump blood through the patient at subcardiac flow rates,

an inflow conduit fluidly coupled to the pump to direct blood to the pump from the cardiovascular system, the inflow conduit having a first end configured to enable fluid communication between the inflow conduit and the cardiovascular system without connection to the left ventricle of the patient; and

an outflow conduit fluidly coupled to the pump to direct blood from the pump to the vasculature, the outflow conduit having a first end configured to enable fluid communication between the outflow conduit and the vasculature via a second blood vessel that is not directly connected to the heart;

wherein at least one of the inflow conduit and the outflow conduit are sized and configured to be implantable using a minimally-invasive surgical procedure, and whereby fluid communication between the first ends of at least one of the inflow and outflow conduits and the vasculature may be made subcutaneously to permit application of the connections in a minimally-invasive procedure; and

wherein the pump is sized and configured to be implanted extrathoracically and subcutaneously without the use of a major invasive procedure.

13. The pumping system of claim 12, wherein the outflow conduit is configured to direct blood to the patient'"'"'s aorta.

14. The pumping system of claim 12, wherein at least one of the inflow conduit and the outflow conduit is sized and configured to be implanted percutaneously.

15. A pumping system for supplementing blood circulation through a patient experiencing congestive heart failure without any component thereof being connected to the left ventricle of the patient, the system comprising:

a pump configured to pump blood through the patient at subcardiac flow rates,

an inflow conduit fluidly coupled to the pump to direct blood to the pump from the cardiovascular system, the inflow conduit having a first end configured to enable fluid communication between the inflow conduit and the cardiovascular system without connection to the left ventricle of the patient; and

an outflow conduit fluidly coupled to the pump to direct blood from the pump to the vasculature, the outflow conduit having a first end configured to enable fluid communication between the outflow conduit and the vasculature via a subclavian artery of the patient;

wherein at least one of the inflow conduit and the outflow conduit are sized and configured to be implantable using a minimally-invasive surgical procedure, and whereby fluid communication between the first ends of at least one of the inflow and outflow conduits and the vasculature may be made subcutaneously to permit application of the connections in a minimally-invasive procedure.

16. The pumping system of claim 15, wherein the pump is sized and configured to be implanted in the patient'"'"'s groin area.

17. The pumping system of claim 15, further comprising an extracorporeal battery.

18. The pumping system of claim 17, wherein the extracorporeal battery is sized and configured to be attached to the patient to permit the patient to be ambulatory.

19. The pumping system of claim 15, further comprising an implantable battery.

20. The pumping system of claim 19, wherein the implantable battery is transcutaneously rechargeable.