Implantable heart assist system and method of applying same

• US 20050256363A1
• Filed: 05/03/2005
• Published: 11/17/2005
• Est. Priority Date: 10/09/1997
• Status: Active Grant

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: ORQIS Medical Corporation
• Inventors: Bolling, Steven F., Viole, Anthony, O'Leary, Shawn
• Granted Patent: US 7,458,929 B2
• Time in Patent Office: Days
• 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. 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 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;

a first conduit comprising at least in part biocompatible synthetic material having a first distal end sized and configured to fluidly couple to a non-primary blood vessel, the first conduit also being fluidly coupled to the pump to conduct blood between the pump and the non-primary blood vessel; and

a second conduit having a first distal end sized and configured to be positioned at least in part within the non-primary blood vessel and within the first conduit, the second conduit being fluidly coupled to the pump to conduct blood between the pump and the patient, the first conduit further comprising means for permitting the second conduit to sealably extend through a wall of said first conduit to form an internal lumen within the proximal end of the first conduit;

whereby the first conduit may be fluidly coupled to the blood vessel subcutaneously to permit application of the extracardiac pumping system in a minimally-invasive procedure through a single site and whereby the second conduit may extend into the non-primary blood vessel so that the distal end of said second conduit may reside either in said blood vessel or a different blood vessel.

2. The extracardiac pumping system of claim 1, wherein the first conduit is configured as an inflow conduit and the second conduit is configured as an outflow conduit.

3. The extracardiac pumping system of claim 1, wherein the first conduit is configured an outflow conduit and the second conduit is configured as an inflow conduit.

4. The extracardiac pumping system of claim 1, wherein the means for permitting the second conduit to sealably extend through a wall of said first conduit comprises an insertion site in said first conduit wall sized to tightly fit over the exterior wall of the second conduit extending therethrough and configured to permit a reliable seal between the first conduit wall and the exterior of the second conduit.

5. The extracardiac pumping system of claim 1, further comprising a branched portion on the first conduit located between the first and second end of said first conduit, the insertion site being positioned on said branched portion.

6. The extracardiac pumping system of claim 1, wherein the means for permitting the second conduit to sealably extend through a wall of said first conduit comprises a connector extending from said first conduit configured to sealably connect to a distal end of said second conduit;

the first conduit further comprising an internal lumen in sealed fluid communication with said connector to permit fluid communication between the second conduit and the internal lumen when the distal end of the second conduit is connected to the connector without said fluid residing in said second conduit significantly leaking into the first conduit.

7. The extracardiac pumping system of claim 1, wherein the pump is a rotary pump.

8. The extracardiac pumping system of claim 1, wherein the pump is implantable.

9. The extracardiac pumping system of claim 1, wherein the system is implantable.

10. The extracardiac pumping system of claim 1, wherein the first conduit is configured to couple to the blood vessel via an anastomosis procedure.

11. 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 first end of a first conduit to a non-primary blood vessel using a minimally invasive procedure to permit the flow of blood between a pump and the non-primary blood vessel, the pump configured to pump blood at volumetric rates that are on average subcardiac;

fluidly coupling a distal end of a second conduit, which is fluidly coupled to the pump at a proximal end, to the patient'"'"'s vasculature through the first conduit and through at least a part of the non-primary blood vessel so that the distal end of said second conduit resides within the same or different blood vessel; and

operating the pump to perfuse blood through the patient'"'"'s circulatory system at volumetric rates that are on average subcardiac between the non-primary blood vessel and the same or different blood vessel.

12. The method of claim 11, wherein the step of fluidly coupling a distal end of the second conduit to the patient'"'"'s vasculature comprises directing the distal end of the second conduit through an insertion site positioned on said first conduit.

13. The method of claim 11, wherein the step of fluidly coupling a distal end of the second conduit to the patient'"'"'s vasculature comprises connecting the distal end of the second conduit to a connector extending from said first conduit.

14. The extracardiac pumping system of claim 11, wherein the first conduit is configured to couple to the blood vessel via an anastomosis procedure.