Implantable heart assist system and method of applying same

• US 8,900,115 B2
• Filed: 07/01/2011
• Issued: 12/02/2014
• Est. Priority Date: 10/09/1997
• Status: Expired due to Fees

• Current Assignee: Thoratec LLC
• Original Assignee: Thoratec LLC
• Inventors: Bolling, Steven F., Gharib, Morteza, Aldea, Gabriel, Gaddis, Mary Lynn, Viole, Anthony J.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US13/175,735
• Publication Number:
  US 20120004495A1
• Time in Patent Office: 1,250 Days
• Field of Search: None
• 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 system for supplementing blood circulation in a patient comprising:

a pump configured to pump blood through the patient at subcardiac flow rates, said pump having an average flow rate that, during normal operation thereof is substantially below that of the patient'"'"'s heart when healthy; and

a conduit fluidly coupled to the pump and configured to withdraw blood from and return blood to the patient'"'"'s vasculature wherein the blood may travel in reverse directions within the conduit;

wherein the pump is configured to be implanted within the patient minimally invasively.

2. The system of claim 1, wherein the pump is selected from the group consisting of a pulsatile pump, a rotary pump, and a continuous flow pump.

3. The system of claim 1, wherein the conduit comprises a first lumen and a second lumen.

4. The system of claim 3, wherein the first and second lumens each comprise a proximal end configured to couple with the pump and a distal end.

5. The system of claim 4, wherein the conduit further comprises an inflow port at the distal end of the first lumen and an outflow port at the distal end of the second lumen.

6. The system of claim 1, wherein the conduit is comprised of a material that is sufficiently flexible so as not to prevent the patient from being ambulatory.

7. A system for supplementing the circulation of blood through a patient, the system comprising:

a pulsatile pump configured to be implanted in the patient; and

a conduit configured to minimally-invasively couple with a non-primary blood vessel of the circulatory system of the patient and configured for fluid communication with the pulsatile pump, and

wherein the system is configured to direct blood from the circulatory system into the conduit to reduce the load on the heart.

8. The system of claim 7, wherein the pump is configured to be implanted extrathoracially in the patient.

9. The system of claim 7, wherein the pump is configured to be implanted subcutaneously in the patient.

10. The system of claim 7, wherein the conduit comprises an inflow port, a first lumen, an outflow port, and a second lumen.

11. The system of claim 10, wherein the conduit is configured to:

direct the blood from the vasculature into the first lumen through the inflow port while the heart is in systole; and

direct the blood from the second lumen through the outflow port and into the vasculature while the heart is in diastole.

12. The system of claim 7, wherein the pump is configured to operate out-of-phase with the heart cycle.

13. The system of claim 12, wherein the system is configured to direct blood from the circulatory system into the conduit just prior to isovolumetric contraction.

14. The system of claim 7, wherein the pulsatile pump comprises a rotary pump.

15. A system for supplementing the circulation of blood through a patient, the system comprising:

a pulsatile pump configured to be implanted extrathoracially in the patient; and

a conduit configured to couple to a peripheral blood vessel of the circulatory system of the patient and configured for fluid communication with the pulsatile pump,

wherein the pulsatile pump is configured to intake into or expel blood from the conduit in a manner to reduce the load on the patient'"'"'s heart during systole.

16. The system of claim 15, wherein the pump is configured to be implanted subcutaneously in the patient.

17. The system of claim 15, wherein the conduit is configured to be coupled to the circulatory system of the patient subcutaneously.

18. The system of claim 15, wherein the conduit is a first conduit comprising a first port and a first lumen.

19. The system of claim 18, wherein the system comprises a second conduit comprising a second port and a second lumen.

20. The system of claim 19, wherein:

the first port is an inflow port, the first lumen is an inflow lumen, the second port is an outflow port, and the second lumen is an outflow lumen;

the first conduit is configured to direct the blood from the vasculature into the inflow lumen through the inflow port while the heart is in systole; and

the second conduit is configured to direct the blood from the outflow lumen through the outflow port and into the vasculature while the heart is in diastole.

21. The system of claim 15, wherein the conduit comprises a first lumen and a second lumen.

22. The system of claim 15, wherein the conduit is configured to couple to the left subclavian artery of the patient.

23. The system of claim 15, wherein the pump is configured to operate out-of-phase with the heart cycle.

24. The system of claim 23, wherein the pump is configured to intake blood into the conduit just prior to isovolumetric contraction.

25. The system of claim 15, wherein the pulsatile pump comprises a rotary pump.

26. A system for supplementing the circulation of blood through a patient using counterpulsation, the system comprising:

a pulsatile pump configured to be implanted extrathoracially in the patient;

a conduit configured to couple to the circulatory system of the patient and configured for fluid communication with the pulsatile pump,

wherein the pulsatile pump is configured to operate in a counter-pulsating manner to reduce the load on the patient'"'"'s heart during systole; and

a continuous flow pump configured to be operated in parallel with the pulsatile pump.