Implantable heart assist system and method of applying same

• US 7,125,376 B2
• Filed: 04/07/2003
• Issued: 10/24/2006
• Est. Priority Date: 10/09/1997
• Status: Expired due to Term

• Current Assignee: TC1 LLC (Abbott Laboratories Incorporated)
• Original Assignee: ORQIS Medical Corporation
• Inventors: Werner, Wolfgang, Beizai, Masoud, Bolling, Steven F., Pecor, Robert, Sirimanne, Laksen, Viole, Anthony, Kelly, Ryan, O'Leary, Shawn
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US10/408,926
• Publication Number:
  US 20040019251A1
• Time in Patent Office: 1,296 Days
• Field of Search: 600/16, 604/8
• US Class Current: 600/16
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• 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 25/007 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 60/165 implantable in, on, or around the heart
• 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 60/422 the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/538 Regulation using real-time blood pump operational parameter data, e.g. motor current
• CPC Class Codes: A61M 60/857 Implantable blood tubes

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 of the intravascular extracardiac system comprises a pump with inflow and outflow conduits that are sized and configured to be implantable intravascularly through a non-primary vessel, whereby it may positioned where desired within the patient'"'"'s vasculature. The system comprises a subcardiac pump that may be driven directly or electromagnetically from within or without the patient. The pump is configured to be operated continuously or in a pulsatile fashion, synchronous with the patient'"'"'s heart, thereby potentially reducing the afterload of the heart. In another embodiment, the system is positioned extracorporeally, with the inflow conduit and outflow conduit applied percutaneously to a non-primary vessel for circulating blood to and from the non-primary vessel or between the non-primary vessel and another blood vessel within the patient'"'"'s vasculature.

Claims

1. An intravascular extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure 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, the pump configured to be positioned within the vasculature of a patient;

an inflow conduit fluidly coupled to the pump to direct blood to the pump, the inflow conduit configured to be positioned within the vasculature of the patient; and

an outflow conduit fluidly coupled to the pump to direct blood away from the pump, the outflow conduit configured to be positioned within the vasculature of the patient;

whereby the pump and the inflow and outflow conduits are configured so as to be inserted subcutaneously into the vasculature in an minimally-invasive procedure; and

wherein the pump comprises an impeller.

2. The intravascular extracardiac pumping system of claim 1, wherein the impeller is helically shaped.

3. The intravascular extracardiac pumping system of claim 1, wherein the impeller is driven mechanically by a motor through a drive wire.

4. The intravascular extracardiac pumping system of claim 1, wherein the impeller is driven electromagnetically by a discrete electromagnetic drive.

5. The intravascular extracardiac pumping system of claim 4, wherein the electromagnetic drive is sized and configured to be implantable.

6. The intravascular extracardiac pumping system of claim 5, wherein the electromagnetic drive is sized and configured to be implantable within the patient'"'"'s vasculature.

7. An intravascular extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure 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, the pump configured to be positioned within the vasculature of a patient;

an inflow conduit fluidly coupled to the pump to direct blood to the pump, the inflow conduit configured to be positioned within the vasculature of the patient; and

an outflow conduit fluidly coupled to the pump to direct blood away from the pump, the outflow conduit configured to be positioned within the vasculature of the patient;

whereby the pump and the inflow and outflow conduits are configured so as to be inserted subcutaneously into the vasculature in an minimally-invasive procedure; and

wherein the pump is a rotary pump.

8. An intravascular extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure 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, the pump configured to be positioned within the vasculature of a patient;

an inflow conduit fluidly coupled to tile pump to direct blood to the pump, the inflow conduit configured to be positioned within the vasculature of the patient; and

an outflow conduit fluidly coupled to the pump to direct blood away from the pump, the outflow conduit configured to be positioned within the vasculature of the patient;

whereby the pump and the inflow and outflow conduits are configured so as to be inserted subcutaneously into the vasculature in an minimally-invasive procedure; and

wherein the pump is configured to operate in pulsatile fashion.

9. An intravascular extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure 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, the pump configured to be positioned within the vasculature of a patient;

an inflow conduit fluidly coupled to the pump to direct blood to the pump, the inflow conduit configured to be positioned within the vasculature of the patient; and

an outflow conduit fluidly coupled to the pump to direct blood away from the pump, the outflow conduit configured to be positioned within the vasculature of the patient;

whereby the pump and the inflow and outflow conduits are configured so as to be inserted subcutaneously into the vasculature in an minimally-invasive procedure; and

wherein the pump comprises a rotatable cable having means for directing blood axially along the cable.

10. An intravascular extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure 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, the pump configured to be positioned within the vasculature of a patient;

an inflow conduit fluidly coupled to the pump to direct blood to the pump, the inflow conduit configured to be positioned within the vasculature of the patient; and

an outflow conduit fluidly coupled to the pump to direct blood away from the pump, the outflow conduit configured to be positioned within the vasculature of the patient;

whereby the pump and the inflow and outflow conduits are configured so as to be inserted subcutaneously into the vasculature in an minimally-invasive procedure; and

wherein the pump comprises an archemedes screw.

11. An intravascular extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure 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, the pump configured to be positioned within the vasculature of a patient;

an inflow conduit fluidly coupled to the pump to direct blood to the pump, the inflow conduit configured to be positioned within the vasculature of the patient;

an outflow conduit fluidly coupled to the pump to direct blood away from the pump, the outflow conduit configured to be positioned within the vasculature of the patient; and

an additional conduit positioned proximate the pump to provide an additional flow path to blood in the vasculature from a point upstream of the inflow conduit to a point downstream of the outflow conduit without passing through the pump

whereby the pump and the inflow and outflow conduits are configured so as to be inserted subcutaneously into the vasculature in an minimally-invasive procedure.

12. An intravascular extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure 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, the pump configured to be positioned within the vasculature of a patient;

an inflow conduit fluidly coupled to the pump to direct blood to the pump, the inflow conduit configured to be positioned within the vasculature of the patient;

an outflow conduit fluidly coupled to the pump to direct blood away from the pump, the outflow conduit configured to be positioned within the vasculature of the patient; and

an additional conduit positioned proximate the pump to provide an additional flow path to blood in the vasculature from a point upstream of an inflow to the pump to a point downstream of an outflow from the pump without passing through the pump;

whereby the pump and the inflow and outflow conduits are configured so as to be inserted subcutaneously into the vasculature in an minimally-invasive procedure.

13. An intravascular extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure 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 avenge flow rate that, during normal operation thereof, is substantially below that of the patient'"'"'s heart when healthy, the pump configured to be positioned within the vasculature of a patient;

an inflow conduit fluidly coupled to the pump to direct blood to the pump, the inflow conduit configured to be positioned within the vasculature of the patient; and

an outflow conduit fluidly coupled to the pump to direct blood away from the pump, the outflow conduit configured to be positioned within the vasculature of the patient; and

a pump driving means;

whereby the pump and the inflow and outflow conduits are configured so as to be inserted subcutaneously into the vasculature in an minimally-invasive procedure.

14. The intravascular extracardiac pumping system of claim 13, wherein the pump driving means is sized and configured to be implantable.

15. The intravascular extracardiac pumping system of claim 14, wherein the pump driving means is sized and configured to be implantable within the vasculature of a patient.

16. The intravascular extracardiac pumping system of claim 13, wherein the pump driving means comprises a drive wire.

17. The intravascular extracardiac pumping system of claim 13, wherein the pump driving means further comprises a motor.

18. The intravascular extracardiac pumping system of claim 13, wherein the pump driving means comprises an electromagnetic drive.

19. An intravascular extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a means for pumping blood; and

a conduit that houses the pumping means and is configured to direct blood from a location upstream of the pumping means to a location downstream of the pumping means;

whereby the pumping means and the conduit are configured to be insertable into a non-primary vessel subcutaneously in an minimally-invasive procedure for positioning within the patient'"'"'s vasculature; and

wherein the pumping means comprises a rotary pump.

20. The intravascular extracardiac pumping system of claim 19, wherein the pumping means is configured to operate in pulsatile fashion.

21. An intravascular extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a means for pumping blood; and

a conduit that houses the pumping means and is configured to direct blood from a location upstream of the pumping means to a location downstream of the pumping means;

whereby the pumping means and the conduit are configured to be insertable into a non-primary vessel subcutaneously in an minimally-invasive procedure for positioning within the patient'"'"'s vasculature;

wherein the pumping means comprises an impeller that is driven electromagnetically by a discrete electromagnetic drive; and

wherein the electromagnetic drive is sized and configured to be implantable.

22. The intravascular extracardiac pumping system of claim 21, wherein the electromagnetic drive is sized and configured to be implantable within the patient'"'"'s vasculature.

23. An intravascular extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a means for pumping blood; and

a conduit that houses the pumping means and is configured to direct blood from a location upstream of the pumping means to a location downstream of the pumping means;

whereby the pumping means and the conduit are configured to be insertable into a non-primary vessel subcutaneously in an minimally-invasive procedure for positioning within the patient'"'"'s vasculature; and

wherein the pumping means comprises a worm pump.

24. An intravascular extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a means for pumping blood; and

a conduit that houses the pumping means and is configured to direct blood from a location upstream of the pumping means to a location downstream of the pumping means;

an additional conduit positioned proximate the pumping means to provide an additional flow path to blood in the vasculature from a point upstream of an inflow to the pumping means to a point downstream of an outflow from the pumping means without passing through the pump; and

whereby the pumping means and the conduit are configured to be insertable into a non-primary vessel subcutaneously in an minimally-invasive procedure for positioning within the patient'"'"'s vasculature.

25. An intravascular extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure without any component thereof being connected to the patient'"'"'s heart, the extracardiac system comprising:

a means for pumping blood; and

a conduit that houses the pumping means and is configured to direct blood from a location upstream of the pumping means to a location downstream of the pumping means;

a second outlet conduit; and

whereby the pumping means and the conduit are configured to be insertable into a non-primary vessel subcutaneously in an minimally-invasive procedure for positioning within the patient'"'"'s vasculature.

26. A method for supplementing the circulation of blood trough a patient without connecting any component to the patient'"'"'s heart, the method comprising the steps of:

providing a parallel flow system comprising a means for pumping blood and a conduit that houses the pump means;

inserting the pump means and the conduit into the patient'"'"'s vasculature in a non-primary vessel subcutaneously in an minimally-invasive procedure;

positioning the parallel flow system within the vasculature; and

operating said pump means to direct blood through the conduit;

wherein the pumping means comprises a rotary pump.

27. The method of claim 26, wherein the pumping means is configured to operate in pulsatile fashion.

28. 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:

providing a parallel flow system comprising a means for pumping blood and a conduit that houses the pump means;

inserting the pump means and the conduit into the patient'"'"'s vasculature in a non-primary vessel subcutaneously in an minimally-invasive procedure;

positioning the parallel flow system within the vasculature; and

operating said pump means to direct blood through the conduit;

wherein the pumping means comprises an impeller; and

wherein the impeller is helically shaped.

29. The method of claim 28, wherein the impeller is driven mechanically by a motor through a drive wire.

30. 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:

providing a parallel flow system comprising a means for pumping blood and a conduit that houses the pump means;

inserting the pump means and the conduit into the patient'"'"'s vasculature in a non-primary vessel subcutaneously in an minimally-invasive procedure;

positioning the parallel flow system within the vasculature; and

operating said pump means to direct blood through the conduit;

wherein the pumping means comprises an impeller;

wherein the impeller is driven electromagnetically by a discrete electromagnetic drive; and

wherein the electromagnetic drive is sized and configured to be implantable.

31. The method of claim 30, wherein the electromagnetic drive is sized and configured to be implantable within the patient'"'"'s vasculature.

32. 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:

providing a parallel flow system comprising a means for pumping blood and a conduit that houses the pump means;

inserting the pump means and the conduit into the patient'"'"'s vasculature in a non-primary vessel subcutaneously in an minimally-invasive procedure;

positioning the parallel flow system within the vasculature; and

operating said pump means to direct blood through the conduit;

wherein the pumping means comprises a worm pump.

33. 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:

providing a parallel flow system comprising a means for pumping blood and a conduit that houses the pump means;

providing an additional conduit positioned proximate the pumping means to provide an additional flow path to blood in the vasculature from a point upstream of an inflow to the pumping means to a point downstream of an outflow from the pumping means without passing through the pump;

inserting the pump means and the conduit into the patient'"'"'s vasculature in a non-primary vessel subcutaneously in an minimally-invasive procedure;

positioning the parallel flow system within the vasculature; and

operating said pump means to direct blood through the conduit.

34. A method of supplementing blood perfusion to reduce the load on a patient'"'"'s heart without the use of a blood oxygenator, the method comprising directing blood within the patient'"'"'s vasculature at subcardiac rates using an implantable pumping means applied via a minimally invasive extracardiac application by connection to at least one non-primary blood vessel.

35. An intravascular extracardiac blood perfusion system comprising a multilumen catheter sized and configured to be applied intravascularly through a non-primary vessel and a pumping means sized and configured to pump blood at subcardiac rates while residing in a first lumen of said multilumen catheter.