Stented balloon pump system and method for using same

• US 6,210,318 B1
• Filed: 03/09/1999
• Issued: 04/03/2001
• Est. Priority Date: 03/09/1999
• Status: Expired due to Term

• Current Assignee: Abiomed, Inc. (Johnson & Johnson)
• Original Assignee: Abiomed, Inc. (Johnson & Johnson)
• Inventors: Lederman, David M.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/264,943
• Time in Patent Office: 756 Days
• Field of Search: 600/16-18, 623/3, 623/3.1, 623/3.16, 623/3.2, 623/3.21
• US Class Current: 600/18
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 60/139 inside the aorta, e.g. intra-aortic balloon 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 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/497 for balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/833 Occluders for preventing backflow

Abstract

A balloon pump system including catheter-mounted pumping balloon configured to be positioned within a desired body passageway to pump a fluid through the body passageway. A stent is percutaneously deployed within the body passageway. The pumping balloon is percutaneously deployed within the stent such that the stent is interposed between the pumping balloon and the walls of the body passageway. The stent substantially limits the compliance of the body passageway, preventing the passageway in the vicinity of the pumping balloon from significantly expanding or contracting in response to forces generated by inflation and deflation of the pumping balloon. As a result, a volume of fluid substantially equivalent to a change in volume of the pumping balloon is displaced when the pumping balloon is inflated or deflated.

Claims

1. A balloon pump system for pumping fluid through a body passageway of a patient, comprising:

a substantially cylindrical stent, having a hollow bore extending longitudinally therethrough, constructed and arranged to be operatively positioned within a desired portion of the body passageway;

a catheter configured to be inserted into the body passageway; and

a balloon pump, mounted on said catheter, constructed and arranged to be operatively positioned within said hollow bore of said stent, said pump being unconnected to and separately positionable with respect to said stent,

wherein said stent substantially reduces compliance of the desired portion of the body passageway, thereby improving the efficiency of said fluid pumping therethrough.

2. The system of claim 1, wherein said balloon pump further comprises:

at least one collapsible and extendable valve operatively coupled to said catheter adjacent to said balloon pump.

3. The system of claim 2, wherein said at least one valve comprises:

at least one passive valve.

4. The system of claim 2, wherein said at least one valve comprises:

at least one active valve.

5. The system of claim 4, further comprising a control drive mechanism for collapsing and extending said balloon pump and said at least one valve, wherein said at least one active valve and said pumping balloon are independently controllable.

6. The system of claim 4, wherein said catheter comprises a first lumen fluidically connected to said at least one active valve, and a second lumen fluidically connected to said pumping balloon, wherein said pumping balloon is cyclically inflatable and deflatable, and said at least one active valve is cyclically collapsed and extended, by fluid flow through said first lumen and said second lumen, respectively.

7. The system of claim 4, wherein said at least one active valve is adapted to be electrically controlled.

8. The system of claim 2, wherein said at least one valve is constructed and arranged such that, when fully extended, said at least one valve substantially occludes the desired portion of the body passageway.

9. The system of claim 4, further comprising:

an extracorporeal controller operatively coupled to said catheter, constructed and arranged to control inflation and deflation of said pumping balloon and to control extension and collapse of said at least one active valve.

10. The system of claim 2, wherein said stent has a length sufficient to enable said pumping balloon and said at least one valve to be operatively positioned within said hollow bore thereof.

11. The system of claim 2, wherein an outer diameter of said balloon pump and an outer diameter of said at least one valve are each approximately equal to an inner diameter of said stent.

12. The system of claim 2, wherein said system is adapted for pumping fluid through a major artery downstream, with respect to normal blood flow, of a natural heart, and wherein said at least one valve comprises:

a first valve, operatively mounted on said catheter adjacent to said balloon pump so as to be positioned downstream of said balloon pump.

13. The system of claim 12, wherein said at least one valve further comprises:

a second valve, mounted on said catheter adjacent to said balloon pump so as to be positioned upstream of said balloon pump.

14. An intravascular pumping system for directly pumping blood, comprising:

a substantially cylindrical intravascular stent adapted to be operatively positioned within a desired portion of a vessel; and

a balloon pump system comprising;

a catheter configured to be inserted into the vessel,

a balloon pump mounted on said catheter and adapted to be operatively positioned within said stent, said pump being unconnected to and separately positionable with respect to said stent; and

a first collapsible and extendable valve operatively coupled to said catheter adjacent to said balloon pump, said first valve substantially occluding the vessel when substantially extended,

wherein said stent is constructed and arranged to substantially limit compliance of a vessel region in which said balloon pump is located.

15. The intravascular pumping system of claim 14, wherein said catheter comprises:

a first lumen fluidically connected to said first valve; and

a second lumen fluidically connected to said balloon pump,

wherein said first valve and said balloon pump are cyclically inflatable and deflatable by fluid flow through said first and second lumen, respectively.

16. The intravascular pumping system of claim 14, further comprising:

an extracorporeal controller operatively coupled to said catheter, constructed and arranged to control inflation and deflation of said balloon pump and to control expansion and contraction of said first valve.

17. The intravascular pumping system of claim 14, wherein said first valve is operatively positioned within said stent.

18. The intravascular pumping system of claim 15, further comprising:

a second collapsible and extendable valve mounted on said catheter adjacent to said balloon pump, said second valve substantially occluding the vessel when substantially expanded,

wherein said catheter further comprises a third lumen operatively coupled to said second valve.

19. A method for pumping fluid through a vessel, comprising:

a) positioning a substantially cylindrical stent having a hollow bore extending longitudinally therethrough within a desired portion of the vessel, thereby substantially limiting compliance of said desired portion of the vessel;

b) after step a), positioning a balloon pump within said hollow bore of said stent;

c) cyclically inflating and deflating said balloon pump; and

d) preventing said portion of the vessel from significantly expanding and contracting in response to inflation and deflation, respectively, of said balloon pump.

20. A balloon pump system for pumping fluid through a body passageway of a patient, comprising:

a substantially crush-resistant locking stent, having a hollow bore extending longitudinally therethrough, constructed and arranged to be operatively positioned within a desired portion of the body passageway;

a catheter configured to be inserted into the passageway; and

a balloon pump, mounted on said catheter, constructed and arranged to be operatively positioned within said hollow bore of said stent, said pump being unconnected to and separately positionable with respect to said stent,

wherein said stent substantially reduces compliance of the desired portion of the body passageway, thereby improving the efficiency of said fluid pumping therethrough.

21. The system of claim 20, wherein said balloon pump further comprises:

at least one collapsible and extendable valve operatively coupled to said catheter adjacent to said balloon pump.

22. The system of claim 21, wherein said at least one valve comprises:

at least one active valve.

23. The system of claim 21, wherein said at least one valve comprises:

at least one passive valve.

24. The system of claim 22, wherein said catheter comprises:

a control drive mechanism for collapsing and extending said balloon pump and said valve, wherein said at least one active valve and said pumping balloon are independently controllable.

25. The system of claim 22, wherein said catheter comprises:

a first lumen fluidically connected to said at least one active valve, and a second lumen fluidically connected to said pumping balloon, and wherein said pumping balloon is cyclically inflatable and deflatable, and said at least one active valve is cyclically collapsed and extended, by fluid flow through said first lumen and said second lumen, respectively.

26. The system of claim 21, wherein said at least one valve is constructed and arranged such that, when extended fully, said at least one valve substantially occludes the desired portion of the body passageway.

27. The system of claim 22, further comprising:

an extracorporeal controller operatively coupled to said catheter, constructed and arranged to control inflation and deflation of said pumping balloon and to control extension and collapse of said at least one active valve.

28. The system of claim 21, wherein said stent has a length sufficient to enable said balloon pump and said at least one valve to be operatively positioned within said hollow bore thereof.

29. The system of claim 21, wherein an outer diameter of said balloon pump and an outer diameter of said at least one valve are each approximately equal to an inner diameter of said stent.

30. The system of claim 21, wherein said system is adapted for pumping fluid through a major artery downstream, with respect to normal blood flow, of a natural heart, and wherein said at least one valve comprises:

a first valve, operatively mounted on said catheter adjacent to said balloon pump so as to be positioned downstream of said balloon pump.

31. The system of claim 30, wherein said at least one valve further comprises:

a second valve, mounted on said catheter adjacent to said balloon pump so as to be positioned upstream of said balloon pump.