Fast response intra-aortic balloon pump

• US 6,241,706 B1
• Filed: 07/16/1999
• Issued: 06/05/2001
• Est. Priority Date: 07/16/1999
• Status: Expired due to Fees

• Current Assignee: Datascope Corporation (Getinge AB)
• Original Assignee: Datascope Corporation (Getinge AB)
• Inventors: Williams, Jonathan R., Leschinsky, Boris
• Primary Examiner(s): Mendez, Manuel
• Application Number:
  US09/356,096
• Time in Patent Office: 690 Days
• Field of Search: 604/30, 604/31, 604/32, 604/35, 604/97.01, 604/97.02, 604/98.01, 604/98.02, 604/99.01, 604/99.02, 604/99.03, 604/99.04, 604/96, 606/192, 606/193, 606/194, 606/195, 600/17, 600/18, 600/495-496
• US Class Current: 604/99.01
• CPC Class Codes: A61M 60/139 inside the aorta, e.g. intra-aortic balloon pumps
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/435 with diastole or systole switching by valve means located between the blood pump and the hydraulic or pneumatic energy source
• CPC Class Codes: A61M 60/497 for balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/843 Balloon aspects, e.g. shapes or materials

Abstract

An intra-aortic balloon pump includes a balloon, a catheter having a relatively small diameter lumen and an extender having a relatively large diameter lumen connected in series. A valve is positioned in the extender adjacent the end of the extender connected to the catheter. The valve enables the extender to be pressurized with a working gas prior to inflation of the balloon and to be evacuated prior to deflation of the balloon. A second valve adjacent the opposite end of the extender permits the intra-aortic balloon pump to commence a pre-inflation step or a pre-deflation step without affecting the pressure in the extender. Separate positive pressure and negative pressure extenders may be provided to reduce the movement of the working gas during inflation and deflation cycles, thereby increasing pneumatic efficiency.

Claims

1. A method for inflating and deflating a medical device, said medical device being connected to a conduit including a tubular inflation extender portion having a lumen, a tubular deflation extender portion having a lumen, and a tubular catheter portion having a lumen, said lumens of said inflation and deflation extender portions being larger in diameter than said lumen of said catheter portion, said catheter portion and said medical device being connected in series with said inflation and deflation extender portions so that one end of said catheter portion is connected in flow communication both to one end of said inflation extender portion and to one end of said deflation extender portion and another end of said catheter portion is connected in flow communication to said medical device, said method comprising:

applying a working gas to said inflation extender portion to develop an inflation pressure therein while interrupting flow communication between said inflation extender portion and said catheter portion, whereby said working gas is prevented from flowing into said catheter portion and said medical device;

establishing flow communication between said inflation extender portion and said catheter portion while interrupting flow communication between said deflation extender portion and said catheter portion, whereby said working gas flows from said inflation extender portion through said catheter portion to said medical device to substantially fully inflate said medical device to a working pressure lower than said inflation pressure; and

establishing a deflation pressure less than said working pressure in said deflation extender portion and establishing flow communication between said deflation extender portion and said catheter portion while interrupting flow communication between said inflation extender portion and said catheter portion, whereby said working gas flows from said medical device through said catheter portion to said deflation extender portion to substantially fully deflate said medical device.

2. A method for inflating and deflating a medical device, said medical device being connected to a conduit including a tubular inflation extender portion having a lumen, a tubular deflation extender portion having a lumen, and a tubular catheter portion having a lumen, said lumens of said inflation and deflation extender portions being larger in diameter than said lumen of said catheter portion, said catheter portion and said medical device being connected in series with said inflation and deflation extender portions so that one end of said catheter portion is connected in flow communication both to one end of said inflation extender portion and to one end of said deflation extender portion and another end of said catheter portion is connected in flow communication to said medical device, said method comprising:

applying a working gas to said inflation extender portion to develop an inflation pressure therein, whereby said working gas flows from said inflation extender portion through said catheter portion to said medical device to substantially fully inflate said medical device to a working pressure;

applying a working gas to said deflation extender portion to develop a deflation pressure therein while interrupting flow communication between said deflation extender portion and said catheter portion, whereby said working gas is prevented from flowing out from said catheter portion and said medical device, said deflation pressure being less than said working pressure; and

establishing flow communication between said deflation extender portion and said catheter portion while interrupting flow communication between said inflation extender portion and said catheter portion, whereby said working gas flows from said medical device through said catheter portion to said deflation extender portion to substantially fully deflate said medical device.

3. A method for inflating and deflating a medical device, said medical device being connected to a conduit including a tubular inflation extender portion having a lumen, a tubular deflation extender portion having a lumen, and a tubular catheter portion having a lumen, said lumens of said inflation and deflation extender portions being larger in diameter than said lumen of said catheter portion, said catheter portion and said medical device being connected in series with said inflation and deflation extender portions so that one end of said catheter portion is connected in flow communication both to one end of said inflation extender portion and to one end of said deflation extender portion and another end of said catheter portion is connected in flow communication to said medical device, said method comprising:

applying a working gas to said inflation extender portion to develop an inflation pressure therein while interrupting flow communication between said inflation extender portion and said catheter portion, whereby said working gas is prevented from flowing into said catheter portion and said medical device;

establishing flow communication between said inflation extender portion and said catheter portion while intermitting flow communication between said deflation extender portion and said catheter portion, whereby said working gas flows from said inflation extender portion through said catheter portion to said medical device to substantially fully inflate said medical device to a working pressure lower than said inflation pressure;

applying a working gas to said deflation extender portion to develop a deflation pressure therein while interrupting flow communication between said deflation extender portion and said catheter portion, whereby said working gas is prevented from flowing out from said catheter portion and said medical device, said deflation pressure being less than said working pressure; and

establishing flow communication between said deflation extender portion and said catheter portion while interrupting flow communication between said inflation extender portion and said catheter portion, whereby said working gas flows from said medical device through said catheter portion to said deflation extender portion to substantially fully deflate said medical device.

4. The method as claimed in claim 3, further comprising the step of providing a hollow inflation element at a free end of said inflation extender portion, wherein said step of applying said working gas to said inflation extender portion includes the steps of supplying said working gas to said hollow inflation element at a pressure greater than the pressure prevailing in said inflation extender portion, and establishing flow communication between said hollow inflation element and said inflation extender portion, whereby said working gas flows from said hollow inflation element into said inflation extender portion.

5. The method as claimed in claim 4, further comprising the step of providing a hollow deflation element at a free end of said deflation extender portion, wherein said step of applying said working gas to said deflation extender portion includes the steps of supplying said working gas to said hollow deflation element at a pressure less than said working pressure, and establishing flow communication between said hollow deflation element and said deflation extender portion, whereby said working gas flows from said deflation extender portion into said hollow deflation element.

6. The method as claimed in claim 5, wherein said hollow deflation element is the same as said hollow inflation element.

7. The method as claimed in claim 3, further comprising the step of providing a hollow element at a free end of said inflation extender portion and at a free end of said deflation extender portion, wherein said step of applying said working gas to said inflation extender portion includes the steps of supplying said working gas to said hollow element at a pressure greater than the pressure prevailing in said inflation extender portion, and establishing flow communication between said hollow element and said inflation extender portion, whereby said working gas flows from said hollow element into said inflation extender portion, and wherein said step of applying said working gas to said deflation extender portion includes the steps of supplying said working gas to said hollow element at a pressure less than said working pressure, and establishing flow communication between said hollow element and said deflation extender portion, whereby said working gas flows from said deflation extender portion into said hollow element.

8. The method as claimed in claim 7, wherein said step of establishing flow communication between said inflation extender portion and said catheter portion occurs while there is flow communication between said hollow element and said inflation extender portion.

9. The method as claimed in claim 8, further comprising the steps of interrupting flow communication between said hollow element and said inflation extender portion while there is flow communication between said inflation extender portion and said catheter portion, and supplying said working gas to said hollow element at a pressure less than said working pressure.

10. The method as claimed in claim 9, wherein said step of applying said working gas to said deflation extender portion includes the step of establishing flow communication between said hollow element and said deflation extender portion, whereby said working gas flows from said deflation extender portion into said hollow element.

11. The method as claimed in claim 3, further comprising the step of interrupting flow communication between said hollow element and said inflation extender portion after said inflation pressure has been developed in said inflation extender portion and prior to said step of establishing flow communication between said inflation extender portion and said catheter portion.

12. The method as claimed in claim 11, further comprising the step of supplying said working gas to said hollow element at a pressure less than said working pressure after flow communication between said hollow element and said inflation extender portion has been interrupted, whereby said working gas does not flow from said inflation extender portion to said hollow element.

13. The method as claimed in claim 12, wherein said step of supplying said working gas to said deflation extender portion includes the step of establishing flow communication between said hollow element and said deflation extender portion.

14. The method as claimed in claim 13, further comprising the step of interrupting flow communication between said hollow element and said deflation extender portion after said deflation pressure has been developed in said deflation extender portion and prior to said step of establishing flow communication between said deflation extender portion and said catheter portion.

15. The method as claimed in claim 11, further comprising the step of providing a variable volume inflation reservoir in flow communication with said inflation extender portion, wherein said step of applying said working gas to said inflation extender portion develops said inflation pressure in both said variable volume inflation reservoir and said inflation extender portion.

16. The method as claimed in claim 15, wherein, when flow communication is established between said inflation extender portion and said catheter portion and said working gas flows from said inflation extender portion through said catheter portion to said medical device, said working gas flows from said variable volume inflation reservoir to said inflation extender portion.

17. The method as claimed in claim 16, further comprising the step of providing a variable volume deflation reservoir in flow communication with said deflation extender portion, wherein said step of applying said working gas to said deflation extender portion develops said deflation pressure in both said variable volume deflation reservoir and said deflation extender portion.

18. The method as claimed in claim 17, wherein, when flow communication is established between said deflation extender portion and said catheter portion and said working gas flows from said medical device through said catheter portion to said deflation extender portion, said working gas flows from said deflation extender portion to said variable volume deflation reservoir.

19. The method as claimed in claim 11, further comprising the step of providing a variable volume deflation reservoir in flow communication with said deflation extender portion, wherein said step of applying said working gas to said deflation extender portion develops said deflation pressure in both said variable volume deflation reservoir and said deflation extender portion.

20. The method as claimed in claim 19, wherein, when flow communication is established between said deflation extender portion and said catheter portion and said working gas flows from said medical device through said catheter portion to said deflation extender portion, said working gas flows from said deflation extender portion to said variable volume deflation reservoir.

21. The method as claimed in claim 3, further comprising the step of providing a hollow element at a free end of said deflation extender portion, wherein said step of applying said working gas to said deflation extender portion includes the steps of supplying said working gas to said hollow element at a pressure less than said working pressure, and establishing flow communication between said hollow element and said deflation extender portion, whereby said working gas flows from said deflation extender portion into said hollow element.

22. A medical apparatus, comprising:

an inflatable member having an inflated condition and a deflated condition;

a catheter having a lumen, a first end connected to said inflatable member and a second end;

an extender having a lumen, a first end connected to said second end of said catheter and a second end, said lumen of said extender being larger in diameter than said lumen of said catheter;

a working gas for inflating said inflatable member;

a pressure source connected to said second end of said extender for supplying said working gas to said extender and for removing said working gas from said extender; and

a first valve positioned adjacent said first end of said extender, said first valve having open and closed conditions, whereby, with said inflatable member in said deflated condition and said first valve in said closed condition, said working gas may be supplied by said pressure source to said extender without placing said inflatable member in said inflated condition, and with said inflatable member in said inflated condition and said first valve in said closed condition, said working gas may be removed by said pressure source from said extender without placing said inflatable member in said deflated condition.

23. The medical apparatus as claimed in claim 22, wherein said pressure source includes a chamber having a primary side, a secondary side and a movable member separating said primary side from said secondary side, said secondary side being connected in flow communication with said second end of said extender, a positive pressure source for supplying a positive pressure to said primary side of said chamber to move said movable member toward said secondary side of said chamber, thereby supplying said working gas to said extender, and a negative pressure source for supplying a negative pressure to said primary side of said chamber to move said movable member toward said primary side of said chamber, thereby removing said working gas from said extender to said secondary side of said chamber.

24. The medical apparatus as claimed in claim 22, further comprising a second valve positioned adjacent said second end of said extender, said second valve having opened and closed conditions, and said pressure source including a hollow element connected in flow communication with said second end of said extender, whereby, with said second valve in said closed condition, said working gas may be supplied at an inflation pressure to said hollow element without supplying said working gas to said extender, and said working gas may be supplied at a deflation pressure to said hollow element without removing said working gas from said extender.

25. The medical apparatus as claimed in claim 24, further comprising a variable volume reservoir connected in flow communication with said extender.

26. The medical apparatus as claimed in claim 25, wherein said variable volume reservoir is connected to said extender between said first and second valves.

27. A medical apparatus, comprising:

an inflatable member having an inflated condition and a deflated condition;

a catheter having a lumen, a first end connected to said inflatable member and a second end;

an inflation extender having a lumen, a first end connected to said second end of said catheter and a second end, said lumen of said inflation extender being larger in diameter than said lumen of said catheter;

a deflation extender having a lumen, a first end connected to said second end of said catheter and a second end, said lumen of said deflation extender being larger in diameter than said lumen of said catheter;

a working gas for inflating said inflatable member;

a pressure source connected to said second end of said inflation extender for supplying said working gas to said inflation extender, and connected to said second end of said deflation extender for removing said working gas from said deflation extender; and

a first valve positioned adjacent said first end of said inflation extender, said first valve having a first position establishing flow communication between said inflation extender and said catheter, and a closed position interrupting flow communication between said inflation extender and said catheter, whereby, with said inflatable member in said deflated condition and said first valve in said closed position, said working gas may be supplied by said pressure source to said inflation extender without placing said inflatable member in said inflated condition, and with said inflatable member in said deflated condition and said first valve in said first position, said working gas may be supplied from said inflation extender through said catheter to said inflatable member.

28. The medical apparatus as claimed in claim 27, wherein said first valve is positioned adjacent said first end of said deflation extender, said first valve having a second position establishing flow communication between said deflation extender and said catheter and interrupting flow communication between said inflation extender and said catheter, whereby, with said inflatable member in said deflated condition and said first valve in said second position, said working gas may be supplied by said pressure source to said inflation extender without placing said inflatable member in said inflated condition.

29. The medical apparatus as claimed in claim 28, wherein said first valve in said first position interrupts flow communication between said deflation extender and said catheter, whereby, with said inflatable member in said inflated condition and said first valve in one of said closed position and said first position, said working gas may be removed by said pressure source from said deflation extender without placing said inflatable member in said deflated condition.

30. The medical apparatus as claimed in claim 28, further comprising a second valve positioned adjacent said second end of said inflation extender, and said pressure source including a hollow element connected in flow communication with said second end of said inflation extender, said second valve having a first position establishing flow communication between said hollow element and said inflation extender, and a closed position interrupting flow communication between said hollow element and said inflation extender, whereby, with said second valve in said closed position, said working gas may be supplied to said hollow element without supplying said working gas to said inflation extender, and with said second valve in said first position, said working gas may be supplied from said hollow element to said inflation extender.

31. The medical apparatus as claimed in claim 30, further comprising a variable volume inflation reservoir connected in flow communication with said inflation extender.

32. The medical apparatus as claimed in claim 31, wherein said variable volume inflation reservoir is connected to said inflation extender between said first and second valves.

33. The medical apparatus as claimed in claim 32, wherein said second valve is positioned adjacent said second end of said deflation extender, said second valve having a second position establishing flow communication between said hollow element and said deflation extender and interrupting flow communication between said hollow element and said inflation extender, whereby, with said second valve in said second position, said working gas may be supplied to said hollow element without supplying said working gas to said inflation extender.

34. The medical apparatus as claimed in claim 33, further comprising a variable volume deflation reservoir connected in flow communication with said deflation extender.

35. The medical apparatus as claimed in claim 34, wherein said variable volume deflation reservoir is connected to said deflation extender between said first and second valves.

36. The medical apparatus as claimed in claim 33, wherein said second valve in said first position interrupts flow communication between said hollow element and said deflation extender, whereby, with said second valve in one of said closed position and said first position, said working gas may be removed from said hollow element without removing said working gas from said deflation extender.

37. The medical apparatus as claimed in claim 27, further comprising a second valve positioned adjacent said second end of said inflation extender, and said pressure source including a hollow element connected in flow communication with said second end of said inflation extender, said second valve having a first position establishing flow communication between said hollow element and said inflation extender, and a closed position interrupting flow communication between said hollow element and said inflation extender, whereby, with said second valve in said closed position, said working gas may be supplied to said hollow element without supplying said working gas to said inflation extender, and with said second valve in said first position, said working gas may be supplied from said hollow element to said inflation extender.

38. The medical apparatus as claimed in claim 37, further comprising a variable volume inflation reservoir connected in flow communication with said inflation extender.

39. The medical apparatus as claimed in claim 38, wherein said variable volume inflation reservoir is connected to said inflation extender between said first and second valves.

40. The medical apparatus as claimed in claim 37, wherein said second valve is positioned adjacent said second end of said deflation extender, said second valve having a second position establishing flow communication between said hollow element and said deflation extender and interrupting flow communication between said hollow element and said inflation extender, whereby, with said second valve in said second position, said working gas may be supplied to said hollow element without supplying said working gas to said inflation extender.

41. The medical apparatus as claimed in claim 40, further comprising a variable volume deflation reservoir connected in flow communication with said deflation extender.

42. The medical apparatus as claimed in claim 41, wherein said variable volume deflation reservoir is connected to said deflation extender between said first and second valves.

43. The medical apparatus as claimed in claim 37, further comprising a third valve positioned adjacent said first end of said deflation extender, said third valve having a first position establishing flow communication between said deflation extender and said catheter, and a closed position interrupting flow communication between said deflation extender and said catheter, whereby, with said inflatable member in said inflated condition and said third valve in said closed position, said working gas may be removed by said pressure source from said deflation extender without placing said inflatable member in said deflated condition, and with said inflatable member in said inflated condition and said third valve in said first position, said working gas may be removed from said inflatable member through said catheter to said deflation extender to place said inflatable member in said deflated condition.

44. The medical apparatus as claimed in claim 43, further comprising a fourth valve positioned adjacent said second end of said deflation extender, said fourth valve having a first position establishing flow communication between said hollow element and said deflation extender, and a closed position interrupting flow communication between said hollow element and said deflation extender, whereby, with said fourth valve in said closed position, said working gas may be removed from said hollow element without removing said working gas from said deflation extender, and with said fourth valve in said first position, said working gas may be removed from said deflation extender to said hollow element.

45. The medical apparatus as claimed in claim 44, further comprising a variable volume deflation reservoir connected in flow communication with said deflation extender.

46. The medical apparatus as claimed in claim 45, wherein said variable volume deflation reservoir is connected to said deflation extender between said third and fourth valves.

47. The medical apparatus as claimed in claim 27, further comprising another valve positioned adjacent said first end of said deflation extender, said another valve having a first position establishing flow communication between said deflation extender and said catheter, and a closed position interrupting flow communication between said deflation extender and said catheter, whereby, with said inflatable member in said inflated condition and said another valve in said closed position, said working gas may be removed by said pressure source from said deflation extender without placing said inflatable member in said deflated condition, and with said inflatable member in said inflated condition and said another valve in said first position, said working gas may be removed from said inflatable member through said catheter to said deflation extender to place said inflatable member in said deflated condition.

48. The medical apparatus as claimed in claim 47, further comprising an additional valve positioned adjacent said second end of said deflation extender, and said pressure source including a hollow element connected in flow communication with said second end of said deflation extender, said additional valve having a first position establishing flow communication between said hollow element and said deflation extender, and a closed position interrupting flow communication between said hollow element and said deflation extender, whereby, with said additional valve in said closed position, said working gas may be removed from said hollow element without removing said working gas from said deflation extender, and with said additional valve in said first position, said working gas may be removed from said deflation extender to said hollow element.

49. The medical apparatus as claimed in claim 48, further comprising a variable volume deflation reservoir connected in flow communication with said deflation extender.

50. The medical apparatus as claimed in claim 49, wherein said variable volume deflation reservoir is connected to said deflation extender between said another valve and said additional valve.

51. A method for inflating and deflating a medical device, said medical device being connected to a conduit including a tubular inflation extender portion having a lumen, a tubular deflation extender portion having a lumen and a working gas at a deflation pressure therein, and a tubular catheter portion having a lumen, said lumens of said inflation and deflation extender portions being larger in diameter than said lumen of said catheter portion, said catheter portion and said medical device being connected in series with said inflation and deflation extender portions so that one end of said catheter portion is connected in flow communication both to one end of said inflation extender portion and to one end of said deflation extender portion and another end of said catheter portion is connected in flow communication to said medical device, said method comprising:

applying a working gas to said inflation extender portion to develop an inflation pressure therein, whereby said working gas flows from said inflation extender portion through said catheter portion to commence inflation of said medical device;

interrupting flow communication between said inflation extender portion and said catheter portion before said medical device has reached a fully inflated condition and establishing flow communication between said deflation extender portion and said catheter portion, whereby said working gas flows from said medical device through said catheter portion to said deflation extender portion to commence deflation of said medical device.