Single lumen catheter with controlled antegrade and retrograde flow

• US 6,059,757 A
• Filed: 06/18/1996
• Issued: 05/09/2000
• Est. Priority Date: 06/18/1996
• Status: Expired due to Fees

• Current Assignee: Cardeon Corporation
• Original Assignee: Cardeon Corporation
• Inventors: Ross, Michael, Macoviak, John A.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US08/665,635
• Time in Patent Office: 1,421 Days
• Field of Search: 604/164, 604/247, 604/264, 604/245, 604/246, 604/256, 604/280, 604/284, 604/43, 604/49, 604/52
• US Class Current: 604/247
• CPC Class Codes: A61M 25/0075 Valve means

Abstract

A catheter device regulates fluid flow within a circulatory vessel. Included is an elongated catheter body configured to access one of a circulatory vessel or a heart chamber. The catheter body includes a proximal end, a distal end, and a first lumen including an open proximal end and a distal end with a port formed at a distal portion of the distal end. An antegrade valve is coupled to an exterior of the catheter body and configured to provide a controllable antegrade flow and a controllable retrograde flow along the exterior of the catheter body. The antegrade flow is greater than the retrograde flow. A retrograde valve may be included which provides a controllable retrograde and antegrade flow along the exterior of the catheter body. When a retrograde valve is used, the retrograde flow is greater than the antegrade flow.

Claims

1. A catheter device to regulate fluid flow within a circulatory vessel, comprising:

an elongated catheter body configured to access one of a circulatory vessel or a heart chamber, wherein the catheter body includes a proximal end, a distal end, and a first lumen including an open proximal end and a distal end with a port formed at a distal portion of the distal end; and

an antegrade valve coupled to an exterior of the catheter body and configured to provide a controllable antegrade flow and a controllable retrograde flow in the circulatory vessel along the exterior of the catheter body by selectively actuating the antegrade valve to assume one of a retracted state, a fully expanded state and a partially expanded state, wherein in the retracted state the antegrade valve permits antegrade and retrograde flow in the circulatory vessel along the exterior of the catheter body, and in the fully expanded state the antegrade valve is autoregulating in response to differing pressures within the circulatory vessel, such that, in response to retrograde flow, the antegrade valve moves toward a closed position in which the antegrade valve substantially occludes the circulatory vessel thereby substantially eliminating retrograde flow in the circulatory vessel along the exterior of the catheter body and, in response to antegrade flow the antegrade valve moves toward an open position in which the antegrade valve permits antegrade flow in the circulatory vessel along the exterior of the catheter body, and in the partially expanded state the antegrade valve is autoregulating in response to differing pressures within the circulatory vessel, such that, in response to retrograde flow, the antegrade valve moves toward a closed position in which the antegrade valve partially occludes the circulatory vessel thereby resisting retrograde flow in the circulatory vessel along the exterior of the catheter body and, in response to antegrade flow, the antegrade valve moves toward an open position in which the antegrade valve permits antegrade flow in the circulatory vessel along the exterior of the catheter body, wherein the antegrade flow is greater than the retrograde flow, thereby providing a controllable antegrade flow and a controllable retrograde flow in the circulatory vessel along the exterior of the catheter body.

2. The catheter device of claim 1, wherein the antegrade valve includes one or more leaflets and wherein when the antegrade valve is in the dosed position the leaflets are configured to overlap one another to eliminate fluid flow gaps.

3. The catheter device of claim 2, wherein the antegrade valve is a central flow valve configured to provide a fluid flow through a center portion of the central flow valve and fluid flow traverses between the central flow valve and the catheter body.

4. The catheter device of claim 2, wherein the antegrade valve is a peripheral flow valve configured to provide the antegrade flow around an exterior of the leaflets and between the leaflets and a circulatory vessel wall.

5. The catheter device of claim 2, wherein the antegrade valve includes one or more retraction and advancement members.

6. The catheter device of claim 2, wherein the antegrade valve includes a retraction connection point at a leaflet.

7. The catheter device of claim 2, further comprising:

one or more unidirectional or bidirectional fluid flow fenestrations formed in the leaflets and configured to regulate the antegrade flow or the retrograde flow.

8. The catheter device of claim 1, wherein the antegrade valve is configured to be coupled in a fixed relationship to the exterior of the catheter body.

9. The catheter device of claim 1, wherein the antegrade valve is configured to be coupled in a moveable relationship to the exterior of the catheter body.

10. The catheter device of claim 1, wherein the antegrade valve includes one leaflet.

11. The catheter device of claim 1, wherein the antegrade valve includes two leaflets.

12. The catheter device of claim 1, wherein the antegrade valve includes a retraction connection point at a leaflet.

13. The catheter device of claim 1, wherein the antegrade valve includes a rim configured to be positioned adjacent to an interior of a circulatory vessel or heart chamber.

14. The catheter device of claim 13, wherein the rim is configured to provide a slidable movement against the interior of the circulatory vessel or heart chamber.

15. The catheter device of claim 1, wherein the antegrade valve is configured to be sufficiently retractable to provide a controllable antegrade and a controllable retrograde fluid flow past the antegrade valve.

20. The catheter device of claim 1, wherein the antegrade valve is configured to regulate fluid flow past the antegrade valve resulting from differential pressures on a first and a second side of the antegrade valve.

21. The catheter device of claim 20, further comprising:

one or more fenestrations formed in the catheter body and configured to provide a directional fluid flow.

22. The catheter device of claim 20, wherein the antegrade valve includes one leaflet.

23. The catheter device claim 22, wherein each of the valve leaflets are configured for movement in a direction towards or away from the exterior of'"'"'the catheter body when the catheter is positioned within one of a circulatory vessel or a heart chamber.

24. The catheter device of claim 1, wherein the antegrade valve includes two or more leaflets coup led to a retraction and advancement member.

25. The catheter device of claim 1, wherein the antegrade valve is configured to minimize a disruption of a lesion formed on an interior surface one of a vessel or a heart chamber.

26. The catheter device of claim 1, wherein a distal end of the antegrade valve is at least partially rounded.

27. The catheter device of claim 1 for use in conjunction with a blood pump, further comprising:

means for coupling the proximal end of the first lumen to the blood pump.

28. The catheter device of claim 27, wherein the distal end of the first lumen is configured to provide a fluid flow to and from the blood pump.

29. The catheter device of claim 1 for use in conjunction with a blood pump coupled to an oxygenator, further comprising:

means for coupling the proximal end of the first lumen to the blood pump.

36. The catheter device of claim 1, wherein the antegrade valve is configured to possess a resting open state that when placed in a circulatory vessel or a heart chamber, a distal end of the antegrade valve is configured to contact an interior wall of the circulatory vessel or the heart chamber.

37. The catheter device of claim 1, wherein the valve is configured to have a retraction position actuated by a retraction and advancement force applied to the valve.

38. The catheter device of claim 1, further comprising a side port formed in the catheter body, wherein the side port provides a direction flow of a fluid.

39. The catheter device of claim 38, further comprising a slidable member coupled to the catheter body and positioned adjacent to the side port and configured to open or close the side port and regulate fluid flow through the side port.

40. The catheter device of claim 1, further comprising a marking coupled to the catheter body to provide an indication of a catheter body position.

41. The catheter device of claim 40, wherein the marking comprises a radio opaque marking.

42. The catheter device of claim 1, wherein the circulatory vessel is an artery.

43. The catheter device of claim 1, wherein the circulatory vessel is a vein.

44. The catheter device of claim 1, wherein the circulatory vessel is a great vessel of the heart.

45. The catheter device of claim 1, wherein the heart chamber is a free mural wall of the heart.

46. The catheter device of claim 1, wherein the catheter body is configured for movement from a first heart chamber to a second heart chamber across a septum.

47. The catheter device of claim 1, wherein the catheter body is advanceable into a circulatory system by one of a percutaneous puncture or a surgical open access.

48. The catheter device of claim 1, further comprising:

a inflatable balloon coupled to the exterior of the catheter body; and

a inflation lumen coupled to the balloon.

18. The catheter device of claim 18, wherein the retraction and advancement member is positioned in an interior of the catheter body.

16. The catheter device of claim 17, further comprising:

a retraction and advancement member coupled to the antegrade valve configured to provide retractable movement of the antegrade valve in a direction towards the catheter body.

17. The catheter device of claim 18, wherein the retraction and advancement member is coupled to an exterior surface of the catheter body.

19. The catheter device of claim 18, wherein the retraction and advancement member is positioned in the first lumen of the catheter body.

30. A catheter device to regulate fluid flow within a circulatory vessel, comprising:

an elongated catheter body configured to access one of a circulatory vessel or a heart chamber, wherein the catheter body includes a proximal end, a distal end, and a first lumen including an open proximal end and a distal end with a port formed at a distal portion of the distal end;

an antegrade valve coupled to an exterior of the catheter body and configured to provide a controllable antegrade flow and a controllable retrograde flow along the exterior of the catheter body, wherein the antegrade flow is greater than the retrograde flow; and

a track formed and extending along at least a portion of the exterior of the catheter body.

31. The catheter device of claim 30, wherein the track is at least partially roofed.

32. The catheter device of claim 30, wherein the track includes a groove formed along at least a portion of a track body.

33. The catheter device of claim 32, wherein the track is configured to receive the antegrade valve, wherein the antegrade valve is configured to move along the groove.

34. The catheter device of claim 32, wherein the groove extends substantially along the entire track, and the antegrade valve is moveable along a length of the track.

35. The catheter device of claim 30, wherein the track is configured to receive one of an imaging device, an elongated surgical instrument and a retraction and advancement member coupled to the antegrade valve.

49. A catheter device for regulating fluid flow within a circulatory vessel, comprising:

an elongated catheter body configured to access one of a circulatory vessel or a heart chamber, wherein the catheter body includes a proximal end, a distal end, and a first lumen including an open proximal end and a distal end with a port formed at a distal portion of the distal end and means for coupling the proximal end of the first lumen to a blood pump; and

an antegrade valve coupled to an exterior of the catheter body and configured to provide a controllable antegrade flow and a controllable retrograde flow along the exterior of the catheter body, wherein the antegrade flow is greater than the retrograde flow;

wherein the blood pump includes a blood port coupled to the proximal end of the first lumen wherein the first lumen extends along the catheter shaft and is positionable within a patient'"'"'s circulatory system, wherein the blood pump is configured to deliver a fluid to or from the first lumen.

50. A catheter device to regulate fluid flow within a circulatory vessel, comprising:

an elongated catheter body configured to access one of a circulatory vessel or a heart chamber, wherein the catheter body includes a proximal end, a distal end, and a first lumen including an open proximal end and a distal end with a port formed at a distal portion of the distal end;

an antegrade valve coupled to an exterior of the catheter body and configured to provide a controllable antegrade flow and a controllable retrograde flow along the exterior of the catheter body, wherein the antegrade flow is greater than the retrograde flow; and

a dual diaphragm chamber device coupled to the first lumen proximal end including a first diaphragm, a second diaphragm and an entry port coupled to the first lumen, an inflow port and an outflow port, wherein the diaphragm chamber is coupled to an irrigation system and to the first lumen.

51. The catheter device of claim 50, wherein the diaphragm chamber is configured to provide an air lock to the first lumen while instruments are introduced into the first lumen.

52. The catheter device of claim 50, wherein the diaphragm chamber has a distal end with a geometry configured to be inserted into one of a heart chamber or a circulatory vessel.

53. A catheter device to regulate fluid flow within a circulatory vessel, comprising:

an elongated catheter body configured to access one of a circulatory vessel or a heart chamber, wherein the catheter body includes a proximal end, a distal end, and a first lumen including an open proximal end and a distal end with a port formed at a distal portion of the distal end; and

a retrograde valve coupled to an exterior of the catheter body and configured to provide a controllable retrograde flow and a controllable antegrade flow in the circulatory vessel along the exterior of the catheter body by selectively actuating the retrograde valve to assume one of a retracted state, a fully expanded state and a partially expanded state, wherein in the retracted state the retrograde valve permits retrograde and antegrade flow in the circulatory vessel along the exterior of the catheter body, and in the fully expanded state the retrograde valve is autoregulating in response to differing pressures within the circulatory vessel, such that, in response to antegrade flow, the retrograde valve moves toward a dosed position in which the retrograde valve substantially occludes the circulatory vessel thereby substantially eliminating antegrade flow in the circulatory vessel along the exterior of the catheter body and, in response to retrograde flow, the retrograde valve moves toward an open position in which the retrograde valve permits retrograde flow in the circulatory vessel along the exterior of the catheter body, and in the partially expanded state the retrograde valve is autoregulating in response to differing pressures within the circulatory vessel, such that, in response to antegrade flow, the retrograde valve moves toward a closed position in which the retrograde valve partially occludes the circulatory vessel thereby resisting antegrade flow in the circulatory vessel along the exterior of the catheter body and, in response to retrograde flow, the retrograde valve moves toward an open position in which the retrograde valve permits retrograde flow in the circulatory vessel along the exterior of the catheter body, wherein the retrograde flow is greater than the antegrade flow, thereby providing a controllable retrograde flow and a controllable antegrade flow in the circulatory vessel along the exterior of the catheter body.

54. The catheter device of claim 53, wherein the retrograde valve includes one or more leaflets.

55. The catheter device of claim 54, wherein the retrograde valve is a central flow valve configured to provide a fluid flow through a center portion of the central flow valve and fluid flow traverses between the central flow valve and the catheter body.

56. The catheter device of claim 54, wherein the retrograde valve is a peripheral. flow valve configured to provide the antegrade flow around an exterior of the leaflets and traverse between the leaflets and a circulatory vessel wall.

57. The catheter device of claim 54, wherein the retrograde valve includes one or more retraction and advancement members valve.

58. The catheter device of claim 54, wherein the retrograde valve includes a retraction connection point at a leaflet.

59. The catheter device of claim 54, further comprising:

one or more unidirectional or bidirectional fluid flow fenestrations formed in the leaflets and configured to regulate the antegrade flow or the retrograde flow.

60. A catheter device to regulate fluid flow within a circulatory vessel, comprising:

an elongated catheter body configured to access one of a circulatory vessel or a heart chamber, wherein the catheter body includes a proximal end, a distal end, and a first lumen including an open proximal end and a distal end with a port formed at a distal portion of the distal end;

an antegrade valve coupled to an exterior of the catheter body and configured to provide a controllable antegrade flow and a controllable retrograde flow along the exterior of the catheter, wherein the antegrade flow is greater than the retrograde flow;

the antegrade valve having an expanded state wherein, in response to retrograde flow, the antegrade valve substantially occludes the circulatory vessel thereby substantially eliminating retrograde flow, and

a retrograde valve coupled to an exterior of the catheter body and configured to provide a controllable retrograde flow and a controllable antegrade flow along the exterior of the catheter, wherein the retrograde flow is greater than the antegrade flow, the retrograde valve having an expanded state wherein, in response to antegrade flow, the retrograde valve substantially occludes the circulatory vessel thereby substantially eliminating antegrade flow.

61. The catheter device of claim 60, wherein the antegrade and retrograde valves include one or more leaflets.

62. The catheter device of claim 61, wherein the antegrade and retrograde valves are each a central flow valve configured to provide a fluid flow through a center portion of the central flow valve and fluid flow traverses between the central flow valve and the catheter body.

63. The catheter device of claim 61, wherein the antegrade valve is a peripheral flow valve configured to provide the antegrade flow around an exterior of the leaflets and between the leaflets and a circulatory vessel wall.

64. The catheter device of claim 61, wherein the antegrade valve includes one or more retraction and advancement members.

65. The catheter device of claim 61, wherein the antegrade valve includes a retraction connection point at a leaflet.

66. The catheter device of claim 61, further comprising:

one or more unidirectional or bidirectional fluid flow fenestrations formed in the leaflets and configured to regulate the antegrade flow or the retrograde flow.

67. A catheter device to regulate fluid flow within a circulatory vessel, comprising:

an elongated catheter body configured to access one, of a circulatory vessel or a heart chamber, wherein the catheter body includes a proximal end, a distal end, and a first lumen including an open proximal end and a distal end with a port formed at a distal portion of the distal end;

an antegrade valve coupled to an exterior of the catheter body and configured to provide a controllable antegrade flow and a controllable retrograde flow along the exterior of the catheter body, wherein the antegrade flow is greater than the retrograde flow; and

a track formed and extending along at least a portion of the exterior of the catheter body.

68. The catheter device of claim 67, wherein the track is at least partially roofed.

69. The catheter device of claim 67, wherein the track includes a groove formed along at least a portion of a track body.

70. The catheter device of claim 69, wherein the track is configured to receive the antegrade valve, wherein the antegrade valve is configured to move along the groove.

71. The catheter device of claim 69, wherein the groove extends substantially along an entire track, and the antegrade valve is moveable along a length of the track.

72. The catheter device of claim 67, wherein the track is configured to receive one of an imaging device, an elongated surgical instrument and a retraction and advancement member coupled to the antegrade valve.

73. A catheter device to regulate fluid flow within a circulatory vessel, comprising:

an elongated catheter body configured to access one, of a circulatory vessel or a heart chamber, wherein the catheter body includes a proximal end, a distal end, and a first lumen including an open proximal end and a distal end with a port formed at a distal portion of the distal end;

an antegrade valve coupled to an exterior of the catheter body and configured to provide a controllable antegrade flow and a controllable retrograde flow along the exterior of the catheter body, wherein the antegrade flow is greater than the retrograde flow; and

a dual diaphragm chamber device coupled to the first lumen proximal end including a first diaphragm, a second diaphragm and an entry port coupled to the first lumen, an inflow port and an outflow port, wherein the diaphragm chamber is coupled to an irrigation system and to the first lumen.

74. The catheter device of claim 73, wherein the diaphragm chamber is configured to provide an air lock to the first lumen while instruments are introduced into the first lumen.

75. The catheter device of claim 73, wherein the diaphragm chamber has a distal end with a geometry configured to be inserted into one of a hear chamber or a circulatory vessel.