Heat exchange catheter with discrete heat exchange elements

• US 6,264,679 B1
• Filed: 08/20/1999
• Issued: 07/24/2001
• Est. Priority Date: 08/20/1999
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: MacHold, Timothy R., Saab, Mark A., Keller, Wade E.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/378,578
• Time in Patent Office: 704 Days
• Field of Search: 607/96, 607/105, 607/113, 606/21-23, 606/27-28
• US Class Current: 607/105
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities

Abstract

A catheter for exchanging heat with a body fluid is disclosed. The catheter includes a main shaft and a heat exchange region having a plurality of heat exchange elements each having a length and opposed ends. Each of the elements is attached on at least one of its ends to the shaft and disposed so that when inserted in a fluid body cavity having body fluid therein, the body fluid may circumferentially surround each heat exchange element along a portion of the length of the heat exchange element. The catheter includes a fluid circulation path therein, which desirably includes the hollow lumen within each of heat exchange elements. The heat exchange elements may be connected at two points along the shaft using manifolds that are in fluid communication with fluid flow paths within the shaft. Alternatively, the heat exchange elements may be connected at only one point and be permitted to float in a proximal or distal direction with respect to the catheter. The heat exchange region may be formed on a distal portion of the catheter, or may be formed along the entire length thereof. In the former configuration, an insulating member, such as a balloon, may be provided along the shaft proximal to the heat exchange region. Ribs may be provided on each heat exchange element to disrupt flow therearound and increase heat exchange. Each of the heat exchange elements may be non-circular in cross-section, and may extend in an undulating path with respect to the catheter shaft.

Claims

1. A heat exchange catheter comprising:

a longitudinal catheter shaft with a proximal end and a distal end;

a heat exchange region comprising a plurality of heat exchange elements, each of said heat exchange elements having a length and opposed ends and each of said heat exchange elements being disposed such that, when the heat exchange region of the catheter is positioned in a body lumen or body cavity that contains body fluid, the body fluid may circumferentially surround at least a portion of each heat exchange element, further including an insulating region on the shaft located proximally with respect to the heat exchange region and wherein the insulating region comprises an inflatable balloon surrounding the shaft.

2. The catheter of claim 1, wherein at least some of the heat exchange elements have a fluid flow path therethrough.

3. The catheter of claim 2, wherein at least some of the heat exchange elements have a non-circular cross-section.

4. The catheter of claim 2, wherein the shaft has a fluid inflow lumen and a fluid outflow lumen and a circulation pathway therebetween for the circulation of heat exchange medium, at least some of the heat exchange elements being in the circulation pathway to enable circulation of a fluid heat exchange medium through the heat exchange elements.

5. The catheter of claim 4, wherein each heat exchange element has an inflow orifice on one end and an outflow orifice on the opposed end, the inflow orifice and the outflow orifice being in communication with the circulation pathway.

6. The catheter of claim 5, wherein each heat exchange element extends in a non-linear path from its inflow orifice to its outflow orifice, the non-linear path having a least one point of inflection.

7. The catheter of claim 5, wherein the catheter includes an inlet manifold open to the inflow lumen and to the inflow orifice of each heat exchange element, and the catheter includes an outlet manifold open to the outflow lumen and to the outflow orifice of each heat exchange element.

8. The catheter of claim 7, wherein the inlet manifold is disposed distally with respect to the outlet manifold.

9. The catheter of claim 7, wherein the heat exchange elements comprise elongate hollow filaments having opposed open ends defining the respective inflow and outflow orifices, and wherein each filament open end communicates with an interior space in a respective manifold.

10. The catheter of claim 7 wherein the heat exchange elements are longer than the distance between the inlet and outlet manifold.

11. The catheter of claim 1, wherein the shaft has a length and the heat exchange region extends a distance that is less than one half the length of the shaft.

12. The catheter of claim 11, wherein the heat exchange region is located on the distal region of the shaft.

13. The catheter of claim 1, wherein the insulating region extends the entire length of the shaft proximal of the heat exchange region.

14. The catheter of claim 1, wherein the insulating region extends approximately 85-90% of the length of the shaft, and a heat exchange region extends substantially along the rest of the shaft.

15. The catheter of claim 1, wherein the shaft is within the balloon and the insulating region comprises a plurality of stand-offs interposed between and spacing apart the inner wall of the balloon and the shaft.

16. The catheter of claim 1, wherein the insulating region comprises a plurality of the balloons surrounding the shaft and a sleeve encompassing the balloons.

17. The catheter of claim 1, wherein there are at least three heat exchange elements.

18. The catheter of claim 17, wherein the heat exchange elements are evenly circumferentially distributed about the shaft.

19. The catheter of claim 1 wherein said catheter shaft comprises a plurality of heat exchange elements substantially surrounded by a sleeve and wherein the heat exchange region comprises portions of the heat exchange elements that protrude out of said sleeve.

20. A heat exchange catheter comprising:

a longitudinal catheter shaft with a proximal end and a distal end;

a heat exchange region comprising a plurality of heat exchange elements each of said heat exchange elements having a length and opposed ends and each of said heat exchange elements being disposed such that, when the heat exchange region of the catheter is positioned in a body lumen or body cavity that contains body fluid, the body fluid may circumferentially surround at least a portion of each heat exchange element, wherein the heat exchange elements are flexible and each is constrained along a portion of its length with respect to the shaft so that a free end of each heat exchange element is permitted to drift freely within the body fluid.

21. The catheter of claim 20, wherein the heat exchange elements comprise very thin-walled balloons.

22. The catheter of claim 20, wherein the heat exchange elements have walls permitting a high rate of conductive heat transfer therethrough.

23. The catheter of claim 20, wherein the heat exchange elements are hollow, the shaft including a fluid circulation path, and the hollow interior of the heat exchange elements being in fluid communication with the fluid circulation path.

24. The catheter of claim 23, wherein each heat exchange element has a distal end and a proximal end, the distal end of each being attached to the catheter shaft.

25. The catheter of claim 23, wherein each heat exchange element has a distal end and a proximal end and extends from a proximal end of the catheter shaft to beyond the distal end of the catheter shaft, the plurality of heat exchange elements being retained closely together by the shaft except at their distal ends where they are separate and permitted to float freely in the body fluid.

26. The catheter of claim 25, further including a proximal manifold for supplying and removing a heat exchange medium to the hollow interior of each heat exchange element.

27. The catheter of claim 26, wherein each heat exchange element is formed with a coaxial flow path, the heat exchange medium being supplied to an inner lumen and removed from an outer lumen.

28. The catheter of claim 26, wherein each heat exchange element comprises a loop of a single lumen tube, the heat exchange medium being supplied to the tube lumen.

29. The catheter of claim 20, wherein the shaft has a length and the heat exchange region extends a distance that is less than one half the length of the shaft.

30. The catheter of claim 29, Wherein the heat exchange region is located on the distal region of the shaft.

31. The catheter of claim 20, further including an insulating region on the shaft located proximally with respect to the heat exchange region.

32. The catheter of claim 31, herein the insulating region comprises an inflatable balloon surrounding the shaft.

33. The catheter of claim 32, wherein the shaft is within the balloon and the insulating region comprises a plurality of stand-offs interposed between and spacing apart the inner wall of the balloon and the shaft.

34. A heat exchange catheter comprising:

a longitudinal catheter shaft with a proximal end and a distal end;

a heat exchange region comprising a plurality of heat exchange elements, each of said heat exchange elements having a length and opposed ends and each of said heat exchange elements being disposed such that when the heat exchange region of the catheter is positioned in a body lumen or body cavity that contains body fluid, the body fluid may circumferentially surround at least a portion of each heat exchange element, wherein each heat exchange element comprises a filament having a distal end and a proximal end, the distal end being attached to the catheter shaft, and further including a spring member positioned between the filament and the shaft and adapted to compress upon application of an external force to the catheter as it is being inserted into the body cavity, and expand in the absence of such an external force to maintain the filament a predetermined radial distance away from shaft.

35. The catheter of claim 34 wherein each filament is further attached at its proximal end to the catheter shaft, each filament being hollow and providing a fluid flow path therethrough for passage of a liquid heat exchange medium.

36. The catheter of claim 35, wherein the shaft has a fluid inflow lumen and a fluid outflow lumen and a circulation pathway therebetween for the circulation of heat exchange medium, at least some of the hollow filaments being in the circulation pathway.

37. The catheter of claim 36, wherein each hollow filament has an inflow orifice on one end and an outflow orifice on the opposed end, the inflow orifice and the outflow orifice being in communication with the circulation pathway.

38. The catheter of claim 37, wherein the catheter includes an inlet manifold open to the inflow lumen and to the inflow orifice of each hollow filament, and the catheter includes an outlet manifold open to the outflow lumen and to the outflow orifice of each hollow filament, wherein the inlet manifold is disposed distally with respect to the outlet manifold.

39. The catheter of claim 34, wherein the shaft has a length and the heat exchange region extends a distance that is less than one half the length of the shaft.

40. The catheter of claim 39, wherein the heat exchange region is located on the distal region of the shaft.

41. The catheter of claim 34, further including an insulating region on the shaft located proximally with respect to the heat exchange region.

42. The catheter of claim 41, wherein the insulating region comprises an inflatable balloon surrounding the shaft.

43. The catheter of claim 42, wherein the shaft is within the balloon and the insulating region comprises a plurality of stand-offs interposed between and spacing apart the inner wall of the balloon and the shaft.

44. A heat exchange catheter comprising:

a longitudinal catheter shaft with a proximal end and a distal end;

a heat exchange region comprising a plurality of heat exchange elements, each of said heat exchange elements having a length and opposed ends and each of said heat exchange elements being disposed such that, when the heat exchange region of the catheter is positioned in a body lumen or body cavity that contains body fluid, the body fluid may circumferentially surround at least a portion of each heat exchange element, wherein each heat exchange element comprises a rod-like filament having a flow disrupting rib disposed thereon.

45. The catheter of claim 44, wherein the flow disrupting rib is helically disposed about the filament.

46. The catheter of claim 44, wherein the flow disrupting rib is circumferentially disposed about the filament.

56. The catheter of claim 44, wherein the shaft has a length and the heat exchange region extends a distance that is less than one half the length of the shaft.

57. The catheter of claim 56, wherein the heat exchange region is located on the distal region of the shaft.

58. The catheter of claim 44, further including an insulating region on the shaft located proximally with respect to the heat exchange region.

59. The catheter of claim 58, wherein the insulating region extends the entire length of the shaft proximal of the heat exchange region.

60. The catheter of claim 59, wherein the insulating region extends approximately 85-90% of the length of the shaft, and a heat exchange region extends substantially along the rest of the shaft.

61. The catheter of claim 58, wherein the insulating region comprises an inflatable balloon surrounding the shaft.

62. The catheter of claim 61, wherein the shaft is within the balloon and the insulating region comprises a plurality of stand-offs interposed between and spacing apart the inner wall of the balloon and the shaft.

63. The catheter of claim 61, wherein the insulating region comprises a plurality of the balloons surrounding the shaft and a sleeve encompassing the balloons.

47. The catheter of clam 44, wherein at least some of the heat exchange elements have a fluid flow path therethrough.

48. The catheter of claim 47 wherein at least some of the heat exchange elements have a non-circular cross-section.

49. The catheter of claim 47, wherein the shaft has a fluid inflow lumen and a fluid outflow lumen and a circulation pathway therebetween for the circulation of heat exchange medium, at least some of the heat exchange elements being in the circulation pathway to enable circulation of a fluid heat exchange medium through the heat exchange elements.

50. The catheter of claim 49, wherein each heat exchange element has an inflow orifice on one end and an outflow orifice on the opposed end, the inflow orifice and the outflow orifice being in communication with the circulation pathway.

51. The catheter of claim 50, wherein each heat exchange element extends in a non-linear path from its inflow orifice to its outflow orifice, the non-linear path having a least one point of inflection.

52. The catheter of claim 50, wherein the catheter includes an inlet manifold open to the inflow lumen and to the inflow orifice of each heat exchange element, and the catheter includes an outlet manifold open to the outflow lumen and to the outflow orifice of each heat exchange element.

53. The catheter of claim 52, wherein the inlet manifold is disposed distally with respect to the outlet manifold.

54. The catheter of claim 52, wherein the heat exchange elements comprise elongate hollow filaments having opposed open ends defining the respective inflow and outflow orifices, and wherein each filament open end communicates with an interior space in a respective manifold.

55. The catheter of claim 52 wherein the heat exchange elements are longer than the distance between the inlet and outlet manifold.