Heat transfer catheter with elastic fluid lumens

• US 20040133256A1
• Filed: 12/17/2003
• Published: 07/08/2004
• Est. Priority Date: 05/31/2001
• Status: Abandoned Application

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: Callister, Jeffrey P.
• Application Number:
  US10/738,066
• Publication Number:
  US 20040133256A1
• Time in Patent Office: Days
• US Class Current: 607/105
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: Y02P 20/141 Feedstock
• CPC Class Codes: Y10T 428/24942 including components having same physical characteristic in differing degree

Abstract

The heat exchange catheters comprise a catheter body having a heat exchange structure formed over a distal region thereof. Heat exchange structure comprises an elastic chamber or balloon which conforms closely to the catheter body when uninflated and which expands to enhance the available heat transfer surface when heat exchange medium is introduced. The elastic structures may consist of elastomeric sheets or membranes or may comprise non-distensible sheets or membranes having elastic elements in order to control expansion and contraction. Methods for fabrication and use are also disclosed.

Claims

1. A heat exchange catheter comprising:

a catheter body having a proximal end and a distal region; and

a heat exchange balloon structure disposed over the distal region;

wherein the heat exchange balloon structure expands and deflates elastically when uninflated.

2. A heat exchange catheter as in claim 1, wherein the heat exchange balloon structure conforms without folding to the distal region of the catheter body when uninflated.

3. A heat exchange catheter as in claim 1, wherein the heat exchange balloon structure has a diameter when uninflated which does not exceed that of the catheter body.

4. A heat exchange catheter as in claim 1, wherein the surface area of the heat exchange balloon structure increases by at least 10% when inflated by heat exchange medium at a pressure in the range from 0.5 psig to 50 psig.

5. A heat exchange catheter as in claim 1, wherein the catheter body comprises a polymeric material having a hardness in the range from 75 A to 80 D.

6. A heat exchange catheter as in claim 4, wherein the catheter body has a length in the range from 15 cm to 100 cm and a diameter in the range from 1 mrn to 4 mm.

7. A heat exchange catheter as in any of claim 1 to 6, wherein the heat exchange balloon structure comprises a polymeric material having a hardness in the range from 65 A to 45 D.

8. A heat exchange catheter as in claim 6, wherein the polymeric material is selected from the group consisting of polyurethanes, silicone rubber, latex, polyvinyls, plasticized PVC, and styrene-ethylene-butylene modified block copolymer with silicone oil.

9. A heat exchange catheter as in claim 7, wherein the catheter body and the balloon comprise the same material having different hardnesses.

10. A heat exchange catheter as in claim 9, wherein the same material is selected from the group consisting of polyurethanes, silicone rubber, latex, polyvinyls, plasticized PVC, and styrene-ethylene-butylene modified block copolymer with silicone oil.

11. A heat exchange catheter comprising:

a catheter body having a proximal end, a distal region, an inflow lumen, and an outflow lumen; and

a heat exchange balloon structure comprising a plurality of elastic polymeric chambers disposed over the distal region and fluidly connected at an inlet end to the inflow lumen and at an outlet end to the outflow lumen.

12. A heat exchange catheter as in claim 11, wherein the elastic polymeric chambers are arranged axially over the distal region.

13. A heat exchange catheter as in claim 11, wherein the elastic polymeric chambers are arranged spirally over the distal region.

14. A heat exchange catheter as in any of claims 11-13, wherein the heat exchange balloon structure comprises from two to twelve elongated chambers.

15. A heat exchange catheter as in claim 14, wherein the elongated chambers are circumferentially spaced apart.

16. A heat exchange catheter as in claim 11, wherein the heat exchange balloon structure conforms without folding to the distal region of the catheter body when uninflated.

17. A heat exchange catheter as in claim 11, wherein the heat exchange balloon structure has a diameter when uninflated which does not exceed that of the catheter body.

18. A heat exchange catheter as in claim 11, wherein the surface area of the heat exchange balloon structure increases by at least 10% when inflated by heat exchange medium at a pressure in the range from 0.5 psig to 50 psig.

19. A heat exchange catheter as in claim 11, wherein the catheter body comprises a polymeric material having a hardness in the range from 75 A to 80 D.

20. A heat exchange catheter as in claim 19, wherein the catheter body has a length in the range from 15 cm to 100 cm and a diameter in the range from 1 mm to 4 mm.

21. A heat exchange catheter as in any of claim 11 to 20, wherein the heat exchange balloon structure comprises a polymeric material having a hardness in the range from 65 A to 45 D.

22. A heat exchange catheter as in claim 21, wherein the catheter body and the balloon comprise the same material having different hardnesses.

23. A heat exchange catheter as in any of claim 11 to 12, wherein the heat exchange balloon structure comprises a polymeric material having a hardness in the range from 65 A to 45 D.

24. A heat exchange catheter comprising:

a catheter body having a proximal end, a distal region, an inflow lumen, and an outflow lumen; and

an elastomer tube coaxially positioned over the distal region;

wherein the elastomer tube is sealed to the catheter body along a multiplicity of lines to define a plurality of separate inflatable chambers, each at which is fluidly connected at an inlet end to the inflow lumen and at an outlet end to the outflow lumen.

25. A heat exchange catheter as in claim 24, wherein the inflatable chambers are arranged axially over the distal region.

26. A heat exchange catheter as in claim 24, wherein the inflatable chambers are arranged spirally over the distal region.

27. A heat exchange catheter as in claim 24, wherein the catheter comprises from two to twelve inflatable chambers.

28. A heat exchange catheter as in claim 27, wherein the inflatable chambers are circumferentially spaced apart.

29. A heat exchange catheter as in claim 24, wherein the heat exchange balloon structure conforms without folding to the distal region of the catheter body when uninflated.

30. A heat exchange catheter as in claim 24, wherein the heat exchange balloon structure has a diameter when uninflated which does not exceed that of the catheter body.

31. A heat exchange catheter as in claim 24, wherein the surface area of the heat exchange balloon structure increases by at least 10% when inflated by heat exchange medium at a pressure in the range from 0.5 psig to 50 psig.

32. A heat exchange catheter as in claim 24, wherein the catheter body comprises a polymeric material having a hardness in the range from 75 A to 80 D.

33. A heat exchange catheter as in claim 32, wherein the catheter body has a length in the range from 15 cm to 100 cm and a diameter in the range from 1 mm to 4 mm.

34. A heat exchange catheter as in any of claim 24 to 33, wherein the heat exchange balloon structure comprises a polymeric material having a hardness in the range from 65 A to 45 D.

35. A heat exchange catheter as in claim 34 wherein the catheter body and the elastomer tube comprise the same material having different hardnesses.

36. A heat exchange catheter as in any of claim 24 to 33, wherein the heat exchange balloon structure comprises a polymeric material having a hardness in the range from 65 A to 45 D.

37. A method for fabricating a catheter, said method comprising:

positioning a tubular catheter body over a mandrel, wherein said catheter body has at least an inflow lumen and an outflow lumen;

placing an elastomer tube over a distal region of the catheter body;

attaching the elastomer tube to the tubular catheter body to define a plurality of separate elastically expandable chambers between the outside of the catheter body and the inside of the elastomer tube, wherein an inlet end of the chamber is fluidly connected to the inflow lumen and an outlet end of the chamber is fluidly connected to the outflow lumen.

38. A method as in claim 37, wherein tubular catheter body comprises a polymer having a hardness in the range from 75 A to 82 D and the elastomer tube comprises an elastomer having a hardness in the range from 65 A to 45 D.

39. A method as claim 38, wherein the polymer is selected from the group consisting of polyurethanes, silicone rubber, latex, polyvinyls, plasticized PVC, and styrene-ethylene-butylene modified block copolymer with silicone oil and the elastomer is selected from the group consisting of polyurethanes, silicone rubber, latex, polyvinyls, plasticized PVC, and styrene-ethylene-butylene modified block copolymer with silicone oil (C-Flex®

), polyurethanes.

40. A method as in claim 39, wherein the polymer and the elastomer are the same material but have different hardnesses.

41. A method as in claim 37, wherein attaching comprises heat staking.

42. A method as in claim 37 or 41, wherein attaching comprises sealing along a multiplicity of lines to define the chambers therebetween.

43. A method as in claim 42, wherein the lines are arranged axially.

44. A method as in claim 42, wherein the lines are arranged spirally.

45. A method as in claim 42, wherein the lines have a width in the range from 0.01 mm to 2 mm to circumferentially separate adjacent chambers.

46. A method for exchanging heat with vascular circulation of a patient, said method comprising;

percutaneously introducing a catheter to a blood vessel of the patient, wherein the catheter includes at least one elastic chamber conformed over a surface thereof;

elastically inflating the chamber with a heat exchange medium, whereby heat is exchanged between the heat exchange medium and the vascular circulation.

47. A method as in claim 46, wherein the catheter is introduced to a blood vessel selected from the group consisting of

a. the inferior vena cava;

b. the superior vena cave;

c. a jugular vein;

d. a carotid artery;

e. the aorta; and

f. a renal artery.

48. A method as in claim 46, wherein the at least one chamber is inflated with the heat exchange medium at a pressure in the range from 0.5 psig to 50 psig and a flow rate in the range from 5 ml/min to 1000 ml/min.

49. A method as in claim 46, wherein elastically inflating comprises pulsing the pressure of the heat exchange medium, whereby the surface of the elastic chamber moves in order to enhance heat transfer.

50. A method as in claim 46, wherein pressure feedback from the pressure of the heat exchange fluid is used to control the expansion of the heat exchange balloon.

51. A method as in claim 46, wherein the flow rate feedback from the heat exchange fluid is used to control the expansion of the balloon.

52. A method as in claim 46, wherein the balloon is expanded to a sized based on the size of the vessel in which the heat exchange region is located.

53. A method as in claim 46, wherein the pulse rate of the expansion/deflation cycle is controlled to optimize heat exchange