Inflatable catheter for selective organ heating and cooling and method of using the same

• US 6,540,771 B2
• Filed: 01/08/2001
• Issued: 04/01/2003
• Est. Priority Date: 01/23/1998
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Innercool therapies Incorporated (Taxus Cardium Pharmaceuticals Group, Inc.)
• Inventors: Lasheras, Juan C., Dobak, John D. III
• Primary Examiner(s): Kearney, Rosiland
• Application Number:
  US09/757,124
• Publication Number:
  US 20010001832A1
• Time in Patent Office: 813 Days
• Field of Search: 128/898, 606/20-25, 607/104-106, 607/113, 604/113, 604/104-106, 604/96.01, 604/97.01, 604/101.1, 604/101.02, 604/101.04, 604/101.05, 604/103.06, 604/103.07, 604/103.08
• US Class Current: 607/105
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61F 2007/0056 for cooling
• 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 system and method are provided which change the temperature of a fluid, such as blood, by heat transfer. Selective cooling or heating of an organ may be performed by changing the temperature of the blood feeding the organ. The catheter system includes an inlet lumen and an outlet lumen structured and arranged to carry a working fluid having a temperature different from the adjacent blood. The outlet lumen is configured to induce turbulence in the adjacent fluid passing adjacent the outlet lumen.

Claims

1. A catheter method of changing the temperature of blood by heat transfer to or from a circulating working fluid, comprising:

inserting an inflatable heat transfer element formed by at least an inlet lumen and an inflatable outlet lumen into an artery or vein;

inflating the inflatable heat transfer element by delivering a circulating working fluid to the inlet lumen of the inflatable heat transfer element, the temperature of the circulating working fluid different from that of the blood such that blood contacts both the inlet lumen and the outlet lumen; and

inducing turbulence in the working fluid by passing the working fluid through a helical turbulence-inducing path formed by the outlet lumen when inflated, and, inducing turbulence in blood flowing past the helical turbulence inducing path formed by the outlet lumen when inflated thereby enhancing heat transfer between the circulating working fluid and the blood.

2. The method of claim 1, further comprising delivering the working fluid at a temperature of between about −

3°

C. and 36°

C.

3. The method of claim 1, further comprising delivering the working fluid at a pressure of less than about 5 atmospheres.

4. The method of claim 3, further comprising delivering the working fluid at a pressure of between about 1 and 5 atmospheres.

5. The method of claim 1, further comprising absorbing more than about 75 watts of heat from the blood.

6. The method of claim 1, further comprising inducing blood turbulence with a turbulence intensity greater than about 0.05 within the carotid artery.

7. The method of claim 1, further comprising delivering the working fluid at a temperature of greater than about 37°

C.

8. The method of claim 1, further comprising inducing blood turbulence in greater than 20% of the period of the cardiac cycle within the carotid artery.

9. The method of claim 8, further comprising inducing blood turbulence throughout the period of the cardiac cycle within the carotid artery.

10. A catheter method of changing the temperature of blood by heat transfer to or from a circulating working fluid, comprising:

inserting an inflatable heat transfer element formed by at least an inlet lumen and an inflatable outlet lumen into a flow of blood in an artery or vein; and

inflating the inflatable heat transfer element by delivering a working fluid having a temperature different than the blood temperature to an interior of the inlet lumen of the inflatable heat transfer element, the outlet lumen of the inflatable heat transfer element having a helical or spiral turbulence-inducing shape when inflated, blood such that blood contacts both the inlet lumen and the outlet lumen, and such that turbulence is induced in a substantial portion of a free stream of blood by contact with both the helical or spiral turbulence-inducing shape of the outlet lumen and the inlet lumen.

11. A method of changing the temperature of blood, comprising:

providing an inflatable heat transfer element, the inflatable heat transfer element formed by at least an inlet lumen and an outlet lumen, at least one of the inlet lumen or the outlet lumen having a turbulence-inducing shape;

inserting the inflatable heat transfer element into a blood vessel;

delivering a circulating working fluid from a working fluid supply to the inflatable heat transfer element, the temperature of the circulating working fluid different from that of the blood;

inflating the inflatable heat transfer element with the circulating working fluid;

inducing turbulence in the working fluid or in the blood by circulating the working fluid through the lumen having the turbulence-inducing shape, thereby enhancing heat transfer between the circulating working fluid and the blood; and

returning the working fluid to the working fluid supply via the outlet lumen.

12. The method of claim 11, wherein the method is a method of heating, and the temperature of the circulating working fluid is greater than about 37°

C.

13. The method of claim 11, wherein the method is a method of cooling, and the temperature of the circulating working fluid is between about −

3°

C. and 36°

C.

14. A method of changing the temperature of blood, comprising:

providing an inflatable heat transfer element having a turbulence-enhancing shape such that the inflatable heat transfer element is formed by at least an inlet lumen and an outlet lumen, at least one of the inlet lumen or the outlet lumen having a shape of a helix;

inserting the inflatable heat transfer element into a blood vessel;

delivering a circulating working fluid from a working fluid supply to the inflatable heat transfer element, the temperature of the circulating working fluid different from that of the blood;

inflating the inflatable heat transfer element with the circulating working fluid;

inducing turbulence in the working fluid or in the blood by circulating the working fluid through the lumen having the turbulence-inducing shape, thereby enhancing heat transfer between the circulating working fluid and the blood; and

returning the working fluid to the working fluid supply via the outlet lumen.

15. A method of changing the temperature of blood, comprising:

providing an inflatable heat transfer element having a turbulence-enhancing shape such that the inflatable heat transfer element is formed by at least an inlet lumen and an outlet lumen, at least one of the inlet lumen or the outlet lumen having a shape of a spiral;

inserting the inflatable heat transfer element into a blood vessel;

delivering a circulating working fluid from a working fluid supply to the inflatable heat transfer element, the temperature of the circulating working fluid different from that of the blood;

inflating the inflatable heat transfer element with the circulating working fluid;

inducing turbulence in the working fluid or in the blood by circulating the working fluid through the lumen having the turbulence-inducing shape, thereby enhancing heat transfer between the circulating working fluid and the blood; and

returning the working fluid to the working fluid supply via the outlet lumen.

16. A method of changing the temperature of blood, comprising:

providing an inflatable heat transfer element, the inflatable heat transfer element formed by at least an inlet lumen and an outlet lumen, at least one of the inlet lumen or the outlet lumen having a turbulence-enhancing shape such that one lumen helically encircles the other;

inserting the inflatable heat transfer element into a blood vessel;

delivering a circulating working fluid from a working fluid supply to the inflatable heat transfer element, the temperature of the circulating working fluid different from that of the blood;

inflating the inflatable heat transfer element with the circulating working fluid;

inducing turbulence in the working fluid or in the blood by circulating the working fluid through the lumen having the turbulence-inducing shape, thereby enhancing heat transfer between the circulating working fluid and the blood; and

returning the working fluid to the working fluid supply via the outlet lumen.

17. The method of claim 16, wherein the turbulence-inducing shape is sufficient to cause a turbulence intensity of at least about 0.05.

18. The method of claim 16, wherein the turbulence-inducing shape is sufficient to cause turbulence characterized by a Nusselt number of at least about 5.

19. The method of claim 16, further comprising disposing the heat transfer element in an artery.

20. The method of claim 19, wherein the artery is the carotid artery.

21. The method of claim 19, wherein the artery is the femoral artery.

22. The method of claim 16, further comprising disposing the heat transfer element in a vein.

23. The method of claim 22, wherein the vein is the femoral vein.

24. The method of claim 22, wherein the vein is the IVC.

25. The method of claim 16, further comprising inducing turbulence in the free stream of the blood flow.

26. The method of claim 16, wherein the outlet lumen is the lumen with a turbulence-inducing shape, and further comprising delivering the circulating working fluid to multiple outlet lumens.

27. The method of claim 26, wherein each outlet lumen has a turbulence-enhancing shape.

28. The method of claim 27, wherein each outlet lumen has the shape of a helix.

29. The method of claim 27, wherein each outlet lumen has the shape of a spiral.

30. The method of claim 27, wherein each outlet lumen helically encircles the inlet lumen.

31. The method of claim 27, wherein each outlet lumen has the shape of a spiral.

32. A method of changing the temperature of blood, comprising:

providing an inflatable heat transfer element having a longitudinal axis, the inflatable heat transfer element formed by at least an inlet lumen and an outlet lumen, the inlet and outlet lumens at least partially coaxial, at least one of the inlet lumen or the outlet lumen having a turbulence-enhancing shape such that the radius of the inlet or outlet lumen varies with respect to position along the axis;

inserting the inflatable heat transfer element into a blood vessel;

delivering a circulating working fluid from a working fluid supply to the inflatable heat transfer element, the temperature of the circulating working fluid different from that of the blood;

inflating the inflatable heat transfer element with the circulating working fluid;

inducing turbulence in the working fluid or in the blood by circulating the working fluid through the lumen having the turbulence-inducing shape, thereby enhancing heat transfer between the circulating working fluid and the blood; and

returning the working fluid to the working fluid supply via the outlet lumen.

33. A method of changing the temperature of blood, comprising:

providing an inflatable heat transfer element, the inflatable heat transfer element formed by at least an inlet lumen and an outlet lumen, at least one of the inlet lumen or the outlet lumen having a turbulence-inducing shape and configured to cause two counter-rotating flows to develop in the circulating working fluid;

inserting the inflatable heat transfer element into a blood vessel;

delivering a circulating working fluid from a working fluid supply to the inflatable heat transfer element, the temperature of the circulating working fluid different from that of the blood;

inflating the inflatable heat transfer element with the circulating working fluid;

inducing turbulence in the working fluid or in the blood by circulating the working fluid through the lumen having the turbulence-inducing shape, thereby enhancing heat transfer between the circulating working fluid and the blood; and

returning the working fluid to the working fluid supply via the outlet lumen.

34. A catheter method of changing the temperature of blood by heat transfer, comprising:

inserting a heat transfer element formed by at least an inlet lumen and an inflatable outlet lumen into an artery or vein;

delivering a circulating working fluid to the heat transfer element, the temperature of the working fluid different from that of the blood; and

passing the circulating working fluid through a helical path formed by the outlet lumen, such that the helical return path enhances the heat transfer between the working fluid and the blood by causing turbulence therein.

35. The method of claim 34, further comprising delivering the circulating working fluid at a temperature of between about −

3°

C. and 36°

C.

36. The method of claim 35, wherein the flexible material is rubber.

37. The method of claim 35, wherein the flexible material is a material capable of undergoing inflation.

38. The method of claim 36, wherein the helical path is segmentally tapered when inflated.

39. The method of claim 36, wherein the outer diameter of the helical path when inflated, is between about 2 millimeters and 8 millimeters and tapers to less than 2 millimeters.

40. The method of claim 38, wherein a length of a segment is between about 1 centimeter and 10 centimeters.

41. The method of claim 34, further comprising delivering the working fluid at a pressure of less than about 5 atmospheres.

42. The method of claim 34, further comprising absorbing more than about 75 watts of heat from the blood.

43. The method of claim 34, further comprising inducing blood turbulence with a turbulence intensity greater than about 0.05 within the artery or vein.

44. The method of claim 34, wherein tie inlet lumen and the outlet lumen are made of a flexible material.

45. The method of claim 34, further comprising more than one helical path.

46. The method of claim 34, wherein the working fluid is saline.

47. The method of claim 34, wherein the helical shape of the outlet lumen is tapered when inflated.

48. The method of claim 34, wherein a longitudinal length of the helical path is between about 5 and 30 centimeters.

49. The method of claim 34, wherein a diameter of the helical path is less than about 8 millimeters when inflated.

50. The method of claim 34, further comprising a working fluid supply including a pump, and wherein the pump circulates the working fluid.

51. The method of claim 50, wherein the working fluid supply is configured to produce a pressurized working fluid at a temperature of between about −

3°

C. and 36°

C. and at a pressure below about 5 atmospheres of pressure.

52. The method of claim 34, wherein the helical path includes a surface coating or treatment to inhibit clot formation.

53. The method of claim 52, wherein the surface coating or treatment includes heparin.

54. The method of claim 34, wherein the working fluid is an aqueous solution.

55. The method of claim 34, wherein the helical path is structured and shaped to have a geometry so as to induce turbulence within a free stream of blood flow when disposed in an artery.

56. The method of claim 55, wherein the artery is a carotid artery.

57. The method of claim 55, wherein the artery is a femoral artery.

58. The method of claim 34, wherein the helical path is structured and shaped to have a geometry so as to induce turbulence within a free stream of blood flow to a turbulence intensity of greater than about 0.05.

59. The method of claim 34, wherein the helical path is structured and shaped to have a geometry so as to cause a turbulence within a free stream of blood flow characterized by a Nusselt number of at least about 5.

60. The method of claim 34, wherein the helical path is structured and shaped to have a geometry so as to induce turbulence within a free stream of blood flow when disposed in a vein.

61. The method of claim 60, wherein the vein is a jugular vein.

62. The method of claim 60, wherein the vein is a femoral vein.

63. The method of claim 60, wherein the vein is the inferior vena cava.

64. The method of claim 34, wherein the inlet lumen is substantially straight.

65. The method of claim 34, wherein the outlet lumen helically encircles the inlet lumen.

66. The method of claim 34, wherein the helical path is such that the outlet lumen helically encircles the inlet lumen.

67. The method of claim 66, further comprising more than one helical path, each helical path encircling an inlet lumen.

68. The method of claim 67, wherein the inlet lumen is substantially straight.

69. The method of claim 68, wherein the inlet lumen is segmentally tapered.

70. The method of claim 66, wherein the structure of the helical path is structured and configured to have a geometry such that the induced turbulence is characterized by a Nusselt number of at least about 5.