Heat exchange catheter having heat exchange surface formed of metal foil

• US 6,436,131 B1
• Filed: 03/09/2000
• Issued: 08/20/2002
• Est. Priority Date: 02/10/1993
• Status: Expired due to Fees

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: Ginsburg, Robert
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US09/522,135
• Time in Patent Office: 894 Days
• Field of Search: 607/96, 607/108-112, 607/114, 607/113, 607/105, 607/106
• US Class Current: 607/106
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/00095 high, i.e. heat conducting
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0086 with a thermostat
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: H10K 2102/3031 : Two-side emission, e.g. transparent OLEDs [TOLED]
• CPC Class Codes: H10K 2102/351 : Thickness
• CPC Class Codes: H10K 50/165 : comprising dopants
• CPC Class Codes: H10K 50/171 : Electron injection layers
• CPC Class Codes: H10K 50/18 : Carrier blocking layers
• CPC Class Codes: H10K 50/828 : Transparent cathodes, e.g. comprising thin metal layers
• CPC Class Codes: H10K 85/311 : Phthalocyanine
• CPC Class Codes: H10K 85/324 : comprising aluminium, e.g. Alq3

Abstract

The present invention provides a method and apparatus for controlling the internal body temperature of a patient. According to the present invention, a catheter is inserted through an incision into a large blood vessel of a patient. By selectively heating or cooling a portion of the catheter lying within the blood vessel, heat may be transferred to or from blood flowing within the vessel and the patient'"'"'s body temperature may thereby be increased or decreased as desired. The invention will find use in treating undesirable conditions of hypothermia and hyperthermia, or for inducing a condition of artificial hypothermia when desired. The method and system further provide for the cooling of initially hypothermic patients whose blood or body temperature has been warmed above the desired target level and the warming of initially hyperthermic patients whose blood or body temperature has been cooled below the desired target temperature.

Claims

1. A heat exchange catheter system for controlling the temperature of at least a portion of the body of a patient comprising:

a) a catheter device for exchanging heat with the patient'"'"'s blood, the catheter device being positionable within a blood vessel of a patient, the blood vessel having a vessel wall which defines a vessel lumen of a first diameter, the catheter comprising,

i) a flexible shaft for insertion into the vasculature of the patient, said shaft having a thermally conductive core; and

,

ii) a heat-absorbing surface, said heat-absorbing surface having a length that is less than the entire length of the catheter, said heat-absorbing surface being thermally coupled to said thermally conductive core, said heat-absorbing surface comprising a thermally conductive metal and said heat-absorbing surface having a diameter that is smaller than the first diameter of the blood vessel lumen such that blood will flow between the heat-absorbing surface and the vessel wall;

b) a temperature sensor for sensing a temperature of the patient; and

c) a control unit that receives temperature information from the temperature sensor and in response to said temperature information selectively varies the rate and direction of heat transference through said heat absorbing surface to control the body temperature of the patient.

2. A heat exchange catheter system according to claim 1 wherein said thermally conductive metal is flexible.

3. A heat exchange catheter system according to claim 1 wherein the heat-absorbing surface is positioned so as to be in direct contact with the patient'"'"'s blood when the catheter shaft is inserted into the patient'"'"'s vasculature.

4. A heat exchange catheter system according to claim 1 wherein the heat-absorbing surface comprises a metal foil that is substantially wrapped about the catheter shaft.

5. A heat exchange catheter system according to claim 1 wherein the heat-absorbing surface comprises a metal foil having a surface area exposed to blood contact of at least about 2 square centimeters.

6. A heat exchange catheter system according to claim 1 wherein said thermally conductive metal comprises a metal foil.

7. A heat exchange catheter system according to claim 1 wherein the thermally conductive metal has a thickness of approximately 0.001 mm to 0.01 mm.

8. A heat exchange catheter system according to claim 1 wherein the metal is selected from the group consisting of:

gold;

silver;

aluminum;

and copper.

9. A heat exchange catheter system according to claim 1 wherein the metal is encapsulated.

10. A heat exchange catheter system according to claim 1 wherein the thermally conductive metal is treated to enhance its biocompatability.

11. A heat exchange catheter system according to claim 10 wherein said cooler comprises a thermoelectric cooler.

12. A heat exchange catheter system according to claim 1 wherein the thermally conductive core comprises a metallic core.

13. A heat exchange catheter system according to claim 1 wherein the thermally conductive core comprises a circulating heat exchange fluid.

14. A heat exchange catheter system according to claim 13 further comprising a heater, a cooler and a controller for selectively transferring heat into or our of the heat exchange fluid.

15. A heat exchange catheter system according to claim 1 wherein said thermally conductive core is conductively coupled to a cooler located externally to the catheter.

16. A system according to claim 1 wherein the thermally conductive core of the catheter device comprises a circulating heat exchange fluid and wherein the catheter device further comprises at least one of a) a heater for heating the heat exchange fluid such that heat will pass from the heat exchange fluid, through the heat absorbing surface and into the blood to cause warming of the patient'"'"'s blood and b) a cooler for cooling the heat exchange fluid such that heat will pass from the patient'"'"'s blood, through the heat absorbing surface and into the heat exchange fluid to cause cooling of the patient'"'"'s blood.

17. A heat exchange catheter system according to claim 14 further comprising a heater, a cooler and a controller for selectively transferring heat into or our of the heat exchange fluid.

18. A heat exchange catheter device for exchanging heat with a patient'"'"'s blood, the catheter comprising:

a shaft for insertion into the vasculature of the patient, said shaft having a thermally conductive core, a heat-absorbing surface, said heat-absorbing surface being thermally coupled to said thermally conductive core, said heat-absorbing surface comprising a thermally conductive metal and said thermally conductive core comprising a metallic core.

19. A heat exchange catheter device according to claim 18 wherein said thermally conductive metal is flexible.

20. A heat exchange catheter device according to claim 18 wherein the heat-absorbing surface is positioned so as to be in direct contact with the patient'"'"'s blood when the catheter shaft is inserted into the patient'"'"'s vasculature.

21. A heat exchange catheter device according to claim 18 wherein the heat-absorbing surface comprises a metal foil that is substantially wrapped about the catheter shaft.

22. A heat exchange catheter device according to claim 18 wherein the heat-absorbing surface comprises a metal foil having a surface area exposed to blood contact of at least about 2 square centimeters.

23. A heat exchange catheter device according to claim 18 wherein said thermally conductive metal comprises a metal foil.

24. A heat exchange catheter device according to claim 18 wherein the thermally conductive metal has a thickness of approximately 0.001 mm to 0.01 mm.

25. A heat exchange catheter device according to claim 18 wherein the metal is selected from the group consisting of:

gold;

silver;

aluminum;

and copper.

26. A heat exchange catheter device according to claim 18 wherein the metal is encapsulated.

27. A heat exchange catheter device according to claim 18 wherein the thermally conductive metal is treated to enhance its biocompatability.

28. A heat exchange catheter device according to claim 18 wherein the thermally conductive metal core contains a circulating heat exchange fluid.

29. A heat exchange catheter device according to claim 28 further comprising a heater, a cooler and a controller for selectively transferring heat into or out of the heat exchange fluid.

30. A heat exchange catheter device according to claim 18 wherein said thermally conductive core is conductively coupled to a cooler located externally to the catheter.

31. A heat exchange catheter device according to claim 30 wherein said cooler comprises a thermoelectric cooler.

32. A system comprising a heat exchange catheter device according to claim 18 further in combination with:

a temperature sensor for sensing a temperature of the patient; and

a control unit that receives temperature information from the temperature sensor and in response to said temperature information selectively varies the amount of heat absorbed by said heat absorbing surface to thereby control the body temperature of the patient.

33. A system according to claim 32 wherein the thermally conductive core of the catheter device comprises a circulating heat exchange fluid and wherein the catheter device further comprises at least one of a) a heater for heating the heat exchange fluid such that heat will pass from the heat exchange fluid, through the heat absorbing surface and into the blood to cause warming of the patient'"'"'s blood and b) a cooler for cooling the heat exchange fluid such that heat will pass from the patient'"'"'s blood, through the heat absorbing surface and into the heat exchange fluid to cause cooling of the patient'"'"'s blood.

34. A system according to claim 33 wherein the control unit is operative to cause the heater or cooler to vary the temperature of the circulating heat exchange fluid, thereby controlling the heating or cooling of the patient'"'"'s blood.

35. A heat exchange catheter device for exchanging heat with a patient'"'"'s blood, the catheter comprising:

a shaft for insertion into the vasculature of the patient, said shaft having a thermally conductive core, a heat-absorbing surface, said heat-absorbing surface being thermally coupled to said thermally conductive core, said heat-absorbing surface comprising a thermally conductive metal and said thermally conductive core comprising a metallic core wherein the heat-absorbing surface comprises a metal foil that is substantially wrapped about the catheter shaft.

36. A heat exchange catheter device according to claim 35 wherein said thermally conductive metal is flexible.

37. A heat exchange catheter device according to claim 35 wherein the heat-absorbing surface is positioned so as to be in direct contact with the patient'"'"'s blood when the catheter shaft is inserted into the patient'"'"'s vasculature.

38. A heat exchange catheter device according to claim 35 wherein the heat-absorbing surface comprises a metal foil having a surface area exposed to blood contact of at least about 2 square centimeters.

39. A heat exchange catheter device according to claim 35 wherein said thermally conductive metal comprises a metal foil.

40. A heat exchange catheter device according to claim 35 wherein the thermally conductive metal has a thickness of approximately 0.001 mm to 0.01 mm.

41. A heat exchange catheter device according to claim 35 wherein the metal is selected from the group consisting of:

gold;

silver;

aluminum;

and copper.

42. A heat exchange catheter device according to claim 35 wherein the metal is encapsulated.

43. A heat exchange catheter device according to claim 35 wherein the thermally conductive metal is treated to enhance its biocompatability.

44. A heat exchange catheter device according to claim 43 wherein said cooler comprises a thermoelectric cooler.

45. A heat exchange catheter device according to claim 35 wherein the thermally conductive metal core contains a circulating heat exchange fluid.

46. A heat exchange catheter device according to claim 45 further comprising a heater, a cooler and a controller for selectively transferring heat into or out of the heat exchange fluid.

47. A heat exchange catheter device according to claim 35 wherein said thermally conductive core is conductively coupled to a cooler located externally to the catheter.

48. A heat exchange catheter device according to claim 47 wherein said cooler comprises a thermoelectric cooler.

49. A heat exchange catheter device according to claim 47 further comprising a heater, a cooler and a controller for selectively transferring heat into or our of the heat exchange fluid.

50. A system comprising a heat exchange catheter device according to claim 35 further in combination with:

a temperature sensor for sensing a temperature of the patient; and

a control unit that receives temperature information from the temperature sensor and in response to said temperature information selectively varies the amount of heat absorbed by said heat absorbing surface to thereby control the body temperature of the patient.

51. A system according to claim 50 wherein the thermally conductive core of the catheter device comprises a circulating heat exchange fluid and wherein the catheter device further comprises at least one of a) a heater for heating the heat exchange fluid such that heat will pass from the heat exchange fluid, through the heat absorbing surface and into the blood to cause warming of the patient'"'"'s blood and b) a cooler for cooling the heat exchange fluid such that heat will pass from the patient'"'"'s blood, through the heat absorbing surface and into the heat exchange fluid to cause cooling of the patient'"'"'s blood.

52. A system according to claim 51 wherein the control unit is operative to cause the heater or cooler to vary the temperature of the circulating heat exchange fluid, thereby controlling the heating or cooling of the patient'"'"'s blood.