Method and apparatus for controlling a patient's body temperature by in situ blood temperature modification

• US 8,506,494 B2
• Filed: 10/31/2007
• Issued: 08/13/2013
• Est. Priority Date: 02/10/1993
• Status: Expired due to Fees

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Inventors: Ginsburg, Robert
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US11/932,509
• Publication Number:
  US 20080114431A1
• Time in Patent Office: 2,113 Days
• Field of Search: 600/481, 600/483, 600504-507, 600/549, 607/96, 607/113
• US Class Current: 600/481
• 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 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: 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: 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

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 comprising:

an elongate, flexible catheter body a distal portion of which is insertable into the vasculature of a patient;

a heat transfer surface disposed on less than the entirety of the distal insertable portion of the catheter body, said heat transfer surface comprising metal and having different thermal conductivity than the remainder of the distal insertable portion of the catheter body; and

apparatus for alternately warming or cooling the heat transfer surface;

wherein the catheter body has a proximal end, a distal end, a heat exchange inflow lumen through which heat exchange fluid is deliverable from the proximal end of the catheter body to the area of the catheter body where the heat exchange surface is located and a heat exchange return lumen through which said heat exchange fluid may flow from the area of the catheter body where the heat exchange surface is located and back out of the proximal end of the catheter body.

2. A system according to claim 1 further comprising a temperature sensor.

3. A system according to claim 2 wherein the temperature sensor is useable to measure the temperature of a subject'"'"'s blood when the catheter is inserted into that subject'"'"'s vasculature.

4. A system according to claim 2 wherein the temperature sensor is located on or in the catheter body.

5. A system according to claim 4 wherein the temperature sensor is spaced-apart from the heat transfer surface.

6. A system according to claim 4 wherein the temperature sensor is located upstream of the heat exchange surface when the catheter is inserted into the subject'"'"'s vasculature.

7. A system according to claim 4 wherein the temperature sensor is located downstream of the heat exchange surface when the catheter is inserted into the subject'"'"'s vasculature.

8. A system according to claim 1 wherein the heat transfer surface comprises a metal selected from the group consisting of:

gold, silver, aluminum and copper.

9. A system according to claim 1 wherein the heat transfer surface is located on a balloon through which the heat exchange fluid circulates.

10. A system according to claim 1 further comprising a control unit which controls the temperature of the heat transfer surface based on at least one measured temperature selected from the group consisting of:

i) blood temperature and ii) body temperature.

11. A system according to claim 10 wherein the catheter body has at least two lumens defined in fluid communication with one another to allow for the circulation of fluid through the catheter and wherein the control unit operates to circulate heated or cooled heat exchange fluid through those lumens.

12. A system according to claim 11 wherein the control unit comprises extracorporeal heat transfer apparatus for heating or cooling the heat exchange fluid.

13. A system according to claim 11 wherein the heat transfer surface comprises a balloon that is inflatable by circulation of fluid through the lumens of the catheter body.

14. A system according to claim 1 wherein the apparatus for alternately warming or cooling the heat transfer surface includes a power supply capable of supplying peak power in the range between 100 and 1500 watts.

15. A system according to claim 14 wherein the power supply is capable of supplying peak power in the range between 300 and 1000 watts.

16. A system according to claim 1 wherein the catheter body further comprises means for increasing the effective heat transfer surface area.

17. A system according to claim 16 wherein the means for increasing the effective heat transfer surface area comprises a rib or fin.

18. A system according to claim 17 wherein the means for increasing the effective heat transfer surface area comprises a helical rib or fin.

19. A system according to claim 1 wherein the temperature of the heat transfer surface is controlled to deter overshooting s target body temperature.

20. A heat exchange catheter system comprising:

an elongate, flexible catheter body a distal portion of which is insertable into the vasculature of a patient;

a heat transfer surface disposed on less than the entirety of the distal insertable portion of the catheter body, said heat transfer surface comprising metal and having different thermal conductivity than the remainder of the distal insertable portion of the catheter body;

apparatus for alternately warming or cooling the heat transfer surface; and

a control unit which controls the temperature of the heat transfer surface based on at least one measured temperature selected from the group consisting of;

i) blood temperature and ii) body temperature;

wherein the catheter body has at least two lumens defined in fluid communication with one another to allow for the circulation of fluid through the catheter and wherein the control unit operates to circulate heated or cooled heat exchange fluid through those lumens.

21. A system according to claim 20 further comprising a temperature sensor.

22. A system according to claim 21 wherein the temperature sensor is useable to measure the temperature of a subject'"'"'s blood when the catheter is inserted into that subject'"'"'s vasculature.

23. A system according to claim 21 wherein the temperature sensor is located on or in the catheter body.

24. A system according to claim 23 wherein the temperature sensor is spaced-apart from the heat transfer surface.

25. A system according to claim 23 wherein the temperature sensor is located upstream of the heat exchange surface when the catheter is inserted into the subject'"'"'s vasculature.

26. A system according to claim 20 wherein the heat transfer surface comprises a metal selected from the group consisting of:

gold, silver, aluminum and copper.

27. A system according to claim 20 wherein the catheter body has a proximal end, a distal end, a wherein the lumens comprise a heat exchange inflow lumen through which heat exchange fluid is deliverable from the proximal end of the catheter body to the area of the catheter body where the heat transfer surface is located and a heat exchange return lumen through which said heat exchange fluid may flow from the area of the catheter body where the heat exchange surface is located and back out of the proximal end of the catheter body.

28. A system according to claim 20 wherein the heat transfer surface is located on a balloon through which the heat exchange fluid circulates.

29. A system according to claim 23 wherein the temperature sensor is located downstream of the heat exchange surface when the catheter is inserted into the subject'"'"'s vasculature.

30. A system according to claim 20 wherein the control unit comprises extracorporeal heat transfer apparatus for heating or cooling the heat exchange fluid.

31. A system according to claim 20 wherein the heat transfer surface comprises a balloon that is inflatable by circulation of fluid through the lumens of the catheter body.

32. A system according to claim 20 wherein the catheter body further comprises means for increasing the effective heat transfer surface area.

33. A system according to claim 32 wherein the means for increasing the effective heat transfer surface area comprises a rib or fin.

34. A system according to claim 33 wherein the means for increasing the effective heat transfer surface area comprises a helical rib or fin.

35. A system according to claim 20 wherein the temperature of the heat transfer surface is controlled to deter overshooting of the target body temperature.