System and method for inducing hypothermia with active patient temperature control employing catheter-mounted temperature sensor and temperature projection algorithm

• US 7,458,984 B2
• Filed: 01/28/2004
• Issued: 12/02/2008
• Est. Priority Date: 01/23/1998
• Status: Expired due to Fees

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Innercool therapies Incorporated (Taxus Cardium Pharmaceuticals Group, Inc.)
• Inventors: Magers, Michael, Yon, Steve A.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US10/767,782
• Publication Number:
  US 20040267339A1
• Time in Patent Office: 1,770 Days
• Field of Search: 607/96, 607104-107
• US Class Current: 607/106
• 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 7/12 Devices for heating or cooling internal body cavities

Abstract

Embodiments of the invention provide a system for temperature control of the human body. The system includes an indwelling catheter with a tip-mounted heat transfer element. The catheter is fluidically coupled to a console that provides a heated or cooled heat transfer working fluid to exchange heat with the heat transfer element, thereby heating or cooling blood. The heated or cooled blood then heats or cools the patient'"'"'s body or a selected portion thereof. In particular, methods and devices, including software, are provided for administering cooling or rewarming and controlling the same based on a projected control temperature measured by a temperature sensor within the catheter.

Claims

1. In a system in which a working fluid is circulated through a catheter and a heal transfer element, the working fluid having a temperature different from a patient temperature, a method of controlling the administration of a thermal therapy, comprising:

entering a target patient temperature into the system;

inserting a catheter having a heat transfer element positioned at a distal tip of the catheter into a blood vessel of a patient, the catheter having a supply lumen fin supplying a working fluid to the heat transfer element and a return lumen for returning a working fluid from the heat transfer element;

circulating a working fluid through the catheter and the heat transfer element, the working fluid having a temperature different from the patient temperature;

circulating a working fluid and not determining a control temperature, for a predetermined period of time based on the difference between a temperature determined from a signal from a temperature sensor mounted at or adjacent the distal tip of the heat transfer element and the target patient temperature;

after the predetermined period of time, receiving a signal from the temperature sensor and determining a control temperature based on the signal;

using the control temperature to control the temperature of the working fluid.

2. The method of claim 1, further comprising causing the working fluid to stop circulating, and wherein the receiving includes:

allowing a first interval of time to pass; and

collecting data from the temperature sensor during a second interval of time. such that the allowing and collecting each follow the causing.

3. The method of claim 2, wherein no data is collected during the first interval.

4. The method of claim 3, wherein data is collected during the second interval at a predetermined frequency.

5. The method of claim 2, wherein the first interval is between about 5 and 15 seconds.

6. The method of claim 5, wherein the first interval is between about 10 and 12 seconds.

7. The method of claim 2, wherein the second interval is between about 10 and 30 seconds.

8. The method claim 7, wherein the second interval is between about 15 and 25 seconds.

9. The method of claim 2, wherein the first interval is about the same length of time as second interval.

10. The method of claim 2, wherein the first and second intervals are different lengths of time.

11. The method of claim 2, further comprising integrating a value of the signal over the first interval with respect to time to derive a first area.

12. The method of claim 11, further comprising integrating a value of the signal over the second interval with respect to time to derive a second area.

13. The method of claim 12, further comprising dividing the first area by the second area to calculate a value that is a function of a time constant of an exponential function.

14. The method of claim 13, further comprising constructing a look-up table for the function of the time constant and the results of the division of the first area by the second area.

15. The method of claim 14, further comprising determining a magnitude of the exponential function using the first area, the second area, and the time constant.

16. The method of claim 15, wherein the determining further comprises calculating the projected control temperature based on the signal from the temperature sensor as measured at the end of the second interval, the magnitude of the exponential function, and the time constant of the exponential function.

17. The method of claim 2, wherein the second interval of time is at least one minute.

18. The method of claim 2, wherein the time during which the working fluid is caused to stop circulating, divided by the sum of the time during which the working fluid is caused to stop circulating plus the time during which the working fluid is circulating, is greater than about 90%.

19. The method of claim 2, wherein the determining includes:

assuming a range of time constants for an exponential;

performing a least squares fit between the collected data and the exponential for each of the range of time constants to calculate an error value that is a function of the time constant; and

minimizing the error value to determine a unique value of the time constant.

20. The method of claim 19, further comprising using the unique value of the time constant to determine the projected control temperature.

21. The method of claim 19, further comprising determining the magnitude of the exponential.

22. The method of claim 19, further comprising determining a first-order linear component and adding the first-order linear component to the exponential to determine the projected control temperature.

23. The method claim 22, further comprising determining a higher-order components and adding the higher-order components to the exponential to determine the projected control temperature.

24. The method of claim 22, further comprising administering an anti-shivering agent to the patient.

25. The method of claim 1, wherein the temperature sensor is selected from the group consisting of thermistors, thermocouples, and combinations thereof.

26. The method of claim 25, wherein the temperature sensor is two thermistors, and further comprising receiving a safety monitor signal from one of the two thermistors.

27. The method of claim 26, further comprising causing the working fluid to stop circulating if a value of control temperature measured by the safety monitor signal falls outside a predetermined range.

28. The method of claim 27, wherein the predetermined range is 31°

C. to 37°

C.

29. The method of claim 1, wherein tile temperature sensor is disposed in a polymer tube.

30. The method of claim 29, wherein the polymer is polyamide.

31. The method of claim 1, wherein the temperature sensor is a thermistor.

32. The method of claim 1, wherein the working fluid has a temperature below the current patient temperature, and wherein the predetermined period of time is greater than about 30 minutes.

33. The method of claim 1, wherein the working fluid has a temperature above the current patient temperature, and wherein the predetermined period of time is greater than about 15 minutes.

34. The method of claim 1, wherein the predetermined period of time is directly proportional to the difference between the current patient temperature and the target patient temperature.

35. The method of claim 1, wherein the circulating includes circulating the working fluid at a maximum pump speed.

36. The method of claim 1, wherein the circulating includes circulating the working fluid at a power of pump speed which is proportional to the difference between the current patient temperature and the target patient temperature.

37. The method of claim 1, wherein the predetermined period of rime is determined by the initial patient temperature minus the sum of the target patient temperature and a constant, divided by the maximum rate of change of temperature, pertaining to a desired thermal therapy.

38. The method of claim 37, wherein the desired thermal therapy is inducing hypothermia.

39. The method of claim 37, wherein the desired thermal therapy is rewarming.

40. The method of claim 1, wherein the temperature sensor is encapsulated in a metal tube.

41. A heat transfer catheter for inducing a therapeutic state of hypothermia in a patient, for maintaining the temperature of a patient, or for rewarming a patient, comprising:

a catheter having a proximal end capable of being coupled to an input of a source of working fluid and a distal end coupled to a heat transfer element;

a supply lumen disposed within the catheter, the proximal end of the supply lumen capable of being coupled to an output of a source of working fluid and a distal end terminating at or within the heat transfer element; and

a temperature sensor disposed on or within the heat transfer element,

wherein the heat transfer element includes at least two heat transfer segments separated by a flexible joint, and

wherein the heat transfer segments have helical ridges and grooves.

42. The catheter of claim 41, wherein the flexible joint includes bellows.

43. A heat transfer catheter for inducing a therapeutic stale of hypothermia in a patient, for maintaining the temperature of a patient, or for rewarming a patient, comprising:

a catheter having a proximal end capable of being coupled to an input of a source of working fluid and a distal end coupled to a heat transfer element;

a supply lumen disposed within the catheter, the proximal end of the supply lumen capable of being coupled to an output of a source of working fluid and a distal end terminating at or within the heat transfer element; and

a temperature sensor disposed on or within the heat transfer element,

wherein the heat transfer element includes a straight supply lumen and a helical return lumen, the helical return lumen encircling the straight supply lumen.

44. The catheter of claim 43, wherein the heat transfer element includes a straight supply lumen and multiple helical return lumens, the multiple helical return lumens encircling the straight supply lumen.