System and method for patient temperature control employing temperature projection algorithm

• US 6,974,463 B2
• Filed: 08/14/2002
• Issued: 12/13/2005
• Est. Priority Date: 02/09/1999
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Innercool therapies Incorporated (Taxus Cardium Pharmaceuticals Group, Inc.)
• Inventors: Magers, Michael, Yon, Steve
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US10/219,874
• Publication Number:
  US 20030088299A1
• Time in Patent Office: 1,217 Days
• Field of Search: 607104-107, 607/113, 604 20- 21, 606 20- 23
• US Class Current: 606/105
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0056 for cooling
• CPC Class Codes: A61F 2007/0086 with a thermostat
• CPC Class Codes: A61F 2007/0093 programmed
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/0096 with a thermometer
• CPC Class Codes: A61F 2007/0288 during operations
• 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
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/006 having a special surface topography or special surface properties, e.g. roughened or knurled surface
• CPC Class Codes: A61M 2205/3606 cooled
• 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 25/0023 by the form of the lumen, e.g. cross-section, variable diameter

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. A method of controlling the administration of a thermal therapy, comprising:

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 for 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;

receiving a signal from a temperature sensor mounted in one of the supply lumen or the return lumen;

determining a control temperature based on the signal; and

using the control temperature to control the temperature of the working fluid, and

further comprising causing the working fluid to stop circulating, and wherein the receiving includes;

allowing a first interval of time to pass;

collecting data from the temperature sensor during a second interval of time,

such that the allowing and collecting each follow the causing.

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

3. The method of claim 2, wherein the temperature sensor is two thermistors, and further comprising receiving a safety monitor signal from one of the two thermistors.

4. The method of claim 1, wherein no data is collected during the first interval.

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

6. The method of claim 4, further comprising causing the working fluid to stop circulating, and wherein the receiving includes:

collecting data from the temperature sensor during an interval of time.

7. The method of claim 4, wherein the temperature sensor is selected from the group consisting of thermistors, thermocouples, and combinations thereof.

8. The method or claim 1, wherein the first interval is between about 5 and 15 seconds.

9. The method of claim 8, wherein the first interval is between about 10 and 12 seconds.

10. The method of claim 8, wherein the temperature sensor is two thermistors, and further comprising receiving a safety monitor signal from one of the two thermistors.

11. The method of claim 9, 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.

12. The method of claim 1, wherein the second interval is between about 10 and 30 seconds.

13. The method of claim 12, wherein the second interval is between about 15 and 25 seconds.

14. The method of claim 1, wherein the temperature sensor is disposed in a polymer tube within the supply lumen or the return lumen.

15. The method of claim 1, wherein the temperature sensor is disposed in the return lumen.

16. The method of claim 14, wherein the polymer is polyamide.

17. The method of claim 1, wherein tho first interval is about the same length of time as the second interval.

18. The method of claim 1, wherein the first and second intervals are different lengths of time.

19. The method of claim 1, further comprising integrating a value of the signal over the first interval with respect to time in derive a first area.

20. The method of claim 19, further comprising integrating a value of the signal over the second interval with respect to time to derive a second area.

21. The method of claim 20, 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.

22. The method of claim 21, 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.

23. The method of claim 22, further comprising determining a magnitude of the exponential function using the first area, the second area, and the time constant.

24. The method of claim 23, 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.

25. The method of claim 1, wherein the second interval of time is at least one minute.

26. The method of claim 1, 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%.

27. The method of claim 1, further comprising circulating a working fluid, and not determining a control temperature, for a predetermined period of time based on the difference between a current patient temperature and a target patient temperature.

28. The method of claim 27, wherein the working fluid has a temperature below the current patient temperature, and wherein the predetermined period or time is greater than about 30 minutes.

29. The method of claim 27, 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.

30. The method of claim 27, wherein the predetermined period of time is directly proportional to the difference between the current patient temperature and the target patient temperature.

31. The method of claim 27, wherein the circulating includes circulating the working fluid at a maximum pump speed.

32. The method of claim 27, 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.

33. The method of claim 27, wherein the predetermined period of time 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.

34. The method of claim 33, wherein the desired thermal therapy is inducing hypothermia.

35. The method of claim 33, wherein the desired thermal therapy is rewarming.

36. The method of claim 1, 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.

37. The method of claim 36, further comprising using the unique value of the time constant to determine the projected control temperature.

38. The method of claim 36, further comprising determining the magnitude of the exponential.

39. The method of claim 36, further comprising determining a first-order linear component and adding the first-order linear component to the exponential to determine the projected control temperature.

40. The method of claim 39, further comprising determining a higher-order components and adding the higher-order components to the exponential to determine the projected control temperature.

41. The method of claim 1, further comprising administering an anti-shivering agent to the patient.

42. The method of claim 1, wherein the temperature sensor is a thermistor or thermocouple.

43. The method of claim 1, wherein the temperature sensor is a thermistor or thermocouple.

44. A computer program, residing on a computer-readable medium, for causing a machine to:

receive a signal from a temperature sensor mounted in one of a supply lumen or a return lumen in which a working fluid is flowing;

cause the working fluid to stop flowing;

allow a first interval of time to pass;

collect data from the temperature sensor during a second interval of time;

determine a control temperature based on the collected data; and

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

45. A computer program, residing on a computer-readable medium, for causing a machine to:

receive a signal from a temperature sensor mounted in one of a supply lumen or a return lumen or a wall of the supply lumen or return lumen in which a working fluid is flowing;

cause the working fluid to stop flowing;

collect data from the temperature sensor during an interval of time;

determine a control temperature based on the collected data; and

use the control temperature to control the temperature or flow rule of the working fluid.