Catheter system with on-board temperature probe

• US 6,679,906 B2
• Filed: 07/13/2001
• Issued: 01/20/2004
• Est. Priority Date: 07/13/2001
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: Roth, Alex T., Hammack, Amy L., Tremulis, William S., Stull, Paul M., Callister, Jeff P.
• Primary Examiner(s): Gibson, Roy D.
• Assistant Examiner(s): JOHNSON III, HENRY M
• Application Number:
  US09/905,389
• Publication Number:
  US 20030014094A1
• Time in Patent Office: 921 Days
• Field of Search: 607/105-106, 607/113
• US Class Current: 607/105
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00088 using thermistors
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0096 with a thermometer
• 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 for controlling the body temperature of a patient by modifying the temperature of blood flowing within a blood vessel of the patient. The catheter system comprises a catheter body having a heat exchange region in contact with the blood; and a temperature probe having a distal end that extends from the catheter body, thereby monitoring the temperature of blood flowing within the blood vessel.

Claims

1. A catheter system for sensing the temperature of a patient, the catheter system comprising:

a fluid flow heat exchange catheter having a shaft and a heat exchange region controlled by a flow of heat exchange fluid;

a temperature probe lumen, the lumen defining an aperture that is located proximal of the heat exchange region;

a deployable temperature probe, the temperature probe including a temperature sensor and a signal carrying mechanism that extends from the temperature sensor to a location outside of the patient, the temperature probe having an undeployed configuration and a deployed configuration, the temperature probe being movable between the undeployed and deployed configurations; and

a removable constraint that constraints the amount of movement of the temperature probe within the temperature probe humen, the temperature probe moving to the deployed configuration upon removal of the constraint by an operator;

wherein when the temperature probe is in the deployed configuration, the temperature sensor is located further from the shaft than when the temperature probe is in the undeployed configuration; and

wherein the temperature sensor generates a signal representing a sensed temperature and the signal carrying mechanism transmits the signal from the temperature sensor to the location outside the patient.

2. A catheter system in accordance with claim 1 wherein the temperature sensor comprises a thermistor.

3. A catheter in accordance with claim 2 wherein the temperature sensor comprises a second thermistor.

4. A catheter system in accordance with claim 1 wherein the shaft includes fluid flow lumens for flow of heat exchange fluid to the heat exchange region.

5. A catheter system in accordance with claim 1 wherein the temperature probe is deployed to the deployed configuration by at least one pull wire.

6. A catheter system in accordance with claim 1 wherein the temperature probe is in the form of a tube containing thermistor wires.

7. A catheter system in accordance with claim 1 wherein the temperature probe lumen is within the catheter shaft and coupled thereto.

8. A catheter system in accordance with claim 1 wherein the temperature probe lumen is external to the catheter shaft and coupled thereto.

9. A catheter system in accordance with claim 8 wherein the temperature probe lumen extends along only a portion of the catheter shaft.

10. A catheter system in accordance with claim 8 wherein the temperature probe lumen extends along an entire length of an inserted portion of the catheter shaft.

11. A catheter system in accordance with claim 1 wherein the temperature probe lumen is incorporated within the catheter shaft and wherein the temperature probe lumen is extruded with the catheter shaft and is within the outer diameter of the shaft.

12. A catheter system in accordance with claim 1 wherein the aperture is located at a distal end of the temperature probe lumen.

13. A catheter system in accordance with claim 12 wherein the aperture comprises a ramp.

14. A catheter system in accordance with claim 13 wherein the ramp includes a shaped surface and the temperature probe includes a portion configured to mate with the shaped surface of the ramp.

15. A catheter system in accordance with claim 14 wherein the shaped surface is flat.

16. A catheter system in accordance with claim 1 wherein the temperature sensor is in a range of 1.8-3.2 mm from the catheter shaft when the temperature probe is in the deployed configuration and is within the outer diameter of the catheter shaft when the temperature probe is in the undeployed configuration.

17. A catheter system in accordance with claim 1 further comprising a controller for receiving the signals from the signal carrying mechanism, the controller being configured to use the signals to control the body temperature of the patient by modifying the temperature of blood flowing within a blood vessel of the patient.

18. A catheter system in accordance with claim 1 wherein the catheter includes an atraumatic tip.

19. A method of monitoring the body temperature of a patient by monitoring the temperature of blood flowing within a blood vessel of the patient, the method comprising:

advancing a catheter body comprising a temperature probe lumen that extends along a catheter shaft and that includes an opening defined at a distal end portion into the patient'"'"'s blood vessel such that the opening is in contact with the patient'"'"'s blood; and

deploying a temperature probe from within the temperature probe lumen such that a distal end portion of the temperature probe protrudes through the opening into the blood flowing within the blood vessel, wherein the deployable temperature probe comprises shape memory material at a tip portion at the distal end portion such that when it warms, it curves through the opening.

20. A method in accordance with claim 19 wherein the distal end of the temperature probe lumen includes a ramp coupled to the opening thereby guiding the distal end portion through the opening.

21. A method in accordance with claim 19 wherein the temperature sensed is venous blood.

22. A method in accordance with claim 20 wherein the blood vessel is the inferior vena cava.

23. A method in accordance with claim 20 wherein the blood vessel is the femoral vein.

24. A catheter system for sensing the temperature of a patient, the catheter system comprising:

a catheter having a shaft and a heat exchange region;

a temperature probe lumen, the lumen defining an aperture that is located proximal of the heat exchange region; and

a deployable temperature probe, the temperature probe including a temperature sensor, a signal carrying mechanism that extends from the temperature sensor to a location outside of the patient, and a constraint that constrains the amount of movement of the temperature probe within the temperature probe lumen, the temperature probe having an undeployed configuration and a deployed configuration, the temperature probe being movable from the undeployed configuration to the deployed configuration upon removal of the constraint by an operator;

wherein when the temperature probe is in the deployed configuration, the temperature sensor is located further from the shaft than when the temperature probe is in the undeployed configuration; and

wherein the temperature sensor generates a signal representing a sensed temperature and the signal carrying mechanism transmits the signal from the temperature sensor to the location outside the patient.

25. A catheter system for sensing the temperature of a patient, the catheter system comprising:

a catheter having a shaft and a heat exchange region;

a temperature probe lumen, the lumen defining an aperture that is located proximal of the heat exchange region; and

a deployable temperature probe, the temperature probe including a temperature sensor and a signal carrying mechanism that extends from the temperature sensor to a location outside of the patient, the temperature probe having an undeployed configuration and a deployed configuration, the temperature probe being heat activated to move automatically between the undeployed and deployed configurations;

wherein when the temperature probe is in the deployed configuration, the temperature sensor is located further from the shaft than when the temperature probe is in the undeployed configuration; and

wherein the temperature sensor generates a signal representing a sensed temperature and the signal carrying mechanism transmits the signal from the temperature sensor to the location outside the patient.

26. A catheter system in accordance with claim 25 wherein the temperature probe comprises nitinol.

27. A catheter system for sensing the temperature of a patient, the catheter system comprising:

a catheter having a shaft and a heat exchange region;

a temperature probe lumen, the lumen defining an aperture that is located proximal of the heat exchange region; and

a deployable temperature probe, the temperature probe including a temperature sensor and a signal carrying mechanism that extends from the temperature sensor to a location outside of the patient, the temperature probe having an undeployed configuration and a deployed configuration, the temperature probe being spring activated to move automatically between the undeployed and deployed configurations;

wherein when the temperature probe is in the deployed configuration, the temperature sensor is located further from the shaft than when the temperature probe is in the undeployed configuration; and

wherein the temperature sensor generates a signal representing a sensed temperature and the signal carrying mechanism transmits the signal from the temperature sensor to the location outside the patient.

28. A catheter system for sensing the temperature of a patient, the catheter system comprising:

a catheter having a shaft and a heat exchange region;

a temperature probe lumen, the lumen defining an aperture that is located proximal of the heat exchange region; and

a deployable temperature probe, the temperature probe including a temperature sensor, a signal carrying mechanism that extends from the sensor to a location outside of the patient, and a biodegradable restraining element the temperature probe having an undeployed configuration and a deployed configuration, the temperature probe being automatically movable between the undeployed and deployed configurations;

wherein when the temperature probe is in the deployed configuration, the temperature sensor is located further from the shaft than when the temperature probe is in the undeployed configuration; and

wherein the temperature sensor generates a signal representing a sensed temperature and the signal carrying mechanism transmits the signal from the temperature sensor to the location outside the patient.

29. A catheter system for sensing the temperature of a patient, the catheter system comprising:

a catheter having a shaft and a heat exchange region;

a temperature probe lumen, the lumen defining an aperture that is located proximal of the heat exchange region; and

a deployable temperature probe, the temperature probe including a temperature sensor and a signal carrying mechanism that extends from the sensor to a location outside of the patient, the temperature probe having an undeployed configuration and a deployed configuration, the temperature probe being movable between the undeployed and deployed configurations;

a controller for receiving signals from the signal carrying mechanism, the controller being configured to use the signals to control the body temperature of the patient by modifying the temperature of blood flowing within a blood vessel of the patient;

wherein when the temperature probe is in the deployed configuration, the temperature sensor is located further from the shaft than when the temperature probe is in the undeployed configuration; and

wherein the temperature sensor generates a signal representing a sensed temperature and the signal carrying mechanism transmits the signal from the temperature sensor to the location outside the patient.

30. A method of monitoring the body temperature of a patient by monitoring the temperature of blood flowing within a blood vessel of the patient, the method comprising:

inserting a catheter body into the patient'"'"'s blood vessel, the catheter body including a temperature probe lumen that extends along a catheter shaft, the temperature probe lumen including an opening defined at a distal end portion of the lumen and a ramp coupled to the opening;

advancing the catheter body such that the opening is in contact with the patient'"'"'s blood; and

deploying a temperature probe from within the temperature probe lumen such that the ramp guides a distal end portion of the temperature probe through the opening and into the blood flowing within the blood vessel;

wherein the blood vessel is selected from the group consisting of the inferior vena cava and the femoral artery.

31. A method in accordance with claim 30 wherein the blood vessel is the inferior vena cava.

32. A method in accordance with claim 30 wherein the blood vessel is the femoral vein.

33. A catheter system for sensing the temperature of a patient, the catheter system comprising:

a fluid flow heat exchange catheter having a shaft and a heat exchange region controlled by a flow of heat exchange fluid;

a temperature probe lumen, the lumen defining an aperture that is located proximal of the heat exchange region; and

a deployable temperature probe selected from the group consisting of

a heat-activated temperature probe,

a spring-activated temperature probe, and

a temperature probe having a biodegradable restraining element,

the temperature probe including a temperature sensor and a signal carrying mechanism that extends from the temperature sensor to a location outside of the patient, the temperature probe having an undeployed configuration and a deployed configuration, the temperature probe being automatically movable between the undeployed and deployed configurations;

wherein when the temperature probe is in the deployed configuration, the temperature sensor is located further from the shaft than when the temperature probe is in the undeployed configuration; and

wherein the temperature sensor generates a signal representing a sensed temperature and the signal carrying mechanism transmits the signal from the temperature sensor to the location outside the patient.

34. A catheter system in accordance with claim 33 wherein the temperature probe is heat activated.

35. A catheter system in accordance with claim 34 wherein the temperature probe comprises a shape-memory material.

36. A catheter system in accordance with claim 35 wherein the temperature probe comprises nitinol.

37. A catheter system in accordance with claim 33 wherein the temperature probe is spring activated.

38. A catheter system in accordance with claim 33 wherein the temperature probe includes a biodegradable restraining element.