Thermodilution catheter having a safe, flexible heating element

• US 5,857,976 A
• Filed: 06/07/1995
• Issued: 01/12/1999
• Est. Priority Date: 01/29/1991
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Quinn, Michael D., Yelderman, Mark L.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US08/485,125
• Time in Patent Office: 1,315 Days
• Field of Search: 600/505, 600/520, 600/561, 600/506
• US Class Current: 600/506
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00482 with a code
• CPC Class Codes: A61B 2018/00178 Electrical connectors
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00988 Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/028 by thermo-dilution
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/6855 with a distal curved tip
• CPC Class Codes: A61B 5/6856 with a distal loop
• CPC Class Codes: A61B 5/6857 with a distal pigtail shape

Abstract

A thermodilution catheter having a heating filament which is fabricated so as to be thin and flexible enough to avoid contact with the patient'"'"'s blood. The heating filament is either inserted in a preformed catheter lumen, incorporated into a wall of the catheter body itself, or wrapped around the catheter body wall and surrounded by an external sheath. Generally, the covering of the heating filament is minimally thin so as to allow the heat from the heating filament to be transferred to the surrounding blood and to minimally increase the overall cross-sectional area. Since the heating filament does not directly touch the patient'"'"'s blood, the outer surface may be made smooth so as to prevent inducement of blood clots. In addition, the heating filament may be maintained at a safe temperature by forming the heating element of a flexible material having a high temperature coefficient of resistance, low thermal capacitance and high thermal conductivity. Preferably, the temperature coefficient of resistance of the material forming the heater filament is greater than 0.001 Ω/Ω-° C. and the resistance of the heating filament is proportional or inversely proportional to its temperature. By monitoring this resistance, the application of power to the heating filament may be regulated to prevent overheating of the heating filament. Calibration techniques are also disclosed whereby a memory containing encoded calibration information is disposed within or connected to a connector of the catheter. This memory may also include a program segment used by a cardiac output computer having a cardiac output calculation program, whereby the portion of code stored in the memory must be input into the cardiac output computer before the determination of the cardiac output can be performed. As a result of these improvements, the invention enables the thermodilution cardiac output calculation to be performed quite safely and accurately in a clinical setting.

Claims

1. A thermodilution catheter apparatus for making a thermodilution measurement, comprising:

a flexible tubular catheter member adapted for introduction into a blood vessel of a patient, said catheter member having at least one lumen;

a flexible heating filament disposed with respect to said catheter member so as not to touch the patient'"'"'s blood when said catheter member is inserted into a blood vessel, the heating filament capable of being heated to apply a predetermined quantity of heat to blood in said blood vessel;

temperature detecting means for detecting downstream temperature variations of said blood as a result of the application of said predetermined quantity of heat to said blood;

means for providing a thermodilution measurement based on the detected temperature variations; and

wherein said heating filament can be slidably received into said at least one lumen.

2. An apparatus according to claim 1, further comprising:

a substantially cylindrical supporting member, and

wherein said at least one lumen has an inner diameter, said heating filament is wrapped in a thin layer about said supporting member, and said supporting member and said thin layer have a combined outer diameter which is approximately equal to said inner diameter of said at least one lumen.

3. An apparatus according to claim 2, wherein said heating filament is approximately 5 to 10 centimeters long and is disposed approximately 10 centimeters from said temperature detecting means.

4. An apparatus according to claim 1, wherein said heating filament has a temperature coefficient of resistance of at least about 0.001 Ohms per Ohm-degree Centigrade.

5. An apparatus according to claim 1, further comprising a memory disposed at a proximal end of said catheter member, said memory storing calibration information including at least one of

(1) heating filament resistance at a given temperature,

(2) heating filament heat transfer efficiency,

(3) heating filament temperature coefficient of resistance, and

(4) thermistor or thermocouple information.

6. An apparatus according to claim 5, wherein said memory stores heating filament calibration information.

7. An apparatus according to claim 6, wherein said memory stores heating filament temperature coefficient of resistance information.

8. An apparatus according to claim 1 further comprising means for determining cardiac output.

9. A thermodilution catheter apparatus for making a thermodilution measurement, comprising:

a flexible tubular catheter member adapted for introduction into a blood vessel of a patient, said catheter member having a one lumen;

a flexible heating filament slidably receivable into said lumen of said catheter member for applying through said catheter member a predetermined quantity of heat to blood in said blood vessel;

temperature detecting means for detecting downstream temperature variations of said blood as a result of the application of said predetermined quantity of heat to said blood;

means for providing a thermodilution measurement based on the detected temperature variations.

10. An apparatus according to claim 9, wherein said heating filament has a temperature coefficient of resistance of at least about 0.001 Ohms per Ohm-degree Centigrade.

11. An apparatus according to claim 9, further comprising a memory disposed at a proximal end of said catheter member, said memory storing calibration information including at least one of

(1) heating filament resistance at a given temperature,

(2) heating filament heat transfer efficiency,

(3) heating filament temperature coefficient of resistance, and

(4) thermistor or thermocouple information.

12. An apparatus according to claim 11, wherein said memory stores heating filament calibration information.

13. An apparatus according to claim 12, wherein said memory stores heating filament temperature coefficient of resistance information.

14. An apparatus according to claim 9 further comprising means for determining cardiac output.

15. A method of applying heat to blood in a blood vessel of a patient for a thermodilution measurement, comprising the steps of:

inserting a flexible tubular catheter member into said blood vessel of said patient;

slidably receiving a flexible heating filament through a lumen of said catheter member;

applying power to said heating filament so as to generate a predetermined quantity of heat, whereby said predetermined quantity of heat is conducted through said catheter member into said blood.

16. A method according to claim 15, wherein said heating filament has a temperature coefficient of resistance of at least about 0.001 Ohms per Ohm-degree Centigrade.

17. A method according to claim 15 further comprising the step of determining cardiac output.

18. A method of applying heat to blood in a blood vessel of a patient for a thermodilution measurement, comprising the steps of:

inserting a flexible tubular catheter member into said blood vessel of said patient;

slidably receiving a flexible heating filament through a lumen of said catheter member;

applying power to said heating filament so as to generate a predetermined quantity of heat, whereby said predetermined quantity of heat is conducted through said catheter member into said blood;

forming said heating filament from a material having a high temperature coefficient of resistance, wherein resistance of said heating filament is either proportional or inversely proportional to temperature and said heating filament has a low thermal capacitance and high thermal conductivity; and

reducing power to said heating filament when resistance of said heating filament exceeds a predetermined resistance amount.

19. A method according to claim 18 further comprising the step of determining cardiac output.

20. A method of thermodilution measurement, comprising the steps of:

inserting a flexible tubular catheter member into a blood vessel of a patient;

slidably receiving a flexible heating filament through a lumen of said catheter member;

applying power to said heating filament so as to generate a predetermined quantity of heat, whereby said predetermined quantity of heat is conducted through said catheter member into said blood; and

detecting downstream temperature variations of said blood as a result of conduction of said predetermined quantity of heat into said blood.

21. A method according claim 20, further comprising the step of calibrating said heating filament using information stored in a memory disposed at a proximal end of said catheter member, said memory storing calibration information including at least one of:

(1) heating filament resistance at a given temperature,

(2) heating filament heat transfer efficiency,

(3) heating filament temperature coefficient of resistance, and

(4) thermistor or thermocouple information.

22. A method according to claim 21, further comprising the steps of:

connecting said memory to a cardiac output computer;

transferring at least some of said calibration information from said catheter member to said cardiac computer; and

calculating cardiac output of said patient using said calibration information in said cardiac output computer.

23. A method according to claim 21, further comprising the steps of:

connecting said memory to a cardiac output computer; and

calculating a cardiac output of said patient using said calibration information stored in said memory.

24. A method according to claim 21, wherein said memory stores heating filament calibration information.

25. A method according to claim 24, wherein said memory stores heating filament temperature coefficient of resistance information.

26. A method according to claim 20 further comprising the step of determining cardiac output.

27. A method of applying heat to blood in a blood vessel of a patient for a thermodilution measurement, comprising the steps of:

slidably receiving a flexible heating filament through a lumen of a catheter member; and

applying power to said heating filament so as to generate a predetermined quantity of heat, whereby said predetermined quantity of heat is conducted through said catheter member into said blood when said catheter member is in said blood.

28. A method according to claim 27 wherein said heating filament has a low thermal capacitance.

29. A method according to claim 27 wherein said heating filament has a high thermal conductivity.

30. A method according to claim 27 and further comprising the step of forming said heating filament from a material having a high temperature coefficient of resistance, wherein said resistance of said heating filament is either proportional or inversely proportional to temperature.

31. A method according to claim 27 and further comprising the step of applying power to said heating filament so as to generate a predetermined quantity of heat, whereby said predetermined quantity of heat is conducted through said catheter member into said blood.

32. A method according to claim 27 further comprising the step of determining cardiac output.

33. A method of applying heat to blood in a blood vessel of a patient for a thermodilution measurement, comprising the steps of:

slidably receiving a flexible heating filament through a lumen of a catheter member; and

applying power to said heating filament so as to generate a predetermined quantity of heat, whereby said predetermined quantity of heat is conducted through said catheter member into said blood; and

reducing power to said heating filament when said resistance of said heating filament exceeds a predetermined resistance amount.

34. A method according to claim 33 further comprising the step of determining cardiac output.

35. A method of applying heat to blood in a blood vessel of a patient for a thermodilution measurement, comprising the steps of:

slidably receiving a flexible heating filament through a lumen of a catheter member;

applying power to said heating filament so as to generate a predetermined quantity of heat, whereby said predetermined quantity of heat is conducted through said catheter member into said blood; and

wherein said catheter is formed from a flexible material such that said catheter can be positioned in a patient to perform cardiac measurements.

36. A method according to claim 35 wherein said flexible material is a polyvinyl chloride.

37. A method according to claim 35 further comprising the step of determining cardiac output.