System and method for controlling the temperature of a catheter-mounted heater

• US 5,755,670 A
• Filed: 02/21/1996
• Issued: 05/26/1998
• Est. Priority Date: 01/29/1991
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: McKown, Russell C., Quinn, Michael D., Yelderman, Mark L.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US08/603,552
• Time in Patent Office: 825 Days
• Field of Search: 128/692, 128/713, 128/736, 606/27-31, 600/481, 600/504-567, 600/526, 600/549
• US Class Current: 600/505
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00482 with a code
• CPC Class Codes: A61B 2018/00166 Multiple lumina
• 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
• CPC Class Codes: G05D 23/2401 using a heating element as a sensing element

Abstract

A system for keeping the surface temperature of an electric resistance-type heater element in a thermodilution catheter within safe physiological limits includes, in the preferred embodiment, a heater element core temperature monitor, a monitor for monitoring the power that is supplied to the heater element, and a surface temperature calculator for calculating the surface temperature of the heater element based on the core temperature, supplied power, and information representing the characteristics of the particular catheter under anticipated clinical conditions. A second aspect of the invention involves a system for determining the supply of power to the heater element based on the core temperature of the heater element. A third aspect of the invention involves a system readiness test for determining, in vivo, that the thermodilution catheter system is properly calibrated before the system is operational. Methods of operation for each of the above-referenced aspects of the invention are also disclosed.

Claims

1. A system for keeping a surface temperature of a blood contacting surface of a thermodilution catheter within safe physiological limits, comprising:

a core temperature monitor for monitoring a core temperature of a core of an electric resistance-type thermodilution heater element of the thermodilution catheter;

a power source for supplying electric power to said thermodilution heater element;

a power monitor for monitoring an amount of the electric power that is supplied to said thermodilution heater element;

condition determining means, for determining when a potentially physiologically harmful temperature condition exists; and

control means, in communication with said core temperature monitor, said power monitor, said power source, and said condition determining means, for controlling the amount of the electric power that is supplied to said thermodilution heater element by said power source, to keep the surface temperature within safe physiological limits.

2. A system according to claim 1, further comprising a resistance monitor which is adapted for communication with said heater element and said core temperature monitor, for monitoring the electrical resistance of said thermodilution heater element.

3. A system according to claim 2, wherein said core temperature monitor comprises a core temperature calculating means for calculating the core temperature of said thermodilution heater element as a function of electrical resistance of said thermodilution heater element as determined by said resistance monitor.

4. A system according to claim 3, wherein said core temperature calculating means functions to calculate the core temperature based on:

(a) a reference resistance of the core at a reference temperature of the core; and

(b) a temperature coefficient of electrical resistance of the core.

5. A system according to claim 4, wherein said core temperature calculating means further functions to calculate the core temperature according to the formula:

space="preserve" listing-type="equation">T.sub.core =T.sub.0 +(R-R.sub.0)/(R.sub.0 *TCR);

where T_core is the core temperature;

T₀ is the reference temperature;

R is said thermodilution heater element resistance measured by said resistance monitor;

R₀ is the reference resistance; and

TCR is the temperature coefficient of electrical resistance of said thermodilution heater element.

6. A system according to claim 2, further comprising means for measuring voltage and current that are supplied to said thermodilution heater element and wherein said resistance monitor comprises means, in communication with said means for measuring, for calculating the electrical resistance of said thermodilution heater element based on the voltage and current that are measured by said means for measuring.

7. A system according to claim 1, further comprising means for measuring voltage and current that are supplied to said thermodilution heater element and wherein said power monitor comprises means, in communication with said means for measuring, for calculating the amount of the electric power that is delivered to said thermodilution heater element based on voltage and current that are measured by said means for measuring.

8. A system according to claim 1, wherein said condition determining means comprises means for determining when the surface temperature exceeds a predetermined physiologically safe temperature limit.

9. A system according to claim 1, further comprising:

surface temperature calculating means, in communication with said core temperature monitor and said power monitor, for calculating the surface temperature; and

wherein said condition determining means is also in communication with said surface temperature calculating means.

10. A system for keeping a surface temperature of a blood contacting surface of a thermodilution catheter within safe physiological limits, comprising:

a core temperature monitor for monitoring a core temperature of a core of an electric resistance-type thermodilution heater element of said thermodilution catheter;

a power source for supplying electric power to said thermodilution heater element;

a power monitor for monitoring the amount of electric power that is supplied to said thermodilution heater element; and

control means, in communication with said core temperature monitor and with said power monitor, for controlling the amount of the electric power that is supplied to said thermodilution heater element by said power source to maintain the surface temperature within safe physiological limits.

11. A system according to claim 10, further comprising a resistance monitor, in communication with the core temperature monitor, for monitoring electrical resistance of said thermodilution heater element.

12. A system according to claim 11, wherein said core temperature monitor comprises core temperature calculating means, which is in communication with said power monitor, for calculating the core temperature of said thermodilution heater element as a function of the electrical resistance of said thermodilution heater element determined by said resistance monitor.

13. A system according to claim 12, wherein said core temperature calculating means functions to calculate said thermodilution heater element core temperature based on:

(a) a reference resistance of the core at a reference temperature of the core; and

(b) a temperature coefficient of electrical resistance of the core.

14. A system according to claim 13, wherein said core temperature calculating means further functions to calculate said thermodilution heater element core temperature according to the formula:

space="preserve" listing-type="equation">T.sub.core =T.sub.0 +(R-R.sub.0)/(R.sub.0 *TCR);

where T_core is the core temperature;

T₀ is a reference temperature;

R is the resistance of said thermodilution heater element measured by said resistance monitor;

R₀ is the reference resistance; and

TCR is the temperature coefficient of electrical resistance of said thermodilution heater.

15. In combination, the system according to claim 10 and the thermodilution catheter.

16. The combination according to claim 15, wherein said thermodilution catheter further comprises a plurality of lumens.

17. The combination according to claim 15 further comprising a module for measuring mixed venous oxygen saturation including a fiber optic bundle, said fiber optic bundle being at least partially in one of said plurality of lumens.

18. In combination, the system according to claim 10 and the thermodilution catheter having the core element.

19. The combination according to claim 18 wherein said thermodilution catheter comprises a plurality of lumens and said core is inside of one of said plurality of lumens.

20. The combination according to claim 18 wherein said core is wound around an outside of said plurality of lumens.

21. A method for keeping a surface temperature of a blood contacting surface of a thermodilution catheter within safe physiological limits, comprising the steps of:

(a) monitoring a core temperature of a core of an electric resistance-type thermodilution heater element of said thermodilution catheter;

(b) supplying electric power to said thermodilution heater element;

(c) monitoring the amount of electric power that is supplied to said thermodilution heater element;

(d) determining whether a potentially physiologically harmful temperature condition exists; and

(e) controlling the amount of the electric power that is supplied to said thermodilution heater element to keep the surface temperature within safe physiological limits.

22. A method according to claim 21, wherein step (a) comprises the steps of:

(a)(i) monitoring the electrical resistance of said thermodilution heater element; and

(a)(ii) calculating the core temperature according to the formula;

space="preserve" listing-type="equation">T.sub.core =T.sub.0 +(R-R.sub.0)/(R.sub.0 *TCR);

where T_core is the core temperature;

T₀ is a reference temperature;

R is the electrical resistance;

R₀ is the electrical resistance at the reference temperature; and

TCR is temperature coefficient of the electrical resistance.

23. A method according to claim 21, wherein step (c) comprises the steps of:

(c)(i) measuring voltage and current that are supplied to said thermodilution heater element and

(c)(ii) calculating the power supplied to said thermodilution heater element based on the measured values of the voltage and the current.

24. A method according to claim 21, wherein step (d) comprises determining whether the surface temperature exceeds a predetermined safe physiological surface temperature limit.

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

(f) calculating the surface temperature, based at least in part on the core temperature and the amount of the electric power that is supplied to the thermodilution heater element; and

wherein the step of determining is based at least in part on the surface temperature.

26. A method according to claim 25, wherein step (f) is performed by calculating the surface temperature according to the formula:

space="preserve" listing-type="equation">T.sub.surface =m.sub.core * T.sub.core +m.sub.power * P.sub.element +b;

where T_surface is the surface temperature, m_core is a constant relating the core temperature to the surface temperature under anticipated clinical conditions;

T_core is the core temperature;

m_power is a constant relating the amount of electric power that is supplied to said thermodilution heater element to incremental increases in the surface temperature that are created by the amount of electrical power under anticipated clinical conditions;

P_element is the amount of electrical power that is supplied to said thermodilution heater element; and

b is a numerical constant.

27. A system for controlling a surface temperature of a blood contacting surface of a thermodilution catheter comprising:

a core temperature monitor for monitoring a core temperature of a core of an electric resistance-type thermodilution heater element of said thermodilution catheter;

a power source for supplying electric power to said thermodilution heater element;

a power monitor for monitoring an amount of the electric power that is supplied to said thermodilution heater element;

control means, in communication with said core temperature monitor, said power monitor and said power source, for controlling the amount of the electric power that is supplied to said thermodilution heater element by said power source, to keep the surface temperature within safe physiological limits; and

surface temperature calculating means, in communication with said core temperature monitor and said power monitor, for calculating the surface temperature.

28. A method for keeping a surface temperature of a blood contacting surface of a thermodilution catheter within safe physiological limits, comprising:

(a) monitoring a core temperature of a core of an electric resistance-type thermodilution heater element of said thermodilution catheter;

(b) supplying electric power to said thermodilution heater element;

(c) monitoring an amount of the electric power that is supplied to said thermodilution heater element by said power source; and

(d) controlling the amount of the electric power that is supplied to said thermodilution heater element by said power source based on the core temperature so that the surface temperature is kept within safe physiological limits.