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

• US 5,553,622 A
• Filed: 11/04/1994
• Issued: 09/10/1996
• 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): Sykes, Angela D.
• Assistant Examiner(s): NASSER, ROBERT L
• Application Number:
  US08/334,443
• Time in Patent Office: 676 Days
• Field of Search: 128/691, 128/692, 128/713, 128/736, 219/497, 374/163, 374/185
• 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 is 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;

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

condition determining means, in communication with said surface temperature calculating 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;

wherein said condition determining means comprises

(i) means for detecting when the surface temperature exceeds a predetermined physiologically safe temperature limit, and

(ii) time-temperature product determining means, for determining a time-temperature product of (1) time during which the surface temperature is above the predetermined physiologically safe temperature limit and (2) extent to which the surface temperature exceeds the predetermined physiologically safe temperature limit,

(iii) a time based integrator for collecting and storing the time-temperature product; and

(iv) means, in communication with said time based integrator, for comparing the time-temperature product to a predetermined maximum time-temperature value; and

the system further comprising condition indicating means, in communication with said condition determining means, for indicating when the time-temperature product exceeds the predetermined maximum time-temperature value.

2. A system according to claim 1, wherein said control means is in communication with said time-temperature product determining means and comprises means for reducing the amount of the electric power delivered to said thermodilution heater element when said condition indicating means indicates that the time-temperature product has exceeded the predetermined maximum time-temperature value.

3. A system according to claim 1, wherein the condition determining means further comprises time measuring means for measuring the amount of time that is taken for the time-temperature product to exceed the predetermined maximum value;

and

the system further comprises means for warning an operator to check the position of said thermodilution catheter if the amount of time measured by the time measuring means is less than a predetermined minimum value.

4. A system according to claim 1, wherein the condition determining means further comprises means for measuring the amount of time that is taken for the time-temperature product to exceed the predetermined maximum value;

and

the system further comprises means for warning an operator that a low flow situation exists if the amount of time measured by the means for measuring the amount of time that is taken for the time-temperature product to exceed the predetermined maximum value is less than a predetermined minimum value.

5. 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.

6. A system according to claim 5, 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 its electrical resistance determined by said resistance monitor.

7. A system according to claim 6, wherein core temperature calculating means functions to calculate the core temperature based on:

(a) a reference resistance at a reference temperature; and

(b) a temperature coefficient of electrical resistance of said thermodilution heater element.

8. A system according to claim 7, wherein said core temperature calculating means further functions to calculate the ore 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.

9. A system according to claim 5, 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.

10. 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.

11. A system according to claim 1, wherein the control means comprises means for reducing the amount of the electric power delivered to said thermodilution heater element when the surface temperature exceeds the safe physiological temperature limits.

12. A system according to claim 11, wherein said surface temperature calculating means functions to calculate the surface temperature based on factors which comprise values for:

(a) the core temperature;

(b) the electric power that is delivered to said thermodilution heating element; and

(c) information that has been empirically determined for said thermodilution catheter under anticipated clinical conditions.

13. A system according to claim 11, wherein said surface temperature calculating means further functions to calculate 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 power delivered to said thermodilution heater element to the incremental increases in the surface temperature that will be created by the power under anticipated clinical conditions;

P_element is the amount of the electric power that is delivered to said thermodilution heater element; and

b is a numerical constant.

14. 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;

wherein said power source comprises means for supplying power at, electively, either a first fixed power level or a second fixed power level which is greater than the first fixed power level; and

said control means controls whether said power source supplies power at the first fixed power level or the second fixed power level.

15. A system according to claim 14, wherein said control means is configured to function such that:

(a) when power is being supplied from said power source to said thermodilution heater element at the first fixed power level, said control means instructs said power source to begin supplying power at the second fixed power level when the core temperature monitored by said core temperature monitor is equal to or less than a first predetermined temperature value; and

(b) when power is being supplied from said power source to said thermodilution heater element at the second fixed power level, said control means instructs said power source to begin supplying power at the first fixed power level when the core temperature monitored by said core temperature monitor is equal to or greater than a second predetermined temperature value; and

(c) the first predetermined temperature value is less than the second predetermined temperature value.

16. A system according to claim 15, wherein, during start-up of the system, said control means functions select either the first power level or the second power level.

17. 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) 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;

(e) determining, based at least in part on the surface temperature, whether a potentially physiologically harmful temperature condition exists; and

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

wherein step (e) comprises the steps of;

(i) collecting and storing a time-temperature integration product based on the extent to which surface temperature exceeds a predetermined safe temperature limit; and

(ii) comparing the time-temperature product to a predetermined maximum time-temperature value.

18. A method according to claim 17, further comprising the step of reducing the amount of the electrical power that is supplied to said thermodilution heater element when the time-temperature integration product exceeds the predetermined maximum time-temperature value.

19. A method according to claim 17, wherein step (e) further comprises measuring the amount of time that is taken for the time-temperature integration product to exceed the predetermined maximum time-temperature value;

and

said method further comprising the step of

warning an operator to check the position of said thermodilution catheter if the amount of time that is measured for the time-temperature integration product to exceed the predetermined maximum value is less than a predetermined minimum time value.

20. A method according to claim 17, wherein step (e) further comprises measuring the amount of time that is taken for the time-temperature integration product to exceed the predetermined maximum time-temperature value;

and

said method further comprising the step of

warning an operator that a low flow situation exists if the amount of time that is measured for the time temperature integration product to exceed the predetermined maximum time-temperature value is less than a predetermined minimum time value.

21. 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,

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

wherein step (d) is performed by alternating the amount of the electrical power that is supplied to said thermodilution heater element between a first fixed power level and a second fixed power level which is greater than the first fixed power level.

22. 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;

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

wherein step (d) is further performed by;

(i) when the electric power is being supplied at a first power level, increasing the electric power to second power level when the core temperature is equal to or less than a first predetermined temperature value; and

(ii) when the electric power is being supplied at the second power level, decreasing the electric power to the first power level when the core temperature is equal to or greater than a second predetermined temperature value; and

(iii) wherein the first predetermined temperature value is less than the second predetermined temperature value.

23. 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;

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

condition determining means, in communication with said surface temperature calculating means, for determining when a potentially physiologically harmful temperature condition exists;

control means, in communication with said core temperature monitors, 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;

wherein said condition determining means comprises means for determining when the surface temperature exceeds a predetermined physiologically safe temperature limit; and

further comprising means, in communication with said determining means, for warning an operator to check the position of said thermodilution catheter when the surface temperature exceeds the predetermined safe physiological temperature limit.