System for quantifying blood flow in tissue and updating tissue baseline conditions

• US 20100241016A1
• Filed: 05/25/2010
• Published: 09/23/2010
• Est. Priority Date: 04/05/2002
• Status: Active Grant

• Current Assignee: Thermal Technologies Incorporated
• Original Assignee: Thermal Technologies Incorporated
• Inventors: Martin, Gregory T., Bowman, H. Frederick
• Granted Patent: US 8,454,525 B2
• Time in Patent Office: Days
• US Class Current: 600/504
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/028 by thermo-dilution
• CPC Class Codes: A61B 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant

Abstract

Methods and apparatus for determining blood flow in tissue are disclosed. The methods and apparatus are used to establish a baseline for both thermal properties of the tissue and non-physiologic conditions. Periodic changes in either or both constituents of the baseline are determined and, when the changes correspond to a need for a new baseline, a new baseline is established.

Claims

1. A method for determining perfusion in living tissue comprising the steps of:

(1) establishing baseline criteria, comprising

(A) determining an unperturbed temperature in a capillary bed;

(B) causing the temperature in the capillary bed to change from a first unperturbed temperature to a second temperature different from said first temperature for a time period, and

(C) determining a value or values for one or more thermal properties in the capillary bed during a first selected portion of said time period;

(2) calculating, using a computing unit, a perfusion value for blood in the capillary bed at a second selected portion of said time period using said thermal property value or values, and

(3) evaluating, using a computing unit, one or more physiological and artifactual conditions to determine if baseline criteria established by step (1) are materially affected by said conditions and if so repeating step (1).

2. A method for determining the perfusion of blood in a volume of tissue comprising the steps of:

(1) establishing thermal baseline criteria corresponding to thermal conditions of the volume of tissue comprising determining an unperturbed tissue temperature;

(2) causing the temperature of the volume of tissue to change from the unperturbed temperature to a second temperature different from the unperturbed temperature during a time interval;

(3) calculating, using a computing unit, at least one of an intrinsic thermal conductivity value and a thermal diffusivity value for the volume of tissue during a first selected portion of said time interval;

(4) calculating, using a computing unit, perfusion in the volume of tissue at a second selected portion of said time interval using said value;

(5) determining need for new baseline criteria for the tissue comprising evaluating one or both of physiologic and artifact conditions; and

(6) repeating step (1) when indicated by step (5).

3. A method for determining perfusion in a volume of tissue comprising the steps of:

(1) establishing baseline criteria, comprising

(A) determining an unperturbed temperature of the tissue;

(B) causing the temperature of the tissue to change from a first unperturbed temperature to a second temperature different from said first temperature for a time period, and

(C) determining a value or values for one or more thermal properties of tissue during said time period;

(2) calculating, using a computing unit, a perfusion value for the tissue during said time period using said thermal property value or values, and

(3) evaluating, using a computing unit, one or more physiological and artifactual conditions to determine if baseline criteria established by step (1) are materially affected by said conditions and if so repeating step (1).

4. A method according to claim 3 wherein said thermal properties include one or both of thermal conductivity and thermal diffusivity.

5. Apparatus for determining the perfusion of blood in living tissue comprising:

means in thermal contact with the tissue for sensing the reference temperature of the tissue when the tissue is unheated;

means in thermal contact with the tissue for heating the tissue;

means for applying power to said heating means sufficiently rapidly to raise the temperature of said heating means to a temperature above said reference temperature so that the power necessary to maintain said heating means temperature varies as a function of time;

data processing means for determining the temperature difference between said heating means temperature and said reference temperature, for determining the resistance of said heating means at said heating means temperature and for determining the time varying relationship between the power required to maintain said heating means at said heating means temperature after said temperature has been reached and the time during which said power is being applied thereto;

said data processing means further being responsive to said temperature difference, said heating means resistance and said time varying power and time relationship for determining a perfusion related value; and

means for evaluating conditions that affect the reference temperature of the tissue and recognizing conditions under which the reference temperature is no longer valid; and

means for providing an output in response to said evaluating and recognizing means.

6. Apparatus according to claim 5 further comprising means for automatically calibrating said sensing means in response to said output.

7. Apparatus according to claim 5 wherein said recognizing means comprises means for recognizing one or more physiological and artifactual conditions.

8. Apparatus according to claim 7 wherein the artifactual conditions comprise one or more of

ambient temperature changes,

electrical interference,

instrumentation drift,

excessive sensor-tissue contact force that can induce capillary collapse,

insufficient sensor-tissue contact force that can result in artifactual transduction of perfusion,

sensor cross-talk, and

motion of the sensor relative to the tissue.

9. A system according to claim 7 wherein the physiological conditions comprise one or more of:

tissue and vascular damage,

tissue edema,

tissue scar formation,

influence of a large vessel,

change in vascular status (e.g.;

blood volume, vasodilation, and vasoconstriction),

changes in perfusion,

changes in blood pressure,

changes in tissue pressure,

changes in tissue temperature,

changes in blood temperature, and

changes in tissue metabolism.

10. Apparatus for determining the perfusion of blood in living tissue comprising:

means adapted to contact tissue for sensing a reference temperature of the tissue when the tissue is unheated;

a heating element for heating tissue including tissue contacted by said heating element, said heating element having a predetermined thermal conductivity and a predetermined thermal diffusivity;

means for applying power to said heating element sufficiently rapidly to raise the temperature of said heating element above said reference temperature so that the power necessary to maintain said heating element temperature varies as a function of time;

data processing means for determining the temperature difference between said heating element temperature and said reference temperature, for determining the resistance of said heating element at said heating element temperature and for determining the time varying relationship between the power required to maintain said heating element at said temperature after said temperature has been reached and the time during which said power is being applied thereto;

said data processing means further being responsive to said temperature difference, said heating element resistance, said applied power in accordance with said time varying power and time relationship, said predetermined thermal conductivity and/or diffusivity of said heating element, and a change in said reference temperature for determining the thermal conductivity and/or the thermal diffusivity of the tissue;

means for computing the perfusion of blood in the tissue as a function of the thermal conductivity and/or the thermal diffusivity of the tissue; and

means for evaluating conditions that affect the reference temperature of the tissue and recognizing conditions under which the reference temperature is no longer valid; and

means for providing an output in response to said evaluating and recognizing means.

11. Apparatus in accordance with claim 10, wherein said sensing means and said heating element comprises a single element capable of sensing the temperature of the tissue and of heating the tissue.

12. Apparatus in accordance with claim 11 wherein said single element is a thermistor bead element.

13. Apparatus in accordance with claim 11, and further including means for maintaining said heating element temperature at a fixed, predetermined value above said reference temperature, said reference temperature being determined and said heating element temperature being maintained over a relatively short time interval during which said reference temperature remains substantially constant whereby said temperature difference and the resistance of said heating element also remain substantially constant.

14. Apparatus in accordance with claim 10, wherein said heating element and said sensing means comprise respectively

a first element adapted to be immersed at a first region of the tissue for heating the first region of the tissue;

and

a second element adapted to be immersed at a second region of the tissue sufficiently remote from said first region as to be not materially affected by the heating of said first element.

15. Apparatus in accordance with claim 14 wherein said first and second elements are thermistor bead elements.

16. Apparatus in accordance with claim 14, for use over a relatively long time period during which said reference temperature varies with time and wherein said second element determines said reference temperature over said time period;

and further including

means for maintaining said first element temperature and the resistance of said first element at said first element temperature at fixed predetermined values over said time period during which said reference temperature varies whereby the temperature difference there between varies over said time period.

17. Apparatus in accordance with claim 14, for use over a relatively long time period during which said reference temperature varies with time wherein said second element determines said reference temperature over said time period;

and further including

means for determining the first element temperature over said time period as a function of said reference temperature and a preselected fixed value of said temperature difference;

means for maintaining the resistance of said first element over said time period at a value such as to maintain the temperature difference between said first element temperature and said reference temperature at said preselected fixed value, said resistance varying as a function of time; and

means for determining the thermal conductivity of the tissue over said time period as a function of said temperature difference, said resistance of said first element, the power applied to heat said first element and said thermal conductivity of said first element.

18. Apparatus in accordance with claim 17, wherein said data processing system includes

means for determining the intrinsic thermal conductivity k_m of the tissue when no fluid is flowing therein;

means for determining the effective thermal conductivity k_eff(t) of the tissue when a fluid having a predetermined heat capacity is flowing therein;

means for determining the ratio of k_eff(t)/k_m over said time period; and

means for determining the rate of flow ω

(t) of said fluid in the tissue as a function of said ratio.

19. Apparatus in accordance with claim 14, for use over a relatively long time period during which said reference temperature varies with time wherein said second element determines said reference temperature over said time period;

and further including

means for determining the resistance of said second element over said time period;

means for determining the desired resistance of said first element over said time period as a function of the resistance of said second element and of a preselected fixed value of the resistance difference between the resistances of said second and said first elements;

means for maintaining the resistance of said first element at said desired resistance so that said resistance difference is maintained at said predetermined fixed value, the resistance of said second element varying as a function of time;

means for determining the temperature of said first element over said time period at said desired resistance of said first element, said temperature varying as a function of time;

means for determining the temperature difference between said first element temperature and said reference temperature over said time period, said temperature difference varying as a function of time; and

means for determining the thermal conductivity of the tissue over said time period as a function of said temperature difference, said resistance of said first element, the power applied to heat said first element and the conductivity of said first element.

20. Apparatus in accordance with claim 19, wherein said data processing system includes

means for determining the intrinsic thermal conductivity k_m of the tissue when no fluid is flowing therein;

means for determining the effective thermal conductivity k_eff(t) of the tissue when a fluid having a predetermined heat capacity is flowing therein;

means for determining the ratio of k_eff(t)/k_m over said time period; and

means for determining the rate of flow ω

(t) of said fluid as a function of said ratio.

21. Apparatus according to claim 10 wherein said evaluating and recognizing means comprises means for recognizing one or more physiological and artifactual conditions.

22. Apparatus according to claim 21 wherein the artifactual conditions comprise one or more of

ambient temperature changes,

electrical interference,

instrumentation drift,

excessive sensor-tissue contact force that can induce capillary collapse,

insufficient sensor-tissue contact force that can result in artifactual transduction of perfusion,

sensor cross-talk, and

motion of the sensor relative to the tissue.

23. A system according to claim 21 wherein the physiological conditions comprise one or more of:

tissue and vascular damage,

tissue edema,

tissue scar formation,

influence of a large vessel,

change in vascular status (e.g.;

blood volume, vasodilation, and vasoconstriction),

changes in perfusion,

changes in blood pressure,

changes in tissue pressure,

changes in tissue temperature,

changes in blood temperature, and

changes in tissue metabolism.