Temperature control and analysis system for hyperthermia treatment

• US 4,638,436 A
• Filed: 09/24/1984
• Issued: 01/20/1987
• Est. Priority Date: 09/24/1984
• Status: Expired due to Term

• Current Assignee: Busey First National Bank Race and Main
• Original Assignee: Labthermics Technologies, Inc.
• Inventors: McCarthy, John F., Leech, Steven C., Badger, Christopher W., Burdette, Everette C.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US06/654,603
• Time in Patent Office: 848 Days
• Field of Search: 364/413, 364/414, 364/415, 128/399, 128/401, 128/736, 128/783, 128/804, 374/121
• US Class Current: 607/102
• CPC Class Codes: A61B 2017/00092 using thermocouples
• CPC Class Codes: A61F 2007/0093 programmed
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A system for controlling a hyperthermia treatment device having energy applicators for heating a portion of a patient'"'"'s body to attain a predetermined temperature protocol for therapeutic treatment of patient tumors. The system monitors energy application and displays a video presentation of correlative temperature data to an operator who responds by adjusting the energy application to achieve the desired treatment protocol. The system further accumulates a hyperthermia treatment data base, and predetermined temperature protocols for the patient are prepared by comparison with data base protocols for similar tumor conditions. Various figures of merit are also determined and stored in the data base and ongoing treatments are comparerd with the data base to characterize the most effective treatment protocol.

Claims

1. A system for controlling a hyperthermia treatment device of the type which has applicator means for applying energy to attain a predetermined temperature protocol for portions of a patient'"'"'s body, the system monitoring said energy application and being capable of adjusting said energy application responsive to operator manipulation, said system comprising:

means for sensing temperature of the patient'"'"'s body and for providing a temperature signal;

computer means having associated instruction and data storage means for interacting with other systems means to perform the energy application, said computer means monitoring said temperature signal and adjusting said energy application responsive to the operator manipulation and having data and instructions defining said predetermined temperature protocol, said computer means utilizing said temperature signal and said protocol defining data and instructions to selectively provide an operator prompt signal indicating the desirability of the operator adjusting said energy application and further providing correlative temperature data associated with said portions of the patient'"'"'s body;

operator means responsive to the operator manipulation for providing an operator signal to control said energy applicator means via said computer means; and

means responsive to said correlative data and said protocol defining data and instructions for displaying a video presentation of said correlative temperature data to the operator, said correlative temperature data displayed in a color coded manner such that preselected colors represent predetermined temperature effectiveness zones of hyperthermia treatment, the operator capable of adjusting said energy application by evaluating said color coded video presentation and providing said operator signal.

2. The system as defined in claim 1 wherein said operator means comprises a remote interaction device.

3. The system as defined in claim 1 wherein said applicator means comprises an ultrasound energy applicator.

4. The system as defined in claim 1 wherein said correlative temperature data comprises selectively at least one of temperature data from (a) a group of said sensing means inside a tumor region, (b) a group of said sensing means outside said tumor region, (c) a mixture of groups from inside and outside said tumor region, (d) a group of said temperature sensing means within said preselected subelement wherein said system is adapted to control the temperature, and (e) a group of said temperature sensing means within and without each said preselected subelement wherein said system is adapted to control the temperature.

5. The system as defined in claim 1 wherein said video presentation comprises at least one of (a) a grid display illustrating subelement areas therein and further showing locations of said temperature sensing means with respect to said tumor and said locations depicted using said preselected color and (b) a bar graph in each said subelement area depicting power level input to each said subelement area.

6. The system as defined in claim 1 wherein said prompt signal comprises time-temperature state information displayed periodically with time.

7. The system as defined in claim 6 wherein said time-temperature state information comprises selectively a temperature sensor number, a digital temperature value, elapsed time and temperature difference from the temperature of said predetermined temperature protocol.

8. The system as defined in claim 1 wherein said correlative temperature data comprises means for showing time rate of temperature increase for each said temperature sensing means.

9. A system for controlling a hyperthermia treatment device applicator means for applying energy to attain a predetermined temperature protocol for treating a tumor in a portion of a patient'"'"'s body, the system cooperating with an operator to monitor and adjust said energy to achieve said protocol, said system comprising:

computer means for controlling said applicator means and coupled to operator means, temperature sensing means, video output means and alphanumeric output means;

operator means responsive to an operator input for providing an operator signal to control said applied energy to achieve said predetermined temperature protocol;

temperature sensing means for providing a temperature sensor signal to said computer means, said computer means utilizing said sensor signal and data and instructions characteristic of said predetermined temperature protocol and selectively providing a prompt signal requesting adjustment of said energy by the operator and further providing correlative temperature data associated with said portions of the patient'"'"'s body;

means for providing a video output responsive to said correlative temperature data;

means for providing an alphanumeric output responsive to said prompt signal; and

means responsive to said video output for displaying a video presentation to the operator of said correlative temperature data, said correlative temperature data displayable using a plurality of colors wherein each said color corresponds to predetermined temperature threshold zones of hyperthermia treatment and the operator responding to said request for energy adjustment by evaluating said video presentation and providing said operator signal.

10. The system as defined in claim 9 wherein said operator means comprises a remote interaction device.

11. The system as defined in claim 9 wherein said computer means utilizes said sensor signal and said preselected temperature protocol by comparing amplitudes of said sensor signal and said preselected temperature protocol.

12. The system as defined in claim 9 wherein said video presentation further includes a grid display illustrating location with respect to said tumor of said temperature sensing means, said temperature sensing means displayable using said plurality of colors corresponding to said threshold zones.

13. The system as defined in claim 9 wherein said temperature sensing means comprises a thermocouple disposed within said patient'"'"'s body.

14. The system as defined in claim 9 wherein said temperature sensing means comprises a thermistor.

15. The system as defined in claim 9 wherein said video presentation comprises at least one of (a) a grid display illustrating subelement areas therein and further showing locations of said temperature sensing means with respect to said tumor and said locations depicted using said preselected color and (b) a bar graph in each said subelement area depicting power level input to each said subelement area.

16. The system as defined in claim 9 wherein said prompt signal comprises time-temperature state information displayed periodically with time.

17. The system as defined in claim 16 wherein said time-temperature state information comprises selectively a temperature sensor number, a digital temperature value, elapsed time and temperature difference from the temperature of said predetermined temperature protocol.

18. The system as defined in claim 9 where said plurality of colors comprises a plurality of grey scale values for one fundamental color.

19. The system as defined in claim 9 wherein said correlative temperature data comprises means for showing time rate of temperature increase for each said temperature sensing means.

20. A method for preparing a predetermined hyperthermia treatment protocol for a tumor in a portion of a patient'"'"'s body using a hyperthermia treatment data base defining a plurality of general hyperthermia treatment protocols, comprising the steps of:

identifying location, size and type characteristics of said tumor in the patient'"'"'s body;

mapping data in said hyperthermia treatment data base corresponding to tumor characteristics identified in said patient'"'"'s body; and

modifying a selected one of said general hyperthermia treatment protocols for said tumor to account for said identified location, size and type characteristics of said tumor in said patient'"'"'s body to develop said predetermined hyperthermia treatment protocol.

21. A method under control of a computer and manipulated by an operator using a predetermined temperature protocol for accumulating a hyperthermia treatment data base for tumors in specific portions of a patient'"'"'s body, comprising the steps of:

(a) applying energy to heat said portions of the patient'"'"'s body;

(b) sensing temperatures in said portions of the patient'"'"'s body;

(c) comparing said sensed temperature with temperature from said predetermined temperature protocol;

(d) selectively generating a prompt signal for observation by said operator requesting adjustment of said energy, said prompt signal generated responsive to said step of comparing, indicating a deviation from said predetermined temperature protocol;

(e) generating correlative temperature data associated with said portions of the patient'"'"'s body;

(f) generating a video output responsive to said correlative temperature data;

(g) displaying a video presentation to said operator responsive to said video output, said video presentation displayable using a plurality of colors wherein each of said colors corresponds to a preselected temperature threshold zone, and said operator responding to said prompt signal by evaluating said video presentation and providing an operator signal to attain said predetermined temperature protocol;

(h) storing said correlative temperature data in storage means; and

repeating steps (a)-(h) until completion of said predetermined temperature protocol and completion of said storing of said correlative temperature data.

22. The method of claim 21 further including the steps of storing treatment effect of said predetermined temperature protocol in said storage means in association with said protocol.

23. A method for establishing a hyperthermia treatment data base useful for preparing a predetermined hyperthermia treatment protocol for therapeutic treatment of tumors in specified portions of a patient'"'"'s body, comprising the steps of:

performing a planned patient hyperthermia treatment protocol by applying energy to heat said portions of the patient'"'"'s body;

measuring time dependent temperature data for said hyperthermia treatment protocol;

storing said time dependent temperature data in a storage means;

calculating a figure of merit from said time dependent temperature data;

determining treatment effect of said hyperthermia treatment protocol; and

storing said treatment effect and said figure of merit in said storage means in association with said time dependent temperature data.

24. The method as defined in claim 23 wherein said step of calculating a figure of merit comprises determination of a deviation of said measured time dependent temperature data from said planned treatment protocol.

25. A method of determining a figure of merit for use in evaluating a hyperthermia treatment of a tumor in a portion of a patient'"'"'s body using an apparatus having a group of temperature sensors disposed in the tumor and another group of temperature sensors disposed in surrounding normal tissue, comprising:

applying energy to heat said portion of the patient'"'"'s body;

sensing temperatures by said group of temperature sensors disposed in said tumor and by said group in said surrounding normal tissue;

determining periodically throughout said hyperthermia treatment a minimum and maximum temperature range for said group of temperature sensors disposed in said tumor and for said group in said surrounding normal tissue;

calculating a time-temperature integrated overlap of said minimum and maximum temperature ranges for each of said groups of temperature sensors;

calculating a time-temperature integrated area for said temperature range for each said group of temperature sensors; and

determining a percentage for said integrated overlap and for said integrated area, said determined percentages compared arithmetically to characterize said figure of merit.

26. The method as defined in claim 25 wherein said integrated area comprises a total area for said hyperthermia treatment within said temperature range for each said group.

27. The method as defined in claim 25 further including the step of assigning temperature threshold zones for each of said groups of temperature sensors, said integrated areas for each said group comprising an area of said temperature range which lies within selected ones of said temperature threshold zones.

28. The method as defined in claim 27 wherein said areas within said temperature threshold zones are time bounded by startup of said hyperthermia treatment and by the end of said integrated overlap.

29. A method of determining a figure of merit for use in evaluating a hyperthermia treatment of a tumor in a portion of a patient'"'"'s body using an apparatus having a group of temperature sensors disposed in the tumor and another group of temperature sensors disposed in surrounding normal tissue, comprising the steps of:

applying energy to heat said portion of the patient'"'"'s body;

sensing temperatures by said group of temperature sensors disposed in said tumor and said group in said surrounding normal tissue;

determining periodically throughout said hyperthermia treatment a minimum and maximum temperature range for said group of temperature sensors disposed in said tumor and for said group in said surrounding normal tissue;

assigning temperature threshold zones for each of said two groups of temperature sensors;

determining time-temperature integrated areas which lie within and which exceed said temperature threshold zones; and

comparing arithmetic relative percentages of said integrated areas which lie within said temperature threshold zones with said integrated areas which exceed said temperature threshold zones, said arithmetic relative percentages characteristic of said figure of merit.

30. The method as defined in claim 29 wherein said step of comparing arithmetic percentages comprises calculating a difference of said percentages.

31. The method as defined in claim 29 wherein said step of comparing arithmetic percentages comprises calculating a ratio of said percentages.

32. A method of determining a figure of merit for use in evaluating a hyperthermia treatment of a tumor in a portion of a patient'"'"'s body using an apparatus having a group of temperature sensors disposed in the tumor and another group of temperature sensors disposed in surrounding normal tissue, comprising the steps of:

applying energy to heat said portion of the patient'"'"'s body;

sensing temperatures by said group of temperature sensors disposed within said tumor and in said surrounding normal tissue;

determining periodically throughout said hyperthermia treatment a minimum and maximum temperature range for said group of temperature sensors disposed in said tumor and for said group of temperature sensors in said surrounding normal tissue;

assigning temperature threshold zones for each of said two groups of temperature sensors;

determining time-temperature integrated areas which lie within and which exceed said temperature threshold zones; and

comparing arithmetic relative percentages of said integrated areas which lie within said temperature threshold zone with said integrated areas which exceed said temperature threshold zones, said relative percentages being characteristic of said figure of merit.

33. The method as defined in claim 32 further including the step of adjusting said applied energy to improve said figure of merit during said hyperthermia treatment.

34. A method for generating a topographical display of temperature isotherms in a set of planes of a patient'"'"'s body for a hyperthermia treatment of a tumor in a portion of said patient'"'"'s body, comprising the steps of:

applying energy to said portion of the patient'"'"'s body;

sensing temperatures in said portion of said patient'"'"'s body;

generating an interpolated set of temperatures for said set of planes from said sensed temperatures;

assigning color codes to said temperature isotherms of said set of planes, each said color code corresponding to predetermined temperature effectiveness zones of hyperthermia treatment for said patient'"'"'s body portion; and

generating said topographical display of said temperature isotherms in said set of planes of the patient'"'"'s body.

35. A method of determining figures of merit for use in a hyperthermia treatment of a tumor in a portion of a patient'"'"'s body using an apparatus having a group of temperature sensors disposed in the tumor and another group of temperature sensors disposed in surrounding normal tissue, comprising the steps of;

applying energy to heat said portion of the patient'"'"'s body;

sensing temperatures periodically throughout said hyperthermia treatment for said group of temperature sensors disposed in said tumor and said group in said surrounding normal tissue;

storing in storage means said sensed temperatures for each said group of temperature sensors;

assigning a temperature threshold zone to each said sensed temperatures;

determining percentages for each said group of said sensed temperatures which lie within each said temperature threshold zone; and

calculating said figures of merit by comparing selected ones of said determined percentages associated with said temperature threshold zones.

36. The method as defined in claim 35 wherein said temperature threshold zones comprise a desirable and an undesirable zone for each said group of temperature sensors, said figure of merit characterized by comparing of said percentages of said sensed temperatures associated with said desirable zones and with said undesirable zones.

37. The method as defined in claim 36 wherein said comparing of said percentages comprises calculating for each said group of sensors a ratio of said percentages associated with said desirable zones to said percentage associated with said undesirable zones.

38. The method as defined in claim 36 wherein said undesirable zone for said group of temperature sensors in the tumor comprises a lower zone and an upper zone and said undesirable zone for said group of temperature sensors in the normal tissue comprises a harmful zone.

39. The method as defined in claim 35 further including the step of adjusting said applied energy to improve said figure of merit during said hyperthermia treatment.

40. A hyperthermia system for achieving a predetermined temperature protocol for a portion of a patient'"'"'s body, the system monitoring energy application to the patient body portion and adapted for adjusting said energy application responsive selectively to operator manipulation and computer control, comprising:

means for applying energy to the patient body portion, said energy applying means having subelement energy applicators providing energy to preselected subelements of the patient body portion;

means for sensing temperature of the patient body portion and for providing temperature signals characteristic of the patient body portion;

computer means, having associated means for storing instructions and data defining said predetermined temperature protocol, for interacting with the other parts of said system to perform said energy application, said computer means monitoring said temperature signals from the patient body portion and adjusting said energy application to said subelement energy applicators responsive selectively to said computer means providing said instructions and data defining said predetermined temperature protocol and to the operator manipulation, and said computer means utilizing said temperature signals and said instructions and data to selectively provide an operator prompt signal indicating the desirability of the system operator adjusting said energy application, said computer means further providing correlative temperature data associated with said patient body portion; and

operator means responsive to the operator manipulation for providing an operator signal to control said energy applying means via said computer means.

41. The system as defined in claim 40 wherein said correlative temperature data comprises selectively at least one of temperature data from (a) a group of said sensing means inside a tumor region, (b) a group of said sensing means outside said tumor region, (c) a mixture of groups from inside and outside said tumor region, (d) a group of said temperature sensing means within said preselected subelement wherein said system is adapted to control the temperature and (e) a group of said temperature sensing means within and without each said preselected subelement wherein said system is adapted to control the temperature.

42. A hyperthermia system for achieving a predetermined temperature protocol for a portion of a patient'"'"'s body, the system monitoring energy application to the patient body portion and adapted for adjusting said energy application responsive selectively to operator manipulation and computer control, comprising:

means for applying energy to the patient body portion, said energy applying means having subelement energy applicators providing energy to preselected subelements of the patient body portion;

means for sensing temperature of the patient body portion and for providing temperature signals characteristic of the patient body portion;

computer means, having associated means for storing instructions and data defining said predetermined temperature protocol, for interacting with the other parts of said system to perform said energy application, said computer means monitoring said temperature signals from the patient body portion and adjusting said energy application to said subelement energy applicators responsive selectively to said computer means providing said instructions and data defining said predetermined temperature protocol and to the operator manipulation, and said computer means utilizing said temperature signals and said instructions and data to selectively provide an operator prompt signal indicating the desirability of the system operator adjusting said energy application, said computer means further providing correlative temperature data associated with said patient body portion; and

operator means responsive to the operator manipulation for providing an operator signal to control selectively each said subelement energy applicator of said energy applying means via said computer means.

43. The system as defined in claim 42 wherein said correlative temperature data comprises selectively at least one of temperature data from (a) a group of said sensing means inside a tumor region, (b) a group of said sensing means outside said tumor region, (c) a mixture of groups from inside and outside said tumor region, (d) a group of said temperature sensing means within said preselected subelement wherein said system is adapted to control the temperature and (e) a group of said temperature sensing means within and without each said preselected subelement wherein said system is adapted to control the temperature.

44. The system as defined in claim 42 further including means responsive to said instructions and data for displaying a video presentation of said correlative temperature data to the operator and displayable in a color coded manner such that preselected colors represent predetermined temperature effectiveness zones of hyperthermia treatment, the operator capable of adjusting the energy application by evaluating said color coded video presentation and providing said operator signal.

45. A hyperthermia system for achieving a predetermined temperature protocol for a portion of a patient'"'"'s body, the system monitoring energy application and adapted for adjusting said energy application responsive selectively to operator manipulation and computer control, comprising:

means for applying energy to preselected subelements of the patient body portion;

means for sensing temperature at a plurality of locations in said patient body portion;

computer means, having associated means for storing instructions and data defining said predetermined temperature protocol, for interacting with other parts of said system to perform said energy application, said computer means monitoring said temperature signals from the patient body portion and adjusting said subelement energy application responsive selectively to said computer means providing said instructions and data defining said predetermined temperature protocol and to the operator manipulation, and said computer means providing correlative temperature data from said temperature signals from said plurality of locations and enabling selectively at least one of said computer means and the system operator to adjust said energy application for each said preselected subelement of said patient body portion responsive to evaluating said temperature signals from selectable ones of said patient body portion subelements.

46. The system as defined in claim 45 wherein said correlative temperature data comprises means for showing time rate of temperature increase for each said temperature sensing means.