Tissue heating and ablation systems and methods which predict maximum tissue temperature

• US 6,293,943 B1
• Filed: 03/04/1998
• Issued: 09/25/2001
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: EP Technology (Boston Scientific Corporation)
• Original Assignee: EP Technology (Boston Scientific Corporation)
• Inventors: Panescu, Dorin, Swanson, David K., Fleischman, Sidney D.
• Primary Examiner(s): Shay, David M.
• Application Number:
  US09/034,977
• Time in Patent Office: 1,301 Days
• Field of Search: 606/27-34, 606/40, 606/41, 606/42, 606/46-49, 607/98-105, 604/20
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00095 high, i.e. heat conducting
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00803 with temperature prediction
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia

Abstract

Systems and methods heat or ablate body tissue by positioning an electrode to transmit heat or ablation energy to a tissue region. The systems and methods measure a first temperature using a temperature sensing element associated with the electrode. The systems and methods also measure a second temperature using a temperature sensing element associated with the electrode. The systems and methods process at least one of the first and second temperatures to derive a prediction of maximum temperature of the tissue region. The systems and methods generate an output that controls the transmission of the heating or ablation energy based, at least in part, upon the maximum tissue temperature prediction.

Claims

1. An apparatus for heating body tissue comprising:

an electrode to transmit heating energy into a body tissue region;

a first sensing element coupled to the electrode for measuring a first temperature;

a second sensing element coupled to the electrode for measuring a second temperature; and

a processing element coupled to the first and second sensing elements to process the first and second temperatures and to derive therefrom a prediction of maximum temperature of the body tissue region.

2. An apparatus according to claim 1

wherein the electrode is configured to transmit radio frequency energy.

3. An apparatus according to claim 1

wherein the processing element includes a neural network predictor.

4. An apparatus according to claim 1

wherein the processing element derives the maximum body tissue temperature prediction based, at least in part, upon fuzzy logic.

5. An apparatus according to claim 1

wherein the processing element processes changes in the first and second temperatures over time to derive the maximum tissue temperature prediction.

6. An apparatus according to claim 1

wherein the processing element derives the maximum body tissue temperature prediction based, at least in part, upon the first temperature measured by the first sensing element and the second temperature measured by the second sensing element.

7. An apparatus according to claim 1

wherein the electrode carries at least one of the first and second sensing elements.

8. An apparatus according to claim 1

wherein at least one of the senising elements is in thermal conductive contact with the electrode.

9. An apparatus according to claim 1

and further including a second electrode spaced along a body from the first mentioned electrode, and

wherein at least one of the sensing elements is located on the body between the first and second electrodes.

10. An apparatus according to claim 1

and further including a third temperature sensing element associated with the second electrode to measure a third temperature, and

wherein the processing element derives a maximum tissue temperature prediction from the first, second and third temperatures.

11. An apparatus according to claim 1 wherein

the processing element employs the prediction of maximum temperature of the body tissue region to control the transmission of heating energy by the electrode based, at least in part, upon the prediction of maximum temperature of the bode tissue region.

12. An apparatus according to claim 11 wherein

the processing element controls the transmission of heating energy by the electrode based upon comparing the prediction of the maximum temperature of the body tissue region to a prescribed temperature.

13. An apparatus according to claim 12 wherein

the prescribed temperature remains essentially constant over time.

14. An apparatus according to claim 12 wherein

the prescribed temperature changes at least once as a function of time.

15. An apparatus according to claim 1 wherein

the processing element generates an output based upon the prediction of maximum temperature of the body tissue region.

16. An apparatus according to claim 15 wherein

the apparatus further includes means for inputting a prescribed temperature and wherein the processing element generates the output based upon comparing the prediction of maximum temperature of the body tissue region with the prescribed temperature.

17. An apparatus according to claim 16, wherein

the prescribed temperature remains essentially constant over time.

18. An apparatus according to claim 16, wherein

the prescribed temperature changes at least once as a function of time.

19. An apparatus according to claim 16 wherein

the processing element applies control principles to compare the prediction of maximum temperature of the body tissue region to the prescribed temperature to generate the output, whereby the control principles are selected from the group consisting of proportional control principles, proportional integral derivative (PID) control principles, adaptive control principles, neural network control principles and fuzzy logic control principles.

20. An apparatus for ablating body tissue comprising

an electrode for contacting a body tissue region to transmit ablation energy into the body tissue region,

a first sensing element in thermal communication with the electrode for measuring temperature of the electrode,

a second sensing element carried by the electrode for measuring temperature of body tissue contacting the electrode, and

a processing element coupled to the first and second sensing elements to process the first and second temperatures and to derive therefrom a prediction of maximum temperature of the body tissue region.

21. An apparatus according to claim 20 wherein the electrode transmits radio frequency energy.

22. An apparatus according to claim 20 wherein the processing element includes a neural network predictor.

23. An apparatus according to claim 20

wherein the processing element derives the maximum body tissue temperature prediction based, at least in part, upon fuzzy logic.

24. An apparatus according to claim 20

wherein the processing element processes changes in the first and second temperatures over time to derive the maximum tissue temperature prediction.

25. An apparatus according to claim 20

wherein the processing element derives the maximum body tissue temperature prediction based, at least in part, upon a first temperature measured by the first sensing element and a second temperature measured by the second sensing element.

26. An apparatus according to claim 20

wherein the electrode carries at least one of the first and second sensing elements.

27. An apparatus according to claim 20

wherein the processing element controls the transmission of ablation energy by the electrode based, at least in part, upon the maximum body tissue temperature prediction.

28. An apparatus according to claim 27

wherein the apparatus further includes means for inputting a prescribed temperature and wherein the processing element controls the transmission of ablation energy based upon comparing the maximum body tissue temperature prediction to the prescribed temperature.

29. An apparatus according to claim 20

and further including, a second electrode spaced along a body from the first mentioned electrode, and

wherein the second sensing element is located on the body between the first and second electrodes.

30. An apparatus according to claim 29

and further including a third temperature sensing element to measure temperature of the second electrode.

31. An apparatus according to claim 20

wherein the processing element generates an output based upon the maximum body tissue temperature prediction.

32. An apparatus according to claim 31

wherein the processing element generates the output based upon comparing the maximum body tissue temperature prediction to a prescribed temperature.

33. An apparatus according to claim 32

wherein the prescribed temperature remains essentially constant over time.

34. An apparatus according to claim 32

wherein the prescribed temperature changes at least once as a function of time.

35. A system for transmitting energy to an electrode for heating body tissue comprising

a generator coupled to an electrode to supply energy to the electrode for heating a body tissue region,

a controller coupled to the generator to control the generator'"'"'s supply of energy to the electrode, the controller comprising

a first sensing element coupled to the electrode for measuring a first temperature,

a second sensing element coupled to the electrode for measuring a second temperature, and

a processing element coupled to the first and second sensing elements to process the first and second temperatures and to derive therefrom a prediction of maximum temperature of the body tissue region and for generating a signal to control energy supplied by the generator based, at least in part, upon the maximum body tissue temperature prediction.

36. A system according to claim 35

and further including a second electrode spaced along a body from the first mentioned electrode, and

wherein at least one of the sensing elements is located on the body between the first and second electrodes.

37. A system according to claim 35

wherein the processing elements derives the maximum body tissue temperature prediction based, at least in part, upon a first temperature measured by the first sensing element and a second temperature measured by the second sensing element.

38. A system according to claim 35

wherein at least one of the sensing elements is in thermal conductive contact with the electrode.

39. A system according to claim 38

and further including a third temperature sensing element associated with the second electrode to measure a third temperature, and

wherein the processing element derives the maximum tissue temperature prediction from the first, second and third temperatures temperatures.

40. A system according to claim 35

wherein the processing element controls the transmission of heating energy by the electrode based, at least in part, upon the maximum body tissue temperature prediction.

41. A system according to claim 40

wherein the apparatus further includes means for inputting a prescribed temperature and wherein the processing element controls the transmission of heating energy based upon comparing the maximum body tissue temperature prediction to the prescribed temperature.

42. A system according to claim 41

wherein the prescribed temperature remains essentially constant over time.

43. A system according to claim 41

wherein the prescribed temperature, changes at least once as a function of time.

44. A system for supplying energy to an electrode for ablating body tissue comprising

a generator adapted to be coupled to an electrode to supply energy to the electrode for ablating body tissue within a region,

a controller coupled to the generator to control the generator'"'"'s supply of energy to the electrode, the controller comprising

a first sensing element in thermal communication with the electrode for measuring temperature of the electrode,

a second sensing element carried by the electrode for measuring temperature of body tissue contacting the electrode, and

a processing element coupled to the first and second sensing elements to process the first and second temperatures and to derive therefrom a prediction of maximum temperature of the body tissue region and for generating a signal to control energy supplied to the generator based, at least in part, upon the maximum body tissue temperature prediction.

45. A system according to claim 44

wherein the processing element controls the transmission of ablation energy by the electrode based, at least in part, upon the maximum body tissue temperature prediction.

46. A system according, to claim 44

wherein the electrode carries at least one of the first and second sensing elements.

47. A system according to claim 44

and further including, a second electrode spaced alone a body from the first mentioned electrode, and

wherein the second sensing element is located on the body between the first and second electrodes.

48. A system according to claim 47

and further including a third temperature sensing element to measure temperature of the second electrode.

49. A system according to claim 44

wherein the apparatus further includes means for inputting a prescribed temperature and wherein the processing element controls the transmission of ablation energy based upon comparing the maximum body tissue temperature prediction to the prescribed temperature.

50. A system according to claim 49

wherein the prescribed temperature remains essentially constant over time.

51. A system according to claim 49

wherein the prescribed temperature changes at least once as a function of time.

52. A method for heating body tissue comprising:

positioning an electrode to transmit heat energy to a body tissue region,

applying energy to the electrode to heat the body tissue region,

measuring a first temperature using a temperature sensing element associated with the electrode,

measuring a second temperature using a temperature sensing element associated with the electrode, and

processing the first and second temperatures to derive a prediction of maximum temperature of the body tissue region.

53. A method according to claim 52

and further including generating an output based upon the maximum body tissue temperature prediction.

54. A method according to claim 53

wherein the apparatus further includes means for inputting a prescribed temperature and wherein the output is based upon comparing the maximum body tissue temperature prediction to the prescribed temperature.

55. A method according to claim 54

wherein the prescribed temperature remains essentially constant over time.

56. A method according to claim 54

wherein the prescribed temperature changes at least once as a function of time.