System, method and apparatus for evaluating tissue temperature

• US 7,048,756 B2
• Filed: 12/11/2003
• Issued: 05/23/2006
• Est. Priority Date: 01/18/2002
• Status: Expired due to Fees

• Current Assignee: Apsara Medical Corporation
• Original Assignee: Apasara Medical Corporation
• Inventors: Eggers, Philip E., Ridihalgh, John L., Altman, Gary, Mayerchak, Mark
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US10/733,970
• Publication Number:
  US 20040122494A1
• Time in Patent Office: 894 Days
• Field of Search: 607/96, 607/103, 607/116, 600 9- 12, 128/898
• US Class Current: 607/113
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: G01K 7/38 the variations of temperature influencing the magnetic permeability

Abstract

Method, system and apparatus for monitoring target tissue temperatures wherein temperature sensors are configured as passive resonant circuits each, with a unique resonating signature at monitoring temperatures extending below a select temperature setpoint. The resonant circuits are configured with an inductor component formed of windings about a ferrite core having a Curie temperature characteristic corresponding with a desired temperature setpoint. By selecting inductor winding turns and capacitance values, unique resonant center frequencies are detectable. Temperature monitoring can be carried out with implants at lower threshold and upper limit temperature responses. Additionally, the lower threshold sensors may be combined with auto-regulated heater implants having Curie transitions at upper temperature limits.

Claims

1. A method for thermally treating a target tissue within the body of a patient, comprising the steps of:

(a) determining temperature and treatment interval therapy data for carrying out said treatment of said target tissue;

(b) providing one or more passive resonant implants, each having an electromagnetic response of given intensity to an extra body applied interrogational electromagnetic field at a predetermined resonant center frequency only when said implant is at a monitor temperature or temperatures below a target temperature corresponding with said therapy data;

(c) providing a heating assembly controllable to derive an output effecting the generation of heat at said target tissue from an application component located externally of said body;

(d) providing an interrogation assembly having an antenna assembly and controllable to derive and apply said extra body interrogational electromagnetic field and having a detector output in correspondence with antenna assembly detections of said implant electromagnetic response at said predetermined resonant center frequency;

(e) locating said one or more implants at an intra-body location effective for response to temperature at the location of said target tissue;

(f) controlling said heating assembly to elevate the temperature of said target tissue;

(g) controlling said interrogation assembly to derive and apply said extra body interrogational electromagnetic field to said located one or more implants for an interrogation interval deriving said detector output; and

(h) controlling said heating assembly in correspondence with said detector output.

2. The method of claim 1 in which:

said step (b) provides one or more of said passive resonant implants as having a said electromagnetic response at a predetermined resonant center frequency when said one or more implants are at a said monitor temperature or temperatures and exhibit a decrease in the intensity of said response at said predetermined resonant center frequency when approaching said target temperature corresponding with said temperature therapy data.

3. The method of claim 1 in which:

said step (b) provides one or more of said passive resonant implants as having a said electromagnetic response at a predetermined resonant center frequency when said one or more implants are at a said monitor temperature or temperatures and exhibit an absence of said response at said predetermined resonant center frequency when at said target temperature.

4. The method of claim 1 in which:

said step (b) provides one or more of said passive resonant implants as an untethered passive resonant circuit with an inductance defining winding and core component, said core having a relative permeability characteristic exhibiting a drop in relative permeability toward a unity value at a Curie temperature corresponding with said target temperature, said circuit resonating at said predetermined resonant center frequency in response to said applied interrogational electromagnetic field when at said monitor temperatures.

5. The method of claim 1 in which:

said step (b) provides one or more of said passive resonant implants as an untethered passive resonant circuit with an inductor component and a capacitor component, said capacitor component and/or said inductor component exhibiting respective capacitance and/or inductance value or values corresponding with said temperature at the location of said target tissue.

6. The method of claim 1 in which:

said step (d) provides said interrogation assembly as deriving said detector output as a Fourier transform corresponding with a said predetermined resonant center frequency.

7. The method of claim 6 in which:

said step (g) controls said interrogation assembly as deriving said detector output subsequent to said interrogation interval.

8. The method of claim 7 in which:

said step (d) provides said interrogation assembly as deriving said detector output as an average of a plurality of said antenna assembly detections.

9. The method of claim 8 in which:

said step (g) controls said heating assembly by effecting the generation of heat at said target tissue in the presence of a said detector output corresponding with temperatures below said limit temperature.

10. The method of claim 1 in which:

said step (a) determines said temperature therapy data as a temperature range extending from a threshold temperature to a limit temperature higher than said threshold temperature; and

said step (b) provides a first said untethered implant having a said electromagnetic response at a first said resonant center frequency corresponding with monitor temperatures below a said threshold temperature and provides a second said untethered implant having a said electromagnetic response at a second said resonant center frequency, different than said first resonant frequency, corresponding with monitor temperatures below said limit temperature.

11. The method of claim 1 in which:

said step (a) determines said temperature therapy data as a temperature range extending from a threshold temperature to a limit temperature higher than said threshold temperature;

said step (b) provides a first said untethered implant having a said electromagnetic response at a said resonant center frequency corresponding with temperatures below said threshold temperature, and provides a second said untethered implant as an auto-regulated heater component formed of a ferromagnetic material within a non-magnetic material, said ferromagnetic material exhibiting a Curie temperature in correspondence with said limit temperature precluding thermal response of said non-magnetic material to an applied alternating field; and

said step (c) provides said heating assembly as controllable to apply alternating current field based heat-inducing energy to said target tissue and said second implant; and

said step (e) locates said first and second implants at said intra-body location.

12. The method of claim 11 in which:

said step (g) controls said heating assembly to apply said alternating field based current when said interrogation assembly is not being controlled to derive said detector output.

13. The method of claim 1 in which:

said step (b) provides one or more of said untethered passive resonant implants as having an electromagnetic response characteristic wherein said electromagnetic response at a predetermined resonant center frequency occurs when said one or more implants are at said monitor temperature or temperatures and said implant or implants exhibiting a decrease in the intensity of said response at said predetermined resonant center frequency when approaching a said target temperature corresponding with said temperature therapy data;

said step (c) provides said heating assembly for the generation of said heat at said target tissue by the application of at least ultrasound frequency energy from said application component;

said step (g) controls said heating assembly to apply said ultrasound energy in response to a said detector output corresponding with said electromagnetic response.

14. The method of claim 13 in which:

Said step (b) provides a first said untethered implant having a said electromagnetic response characteristic and a second said untethered implant as a heater component formed at least in part with ultrasound absorptive material.

15. The method of claim 1 in which:

Said step (a) determines said therapy data to effect induction of therapeutic levels of heat shock protein from said target tissue volume.

16. The method of claim 1 in which said step (a) determines said therapy data to effect hyperthermia therapy for the treatment of cancer.

17. The method of claim 1 in which said step (a) determines said therapy data to effect thermal therapy for the repair of boney tissue.

18. The method of claim 1 in which said step (a) determines said therapy data to effect induction of heat shock protein from a said tissue carrying infectious disease.

19. The method of claim 1 in which:

said step (b) further comprises the step;

(b1) providing one or more heating components responsive to said heating assembly output to elevate in temperature; and

said step (e) locates said one or more heating components at a said intra-body location effective for heating tissue.

20. The method of claim 19 in which:

said step (b1) provides a said heating component as a stent having a generally cylindrically shaped outward luminal engagement surface;

said step (b) provides said implant as one or more temperature sensors coupled in thermal exchange relationship with said stent; and

said step (e) locates said stent and temperature sensor within a blood vessel.

21. The method of claim 20 in which:

said step (b1) provides said heating component stent as further comprising a release agent material supported in thermal exchange relationship therewith and responsive to effect its dispersion to limit restenosis when said stent is at said determined temperature.

22. The method of claim 20 in which:

said step (b) provides a said temperature sensor as being coupled with said stent outward luminal engagement surface.

23. The method of claim 20 in which:

said steps (b) and (b1) provide said temperature sensor as being coupled with said stent with a flexible band surmounting said outward engagement surface and said temperature sensor.

24. The method of claim 20 in which:

said step (a) determines said therapy data to effect hyperthermia therapy for the treatment of restenosis.

25. The method of claim 20 in which:

said step (c) provides said heating assembly output as an ultrasound output; and

said step (b1) provides said stent as being formed of ultrasound absorptive material.

26. The method of claim 20 in which:

said step (c) provides said heating assembly output as an alternating current based field; and

said step (b1) provides said stent as being formed of non-magnetic material.

27. The method of claim 1 in which:

Said step (a) determines said therapy data to effect induction of therapeutic levels of apoptosis in said target tissue volume.

28. The method of claim 1 in which:

Said step (a) determines said therapy data to effect induction of therapeutic levels of necrosis in said target tissue volume.

29. The method of claim 1 in which:

said step (a) determines said therapy data to effect hyperthermia therapy for the treatment of neoplasia.

30. The method of claim 1 wherein the target tissue is a neoplasm.

31. The method of claim 1 wherein the target tissue is a tumor.

32. The method of claim 1 in which:

said elevated temperature of step (f) as being within a range from about 39°

C. to about 70°

C.

33. The method of claim 1 in which:

said elevated temperature of step (f) as being within a range from about 41°

C. to about 50°

C.

34. The method of claim 1 in which:

said elevated temperature of step (f) as being within a range from about 42°

C. to about 45°

C.

35. The method of claim 1 in which:

said elevated temperature of step (f) as being within a range from about 37°

C. to about 41°

C.

36. The method of claim 1 in which:

said elevated temperature of step (f) as being elevated to within a range from about 4°

C. to about 13°

C. over normal body temperature of the patient.

37. The method of claim 1 in which:

said elevated temperature of step (f) as being elevated to within a range from about 2°

C. to about 33°

C. over normal body temperature of the patient.

38. A method for thermally treating target tissue within the body of a patient, comprising the steps of:

(a) determining temperature and treatment interval therapy data for carrying out said treatment of said target tissue;

(b) providing one or more untethered passive resonant sensor implants, each having an electromagnetic response to an extra body applied interrogational electromagnetic field at a resonant center frequency when said sensor implant is at monitor temperatures;

(c) providing one or more untethered passive auto-regulating heaters having a thermal response to an extra body applied alternating current field to elevate in temperature to a predetermined temperature or temperatures, whereat said heaters are thermally unresponsive to said applied alternating current field;

(d) providing a heating assembly controllable to derive said applied alternating current field from an application component located externally of said body effecting said thermal response;

(e) providing an interrogation assembly having an antenna assembly and controllable to derive and apply said extra body interrogational electromagnetic field and having a detector output in correspondence with antenna assembly detections of said sensor implant electromagnetic response at said monitor temperatures;

(f) locating one or more said sensor implants at an intra-body location effective for response to temperature at the location of said target tissue;

(g) locating one or more said heaters at an intra-body location effective for heating said target tissue;

(h) controlling said heating assembly to elevate the temperature of said one or more passive auto-regulating heaters;

(i) controlling said interrogation assembly to derive and apply said extra body interrogational electromagnetic field to said located one or more sensor implants for an interrogational interval deriving said detector output; and

(j) controlling said heating assembly in correspondence with said detector output.

39. The method of claim 38 in which:

said step (b) provides one or more of said untethered passive resonant sensor implants as having a said electromagnetic response at a predetermined resonant center frequency when said one or more sensor implants are at a said monitor temperature or temperatures and exhibit a decrease in the intensity of said response at said predetermined resonant center frequency when at temperatures approaching a target temperature condition corresponding with said temperature therapy data.

40. The method of claim 38 in which:

said step (b) provides one or more said untethered passive resonant sensor implants as having a said electromagnetic response at a predetermined resonant center frequency when said one or more sensor implants are at a said monitor temperature or temperatures and exhibit an absence of said response at said predetermined resonant center frequency when at a target temperature condition corresponding with said temperature therapy data.

41. The method of claim 38 in which:

said step (b) provides one or more of said passive resonant sensor implants as a passive resonant circuit with an inductor component and a capacitor component, said capacitor component and/or said inductor component exhibiting respective capacitance and/or inductance value or values corresponding with said temperature at the location of said target tissue.

42. The method of claim 38 in which:

said step (e) provides said interrogation assembly as deriving said detector output as a Fourier transform corresponding with said predetermined resonant center frequency.

43. The method of claim 42 in which:

said step (e) provides said interrogation assembly as deriving said detector output subsequent to said interrogation interval.

44. The method of claim 43 in which:

said step (e) provides said interrogation assembly as deriving said detector output as an average of a plurality of said antenna assembly detections.

45. The method of claim 38 in which:

said step (a) determines said temperature therapy data as a temperature range extending from a threshold temperature to a limit temperature higher than said threshold temperature;

said step (b) provides said one or more untethered passive resonant sensors having a said electromagnetic response at a said resonant center frequency corresponding with monitor temperatures below a said threshold temperature; and

said step (c) provides said one or more untethered passive auto-regulating heaters to elevate in temperature to a said predetermined temperature corresponding with said limit temperature.

46. The method of claim 45 in which:

said step (b) provides said one or more untethered passive resonant sensors having a said electromagnetic response at a said resonant center frequency corresponding with monitor temperatures below a said limit temperature.

47. The method of claim 38 in which:

said step (a) determines said temperature therapy data as a temperature range extending from a threshold temperature to a limit temperature higher than said threshold temperature;

said step (b) provides said one or more untethered passive resonant sensors having a said electromagnetic response at a said resonant center frequency corresponding with monitor temperatures below a said limit temperature; and

said step (c) provides said one or more untethered passive auto-regulating heaters to elevate in temperature to a said predetermined temperature corresponding with said threshold temperature.

48. The method of claim 38 in which:

said step (a) determines said treatment interval therapy data to effect induction of therapeutic levels of apoptosis in said target tissue.

49. The method of claim 38 in which:

said step (a) determines said treatment interval therapy data to effect induction of therapeutic levels of necrosis in said target tissue.

50. The method of claim 38 in which:

said step (a) determines said treatment interval therapy data to effect hyperthermia therapy for the treatment of neoplasia.

51. The method of claim 38 wherein the target tissue is a neoplasm.

52. The method of claim 38 wherein the target tissue is a tumor.

53. The method of claim 38 in which:

the temperature of said target tissue is elevated to within a range from about 39°

C. to about 70°

C.

54. The method of claim 38 in which:

the temperature of said target tissue is elevated to within a range from about 41°

C. to about 50°

C.

55. The system of claim 38 in which:

the temperature of said target tissue is elevated to within a range from about 42°

C. to about 45°

C.

56. The system of claim 38 in which:

the temperature of said target tissue is elevated to within a range from about 37°

C. to about 41°

C.

57. The system of claim 38 in which:

the temperature of said target tissue is elevated within a range from about 4°

C. to about 13°

C. over normal body temperature of said patient.

58. The system of claim 38 in which:

said temperature of said target tissue is elevated within a range from about 2°

C. to about 33°

C. over normal body temperature of said patient.