Method and system for direct heating of fluid solution in a hollow body organ

• US 5,653,692 A
• Filed: 09/07/1995
• Issued: 08/05/1997
• Est. Priority Date: 09/07/1995
• Status: Expired due to Term

• Current Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Original Assignee: InnerDyne Medical, Inc. (Johnson Controls International plc)
• Inventors: Laird, Robert J., Masterson, Steven P.
• Primary Examiner(s): McDermott, Corrine M.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US08/525,436
• Time in Patent Office: 698 Days
• Field of Search: 604/113, 604/114, 604/96, 604/118, 604/105, 604/107, 604/49, 606/33, 606/49, 606/27, 606/32, 607/113, 607/122, 607/138
• US Class Current: 604/113
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 2017/00132 Setting operation time of a device A61B2017/00123 takes precedence
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element

Abstract

The invention provides improved methods and devices for heating a thermally conductive fluid within an internal body organ to thermally ablate or necrose the body organ. In an exemplary embodiment, the invention provides a thermal ablation device having an elongate member with a proximal end and a distal end. A heating apparatus is provided near the distal end of the elongate member which is constructed to heat a thermally conductive fluid without substantial direct heating of the heating apparatus. A fluid circulator is provided near the heating apparatus which circulates the thermally conductive fluid past the heating apparatus.

Claims

1. A thermal ablation device for thermally ablating a hollow body organ, the device comprising:

an elongate member having a proximal end, a distal end, and a heating chamber near the distal end;

a heating apparatus operably attached to the elongate member near the distal end, the heating apparatus being constructed to heat a thermally conductive fluid without substantial direct heating of the heating apparatus; and

a fluid circulator operably attached to the elongate member near the heating apparatus which circulates the thermally conductive fluid past the heating apparatus;

wherein the heating apparatus and the fluid circulator are disposed in the heating chamber, and wherein the heating chamber includes an inlet and an outlet which are exposed to the hollow body organ and which are disposed such that the thermally conductive fluid may be drawn through the inlet from the hollow body organ, circulated past the heating apparatus, expelled through the outlet into contact with the hollow body organ and recirculated through the inlet upon operation of the fluid circulator.

2. A thermal ablation device as in claim 1, wherein the fluid circulator comprises an impeller.

3. A thermal ablation device as in claim 2, wherein the impeller includes a proximal end and a distal end, wherein the elongate member includes a central lumen, and further comprising an insulated elongate shaft attached at the distal end of the impeller, said shaft extending through the central lumen of the elongate member.

4. A thermal ablation device as in claim 3, further comprising a motor for rotating the shaft.

5. A thermal ablation device as in claim 1, wherein the heating apparatus comprises a pair of spaced-apart electrodes.

6. A thermal ablation device as in claim 5, wherein the pair of electrodes comprise ring electrodes.

7. A thermal ablation device as in claim 6, further comprising a radio frequency power supply which supplies current to the electrodes.

8. A thermal ablation device as in claim 1, wherein the heating apparatus comprises a wire coil.

9. A thermal ablation device as in claim 8, further comprising an alternating current power supply which supplies alternating current to the wire coil.

10. A thermal ablation device as in claim 1, wherein at least a portion of the elongate member is constructed of a dielectric material.

11. A thermal ablation device as in claim 1, further comprising a pair of spaced apart occlusion members about the periphery of the elongate member for receiving the cervical os.

12. A thermal ablation device as in claim 11, wherein one of the occlusion members is axially translatable relative to the other occlusion member.

13. A thermal ablation device as in claim 11, wherein one of the occlusion members is radially expansible.

14. A thermal ablation device as in claim 1, further comprising a temperature sensor within the chamber.

15. A thermal ablation device as in claim 14, wherein the elongate member includes an exterior surface, and further comprising a temperature sensor disposed on the exterior surface of the elongate member.

16. A thermal ablation device as in claim 1, wherein the elongate member further includes an inflow lumen and an outflow lumen.

17. A thermal ablation device as in claim 16, further comprising an open fluid reservoir in communication with the inflow lumen, said fluid reservoir holding a supply of the thermally conductive fluid.

18. A thermal ablation device, comprising:

an elongate member having a proximal end and a distal end, wherein the elongate member defines a heating chamber near the distal end;

a pair of spaced-apart electrodes operably attached to the elongate member and disposed within the heating chamber;

an impeller operably attached to the elongate member, the impeller being disposed within the heating chamber and spaced-apart from the pair of electrodes, wherein a thermally and electrically conductive fluid may be circulated between the electrodes upon operation of the impeller; and

a pair of spaced apart occlusion members about the periphery of the elongate member for receiving the cervical os, wherein one of the occlusion members is axially translatable relative to the other occlusion member.

19. A thermal ablation device as in claim 18, wherein the electrodes comprise ring electrodes.

20. A thermal ablation device as in claim 18, further comprising a radio frequency power supply which supplies current to the electrodes.

21. A thermal ablation device as in claim 18, wherein the heating chamber includes an inlet and an outlet which are disposed such that the thermally conductive fluid may be drawn through the inlet, circulated between the electrodes, and expelled through the outlet upon operation of the impeller.

22. A thermal ablation device as in claim 18, wherein at least a portion of the elongate member is constructed of a dielectric material.

23. A thermal ablation device as in claim 18, wherein the elongate member includes a central lumen, and further comprising an insulated elongate shaft attached at a distal end to the impeller, said shaft extending through the central lumen of the elongate member.

24. A thermal ablation device as in claim 23, further comprising a motor for rotating the shaft.

25. A thermal ablation device as in claim 18, wherein one of the occlusion members is radially expansible.

26. A thermal ablation device as in claim 18, further comprising a temperature sensor within the chamber.

27. A thermal ablation device as in claim 18, further comprising a temperature sensor disposed on an exterior surface of the elongate member.

28. A thermal ablation device as in claim 18, wherein the elongate member further includes an inflow lumen and an outflow lumen.

29. A thermal ablation device as in claim 28, further comprising an open fluid reservoir in communication with the inflow lumen, said fluid reservoir holding a supply of the thermally conductive fluid.

30. A method for thermally ablating a hollow body organ, said method comprising:

introducing a thermally conductive fluid and a heating apparatus having a fluid circulator into the hollow body organ so that the fluid circulator is within the hollow body organ;

operating the heating apparatus to heat the fluid within the hollow body organ, with the temperature of the heating apparatus generally not exceeding the temperature of the fluid while heating the fluid; and

continuously circulating the fluid within the hollow body organ with the fluid circulator without substantially varying the pressure within the hollow body organ.

31. A method as in claim 30, wherein the thermally conductive fluid is also electrically conductive, and wherein the heating step comprises passing radio frequency current through the fluid.

32. A method as in claim 30, wherein the heating step comprises generating an alternating magnetic flux within the fluid.

33. A method as in claim 30, wherein the circulating step comprises rotating an impeller within the hollow body organ.

34. A method for thermally ablating a hollow body organ, said method comprising:

introducing a thermally and electrically conductive fluid into the hollow body organ;

passing radio frequency current through the fluid while the fluid is within the hollow body organ to heat the fluid; and

circulating the fluid within the hollow body organ without substantially varying the pressure within the hollow body organ;

wherein the hollow body organ comprises the uterus, and further comprising heating the fluid until a substantially uniform temperature in the range from 60°

C. to 100°

C. is obtained within the uterus, and wherein the intrauterine pressure is in maintained at a substantially constant pressure in the range from 30 mmHg to 50 mmHg.

35. A method as in claim 34, wherein the heating step comprises introducing a pair of spaced-apart electrodes into the hollow body organ and passing radio frequency current between the pair of electrodes.

36. A method as in claim 34, wherein the circulating step comprises rotating impeller within the hollow body organ.

37. A method as in claim 36, wherein the impeller is rotated in the range from about 10,000 to 30,000 revolutions per minute.

38. A method as in claim 34, further comprising sensing the temperature within the hollow body organ.

39. A method as in claim 34, wherein the hollow body organ comprises the uterus, and further comprising sealing the uterus at the cervical os prior to circulating the fluid.

40. A method as in claim 34, further comprising filling the hollow body organ substantially completely with the fluid prior to heating and circulating the fluid.

41. A method as in claim 40, wherein the filling step comprises flushing any gasses from the hollow body organ while introducing the fluid into the hollow body organ.

42. A method for thermally ablating a hollow body organ, said method comprising:

introducing a thermally conductive fluid into the hollow body organ;

generating an alternating magnetic flux within the fluid to heat the fluid within the hollow body organ; and

continuously circulating the fluid within the hollow body organ with a fluid circulator disposed within the hollow body organ without substantially varying the pressure within the hollow body organ.

43. A method as in claim 42, wherein the generating step comprises passing alternating current through a wire coil disposed within the hollow body organ.

44. A method as in claim 43, wherein the circulating step further comprises circulating the fluid through the wire coil.

45. A thermal ablation device, comprising:

an elongate member having a proximal end, a distal end, the elongate member defining a heating chamber near the distal end;

a pair of spaced-apart electrodes operably attached to the elongate member and disposed within the heating chamber;

an impeller operably attached to the elongate member, the impeller being disposed within the heating chamber and spaced-apart from the pair of electrodes, wherein a thermally and electrically conductive fluid may be circulated between the electrodes upon operation of the impeller; and

a temperature sensor disposed on an exterior surface of the elongate member.

46. A method for thermally ablating a hollow body organ, said method comprising:

introducing a thermally conductive fluid and a heating apparatus having a fluid circulator into the hollow body organ so that the fluid circulator is within the hollow body organ;

operating the heating apparatus to heat the fluid within the hollow body organ, with the temperature of the heating apparatus generally not exceeding the temperature of the fluid while heating the fluid; and

circulating the fluid within the hollow body organ without substantially varying the pressure within the hollow body organ, wherein the circulating step comprises rotating the impeller within the hollow body organ.

47. A method for thermally ablating a hollow body organ, said method comprising:

introducing a thermally and electrically conductive fluid into the hollow body organ;

passing radio frequency current through the fluid while the fluid is within the hollow body organ to heat the fluid; and

circulating the fluid within the hollow body organ without substantially varying the pressure within the hollow body organ;

wherein the heating step comprises introducing a pair of spaced-apart electrodes into the hollow body organ and passing radio frequency current between the pair of electrodes.

48. A method for thermally ablating a hollow body organ, said method comprising:

introducing a thermally and electrically conductive fluid into the hollow body organ;

passing radio frequency current through the fluid while the fluid is within the hollow body organ to heat the fluid; and

circulating the fluid within the hollow body organ without substantially varying the pressure within the hollow body organ, wherein the circulating step comprises rotating impeller within the hollow body organ.

49. A method as in claim 48, wherein the hollow body organ comprises the uterus, and further comprising heating the fluid until a substantially uniform temperature in the range from 60°

C. to 100°

C. is obtained within the uterus.

50. A method as in claim 49, wherein the intrauterine pressure is in maintained at a substantially constant pressure in the range from 30 mmHg to 50 mmHg.