Method and device for thermal ablation having improved heat transfer

• US 5,433,708 A
• Filed: 06/07/1993
• Issued: 07/18/1995
• Est. Priority Date: 05/17/1991
• Status: Expired due to Term

• Current Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Original Assignee: InnerDyne, Inc. (Medtronic Plc)
• Inventors: Behl, Robert S., Dubrul, William R., Nichols, Colin J.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): MULCARE, NANCY C
• Application Number:
  US08/073,639
• Time in Patent Office: 771 Days
• Field of Search: 606/27-31, 604/113, 604/114, 607/96, 607/104-107, 607/138
• US Class Current: 604/113
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00092 using thermocouples
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/00095 high, i.e. heat conducting
• CPC Class Codes: A61B 2018/00422 Angioplasty
• CPC Class Codes: A61B 2018/044 the surgical action being effected by a circulating hot fluid
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2090/3933 Liquid markers
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61F 2007/0059 with an open fluid circuit
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities

Abstract

A thermal ablation catheter includes an elongate body member having a heating element disposed over a predetermined length of its distal end. The heating element is suspended away from an exterior surface of the elongate member to form a circulation region thereunder. Thermally conductive fluid can be introduced through a lumen in the elongate member and distributed within the circulation region to improve heat transfer. The catheter is used to introduce the thermally conductive medium to a hollow body organ where the heating element raises the temperature of the medium sufficiently to induce injury to the lining of the organ. Optionally, an introducer sheath having an expandable cage at its distal end may be used in combination with a thermal ablation catheter. The expandable cage helps center the heating element on the catheter within the body organ and prevents direct contact between the heating element and the wall of the organ. Heat transfer and temperature uniformity can be enhanced by inducing an oscillatory flow of the heat transfer medium through the catheter while heat is being applied.

Claims

1. A thermal ablation catheter comprising:

an elongate member adapted for insertion into a hollow body cavity;

said elongate member having a proximal end, a distal end, and a lumen extending between said proximal and distal ends;

a convective heating element disposed over a predetermined length of the distal end of the elongate member and exposed to an environment external to said catheter;

means for suspending the heating element away from an exterior surface of the elongate member to form a circulation region between the surface and the heating element; and

means for distributing a heat transfer fluid from the lumen to the circulation region between the member surface and the heating element, wherein the heating element is capable of heating said heat transfer fluid to a temperature above 45°

C.

2. A thermal ablation catheter as is in claim 1, wherein the elongate member is at least partly flexible.

3. A thermal ablation catheter as in claim 1, wherein the heating element is an electrically resistive coil having spaced-apart windings.

4. A thermal ablation catheter as in claim 1, wherein the means for suspending comprises three or more axial ribs formed along the distal end of the elongate member with trough regions between adjacent ribs defining the circulation region.

5. A thermal ablation catheter as in claim 4, wherein the means for distributing a heat transfer fluid comprises a plurality of ports in the elongate member opening into the trough regions.

6. A thermal ablation catheter as in claim 5, wherein the heating element is a coiled wire having a diameter in the range from about 0.05 mm to 0.25 mm, wherein adjacent windings of the coil are spaced-apart by from 0.5 to 2 wire diameters to permit free flow of heat transfer fluid through the heating element.

7. A thermal ablation catheter as in claim 1, further comprising a cage structure surrounding the heating element and means for expanding the cage structure at the distal end of the elongate member.

8. A thermal ablation catheter as in claim 7, wherein the means for expanding a cage is an introducer sheath having a proximal end, a distal end, and the expandable cage at its distal end.

9. A thermal ablation system comprising:

a catheter including an elongate member having proximal and distal ends an axial lumen, a resistive heating element mounted on an exterior surface over a predetermined length at the distal end of the elongate member, and a plurality of apertures extending radially outward from the axial lumen within the predetermined length of the exterior surface;

a power supply connected to the resistive heating element; and

means for inducing an oscillatory flow of thermally conductive medium past the resistive heating element in two directions.

10. A thermal ablation system as in claim 9, further comprising:

an introducer sheath having a proximal end, a distal end, an axial lumen for receiving the elongate member of the catheter, and an expandable cage at its distal end, wherein the expandable cage will surround the heating element when the catheter is in place in the axial lumen of the sheath.

11. A thermal ablation system as in claim 10, further comprising at least one temperature sensing element on the expandable cage.

12. A thermal ablation system as in claim 11, wherein the temperature sensing element is at a point of maximum radial expansion on the expandable cage.

13. A thermal ablation system as in claim 9, wherein the means for inducing an oscillatory flow includes:

an oscillatory pump connected to a proximal end of the lumen in the elongate member.

14. A thermal ablation system as in claim 13, wherein the oscillatory pump is a syringe connected to the lumen of the elongate member.

15. A thermal ablation system as in claim 9, wherein the resistive heating element comprises a coil having spaced-apart windings and the catheter further includes means for suspending the coil away from an exterior surface of the elongate member to form a circulation region between the surface and the coil.

16. A thermal ablation system as in claim 15, wherein the means for suspending the coil comprises three or more axial ribs formed along the distal end of the elongate member with trough regions between adjacent ribs defining the circulation regions.

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

percutaneously introducing a catheter into the interior of said hollow body organ, said catheter having a heating element and fluid distributing means at its distal end, wherein the heating element is directly exposed to fluid within the organ;

introducing a thermally conductive medium into the hollow body organ through the fluid distributing means so that the medium is unconstrained and in direct thermal contact with the interior wall of the organ;

heating the thermally conductive medium within the hollow body organ using the heating element; and

alternately aspirating and expelling volumes of thermally conductive medium through the fluid distributing means past the heating element in a reversing flow pattern with substantially all the aspirated medium and all the expelled medium flowing past the heating element to effect mixing of the fluid and increase heat flux and uniformity of temperature distribution.

18. A method as in claim 17, further comprising:

expanding a cage structure within the hollow body organ; and

positioning the heating element of the catheter within the expanded cage structure prior to heating the thermally conductive medium.

19. A method as in claim 18, further comprising sensing the temperature using at least one sensor disposed on the expanded cage structure.

20. A method as in claim 19, wherein the sensor is located at a point of maximum radial expansion on the expandable cage structure.

21. A method as in claim 17, wherein the aspirating and expelling steps are effected with a syringe connected to the fluid distributing means.

22. A method as in claim 17, wherein the volumes which are aspirated and expelled are in the range from 0.1 ml to 3 ml.

23. A method as in claim 17, wherein the volumes are aspirated and expelled at a frequency in the range from 0.01 to 5 Hz.

24. A method as in claim 17, wherein the preselected temperature is in the range from 45°

C. to 70°

C.

25. A method as in claim 17, wherein the hollow body organ is the gallbladder, the temperature is in the range from 50°

C. to 65°

C., the frequency of aspiration and expelling is from 0.1 Hz to 5 Hz, the volumes are in the range from 0.1 ml to 3 ml, and the total treatment time is from 15 minutes to 45 minutes.

26. A thermal ablation catheter comprising:

an elongate member having a proximal end, a distal end, and a lumen extending between said proximal and distal ends;

a heating element disposed over a predetermined length of the distal end of the elongate member;

means for suspending the heating element away from an exterior surface of the elongate member to form a circulation region between the surface and the heating element, wherein the means for suspending comprises three or more axial ribs formed along the distal end of the elongate member with trough regions between adjacent ribs defining the circulation region; and

means for distributing a heat transfer fluid from the lumen to the region between the member surface and the heating element.

27. A thermal ablation catheter as is in claim 26, wherein the elongate member is at least partly flexible.

28. A thermal ablation catheter as in claim 26, wherein the heating element is a coil having spaced-apart windings.

29. A thermal ablation catheter as in claim 26, wherein the means for distributing a heat transfer fluid comprises a plurality of ports in the elongate member opening into the trough regions.

30. A thermal ablation catheter as in claim 29, wherein the heating element is a coiled wire having a diameter in the range from about 0.05 mm to 0.25 mm, wherein adjacent windings of the coil are spaced-apart by from 0.5 to 2 wire diameters to permit free flow of heat transfer fluid through the heating element.

31. A thermal ablation catheter as in claim 26, further comprising a cage structure surrounding the heating element and means for expanding the cage structure at the distal end of the elongate member.

32. A thermal ablation catheter as in claim 31, wherein the means for expanding a cage is an introducer sheath having a proximal end, a distal end, and the expandable cage at its distal end.

33. A thermal ablation system comprising:

a catheter including an elongate member adapted for insertion into a hollow body cavity;

said elongate member having proximal and distal ends and a resistive heating element having spaced-apart windings mounted on an exterior surface at the distal end of the elongate member;

means for suspending the coil away from an exterior surface of the elongate member to form a circulation region between the surface and the coil;

a power supply connected to the resistive heating element; and

means for inducing an oscillatory flow of thermally conductive medium past the resistive heating element.

34. A thermal ablation system as in claim 33, further comprising:

an introducer sheath having a proximal end, a distal end, and an axial lumen for receiving the elongate member of the catheter, and an expandable cage at its distal end, wherein the expandable cage will surround the heating element when the catheter is in place in the axial lumen of the sheath.

35. A thermal ablation system as in claim 34, further comprising at least one temperature sensing element on the expandable cage.

36. A thermal ablation system as in claim 35, wherein the temperature sensing element is at a point of maximum radial expansion on the expandable cage.

37. A thermal ablation system as in claim 33, wherein the means for inducing an oscillatory flow includes:

a lumen extending from the proximal end to the distal end of the elongate member;

an oscillatory pump connected to the proximal end of the lumen; and

a plurality of ports in the elongate member opening from the lumen and through the heating element.

38. A thermal ablation system as in claim 37, wherein the oscillatory pump is a syringe connected to the lumen of the elongate member.

39. A thermal ablation system as in claim 33, wherein the means for suspending the coil comprises three or more axial ribs formed along the distal end of the elongate member with trough regions between adjacent ribs defining the circulation regions.

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

percutaneously introducing a catheter into the interior of said hollow body organ, said catheter having a heating element and fluid distributing means at its distal end, wherein the heater element is directly exposed to fluid within the organ;

expanding a cage structure within the hollow body organ;

positioning the heating element of the catheter within the expanded cage structure;

introducing a thermally conductive medium into the hollow body organ through the fluid distributing means so that the medium is unconstrained and in direct thermal contact with the interior wall of the organ;

heating the thermally conductive medium within the hollow body organ using the heating element; and

alternately aspirating and expelling volumes of thermally conductive medium through the fluid distributing means to effect mixing of the fluid and increase heat flux and uniformity of temperature distribution.

41. A method as in claim 40, further comprising sensing the temperature using at least one sensor disposed on the expanded cage structure.

42. A method as in claim 41, wherein the sensor is located at a point of maximum radial expansion on the expandable cage structure.

43. A method as in claim 40, wherein the aspirating and expelling steps are effected with a syringe connected to the fluid distributing means.

44. A method as in claim 40, wherein the volumes which are aspirated and expelled are in the range from 0.1 ml to 3 ml.

45. A method as in claim 40, wherein the volumes are aspirated and expelled at a frequency in the range from 0.01 to 5 Hz.

46. A method as in claim 40, wherein the preselected temperature is in the range from 45°

C. to 70°

C.

47. A method as in claim 40, wherein the hollow body organ is the gallbladder, the temperature is in the range from 50°

C. to 65°

C., the frequency of aspiration and expelling is from 0.1 Hz to 5 Hz, the volumes are in the range from 0.1 ml to 3 ml, and the total treatment time is from 15 minutes to 45 minutes.

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

percutaneously introducing a catheter into the interior of said hollow body organ, said catheter having a heating element and fluid distributing means at its distal end, wherein the heater element is directly exposed to fluid within the organ and the fluid distributing means directs fluid generally radially through the heating element;

introducing a thermally conductive medium into the hollow body organ through the fluid distributing means so that the medium is unconstrained and in direct thermal contact with the interior wall of the organ;

heating the thermally conductive medium within the hollow body organ using the heating element; and

alternately aspirating and expelling volumes of thermally conductive medium through the fluid distributing means to effect mixing of the fluid and increase heat flux and uniformity of temperature distribution.

49. A method as in claim 48, further comprising:

expanding a cage structure within the hollow body organ; and

positioning the heating element of the catheter within the expanded cage structure prior to heating the thermally conductive medium.

50. A method as in claim 49, further comprising sensing the temperature using at least one sensor disposed on the expanded cage structure.

51. A method as in claim 50, wherein the sensor is located at a point of maximum radial expansion on the expandable cage structure.

52. A method as in claim 48, wherein the aspirating and expelling steps are effected with a syringe connected to the fluid distributing means.

53. A method as in claim 48, wherein the volumes which are aspirated and expelled are in the range from 0.1 ml to 3 ml.

54. A method as in claim 48, wherein the volumes are aspirated and expelled at a frequency in the range from 0.01 to 5 Hz.

55. A method as in claim 48, wherein the preselected temperature is in the range from 45°

C. to 70°

C.

56. A method as in claim 48, wherein the hollow body organ is the gallbladder, the temperature is in the range from 50°

C. to 65°

C., the frequency of aspiration and expelling is from 0.1 Hz to 5 Hz, the volumes are in the range from 0.1 ml to 3 ml, and the total treatment time is from 15 minutes to 45 minutes.

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

introducing a catheter into the interior of said hollow body organ;

introducing a thermally conductive medium into the hollow body organ so that the medium is unconstrained and in direct thermal conduct with the interior wall of the organ; and

alternately aspirating and expelling volumes of the thermally conductive medium through the catheter and past a heating element in a reversing flow pattern with substantially all the aspirated medium and all the expelled medium flowing past the heating element to effect mixing of the fluid and increase heat flux and uniformity of temperature distribution.

58. A method as in claim 57, wherein the catheter is introduced percutaneously.

59. A method as in claim 57, wherein the thermally conductive medium is introduced through the catheter.

60. A method as in claim 57, wherein the heating element is on the distal end of the catheter.