Thermal dilatation catheter and method

• US 5,178,620 A
• Filed: 02/22/1991
• Issued: 01/12/1993
• Est. Priority Date: 06/10/1988
• Status: Expired due to Term

• Current Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Original Assignee: Advanced Angioplasty Products, Inc.
• Inventors: Eggers, Philip E., Thapliyal, Hira V.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US07/660,320
• Time in Patent Office: 690 Days
• Field of Search: 604/20, 604/96-103, 604/113, 604/114, 606/28, 606/31, 606/41, 606/194, 128/341-344, 128/348.1, 128/399-402, 128/786
• US Class Current: 606/41
• 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 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/162 located on the probe body
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

This invention provides a method and an apparatus for selectively heating a resistive mass which partially or fully occludes a particular tubal passage, such as a blood vessel or the urethra. As a result, the tubal passage is effectively softened or weakened, allowing the tubal passage to be more readily recanalized by expansion of a balloon or other dilatation means. This invention also provides a method and an apparatus for effectively boring through a partially or fully occluded tubal passage by simultaneously applying both (1) heat to the occlusive mass surrounding the tip of the catheter and (2) pressure against the mass within the partially or fully occluded passage.

Claims

1. A heatable dilatation catheter comprising

a catheter member;

dilation means affixed to the catheter member;

a guidewire extending through the catheter member;

a first electrode affixed to the guidewire;

a second electrode affixed to the catheter member, the second electrode electrically insulated from and spaced by a distance of at least one catheter diameter from the first electrode; and

means for selectively communicating an electric current to the first and the second electrodes to thereby cause heating of a resistive mass therebetween.

2. A catheter as in claim 1 wherein the first electrode comprises the guidewire itself.

3. A catheter as in claim 2 wherein the second electrode is affixed to the distal end of the catheter member.

4. A catheter as in claim 3 wherein the dilation means comprises a balloon.

5. A catheter as in claim 4 wherein the catheter member comprises a longitudinally-extending tube having the guidewire therethrough.

6. A catheter as in claim 1 further comprising:

temperature sensing means disposed proximate to the distal end of the catheter member for sensing temperature of regions surrounding the distal end.

7. A catheter as in claim 6 wherein the temperature sensing means is in communication with a proximal end of the catheter member to enable control of the electric current.

8. A catheter as in claim 1 further comprising:

a third electrode affixed to the catheter at a distal end of the dilatation means, the third electrode electrically insulated from and spaced by a distance of at least two catheter diameters from each of the first and the second electrodes;

a fourth electrode affixed to the catheter at a proximal end of the dilation means, the fourth electrode electrically insulated from and spaced by a distance of at least two catheter diameters from each of the first, second and third electrodes; and

means for selectively communicating an electric current to the third and the fourth electrodes to thereby cause heating of a resistive mass therebetween.

9. A catheter as in claim 1 wherein:

the first electrode extends annularly around a circumferential portion of the surface of the guidewire;

the second electrode extends annularly around a circumferential portion of the catheter member.

10. A catheter as in claim 8 wherein:

the third electrode extends annularly around a circumferential portion of the catheter member; and

the fourth electrode extends annularly around a circumferential portion of the catheter member.

11. A catheter as in claim 1 which is an angioplasty catheter.

12. A catheter as in claim 8 which is an angioplasty catheter.

33. The method of claim 3 wherein the resistive obstruction is an arteriosclerotic obstruction.

36. A catheter as in claim 1 which is a prostatic dilatation catheter.

43. A catheter as in claim 8 in which said electrodes are positioned on the surface of and extend circumferentially around a dilatation means.

50. A means for selectively communicating an electric current as in claim 1 which operates at a frequency in the range from 20 kilohertz to 8 megahertz.

51. A means for selectively communicating an electric current as in claim 8 which operates at a frequency in the range from 20 kilohertz to 8 megahertz.

13. A heatable dilatation catheter comprising:

at least two electrodes located on the catheter electrically insulated from each other and spaced by a distance of at least two catheter diameters;

means for selectively communicating an electric current to the electrodes to thereby cause heating of the resistive mass located between the electrodes; and

temperature-sensing means disposed proximate a distal end of the catheter for sensing temperature of the resistive mass being heated.

14. The catheter as in claim 13 wherein the temperature-sensing means is in communication with the proximal end of the catheter to enable control of the electric current.

15. The catheter as in claim 14 wherein the first electrode is affixed to the guidewire and spaced from the second electrode by a distance of at least one catheter diameter.

16. A catheter as in claim 15 which is an angioplasty catheter.

17. The catheter as in claim 15 further comprising:

a third electrode affixed to the catheter at a distal end of the dilation means, the, third electrode electrically insulated from each of the first and the second electrodes;

a fourth electrode affixed to the catheter at a proximal end of the dilation means, the fourth electrode electrically insulated from each of the first, second and third electrodes, and spaced by a distance of at least two catheter diameters from the third electrode; and

means for selectively communicating an electric current to the third and the fourth electrodes to thereby cause heating of a resistive mass therebetween

18. A catheter as in claim 17 which is an angioplasty catheter.

37. A catheter as in claim 15 which is a prostatic dilatation catheter.

38. A catheter as in claim 17 which is a prostatic catheter.

44. A catheter as in claim 13 in which said electrodes are positioned on the surface of and extend circumferentially around a dilatation means.

52. A means for selectively communicating an electric current as in claim 13 which operates at a frequency in the range from 20 kilohertz to 8 megahertz.

19. A heatable dilatation catheter comprising:

at least two electrodes located on the catheter electrically insulated from each other and spaced by a distance of at least two catheter diameters, each of the electrodes extending circumferentially in an annular band around the periphery of the catheter; and

means for selectively communicating an electric current to the electrodes to thereby cause heating of a resistive mass located between the electrodes.

20. The catheter as in claim 19 further comprising:

a guidewire extending through the catheter; and

wherein the first electrode is affixed to the guidewire.

21. The catheter as in claim 20 further comprising temperature-sensing means disposed proximate a distal end of the catheter for sensing temperature of the resistive means being heated.

22. A catheter as in claim 21 which is an angioplasty catheter.

23. The catheter as in claim 21 further comprising:

a third electrode affixed to the catheter at a distal end of the dilation means, the third electrode electrically insulated from and spaced by a distance of at least two catheter diameters from each of the first and the second electrodes;

a fourth electrode affixed to the catheter at a proximal end of the dilation means, the fourth electrode electrically insulated from and spaced by a distance of at least two catheter diameters from each of the first, second and third electrodes; and

means for selectively communicating an electric current to the third and the fourth electrodes to thereby cause heating of a resistive mass therebetween.

24. A catheter as in claim 23 which is an angioplasty catheter.

39. A catheter as in claim 21 which is a prostatic catheter.

40. A catheter as in claim 24 which is a prostatic catheter.

45. A catheter as in claim 19 in which said electrodes are positioned on the surface of and extend circumferentially around a dilatation means.

53. A means for selectively communicating an electric current as in claim 19 which operates at a frequency in the range from 20 kilohertz to 8 megahertz.

25. A heatable dilatation catheter comprising:

a catheter member;

a dilatation means affixed to the catheter member;

a guidewire extending through the catheter member;

a first electrode affixed to the guidewire;

a second electrode affixed to the catheter member and electrically insulated from and spaced by a distance of at least one catheter diameter from the first electrode;

a third electrode affixed to the catheter member at a distal end of the dilation means, the third electrode electrically insulated from each of the first and the second electrodes;

a fourth electrode affixed to the catheter at a proximal end of the dilation means, the fourth electrode electrically insulated from each of the first, second and third electrodes, and spaced by a distance of at least two catheter diameters from the third electrode; and

means for selectively communicating an electric current to the first, second, third, and fourth electrodes to thereby cause heating of a resistive mass disposed in proximity to the electrodes.

26. A catheter as in claim 25 which is an angioplasty catheter

41. A catheter as in claim 25 which is a prostatic catheter.

46. A catheter as in claim 25 in which said third and fourth electrodes are positioned on the surface of and extend circumferentially around a dilatation means.

54. A means for selectively communicating an electric current as in claim 25 which operates at a frequency in the range from 20 kilohertz to 8 megahertz.

27. In a heatable catheter having a dilation means, the improvement comprising:

a first electrode located on an extensible guidewire;

a second electrode located at a distal end of the catheter electrically insulated from the first electrode;

a third electrode located at a distal end of the dilation means electrically insulated from the first and second electrodes;

a fourth electrode located at a proximal end of the dilation means electrically insulated from the first, second, and third electrodes;

whereby the first and second electrodes are separated by a distance of at least one catheter diameter from each other;

whereby the third and fourth electrodes are separated by a distance of at least two catheter diameters from each other;

whereby the guidewire comprises the first electrode;

whereby the second, third, and fourth electrodes are annular metallic regions having a wire extending therefrom;

means for selectively communicating an electric current to the electrodes to thereby cause heating of a resistive mass located between the electrodes;

whereby the means for communicating an electric current to the second, third, and fourth electrodes comprises at least one wire contained within the catheter; and

whereby the guidewire comprises the means for communicating an electric current to the first electrode.

28. A catheter as in claim 27 which is an angioplasty catheter.

42. A catheter as in claim 27 which is a prostatic catheter.

47. A catheter as in claim 27 in which said third and fourth electrodes are positioned on the surface of and extend circumferentially around a dilatation means.

55. A means for selectively communicating an electric current as in claim 27 which operates at a frequency in the range from 20 kilohertz to 8 megahertz.

29. A method of heating a resistive mass obstruction or portion thereof in a tubal passage, the method comprising the steps of:

positioning at least two electrodes, electrically insulated from each other and spaced by a distance of at least two estheter diameters, on either side of the obstruction or portion thereof;

conducting a high frequency current between the electrodes through the obstruction to thereby heat the obstruction to an elevated temperature;

sensing the elevated temperature; and

controlling the high frequency current to thereby control the elevated temperature.

30. The method of claim 29 whereby the step of positioning comprises positioning the two electrodes by means of a catheter.

31. The method of claim 29 wherein the resistive obstruction is an arteriosclerotic obstruction.

34. The method of claim 29 wherein the resistive obstruction is a prostatic obstruction.

48. A catheter as in claim 29 in which said electrodes are positioned on the surface of and extend circumferentially around a dilatation means.

56. A means for selectively communicating an electric current as in claim 29 in which the operating frequencyis in the range from 20 kilohertz to 8 megahertz.

57. A means for selectively communicating an electric current as in claim 34 in which the operating frequency is in the range from 20 kilohertz to 8 megahertz.

32. A method of dilatating a resistive mass obstruction or a portion thereof in a tubal passage, the method comprising the steps of:

positioning a first electrode, an inflatable expansion means, and a second electrode against the obstruction, the first and second electrodes being electrically insulated from each other and spaced by a distance of at least two catheter diameters;

conducting a high frequency current between the electrodes through the obstruction to thereby heat the obstruction to an elevated temperature;

sensing the elevated temperature;

controlling the high frequency current to thereby control the elevated temperature; and

inflating the expansion means against the obstruction.

35. The method fo claim 32 wherein the resistive obstruction is a prostatic obstruction.

49. A catheter as in claim 32 in which said electrodes are positioned on the surface of and extend circumferentially around a dilatation means.