Method for treating hemorrhoids

• US 6,135,997 A
• Filed: 11/16/1998
• Issued: 10/24/2000
• Est. Priority Date: 03/05/1996
• Status: Expired due to Term

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: VNUS Medical Technologies Incorporated (Medtronic Plc)
• Inventors: Laufer, Michael D., Farley, Brian E.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/193,319
• Time in Patent Office: 708 Days
• Field of Search: 606/27, 606/40, 606/32, 604/104-107, 604/19-21, 604/93, 607/1, 607/2, 607/96, 607/101, 607/103, 607/122, 600/9, 600/11
• US Class Current: 606/27
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• 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 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00488 Esophagus
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00755 Resistance or impedance
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/1465 Deformable electrodes
• CPC Class Codes: A61B 2018/1497 : Electrodes covering only part of the probe circumference

Abstract

A catheter delivers an electrode within a vein for a minimally invasive treatment of hemorrhoids using RF energy. The catheter is introduced into a patient and positioned within the section of the vein to be treated. The electrode radiates high frequency energy towards the vein, and the surrounding venous tissue becomes heated and begins to shrink. The catheter includes a controllable member for limiting the amount of shrinkage of the vein to the diameter of the member. The electrode remains active until there has been sufficient shrinkage of the vein. The extent of shrinkage of the vein can be detected by fluoroscopy. After treating one section of the vein, the catheter and the electrode can be repositioned within the hemorrhoidal venous system to treat different sections until all desired venous sections and valves are repaired and rendered functionally competent. Shrinkage of the vein further thickens and stiffens the vein wall which reduces the potential for the hemorrhoid vein to dilate.

Claims

1. A method of applying energy to cause shrinkage of a dilated vein for treating hemorrhoids, the method comprising the steps of:

introducing a catheter having a working end and means for heating located at the working end, to a treatment site in a vein;

positioning the means for heating at the treatment site in the vein;

applying energy from the means for heating to heat the treatment site and cause shrinkage of the vein;

terminating the emission of energy from the means for heating after sufficient shrinkage of the vein so as to reduce the hemorrhoid while the vein remains patent.

2. The method of claim 1, wherein the step of introducing the catheter includes the step of advancing the catheter through the iliac vein.

3. The method of claim 1, wherein the step of positioning the means for heating at the treatment site further includes the step of placing the means for heating at the treatment site so that heating of the venous valve is minimized.

4. The method of claim 1, wherein the step of positioning the means for heating further includes the step of arranging the means for heating for achieving circumferential shrinkage of the vein.

5. The method of claim 1, wherein the step of positioning the means for heating further includes the step of moving the means for heating into apposition with the vein wall at the treatment site.

6. The method of claim 1, wherein the step of positioning further includes the step of increasing an effective diameter of the catheter to place the means for heating into apposition with the vein wall;

and the step of applying energy further includes the step of reducing the effective diameter of the catheter so as to maintain apposition with the vein wall as the vein wall shrinks.

7. The method of claim 1, wherein the step of applying energy further includes the step of limiting the shrinkage of the vein to a selected diameter.

8. The method of claim 1, wherein the step of applying energy further includes the step of controlling the energy from the means for heating so as to minimize coagulation in the vein.

9. The method of claim 1, wherein the step of applying energy further includes the step of controlling the energy from the means for heating so as to control the spread of heating at the treatment site of the vein.

10. The method of claim 1, further comprising the step of determining the extent of shrinkage of the vein.

11. The method of claim 10, further comprising the step of determining the extent of shrinkage of the vein using fluoroscopy.

12. The method of claim 1, further comprising the steps of positioning the means for heating at a second treatment site;

and repeating the applying and terminating steps.

13. A method of applying energy to cause the shrinkage of a dilated vein for treating hemorrhoids, the method comprising the steps of:

introducing a catheter having a working end and an electrode located at the working end, to a treatment site in the vein;

positioning the electrode at the treatment site in the vein;

applying radio frequency energy from the electrode to heat the treatment site and cause shrinkage of the vein;

terminating the applying of radio frequency energy from the electrode after sufficient shrinkage of the vein so as to reduce the hemorrhoids while that the vein remains patent.

14. The method of claim 13, wherein the step of introducing the catheter includes the step of advancing the catheter through the external iliac vein.

15. The method of claim 13, wherein the step of positioning the electrode at the treatment site further includes the step of placing the electrode at the treatment site so as to minimize heating of the venous valve.

16. The method of claim 13, wherein the step of positioning the electrode further includes the step of arranging a plurality of electrodes on the catheter for achieving circumferential shrinkage of the vein and minimizing axial shortening.

17. The method of claim 13, wherein the step of positioning further comprises the step of inflating a balloon with an inflation medium so that the balloon engages the vein;

wherein the step of applying energy further includes the step of heating the inflation medium by the heating means, wherein the treatment site is heated by the conduction of heat from the balloon.

18. The method of claim 13, wherein the step of positioning the electrode further includes the step of moving the electrode into apposition with the vein wall at the treatment site.

19. The method of claim 13, wherein the step of positioning further includes the step of deflecting an elongate member to place the electrode in apposition with the vein wall at the treatment site.

20. The method of claim 13, wherein the step of positioning further includes the step of inflating a balloon on the catheter to engage an elongate member, wherein the elongate member is deflected to place the electrode in apposition with the vein wall at the treatment site.

21. The method of claim 13, wherein the step of positioning the electrode at the treatment site further includes the step of inflating a balloon on the catheter to move the electrode into apposition with the vein wall.

22. The method of claim 13, wherein the step of positioning further includes the step of moving a deflection wire through the catheter to deflect the catheter and the electrode to one side of the vein at the treatment site.

23. The method of claim 13, wherein the step of positioning further includes the step of actuating a deflection wire on one side of the catheter so as to move the catheter and the electrode on the side of the catheter opposite the deflection wire to one side of the vein.

24. The method of claim 13, wherein the step of positioning further includes the step of inflating a balloon on one side of the catheter so as to move the catheter and the electrode on the other side of the catheter to one side of the vein at the treatment site.

25. The method of claim 13, wherein the step of positioning further includes the step of inflating a balloon on the catheter to center the catheter and the electrode within the vein.

26. The method of claim 13, wherein the step of applying energy further includes the step of limiting the shrinkage of the vein to a selected diameter.

27. The method of claim 13, wherein the step of applying energy further includes the step of limiting the shrinkage of the vein by inflating a balloon to a selected diameter;

wherein the inflated balloon prevents shrinkage of the vein beyond the selected diameter.

28. The method of claim 13, wherein the step of positioning the electrode further includes the step of placing the electrode into apposition with the vein wall;

and the step of applying energy further includes the step of reducing an effective diameter of the catheter in a controlled manner so as to maintain apposition with the vein wall as the vein wall shrinks until a diameter for the vein is achieved, wherein the vein continues to function.

29. The method of claim 13, wherein the step of positioning the electrode further includes the step of placing the electrode into apposition with the vein by increasing an effective diameter of the catheter, wherein the shrinkage of the vein reduces the effective diameter of the catheter;

and

the step of limiting the shrinkage of the vein further includes the step of preventing the effective diameter of the catheter from being reduced to less than a selected diameter representing the sufficient shrinkage of the vein.

30. The method of claim 13, wherein the step of applying energy further includes the step of limiting the shrinkage of the vein to the fixed diameter of the catheter at the working end.

31. The method of claim 13, wherein the electrode includes a plurality of longitudinal electrodes, and the step of applying the high frequency energy further includes the step of providing the high frequency energy to the longitudinal electrodes along the circumference of the working end of the catheter;

wherein the vein is shrunk circumferentially and axial shrinkage of the vein is minimized.

32. The method of claim 13, wherein the electrode is a ring electrode, and the step of applying the high frequency energy further includes the step of providing radio frequency energy to the ring electrode at the working end of the catheter.

33. The method of claim 13, wherein the step of applying the high frequency energy further includes the step of providing an inert tip at the working end of the catheter past the electrode.

34. The method of claim 13, further comprising the step of delivering a cooling fluid to the treatment site for preventing thermal coagulation.

35. The method of claim 13, further comprising the step of determining the extent of shrinkage of the vein.

36. The method of claim 13, further comprising the step of determining the extent of shrinkage of the vein using fluoroscopy.

37. The method of claim 13, further comprising the step of determining the extent of shrinkage of the vein using ultrasound imaging.

38. The method of claim 13, further comprising the step of determining when to terminate the applying of radio frequency energy by measuring the time at which a specific temperature has been achieved at the treatment site.

39. A method of applying energy to cause shrinkage of a vein for restoring the competency of a venous valve in treating hemorrhoids, the method comprising the steps of:

introducing a catheter having a working end and means for heating located at the working end, to a treatment site in a vein;

positioning the means for heating at the treatment site in the vein;

applying energy from the means for heating to heat the treatment site and cause shrinkage of the vein;

terminating the emission of energy from the means for heating after sufficient shrinkage of the vein so as to restore venous valve competency and reduce the hemorrhoids.

40. A method of applying energy to cause the shrinkage of a vein for restoring the competency of a venous valve in treating hemorrhoids, the method comprising the steps of:

introducing a catheter having a working end and an electrode located at the working end, to a treatment site in the vein;

positioning the electrode at the treatment site in the vein;

applying high frequency energy from the electrode to heat the treatment site and cause shrinkage of the vein;

terminating the application of energy from the electrode after sufficient shrinkage of the vein so as to restore venous valve competency and reduce the hemorrhoids.

41. The method of claim 40, wherein the step of introducing the catheter includes the step of advancing the catheter through the iliac vein.

42. The method of claim 40, wherein the step of positioning the electrode at the treatment site further includes the step of placing the electrode at the treatment site so as to minimize heating of the venous valve.

43. The method of claim 40, wherein the step of positioning the electrode at the treatment site further includes the step of placing the electrode across the venous valves at the treatment site.

44. The method of claim 40, wherein the step of positioning the electrode at the treatment site further includes the step of introducing the catheter retrograde to venous flow and advancing the catheter to the cusps of the venous valves at the treatment site.

45. The method of claim 40, wherein the step of positioning the electrode further includes the step of arranging a plurality of electrodes on the catheter for achieving circumferential shrinkage of the vein and minimizing axial shortening.

46. The method of claim 40, wherein the step of positioning further comprises the step of inflating a balloon with an inflation medium so that the balloon engages the vein;

wherein the step of applying energy further includes the step of heating the inflation medium by the heating means, wherein the treatment site is heated by the conduction of heat from the balloon.

47. The method of claim 40, wherein the step of positioning the electrode further includes the step of moving the electrode into apposition with the vein wall at the treatment site.

48. The method of claim 40, wherein the step of positioning further includes the step of deflecting an elongate member radially outward from the catheter to place the electrode in apposition with the vein wall at the treatment site.

49. The method of claim 40, wherein the step of positioning further includes the step of inflating a balloon on the catheter to deflect an elongate member, wherein the electrode is placed in apposition with the vein wall at the treatment site.

50. The method of claim 40, wherein the step of positioning further includes the step of inflating a balloon on the catheter to deflect move the electrode into contact with the vein wall at the treatment site.

51. The method of claim 40, wherein the step of positioning further includes the step of moving a deflection wire through the catheter to deflect the catheter and the electrode to one side of the vein at the treatment site.

52. The method of claim 40, wherein the step of positioning further includes the step of actuating a deflection wire on one side of the catheter to move the catheter and the electrode on the side of the catheter opposite the deflection wire to one side of the vein.

53. The method of claim 40, wherein the step of positioning further includes the step of inflating a balloon on one side of the catheter so as to move the catheter, and the electrode on the side of the catheter opposite the balloon, to one side of the vein at the treatment site.

54. The method of claim 40, wherein the step of positioning further includes the step of inflating a balloon on the catheter to center the catheter and the electrode within the vein.

55. The method of claim 40, wherein the step of applying energy further includes the step of limiting the shrinkage of the vein to a selected diameter.

56. The method of claim 40, wherein the step of applying energy further includes the step of limiting the shrinkage of the vein by inflating a balloon to a selected diameter;

wherein the inflated balloon prevents shrinkage of the vein beyond the selected diameter.

57. The method of claim 40, wherein the step of positioning the electrode further includes the step of placing the electrode into apposition with the vein wall;

and the step of applying energy further includes the step of reducing an effective diameter of the catheter in a controlled manner so as to maintain contact with the vein wall as the vein wall shrinks, until a selected diameter for the vein is achieved for restoring venous valve competency.

58. The method of claim 40, wherein the step of positioning the electrode further includes the step of placing the electrode into apposition with the vein by increasing an effective diameter of the catheter, wherein the shrinkage of the vein reduces the effective diameter of the catheter;

and

the step of limiting the shrinkage of the vein further includes the step of preventing the effective diameter of the catheter from being reduced to less than a selected diameter representing the sufficient shrinkage of the vein.

59. The method of claim 40, wherein the step of applying energy further includes the step of limiting the shrinkage of the vein to the fixed diameter of the catheter at the working end.

60. The method of claim 40, wherein the step of applying energy further includes the step of controlling the frequency of the energy from the electrode so as to minimize coagulation of blood in the vein.

61. The method of claim 40, wherein the step of applying energy further includes the step of controlling the frequency of the energy from the electrode so as to control the spread of heating at the treatment site of the vein.

62. The method of claim 40, wherein the step of applying energy further includes the step of controlling the frequency and total power of the energy so as to cause the external wall of the hemorrhoidal vein to become affixed to adjacent tissue.

63. The method of claim 40, wherein the step of applying the high frequency energy further includes the step of providing the high frequency energy to a plurality of longitudinal electrodes located around the circumference of the working end of the catheter.

64. The method of claim 40, wherein the step of applying the high frequency energy further includes the step of providing an inert tip at the working end of the catheter past the electrode.

65. The method of claim 40, further comprising the step of delivering a cooling fluid into the vein near the treatment site for preventing thermal coagulation.

66. The method of claim 40, further comprising the step of determining the extent of shrinkage of the vein.

67. The method of claim 40, further comprising the step of determining the extent of shrinkage of the vein using fluoroscopy.

68. The method of claim 40, further comprising the step by infusing radiopaque contrast solution through the catheter lumen to assess valve competence via descending venography.

69. The method of claim 40, further comprising the step of determining the extent of shrinkage of the vein using ultrasound imaging.

70. The method of claim 40, further comprising the step of determining when to terminate the applying of radio frequency energy by measuring the time at which a specific temperature has been achieved at the treatment site using a temperature sensor located on the electrode in contact with the vein wall.

71. The method of claim 70, further comprising the step of providing a filtering circuit to eliminate radio frequency noise from a temperature signal from the temperature sensor located on the electrode.