Method and apparatus for tubal occlusion

• US 20040255958A1
• Filed: 03/29/2004
• Published: 12/23/2004
• Est. Priority Date: 02/01/1999
• Status: Active Grant

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Adiana, Inc. (Hologic Incorporated)
• Inventors: Harrington, Douglas C., Carr-Brendel, Victoria E., Bowman, Brett S.
• Granted Patent: US 7,842,035 B2
• Time in Patent Office: Days
• US Class Current: 128/898
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/162 located on the probe body
• CPC Class Codes: A61F 6/225 transcervical

Abstract

Methods and devices for occlusion of the fallopian tubes of a woman. The method involves thermally damaging the lining of the utero-tubal junction with relatively low power, followed by placement of a reticulated foam plug. In one embodiment, vascularized tissue grows into the plug and prevents or discourages formation of scar tissue around the plug. Another embodiment with a relatively small foam pore size encourages formation of a vascularized capsule around the plug. The presence of this vascularized capsule limits the patient'"'"'s foreign body response, so that the capsule does not constrict around the plug. Also presented is a catheter designed for wounding the epithelial layer of the utero-tubal junction, and a method of using the catheter to form a long yet shallow lesion in the utero-tubal junction.

Claims

1. A method of occluding the ovarian pathway of a female body, said method comprising the steps of:

applying a heating element to a target segment of the pathway, and operating the heating element to heat the target segment in the pathway;

limiting the heating of the target segment by applying power of 0.1 to 5 watts to the heating element for a period of at least about 5 seconds;

installing a plug into the target segment of the pathway.

2. The method of claim 1 additionally comprising the step of providing the heating element in the form of at least one electrode adapted for application to the ovarian pathway.

3. The method of claim 2 additionally comprising the step of applying RF energy to the target segment through the electrode.

4. The method of claim 1 additionally comprising the step of providing the heating element in the form of at least two electrodes adapted for application to the ovarian pathway, and applying bi-polar RF energy to said electrodes.

5. The method of claim 1 additionally comprising the step of providing the heating element in the form of at least one resistive heating element adapted for application to the ovarian pathway.

6. The method of claim 1 additionally comprising the step of providing the heating element in the form of at least one microwave heating element adapted for application to the ovarian pathway.

7. The method of claim 1 additionally comprising the step of providing the heating element in the form of at least one ultrasound heating element adapted for application to the ovarian pathway.

8. The method of claim 1 additionally comprising the step of providing the heating element in the form of at least one laser heating element adapted for application to the ovarian pathway.

9. The method of claim 1 additionally comprising the step of providing the plug in the form of a reticulated foam plug having pores with pore sizes in the range of 40 to 200 microns.

10. The method of claim 1 additionally comprising the step of providing the plug in the form of a reticulated foam plug having pores with pore sizes in the range of 1 to 20 microns.

11. The method of claim 9 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of 20-100 Shore A.

12. The method of claim 9 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of about 60 Shore A.

13. The method of claim 9 additionally comprising the step of providing the foam plug in the form of an ePTFE plug.

14. The method of claim 9 additionally comprising the step of providing the foam plug in the form of an acrylic copolymer plug.

15. The method of claim 10 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of 20-100 Shore A.

16. The method of claim 10 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of about 60 Shore A.

17. The method of claim 10 additionally comprising the step of providing the foam plug in the form of an ePTFE plug.

18. The method of claim 10 additionally comprising the step of providing the foam plug in the form of an acrylic copolymer plug.

19. A method of occluding the ovarian pathway of a female body, wherein the ovarian pathway is lined by an epithelial layer on the inner surface of the ovarian pathway, and wherein the ovarian pathway is further characterized by a lamina propria layer surrounding the epithelial layer, a circular muscle layer surrounding the lamina propria layer and a longitudinal muscle layer surrounding the circular muscle layer, said method comprising the steps of:

applying a wounding element in the form of a catheter-mounted heating element and operating the wounding element to cause a wound in the segment of the pathway that necroses the epithelial layer;

limiting the outward extent of the wound to the circular muscle layer by limiting the heating of the target segment by applying power of 0.1 to 5 watts to the heating element for a period of at least about 5 seconds;

installing a foam plug comprising a reticulated foam into the wounded segment of the pathway; and

allowing the wounded segment of the pathway to heal with the foam plug installed.

20. The method of claim 19 additionally comprising the step of providing the heating element in the form of at least one electrode adapted for application to the ovarian pathway.

21. The method of claim 20 additionally comprising the step of applying RF energy to the target segment through the electrode.

22. The method of claim 19 additionally comprising the step of providing the heating element in the form of at least two electrodes adapted for application to the ovarian pathway, and applying bi-polar RF energy to said electrodes.

23. The method of claim 19 additionally comprising the step of providing the heating element in the form of at least one resistive heating element adapted for application to the ovarian pathway.

24. The method of claim 19 additionally comprising the step of providing the heating element in the form of at least one microwave heating element adapted for application to the ovarian pathway.

25. The method of claim 19 additionally comprising the step of providing the heating element in the form of at least one ultrasound heating element adapted for application to the ovarian pathway.

26. The method of claim 19 additionally comprising the step of providing the heating element in the form of at least one laser heating element adapted for application to the ovarian pathway.

27. The method of claim 19 additionally comprising the step of providing the plug in the form of a reticulated foam plug having pores with pore sizes in the range of 40 to 200 microns.

28. The method of claim 19 additionally comprising the step of providing the plug in the form of a reticulated foam plug having pores with pore sizes in the range of 1 to 20 microns.

29. The method of claim 27 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of 20-100 Shore A.

30. The method of claim 27 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of about 60 Shore A.

31. The method of claim 27 additionally comprising the step of providing the foam plug in the form of an ePTFE plug.

32. The method of claim 27 additionally comprising the step of providing the foam plug in the form of an acrylic copolymer plug.

33. The method of claim 28 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of 20-100 Shore A.

34. The method of claim 28 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of about 60 Shore A.

35. The method of claim 28 additionally comprising the step of providing the foam plug in the form of an ePTFE plug.

36. The method of claim 28 additionally comprising the step of providing the foam plug in the form of an acrylic copolymer plug.

37. A method of occluding the ovarian pathway of a female body, the ovarian pathway being characterized by an epithelial layer lining the inside of the ovarian pathway, a lamina propria layer surrounding the epithelial layer, a circular muscle layer surrounding the lamina propria layer and a longitudinal muscle layer surrounding the circular muscle layer, said method comprising the steps of:

applying a heating element to a target segment of the pathway, and operating the heating element to heat the target segment in the pathway;

limiting the heating of the target segment to avoid wounding the longitudinal layer by limiting the heating of the target segment by applying power of 0.1 to 5 watts to the heating element for a period of at least about 5 seconds;

installing a plug into the target segment of the pathway.

38. The method of claim 37 additionally comprising the step of providing the heating element in the form of at least one electrode adapted for application to the ovarian pathway.

39. The method of claim 38 additionally comprising the step of applying RF energy to the target segment through the electrode.

40. The method of claim 37 additionally comprising the step of providing the heating element in the form of at least two electrodes adapted for application to the ovarian pathway, and applying bi-polar RF energy to said electrodes.

41. The method of claim 37 additionally comprising the step of providing the heating element in the form of at least one resistive heating element adapted for application to the ovarian pathway.

42. The method of claim 37 additionally comprising the step of providing the heating element in the form of at least one microwave heating element adapted for application to the ovarian pathway.

43. The method of claim 37 additionally comprising the step of providing the heating element in the form of at least one ultrasound heating element adapted for application to the ovarian pathway.

44. The method of claim 37 additionally comprising the step of providing the heating element in the form of at least one laser heating element adapted for application to the ovarian pathway.

45. The method of claim 37 additionally comprising the step of providing the plug in the form of a reticulated foam plug having pores with pore sizes in the range of 40 to 200 microns.

46. The method of claim 37 additionally comprising the step of providing the plug in the form of a reticulated foam plug having pores with pore sizes in the range of 1 to 20 microns.

47. The method of claim 45 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of 20-100 Shore A.

48. The method of claim 45 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of about 60 Shore A.

49. The method of claim 45 additionally comprising the step of providing the foam plug in the form of an ePTFE plug.

50. The method of claim 45 additionally comprising the step of providing the foam plug in the form of an acrylic copolymer plug.

51. The method of claim 46 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of 20-100 Shore A.

52. The method of claim 46 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of about 60 Shore A.

53. The method of claim 46 additionally comprising the step of providing the foam plug in the form of an ePTFE plug.

54. The method of claim 46 additionally comprising the step of providing the foam plug in the form of an acrylic copolymer plug.