Method and apparatus for tubal occlusion

• US 7,842,035 B2
• Filed: 03/29/2004
• Issued: 11/30/2010
• Est. Priority Date: 02/01/1999
• Status: Expired due to Fees

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Cytyc Corporation (Hologic Incorporated)
• Inventors: Harrington, Douglas C., Bowman, Brett S., Carr-Brendel, Victoria E.
• Primary Examiner(s): Johnson, III; Henry M
• Assistant Examiner(s): ROANE, AARON F
• Application Number:
  US10/812,476
• Publication Number:
  US 20040255958A1
• Time in Patent Office: 2,437 Days
• Field of Search: 128830-833, 606/28, 606 41- 50, 607/138
• US Class Current: 606/50
• 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:

providing a device comprising a catheter body defining a proximal end and a distal end, a wounding segment extending distally from the distal end of the catheter body and movable relative to the catheter body between an extended position and a retracted position, a heating element disposed on or about the wounding segment, and at least one plug housed within the wounding segment and sized and dimensioned to be implanted into a target segment within the ovarian pathway;

inserting the catheter body and wounding segment into the ovarian pathway;

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

maintaining both the catheter body and at the least one plug stationary relative to the target segment while simultaneously (i) moving the wounding segment relative to the catheter body from the extended position toward the retracted position and (ii) exposing and implanting said stationary plug within the target segment of the pathway.

2. The method of claim 1, wherein the heating element is in the form of a RF electrode array adapted for application to the ovarian pathway.

3. The method of claim 1, wherein operating the heating element further comprises applying RF energy to the target segment through the RF electrode array.

4. The method of claim 1, wherein operating the heating element further comprises applying bi-polar RF energy to the target segment through the RF electrode array.

5. 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 to encourage vascularized tissue ingrowth in the foam plug.

6. The method of claim 5 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of 20-100 Shore A.

7. The method of claim 5 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of about 60 Shore A.

8. The method of claim 5 additionally comprising the step of providing the foam plug in the form of an ePTFE plug.

9. The method of claim 5 additionally comprising the step of providing the foam plug in the form of an acrylic copolymer plug.

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 to encourage vascularized capsule growth around the plug.

11. 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.

12. 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.

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

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

15. The method of claim 1 additionally comprising the step of limiting the heating of the target segment by applying power of less than of 0.1 to 5 watts to the heating element for a period of at least about 5 seconds.

16. The method of claim 1, wherein the at least one plug defines pores selectively sized to encourage at least one of vascularized tissue ingrowth and vascularized capsule growth.

17. 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:

providing a device comprising a catheter body defining a proximal end and a distal end, a wounding element including a RF electrode array extending distally from the distal end of the catheter body and movable relative to the catheter body between an extended position and a retracted position and including, and at least one plug housed within the wounding segment and defining pores selectively sized to encourage at least one of vascularized tissue ingrowth and vascularized capsule growth;

inserting the catheter body and wounding element into the ovarian pathway;

applying and operating the electrode array to cause a wound in the target 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 RF electrode array for a period of at least about 5 seconds;

maintaining both the catheter body and at the least one plug stationary relative to the target segment while simultaneously (i) moving the wounding segment relative to the catheter body from the extended position toward the retracted position and (ii) exposing and implanting said stationary plug within the wounded target segment of the pathway; and

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

18. The method of claim 17, wherein the RF electrode array is adapted for application to the ovarian pathway.

19. The method of claim 17, wherein operating the wounding element further comprises applying RF energy to the target segment through the RF electrode array.

20. The method of claim 17, wherein operating the wounding element further comprises applying bi-polar RF energy to the RF electrode array.

21. The method of claim 17 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 to encouraged vascularized tissue ingrowth into the foam plug.

22. The method of claim 21 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of 20-100 Shore A.

23. The method of claim 21 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of about 60 Shore A.

24. The method of claim 21 additionally comprising the step of providing the foam plug in the form of an ePTFE plug.

25. The method of claim 21 additionally comprising the step of providing the foam plug in the form of an acrylic copolymer plug.

26. The method of claim 17 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 to encourage vascularized tissue capsule growth around the foam plug.

27. The method of claim 26 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of 20-100 Shore A.

28. The method of claim 26 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of about 60 Shore A.

29. The method of claim 26 additionally comprising the step of providing the foam plug in the form of an ePTFE plug.

30. The method of claim 26 additionally comprising the step of providing the foam plug in the form of an acrylic copolymer plug.

31. 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:

providing a device comprising a catheter body defining a proximal end and a distal end, a heating element extending distally from the distal end of the catheter body and movable relative to the catheter body between an extended position and a retracted position and including, and at least one plug housed within the heating element, wherein the at least one plug is sized and dimensioned to be implanted into a target segment within the ovarian pathway and defines pores selectively sized to encourage at least one of vascularized tissue ingrowth and vascularized capsule growth;

inserting the catheter body and heating element into the ovarian pathway;

applying the 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; and

maintaining both the catheter body and at the least one plug stationary relative to the target segment while simultaneously (i) moving the heating element relative to the catheter body from the extended position toward the retracted position and (ii) exposing and implanting said stationary plug within the target segment of the pathway.

32. The method of claim 31, wherein the heating element includes a RF electrode array adapted for application to the ovarian pathway.

33. The method of claim 32, wherein operating the heating element further comprises applying RF energy to the target segment through the RF electrode array.

34. The method of claim 32, wherein operating the heating element further comprises applying bi-polar RF energy to the target segment through the RF electrode array.

35. The method of claim 31 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 to allow vascularized tissue ingrowth into the foam plug.

36. The method of claim 35 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of 20-100 Shore A.

37. The method of claim 35 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of about 60 Shore A.

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

39. The method of claim 35 additionally comprising the step of providing the foam plug in the form of an acrylic copolymer plug.

40. The method of claim 31 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 to allow vascularized capsule growth around the foam plug.

41. The method of claim 40 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of 20-100 Shore A.

42. The method of claim 40 additionally comprising the step of providing the foam plug in the form of silicone foam having a durometer value of about 60 Shore A.

43. The method of claim 40 additionally comprising the step of providing the foam plug in the form of an ePTFE plug.

44. The method of claim 40 additionally comprising the step of providing the foam plug in the form of an acrylic copolymer plug.