Contraceptive transcervical fallopian tube occlusion devices and their delivery

• US 7,428,904 B2
• Filed: 05/14/2004
• Issued: 09/30/2008
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Alien Technology Corporation
• Inventors: Nikolchev, Julian, Thurmond, Amy, Ton, Dai
• Primary Examiner(s): Brown; Michael A.
• Application Number:
  US10/845,645
• Publication Number:
  US 20040206358A1
• Time in Patent Office: 1,600 Days
• Field of Search: 128830-841
• US Class Current: 128/830
• 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 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 6/18 Inserters or removers ; Apparatus for loading an intra-uterine device into an insertion tube
• CPC Class Codes: A61F 6/22 implantable in tubes occluding by internal devices A61B17/12022
• CPC Class Codes: A61F 6/225 transcervical

Abstract

The invention provides intrafallopian devices and non-surgical methods for their placement to prevent conception. The efficacy of the device is enhanced by forming the structure at least in part from copper or a copper alloy. The device is anchored within the fallopian tube by imposing a secondary shape on a resilient structure, the secondary shape having a larger cross-section than the fallopian tube. The resilient structure is restrained in a straight configuration and transcervically inserted within the fallopian tube, where it is released. The resilient structure is then restrained by the walls of the fallopian tube, imposing anchoring forces as it tries to resume the secondary shape.

Claims

1. A method for sterilizing a female patient using an elongated instrument assembly having a distal end, said method comprising:

inserting the distal end of the elongated instrument assembly transcervically into the female patient, the distal end of the elongated instrument having a detachable body;

applying tissue damaging energy from the elongated instrument to a surrounding tissue of a fallopian tube of said female patient;

detaching the detachable body from the distal end of the elongated instrument assembly; and

removing a remaining portion of the elongated instrument assembly from the female patient, wherein a permanent scar formation in a region of the surrounding tissue permanently attaches to the detachable body.

2. The method of claim 1 wherein the tissue damaging energy comprises electrical energy and wherein the permanent scar formation encapsulates the detachable body.

3. A method as in claim 1 wherein said detachable body is resilient and imposes an anchoring force against said surrounding tissue and wherein said detachable body is radially restrained within a lumen of the elongated instrument assembly before the inserting transcervically.

4. A method as in claim 1 wherein said elongated instrument assembly comprises a conductive interface which is coupled to a surface assembly which is coupled to said elongated instrument assembly.

5. A method as in claim 1 wherein said elongated instrument assembly comprises an elongate body and a shaft which is disposed within said elongate body.

6. A method as in claim 1 wherein said applying precedes said detaching of said detachable body.

7. A method as in claim 1 wherein said detachable body has a first configuration prior to said detaching and a second configuration after said detaching.

8. A method as in claim 7 wherein said first configuration has an outer diameter which is less than an inner diameter of said fallopian tube.

9. A method as in claim 1 wherein said detachable body comprises a polymer material.

10. A method comprising:

inserting a catheter having an electrically conductive surface assembly mounted on a distal end of the catheter through the vagina and the cervical canal of a patient and into the uterus of the patient;

advancing a detachable assembly, which is coupled to the catheter, into a fallopian tube of the patient;

applying electrical energy to the electrically conductive surface assembly;

detaching the catheter from the detachable assembly, wherein a permanent scar formation in the fallopian tube permanently encapsulates the detachable assembly.

11. A method as in claim 10 wherein said detachable assembly is resilient and imposes an anchoring force against the fallopian tube and wherein said detachable assembly is radially restrained within a lumen of the catheter before the inserting.

12. A method as in claim 10 wherein said catheter comprises a conductive interface which is coupled to said electrically conductive surface assembly.

13. A method as in claim 10 wherein said catheter comprises an elongate body and a shaft which is disposed within said elongate body.

14. A method as in claim 10 wherein said applying precedes said detaching of said detachable assembly.

15. A method as in claim 10 wherein said detachable assembly has a first configuration prior to said detaching and a second configuration after said detaching.

16. A method as in claim 15 wherein said first configuration has an outer diameter which is less than an inner diameter of said fallopian tube.

17. A method as in claim 10 wherein said detachable assembly comprises a polymer material.

18. A method as in claim 13 wherein said catheter further comprises a lumen through which said shaft is slidable.

19. A method as in claim 10 wherein said applying said electrical energy is through a shaft within a lumen of said catheter.

20. An intrafallopian delivery system for transcervical introduction of a device, the delivery system comprising:

a first portion having an elongate body and a shaft for delivering tissue damaging energy;

a second portion detachably coupled to said elongate body, said second portion being sized to fit within a fallopian tube and being detachable from said elongate body to remain permanently within said fallopian tube and wherein said tissue damaging energy causes a scar formation, in said fallopian tube, which permanently attaches to said second portion.

21. A delivery system as in claim 20 wherein said tissue damaging energy comprises electrical energy and wherein said shaft delivers electrical current.

22. A delivery system as in claim 20 wherein said second portion is resilient and imposes an anchoring force against said fallopian tube and wherein said second portion is radially restrained within a lumen of the elongate body before the transcervical introduction.

23. A delivery system as in claim 20 wherein said shaft is disposed within a lumen of said elongate body.

24. A delivery system as in claim 20 wherein said tissue damaging energy is delivered before said second portion is detached from said elongate body.

25. A delivery system as in claim 20 wherein said second portion has a first configuration prior to being detached and a second configuration after being detached.

26. A delivery system as in claim 25 wherein said first configuration has an outer diameter which is less than an inner diameter of said fallopian tube.

27. A delivery system as in claim 20 wherein said second portion comprises a polymer material.

28. A delivery system as in claim 20 further comprising an introducer through which said elongate body is inserted.

29. A delivery system as in claim 20 wherein said second portion has a surface which attaches to said scar formation.

30. An intrafallopian catheter system for transcervical introduction of an intrafallopian device, said catheter system comprising:

an elongate body having a shaft for delivering electrical energy;

a detachable body which is detachably coupled to said elongate body, said detachable body being sized to fit within a fallopian tube and being detachable from said elongate body to remain permanently within said fallopian tube and wherein said electrical energy causes a scar formation, in said fallopian tube, which permanently encapsulates said detachable body.

31. A catheter system as in claim 30 wherein said detachable body is resilient and imposes an anchoring force against said fallopian tube and wherein the detachable body is radially restrained within a lumen of the elongate body before the transcervical introduction.

32. A catheter system as in claim 30 wherein said shaft is disposed within a lumen of said elongate body.

33. A catheter system as in claim 30 wherein said electrical energy is delivered before said detachable body is detached from said elongate body.

34. A catheter system as in claim 30 wherein said detachable body has a first configuration prior to being detached and a second configuration after being detached.

35. A catheter system as in claim 34 wherein said first configuration has an outer diameter which is less than an inner diameter of said fallopian tube.

36. A catheter system as in claim 30 wherein said detachable body comprises a polymer material.

37. A catheter system as in claim 30 further comprising an introducer through which said elongate body is inserted.

38. A catheter system as in claim 30 wherein said detachable body has a surface which attaches to said scar formation.

39. A method for sterilizing a female patient, said method comprising:

delivering a body transcervically into the female patient;

delivering energy to a surrounding tissue of a fallopian tube of said female patient;

wherein a scar formation in a region of the surrounding tissue permanently attaches to the body.

40. The method of claim 39 wherein the energy comprises electrical energy and wherein the scar formation encapsulates the body.

41. A method as in claim 39 wherein said body is resilient and imposes an anchoring force against said surrounding tissue and wherein the body is radially restrained in a lumen of a delivery device before the delivery of the body transcervically.

42. A method as in claim 39 wherein an elongated instrument assembly delivers said body and is detachably coupled to said body.

43. A method as in claim 39 wherein said body is not expelled from said fallopian tube.

44. A method as in claim 39 wherein said body comprises a polyester material.

45. A method as in claim 39 wherein said body has a first configuration prior to said delivering and a second configuration after said delivering.

46. A method as in claim 45 wherein said first configuration has an outer diameter which is less than an inner diameter of said fallopian tube.

47. A method as in claim 39 wherein said body comprises a polymer material.

48. A method as in claim 40 wherein said electrical energy causes permanent tissue damage.