Contraceptive transcervical fallopian tube occlusion devices and methods

• US 20050172972A1
• Filed: 04/15/2005
• Published: 08/11/2005
• Est. Priority Date: 06/07/1995
• Status: Abandoned Application

• Current Assignee: Bayer Essure Inc. (Bayer AG)
• Original Assignee: Conceptus Incorporated (Bayer AG)
• Inventors: Nikolchev, Julian N., Bacich, Steven, Khera, Ashish, Gurskis, Donnell W., Ton, Dai T.
• Application Number:
  US11/106,804
• Publication Number:
  US 20050172972A1
• Time in Patent Office: Days
• 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 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/12059 Joint of soluble material
• CPC Class Codes: A61B 2017/12063 electrolytically detachable
• CPC Class Codes: A61B 2017/12077 Joint changing shape upon application of heat, e.g. bi-metal or reversible thermal memory
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• 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
• CPC Class Codes: Y10T 29/49826 Assembling or joining

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 a lumen-traversing region of the resilient structure which has a helical outer surface, together with a portion of the resilient structure which is biased to form a bent secondary shape, 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. Optionally, permanent sterilization is effected by passing a current through the resilient structure to the tubal walls.

Claims

1. A device for occluding a body lumen or passageway, comprising:

a) a tubular member having a first end, a second end, a lumen extending therein, and an open-walled structure configured to allow tissue growth therethrough; and

b) a tissue growth supporting member disposed within at least a section of the tubular member lumen, which is configured to support tissue growth to thereby occlude the body lumen.

2. The device of claim 1 wherein the tissue growth supporting member is permeable to allow for tissue ingrowth.

3. The device of claim 1 wherein the tissue growth supporting member comprises a porous structure.

4. The device of claim 1 wherein the tissue growth supporting member comprises a membranal structure.

5. The device of claim 1 further including a mesh layer longitudinally disposed along at least a section of at least one of an inner and an outer surface of the tubular member.

6. The device of claim 5 wherein the mesh layer is longitudinally disposed along substantially the entire length of the at least one of the inner and the outer surface of the tubular member.

7. The device of claim 1 wherein the tissue growth supporting member is disposed within the lumen of the tubular member along substantially the entire length of the tubular member.

8. The device of claim 1 wherein the tissue growth supporting member is disposed within the lumen of the tubular member in a plurality of sections intermittently spaced along the length of the tubular member.

9. The device of claim 1 wherein the tissue growth supporting member is disposed within the lumen of the tubular member at the first end of the tubular member.

10. The device of claim 9 including a mesh layer longitudinally disposed along at least a section of at least one of an inner and outer surface of the tubular member.

11. The device of claim 1 wherein the tubular member comprises a material selected from the group consisting of stainless steel, superelastic material, shape memory material, rigid plastics, semirigid plastics, metal, NiTi, tantalum, platinum, and gold.

12. The device of claim 1 wherein the tubular member further includes anchoring members configured to secure the tubular member to a wall defining the body lumen.

13. The device of claim 1 wherein the tubular member expands from a first configuration to a second larger configuration by the release of a radially compressive force.

14. The device of claim 13 wherein the tubular member comprises a superelastic material.

15. The device of claim 9 wherein the tubular member expands from a first configuration to a second larger configuration, and the second larger configuration comprises a radially expanded diameter increasing along at least a section thereof from the first end of the tubular member to the second end of the tubular member.

16. The device of claim 1 wherein the tubular member comprises a lattice-like framework.

17. The device of claim 16 wherein the lattice-like framework comprises a thin walled metallic tube having a pattern of cuts configured to allow the tubular member to be expanded to a large diameter configuration.

18. The device of claim 16 wherein the lattice-like framework comprises a braid of wire.

19. The device of claim 16 wherein the lattice-like framework comprises a helical coil of wire.

20. The device of claim 1 wherein the surface of the tubular member is configured to promote epithelialization.

21. The device of claim 1 coated at least in part with a compound to promote tissue cell growth.

22. The device of claim 1 further comprising a material capable of provoking an inflammatory response.

23. The device of claim 22 wherein the inflammatory material comprises copper or copper alloy.

24. The device of claim 22 wherein the inflammatory material comprises a radioactive material.

25. The device of claim 1 wherein the tubular member has an expanded portion and said open-wall structure facilitates the ingrowth of tissue cells thereby securing at least a section of the expanded portion of the tubular member to a wall portion of the body lumen.

26. The device of claim 1 further including a plug releasably secured to the tissue growth supporting member.

27. The device of claim 26 wherein the plug is formed at least in part of a material capable of provoking an inflammatory response.

28. The device of claim 1 wherein the tissue growth supporting member extends transversely across the lumen of the tubular member.

29. A device for occluding a body lumen or passageway, comprising:

a) an open-walled coil member having a first end, and a second end and a lumen extending therein; and

b) a tissue growth supporting member disposed within at least a section of the coil member lumen, which is configured to support tissue growth to thereby occlude the body lumen or passageway.

30. A contraceptive device installed within a lumen of the patient'"'"'s reproductive system, comprising:

a) an open-walled coil member having a first end, a second end, and a lumen extending therein, and having at least a portion thereof which is secured to a body wall portion defining at least in part the lumen of the patient'"'"'s reproductive system; and

b) an occluding member disposed within at least a section of the lumen of the coil member, comprising an epithelialized tissue growth supporting member which occludes the lumen of the patient'"'"'s reproductive system sufficiently to prevent the passage of reproductive cells therethrough.

31. The installed contraceptive device of the claim 30 wherein the coil member is epithelialized along at least a length thereof.

32. A contraceptive system, comprising

a) a catheter having a proximal end, a distal end, and a lumen extending at least in part therein;

and

b) a contraceptive device releasably connected to the catheter, having a tubular member having a first end, a second end, a lumen extending therein, and an open-walled structure, and having a tissue growth supporting member disposed within at least a section of the lumen of the tubular member, which is configured to support tissue growth to thereby occlude the reproductive body lumen.

33. The contraceptive system of claim 32 including an expanding member on a distal section of the catheter to expand at least a portion of the tubular member.

34. A method of contraception comprising the steps of:

a) inserting within a desired body lumen a contraceptive device comprising an open-walled tubular member and a tissue growth supporting member disposed within at least a section of the tubular member;

b) expanding the tubular member within the body lumen;

c) securing the expanded tubular member to a wall portion defining at least in part the body lumen; and

d) epithelializing the tissue growth supporting member to occlude the body lumen.

35. The method of claim 34 wherein the step of securing the tubular member to the wall portion comprises epithelializing the tubular member within the body lumen.

36. The method of claim 35 wherein the contraceptive device further includes one or more connecting members on a surface of the tubular member, and wherein the step of securing the tubular member to the wall portion further comprises embedding the connecting members in the wall portion.

37. The method of claim 34 wherein the contraceptive device is disposed on an expandable member of a delivery catheter, and wherein the step of expanding the tubular member comprises inflating the expandable member.

38. The method of claim 37 wherein the tissue growth supporting member of the contraceptive device is transversely disposed within a lumen of the tubular member at a first end of the tubular member, and a distal end of the expandable member of the catheter is disposed in the tubular member lumen proximal to the tissue growth supporting member, and the step of inflating the expandable member expands the tubular member to a larger diameter increasing along at least a section of the tubular member from a second end to the first end of the tubular member.

39. The method of claim 38 wherein at least the second end of the tubular member is expanded into contact with the wall portion of the body lumen.

40. The method of claim 39 further including the step of deflating the expandable member and withdrawing the delivery catheter from the body lumen.

41. The method of claim 34 wherein the step of expanding the tubular member comprises the step of releasing a radially compressive force on the tubular member.

42. The method of claim 41 wherein the contraceptive device is disposed within a lumen of a delivery catheter, and the step of releasing the radially compressive force comprises longitudinally displacing the tubular member out a distal end of the delivery catheter.

43. The method of claim 34 wherein the expanded tubular member is disposed within the body lumen for sufficient time for it to be epithelialized within the body lumen and thereby secured to the wall portion.

44. A device for occluding a body lumen or passageway, comprising:

a) a tubular member having a first end, and a second end, and a lumen extending therein, which is at least in part expandable within the reproductive body lumen from a first configuration to a second larger configuration; and

b) a tissue growth supporting member disposed within at least a section of the tubular member lumen, which is configured to support tissue growth to thereby occlude the body lumen or passageway.

45. The device of claim 44 wherein the tissue growth supporting member comprises bundled fibers.