Contraceptive transcervical fallopian tube occlusion devices and methods

• US 7,921,848 B2
• Filed: 08/13/2003
• Issued: 04/12/2011
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Conceptus Incorporated (Bayer AG)
• Inventors: Nikolchev, Julian N., Bacich, Steven, Khera, Ashish, Gurskis, Donnell W., Ton, Dai T.
• Primary Examiner(s): Brown; Michael A.
• Application Number:
  US10/641,333
• Publication Number:
  US 20040127918A1
• Time in Patent Office: 2,799 Days
• Field of Search: 128830-841, 606191-198
• 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
• 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 reproductive body lumen, comprising:

an open-walled outer tubular member having a first end, a second end, a lumen extending therein;

an inner member extending through the lumen and surrounded by the open-walled outer tubular member;

a tissue ingrowth supporting member radially disposed between an inner surface of the open-walled outer tubular member and an outer surface of the inner member to support tissue ingrowth to thereby permanently occlude the body lumen; and

a material disposed over the inner member to provide immediate prevention of conception.

2. The device of claim 1, wherein the material comprises a copper material.

3. The device of claim 2, wherein the copper material comprises an alloy.

4. The device of claim 2, wherein the copper material comprises a copper wire, a copper bead, or a copper coating.

5. The device of claim 1, wherein the material comprises a spermicide.

6. An intrafallopian contraceptive system, comprising:

an open-walled outer member surrounding an inner member, and a tissue ingrowth promoting member radially disposed between an inner surface of the open-walled outer member and an outer surface of the inner member to occlude a fallopian tube for preventing conception; and

a material formed over the inner member to provide immediate prevention of conception.

7. The intrafallopian contraceptive system of claim 6, wherein the material is a contraceptive to prevent conception.

8. The intrafallopian contraceptive system of claim 7, wherein the contraceptive is copper.

9. The intrafallopian contraceptive system of claim 8, wherein the copper is released at a release rate related to the surface area and volume of copper over the inner member.

10. The intrafallopian contraceptive system of claim 9, wherein the release rate of copper is about 25 micrograms per day.

11. The intrafallopian contraceptive system of claim 7, wherein the contraceptive is a spermicide.

12. A contraceptive device for use in a fallopian tube having a tubal wall, the contraceptive device comprising:

a stent-shape tubular retention structure adapted to radially expand to engage the tubal wall of the fallopian;

an inner member extending through and surrounded by the stent-shape tubular retention structure;

a tissue ingrowth supporting member radially disposed between an inner surface of the stent-shape tubular retention structure and an outer surface of the inner member to cause occlusion of the fallopian tube for preventing conception; and

a material formed over the inner member to provide immediate prevention of conception once the contraceptive device has been inserted into the fallopian tube.

13. The contraceptive device of claim 12, wherein the stent-shape tubular retention structure comprises a slotted structure, the slotted structure comprising a Malecott retention structure or a braided filament retention structure.

14. The contraceptive device of claim 12, further comprising a latching mechanism to prevent collapse of the stent-shape tubular retention structure once forcibly expanded.

15. The contraceptive device of claim 12, wherein the stent-shape tubular retention structure is self-expanding.

16. The contraceptive device of claim 12, wherein the tissue ingrowth supporting member is within an inner surface and outside of an outer surface of the stent-shape tubular retention structure.