Contraceptive transcervical fallopian tube occlusion devices and methods

• US 8,171,936 B2
• Filed: 10/20/2010
• Issued: 05/08/2012
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: Bayer Essure Inc. (Bayer AG)
• Original Assignee: Conceptus Incorporated (Bayer AG)
• Inventors: Nikolchev, Julian N., Ton, Dai T., Khera, Ashish, Gurskis, Donnell W., Bacich, Steven
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US12/908,756
• Publication Number:
  US 20110030696A1
• Time in Patent Office: 566 Days
• Field of Search: 128830-841, 606/151, 606/191
• 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 copper alloy. The device is anchored within the fallopian tube by a lumen-traversing region of the resilient structure which has 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 s effected by passing a current through there resilient structure to the tubal walls.

Claims

1. A delivery system comprising:

an occlusion device comprising;

a proximal portion adjacent a proximal end and a distal portion adjacent a distal end, the distal portion having flexibility suitable to function as a guidewire; and

an expandable element affixed to a flexible inner member; and

a delivery catheter slidably disposed over the proximal portion of the occlusion device so that the distal portion of the occlusion device remains exposed when the occlusion device and delivery catheter are advanced within a body lumen;

wherein the occlusion device is expandable from a low profile configuration within the delivery catheter to a deployed profile configuration when deployed from the delivery catheter.

2. The delivery system of claim 1 wherein the occlusion device comprises a looped portion.

3. The delivery system of claim 1 further comprising an atraumatic tip at the distal end of the occlusion device.

4. The delivery system of claim 1 wherein the occlusion device forms a plurality of loops when deployed from the delivery catheter.

5. The delivery system of claim 1 wherein the flexible inner member is a coil.

6. The delivery system of claim 5 further comprising a flexible elongate body, wherein the flexible inner member coaxially surrounds the flexible elongate body.

7. The delivery system of claim 5 further comprising an elongate body in detachable engagement with the occlusion device for deploying the occlusion device from the delivery catheter.

8. The delivery system of claim 1 wherein the expandable element comprises a polymer.

9. The delivery system of claim 1 further comprising a linkage element that releasably attaches the proximal end of the occlusion device to the delivery system.

10. A delivery system comprising:

an occlusion device comprising;

a polymer ring; and

a proximal portion adjacent a proximal end and a distal portion adjacent a distal end, the distal portion having flexibility suitable to function as a guidewire; and

a delivery catheter slidably disposed over the proximal portion of the occlusion device so that the distal portion of the occlusion device remains exposed when the occlusion device and delivery catheter are advanced within a body lumen;

wherein the occlusion device is expandable from a low profile configuration within the delivery catheter to a deployed profile configuration when deployed from the delivery catheter.

11. The delivery system of claim 10 wherein the polymer ring is formed over a flexible inner member.

12. The delivery system of claim 11 wherein the flexible inner member is a coil.

13. The delivery system of claim 11 further comprising a flexible elongate body, wherein the flexible inner member coaxially surrounds the flexible elongate body.

14. The delivery system of claim 10 further comprising a plurality of polymer rings.

15. A method of delivering an occlusion device comprising:

advancing a delivery catheter through a body lumen using an exposed distal portion of an occlusion device as a guidewire; and

deploying the occlusion device from the delivery catheter;

wherein the occlusion device expands from a low profile configuration within the delivery catheter to a deployed profile configuration when deployed from the delivery catheter.

16. The method of claim 15 wherein the occlusion device forms a plurality of loops when deployed from the delivery catheter.

17. The method of claim 15 wherein the occlusion device comprises an expandable element affixed to a flexible inner member, and the expandable element expands after deployment from the delivery catheter.

18. The method of claim 17 wherein the expandable element comprises a polymer and the flexible inner member is a coil.

19. The method of claim 15 wherein deploying the occlusion device from the delivery catheter comprises unthreading a proximal end of the occlusion device.