Occlusion devices and methods

• US 8,327,852 B2
• Filed: 11/11/2011
• Issued: 12/11/2012
• 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:
  US13/294,758
• Publication Number:
  US 20120055491A1
• Time in Patent Office: 396 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 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 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 resilisent structure to the tubal walls.

Claims

1. An occlusion device comprising:

an inner coil;

an element which supports tissue ingrowth positioned around the inner coil; and

an outer coil affixed to the inner coil and positioned around the inner coil and the element which supports tissue ingrowth.

2. The occlusion device of claim 1, wherein a body winding pitch of the outer coil is greater than a body winding pitch of the inner coil.

3. The occlusion device of claim 1, wherein the element comprises a polymer.

4. The occlusion device of claim 1, wherein the inner coil comprises platinum.

5. The occlusion device of claim 4, wherein the inner coil is formed from a wire having a diameter between about 0.002 and 0.009 inches.

6. The occlusion device of claim 4, wherein the inner coil has a diameter between about 0.010 and 0.040 inches.

7. The occlusion device of claim 1, wherein the outer coil comprises platinum.

8. The occlusion device of claim 1, further comprising an atraumatic tip at a distal end of the inner coil.

9. The occlusion device of claim 1, wherein the inner coil is longer than the outer coil.

10. A method of forming an occlusion device comprising:

positioning an element which supports tissue ingrowth around an inner coil; and

affixing an outer coil to the inner coil such that the outer coil is positioned around the inner coil and the element which supports tissue ingrowth.

11. The method of claim 10, further comprising winding the outer coil over the inner coil and the element.

12. The method of claim 10, further comprising forming an atraumatic tip at a distal end of the inner coil.

13. The method of claim 10, wherein the element comprises a polymer.

14. A method for occluding a body lumen comprising:

advancing a catheter to a target region within an body lumen; and

deploying an occluding device from the catheter at the target region of the body lumen, wherein the occluding device comprises;

an inner coil;

an element which supports tissue ingrowth positioned around the inner coil; and

an outer coil affixed to the inner coil and positioned around the inner coil and the element which supports tissue ingrowth.

15. The method of claim 14, further comprising accessing the body lumen with a guidewire, and then advancing the catheter over the guidewire.