Contraceptive transcervical fallopian tube occlusion devices and their delivery

• US 8,066,007 B2
• Filed: 07/31/2006
• Issued: 11/29/2011
• 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: Thurmond, Amy, Ton, Dai, Nikolchev, Julian
• Primary Examiner(s): Brown; Michael A.
• Application Number:
  US11/497,468
• Publication Number:
  US 20070044808A1
• Time in Patent Office: 1,947 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 female contraceptive method comprising:

delivering a first expandable anchor to a first location of a female reproductive organ, the first expandable anchor being radially restrained before being delivered, the first expandable anchor being delivered through a shaft which is transcervically introduced;

delivering a second expandable anchor to a second location of a female reproductive organ, the second expandable anchor being radially restrained before being delivered, the second expandable anchor being adjacent a straight section of a contraceptive device after being delivered, wherein the straight section comprises a substantial portion of the contraceptive device; and

performing an operation with the shaft after the delivery of the first expandable anchor but before the delivery of the second expandable anchor.

2. A method as in claim 1 wherein the operation comprises delivering a current through the shaft.

3. A method as in claim 1 wherein the first expandable anchor expands at the first location and the second expandable anchor expands at a second location after the first expandable anchor expands.

4. The method as in claim 1, wherein the first expandable anchor comprises an agent to cause tissue growth and the second expandable anchor comprises an agent to cause tissue growth.

5. The method as in claim 1, wherein the first expandable anchor comprises a first resilient structure and the second expandable anchor comprises a second resilient structure.

6. A device comprising:

a delivery shaft configured to be transcervically introduced into a female reproductive organ;

a first expandable anchor coupled to the delivery shaft;

a second expandable anchor coupled to the delivery shaft, the first expandable anchor being radially restrained before being delivered by the delivery shaft and the second expandable anchor being radially restrained before being delivered by the delivery shaft, the second expandable anchor being adjacent a straight section of a contraceptive device after being delivered, wherein the straight section comprises a substantial portion of the contraceptive device after being delivered, and wherein the delivery shaft is configured to perform an operation after delivering the expandable anchor and before delivering the second expandable anchor.

7. A device as in claim 6 wherein the first expandable anchor expands at a first location and the second expandable anchor expands at a second location after the first expandable anchor expands.

8. A device as in claim 7 wherein the first expandable anchor and the second expandable anchor each comprise a pre-formed resilient structure which is adapted to resiliently engage a surrounding wall of a fallopian tube.

9. A device as in claim 8 further comprising fibers coupled to each of the first expandable anchor and the second expandable anchor, the fibers promoting tissue growth in a fallopian tube.

10. The device as in claim 6, wherein the first expandable anchor comprises an agent to cause tissue growth and the second expandable anchor comprises an agent to cause tissue growth.

11. The device as in claim 6, wherein the first expandable anchor comprises a first resilient structure and the second expandable anchor comprises a second resilient structure.

12. A device comprising:

a delivery shaft configured to be transcervically introduced into a female reproductive organ;

a first expandable anchor disposed on the delivery shaft;

a second expandable anchor disposed on the delivery shaft, the first expandable anchor being radially restrained before being delivered by the delivery shaft and the second expandable anchor being radially restrained before being delivered by the delivery shaft, the second expandable anchor being adjacent a straight section of a contraceptive device after being delivered, wherein the straight section comprises a substantial portion of the contraceptive device after being delivered, and wherein the delivery shaft is configured to perform an operation after delivering the first expandable anchor and before delivering the second expandable anchor.

13. A device as in claim 12 wherein the first expandable anchor expands at a first location and the second expandable anchor expands at a second location after the first expandable anchor expands.

14. A device as in claim 13 wherein the first expandable anchor and the second expandable anchor each comprise a pre-formed resilient structure which is adapted to resiliently engage a surrounding wall of a fallopian tube.

15. A device as in claim 14 further comprising:

fibers coupled to each of the first expandable anchor and the second expandable anchor, the fiber promoting tissue growth in a fallopian tube.

16. The device as in claim 12, wherein the first expandable anchor comprises an agent to cause tissue growth and the second expandable anchor comprises an agent to cause tissue growth.

17. The device as in claim 12, wherein the first expandable anchor comprises a first resilient structure and the second expandable anchor comprises a second resilient structure.

18. A device comprising:

a delivery shaft configured to be transcervically introduced into a female reproductive organ;

a first expandable element designed to prevent axial movement coupled to the delivery shaft;

a second expandable element designed to prevent axial movement coupled to the delivery shaft, the first expandable element being radially restrained before being delivered by the delivery shaft and the second expandable element being radially restrained before being delivered by the delivery shaft, the second expandable element being adjacent a straight section of a contraceptive device after being delivered, wherein the straight section comprises a substantial portion of the contraceptive device after being delivered, and wherein the delivery shaft is configured to perform an operation after delivering the first expandable element and before delivering the second expandable element.

19. A device as in claim 18 wherein the first expandable element expands at a first location and the second expandable element expands at a second location after the first expandable element expands.

20. A device as in claim 19 wherein the first expandable element and the second expandable element each comprise a pre-formed resilient structure which is adapted to resiliently engage a surrounding wall of a fallopian tube.

21. A device as in claim 20 further comprising:

fibers coupled to each of the first expandable element and the second expandable element, the fiber promoting tissue growth in a fallopian tube.

22. The device as in claim 18, wherein the first expandable anchor comprises an agent to cause tissue growth and the second expandable anchor comprises an agent to cause tissue growth.

23. The device as in claim 18, wherein the first expandable anchor comprises a first resilient structure and the second expandable anchor comprises a second resilient structure.

24. A device comprising:

a longitudinally disposed member having a distal portion and a proximal portion;

a first expandable anchor coupled to the longitudinally disposed member near the distal portion, the first expandable anchor being radially restrained before being delivered to a fallopian tube;

a second expandable anchor coupled to the longitudinally disposed member near the proximal portion, the second expandable anchor being radially restrained before being delivered to a fallopian tube, the second expandable anchor being adjacent a straight section of a contraceptive device after being delivered, wherein the straight section comprises a substantial portion of the contraceptive device after being delivered;

a delivery shaft coupled to the longitudinally disposed member, the delivery shaft being adapted to introduce the longitudinally disposed member into the fallopian tube and to detach from the longitudinally disposed member to leave the longitudinally disposed member within the fallopian tube.

25. A device as in claim 24 wherein the first expandable anchor expands at a first location after being delivered and the second expandable anchor expands at a second location after being delivered and wherein the first expandable anchor expands before the second expandable anchor expands.

26. A device as in claim 24 wherein the first expandable anchor and the second expandable anchor each comprise a preformed resilient structure which is adapted to resiliently engage a surrounding wall of the fallopian tube.

27. A device as in claim 26 further comprising fibers coupled to the female contraceptive device.

28. The device as in claim 24, wherein the first expandable anchor comprises an agent to cause tissue growth and the second expandable anchor comprises an agent to cause tissue growth.

29. The device as in claim 24, wherein the first expandable anchor comprises a first resilient structure and the second expandable anchor comprises a second resilient structure.