Contraceptive transcervical fallopian tube occlusion devices and methods

• US 6,684,884 B2
• Filed: 07/23/2001
• Issued: 02/03/2004
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• 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.
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US09/912,067
• Publication Number:
  US 20020020417A1
• Time in Patent Office: 925 Days
• Field of Search: 128/830, 128/831, 606/108, 606/151, 606/159, 606/191, 606/194
• 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 method of contraception comprising the steps of:

a) inserting within a fallopian tube a contraceptive device comprising a tubular structure and a tissue ingrowth element connected thereto;

b) expanding the tubular structure within the body lumen;

c) securing the expanded tubular structure to a wall portion defining at least in part the fallopian tube; and

d) effecting tissue ingrowth into the tissue ingrowth element to occlude the body lumen.

2. The contraceptive method of claim 1, wherein said inserting of the contraceptive device comprises transcervically advancing the contraceptive device and positioning the contraceptive device adjacent an isthmus of the fallopian tube.

3. The contraceptive method of claim 2, wherein said inserting of the contraceptive device comprises transcervically advancing the contraceptive device and positioning the contraceptive device adjacent a utero-tubal junction of the fallopian tube.

4. The contraceptive method of claim 1, wherein said expanding of the tubular structure comprises releasing the tubular structure from a first configuration having a first cross-section to a second configuration, the tubular structure in the second configuration forming a bent secondary shape with a second cross-section larger than the first cross-section.

5. The contraceptive method of claim 1, wherein the tubular structure has a contraceptive device lumen, and wherein said expanding of the tubular structure comprises radially expanding the tubular structure so that the contraceptive device lumen increases from a first cross-section to a second cross-section.

6. The contraceptive method of claim 5, wherein the tubular structure comprises a resilient helical coil, and wherein said radially expanding the tubular structure comprises releasing the coil to expand resiliently.

7. The contraceptive method of claim 5, wherein the tubular structure comprises at least one of braided filaments, a slotted tube, and a vascular stent-like structure.

8. The contraceptive method of claim 1, wherein said securing of the expanded tubular structure comprises resiliently engaging the tubular member against the wall portion so as to anchor the contraceptive device.

9. The contraceptive method of claim 8, wherein said resiliently engaging of the tubular structure comprises radially expanding a lumen of the tubular structure.

10. The contraceptive method of claim 9, wherein said radially expanding of the tubular member is performed so that a portion of the fallopian tube remains open outside the expanded tubular member, and wherein the tissue ingrowth into and around the expanded tubular member provides functional occlusion of the fallopian tube.

11. The contraceptive method of claim 9, wherein said radially expanding of the tubular member comprises releasing a superelastic alloy.

12. The contraceptive method of claim 8, wherein said resiliently engaging of the tubular structure comprises engaging a proximal anchor of the tubular structure against the wall portion and a distal anchor of the tubular structure against the wall portion with a lumen-traversing portion disposed therebetween.

13. The contraceptive method of claim 1, wherein said securing of the expanded tubular member comprises torqueing a sharp helical outer edge of the tubular member against the wall portion.

14. The contraceptive method of claim 1, wherein the tissue ingrowth element comprises polyester fibers, and wherein said effecting tissue ingrowth comprises promoting growth of tissue with the polyester fibers.

15. The contraceptive method of claim 14, wherein the tubular member comprises a coil, and further comprising winding the fibers into the coil.

16. The contraceptive method of claim 1, wherein the tissue ingrowth element comprises a material selected from at lease one of a fabric, a felt, a braid, and a weave, and wherein said effective tissue ingrowth comprises promoting growth of tissue with the material.

17. The contraceptive method of claim 1, wherein the tissue ingrowth element comprises a mesh, and wherein said effecting tissue ingrowth comprises promoting growth of tissue with the mesh.

18. The contraceptive method of claim 1, wherein the tissue ingrowth element extends radially outwardly beyond the tubular structure and into a lumen of the tubular structure, said effecting tissue ingrowth comprising promoting growth of tissue around and into the tubular structure so as to permanently occlude the fallopian tube.

19. A contraceptive device, comprising a tubular body which has a longitudinal axis, which is at least in part radially expandable about the longitudinal axis within a lumen of a patient'"'"'s reproductive system from a first tubular configuration to a second tubular configuration having larger transverse dimensions than the first tubular configuration, which has an open structure in the expanded configuration for ingrowth of tissue cells for securing the expanded portion of the tubular body to a wall portion of the patient'"'"'s reproductive system lumen, and which has a member within the tubular body which is configured for tissue growth, wherein the tubular body comprises braided filaments configured to allow the tubular body to be expanded to the open structure.

20. The contraceptive device of claim 19 wherein the tubular structure comprises a tube having a pattern of slots to allow the tubular structure to be expanded to the open structure.

21. The contraceptive device of claim 19, wherein the tubular structure is formed of a helical wire configured to allow the tubular structure to be expanded to the open structure.

22. A contraceptive device, comprising:

a) a tubular body which has a longitudinal axis, which is at least in part radially expandable about the longitudinal axis within a lumen of a patient'"'"'s reproductive system from a first tubular configuration to a second tubular configuration having larger transverse dimensions than the first tubular configuration to facilitate securing a least a portion of the tubular body to a wall portion defining at least in part a lumen of a patient'"'"'s reproductive system and which has an open structure in the expanded configuration for ingrowth of tissue cells, wherein the tubular body comprises braided filaments configured to allow the tubular body to be expanded to the open structure; and

b) a member within the expandable tubular body which is configured for tissue growth.

23. The contraceptive device of claim 22 wherein the tubular structure comprises a tube having a pattern of slots to allow the tubular member to be expanded to the open structure.

24. The contraceptive device of claim 22, wherein the tubular structure is formed of a helical wire configured to allow the tubular structure to be expanded to the open structure.