METHODS AND APPARATUS FOR OCCLUDING REPRODUCTIVE TRACTS TO EFFECT CONTRACEPTION

• US 20110259342A1
• Filed: 06/30/2011
• Published: 10/27/2011
• Est. Priority Date: 05/11/2006
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Essure Inc. (Bayer AG)
• Inventors: Tremulis, William S., Callister, Jeffrey P.
• Granted Patent: US 8,550,085 B2
• Time in Patent Office: Days
• US Class Current: 128/831
• CPC Class Codes: A61F 6/22 implantable in tubes occluding by internal devices A61B17/12022
• CPC Class Codes: A61F 6/225 transcervical

Abstract

Systems and methods of visibly marking a reproductive tract, e.g., at least one ostium of the Fallopian tubes accessed transvaginally and transcervically, to indicate delivery of an occlusion device into the corresponding at least one Fallopian tube to effect contraception are disclosed. Marking is effected by delivery of a dye that stains the ostium and/or extension of the marking member from the delivered occlusion device into view in the uterine cavity or ostium. A catheter (or catheters) preferably introduced through a hysteroscope that illuminates and provides visualization of the uterine cavity and the ostia of the Fallopian tubes is employed to insert each contracted, stent-like, occluding device into each Fallopian tube and to mechanically expand or release to self-expand the occluding device.

Claims

1. A contraceptive system that effects occlusion of a reproductive tract comprising:

an occluding device adapted to be installed within a reproductive tract lumen to occlude the reproductive tract lumen;

means for installing the occluding device within the reproductive tract lumen; and

an elongated flexible suture connected to the occluding device, wherein the elongated flexible suture trails proximally from the occluding device after the occluding device is installed within the reproductive tract lumen.

2. The contraceptive system of claim 1, the occluding device further comprising:

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

a tissue growth supporting member disposed within at least a section of the member lumen that encourages or supports tissue growth to thereby chronically occlude the reproductive body lumen.

3. The contraceptive system of claim 1, wherein the means for installing the occluding device comprises:

an elongated occluding device delivery catheter having a catheter shaft extending between a shaft proximal end and a shaft distal end; and

a push member within the catheter shaft to apply force against the occluding device and eject the occluding device distally out of the catheter shaft.

4. The contraceptive system of claim 3, wherein the occluding device self-expands to engage with tissue lining of the reproductive tract lumen when ejected from the catheter shaft.

5. The contraceptive system of claim 4, further comprising a second occluding device disposed within the catheter shaft.

6. The contraceptive system of claim 1, wherein the occluding device further comprises a tubular member having a first end, a second end and a member lumen extending therein.

7. The contraceptive system of claim 6, wherein the means for installing the occluding device comprises:

an elongated occluding device delivery catheter having a catheter shaft extending between a shaft proximal end and a shaft distal end; and

a balloon inflation lumen extending substantially between the shaft proximal end and an expandable balloon within the member lumen; and

means for selectively delivering a balloon inflating fluid through the balloon inflation lumen and into the balloon to expand the balloon against the tubular member to effect the expansion of the tubular member within the reproductive tract and for withdrawing the balloon inflating fluid to deflate the balloon and enable retraction of the catheter from the reproductive tract lumen.

8. The contraceptive system of claim 1, wherein the reproductive tract lumen is a fallopian tube and the elongated flexible suture is adapted to extend into a uterine cavity after the occluding device is installed within the fallopian tube.

9. The contraceptive system of claim 1, wherein the occluding device is compressible and expandable.

10. The contraceptive system of claim 2, wherein the tubular member is selectively expandable within the reproductive tract lumen by the means for installing;

and

the means for installing further comprises means for expanding the tubular member within the reproductive tract lumen to engage with tissue lining of the reproductive tract lumen.

11. The contraceptive system of claim 1, wherein the elongated flexible suture is attached to the occluding device near a distal end of the occluding device.

12. The contraceptive system of claim 1, wherein the elongated flexible suture is attached to the occluding device near a proximal end of the occluding device.

13. A contraceptive system that effects occlusion of a reproductive tract comprising:

an occluding device adapted to be installed within a reproductive tract lumen to occlude the reproductive tract lumen;

an elongated occluding device delivery catheter having a catheter shaft enclosing a shaft lumen and extending between a shaft proximal end and a shaft distal end, the shaft lumen terminating in a distal chamber at the shaft distal end, wherein the occluding device is disposed in the distal chamber;

a push member within the catheter shaft to apply force against the occluding device and eject the occluding device distally out of the distal chamber; and

an elongated flexible suture connected to the occluding device, wherein the elongated flexible suture trails proximally from the occluding device after the occluding device is installed within the reproductive tract lumen.

14. The contraceptive system of claim 13, wherein the reproductive tract lumen is a fallopian tube, and the elongated flexible suture is adapted to extend into a uterine cavity after the occluding device is installed within the fallopian tube.

15. The contraceptive system of claim 13, wherein the elongated flexible suture is biodegradable.

16. The contraceptive system of claim 13, wherein the occluding device self-expands to engage with tissue lining of the reproductive tract lumen when ejected from the distal chamber.

17. The contraceptive system of claim 13, wherein the occluding device is compressible and expandable when disposed within the reproductive tract lumen.

18. The contraceptive system of claim 13, wherein the elongated flexible suture is attached to the occluding device near a distal end of the occluding device.

19. The contraceptive system of claim 13, wherein the elongated flexible suture is attached to the occluding device near a proximal end of the occluding device.

20. The contraceptive system of claim 13, wherein the occluding device comprises a foam.