Methods and apparatus for occluding reproductive tracts to effect contraception

• US 8,550,085 B2
• Filed: 06/30/2011
• Issued: 10/08/2013
• Est. Priority Date: 05/11/2006
• Status: Expired due to Fees

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Conceptus Incorporated (Bayer AG)
• Inventors: Callister, Jeffrey P., Tremulis, William S.
• Primary Examiner(s): Bianco, Patricia
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US13/174,648
• Publication Number:
  US 20110259342A1
• Time in Patent Office: 831 Days
• Field of Search: 128830-831, 606/135, 606157-158, 606/193, 606/191, 606/200, 606/213, 600 33- 35, 600/427, 600423-424
• US Class Current: 128/830
• 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 comprising an expandable tubular member having an open-walled lattice structure, the 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 slack suture comprising an attached end and a terminal end, the elongated slack suture connected to the open-walled lattice structure at the attached end, wherein the elongated slack suture trails limply from the attached end inside the reproductive tract lumen to the terminal end outside the reproductive tract lumen after the occluding device is installed within the reproductive tract lumen.

2. The contraceptive system of claim 1, wherein the expandable tubular member includes a first end, a second end, and a member lumen extending therethrough, and the occluding device further comprising:

a tissue growth supporting member disposed within at least a section of the member lumen, the tissue growth supporting member supporting tissue growth to 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 expandable tubular member self-expands to engage with a 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 expandable tubular member includes a first end, a second end, and a member lumen, wherein the attached end of the elongated slack suture is tied to the open-walled lattice structure between the first end and the second end, and wherein the elongated slack suture is adapted to extend from the attached end to the terminal end beyond the first end.

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;

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 expandable balloon to expand the expandable balloon against the expandable tubular member to effect the expansion of the expandable tubular member within the reproductive tract and for withdrawing the balloon inflating fluid to deflate the expandable balloon and enable retraction of the elongated occluding device delivery 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 slack 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 expandable 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 expandable tubular member within the reproductive tract lumen to engage with a tissue lining of the reproductive tract lumen.

11. The contraceptive system of claim 1, wherein the occluding device includes a distal end and a proximal end, and wherein the elongated slack suture connects to the open-walled lattice structure nearer to the distal end of the occluding device than to the proximal end of the occluding device.

12. The contraceptive system of claim 1, wherein the occluding device includes a distal end and a proximal end, and wherein the elongated slack suture connects to the open-walled lattice structure nearer to the proximal end of the occluding device than to the distal end of the occluding device.

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

an occluding device comprising an expandable tubular member having an open-walled lattice structure, the 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 to eject the occluding device distally out of the distal chamber; and

an elongated slack suture comprising an attached end and a terminal end, the elongated slack suture connected to the open-walled lattice structure at the attached end, wherein the elongated slack suture trails limply from the attached end inside the reproductive tract lumen to the terminal end outside the reproductive tract lumen 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, wherein the expandable tubular member includes a first end, a second end, and a member lumen extending therethrough, wherein the elongated slack suture connects to the open-walled lattice structure between the first end and the second end, and wherein the elongated slack suture is adapted to extend from the attached end to the terminal end beyond the first end and into a uterine cavity after the occluding device is installed within the fallopian tube.

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

16. The contraceptive system of claim 13, wherein the occluding device self-expands to engage with a 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 occluding device comprises a distal end and a proximal end, and wherein the elongated slack suture connects to the open-walled lattice structure nearer to the distal end of the occluding device than to the proximal end of the occluding device.

19. The contraceptive system of claim 13, wherein the occluding device comprises a distal end and a proximal end, and wherein the elongated slack suture connects to the open-walled lattice structure nearer to the proximal end of the occluding device than to the distal end of the occluding device.

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