Methods and Apparatus for Occluding Reproductive Tracts to Effect Contraception

• US 20070261699A1
• Filed: 05/11/2006
• Published: 11/15/2007
• Est. Priority Date: 05/11/2006
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Conceptus Incorporated (Bayer AG)
• Inventors: Callister, Jeffrey, Tremulis, William
• Granted Patent: US 7,975,697 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 delivered into and released in a reproductive tract to occlude the reproductive tract lumen;

means for inserting and securing an occluding device within a reproductive tract to occlude the reproductive tract lumen; and

means for forming a mark on body tissue adjacent the reproductive tract to indicate delivery of the occluding device within a reproductive tract.

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

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 2, wherein the means for forming a mark comprises a dye emitting body borne on the occluding device that emits marking dye on contact with body tissue or fluid to form a mark on body tissue.

4. The contraceptive system of claim 2, wherein the means for forming a mark comprises a dye emitting body borne on the tissue growth supporting member that emits marking dye on contact with body tissue or fluid to form a mark on body tissue.

5. The contraceptive system of claim 2, wherein the means for forming a mark comprises a dye emitting body borne on the tubular member that emits marking dye on contact with body tissue or fluid to form a mark on body tissue.

6. The contraceptive system of claim 1, wherein:

the occluding device further comprises a tubular member having a first end, a second end, a member lumen extending therein, and an open-walled structure; and

the means for forming a mark comprises a dye emitting body borne on the occluding device that emits marking dye on contact with body tissue or fluid to form a mark on body tissue.

7. The contraceptive system of claim 1, wherein the inserting and securing device further comprises an elongated occluding device delivery catheter having a catheter shaft extending between a shaft proximal end and a shaft distal end, the catheter further comprising:

means for disposing the occluding device at the shaft distal end during introduction into the reproductive tract; and

means for releasing the occluding device from the shaft distal end within the reproductive tract.

8. The contraceptive system of claim 7, wherein the means for forming a mark comprises a dye emitting body borne on the catheter shaft proximate the shaft distal end that emits marking dye on contact with body tissue or fluid to form a mark on body tissue.

9. The contraceptive system of claim 7, wherein:

the catheter shaft comprises a plurality of brushes extending from the catheter shaft proximate the shaft distal end; and

the means for forming a mark comprises a dye emitting body borne on the plurality of brushes that emits marking dye on contact with body tissue or fluid to form a mark on body tissue.

10. The contraceptive system of claim 7, wherein the marking means comprises:

a dye delivery lumen extending substantially between the shaft proximal end to a dye emitting port proximate the shaft distal end; and

means for selectively delivering a dye bolus through the dye delivery lumen and out of the dye emitting port to contact and stain body tissue of the reproductive tract.

11. The contraceptive system of claim 7, wherein the disposing means comprises an expandable member on a distal section of the catheter shaft disposed within the outer member lumen to expand at least a portion of the tubular member.

12. The contraceptive system of claim 7, wherein:

the disposing means comprises an expandable balloon extended through the device lumen with the balloon substantially contracted; and

the releasing means comprises;

a balloon inflation lumen extending substantially between the shaft proximal end and the balloon; 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.

13. The contraceptive system of claim 1, wherein the inserting and securing device further comprises:

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 open at the shaft distal end and dimensioned to receive at least one occluding device within the distal chamber during introduction into the reproductive tract; and

means operable from the shaft proximal end for driving the occluding device from the distal chamber and disposing the occluding device within the reproductive tract.

14. The contraceptive system of claim 1, wherein the means for forming a mark comprises a dye emitting body borne on a marking member coupled to the occluding device, the marking member adapted to extend from the reproductive tract during or following disposition of the occluding device therein.

15. The contraceptive system of claim 1, wherein the reproductive tract comprises the Fallopian tubes, and wherein:

the inserting and securing device comprises an elongated occluding device delivery catheter further comprising;

a catheter shaft enclosing a shaft lumen and extending between a shaft proximal end and a shaft distal end adapted to be advanced through the uterine cavity into the Fallopian tubes, the shaft lumen terminating in a distal chamber open at the shaft distal end and dimensioned to receive first and second occluding devices within the distal chamber during introduction of the shaft distal end into a Fallopian tube; and

means operable from the shaft proximal end for driving the first occluding device from the distal chamber and disposing the first occluding device within a first selected Fallopian tube and operable from the shaft proximal end for driving the second occluding device from the distal chamber and disposing the second occluding device within the second Fallopian tube; and

the means for forming a mark to indicate the delivery of the occluding device comprises means for marking the tissue of the ostium of at least the first selected Fallopian tube.

16. The contraceptive system of claim 15, wherein the means for forming a mark comprises one of:

a dye emitting body borne on a marking member coupled to the first occluding device, the marking member adapted to extend from the first Fallopian tube into the uterine cavity during or following disposition of the first occluding device in the first Fallopian tube;

means for delivering a bolus of dye through the catheter shaft and emitting the dye proximate the shaft distal end when the shaft distal end is proximate the ostium of the first Fallopian tube;

a dye emitting body borne on the catheter shaft proximate the shaft distal adapted to contact and stain the ostium of the first Fallopian tube; and

a dye emitting body borne by the first occluding device adapted to contact and stain the ostium of the first Fallopian tube.

17. The contraceptive system of claim 1, wherein:

the tubular member is compressible and expandable when disposed within the reproductive tract; and

the inserting and securing device further comprises;

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

an expandable member at the shaft distal end supporting the occluding device during introduction into the reproductive tract;

means for expanding the expandable member to expand the occluding device within the reproductive tract; and

means for contracting the expandable member to enable withdrawal of the catheter.

18. The contraceptive system of claim 1, wherein:

the tubular member is selectively expandable by said inserting and securing means within the reproductive tract; and

the inserting and securing means further comprises means for expanding the tubular member within the reproductive tract to engage with the reproductive tract tissue lining.

19. The contraceptive system of claim 1, wherein:

the tubular member is compressible and self-expandable when disposed within the reproductive tract; and

the inserting and securing device further comprises means for releasing the tubular member into the reproductive tract to self-expand and engage with the reproductive tract tissue lining.

20. The contraceptive system of claim 1, wherein the reproductive tract comprises the Fallopian tubes, and wherein:

the occluding device is adapted to be delivered into and released in a Fallopian tube to occlude the Fallopian tube lumen and comprises a marking member coupled to the occluding device; and

the inserting and securing means comprises means for inserting the occluding device within the Fallopian tube to occlude the Fallopian tube lumen and for extending the marking member from the Fallopian tube lumen and ostium to or into the uterine cavity to indicate delivery of the occluding device within the Fallopian tube.

21. The contraceptive system of claim 20, wherein the marking member is biodegradable over time.

22. The contraceptive system of claim 20, wherein the marking member is formed with a dye emitting body that forms a visible stain on the tissue of the ostium or uterine cavity.

23. The contraceptive system of claim 1, further comprising an elongated guide member extending between guide member proximal and distal end and adapted to be advanced into the reproductive tract, and wherein:

the inserting and securing device further comprises an elongated occluding device delivery catheter comprising;

a catheter shaft enclosing a guide lumen adapted to receive the elongated guide member to enable advancement of the catheter shaft over the guide member and extending between a shaft proximal end and a shaft distal end;

means for disposing the occluding device at the shaft distal end during introduction into the reproductive tract; and

means for releasing the occluding device from the shaft distal end within the reproductive tract; and

the means for forming a mark to mark body tissue adjacent the reproductive tract to indicate delivery of the occluding device within a reproductive tract comprises a dye emitting body borne on at least a segment of the guide member proximate the guide member distal end adapted to contact and visibly stain the reproductive tract.

24. A method of occluding a Fallopian tube comprising:

providing an occluding device adapted to be delivered into and released in a Fallopian tube to occlude the Fallopian tube lumen and having a marking member coupled to the occluding device; and

inserting and securing the occluding device within the Fallopian tube to occlude the Fallopian tube lumen and to extend the marking member from the Fallopian tube lumen into the uterine cavity to indicate delivery of the occluding device within the Fallopian tube.

25. The method of claim 24, wherein the marking member is biodegradable over time.

26. The method of claim 24, wherein the marking member is formed with a dye emitting body that forms a visible stain on the tissue of the ostium or uterine cavity.

50. The method of claim 26, wherein the marking member is biodegradable over time.

27. A method of occluding a reproductive tract to effect contraception comprising the steps of:

providing an occluding device;

inserting and securing the occluding device within a reproductive tract to occlude the reproductive tract lumen; and

forming a mark on body tissue adjacent the reproductive tract to indicate delivery of the occluding device within a reproductive tract.

28. The method of claim 27, wherein the forming step comprises delivering a dye emitting body borne on the occluding device that emits marking dye on contact with body tissue or fluid to form the mark on body tissue.

29. The method of claim 27, wherein the step of providing an occluding device further comprises providing an occluding device having a tubular member and a tissue growth supporting member disposed within at least a portion of a tubular member lumen that encourages or supports tissue growth to thereby chronically occlude the reproductive body lumen.

30. The method of claim 29, wherein the inserting and securing step further comprises securing the tubular member to the reproductive tract tissue lining by epithelializing the tubular member within the reproductive tract.

31. The method of claim 29, wherein the forming step comprises delivering a dye emitting body borne on the tubular member that emits marking dye on contact with body tissue or fluid to form the mark on body tissue.

32. The method of claim 29, wherein the forming step comprises delivering a dye emitting body borne on the tissue growth supporting member that emits marking dye on contact with body tissue or fluid to form the mark on body tissue.

33. The method of claim 27, wherein:

the step of providing an occluding device further comprises providing an occluding device having an expandable tubular member; and

the inserting and securing step comprises expanding the tubular member within the reproductive tract to engage with the reproductive tract tissue lining and to occlude the reproductive tract lumen.

34. The method of claim 27, wherein:

the step of providing an occluding device further comprises providing an occluding device having a tubular member having a first end, a second end, a member lumen extending therein, and an open-walled structure; and

the forming step comprises providing a dye emitting body borne on the occluding device that emits marking dye on contact with body tissue or fluid to form the mark on body tissue.

35. The method of claim 27, wherein the inserting and securing step further comprises the steps of:

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

disposing the occluding device at the shaft distal end during introduction into the reproductive tract; and

releasing the occluding device from the shaft distal end within the reproductive tract.

36. The method of claim 35, wherein the forming step comprises:

providing a plurality of brushes extending from the catheter shaft proximate the shaft distal end with a dye emitting body borne on the plurality of brushes; and

extending the brushes and dye emitting body against body tissue and fluids during or following release of the occluding device to form the mark on body tissue.

37. The method of claim 35, wherein the forming step comprises providing a dye emitting body borne on the catheter shaft proximate the shaft distal end that emits marking dye on contact with body tissue or fluid to form the mark on body tissue.

38. The method of claim 35, wherein:

the step of providing an elongated occluding device delivery catheter comprises providing a dye delivery lumen extending substantially between the shaft proximal end to a dye emitting port proximate the shaft distal end; and

the forming step comprises selectively delivering a dye bolus through the dye delivery lumen and out of the dye emitting port to contact and stain body tissue of the reproductive tract.

39. The method of claim 35, wherein:

the step of providing an elongated occluding device delivery catheter comprises providing an expandable member on a distal section of the catheter shaft adapted to be disposed within the outer member lumen to expand at least a portion of the tubular member;

the disposing step comprises disposing the occluding device over the expandable member during introduction into the reproductive tract; and

the releasing step comprises expanding the expandable member to expand the occluding device and contracting the expandable member to withdraw the expandable member from the occluding device.

40. The method of claim 35, wherein:

the step of providing an elongated occluding device delivery catheter comprises;

providing an expandable balloon on a distal section of the catheter shaft adapted to be disposed, when deflated, within the outer member lumen to adapted to expand at least a portion of the tubular member when inflated; and

providing a balloon inflation lumen extending substantially between the shaft proximal end and the balloon;

the disposing step comprises disposing the occluding device over the deflated balloon during introduction into the reproductive tract; and

the releasing step comprises;

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

withdrawing the balloon inflating fluid to deflate the balloon and enable retraction of the balloon from the occluding device and the catheter from the reproductive tract.

41. The method of claim 35, further comprising the step of:

providing an elongated guide member extending between guide member proximal and distal end and adapted to be advanced into the reproductive tract, and having a dye emitting body borne on a guide member segment proximate the guide member distal adapted to contact and visibly stain the reproductive tract; and

wherein;

the step of providing an elongated occluding device delivery catheter comprises providing a guide lumen extending between the shaft proximal end and a shaft distal end adapted to receive the elongated guide member to enable advancement of the catheter shaft over the guide member; and

the step of forming a mark on body tissue adjacent the reproductive tract to indicate delivery of the occluding device within a reproductive tract comprises applying the dye emitting body borne on the guide member segment to tissue to contact and visibly stain the reproductive tract.

42. The method of claim 27, wherein:

the inserting and securing step further comprises the steps of;

providing 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 open at the shaft distal end;

disposing at least one occluding device within the distal chamber during introduction into the reproductive tract; and

driving the occluding device from the distal chamber and disposing the occluding device within the reproductive tract.

43. The method of claim 27, wherein:

the step of providing an occluding device comprises providing the marking member coupled to the occluding device and bearing a dye emitting body;

the forming step comprises extending the marking member from the reproductive tract during or following disposition of the occluding device therein in the inserting and securing step.

44. The method of claim 27, wherein the reproductive tract comprises the Fallopian tubes, and wherein:

the step of providing an occluding device comprises providing first and second occluding devices;

the inserting and securing step further comprises;

providing 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 adapted to be advanced through the uterine cavity into the Fallopian tubes, the shaft lumen terminating in a distal chamber open at the shaft distal end and dimensioned to receive first and second occluding devices within the distal chamber during introduction of the shaft distal end into a Fallopian tube;

disposing the first and second occluding devices within the distal chamber;

driving the first occluding device from the distal chamber and disposing the first occluding device within a first selected Fallopian tube; and

driving the second occluding device from the distal chamber and disposing the second occluding device within the second Fallopian tube; and

the step of forming the mark to indicate the delivery of the occluding device comprises marking the tissue of the ostium of at least the first selected Fallopian tube to signify the disposition of the occluding device therein.

45. The method of claim 27, wherein the reproductive tract comprises the Fallopian tubes, and wherein:

the step of providing an occluding device comprises providing first and second occluding devices, at least the first occluding device comprising a marking member coupled to the occluding device; and

the inserting and securing step further comprises;

providing 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 adapted to be advanced through the uterine cavity into the Fallopian tubes, the shaft lumen terminating in a distal chamber open at the shaft distal end and dimensioned to receive first and second occluding devices within the distal chamber during introduction of the shaft distal end into a Fallopian tube;

disposing the first and second occluding devices within the distal chamber;

driving the first occluding device from the distal chamber and disposing the first occluding device within a first selected Fallopian tube; and

driving the second occluding device from the distal chamber and disposing the second occluding device within the second Fallopian tube; and

the forming step comprises marking the tissue of the ostium of at least the first selected Fallopian tube with the marking member to signify the disposition of the occluding device therein.

46. The method of claim 45, wherein the step of providing the first occluding device comprises providing the marking member coupled to the first occluding device and bearing a dye emitting body that visibly stains the tissue of the ostium.

47. The method of claim 46, wherein the forming step comprises extending the marking member from the first Fallopian tube into the uterine cavity during or following disposition of the first occluding device in the first Fallopian tube.

48. The method of claim 45, wherein:

the step of providing the first occluding device comprises providing the marking member coupled to the first occluding device and extending away from the first occluding device; and

the forming step comprises extending the marking member from the first Fallopian tube into the uterine cavity during or following disposition of the first occluding device in the first Fallopian tube.

49. A method of occluding a reproductive tract to effect contraception comprising the steps of:

inserting and securing an occluding device having the marking member extending from the device at an installation site within a Fallopian tube not visible from the uterine cavity to occlude the Fallopian tube lumen; and

extending the marking member through the Fallopian tube into the uterine cavity to visually mark the installation of the occluding device within the Fallopian tube.