METHODS AND DEVICES FOR OCCLUDING AN OVARIAN PATHWAY

• US 20090056722A1
• Filed: 08/28/2007
• Published: 03/05/2009
• Est. Priority Date: 08/28/2007
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Conceptus Incorporated (Bayer AG)
• Inventors: Swann, Betsy
• Granted Patent: US 8,100,129 B2
• Time in Patent Office: Days
• US Class Current: 128/831
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 8/481 involving the use of contrast agent, e.g. microbubbles introduced into the bloodstream analysis of echo signal exploiting properties of a contrast enhancer in devices for short-range imaging with acoustic waves G01S7/52039
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 6/20 Vas deferens occluders; Fallopian occluders
• CPC Class Codes: A61F 6/225 transcervical

Abstract

Methods and devices of sterilization by which the ovarian pathway is occluded by a plug, wherein placement of the plug may be visually confirmed, Other methods and devices are also described.

Claims

1. A method of occluding an ovarian pathway, the method comprising:

delivering a catheter device into an ovarian pathway, the ovarian pathway having a ostium;

wounding the ovarian pathway with the catheter device at a point beyond the ostium;

delivering a plug including a visual marker into the wounded segment of the fallopian tube, wherein the plug is delivered from the catheter device; and

visually confirming the placement of the plug by observing the presence of the visual marker about the ostium.

2. The method of claim 1 additionally comprising visually aligning a marker on the catheter device with the ostium before wounding.

3. The method of claim 1 wherein wounding comprises heating a portion of the interface between the ovarian pathway and catheter between about 50 to 70°

C. for a period of about 20 to 80 seconds.

4. The method of claim 3 wherein heating is performed by applying RF energy.

5. The method of claim 1 wherein the plug is a porous foam plug.

6. The method of claim 5 wherein the foam plug comprises a porous silicone matrix.

7. The method of claim 1 wherein the visual marker is a tail coupled to the plug.

8. A medical device for the occlusion of an ovarian pathway comprising:

a foam body, wherein the foam is designed to promote ovarian pathway tissue in-growth into the body; and

an elongated tail marker coupled to the foam body.

9. The device of claim 8 wherein the foam body is constructed from porous silicone.

10. The device of claim 8 wherein the tail marker is a coil.

11. The device of claim 10 wherein the coil is constructed from a shape memory alloy or a shape memory polymer.

12. The device of claim 8 wherein the tail marker is constructed from a porous silicone.

13. The device of claim 8 additionally comprising at least one of a radiopaque substance or an echogenic substance coupled to the body.

14. The device of claim 13 wherein the radiopaque substance is a metallic substance suspended in the foam body.

15. The device of claim 14 wherein the metallic substance is a wire core.

16. The medical device of claim 8 additionally comprising at least one anchor coupled to and extending from the foam body.

17. The device of claim 16 wherein the anchor is constructed from a shape memory alloy or a shape memory polymer.

18. A medical device for the occlusion of ovarian pathways, comprising:

an elongated catheter with a lumen disposed therein;

an inner pusher slidably housed within the lumen;

at least two foam body occlusion devices, each designed to occlude one ovarian pathway, slidably housed within the lumen and adjacent to the inner pusher; and

a marker element slidably housed between the occlusion devices.

19. The medical device of claim 18 wherein the marker element is biodegradable.

20. A method of occluding ovarian pathways of a female body, the method comprising:

delivering a catheter device into a first ovarian pathway with an endoscope device;

delivering a first foam body occlusion device into the first ovarian pathway;

confirming delivery of the first occlusion device by ejecting a marker element from the catheter device;

delivering the catheter device into a second ovarian pathway with the endoscope device; and

delivering a second foam body occlusion device into the second ovarian pathway.

21. The method of claim 20 wherein the marker element is bio-degradeable.

22. The method of claim 21 wherein the marker element is a dye capsule.

23. The method of claim 20 wherein the first and second occlusion devices are plugs.

24. The method of claim 20 additionally comprising wounding the first ovarian pathways.

25. The method of claim 24 wherein wounding is performed using the catheter.

26. The method of claim 25 wherein the catheter is capable of wounding using RF energy.

27. The method of claim 20 additionally comprising wounding the second ovarian pathway.

28. The method of claim 27 wherein wounding is performed using the catheter.

29. The method of claim 27 wherein the catheter us capable of wounding using RF energy.

30. A method of occluding ovarian pathway of a female body, the method comprising:

delivering a catheter device into an ovarian pathway with an endoscopic device, the ovarian pathway having an ostium;

delivering an elongated foam occlusion device into the ovarian pathway, wherein after delivery a visible portion of the elongated foam occlusion device is the proximal to the ostium; and

confirming delivery of the elongated foam occlusion device by observing the visible portion of the elongated foam occlusion device.

31. The method of claim 30 wherein the elongated foam occlusion device is in a length range of 4 mm-4 cm.

32. The method of claim 30 wherein the elongated foam occlusion device includes a proximal end with a reduced diameter.

33. The method of claim 30 additionally comprising wounding the ovarian pathway approximately 1 cm past the ostium.

34. A medical device for the occlusion of an ovarian pathway, comprising:

an elongated foam plug, wherein the foam plug is designed for placement in an ovarian pathway and includes a tear-away joint.

35. The medical device of claim 34 wherein the foam plug is constructed from a porous silicone.

36. The medical device of claim 34 wherein the foam plug includes a tail marker.

37. The medical device of claim 36 wherein the tail marker is constructed from a porous silicone.

38. A method for confirming successful delivery of a plug previously delivered in an ovarian pathway, comprising:

observing a proximal portion of a plug exiting out of a ovarian pathway; and

removing the proximal portion of the plug.

39. The method of claim 38 wherein the plug is constructed from porous foam.

40. The method of claim 38 where observing is performed using an endoscope.

41. A method for occlusion of an ovarian pathway, the method comprising:

delivering energy to a first area of the ovarian pathway, the energy wounding the first area; and

deploying a device in the ovarian pathway, the device being proximate to the first area and covering, within the ovarian pathway, a second area, wherein the first area and the second area are substantially different in size.

42. A method as in claim 41 wherein the first area is at least twice the size of the second area.

43. A method as in claim 41 wherein the second area us at least twice the size of the first area.

44. A medical device for the occlusion of ovarian pathways, comprising:

an elongated catheter with a first lumen and a second lumen disposed therein;

a first inner pusher slidably housed within the first lumen;

a second inner pusher slidably housed within the second lumen; and

at least two foam body occlusion devices, each designed to occlude one ovarian pathway each slidably housed within the first and second lumens and adjacent to the first and second inner pushers respectively.

45. The medical device of claim 44 wherein each occlusion device comprises a foam body, wherein the foam is designed to promote ovarian pathway tissue in-growth into the foam body.

46. A medical device for the occlusion of an ovarian pathway, comprising:

an elongated mid section with a first end and a second end;

at least one enlarged end portion attached to an end of the elongated mid section, wherein the enlarged end portion has a cross-sectional profile which is larger than a cross sectional profile of the elongated mid section and wherein the enlarged end portion is least partially hollow.

47. The medical device of claim 46 wherein the elongated mid section and at least one enlarged end portion is constructed from porous foam.

48. The medical device of claim 47 wherein the enlarged end portion includes at least one layer to provide anchoring force against an ovarian pathway.

49. The medical device of claim 46 additionally comprising a tail coupled to the at least one enlarged end portion.

50. The medical device of claim 46 wherein the enlarged end portion includes a frame.

51. The medical device of claim 46 additionally comprising an elongated insert coupled to the elongated mid section, wherein the elongated insert includes an element for repositioning or removal of the medical device after placement within an ovarian pathway.