Method and apparatus for non-surgically sterilizing female reproductive organs

• US 4,606,336 A
• Filed: 11/23/1984
• Issued: 08/19/1986
• Est. Priority Date: 11/23/1984
• Status: Expired due to Term

• Current Assignee: James W. Zeluff
• Original Assignee: James W. Zeluff
• Inventors: Zeluff, James W.
• Primary Examiner(s): Cockeram, Herbert S.
• Application Number:
  US06/674,244
• Time in Patent Office: 634 Days
• Field of Search: 604/55, 128/127, 128/130, 128/82.1
• US Class Current: 128/831
• CPC Class Codes: A61F 6/225 transcervical

Abstract

An ostial occlusion device forms an hermetic seal around the tubal ostium of the uterotubal junction and includes a hub fabricated from a non-porous material having a circumferential edge and upper and lower surfaces. A locator pin is oriented perpendicular to and extends outward from the lower surface of the hub and is insertable into the fallopian tube at the uterotubal junction to center the hub about the tubal ostium. A ring of porous material surrounds the circumferential edge of the hub and includes an exposed lower surface which contacts the tissue surrounding the tubal ostium and receives fibroblast ingrowth to create an hermetic seal around the tubal ostium. This hermetic seal isolates the fallopian tube from the uterine cavity and renders the female reproductive system infertile.

Claims

1. An ostial occlusion device for forming an hermetic seal around the tubal ostium of the female reproductive system comprising:

a. a hub fabricated from a rigid, non-porous material including a circumferential edge and an upper surface and a lower surface;

b. means fabricated from a rigid, non-porous material oriented perpendicular to and extending outward from the lower surface of the hub insertable into the uterotubal junction of the female reproductive system for centering the nub about the tubal ostium; and

c. a ring of porous material surrounding the circumferential edge of the hub and including an exposed lower surface for contacting the tissue surrounding but not including the tubal ostium and for receiving fibroblast ingrowth to create an hermetic seal surrounding but not including the tubal ostium to provide fluid isolation between the fallopian tube and the uterine cavity to thereby render the female reproductive system infertile,

whereby the non-porous lower surface of the hub extends radially outward from the hub centering means over the tissue immediately adjacent to the tubal ostium to prevent fibroblast ingrowth into said tissue.

2. The ostial occlusion device of claim 1 wherein the hub is fabricated from a rigid material and includes a cylindrical body having a constant radius, smooth circumferential edge.

3. The ostial occlusion device of claim 2 wherein the hub centering means includes a locator pin coupled to the center of the lower surface of the hub.

4. The ostial occlusion device of claim 3 wherein the length of the locator pin is equal to or greater than twice the hub diameter.

5. The ostial occlusion device of claim 1 wherein the ring of porous material is formed from a biocompatible material which stimulates ingrowth of fibroblastic tissue.

6. The ostial occlusion device of claim 1 wherein the porous material includes pores exceeding one micron in size.

7. The ostial occlusion device of claim 6 wherein the porous material includes pores having a size less than twenty microns.

8. The ostial occlusion device of claim 1 further including removal means for permitting a tool to grip ostial occlusion the device and remove it from the female reproductive system.

9. The ostial occlusion device of claim 8 wherein said removal means includes an eyelet coupled to the hub.

10. The ostial occlusion device of claim 9 wherein the eyelet is coupled to the upper surface of the hub.

11. The ostial occlusion device of claim 1 wherein the exposed lower surface of the ring of porous material is aligned with the lower surface of the hub.

12. The ostial occlusion device of claim 1 wherein the hub and the hub centering means are fabricated from radiopaque material.

13. The ostial occlusion device of claim 3 wherein the locator pin is formed as a cylinder having a smooth outer surface freely insertable into and removable from the fallopian tube.

14. The ostial occlusion device of claim 13 wherein the locator pin includes a blunt tip.

15. The ostial occlusion device of claim 13 wherein the upper and lower surfaces of the ring of porous material are aligned with the upper and lower surfaces of the hub and wherein the ring of porous material is formed as a torus surrounding and firmly contacting the circumferential edge of the hub.

16. The ostial occlusion device of claim 15 wherein the outer diameter of the ring of porous material is equal to or less than three millimeters.

17. The ostial occlusion device of claim 1 further comprising a layer of adhesive applied to the ring of porous material to initially secure the porous material to the tissue surrounding the tubal ostium to thereby maintain a fixed spatial relationship between the ostial occlusion device and the female reproductive system as fibroblast ingrowth commences.

18. The ostial occlusion device of claim 1 further comprising a layer of adhesive applied to the ring to initially secure the porous material to the tissue surrounding the tubal ostium to thereby maintain a fixed spatial relationship between the ostial occlusion device and the female reproductive system as fibroblast ingrowth commences.

19. A method for forming an hermetic seal at the junction between the fallopian tube and the uterine cavity of the female reproductive system to render a female infertile, comprising the steps of:

a. introducing an ostial occlusion device through the vagina and cervix into the uterine cavity, the ostial occlusion device including (1) a hub having a circumferential edge and upper and lower surfaces;

(2) hub centering means extending outward from the lower surface of the hub; and

(3) a ring of porous material surrounding the circumferential edge of the hub and including an exposed lower surface;

b. inserting the hub centering means of the ostial occlusion device into the uterotubal junction until the exposed lower surface of the ring of porous material contacts the tissue surrounding the tubal ostium area of the uterotubal junction; and

c. maintaining the lower surface of the ring of porous material in contact with the tissue surrounding the uterotubal junction until fibroblast ingrowth into the porous material commences.

20. The method of claim 19 including the further step of visually identifying the uterotubal junction prior to inserting the ostial occlusion device into the uterotubal junction.

21. The method of claim 19 wherein the step of introducing the ostial occlusion device is accomplished by an hysteroscope.

22. The method of claim 21 wherein the ostial occlusion device is housed within a carrier within the hysteroscope.

23. The method of claim 19 wherein the hub is fabricated from a rigid, non-porous material for preventing fibroblast ingrowth between the tubal ostium area of the uterotubal junction and the lower surface of the hub.

24. The method of claim 19 including the further step of increasing the degree of fibroblast ingrowth between the porous material and the adjacent tissue surrounding the uterotubal junction to complete the formation of an hermetic seal between the fallopian tube and the uterine cavity of the female reproductive system.

25. The method of claim 24 wherein the hub centering means further includes removal means for permitting a tool to grip the ostial occlusion device and remove it from the female reproductive system and including the further step of using the tool to remove the ostial occlusion device from the uterotubal junction to destroy the hermetic seal between the fallopian tube and the uterine cavity to reopen the uterotubal junction.

26. The method of claim 23 wherein the ring of porous material is formed from a biocompatible material which stimulates ingrowth of fibroblast tissue.

27. The method of claim 19 further comprising a layer of adhesive applied to the ostial occlusion device for temporarily maintaining the lower surface of the ring of porous material in contact with the tissue surrounding the uterotubal junction until the ingrowth of fibroblast material has advanced to a predetermined level.

28. The method of claim 27 wherein the layer of adhesive is applied to the ring of porous material.

29. The method of claim 27 wherein the layer of adhesive is applied to the hub centering means.

30. The method of claim 22 including the further step of displacing the carrier from the hysteroscope and aligning the carrier with the uterotubal junction prior to inserting the ostial occlusion device into the uterotubal junction.

31. The method of claim 19 wherein the hub centering means includes a locator pin coupled to the center of the lower surface of the hub.