System and a method for the long term cure of recurrent urinary female incontinence

• US 6,039,686 A
• Filed: 07/08/1998
• Issued: 03/21/2000
• Est. Priority Date: 03/18/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: American Medical Systems Incorporated (Endo International PLC)
• Inventors: Kovac, S. Robert
• Primary Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US09/111,525
• Time in Patent Office: 622 Days
• Field of Search: 600/29, 600/30, 128/897, 128/898, 128/885-887, 128/DIG. 25, 606/232, 606/65, 606/67, 606/72, 606/73, 606/75, 623/12.16
• US Class Current: 600/30
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes

Abstract

A pubic bone-mounted urethra stabilization and support system and method therefor for the long term cure of recurrent female urinary incontinence. The system comprises, a pair of anchors affixed to the posterior/inferior pubic bone, sutures attach to the anchors and a mesh sling passing behind and about the urethra and the adjacent endopelvic fascia and having ends attached to the anchors by the anchor-mounted sutures. The method includes the steps of accessing said urethra with the endopelvic fascia therebehind and the pubic bone, properly locating and attaching the anchors to the pubic bone, properly locating the sling about the urethra and adjacent endopubic fascia and suturing and tensioning the ends of the sling to the anchors, causing said sling to restore, support and stabilize functional urethral continence anatomy and prevent urethral descent under intraabdominal pressure.

Claims

1. A pubic bone-mounted urethra stabilization and support system for the long term cure of recurrent female urinary incontinence, said system comprising a pair of anchors adapted to be affixed to the posterior/inferior pubic bone to either side of the symphysis pubis, a surgical sling means adapted to be passed behind and about the urethra and the endopelvic fascia therebehind, for replacing damaged pubourethral ligaments and for supporting the urethra in its normal anatomic retropubic position said surgical sling means having spaced lateral end portions, each of said anchors operatively engaging one of said sling end portions, and adjustment means to position said surgical sling means relative to said anchors for restoring, supporting and stabilizing functional urethral continence anatomy and to prevent urethral descent under intraabdominal pressure.

2. The structure claimed in claim 1 wherein said surgical sling means also has upper and lower longitudinal edges, said sling end portions terminating in end edges.

3. The structure claimed in claim 2 including a pair of sutures connected to the upper and lower edges of said surgical sling means and adapted to extend on one side of the urethra for attachment to the endopelvic fascia and a similar pair of sutures connected to the upper and lower edges of said surgical sling means and adapted to extend on the other side of urethra for attachment to said endopelvic fascia.

4. The structure claimed in claim 3 wherein said pairs of sutures to either side of the urethra are so located as to form therebetween a trough-like configuration in said surgical sling means to prevent undue tension on the urethra by said surgical sling means when tied to said anchors.

5. The structure claimed in claim 1 wherein said surgical sling means has a trough-like configuration to prevent undue tension on the urethra.

6. The structure claimed in claim 5 wherein said surgical sling means is made from surgical mesh.

7. The structure claimed in claim 6 including a pair of permanent sutures affixed to each of said anchors, the anchor sutures of each pair being woven in opposite directions transversely through one of said surgical sling means end portions, said anchor sutures comprising said adjustment means.

8. The structure claimed in claim 7, including a pair of sutures to one side of the urethra attaching said upper and lower edges of said surgical sling means to the endopelvic fascia and a similar pair of sutures to the other side of the urethra attaching said upper and lower edges of said surgical sling means to the endopelvic fascia.

9. The structure claimed in claim 8, wherein the pairs of sutures to either side of the urethra are so located as to form therebetween a trough-like configuration in said surgical sling means to prevent undue tension on said urethra by said sling when tied to said anchors.

10. The structure claimed in claim 9 wherein said surgical sling means upper and lower edges are about 6 cm long, said sling end portions having end edges about 3 cm long.

11. The structure claimed in claim 2 wherein said end edges are formed other than rectilinear.

12. The structure claimed in claim 2 wherein said end portions of said surgical sling means each have at least one hole therethrough said anchors comprising anchor screws each having a shank and a head, said holes being sized to just nicely receive said anchor screw shanks.

13. The structure claimed in claim 2 wherein each of said end portions has at least two holes therethrough, locating said holes in each sling end portion in side-by-side relationship and longitudinally of said sling, said holes comprising said adjustment means.

14. The structure claimed in claim 13 including reinforcing stitching about the periphery of said holes.

15. The structure claimed in claim 1 wherein said surgical sling means is sufficiently dimensioned, configured and constructed relative to the urethra so as to be adapted to be passed behind and about the intermediate 60% portion of the urethra from the lower 20% portion to the upper 20% portion of the urethra.

16. The structure claimed in claim 1 including a pair of permanent sutures affixed to each of said anchors, the anchor sutures of each pair being woven in opposite directions transversely through one of said surgical sling end portions, said anchor sutures comprising said adjustment means.

17. The structure claimed in claim 1 wherein said surgical sling means comprises a rectangular piece of mesh about 6 cm long and about 3 cm wide.

18. The structure claimed in claim 1 wherein said anchors comprise anchor screws each of which extend through a hole in one of the sling end portions, said anchors screws when extending through said holes comprising said adjustment means.

21. The method claimed in claim 18 wherein said sling upper and lower edges are formed about 6 cm long and said sling end edges are formed about 3 cm long.

27. The method claimed in claim 1 including the step of locating said anchors about 1 cm laterally of the symphysis pubis and about 0.5 cm posteriorly and superiorly of the inferior edge of the ischial ramus of the pubic bone.

29. The method claimed in claim 27, including the step of locating said sling behind and about the intermediate 60% portion of the urethra from the lower 10% portion to the upper 20% portion of the urethra.

30. The method claimed in claim 29, including the steps of attaching said sling at the upper and lower edges thereof to the endopelvic fascia at either side of the urethra by a pair of sutures at either side of the urethra.

31. The method claimed in claim 30, including the step of locating said pairs of sutures to either side of the urethra joining said upper and lower longitudinal edges of said sling to the endopelvic fascia in a manner forming therebetween a trough-like configuration in said sling to prevent due tension on the urethra by said sling.

33. The method claimed in claim 21 including the step of locating said pairs of sutures to either side of the urethra joining said upper and lower longitudinal edges of said sling to the endopelvic fascia in a manner forming therebetween a trough-like configuration in said sling to prevent undue tension on the urethra by said sling.

19. A method of providing a long term cure for recurrent female urinary incontinence comprising the step of first making an incision in a vaginal wall through which the following additional steps are performed including mounting a pair of anchors in the posterior/inferior pubic bone to either side of the symphysis pubis, providing a surgical sling, locating said sling behind and about the urethra and the endopelvic fascia therebehind, said sling having lateral end portions, causing each of said anchors to operatively engage one of said sling end portions, and positioning said sling relative to said anchors to restore, support and stabilize functional urethral continence anatomy and to prevent urethral descent under intraabdominal pressure.

20. The method claimed in claim 19, including the step of making said sling of a piece of surgical mesh having upper and lower longitudinal edges, said end portions terminating in end edges.

22. The method claimed in claim 20 including a pair of permanent sutures affixed to each of said anchors, weaving the sutures of each pair in opposite directions transversely through one of said surgical mesh sling end portions and tying said sutures to affix said sling end portions to their respective anchors.

23. The method claimed in claim 20 including the steps of providing at least one pair of holes, locating one hole of said pair in each end portion of said sling, providing a pair of headed anchor screws, sizing said holes to just nicely receive the shanks of said anchor screws, inserting the shanks of said anchor screws through said holes and affixing said anchor screws and thus said sling to the posterior/interior pubic bone to either side of the symphysis pubis.

24. The method claimed in claim 23, including the steps of providing at least two pairs of said holes, locating one hole from each pair in each of said sling end portions, and locating said holes in each sling end portion in side-by-side relationship longitudinally of said sling to facilitate adjustment.

25. The method claimed in claim 24, including the step of providing reinforcing stitching about the periphery of said holes.

26. The method claimed in claim 19 including the step of locating said sling behind and about the intermediate 60% portion of the urethra from the lower 10% portion to the upper 20% portion of the urethra.

28. The method claimed in claim 19 including the step of forming a trough-like configuration in the sling to prevent undue tension on the urethra.

32. The method claimed in claim 20, including the steps of attaching said sling at the upper and lower edges thereof to the endopelvic fascia at either side of the urethra by a pair of sutures at either side of said urethra.

34. The method claimed in claim 19 wherein said incision in the vaginal wall is triangular shaped.