Implant for treatment of vaginal and/or uterine prolapse

• US 7,975,698 B2
• Filed: 05/23/2005
• Issued: 07/12/2011
• Est. Priority Date: 05/21/2004
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Browning, James
• Primary Examiner(s): Bianco; Patricia M
• Assistant Examiner(s): Patel; Tarla R
• Application Number:
  US11/597,018
• Publication Number:
  US 20080196729A1
• Time in Patent Office: 2,241 Days
• Field of Search: 128/830, 128/834, 128/885, 600/29, 600/30, 606/151, 606/157, 606/185, 623/23.72, 623/23.57
• US Class Current: 128/834
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0054 with pressure applied to urethra by an element placed around the penis, e.g. penis clamp
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 6/225 transcervical

Abstract

An implant suitable for treatment of treatment of vaginal and/or uterine prolapse and/or pelvic floor reconstruction. The implant comprises a vaginal support member substantially sized or shaped to the portion of the vaginal wall to be supported and at least two extension portions projecting from the support member, wherein at least one extension portion has fixation means for anchoring the extension portion into pelvic paravaginal fibro-fatty issue without being faxed into defined structural tissues. A method of treating treatment of vaginal and/or uterine prolapse and/or pelvic floor reconstruction using the implant is also provided.

Claims

1. An implant for use in vaginal wall support comprising:

a vaginal support member substantially sized and shaped to the portion of the vaginal wall to be supported; and

at least two extension portions projecting from the support member, wherein each extension portion has a plurality of fixation means provided thereon for anchoring the extension portion into pelvic paravaginal tissue wherein the fixation means are provided in a first arrangement to allow insertion and bi-directional adjustment of the fixation means within the paravaginal tissue while causing minimal tissue disruption and when suitably located, the fixation means adopt a second arrangement wherein the fixation means grip the tissues of the pelvic paravaginal tissue.

2. The implant of claim 1, wherein the paravaginal tissue is tissue of the retropubic space, paraurethral space, pararectal space or ischiorectal fossa.

3. The implant of claim 1, wherein the fixation means comprises adhesive portions.

4. The implant of claim 3, wherein the adhesive portions comprise cyanoacrylate.

5. The implant of claim 1, wherein the fixation means is resiliently deformable.

6. The implant of claim 5, wherein at least part of the fixation means is shaped such that it can recoil from a deformed shape to a resting shape which provides greater resistance than the deformed shape in the pelvic paravaginal tissue.

7. The implant of claim 1, wherein the fixation means is sized and shaped to provide multiple fixation at a plurality of layers in the paravaginal tissue.

8. The implant of claim 1, wherein the extension portions are flexible.

9. The implant of claim 1, comprising at least four extension portions.

10. The implant of claim 9, comprising multiple pairs of extension portions.

11. The implant of claim 1, wherein each fixation means is less than or equal to 2 cm in length.

12. The implant of claim 1, wherein each fixation means is less than or equal to 1 cm in width.

13. The implant of claim 1, wherein the extension portions have a length in the range of 1 cm to 10 cm.

14. The implant of claim 13, wherein the extension portions have a length in the range of 4 cm to 8 cm.

16. The implant of claim 1, wherein the vaginal support member is substantially elliptical in shape.

17. The implant of claim 16, wherein the vaginal support member is an ellipse or a truncated ellipse.

18. The implant of claim 1, wherein the vaginal support member is substantially ovoid in shape.

19. The implant of claim 1, wherein the vaginal support is bifurcated and comprises at least two zones which can pass around the urethra.

20. The implant of claim 1, wherein the vaginal support member has a length in the range of 4 to 12 cm.

21. The implant of claim 1, wherein the vaginal support member has a width in the range of 3 to 8 cm.

22. The implant of claim 1, wherein the vaginal support member comprises mesh material.

23. The implant of claim 1, comprising absorbable or resorbable material.

24. The implant of claim 1, wherein the implant comprises medicament.

25. A kit for a surgical procedure to treat vaginal prolapse comprising:

the implant of claim 1, and

an insertion tool which is sized and shaped to insert, position, and release the implant in the pelvic paravaginal tissue.

26. The implant of claim 1 , wherein the fixation means comprises a member that is inwardly tapered in a direction of insertion.

15. The implant of claim , wherein the extension portions have a width in range of 0.5 mm to 15 mm.

27. A method of supporting all or part of a vaginal wall comprising the steps of:

providing a surgical implant comprising a support member substantially sized and shaped to the portion of the vaginal wall to be supported, said implant having at least two extension portions projecting from the support member for implanting the implant into pelvic paravaginal tissue, and wherein each extension portion has a plurality of fixation means provided thereon;

positioning said surgical implant on the vaginal wall;

inserting said first extension portion into paravaginal tissue and anchoring the fixation means in the paravaginal tissue without the extension portion or the fixation means being fixed into defined structural tissue;

inserting said second extension portion into paravaginal tissue and anchoring the fixation means in the paravaginal tissue without the extension portion or the fixation means being fixed into defined structural tissue, such that the vaginal support member supports the vaginal wall wherein the fixation means are provided in a first arrangement to allow insertion and bi-directional adjustment of the fixation means within the paravaginal tissue while causing minimal tissue disruption and when suitably located, the fixation means adopt a second arrangement wherein the fixation means grip the tissues of the pelvic paravaginal tissue.

28. The method of claim 27, wherein at least one of said first or second extension portion is inserted into at least one of the tissues of the retropubic space, paraurethral space, pararectal space or ischiorectal fossa.

29. The method of claim 27, wherein the surgical implant comprises a third extension portion, said third extension portion being inserted into paravaginal tissue without said third extension portion or a fixation means being fixed into defined structural tissue.

30. The method of claim 27, wherein the fixation means comprise an adhesive.

31. The method of claim 30, wherein the adhesive is cyanoacrylate.