IMPLANT FOR TREATMENT OF VAGINAL AND/OR UTERINE PROLAPSE

• US 20110201872A1
• Filed: 04/28/2011
• Published: 08/18/2011
• Est. Priority Date: 05/21/2004
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Browning, James
• Granted Patent: US 8,215,310 B2
• Time in Patent Office: Days
• US Class Current: 600/30
• 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/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 tissue without being fixed into a defined structural tissue.

2. The implant as claimed in claim 1 wherein the paravaginal fibro-fatty tissue is tissue of the retropubic space, paraurethral space, pararectal space and/or ischiorectal fossa.

3. The implant as claimed in any preceding claim wherein, in use, the fixation means are provided in a first arrangement to allow insertion and bi-directional adjustment of the fixation means within the paravaginal tissue whilst 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 fibro-fatty tissue.

4. The implant as claimed in any preceding claim wherein the fixation means comprises adhesive portions.

5. The implant as claimed in any preceding claim wherein the fixation means is resiliently deformable.

6. The implant as claimed in 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 fibro-fatty tissue.

7. The implant as claimed in any preceding claim wherein the fixation means is sized and/or shaped to provide multiple sites of fixation at a plurality of layers in the paravaginal fibro-fatty tissue.

8. The implant as claimed in any preceding claim wherein the extension portions are flexible.

9. The implant as claimed in any preceding claim comprising at least four extension portions.

10. The implant as claimed in claim 9 comprising multiple pairs of extension portions.

11. The implant as claimed in any preceding claim wherein each fixation means is less than or equal to 2 cm in length.

12. The implant as claimed in any preceding claim wherein each fixation means is less than or equal to 1 cm in width.

13. The implant as claimed in any preceding claim wherein the extension portions have a length in the range 1 cm to 10 cm.

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

15. The implant as claimed in any preceding claim wherein the extension portions have a width in the range 0.5 mm to 15 mm.

16. The implant as claimed in any preceding claim wherein the vaginal support member is substantially elliptical in shape

17. The implant as claimed in claim 16 wherein the vaginal support member is an ellipse or a truncated ellipse.

18. The implant as claimed in any one of claims 1 to 15 wherein the vaginal support member is substantially ovoid in shape.

19. The implant as claimed in any one of claims 1 to 15 wherein the vaginal support is bifurcated and comprises at least two zones which can pass around the urethra.

20. The implant as claimed in any preceding claim wherein the vaginal support member has a length in the range 4 to 12 cm.

21. The implant as claimed in any preceding claim wherein the vaginal support member has a width in the range 3 to 8 cm.

22. The implant as claimed in any preceding claim wherein the vaginal support member comprises mesh material.

23. The implant as claimed in any preceding claim comprising absorbable or resorbable material.

24. The implant as claimed in any preceding claim wherein the implant comprises medicament.

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

positioning a surgical implant as claimed in any one of claims 1 to 24 on the vaginal wall,

inserting said first extension portion into paravaginal fibro-fatty tissue without the extension portion or fixation means being fixed into defined structural tissue,

inserting said second extension portion into paravaginal fibro-fatty tissue without the extension portion or fixation means being fixed into defined structural tissue,

such that the vaginal support member is suspended from said first and second extension portions and supports the vaginal wall.

26. The method as claimed in claim 25, wherein at least one of said first or second extension portion is inserted into at least one of the tissues of the retro-pubic space, paraurethral space, pararectal space and/or ischiorectal fossa.

27. The method of claim 25 further comprising the step of inserting further extension portions into paravaginal fibro-fatty tissue without the further extension portions or fixation means being fixed into defined structural tissue.

28. Use of an implant as claimed in any one of claims 1 to 24 for the treatment of uterine/vaginal prolapse or pelvic floor reconstruction or to prevent prolapse or where prolapse and urinary stress incontinence coexist.

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

an implant as claimed in any one of claims 1 to 24, and

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