Implant for treatment of vaginal and/or uterine prolapse

• US 8,215,310 B2
• Filed: 04/28/2011
• Issued: 07/10/2012
• 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
• Assistant Examiner(s): PATEL, TARLA R
• Application Number:
  US13/096,582
• Publication Number:
  US 20110201872A1
• Time in Patent Office: 439 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 configured to treat prolapse of a pelvic organ, the implant comprising:

a support member; and

an extension portion projecting from the support member and having a barbed fixation means provided thereon for anchoring the extension portion into pelvic paravaginal tissue, the barbed fixation means provided to allow bi-directional adjustment of the barbed fixation means relative to the tissue, and when suitably located, the barbed fixation means configured to engage the tissue.

2. The implant of claim 1, wherein the pelvic organ is a vagina and the support member is substantially sized and shaped to support a wall of the vagina.

3. The implant of claim 2, wherein the support member is a vaginal support member and the vaginal support member is bifurcated.

4. The implant of claim 1, wherein the paravaginal tissue is fibro-fatty tissue.

5. The implant of claim 1, wherein the paravaginal tissue is tissue of the retropubic space.

6. The implant of claim 1, wherein the paravaginal tissue is tissue of the paraurethral space.

7. The implant of claim 1, wherein the paravaginal tissue is tissue of the pararectal space.

8. The implant of claim 1, wherein the paravaginal tissue is tissue of the ischiorectal fossa.

9. The implant of claim 1, wherein the paravaginal tissue is fibro-fatty tissue alongside of the vagina.

10. The implant of claim 1, wherein the barbed fixation means is provided for anchoring the extension portion into pelvic paravaginal tissue without a skin exit wound.

11. The implant of claim 1, comprising multiple extension portions each having a barbed fixation means.

12. The implant of claim 1, wherein the support member comprises a mesh material having a mass density of less than 50 g/m².

13. The implant of claim 1, wherein the support member comprises a mesh material having a mass density of less than 30 g/m².

14. The implant of claim 1, wherein the support member comprises a mesh material having a mass density of less than 25 g/m².

15. The implant of claim 1, wherein the support member comprises a mesh material having a mass density of less than 20 g/m².

16. An implant configured to treat prolapse of a pelvic organ, the implant comprising:

a support member; and

an extension portion projecting from the support member and having a barbed fixation means provided thereon for anchoring the extension portion into pelvic paravaginal tissue, the barbed fixation means provided to allow bi-directional adjustment of the barbed fixation means relative to the tissue, and when suitably located, the barbed fixation means configured to engage the tissue;

wherein the support member comprises a mesh material having a mass density of less than 50 g/m².

17. A kit configured to treat prolapse of a pelvic organ, the kit comprising:

an implant including a support member, and an extension portion projecting from the support member and having a barbed fixation means provided thereon for anchoring the extension portion into pelvic paravaginal tissue, the barbed fixation means provided to allow bi-directional adjustment of the barbed fixation means relative to the tissue, and when suitably located, the barbed fixation means configured to engage the tissue; and

an insertion tool provided for placement of the implant.

18. The kit of claim 17, wherein the insertion tool includes a prong to which the extension portion is releasably mounted.