Implantable device configured to treat pelvic organ prolapse

• US 10,064,714 B2
• Filed: 05/19/2015
• Issued: 09/04/2018
• 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): Patel, Tarla
• Application Number:
  US14/715,603
• Publication Number:
  US 20150282919A1
• Time in Patent Office: 1,204 Days
• Field of Search: 128830, 128834, 128885, 600 29, 600 30, 606151, 606157, 606185, 623 2372, 623 2357
• 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 configured to treat prolapse of a pelvic organ includes a support member and an extension portion projecting from the support member. The extension portion has a barbed fixation means provided thereon for anchoring the extension portion into pelvic paravaginal tissue. The barbed fixation means allow bi-directional adjustment of the barbed fixation means relative to the tissue, and when suitably located, the barbed fixation means engage the tissue. The support member comprises a mesh material having a mass density of less than 50 g/m².

Claims

1. An implantable device configured to treat pelvic organ prolapse in a patient, the implantable device comprising:

a support; and

a plurality of tissue barbs projecting from the support;

wherein each of the plurality of tissue barbs engages with pelvic paravaginal tissue to fixate the implantable device in the patient;

wherein the pelvic paravaginal tissue is structurally undefined fibro-fatty tissue lacking substantial organized collagen.

2. The implantable device of claim 1, wherein each of the plurality of tissue barbs is configured to allow bi-directional adjustment relative to the pelvic paravaginal tissue.

3. The implantable device of claim 1, wherein each of the plurality of tissue barbs is configured to allow bi-directional adjustment relative to the pelvic paravaginal tissue, and when suitably located, each of the plurality of tissue barbs engages the pelvic paravaginal tissue.

4. The implantable device of claim 1, wherein the pelvic paravaginal tissue is fibro-fatty tissue.

5. The implantable device of claim 1, wherein the pelvic paravaginal tissue is tissue of a retropubic space.

6. The implantable device of claim 1, wherein the pelvic paravaginal tissue is tissue of a paraurethral space.

7. The implantable device of claim 1, wherein the pelvic paravaginal tissue is tissue of a pararectal space.

8. The implantable device of claim 1, wherein the pelvic paravaginal tissue is tissue of an ischiorectal fossa.

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

10. The implantable device of claim 1, wherein each of the plurality of tissue barbs is configured to engage with the pelvic paravaginal tissue without a skin exit wound.

11. The implantable device of claim 1, wherein the support is a mesh having a mass density of less than 50 g/m².

12. The implantable device of claim 1, wherein the support is a mesh having a mass density of less than 30 g/m².

13. The implantable device of claim 1, wherein the support is a mesh having a mass density of less than 25 g/m².

14. The implantable device of claim 1, wherein the support is a mesh having a mass density of less than 20 g/m².

15. The implantable device of claim 1, wherein the support is a mesh having a mass density between 20 g/m² and 50 g/m².

16. The implantable device of claim 1, wherein each of the plurality of tissue barbs is configured to engage with the pelvic paravaginal tissue with reduced disruption of the pelvic paravaginal tissue.

17. The implantable device of claim 1, wherein each of the plurality of tissue barbs is deformable into an insertion state configured for insertion into the pelvic paravaginal tissue, and wherein each of the plurality of tissue barbs is recoverable from the insertion state to provide resistance against retraction of each of the plurality of tissue barbs out of the pelvic paravaginal tissue.

18. The implantable device of claim 1, wherein each of the plurality of tissue barbs is formed from a polymer tape.

19. The implantable device of claim 1, wherein each of the plurality of tissue barbs is deformable into an insertion state configured for insertion into the pelvic paravaginal tissue, and wherein each of the plurality of tissue barbs is recoverable from the insertion state to provide an engagement state where each of the plurality of tissue barbs recovers to one of a Y-shape, a 7-shape, a T-shape, an arrowhead-shape, and a cloverleaf-shape.