Implants with absorbable and non-absorbable features for the treatment of female pelvic conditions

• US 9,468,512 B2
• Filed: 10/06/2011
• Issued: 10/18/2016
• Est. Priority Date: 10/06/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Inventors: Koullick, Edouard A., Dinh, Thomas Q., Grant, Robert C.
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US13/877,695
• Publication Number:
  US 20130197300A1
• Time in Patent Office: 1,839 Days
• Field of Search: 600/37, 600 29- 32, 128/834, 128/885, 128897-899
• US Class Current: 1/1
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2420/00 Materials or methods for coatings medical devices
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 23/06 Polyethene

Abstract

Described are methods, devices, and systems related to implants for the treatment of a female pelvic condition. The implants include absorbable and non-absorbable materials and can be introduced into the pelvic area transvaginally. Meshes of the invention provide benefits relating to improved tissue integration into the mesh, reduced infection likelihood, improved patient comfort following implantation, or combinations of thereof.

Claims

1. An implant configured for transvaginal insertion into a female patient to treat a pelvic disorder, the implant comprising:

a first non-absorbable mesh layer, a second absorbable layer comprising an absorbable hydroxyalkanoate polymer, wherein the second absorbable layer is non-porous and prevents migration of cells through the second layer prior to degradation of the second absorbable layer within the female patient, and an absorbable adhesive or protruding member comprising an absorbable polyester that is different than the hydroxyalkanoate polymer, that has a rate of degradation that is faster than the hydroxyalkanoate polymer, and which secures the first layer to the second layer, wherein the absorbable adhesive or the protruding member is formulated to absorb more rapidly in vivo than the second absorbable layer.

2. The implant of claim 1 wherein the first layer comprises a woven, knitted, or molded construction.

3. The implant of claim 1 wherein the first layer comprises polypropylene filaments or molded polypropylene.

4. The implant of claim 1 wherein the second layer has a side in contact with the first layer which comprises the protruding member configured to secure the first layer to the second layer.

5. The implant of claim 1 wherein the absorbable polyester is a polyester copolymer.

6. The implant of claim 1 wherein the first layer has a thickness in the range of 0.005 to 0.02 inches.

7. The implant of claim 1 wherein the second layer is a continuous film of absorbable material that is attached to the first non-absorbable mesh layer.

8. The implant of claim 1 wherein the second layer has a thickness in the range of 0.005 to 0.02 inches.

9. The implant of claim 1 wherein the second layer comprises a hydoxyalkanoate homopolymer.

10. The implant of claim 1 wherein the second layer comprises polyhydroxybutyrate.

11. The implant of claim 1 further comprising a bioactive agent.

12. The implant of claim 11 wherein the bioactive agent is selected from antibiotics, antimicrobials, inhibitors of epithelial cell activation and/or migration, and compounds that enhance wound regeneration selected from epidermal grown factor (EGF), transforming growth factor α

or β

(TGF-α

or β

), vascular endothelial growth factor, platelet derived growth factor, and fibroblast growth factor.

13. The implant of claim 11 wherein the bioactive agent is present in the second absorbable layer and diffuses from the second absorbable layer or is released from the second absorbable layer upon degradation of absorbable material in the second absorbable layer.

14. The implant of claim 11 wherein the bioactive agent is present in a coating of absorbable material formed on the mesh of the first layer or the second layer.

15. The implant of claim 1 which is configured for the treatment of a pelvic disorder selected from urinary incontinence, vaginal prolapse, cystocele, and rectocele.

16. The implant of claim 1 further comprising a tissue anchor or fastener.

17. The implant of claim 1, the implant further comprising:

a central portion and two or more arms that extend from the central portion, wherein the central portion comprises the first non-absorbable mesh layer, and the second absorbable layer, and the two or more arms comprise an absorbable material.

18. The implant of claim 1 wherein the absorbable polyester comprises one or more monomer(s) selected from the group consisting of hydroxyalkanoate, lactide, glycodlide, and caprolactone.