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

• US 10,492,897 B2
• Filed: 10/17/2016
• Issued: 12/03/2019
• Est. Priority Date: 10/06/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Koullick, Edouard A., Dinh, Thomas Q., Grant, Robert C.
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US15/295,688
• Publication Number:
  US 20170035542A1
• Time in Patent Office: 1,142 Days
• Field of Search: 600 37, 600 29- 32, 128834, 128885, 128897-899
• 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 or disease, the implant comprising:

a non-absorbable mesh layer, the non-absorbable mesh layer including an absorbable material, the absorbable material being a bioactive agent that is selected from at least one of an antibiotic, an antimicrobial, an inhibitor of epithelial cell activation, a migration, or a compound that enhances wound regeneration, the absorbable material being in a form of at least one of a coating on the non-absorbable mesh layer, an absorbable filament associated with the non-absorbable mesh layer, or a second layer associated with the non-absorbable mesh layer;

an absorbable layer, the absorbable layer being formed from a bioabsorbable polymer,

the absorbable layer has a rate of degradation that is faster than a rate of degradation of the absorbable material in the non-absorbable mesh layer; and

an attachment member disposed on the absorbable layer, the attachment member being configured to absorb more rapidly in vivo than the absorbable layer.

2. The implant of claim 1, wherein the bioactive agent is estrogen or estradiol.

3. The implant of claim 2, further comprising a second bioactive agent selected from the group consisting of an antibiotic, an antimicrobial, an inhibitor of epithelial cell activation and/or migration, 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.

4. The implant of claim 1, wherein the bioactive agent diffuses from or is released from the absorbable material upon degradation of the absorbable material.

5. The implant of claim 1, wherein the absorbable material comprises a hydroxyalkanoate polymer.

6. The implant of claim 5, wherein the absorbable material further comprises polyhydroxybutyrate.

7. The implant of claim 1, wherein the absorbable material comprises a polyester copolymer.

8. The implant of claim 7, wherein the polyester copolymer has a rate of degradation that is faster than the bioabsorbable polymer which is a hydroxyalkanoate polymer.

9. The implant of claim 8, wherein the bioabsorbable polymer further comprises a bioactive agent selected from the group consisting of an antibiotic, an antimicrobial, an inhibitor of epithelial cell activation and/or migration, 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.

10. The implant of claim 1, wherein the absorbable material further comprises an absorbable polyester that includes one or more monomer(s) selected from the group consisting of hydroxyalkanoate, lactide, glycolide, and caprolactone.

11. The implant of claim 1, wherein the absorbable layer is non-porous and prevents migration of cells through the absorbable layer prior to degradation of the absorbable layer within a female patient.

12. The implant of claim 11, wherein the absorbable layer has a thickness in a range of 0.005 to 0.02 inches.

13. The implant of claim 11, wherein the attachment member is an absorbable adhesive or protruding member, wherein the attachment member includes an absorbable material that has a rate of degradation that is faster than the bioabsorbable polymer of the absorbable layer.

14. The implant of claim 13, wherein the absorbable layer has a side portion in contact with the non-absorbable mesh layer, the absorbable layer including the absorbable adhesive or the protruding member that is configured to secure the non-absorbable mesh layer to the absorbable layer.

15. The implant of claim 11, wherein the absorbable layer comprises an absorbable material in a form of a coating.

16. The implant of claim 1, wherein the non-absorbable mesh layer comprises polypropylene filaments or molded polypropylene.

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 non-absorbable mesh layer, and the two or more arms comprise the absorbable material.

18. A method for surgically implanting a mesh in a female patient to treat a pelvic disorder or disease, the method comprising:

(a) providing an implant, the implant including;

a non-absorbable mesh layer, the non-absorbable mesh layer including an absorbable material, the absorbable material being a bioactive agent that is least one of an antibiotic, an antimicrobial, an inhibitor of epithelial cell activation, a migration, or a compound that enhances wound regeneration, the absorbable material being in a form of at least one of a coating on the non-absorbable mesh layer, an absorbable filament associated with the non-absorbable mesh layer, or a second layer associated with the non-absorbable mesh layer;

an absorbable layer, the absorbable layer being formed from a bioabsorbable polymer, the absorbable layer has a rate of degradation that is faster than a rate of degradation of the absorbable material in the non-absorbable mesh layer; and

an attachment member disposed on the absorbable layer, the attachment member being configured to absorb more rapidly in vivo than the absorbable layer;

(b) creating an incision in vaginal tissue of the female patient; and

(c) transvaginally inserting the implant into the female patient so the absorbable layer faces the incision site, wherein the implant treats the pelvic disorder or disease.

19. The method of claim 18, wherein the bioactive agent is released from the implant to remodel tissue, to reduce infection likelihood, or both.