Surgical implants and related methods

• US 7,722,527 B2
• Filed: 04/26/2005
• Issued: 05/25/2010
• Est. Priority Date: 05/03/2004
• Status: Active Grant

• Current Assignee: ENDO Operations Limited (Endo, Inc.)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Gohman, James A., Bouchier, Mark S., Lund, Robert E.
• Primary Examiner(s): Lacyk; John P
• Application Number:
  US11/115,655
• Publication Number:
  US 20050267325A1
• Time in Patent Office: 1,855 Days
• Field of Search: 600/30, 600/37, 600/29, 600/16, 606/142, 606/99, 606/153, 606/185, 606/151, 606/232, 623/23.65, 623/11.11, 623/2.1, 128/885, 128/897, 128/898
• US Class Current: 600/30
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/06004 Means for attaching suture to needle tipping A61B17/06195; connecting wire to other metallic objects B21F15/00
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes

Abstract

The invention relates to implantable surgical articles, particularly those useful for pelvic health, and related methods of making and using the articles, wherein the implantable articles include a rivet to attach materials together.

Claims

1. A surgical implant comprising a support portion and an elongate extension portion extending from the support portion, the support portion and the elongate extension portion comprising a material selected from a synthetic mesh material, a synthetic film material, and a biologic material, and being joined by a polymeric rivet, the polymeric rivet being located within apertures of the support portion and the extension portion and extending through a thickness of at least one of the support portion and the elongate extension portion, wherein the implant is capable of being used as a urethral support, a rectal support, or a vaginal prolapse support, wherein the polymeric rivet comprises thermoplastic having a processing temperature in the range from 350 to 500 degrees Fahrenheit.

2. The implant of claim 1, wherein the extension portion comprises a synthetic mesh material or a synthetic film material selected from a solid or semi-solid film, a braided material, a knit material, a tied material, a mesh, a woven material, and a non-woven fabric-type material.

3. The implant of claim 1, wherein the support portion comprises biologic material and the extension portion comprises synthetic mesh material.

4. The implant of claim 3, wherein

the support portion comprises biologic material having a formed aperture,

the extension portion comprises synthetic mesh material, and

the polymeric rivet comprises a molded shaft that extends from a surface of the synthetic mesh material through interstices in the synthetic mesh material and through the formed aperture.

5. The implant of claim 4, wherein

the extension portion comprises two aligned pieces of synthetic mesh material, and the formed aperture of the biologic material is located between the two aligned pieces of synthetic mesh, and

the polymeric rivet comprises a molded shaft that extends from a surface of a first piece of synthetic mesh material, through interstices in the first piece, through the formed aperture, and through interstices of a second piece of synthetic mesh material.

6. The implant of claim 1, wherein the polymeric rivet comprises a thermoplastic polyolefin material.

7. The implant of claim 1, comprising

a support portion

two extension portions attached to the support portion by polymeric rivets,

a dilator at ends of each of the extension portions, and

insertion sheaths covering each extension portion.

8. The implant of claim 7, wherein the support portion comprises biologic material and the extension portions comprise synthetic mesh material.

9. The implant of claim 1, wherein the polymeric rivet comprises a molded shaft that extends from one surface of the implant, through a full thickness of the implant, and to another surface of the implant.

10. The implant of claim 9 wherein the polymeric rivet includes two rivet heads at opposing surfaces of the implant.

11. A surgical kit comprising the implant of claim 1 and an insertion tool.

12. The kit of claim 11, wherein the implant is selected from a urethral support, a rectal support, and a vaginal prolapse support.

26. The surgical implant of claim 1 wherein the synthetic mesh material and the synthetic film material comprise polymeric fibers.

29. The implant of claim 26 wherein the extension portion comprises a synthetic mesh material or a synthetic film material selected from a solid or semi-solid film, a braided material, a knit material, a tied material, a mesh, a woven material, and a non-woven fabric-type material.

32. The surgical implant of claim 1 wherein the polymeric rivet is molded.

33. The surgical implant of claim 29 wherein the molded polymeric rivet comprises a shaft that extends from one surface of the implant, through a full thickness of the implant, and to another surface of the implant.

13. A method of forming or assembling a surgical implant, the method comprising

providing portions of implant material, each portion comprising an aperture,

contacting the portions of implant material with the apertures aligned,

inserting a polymeric rivet material from a surface of either implant material, the polymeric rivet material extending into the apertures, and

processing the polymeric rivet material to attach the implant materials.

14. A method of forming or assembling a surgical implant, the method comprising

providing a support portion comprising a material selected from a synthetic mesh material, a synthetic film material, and a biologic material, and comprising a support portion aperture,

providing an extension portion comprising a material selected from a synthetic mesh material, a synthetic film material, and a biologic material, and comprising an extension portion aperture,

contacting the extension portion and the support portion with aligned extension portion aperture and support portion aperture,

inserting a polymeric rivet material from a surface of either the extension portion or the support portion, the polymeric rivet material extending into the extension portion aperture and the support portion aperture, and

processing the polymeric rivet material to attach the extension portion to the support portion, wherein the polymeric rivet comprises thermoplastic having a processing temperature in the range from 350 to 500 degrees Fahrenheit.

15. The method of claim 14, wherein the polymeric rivet material is a thermoplastic polymeric material, the method further comprising inserting the polymeric rivet material as heated flowable polymeric rivet material and allowing the inserted polymeric rivet material to solidify to attach extension portion to support portion.

16. The method of claim 15, further comprising using a mold to maintain contact between extension portion and support portion, wherein the mold defines a space for injecting flowable polymeric rivet material into interstices of the extension portion and the support portion.

27. The surgical implant of claim 14 wherein the synthetic mesh material and the synthetic film material comprise polymeric fibers.

30. The implant of claim 27 wherein the extension portion comprises a synthetic mesh material or a synthetic film material selected from a solid or semi-solid film, a braided material, a knit material, a tied material, a mesh, a woven material, and a non-woven fabric-type material.

34. The surgical implant of claim 30 wherein the molded polymeric rivet further comprises a rivet head attached to the shaft.

35. The method of claim 16, wherein the space defined by the mold is shaped such that a polymeric rivet formed in the space comprises a shaft that extends from one surface of the implant, through a full thickness of the implant, and to another surface of the implant.

17. An insert mold adapted to assemble materials of a medical implant, the mold comprising

closeable surfaces sized to contain portions of implant material, each portion comprising an aperture,

a surface comprising an injection port adapted to be aligned with the apertures,

a gasket,

wherein when the closeable surfaces are closed to contain the implant material with aligned apertures, the gasket partially defines a space that contains the aligned apertures.

18. An insert mold according to claim 17, comprising

closeable surfaces sized to contain surgical implant material comprising and end portion and a support portion, the end portion comprising an end portion aperture and the support portion comprising a support portion aperture,

a surface comprising an injection port adapted to be aligned with the end portion aperture and the support portion aperture,

a gasket,

wherein when the closeable surfaces are closed to contain the end portion and the support portion, with aligned apertures, the gasket partially defines a space that contains the aligned apertures.

19. The mold of claim 17, wherein the gasket has a hardness in the Shore A range.

20. Apparatus comprising, in combination, the insert mold of claim 17 and a microinjector, the microinjector:

operating at a temperature in the range from 350 to 500 degrees Fahrenheit;

producing a single injection volume of injected material in the range from about 0.001 cubic centimeters to about 0.1 cubic centimeters, and

including an injection barrel having a diameter in the range from about 0.125 to 0.5 inches, and an injector nozzle having a diameter in the range from about 0.01 to about 0.10 inches.

21. A method of producing a surgical implant, the implant comprising a support portion and an elongate extension portion extending from the support portion, the support portion and the elongate extension portion being joined by a polymeric rivet, the polymeric rivet being located within apertures of the support portion and the extension portion and extending through a thickness of at least one of the support portion and the elongate extension portion, wherein the implant is capable of being used as a urethral support, a rectal support, or a vaginal prolapse support,

the method comprising

providing an extension portion of an implant comprising an extension portion aperture,

providing a support portion of an implant comprising a support portion aperture,

using an insert mold according to claim 17 to contact the extension portion and the support portion with aligned extension portion aperture and support portion aperture, and

using an injector assembly to inject flowable polymeric material into the extension portion aperture and the support portion aperture.

22. The method of claim 21, wherein one or more of the extension portion and the support portion comprises a synthetic mesh material, and wherein the method comprises compressing the synthetic mesh material by contacting the mesh material with the gasket.

23. A surgical implant comprising implant materials joined by a polymeric rivet, the polymeric rivet extending from a surface of the implant, though apertures of at least two portions of implant material, wherein

the two portions of implant material comprise an extension portion and a support portion,

the extension portion comprises a synthetic material selected from a solid or semi-solid film, a braided material, a knit material, a tied material, a mesh, a woven material, and a non-woven fabric-type material, and

the support portion comprises a material selected from

a biologic material and

a synthetic material selected from a solid or semi-solid film, a braided material, a knit material, a tied material, a mesh, a woven material, and a non-woven fabric-type material,

wherein the polymeric rivet comprises thermoplastic having a processing temperature in the range from 350 to 500 degrees Fahrenheit.

24. The implant of claim 23 wherein the polymeric rivet comprises a thermoplastic polyolefin.

25. The implant of claim 23 wherein the polymeric rivet includes two rivet heads at opposing surfaces of the implant.

28. The surgical implant of claim 23 wherein the synthetic mesh material and the synthetic film material comprise polymeric fibers.

31. The implant of claim 28 wherein the extension portion comprises a synthetic mesh material or a synthetic film material selected from a solid or semi-solid film, a braided material, a knit material, a tied material, a mesh, a woven material, and a non-woven fabric-type material.