Thin soft tissue surgical support mesh

• US 6,375,662 B1
• Filed: 11/23/1999
• Issued: 04/23/2002
• Est. Priority Date: 08/04/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Schmitt, Peter J.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/447,971
• Time in Patent Office: 882 Days
• Field of Search: 606/151, 606/1, 606/108, 606/198, 606/107, 623/1, 623/11, 623/16
• US Class Current: 606/151
• 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 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

A soft and pliable surgical support mesh exhibiting increased resistance to inhabitation of infectious matter. The mesh includes a support trellis formed of multifilament yarns wherein the interstitial voids located between the filaments of said yarns are enclosed within an infection-impervious matrix. The meshes may be designed to be extremely thin yet retain the requisite strength for repairing soft tissue, which allows for a low profile when folded for delivery.

Claims

1. A soft and pliable soft tissue mesh, comprising;

a support trellis formed of multifilament yarns encapsulated within an infection-impervious matrix whereby the interstitial voids located between the filaments of said yarns are enclosed within said matrix.

2. The mesh according to claim 1, wherein said matrix exteriorly surrounds said yarns and is formed of a material having a flexibility at least as great as the flexibility of the material forming the filaments of said yarns.

3. The mesh according to claim 2, wherein said matrix penetrates into said yarns to substantially fill the interstitial voids located therein.

4. The mesh according to claim 3, wherein said matrix is formed from a polymer selected from the group consisting of polyester, polypropylene, polyethylene, polyurethane, poly(meth)acrylate, and copolymers thereof.

5. The mesh according to claim 1, wherein said yarns are formed of a plurality of bi-component filaments each having a flexible core and a fusible sheath surrounding said core, and wherein said sheath has a fusing temperature lower than the melting temperature of said core whereby said sheaths fuse together to enclose said interstitial voids upon heating of said trellis.

6. The mesh according to claim 5, wherein said core is formed of a polyethylene terephthalate polyester and said sheath is formed of a polyethylene terephthalate/isophthalate copolyester.

7. The mesh according to claim 1, wherein said multifilament yarns overlap one another at regularly-spaced junctions to form said support trellis, and wherein said overlapping yarns are adhered to one another at said junctions to enhance ravel resistance of said mesh.

8. The mesh according to claim 1, wherein said matrix is drug permeable, and wherein a medicinal drug is incorporated into said matrix for release into the body of a patient after implantation of said mesh therein.

9. The mesh according to claim 1, wherein the mesh has a thickness less than about 0.20 millimeters.

10. The mesh according to claim 1, wherein said multifilament yarns have no twist imparted thereto.

11. The mesh according to claim 1, wherein said trellis defines pores having a size in the range of about 50 microns to about 400 microns.

12. The mesh of claim 1, wherein said trellis has a thickness in the range of about 0.05 millimeters to about 0.50 millimeters.

13. The mesh of claim 1, wherein said trellis has a thickness less than about 0.20 millimeters.

14. The mesh of claim 13, wherein said trellis is sufficiently thin to permit insertion into a trocar having a diameter of about 5 millimeters or less.

15. The mesh of claim 14, wherein said mesh is heat conditioned for a sufficient time at a sufficient temperature to effectuate a shape-memory in an unfurled state.

16. The mesh of claim 14, wherein said mesh includes yarns or filaments made from a shape-memory material.

17. The mesh of claim 14, wherein said mesh further includes an individual thread having a shape-memory imparted thereto.

18. The mesh of claim 17, wherein said thread having a shape-memory imparted thereto is formed of nitinol.

19. The mesh according to claim 1, wherein said multifilament yarns are capable of being flattened to thereby provide a reduced thickness and a low profile.

20. The mesh according to claim 1, wherein said mesh has a burst strength of about 300 psi.

21. A method of producing a soft and pliable surgical mesh exhibiting increased resistance to inhabitation of infectious matter from a support trellis formed of multifilament yarns, comprising:

encapsulating said multifilament yarns within an infection-impervious matrix whereby the interstitial voids located between the filaments of said yarns are enclosed with said matrix.

22. The method according to claim 21, wherein said encapsulating step includes the step of applying a resin to the exterior of said yarns prior to the forming of said trellis.

23. The method according to claim 22, wherein said resin is applied to the exterior of said trellis sufficient quantity and for a sufficient period of time to allow said resin to penetrate into said yarns and substantially fill said voids.

24. The method according to claim 21, wherein said encapsulating step includes the step of applying a resin to the exterior of said yarns subsequent to the forming of said trellis.

25. The method according to claim 24, wherein said resin is applied to the exterior of said trellis in sufficient quantity and for a sufficient period of time to allow said resin to penetrate into said yarn and substantially fill said voids.

26. The method according to claim 21, wherein said yarns are formed of a plurality of bi-component filaments each having a flexible core and a fusible sheath surrounding said core, and wherein said encapsulating step includes the step of heating said trellis above the fusing temperature of said sheaths whereby said sheaths fuse together.

27. The method according to claim 26, wherein said fusing step is accomplished by application of thermal or light wave radiation to said trellis.

28. The method according to claim 21, further comprising the step of incorporating a medicinal drug into said matrix for release therefrom after implantation of said mesh into the body of a patient.

29. The method according to claim 21, further comprising the step of sealing said encapsulated trellis in a sterile package.

30. The method according to claim 21, further comprising the step of applying a compressive force to press the mesh to a desired thickness.

31. The method according to claim 26, wherein said heating step further includes heating said mesh at a temperature with the range of about 200 to about 210°

C.

32. The method according to claim 21, further comprising the step of placing the mesh in an oven and heating the mesh to a temperature in the range of approximately 180 to approximately 210°

C. such that the sheaths of the individual filaments fuse together.

33. The method according to claim 21, wherein said encapsulating step occurs before the forming of said trellis.

34. The method according to claim 21, wherein said trellis is formed before said encapsulating step.

35. The method according to claim 21, further comprising the step of:

heat conditioning said mesh for a sufficient time at a sufficient temperature to effectuate a shape-memory in an unfurled state.

36. The method according to of claim 21, wherein said forming step includes providing filaments made from a shape-memory material.

37. The method according to claim 21, wherein said forming step includes providing multifilament yarns with no twist imparted thereto.