Quilted implantable graft

Patent metadata

Field	Value
Publication number	US-10688219-B2
Application number	US-48200209-A
Country	US
Kind code	B2
Filing date	Jun 10, 2009
Priority date	Jun 10, 2008
Publication date	Jun 23, 2020
Grant date	Jun 23, 2020

Abstract

Described are embodiments of a multilaminate or multiple layer implantable surgical graft comprising remodelable collagenous sheet material, the graft including one or more interweaving members to stitch together the graft to help prevent the layers from delaminating or separating during handling and the initial stages of remodeling. The interweaving members may comprise lines of suture, thread, individual stitches, strips of material, etc. that are woven through the layers of biomaterial in a desired pattern. In one embodiment, the interweaving members comprise a pharmacologically active substance, such as a drug, growth factors, etc. to elicit a desired biological response in the host tissue. In another embodiment, the graft further comprises a reinforcing material, such as a synthetic mesh, within the layers of remodelable biomaterial and stitched together by one or more interweaving members.

First claim

What is claimed is:

1. A surgical graft, comprising:
a remodelable collagenous material, said remodelable collagenous material comprising a plurality of sheets disposed in a multilayer configuration in which said sheets are bonded to one another in a bonded laminate structure wherein said sheets are bonded to one another by lyophilization of the multilayer configuration to form said bonded laminate structure, wherein said plurality of sheets has up to eight sheets;
one or more lines of lock stitches affixing together said plurality of sheets of remodelable collagenous material supplemental to bonding of said bonded laminate structure;
wherein lines of said one or more lines of lock stitches comprise lock stitches longitudinally spaced apart from one another by at least 1 mm within the lines;
wherein lock stitches longitudinally spaced from one another within said lines of lock stitches are provided by a first suture and a second suture, said first suture defining a plurality of loop segments that penetrate through a thickness of said bonded laminate structure from a first side of said laminate structure to a second side of said laminate structure, said loop segments of said first suture looping over segments of said second suture at said second side of said laminate structure;
wherein said second suture is free of loops in said lock stitches of said one or more lines of lock stitches;
wherein said lines of lock stitches form a pattern across said surgical graft, the pattern including one or more lines of lock stitches inward of and following a periphery of the surgical graft and extending around intersections defined by lines of lock stitches intersecting in a central portion of the surgical graft;
wherein said lines of lock stitches are configured to provide increased strength to the surgical graft;
wherein said lines of lock stitches are formed with a non-resorbable synthetic material; and
wherein said lines of lock stitches are configured to provide continued reinforcement to complement remodeled patient tissue that replaces said remodelable collagenous material after implantation of the surgical graft in a patient.

2. The surgical graft of claim 1 , wherein said lines of lock stitches form a rectangular configuration.

3. The surgical graft of claim 1 , wherein said lines of lock stitches form a diamond configuration.

4. The surgical graft of claim 1 , wherein the pattern comprises a plurality of said lines of lock stitches generally coextending with adjacent ones of said lines of lock stitches in a parallel configuration.

5. The surgical graft of claim 1 , wherein said surgical graft includes a first outer surface and a second outer surface facing opposite thereto, said surgical graft further comprising first and second regions of said first and second outer surface.

6. The surgical graft of claim 5 , wherein the density of said lock stitches in said first region of said graft is greater than the density of said lock stitches in said second region, the first region generally extending along the periphery of said surgical graft.

7. The surgical graft of claim 5 , wherein the density of said lock stitches in said second region of said graft is greater than the density of said lock stitches in said first region, the second region generally disposed about the center of said surgical graft.

8. The surgical graft of claim 1 , further comprising a bioactive agent that is impregnated into and/or surface-applied to the first suture and the second suture, the first suture and the second suture configured to deliver said bioactive agent into adjacent tissue when implanted therein.

9. The surgical graft of claim 8 , wherein said bioactive agent is selected from a group consisting of an analgesic, an anti-inflammatory agent, and an antibiotic.

10. The surgical graft of claim 8 , wherein the bioactive agent is effective for stimulation of tissue ingrowth into said plurality of sheets of remodelable collagenous material.

11. The surgical graft of claim 1 , wherein the remodelable collagenous material comprises an extracellular matrix material that has been harvested intact from a mammalian source and subject to processing to render said surgical graft acellular while retaining a level of bioactivity therein.

12. The surgical graft of claim 1 , wherein said sheets are harvested intact from a mammalian source.

13. The surgical graft of claim 1 , wherein a synthetic mesh material is disposed between sheets of said plurality of sheets and wherein the synthetic mesh material comprises polymeric strands having a diameter of less than 0.15 mm, the strands being configured to persist and reinforce tissue about the site of implantation after remodeling of said remodelable collagenous matrix material is substantially complete.

14. The surgical graft of claim 1 , wherein the pattern comprises a plurality of said lines of lock stitches generally coextending with adjacent ones of said lines of lock stitches in a concentric configuration.

15. A surgical graft, comprising:
a remodelable extracellular matrix material comprising a plurality of sheets thereof disposed in a multilayer configuration in which said sheets are bonded to one another in a bonded laminate structure, said sheets harvested intact from a mammalian source, wherein said sheets are bonded to one another by lyophilization of the multilayer configuration to form said bonded laminate structure;
one or more lines of lock stitches further binding said plurality of laminated sheets theretogether in such a manner as to increase resistance of the bonded laminate structure to delamination;
wherein lock stitches longitudinally spaced from one another within said one or more lines of lock stitches are provided by a first suture and a second suture, said first suture defining a plurality of loop segments that penetrate through a thickness of said bonded laminate structure from a first side of said laminate structure to a second side of said laminate structure, said loop segments of said first suture looping over segments of said second suture at said second side of said laminate structure;
wherein the second suture in the lock stitches of the one or more lines of lock stitches is free of loops;
wherein the first suture and second suture comprise a synthetic material;
wherein lines of said one or more lines of lock stitches comprise lock stitches longitudinally spaced apart from one another by at least 1 mm within the lines; and
wherein said one or more lines of lock stitches form a pattern across said surgical graft, the pattern including a stitch line inward of and following a peripheral edge of the surgical graft and stitch lines that intersect in a central portion of the surgical graft; and
wherein said stitch lines that intersect in a central portion of the graft include stitch lines that run parallel to one another, with said stitch lines that run parallel to one another being laterally spaced from one another two to four cm.

16. The surgical graft of claim 15 , further comprising a bioactive agent that is impregnated into and/or surface-applied to the first suture and the second suture such that said bioactive agent is delivered into adjacent host tissue when implanted therein.

17. A surgical graft, comprising:
a plurality of sheets of remodelable extracellular matrix material disposed in a multilayer configuration having a first side and a second side opposite the first side, the sheets harvested intact from a mammalian source;
one or more lines of lock stitches binding said plurality of sheets together;
wherein each of the one or

Assignees

• Patel Umesh H
• Miller Jeffrey
• Cook Biotech Inc

Inventors

• Patel Umesh H
• Miller Jeffrey

Classifications

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title

• A61F2210/0076

  multilayered, e.g. laminated structures · CPC title

• A61F2/0063

  Implantable repair or support meshes, e.g. hernia meshes · CPC title

• A61L27/3633 Primary

  Extracellular matrix [ECM] · CPC title

• B32B2535/00

  Medical equipment, e.g. bandage, prostheses or catheter · CPC title