US2021386912A1PendingUtilityA1

Quilted implantable graft

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Assignee: COOK BIOTECH INCPriority: Jun 10, 2008Filed: Aug 30, 2021Published: Dec 16, 2021
Est. expiryJun 10, 2028(~1.9 yrs left)· nominal 20-yr term from priority
A61F 2210/0076A61F 2220/0075A61F 2/0063B32B 5/06B32B 5/26B32B 2535/00A61L 27/3633A61L 27/38B32B 2307/7163A61L 27/50A61L 27/56B32B 2262/08A61L 27/14B32B 7/08A61L 27/24
65
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Claims

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.

Claims

exact text as granted — not AI-modified
1 - 20 . (canceled) 
     
     
         21 . A method for reinforcing patient tissue at an implant site of a patient, comprising:
 implanting at the implant site a surgical graft including a plurality of sheets of remodelable collagenous material disposed in a multilayer configuration and affixed together by at least one length of suture interwoven through the plurality of sheets to create a pattern of stitches.   
     
     
         22 . The method of  claim 21 , wherein the patient tissue comprises herniated tissue. 
     
     
         23 . The method of  claim 22 , wherein the remodelable collagenous material comprises submucosal tissue. 
     
     
         24 . The method of  claim 21 , wherein:
 the sheets of remodelable collagenous material comprise submucosal tissue;   the remodelable collagenous material is lyophilized;   the remodelable collagenous material includes native fibroblast growth factor-2 retained from a source tissue for the remodelable collagenous material;   the stitches are lock stitches: and   the pattern of stitches comprises a first set of stitch lines laterally spaced from one another, and a second set of stitch lines laterally spaced from one another, with said first set of stitch lines extending in a first direction and said second set of stitch lines extending in a second direction different from said first direction, and with said first set of stitch lines intersecting said second set of stitch lines.   
     
     
         25 . The ethod of  claim 24 , wherein the patient tissue comprises herniated tissue. 
     
     
         26 . The method of  claim 21 , wherein the sheets of the plurality of sheets are not bonded to adjacent ones except by said at least one length of suture. 
     
     
         27 . The method of  claim 24 , wherein lines of said first set of stitch lines and lines of said second set of stitch lines comprises stitches longitudinally spaced apart from one another by a distance of at least 1 mm within the lines. 
     
     
         28 . The method of  claim 27 , wherein said distance is 1 to 7 mm. 
     
     
         29 . A method for reinforcing patient tissue at an implant site of a patient, comprising:
 implanting a surgical graft at an implant site in the patient so as to reinforce tissue at the implant site, the surgical grail including a. plurality of sheets of remodel able collagenous material disposed in a multilayer configuration and affixed together by at least one non-resorbable suture interwoven through the plurality of sheets to create a pattern of stitches;   wherein the at least one note-resorbable suture is effective to: (i) provide reinforcement of a surgical graft during degradation of a remodelable collagenous material and the establishment of remodeled tissue of the patient at the implant site; and (ii) provide continued reinforcement to compliment the remodeled tissue at the implant site.   
     
     
         30 . The method of  claim 29 , wherein the patient tissue includes herniated tissue. 
     
     
         31 . The method of  claim 29 , wherein the sheets of the plurality of sheets are not bonded to adjacent ones except by said at least one non-resorbable suture. 
     
     
         32 . The method of  claim 29 , wherein:
 the sheets of remodelable collagenous material comprise submucosal tissue;   the remodelable collagenous material is lyophilized;   the remodelable collagenous material includes native fibroblast growth factor-2 retained from a source tissue for the remodelable collagenous material;   the stitches are lock stitches; and   the pattern of stitches comprises a first set of stitch lines laterally spaced from one another, and a second set of stitch lines laterally spaced from one another, with said first set of stitch lines extending in a first direction and said second set of stitch lines extending in a second direction different from said first direction, and with said first set of stitch lines intersecting said second set of stitch lines.   
     
     
         33 . The method of  claim 32 , wherein the patient tissue includes herniated tissue. 
     
     
         34 . The method of  claim 32 , wherein the sheets of the plurality of sheets are not bonded to adjacent ones except by said at least one non-resorbable suture. 
     
     
         34 . The method of  claim 32 , wherein lines of said first set of stitch lines and lines of said second set of stitch lines comprises stitches longitudinally spaced apart from one another by a distance of at least 1 mm within the lines. 
     
     
         35 . A method for reinforcing patient tissue, comprising:
 (a) implanting a surgical graft at an implant site to reinforce tissue of a patient, the surgical graft including:
 a plurality of sheets of remodelable collagenous material arranged in a multilayer configuration and affixed together by at least one non-resorbable suture interwoven through the plurality of sheets to create a pattern of stitches, so that the remodelable collagenous material undergoes remodeling to form remodeled patient tissue at the implant site; 
 wherein the sheets of remodelable collagenous material comprise submucosal tissue; 
 wherein the remodelable collagenous material is lyophilized; 
 wherein the stitches are lock stitches; and 
 wherein the pattern of stitches comprises a first set of stitch lines laterally spaced from one another and a second set of stitch lines laterally spaced from one another, with said first set of stitch lines extending in a first direction and said second set of stitch lines extending in a second direction different from said first direction, and with said first set of stitch lines intersecting said second set of stitch lines; 
   (b) while the sheets of remodelable extracellular matrix material undergo said remodeling to form remodeled patient tissue at the implant site, providing strength to the surgical graft with the at least one non-resorbable suture; and   (c) after formation of the remodeled patient tissue, reinforcing the new patient tissue at the implant site with the at least one non-resorbable suture.   
     
     
         37 . The method of claim  36 , wherein the tissue of the patient includes herniated tissue. 
     
     
         38 . The method of claim  36 , wherein the sheets of the plurality of sheets are not bonded to adjacent ones except by said at least one non-resorbable suture. 
     
     
         39 . The method of  claim 38 , wherein the tissue of the patient includes herniated tissue. 
     
     
         40 . The method of claim  36 , wherein lines of said first set of stitch lines and lines of said second set of stitch lines comprises stitches longitudinally spaced apart from one another by a distance of at least 1 mm within the lines.

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