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Reinforced tissue graft

a tissue graft and reinforced technology, applied in the field of tissue grafts, can solve the problems of incisional hernia incidence rate, synthetic and biological grafts have only shown limited success, and researchers have experienced major challenges in designing methods to repair abdominal wall defects, etc., to achieve the effect of reducing the tearing of the graft, and reducing the cyclic stretching of the gra

Inactive Publication Date: 2013-05-09
THE CLEVELAND CLINIC FOUND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patent describes a graft made of biodegradable collagen and a synthetic or natural material that can be remodeled. The graft has reinforcing fibers stitched in to prevent tearing and improve fixation. The graft's properties are improved while it is being remodeled.

Problems solved by technology

Researchers have experienced major challenges in designing methods to repair abdominal wall defects that result from traumatic injuries, surgical procedures (incisional hernias) or chronic diseases.
Currently available synthetic and biological grafts have demonstrated only limited success.
While the use of synthetic meshes has lowered incidence rates of incisional hernias to below 10%, these repairs are still frequently complicated by infection, visceral adhesion, extrusion and fistulation, and require re-operation.
While grafts derived from acellular dermis possess biomechanical properties that are similar to abdominal wall fascia, and have shown promise for hernia repair, they lose mechanical strength and integrity after implantation, resulting in laxity, stretching and poor suture retention, which in turn can lead to complications, such as bulging, dehiscence, and hernia recurrence.

Method used

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  • Reinforced tissue graft
  • Reinforced tissue graft
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Examples

Experimental program
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Effect test

example 1

[0103]This example shows stitching dermis and synthetic mesh together using reinforcing fiber improves the mechanical properties of the construct and mitigates tearing and / or improves fixation retention of the layers compared to using either material alone or both materials without stitching them together.

[0104]In this example, four groups were investigated:[0105]1. Dermis (native acellular dermis)[0106]2. Mesh (synthetic UHMWPE mesh)[0107]3. Dermis layered against mesh (but not stitched)[0108]4. Dermis layered against mesh and stitched together using 6PLA / 2PGA polymer braids.

[0109]Uniaxial suture retention tests were used to verify the efficacy of stitching as a method to reinforce the two layers and improve the mechanical properties of the construct by mitigating tearing and / or improving fixation retention of the layers.

[0110]All human dermis grafts included allogeneic or xenogeneic dermis. All 6PLA / 2PGA braids used for reinforcing the layers were obtained from Concordia Fibers, C...

example 2

[0115]In this example, the biodegradable layer is stitched to a synthetic mesh layer with a stitch pattern known to impart a suture retention load to the construct that is greater than the suture retention load of the dermis alone, the mesh alone, or dermis and mesh that are not stitched together (Example 1). The biodegradable layer could be, for example, ECM derived from human allogeneic or xenogeneic dermis, the synthetic mesh could be made from polypropylene and the stitching fiber could be a PLLA / PGA braid obtained from Concordia Fibers, Coventry, R.I. In other embodiments, the synthetic mesh and the stitching fiber could be derived from other synthetic biomaterials with different biodegradation profiles (such as UHMWPE, ePTFE, PLGA and PLLA) or natural biomaterials (such as silk and collagen).

[0116]The stitched biodegradable and synthetic mesh layered constructs are hydrated for 30 minutes in saline solution at 37° C. A single simple suture loop of #2 FiberWire is applied to ea...

example 3

[0130]In this example, the tissue layer is reinforced with fiber in a manner that strengthens and stiffens the tissue layer and is also used for attachment to host tissues.

[0131]The tissue layer could be, for example, a 0.5×6 cm strip of ECM derived from human fascia lata (Musculoskeletal Transplant Foundation, Edison, N.J.) and the fiber could be a UHMWPE braid (ForceFiber, TeleFlex Medical OEM, Kenosha, Wis.) stitched in a single pass across the tissue layer (FIG. 17).

[0132]Two pairs of human cadaveric shoulders (mean age, 55±9 years) were used in this study (Anatomy Gifts Registry, Glen Burnie, Md. and ScienceCare, Aurora, Colo.). In each shoulder, the supraspinatus was sharply released from the proximal humerus and primarily repaired back to its insertion with anchors. For each pair of shoulders, one repair was randomly assigned for augmentation with a reinforced fascia strip (FIG. 18A) and the other repair was augmented with the reinforcing fiber alone (FIG. 18B). The strips or...

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Abstract

A biocompatible tissue graft includes a first layer of a bioremodelable collageneous material, a second layer of biocompatible synthetic or natural remodelable or substantially remodelable material attached to the first layer; and at least one fiber that is stitched in a reinforcing pattern in the first layer and / or second layer to mitigate tearing and / or improve fixation retention of the graft, and substantially maintain the improved properties while one or more of the layers is remodeling.

Description

RELATED APPLICATIONS[0001]This application is a Continuation-in-Part of International Application No. PCT / US2011 / 042138, filed Jun. 28, 2011, which claims priority from U.S. Provisional Application No. 61 / 359,067, filed Jun. 28, 2010, this application is also a Continuation-in-part of U.S. patent application Ser. No. 12 / 934,791, filed Sep. 27, 2010, which is a National phase filing of PCT / US2009 / 038570, filed Mar. 27, 2009, which claims priority from U.S. Provisional Application Ser. No. 61 / 040,066, filed Mar. 27, 2008, and also claims priority from U.S. Provisional Application Ser. No. 61 / 720,173, filed Oct. 30, 2012, the subject matter of which are incorporated herein by reference in their entirety.TECHNICAL FIELD[0002]The present invention is directed to tissue grafts and, in particular, is directed to a multilayered, reinforced tissue graft.BACKGROUND OF THE INVENTION[0003]Researchers have experienced major challenges in designing methods to repair abdominal wall defects that re...

Claims

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Application Information

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IPC IPC(8): A61F2/02
CPCA61F2/02A61L27/3633A61F2/08A61L2420/08A61L27/38A61L27/48A61L2420/04A61L27/34A61F2210/0076
Inventor DERWIN, KATHLEEN A.IANNOTTI, JOSEPH P.SAHOO, SAMBIT
Owner THE CLEVELAND CLINIC FOUND
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