US2014186461A1PendingUtilityA1

Human Amniotic Membrane Lyophilized Grafts

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Individually held — no corporate assignee on recordPriority: Sep 10, 2012Filed: Sep 10, 2012Published: Jul 3, 2014
Est. expirySep 10, 2032(~6.1 yrs left)· nominal 20-yr term from priority
Inventors:Terry W. Broussard
A61L 27/60A61L 27/507C12N 5/0605A61L 27/3662A61L 27/3641A61L 27/3679A61L 2430/10A61L 2430/34A61L 27/3604A61L 27/3691A61K 35/50A61F 2/02
34
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Claims

Abstract

Described herein are human amniotic membrane tissue grafts derived from the placenta. The grafts are composed of three layers as seen in the amniotic membrane in utero. These grafts are processed using physiologic solutions, lyophilized and terminal sterilized (via gamma irradiation in a frozen state) that thereby preserves the graft in such a manner as to retain the naturally occurring biological properties of the amniotic membrane and offer a sterile graft for transplantation. By dehydration via lyophilization and terminal sterilization, the graft has the advantage of storage at ambient temperatures for prolonged periods of time prior to transplantation.

Claims

exact text as granted — not AI-modified
1 - 12 . (canceled) 
     
     
         13 . A tissue graft comprising a freeze dried human amniotic membrane, said amniotic membrane comprising the following layers in the following order:
 a) a first epithelium layer,   b) a second basement membrane layer, and   c) a third stroma layer comprising an upper compact layer, a middle fibroblast layer, and a lower spongy layer.   
     
     
         14 . The tissue graft of  claim 13 , wherein said amniotic membrane contains naturally occurring growth factors and a collagen matrix. 
     
     
         15 . The tissue graft of  claim 13 , having a thickness ranging from 60-150 microns. 
     
     
         16 . A method of repairing tissues in a patient, said method comprising wrapping or replacing a damaged tissue with the tissue graft of  claims 13 . 
     
     
         17 . The method of  claim 16 , wherein said damaged tissue is a damaged tendon, damaged oral tissue, damaged gastrointestinal mucosa, damaged epidermal tissue, damaged cardiac tissue, damaged arterial tissue or damaged venous tissue. 
     
     
         18 . A method of repairing tissues in a patient, said method comprising wrapping or replacing a damaged tissue with the tissue graft of  claims 14 . 
     
     
         19 . The method of  claim 18 , wherein said damaged tissue is a damaged tendon, damaged oral tissue, damaged gastrointestinal mucosa, damaged epidermal tissue, damaged cardiac tissue, damaged arterial tissue or damaged venous tissue. 
     
     
         20 . A method of repairing tissues in a patient, said method comprising wrapping or replacing a damaged tissue with the tissue graft of  claims 15 . 
     
     
         21 . The method of  claim 20 , wherein said damaged tissue is a damaged tendon, damaged oral tissue, damaged gastrointestinal mucosa, damaged epidermal tissue, damaged cardiac tissue, damaged arterial tissue or damaged venous tissue. 
     
     
         22 . A method for preparing a tissue graft, comprising the steps:
 a) obtaining human placental tissue;   b) separating amniotic membrane from said placental tissue;   c) cleaning said separated amniotic membrane;   d) lyophilizing said cleaned amniotic membrane; and   e) packaging said lyophilized amniotic membrane to provide a tissue graft.   
     
     
         23 . The method of  claim 22 , further comprising sterilizing said amniotic membrane. 
     
     
         24 . The method of  claim 22 , wherein the amniotic membrane is terminally sterilized using gamma irradiation while frozen. 
     
     
         25 . The method of  claim 22 , wherein the amniotic membrane is cleaned with a physiologic saline solution. 
     
     
         26 . The method of  claim 22 , wherein the placenta or amniotic membrane is tested for infectious disease before proceeding. 
     
     
         27 . The method of  claim 22 , further comprising sectioning said amniotic membrane before packaging.

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