US2020261222A1PendingUtilityA1

Biological tissue for surgical implantation

Assignee: EDWARDS LIFESCIENCES CORPPriority: Oct 27, 2006Filed: Apr 28, 2020Published: Aug 20, 2020
Est. expiryOct 27, 2026(~0.2 yrs left)· nominal 20-yr term from priority
A01N 1/124A61L 27/3604A61F 2/2415A61L 27/507A61L 2430/40A61L 27/3687A01N 1/0215
73
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Claims

Abstract

A method of treating a biological tissue that enables dry storage of said tissue is disclosed. In one embodiment, the method comprises contacting the biological tissue with a non-aqueous treatment solution comprising a polyhydric alcohol and a C1-C3 alcohol and removing a portion of the treatment solution from the solution-treated biological tissue. Also disclosed is biological tissue prepared using the above process and prosthetic devices made with such tissue.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A packaged bioprosthetic device comprising:
 a bioprosthetic device comprising a fixed biological tissue, wherein the fixed biological tissue is preserved with propylene glycol; and   a sealed packaging containing the fixed biological tissue.   
     
     
         2 . The packaged bioprosthetic device of  claim 1 , wherein the fixed biological tissue is cross-linked with an aldehyde. 
     
     
         3 . The packaged bioprosthetic device of  claim 2 , wherein the aldehyde is a glutaraldehyde. 
     
     
         4 . The packaged bioprosthetic device of  claim 1 , wherein the fixed biological tissue has been subjected to one or both of a chemical decellularization and an enzyme decellularization. 
     
     
         5 . The packaged bioprosthetic device of  claim 1 , wherein the fixed biological tissue is selected from the group consisting of a pericardium, an aortic root, a pulmonary root, a valve, a tendon, a ligament, a skin, a peritoneum, a facia, and a pleura. 
     
     
         6 . The packaged bioprosthetic device of  claim 5 , wherein the pericardium is a bovine pericardium. 
     
     
         7 . The packaged bioprosthetic device of  claim 1 , wherein the bioprosthetic device is selected from the group consisting of a heart valve, a vascular graft, a stent covering, and a pericardial patch. 
     
     
         8 . The packaged bioprosthetic device of  claim 1 , wherein the bioprosthetic device is sterilized. 
     
     
         9 . The packaged bioprosthetic device of  claim 1 , wherein the fixed biological tissue is dimensionally stable. 
     
     
         10 . A packaged bioprosthetic device comprising:
 a bioprosthetic device comprising a fixed biological tissue, wherein the fixed biological tissue comprises propylene glycol; and   a sealed packaging containing the fixed biological tissue.   
     
     
         11 . The packaged bioprosthetic device of  claim 10 , wherein the fixed biological tissue is cross-linked with an aldehyde. 
     
     
         12 . The packaged bioprosthetic device of  claim 11 , wherein the aldehyde is a glutaraldehyde. 
     
     
         13 . The packaged bioprosthetic device of  claim 10 , wherein the fixed biological tissue has been subjected to one or both of a chemical decellularization and an enzyme decellularization. 
     
     
         14 . The packaged bioprosthetic device of  claim 10 , wherein the fixed biological tissue is selected from the group consisting of a pericardium, an aortic root, a pulmonary root, a valve, a tendon, a ligament, a skin, a peritoneum, a facia, and a pleura. 
     
     
         15 . The packaged bioprosthetic device of  claim 14 , wherein the pericardium is a bovine pericardium. 
     
     
         16 . The packaged bioprosthetic device of  claim 10 , wherein the bioprosthetic device is selected from the group consisting of a heart valve, a vascular graft, a stent covering, and a pericardial patch. 
     
     
         17 . The packaged bioprosthetic device of  claim 10 , wherein the bioprosthetic device is sterilized. 
     
     
         18 . The packaged bioprosthetic device of  claim 10 , wherein the fixed biological tissue is dimensionally stable. 
     
     
         19 . A packaged bioprosthetic heart valve comprising:
 a bioprosthetic heart valve comprising
 a stent, and 
 a fixed biological tissue, wherein the fixed biological tissue is crosslinked with glutaraldehyde and preserved with propylene glycol; and 
   a sealed packaging containing the fixed biological tissue;   wherein the bioprosthetic heart valve is sterilized.   
     
     
         20 . The packaged bioprosthetic device of  claim 20 , wherein the fixed biological tissue has been subjected to one or both of a chemical decellularization and an enzyme decellularization.

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