Extracellular matrix sheet structures

Abstract

An implantable medical product and method of use for substantially reducing or eliminating harsh biological responses associated with conventionally implanted medical devices, including inflammation, infection and thrombogenesis, when implanted in in a body of a warm blooded mammal. The bioremodelable pouch structure is configured and sized to receive, encase and retain an electrical medical device therein and to allow such device to be inserted into the internal region or cavity of the pouch structure; with the pouch structure formed from either. (a) first and second sheets, or (b) a single sheet having first and second sheet portions. After receiving the electrical device, the edges around the opening are closed by suturing or stapling. The medical device encased by the bioremodelable pouch structure effectively improves biological functions by promoting tissue regeneration, modulated healing of adjacent tissue or growth of new tissue when implanted in the body of the mammal.

What is claimed is: 
     
         1 . An implantable medical product, comprising:
 a bioremodelable pouch structure comprising one or more sheets, and having an internal region or cavity and an opening, wherein the pouch structure is configured and sized to receive, encase and retain an electrical medical device therein and to allow such device to be inserted into the internal region or cavity of the pouch structure; with the pouch structure formed from either: (a) first and second sheets, or (b) a single sheet having first and second sheet portions, with each sheet or sheet portion including edges, wherein the edges of the ECM sheets or sheet portions forming the opening are configured for closing by stitching or stapling those edges after receiving the device;   wherein the pouch structure substantially reduces or eliminates harsh biological responses associated with conventionally implanted medical devices, including inflammation, infection and thrombogenesis, when implanted in in a body of a warm blooded mammal; and   wherein the pouch structure effectively improves biological functions by promoting tissue regeneration, modulated healing of adjacent tissue or growth of new tissue when implanted in the body of the mammal.   
     
     
         2 . The product of  claim 1  wherein the internal region or cavity of the pouch structure contains a composition that is a pharmacological agent. 
     
     
         3 . The product of  claim 2 , wherein the pharmacological agent is or includes an antibiotic agent. 
     
     
         4 . The product of  claim 1  wherein said pouch structure comprises acellular ECM material from a decellularized mammalian tissue source, said decellularized mammalian tissue source being small intestine submucosa (SIS), urinary bladder submucosa, stomach submucosa, epithelium of mesodermal origin, dermal extracellular matrix, subcutaneous extracellular matrix, gastrointestinal extracellular matrix, tissue surrounding growing bone, placental extracellular matrix, omentum extracellular matrix, cardiac extracellular matrix, kidney extracellular matrix, pancreas extracellular matrix, lung extracellular matrix, urinary basement membrane, liver basement membrane, or a combination thereof. 
     
     
         5 . The product of  claim 1 , wherein the pouch structure has a periphery that is at least partially arcuate. 
     
     
         6 . The product of  claim 1 , wherein the pouch structure is generally rectangular. 
     
     
         7 . The product of  claim 1 , wherein the pouch structure includes a single sheet that is configured to form a closed end of the pouch structure, with the opening located on the opposite side from the closed end. 
     
     
         8 . The product of  claim 1 , wherein the pouch structure has first and second sheets with the edges of the sheets joined together by stitching or stapling. 
     
     
         9 . An implantable medical product, comprising:
 a bioremodelable pouch structure comprising one or more sheets, and having an internal region or cavity and an opening, wherein the pouch structure is configured and sized to receive, encase and retain an electrical medical device therein and to allow such device to be inserted into the internal region or cavity of the pouch structure; with the pouch structure formed from either: (a) first and second sheets, or (b) a single sheet having first and second sheet portions, with each sheet or sheet portion including edges, wherein the edges of the ECM sheets or sheet portions forming the opening are configured for closing by stitching or stapling those edges after receiving the device; and   an electrical medical device contained within the internal region or cavity of the pouch structure;   wherein the edges of the ECM sheets or sheet portions forming the opening are closed by stitching or stapling after receiving the device within the internal region or cavity;   wherein the pouch structure substantially reduces or eliminates harsh biological responses associated with conventionally implanted medical devices, including inflammation, infection and thrombogenesis, when implanted in in a body of a warm blooded mammal; and   wherein the pouch structure effectively improves biological functions by promoting tissue regeneration, modulated healing of adjacent tissue or growth of new tissue when implanted in the body of the mammal.   
     
     
         10 . The product of  claim 9 , wherein the internal region or cavity of the pouch structure also contains a composition that is a pharmacological agent. 
     
     
         11 . The product of  claim 10 , wherein the pharmacological agent is or includes an antibiotic agent. 
     
     
         12 . The product of  claim 9 , wherein the medical device is a pacemaker, defibrillator, synthetic heart valve, ventricular assist device, artificial heart, physiological sensor, catheter, or an associated component thereof. 
     
     
         13 . The product of  claim 9 , wherein the pouch structure has a periphery that is at least partially arcuate. 
     
     
         14 . The product of  claim 9 , wherein the pouch structure is generally rectangular. 
     
     
         15 . A method of substantially reducing or eliminating harsh biological responses associated with conventionally implanted medical devices, including inflammation, infection and thrombogenesis, which comprises:
 placing a medical device into a bioremodelable pouch structure comprising one or more sheets, and having an internal region or cavity and an opening, wherein the pouch structure is configured and sized to receive, encase and retain an electrical medical device therein and to allow such device to be inserted into the internal region or cavity of the pouch structure; with the pouch structure formed from either: (a) first and second sheets, or (b) a single sheet having first and second sheet portions, with each sheet or sheet portion including edges, wherein the edges of the ECM sheets or sheet portions forming the opening are configured for closing by stitching or stapling those edges after receiving the device; and   implanting the pouch structure and contained medical device into a body of a warm blooded mammal, wherein the pouch structure substantially reduces or eliminates harsh biological responses, including inflammation, infection and thrombogenesis, and effectively improves biological functions by promoting tissue regeneration, modulated healing of adjacent tissue or growth of new tissue in the body of the mammal.   
     
     
         16 . The method of  claim 15 , wherein the edges of the ECM sheets or sheet portions forming the opening are closed by stitching or stapling after receiving the device within the internal region or cavity. 
     
     
         17 . The method of  claim 16 , wherein one or more electrical lead conduits from the medical device protrude through the stitched or stapled opening.