Extracellular matrix sheet structures

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.

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.