Extracellular Matrix Encasement Structures and Methods
A bioremodelable encasement structure comprising a pouch formed from at least one sheet of bioremodelable material, the pouch including an internal region that is configured to receive a device therein, the bioremodelable material comprising mesothelial tissue.
1 . A bioremodelable encasement structure, comprising:
a bioremodelable encasement structure formed from at least one sheet member comprising a bioremodelable composition, said bioremodelable composition comprising processed acellular small intestine submucosa (SIS), said SIS comprising a dry weight DNA content of less than 1 μg/g and bFGF content of at least 140 pg/mg of said SIS, said SIS further exhibiting at least 96% decellularization and a tensile strength of at least 9 N,
said encasement structure having an internal region configured to receive a device therein,
said encasement structure being configured to induce modulated healing of tissue when implanted in a subject, said modulated healing including induced host tissue proliferation, bioremodeling, and regeneration of tissue structures with site-specific structural and functional properties.
2 . The encasement structure of claim 1 , wherein said bioremodelable composition includes an additional bioactive agent component.
3 . The encasement structure of claim 2 , wherein said bioactive agent component comprises a biologically active agent.
4 . The encasement structure of claim 3 , wherein said biologically active agent comprises a growth factor selected from the group consisting of transforming growth factor alpha (TGF-α), transforming growth factor beta (TGF-β), fibroblast growth factor-2 (FGF-2), basic fibroblast growth factor (bFGF), and vascular epithelial growth factor (VEGF).
5 . The encasement structure of claim 3 , wherein said biologically active agent comprises a cell selected from the group consisting of a stem cell, cardiomyocyte, myofibroblast, mesenchymal stem cell, exogenous cell, endogenous cell, progenitor cell and macrophage.
6 . The encasement structure of claim 3 , wherein said biologically agent component comprises a pharmacological agent selected from the group consisting of an antibiotic, antifungal agent, anti-viral agent, anticoagulant, antithrombic agent and anti-inflammatory.
7 . The encasement structure of claim 6 , wherein said pharmacological agent comprises a statin selected from the group consisting of atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin.
8 . The encasement structure of claim 1 , wherein said device comprises a medical device selected from the group consisting of a pacemaker, defibrillator and ventricular assist device.
9 . A medical product, comprising:
a bioremodelable encasement structure comprising an internal region configured to receive a device therein, said encasement structure comprising at least one sheet member comprising a bioremodelable composition, said bioremodelable composition comprising processed acellular small intestine submucosa (SIS), said SIS comprising a dry weight DNA content of less than 1 μg/g and bFGF content of at least 140 pg/mg of said SIS, said SIS further exhibiting at least 96% decellularization and a tensile strength of at least 9 N,
said encasement structure having an internal region configured to receive a device therein; and
an implantable medical device disposed in said pouch internal region, wherein an encased medical device is formed,
said encased medical device being configured to induce modulated healing of tissue when implanted in a subject, said modulated healing including induced host tissue proliferation, bioremodeling, and regeneration of tissue structures with site-specific structural and functional properties.
10 . The medical product of claim 9 , wherein said bioremodelable composition includes an additional bioactive agent component.
11 . The medical product of claim 10 , wherein said bioactive agent component comprises a biologically active agent.
12 . The medical product of claim 11 , wherein said biologically active agent comprises a growth factor selected from the group consisting of transforming growth factor alpha (TGF-α), transforming growth factor beta (TGF-β), fibroblast growth factor2 (FGF-2), basic fibroblast growth factor (bFGF), and vascular epithelial growth factor (VEGF).
13 . The medical product of claim 11 , wherein said biologically active agent comprises a cell selected from the group consisting of a stem cell, cardiomyocyte, myofibroblast, mesenchymal stem cell, exogenous cell, endogenous cell, progenitor cell and macrophage.
14 . The medical product of claim 11 , wherein said biologically agent component comprises a pharmacological agent selected from the group consisting of an antibiotic, antifungal agent, anti-viral agent, anticoagulant, antithrombic agent and anti-inflammatory.
15 . The medical product of claim 14 , wherein said pharmacological agent comprises a statin selected from the group consisting of atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin.
16 . The medical product of claim 9 , wherein said medical device is selected from the group consisting of a pacemaker, defibrillator and ventricular assist device.