Extracellular Matrix Encasement Structures and Methods

Abstract

A remodelable encasement structure comprising a pouch formed from at least one sheet of bioremodelable material, the pouch including an internal region and at least one lead conduit, the internal region being configured to receive a device therein, the lead conduit being configures to receive at least one device lead therein, the bioremodelable material comprising an extracellular matrix (ECM) composition that includes an ECM component derived from a mammalian source.

What is claimed is: 
     
         1 . A bioremodelable encasement structure, comprising:
 a bioremodelable encasement structure formed from at least one sheet member comprising a bioremodelable composition, said encasement structure having an internal region configured to receive a device therein,   said bioremodelable composition comprising acellular ECM from a mammalian tissue source selected from the group consisting of small intestine submucosa (SIS), urinary bladder submucosa (UBS), urinary basement membrane (UBM), liver basement membrane (LBM), stomach submucosa (SS), mesothelial tissue, collagen, subcutaneous extracellular matrix, large intestine extracellular matrix, placental extracellular matrix, omentum extracellular matrix, heart extracellular matrix, and lung extracellular matrix, said bioremodelable composition further comprising a statin selected from the group consisting of atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin,   said encasement structure being configured to induce modulated healing of damaged tissue when implanted in a subject, said modulated healing including modulation of inflammation of said tissue and induced cell and 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 further comprises an additional biologically active agent. 
     
     
         3 . The encasement structure of  claim 2 , 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). 
     
     
         4 . The encasement structure of  claim 2 , 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. 
     
     
         5 . 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.