Systems, apparatus and methods for sealing perivalvular leaks
A biocompatible and biodegradable construct comprising a base expandable member and an outer coating comprising poly(glycerol sebacate) (PGS), the base expandable member comprising acellular extracellular matrix (ECM) derived from a mammalian tissue source, the acellular ECM exhibiting a flexible, porous, expandable structure, which is adapted to expand upon exposure to and absorption of a bodily fluid, wherein the construct seals a perivalvular leak when disposed proximate thereto.
1. A perivalvular leak sealing apparatus, consisting of:
a biomaterial construct comprising an extracellular matrix (ECM) composition, said ECM composition comprising acellular extracellular matrix (ECM) derived from a mammalian tissue source,
said biomaterial construct further comprising an outer coating comprising poly(glycerol sebacate)(PGS),
said biomaterial construct further comprising a self-expanding, remodelable, porous, absorbent sponge-like structure adapted to receive and absorb a bodily fluid, and expand upon said absorption of said bodily fluid,
said biomaterial construct adapted to expand upon said absorption of said bodily fluid, whereby said biomaterial construct transitions from a pre-deployment configuration, wherein said biomaterial construct is capable of being positioned proximate a perivalvular leak, to an expanded post-deployment expanded configuration, wherein said biomaterial construct is positioned in intimate contact with cardiovascular tissue proximate said perivalvular leak and abates said perivalvular leak during a first leak sealing stage, and, after said positioning of said biomaterial construct in said intimate contact with said cardiovascular tissue, said biomaterial construct remodels and induces remodeling of said cardiovascular tissue and regeneration of new cardiovascular tissue proximate said perivalvular leak, wherein said biomaterial construct further abates said perivalvular leak during a second leak sealing stage.
2. The apparatus of claim 1 , wherein said mammalian tissue source is selected from the group consisting of small intestine submucosa (SIS), urinary bladder submucosa (UBS), stomach submucosa (SS), central nervous system tissue, mesothelial tissue, placental tissue, omentum tissue, cardiac tissue, kidney tissue, pancreas tissue, lung tissue, and combinations thereof.
3. The apparatus of claim 1 , wherein said ECM composition further comprises at least one supplemental biologically active agent.