Extracellular matrix material conduits and methods of making and using same
View Patent ↗Extracellular matrix (ECM) valve conduits are disclosed. Methods for regenerating atrioventricular valves to replace defective atrioventricular valves within a heart of a subject using the ECM valve conduits are also disclosed. Methods of sterilizing and decellularizing an ECM material are also disclosed.
1. A valve conduit for regenerating an atrioventricular (AV) valve to replace a defective AV valve within a heart of a subject, the AV valve being adapted to be attached to an annular region of the heart, the defective AV valve comprising first cardiovascular tissue, the defective AV valve further comprising a first plurality of valve leaflets, comprising:
a bioabsorbable tubular conduit comprising sterile, acellular small intestine submucosa (SIS), said SIS comprising less than 4% DNA content and a dry weight bFGF content of at least 140 pg/mg of said SIS, said SIS further exhibiting at least 96% decellurization and a tensile strength of at least 9 N,
said SIS further comprising an exogenously added growth factor selected from the group consisting of transforming growth factor alpha (TGF-alpha), transforming growth factor beta (TGF-beta), fibroblast growth factor-2 (FGF-2), basic fibroblast growth factor (bFGF) and vascular epithelial growth factor (VEGF),
said tubular conduit defining a lumen and having an inlet portion and an outlet portion, said inlet portion of said tubular conduit being configured to attach to said annular region of said heart of said subject, said outlet portion of said tubular conduit being configured to attach to papillary muscles within said subject's heart,
said tubular conduit member being configured to induce generation of a plurality of regenerated valve leaflets in said tubular conduit member lumen when said tubular conduit member is coupled to said first cardiovascular tissue of said annular region,
said plurality of regenerated valve leaflets comprising second cardiovascular tissue, said second cardiovascular tissue and said first cardiovascular tissue being similar, said plurality of regenerated valve leaflets being configured to function in a manner similar to said first plurality of valve leaflets of said defective AV valve.
2. A valve conduit for regenerating an atrioventricular (AV) valve to replace a defective AV valve within a heart of a subject, the AV valve being adapted to be attached to an annular region of the heart, the defective AV valve comprising first cardiovascular tissue, the defective AV valve further comprising a first plurality of valve leaflets, comprising:
a bioabsorbable tubular conduit comprising sterile, acellular small intestine submucosa (SIS), said SIS comprising less than 4% DNA content and a dry weight bFGF content of at least 140 pg/mg of said SIS, said SIS further exhibiting at least 96% decellurization and a tensile strength of at least 9 N,
said SIS further comprising an exogenously added statin selected from the group consisting of atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin,
said tubular conduit defining a lumen and having an inlet portion and an outlet portion, said inlet portion of said tubular conduit being configured to attach to said annular region of said heart of said subject, said outlet portion of said tubular conduit being configured to attach to papillary muscles within said subject's heart,
said tubular conduit member being configured to induce generation of a plurality of regenerated valve leaflets in said tubular conduit member lumen when said tubular conduit member is coupled to said first cardiovascular tissue of said annular region,
said plurality of regenerated valve leaflets comprising second cardiovascular tissue, said second cardiovascular tissue and said first cardiovascular tissue being similar, said plurality of regenerated valve leaflets being configured to function in a manner similar to said first plurality of valve leaflets of said defective AV valve.