| 主权项 |
1. A valve conduit to replace a defective semi-lunar valve prepared by the steps of:
providing a sheet of acellular extracellular matrix (ECM) material; removing the defective semi-lunar valve from the heart of the first subject; positioning said sheet of ECM material in a folded position, said sheet having a top portion comprising a top edge of said sheet and a bottom portion comprising a bottom edge of said sheet; wherein, in said folded position, said bottom edge of said sheet is folded toward said top edge of said sheet such that said bottom edge of said sheet is spaced a first distance from said top edge of said sheet; securing said sheet of ECM material in said folded position, thereby forming a folded ECM valve construct having an upper portion, a lower portion, a first side edge, and a second side edge, said lower portion comprising a first layer and a second layer, said first layer of said lower portion corresponding to said folded bottom portion of said sheet of said ECM material; attaching said first layer to said second layer only at locations adjacent and along said bottom edge of said sheet, wherein said first and second layers are attached at first and second attachment points, said first attachment point being spaced from said second attachment point by a second distance, wherein a sinus-promoting portion is formed on said ECM valve construct upper portion and a commissure-promoting portion is formed on said ECM valve construct lower portion first layer; positioning said ECM valve construct in an aligned position, in which said first side edge of said ECM valve construct is in alignment with said second side edge of said ECM valve construct; with said ECM valve construct in said aligned position, securing said first side edge of said ECM valve construct to said second side edge of said ECM valve construct at a securement location, thereby forming an ECM valve conduit having a lumen and a longitudinal axis, wherein said lower portion of said ECM valve construct corresponds to an inlet portion of said ECM valve conduit, said inlet portion of said ECM valve conduit defining an inlet in fluid communication with said lumen of said ECM valve conduit, wherein said first layer of said lower portion of said ECM valve construct corresponds to an inner layer positioned within said lumen of said ECM valve conduit, wherein said upper portion of said ECM construct corresponds to an outlet portion of said ECM valve conduit, and wherein said second layer of said lower portion of said ECM valve construct cooperates with said upper portion of said ECM valve construct to define an outer wall of said ECM valve conduit, wherein said inner layer of said ECM valve conduit is continuous around its circumference except at said first and second attachment points and said securement location; and attaching said ECM valve conduit to an annular region of a subject's heart and said subject's artery, whereby said inlet portion of said ECM valve conduit is positioned proximate said annular region, wherein, following attachment of said ECM valve conduit to said annular region of said subject's heart and said subject's artery, said commissure-promoting portion of said ECM valve conduit inner layer remodels and fuses with said upper portion of said ECM valve construct, wherein a regenerated valve leaflet of a replacement semi-lunar valve is formed in said ECM valve conduit lumen, and said sinus-promoting portion remodels and fuses with said ECM valve conduit inner layer of said ECM valve conduit, wherein a regenerated sinus portion of said replacement semi-lunar valve is formed, said regenerated valve leaflet and said regenerated sinus portion of said ECM valve conduit comprising remodeled cardiovascular tissue. |
