Compositions derived from placenta and methods of producing the same
Inventors
Daniel, John • Griffiths, Sarah • Berg, Richard
Assignees
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Publication Number
US-12064530-B2
Publication Date
2024-08-20
Expiration Date
Abstract
Compositions comprising perforated, unseparated amnion/chorion; perforated, separated amnion; and perforated, separated chorion derived from the placenta and methods of preparing and using those compositions are provided. Perforation of placental tissue before or during processing may allow for one or more benefits such as more efficient removal of blood remnants, retention of wound healing and tissue regeneration components, better handling characteristics, or improved healing capacity. The present invention also includes methods of healing a wound of the skin, eye, nerve, tendon, or dura comprising applying the perforated compositions of the invention to the wound.
Core Innovation
The invention relates to cleansing an unseparated amnion/chorion sheet or composition thereof by obtaining an unseparated amnion/chorion tissue dissected away from the placental disc and umbilical cord, perforating the unseparated amnion/chorion tissue, and washing the unseparated amnion/chorion tissue with at least one washing medium over two or more washing steps to remove blood remnants. Perforating occurs before or between two washing steps.
In described embodiments, the perforating is performed by making one or more holes that partially traverse the thickness of the unseparated amnion/chorion tissue, and the washing is carried out using washing environments and washing media selected from aqueous and saline/buffer solutions and cell culture medium. The washing media include water, a sodium chloride solution, sodium hypochlorite, hydrogen peroxide, Lactated Ringer's solution, Ringer's solution, and buffer solutions such as PBS, TBS, HBSS, DPBS, EBSS, SSC, HEPES-buffered saline, and Gey's balanced salt solution.
Additional processing features in the disclosed method include pretreating the unseparated amnion/chorion tissue by picking material away from the tissue, or dabbing, rubbing, or massaging the tissue, followed by a first washing step with a first washing medium, then perforating, and then washing with at least one additional washing medium over two or more additional washing steps to remove blood remnants. The method further includes dehydrating the unseparated amnion/chorion tissue and sterilizing the tissue or the sheet.
Claims Coverage
The document contains two independent claims that cover cleansing of unseparated amnion/chorion tissue with perforation timed before or between washing steps, and a sequence that combines pretreatment, washing with first and additional washing media, perforating, dehydration, and sterilizing.
Perforating before or between washing steps to remove blood remnants
Obtaining an unseparated amnion/chorion tissue dissected away from the placental disc and umbilical cord, perforating the unseparated amnion/chorion tissue, and washing the unseparated amnion/chorion tissue with at least one washing medium over two or more washing steps to remove blood remnants, wherein perforating occurs before or between two washing steps.
Pretreating, washing with first and additional washing media, perforating, dehydrating, and sterilizing
Obtaining an unseparated amnion/chorion tissue dissected away from the placental disc and umbilical cord, pretreating the unseparated amnion/chorion tissue by picking material away from the tissue, or dabbing, rubbing, or massaging the tissue, washing the unseparated amnion/chorion tissue with a first washing medium, perforating the unseparated amnion/chorion tissue, washing the unseparated amnion/chorion tissue with at least one additional washing medium over two or more additional washing steps to remove blood remnants, dehydrating the unseparated amnion/chorion tissue, and sterilizing the tissue or the sheet.
Across the independent claims, the central inventive theme is cleansing of unseparated amnion/chorion by combining perforation timed before or between washing steps with multiple washing steps using washing media to remove blood remnants, optionally preceded by physical pretreatment and followed by dehydration and sterilizing.
Stated Advantages
Reduces blood remnants from the unseparated amnion/chorion tissue.
Reduces hemoglobin content (dry mass) of an unseparated amnion/chorion sheet by more than about 50%, 60%, 70%, 80%, 90%, or 95% compared to the unseparated amnion/chorion tissue before perforating and washing.
Documented Applications
Use for wound healing of skin, eye, nerve, tendon, and dura using placenta-derived graft compositions containing perforated unseparated amnion/chorion.
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