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-11116871-B2
Publication Date
2021-09-14
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 placenta-derived unseparated amnion/chorion sheets that include perforations and have a low hemoglobin content, while the sheet or composition is dehydrated. The disclosure defines unseparated amnion/chorion configurations and distinguishes unseparated sheets from separated amnion sheets and separated chorion sheets, with the unseparated form characterized by perforations to manage blood remnants.
The problem addressed is the presence of blood remnants and hemoglobin in placenta-derived membrane products, which the disclosure states are reduced more efficiently when perforation is performed prior to preservation. Perforating prior to preservation is described as enabling more efficient blood-remnant removal while retaining wound-healing/regenerative components associated with the amnion/chorion membrane.
The invention further focuses on membrane-layer structure and perforation geometry, including the amnion, an intermediate (spongy) layer, and the chorion, and describes perforations that can traverse or partially traverse specific layers and basement membranes. The disclosure provides parameter relationships involving hemoglobin content, dry mass, water absorption potential, protein content, mean thickness, intermediate-layer mean thickness, and perforation features, and reports comparative retention and changes in intermediate-layer thickness and composition-related measures.
Claims Coverage
Two independent claims are identified. Both claims require a dehydrated placenta-derived unseparated amnion/chorion sheet or a composition including at least one such sheet with a perforation and low hemoglobin content, and one independent claim additionally specifies an intermediate-layer mean thickness greater than about 5 μm.
Unseparated amnion/chorion sheet with perforation and low hemoglobin content
An unseparated amnion/chorion sheet comprising a perforation, wherein the unseparated amnion/chorion sheet has a hemoglobin content of less than about 5 μg per mg of dry mass of the sheet, wherein the unseparated amnion/chorion sheet is dehydrated.
Composition of unseparated perforated amnion/chorion sheets with intermediate layer thickness and low hemoglobin content
A composition comprising at least one unseparated amnion/chorion sheet, wherein the at least one unseparated amnion/chorion sheet comprises a perforation and an intermediate layer having a mean thickness of greater than about 5 μm, wherein the composition has a hemoglobin content of less than about 5 μg per mg of dry mass of the composition, and wherein the unseparated amnion/chorion sheet is dehydrated.
The claim coverage centers on dehydrated perforated unseparated amnion/chorion sheets and compositions that meet low hemoglobin content thresholds, with an additional structural constraint in one independent claim requiring an intermediate-layer mean thickness greater than about 5 μm.
Stated Advantages
More efficient blood-remnant removal when perforation is performed prior to preservation.
Retention of wound-healing/regenerative components despite perforation prior to preservation.
Improved handling/thickness.
Documented Applications
Applying the membrane products to wound healing applications including skin, eye, nerve, tendon, and dura.
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