Enriched Multilayer Amnion Graft for Consistent Wound Healing
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Solution Overview
Problem
Existing amniotic tissue grafts vary in bioactive factor concentration due to donor and handling, limiting their therapeutic effectiveness and consistency in wound healing and tissue repair.
Innovation Solution
A multilayer amnion derived tissue graft with preserved epithelium and removed chorion, enhanced with an enrichment composition to increase proteins, cells, and/or growth factors, and/or cytokines, up to 1000 times the native concentration, for improved therapeutic efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If amniotic tissue grafts are used for wound healing, then therapeutic effect is provided through bioactive factors, but the concentration of bioactive factors varies due to donor and handling, limiting consistency
Solution Approach 1:
The patent applies parameter changes by modifying the concentration level of bioactive factors through the enrichment composition coating process. The coating contains elevated concentrations of proteins, growth factors, cytokines, and cells that are deposited onto the amnion graft surface, transforming the graft from having variable native concentrations to having controlled, enhanced concentrations of therapeutic factors.
Solution Approach 2:
The patent creates a composite structure by combining the amnion tissue graft with an enrichment composition coating. This composite comprises the base amnion layers (epithelium, stromal matrix) plus the added enrichment layer containing concentrated bioactive factors, stem cells, and proteins, resulting in a multi-component therapeutic product with consistent and enhanced efficacy.
2Reliability
If enrichment composition is applied to increase bioactive factor concentration, then therapeutic efficacy is improved, but manufacturing complexity increases
Solution Approach 1:
The patent applies preliminary action by pre-preparing the enrichment composition containing concentrated bioactive factors, growth factors, and stem cells before applying it to the amnion graft. This pre-formulated coating is then deposited onto the graft surface in a controlled manner, ensuring consistent therapeutic potency without requiring complex in-situ preparation during graft manufacturing.
Data Source
AI summary
An enriched amnion derived tissue graft has a stromal matrix layer and an epithelium layer. A stromal matrix layer may contain a basement membrane layer, a compact layer, a fibroblast layer, and an intermediate layer. An amnion derived tissue graft may have a plurality of tissue layers and the layers may be configured with the epithelium layers toward the inside and the stromal matrix layers toward the outside surface. An enriched portion may be coated onto or be configured within a tissue layer and have an increased concentration of cells, of proteins, growth factors, seed cells, pharmaceuticals or any combination thereof. A carrier fluid such as amniotic fluid may be used to produce an enrichment composition for coating the tissue graft. The cells within the enriched portion may be stem cells from the amnion, or cells from other tissue and may be seed cells selected based on the treatment location.


