Human placental tissue graft products, methods, and apparatuses
Inventors
Goldstein, Steven • MARTINEZ, Adam • LAW, Candace
Assignees
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Abstract
Provided herein are tissue grafts, and in particular human placenta-derived tissue grafts and methods and articles for the manufacture and use thereof.
Core Innovation
The invention relates to a method of producing a tissue graft from a fetal support tissue membrane, including removing decidua cells and trophoblast cells from the membrane. The method compresses and dehydrates the membrane, while decontaminating the membrane, and mounts the processed membrane to a flexible backing material to produce a formed tissue graft.
A central aspect of the method is that the native connective architecture between an amnion layer and a chorion layer is maintained intact throughout the process. The amnion layer is not decellularized, and compressing and dehydrating are performed simultaneously using a moisture-permeable support platform and a gas-impermeable sealing sheet with a vacuum-driven depressurizing step that pulls a vacuum across the platform.
The method specifies an apparatus arrangement in which the chamber defines an opening at one end and is in fluid connection with a vacuum source, with the moisture-permeable support platform covering the opening. A moisture, liquid, and vapor permeable material layer is positioned between a perforated rigid support layer and the membrane, and the membrane is positioned between the gas-impermeable sealing sheet and the moisture, liquid, and vapor permeable material layer.
Claims Coverage
The partial document identifies one independent claim describing the method of producing the tissue graft with multiple structural and process constraints. The inventive feature set centers on three combined features.
Maintaining native connective architecture while not decellularizing amnion
The native connective architecture between an amnion layer and a chorion layer of the membrane is maintained intact throughout the method, and the amnion layer is not decellularized.
Simultaneous compressing and vacuum-driven dehydrating using permeable and sealing layers
The steps of compressing the membrane and dehydrating the membrane are performed simultaneously, and comprise positioning the membrane between a moisture-permeable support platform and a gas-impermeable sealing sheet, then depressurizing a chamber below the moisture-permeable support platform to pull a vacuum across the platform using a vacuum source.
Chamber-platform configuration with permeable layers and sealing sheet
The chamber defines an opening at one end and is in fluid connection with the vacuum source, the moisture-permeable support platform covers the opening, and the platform comprises a perforated rigid support layer and a moisture, liquid, and vapor permeable material layer positioned between the perforated rigid support layer and the membrane.
The independent claim focuses on preserving native amnion/chorion connective architecture while keeping the amnion layer not decellularized, performing compressing and dehydrating simultaneously by vacuum-driven depressurizing, and using the specified chamber and permeable-layer arrangement during processing.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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