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Publication Number
US-12390493-B2
Publication Date
2025-08-19
Expiration Date
Abstract
A fibrous birth tissue composition fabricated from placental tissue is provided. Methods of processing a mammal's placental tissue to form a fibrous birth tissue composition are provided. Regenerative methods are also provided.
Core Innovation
The invention relates to fibrous birth tissue compositions for treating wounds, where the fibrous birth tissue composition comprises at least one porcine placental membrane that is treated with bioburden reduction, detergent treatment, and viral inactivation, followed by dehydrating the porcine placental membrane. The dehydrated membrane is then cut or milled into one or more fibers and passed through a sieve to isolate macro fibrils that form the fibrous porcine birth tissue composition.
The document emphasizes formation of self-adhering fibers that remain in contact with a wound bed and support exudate handling. It also describes retention of extracellular matrix components such as collagen I and collagen IV, elastin, laminin, fibronectin, and hyaluronic acid as part of the resulting fibrous material, with pH control within a range of about 6.8 to 7.2 during processing.
In addition to wound treatment, the document describes integration of the fibrous porcine birth tissue composition into bone substitute formulations, including a porcine bone context and reference to BMP-2 within the described formulations. The document frames these uses around maintaining ECM protein presence while delivering a fibrous, self-adhering, macro fibril material suitable for placement on or around a wound or wound bed.
Claims Coverage
The independent claim covers a wound-treating method with an ordered workflow producing a fibrous porcine birth tissue composition from porcine placental membrane, including bioburden reduction, detergent treatment, viral inactivation, dehydration, cutting or milling into fibers, and sieving to isolate macro fibrils, followed by placing the composition on or around a wound or wound bed. The claim family further refines wound and wound-bed categories and adds functional and processing limitations.
Placing a fibrous birth tissue composition on or around a wound or wound bed
A method of treating a wound by placing a fibrous birth tissue composition on or around a wound or wound bed.
Preparing the fibrous porcine birth tissue composition from treated porcine placental membrane
The fibrous birth tissue composition comprises at least one porcine placental membrane treated with bioburden reduction, detergent treatment, and viral inactivation, followed by dehydrating the porcine placental membrane.
Cutting or milling and sieving to isolate macro fibrils as the fibrous composition
Dehydrated porcine placental membrane is cut or milled into one or more fibers, and the one or more fibers are passed through a sieve to isolate macro fibrils that form the fibrous porcine birth tissue composition.
Using detergent treatment with anionic detergent and protease enzyme
The method includes a detergent treatment step using a detergent formulation that contains at least one anionic detergent and at least one protease enzyme.
Applying to specific wound or wound-bed sites
The wound or wound bed is a surgical site, ulcer, abrasion, tissue void, or burn.
Treating specific ulcer subcategories
The ulcer is a pressure ulcer, venous ulcer, diabetic ulcer, or chronic vascular ulcer.
Delivering a fibrous composition that adheres to the wound
The fibrous birth tissue composition is configured to adhere to a wound.
Delivering a fibrous composition that absorbs wound exudate
The fibrous birth tissue composition is configured to absorb wound exudate.
Across the claim coverage, the main inventive aspects are producing a fibrous birth tissue composition from treated porcine placental membrane, dehydrating and cutting or milling to fibers, sieving to isolate macro fibrils, and placing the resulting fibrous composition on or around a wound or wound bed, with additional refinements for detergent formulation, treated site categories, and functional requirements of adhesion and exudate absorption.
Stated Advantages
Self-adhering fibers remain in contact with the wound bed.
Absorbs wound exudate.
Retention or presence of ECM proteins such as collagen I and collagen IV, elastin, laminin, fibronectin, and hyaluronic acid after processing is confirmed by immunostaining.
Provides a fibrous birth tissue composition for treating a wound or wound bed by placement on or around the site.
Documented Applications
Treating wounds by placing a fibrous birth tissue composition on or around a wound or wound bed.
Treating surgical sites, ulcers, abrasions, tissue voids, or burns.
Treating ulcers including pressure ulcers, venous ulcers, diabetic ulcers, or chronic vascular ulcers.
Use in bone substitute formulations described in the document, including porcine bone context and reference to BMP-2.
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