Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11602548-B1
Publication Date
2023-03-14
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 a fibrous porcine birth tissue composition in which at least one porcine placental membrane is treated with a bioburden reduction step, a detergent treatment step, and a viral inactivation step. The treated porcine placental membrane is then dehydrated, 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 fibrous porcine birth tissue composition is suitable for wound treatment.
The detergent treatment includes at least one anionic detergent and at least one protease enzyme. In the detailed examples and characterization described in the document, immunostaining is used to confirm the presence of extracellular matrix components in sterilized processed porcine placental membranes, including collagen I, collagen IV, elastin, laminin, fibronectin, and hyaluronic acid.
A related aspect includes a method of preparing the fibrous porcine birth tissue composition by exposing porcine placental tissue to sequential treatment steps including sodium chloride, detergent solution, sodium hydroxide, and buffer solution while measuring pH. The process includes repeating buffer solution, decanting, and measuring pH until the pH is between about 6.8 and about 7.2, followed by cutting or milling into cut or milled fibers and sieving to isolate macro fibrils suitable for wound treatment. The document further describes optional packaging and terminal sterilization of the packaged composition.
Claims Coverage
The document includes two independent claims that define a fibrous porcine birth tissue composition and a method for preparing the fibrous porcine birth tissue composition, together covering three core technical areas: membrane treatment, conversion to dehydrated fibers and sieved macro fibrils, and suitability for wound treatment. The independent method claim further adds a sequential treatment workflow with pH measurement and repeating buffer/pH adjustment until a specified pH range is reached, followed by cutting or milling and sieving.
Fibrous porcine birth tissue composition with treated porcine placental membrane macro fibrils
A fibrous porcine birth tissue composition comprising at least one porcine placental membrane treated with a bioburden reduction step, a detergent treatment step, and a viral inactivation step, followed by dehydrating the porcine placental membrane, subsequently cutting or milling the dehydrated porcine placental membrane into one or more fibers, and passing the one or more fibers through a sieve to isolate macro fibrils that form the fibrous porcine birth tissue composition, wherein the fibrous porcine birth tissue composition is suitable for wound treatment.
Detergent comprising anionic detergent and protease enzyme
The fibrous porcine birth tissue composition wherein the detergent includes at least one anionic detergent and at least one protease enzyme.
Method of preparing using sequential sodium chloride, detergent, sodium hydroxide, and buffer with pH adjustment
A method of preparing a fibrous porcine birth tissue composition, comprising introducing sodium chloride solution to porcine placental tissue, decanting and rinsing, introducing detergent solution, decanting and rinsing, introducing sodium hydroxide, rinsing, introducing buffer solution, decanting, measuring pH, repeating buffer solution, decanting, and measuring pH until the pH of the porcine placental tissue is between about 6.8 and about 7.2, then cutting or milling the porcine placental tissue into cut or milled fibers and passing the fibers through a sieve to isolate macro fibrils that form the fibrous porcine birth tissue composition, wherein the fibrous porcine birth tissue composition is suitable for wound treatment.
Across the independent claims, the coverage is directed to producing a fibrous porcine birth tissue composition by treating porcine placental membranes, dehydrating and converting the material into fibers and sieved macro fibrils, and ensuring suitability for wound treatment. The independent method claim additionally emphasizes sequential sodium chloride, detergent, sodium hydroxide, and buffer exposure with pH measurement and repeating buffer steps until a pH range between about 6.8 and about 7.2 is reached before cutting or milling and sieving.
Stated Advantages
The fibrous porcine birth tissue composition is suitable for wound treatment.
Documented Applications
Wound treatment using the fibrous porcine birth tissue composition.
Interested in licensing this patent?