Flowable birth tissue composition and related methods
Inventors
Klitzke, Kurt • Hargis, Jon G.
Assignees
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Publication Number
US-11026980-B1
Publication Date
2021-06-08
Expiration Date
Abstract
A flowable birth tissue composition fabricated from birth tissue is provided. Methods of processing a mammal's placental tissue to form a flowable birth tissue composition are provided. Various methods of treatment and uses are also provided.
Core Innovation
The invention relates to a flowable birth tissue composition made from mammalian placental tissue, including porcine placental tissue. The composition includes detergent-treated, milled porcine placental tissue mixed with at least one carrier to form the flowable porcine birth tissue composition, and the detergent includes at least one anionic detergent and at least one protease enzyme.
The disclosed placental tissue can include placental tissue membranes or components, including a dehydrated porcine placental membrane. The dehydrated porcine placental membrane is associated with extracellular matrix components including collagen I, collagen IV, elastin, laminin, fibronectin, and hyaluronic acid.
The porcine placental tissue can exhibit a pH between about 6.8 and about 7.2. The composition further uses carriers such as water, saline, 0.9% sodium chloride injection, aqueous hyaluronic acid, dextrose solution, amniotic fluid, Hank’s solution, and Ringer’s solution, and can optionally include at least one bioresorbable bead.
The background problem addressed is the need for regenerative tissue compositions and materials derived from birth tissue that can be prepared as a flowable composition and used for tissue repair-related applications. The document describes processing features including bioburden reduction, detergent treatment with an anionic detergent plus protease, and viral inactivation.
Claims Coverage
The independent claim covers a flowable porcine birth tissue composition defined by detergent-treated, milled porcine placental tissue mixed with at least one carrier, where the detergent includes at least one anionic detergent and at least one protease enzyme. The coverage also includes associated refinements directed to membrane-derived extracellular matrix components, a pH range, named carrier options, and an optional bioresorbable bead.
Detergent-treated milled porcine placental tissue
A flowable porcine birth tissue composition comprising detergent-treated, milled porcine placental tissue.
Flowable composition formed by mixing with at least one carrier
The placental tissue is mixed with at least one carrier to form the flowable porcine birth tissue composition.
Anionic detergent plus protease enzyme detergent
The detergent includes at least one anionic detergent and at least one protease enzyme.
Dehydrated porcine placental membrane with defined ECM components
The flowable porcine birth tissue composition includes a dehydrated porcine placental membrane comprising collagen I, collagen IV, elastin, laminin, fibronectin and hyaluronic acid.
Porcine placental tissue pH window
The porcine placental tissue exhibits a pH of between about 6.8 and about 7.2.
Defined carriers including specific named solutions
The at least one carrier comprises water, saline, 0.9% sodium chloride injection, aqueous hyaluronic acid, dextrose solution, amniotic fluid, Hank's solution, Ringer's solution, or any combination thereof.
Optional bioresorbable bead component
The flowable birth tissue composition further comprises at least one bioresorbable bead.
Across the independent claim and its associated refinements, the coverage centers on producing a flowable porcine birth tissue composition from detergent-treated, milled porcine placental tissue mixed with at least one carrier, using a detergent system comprising an anionic detergent and a protease enzyme, with optional membrane-derived extracellular matrix components, a pH constraint, named carrier options, and an optional bioresorbable bead.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Wound treatment using a liquid flowable birth tissue composition.
Tissue bulking using a kit concept for bulking structural tissue.
Vascular embolization using the flowable birth tissue composition.
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