Flowable birth tissue composition and related methods
Inventors
Klitzke, Kurt • Hargis, Jon G.
Assignees
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Publication Number
US-12144830-B2
Publication Date
2024-11-19
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 porcine birth tissue composition for treating a wound by administering a therapeutically effective amount in or around a wound to a patient. The composition includes detergent-treated, milled porcine placental tissue mixed with at least one carrier to form the flowable porcine birth tissue composition. The detergent contains at least one anionic detergent and at least one protease enzyme.
The flowable porcine birth tissue composition is further characterized by detergent-treated, milled porcine placental tissue having a pH range of 6.8 to 7.2, and by the milled porcine placental tissue being present at 0.01 g/mL to 2.0 g/mL in the flowable composition. In addition, the porcine placental tissue can include a dehydrated porcine placental membrane comprising collagen I, collagen IV, elastin, laminin, fibronectin, and hyaluronic acid.
The disclosed composition can be formulated with pharmaceutically acceptable carriers, including liquid or gel or suspension gel forms, and can include dehydrated porcine placental membrane components and optional bioresorbable beads sized for needle/cannula delivery. The document also describes processed membranes retaining extracellular matrix proteins and an example of administering a liquid flowable birth tissue composition by injection into a tendon with improvement observed by ultrasound.
Claims Coverage
The provided claims include two independent claims covering a method of treating a wound by administering a flowable porcine birth tissue composition. Both independent claims share the core inventive composition concept, including detergent-treated, milled porcine placental tissue mixed with a carrier using an anionic detergent and protease enzyme, with one claim additionally specifying a quantitative tissue amount range.
Flowable porcine birth tissue composition with detergent-treated milled placental tissue
Administering a therapeutically effective amount of a flowable porcine birth tissue composition in or around a wound, where the composition comprises detergent-treated, milled porcine placental tissue and at least one carrier, and wherein the placental tissue is mixed with the at least one carrier to form the flowable porcine birth tissue composition.
Detergent composition with anionic detergent and protease enzyme
The method includes that the detergent includes at least one anionic detergent and at least one protease enzyme in the detergent-treated, milled porcine placental tissue.
Quantitative placental tissue concentration in the flowable composition
Administering a therapeutically effective amount of a flowable porcine birth tissue composition in or around a wound, where the flowable porcine birth tissue composition comprises 0.01 g/mL to 2.0 g/mL of detergent-treated, milled porcine placental tissue and at least one carrier, with the detergent including at least one anionic detergent and at least one protease enzyme.
Across independent claims, the inventive coverage centers on administering a flowable porcine birth tissue composition comprising 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. One claim further narrows the composition by requiring a defined 0.01 g/mL to 2.0 g/mL concentration range for the detergent-treated, milled placental tissue.
Stated Advantages
Documented Applications
Treating a wound by administering the flowable porcine birth tissue composition in or around the wound, including types described in dependent claim refinements such as surgical site, burn, cut, abrasion, tissue void, or ulcer, and wounds on or around specified anatomical tissues or body regions.
A described example includes administering a liquid flowable birth tissue composition injected into a tendon, with significant improvement observed on ultrasound after weeks.
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