Flowable birth tissue composition and related methods
Inventors
Klitzke, Kurt • Hargis, Jon G.
Assignees
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Publication Number
US-12161677-B2
Publication Date
2024-12-10
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 describes preparing a flowable porcine birth tissue composition from porcine placental tissue by treating the tissue with sequential process steps. The process includes introducing a sodium chloride solution to the porcine placental tissue, decanting the sodium chloride solution, and rinsing with water, followed by introduction of at least one anionic detergent solution with at least one protease enzyme and subsequent decanting and water rinsing.
After the sodium hydroxide step, the process introduces a buffer solution, followed by decanting the buffer solution and rinsing with water. The treated tissue is then milled to form a placental tissue powder, a pharmaceutically acceptable carrier is added to the placental tissue powder, and the mixture is homogenized to form a flowable porcine birth tissue composition.
In further embodiments, hyaluronic acid and a radioprotective solution are mixed to form a suspension gel, and the placental tissue powder is added to the suspension gel. The resulting mixture is homogenized to form a flowable porcine birth tissue composition, including embodiments where the flowable composition is a liquid or further limited to a gel. Additional embodiments include packaging and terminal sterilizing the packaged composition.
Claims Coverage
The independent claims cover methods of preparing a flowable porcine birth tissue composition using sequential treatment of porcine placental tissue with salt, anionic detergent plus protease, sodium hydroxide, and buffer, followed by milling and homogenization with a carrier. A further independent claim specifies mixing with hyaluronic acid and a radioprotective suspension gel before homogenization. Across the independent claims, there are 4 inventive feature groupings.
Sequential treatment with salt, anionic detergent plus protease, sodium hydroxide, and buffer
Introducing a sodium chloride solution to porcine placental tissue, decanting the sodium chloride solution, rinsing with water, introducing at least one anionic detergent solution with at least one protease enzyme, decanting the anionic detergent solution, rinsing with water, introducing a sodium hydroxide solution, rinsing with water, introducing a buffer solution, decanting the buffer solution, and rinsing with water.
Milling to placental tissue powder and forming a flowable composition with a pharmaceutically acceptable carrier
Milling the porcine placental tissue to form a placental tissue powder, adding a pharmaceutically acceptable carrier to the porcine placental tissue powder, and homogenizing to form a flowable porcine birth tissue composition.
Suspension gel formulation with hyaluronic acid and a radioprotective solution
Mixing hyaluronic acid and a radioprotective solution to form a suspension gel, adding the placental tissue powder to the suspension gel, and homogenizing the mixture to form a flowable porcine birth tissue composition.
Packaging and terminal sterilization of the flowable composition
Packaging a flowable porcine birth tissue composition and terminally sterilizing the packaged composition.
Overall, the claim set covers methods that produce a flowable porcine birth tissue composition by sequentially treating porcine placental tissue, milling to powder, and homogenizing with a carrier. A further independent claim specifies formulation via a hyaluronic-acid radioprotective suspension gel, with additional limitations directed to packaging, terminal sterilization, and the physical form as liquid or gel.
Stated Advantages
Documented Applications
Wound healing and vascular embolization are described as uses, including a kit for bulking structural tissue, bulking structural tissue, and vascular embolization.
An animal case is described involving a tendon injection example using a liquid composition.
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