Fetal support tissue products and methods of use
Inventors
Assignees
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Publication Number
US-11707492-B2
Publication Date
2023-07-25
Expiration Date
Abstract
Methods of treating a complex wound by administering to a complex wound in the individual a therapeutically effective amount of a fetal support tissue product to treat the complex wound. Methods of treating a complex lower extremity ulcer by administering to a complex lower extremity ulcer in the individual a therapeutically effective amount of a fetal support tissue product to treat the complex lower extremity ulcer. Methods of reducing or preventing scar formation from granulation tissue by administering a fetal support tissue product to granulation tissue. Methods of repairing a spina bifida defect by administering to the defect in the individual a therapeutically effective amount of an umbilical cord product.
Core Innovation
The invention relates to a fetal support tissue product for treating a complex wound in an individual in need thereof. The product comprises previously frozen umbilical cord amniotic membrane and is formulated as an allograft from which water has not been substantially removed.
The treated complex wound comprises a wound characterized by exposed bone, muscle, tendon, joint capsule, or a combination thereof. The method provides re-vascularized and re-epithelialized healing by administering the fetal support tissue product as a therapeutically effective amount.
The disclosed products and methods include formulations derived from fetal support tissue, including placental amniotic membrane, umbilical cord, and umbilical cord amniotic membrane, including derivatives. A particular product definition includes an umbilical cord product substantially free of blood and lacking the umbilical cord vein and/or the umbilical cord arteries.
The document also describes use of the fetal support tissue product in reducing or preventing scar formation from granulation tissue and repairing spina bifida defects, including in utero treatment, with associated wound-management workflows.
Claims Coverage
The document provides one independent method claim focused on administering a specific fetal support tissue product to treat a complex wound, with re-vascularization and re-epithelialization. Dependent claims further refine the wound types, product processing/formulation, and product definitions.
Fetal support tissue allograft from which water has not been substantially removed
Administering to a complex wound a therapeutically effective amount of a fetal support tissue product comprising previously frozen umbilical cord amniotic membrane, formulated as an allograft from which water has not been substantially removed.
Re-vascularized and re-epithelialized complex wound healing
The complex wound is characterized by exposed bone, muscle, tendon, joint capsule, or a combination thereof, and the complex wound is re-vascularized and re-epithelialized by the fetal support tissue product.
Complex wound characterized by exposed anatomical components
The complex wound comprises a wound characterized by exposed bone, muscle, tendon, joint capsule, or a combination thereof.
Aseptic processing or terminal sterilization
The fetal support tissue product is aseptically processed and/or terminally sterilized.
Blood-free umbilical cord product lacking specific vessels
Producing a fetal support tissue product that is substantially free of blood and either lacks an umbilical cord vein or lacks umbilical cord arteries.
Coverage centers on using a previously frozen umbilical cord amniotic membrane allograft in which water has not been substantially removed to re-vascularize and re-epithelialize complex wounds characterized by exposed bone, muscle, tendon, and/or joint capsule. Dependent refinements add aseptic processing or terminal sterilization and narrower product definitions such as blood-free umbilical cord products lacking the umbilical cord vein and/or umbilical cord arteries.
Stated Advantages
Re-vascularized and re-epithelialized healing of complex wounds characterized by exposed bone, muscle, tendon, joint capsule, or a combination thereof.
Reducing or preventing scar formation from granulation tissue.
Repairing spina bifida defects, including in utero repair.
Documented Applications
Treating complex wounds including wounds characterized by exposed bone, muscle, tendon, joint capsule, or combinations thereof, including complex lower extremity/foot ulcers and ischemic/infected ulcers with exposed bone.
Reducing or preventing scar formation from granulation tissue.
Repairing spina bifida defects, including spina bifida cystica and myeloschisis, including in utero repair.
Wound management contexts described include debridement and bone resection/open cortex workflows, as well as treatment of radiation wounds with observed bone regrowth.
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