Translucent, dehydrated placental tissue and methods of producing and using the same
Inventors
Daniel, John • Griffiths, Sarah • Roy, Annelise Mowry
Assignees
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Publication Number
US-11154641-B2
Publication Date
2021-10-26
Expiration Date
Abstract
Compositions comprising translucent, dehydrated placental tissue and methods of preparing and using those tissues are provided. Repeated dehydration techniques may produce translucent, dehydrated placental tissues, including translucent, dehydrated placental membrane and umbilical cord, with improved visualization and/or handling characteristics. The present invention also includes methods of healing a wound of the skin, eye, nerve, tendon, muscle, dental region, or dura, including burns, comprising applying the translucent, dehydrated placental tissues of the invention to the wound.
Core Innovation
The invention relates to a dehydrated placental tissue comprising an intermediate layer, wherein the dehydrated placental tissue is translucent. The placental tissue includes placental membrane and umbilical cord, including an intermediate layer and/or Wharton’s Jelly. The disclosed tissue is intended to address undesirable appearance when dehydrated placental tissues are produced using current drying approaches.
The problem addressed is that current drying of placental tissue produces tissue that is opaque and brittle. In addition, intermediate layer and/or Wharton’s Jelly are described as contributing to undesirable appearance when dehydrated, which motivates producing a translucent, dehydrated tissue. The disclosure includes a translucency evaluation approach using visual inspection and light transmission measurements.
Translucency is evaluated by visual inspection with markings such that the markings are visible through the tissue. Light transmission is also evaluated using spectrophotometric light transmission across a wavelength range of 360 nm to 750 nm, including specified sub-ranges. The disclosure further describes that repeated dehydration cycles with hydration between dehydration steps yield translucent tissue with improved handling/pliability and less cracking, supported by histology comparisons and light-transmission measurements.
Claims Coverage
The independent claim defines dehydrated placental tissue with an intermediate layer and translucency. The remaining dependent claims refine the translucency requirement using visual inspection with markings and spectrophotometry-based thresholds, and further characterize the tissue by quantitative parameters such as moisture content, hemoglobin content, and intermediate-layer mean thickness.
Intermediate layer translucent dehydrated placental tissue
A dehydrated placental tissue comprising an intermediate layer, wherein the dehydrated placental tissue is translucent.
Visual translucency with visible markings
The dehydrated placental tissue appears translucent by visual inspection when held between a visible light source and a surface having marking(s), wherein the marking(s) are visible through the tissue.
Spectrophotometric light transmission threshold
The dehydrated placental tissue meets spectrophotometry-based light-transmission requirements with at least 80% of the placental tissue having >60% transmission at 360–410 nm and >80% transmission at 580–750 nm.
Moisture content range
The dehydrated placental tissue has a moisture content of from 0.5% to 50%.
Hemoglobin content threshold
The dehydrated placental tissue has a hemoglobin content of less than 13 μg/mg of dry mass of the tissue.
Application to treating or covering a wound
A method of treating or covering a wound by applying the dehydrated placental tissue to the wound of a subject.
Overall, the claim set centers on producing dehydrated placental tissue with an intermediate layer that is translucent, with translucency verified by both visual inspection with markings and spectrophotometric light transmission thresholds, further characterized by moisture and hemoglobin content and used by applying the translucent dehydrated tissue to wounds.
Stated Advantages
Produces a translucent, dehydrated placental tissue rather than an opaque tissue.
Improves handling/pliability and results in less cracking compared with brittle/opaque tissue produced by current drying.
Documented Applications
Treating or covering wounds by applying the dehydrated placental tissue to a wound of a subject.
Wound-healing applications across multiple tissue/organ sites including skin wounds, eye wounds (including burns, lacerations, ulcers), nerve, tendon, muscle, dental, and dura.
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