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-11738115-B2
Publication Date
2023-08-29
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 preparing dehydrated placental tissue, including placental membranes and an umbilical cord, where the dehydrated tissue retains an intermediate layer and/or Wharton’s Jelly. The disclosure addresses a dehydration challenge in which extracellular matrix components can cause opacity and brittleness when subjected to standard dehydration processes, and it seeks translucent and more pliable dehydrated placental tissue rather than opaque, brittle tissue.
The disclosed method includes dehydrating the placental tissue in a first dehydration environment, hydrating the placental tissue in a hydration environment, and then dehydrating the placental tissue in a second dehydration environment. The disclosure further includes repeated dehydration cycles in which dehydration is optionally performed using a variety of dehydration techniques, with hydration between dehydration cycles.
The resulting dehydrated placental tissue is characterized by translucency and pliability, including intermediate layer and/or Wharton’s Jelly presence. Translucency is assessed by visual inspection and by percent light transmission using spectrophotometry across defined wavelengths, and the disclosure reports that repeated dehydration cycles improve translucent tissue characteristics compared with single dehydration cycles.
Claims Coverage
The independent claim covers a method of preparing dehydrated placental tissue using a first dehydration environment followed by hydration and then a second dehydration environment. The claim set includes five inventive features that refine the process conditions and define tissue characteristics.
First and second dehydration environments with intermediate hydration
Dehydrating placental tissue in a first dehydration environment, hydrating the placental tissue in a hydration environment, and dehydrating the placental tissue in a second dehydration environment.
Dehydration environments defined by temperature and vacuum pressure ranges
Dehydration is performed in dehydration environments defined by specified temperature and vacuum pressure ranges.
Time periods for dehydration and optional hydration between steps
At least one dehydration step and hydration between dehydration steps are performed for specified time periods.
Quantitative translucency by spectrophotometric light transmission thresholds
Dehydrated placental tissue has specified light transmission percentages measured by spectrophotometry at defined wavelengths, including thresholds such as greater than 60% at 360–410 nm and/or greater than 80% at 580–750 nm.
Hemoglobin content limit for the dehydrated tissue
Dehydrated placental tissue has a hemoglobin content below 13 ng/mg dry mass.
Overall, the claims coverage centers on a repeated-dehydration workflow with an intermediate hydration step to prepare dehydrated placental tissue, with refinements that define dehydration environment parameters, specify time periods, enforce spectrophotometric translucency thresholds, and limit hemoglobin content.
Stated Advantages
Provides translucent dehydrated placental tissue rather than opaque tissue associated with standard dehydration.
Provides more pliable dehydrated placental tissue rather than brittle tissue associated with standard dehydration.
Reduces blood remnants/hemoglobin content in the dehydrated tissue, as reflected by a hemoglobin content limit.
Documented Applications
Wound-healing applications using translucent dehydrated placental tissue, including skin, eye, nerve, tendon, muscle, dental region, and dura, including burns.
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