Bioenergetic bone
Inventors
Ganey, Timothy • Weston, Wendy W. • Quevedo, Miguel • Oglesby, Stuart • Anderson, Tracy Scott
Assignees
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Publication Number
US-11471559-B2
Publication Date
2022-10-18
Expiration Date
Abstract
A biological composition has a mixture of mechanically selected allogeneic biologic material derived from bone marrow. The mixture has non-whole cellular components including vesicular components and active and inactive components of biological activity, cell fragments, cellular excretions, cellular derivatives, and extracellular components. The mixture including non-whole cell fractions including one or more of exosomes, transcriptosomes, proteasomes, membrane rafts, lipid rafts. The mixture is compatible with biologic function.
Core Innovation
The invention relates to a biological composition that combines mechanically selected bone marrow-derived non-whole cellular components and non-cellular fractions, including exosomes, vesicular components, organelle fragments, and active and inactive components of biological activity, together with freeze-dried bone particles. The bone marrow-derived mixture excludes and is isolated from whole cells to yield non-cellular fractions or non-cellular components or combinations.
Freeze-dried enhanced bone particles include enhanced cortical bone particles and enhanced cancellous bone particles that are ground and sieved to a size of 100-300 µm and are added to the bone marrow-derived non-cellular mixture. The bone particles are suspended in saline and sealed in a container, then exposed to a mechanical, atmospheric, or membrane charge adjustment by creating a vacuum within the sealed container and exposing the saline-suspended bone particles to a shock wave of a compressed wave of high amplitude to create bone inductive enhanced bone particles.
A protectant or cryoprotectant of polyampholyte is added to treat the mixture of mechanically selected biologic material and the freeze-dried enhanced bone particles, creating a physical or electrical or chemical gradient, or combination thereof, for osteoinductive bone tissue regeneration. The mixture is compatible with biologic function and can be implanted directly into the patient or a graft recipient.
Claims Coverage
The partial content includes two independent claims. The claims center on an implantable freeze-dried biological composition that combines non-cellular bone-marrow-derived fractions with enhanced cortical and cancellous bone particles, with polyampholyte used to create physical, electrical, and/or chemical gradients for osteoinductive or tissue regeneration; both claims also require pre-freeze-drying treatment in an unfrozen, non-freeze-dried state and freeze-drying for greater than 24 hours without adverse effects on the enhanced bone particles’ properties.
Non-whole-cell bone-marrow-derived non-cellular fractions
A mixture of mechanically selected biologic material derived from bone marrow having non-whole cellular components and non-cellular fractions including exosomes, vesicular components, organelle fragments, and active and inactive components of biological activity, wherein the mixture excludes and is isolated from whole cells to yield non-cellular fractions or non-cellular components or combinations.
Shock-wave and vacuum processing to create bone inductive enhanced bone particles prior to freeze-drying
Freeze-dried bone particles are suspended in saline and sealed in a container, then exposed to a mechanical, atmospheric, or membrane charge adjustment by creating a vacuum within the sealed container and exposing the saline-suspended bone particles to a shock wave of a compressed wave of high amplitude through the container to create enhanced bone particles that are bone inductive prior to freeze-drying.
Enhanced cortical and cancellous bone particles combined with the bone-marrow-derived mixture
The enhanced bone particles include a mixture of enhanced cortical bone particles and enhanced cancellous bone particles, and the enhanced particles are added to the mixture derived from bone marrow.
Polyampholyte protectant or cryoprotectant for regeneration gradients
A protectant or cryoprotectant of polyampholyte is added to the mixture, and the protectant or cryoprotectant treats the mixture of mechanically selected biologic material to create a physical, electrical, or chemical gradient, or combination thereof, for osteoinductive bone tissue regeneration or tissue regeneration.
Unfrozen, non-freeze-dried polyampholyte treatment before freeze-drying
The mixture of mechanically selected biologic material derived from bone marrow is treated in the protectant or cryoprotectant of polyampholyte in the unfrozen, non-freeze-dried state prior to preservation, cryopreservation, or freeze drying to form preserved unfrozen, frozen cryopreserved, or freeze-dried compositions including the polyampholyte protectant or cryoprotectant.
Freeze-drying for more than 24 hours without adverse effects
Freeze-drying is run for greater than 24 hours to dry the enhanced bone particles without adversely affecting the structural or physical properties of the enhanced bone particles.
Across the independent claims, the core claim coverage requires non-whole-cell bone-marrow-derived non-cellular fractions, saline-suspended sealed bone particles processed with vacuum and a shock wave of a compressed wave of high amplitude to create enhanced cortical and cancellous bone particles, incorporation of those particles into the mixture, polyampholyte treatment to form regeneration gradients, and freeze-drying for greater than 24 hours without adverse effects, yielding a composition compatible with biologic function for direct implantation.
Stated Advantages
Freeze-drying for greater than 24 hours dries the enhanced bone particles without adversely affecting the structural or physical properties of the enhanced bone particles.
Polyampholyte treatment creates physical, electrical, or chemical gradients, or combinations thereof, for osteoinductive bone tissue regeneration or tissue regeneration.
The resulting biological composition is compatible with biologic function and can be implanted directly into the patient or a graft recipient.
Documented Applications
Direct implantation into the patient or a graft recipient of the freeze-dried composition compatible with biologic function.
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