Bioenergetic bone
Inventors
Ganey, Timothy • Weston, Wendy W. • Quevedo, Miguel • Oglesby, Stuart • Anderson, Tracy Scott
Assignees
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Publication Number
US-12419991-B2
Publication Date
2025-09-23
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 method of making a biological composition by processing bone marrow and vertebral bone from a human cadaver donor. The method includes grinding a cut vertebral body to produce a mixture comprising crushed vertebral bone and bone marrow, and mechanically separating cellular and non-cellular components of the bone marrow from the vertebral bone in the mixture by tumbling and sieving, using a decanted fluid and producing whole cells and non-whole cellular components.
Non-cellular fractions are concentrated and enriched by centrifugation and by filtering through a blood filter to remove remaining vertebral bone. Cellular components and non-cellular components are then separated directly by density gradient centrifugation to establish a cell density gradient, and non-cellular fractions, non-cellular components, or combinations thereof are collected from predetermined density regions.
The collected fractions are washed and then suspended to a predetermined concentration in a polyampholyte cryoprotectant to form a coated biological composition. The coated biological composition is frozen at a predetermined controlled rate and packaged with a bone blend that includes particles of 100 to 300 μm of demineralized cortical bone, mineralized cortical bone, and mineralized cancellous bone.
Claims Coverage
The claims coverage includes one independent claim and dependent refinements. The inventive coverage centers on making a coated biological composition from donor vertebral bone marrow by mechanical separation, centrifugation plus filtration, density-gradient fraction collection, washing and suspension in a polyampholyte cryoprotectant, followed by controlled-rate freezing and packaging with a specified-size bone blend.
Method of producing a coated biological composition from vertebral bone marrow
A method comprising grinding a cut vertebral body from a human cadaver donor to produce a mixture of crushed vertebral bone and bone marrow, and mechanically separating cellular and non-cellular components of the bone marrow from the vertebral bone in the mixture by tumbling and sieving the vertebral bone from a decanted fluid comprising whole cells and non-whole cellular components.
Enrichment by centrifugation, blood filtration, and density gradient separation
Concentrating the decanted fluid by centrifugation, filtering the decanted fluid through a blood filter to remove remaining vertebral bone, and separating cellular and non-cellular components directly by density gradient centrifugation to establish a cell density gradient and collect non-cellular fractions, non-cellular components, or combinations thereof from predetermined density regions.
Polyampholyte cryoprotectant coating and controlled-rate freezing
Washing the non-cellular fractions, non-cellular components, or combinations thereof, suspending the washed mixture to a predetermined concentration in a polyampholyte cryoprotectant to form a coated biological composition, and freezing the coated biological composition at a predetermined controlled rate.
Packaging with a bone blend of specified size demineralized, mineralized cortical, and mineralized cancellous particles
Packaging a bone blend having particles of 100 to 300 μm of demineralized cortical bone, mineralized cortical bone, and mineralized cancellous bone with the coated biological composition.
Thawing and saline dilution of the coated biological composition for use with the bone blend
The method further thaws the frozen coated biological composition at 37 degrees C for 2 to 3 minutes and dilutes the thawed coated biological composition in saline before mixing with the bone blend and implanting the diluted mixture into a patient.
Freezing combined coated composition and bone blend
The bone blend is mixed with the coated biological composition before freezing in step (i).
Refrigerated storage after thawing and mixing
The thawed coated biological composition mixed with the bone blend is refrigerated after step (m) for storage prior to step (n).
Room-temperature storage after thawing and mixing
The thawed coated composition mixed with the bone blend is stored at room temperature after step (m) for storage prior to step (n).
Across the independent claim and the included dependent refinements, the inventive coverage centers on making a coated biological composition from donor vertebral bone marrow by mechanical separation, centrifugation plus filtration, density-gradient fraction collection, washing and suspension in a polyampholyte cryoprotectant, followed by controlled-rate freezing and packaging with a specified-size bone blend.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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