Malleable demineralized bone composition and method of manufacture
Inventors
Gonzales, Silvia Daniela • Namin, Shabnam • Ganey, Timothy
Assignees
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Publication Number
US-11406734-B2
Publication Date
2022-08-09
Expiration Date
Abstract
A malleable demineralized bone composition consists of cortical bone made from a first portion and a second portion. The first portion and second portion of cortical bone is made from cut pieces freeze dried then ground into particles and demineralized then freeze-dried. A volume of the second portion is placed in a solution of sterile water to create a mixture, the water volume being seven times the volume of the second portion, the mixture is autoclaved under heat and pressure to form a gelatin, and the first portion is mixed with the gelatin to form a malleable putty or paste.
Core Innovation
The invention provides a malleable demineralized bone composition consisting of cortical bone, produced as an aseptic paste/putty made from two cortical bone portions. One portion is processed into freeze-dried demineralized bone matrix (DBM) particles, and a second portion is processed into freeze-dried DBM particles and then used to form gelatin by mixing with sterile water and autoclaving. The method combines the gelatin with the first freeze-dried DBM particles at a gelatin:DBM ratio of 80:20 or less to create a moldable putty or paste.
The problem addressed is to obtain a malleable and cohesive DBM-based putty/paste that is moldable into different shapes while avoiding visible cracking, and that maintains its shape after immersion. The resulting malleable and cohesive putty or paste is described as moldable into different shapes with no visible cracks and maintaining its shape while immersed in normal saline or water for a minimum of one minute.
The document describes producing the DBM particles from cortical bone through cutting, freeze-drying, grinding, demineralizing, and freeze-drying to form freeze-dried DBM particles. It further describes dividing the freeze-dried DBM particles into a first portion and a second portion, autoclaving a volume of the second portion mixed with sterile water to form gelatin, cooling the gelatin, and mixing the first portion particles with the cooled gelatin. A QC and performance basis is provided for malleability, including crack-free molding and shape retention during immersion.
Claims Coverage
The partial content includes two independent claims (methods for making the same malleable demineralized bone composition). Across both claims, the coverage centers on preparing freeze-dried DBM particles from cortical bone, forming gelatin by autoclaving DBM with sterile water, and mixing gelatin with DBM at a gelatin:DBM ratio of 80:20 or less to yield a moldable putty/paste with crack-free molding and shape retention after immersion.
Preparation of freeze-dried demineralized bone matrix particles from cortical bone
Preparing cortical bone by cutting the cortical bone into pieces, freeze-drying the pieces and then grinding into particles and demineralizing the ground particles and freeze-drying the demineralized ground particles to form freeze-dried demineralized bone matrix (DBM) particles.
Gelatin formation by autoclaving a DBM particle portion with sterile water and cooling
Dividing the freeze-dried DBM particles into a first portion and a second portion; autoclaving a volume of the second portion of DBM particles mixed with sterile water to form a gelatin; cooling the gelatin.
Mixing gelatin with freeze-dried DBM at a gelatin:DBM ratio of 80:20 or less to form malleable, cohesive putty or paste
Mixing the freeze-dried ground particles of the first portion with the gelatin from the second portion at a ratio of 80:20 or less gelatin to DBM to create a malleable and cohesive putty or paste, wherein the putty or paste is moldable into different shapes with no visible cracks and maintains its shape while immersed in normal saline or water for a minimum of one minute.
Two-part cortical bone workflows producing different freeze-dried DBM particle portions
Preparing a first portion of cortical bone by cutting the cortical bone into pieces, freeze-drying the pieces and then grinding into particles and demineralizing the ground particles and thereafter freeze-drying the demineralized ground particles to form a first portion of demineralized bone matrix (DBM) particles; preparing a second portion of cortical bone by shaving cortical bone plates cut into 6.5 cm long pieces, cleaning and then shaving to form shavings, then freeze-drying the shavings, grinding the freeze-dried shavings to obtain a particle size less than 150 μm, and demineralizing the particles thereafter freeze-drying to form a second portion of DBM particles.
Both independent claims require forming gelatin from a DBM particle portion by autoclaving with sterile water and cooling, then mixing gelatin with freeze-dried DBM at a gelatin:DBM ratio of 80:20 or less. The resulting malleable and cohesive putty or paste is defined by crack-free moldability into different shapes and maintaining shape after immersion in normal saline or water for at least one minute.
Stated Advantages
Produces a malleable and cohesive putty or paste that is moldable into different shapes with no visible cracks.
Maintains its shape while immersed in normal saline or water for a minimum of one minute.
Documented Applications
Osteoinduction testing using a C2C12 differentiation assay [procedural detail omitted for safety].
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