Bone gel sheet composition and method of manufacture
Inventors
Weston, Wendy W. • Gonzales, Silvia Daniela • Maldonado, Edgar S.
Assignees
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Publication Number
US-11648334-B2
Publication Date
2023-05-16
Expiration Date
Abstract
A bone gel composition consists of cortical bone. The cortical bone is made from cut pieces freeze-dried then ground into particles and demineralized then freeze-dried. A volume of the particles is placed in a solution of sterile water to create a mixture, the water volume being at least twice the particle volume, the mixture is autoclaved under heat and pressure to form a gelatin, the resulting bone gel is formed into sheets having a thickness (t).
Core Innovation
The invention provides a method of making a bone gel composition consisting of cortical bone. Cortical bone is prepared by cutting the cortical bone into pieces, freeze-drying the pieces, and grinding them into particles of a size up to 125 microns. The ground particles are then demineralized and freeze-dried to form DBM particles.
The DBM particles are autoclaved as a volume of the DBM particles mixed with sterile water in a 1:2 ratio by volume for a predetermined time at a pre-set temperature and pressure to form a gelatin. The gelatin consists of the volume of the DBM particles and the sterile water, and the gelatin is cooled to form a bone gel.
The bone gel is formed into sheets of bone gel having a thickness in the range of 1.0 to 10.0 mm. The sheets are cut to a desired circular, semi-circular or polygonal shape, and the cut sheets are frozen either before or after packaging. When the cut sheets are cut into different shapes with no visible cracks, the sheets maintain the cut shape while immersed in normal saline or water for a minimum of one minute.
Claims Coverage
The document contains one independent claim. It includes inventive features that define a cortical-bone-derived DBM particle preparation, autoclaving DBM particles mixed with sterile water to form gelatin, cooling to form a bone gel, sheet formation with a defined thickness range, shaping into specified sheet geometries, and freezing or packaging with a shape-maintenance performance condition in normal saline or water.
Cortical bone to DBM particles by freeze-drying, grinding, demineralizing, and freeze-drying
Preparing cortical bone by cutting the cortical bone into pieces, freeze-drying the pieces and then grinding into particles of a size up to 125 microns and demineralizing the ground particles and then freeze-drying the demineralized ground particles to form DBM particles.
Autoclaving DBM particles with sterile water in a 1:2 ratio to form gelatin
Autoclaving a volume of the DBM particles mixed with sterile water in a 1:2 ratio by volume for a predetermined time at a pre-set temperature and pressure to form a gelatin, the gelatin consisting of the volume of the DBM particles and the sterile water.
Cooling to form a bone gel and forming into thickness-defined sheets
Cooling the gelatin to form a bone gel; forming the bone gel into sheets of bone gel of a thickness in the range of 1.0 to 10.0 mm.
Cutting sheet shapes and freezing or packaging while maintaining shape in saline or water
Cutting the sheets of bone gel to a desired circular, semi-circular or polygonal shape; freezing or packaging the cut sheets of bone gel, wherein the cut sheets of bone gel are frozen either before or after packaging, wherein the sheets of bone gel when cut into different shapes with no visible cracks maintains the cut shape while immersed in normal saline or water for a minimum of one minute.
Overall, the claim coverage centers on making cortical bone-derived DBM particles, autoclaving DBM particles with sterile water in a defined volume ratio to form gelatin that is cooled into a bone gel, shaping the gel into thickness-defined sheets of specified geometries, and freezing or packaging while maintaining cut shape in normal saline or water for at least one minute.
Stated Advantages
Maintains the cut shape while immersed in normal saline or water for a minimum of one minute when cut into different shapes with no visible cracks.
Documented Applications
No documented applications found
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