Cohesive bone composition

• US 10,123,876 B2
• Filed: 07/12/2017
• Issued: 11/13/2018
• Est. Priority Date: 04/22/2016
• Status: Active Grant

• Current Assignee: Vivex Biologics Group, Inc.
• Original Assignee: Vivex Biomedical, Inc. (Vivex Biologic, Inc.)
• Inventors: Namin, Shabnam, Weston, Wendy W., Maldonado, Edgar S., Gonzales, Silvia Daniela
• Primary Examiner(s): Stewart, Alvin
• Application Number:
  US15/647,995
• Publication Number:
  US 20170312081A1
• Time in Patent Office: 489 Days
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/4644 Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material bone material A61F2/28; disintegrating or milling devices B02C
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2310/00359 Bone or bony tissue
• CPC Class Codes: A61K 35/32 Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/365 Bones
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids

Abstract

A cohesive bone composition is made from a moldable bone composition intermixed with a bone gel composition. The cohesive bone composition is made from human cadaver bone. A fluid can be added, the fluid may also be laden with cells.

Claims

1. A method of manufacturing a cohesive bone composition of a mixture of a moldable bone composition and a bone gel composition comprises the steps of:

wherein the method of manufacturing a moldable bone composition comprises the steps of;

cutting cortical bone plates into long pieces;

shaving the cortical bone plates to form cortical strands or shavings 3 mm or greater in length;

demineralizing a first portion of the cortical shavings;

grinding another portion of the cortical shavings;

resulting in cortical bone having three portions, a demineralized cortical shavings portion, a mineralized cortical shavings portion and a powered cortical portion;

cutting and grinding cancellous bone to form a portion of mineralized crushed cancellous bone from a size of 1000 to 1700 microns;

freeze-drying each portion;

mixing together all of the portions in a predetermined ratio to form a freeze-dried composition; and

wherein the method of making a bone gel composition consisting of cortical bone comprises the steps of;

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 the freeze-drying the demineralized ground particles to form DBM particles;

autoclaving a volume of the DBM particles mixed with sterile water in a 2;

1 ratio by volume for a predetermined time at a pre-set temperature and pressure to form a gelatin;

cooling the gelatin to form a bone gel composition;

packaging the resulting bone gel composition; and

wherein a volume of moldable bone composition is mixed with a volume of the bone gel composition and wetted with a fluid to form the cohesive bone composition.

2. The method of manufacturing a cohesive bone composition of claim 1 further comprises the step of adding a vial of fluid to the packages.

3. The method of manufacturing a cohesive bone composition of claim 2 wherein the vial of fluid can be sterile water, lactated Ringer'"'"'s solution, normal saline, plasma, blood or any other commonly used material with or without cells added.