Cohesive bone composition

• US 9,788,950 B1
• Filed: 04/22/2016
• Issued: 10/17/2017
• Est. Priority Date: 04/22/2016
• Status: Active Grant

• Current Assignee: Vivex Biologics Group, Inc.
• Original Assignee: Vivex Biomedical, Inc. (Vivex Biologic, Inc.)
• Inventors: Weston, Wendy W., Maldonado, Edgar S., Gonzales, Silvia Daniela, Namin, Shabnam
• Primary Examiner(s): Stewart, Alvin
• Application Number:
  US15/136,534
• Publication Number:
  US 20170304055A1
• Time in Patent Office: 543 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 cohesive bone composition comprises:

a moldable bone composition mixed with a bone gel composition;

the moldable bone composition consisting of a mixture of cortical bone and cancellous bone, the cortical bone is formed in three portions, a mineralized shaving portion and a demineralized shaving portion and a mineralized powder portion, the cancellous bone is formed in a mineralized crushed cancellous portion, the portions are freeze-dried and mixed together to form a freeze-dried bone composition and when subjected to a fluid, the composition can be molded to a desired shape;

the bone gel composition consisting of cortical bone consists of cortical bone made from cut pieces freeze dried then ground into particles and demineralized then freeze-dried, wherein a volume of the particles is placed in a solution of sterile water to create a mixture, the water volume being twice the volume of the particles, the mixture is autoclaved under heat and pressure to form a gelatin, the resulting bone gel is placed in jars for later use; 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 cohesive bone composition of claim 1 wherein the moldable bone composition crushed cancellous bone is made from freeze-dried morselized cancellous ground to a size of 1000 to 1700 microns.

3. The cohesive bone composition of claim 1 wherein the moldable bone composition cortical bone powder is ground to 300 microns or less.

4. The cohesive bone composition of claim 1 wherein the moldable bone composition cortical shavings are long thin strips cut from cortical bone plates having a length of greater than 5 cm.

5. The cohesive bone composition of claim 4 wherein the moldable bone composition cortical shavings are strands having a length greater than 3 mm.

6. The cohesive bone composition of claim 1 wherein the moldable bone composition mixture has a percentage of demineralized cortical bone shaving portion by weight in the range of 15 to 25%.

7. The cohesive bone composition of claim 1 wherein the moldable bone composition mixture has a percentage of mineralized dry cortical bone shaving by volume in the range of 70 to 50%.

8. The cohesive bone composition of claim 1 wherein the moldable bone composition mixture has a percentage of mineralized dry cortical bone powder by volume in the range of 5 to 15%.

9. The cohesive bone composition of claim 1 wherein the moldable bone composition mixture has a percentage of dry crushed cancellous by volume in the range of 5 to 15%.

10. The cohesive bone composition of claim 1 wherein the moldable bone composition has a percentage of demineralized cortical bone shaving by weight of 20%.

11. The cohesive bone composition of claim 1 wherein the moldable bone composition has a percentage of dry mineralized cortical bone shaving by volume of 60%.

12. The cohesive bone composition of claim 1 wherein the moldable bone composition has a percentage of dry cortical bone powder by volume of 10%.

13. The cohesive bone composition of claim 1 wherein the moldable bone composition has a percentage of dry crushed cancellous by volume of 10%.

14. The cohesive bone composition of claim 1 wherein the moldable bone composition has a percentage of 20% demineralized cortical bone shaving, 60% dry mineralized cortical bone shaving, 10% dry cortical bone powder and 10% dry crushed cancellous.

15. The cohesive bone composition of claim 1 wherein the moldable bone composition formed as a freeze-dried material packaged in jars wherein the packaged mixture is stored at room temperature or frozen.

16. The cohesive bone composition of claim 1 wherein the bone gel composition cortical bone has the cut pieces having a width, a length and a thickness in the range of 1 to 4 mm.

17. The cohesive bone composition of claim 16 wherein the bone gel composition cortical bone pieces are ground to a particle size up to 125 microns.

18. The cohesive bone composition of claim 1 wherein the bone gel composition when placed in jars is then frozen.