Moldable bone composition

• US 10,463,767 B2
• Filed: 04/22/2016
• Issued: 11/05/2019
• Est. Priority Date: 04/22/2016
• Status: Active Grant

• Current Assignee: Vivex Biologics Group, Inc.
• Original Assignee: Vivex Biologics Group, Inc.
• Inventors: Maldonado, Edgar S., Gonzales, Silvia Daniela, Weston, Wendy W., Namin, Shabnam
• Primary Examiner(s): Schillinger, Ann
• Application Number:
  US15/136,339
• Publication Number:
  US 20170304053A1
• Time in Patent Office: 1,292 Days
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• 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: 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 27/3691 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

Abstract

A moldable bone composition consists 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 free-dried and mixed together to form a freeze-dried moldable bone composition.

Claims

1. A moldable bone composition for treatment of osseous defects and bone voids consisting of a mixture of:

cortical bone and cancellous bone, the cortical bone is formed in three portions, a dry mineralized shaving portion and a dry demineralized shaving portion and a dry mineralized powder portion;

the cancellous bone is formed in a dry mineralized crushed cancellous portion, the portions are each dried by freeze-drying and mixed together to form a freeze-dried bone composition having four primary freeze-dried elements in a particular ratio or proportion forming the mixture, the freeze-dried bone composition packaged in a container with the mixture of the four primary freeze-dried elements dry configured to be molded to a desired shape by a physician after opening the package and wetting the composition with a suitable liquid to achieve moldable characteristics;

a quantity of cells including stem cells suspended in a volume of suitable liquid or fluid in a vial for wetting the bone composition to form a wetted moldable bone composition configured to be molded into the desired shape for packing a spinal fusion implant or a bone defect or void; and

wherein the freeze-dried bone composition in the container has the quantity of cells, including stem cells suspended in the liquid poured from the vial into the container to create the wetted bone composition with cells.

2. The moldable bone composition of claim 1 wherein the crushed cancellous bone is made from freeze-dried morselized cancellous ground to a size of 1000 to 1700 microns.

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

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

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

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

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

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

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

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

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

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

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