Malleable demineralized bone composition and method of manufacture

• US 10,357,593 B2
• Filed: 03/07/2018
• Issued: 07/23/2019
• Est. Priority Date: 04/22/2016
• Status: Active Grant

• Current Assignee: Vivex Biologics Group, Inc.
• Original Assignee: Vivex Biomedical, Inc. (Vivex Biologic, Inc.)
• Inventors: Maldonado, Edgar S., Gonzales, Silvia Daniela
• Primary Examiner(s): Schillinger, Ann
• Application Number:
  US15/914,529
• Publication Number:
  US 20180193526A1
• Time in Patent Office: 503 Days
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/222 Gelatin
• 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

Abstract

A malleable demineralized bone composition consists of cortical bone made from a first portion and a second portion. The first portion of cortical bone is made from cut pieces freeze dried then ground into particles and demineralized then freeze-dried. The second portion of cortical bone is shaved into shavings. The shavings are long thin strips subjected to freeze-drying. The freeze-dried shavings are ground and demineralized and 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 twice 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.

Claims

1. A method of making a malleable demineralized bone composition consisting of demineralized bone matrix (DBM) particles of cortical bone and water comprises the steps of:

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 DBM particles;

preparing a second portion of cortical bone by shaving wherein cortical bone is cut into long pieces, cleaned and then shaved to form shavings of cortical bone tissue then freeze-drying the shavings, grinding the freeze-dried shavings to obtain a particle size less than 150 μ

m and demineralizing the particles thereafter freeze-drying to form a second portion of DBM particles;

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

1 ratio by volume for a predetermined time of 1.25 hours including condition of 15 minutes, exposure of 30 minutes and drying of 30 minutes at a pre-set temperature and pressure during exposure of 121.1 degrees C. and 30.15 psi respectively to form a gelatin;

cooling the gelatin made from the second portion; and

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 putty or paste.

2. The method of making a malleable demineralized bone composition of claim 1 wherein the second portion is long strips cut from cortical bone, the strips having a length of greater than 5 cm.

3. The method of making a malleable demineralized bone composition of claim 2 wherein the cortical shavings are ground to a particle size up to 125 microns.

4. The method of making a malleable demineralized bone composition of claim 1 wherein the first portion has the cut pieces having a width, a length and a thickness in the range of 1 to 4 mm.

5. The method of making a malleable demineralized bone composition of claim 1 wherein the cortical bone ground particles of the first portion are less than 1000 microns.

6. The method of making a malleable demineralized bone composition of claim 5 wherein the ground particles of the first portion greater than 100 microns.

7. The method of making a malleable demineralized bone composition of claim 5 wherein the ground particles of the first portion are sieved to a first size range of 125 to 300 microns, a second size range 300 to 500 microns and a third range 500 to 850 microns.

8. The method of making a malleable demineralized bone composition of claim 7 wherein the size first through third ranges have a ratio of 40:

40;

20 by weight, respectively.

9. The method of making a malleable demineralized bone composition of claim 1 wherein the ratio of gelatin to particles from the first portion is 80:

20 by volume.

10. The method of making a malleable demineralized bone composition of claim 1 wherein the mixture formed as a malleable putty or paste is packaged in a capped syringe.

11. The method of making a malleable demineralized bone composition of claim 10 wherein the packaged mixture is stored at room temperature.