Malleable demineralized bone composition and method of manufacture

• US 10,596,298 B2
• Filed: 04/22/2016
• Issued: 03/24/2020
• 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
• Primary Examiner(s): Schillinger, Ann
• Application Number:
  US15/136,301
• Publication Number:
  US 20170304494A1
• Time in Patent Office: 1,432 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 malleable demineralized bone composition consisting of cortical bone wherein a first portion of cortical bone is made from cut pieces freeze dried then ground into particles and demineralized then freeze-dried and a second portion of cortical bone is shaved into shavings, the shavings being strips subjected to freeze-drying, the freeze-dried shavings being ground and demineralized to a particle size up to 125 microns and then freeze-dried a second time;

and wherein a volume of the freeze-dried particles of the second portion placed in a solution of sterile water to create a mixture, the water volume being twice the volume of freeze-dried particles of the second portion, the mixture consisting of only demineralized cortical bone particles up to 125 microns and sterile water is autoclaved over 1.25 hours including conditioning of 15 minutes, exposure of 30 minutes and drying of 30 minutes, the exposure being under heat of 121.1 degrees C. at a pressure of 30.15 psi to liquify the bone particles to form a gelatin, the gelatin being cooled not to exceed 40°

C. when the first portion is mixed with the liquid gelatin and thereafter cooled to form a malleable putty or paste, wherein the ratio of gelatin to particles from the first portion is 80;

20 by volume and 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 and wherein the first size through second size and third size have a ratio of 40;

40;

20 by weight, respectively.

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

3. The 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.

4. The malleable demineralized bone composition of claim 1 wherein the cortical bone ground particles of the first portion are less than 850 microns.

5. The malleable demineralized bone composition of claim 4 wherein the ground particles of the first portion greater than 125 microns.

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

7. The malleable demineralized bone composition of claim 6 wherein the packaged mixture is stored at room temperature.