Claims for Patent: 10,357,593

Summary for Patent: 10,357,593

Title:	Malleable demineralized bone composition and method of manufacture
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.
Inventor(s):	Maldonado; Edgar S. (Miami, FL), Gonzales; Silvia Daniela (Miami, FL)
Assignee:	Vivex Biomedical, Inc. (Atlanta, GA)
Application Number:	15/914,529
Patent 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 .mu.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.

Details for Patent 10,357,593

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2036-04-22