US 12,419,991 B2
Bioenergetic bone
Timothy Ganey, Tampa, FL (US); Wendy W. Weston, Miami, FL (US); Miguel Quevedo, Miami, FL (US); Stuart Oglesby, Miami, FL (US); and Tracy Scott Anderson, Atlanta, GA (US)
Assigned to Vivex Biologics Group, Inc., Atlanta, GA (US)
Filed by Vivex Biologics Group, Inc., Atlanta, GA (US)
Filed on May 30, 2022, as Appl. No. 17/827,934.
Application 17/827,934 is a division of application No. 15/818,147, filed on Nov. 20, 2017, granted, now 11,471,559.
Prior Publication US 2022/0288274 A1, Sep. 15, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61L 27/36 (2006.01); A61K 35/28 (2015.01); A61K 35/32 (2015.01)
CPC A61L 27/3608 (2013.01) [A61K 35/28 (2013.01); A61K 35/32 (2013.01); A61L 27/3604 (2013.01); A61L 27/365 (2013.01); A61L 27/3687 (2013.01); A61L 27/3691 (2013.01); A61L 2430/02 (2013.01)] 12 Claims
 
1. A method of making a biological composition, comprising:
(a) grinding a cut vertebral body from a human cadaver donor to produce a mixture comprising crushed vertebral bone and bone marrow;
(b) mechanically separating cellular and non-cellular components of the bone marrow from the vertebral bone in the mixture by tumbling and sieving the vertebral bone from a decanted fluid of the bone marrow comprising cellular components comprising whole cells, and non-whole cellular components comprising non-whole cell components;
(c) concentrating the decanted fluid by centrifugation;
(d) filtering the decanted fluid through a blood filter to form a mixture including the cellular and non-whole cellular components and remove any remaining vertebral bone;
(e) separating the cellular components and non-whole cellular components of the bone marrow directly from the mixture of step (d) by density gradient centrifugation, wherein the separation by centrifugation establishes a cell density gradient;
(f) collecting non-cellular fractions, non-cellular components, or combinations thereof of predetermined density from the gradient;
(g) washing the non-cellular fractions, non-cellular components, or combinations thereof to create a mixture;
(h) suspending the mixture of step (g) to a predetermined concentration in a polyampholyte cryoprotectant to form a coated biological composition;
(i) freezing the coated biological composition at a predetermined controlled rate; and
(j) packaging a bone blend having particles of 100 to 300 μm of demineralized cortical bone, mineralized cortical bone, and mineralized cancellous bone with the coated biological composition.