Demineralized osteochondral plug
A shelf-stable, demineralized, and freeze-dried osteochondral plug comprising cartilage, subchondral bone, and the underlying cancellous bone is provided. Methods of preparing the demineralized osteochondral plug and methods of repairing a defect site are also provided.
1 . A shelf-stable osteochondral plug comprising a layer of cartilage and the underlying bone, wherein the plug is demineralized and freeze-dried.
2 . The osteochondral plug according to claim 1 , wherein the underlying bone comprises the subchondral bone and cancellous bone.
3 . The osteochondral plug according to claim 1 , wherein the osteochondral plug has a water content of less than about 6% by weight.
4 . The osteochondral plug according to claim 1 , wherein the osteochondral plug is demineralized to have a calcium content of less than about 8% by weight.
5 . The osteochondral plug according to claim 1 , wherein the osteochondral plug has a shelf-life of at least about 10 days.
6 . The osteochondral plug according to claim 1 , wherein the osteochondral plug is cylindrical in shape.
7 . The osteochondral plug according to claim 6 , wherein the osteochondral plug is from about 2 millimeters to about 30 millimeters in diameter.
8 . The osteochondral plug according to claim 6 , wherein the osteochondral plug is from about 5 millimeters to about 20 millimeters in height.
9 . The osteochondral plug according to claim 1 , wherein the underlying bone further comprises perforations.
10 . A method of preparing an osteochondral plug comprising:
a. removing from a donor site an intact donor tissue comprising a region of cartilage and the underlying bone;
b. removing a substantial amount of the content of at least one mineral component in the donor tissue; and
c. dehydrating the donor tissue to have a water content of less than about 6% by weight.
11 . The method of claim 10 , wherein the dehydrating is selected from the group consisting of: freeze drying, vacuum drying, air drying, temperature flux drying, organic solvents, and combinations thereof.
12 . The method of claim 11 , wherein the dehydrating is freeze drying.
13 . The method of claim 10 , wherein removing a substantial amount of the content of at least one mineral comprises reducing the calcium concentration in the donor tissue to less than about 8% calcium by weight.
14 . The method of claim 13 , wherein removing a substantial amount of the content of at least one mineral comprises treating the osteochondral plug with a demineralizing agent.
15 . The method of claim 14 , wherein the demineralizing agent is selected from the group consisting of acid-baths, calcium chelator-baths, and combinations thereof.
16 . The method of claim 10 , further comprising storing the osteochondral plug for a period of greater than about 10 days.
17 . A method of repairing a cartilage defect site, comprising:
a. hydrating a shelf-stable demineralized osteochondral plug with a hydrating fluid;
b. preparing a defect site to receive the demineralized osteochondral plug; and
c. applying the osteochondral plug to the defect site.
18 . The method according to claim 17 , wherein preparing the defect site comprises providing an opening in the bone to receive the demineralized osteochondral plug.
19 . The method according to claim 17 , further comprising shaping the demineralized osteochondral plug to facilitate a press-fit into the defect site.
20 . The method according to claim 19 , wherein shaping the demineralized osteochondral plug comprises contouring a bone region of the demineralized osteochondral plug to the same or larger dimensions than a damaged cartilage region in the defect site.
21 . The method according to claim 17 , wherein the hydrating fluid is an aqueous fluid selected from the group consisting of: water, saline, blood, blood products, platelet concentrate, growth factor solution, and combinations thereof.
22 . The method according to claim 17 , wherein the hydrating occurs immediately prior to the applying of the demineralized osteochondral plug to the defect site.
23 . The method according to claim 17 , further comprising adding a tissue-health promoting agent to the demineralized osteochondral plug, wherein the tissue-health promoting agent is selected from the group consisting of: chondrocytes, undifferentiated cells, differentiation media, growth factors, platelet concentrate, nutrients, bone morphogenic proteins, osteogenic factors, and combinations thereof.