BONE MATRIX WITH CHANNELS TO DELIVER DESIRED AMOUNT OF HYDRATION, METHOD OF MAKING AND METHOD OF USING THE SAME
The present invention relates to shaped, bone-based products for the delivery of a measured quantity of biologic material for use. The products can be used alone or in combination with a biologic material as a surgical implant. The present invention also relates to a method to make the product and a method of using the product.
1 . A shaped product comprising a bone material wherein the product is configured to define at least one channel and/or void having a volume to receive at least one biologic material.
2 . The product of claim 1 , wherein the shaped product is selected from the group consisting of a cylinder, a cube, a block, a strip, a sphere, a disc, a doughnut and combinations thereof.
3 . The product of claim 1 , wherein a shape of the at least one channel and/or void is selected from the group consisting of a cylinder, a cone, a cube, a block, a strip, a sphere, a disc, a doughnut and combinations thereof
4 . The product of claim 1 , wherein the at least one biologic material is selected from the group consisting of a bone marrow aspirate, a serum albumin, a whole blood, a plasma, a concentrated bone marrow aspirate, a platelet rich plasma, and combinations thereof
5 . The product of claim 1 , wherein the volume of the at least one channel and/or void to receive the at least one biologic material and a volume of the shaped, bone-based product have an established ratio.
6 . The product of claim 5 , wherein the established ratio is between about 10:1 and about 1:1.
7 . The product of claim 1 , wherein the product receives the biologic material, and wherein the biologic material is selected from the group consisting of a bone marrow aspirate, a whole blood, a serum albumin, a plasma, a concentrated bone marrow aspirate, a platelet rich plasma, and combinations thereof.
8 . The product of claim 1 , wherein the bone material is mineralized, partially demineralized, fully demineralized, or combinations thereof.
9 . The product of claim 1 , wherein the bone material is selected from the group consisting of bone fibers, bone particles, a bone sponge, and combinations thereof.
10 . The product of claim 1 , wherein the product further comprises at least one bioactive agent, at least one crystalloid, at least one colloid, at least one polymer, and at least one carrier.
11 . The product of claim 1 , wherein the product is at least partially dehydrated and a residual moisture content of the product is less than about 20%.
12 . The product of claim 1 , wherein the product is compressible to about 10% of a pre-dehydration size.
13 . The product of claim 1 , wherein a ratio of void (porosity) to the bone material of the product is between about 1:99 and about 1:11 to provide a porous bone material.
14 . The product of claim 1 , wherein a material of the bone is an allogeneic tissue, an autogeneic tissue, a xenogeneic tissue, or combinations thereof.
15 . The product of claim 13 , wherein the at least one channel and/or void to porous bone material ratio is between about 15:1 and about 1:1.
16 . A method to form a shaped product, comprising: forming a shaped product, wherein the shaped product comprises at least one channel and/or void, and wherein the at least one channel and/or void provides a rehydrating fluid to the product.
17 . The method of claim 16 , wherein the at least one channel and/or void are formed with a mold.
18 . The method of claim 16 , wherein the at least one channel and/or void are formed after the product is formed by removing material of the product.
19 . A method to implant a shaped bone based implant product, wherein the product comprises at least one channel and/or void, comprising:
providing a rehydrating fluid to the at least one void or channel;
rehydrating the product; and
providing the bone product to a patient.
20 . The method claim 19 , further comprising providing the product is provided to the patient using an implant tool.