Abstract: The present invention is a kit and a method of using a kit for treating bone including a fill material mixture made of osteoconductive material, osteoinductive material and a lubricating carrier, a porous container to receive the fill material mixture and a tool that flowably introduces the fill material mixture into the porous container.

Abstract: Mixtures, such as gels or pastes, comprising freeze-milled cartilage particles and exogenous growth factors are used for repairing chondral defects. Such mixtures may be applied to constructs comprising cancellous bone for implantation at the defect site. Suitable growth factors include variants of FGF-2, particularly variants that include a sole amino acid substitution for asparagine at amino acid 111 of the ?8-?9 loop of the FGF-2 peptide. Such FGF-2 variants are released slowly and continuously at a constant rate from cartilage pastes. In other embodiments, the amino acid substituted for asparigine is glycine. Other variants that may be used include FGF-9 variants having truncated chains and a sole amino acid substitution in the ?8-?9 loop of the FGF-9 peptide either for tryptophan at amino acid 144 or for asparagine at amino acid 143.

Abstract: The invention is directed toward a composite material for use in a medical application, comprising a biological material and a reinforcement material. The biological material may be overlayed onto the reinforcement layer, or the material may be attached together. In one embodiment, the composite material may be arranged in layers, such that the biological material is in a first layer and the reinforcement material is in a second layer. In another embodiment, the reinforcement material may be in a layer sandwiched between two layers of biological material. In a certain embodiment, the reinforcement material is in the form of a mesh.

Abstract: In certain embodiments, the present invention relates to a process for preparing skin removed from a human donor, including a living human donor, and removing cellular components and forming a decellular matrix having as major components collagens and elastins while disinfecting the tissue. In other embodiments, the present invention relates to a process for treating a decellularized soft tissue by freezing the same at a plurality of decreasing temperatures at atmosphere or higher such that there is formation of ice crystals having a size greater than 2.0 and lyophilizing the soft tissue under vacuum to remove the water to less than 6% forming a porous matrix.

Abstract: Constructs that are at least partially constructed of allograft cancellous bone are disclosed, along with cartilage particles that may be used with the constructs for repairing articular cartilage defects. A multi-piece construct includes a base member, a cap member and at least one pin that secures the cap member to the base member. The base member may be constructed of mineralized cancellous bone, and is used to replace the subchondral bone removed when a surgeon cuts a bore in the area of an adjacent cartilage defect. The base member includes a blind bore and first and second through-going transverse bores in opposite sides of a wall of the base member. The cap member includes an upper section that has a thickness that is similar to that of a patient's surrounding articular cartilage layer and a stem depending from the upper section that is dimensioned to be received in and by the blind bore of the base member.

Abstract: An allograft osteochondral plug is combined with a mixture that includes freeze-milled cartilage particles, and such combination is used to repair defects in articular cartilage. The plug includes an subchondral bone portion and an integral overlying cartilage cap which is treated to remove cellular debris and proteoglycans. At least a portion of the plug has a lateral dimension selected to form an interference fit against a tissue layer exposed as a result of a bore formed in a defect area in articular cartilage of a host. The cartilage particle mixture is placed adjacent at least a portion of the plug for promoting cartilage cell migration into (i.e., from the adjacent host cartilage) and proliferation in the bore, and for enhancing tissue integration between the plug and patient (i.e., host) tissue when the plug is inserted into the bore. Methods for surgical implantation of the plug into a patient are also disclosed.

Abstract: The invention is directed toward an osteoimplant for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing composition of demineralized allograft bone material mixed with an aqueous phosphate buffered gelatin which when lyophilized to remove water from the composition crosslinks the gelatin to form a solid structure and when rehydrated is flexible

Abstract: The invention is directed toward an improved formable bone composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing compound of demineralized lyophilized allograft bone particles ranging from about 100 to 850 microns. The bone particles are mixed in an excipient carrier combination containing carboxymethylcellulose, sodium hyaluronate, and a sodium phosphate saline buffer, the carboxymethylcellulose component of the carrier ranging from about 5.0 to about 11.0% of the composition and the sodium hyaluronate component of the carrier ranging from about 0.3 to about 0.7% of the composition, the composition having a pH between 6.5-7.5.

Abstract: The invention is directed toward a cartilage repair assembly comprising a shaped allograft structure of subchondral bone with an integral overlying cartilage cap which is treated to remove cellular debris and proteoglycans and milled allograft cartilage in a bioabsorbable carrier. The shaped structure is dimensioned to fit in a drilled bore in a cartilage defect area so that either the shaped bone or the cartilage cap engage the side wall of the drilled bore in an interference fit and is in contact with a milled cartilage and biocompatible carrier mixture allowing cell transfer throughout the defect area. A method for inserting the shaped allograft structure into a cartilage defect area is also disclosed.

Abstract: The invention is directed toward a cartilage repair assembly comprising a shaped structure of subchondral bone with an integral overlying cartilage cap which is treated to remove cellular debris and proteoglycans and milled cartilage in a bioabsorbable carrier. The shaped structure is dimensioned to fit in a drilled bore in a cartilage defect area so that said shaped bone and cartilage cap when centered in the bore does not engage the side wall of the bore in an interference fit and is surrounded by milled cartilage and carrier. A method for inserting the assembly into a cartilage defect area is disclosed.

Abstract: The invention is directed toward a cartilage repair assembly comprising a cylindrically shaped allograft structure of subchondral bone with an integral overlying smaller diameter cartilage cap which is treated to remove cellular debris and proteoglycans. The shaped structure is dimensioned to fit in a drilled bore in a cartilage defect area so that the subchondral bone of the structure engages the side wall of the bone portion of the drilled bore in an interference fit while the cartilage cap is spaced from cartilage portion of the side wall of the drilled bore forming a gap in which a milled cartilage and biocompatible carrier mixture is placed allowing cell transfer throughout the defect area. A method for inserting the shaped allograft structure into a cartilage defect area is also disclosed.

Abstract: The invention is directed toward a cartilage repair assembly comprising a shaped structure of subchondral bone with an integral overlying cartilage cap which is treated to remove cellular debris and proteoglycans and milled cartilage in a bioabsorbable carrier. The shaped structure is dimensioned to fit in a drilled bore in a cartilage defect area so that said shaped bone and cartilage cap when centered in the bore does not engage the side wall of the bore and is positioned from the side wall of the bone a distance ranging from 10 microns to 1000 microns and is surrounded by milled cartilage and a fibrin thrombin glue. A method for inserting the assembly into a cartilage defect area is disclosed.

Abstract: A method for producing a cleaned bone graft with osteoinductivity above 2.0 suitable for transplantation into a human. The first step is sonicating a bone graft in a nonionic detergent in an ultrasonic cleaner at a temperature ranging from about 33° C. to about 37° C. and for a time period ranging from 15 minutes to 2 hours effective to produce a cleaned bone graft essentially free from bone marrow. The bone graft is sonicated in purified water in an ultrasonic cleaner at a temperature ranging from about 33° C. to about 37° C. a plurality of times to remove the detergent producing a cleaned bone graft. The bone graft is then sonicated in hydrogen peroxide in an ultrasonic cleaner at a temperature ranging from about 33° C. to about 37° C. for a time period ranging from 10 minutes to about 2 hours effective to retain osteoinductivity of the bone graft and again sonicated in purified water in an ultrasonic cleaner at a temperature ranging from about 33° C. to about 37° C.

Abstract: The invention is directed toward a sterile cartilage defect implant material comprising milled lyophilized allograft cartilage pieces ranging from 0.01 mm to 1.0 mm in size in a bioabsorbable carrier taken from a group consisting of sodium hyaluronate, hyaluronic acid and its derivatives, gelatin, collagen, chitosan, alginate, buffered PBS, Dextran or mixed polymers with allograft chondrocytes added in an amount ranging from 2.5×105 to 2.5×107.

Abstract: The invention is directed toward a bone block, a bone-tendon-bone assembly and method of tendon reconstruction in which at least one tendon replacement is extended between two bone blocks and fixed within each of two bone tunnels in the bones of a joint using interference screws. Each bone block has a central through going bore and at least one substantially parallel channel longitudinally cut in the exterior of the bone block body in which the ligament replacements are seated. One end of each bone block has a rounded recess leading from the central bore to the exterior parallel channel.

Abstract: The invention is directed toward a bone block, a bone-tendon-bone assembly and method of tendon reconstruction in which at least one tendon replacement is extended between two bone blocks and fixed within each of two bone tunnels in the bones of a joint using interference screws. Each bone block has a central through going bore and at least one substantially parallel channel longitudinally cut in the exterior of the bone block body in which the ligament replacements are seated. One end of each bone block has a rounded recess leading from the central bore to the exterior parallel channel.

Abstract: The invention is directed toward a bone block, a bone-tendon-bone assembly and method of tendon reconstruction in which at least one tendon replacement is extended between two bone blocks and fixed within each of two bone tunnels in the bones of a joint using interference screws. Each bone block has a central through going bore and at least one substantially parallel channel longitudinally cut in the exterior of the bone block body in which the ligament replacements are seated. One end of each bone block has a rounded recess leading from the central bore to the exterior parallel channel.

Abstract: The invention is directed toward a bone block, a bone-tendon-bone assembly and method of tendon reconstruction in which at least one tendon replacement is extended between two bone blocks and fixed within each of two bone tunnels in the bones of a joint using interference screws. Each bone block has a central through going bore and at least one substantially parallel channel longitudinally cut in the exterior of the bone block body in which the ligament replacements are seated. One end of each bone block has a rounded recess leading from the central bore to the exterior parallel channel.

Abstract: A sterile implant for treatment of a spinal disc defect comprising an allograft cortical bone demineralized to a Type I collagen having a specific shape which is treated to eliminate osteoinductivity. The implant is lyophilized and compressed into smaller first shape which 20 to 80% from its original shape in at least one dimension and hardened. The implant expanding when hydrated into a second shape having the shape memory of the first shape and expanded in dimensional size from the first compressed shape.

Abstract: The invention is directed toward a malleable bone putty and a flowable gel composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing compound of demineralized lyophilized allograft bone powder. The bone powder has a particle size ranging from about 100 to about 850 microns and is mixed in a high molecular weight hydrogel carrier, the hydrogel component of the carrier ranging from about 0.3 to 3.0% of the composition and having a molecular weight of about at least 10,000 Daltons. The composition contains about 25% to about 40% bone powder and can be additionally provided with BMP's and a sodium phosphate buffer.