Abstract: The invention is directed toward a method and instrumentation to replace a damaged human knee joint meniscus with an allograft meniscus. The implant has its bone base cut to a desired width in a workstation. The finished base is measured in the sizing groove of the sizing block for width and length. The tibia is then drilled with drill to the appropriate depth and length and groove is formed in the tibia with a tissue chisel so that the width is the same as the width of the bone base. The bone base is press fit into the tibia groove and may be secured with a bone screw.

Abstract: An implant inserter device having an outer collar, an inner sleeve slidably and rotatably received within the outer collar, and a push rod slidably received within the inner sleeve. The outer collar has at least one cammed surface formed on an interior surface thereof, while the inner sleeve has at least one rib projecting outwardly from an exterior surface thereof. The rib is releasably engageable with the cammed surface when the inner sleeve is rotated relative to the outer collar. As a result, a distal end of the inner sleeve collapses from an undeformed position, in which the inner sleeve does not grip an implant housed therein, and a deformed position, in which the inner sleeve grips the implant. The push rod is movable between an extended position and a retracted position for urging the implant through and from the inner sleeve for insertion into a defect in damaged cartilage and bone.

Abstract: A composition for spinal disc repair comprising a plurality of uniformly shaped demineralized cancellous bone pieces ranging in size from about 2.0 mm to about 4.0 mm loaded into a porous mesh container with the cancellous bone pieces being treated so that they are not osteoinductive and are packed in the porous mesh container under compression forces.

Abstract: Described herein are methods and compositions related to biologic matrices comprising at least one anti-infective. In certain embodiments, the invention relates to a biologic matrix comprising a slowed release anti-infective agent. In a particular embodiment, the invention relates to an acellular dermal matrix comprising a slowed release antiinfective agent, wherein the anti-infective agent is triclosan. In further embodiments, the the biologic matrix is suitable for use in surgical procedures, such as, for example, for the replacement of damaged or inadequate integumental tissue or for the repair, reinforcement or supplemental support of soft tissue defects.

Abstract: A meniscus repair composition for application to a meniscus defect site to promote growth of new tissue at the meniscus defect site is provided. The composition comprises: from about 10 to about 50 percent by weight of allograft meniscus particles having an average particle size of from about 10 ?m to about 500 ?m; a carrier selected from the group consisting of sodium hyaluronate, gelatin, collagen, polyethylene glycol, glycerin, carboxymethylcellulose, dextrose, blood derivatives, aqueous solutions thereof, and mixtures thereof; and a curing agent. The curing agent may be the carrier where the carrier is cross-linkable. When introduced to a defect site in a meniscus and cured, the composition will not flow away from the defect site, and the composition is non-adhering to the defect site after it is cured.

Abstract: A meniscus repair composition for application to a meniscus injury to promote growth of new tissue at the meniscus injury site is provided. The composition comprises: from about 10 to about 50 percent by weight of allograft meniscus particles having an average particle size of from about 10 ?m to about 500 ?m; and a carrier comprising a solid fibrin web matrix. When introduced to a defect site in a meniscus, the composition is non-adhering to the defect site. A method for repairing a meniscus injury comprises administering a meniscus repair composition to the injury site.

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: 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 present invention relates to a process for preparing skin removed from a human donor, removal of cellular components and sterilizing the decellularized skin. The process comprises the following steps: (1) decellularizing the skin, including inspection for visual defects, trimming and soaking the tissue in a detergent and rinsing same with sterile water; (2) sterilizing the skin under pressure at a temperature for a time period to maximize sterilization; and (3) processing the tissue by cutting the tissue to size.

Abstract: The present invention is a process for preparing soft tissue such as tendons, ligaments, cartilage, fascia, dermis, human valves and human veins for implant in a human and removes cellular components and forms an decellular matrix having as major components collagens and elastins while sterilizing the tissue. The process comprises the following steps: (1) isolating from a suitable donor a desired soft tissue sample of the biological material; (2) processing and decellularizing the soft tissue including inspection for visual defects, trimming and soaking the tissue in a detergent depending on whether the tissue is fascia or dermis and rinsing same with sterile water; (3) sterilizing the soft tissue in a vacuum and soaking the tissue in an antibiotic composition or peracetic acid depending on whether the soft tissue is fascia or dermis and rinsing same; (4) processing the tissue by cutting the tissue to size and perforating the tissue; and (5) dipping the tissue in 70% ethanol and packaging the tissue.

Abstract: The present invention is a process for preparing skin removed from a human donor, removal of cellular components and sterilizing the decellularized skin. The process comprises the following steps: (a) decellularizing the skin including soaking the skin in a detergent and rinsing same with sterile water; (b) sterilizing the skin under vacuum with one or more of ozone, vapor H2O2, plasma H2O2, ethylene oxide gas, or sodium hydroxide for a time period to achieve a concentration to achieve sterilization of the skin; and (c) processing the skin by cutting the skin to a designated size.

Abstract: The invention is directed toward a cartilage repair assembly comprising a shaped allograft two piece construct with a demineralized cancellous cap and a mineralized cylindrical base member defining a blind bore with a through going transverse bore intersecting the blind bore. The demineralized cancellous cap has a cylindrical top portion and a smaller diameter cylindrical stem extending away from the top portion which fits into the blind bore of the mineralized base member. The cap stem defines a transverse through going bore which is aligned with the through going bore of the base member to receive a cylindrical cortical pin holding the cap within the base member. The shaped structure is dimensioned to fit in a drilled bore in a cartilage defect area so that the assembly engages the side wall of the drilled bore in an interference fit.

Abstract: The present invention relates to a process for preparing skin removed from a human donor, removal of cellular components and sterilizing the decellularized skin. The process comprises the following steps: (1) decellularizing the skin including soaking the tissue in a detergent and rinsing same with sterile water; (2) sterilizing the skin with electronic beam irradiation, gamma irradiation or ultraviolet light for a time period to achieve a concentration to maximize sterilization; and (3) processing the tissue by cutting the tissue to a designated size.

Abstract: An implant for articular cartilage repair includes (1) a three-dimensional body formed of cancellous bone having a demineralized section that contains bone morphogenetic proteins (BMP's) that are released by the demineralization but retained in the body, and (2) a cartilage layer formed on a surface of the demineralized section. The cartilage layer is formed by a method including the steps of (a) isolating chondrocytes from articular cartilage of a donor; (b) cultivating the isolated chondrocytes in a medium; (c) suspending the cultivated chondrocytes in agarose; (d) adding the cultivated chondrocytes to the demineralized section of the body, whereby the cultivated chondrocytes are stimulated by the BMP's retained in the body; and (e) incubating the cultivated chondrocytes to form a plurality of layers of chondrocytes on the demineralized section, wherein the plurality of layers of chondrocytes forms the cartilage layer.

Abstract: A portable surgical workstation for implant formation comprising a base with a central planar section. The central planar section has a plurality of tracks and a throughgoing slot with a recessed stepped surrounding surface formed on a bottom surface of the central planar section. A vise assembly mounted to the base comprises a fixed jaw member secured to the base, a traveling jaw member moveably mounted to the base and a fixed drive housing mounted to the base. The traveling jaw member has a plurality of rail members adapted to be slidably mounted in the central planar section tracks. The fixed drive housing has a threaded longitudinal bore which receives a threaded drive shaft, one end of the drive shaft being secured in the traveling jaw member to transport the traveling jaw member.

Abstract: A portable surgical workstation for implant formation comprising a base with a central planar section. The central planar section has a plurality of tracks and a throughgoing slot with a recessed stepped surrounding surface formed on a bottom surface of the central planar section. A vise assembly mounted to the base comprises a fixed jaw member secured to the base, a traveling jaw member moveably mounted to the base and a fixed drive housing mounted to the base. The traveling jaw member has a plurality of rail members adapted to be slidably mounted in the central planar section tracks. The fixed drive housing has a threaded longitudinal bore which receives a threaded drive shaft, one end of the drive shaft being secured in the traveling jaw member to transport the traveling jaw members.

Abstract: The present invention is a process for preparing soft tissue such as tendons, ligaments, cartilage, fascia, dermis, human valves and human veins for implant in a human and removes cellular components and forms an decellular matrix having as major components collagens and elastins while sterilizing the tissue. The process comprises the following steps: (1) isolating from a suitable donor a desired soft tissue sample of the biological material; (2) processing and decellularizing the soft tissue including inspection for visual defects, trimming and soaking the tissue in a detergent depending on whether the tissue is fascia or dermis and rinsing same with sterile water; (3) sterilizing the soft tissue in a vacuum and soaking the tissue in an antibiotic composition or peracetic acid depending on whether the soft tissue is fascia or dermis and rinsing same; (4) processing the tissue by cutting the tissue to size and perforating the tissue; and (5) dipping the tissue in 70% ethanol and packaging the tissue.

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 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 polymers with allogenic chondrocytes or bone marrow cells in an amount exceeding the natural occurrence of same in hyaline cartilage and adding a cell growth additive.

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 polymers with allogenic chondrocytes or bone marrow cells in an amount exceeding the natural occurrence of same in hyaline cartilage and adding a cell growth additive.