Abstract: Systems and methods for the automated demineralization of bone and decellularization of soft tissue include a mixing assembly communicatively coupled with a control and reporting system. The mixing assembly includes a housing that supports a cannister sub-assembly forming a mixing chamber having a reagent inlet, a reagent outlet, and an internal fluid agitator. A motor is operably coupled with the agitator and configured to spin the agitator in first and second directions relative to the cannister, thereby agitating fluid contained within the mixing chamber. At least one pump is configured to progressively inject measured quantities of a plurality of reagents into the mixing chamber. The associated control and reporting system includes a user terminal that displays a graphical user interface enabling a user to initiate an automated demineralization or decellularization procedure in which the mixing assembly demineralizes tissue placed within the mixing chamber. Other embodiments are also disclosed.

Abstract: There is disclosed a system and methods for safely and securely gripping osseous-based tissue during allograft processing. One embodiment includes a first forceps half pivotally coupled to a second forceps half, where the first and the second forceps halves combine to form a handle portion and a head portion. The handle portion may define a first longitudinal axis, and the head portion may define a second longitudinal axis that intersects the first longitudinal axis at a varying head angle. The first and the second halves move between an open position in which the first and second forceps halves at the head portion are separated and a closed position in which the first and second forceps halves at the head portion are together. The forceps may also include an open-biasing spring element attached between the first and second forceps halves and a selective locking mechanism. Other embodiments are also disclosed.

Abstract: An extraction system for testing microbial contamination includes a biocompatible outer vessel that has a side wall and a biocompatible suspension system that is positionable within an interior of the biocompatible outer vessel. The biocompatible suspension system includes a horizontal member on which a sample may be supported and a securement mechanism that is engagable with the side wall of the biocompatible outer vessel to maintain the suspension system at a desired position within the biocompatible outer vessel.

Abstract: There is disclosed an acellular dermal matrix (ADM) graft stored as a packaged ADM graft pocket product prepared by a process that includes providing a portion of ADM tissue having a thickness between 1 mm and 2 mm. The process includes scoring the portion of the ADM tissue into a pre-defined shape to form the domed shape ADM graft. The process includes verifying the thickness of the domed shape ADM graft; shaping the domed shape ADM graft to form an ADM graft pocket configured to receive a breast implant. The process includes packaging the ADM graft pocket to form a packaged ADM graft pocket. The process includes irradiating the packaged ADM graft pocket to a sterility assurance level of a desired level to form the packaged ADM graft pocket product. Other embodiments are also disclosed.

Abstract: There is disclosed apparatus for effecting osteochondral restoration. In an embodiment, the apparatus includes a tube having a distal end, a proximal end and a lumen extending therebetween. A drill shaft is rotatably disposed in the lumen of the tube, the drill shaft comprising a distal end and a proximal end. At least one cutting blade is disposed at the distal end of the drill shaft. A coring housing extends from the distal end of the tube and disposed around the at least one cutting blade, the coring housing terminating in a distal cutting surface. Other embodiments are also disclosed.

Abstract: The disclosure provides bone graft materials, methods for their use and manufacture. Exemplary bone graft materials comprise combining a radiopaque component with a cancellous bone component to produce a bone graft material, wherein the cancellous bone component comprises native osteoreparative cells. Methods for treating a subject with the bone graft material are also provided.

Abstract: Systems and methods for the automated demineralization of bone and decellularization of soft tissue include a mixing assembly communicatively coupled with a control and reporting system. The mixing assembly includes a housing that supports a cannister sub-assembly forming a mixing chamber having a reagent inlet, a reagent outlet, and an internal fluid agitator. A motor is operably coupled with the agitator and configured to spin the agitator in first and second directions relative to the cannister, thereby agitating fluid contained within the mixing chamber. At least one pump is configured to progressively inject measured quantities of a plurality of reagents into the mixing chamber. The associated control and reporting system includes a user terminal that displays a graphical user interface enabling a user to initiate an automated demineralization or decellularization procedure in which the mixing assembly demineralizes tissue placed within the mixing chamber. Other embodiments are also disclosed.

Abstract: The disclosure provides bone graft materials, methods for their use and manufacture. Exemplary bone graft materials comprise combining a radiopaque component with a cancellous bone component to produce a bone graft material, wherein the cancellous bone component comprises native osteoreparative cells. Methods for treating a subject with the bone graft material are also provided.

Abstract: Compositions comprising a cartilage sheet comprising a plurality of interconnected cartilage tiles and a biocompatible carrier are provided. Methods of manufacturing cartilage compositions comprising a cartilage sheet comprising a plurality of interconnected cartilage tiles are also provided.

Abstract: Compositions comprising a cartilage sheet comprising a plurality of interconnected cartilage tiles and a biocompatible carrier are provided. Methods of manufacturing cartilage compositions comprising a cartilage sheet comprising a plurality of interconnected cartilage tiles are also provided.

Abstract: Systems and methods for the automated demineralization of bone and decellularization of soft tissue include a mixing assembly communicatively coupled with a control and reporting system. The mixing assembly includes a housing that supports a cannister sub-assembly forming a mixing chamber having a reagent inlet, a reagent outlet, and an internal fluid agitator. A motor is operably coupled with the agitator and configured to spin the agitator in first and second directions relative to the cannister, thereby agitating fluid contained within the mixing chamber. At least one pump is configured to progressively inject measured quantities of a plurality of reagents into the mixing chamber. The associated control and reporting system includes a user terminal that displays a graphical user interface enabling a user to initiate an automated demineralization or decellularization procedure in which the mixing assembly demineralizes tissue placed within the mixing chamber. Other embodiments are also disclosed.

Abstract: Provided are enriched tissue extracts and methods of making and using such extracts. The enriched tissue extracts contain biologically active components. Some extracts produced by the methods contain extracellular vesicles. The methods can involve administering a physical stress on a biological sample comprising live cells or otherwise stimulating the live cells of the biological sample. Also contemplated are methods in which the biological sample does not contain live cells. The biological sample is incubated in an extraction solution for a period of time sufficient for extraction of biologically active components from the biological sample. Methods of using the extracts, or extracellular vesicles isolated therefrom, therapeutically and for in vitro purposes are also provided.

Abstract: Periosteum harvesting and processing systems and methods enable rapid, efficient, and repeatable harvesting of periosteum tissue from human long bones and processing of the tissue into individual fibers for use in strengthening surgical allograft products. One harvesting and processing method involves providing a human long bone, securing the long bone between two rotating live centers, scraping, using one of a plurality of harvesting tools selected from a harvesting and processing kit, periosteum tissue from the long bone, executing a first wash cycle comprising a hydrogen peroxide wash, executing a second wash cycle comprising an isopropyl alcohol wash, executing a third wash cycle comprising a phosphate buffered saline wash, compressing the periosteum tissue to remove excess fluid, cryofracturing the tissue until a desired fiber size is achieved, and separating the periosteum tissue into individual periosteum fibers having the desired fiber size. Other embodiments are also disclosed.

Abstract: An extraction system for testing microbial contamination includes a biocompatible outer vessel that has a side wall and a biocompatible suspension system that is positionable within an interior of the biocompatible outer vessel. The biocompatible suspension system includes a horizontal member on which a sample may be supported and a securement mechanism that is engagable with the side wall of the biocompatible outer vessel to maintain the suspension system at a desired position within the biocompatible outer vessel.

Abstract: A pre-sutured allograft construct and method of manufacture for repairing, replacing, reconstructing, or augmenting a hip or shoulder labrum may include a folded tissue portion extending from a first end to a second end and forming top, middle, and bottom folds. A stitched pattern secures the folded tissue portion into a graft roll having an overall length extending from a first adjustable region, through a central region, and through a second adjustable region. A continuous series of whip stitches extends from the first adjustable region, through the central region, and through the second adjustable region. A series of triple circumferential stitches overlays the whip stitches in the first and the second adjustable regions, while a series of circumferential stitches alternates with the whip stitches in the central region. The construct is pre-manufactured as an allograft product, but is adjustable during the surgical procedure within the body. Other embodiments are also disclosed.

Abstract: The disclosure provides bone graft materials, methods for their use and manufacture. Exemplary bone graft materials comprise combining a radiopaque component with a cancellous bone component to produce a bone graft material, wherein the cancellous bone component comprises native osteoreparative cells. Methods for treating a subject with the bone graft material are also provided.

Abstract: An extraction system for testing microbial contamination includes a biocompatible outer vessel that has a side wall and a biocompatible suspension system that is positionable within an interior of the biocompatible outer vessel. The biocompatible suspension system includes a horizontal member on which a sample may be supported and a securement mechanism that is engagable with the side wall of the biocompatible outer vessel to maintain the suspension system at a desired position within the biocompatible outer vessel.