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 a tool having a set of features for forming a domed acellular dermal matrix (ADM) graft. An acellular dermal matrix (ADM) graft product includes an ADM graft derived from full-thickness skin, with a pre-formed domed shape having a mesh pattern formed therein. In an embodiment, the set of features include a shaping tool feature and a scoring tool feature. The shaping tool feature has a shaping portion configured to shape a dome shaped ADM graft. The scoring tool feature has a scoring portion configured to impart a desired mesh pattern into the domed shaped ADM graft. 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: 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: Provided are systems and methods for treating or processing tissue, and tissue products made using such systems and methods. The methods involve combining tissue with a processing solution in a processing vessel and applying resonant acoustic energy thereto. In some instances, the tissue is processed in the absence of processing solution. The resonant acoustic energy rapidly agitates the tissue with the processing solution by vibration. The general method provided is broadly applicable to a variety of tissue processing methods, the processing solution and features of the resonant acoustic energy being selected based on the type of tissue to be processed and the nature of the processing to be performed. Exemplary methods include methods of bone demineralization, tissue decellularization, tissue cryopreservation, production of stromal vascular fraction, tissue homogenization, tissue cleansing, and tissue decontamination, and assessment of microbial load.

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 acellular dermal matrix (ADM) graft product includes an ADM graft derived from full-thickness skin, with a pre-formed shape having a mesh pattern formed therein. The ADM graft is disposed in a sterilization package and irradiated to provide a two year shelf-life for the ADM graft product, which is used in the time-saving, efficient, and effective surgical reconstruction of soft tissue defects. One manufacturing method involves providing a portion of full-thickness donor-derived skin, removing an epidermis and a fat layer form the portion of the skin, decellularizing the portion of the skin to form a portion of ADM graft material, pre-shaping and meshing the ADM graft material, verifying a thickness of the ADM graft material, and packaging the pre-shaped, meshed ADM graft material in a sterilizable package and irradiating for a two-year shelf-life to form the ADM graft product. Other embodiments are also disclosed.

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 in this disclosure are various composite grafts having a trabecular scaffold with voids defined in at least a portion of the scaffold and a biological component positioned in at least some of the voids of the scaffold. The grafts may have a synthetic scaffold or a bone substrate scaffold. The grafts may be osteogenic, chondrogenic, osteochondrogenic, or vulnerary in nature. Also provided are methods of using the composite grafts to treat a tissue defect in a subject. Methods of manufacturing are also provided. Synthetic scaffolds are manufactured by additive manufacturing. Agitation is used to combine the biological component with the scaffold of the graft.

Abstract: Provided in this disclosure are various composite grafts having a trabecular synthetic scaffold with voids defined in at least a portion of the scaffold and a biological component positioned in at least some of the voids of the scaffold. The grafts may be osteogenic, chondrogenic, osteochondrogenic, or vulnerary in nature. Also provided are methods of using the composite grafts to treat a tissue defect in a subject. Methods of manufacturing are also provided. Grafts are manufactured by additive manufacturing. Agitation may be used to combine composite grafts with additional biological component.

Abstract: Provided are systems and methods for treating or processing tissue, and tissue products made using such systems and methods. Also provided are ball mill processing devices and systems useful for processing materials such as tissue. The methods involve combining tissue with or without a processing solution in a processing vessel and applying resonant acoustic energy thereto. The resonant acoustic energy rapidly agitates the tissue with the processing solution by vibration, thereby improving the rate and/or efficiency of processing. The general method provided is broadly applicable to a variety of tissue processing methods, the processing solution and features of the resonant acoustic energy being selected based on the type of tissue to be processed and the nature of the processing to be performed.

Abstract: Provided are systems and methods for treating or processing tissue, and tissue products made using such systems and methods. The methods involve combining tissue with a processing solution in a processing vessel and applying resonant acoustic energy thereto. In some instances, the tissue is processed in the absence of processing solution. The resonant acoustic energy rapidly agitates the tissue with the processing solution by vibration. The general method provided is broadly applicable to a variety of tissue processing methods, the processing solution and features of the resonant acoustic energy being selected based on the type of tissue to be processed and the nature of the processing to be performed. Exemplary methods include methods of bone demineralization, tissue decellularization, tissue cryopreservation, production of stromal vascular fraction, tissue homogenization, tissue cleansing, and tissue decontamination, and assessment of microbial load.

Abstract: Described are permeable pouches for tissue containment and methods for their use and manufacture. Exemplary pouches include a permeable material formed to create a cavity into which tissue graft material can be placed. Tissue graft material may be enclosed within a sealed pouch or within an unsealed pouch.