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: 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 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: 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: 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: 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: 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: Embodiments of the present technology include a method of making a bone composite graft for administration to a patient. The method may include combining a human cadaveric bone material with a plurality of polymethyl methacrylate binder particles and spincasting the combined human cadaveric bone material and polymethyl methacrylate binder particles to produce the bone composite graft. The method may also include ablating the bone composite graft to increase the surface area of bone material exposed. The human cadaveric bone material may be immobilized in the plurality of polymethyl methacrylate binder particles. The human cadaveric bone material may be present in an amount that is 50 weight percent of the bone composite graft, or less. Additionally, the bone composite graft may have a yield strength that is at least 13,000 N/cm2 and no greater than 15,000 N/cm2.

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: 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: Composite grafts including a biocompatible, synthetic scaffold; and a biological tissue component obtained or derived from a deceased donor tissue, wherein the biological tissue component is embedded in the biocompatible, synthetic scaffold, are provided as systems relating thereto. Methods of manufacture and methods of treatment using such grafts are also provided.

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: Embodiments of the present invention provides bone graft compositions, and methods for their use and manufacture. A bone graft composition may include a first amount of demineralized cortical bone that includes non-spherical particles. The composition may further include a second amount of demineralized cancellous bone. The composition may also include a third amount of non-demineralized cortical bone. The demineralized cortical bone, the demineralized cancellous bone, and the non-demineralized cortical bone may be obtained from the same cadaveric donor.

Abstract: Embodiments of the present technology include a graft for administration at a treatment site of a patient. The graft may include a human cadaveric bone material bonded together with a polymeric binder. The human cadaveric bone material may include demineralized bone particles. The demineralized bone particles may have an average diameter less than 1.1 mm, less than 750 ?m, less than 500 ?m, or less than 250 ?m. The human cadaveric bone material may include non-demineralized bone, cancellous bone, and/or cortical bone in embodiments. In some embodiments, bone from animals other than humans may be used, and the patient may be an animal other than a human.

Abstract: Embodiments of the present technology include a graft for administration at a treatment site of a patient. The graft may include a human cadaveric bone material bonded together with a polymeric binder. The human cadaveric bone material may include demineralized bone particles. The demineralized bone particles may have an average diameter less than 1.1 mm, less than 750 ?m, less than 500 ?m, or less than 250 ?m. The human cadaveric bone material may include non-demineralized bone, cancellous bone, and/or cortical bone in embodiments. In some embodiments, bone from animals other than humans may be used, and the patient may be an animal other than a human.

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.

Abstract: Composite grafts including a biocompatible, synthetic scaffold; and a biological tissue component obtained or derived from a deceased donor tissue, wherein the biological tissue component is embedded in the biocompatible, synthetic scaffold, are provided as systems relating thereto. Methods of manufacture and methods of treatment using such grafts are also provided.