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: 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: 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 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: 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: There is disclosed a system for cleaning and disinfecting allograft material. In an embodiment, the system includes a sterile bag and a motorized paddle blender. The sterile bag having an outer wall configured to withstand blending forces, at least one paddle contact section, and an allograft retaining section separate from the at least one paddle contact section. The motorized paddle blender having at least one paddle configured to apply blending forces on the sterile bag on the at least one paddle contact area, a motorized portion to actuate the at least one paddle, and a door component configured to hold the sterile bag adjacent the at least one paddle. The at least one paddle and the allograft retaining section are configured to prevent the paddle from contacting the allograft material when the blending forces are applied on the sterile bag on the at least one paddle contact area.

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: There is disclosed a system for cleaning and disinfecting allograft material. In an embodiment, the system includes a sterile bag and a motorized paddle blender. The sterile bag having an outer wall configured to withstand blending forces, at least one paddle contact section, and a free-floating mesh bag configured to retain the allograft material. The motorized paddle blender having at least one paddle configured to apply blending forces on the sterile bag on the at least one paddle contact area, a motorized portion to actuate the at least one paddle, and a door component configured to hold the sterile bag adjacent the at least one paddle. The at least one paddle and the allograft retaining section are configured to prevent the paddle from contacting the allograft material when the blending forces are applied on the sterile bag on the at least one paddle contact area.

Abstract: There is disclosed a system for cleaning and disinfecting allograft material. In an embodiment, the system includes a sterile bag and a motorized paddle blender. The sterile bag having an outer wall configured to withstand blending forces, at least one paddle contact section, and a free-floating mesh bag configured to retain the allograft material. The motorized paddle blender having at least one paddle configured to apply blending forces on the sterile bag on the at least one paddle contact area, a motorized portion to actuate the at least one paddle, and a door component configured to hold the sterile bag adjacent the at least one paddle. The at least one paddle and the allograft retaining section are configured to prevent the paddle from contacting the allograft material when the blending forces are applied on the sterile bag on the at least one paddle contact area.

Abstract: There is disclosed a system for cleaning and disinfecting allograft material. In an embodiment, the system includes a sterile bag and a motorized paddle blender. The sterile bag having an outer wall configured to withstand blending forces, at least one paddle contact section, and an allograft retaining section separate from the at least one paddle contact section. The motorized paddle blender having at least one paddle configured to apply blending forces on the sterile bag on the at least one paddle contact area, a motorized portion to actuate the at least one paddle, and a door component configured to hold the sterile bag adjacent the at least one paddle. The at least one paddle and the allograft retaining section are configured to prevent the paddle from contacting the allograft material when the blending forces are applied on the sterile bag on the at least one paddle contact area.

Abstract: There is disclosed a system for cleaning and disinfecting allograft material. In an embodiment, the system includes a sterile bag and a motorized paddle blender. The sterile bag having an outer wall configured to withstand blending forces, at least one paddle contact section, and an allograft retaining section separate from the at least one paddle contact section. The motorized paddle blender having at least one paddle configured to apply blending forces on the sterile bag on the at least one paddle contact area, a motorized portion to actuate the at least one paddle, and a door component configured to hold the sterile bag adjacent the at least one paddle. The at least one paddle and the allograft retaining section are configured to prevent the paddle from contacting the allograft material when the blending forces are applied on the sterile bag on the at least one paddle contact area.

Abstract: There is disclosed a method of procuring allograft tissue. In an embodiment, the method includes inserting an allograft through an opening into a procurement extraction container, sealing the opening, adding extraction fluid through a second opening, agitating the fluid, collecting the fluid for detection of contamination, and sealing the second opening. There is disclosed a procurement extraction container. In one embodiment, the container includes a wall defining an interior to receive the allograft, an opening into the interior, sized to receive the allograft, a closure device for the opening, the closure device providing a hermetic seal, a second opening providing a second passageway into the interior, the second opening having a connector interface and a second closure device providing a hermetic seal so as to provide, with the first closure and the at least one wall, a sterile barrier. Other embodiments are also disclosed.

Abstract: There is disclosed a method of procuring allograft tissue. In an embodiment, the method includes inserting an allograft through an opening into a procurement extraction container, sealing the opening, adding extraction fluid through a second opening, agitating the fluid, collecting the fluid for detection of contamination, and sealing the second opening. There is disclosed a procurement extraction container. In one embodiment, the container includes a wall defining an interior to receive the allograft, an opening into the interior, sized to receive the allograft, a closure device for the opening, the closure device providing a hermetic seal, a second opening providing a second passageway into the interior, the second opening having a connector interface and a second closure device providing a hermetic seal so as to provide, with the first closure and the at least one wall, a sterile barrier. Other embodiments are also disclosed.

Abstract: There is disclosed a system for cleaning and disinfecting allograft material. In an embodiment, the system includes a sterile bag and a motorized paddle blender. The sterile bag having an outer wall configured to withstand blending forces, at least one paddle contact section, and an allograft retaining section separate from the at least one paddle contact section. The motorized paddle blender having at least one paddle configured to apply blending forces on the sterile bag on the at least one paddle contact area, a motorized portion to actuate the at least one paddle, and a door component configured to hold the sterile bag adjacent the at least one paddle. The at least one paddle and the allograft retaining section are configured to prevent the paddle from contacting the allograft material when the blending forces are applied on the sterile bag on the at least one paddle contact area.

Abstract: There is disclosed a method of procuring allograft tissue. In an embodiment, the method includes inserting an allograft through an opening into a procurement extraction container, sealing the opening, adding extraction fluid through a second opening, agitating the fluid, collecting the fluid for detection of contamination, and sealing the second opening. There is disclosed a procurement extraction container. In one embodiment, the container includes a wall defining an interior to receive the allograft, an opening into the interior, sized to receive the allograft, a closure device for the opening, the closure device providing a hermetic seal, a second opening providing a second passageway into the interior, the second opening having a connector interface and a second closure device providing a hermetic seal so as to provide, with the first closure and the at least one wall, a sterile barrier. Other embodiments are also disclosed.

Abstract: There is disclosed a method of procuring allograft tissue. In an embodiment, the method includes inserting an allograft through an opening into a procurement extraction container, sealing the opening, adding extraction fluid through a second opening, agitating the fluid, collecting the fluid for detection of contamination, and sealing the second opening. There is disclosed a procurement extraction container. In one embodiment, the container includes a wall defining an interior to receive the allograft, an opening into the interior, sized to receive the allograft, a closure device for the opening, the closure device providing a hermetic seal, a second opening providing a second passageway into the interior, the second opening having a connector interface and a second closure device providing a hermetic seal so as to provide, with the first closure and the at least one wall, a sterile barrier. Other embodiments are also disclosed.

Abstract: The invention is directed to a process for producing demineralized osteoinductive bone, and demineralized osteoinductive bone produced thereby. The process achieves demineralization of bone by subjecting bone, including for example ground bone, bone cubes, chips, strips, or essentially intact bone, to a rapid continuous acid demineralization process. The process includes subjecting bone to a continuous exchange of demineralizing acid solution where the demineralizing acid solution is recirculated from the substantially closed container through an ion exchange media to remove calcium and phosphate thereby producing a regenerated acid, and returning the regenerated acid to the substantially closed container to produce osteoinductive demineralized bone. The process allows bone to be rapidly demineralized to a precise and specific desired residual calcium level, without sacrificing osteoinductivity.

Abstract: The invention is directed to a process for producing demineralized osteoinductive bone, and demineralized osteoinductive bone produced thereby. The process achieves demineralization of bone by subjecting bone, including for example ground bone, bone cubes, chips, strips, or essentially intact bone, to a rapid continuous acid demineralization process. The process includes subjecting bone to a continuous exchange of demineralizing acid solution where the demineralizing acid solution is recirculated from the substantially closed container through an ion exchange media to remove calcium and phosphate thereby producing a regenerated acid, and returning the regenerated acid to the substantially closed container to produce osteoinductive demineralized bone. The process allows bone to be rapidly demineralized to a precise and specific desired residual calcium level, without sacrificing osteoinductivity.

Abstract: The invention is directed to a process for producing demineralized osteoinductive bone, and demineralized osteoinductive bone produced thereby. The process achieves demineralization of bone by subjecting bone, including for example ground bone, bone cubes, chips, strips, or essentially intact bone, to a rapid continuous acid demineralization process. The process includes subjecting bone to a continuous exchange of demineralizing acid solution where the demineralizing acid solution is recirculated from the substantially closed container through an ion exchange media to remove calcium and phosphate thereby producing a regenerated acid, and returning the regenerated acid to the substantially closed container to produce osteoinductive demineralized bone. The process allows bone to be rapidly demineralized to a precise and specific desired residual calcium level, without sacrificing osteoinductivity.