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 method of debriding bone including incubating the bone and associated soft tissue, with one or more debriding solutions where the debriding solution may include one or more alkaline solutions. Incubation is optionally carried out with one or more debriding agents including inert dry granular or particulate material including for example beads, and the granular phase of an alkaline agent, including for example granular sodium hydroxide. The incubating may be carried out with agitation. In another embodiment, the medullary canal of the bone is subjected to a positive pressure stream of debriding solution under conditions sufficient to loosen the associated soft tissue from the bone at the interface of the soft tissue and bone. In a further embodiment, the debriding solution is provided as a gel.

Abstract: The present invention provides a plasticized dehydrated or freeze-dried bone and/or soft tissue product that does not require special conditions of storage, for example refrigeration or freezing, exhibits materials properties that approximate those properties present in normal hydrated tissue, is not brittle, does not necessitate rehydration prior to clinical implantation and is not a potential source for disease transmission. The invention replaces water in the molecular structure of the bone or soft tissue matrix with one or more plasticizers allowing for dehydration of the tissue, yet not resulting in an increase in brittleness of the plasticized product, and resulting in compressive and/or tensile properties similar to those of normal hydrated bone. Replacement of the chemical plasticizers by water prior to implantation is not required and thus, the dehydrated bone or soft tissue plasticized product can be placed directly into an implant site without significant preparation in the operating room.

Abstract: The present invention provides a plasticized dehydrated or freeze-dried bone and/or soft tissue product that does not require special conditions of storage, for example refrigeration or freezing, exhibits materials properties that approximate those properties present in normal hydrated tissue, is not brittle, does not necessitate rehydration prior to clinical implantation and is not a potential source for disease transmission. The invention replaces water in the molecular structure of the bone or soft tissue matrix with one or more plasticizers allowing for dehydration of the tissue, yet not resulting in an increase in brittleness of the plasticized product, and resulting in compressive and/or tensile properties similar to those of normal hydrated bone. Replacement of the chemical plasticizers by water prior to implantation is not required and thus, the dehydrated bone or soft tissue plasticized product can be placed directly into an implant site without significant preparation in the operating room.

Abstract: The present invention provides a plasticized dehydrated or freeze-dried bone and/or soft tissue product that does not require special conditions of storage, for example refrigeration or freezing, exhibits materials properties that approximate those properties present in normal hydrated tissue, is not brittle, does not necessitate rehydration prior to clinical implantation and is not a potential source for disease transmission. The invention replaces water in the molecular structure of the bone or soft tissue matrix with one or more plasticizers allowing for dehydration of the tissue, yet not resulting in an increase in brittleness of the plasticized product, and resulting in compressive and/or tensile properties similar to those of normal hydrated bone. Replacement of the chemical plasticizers by water prior to implantation is not required and thus, the dehydrated bone or soft tissue plasticized product can be placed directly into an implant site without significant preparation in the operating room.

Abstract: A tissue biopsy cell suspender device includes a receptacle having a sealable opening. The receptacle contains a sufficient quantity of an aqueous medium to support an enzymatic dissociation of cells from a tissue biopsy sample. The device has a removable closure with a first sealing position and a second sealing position for sealing the opening in the receptacle. The device further includes a frangible container having a sufficient quantity of an enzyme therein to dissociate cells from the tissue biopsy sample. The frangible container is covered with a membrane that is permeable to water and to the enzyme. The frangible container is disposed within the receptacle so that the container is intact when the closure is in the first sealing position and the container is breached when the closure is in the second sealing position. When the frangible container is breached, the enzyme is released to permeate into the medium and for dissociation of the cells from the tissue sample.

Abstract: Fibrous connective tissue for surgical implantation is made substantially antigen-free by contact with one or more extraction agents. Solutions or mixtures of molecules having bipolar regions act as antigen removing permeation enhancers. Cationic, anionic, non-ionic or amphoteric surfactants are suitable bipolar permeation enhancers. One or more extraction agents can be combined to form extraction mixtures.

Abstract: Fibrous connective tissue for surgical implantation is made substantially antigen-free by contact with one or more extraction agents. Solutions or mixtures of molecules having bipolar regions act as antigen removing permeation enhancers. Cationic, anionic, non-ionic or amphoteric surfactants are suitable bipolar permeation enhancers. One or more extraction agents can be combined to form extraction mixtures.

Abstract: A flowable demineralized bone powder composition is provided for use in surgical bone repair.

Abstract: A method and assembly for treating living and non-living biological environments with varying doses of fluids in vitro. The assembly comprises a vessel, a closure and a tubular membrane extending from the closure and suspended into the vessel to provide rapid and uniform equilibration of fluids into the vessel. The assembly provides means for carrying out pharmacokinetic and toxicokinetic studies.

Abstract: A shaped piece of swollen demineralized bone which can also be plasticized is provided for use in surgical bone repair.

Abstract: An osteogenic composition is obtained from demineralized bone tissue.

Abstract: A process for treating musculoskeletal tissue which comprises contacting musculoskeletal tissue with both an effective amount of at least one treating agent selected from the class consisting of antibiotics and disinfectants, and an agent to increase diffusion of the treating agent into the tissue, such as a surfactant or a permeation enhancer. The disinfectant and/or antibiotic function in killing bacteria, vegetative organisms, and viruses (including HIV virus) which may be remaining in the musculoskeletal tissue. A preferred disinfectant is ethanol.

Abstract: A shaped piece of swollen demineralized bone which can also be plasticized is provided for use in surgical bone repair.

Abstract: A flowable demineralized bone powder composition is provided for use in surgical bone repair.

Abstract: Swollen demineralized bone particles are formulated into a flowable osteogenic composition which is useful in the repair of osseous defects.

Abstract: An osteogenic composition is obtained from demineralized bone tissue.

Abstract: Bone is enzymatically debrided prior to undergoing further processing which renders the bone suitable for osteoprosthetic use.

Abstract: A process for cryopreserving a biological material which comprises contacting the biological material with both an effective amount at least one cryopreservation agent, and an agent to increase diffusion of the cryopreservation agent into the biological material, such as a surfactant or a permeation enhancer.

Abstract: A flowable demineralized bone powder composition is provided for use in surgical bone repair.