Abstract: The present invention is directed toward recellularizing a devitalized cartilage graft with viable recellularizable cells in vivo, in situ, or in vitro to render the tissue vital. The present invention is also directed toward repairing a cartilage defect and implanting a cartilage graft into a human or animal by crafting a cartilage matrix into individual grafts, disinfecting and cleaning the cartilage graft, applying a pretreatment solution to the cartilage graft, removing cellular debris using an extracting solution to produce a devitalized cartilage graft, recellularizing the devitalized cartilage graft, implanting the cartilage graft into the cartilage defect with or without an insertion device, and sealing the implanted cartilage graft with recipient tissue. The devitalized cartilage graft is optionally stored between the removing cellular debris and the recellularizing steps.

Abstract: The present invention is directed to a device for the growth of new bone or bone-like tissue under in vitro cell culture conditions.

Abstract: A process for the preparation of a tissue matrix suitable for regenerative repair of tissues, including contacting an isolated connective tissue with an amount of detergent and an amount of disinfectant to significantly reduce at least one of lipids, phospholipids, nucleic acids, major histocompatibility (MHC) antigens, contaminating microorganisms, and endotoxins. The process further provides for less significant reduction in proteoglycan content while retaining the overall structure of the tissue matrix produced. Processing may further include micronizing the tissue matrix. Also, a tissue matrix having a scaffold portion and non-structural portion, collectively structured to promote cellular infiltration, attachment, and proliferation. The tissue matrix may be in the form of a sheet, thick sheet, or micronized. Also, kits including a prepared tissue matrix for use in regenerative repair, and kits for preparing a tissue matrix.

Abstract: The invention provides methodologies and apparatus for producing devitalized soft-tissue implants where the implant retains metabolically non-viable and/or reproductively non-viable cells, and preferably retains large molecular weight cytoplasmic proteins, such implants produced both in small quantities and in commercializable quantities. Such soft-tissue implants include vascular graft substitutes. A devitalized graft is produced by subjecting the tissue sample to an induced pressure mediated flow of an extracting solution, optionally followed by inducing a pressure mediated flow of a salt solution, then washing the tissue to produce the devitalized graft. The devitalized grafts produced are uniform and non-immunogenic. The inventive method allows for the production of multiple devitalized soft tissue implants, where processing time is significantly less than prior art processes and the number of implants produced per day is increased over prior art processes.

Abstract: The invention is further directed to producing a cleaned, disinfected, and devitalized cartilage graft by optionally cleaning and disinfecting the cartilage graft; treating the cartilage graft in a pretreatment solution; treating the cartilage graft in an extracting solution; washing the extracted cartilage graft with a rinsing solution; and subsequently soaking the devitalized cartilage graft in a storage solution. The devitalized cartilage graft is essentially free from metabolically viable and/or reproductively viable cells and the rinsing solution is hypotonic solution or isotonic solution. The present invention is further directed to a cleaned, disinfected, and devitalized cartilage graft and a process for cleaning, disinfecting, and devitalizing cartilage grafts.

Abstract: Tissue repair compositions, particularly bone repair compositions, containing demineralized bone fragments and homogenized connective tissues, and methods for making the same. The compositions can be used in the form of an injectable gel, an injectable paste, a paste, a putty, or a rehydratable freeze-dried form.

Abstract: The present invention is directed to a device for the growth of new bone or bone-like tissue under in vitro cell culture conditions.

Abstract: Tissue repair compositions, particularly bone repair compositions, containing demineralized bone fragments and homogenized connective tissues, and methods for making the same. The compositions can be used in the form of an injectable gel, an injectable paste, a paste, a putty, or a rehydratable freeze-dried form.

Abstract: Tissue repair compositions, particularly bone repair compositions, containing demineralized bone fragments and homogenized connective tissues. The compositions can be used in the form of an injectable gel, an injectable paste, a paste, a putty, or a rehydratable freeze-dried form.

Abstract: Implantable orthopedic prosthetic devices containing tissue repair compositions that contain demineralized bone fragments and homogenized connective tissue.

Abstract: The invention provides a plasticized 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 natural tissue, is not brittle, does not necessitate rehydration prior to clinical implantation and is not a potential source for disease transmission. Replacement of the chemical plasticizers by water prior to implantation is not required and thus, the plasticized bone or soft tissue product can be placed directly into an implant site without significant preparation in the operating room.

Abstract: The present invention relates to a process for the production of marine invertebrate type V telopeptide containing collagen preparations from marine invertebrates, compositions containing preparations, and methods of using these preparations. The collagen preparation includes telopeptide containing and optionally invertebrate atelopeptide containing, type V fibrillar collagen. The present collagen preparations may be employed in a variety of products including for example, cosmetic, pharmacological, dental, and cell culture products.

Abstract: The invention is directed to a composite bone graft for implantation in a patient, and methods of making and using the composite bone graft, along with methods for treating patients by implanting the composite bone graft at a site in a patient. The composite bone graft includes two or more connected, discrete, bone portions, and includes one or more biocompatible connectors which hold together the discrete bone portions to form the composite bone graft. The composite bone graft may include one or more textured bone surfaces. The textured surface preferably includes a plurality of closely spaced protrusions, preferably closely spaced continuous protrusions. The composite bone graft is useful for repairing bone defects caused by congenital anomaly, disease, or trauma, in a patient, for example, for restoring vertical support of the anterior and/or posterior column. Implantation of the composite bone graft results in improved graft stability and osteoinductivity, without a decrease in mechanical strength.

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 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 an apparatus for producing demineralized osteoinductive bone. The apparatus demineralizes bone by subjecting bone, including, for example, ground bone, bone cubes, chips, strips, or essentially intact bone, to either a rapid high volume pulsatile acidification wave process or to a rapid continuous acid demineralization process. The pulsatile acidification wave process includes subjecting bone to two or more rapid pulse/drain cycles in which one or more demineralizing acids is rapidly pulsed into a vessel containing bone, and after a desired period of time, is rapidly drained from the vessel. The continuous acid demineralization process includes subjecting bone to a continuous exchange of demineralizing acid solution in which the demineralizing acid solution is recirculated from the container holding the bone through an ion exchange media.

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 is directed to a method of growing new bone, bone-like tissue or extracellular matrix under in vitro cell culture conditions. The method utilizes a bioreactor allowing for the flow of nutrient solutions into, through, and out of the bioreactor, wherein ground demineralized bone and bone-forming cells are present in the bioreactor. The resulting bone, bone-like tissue or extracellular matrix produced by the invention are within the scope of the present invention. In addition, the present invention is directed to the bioreactor device used to grow the new bone, bone-like tissue, or extracellular matrix.

Abstract: The invention provides methodologies and apparatus for producing acellular soft-tissue implants, both in small quantities and in commercializable quantities. Such soft-tissue implants include vascular graft substitutes. An acellular graft is produced by subjecting the tissue sample to an induced pressure mediated flow of an extracting solution, followed by inducing a pressure mediated flow of a treating solution, then washing the treated tissue to produce the acellular graft. The acellular grafts produced are uniform and non-immunogenic. The inventive method allows for the production of multiple decellularized soft tissue implants, where processing time is significantly less than prior art processes and the number of implants produced per day is increased over prior art processes. In clinical use, the decellularized grafts produced exhibit significantly improved in long-term durability and function.

Abstract: The invention provides methodologies and apparatus for producing devitalized soft-tissue implants where the implant retains metabolically non-viable and/or reproductively non-viable cells, and preferably retains large molecular weight cytoplasmic proteins, such implants produced both in small quantities and in commercializable quantities. Such soft-tissue implants include vascular graft substitutes. A devitalized graft is produced by subjecting the tissue sample to an induced pressure mediated flow of an extracting solution, optionally followed by inducing a pressure mediated flow of a salt solution, then washing the tissue to produce the devitalized graft. The devitalized grafts produced are uniform and non-immunogenic. The inventive method allows for the production of multiple devitalized soft tissue implants, where processing time is significantly less than prior art processes and the number of implants produced per day is increased over prior art processes.