Abstract: The invention provides methodologies and apparatus for producing a cellular 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 nonimmunogenic. 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: Tissue repair compositions, particularly bone repair compositions, containing (a) bone fragments and (b) homogenized connective tissue, and methods for making the same are provided. Some of the inventive tissue repair compositions contain a radioprotectant. 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. Kits for using such tissue repair compositions are also provided.

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 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 is directed to a fiber, preferably bone fiber, having a textured surface, which acts as an effective binding substrate for bone-forming cells and for the induction or promotion of new bone growth by bone-forming cells, which bind to the fiber. Methods of using the bone fibers to induce or promote new bone growth and bone material compositions comprising the bone fibers are also described. The invention further relates to a substrate cutter device and cutter, which are effective in producing substrate fibers, such as bone fibers.

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 is directed to a fiber, preferably bone fiber, having a textured surface, which acts as an effective binding substrate for bone-forming cells and for the induction or promotion of new bone growth by bone-forming cells, which bind to the fiber. Methods of using the bone fibers to induce or promote new bone growth and bone material compositions comprising the bone fibers are also described. The invention further relates to a substrate cutter device and cutter, which are effective in producing substrate fibers, such as bone fibers.

Abstract: The invention is directed to a process for making a tissue repair implant having a porous sponge-like structure to repair bone, cartilage, or soft tissue defects by producing a connective tissue homogenate from one or more connective tissues; mixing the connective tissue homogenate with a carrier solution to produce a connective tissue carrier; optionally mixing one or more natural or synthetic bone fragements with said connective tissue carrier to produce a tissue repair mixture; freezing or freeze-drying the tissue repair mixture to produce a porous sponge-like structure and create a three-dimensional framework to entrap the natural or synthetic bone fragments, treating the frozen or freeze-dried porous sponge-like structure with one or more treatment solutions to produce a stabilized porous sponge-like structure. A crudely fragmented connective tissue from one or more connective tissues is optionally mixed with the tissue repair mixture before freezing or freeze-drying.

Abstract: The invention provides a plasticized tissue or organ 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: 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: 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: 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 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 invention is directed to producing a shaped cartilage matrix isolated from a human or animal where the cartilage has been crafted to facilitate disinfection, cleaning, devitalization, recellularization, and/or integration after implantation. The invention relates to a process for repairing a cartilage defect and implantation of a cartilage graft into a human or animal by crafting the 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, 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 recellularized in vitro, in vivo, or in situ with viable cells to render the tissue vital before or after the implantation.

Abstract: The invention is directed towards a process for implanting a cartilage graft into a cartilage defect and sealing the implanted cartilage graft with recipient tissue by creating a first bore down to the bone portion of the cartilage defect, creating a second shaped bore that is concentric to and on top of the first bore to match the shape and size of the cartilage graft, treating the first bore and the second shaped bore at the defect site with a bonding agent, treating the circumferential area of the cartilage graft with a bonding agent, inserting the cartilage graft into the defect site and wherein the superficial surface of the cartilage graft is at the same height as the surrounding cartilage surface. The first and second bonding agents may be activated by applying a stimulation agent to induce sealing, integration, and restoration of the hydrodynamic environments of the recipient tissue.

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 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: Processes for producing a tissue graft comprising acellularizing or devitalizing a tubular tissue to produce a tissue matrix. The tissue matrix is then populated with at least some viable cells. The processing and the populating steps are performed in a closed system, such as a bioreactor. Tissue grafts produced using the inventive processes may be capable of withstanding physiological stress and strain conditions present at a site into which the tissue graft is implanted.