Abstract: Allogenic or xenogenic materials are used to provide intervertebral disc nucleus implants and/or annular plugs. The allogenic or xenogenic materials comprise natural disc annulus material, which may have a portion of the anterior longitudinal ligament attached. The tissue may be used “as is” without an additional core or covering, or it may be used in combination with other materials. The material may be rolled, folded, layered and/or sutured, stapled, or glued to provide a solid plug of natural biological material. The implant may be provided as a dehydrated, substantially rod-shaped segment having a diameter less than the diameter of the hydrated material, and may have one or more ends of the dehydrated rod terminate with a further reduced diameter portion, preferably a point.

Abstract: Provided are procedures and instruments for preparing and transplanting osteochondral allograft plugs to a host bone to repair an articular cartilage defect. An allograft bone plug having a cartilage plate and cancellous bone tissue attached thereto is removed from a donor bone. The allograft plug is further shaped by removing or cutting away cancellous bone tissue to form a cancellous stalk extending from the cartilage plate. The formed cancellous stalk can have any suitable shape including cylindrical, conical, and rectilinear. At the recipient site of the host bone, a cutout is formed corresponding in shape to the allograft plug. The allograft plug is inserted into the cutout such that the cancellous stalk is retained in the host bone and the cartilage plate aligns with the condyle surface of the host bone. Aspects of the invention may also be applicable to preparing and transplanting osteochondral autograft plugs.

Abstract: This invention provides organic/inorganic composite biomaterials constituted by composites of hydroxyapatite and collagen and having an average fiber length of 60 ?m or longer, and a process for producing the same in which the calcium ion and phosphate ion concentrations in the reaction vessel are optimized through regulation of the concentration of a starting material and the flow rate. The organic/inorganic composite biomaterials have mechanical strength and a biodegradation rate suitable for artificial bones through the introduction of crosslinking therein.

Abstract: Non-glutaraldehyde fixation of an organ or a prosthesis for implantation in a mammal is based upon carbodiimide treatment. A solution containing a sterilizing agent, such as EDC, in combination with a coupling enhancer, such as Sulfo-NHS, and a high concentration of a diamine cross linking agent is used. As a result, only minimal surface reduction occurs during fixation, and the resultant products show a dramatic increase in resistance to calcification.

Abstract: A sterile implant for treatment of a spinal disc defect comprising an allograft cortical bone demineralized to a Type I collagen having a specific shape which is treated to eliminate osteoinductivity. The implant is lyophilized and compressed into smaller first shape which 20 to 80% from its original shape in at least one dimension and hardened. The implant expanding when hydrated into a second shape having the shape memory of the first shape and expanded in dimensional size from the first compressed shape.

Abstract: A bioreactor and a method for growing engineered tissue provide facing surfaces in a vessel for containing cell-culture media. The facing surfaces are equidistant and define a gap therebetween while providing substrates for cell tissue growth. By maintaining conditions within the vessel conducive to cell tissue growth and moving the surfaces relative to one another within such cell culture media, tissue growing thereupon is subjected to physiological flow and shear stress, preferably through the use of oscillating motion, and engineered tissue is produced.

Abstract: A novel apparatus and device is described for reconstituting a bone sample with a biological fluid, such as concentrated plasma or saline solutions, for example, prior to surgical implantation into a patient. In particular, the invention comprises, in certain aspects, a container in which a bone sample may be reconstituted with the desired fluid by applying a vacuum within the container, thereby driving the fluid into the bone for complete, or near complete, permeation of the fluid into the interstices of the bone sample prior to surgical implantation.

Abstract: An actuable truss with ordered or disordered planar or strut elements or pore walls may be seeded with tissue cells, wherein application of a magnetic field may result in mechanical strain on the cells and increased fluid flow in and out of the truss structure. Modified polymers, such as ?-Fe2O3/PLGA, may be used to form actuable scaffolds suitable for tissue engineering. It is also disclosed a device with a trap-door that may be remotely actuated by applying a magnetic field. Such a device may be employed to deliver and control the release of other micro-devices or materials such as drugs to a specific location inside the body of a human or an animal.

Abstract: Selectively demineralized bone-derived implants are provided. In one embodiment, a bone sheet for implantation includes a demineralized field surrounding mineralized regions. In another embodiment, a bone defect filler includes a demineralized cancellous bone section in a first geometry. The first geometry is compressible and dryable to a second geometry smaller than the first geometry, and the second geometry is expandable and rehydratable to a third geometry larger than the second geometry.

Abstract: The present invention relates to a method for enhancing ingrowth of host bone comprising: modifying a bone graft structure to provide an ionic gradient to produce a modified bone graft structure; and implanting the modified bone graft structure. The present invention also relates to a method of enhancing the binding of growth factors and cell cultures to a bone graft structure comprising: applying ex vivo an effective quantity of an ionic force change agent to the surface of a bone graft structure to produce a binding-sensitized bone graft structure; implanting the binding-sensitized bone graft structure into a host bone; and administering to the binding-sensitized bone graft structure a molecule, a cell culture or a combination thereof.

Abstract: A method for dehydrating a monolithic bone intended for implantation is provided. The method serves to conserve at least one of the biomechanical properties of the bone during the dehydration of the bone and its subsequent packaging. Also provided is a monolithic bone for implantation and a method of using the bone for the repair of damaged bone.

Abstract: An osteoimplant includes at least partially demineralized cancellous bone as a substrate, which is impregnated with demineralized cortical bone matrix (DBM). The implant may include a binding agent to adhere the DBM to the cancellous bone substrate, and may also include a soft tissue barrier that covers a portion of the external surface of the implant. The cancellous bone substrate may be selectively demineralized, so as to provide regions with greater malleability, and other regions with greater structural properties.

Abstract: Allogenic or xenogenic materials are used to provide intervertebral disc nucleus implants and/or annular plugs. The allogenic or xenogenic materials comprise natural disc annulus material, which may have a portion of the anterior longitudinal ligament attached. The tissue may be used “as is” without an additional core or covering, or it may be used in combination with other materials. The material may be rolled, folded, layered and/or sutured, stapled, or glued to provide a solid plug of natural biological material. The implant may be provided as a dehydrated, substantially rod-shaped segment having a diameter less than the diameter of the hydrated material, and may have one or more ends of the dehydrated rod terminate with a further reduced diameter portion, preferably a point.

Abstract: A cortical bone implant is formed of two or more planks of bone which are connected with one or more offset pins. The pins may be right circular cylinders inserted into a corresponding offset bore which offset bends the inserted pin. The bending creates compression and tensile loads in the pin which loads creates friction compression forces on the planks connecting them to the pins by friction. The pins may have different shapes to form the offsets and different configurations for friction attachment to the planks. The implants may be formed of flat or L-shaped planks or bones formed into other shapes including interlocking arrangements. Processes and fixtures are disclosed for forming the pins, planks and implants. Various embodiments of the pins, planks, implants and processes are disclosed.

Abstract: An implant which is particularly suitable for the repair and/or replacement of a skeletal joint, e.g., a vertebral joint, includes a unit of monolithic bone possessing at least one demineralized region exhibiting properties of flexibility and resilience, the demineralized region having diminished or insignificant capacity for promoting new bone growth.

Abstract: A porous three-dimensional tissue repair matrix is provided which is biodegradable. The matrix is preferably formed from mineralized collagen where the mineral comprises particulate calcium phosphate immobilized in the matrix.

Abstract: A surgical instrument includes a tubular member, a partition member for partitioning the inside of the tubular member, first and second shafts movable in forward and backward directions, an end effector, a base member connected to the second shaft, a supporting pin for supporting the base member to mount the end effector on the tubular member, a first connection member being movable in both forward and backward directions in the base member to open and close jaws connected to the end effector, a second connection member being movable through a joint formed by the supporting pin, a first operation control portion for manipulating the end effector via the first shaft, and a second operation control portion for moving the second shaft in both forward and backward directions to control the angle of the joint.

Abstract: The present invention relates to a method of making a tissue graft material. The method includes placing body tissue and a blood component in a chamber and extruding the body tissue and blood component from an opening in the chamber to form the tissue graft material.

Abstract: The invention provides an article of manufacture comprising a substantially non-immunogenic bone xenograft (X) for implantation into a defect (D) located in a bone portion (10) of a human. The invention further provides methods for preparing a bone xenograft (X) by removing at least a portion of bone from a non-human animal to provide a xenograft (X); washing the xenograft (X) in saline and alcohol; and subjecting the xenograft (X) to at least one of the treatments including exposure to ultraviolet radiation, immersion in alcohol, ozonic, and freeze/thaw cycling. In addition to or in lieu of the above treatments, the methods include a cellular disruption treatment, and digestion of the carbohydrate moieties of the xenograft (X) with a glycosidase followed by treatment for sialylation.

Abstract: The present invention relates to a method of utilizing body tissue by forming an implant that includes body tissue positioned in a cage. The cage is formed of material which expands when exposed to body fluid and the cage is positioned in a patient's body at a location where the cage is exposed to such body fluid so that the cage expands in the patients' body as the cage absorbs body fluid. The cage can be provided with openings extending substantially from a first end to a second end to allow tissue ingrowth. The body tissue can be heated or cooled and then shaped prior to placement in the cage. Also, the cage material can be biodegradable.

Abstract: An orthopedic implant is formed from a sheet of moldable material such as a polymer or a bioresorbable material using an instrument. The material is heated above its glass transition temperature so that it can be formed into the desired shape of the implant. Then the material is cooled below its glass transition temperature to harden the material such that it retains the implant shape. During surgery, a surgeon can form implants to fit unique orthopedic applications by using instruments having various internal and external mold forms between which the sheet of moldable material can be rolled, wound, pressed or drawn.

Abstract: A method of using body tissue includes removing tissue from a donor site and separating at least one component from the tissue while maintaining the tissue cells in a viable condition. The viable tissue cells are then implanted in a patient. The tissue cells may be positioned on a structural support before implantation in a patient. The method may also include harvesting cancellous bone and extruding the cancellous bone cells while maintaining the cells in a viable condition.

Abstract: An improved segmentally demineralized bone implant, useful inter alia as a replacement ligament or tendon possesses at least one demineralized, flexible segment exhibiting reduced osteoinductive properties. The reduction in osteoinductive properties results in the suppression, inhibition or delay of new bone ingrowth in, and consequently remineralizing of, the demineralized segment thereby allowing the segment to retain or prolong its flexible character following insertion of the implant in the body.

Abstract: A bone transplant consists of a transplant body which is curved in a channel shape and which consists of bone material of human or animal origin.

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: Disclosed and claimed is bone or bone tissue supplemented with a therapeutically effective compound and methods for supplementing bone or bone tissue with the therapeutically effective compound.

Abstract: A method by which immune responses to cortical bone grafts and other substrates (e.g., cement, IPN, etc.) can be minimized and at the same time graft osteoinductive potential can be improved, and improved graft substrate materials are disclosed. The method of the invention provides new types of bone grafts that incorporate into host bone more thoroughly and more rapidly, eliminating long-term complications, such as fracture, non-union, infection, and rejection. In the method of the invention, bone grafts or other substrates are modified to have an osteoinductive surface modification that the recipient's body will accept as its own tissue type and therefore will not reject or otherwise cause to fail. The osteoinductive surface modification comprises a biopolymer matrix coating that is seeded with periosteal cells that have been previously harvested either from the graft recipient or from an allogenic or xenogenic donor source.

Abstract: A cortical bone implant is formed of two or more planks of bone which are connected with one or more offset pins. The pins may be right circular cylinders inserted into a corresponding offset bore which offset bends the inserted pin. The bending creates compression and tensile loads in the pin which loads creates friction compression forces on the planks connecting them to the pins by friction. The pins may have different shapes to form the offsets and different configurations for friction attachment to the planks. The implants may be formed of flat or L-shaped planks or bones formed into other shapes including interlocking arrangements. Processes and fixtures are disclosed for forming the pins, planks and implants. Various embodiments of the pins, planks, implants and processes are disclosed.

Abstract: A bone repair apparatus is provided where a biologically compatible structure has a compound carried on the structure that mimics collagen binding to cells. Living cells derived from fibroblasts are carried on the structure and display at least one morphologic change consistent with an osteogenic phenotype. The preferred method for practicing the invention includes harvesting a quantity of fibroblasts from a patient in need of a bone graft, growing the tissue under cell growth conditions, and seeding at least some cells of the cultured tissue on the biologically compatible structure with the collagen mimic thereon. The culture tissue cells are seeded on the structure and incubated under cell growth conditions, which results in the differentiation of the cells to bone-like cells and thus provides a tissue engineered apparatus ready for use as a bone graft.

Abstract: A shaped particle for use in an array of interlocking particles to repair, replace, improve or augment a bone deficiency is provided. The particle is comprised of bone material and, in a preferred embodiment, has six extremities, and the interstitial spaces between the extremities of one particle accept the extremities of an adjacent particle in an array. In a preferred embodiment, the bone material is demineralized bone material. In some embodiments, the particle is suspended in a material that facilitates application of the particle to bone, and the material may contain biological factors that augment bone growth or prevent infection.

Abstract: Methods and devices are provided for regenerating a meniscus. The devices comprise a layer of toughened naturally occurring extracellular matrix. The devices may, optionally, further comprise a biologic material to provide a framework for meniscus regeneration. The methods comprise the steps of removing a portion of a meniscus to provide a space, and inserting a device comprising a layer of toughened naturally occurring extracellular matrix into the space.

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: An osteoimplant is provided which comprises a coherent aggregate of elongate bone particles, the osteoimplant possessing predetermined dimensions and shape. The osteoimplant is highly absorbent and sponge-like in nature. Also provided herein are a method of fabricating the osteoimplant and a method of repairing and/or treating bone defects utilizing the osteoimplant.

Abstract: A composite bone marrow graft material is provided having an enriched population of uniformly distributed progenitor cells. The graft material includes clot material preferably derived from non-anticoagulated bone marrow aspirate, which significantly improves the efficacy of the graft. A method for preparing such bone graft material is also provided. A kit is also provided containing sterilized implements useful in preparing enriched composite bone marrow graft material.

Abstract: A biological material comprising a continuous layer of cartilaginous tissue reconstituted in vitro which contains components associated with cartilage mineralization. The biological material may be cultured with a mineralizing agent to form a mineralized biological material. The mineralized biological material is characterized by having a biochemical composition and physiological organization substantially similar to the deep and contiguous calcified cartilage zones of articular cartilage found in animals in vivo. Methods for preparing the biological materials and methods of using the biological materials are described.

Abstract: Donor material from a xenogeneic source is modified to enhance its survival time in a recipient by treating the donor material using low-dose photodynamic therapy (PDT). The donor material, such as an organ or cell suspension, is treated with a photosensitizer and irradiated in a low-dose protocol before transplantation into a xenogeneic recipient.

Abstract: Cells grown on a microcarrier are separated from the microcarrier by enzymatically digesting the microcarrier. More specifically, chondrocytes may be grown on dextran microcarrier beadlets and then the beadlets digested using dextranase to separate the chondrocytes from the carrier. Cells can also be grown on chitosan microcarriers to be used for implantation. In addition, cells can be grown on polysaccharide polymers to be used as implant devices. Various polymers serve as scaffolds for cells to be used for implantation. The polymers can be used for cell culture as well as for preparing scaffolds useful for tissue replacement such as cartilage tissue.

Abstract: Tissue culture and banking is used to guard against the spread of transmittable diseases. In one disclosed example, living nucleus pulposis cells obtained from recently deceased human or animal donors are used to restore disc function and eliminate pain in patients with disc disease. In the preferred embodiment, the donor nucleus is morselized to allow insertion through a small puncture in the annulus fibrosis with a needle and syringe. Although the description makes specific reference to human disc cells, the invention may be used as a way to provide disease-free disc tissue derived from animal sources, and is applicable as well to other types of biologic tissues and materials such pancreas cells, cartilage cells, and so forth. Additional therapeutic substances like culture medium, growth factors, differentiation factors, hydrogels polymers, antibiotics, anti-inflammatory medications, or immunosuppressive medications could be added to the transplanted cells or tissue.

Abstract: Selectively partially and demineralized bone-derived implants, their methods of preparation and use are provided. In one embodiment, a cranial void filler preferably having a T-shape formed of an upper mineralized cortical bone section and at least a partially demineralized lower section adapted to fill a cranial void is disclosed. In another embodiment, a plate preferably having a dog-bone-shape having mineralized and at least partially demineralized sections is disclosed. In a further embodiment, a unitary cord having a first mineralized section with a plurality of slits to provide flexibility and a second at least partially demineralized section is described. Also disclosed is an implant for laminoplasty having at least a partially demineralized section and a mineralized section. A method of forming an implant of demineralized fibers also is disclosed.

Abstract: Selectively demineralized bone-derived implants are provided. In one embodiment, a bone sheet for implantation includes a demineralized field surrounding mineralized regions. In another embodiment, a bone defect filler includes a demineralized cancellous bone section in a first geometry. The first geometry is compressible and dryable to a second geometry smaller than the first geometry, and the second geometry is expandable and rehydratable to a third geometry larger than the second geometry.

Abstract: A process for fabricating shaped material from demineralized bone particles includes the steps of applying a liquid slurry of demineralized bone particles to a support, removing excess liquid form the demineralized bone particles to provide a cohering shaped mass of demineralized bone particles, and warming the shaped mass of demineralized bone particles at a predetermined temperature and for a predetermined time period. The resultant bone mass exhibits enhanced tensile strength and minimal bone particle disassociation upon rehydration thereby improving product handling and application at the operative site.

Abstract: Cartilage tissue and implants comprising tissue are produced in vitro starting from cells having the ability to form an extracellular cartilage matrix. Such cells are brought into a cell space (1) and are left in this cell space for producing an extracellular cartilage matrix. The cells are brought into the cell space to have a cell density of ca. 5×107 to 109 cells per cm3 of cell space. The cell space (1) is at least partly separated from a culture medium space (2) surrounding the cell space by means of a semi-permeable wall (3) or by an open-pore wall acting as convection barrier. The open-pore wall can be designed as a plate (7) made of a bone substitute material and constituting the bottom of the cell space (1). The cells settle on such a plate (7) and the cartilage tissue growing in the cell space (1).

Abstract: The invention describes a process for the production of a human cartilage implant from chondrocytes cultured in vitro, which come as close as possible to the original with respect to their biochemical composition and biomechanical properties. Up to 20% by vol. of human serum are used as medium addition in the process. The chondrocytes can be kept in monolayer culture until the 12th passage in order firstly to be re-differentiated, incubated under a reduced oxygen partial pressure, and subsequently stimulated to form a three-dimensional cartilage tissue due to aggregation under an oxygen partial pressure of 21%.

Abstract: Living intervertebral disc cells are harvested, cultured and combined with type-specific collagen-glycosaminoglycan extracellular matrix analogues to restore disc function and eliminate pain in patients with disc disease. In the preferred embodiment, the engineered disc tissue is morselized to allow insertion through a small puncture in the annulus fibrosis with a needle and syringe. Additional therapeutic substances such as culture medium, growth factors, differentiation factors, hydrogels polymers, antibiotics, anti-inflammatory medications, or immunosuppressive medications are disclosed as additives to the engineered disc tissue.

Abstract: A tissue press for shaping or compressing a piece of tissue comprises first and second members movable relative to each other. A first forming element of a predetermined shape is selectively engageable on the first member. A second forming element of predetermined shape is selectively engageable on the second member. The first and second forming elements are positionable on opposite sides of the piece of tissue. The first and second members are relatively movable between a first spaced apart condition and a second condition in which the piece of tissue is held between the first and second forming elements. Means are preferably provided for monitoring and controlling the amount of pressure applied to the piece of tissue, in order to maintain the tissue in a viable living condition. Means may also be provided for draining off fluid from compressed tissue, so that the tissue can be implanted in a compressed state and imbibe fluid from the host site.

Abstract: Methods of reforming degenerated intervertebral discs are provided in accordance with methods of the invention. Hybrid materials useful in methods of the present invention are also provided.

Abstract: Implantable devices useful for creating bony fusion particularly in intervetebral spinal fusion. The device is formed of bone and has an at least partially demineralized portion between two rigid bone portions creating an area of flexibility. In one application, the area of flexibility may be used to move the device between a reduced size insertion configuration and an expanded implanted configuration. In another use, the area of flexibility may be useful to dampen shock applied to the implant. A method is also disclosed for making the implants and inserting the implants into an intervertebral disc space to promote interbody fusion.

Abstract: A tissue press for shaping or compressing a piece of tissue comprises first and second members movable relative to each other. A first forming element of a predetermined shape is selectively engageable on the first member. A second forming element of predetermined shape is selectively engageable on the second member. The first and second forming elements are positionable on opposite sides of the piece of tissue. The first and second members are relatively movable between a first spaced apart condition and a second condition in which the piece of tissue is held between the first and second forming elements. Means are preferably provided for monitoring and controlling the amount of pressure applied to the piece of tissue, in order to maintain the tissue in a viable living condition. Means may also be provided for draining off fluid from compressed tissue, so that the tissue can be implanted in a compressed state and imbibe fluid from the host site.

Abstract: A reconstructive structure for a cartilaginous element having a plurality of superimposed layers of intestinal submucosa tissue compressed and secured together and shaped to provide a reconstructive structure having the anatomical shape of the cartilaginous element to be reconstructed is described. The method of forming the reconstructive structure includes superimposing the planar layers of the intestinal submucosa tissue, securing the layers to form a multi-layered structure and cutting the resulting multi-layered structure to the desired shape.

Abstract: Conditioning of the surface of silica-based glass or ceramic by differential immersion in a serum protein-containing solution, and the resultant microporous Ca—P surface layer having serum-protein like organic molecules, as defined herein intermingled throughout, is described.