Abstract: A method of using body tissue is disclosed. Pieces of body tissue are obtained, they are shaped to form an article having a desired configuration, and the article is implanted into a patient's body.

Abstract: The present invention relates to an implant comprising two or more bone fragments that are combined to form a single unit. Cancellous bone or cortical bone is removed from a source and fashioned into bone components with desirable shapes and sizes. The bone components may be integrated to form implants for implantation in the body. Bone stock may be formed by combining sections of various bones of the body, and the bone stock may be further fashioned for use as implants with particular geometries.

Abstract: A method of using body tissue includes obtaining graft tissue. A medicinal substance is added to the graft tissue. The graft tissue is shaped to a predetermined configuration while the graft tissue is outside of a patient's body. The graft tissue is moved into the patient's body while the graft tissue has the predetermined configuration. While the graft tissue is in the patient's body, the graft tissue is allowed to expand and absorb liquid from the patient's body. A mechanical interlock may be established between the graft tissue and tissue in the patient's body during expansion of the graft tissue and absorption of liquid from the patient's body.

Abstract: The invention is directed toward a cancellous bone block assembly with at least one tendon replacement member being extended between two shaped cancellous bone blocks. Each substantially cylindrically shaped cancellous bone block has a central through going bore, a flat exterior longitudinal surface and a channel longitudinally cut in the exterior of the bone block body opposite the flat longitudinal surface. The tendon replacement member is inserted through the central through going bore around the end of the block and looped back along the flat longitudinal side where it is tied to the back of the tendon loop. A channel cut in the exterior surface is adapted to receive an interference screw to keep the block anchored in a bone tunnel previously cut in the respective bone.

Abstract: An implantable, biocompatible, osteogenic bone graft comprises at least one zone of impermeability to soft tissue ingrowth which is integral with the bone graft. Application of the bone graft to a bone repair site leads to selective rapid new bone ingrowth and inhibits or prevents soft tissue, e.g., gingival, epithelial, connective and/or muscle tissue, ingrowth in those areas adjacent to the zone(s) of impermeability to soft tissue ingrowth. The bone graft can be employed in a wide variety of bone repair procedures.

Abstract: A method of repairing a long bone having a defect is provided. The method includes the steps of: (a) mechanically fixating the long bone or portions thereof; and (b) filling the defect with a biodegradable scaffold impregnated with growth factors and/or osteoprogenitor cells and awaiting for osteointegration to take place.

Abstract: Implantable substrate for the healing and/or protection of connecting tissue, preferably cartilage, comprising at least one composition for the activation of locally present cells for tissue regeneration and at least one structure for cell invasion in vivo and/or for the formation of cell matrix and/or for the release of constituents of the employed composition.

Abstract: A method of manufacturing an osteoinductive osteoimplant is provided which comprises the steps of: demineralizing part or all of at least one surface of a monolithic section of cortical bone to a depth of at least about 100 microns; and, configuring the monolithic section of cortical bone to provide an osteoimplant possessing an outer surface possessing at least one demineralized zone and a non-demineralized zone. An implant produced according to the above method demonstrates improved osteoinduction without producing any clinically significant reduction of strength in critical regions of the osteoimplant.

Abstract: An implant composed substantially of cortical bone is provided for use in cervical Smith-Robinson vertebral fusion procedures. The implant is derived from allograft or autograft cortical bone sources, is machined to form a symmetrically or asymmetrically shaped (e.g. a substantially “D”-shaped) implant having a canal running therethrough according to methods of this invention, and inserted into the space between adjacent cervical vertebrae to provide support and induce fusion of the adjacent vertebrae. Osteogenic, osteoinductive or osteoconductive materials may be packed into the canal of the implant to expedite vertebral fusion and to allow autologous bony ingrowth.

Abstract: The present invention relates to an implantable cage for holding tissue graft material. The cage includes a chamber configured and dimensioned to receive the tissue graft material and at least one side wall defining the chamber. In one embodiment, the cage is made of a biodegradable material. In another embodiment, the cage is made of a material that includes a bone-growth enhancer.

Abstract: The composition as described serves for in vivo cartilage repair. It basically consists of a naturally derived osteoinductive and/or chondroinductive mixture of factors (e.g. derived from bone) or of a synthetic mimic of such a mixture combined with a nanosphere delivery system. A preferred mixture of factors is the combination of factors isolated from bone, known as BP and described by Poser and Benedict (WO 95/13767). The nanosphere delivery system consists of nanospheres defined as polymer particles of less than 1000 nm in diameter (whereby the majority of particles preferably ranges between 200-400 nm) in which nanospheres the combination of factors is encapsulated. The nanospheres are loaded with the mixture of factors in a weight ratio of 0.001 to 17% (w/w), preferably of 1 to 4% (w/w) and have a release profile with an initial burst of 10 to 20% of the total load over the first 24 hours and a long time release of at least 0.1 per day during at least seven following days.

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: An implant (prosthesis) comprising a batch of a mixture of porous grains/granular material of tissue-compatible type and disintegrated tissue-compatible biological material (preferably endogenous material, such as bone meal). The batch further comprises a component which allows moulding or modelling of the batch, and the batch is enclosed in a pouch or wrap made of a flexible tissue-compatible material and having pores/apertures/perforations or the like of a size which allows outgrowth and ingrowth of tissue of the biological material. The implant is applicable in many contexts, such as a fixing agent for a hip-bone prosthesis, as a filler in plastic surgery and as a bone growth promoting agent when treating rheumatism.

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 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 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: The present invention provides a synthetic, poorly-crystalline apatitic (PCA) calcium phosphate material seeded with cells. Preferably, the cells are tissue-forming or tissue-degrading cells. The compositions provided by the present invention are useful for a variety of applications, including in vivo and in vitro tissue growth (preferably bone or cartilage), osseous augmentation, and methods of diagnosing disease states by assaying tissue-forming potential of cells isolated from a host. The invention also provides in vitro cell culture systems and cell encapsulation matrices.

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: The present invention discloses an in vitro engineered osteochondral graft comprising a porous matrix block, more particularly, a porous polylactic acid polymer block, press-coated with mesenchymal stem cells (MSCs), wherein a cartilage layer is formed on the surface of the matrix block. This invention may be used for treating articular cartilage defects.

Abstract: Instrumentation for manufacturing a bone dowel from human or animal cadaveric bone and instrumentation for evaluating the suitability of the bone and/or dowel for implant use after each step of the manufacturing process is provided. Such instrumentation for manufacturing a bone dowel includes a blanking or coring apparatus, a milling apparatus a threading apparatus and a tapping apparatus. A gauge is provided to inspect and determine the suitability of the bone dowel at each step of the manufacturing process. By inspecting the dowel being manufactured after each step of the manufacturing process, time and effort which is needlessly wasted during completion of the manufacturing of dowels which are unsuitable for implant use (due to unsuitable bone and/or inaccurate machining of bone) can be avoided. Instrumentation for more accurately positioning bone and the partially manufactured dowel into the instrumentation for machining the dowel is also provided.

Abstract: The present invention relates to a tissue grafting material that includes a first tissue element harvested from an individual, a carrier, and a therapeutic substance contained in the carrier. The carrier and therapeutic substance are incorporated into the first tissue element and the first tissue element, carrier, and therapeutic substance form a unitary implant.

Abstract: Implants for use in the spinal column are disclosed. The implants comprise a bone allograft coupled with a non-allogenic plate. The plate has ends that fasten to opposing spine segments, and an intermediate portion that engages the allograft using deformable fingers, or with a hollow portion sized to receive and hold part of the allograft, or with fixed tabs. Methods of using the implants are also disclosed.

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: A composition or device suitable for orthopedic or dental implantation to bone, characterized by tartrate-resistant acid phosphatase (TRAP) adsorbed to a porous hydroxyapatite substratum.

Abstract: An orthopaedic device for repairing and regenerating cartilage includes a plug configured to be positioned in a hole formed in the cartilage and an anchor configured to support the plug. One or both of the plug and the anchor may be formed from naturally occurring extracellular matrix such as small intestine submucosa. A method for repairing and regenerating cartilage is also disclosed.

Abstract: The present invention relates to a method of forming a bone composite, comprising: providing bone tissue; grinding said bone tissue to form ground tissue; molding the ground bone tissue into a bone composite; applying a binder to the bone composite; applying a vacuum to the mold, and optionally milling or refining the bone composite to the desired shape. The present invention also encompasses bone tissue composites made therefrom. The composites may be, for example, a bone pin, screw, or prosthesis.

Abstract: A method for the repair of a cartilaginous tissue defect, a cartilage repair device and a method of making a cartilage repair device are disclosed. In the method for the repair of a cartilaginous tissue defect, a device comprising a synthetic polymer is implanted into the defect, and a biological lubricant is administered to the defect. The device comprises a synthetic polymer and a biological lubricant.

Abstract: A method for the repair of a cartilagenous tissue defect, a cartilage repair device and a method of making a cartilage repair device are disclosed. In the method for the repair of a cartilagenous tissue defect, a device comprising a scaffold, for example an extracellular matrix material, is implanted into the defect, and a biological lubricant is administered to the defect. The device comprises a scaffold, for example a naturally occurring extracellular matrix material, and a biological lubricant.

Abstract: A kit and a method for making a porous cement which self sets to hydroxyapatite and has an interconnected porosity is produced by mixing a calcium source and a phosphate source with a carbonate source and mixing this powdered component with a liquid component having an acid component. The liquid component comprises water or an aqueous solution containing an acid. The acid and the carbonate react to form carbon dioxide thereby producing an interconnected porosity in the normally solid self-hardening bone cement. The method requires only a relatively low weight percent of the acid and base to be mixed with the liquid and powder cement components.

Abstract: The present invention is directed to a textured bone allograft for implantation in a patient, having one or more textured bone surfaces, and methods of making and using the textured bone graft. The textured surface preferably includes a plurality of closely spaced discrete, continuous, or a combination thereof, protrusions. The textured bone allograft 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 column. Implantation of the textured bone allograft results in improved graft stability and osteoinductivity, without a decrease in mechanical strength. The textured bone allograft does not shift, extrude or rotate, after implantation.

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: The invention provides a multi-layer membrane comprising a matrix layer predominantly of collagen II and having an open sponge-like texture, and at least one barrier layer having a close, relatively impermeable texture. Such a membrane is particularly suitable for use in guided tissue regeneration, in particular for use in vivo in the reconstruction of bone or cartilage tissue.

Abstract: An implant is provided as a solid aggregate of bone-derived elements, e.g., particles, powders, granules, fibers, strips and/or large pieces of xenogenic, allogenic, transgenic, tissue engineered or autologous cortical and/or cancellous bone, employing as binding agent for the bone-derived elements a precipitate or crystalline bridge of metal oxide, metal hydroxide, metal salt of an inorganic acid, metal salt of an organic acid, metal-containing silica based glass, or mixture thereof, the binding agent possessing at least slight solubility in polar solvent, adjacent bone-derived elements being bonded to each other through engagement with particles or bridge-like structures of bonding agent.

Abstract: An interbody spinal implant comprising cortical bone having a width less than one-half the width of the disc space into which it is adapted to be inserted. The implant has a leading end that is asymmetrical from side to side and/or includes a straight portion adapted to be used in side-by-side pairs.

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: Apparatus and methods for treating a spinal disc are disclosed. An opening is created in the annulus fibrosis, and nucleus pulposus is removed from the interior of the disc. The interior is lined with a nonporous, bioabsorbable liner, and filled with a fill material, such as nucleus pulposus, to cause the liner to expand to engage tissue surrounding the interior. The liner may be a sheet of extra-cellular matrix material that is introduced into the interior, or a bladder of extra-cellular matrix material including a neck communicating with an interior region of the bladder. The sheet or bladder may be carried by a delivery device, e.g., a catheter or rod. After the interior region is filled, the opening is closed using a plug or other closure device. The plug may include threads on its external surface for securing the plug in the opening.

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: 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: 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: 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: The invention is directed toward a malleable bone putty and a flowable gel composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing compound of demineralized lyophilized allograft bone powder. The bone powder has a particle size ranging from about 100 to about 850 microns and is mixed in a high molecular weight hydrogel carrier contain a sodium phosphate saline buffer, the hydrogel component of the carrier ranging from about 0.75 to 4.5% of the composition and having a molecular weight of about at least 160,000 Daltons. The composition has a pH between 6.8-7.4 contains about 25% to about 35% bone powder and can be additionally provided with BMP's.

Abstract: Methods of repairing a joint formed by at least two bone sections are provided wherein a biocompatible osteogenic band fabricated from an osteogenic biological material such as bone, tendon, ligament and collagen is affixed to two or more bone sections.

Abstract: Osteoarticular allografts are transplanted by techniques which ensure substantial surface contour matching. Specifically, surgical techniques are provided whereby a plug from an osteochondral allograft may be transplanted to a cavity site which remains after a condylar defect is removed from a patient's condyle. In this regard, the present invention essentially includes placing an osteochondral allograft in substantially the same orientation as the patient condyle, and then removing the transplantable plug therefrom and forming the cavity site in the patient condyle while maintaining their relative same orientation. In this manner, the surface of the transplanted plug is matched to the contour of the excised osteochondral tissue.

Abstract: Osteogenic sponge compositions having enhanced osteoinductive properties for use in bone repair are described. The compositions include a quickly resorbable porous carrier, a more slowly resorbed mineral scaffold and an osteogenic factor, preferably a bone morphogenetic protein. The compositions enable increased osteoinductive activity while retaining a reliable scaffold for the formation of new bone at an implant site. Methods for therapeutic use of the compositions are also described.

Abstract: Open chambered spacers, implanting tools and methods are provided. The spacers 500′ include a body 505′ having a wall 506′ which defines a chamber 530′ and an opening 531′ in communication with the chamber 530′. In one embodiment the wall 506′ includes a pair of arms 520′, 521′ facing one another and forming a mouth 525′ to the chamber 530′. Preferably, one of the arms 520′ is truncated relative to the other, forming a channel 526. In one aspect the body 505′ is a bone dowel comprising an off-center plug from the diaphysis of a long bone. The tools 800 include spacer engaging means for engaging a spacer and occlusion means for blocking an opening defined in the spacer. In some embodiments, the occlusion means 820 includes a plate 821 extendable from the housing 805.

Abstract: This invention provides a method and means for securing a tissue to a bone or non-tissue prosthesis by affixing a collagenous material to said bone or non-tissue prosthesis, and affixing said tissue to said collagenous material.

Abstract: An intervertebral implant having a composite wedge/dowel configuration is provided. The intervertebral implant includes a central body portion and a pair of radially extending wings. The radially extending wings can be tapered from a first end of the implant to the second end of the implant along an axis parallel to the longitudinal axis of the central body portion. Alternately, the radially extending wings can be tapered along an axis transverse to the longitudinal axis of the cylindrical body portion or along any other axis between parallel and transverse to the longitudinal axis. A throughbore or plurality of throughbores extend from a top surface of the implant through the implant to a bottom surface of the implant. The implant may be formed from a cortical ring cut from the diaphysis of a long bone by milling the top and bottom surfaces of the cortical ring to form the substantially central body portion and the tapered radially extending wings.

Abstract: Spinal spacers 20 are provided for fusion of a motion segment. The spacers include a load bearing member 21 having a wall 22 sized for engagement within a space between adjacent vertebrae to maintain the space and an effective amount of an osteogenic composition to stimulate osteoinduction. The osteogenic composition includes a substantially pure osteogenic factor in a pharmaceutically acceptable carrier. In one embodiment the load bearing member includes a bone graft impregnated in an osteogenic composition. In another embodiment, the osteogenic composition 30 is packed within a chamber 25 defined in the graft. Any suitable configuration of a bone graft is contemplated, including bone dowels, D-shaped spacers and cortical rings.