Abstract: A moisture resistant package for storing and transporting sterile items, such as specimens of human or animal tissue, comprises an inner tray that fits within a moisture resistant outer tray. The inner tray has a cavity for storing the specimen. The specimen is enclosed within the cavity by a non-porous inner lid that is sealed to the inner tray by an adhesive to create a moisture and microbial contaminant resistant environment that prevents moisture uptake into the specimen. The inner tray is enclosed within a complementary shaped cavity of the outer tray by an outer lid sealed to the outer tray to complete the assembly of the package. Thereafter, the package is terminally sterilized (using gas or radiation) so that the inner tray can be introduced into a sterile environment when it is removed from the outer tray.

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 treating a condition in a vertebrate animal characterized by bone having increased porosity and/or decreased bone mineral density. The porous bone is injected with an effective amount of a flowable bone composition. Also provided is a kit for the treatment of porous bone wherein a flowable bone composition is contained within an injectable delivery system.

Abstract: A distractor/guide sleeve assembly is provided which includes a body having a cylindrical throughbore and a distractor assembly mounted thereon. The distractor assembly includes a rotatable dial, a pair of distractor rods, and two pairs of jaws. A plate is secured to the distal end of each distractor rod. Each plate includes a plurality of cam members which are slidably positioned in cam slots formed in the jaws of each of the pairs of jaws. The dial is operably connected to the jaws via the distractor rods such that rotation of the dial effects movement of the pairs of jaws between approximated and distracted positions. An insertion tool is also provided which includes a handle and distal engaging structure for releasably engaging an implant. The engaging structure includes a pair of prongs or protrusions having a slip resistant outer surface. The prongs are configured to be releasably received within correspondingly shaped bores formed in an implant.

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 distractor/guide sleeve assembly is provided which includes a body having a cylindrical throughbore and a distractor assembly mounted thereon. The distractor assembly includes a rotatable dial, a pair of distractor rods, and two pairs of jaws. A plate is secured to the distal end of each distractor rod. Each plate includes a plurality of cam members which are slidably positioned in cam slots formed in the jaws of each of the pairs of jaws. The dial is operably connected to the jaws via the distractor rods such that rotation of the dial effects movement of the pairs of jaws between approximated and distracted positions. An insertion tool is also provided which includes a handle and distal engaging structure for releasably engaging an implant. The engaging structure includes a pair of prongs or protrusions having a slip resistant outer surface. The prongs are configured to be releasably received within correspondingly shaped bores formed in an implant.

Abstract: Spinal and other implants may be bone or synthetic material shaped as rings, C-shaped or rectangular and so on and also may have serrated wedge shaped top and bottom surfaces to match the disc space lordosis of adjacent ertebra and so on. The implants have one or more recesses aligned in an insertion direction at either or both outer peripheral sides of the implant. In a ring implant, e.g., formed from a transverse slice of the diaphysis of a long bone or otherwise, the recesses are aligned overlying the opposing sides of the ring parallel to the insertion direction, which sides are stronger than the more central region overlying and aligned with a central chamber in the implant. The alignment ith the opposing sides minimizes damage to the implant at the weaker more central region in response to implant insertion forces.

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: A ramp-shaped intervertebral implant is disclosed. The implant has a body having a first end, a second end, a top surface and a bottom surface. At least one of the top and bottom surfaces is tapered and converges towards the second end of the body. An opening extends through the body and has one end opening onto the top surface of the implant and the other end opening onto the bottom surface of the implant. The implant can be formed from the diaphysis or metaphysis of a long bone, wherein the intramedullary canal of the long bone defines the opening. Alternately, the implant can be made from any biocompatible material having the requisite strength requirement.

Abstract: A dowel insertion tool includes a T-shaped handle and a hollow sleeve which extends distally from the T-shaped handle. A shaft extends from the handle through the hollow sleeve and includes a transverse extension. A rotatable knob having an annular channel positioned to receive the transverse extension is supported adjacent the handle. A pin is secured to the knob and extends into a helical camming channel formed in the sleeve. Upon rotation of the knob, the pin moves within the camming channel to move the knob longitudinally about the sleeve. Movement of the knob effects longitudinal movement of the shaft. A support plate is secured to the distal end of the shaft. A pair of prongs are slidably secured to the plate. Each of the prongs includes an enlarged head portion which is slidably positioned within a slot formed in the plate. A guide member is secured to the distal end of the sleeve. The guide member includes a pair of guide bores dimensioned to receive a distal end of the prongs.

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: 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: A load-bearing osteoimplant, method of making the osteoimplant and method for repairing bone using the osteoimplant are provided. The osteoimplant comprises a shaped, compressed composition of bone particles. The osteoimplant possesses a bulk density of greater than about 0.7 g/cm3 and a wet compressive strength of at least about 3 MPa.

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: A C-shaped or ring shaped implant formed of cortical bone has its C-shaped or inner channel filled with a bone promoting material which is preferably demineralized bone fibers formed as a flexible wet sheet or may be cancellous bone, pressed bone fibers formed from demineralized cortical bone chips soaked in acid, or a flex material formed of demineralized bone growth promoting bone fibers. The discrete bone filler element may be secured by a bonding agent, pins or screws, metal, polymer or bone material. The bone filler material is preferably bonded by filling a section of a long bone medullary cavity with wet bone fibers and then drying the fibers to bond them to the outer bone. A filled bone ring may be sliced to form annular filled sections which are then divided into mirror image C-shaped halves each forming an implant. Flex material of compressed bone fibers may be formed with an opening shaped to receive a cortical bone implant element having a C-shaped channel.

Abstract: A rod-to-rod coupler includes a body having first and second coupler portions. Each coupler portion defines a concavity configured to receive a portion of an elongated spinal rod. A screw and nut assembly which includes a screw and a flanged nut is positioned adjacent each concavity. Each flanged nut has a flange portion which extends at least partially over one concavity. After the rod-to-rod coupler has been positioned with the concavities located over adjacent spinal rods, the screw can be rotated to move the flanged nut into engagement with a spinal rod to secure the spinal rod within a concavity. In one embodiment, one coupler portion is formed with a blind bore and the other coupler portion is formed with an extension which is slidably received within the blind bore. The extension is slidable within the blind bore to selectively adjust the distance between the concavities of the first and second coupler portions. A set screw is provided to secure the extension at a fixed position within the blind bore.

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: An interference screw suitable for surgical use is provided. The interference screw is constructed from bone and includes an elongated body having an outer threaded surface, a tapered insertion end and a central throughbore. Insertion tool engaging structure is formed along the walls defining the throughbore. The insertion tool engaging structure extends from the proximal end of the elongated body over a substantial portion of the length of the elongated body. The insertion tool engaging structure functions to distribute the forces required to insert the interference screw throughout the body of the interference screw to prevent fracturing of the interference screw during insertion into bone.

Abstract: An osteogenic osteoimplant in the form of a flexible sheet comprising a coherent mass of bone-derived particles, the osteoimplant having a void volume not greater than about 32% and a method of making an osteogenic osteoimplant having not greater than about 32% void volume, the method comprising: providing a coherent mass of bone-derived particles; and, mechanically shaping the coherent mass of bone-derived particles to form an osteogenic osteoimplant in the form of a flexible sheet.

Abstract: A method for promoting the growth of bone, periodontium, or ligament in a warm-blooded vertebrate, the method comprising: producing a surgical flap to expose the bone, periodontium or ligament; debriding the bone, periodontium or ligament to remove organic matter from the bone, periodontium or ligament; implanting an effective amount of an osteogenic bone graft material, the bone graft material consisting of an osteoimplant having not greater than about 32% void volume formed at least in part from elongate bone-derived elements optionally in combination with bone powder; replacing the flap; and, allowing the bone, periodontium or ligament to regrow.