Abstract: A bioabsorbable material such as a terpolymer of poly-(L-lactide/D-lactide/glycolide). The material may consist of 85 molar percent L-lactide, 5 molar percent D-lactide, and 10 molar percent glycolide. The material may have a heat of fusion of about 15-25 J/G, tensile strength retention at 26 weeks of incubation of at least about 50%, and tensile strength retention at 52 weeks of incubation of at most about 25%. The material may be used in implantable devices such as bone fixation devices.

Abstract: A glenoid component includes an oval body having a concave lateral articulating surface and an opposing medial surface with a keel extending from the medial surface. The keel extends along a line which is anteriorly offset from the center line of the concave surface and is not collinear with any radius of the concave surface. New methods and tools are provided for the implantation of the glenoid component. Sizer drill guides are provided with an alignment arm which assures that the anterior/posterior angle of the pilot hole is approximately 65 degrees. An improved reamer tool is provided which allows the practitioner to attach a reamer head of selected size to the reamer rather than choosing among several reamers of different size at the time of the procedure. A new keel drill guide is provided which locates three drill guide holes in a plane which is offset approximately 2 mm anterior of the pilot hole.

Abstract: A medical implant made of polymeric material having an increased oxidation resistance is formed by a method including the steps of placing a resin powder in a sealed container. A substantial portion of the oxygen is removed from the sealed contained by either a vacuum, an oxygen absorbent or by flushing with inert gas. The container is then repressurized with a gas such as nitrogen, argon, helium or neon so that long term storage may be possible. On use, the resin in transferred to a forming device which both melts and forms the resin in an oxygen reduced atmosphere to produce a polymeric raw material such as a rod or bar stock. The medical implant is then formed from this raw material annealed and sealed in an airtight package in an oxygen reduced atmosphere. The implant is then radiation sterilized and thereafter annealed in the package for a predetermined time and temperature sufficient to form cross-links between any free radicals in neighboring polymeric chains.

Abstract: IM tibia revision tools include a trial stem extender having multiple notches which serve both as depth witness marks and holders for a stop clip, a collection of different sized tibial templates, each template adapted to receive an angular offset positioning guide, a collection of offset bushings, each bushing each bushing having a different offset distance and each being adapted to cooperate with the trial stem extender and the angular offset positioning guide, a neutral bushing for locating the position of the implant boss relative to the tibia and for reaming the tibia to accept the boss of the implant, a fin punch guide and fin punch for preparing the tibia to receive the keel of the tibial component, and a tool for translating the angular offset measurement to the tibial component. Tibial components according to the invention have three parts: the baseplate portion, the offset portion, and the stem portion.

Abstract: Femoral resection tools of the present invention include a posterior condyle alignment guide, an IM rod with an adjustable valgus bushing assembly, left and right external rotation plates, an anterior sizing boom having a stylus and a pair of medial/lateral drill guide assemblies (in one embodiment of the invention the drill guide assemblies are the combination of medial/lateral extension arms and attached (detachable) proximal positioning fixtures; in another embodiment, the proximal positioning fixtures are not part of the drill guide assembly per se), a plurality of self-tapping screws, proximal positioning fixtures (apart from any positioning fixtures that may be integrated into a drill guide assembly), and different size cutting guide blocks, each adapted to fit over the proximal positioning fixtures. Methods for utilizing the aforementioned tools so that five resections can be performed are also described.

Abstract: A hand instrument and method for use by a surgeon to target the appropriate entry point and trajectory on bony tissue through which an instrument, such as a nail, pin, screw, rod, wire, drill bit, or other implant is passed. Imbedded within the instrument is at least one relatively radio-opaque target which allows the user to predict with the use of an x-ray or fluoroscopic imaging device the placement of said instrument or implant before drilling it into place with the use of an x-ray or fluoroscopic imaging device. By manipulating the device around the axis of the guide piece, the surgeon can predict the placement of the instrument or implant without iterative insertion and removal of the instrument or implant itself.

Abstract: A glenoid component includes an oval body having a concave lateral articulating surface and an opposing medial surface with a keel extending from the medial surface. The keel extends along a line which is anteriorly offset from the center line of the concave surface and is not collinear with any radius of the concave surface. New methods and tools are provided for the implantation of the glenoid component. Sizer drill guides are provided with an alignment arm which assures that the anterior/posterior angle of the pilot hole is approximately 65 degrees. An improved reamer tool is provided which allows the practitioner to attach a reamer head of selected size to the reamer rather than choosing among several reamers of different size at the time of the procedure. A new keel drill guide is provided which locates three drill guide holes in a plane which is offset approximately 2 mm anterior of the pilot hole.

Abstract: A medical implant made of polymeric material having an increased oxidation resistance is formed by a method including the steps of placing a resin powder in a sealed container. A substantial portion of the oxygen is removed from the sealed container by either a vacuum, an oxygen absorbent or by flushing with inert gas. The container is then repressurized with a gas such as nitrogen, argon, helium or neon so that long term storage may be possible. On use, the resin is transferred to a forming device which both melts and forms the resin in an oxygen reduced atmosphere to produce a polymeric raw material such as a rod or bar stock. The medical implant is then formed from this raw material annealed and sealed in an airtight package in an oxygen reduced atmosphere. The implant is then radiation sterilized and thereafter annealed in the package for a predetermined time and temperature sufficient to form cross-links between any free radicals in neighboring polymeric chains.

Abstract: Orthopaedic wires, cables, and methods of making them are based on the discovery that, in clinical orthopaedic applications, material toughness and fatigue strength are as important or more important than ultimate tensile strength. The wires and cables of the invention have a tensile strength lower than 280 ksi, but higher than 175 ksi. The presently preferred wires and cables have a tensile strength of 210-240 ksi. The fatigue strength of the wires and cables of the invention is between six and ten times that of other high strength cables used in orthopaedic applications. One method of making the wires and cables includes annealing high tensile strength wire or cable to reduce its tensile strength and thereby increase its fatigue strength. Another method is to cold work fully annealed wire or cable to the extent of decreasing its cross section by approximately 18%.

Abstract: An article for use in the preparation of a hydrogel prosthetic nucleus, for an intervertebral disc, having equilibrium water contents (EWCs) of from about 30 to about 90% and compressive strengths of at least 4 meganewtons per square meter (MNm−2), at their EWCs, when subjected to the same constraints as the normal nucleus, comprising one or more xerogel rods containing from zero to less than the EWC.

Abstract: IM revision tools include reamers with depth markings or stops, an impactor-extractor with a coupling for attaching to tools which are inserted into and removed from the IM canal, a resection guide tower to which a cutting block is attached and which includes a notch which serves as both a witness mark and a holder for a femoral or tibial collar, a reversible clean-up cutting block with a quick-connect clamp attachable to the guide tower for resecting the distal femur and separate left and right clean-up cutting blocks for resecting the proximal tibia, a selection of spacer blocks for measuring the space between the tibia and femur to determine the size of the components to be installed, a multiple cut cutting guide for preparing the femur, a set of 5 and 10 mm trial wedges, a trial stem valgus adapter, femoral sizing indicators which include indications of anterior/posterior offset, a stabilizer box cutting template which is attachable to the multiple cut cutting guide, and anterior/posterior offset adapters

Abstract: A method for reducing residual ethylene oxide levels in sterilized goods by reacting the residual ethylene oxide with water after the sterilization reaction is completed, thus converting some of the ethylene oxide into ethylene glycol according to the formula (I): The sterilizable material may be subjected to deep vacuum degassing following the reaction of formula (I).

Abstract: IM tibia revision tools include a trial stem extender having multiple notches which serve both as depth witness marks and holders for a stop clip, a collection of different sized tibial templates, each template adapted to receive an angular offset positioning guide, a collection of offset bushings, each bushing each bushing having a different offset distance and each being adapted to cooperate with the trial stem extender and the angular offset positioning guide, a neutral bushing for locating the position of the implant boss relative to the tibia and for reaming the tibia to accept the boss of the implant, a fin punch guide and fin punch for preparing the tibia to receive the keel of the tibial component, and a tool for translating the angular offset measurement to the tibial component. Tibial components according to the invention have three parts: the baseplate portion, the offset portion, and the stem portion.

Abstract: A hand instrument and method for use by a surgeon to target the appropriate entry point and trajectory on bony tissue through which an instrument, such as a nail, pin, screw, rod, wire, drill bit, or other implant is passed. Imbedded within the instrument is at least one relatively radio-opaque target which allows the user to predict with the use of an x-ray or fluoroscopic imaging device the placement of said instrument or implant before drilling it into place with the use of an x-ray or fluoroscopic imaging device. By manipulating the device around the axis of the guide piece, the surgeon can predict the placement of the instrument or implant without iterative insertion and removal of the instrument or implant itself.

Abstract: A bioabsorbable material such as a terpolymer of poly-(L-lactide/D-lactide/glycolide). The material may consist of 85 molar percent L-lactide, 5 molar percent D-lactide, and 10 molar percent glycolide. The material may have a heat of fusion of about 15-25 J/G, tensile strength retention at 26 weeks of incubation of at least about 50%, and tensile strength retention at 52 weeks of incubation of at most about 25%. The material may be used in implantable devices such as bone fixation devices.

Abstract: Apparatus for storing, mixing, and dispensing a two-component bone cement includes a first component supply section, a mixing section, and a drive base. One or more ampules of the first (liquid) component, provided within the first component supply section, are broken or cut when a lever is rotated. The second (powder) component is provided within the mixing section. During the mixing process, a vacuum is applied within the mixing section, assisting in the delivery of the first component through a filter while preventing the passage of broken glass or plastic from the ampules. Mixing is done by a pair of paddles and a helical spring rotating within the mixing station, being driven in one direction, or in alternating opposite directions of rotation, by the drive base.

Abstract: A medical implant made of polymeric material having an increased oxidation resistance is formed by a method including the step of placing a resin powder in a sealed container. A substantial portion of the oxygen is removed from the sealed container by either a vacuum, an oxygen absorbent or by flushing with inert gas. The container is then repressurized with a gas such as nitrogen, argon, helium or neon so that long term storage may be possible. On use, the resin is transferred to a forming device which both melts and forms the resin in an oxygen reduced atmosphere to produce a polymeric raw material such as a rod or bar stock. The medical implant is then formed from this raw material annealed and sealed in an airtight package in an oxygen reduced atmosphere. The implant is then radiation sterilized and thereafter annealed in the package for a predetermined time and temperature sufficient to form cross-links between any free radicals in neighboring polymeric chains.

Abstract: Modular prosthetic shoulder components include a number of different sized humeral heads, each having a spherical outer surface and an interior tapered bore, a frustroconical intermediate head component dimensioned to lockingly mate with the tapered bore of the humeral heads and having a diametrical slot, and a humeral stem trunnion component having a rectilinear peg dimensioned to lockingly engage the diametrical slot in the intermediate head component. The components are assembled by inserting the intermediate head component into the tapered bore of a humeral head, inserting the peg of the trunnion component into the slot of the intermediate head component, and pressing the components together. The intermediate head component taper locks with the humeral head and force-fit locks onto the peg of the trunnion component.

Abstract: IM tibia revision tools include a trial stem extender having multiple notches which serve both as depth witness marks and holders for a stop clip, a collection of different sized tibial templates, each template adapted to receive an angular offset positioning guide, a collection of offset bushings, each bushing each bushing having a different offset distance and each being adapted to cooperate with the trial stem extender and the angular offset positioning guide, a neutral bushing for locating the position of the implant boss relative to the tibia and for reaming the tibia to accept the boss of the implant, a fin punch guide and fin punch for preparing the tibia to receive the keel of the tibial component, and a tool for translating the angular offset measurement to the tibial component. Tibial components according to the invention have three parts: the baseplate portion, the offset portion, and the stem portion.

Abstract: Orthopaedic wires, cables, and methods of making them are based on the discovery that, in clinical orthopaedic applications, material toughness and fatigue strength are as important or more important than ultimate tensile strength. The wires and cables of the invention have a tensile strength lower than 280 ksi, but higher than 175 ksi. The presently preferred wires and cables have a tensile strength of 210-240 ksi. The fatigue strength of the wires and cables of the invention is between six and ten times that of other high strength cables used in orthopaedic applications. One method of making the wires and cables includes annealing high tensile strength wire or cable to reduce its tensile strength and thereby increase its fatigue strength. Another method is to cold work fully annealed wire or cable to the extent of decreasing its cross section by approximately 18%.