Abstract: An osteoimplant composite comprising a plurality of particles of an inorganic material, a bone substitute material, a bone-derived material, or any combination thereof; and a polymer material with which the particles are combined. The composite is either naturally moldable or flowable, or it can be made moldable or settable. After implantation, the composite may be set to provide mechanical strength to the implant. The inventive composite have the advantage of being able to fill irregularly shape implantation site while at the same time being settable to provide the mechanical strength required for most orthopedic applications. The invention also provides methods of using and preparing the moldable and flowable composites.

Abstract: A device for releasing a therapeutic agent in the body space in the form of a prosthetic joint implant having a first portion such as a stemmed portion for contacting bone tissue in an intramedullary canal of a long bone. The implant has a second portion which extends into the body space such as a joint space. The joint component contains a reservoir filled with a bioabsorbable/resorbable polymer which includes a therapeutic agent. The reservoir is open or in contact with the joint space as the body fluid diffuses in and out of the polymeric device it carries the drug into the joint space.

Abstract: An osteoimplant composite comprising a plurality of particles of an inorganic material, a bone substitute material, a bone-derived material, or any combination thereof; and a polymer material with which the particles are combined. The composite is either naturally moldable or flowable, or it can be made moldable or settable. After implantation, the composite may be set to provide mechanical strength to the implant. The inventive composite have the advantage of being able to fill irregularly shape implantation site while at the same time being settable to provide the mechanical strength required for most orthopedic applications. The invention also provides methods of using and preparing the moldable and flowable composites.

Abstract: An osteoimplant composite comprising a plurality of particles of an inorganic material, a bone substitute material, a bone-derived material, or any combination thereof; and a polymer material with which the particles are combined. The composite is either naturally moldable or flowable, or it can be made moldable or settable. After implantation, the composite may be set to provide mechanical strength to the implant. The inventive composite have the advantage of being able to fill irregularly shape implantation site while at the same time being settable to provide the mechanical strength required for most orthopedic applications. The invention also provides methods of using and preparing the moldable and flowable composites.

Abstract: An osteoimplant composite comprising a plurality of particles of an inorganic material, a bone substitute material, a bone-derived material, or any combination thereof; and a polymer material with which the particles are combined. The composite is either naturally moldable or flowable, or it can be made moldable or settable. After implantation, the composite may be set to provide mechanical strength to the implant. The inventive composite have the advantage of being able to fill irregularly shape implantation site while at the same time being settable to provide the mechanical strength required for most orthopedic applications. The invention also provides methods of using and preparing the moldable and flowable composites.

Abstract: An osteoimplant composite comprising a plurality of particles of an inorganic material, a bone substitute material, a bone-derived material, or any combination thereof; and a polymer material with which the particles are combined. The composite is either naturally moldable or flowable, or it can be made moldable or settable. After implantation, the composite may be set to provide mechanical strength to the implant. The inventive composite have the advantage of being able to fill irregularly shape implantation site while at the same time being settable to provide the mechanical strength required for most orthopedic applications. The invention also provides methods of using and preparing the moldable and flowable composites.

Abstract: A process for forming a rod of bioabsorbable polymeric material includes extruding the material at a temperature above its melting point at a controlled rate of between 0.4 to 20 feet per minute to form a continuous rod. The continuous rod is then cooled by passing the rod through a cooling bath to cause nucleation. The continuous rod is passed through a first puller running at least at the same speed as the extruder. A second puller is provided which is moving faster than the first puller so that the continuous rod is elongated at a ratio of between 2 and 12 times. During this elongation, the rod is heated to a temperature of between 55° C. and 140° C. in an oven located between the first and second pullers. The rod is annealed at a temperature of between 70° C. and 110° C. after being elongated but prior to exiting the second puller. Upon exiting the second puller, the tension in the rod is released and the continuous rod is then allowed to cool.

Abstract: A device for releasing a therapeutic agent in the body space in the form of a prosthetic joint implant having a first portion such as a stemmed portion for contacting bone tissue in an intramedullary canal of a long bone. The implant has a second portion which extends into the body space such as a joint space. The joint component contains a reservoir filled with a bioabsorbable/resorbable polymer which includes a therapeutic agent. The reservoir is open or in contact with the joint space as the body fluid diffuses in and out of the polymeric device it carries the drug into the joint space.

Abstract: A process for forming a rod of bioabsorbable polymeric material includes extruding the material at a temperature above its melting point at a controlled rate of between 0.4 to 20 feet per minute to form a continuous rod. The continuous rod is then cooled by passing the rod through a cooling bath to cause nucleation. The continuous rod is passed through a first puller running at least at the same speed as the extruder. A second puller is provided which is moving faster than the first puller so that the continuous rod is elongated at a ratio of between 2 and 12 times. During this elongation, the rod is heated to a temperature of between 55° C. and 140° C. in an oven located between the first and second pullers. The rod is annealed at a temperature of between 70° C. and 110° C. after being elongated but prior to exiting the second puller. Upon exiting the second puller, the tension in the rod is released and the continuous rod is then allowed to cool.

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: The present invention is a system for installing bioabsorbable plates for general bone repair, as for example, facial or cranial osteosynthesis. The present invention includes an improved plate and fastener system which reduces if not eliminates stresses within the plate. It also includes an improved fastener container and driver for handling and installing fasteners. The system employs a unique water bath for heating the bioabsorbable plate so they can be deformed to the contours of the bone being repaired. Additionally, there is a hand tool for localized heating and deformation of the plate when positioned against the bone to further ensure conformity with the bone structure. These and other features are contained within a kit which is easily sterilized.

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 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: 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: Processes are set forth for forming high strength thermoplastic polymer bone fixation devices used, for example, in orthopedic surgery, where "strength" is quantified in terms of a given device's pullout strength, tensile modulus, shear strength and breaking torque strength. Products of the aforementioned process are contemplated by the invention as well, with both "bioabsorbable" devices, for example, screws which are absorbable in an animal body and do not need to be removed after the bone in which they are inserted has healed; and non-bioabsorbable devices being described.

Abstract: Processes are set forth for forming high strength thermoplastic polymer bone fixation devices used, for example, in orthopedic surgery, where "strength" is quantified in terms a given device's pullout strength, tensile modulus, shear strength and breaking torque strength. Products of the aforementioned process are contemplated by the invention as well, with both "bioabsorbable" devices, for example, screws which are absorbable in an animal body and do not need to be removed after the bone in which they are inserted has healed; and non-bioabsorbable devices being described.

Abstract: An anti-displacement device and method are disclosed for implantation of a prosthetic bone joint in a bone. A biodegradable biocompatable anti-displacement device comprising a biodegradable biocompatible polymer is directed through an orifice, defined by a cup of a prosthetic bone joint, and into interfering contact with bone tissue of the bone. Displacement of the cup is thereby sufficiently limited to allow bone tissue growth at the cup to fix the prosthetic bone joint to the bone while body fluid at the bone tissue and contacting the elongate member biodegrades the elongate member.

Abstract: Disclosed are method and composition for periodically coating the internal, food absorbing surface of the small intestine of a mammal by ingesting said composition which is capable of forming at least a partial nutrient barrier on said intestine.

Abstract: An absorbable internal bone fixation device is disclosed. The device is made from a high molecular weight polymer of L(-)lactide having an inherent viscosity above 4.5. The polymer contains less than 2% unreacted monomer and is polymerized under conditions of selected monomer to catalyst ratios and temperature.

Abstract: An absorbable internal bone fixation device is disclosed. The device is made from a high molecular weight polymer of L(-)lactide having an inherent viscosity above 4.5. The polymer contains less than 2% unreacted monomer and is polymerized under conditions of selected monomer to catalyst ratios and temperatures.