Abstract: A method for tissue augmentation in a mammal is provided comprising injecting a polymer at a tissue site in need of augmentation and having a tissue temperature, the polymer comprising repeating peptide monomeric units selected from the group consisting of nonapeptide, pentapeptide and tetrapeptide monomeric units, wherein the monomeric units form a series of &bgr;-turns separated by dynamic bridging segments suspended between the &bgr;-turns, wherein the polymer has an inverse temperature transition Tt less than the tissue temperature, and wherein the polymer is injected as a water solution at coacervate concentration in the substantial absence of additional water. A kit containing the injectable bioelastic polymer and a syringe is also provided.

Abstract: Devices implantable in animal bodies, possibly configured as self-inflating spinal disc prostheses. Alternatively, non-implantable water-desalination and/or purification devices. The devices include specified types of water-absorbing solute encapsulated by non-porous, water-permeable polymer membranes having specified properties. Also, methods of using the devices in biomedical applications or water treatment.

Abstract: A process of compression moulding an article from a polymer powder comprising; a) applying a polymer powder to a mould; b) compacting the polymer powder by the application of a pressure P; c) raising the temperature of the surface of the mould to a value above the melting temperature of the polymer powder; and d) maintaining a temperature TM at the surface of the mould for a period of time tM and then cooling to a temperature below the crystallisation temperature of the polymer; where TM and tM are controlled so as to provide a moulded article comprising a polymer of predetermined maximum reptated molecular weight. The compression moulded articles produced by this process are useful as orthopaedic prostheses, such as components of knee, hip, shoulder, elbow, wrist, ankle, finger or toe joint replacements.

Abstract: An implant for deployment in select locations or select tissue for regeneration of tissue is disclosed. The implant comprising collagen and or other bio-resorbable materials, where the implant may also be used for therapy delivery. Additionally, the implant may be “matched” to provide the implant with similar physical and/or chemical properties as the host tissue.

Abstract: A polyurethane article with shape memory, comprising a mixture of thermoplastic polyurethane and reactive monomer cross-linker which is formed into a shaped article, irradiated, expanded and applied to a medical device, specifically a biomedical electrical lead.

Abstract: The present invention relates to tissue scaffold implant devices useful in the repair and/or regeneration of diseased and/or damaged musculoskeletal tissue and that include a tissue scaffold component fixedly attached to a scaffold fixation component via a polymeric adhesive layer, and to methods of making such tissue scaffold implant devices.

Abstract: Artificial joints wherein the mating surfaces are both non-metallic, preferably plastic, even more preferably polyethylene and even more preferably ultra-high molecular weight polyethylene. Because neither of the bearing surfaces of the artificial joint are made of metal, there is a potential for greatly reduced wear, and consequently, a potential for reducing the number of joint replacement surgeries.

Abstract: A medical prosthesis for use within the body which is formed of radiation treated ultra high molecular weight polyethylene having substantially no detectable free radicals, is described. Preferred prostheses exhibit reduced production of particles from the prosthesis during wear of the prosthesis, and are substantially oxidation resistant. Methods of manufacture of such devices and material used therein are also provided.

Abstract: Disclosed is an osteogenic device capable of inducing the formation of endochondral bone in a shape conforming substantially to the shape of the device when implanted in a mammalian host. The device includes an osteogenic protein dispersed within a porous matrix comprising a polymer of collagen and glycosaminoglycan cross-linked to an MC value of about 800 to about 60,000. Also disclosed are a method of inducing mammalian bone growth, and a method of inducing conductive bone growth from viable mammalian bone.

Abstract: An orthopedic implant comprising a thermoplastic polymer or a composite comprising, in one embodiment, polyetheretherketone reinforced with 10% by volume of glass fibers, with an elastic modulus approximating the elastic modulus of bone. A porous coating is formed on the implant surface by creating a roughness thereon, by coating the surface with hydroxyapatite or by embedding a biocompatible material such as titanium in the surface. A two piece embodiment of the implant is joined and locked together, after the opposite ends of each piece are inserted in the medullary canal, using an interlocking mechanism comprising a fluted protrusion on one piece and a corresponding fluted cavity in the other piece with the fluted portions being complementarily tapered.

Abstract: An implantable prosthetic bearing is constructed of a composite material having a first layer and second layer. The first layer has an articulating surface defined therein, whereas the second layer has a engaging surface defined therein for engaging either another prosthetic component or the bone itself. The first layer of the implantable prosthetic bearing is constructed of a polymer such as polyethylene or UHMWPE, whereas the second layer is constructed of a copolymer of ethylene and an acrylate. The ethylene portion of the copolymer provides for adhesion to the polymer of the first layer, whereas the acrylate portion of the copolymer provides for adhesion to commonly utilized bone cements. A method of making a prosthetic bearing is also disclosed.

Abstract: An implantable prosthetic bearing is constructed of a composite material having a first layer and second layer. The first layer has an articulating surface defined therein, whereas the second layer has a engaging surface defined therein for engaging either another prosthetic component or the bone itself. The first layer of the implantable prosthetic bearing is constructed of crosslinked polymer such as UHMWPE, whereas the second layer of the implantable prosthetic bearing is constructed of polymer such as UHMWPE that is either non-crosslinked or crosslinked to a lesser degree than the first layer. In such a manner, the first layer possesses mechanical properties which are advantageous in regard to the articulating surface (e.g., enhanced wear and oxidation resistance), whereas the second layer possesses mechanical properties which are advantageous in regard to the engaging surface (e.g., high ductility, toughness, and creep resistance). A method of making a prosthetic bearing is also disclosed.

Abstract: An artificial joint assembly that contains a first member of bone and, attached to the first member, a second member that contains shape memory material; the second member is located, at least in part, within the first member.

Abstract: The present invention relates to the prevention and decrease of osteolysis produced by wear of the ultrahigh molecular weight polyethylene (UHMWPE). Methods are disclosed for the isolation of wear particles, preparation of implants exhibiting decreased wear in comparison to conventional UHMWPE and preparation of implants that cause decreased biological response in comparison to conventional UHMWPE. The implants created by these methods are also included in the present invention.

Abstract: An orthopedic surgical implant of one or more components having a surface which is to be contacted by body tissue and/or fluid. The surface contains an inorganic antimicrobial agent either incorporated in the material forming a component having the surface or incorporated in a coating, such as of the adhesive or powder spray type, applied to the surface.

Abstract: The devices disclosed herein are composite implantable devices having a gradient of one or more of the following: materials, macroarchitecture, microarchitecture, or mechanical properties, which can be used to select or promote attachment of specific cell types on and in the devices prior to and/or after implantation. In preferred embodiments, the implants include complex three-dimensional structure, including curved regions and saddle-shaped areas. In various embodiments, the gradient forms a transition zone in the device from a region composed of materials or having properties best suited for one type of tissue to a region composed of materials or having properties suited for a different type of tissue.

Abstract: A biodegradable implant and a method for manufacturing one. The implant comprises a matrix component containing at least one biodegradable polymer or copolymer and a plasticizer that is adapted to substantially reduce the rigidity of the implant. The plasticizer substantially exists from the implant after coming into contact with tissue fluids of the organ system in such a manner that the bending resistance of the implant prior to the insertion of the implant into the organ system is substantially lower than after its insertion into the organ system.

Abstract: A hard tissue repairing material including a base material and a surface layer having a crystalline zirconia covering the base material, being characterized in that the film includes a Zr—OH group. A middle layer may be formed between the base material and the surface layer and, in such case, includes at least one element of the base material and at least one element of the surface layer having a crystalline zirconia.

Abstract: A medical implant having at least a portion thereof made of a formable, pyromellitic, dianhydride (PMDA)-free, non-halogenated, aromatic polyimide is disclosed. Further disclosed are a process of manufacturing the implant and a method of implanting the implant in a subject in need thereof.

Abstract: The present invention relates to a method and a device for alleviating and/or preventing conditions relating to damaged joints involving articulating surfaces. In a first aspect the present invention relates to a prosthetic device for insertion into a joint cavity of a joint of a vertebrate, such as a human, said device consisting of a biocompatible material comprising at least a first polymeric component and a second polymeric component, wherein the chain length of the first polymeric component is longer than the chain length of the second polymeric component, the polymeric components in particular being polyethylene, polypropylene and/or polyvinylpyrrolidone.

Abstract: The present invention involves compositions for use as granular bone replacements. The compositions of the present invention are comprised of hyaluronic acid esters or salts of hyaluronic acid in association with a pharmacologically active compound wherein the molecular weight of the hyaluronic acid is below 250,000 and either artificial or natural bone granules. The present invention further involves a method of promoting the growth or repair of damaged or defective bones in either humans or animals using the compositions of hyaluronic acid derivatives and bone granules.

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: The present invention features a regenerative bone implant. The implant includes a biocompatible and biodegradable matrix having pores, and a biocompatible and biodegradable biopolymer disposed in the pores and covalently bonded to the matrix. Optionally, the implant can further include a bone formation promoter that is also disposed in the pores and can be covalently bonded to the matrix.

Abstract: A surgical implant comprising biodegradable polymer interspersed with ceramic particulate that is visible to radioscopy.

Abstract: The present invention comprises a poly (vinyl alcohol) hydrogel construct having a wide range of mechanical strengths for use as a human tissue replacement. The hydrogel construct may comprise a tissue scaffolding, a low bearing surface within a joint, or any other structure which is suitable for supporting the growth of tissue.

Abstract: A joint prosthesis (10) including a first component (12)for cooperation with a first long bone (14) and a second component (16) for cooperation with a second long bone (20) is provided. The joint prosthesis (10) also includes a bearing component (222) positionable between the first component (12) and the second component (16) and cooperable with the first (12) and second (16) components. The bearing component (222) has a reinforcing component (236) having a first end (286) and a second end (294) and a polymeric material (207). The polymeric material (207) surrounds at least 99% of the surface area of the reinforcing component (236) and is molded to the reinforcing component (236) so that the material may be sterilized by a predominately surface sterilizing technology. The bearing component (222) defines a first peripheral region (271) and a second peripheral region (282).

Abstract: This invention relates to a material that degrades after implantation into a patient's tissue, and resorbs into the patient's body, which material is manufactured of polymer, copolymer or polymer alloy. The material has a non-crystalline, i.e., amorphous structure and is molecularly oriented and reinforced by mechanical deformation. Further, the material can be formed into surgical devices, such as screws and pins, for implantation into a patient.

Abstract: A method for improving the wear resistance of an implant, made of polyethylene, by crosslinking its bearing surface layer, while leaving its non-bearing interior uncrosslinked. Such crosslinking may be achieved by electron-beam irradiation or by chemical crosslinking of the implant or the polyethylene from which the implant is made. The resulting implant or polyethylene may be further treated to remove the residual free radicals (generated by the electron beam crosslinking process); to remove residual chemicals (generated by the chemical crosslinking process); to remove its most oxidized layer; to stabilize its size and shape; to improve, by remelting, its oxidation resistance; and/or to reshape it into the final implant. Also presented are the resulting implant and polyethylene.

Abstract: Processes for fabricating a customized, three-dimensional, bioerodable, polymeric prosthetic implant are provided. In a highly preferred embodiment, the prosthetic implant has a porous network. The method employs a sterolithography instrument, a solution comprising chains of one or more photocurable, bioerodable polymers and a photoinitiator, and a three-dimensional CAD image. In a highly preferred embodiment, the solution comprises poly (propylene) fumarate (PPF) and a solvent for controlling the viscosity of the solution. During the fabrication process, the solution is placed in a container in the stereolithography instrument. The container also holds a movable build platen for supporting each of the covalently bonded layers of the polymeric prosthetic implant that are formed when successive layers of the solution are exposed to UV light energy.

Abstract: The present invention relates to the prevention and decrease of osteolysis produced by wear of the ultrahigh molecular weight polyethylene (UHMWPE). Methods are disclosed for the isolation of wear particles, preparation of implants exhibiting decreased wear in comparison to conventional UHMWPE and preparation of implants that cause decreased biological response in comparison to conventional UHMWPE. The implants created by these methods are also included in the present invention.

Abstract: Disclosed is an osteogenic device capable of inducing the formation of endochondral bone in a shape conforming substantially to the shape of the device when implanted in a mammalian host. The device includes an osteogenic protein dispersed within a porous matrix comprising a polymer of collagen and glycosaminoglycan cross-linked to an MC value of about 800 to about 60,000. Also disclosed are a method of inducing mammalian bone growth, and a method of inducing conductive bone growth from viable mammalian bone.

Abstract: A strand-like implant of resorbable polymer material is substantially formed as a random copolymer of L-lactide and glycolide, which are present in a composition in a range of more than 80 mole % lactide and less than 20 mole % glycolide to 95 mole % lactide and 5 mole % glycolide, particularly in a ratio of 90:10, and has in the textile structure a tensile strength of more than 200 N/mm2.

Abstract: An orthopaedic implant includes a flexible bag; a structural support at least partially within the bag; and a hardened polymer within the bag. The orthopaedic implant is implanted within the bone by forming a cavity in the bone; inserting a flexible bag into the cavity; filling the bag with a polymer; and hardening the polymer.

Abstract: A method for tissue augmentation in a mammal is provided comprising injecting a polymer at a tissue site in need of augmentation and having a tissue temperature, the polymer comprising repeating peptide monomeric units selected from the group consisting of nonapeptide, pentapeptide and tetrapeptide monomeric units, wherein the monomeric units form a series of &bgr;-turns separated by dynamic bridging segments suspended between the &bgr;-turns, wherein the polymer has an inverse temperature transition Tt less than the tissue temperature, and wherein the polymer is injected as a water solution at coacervate concentration in the substantial absence of additional water. A kit containing the injectable bioelastic polymer and a syringe is also provided.

Abstract: Methods and compositions for fabricating prosthetic medical devices exhibiting improved wear resistance include selectively cross-linking polymeric resins then curing and shaping the polymer into a finished article. The selectively cross-linked polymeric compositions may be created by blending a specific amount of cross-linked resins with a specific amount of uncross-linked resins then cured into a polymeric matrix whereby the desired degree or percentage of overall cross-linking is obtained. The polymeric material may then be formed directly into a finished article by injection molding the polymeric material.

Abstract: An orthopaedic implant includes a flexible bag having at least a portion thereof which is expandable under pressure; and a polymer within the bag. The orthopaedic implant is implanted within a bone by forming a cavity in the bone; inserting a flexible bag into the cavity, the flexible bag having at least a portion thereof which is expandable under pressure; pressure filling the bag with a polymer, whereby the expandable portion of the bag expands to substantially entirely fill the cavity in the bone; and hardening the polymer.

Abstract: A prosthetic device formed from a polymer which, when contacted with a calcium salt, calcium is deposited on or in the polymer. The polymer includes a soft component and a hard component. The device has bone-bonding properties. The soft component provides for the deposition of calcium on or in the soft component and preferably is a polyalkylene glycol, and the hard component preferably is a polyester. A preferred material is a polyethylene glycol/polybutylene terephthalate copolymer.

Abstract: An essentially non-osteoconductive medical device is described comprising a biodegradable terephthalate copolymer comprising the recurring monomeric units shown in formula I: wherein R is a divalent organic moiety; x is ≧1; and n is 3-7,500, where the biodegradable polymer is sufficiently pure to be biocompatible and is capable of forming biocompatible residues upon biodegradation. Compositions containing the copolymers and biologically active substances, articles useful for implantation or injection into the body fabricated from the compositions, and methods for controllably releasing biologically active substances using the copolymers, are also described.

Abstract: Devices implantable in animal bodies, possibly configured as self-inflating spinal disc prostheses. Alternatively, non-implantable water-desalination and/or purification devices. The devices include specified types of water-absorbing solute encapsulated by non-porous, water-permeable polymer membranes having specified properties. Also, methods of using the devices in biomedical applications or water treatment.

Abstract: Bioactive compositions that induce or enhance the repair of damaged or diseased connective tissues upon contact of the tissues with the compositions in vivo include an effective amount of pleiotrophin. A delivery vehicle is also included in the compositions. The compositions may be delivered to the repair sites by injection or by implantation.

Abstract: Vascular grafts, and methods for making the same, are provided. The vascular grafts comprise a graft tissue derived from a biological source that is enclosed within an external synthetic sleeve. The synthetic sleeve has an extended length that is greater than the length of the graft tissue. However, the sleeve is longitudinally compressed such that it has a resting length substantially similar to the length of the graft tissue.

Abstract: An implant composition having controlled resorption rate in vivo for stimulating bone growth, a method of making the implant composition, and a kit of implant materials are disclosed. The implant composition includes a calcium sulfate compound, polymer containing particles, and a setting agent for setting the calcium sulfate compound and the polymer containing particles into a heterogeneous solid composition. Upon setting, the calcium sulfate compound forms a matrix and the polymer containing particles settled within the matrix. The resorption rate of the implant composition in vivo can be controlled of between eight and twenty-four weeks, which substantially matches the rate of bone growth. The implant composition of the present invention can be used for the repair, augmentation, and other treatment of bone.

Abstract: Disclosed are methods for soft tissue augmentation in a mammal wherein a composition comprising a biocompatible polymer having a water equilibrium content of less than about 15% and a biocompatible solvent is delivered to the tissue of the mammal to be augmented.

Abstract: An orthopaedic implant for implanting between adjacent vertebrae and a spine, includes a generally annular bag; and a hardened polymer with the bag. The method of fusing adjacent vertebrae in a spine includes the steps of forming an access hole in an annulus of a disc between the adjacent vertebrae; removing the nucleus within the disc to form a cavity surrounded by the annulus; placing a generally annular bag within the cavity; filling the bag with a polymer; injecting bone particles into the cavity surrounded by the annular bag; and hardening the polymer.

Abstract: A prosthetic device formed from a polymer which, when contacted with a calcium salt, calcium is deposited on or in the polymer. The polymer includes a soft component and a hard component. The device has bone-bonding properties. The soft component provides for the deposition of calcium on or in the soft component and preferably is a polyalkylene glycol, and the hard component preferably is a polyester. A preferred material is a polyethylene glycol/polybutylene terephthalate copolymer.

Abstract: This invention provides molded, biodegradable porous polymeric implant materials having a pore size distribution throughout the material which is substantially uniform. These materials can be molded into implants of any desired size and shape without loss of uniformity of pore size distribution. The implants are useful as biodegradable scaffolds for cell growth in healing of tissue defects. Particulate implant materials are provided, especially useful as autologous bone graft materials.

Abstract: There are numerous medical situations involving deficiencies of living tissue and where increase of living tissue mass is desired. Methods are described wherein a configured, shell-like device that is capable of being penetrated by living cells and tissues, is implanted into the body of a mammal in such a way as to establish a space, the space being at least partly, bounded by the device. The configuration of the device is such that the configuration of the established space is essentially the same as the configuration of living tissue that is desired for treatment of the tissue deficiency. At least one tissue stimulating molecular substance is placed within the established space for the purpose of stimulating the growth of desired living tissue within the established space. A kit for the generation of desired living tissue, comprised of the components mentioned above, is also disclosed.

Abstract: Medical devices are formed from metal/polymer composites that have improved characteristics. The metal/polymer composites have a relatively thick metal coating with an average metal thickness of greater than about 3 microns. The composite has mechanical properties, such as mechanical strength, durability and resiliency, contributed by the metal coating. The metal/polymer composites can be formed by solution based or vapor based approaches.

Abstract: A web of continuous filaments which are made of at least one semi-crystalline polymeric component covalently bonded as a linear block copolymer with or blended with one or more semi-crystalline or amorphous polymeric components. The filaments are intermingled together to form a porous web of filaments, the filaments having multiple contact points with each other within the web. The filaments are bonded at the contact points without requisite for added adhesive binders, adjuncts or post extrusion melt processing. The web may be bioresorbable. The web may also be provided in forms with relatively high cohesive shear strength. The polymeric components of the filaments exist, at least temporarily, in a homogenous substantially phase miscible uncrystallized state.

Abstract: An article of manufacture for load bearing medical use such as a joint implant suitable for total joint replacement. The article comprises a polyurethane-containing component and is monolithic with respect to polyurethane-containing component(s). The joint for long term load applications is structurally an articulated joint and the polyurethane component provides a surface for articulation with the polyurethane.