Abstract: Compositions useful for repairing osseous defects include particulate bioactive and biocompatible glass including 40 to 58% by weight silica, 10 to 320 by weight calcia, 10 to 320 by weight soda and 2 to 10% by weight phosphorus pentoxide. The particles have a size distribution of: 20 to 65% by weight, 50 microns to less than 297 microns; 20 to 45% by weight, 297 to less than 350 microns; and 15 to 40% by weight, 350 microns to less than 420 microns. Methods for repairing osseous defects utilizing such compositions are also provided.

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: A bioerodible cement system, which, upon mixing of the system parts, forms a cured bioerodible cement, said system comprising a first part comprising a first bioerodible polymer capable of producing acidic products upon hydrolytic degradation; and a second part comprising a second bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said cured cement is disclosed. In a preferred embodiment, the second bioerodible polymer comprises polypropylene fumarate (PPF), which is cross-linked during curing, desirably by a vinyl monomer such as vinyl pyrrolidone (VP) to form the biopolymeric scaffolding which provides the cured cement with dimensional and geometric stability.

Abstract: Polymers having non-thrombogenic properties can be prepared by copolymerizing monomers of at least three classes selected from (a) monomers having sulphate groups, (b) monomers having sulphonate groups, (c) monomers having sulphamate groups, (d) monomers having polyoxyalkylene ether groups, and (e) monomers having zwitterionic groups. The polymers can additionally be provided with anti-thrombogenic properties by including an additional comonomer having a pendant heparin (or hirudin, warfarin or hyaluronic acid) group. The polymers can be used as coating materials for medical devices, such as tubing or connectors, in order to provide them with non-thrombogenic, and optionally anti-thrombogenic, properties.

Abstract: In a method for producing a cement for medical use, a liquid component containing a polymerizable substance is combined with a solid component comprising a plastic substance to provide a setting mass to form the cement. In order to e.g. improve the biological and mechanical properties of the cement and allow it to be mixed by modern mixing procedures, which further improves the cement quality, said plastic substance is mixed with a particulate crystalline ceramic material prior to combining said liquid and solid components. A cement for medical use is also defined as is the use of set cement as an anchorage for the fixation of prostheses or parts of prostheses or bone and as a substitute material for bone.

Abstract: A bioerodible polymeric semi-IPN alloy which comprises a first bioerodible polymer capable of producing acidic products upon hydrolytic degradation; a second bioerodible polymer, which provides a biopolymeric scaffolding or internal reinforcement; and optionally a buffering compound that buffers the acidic products within a desired pH range. In a preferred embodiment, the second bioerodible polymer comprises polypropylene fumarate (PPF), which is cross-linked, desirably by a vinyl monomer such as vinyl pyrrolidone (VP) to form the biopolymeric scaffolding which provides the semi-IPN with dimensional and geometric stability.

Abstract: A composition for the promotion of adhesion between a rubber formulation and a textile substrate is provided. The inventive composition comprises either a mixture of specific amine functional silanes and organo-functional silanes having reactive groups or groups with an affinity for rubber. The inventive method entails the use of the inventive composition or a silane compound having both an amine moiety and a reactive group having an affinity for rubber formulations, particularly an unsaturated carbon-carbon bond. The composition may be utilized to adhere any standard reinforcement-type textile, such as polyester or polyamide, to a standard rubber composition, such as SBR, NBR, or EPDM. A method for adhering textiles to rubber formulations is also provided involving a pre-dip, -spray, -coat, and the like, of the inventive composition on a reinforcement-type textile surface followed by the contacting of the rubber formulation.

Abstract: Dental composites are provided on the basis of customary polymerizable monomers, initiators, fillers and other auxiliaries, which additionally contain the plaque-inhibiting addition of salts of acid-functional polymers having mono- or polyvalent cations.

Abstract: A process for making bioactive glasses is described including preparing a reaction mixture of reactants capable of forming a sol-gel, aging the reaction mixture, near equilibrium drying a gel resulting from the reaction mixture, and heating the near equilibrium-dried gel described. Also described are near equilibrium-dried bioactive glass compositions.

Abstract: A bioactive ceramic composition including 47 to 51% SiO.sub.2, 23 to 25% CaO, 23 to 25% Na.sub.2 O and 0 to 6% P.sub.2 O.sub.5, the bioactive ceramic having a bioacitivity level such that the composition forms at least a thin layer of HCA within about 30 hours of implantation into a patient. The bioactive ceramic composition having a crystallinity of 34 to 60 volume percent and a crystalline phase of 1Na.sub.2 O.2CaO.3SiO.sub.2.

Abstract: A high bending strength and high density material for osteosynthesis, which comprises a biodegradable and bioabsorbable crystalline thermoplastic polymer material, and a high strength implant material, comprising a composite material in which a bioceramics powder of from 0.2 to 50 .mu.m in particle size is dispersed in the polymer material, wherein crystals of the polymer material are pressure-oriented not in a uni-axial direction but basically in parallel with a plurality of reference axes; and a production method by pressure orientation, which comprises preparing in advance a biodegradable and bioabsorbable crystalline thermoplastic polymer material or a dispersed mixture of the polymer material and a bioceramics powder and melt-molding it into a pre-molded material which is then press-charged at a cold temperature into a cavity of a closed type forming mold, thereby obtaining an oriented molding.

Abstract: There is provided a polymethylmethacrylate (PMMA) bone cement composition that includes the addition of from about 10% by weight to about 30% by weight of calcium hydroxide. The bone cement is used for orthopaedic procedures, injuries, or disease states that have compromised the metabolism of local hard and soft tissues, largely due to an acidic environment. In an aqueous environment, the calcium hydroxide is slowly released from pores in the polymer matrix as calcium and hydroxyl ions to provide a method for stimulating healing by maintaining or elevating local pH in the tissues adjacent to bone cement. It has also been found that the calcium hydroxide ameliorates the toxic effects of antibiotics which are often included in the bone cement.

Abstract: Composites suitable for use as prostheses for attachment to soft tissues, such as cartilage, tendons, skin, tympanic membrane and gingiva, as well as to cancellous or trabecular bone, are based on combination of a polyolefinic binder with certain bioactive glass materials. The composites bond actively with soft tissues and are readily formulated achieve mechanical properties comparable to those of the soft tissue of interest.

Abstract: A dental material based on an organic polymerisable binding agent has a content ofA) one or more mixed apatites of the typeA1) A.sub.10 (XO.sub.4).sub.6 Z.sub.2 +/B*.sub.10-u C*.sub.u (Y*).sub.6 Z'.sub.2 and/orA2) A'.sub.10-r (X'O.sub.4).sub.6-s Z".sub.2-t +/B'.sub.r (Y').sub.s Q.sub.t -B".sub.10-u' C'.sub.u' (Y").sub.6 Z'".sub.2 and/orA3) A".sub.10-r' (X"O.sub.4).sub.6-s' Z"".sub.2-t' +/A'".sub.r' (X'"O.sub.4).sub.s' +/B'".sub.10-u" C".sub.u" (Y'").sub.6 Z'"".sub.2in which the formulae assume the significance specified in the description, in a quantity that is effective for the absorption of ions from the biological application environment of the dental material. The polymerisable dental material has variably adjustable transparency, good polishability, high strength and the capacity to release and absorb ions into and from a biological environment. Also described is a process for using the mixed apatites A1), A2) and/or A3) in polymerisable dental materials.

Abstract: The present invention provides pharmaceutical compositions comprising a morphogenic protein stimulatory factor (MPSF) for improving the tissue inductive activity of morphogenic proteins, particularly those belonging to the BMP protein family. Methods for improving the tissue inductive activity of a morphogenic protein in a mammal using those compositions are provided. This invention also provides implantable morphogenic devices comprising a morphogenic protein and a MPSF disposed within a carrier, that are capable of inducing tissue formation in allogeneic and xenogeneic implants. Methods for inducing local tissue formation from a progenitor cell in a mammal using those devices are also provided. A method for accelerating allograft repair in a mammal using morphogenic devices is provided.

Abstract: Novel fillers comprising combeite glass-ceramic are provided, along with filled polymerizable resin composites. Further provided are methods for making the combeite crystallite-containing novel fillers for use in hardenable, biocompatible bone restorations. Hard, shaped bodies or orthopaedic, dental and other uses are also provided.

Abstract: Biodegradable polymer networks are provided which are useful in a variety of dental and orthopedic applications. The biodegradable polymer networks can be formed in one embodiment by polymerizing anhydride prepolymers including crosslinkable groups, such as unsaturated moieties. The anhydride prepolymers can be crosslinked, for example in a photopolymerization reaction by irradiation of the prepolymer with light in the presence of a free radical initiator. Suitable anhydride prepolymers include dianhydrides of a dicarboxylic acid and a carboxylic acid molecule comprising a crosslinkable group. For example, methacrylic acid dianhydrides of monomers or oligomers of a diacid such as sebacic acid or 1,3-bis(p-carboxyphenoxy)-hexane can be used. The anhydride prepolymers can be applied in vivo to a site where an orthopedic implant is needed, and then may be crosslinked, for example, by irradiation with U.V. light, to form a biodegradable implant such as a rods, pin or plate.

Abstract: A process for making bioactive glasses is described including preparing a reaction mixture of reactants capable of forming a sol-gel, aging the reaction mixture, near equilibrium drying a gel resulting from the reaction mixture, and heating the -near equilibrium-dried gel described. Also described are near equilibrium-dried bioactive glass compositions.

Abstract: The invention relates to fluoride-releasing, polymerizable dental composite aterials having good mechanical stability, containing:(a) one or more ethylenically unsaturated polymerizable monomers based on di- or multi-functional (meth)acrylates;(b) initiators and optionally activators; and(c) usual fillers, and optionally pigments, thixotropic agents, plasticizers and other auxiliaries; and(d) one or more sufficiently water-soluble inorganic complex fluorides of the general formulaA.sub.n MF.sub.mwherein,A is a monovalent cation, M is a metal of the III-V main group or II-V sub-group, n is a whole number from 1 to 3 and m is whole number from 3 to 6.

Abstract: An improved biocompatible composition consisting of physiologically stable beads or particles carried in a lubricative suspension, solution, other fluid or gel. The composition is intended to be delivered into the body through a small-bored needle, cannula, or other catheter into a tissue site for the purpose of augmenting the tissue. In particular, the composition is useful for augmenting tissue in the area of the cardiac orifice of the stomach to reduce gastric reflux, in the area of the internal or external sphincter of the anal canal to reduce fecal incontinence or in the area of urethral tissue for the purpose of treating urinary incontinence.

Abstract: A porous material with an appropriate surface chemistry that promotes capillary endothelialization is disclosed. The material has a porosity that is sufficient to allow capillary endothelialization and a tenaciously bound adhesion molecule that promotes the ingrowth of endothelial cells into the porosity of the material.

Abstract: A novel pathway for the synthesis of poly(propylene fumarate) includes first producing bis-hydroxypropyl fumarate and then its transesterification into poly(propylene fumarate). This synthetic pathway permits production of high molecular weight poly(propylene fumarate) and enables the production of a composite material useful in orthopedic procedures.

Abstract: Composites suitable for use as prostheses for attachment to soft tissues, such as cartilage, tendons, skin, tympanic membrane and gingiva, as well as to cancellous or trabecular bone, are based on combination of a polyolefinic binder with certain bioactive glass materials. The composites bond actively with soft tissues and are readily formulated achieve mechanical properties comparable to those of the soft tissue of interest.

Abstract: A collagen-hydrogel for promoting epithelial cell growth and regeneration of the stroma is shown. Also shown is an optical lens for the eye, fabricated from the collagen-hydrogel, which, when affixed to Bowman's membrane, promotes and supports epithelial cell growth, enables corneal epithelium of the cornea of an eye, during the healing process, to attach to and cover the anterior surface of the lens implanting the same and to regenerate the stroma which grows over the edge of and attaches to the optical lens. Laid down in the layers of the regenerated stroma are new keratocytes and collagen fibial produced from keratocytes. The collagen-hydrogel is a hydrogel polymer formed by the free radical polymerization of a hydrophilic monomer solution gelled and crosslinked in the presence of an aqueous stock solution of collagen to form a three dimensional polymeric meshwork for anchoring collagen. The collagen-hydrogel material has a ratio by weight of collagen-to-hydrogel in the range of about 0.

Abstract: A bone inducing material comprising a piezoelectric porous membrane having through-holes of an average pore size of about 0.1 to 5 .mu.m is disclosed. When the bone inducing material according to the present invention is used, bone is rapidly regenerated, and new formation of bone occurs. The bone inducing material is particularly useful in the dental field, for example, for treatment of periodontal diseases by GTR method.

Abstract: The invention provides moldable, biodegradable composition for use with bone and other tissues. The composition comprises a poly(caprolactone) thermoplastic polymer processed alone or compounded with a biocompatible, biodegradable substance that controls crystallization of the polymer and functions to soften the composition. The composition may further include a biologically-active agent such as an antibiotic for sustained delivery in an animal, a coloring agent for tinting the composition, and other additives as desired.

Abstract: Novel fillers comprising combeite glass-ceramic are provided. hardenable restorative compositions comprising particulate combeite glass-ceramic provide improved biocompatibility in bone restorations. Hard, shaped bodies for orthopaedic, dental and other uses are also provided.

Abstract: Composite materials formed from bone bioactive glass or ceramic fibers and structural fibers are disclosed. In preferred embodiments, a braid or mesh of interwoven bone bioactive glass or ceramic fibers and structural fibers is impregnated with a polymeric material to provide a composite of suitable biocompatibility and structural integrity. Most preferably, the mesh or braid is designed so that the bioactive fibers are concentrated at the surface of the implant to create a surface comprised of at least 30% bioactive material, thereby providing enhanced bone ingrowth. The interweaving between the bone bioactive glass or ceramic fibers and the core of structural fibers overcomes the problems found in prior composite systems where the bioactive material delaminates from the polymer. Preferred bioactive materials include calcium phosphate ceramics and preferred structural fibers include carbon fibers. Further preferred bioactive materials include aluminum oxide at greater than 0.2%, by mole.

Abstract: Provided is a biomaterial comprising an interpenetrating polymer network (IPN), wherein one of the polymer components is an acidic polysaccharide or a semi-synthetic derivative thereof. The polysaccharide can be hyaluronic acid, and the second polymer component can be a non-toxic, non-carcinogenic synthetic chemical polymer. The derivative can be a total or partial hyaluronic acid ester or a hyaluronic acid salt. The ester or salt can be formed with a pharmacologically active molecule. Methods for preparing the IPN are also disclosed. The acidic polysaccharide or derivative thereof and the synthetic chemical polymer comprising the IPN can be cross-linked, or the synthetic chemical polymer can be grafted onto the acidic polysaccharide. The cross-linking or grafting can be achieved using compounds capable of generating radicals, or via functional groups on the acidic polysaccharide and the synthetic chemical polymer. The IPN can be formed prior to cross-linking or grafting.

Abstract: Absorbable, segmented copolymers of aliphatic polyesters based on lactone monomers lactide, and p-dioxanone are described. The segmented copolymers exhibit a broad range of properties, especially high strength and long elongations. This unique elastomeric behavior makes the copolymers of the present invention useful in a variety of medical device applications, especially adhesion prevention barriers and hemostatic devices.

Abstract: The present invention provides injectable, bioabsorbable microdispersions suitable for use as a soft tissue repair or augmentation material in animals comprising a fluid carrier that is a liquid polymer selected from the group consisting of liquid polymers and a particulate material. Additionally, the present invention also discloses methods of using these microdispersions for tissue augmentation and repair as well as kits which include prefilled containers to facilitate the use of these materials.

Abstract: A biomaterial with a thromboresistant surface and a method for forming same are provided. The thromboresistant surface is comprised of a distinct coating layer of a chitosan-based membrane and a biologically active material. The biologically active material is capable of converting the chitosan membrane coating from a highly thrombogenic to an essentially non-thrombogenic one. The biologically active material can be a polymeric substance, such as polyvinyl alcohol, forming a polymeric blend with the chitosan, or, can be a biological substance, such as serum albumin, embedded in or attached to the chitosan membrane which has been activated with a treatment of glutardialdehyde. The thromboresistant biomaterial is suitable for use in vascular grafts having an inside diameter of less than 6 millimeters.

Abstract: A bioactive cement comprises a filler consisting of nonalkali glass powder containing Ca, monomer containing hydrophilic dimethacrylate, a polymerization starter, and a polymerization promotor. The nonalkali glass powder containing Ca comprises a composition by weight of 40-50% CaO, 30-40% SiO.sub.2, 10-20% P.sub.2 O.sub.5, 0-10% MgO, and 0-2% CaF.sub.2. The hydrophilic dimethacrylate is 2,2-bis[4-(3-methacryloxy-2-hydroxy propoxy)phenyl]propane. The bioactive cement is capable of forming a hydroxyapatite layer on a surface of a hardened cement body when the hardened cement body is brought into contact with body fluid.

Abstract: Demineralized bone particles having a median length to median thickness ratio of at least about 10:1 are incorporated in an osteogenic composition useful for repairing bone defects.

Abstract: The invention is a resorbable, viscous to solid wax for the mechanical staunching of blood on hard body tissue, particularly bones, based on oligomers of glycolic acid and/or lactic acid and derivatives thereof with monofunctional and/or polyfunctional alcohols and/or corresponding carboxylic acids. The new waxes are characterized by containing body-compatible salts of organic and/or inorganic acids which are formed by corresponding reaction of any free carboxyl groups present in the oligomer wax and/or are incorporated in the wax in homogeneous distribution as added salts.

Abstract: A method is provided for improving the in vivo strength retention of a bioabsorbable implantable medical device such as a suture.

Abstract: New corneal implants and methods for producing such implants are disclosed. The present corneal implants comprise a lens body which is optically clear and is structured to be surgically attached in or on the cornea of a mammalian eye, the lens body including a core having an outer surface and made of a hydrogel composition containing water and a hydrophilic polymeric material, and a coating comprising a synthetic polymeric component located on the outer surface, covalently bonded to the hydrogel composition and having enhanced ability to support epithelial cell growth and/or adhesion relative to the hydrogel composition.

Abstract: A process is provided for manufacturing nonwoven, nonbiodegradable tissue ingrowth-inducing, tissue-interfacing substrates with predetermined oriented uniform pore diameter, pore density and pore depth. Pins are inserted to a predetermined depth into a softened thermoplastic substrate or, heated pins are inserted into the substrate, then removed to form the predetermined pore pattern.

Abstract: The invention is a resorbable, viscous to solid wax for the mechanical staunching of blood on hard body tissue, particularly bones, based on oligomers of glycolic acid and/or lactic acid and derivatives thereof with monofunctional and/or polyfunctional alcohols and/or corresponding carboxylic acids. The new waxes are characterized by containing body-compatible salts of organic and/or inorganic acids which are formed by corresponding reaction of any free carboxyl groups present in the oligomer wax and/or are incorporated in the wax in homogeneous distribution as added salts.

Abstract: The invention relates to a process for the production of crosslinked dental mouldings, in particular for teeth made of plastic, the compositions used therefore and the articles obtained.

Abstract: A periodontium-regenerating material for the regenerative treatment of the periodontium consists of bio-degradable/absorable copolymers of lactide/.epsilon.-caprolactone or lactide/glycolide having a weight-average molecular weight of 40,000 to 500,000 as well as a dynamic modulus of 5.times.10.sup.7 to 5.times.10.sup.9 dynes/cm.sup.2 and a elongation rate of 100 to 2,000 %, both measured at room temperature (25.degree. C.). Those copolymers may be used in the form of a sheet or film which may or may not be porous.

Abstract: A collagen-hydrogel for promoting epithelial cell growth and regeneration of the stroma is shown. Also shown is an optical lens for the eye, fabricated from the collagen-hydrogel, which, when affixed to Bowman's membrane, promotes and supports epithelial cell growth, enables corneal epithelium of the cornea of an eye, during the healing process, to attach to and cover the anterior surface of the lens implanting the same and to regenerate the stroma which grows over the edge of and attaches to the optical lens. Laid down in the layers of the regenerated stroma are new keratocytes and collagen fibial produced from keratocytes. The collagen-hydrogel is a hydrogel polymer formed by the free radical polymerization of a hydrophilic monomer solution gelled and crosslinked in the presence of an aqueous stock solution of collagen to form a three dimensional polymeric meshwork for anchoring collagen. The collagen-hydrogel material has a ratio by weight of collagen-to-hydrogel in the range of about 0.

Abstract: The invention is a resorbable, viscous to solid wax for the mechanical staunching of blood on hard body tissue, particularly bones, based on oligomers of glycolic acid and/or lactic acid and derivatives thereof with monofunctional and/or polyfunctional alcohols and/or corresponding carboxylic acids. The new waxes are characterized by containing body-compatible salts of organic and/or inorganic acids which are formed by corresponding reaction of any free carboxyl groups present in the oligomer wax and/or are incorporated in the wax in homogeneous distribution as added salts.

Abstract: A method of making a collagen-hydrogel is shown. The method comprises the steps of forming a radical free polymer of a hydrophilic monomer; mixing the hydrophilic monomer with a stock solution of collagen in the presence of a weak solution of ammonium persulfate and sodium metabisuleate forming a clear viscous monomer solution; and heating said viscous monomer solution in the presence of a crosslinking agent to polymerize the same into a three dimensional polymeric meshwork having collagen from the stock solution of collagen interdispersed within the three dimensional polymeric meshwork.

Abstract: This invention relates to an implantable medical device capable of encouraging cellular growth and regeneration of function fabricated totally or in part from one or more bioresorbable polymers, as for example bioresorbable homopolymers derived from the polymerization of alpha-hydroxy carboxylic acids, where at least one of the polymers has an average molecular weight of from about 234,000 to about 320,000 as measured by gel permeation chromatography.

Abstract: Benzotriazole compounds having the formula: ##STR1## wherein R.sub.1 is H, Cl, or OCH.sub.3 ; R.sub.2 is a hydroxynaphthyl group; and R.sub.3 is a vinyl unsaturated polymerizable group. Homopolymers or copolymers thereof are effective as UV light stabilizers and absorbers.

Abstract: A material which transmits wound moisture, made up of an upper layer of an elastomer having a thickness of 0.01-0.2 mm which is provided with pores having a diameter not exceeding 0.7 .mu.m and a pore density of 1-75% of the surface, and a lower layer of an elastomer having a thickness of 0.05-1 mm which is provided with macropores having a diameter of 50-200 .mu.m, at least some of the walls of said macropores being provided with micropores having a diameter of 0.1-0.25 .mu.m, is provided. The material of the invention meets a number of conditions making it suitable for the use of artificial skin.

Abstract: A collagen-hydrogel for promoting epithelial cell growth is shown. Also shown is an optical lens for the eye, fabricated from the collagen-hydrogel, which, when affixed to Bowman's membrane, promotes and supports epithelial cells growth and enables corneal epithelium of the cornea of an eye, during the healing process, to attach to and cover the anterior surface of the lens implanting the same. The collagen-hydrogel is a hydrogel polymer formed by the free radical polymerization of a hydrophilic monomer solution gelled and crosslinked in the presence of an aqueous solution of macromolecules to form a three dimensional polymeric meshwork for anchoring macromolecules. Macromolecules comprising a constituent of a ground substance of tissue, which in the preferred embodiment is a native collagen, are interspersed within the polymeric network forming the hydrogel resulting in a collagen-hydrogel for promoting epithelial cell growth.

Abstract: This invention relates to porous, biodegradable materials in which the pore size, biodegradation rate, and pore volume fraction are controlled and within values at which skin contraction rates around an implant-containing wound are delayed or slowed.

Abstract: Novel polycarbonate homopolymers and implantable bioresorbable medical devices fabricated therefrom.