Abstract: A composite biotic implant of the invention is prepared by coating a metal substrate with ceramic particles preferably having bio-compatibility, and plastic working the coated substrate to cause plastic deformation of the metal substrate, thereby embedding the ceramic particles in a surface layer of the metal substrate. Optionally, ceramic material having bio-compatibility is coated over the surface of the ceramic particle embedded substrate. A composite implant exhibiting a firm bond is thus obtained.

Abstract: A prosthesis is provided having at least a smooth non-articulating load bearing surface disposed adjacent a bone. The prosthesis includes a substrate formed from a metallic alloy. At least the regions of the substrate defining the load bearing surface are coated with a biologically inert abrasion resistant material harder than the substrate for preventing leaching of ions from the substrate into adjacent body tissue and for preventing wear. The coating may be titanium nitride or zirconium or other such material exhibiting biological inertness and acceptable hardness. The coating preferably defines a thickness of 8-10 microns.

Abstract: A porous bioabsorbable surgical implant material is prepared by coating particles of bioabsorbable polymer with tissue ingrowth promoter. Typical bioabsorbable polymers include polymers of glycolide, lactide, caprolactone, trimethylene carbonate, dioxanone, and physical and chemical combinations thereof. The tissue ingrowth promoter can include calcium hydroxide and/or a hydrophilic coating material. The hydrophilic coating material can be bioabsorbable or non-bioabsorbable. A typical non-bioabsorbable hydrophilic coating material is polyhydroxyethyl methacrylate (PHEMA). The bioabsorbable implant material may also contain a therapeutic agent. Typical therapeutic agents include an antimicrobial agent, dye, growth factors and combinations thereof.

Abstract: An improved method of making a medical device having immobilized heparin on a blood-contacting surface in which heparin is admixed with sufficient periodate to react with not more than two sugar units per heparin molecule in a buffer solution having a pH in the range of about 4.5-8. This mixture is reacted for at least 3 hours while protected from light and is then applied to the immobilized amine groups. This is an improvement over the prior art methods which included using an excess of periodate and then stopping the reaction at a desired point by the addition of glycerol since the conversion of only a few of the natural functional groups to aldehydes better preserves the antithrombotic bioeffectiveness of the heparin molecules bound to the surface. The invention also avoids the prior art steps of drying and reconstituting the heparin by providing a reacted mixture of heparin and periodate that can be stored as a stable liquid and applied directly to the aminated surface several days later.

Abstract: A method and apparatus prepares a joint surface to receive a prosthetic joint implant during the replacement of a defective human joint. In particular the invention provides an implant preparation device that will smooth or alter a bearing surface of a first side of a joint before surgically attaching a joint implant to a second side of the joint. The implant or joint preparation device has an abrasive bearing surface that is used to smooth the bearing surface of the remaining natural joint.

Abstract: A technique for producing a highly convoluted surface on a prosthetic device is achieved by applying a layer of aspherical metallic powder on the surface of the device. The metallic powder, which may be the same as or different from the material of the device, is applied in a thickness of up to approximately 200 microns and has a size range of approximately -80 to +635 mesh so as to result in a desirable surface roughness defined by a peak to valley variation of up to approximately 200 microns. A resulting device has an enhanced surface which provides, alternatively, an improved press fit into a receiving bone, or improved cement fixation, or improved reception of a ceramic coating.

Abstract: A screw device for a bone joint particularly for stabilizing at least two vertebrae includes a monobloc tubular body with a thread on its exterior, and being longitudinally grooved on its interior deep enough as to form openings at the root of the thread communicating between the exterior of the body at the root and the interior of the body. The openings in the tubular body having circumferential cutting edges. A closure element is provided for screwed attachment to the open end of the tubular body.

Abstract: Methods for forming osseous tissue in defects in sites in the appendicular skeleton or sites exhibiting reduced metabolic state using bioactive glass granules containing 40 to 58% SiO.sub.2, 10 to 30% NaO, 10 to 30% CaO, and 0 to 10% P.sub.2 O.sub.5, and in the size range of from 200 to 300 micrometers, are described.

Abstract: Surgical procedures for stabilizing a spine include exposing a portion of each of adjacent vertebrae requiring fusion and placing an osteoinductive material within an area between the portions of the adjacent vertebrae in contact with the cortical bone of the portions. In another aspect, surgical procedures for stabilizing a spine are provided which include exposing a portion of each of adjacent vertebrae requiring fusion, adding an osteoinductive cytokine to a carrier material and placing the carrier material between the portions of the adjacent vertebrae in contact with the cortical bone of the portions.

Abstract: Provided are orthopedic fasteners and replacements such as nails, screws, pins, hip and knee replacements, etc., coated with hydrogels and other biocompatible/biodegradable materials which expand in the presence of liquids. Swelling of such coatings causes the fastener or replacement to be securely fixed into position once inserted into bone material. Useful coating materials include methacrylates, hyaluronic acid esters, and crosslinked esters of hyaluronic acid resulting from the esterification of hyaluronic acid with polyhydric alcohols. Also provided is a method for fixing a bone or bone replacement in position employing such coated orthopedic fasteners or replacements.

Abstract: An instrument for applying an orthopedic fastener activated by a setting pin includes a member for abutting the fastener, a member for grasping the setting pin, and means for moving said members relative to each other. The instrument may be used endoscopically in conjunction with a cannula. An endoscopic drilling member is provided for deployment through the cannula to create a hole for emplacement of the fastener into bone or hard tissue.

Abstract: A suture anchor having an anchor member, a central shaft and outwardly extending wing members. A suture mounting hole is provided in the suture anchor for receiving a surgical suture. The suture anchor is inserted into a bore hole in a bone as part of an orthopedic surgical procedure wherein soft tissue such as a tendon is attached to the surface of the bone. Optionally, bone tissue may be attached to the surface of the bone. The wings may have cutting edges or piercing points. The suture anchors may have screw threads on their outer surfaces.

Abstract: A bone substitute, which provides both the fracture toughness of titanium or titanium alloys and the bioactivity of apatite, wherein titanium or titanium alloys and apatite are tightly adhered, is produced by soaking a substrate of titanium or titanium alloy in an alkaline solution to form a layer comprising amorphous alkali titanate, followed by the heating of the said substrate up to at most the titanium or titanium alloy transition temperature so as to form a stabilized amorphous alkali titanate layer and a sufficient concentration gradient of alkali and titanium ions to permit the growth of apatite thereon from solutions containing apatite-containing ions.

Abstract: The invention refers to the use of a series of calcium orthophosphate cements as bio-materials, starting from a number of components by grinding and sieving to obtain the adequate grain size, the needed quantity being weighed and the blend of powder products being put into recipients to be shaken up for its homogenization, the mix being placed afterwards, in the desired portions, into a container to be supplied to the specialists, together with capsules containing water or a water solution.

Abstract: Medical devices which are currently proposed to use elements made form shape memory alloys may be improved by the use of stress-induced martensite alloy elements instead. The use of stress-induced martensite decreases the temperature sensitivity of the devices, thereby making them easier to install and/or remove.

Abstract: A femoral hip component for use in hip arthroplasty has a stem portion for contact with bone cement. The stem portion is formed from a biocompatible material having a surface finish of less than about four microinches. This surface is coated with a uniform layer of material selected from the group consisting of diamond-like carbon, chromium carbide, titanium nitride, titanium carbo-nitride, chromium and zirconium and a combination thereof.

Abstract: An intraocular lens (IOL) with an oligodynamic metallic coating on its peripheral portion to substantially inhibit the migration of microorganisms towards the optical axis of the lens, where said coating is either an oligodynamic metal, or the combination of an oligodynamic metal and one or more noble metals which are more electronegative than said oligodynamic metal for substantially reducing the formation of secondary cataracts in the central posterior region of the optic in the capsular bag.

Abstract: The invention is directed to an apparatus for external fixation and stabilization of a fracture in a bone including a one-piece fixation rod, at least two fixation pins attachable to the bone, and at least two clamp assemblies. Each clamp assembly interconnects at least one fixation pin and the fixation rod, The fixation rod is compressible in an axial direction upon occurrence of axial loads typical to those experienced at the fracture, thereby allowing an axial compression loading to be placed on the bone at the fracture when the apparatus is in use. The fixation rod consists essentially of a non-homogeneous, i.e., composite, material.

Abstract: Metal/Composite hybrid orthopedic implants are disclosed that are useful prosthetic devices. The hybrid implant comprises an intraosseous metal portion and an intraosseous composite portion. The composite portion is comprised of filaments nonlinearly disposed to produce a structure of variable modulus along its length. Also disclosed are a variety of means to secure the metal portion to the composite portion. The method of making the various implants is also disclosed.

Abstract: The present invention provides an external skeletal fixator for treating an injured mammalian limb. The fixator has a plurality of transfixation pins which pass through the intact bone of the injured limb proximal to the injured bone. These pins extend beyond the outer edges of the intact bone. These pins are supported by support members which abut the intact bone, extending through the soft tissue. These support members are, in turn, supported by a superstructure capable of supporting the weight of the animal, which superstructure extends beyond the distal end of the injured limb. Thus in the case of a weight bearing limb, the weight of the animal is transferred from the intact bone to the pins, to the supporting members, to the superstructure, to the ground, thus bypassing the injured bone.

Abstract: The present invention relates to composite materials having a core portion formed from a first bioabsorbable material and at least one shell portion of a second bioabsorbable material joined to the core portion. The first and second bioabsorbable materials have different rates of bioabsorption. In a preferred embodiment, the core portion is coextruded with the shell portion to form a composite filament or sheet. The materials of the present invention may be used as sutures or formed into medical devices or surgical articles for implantation within a living organism.

Abstract: An apparatus for fixation of a fractured bone. The apparatus includes a first elongation member that is able to at least partially be inserted into two portions of the bone, as well as a second elongated member that is operable to also be partially inserted into the two portions of the bone. The first and second elongated members include an abrasive surface that is able to resist relative rotation between elongated members and a fixation clamp to which the locking members are secured.

Abstract: A process for enhancing the security of implantable surgical devices secured to bone tissue comprising implanting in bone tissue a surgical device with a biocompatible adhesive and/or sealant selected from the group consisting of: p1 (a) a material made from monomers of the formula:CHR.sup.1 .dbd.CX.sup.1 Y.sup.1wherein X.sup.1 and Y.sup.1 are each strong electron withdrawing groups, and R.sup.1 is hydrogen or, provided that X.sup.1 and Y.sup.1 are both cyano groups, a C.sub.1 -C.sub.4 alkyl group;(b) a semi-crystalline aliphatic poly(ester) of the formula:[--0--R.sup.11 --C(0)--].sub.y,wherein R.sup.11 is selected from the group consisting of --CR.sup.12 H--, --(CH.sub.2).sub.3 --0--, --CH.sub.2 --CH.sub.2 --O--CH.sub.2 --, CR.sub.12 H--CH.sub.2, --(CH.sub.2).sub.4 --, --(CH.sub.2).sub.z --O--C(O)-- and --(CH.sub.2).sub.z --C(O)--CH.sub.2 --; R.sup.

Abstract: A ceramic device providing an environment for the promotion and formation of new bone. The ceramic device is made of a sinter of calcium phosphate compound, containing a plurality of perfect spherical pores whose diameter ranges from 10-450 .mu.m to provide a suitable environment for the formation of new bone. A plurality of micro pores is included whose diameter ranges from 0.01-0.5 .mu.m which surrounds the perfect spherical pores to interconnect the perfect spherical pores with an outer surface of the ceramic device with the micro pores interconnecting with each other.

Abstract: Compositions containing a high concentration of the full repertoire of immunoglobulins, including IgA, IgM and IgG, are used to combat infections from microorganisms and viruses at a wound, surgical, or burn site, or normal tissue at times of risk of infection. The compositions can contain elevated antibody titers for several specific pathogens including S. aureus, CNS, Enterococci, S. epidermidis, P. aeruginosa, E. coli, and Enterobacter spp., etc. The compositions are applied directly to a wound or burn site as an ointment, creme, fluid, spray, or the like, prior to viral or bacterial attachment or biofilm formation such that adhesion of the pathogens is inhibited and the pathogens closest to the wound or burn site will be pre-opsonized for phagocytic killing prior to toxin release.

Abstract: The invention relates to a bone replacement material consisting of a three-dimensional supporting framework of elementary bodies connected to one another and surrounding defined spaces, and a coating mass of fillers (based on strong calcium compounds) and a binding substance (matrix). The binding substance and the fillers are absorbable and the fillers are highly porous spherical particles with a diameter of between 15 and 50 .mu.m and a pore volume of between 50 to 80%, to which some filamentous material can be added.The bone replacement material of the invention is suited to produce coatings for prostheses, thus serving as an anchoring part for prostheses. It can also be used as a complete implant.

Abstract: A biodegradable, bioresorbable, three-dimensional template for repair and replacement of diseased or injured bone which provides mechanical strength to bone while also providing a guide for growth of bone tissue. Preferably, the template is formed of biodegradable materials, for example, poly(L-lactic acid), poly(D, L-lactic acid), poly (D, L-lactic-co-glycolic acid), poly (glycolic acid), poly (.epsilon.-caprolactone), polyortho esters, and polyanhydrides, and has the capacity of being rendered porous, either in vitro or in vivo. A pore-forming component, which may or may not be a polymeric material, is mixed within a continuous matrix formed of a biodegradable material, the pore-forming component having a rate of degradation which exceeds that of the matrix. Differential dissolution or biodegradation provides porosity to the template.

Abstract: An orthopedic implant, such as the bone-implantable portion of a joint prosthesis, in which a rigid stem is dimensioned to be received in the intramedullary canal of a bone, and in which the stem has at least a portion of its length encased in a preformed mantle consisting of a self-reinforced poly(methylmethacrylate) fiber composition where the fibers are oriented in predetermined directions with respect to the axis of the stem, are of a diameter within the range of about 5 to 500 microns (.mu.m), and have aligned molecular chains that provide such fibers with longitudinal heat relaxation ratios of no less than about 6 to 1 is disclosed. Also disclosed are the methods for making such an implant and for securing it in an intramedullary canal.

Abstract: A fastener including an elongated body having one or more ridges passing across its exterior surface intersecting root portions between them. Each ridge has a crest portion with edges bounded by distal and proximal slope portions extending inwardly from the crest edges to the root portions. A coating is disposed on the crest portion and at least part of the distal slope portion but not on at least part of the root portion. The coating has a selected coefficient of friction different from that of the exterior surface of the elongated body. The fastener further includes an element for engaging a driver to enable insertion of the elongated body into a tissue of the patient. The coating modifies the amount of force which must be applied to the driver to insert the fastener.

Abstract: A medullary nail has a plug-like insert arranged in the end region of the nail. The insert consists of a readily drillable or screwable material that is suitable for receiving a corresponding attachment element such as a bone screw or a bone pin. The medullary nail is otherwise of standard metal construction, preferably of stainless steel.

Abstract: A metallic implant base is coated with two bioactive ceramic layers. An inner bioactive ceramic layer is coated on the implant base. An outer bioactive ceramic layer is coated on the inner bioactive ceramic layer. The inner bioactive layer is vitrified at a ratio of not less than 50 volume percent, thereby improving the bonding of the inner bioactive layer to the metallic implant base and preventing migration of the metal ions from the metallic implant base. The outer bioactive ceramic layer is vitrified to a ratio of substantially less than 50 volume percent, thereby providing a desired porosity.

Abstract: Improved polymeric orthopaedic compositions are disclosed wherein sized, functional fibers are incorporated into a physiologically acceptable matrix. The compositions of the invention can be fabricated in the form of particulate powders adapted for reinforcment of bone cements, continuous media for such cements, and orthopaedic implant coatings. A complete implant attachment system is also provided, made up of a fiber reinforced implant coating, and a compatible fiber-reinforced cement. In preferred forms, the fibers have a layer of sizing thereover which is chemically joined both to the surface of the fibers and to the surrounding matrix, and the fibers are present at a level of at least about 6 volume percent. If desired, sized radiopaque particles may be incorporated into the compositions of the invention. The fibers are advantageously polymeric in nature and of intermediate stiffness, whereas the matrix fraction is preferably polymethylmethacrylate.

Abstract: Articles comprised of bioactive agents coupled to or repelled by a graft polymer (made, for example, from monomers such as N-(3-aminopropyl) methacrylamide hydrochloride (APMA), 2-acrylamido-2-methylpropane sulfonic acid (AMPS), acrylamide (AAm), and acrylic acid (AA)) which is in turn bonded to a polymeric substrate surface. The articles are useful as thromboresistant and/or antimicrobial medical devices.

Abstract: The prevailing opinion, supported by observations, has been in the art, that any implant of titanium or of another similar material is to have a contact surface roughness of more than 20 .mu.m to yield a good bond between bone and implant. The present invention is based upon the recognition, that the bond between bone and implant may be substantially improved by providing the contact surface of the implant with a micro-roughness of 2 .mu.m or less. According to the method of the invention such micro-roughness can be readily produced by subjecting the contact surface to pickling in a reducing acid.

Abstract: An appliance for temporarily covering a bone surgery site, such as a recess in a bone filled with bone-building material, such as hydroxylapatite granules, for promoting post-surgery healing includes a flexible sleeve adapted to wrapped around the bone, which carries a covering membrane on one side thereof facing the bone and which carries a reinforcing ply on a side facing away from the bone. The sleeve has two free closure edges, which can be firmly attached to each other with connecting elements which engage into the reinforcing ply, so as to hold the appliance wrapped around the bone.

Abstract: An antibiotic eluding intramedullary nail apparatus for use in the intramedullary fixation of fractured long bones, such as femurs, tibias, fibulas, humeri, ulnas and radii, as well as other orthopedic and bone reconstructive procedures, and, in particular fractures associated with an open wound exposing the soft tissue and medullary canal of the fractured bone to bacteria and other infectious micro-organisms.

Abstract: Bone-treating devices made of biodegradable polymers having a high-density and a high-orientation along the major axis, which have a density of 1.260 g/cm.sup.3 or more (when measured by the sink and float method) and which possess the bending strength and the bending strength-retaining characteristic defined by the following equations:A.gtoreq.B.gtoreq.23 (kgf/mm.sup.2) (1)B/A.gtoreq.0.85 (2)wherein A is the initial bending strength and B is the bending strength after 90-days immersion of the devices in a phosphate buffer at 37.degree. C. and preparing the same.

Abstract: A method and apparatus for surgical correction of malformations of digits of a foot. Part of the joint is removed to expose bone ends. The bone ends are spaced apart from each other at a distance greater than would be suitable for knitting of said bone ends to each other with bone tissue. Holes are bored in each of the bone ends. An implant, including shafts and a central spacer, is inserted into each of the holes in the bones. This implant consists entirely of absorbable material. The implant is left permanently in place to be completely absorbed as it is replaced by fibrous scar tissue. This tissue forms an effective joint replacement.

Abstract: A metallic implantable finger joint has a biocompatible protective coating and includes both a base member and a protraction member. The base member is formed with a recess and has a protrusion projecting from inside the recess. The protraction member has a hemispherical surface which is slidingly engageable with the recess of the base member. Additionally, the protraction member is formed with a groove which engagingly receives the protrusion from the base member. This engagement is such that when the base member is juxtaposed with the protraction member, the interaction between the protrusion and the groove allows for relative movement between the members in flexion-extension, lateral rotation and pure rotation. The finger joint can also include implant barbs which are selectively engageable with the base member and the protraction member.

Abstract: Novel composite orthopedic devices with modulus variations are disclosed. The device contains an extraosseous portion attached to a first intraosseous portion which is secured to a second intraosseous portion; the intraosseous portions may interface with the intramedullary canal of the human femur. The modulus varies along the length of the device, decreasing from the extraosseous portion to the second intraosseous portion. The variations in modulus are achieved by forming the device from a composite comprising filaments nonlinearly disposed about the longitudinal axes of the device and within a polymer matrix. The method of making the present orthopedic device is also disclosed.

Abstract: Bone screws are disclosed with and without heads and with the screw shaft provided with axially adjacent longitudinally extending regions, one or more of which have bone ingrowth porous surfaces and alternate with regions having threaded surfaces. The headed embodiments have a region with a threaded surface nearest the head.

Abstract: A load-bearing, bioabsorbable surgical repair device manufactured from a copolymer having a plurality of first linkages of lactide or lactide/glycolide, and a plurality of second linkages of a polymer having a glass transition temperature below ambient temperature. The second linkages preferably are selected from: 1,3-dioxan-2-one; 1,4-dioxan-2-one; and .epsilon.-caprolactone.

Abstract: Improved polymeric orthopaedic compositions are disclosed wherein sized, functional fibers are incorporated into a physiologically acceptable matrix. The compositions of the invention can be fabricated in the form of particulate powders adapted for reinforcment of bone cements, continuous media for such cements, and orthopaedic implant coatings. A complete implant attachment system is also provided, made up of a fiber reinforced implant coating, and a compatible fiber-reinforced cement. In preferred forms, the fibers have a layer of sizing thereover which is chemically joined both to the surface of the fibers and to the surrounding matrix, and the fibers are present at a level of at least about 6 volume percent. If desired, sized radiopaque particles may be incorporated into the compositions of the invention. The fibers are advantageously polymeric in nature and of intermediate stiffness, whereas the matrix fraction is preferably polymethylmethacrylate.

Abstract: A method and apparatus for anchoring flaps of tissue in the body utilizes panels of material including a plurality of outwardly extending quills, or pins, to engage and secure the flaps of tissue in place.

Abstract: The invention features a method for preparing coated implants. The method includes the steps of: (a) providing a gel of amorphous calcium phosphate having a calcium to phosphorous ratio of 0.5 to 1.6; (b) dispersing the gel of amorphous calcium phosphate in an aqueous liquid to form a colloidal mixture which is between 60% and 99% by weight water; (c) immersing an implant to be coated in the colloidal mixture; and (d) with the implant acting as an anode, electrodepositing material in the colloidal mixture on the implant to form a substantially uniform coating.

Abstract: A method and apparatus for surgical correction of malformations of digits of a foot. Part of the joint is removed to expose bone ends. The bone ends are spaced apart from each other at a distance greater than would be suitable for knitting of said bone ends to each other with bone tissue. Holes are bored in each of the bone ends. An implant, including shafts and a central spacer, is inserted into each of the holes in the bones. This implant consists entirely of absorbable material. The implant is left permanently in place to be completely absorbed as it is replaced by fibrous scar tissue. This tissue forms an effective joint replacement.

Abstract: A means for fastening a capping on bone tissue or the like over an area of original, locally depressed, chipped or fractured tissue to promote the growth of additional tissue is disclosed, comprising generally, a pin which has, at one end, a bead for attachment of a foil and, at the other end, an external thread for threading into the original tissue or bone. Between the bead and the thread is a smooth-walled segment whose diameter is preferably larger than the diameter of the external thread. The method, unlike previous prior art methods, facilitates growing of the bone between two teeth or between teeth and a denture. The method permits, for example, restoring a jawbone to a larger extent than over areas where there were only slight depressions.

Abstract: A biocompatible titanium alloy with low elastic modulus containing titanium, about 10-20 wt. % or 35 to about 50 wt. % niobium and up to 20 wt. % zirconium useful for fabricating of orthopedic implants. This invention relates generally to high strength, biocompatible alloys suitable for use as a material for a medical prosthetic implant and, in particular, a titanium alloy which has a relatively low modulus of elasticity (e.g. closer to that of bone than other typically-used metal alloys) and does not include any elements which have been shown or suggested as having short term or long term potential adverse effect from a standpoint or biocompatibility.

Abstract: Orthopedic implants of zirconium or zirconium-based alloy coated with blue or blue-black zirconium oxide or zirconium nitride to provide low friction, highly wear resistant coatings especially useful in artificial joints, such as hip joints, knee joints, elbows, etc. The invention zirconium oxide or nitride coated prostheses are also useful to reduce microfretting wear in multi-component surgical implants subject to such wear. Further, the coatings provide a barrier against implant corrosion caused by ionization of the metal prosthesis. Such protection can be extended by the use of oxidized or nitrided porous coatings of zirconium or zirconium alloy beads or wire mesh into which bone spicules may grow so that the prosthesis may be integrated into the living skeleton.

Abstract: Calcium phosphate minerals are formed by using phosphoric acid source substantially free of uncombined water in conjunction with a calcium source, normally as any combination of carbonate, phosphate and hydroxide, and, as required, any additional base to neutralize the phosphoric acid. Protein may be optionally added. The resulting product is readily formed and then sets to a hard, stable, workable shaped object.