Abstract: Anatomically contoured anterior cervical plates with bone ingrowth surfaces, providing for intersegmental compressive preloading, and a rigid and locked interface to all of the bone screws, with those engaging the vertebrae deployed in highly convergent pairs. The bone screws have a tapered self-tapping leading end, an increasing root diameter with a generally constant outer diameter with a thread that is narrow and sharp throughout and an enlarged head portion capable of an interference fit to the receiving holes of the plate. Instrumentation consists of plate holders, a compression apparatus and a pilot hole forming device that interlocks with the plate. Methods for spinal compression and bone hole preparation are provided.

Abstract: An orthopaedic bone plate includes a flexible bag having a plurality of through holes; and a hardened polymer within the bag. The bone plate is attached to a bone by placing the bag against the bone; affixing the bag to the bone using a plurality of fasteners which extend through the bag; injecting a polymer into the bag; and hardening the polymer in the bag.

Abstract: A prophylactic implant is provided for protecting osteoporosis-affected bone segments against fractures, in particular the neck of the femur, the vertebral column and the wrist. According to a proposed solution, the implant comprises a thin-walled hollow reinforcing body (1) having such a large number of passages (2) in its outer wall (3) that the ratio of the total area of the passages (2) to the total surface area is at least 1:2.

Abstract: An adhesive composition for surgical use including an &agr;-cyanoacrylate adhesive composition with a polymer characteristic for biodegrading and bioabsorbing the adhesive into the body of a living organism. It is preferred that the polymer is a co-polymer of DL-lactic acid and &egr;-caprolactone or a co-polymer of DL-lactic acid, ethylene glycol and &egr;-caprolactone, or a co-polymer of ethylene glycol and &egr;-caprolactone.

Abstract: A process is disclosed for producing osteoinductive bone using a controlled-flow apparatus. The present apparatus allows for the controlled extraction of undesirable constituents from a body tissue. The present invention provides for the demineralization of ground bone particles or pieces of cancellous or cortical bone which permits the controlled and reproducible demineralization of bone to produce bone which is maximally osteoinductive. It has been demonstrated that ground cadaveric bone which is demineralized to a residual calcium level approximating 2% by dry weight of bone is optimally osteoinductive as assayed using in vivo and in vitro assays of osteoinductivity. The present controlled-flow apparatus includes one or more solution containers which supply solutions to be pumped into one or more vessels filled with tissue samples to be extracted. Solvent outflowing from the vessels can be monitored for pH, calcium ion concentration or conductivity as a basis for determining when extraction is complete.

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 medical implant or device fabricated, in any manner, from a niobium (Nb)—titanium (Ti)—zirconium (Zr)—Molybdenum (Mo) alloy (NbTiZrMo alloy). The implant or device has components at least partially fabricated from a metal alloy comprising a) between about 29 and 70 weight percent Nb; b) between about 10 and 46 weight percent Zr; c) between about 3 and 15 weight percent Mo; and a balance of titanium. The inventive alloy provides for a uniform beta structure which is corrosion resistant, and can be readily processed to develop high-strength and low-modulus, with the ability for conversion oxidation or nitridization surface hardening of the medical implant or device.

Abstract: A highly porous three-dimensional biodegradable poly(organophosphazene) matrix with hydrolytically unstable side chains is prepared and used as a scaffold for the growth of osteoblast cells. In a preferred embodiment, the poly(organophosphazene) includes between 10 and 90% hydrolytically unstable side chains including glucosyl, glyceryl, glyceryl, imidazolyl or ethoxy units, for example, poly[(methylphenoxy)(ethyl glycinato) phosphazene]. The addition of the glucosyl, glycinyl or glyceryl side chains to the polymer can also be used generally to enhance growth rates of cells adhered to the polymer, presumably through uptake and metabolism of the simple sugar or alcohol units.

Abstract: An osteosynthetic implant for a mechanical connection of fractured elements, made of a polymeric biodegradable base material, for use in reconstructive osteosynthesis. An active ingredient assists the regeneration of bone tissue in a fracture area and acts together with the implant to assist growth in the fracture area, so that the mechanical load-bearing capability of the healing fracture increases faster or at least as fast as the load-bearing capability biodegradable implant decreases when decomposing.

Abstract: A bone plating system for the internal stabilization of a fractured bone is disclosed. The system includes a bone plate having a plurality of conical plate holes tapering toward a bone contact surface and at least two bone screws for anchoring the bone plate to a bone. The screws have a conical head with a textured or structured lateral outside surface which is greater in hardness than the portion of the bone plate which is proximal to the plate holes. The present system provides positive locking between the screw heads and the plate holes.

Abstract: Anatomically contoured anterior cervical plates with bone ingrowth surfaces, providing for intersegmental compressive preloading, and a rigid and locked interface to all of the bone screws, with those engaging the vertebrae deployed in highly convergent pairs. The bone screws have a tapered self-tapping leading end, an increasing root diameter with a generally constant outer diameter with a thread that is narrow and sharp throughout and an enlarged head portion capable of an interference fit to the receiving holes of the plate. Instrumentation consists of plate holders, a compression apparatus and a pilot hole forming device that interlocks with the plate. Methods for spinal compression and bone hole preparation are provided.

Abstract: A substrate is rendered highly lubricious and wettable, by treating the substrate so that it becomes amine-functionalized, and chemically joining an aldonic acid to amine groups on the substrate. In the preferred embodiment, the chemical joining is performed with the aid of a coupling agent, such as a water-soluble carbodiimide, the coupling agent participating in the reaction which joins the aldonic acid to the amine groups, and which forms a residue that can be discarded. The coupling agent makes it possible to perform the process at room temperature. The method can be used to coat articles such as contact lenses, intra-ocular lenses, or other devices which are intended to be temporarily or permanently implanted in the body. The method can also be used in other fields, such as in coating of goggles, windshields, and other objects.

Abstract: A bone connective prosthesis and method of forming same comprising the addition of a biocompatible plasticizer to a PMMA film and/or bone cement, which preferably copolymerizes with the PMMA film and/or bone cement. Preferably, this plasticizer comprises the FDA approved, biocompatible hydrophilic monomer known as 2-hydroxyethyl methacrylate (commonly referred to as "HEMA") and its associated water. HEMA has the ability to absorb water. An important feature of this invention is that this ability to absorb water results in a measurable and controllable plasticization.In one embodiment of the present invention, the plasticizer (HEMA and its associated water) copolymerizes with the PMMA film to form a PMMA/HEMA coating which is preferably used as a coating on a bone prosthesis. In a further embodiment, the plasticizer (HEMA and its associated water) copolymerizes with a PMMA base bone cement to form a PMMA/HEMA bone cement.

Abstract: The present invention relates to an implant for use in the human body, an implant substrate being coated with a material which contains chemical compounds between one or more metals (M) of group IV A of the periodic system, nitrogen (N) and oxygen (O), 2 to 45% of the volume in the coating material being formed by voids whose sizes range from (0.4 nm).sup.3 to (50 nm).sup.3, and the remaining volume having a composition of a metal of group IV A of the periodic system to nitrogen to oxygen of 1:(0.1 to 1.7):(0.1 to 1.7), a material having formula MN.sub.x O.sub.y (wherein x,y=0.1-1.7) resulting.The invention also relates to the use of this implant for implantation into the animal or human body.

Abstract: The present invention relates to a bone screw cap or stopper, comprising a shank (5) that fits closely to the outer contour of the head (2) of the screw and means (4) for detachably connecting the cap or stopper to the bone screw (1). Especially this stopper comprises an extended shank whose section is at least as large as the largest sectional part of the bone screw, and the length of the extended shank is preferably such that the end of the stopper remote from the bone screw extends to the subcutis.

Abstract: Disclosed is a method of enhancing the biocompatibility of a substrate by providing the substrate with a continuous bio-active surface coating. This method includes applying to the substrate a first coating which includes an aqueous dispersion or emulsion of a polymer containing an organic acid functional group and an excess of a polyfunctional cross-linking agent which is reactive with the organic acid groups of the polymer. A continuous bio-active surface coating is then formed over the dried first coating by applying thereover a bio-active agent containing an organic acid functional group or metal salt thereof. The first and second coatings are then dried to covalently bond the organic acid functional groups of the bio-active agent to the polymer through the excess unreacted polyfunctional cross-linking agent.

Abstract: A fastener for securing an osteosynthesis plate to a plurality of bone segments is provided. The fastener in the form of a fastener blank includes an elongated shank adapted for insertion through an opening in the plate and into a hole formed in the bone. The upper end of the shank forms a head that serves to secure the plate to the bone. The elongated shank is constructed of a material which when heated will deform to form a tight fit within the hole drilled in the bone. The fastener is preferably made of a resorbable material. The invention also provides a method for securing a plate to a bone using the fasteners of the invention. A fastener blank is positioned into the hole so that a portion of the blank extends into the hole provided in the bone and another portion overlies the plate. The blank is heated to raise the temperature of the blank above the transition temperature of the material from which it is made and deform the blank into a tight fit within the hole.

Abstract: A carvable implant material for use in surgery and especially in plastic and reconstructive surgery. At least two layers of porous PTFE (polytetrafluoroethylene) sheet material are laminated together by an adhesive placed between the adjacent layers of porous PTFE sheet material. Alternatively, a plurality of discrete pieces of porous PTFE may be adhered together by an adhesive. The presence of the adhesive provides a significant increase in stiffness and hence in carvability beyond that possible in a single layer of porous PTFE without the adhesive. Preferred adhesives are thermoplastic fluoropolymers of lower crystalline melt temperature than PTFE, such as FEP or PFA.

Abstract: Surgical devices such as implants or suture fastenings are assembled from a plurality of discrete components, one of which components includes a heat bondable plastic material for bonding the components together. At least two components are bonded to each other by the applying heat to the heat bondable plastic material of one component. The heat bondable plastic material is preferably a polymeric or composite material suitable for surgical applications and implantation in humans, and may be a biodegradable material. A laser may be used as the heat source. The present invention is advantageously embodied in heat bonded fastenings for sutures or K-wires, in which a variety of different suture anchors are usable, including expandable distal suture anchors.

Abstract: An interference screw is provided by machining a fragment of autograft or allograft cortical bone from a donor or from a recipient's amputated bone. The interference screw has a cortical surface into which a self-tapping thread is machined. The interference screw has a machined pointed, rounded or flush end and an opposite machined end which mates with a drive means, and has advantages over conventional interference screws known in the art in that subsequent to implantation, no residual hardware that must later be removed remains at the implant site.

Abstract: A method for internal fixation of vertebra of the spine to facilitate graft fusion includes steps for excising the nucleus of an affected disc, preparing a bone graft, instrumenting the vertebrae for fixation, and introducing the bone graft into the resected nuclear space. Disc resection is conducted through two portals through the annulus, with one portal supporting resection instruments and the other supporting a viewing device. The fixation hardware is inserted through small incisions aligned with each pedicle to be instrumented. The hardware includes bone screws, fixation plates, engagement nuts, and linking members. In an important aspect of the method, the fixation plates, engagement nuts and linking members are supported suprafascially but subcutaneously so that the fascia and muscle tissue are not damaged. The bone screw is configured to support the fixation hardware above the fascia.

Abstract: A layer of material is interposed between a metallic texture coating and the substrate of a component of a prosthetic implant, the layer being bonded to the substrate and, in turn, receiving the metallic texture coating so as to deter propagation of fatigue-induced cracks from the metallic texture coating into the substrate.

Abstract: A calcium phosphate cement and a calcium phosphate cement composition are disclosed. The calcium phosphate cement comprises a calcium phosphate powder having an average particle diameter of 20 .mu.m or smaller and a tap density of 35% or higher, and a polysaccharide. The polysaccharide is preferably a dextran sulfate (e.g., dextran sulfate sodium) having an average particle diameter of 0.1 to 100 .mu.m. The calcium phosphate cement composition comprises the above specific calcium phosphate powder and a liquid for cement mixing comprising an aqueous solution containing 30 to 60 wt % dextran sulfate (e.g., dextran sulfate sodium or dextran sulfate potassium). The calcium phosphate powder preferably comprises a tetracalcium phosphate powder and an equimolar amount of a calcium hydrogen phosphate powder as main components.

Abstract: A biodegradable device for repairing torn meniscal cartilage comprising a shaft and tissue gripping means at both ends. One end is adapted to pierce the tissue and the opposite end is adapted to fit a driver. The central portion of the device is essentially smooth along its length. The device has been subjected to a drawing operation after fabrication leaving the molecules in the shaft in a higher state of residual stress. When the device is exposed to an aqueous environment, the water absorbed by the polymer lowers the glass transition temperature of the polymer. Lowering glass transition temperature allows increased molecular mobility causing the device to contract. The contraction pulls the torn tissues into close apposition during healing. As the tissue heals, the tension is released by the polymer resorbing.

Abstract: A system and method for shimming a hole drilled in a bone for the insertion of an orthopedic screw. The system includes a sleeve with an elongated sleeve shaped body having an external surface and an internal surface, a first end, a mid portion, and a second end. The mid portion of the body is made from woven fibers that are free to move relative to one another and being woven in a crisscrossing spiral arrangement along the sleeve shaped body. The first end of the body includes an opening that can accept a rod. The second end of the body is smaller than the first end of the body, so that the first end of the sleeve shaped body may be inserted into the hole with the aid of the rod, and so that when the orthopedic screw is inserted into the elongated sleeve the woven fibers of the body will move relative to one other to accommodate the orthopedic screw and take up any space between the screw and the hole.

Abstract: A method of providing biocompatible surface texturing on a metal component of an implantable device and the device so produced. The coating is provided by applying particles of metal falling substantially entirely in the range of 1 to 5 microns to a surface of said component to provide a layer of generally uniform thickness and sintering said particles to one another and to said component to provide a generally continuous external surface having surface texturing in the form of projections formed from said sintered particles. The particles are preferably applied to a depth of 1 to 25 microns. In a preferred embodiment particles of titanium are applied to a surface of a titanium component.

Abstract: A fastener for use in soft tissue repair includes a resorbable polymer or suture core having one or more collagen bands in surrounding relation to the core. The bands are expandable between a dehydrated state for insertion and a hydrated state for healing, and are dimensioned and positioned to bring two sides of a tear into apposition to promote healing of the tear. The fastener insertion method includes driving an elongated tube across the tear, inserting a fastener down the tube until it breaches the tears and removing the tube, leaving the fastener in position to expand and promote healing of the tear.

Abstract: A foil or membrane for covering bone defect locations and for promoting bone regeneration, comprised of titanium and which is inelastic, stress-free and plastically deformable. The foil has a thickness of less than 0.1 mm. The thickness lies especially in a range of 0.025 mm. It is advantageously roughened at least on one surface or grooved. Cut pieces have a cut burr which projects from one surface and in the use of the foil, turned to the bone with sealing edges. A method of making such a foil with the aforesaid characteristics comprises a removal of the surfaces of the rolled foil by a chemical foil until the desired thickness is reached. A nail for fixing the foil in position has a spherical shaped head and in its concavity merges with a saw-tooth barbed pin with a radius.

Abstract: A flowable, paste-like composition capable of setting in a clinically relevant period of time into an antimicrobial agent loaded apatitic product having sufficient compressive strength to serve as a cancellous bone structural material is provided. The subject compositions are prepared by combining dry ingredients with a physiologically acceptable lubricant and an antimicrobial agent, where the dry ingredients comprise at least two different calcium phosphates. The subject compositions find use in a variety of different applications, including orthopaedic, dental and cranio-maxillofacial applications.

Abstract: Sterile bone fixation devices, such as bone screws, pins, anchors and plates, fabricated from bone tissue and the method of making such devices.

Abstract: A medical device such as a stent, surgical staple, bone anchoring device or bone fixation device, intended to be deployed within the body, composes a shape memory alloy (SMA) portion with an austenitic and unaustenitic state with different memorized configurations in each of these states. The SMA which is initially in an initial configuration in which it can be placed into position within the body, can be mechanically deformed into an operational configuration in which it remains deployed within the body.

Abstract: Carbonated hydroxyapatite compositions and their preparation are described. The compositions are biologically resorbable and are prepared as flowable masses which can be administered by syringe to set in situ to serve as a support structure, filler, prosthesis or the like. Optionally the compositions may include proteins or serve as a depot for compositions of phrarmacological interest.

Abstract: This invention describes a biocompatible, radiopaque, high-strength, low-modulus, titanium based alloy having about 2-30 weight percent Mo and up to about 30 weight percent Hf. This alloy is suitable for use in the fabrication of medical implants and devices having low modulus, improved corrosion resistance and surface hardening. To increase strength, Cr, Si and Fe can be added in small amounts as well as increasing levels of interstitial oxygen, nitrogen or carbon. To maintain low elastic modulus, Mo can be partially substituted by Nb.

Abstract: Carbonated hydroxyapatite compositions and their preparation are described. The compositions are biologically resorbable and are prepared as flowable masses which can be administered by syringe to set in situ to serve as a support structure, filler, prosthesis or the like.

Abstract: A method for repairing fractured bone. The method includes the steps of reducing the fracture, securing a fixation device to the bone through at least one hole formed in the bone in order to stabilize the fracture, removing the fixation device from said bone after the fracture has healed, providing an osteoductive resorbable bone implant, and inserting the resorbable bone implant into the hole in the bone so that bone growth into the hole is facilitated.

Abstract: A surgical fastening device, such as a suture, staple, clip, pin or the like, is rendered therapeutically radioactive in order to inhibit cellular proliferation at a wound or surgical repair site, by implantation of a radioisotope into the material of the device. The device can be made of any material, including metals, nonmetals, plastics and ceramics.

Abstract: The invention proposes a body showing an antibacterial effect for application as a medical or surgical aid, wherein the body is designed as a flexible synthetic-material hose (8) that is provided with an antibacterially-acting coating, and the hose (8) is provided with a slit (8a) over its entire length.

Abstract: A process and product comprising collagen and demineralized bone particles. The product may contain a maximum of 20% by weight inorganic materials. The product may densified by compression. Additional osteogenic factors, mitogens, drugs or antibiotics may be incorporated therein. Inorganic materials may be bound to the organic matrix via precoating with a calcium or hydroxyapatite binding protein, peptide or amino acid. The materials also display long lasting drug release characteristics.

Abstract: Carbonated hydroxyapatite compositions and their preparation are described. The compositions are biologically resorbable and are prepared as flowable masses which can be administered by syringe to set in situ to serve as a support structure, filler, prosthesis or the like. Optionally the compositions may include proteins or serve as a depot for compositions of phrarmacological interest.

Abstract: An orthopedic interference screw for compression anchoring a bone graft in a bore formed in a bone mass. The interference screw includes a biocompatible body with a root. A screw thread is formed over substantially all of the root. The screw thread includes buttress structure on only one side of the screw thread so that forces applied to the screw thread from a side remote from the buttress structure will be buttressed by the buttress structure.

Abstract: A tissue press for shaping or compressing a piece of tissue comprises first and second members movable relative to each other. A first forming element of a predetermined shape is selectively engageable on the first member. A second forming element of predetermined shape is selectively engageable on the second member. The first and second forming elements are positionable on opposite sides of the piece of tissue. The first and second members are relatively movable between a first spaced apart condition and a second condition in which the piece of tissue is held between the first and second forming elements. The means for shaping or compressing a piece of tissue may extrude the tissue. Means may also be provided for draining off fluid from compressed tissue, so that the tissue can be implanted in a compressed state and imbibe fluid from the host site. A retainer, which may be expandable, can be used to maintain the tissue graft in a compressed condition.

Abstract: Medical devices, most particularly prosthesis, are defined having at least one porous tissue-mating surface. The tissue-mating surface of the device includes therein a biodegradable carrier, such as a biodegradable polymer. The pores or intersticial spaces of the tissue-mating surface of the device are impregnated with the biodegradable polymer. The prosthesis of the present invention provides for enhanced rigid fixation, as pores at the surface of said device provide for bony ingrowth as the biodegradable carrier, i.e., polymer, degrades. Methods for preparing said prosthesis are described. Methods for delivering a pharmacologically active substance by including a pharmacologically active substance in the biodegradable carrier (e.g., polymer) are also disclosed.

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: Sterile bone fixation devices, such as bone screws, pins, anchors and plates, fabricated from bone tissue and the method of making such devices.

Abstract: Compositions for bone repair have been developed based on linear hydrophobic degradable polymers and monomers or macromers, at least one of which includes an anhydride linkage. The monomers and/or macromers crosslink each other but not to the linear polymer to form semi-interpenetrating networks. The compositions can include various excipients, therapeutic and/or diagnostic agents. The compositions can be polymerized in the presence of dissolvable particles such as inorganic salts and proteinaceous materials to provide a porous polymer network. The compositions can be injected into a patient and polymerized in situ or can be polymerized ex vivo and implanted. When polymerized ex vivo, the composition can be shaped into various articles, such as pins, screws, and hollow tubes, which can be used to repair broken bones.

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: Cover device for temporarily covering bone voids, particularly a recess, which are filled with ossiferous material such as hydroxyl apatite granules, in the proper bone tissue of the body, comprises a perforated reinforcement element for covering the void in essentially a shape-stable fashion that is composed of relatively stiff but flexible material such as a supporting grid of metal or the like, and a single-layer or multi-layer cover membrane carried by the reinforcement element, and at least one of the layers of the cover membrane is applied as a solution film onto the reinforcing element after the use-specific shaping of the element as well as a method for the production of the element.

Abstract: An artificial (namely synthetic) bone material is made up of a strength sustaining first component and of a biointegration promoting second component. The first component is made, for example of a bioceramic material providing a material strength, especially a compression strength, of at least 1000 N/cm.sup.2. The second component is made also of bioceramic material or even of bone tissue or it may contain bone tissue in combination with other biointegration enhancing components. Biointegration is greatly improved if the material of the second component comprises a specific surface of at least 1.5 m.sup.2 /gram. The second component is incorporated in accessible voids such as open cells, pores, bores, holes and/or other cavities of the first component, whereby the first component forms a frame or matrix for the second component and imparts to the artificial bone the required strength prior to, during, and after implantation.

Abstract: A polyaxial orthopedic device for use with rod implant apparatus includes a hook or a screw having a recess which includes a lower portion and an upper portion, the up per portion is curvate. A rod receiving head having a channel formed therein, and a central bore which is curvately tapered at the inside bottom, and equivalently curvately tapered on the exterior surface, is polyaxially seated in the upper portion of the recess while a post element is inserted down through the head into the lower portion of the recess. The upper portion of the post is widened and curvate so that it seats in the curved lower interior of the bore of the head. The insertion of a rod into the head, onto the top of the post and the subsequent application of a downward force thereon by a nut causes the assembly to lock together, independent of the polyaxial angle of the head to the post and hook, or screw.

Abstract: The invention discloses pH-controlling devices that comprise a biodegradable polymer and a pH-controlling substance, particularly an alkaline, acidic or buffering agent. By way of example, such alkaline agents include calcium carbonate and sodium bicarbonate. Methods of preparing such devices are also described. Methods for enhancing biocompatibility of an implantable device are also provided, as neutralizing alkaline materials are released at a rate that offsets changes in pH typically observed as polymers degrade to various acidic or alkaline by-products. By way of example, biodegradable polymers include PLA, PGA, polycaprolactone, copolymers thereof, or mixtures thereof. A new technique is also disclosed to increase the surface porosity of porous implants which have a tendency to form relatively impermeable coverings. This technique entails the use of mechanical means to remove at least part of said covering, thus increasing the implant's surface porosity and permeability.