Abstract: A biocompatible interference screw for soft tissue or bone-to-bone fixation comprises a screw body extending from a screw head to a distal tip of the screw. The screw body has an outer surface, and comprises polyether-ether-ketone (PEEK) material. Advantageously, the body outer surface has a textured surface finish for substantially improving pull-out strength of the interference screw. The textured surface finish is textured, in preferred embodiments, with a minimum of approximately 16 micro inches of surface roughness. The screw head comprises a tapered square keyhole for receiving a distal end of a driver instrument. The screw comprises a series of threads, which have a relatively smooth profile, in order to prevent graft tissue laceration as the screw is being inserted. The distal tip of the screw body comprises a narrow tip, and a distal end of the screw body is angled inwardly toward the narrow distal tip.

Abstract: A method of treating a spinal disk according to the present invention can include inserting an alloplastic bulking agent into the spinal disk to treat the defect. The alloplastic bulking agent has a plurality of microparticles. The bulking agent results in at least one of sealing the defect, increasing a pressure of the disk, increasing a height of the disk, improving stability of the disk and improving structural integrity of the disk.

Abstract: A device and method for providing antimicrobial activity around a surgical implant. Antimicrobial activity is provided by the inclusion of a highly conductive material to a surgical implant and providing a low electrical charge to the implant. Electrical charge is provided by a static generator or battery attached to the implant or attached via electrical leads.

Abstract: Bone fixation devices, assemblies, and methods are provided. An expandable bone fixation implant can be implanted into a patient and attached to an underlying bone via a percutaneous or alternative fixation procedure in order to provide fixation and stabilization of the underlying bone.

Abstract: A flexible, bendable organic decalcified or partially decalcified bone, cortical or cancellous, adapted for use in augmentation or repair of animal skeletal structures comprising a continuous plate or sheet of natural bone, as well as dermis is described. The thickness, flexibility and tensile strength of the construct is such as to allow it to be shaped and contoured without damage to it. The composition is ultimately remodeled by the body, thus obviating the need for additional surgical intervention. The clinical indications for the use of the invented construct are many, but are particularly prominent in dentistry, oral and maxillofacial surgery and implantology. It is particularly useful in the maxillary sinus augmentation. A unique new method, different from previously described methods for the preparation of the disclosed constructs, is described.

Abstract: The invention relates to novel internal fixation devices, such as bone plates, generally and novel craniomaxillofacial bone plates more specifically and systems for bonding the same. More specifically, the invention relates to bone plates made of a polymer blend of (poly)lactic acid and Ecoflex as well as a novel hot-melt adhesive polymer blend of the same material.

Abstract: Methods of reducing device drag on implantable articles are disclosed herein. The methods include coating the contact surfaces of implantable articles with bioabsorbable lubricating coatings.

Abstract: An implantation device for fixating a bone has a main body. The main body has a peripheral region and comprises a polymeric material. The peripheral region comprises the polymeric material and a plasticizer. In particular, the peripheral region may be adapted to be fixed to a bone. A method for producing the implantation device includes the steps of forming an implantation device using polymer material, and dipping at least a portion of the implantation device into a plasticizer in such a way that a peripheral region of the implantation device is plasticized.

Abstract: A prosthetic device having a generally fixed member formed from a low friction material such as ultra-high molecular weight polyethylene and an articulating titanium member, which includes an articular bearing surface. The articular surface is a zirconium oxide layer formed by applying a coating of zirconium onto the titanium member and heating this in an oxygen-containing environment. This causes the zirconium to oxidize and further causes the zirconium to migrate into the titanium member forming a titanium zirconium diffusion layer, which prevents delamination.

Abstract: Bone repair materials are disclosed, from which ions are hardly eluted in living body and which are superior in apatite-forming ability and resistance to apatite peeling and have a scratch resistance high enough for practical use. The material comprises a substrate made of titanium or titanium alloys, and a surface layer, made substantially of titanium oxide, along the surface of the substrate. The substrate has on the surface thereof irregularities of from 1 nm to 10 ?m in average in both width and depth. The layer has a zeta potential of +4.5 mV or more under an aqueous solution environment of pH 6 to 8, and a critical scratch resistance of 35 mN or more when vibration 100 ?m in amplitude is added to a stylus with a spring constant of 200 g/mm on the surface layer and the stylus is moved at a rate of 10 mm/sec under a load increasing at a rate of 100 mN/min.

Abstract: Silver and/or zinc ion releasing implants, systems and method of operating, inserting and activating/inactivating them are described. In some variations the implant is configured as a bone implant that includes a bone-screw or intramedullary rod like body configured to receive a treatment cartridge having a plurality of ion-releasing members configured as an anode that can controllably engage with a catheter to turn galvanic release of ions on/off as desired. These devices may be configured to release silver ions (and/or zinc ions) above a predetermined level for a predetermined period of time and may maintain a concentration of ions over a relatively large volume of tissue. The ion-releasing members may be configured to reduce or prevent implant movement.

Abstract: A bone plate system is disclosed which includes a bone plate having at least one plate hole, at least one pin adapted to be disposed in the at least one plate hole, and a polymer component disposed between the at least one pin and the bone plate. The polymer component includes a polymer that may be melted through the application of ultrasonic energy. The at least one pin is constructed of a material that will not melt under such application of ultrasonic energy. The re-solidified polymer component creates a bond between the at least one pin and the bone plate to provide a more rigid and secure mating therebetween, and to at least substantially prevent backout of the at least one pin with respect to the bone plate. A method of implanting the bone plate system is also disclosed.

Abstract: A including a selectively applied bone growth promoting agent is disclosed. The types of spinal fixation systems which may include a selectively applied bone growth promoting agent include systems comprised of rods, plates, screws, and hooks as well as other types of prostheses.

Abstract: Implants, such as interbody spacers, fusion devices and bone grafts, are provided having improved mechanical properties and/or degradation profiles. Such implants include a three-dimensional scaffold formed from particles, such as microspheres, which may in some embodiments be resorbable or biodegradable and which may have at least two different degradation rates. In some embodiments, the scaffold may be elastomeric. The three-dimensional scaffold may be for example, porous or semi-porous. Also provided are kits including such implants, and methods of producing and using the same.

Abstract: A bone void filler material, including a hydrogel component provided by microparticulates of pre-set hydrogel material dispersed within a carrier component to maintain the microparticulates substantially proximate to one another so that the resulting fill material is rendered as a substantially flowable mass.

Abstract: An implant system includes a fixation device that, in turn can include an expandable implant alone or in combination with an auxiliary implant. The expandable implant includes an expandable implant body that is made from an expandable material. The expandable material includes a polymer matrix and an expandable gas source contained within at least a portion of the polymer matrix. The implant system can further include an energy source configured to heat the polymer matrix to a temperature above its glass transition temperature, thereby causing the gas source to expand inside the polymer matrix. The fixation device can further include an insertion instrument configured to implant the fixation device into an anatomical cavity.

Abstract: Orthopedic implants having improved strength and imaging characteristics are provided. The implants can comprise an inner core member that is encased at least in part by an outer encasing member. The inner core member can be formed of a first material that imparts improved strength to the implant, while the outer encasing member is formed of a second material that imparts improved imaging characteristics to the implant. Alternatively, the implants can include a single-piece member formed of a first material that is coated by a coating layer of a second material.

Abstract: Systems and methods are disclosed for the treatment of a target tissue by directionally delivering energy and/or bioactive materials to achieve a therapeutic effect. A balloon catheter system having a balloon portion and a plurality of electrodes may be energized to selectively deliver energy, bioactive materials, or a combination thereof to target tissue including tissues disposed about a lumen. The tissue may be targeted by applying energy, making tissue impedance analysis, and further selectively energizing electrodes through the use of an energy source with a controller.

Abstract: An orthopedic screw is used in a fixation device for treating fractures. The device has a body with holes to accept the bone screws. The bone screws have a layer of bioresorbable material on the shaft. Engagement between the bone screws and the body is initially through the bioresorbable material, which engagement rigidly fixes the relative angular orientation between the bone screws and the body when the device is applied to a bone. As the bioresrobable material is resorbed the angular relation between the bone screws and the body is no longer rigidly fixed, thereby effecting a transformation from rigid osteosynthesis to flexible osteosynthesis to allow micromotion between the bone fragments which promotes healing.

Abstract: The present invention relates to an X-ray visible medical device comprising a medical device and a layer bound onto the medical device, wherein the layer is composed of an X-ray contrast material or a composite of the X-ray contrast material and a biocompatible polymer. Also disclosed is a method for preparing the X-ray visible medical device.

Abstract: The invention relates in general level to a method for coating articulating surfaces of medical products. The invention also relates to coated medical products manufactured by the method. The coating is carried out by employing ultra short pulsed laser deposition wherein pulsed laser beam is preferably scanned with a rotating optical scanner including at least one mirror for reflecting the laser beam. The invention has several both industrially and qualitatively advantageous effects such as high coating production rate, excellent coating properties and overall low manufacturing costs.

Abstract: The subject matter of the invention is a load carrier for a bone fixation system, with a locally varying material strength with unchanging material elasticity, and a method for producing such a load carrier. The load carrier, matched in view of the load flow acting on the fixation system, can also be used in critical anatomical regions, e.g. for hand implants.

Abstract: Implants having improved mechanical properties and/or degradation profiles, kits including such implants, and methods of producing and using the same.

Abstract: An implant (4) is provided with attachment and hole-insert parts (2, 3) with surfaces which have different degrees of finishing and/or degrees of roughness and/or porosities (2f, 2g). Arranged on the surfaces there is at least one dozen (A-B) in which the degree of finishing and/or the degree of roughness and/or the porosity is continuously changed. The changes in porosity in said zones can mirror continuous or discontinuous changes in the bone in question, for example the jaw bone or tooth bone. The continuously changed zones can be obtained with the aid of electrolyte (15) and, connected to the latter, an anode and cathode arrangement (13, 14). When establishing the porosity, it is possible to mask different portions of the respective implant and to control the temperature of the implant.

Abstract: The invention provides a connecting rod for bone anchors such as pedicle screws. The rod is constructed to include a main shaft portion that is not bioresorbable and a tip portion that is bioresorbable. The tip facilitates percutaneous insertion into a patient's body. After placement of the rod, the bioresorbable tip is resorbed preventing post-operative complications such as impingement of adjacent spinal facet joints.

Abstract: The present disclosure is directed, at least in part, to a method of producing ceramic layers on magnesium and its alloys, a magnesium implant with a ceramic layer made by the method, and a magnesium implant having a biocompatible ceramic layer substantially free of material which impairs the biocompatibility of said biocompatible ceramic layer.

Abstract: A method of treating a spinal disk according to the present invention can include inserting an alloplastic bulking agent into the spinal disk to treat the defect. The alloplastic bulking agent has a plurality of microparticles. The bulking agent results in at least one of sealing the defect, increasing a pressure of the disk, increasing a height of the disk, improving stability of the disk and improving structural integrity of the disk.

Abstract: Surgical fasteners that combine mechanical and osteogenic means of fixation to maximize in vivo stability and long-term performance. The fastener generally includes a head and a shaft. The fastener is fenestrated and includes a channel that leads into one or more openings along the shaft. Bone void filling materials is delivered through the channel to the shaft to improve anchoring. In one embodiment, the osteogenic means comprise a coating applied to the fastener to improve bony apposition. The fastener with combined mechanical and osteogenic means provides initial, immediate anchoring and long term anchoring.

Abstract: A spinal implantable device may include composite material comprising matrix including PEEK. The PEEK matrix may be reinforced with carbon fibers that amount to at least 60% of the composite material. The carbon fibers are arranged in a substantially parallel arrangement and compressed in a direction perpendicular to a longitudinal direction of the carbon fibers.

Abstract: Spinal stabilization mechanisms act to prevent lateral bending, extension, and rotation across adjacent vertebrae. Methods for spinal stabilization includes placing one or more anchors at each vertebral level, positioning one or more sutures around each anchor at each level such that the each suture forms a loop or band around two adjacent anchors, applying tension to the ends of each suture to tighten the suture loop around the anchors and welding overlapping ends of each suture together to form suture bands connecting the anchors and thereby preventing lateral bending, extension, and rotation of the spinal segment. An in-growth component is placed over the anterior portions of the three adjacent vertebrae and the disk space therebetween. An anti-adhesion patch is placed over the in-growth component, anchors and elongate members. The anti-adhesion patch has one or more notches that provide access to at least two of the anchors and a flap extending from between the notches.

Abstract: A spinal fixation system including a selectively applied bone growth promoting agent is disclosed. The types of spinal fixation systems which may include a selectively applied bone growth promoting agent include systems comprised of rods, plates, screws, and hooks as well as other types of prostheses.

Abstract: Continuous processing methods for making absorbable polymeric non-wovens with one or more of the following properties: high burst strength, fine fibers of average diameter from 1 ?m to 50 ?m, and thickness from 10 ?m to 50 mm, have been developed. Improved fiber cohesion is made possible by allowing the fibers of the non-woven to initially remain molten during web collection. In the preferred embodiment, the polymer is a polyhydroxyalkanoate, and in the most preferred embodiment, the polymer comprises 4-hydroxybutyrate. A particularly preferred embodiment is a non-woven of poly-4-hydroxybutyrate or copolymer thereof, wherein the non-woven has a burst strength greater than 0.1 Kgf, wherein the non-woven is derived by a continuous melt-blown process. The non-wovens can be used for a variety of purposes including fabrication of medical devices.

Abstract: An abrading device including an advanced burr and appliqué for a burr and a new process for making cutting tools for fine material removal applications such as in bone and tissue surgeries. An appliqué sheet is first engineered by CAD with an abrading surface having cutting facets. The appliqué is attached to a surface of a tool blank and then metallurgically bonded and coated by the BRAZOL® or Co—P process. The tool blank has a proximal shank attachable to a driver and a distal surface to which the appliqué is affixed. Since each facet is attached to surrounding facets and then strongly bonded to the tool, the facets do not dislodge when used to abrade a surface of an object. The BRAZOL® or Co—P coating imparts excellent wear resistance and lubricity to the cutting facets. This results in excellent operational and material removal characteristics. This approach to making surgical and fine industrial tools offers engineered flexibility in design rather than process dependent designs.

Abstract: Bioabsorbable coatings for bioabsorbable implantable medical devices having dragging or engagement surfaces. The coatings on a surface of the devices reduce device drag.

Abstract: The present invention relates to a bone implant device, particularly for dental and orthopedic prosthesis on the vertebral column, having a quicker osteo-integration compared to the prior art devices. Particularly, the present invention relates to an implant device, of metal or polymer nature, a layer of hyaluronic acid being chemically bound on the surface thereof, for use in applications in contact with the bone, with activity of stimulating the bone tissue growth, as well as a process for preparing the same.

Abstract: An implantable article including a biocompatible substrate and a bioactive strontium-substituted calcium phosphate ceramic apatite coating chemically bonded to at least a portion of the surface of the biocompatible substrate, wherein the strontium-substituted calcium phosphate ceramic apatite coating includes nanopores, nanocrystals and strontium ions, and includes a hexagonal crystal structure of apatite having a molar ratio of strontium ions to calcium ions of about 0.0001 to about 0.5, and the strontium ions inhibit bone resorption in vitro and enhance bone formation in vivo so that the implantable article exhibits enhance fixation and bone ingrowth in and around the implantable article.

Abstract: An embodiment of the invention includes a method of fastening together two tissue portions. The method may include positioning a medical device adjacent a region of tissue having two tissue portions. The medical device may include a male member and a female member having a first bioabsorbable material overlying one of a non-bioabsorbable material and a second bioabsorbable material. The first bioabsorbable material may have a first degradation rate, and the second bioabsorbable material may have a second degradation rate slower than the first degradation rate. The method may also include inserting the male member inside the female member so as to inhibit withdrawal of the male member from the female member with the two tissue portions between the male member and the female member.

Abstract: The invention describes a surgical implant that is equipped to provide neurological data during and after implantation. Neurological monitoring ensures accurate insertion of the implant with minimal disturbance of neural structures. The implant includes at least one electrically conductive region that is utilized to determine the distance from and direction to a nerve with respect to the implant.

Abstract: The present invention relates to a new composition and medical implant made therefrom, the composition comprising a thick diffusion hardened zone, and preferably further comprising a ceramic layer. The present invention relates to orthopedic implants comprising the new composition, methods of making the new composition, and methods of making orthopedic implants comprising the new composition.

Abstract: An intervertebral disc device is provided to support or repair one or both of the disc annulus and the disc nucleus. The intervertebral disc device includes an annulus support and an elongated member to support the disc nucleus. The disc annulus support has an elongated wire and an annulus closure. The disc nucleus has an elongated member that is expandable. Any of the devices can be loaded with biologics. Moreover, any of the devices may include a scarring factor to promote fibrous growth.

Abstract: A fixation device for securing tissue to a bone. The fixation device includes an anchor having a hollow body defining a longitudinal passage, and a plug configured to be received in at least a portion of the passage. The body comprises a cylindrical portion and a tapered tip portion. The cylindrical portion comprises a plurality of thin-walled window covers such that after implantation the window covers are resorbed first relative to other portions of the cylindrical portion for defining a plurality of apertures on the cylindrical portion.

Abstract: A composition comprising an alloplastic injectable suspension for use as a dermal filler comprising a biocompatible and pliable material and a physiologically acceptable suspending agent is provided. A method of making a composition comprising an alloplastic injectable suspension for use as a dermal filler comprising a biocompatible and pliable material and a physiologically acceptable suspending agent, said method comprising admixing a biocompatible and pliable material with a physiologically acceptable suspending agent, is also provided. A method of augmenting soft tissue to provide long-term reduction of a skin defect, said method comprising stimulating collagen beneath the skin defect is further provided.

Abstract: A method of measuring healing strength of bone includes a bone fixation plate (14) implanted at the healing area between bone segments (12). The bone fixation plate (14) includes high aspect ratio material with electric current conduction properties responsive to strain. This method causes an induced, or directly applied, electric current to pass through the high aspect ratio material. Analysis of the change in this current by a series of increasing loads placed on the healing body part indicates what level of load produces strain on the bone fixation plate (14). As healing strength increases, evidence of strain on the bone fixation plate (14) occurs at a greater load. Physicians determine thereby the strength of bone healing and safe levels of activity for patients while bone healing progresses.

Abstract: A bone anchor including a bone engaging element and an implant engaging element. The bone engaging element includes a first portion formed of a first material and a second portion formed of a second material and extending at least partially along a length of the first portion, and with the second portion of the bone engaging element positioned between the first portion and adjacent bone tissue when the bone engaging element is engaged with the bone to provide an interface with the adjacent bone tissue. In one embodiment, the first portion of the bone engaging element exhibits a first level of rigidity and the second portion exhibits a second level of rigidity less than the first level of rigidity. In another embodiment, the bone engaging element includes external threads, with the second portion of the bone engaging element defining at least a portion of the external threads.

Abstract: The present invention relates to a percutaneous implant abutment for bone anchored implant devices adapted to be anchored in the craniofacial region of a person, such as bone anchored hearing aids. The abutment comprises a skin penetration body having a skin contacting surface. The skin contacting surface has been modified.

Abstract: A pre-configured implant cover fabricated from a drug-eluting biocompatible matrix containing at least one elutable drug, a kit containing at least one elutable drug implant cover, and a method of using the same.

Abstract: A bone screw includes a head portion and shank portion. The shank portion includes a regularly outwardly expanding threaded portion.

Abstract: An implant to be fastened to a tissue, a tool a kit and a method. The implant has a first end, a second end and an elongated shank made at least partly of a first polymer material. The implant comprises a contact surface for receiving external mechanical energy for deforming the shape of the implant such that the shape of the implant can be deformed and locked in the tissue by the effect of said mechanical energy.

Abstract: A covering for delivering a substance or material to a surgical site is provided. The covering, with substance provided therein, may be referred to as a delivery system. Generally, the covering may be a single or multi-compartment structure capable of at least partially retaining a substance provided therein until the covering is placed at a surgical site. In some embodiments, the covering may be configured and sized for receipt by an implant device. Upon placement, the covering may facilitate transfer of the substance or surrounding materials. For example, the substance may be released (actively or passively) to the surgical site. The covering may participate in, control, or otherwise adjust the release of the substance.

Abstract: Endosseous implant to be applied to a human or animal bone, wherein the surface of the implant is made from titanium or a titanium alloy, said implant having a smooth or rough surface texture, which is characterized in that said surface has been treated with at least one selected organic phosphonate compound or a pharmaceutically acceptable salt or ester or an amide thereof; process for producing said implants.