Abstract: A medical implant and a method of implanting a medical implant are described. The medical implant can be elongate and for fixation in a patient, and can include an apical bone anchoring portion for bone apposition, and an unthreaded coronal portion. The coronal portion can have a length (L2) exceeding or equaling a length (L1) of the apical portion. The apical portion can have a maximum outer diameter (D1) that is equal to or larger than a maximum outer diameter (D2) of the coronal portion. In a method of implanting a medical implant, an apical part can be affixed in the zygomatic bone, and a coronal part can be positioned outside the maxilla in the mucous membrane.

Abstract: Biodegradable contraceptive implants and methods of making and using thereof, are preferably formed of poly(?-pentadecalactone-co-p-dioxanone) [poly(PDL-co-DO)], a family of polyester copolymers that degrade slowly in the presence of water. The material is suitable as the basis of a biodegradable contraceptive implant that provides sustained release of a progestin at a rate similar to a commercially available nondegradable implant. In a preferred embodiment, the progestin is levonorgestrel (LNG), a hormone that prevents pregnancy by preventing the release of an egg from the ovary or by preventing fertilization of the egg by sperm. The implant may be inserted subcutaneously, allowing degradation over a period of up to about 18 or 24 months, eliminating the need for removal by a trained practitioner.

Abstract: Stand-alone interbody fusion devices for engagement between adjacent vertebrae. The stand-alone interbody fusion devices may include a spacer and one or more inserts or members coupled to the spacer. The inserts or members may be configured and designed to provide the apertures which are designed to retain bone fasteners, such as screws, and secure the implant to the adjacent vertebrae.

Abstract: An ultrasonic osteotome bit, comprising a bit body (1), a bit bar (2) and a bit tip (3). One end of the bit bar (2) is connected to the bit tip (3), and the other end of the bit bar (2) is connected to the bit body (1). The bit tip (3) is of a prism or substantially prism structure with the cross section of a polygonal structure, and the bit tip (2) has at least two cutting faces of different cutting widths. The bit is provided with a liquid flow hole (41), and the bit tip (3) is provided with a knurled structure that extends from a foremost end face of the bit tip (3) towards the bit bar (2) to form a file-type bit. The ultrasonic osteotome bit not only meets the requirement of a surgeon for the accuracy of bone cutting width, but also saves the time required to replace bits of different widths, thereby improving the surgical efficiency.

Abstract: A device for facilitating the formation of new bone tissue includes a body that defines an upper portion and a lower portion, the lower portion having a substantially frustum-like shape, the upper portion having a substantially cylindrical shape. The lower portion is adapted to be inserted into the medullary canal of a bone.

Abstract: Medical devices are disclosed. For example, a medical device includes an elongated member. The medical device includes a hole forming surface along a portion of the elongated member. The medical device includes an open cell element in physical communication with the elongated member. The open cell element is configured to house at least a first portion of a biocompatible substance.

Abstract: Provided is a system and method for providing a non-binding allograft subtalar joint implant for surgical implant into a person's foot proximate to the ankle. This system for repair includes at least one sterile non-binding allograft subtalar joint implant provided as a pre-formed allograft rod plug “ARP” having a diameter about equal to an average width of a canal between a person's talus and calcaneus bones, the ARP being resiliently compressible and flexible. When snuggly disposed between the person's talus and calcaneus bones, the ARP compresses during normal use of the person's foot and maintains the canal in an anatomically correct alignment and reduces a tendency for abnormal motion between the person's talus and calcaneus bones. An associated method of use is also provided.

Abstract: A tendon repair implant delivery system and methods incorporating a guide member having a temporary fixation member on or adjacent to the distal end. The point of fixation defines a target site for placement of the tendon repair implant which is subsequently affixed to the tendon.

Abstract: A subtalar implant for arthroereisis of the talocalcaneal joint. The implant is intended to be inserted into the talocalcaneal joint via its lateral orifice and has an oblong shape that extends longitudinally along an axis of insertion of the implant. The implant includes: a head with the shape of a cone of revolution centred on the axis of insertion; an anchoring thread; and a rod having the shape of a cylinder of revolution. The rod has, on its surface, the anchoring thread and being configured to be inserted up to the axis of rotation of the talocalcaneal joint. The head has, on its radially outer surface, a retaining element for retaining the implant in rotation about the axis of insertion, the retaining element exerting retention against a colonising tissue.

Abstract: A radial head trial device for replacement of a proximal radial head includes a stem component having a center longitudinal axis extending between a proximal end and a distal end, a head component axially and removably attachable to the stem component, wherein the head component is interchangeable with a selection of other head components each axially and removably attachable to the stem component, an anti-rotation feature, and a recess, wherein the anti-rotation feature is structured to be received in the recess to prohibit rotation of the head component relative to the stem component.

Abstract: An exemplary surgical staple may include a base including a first end and a second end; a single tine extending from the second end of the base; and a barb extending from the base at a location between the first end of the base and the second end of the base. An end of such a staple may be frangibly affixed to a feeder belt. Another exemplary surgical apparatus may include at least one staple including a base including a first end and a second end, a first tine extending from the second end of the base, and a second tine extending from the base at a location between the first end of the base and the second end of the base.

Abstract: An implant system includes a first portion, a second portion, and a third portion. The first portion includes a hydrogel. The second portion includes a porous material and the hydrogel in pores of the porous material. The third portion includes the porous material. The first portion is free of the porous material. The third portion is free of the hydrogel. Methods of making and using the implant system.

Abstract: A biodegradable polymeric stent made from poly(L-lactide) and a low concentration of L-lactide monomer is disclosed. The concentration of L-lactide is adjusted to provide a degradation behavior that is suitable for different treatment applications including coronary, peripheral, and nasal.

Abstract: A medical implant comprising a composite material which is composed of reinforcement fibers made of a magnesium-containing, bio-corrosive alloy, another bio-corrosive alloy containing a main component that is selected from the group consisting of Mg, Ca, Fe, and Y, or a non-biodegradable fiber material, embedded in a matrix made of crystalline magnesium or magnesium alloys.

Abstract: An osteotomy implant including a porous portion, a solid portion, and a hinge portion. The porous portion includes a first part and a second part that defines a clearance therebetween. A solid portion abuts the porous portion. A hinge portion of the solid portion is coupled to the first part and the second part. The hinge portion is configured to enable the implant to be changed from a first configuration to a second configuration.

Abstract: A multi-layer osteogenic, osteoconductive and/or osteoinductive carrier device or system for applying an osteoinductive substance to a bone surface, and methods for making and using said carrier are disclosed. The multi-layer osteogenic carrier device can comprise a delivery layer comprising a porous material and an osteogenic material; and a support layer in communication with the delivery layer, the support layer capable of substantially conforming to an anatomical feature, wherein the support layer can hold the delivery layer in proximity to the anatomical feature. The multi-layer osteogenic carrier device can further comprise an adhesive layer capable of adhering the carrier to at least a portion of an anatomical feature, the adhesive layer in communication with at least a portion of the delivery layer. The carrier can be applied to and compressed to conform to the decorticated bone of a fusion site and kept in place by a rod clip attached to a spinal stabilization system.

Abstract: Coatings for an implantable medical device and a method of fabricating thereof are disclosed, the coatings comprising polymers of lactic acid.

Abstract: A method for producing a medical implant, such as a bone screw, a bone nail, a bone pin, a plate, a suture anchor, etc. for fastening soft parts, such as tendons, muscles, and ligaments, to a bone, or in the form of an endoprosthesis or at least a part thereof, from a magnesium alloy having a magnesium fraction of at least 80 wt %, in particular of at least 90 wt %, including the following steps: a) melting the magnesium alloy to obtain an alloy melt, b) atomizing the alloy melt under a protective-gas atmosphere and cooling the atomized alloy melt to below the solidification point thereof in order to obtain an alloy powder, c) shaping the alloy powder by pressing to obtain an alloy green body, d) extruding the alloy green body to obtain a magnesium alloy molded part, and e) producing the medical implant from the magnesium alloy molded part.

Abstract: A bone replacement filler comprising a biomedical ceramic particulate, wherein the filler is able to flow without the application of an external shear stress or compressive force or under a relatively low shear stress or compressive force, but resists flow or does not flow when subjected to a higher shear stress or compressive force, and wherein at least some of the particles in the ceramic particulate have a micro-porous surface structure and/or a micro-porous sub-surface structure.

Abstract: Absorbable polyester fibers, braids, and surgical meshes with prolonged strength retention have been developed. These devices are preferably derived from biocompatible copolymers or homopolymers of 4-hydroxybutyrate. These devices provide a wider range of in vivo strength retention properties than are currently available, and could offer additional benefits such as anti-adhesion properties, reduced risks of infection or other post-operative problems resulting from absorption and eventual elimination of the device, and competitive cost. The devices may also be particularly suitable for use in pediatric populations where their absorption should not hinder growth, and provide in all patient populations wound healing with long-term mechanical stability. The devices may additionally be combined with autologous, allogenic and/or xenogenic tissues to provide implants with improved mechanical, biological and handling properties.

Abstract: A method of supporting a defect in the tissue of a living being includes the steps of: a) providing a delivery instrument that includes an elongated instrument, at least one barrier element, and a plurality of connecting members; b) inserting the elongated instrument into the tissue at or near the defect; c) deploying the barrier element from the delivery instrument into tissue at or near the defect, the barrier element having at least one connecting member attached thereto; d) extending at least one passage means from the delivery instrument; e) engaging at least a portion of the at least one connecting member with the at least one passage means, whereby the at least one passage means causes the at least one connecting member to pass through the tissue, and f) withdrawing the elongated instrument from the tissue, thereby deploying and securing the barrier element to support the tissue.

Abstract: An osteosynthesis device that is both resorbable and radiopaque, produced using gradually degrading materials, includes at least one plate and a set of screws made of resorbable material, in which the plate consists of a composite mixture including i) a resorbable polymer or copolymer compound and ii) an inorganic filler that consists of at least one resorbable ceramic. The screws can be made of resorbable polymer, or of a composite mixture with at least one resorbable ceramic. The device is totally resorbable and radiopaque, and it offers a high level of safety, ensuring a strong and durable fixation of the screws to the plate and in the bone during the entire period needed for bone uniting.

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: A method for producing a medical implant, such as a bone screw, a bone nail, a bone pin, a plate, a suture anchor, etc. for fastening soft parts, such as tendons, muscles, and ligaments, to a bone, or in the form of an endoprosthesis or at least a part thereof, from a magnesium alloy having a magnesium fraction of at least 80 wt %, in particular of at least 90 wt %, including the following steps: a) melting the magnesium alloy to obtain an alloy melt, b) atomizing the alloy melt under a protective-gas atmosphere and cooling the atomized alloy melt to below the solidification point thereof in order to obtain an alloy powder, c) shaping the alloy powder by pressing to obtain an alloy green body, d) extruding the alloy green body to obtain a magnesium alloy molded part, and e) producing the medical implant from the magnesium alloy molded part.

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 method of performing a surgical anterior extradiscal correction of a thoracolumbar pathology includes steps of surgically approaching a patient's spine and correcting a thoracolumbar pathology, aligning adjacent vertebral bodies, and securing the vertebral bodies in a desired relative position with anterior instrumentation that penetrates at least one of the vertebral bodies. The anterior instrumentation includes a bioabsorbable element and in one embodiment includes first and second bioabsorbable anchors for penetrating anterior portions of respective first and second sacral, thoracic or lumbar vertebral bodies and bioabsorbable instrumentation that fixedly connects the first bioabsorbable anchor to the second bioabsorbable anchor. This permits the first sacral, thoracic or lumbar vertebral body to be surgically fixed to the second sacral, thoracic or lumbar vertebral body for a predetermined period of time, when the bioabsorbable apparatus will be absorbed by a patient's body.

Abstract: A method for utilizing an implant in a human breast includes forming a breast cavity within the breast at a lumpectomy site, the breast cavity having surrounding tissue; forming a substantially radio-opaque implant constructed of biocompatible and biodegradable material configured to allow for in-growth of fibrous tissue into and replacing the biocompatible and biodegradable material, the biocompatible and biodegradable material being elastically compressible; sizing the substantially radio-opaque implant to occupy the breast cavity; and implanting within the breast cavity the substantially radio-opaque implant to support the tissue surrounding the breast cavity, the step of implanting including compressing the biocompatible and biodegradable material.

Abstract: A device for temporarily splinting toes, especially for the treatment of hammertoes and other defective positions of toes, consisting of a tube composed of a bio-absorbable material and a guide wire. The tube has an inner diameter of d, whereas the guide wire has an external diameter D, such that D<d. The device enables contact between the ball of the toe and the floor to be reestablished.

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: Echogenic medical devices, methods of fabrication and methods of use are disclosed. The device can be adapted to be inserted into a patient. The echogenic construction can be incorporated into the device at the time of fabrication providing acoustic impedance different from that of the surrounding biological tissue or fluid. The medical device is designed for use with an ultrasound imaging system to provide real-time location of the insertion and guidance at the time the device is implanted in a patient, such as in brachytherapy. Following placement of the device the position can be evaluated over time to insure the device remains in proper alignment and functional. Furthermore, the device is designed to incorporate a spacer element at one or both ends to provide separation between radioactive elements.

Abstract: A method of partial breast radiation therapy includes placing within a breast cavity a substantially radio-opaque implant constructed of biocompatible material, said substantially radio-opaque implant supporting the tissue surrounding the breast cavity; and directing a radiation beam to said substantially radio-opaque implant serving as a target for delivery of radiation therapy to margins around the breast cavity, such that the radiation beam does not materially irradiate the whole of the breast.

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: A bone anchor is provided that can toggle in two planes for secure anchorage within a bone cavity. The bone anchor includes an oblique suture channel configured such that a suture strand extending through the bone anchor can be tensioned to toggle the bone anchor inside the bone cavity. The suture strand can be located on the same side of the anchor body to maximize the area of the anchor surface which engages bone, resulting in increased engagement into bone and resistance to tensile forces.

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: A constraining apparatus includes a constraining structure that captures a first and a second anatomical structure. A motion limiting member coupled with the constraining structure is adapted to provide a force resistant to relative movement of the first anatomical structure away from the second anatomical structure. A regulating member is detachably coupled with the motion limiting member or the constraining structure and is adapted to change the resistant force provided by the motion limiting member when the regulating member is in direct engagement with the motion limiting member or constraining structure.

Abstract: A device is formed by a discontinuous process into a bone screw, plate, or fastener, wherein the device has a degree of polymer alignment and strength, and upon reheating above glass transition temperature of the polymer, the device remains dimensionally stable, as it maintains its dimensions, strength, and degree of polymer orientation. In practice of the present invention, the polymer slug is pressed into the die cavity by the actuation of ram press, causing the slug to conform to the die cavity.

Abstract: A novel method of partial breast radiation utilizing a breast implant which can provide a stable and improved target for stereotactic radiation treatment.

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

Abstract: Controlled release of biopharmaceutical growth factors from a hydroxyapatite coating on a bioresorbable interference screw used in cruciate ligament reconstruction surgery on a human. Biologically active scaffolds, such as interference bone screws used for ligament fixation, made by growing calcium phosphate-based hydroxyapatite coatings on bioresorbable poly(?-hydroxy ester) scaffolds that provide controlled mineral dissolution and controlled release of bone morphogenetic protein-2. The biologically active scaffold provides improved bioavailability of BMP-2 growth factor that in turn provides enhanced graft-bone healing in the tibial bone tunnel. The coating method uses surface hydrolysis and modified simulated body fluid incubation which does not require solvent or heat and is conducted at room temperature.

Abstract: The present invention provides a method of producing polyalkylene terephthalate, which comprises: introducing a prepolymer of polyalkylene terephthalate that is in a molten state comprising 70 mol % or more of ethylene terephthalate or 1,4-butylene terephthalate repeating units and having an intrinsic viscosity [?] between 0.2 and 2 dl/g through a feed opening to a polymerization reactor; discharging the introduced prepolymer from holes of a perforated plate; and polymerizing the prepolymer under reduced pressure, while allowing the prepolymer to fall along the surface of a support that is open towards the outside at a temperature between the [crystalline melting point?10° C.] of the prepolymer or higher and the [crystalline melting point+30° C.] of the prepolymer or lower under the conditions represented by a formula S1/S2>1, wherein S1 is the surface area of falling polyalkylene terephthalate, and S2 is the area where the support is in contact with polyalkylene terephthalate.

Abstract: Biological-based polyurethanes and methods of making the same. The polyurethanes are formed by reacting a biodegradable polyisocyanate (such as lysine diisocyanate) with an optionally hydroxylated biomolecule to form polyurethane. The polymers formed may be combined with ceramic and/or bone particles to form a composite, which may be used as an osteoimplant.

Abstract: A method of manufacturing biodegradable/bioresorbable tissue augmentation/reconstruction devices by defining material density distributions at selected time points during a material degradation lifecycle. These different density distributions are then superposed using general linear and/or nonlinear functions that could include both time and degraded base stiffness weighting factors. The material density distribution may be created using topology optimization, image-based design or computed aided design methods to create a degradable device that retains sufficient physical properties (ie modulus, strength, electrical conductivity, thermal conductivity) through the material degradation lifecycle process. Thus, any bulk degrading material can be designed using this process for any tissue augmentation/reconstruction application.

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 for fabricating a device for repairing torn tissue or muscle such as the meniscus of the knee. The device includes a pair of anchoring members having a plurality of barb-like projections extending outwardly therefrom. The anchoring members are joined by a flexible linking member which connects the ends of the anchoring members opposite one another. Such a device can be fabricated by insert molding of the appropriate members together.

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: Compounds exhibiting angiogenic properties incorporating the structure of Formula I: R3—NH—NH—C(?O)—R2—P—R1??(I) wherein P is a water-soluble, biodegradable polymer, R1 is hydrogen, lower alkyl, lower alkoxy or —R2—C(?O)—NH—NH—R3; each R2 is independently —CH2—, —NH— or O; and each R3 is independently hydrogen or a residue of a naturally occurring alpha-L-amino acid or dipeptide thereof. Polymer networks crosslinked with hydrazide compounds are also disclosed, together with implantable medical devices incorporating the compounds and crosslinked polymers, and angiogenesis-promoting treatment methods, including wound-treatment methods.

Abstract: Disclosed is a fastener that can be mounted to a bone of a patient and can foreshorten and swell of a desired period of time. The fastener can include a head portion and a body portion extending from the head portion. At least one of the head portion and the body portion has a first width that changes to a second width greater than the first width and collectively the head portion and the body portion have a first length that changes to a second length shorter than the first length upon the head portion and the body portion being exposed to a temperature below a glass transition temperature of a polymeric material forming the head portion and the body portion.

Abstract: A surgical rivet device for the repair of torn menisci and other intra-articular bodily tissues is disclosed in which the device comprises a shaft, projecting fins and a penetration head at one end and a wide rear portion. The device is inserted by a driving mechanism through both sides of the torn meniscus, compressing the tear in the meniscus between the fins near the head and the wide rear portion, holding the tear together. After insertion, the driving mechanism is separated from the rivet, leaving the rivet device in the patient. The rivet device is entirely biodegradable and absorabable by the body.