Abstract: The present invention relates to methods for determining meniscal size and shape for use in designing therapies for the treatment of various joint diseases. The invention uses an image of a joint that is processed for analysis. Analysis can include, for example, generating a thickness map, a cartilage curve, or a point cloud. This information is used to determine the extent of the cartilage defect or damage and to design an appropriate therapy, including, for example, an implant. Adjustments to the designed therapy are made to account for the materials used.

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

Abstract: A magnesium-based medical device which can adjust a degree of corrosion within a wide range of period such that the device can maintain a sufficient strength only during a desired period and disappears within a desired period thereafter and a manufacturing method thereof are provided. A magnesium-based medical device of the present invention is a magnesium-based medical device in which a base material is made of magnesium or a magnesium alloy, wherein a corrosion-resistant film is formed on a surface of the base material, and variation in surface hardness of the formed corrosion-resistant film in the in-plane direction is less than 21 in terms of a dispersion value of Vickers hardness.

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: An implantable medical device is disclosed. The device is fabricated at least in part from a biocompatible, biodegradable composition. The composition is composed of a biocompatible, biodegradable polymer and a biocompatible, biodegradable wax. The concentration of the wax at the surface of the device is greater than the concentration of the wax in the body of the implantable device. The increased concentration of wax at the device surface may be attained when the device is heated to a temperature greater than the melting point of the wax and the glass transition temperature of the polymer, but lower than melting point of the polymer.

Abstract: A medical device for surgical applications including a body. The body includes bioabsorbable basic material and has a longitudinal axis. The body includes an inner region and a peripheral region transverse to the longitudinal axis so that the peripheral region surrounds the inner region. The inner region is made of bioabsorbable basic material and the peripheral region includes the bioabsorbable basic material. The peripheral region includes a bioabsorbable reinforcing structure in addition to the bioabsorbable basic material.

Abstract: A device is formed by the process into a bone screw or fastener, wherein the head has a degree of polymer alignment and strength, and wherein the shank has a higher degree of polymer alignment and strength. 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. Through this process, the polymer molecular orientation is aligned to different degrees, in different zones of the device.

Abstract: A method and apparatus for repairing a bone defect in a cranium includes a frame defining a plurality of openings. The frame may be adapted to generally span the bone defect in an implanted position. Bone-growth promoting material may generally overlap the openings and secured to the frame to cover at least some of the respective plurality of openings. At least one stabilizing member may be attached to the frame for stabilizing the apparatus relative to the cranium.

Abstract: A device is formed by the process into a bone screw or fastener, wherein the head has a degree of polymer alignment and strength, and wherein the shank has a higher degree of polymer alignment and strength. 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. Through this process, the polymer molecular orientation is aligned to different degrees, in different zones of the device.

Abstract: A novel high tensile strength semi-absorbable composite suture with minimized non-absorbable mass. The suture has a core made from a bioabsorbable polymer. The core is covered by a braided sheath. The braided sheath is made from an absorbable yarn and a bioabsorbable yarn. The bioabsorbable yarn is made from a least one filament of a bioabsorbable polymer. The nonabsorbable yarn is made from at least one filament of ultra high molecular weight polyethylene.

Abstract: A novel high tensile strength semi-absorbable composite suture with minimized non-absorbable mass. The suture has a core made from a bioabsorbable polymer. The core is covered by a braided sheath. The braided sheath is made from an absorbable yarn and a bioabsorbable yarn. The bioabsorbable yarn is made from a least one filament of a bioabsorbable polymer. The nonabsorbable yarn is made from at least one filament of ultra high molecular weight polyethylene.

Abstract: Bone graft compositions comprising demineralized bone matrix, calcium phosphate, collagen and bioinductive cellular solution. Methods to repair and heal defective and missing bone using the bone graft compositions are also described.

Abstract: Provided is a method of producing a bioabsorbable, implantable substrate having a graded molecular weight distribution, comprising exposing at least a portion of the implantable substrate to electron beam irradiation. There is also provided a bioabsorbable, implantable substrate comprising a bioabsorbable polymer having a graded molecular weight distribution through at least a portion of its thickness.

Abstract: Star polymers of soft segment forming monomers are useful in forming surgical devices. The star polymers can be endcapped with diketene acetals, mixed with a filler and/or cross-linked. The polymer compositions are useful, for example, as fiber coatings, surgical adhesives or bone putty, or tissue growth substrate.

Abstract: A bioabsorbable, cannulated tissue tack having an oblong head is used in sutureless soft tissue fixation to bone, particularly in arthroscopic shoulder surgery. A plurality of ribs are formed along the shaft of the tack. Repair of the glenohumeral joint is performed by installing the tack through a hole formed through the soft tissue of the labrum and into the cancellous bone of the glenoid rim. Aligning the oblong head of the tack lengthwise along the glenoid rim provides a low profile that avoids articular impingement on the tack head.

Abstract: A surgical implant made of a polymer, copolymer, polymer mixture or polymer composite that dissolves in the organ system. The manufacturing material is dyed with the coloring agent D&C Violet No. 2 or D&C Green No. 6. Preferably, the amount of the coloring agent is at most approximately 0.03 percent by weight and the implant is sterilized by radiation.

Abstract: A fastener for the treatment of fractures and the materials for production thereof. The fastener having a head with a contact portion for an installation tool and an attaching part having a treaded portion. The threads of the threaded portion are 5 to 20 % of the height of the outer diameter of the thread. The material for producing the fastener is a blend containing a biodegradable base material and one or more copolymer additives so that at room temperature the ductility of the blend is substantially higher than that of the pure base material. The base material may be a biodegradable polymer and/or a copolymer.

Abstract: Star polymers of soft segment forming monomers are useful in forming surgical devices. The star polymers can be endcapped with isocyanate, mixed with a filler and/or cross-linked. The polymer compositions are useful, for example, as fiber coatings, surgical adhesives or bone putty, or tissue growth substrate.

Abstract: A screw formed of cortical bone for use in the human body with an implant having a screw hole for receiving at least a portion of a screw therethrough, includes a shaft with a thread along at least a portion of its length. The thread has an outer diameter dimensioned to pass through the screw hole in the implant. The trailing end of the screw is configured to cooperatively engage at least a portion of the screw hole of the implant so as to prevent the screw from linear motion along the mid-longitudinal axis of the shaft in a direction opposite to the direction of insertion when the screw is threaded through the screw hole to attach the implant to a bone portion of the human body. The screw is formed substantially of cortical bone of a single cortical thickness.

Abstract: A device is described for joining a first phalange to a second adjacent phalange, such as the proximal phalange to the intermediate phalange at the proximal interphalangeal joint. The device is a substantially elongated member comprised of a resorbable material, such as, but not limited to polylactic acid, polyglycolic acid, and combinations thereof. The member has a first end portion, a middle portion, and second end portion spaced and opposed from the first end portion. The middle portion has a curvature such that an angle is formed between the first end portion and the second end portion, wherein the angle is substantially anatomically correct with respect to the particular joint, such as the proximal interphalangeal joint.

Abstract: A spine stabilization system includes a flexible member attachable to a portion of the spinal column. The member includes components that are oriented and function similar to the natural fiber orientation of the anterior longitudinal ligament and annulus tissue. The use of components resist loading applied by extension and rotation of the spine, while the flexibility of the member does not subject it to the compressive loading of the spinal column segment to which it is attached.

Abstract: The present invention relates to resorbable glass scaffolds for use in biological applications and methods for making same. Specifically, these scaffolds are composed of phosphate glass fibers, where the rate of dissolution into biological fluids is controlled by the length of time the glass is held above its melt temperature prior to spinning the fiber.

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: 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: 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: 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 orthopedic interference screw has a hard, self-threading front section and a bioabsorbable rear section. The two sections are conjoined and threaded such that the hard front section cuts threads into the bone and the softer rear section follows the threads into the bone. Preferably, the screw has an axial bore for matingly receiving a turning tool such as a hex wrench.

Abstract: A biodegradable fixation element is provided for anchoring a transplant on bone. A rigid body is made of a biodegradable material, said body having an outer side and a hollow interior surrounded by a wall of said body. Numerous perforations are provided in said wall of said body for allowing growth of bone material into said interior of said body via said numerous perforations. It is proposed that the perforations are formed between said anchoring members and said perforations are formed as holes passing through said wall of said body (FIG. 1).

Abstract: A spine stabilization system includes a flexible member attachable to a portion of the spinal column. The member includes components that are oriented and function similar to the natural fiber orientation of the anterior longitudinal ligament and annulus tissue. The use of components resist loading applied by extension and rotation of the spine, while the flexibility of the member does not subject it to the compressive loading of the spinal column segment to which it is attached.

Abstract: A bioabsorbable rivet and pin fastener is formed as an elongated unit that may be used for anchoring, or for attachment of a fixation plate. The rivet has a head mechanically connected to two or more legs that extend generally distally from the head and may flex outwardly from a central rivet axis. The pin is integral with the rivet and oriented along the central axis by a connection such as a web or a plurality of braces, forming an integral, aligned, one-piece assembly that may, for example, be molded as a single piece. The connection breaks under force as the pin is driven into the rivet, so that the pin contacts internal surfaces of the legs and pushes the legs outward into frictional engagement with the surrounding bone. The one-piece assembly may be formed in a gated mold having a central pin with a relief passage that defines the braces between upper and lower portions of the rivet.

Abstract: Biocompatible polyhydroxyalkanoate compositions with controlled degradation rates have been developed. In one embodiment, the polyhydroxyalkanoates contain additives to alter the degradation rates. In another embodiment, the polyhydroxyalkanoates are formed of mixtures of monomers or include pendant groups or modifications in their backbones to alter their degradation rates. In still another embodiment, the polyhydroxyalkanoates are chemically modified. Methods for manufacturing the devices which increase porosity or exposed surface area can be used to alter degradability. For example, as demonstrated by the examples, porous polyhydroxyalkanoates can be made using methods that creates pores, voids, or interstitial spacing, such as an emulsion or spray drying technique, or which incorporate leachable or lyophilizable particles within the polymer. Examples describe poly(4HB) compositions including foams, coatings, meshes, and microparticles.

Abstract: The present invention is directed to an implantable medical device, the device contraining a body and a first lubricated surface for contacting tissue, or a second surface of the device, or a surface of a second medical device, the implantable device fabricated at least in part from a biocompatible, biodegradable composition, the composition containing a biocompatible, biodegradable polymer and a biocompatible, biodegradable wax, wherein the concentration of the wax at the first lubricated surface of the implantable device is greater than the concentration of the wax in the body of the implantable device, and to methods of making the device wherein the device is heated to a temperature greater than the melting point of the wax, greater than the glass transition temperature of the polymer, and lower than melting point of the polymer, thereby providing the lubricated surface.

Abstract: One aspect of the present invention is a connective tissue distraction device comprising: a first transmitting structure for transmitting force to a first tissue region and a second transmitting structure for transmitting force to a second tissue region by contact with bone, and an expansion device for exerting force distracting the first transmitting structure from the second transmitting structure. At least one of the first transmitting device, the second transmitting device and the expansion structure comprises in whole or in part a biodegradable, bioerodible or bioresorbable material.

Abstract: The present invention relates to methods for determining meniscal size and shape for use in designing therapies for the treatment of various joint diseases. The invention uses an image of a joint that is processed for analysis. Analysis can include, for example, generating a thickness map, a cartilage curve, or a point cloud. This information is used to determine the extent of the cartilage defect or damage and to design an appropriate therapy, including, for example, an implant. Adjustments to the designed therapy are made to account for the materials used.

Abstract: The present invention relates in general to implantable, resorbable copolymers containing L-lactide and glycolide repeat units, and in particular to terpolymers containing L-lactide, glycolide, and one other type of repeat unit selected from the group consisting of D-lactide, D,L-lactide, and &egr;-caprolactone. Medical devices for in vivo implantation applications containing such implantable, resorbable copolymers are also described, as well as methods for making such copolymers and devices.

Abstract: Polymer compositions comprising poly-glycolic acid (PGA) or a functional derivative thereof with a tensile strength of at least 1200 MPa are disclosed. Processes suitable for manufacturing said compositions are also described, comprising rendering PGA into an amorphous state then drawing to form a highly orientated polymer structure. The polymer compositions can be used to make artefacts, for example sutures, or used in combination with other polymers or non-polymeric substances to produce other artefacts, for example medical devices suitable for implantation into the human body. Processes for the production of said artefacts are also described.

Abstract: The present invention relates to a method for coating a medical implant, wherein the implant is submersed in an aqueous solution of magnesium, calcium and phosphate ions through which a gaseous weak acid is passed, the solution is degassed, and the coating is allowed to precipitate onto the implant. The invention further relates to a medical implant coated in said method and to a device for use in said method.

Abstract: Disclosed is an artificial vertebra having a bone-marrow regenerating function, comprising a hydroxyapatite (HAp)/collagen (Col) composite body formed by pressure-dehydrating a coprecipitate of hydroxyapatite and collagen to have a nanocomposite structure in which HAp particles are conjugated along a Col fiber while aligned each of the c-axes of the HAp particles along the Col fiber. The HAp/Col composite body is formed with a perforated aperture for allowing a blood vessel and an osteogenic cell to intrude thereinto. The present invention also provides a biodecomposable/bioabsorbable support for fixing an artificial vertebra, comprising a polylactic acid plate prepared by injection-molding molten polylactic acid and then extrusion-molding the injection-molded polylactic acid in such a manner that it is draw-oriented in a uniaxial direction. The plate has four corner regions each formed with a screw hole for fixing the plate to vertebral bodies.

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: A clip to interconnect primary and secondary bone zones having edges, comprising in a first tab to extend over a surface of the secondary bone zone, above a level defined by that surface, and an extension of the tab projecting below the level, and a first projection carried by the extension for penetrating the primary bone zone below the first level, and the extension having bowed configuration, to enable forcible driving of the projection, to effect penetrating.

Abstract: A fully biodegradable fibre reinforced composite adapted for use as a medical implant which is shaped and processed by means of a resin reaction injection transfer molding process adapted for predetermining shape, physical properties and degradation profile, shaped preform and/or composition for preparation of the shaped composite, process for the production of the shaped composite comprising obtaining a shaped preform and impregnating with resin with simultaneous processing thereof, shaped composite comprising thermoplastic matrix and fibres adapted for use as a medical implant, characterised by a differential degradation of matrix with respect to fibres adapted to degrade via an intermediate shaped structure comprising residual porous matrix or residual fibre form respectively and selection of composite is made for primary growth of a preferred cell type, throughout voids created by degraded matrix or fibre respectively, according to the desired healing or reconstruction locus, the shaped composites for use

Abstract: The present invention relates generally to body tissue fixation systems, including body tissue fixation hardware comprising biocompatible, bioabsorbable (resorbable) thermoplastic plates, and methods of using those systems and hardware.

Abstract: A clip to inter-connect primary and secondary bone zones having spaced apart edges, comprising in combination two clip sections, and a first tab to extend over a surface of the secondary bone zone at a first level, the first tab carried by one of the sections; a projection to anchor the other clip section to the primary bone zone, and a tab extension projecting below the first level, and having at least one through opening to receive a the projection for penetrating the primary bone zone below the first level.

Abstract: A spine stabilization system includes a flexible member attachable to a portion of the spinal column. The member includes components that are oriented and function similar to the natural fiber orientation of the anterior longitudinal ligament and annulus tissue. The use of components resist loading applied by extension and rotation of the spine, while the flexibility of the member does not subject it to the compressive loading of the spinal column segment to which it is attached.

Abstract: A surgical implant made of a polymer, copolymer, polymer mixture or polymer composite that dissolves in the organ system. The manufacturing material is dyed with the coloring agent D&C Violet No. 2 or D&C Green No. 6. Preferably, the amount of the coloring agent is at most approximately 0.03 percent by weight and the implant is sterilized by radiation.

Abstract: This invention provides a biodegradable and bioabsorbable implant material having a high mechanical strength wherein its shape after deformation within ordinary temperature range can be fixed and maintained so that its shape can be easily adjusted at the site of operation, and it has substantially no anisotropy in view of strength so that it does not cause whitening, breakage and sharp decrease in strength when its bending deformation is repeated in any direction and it has toughness.

Abstract: A temperature sensitive fastener is formed by extruding, then pulforming and then machining the fastener. The pulforming forms uniaxial longitudinal stress in the fastener. The fastener has a head and a shank. The fastener is positioned in an osteosynthesis plate so that an opening in the plate is substantially coaxial with the bore on the bone. The shank extends into the opening in the plate and into one of the bone portions. The head overlies the plate. The fastener is heated to relieve the stresses in the shank so that the shank expands to frictionally secure the shank to the bore without deforming the material and thereby preventing thermal necrosis.

Abstract: A tissue fastener comprises a shaft having a member disposed thereon for lodging the shaft within the tissue, the shaft having a region that is relatively flexible to render a tissue engaging head disposed at a proximal end of the shaft movable with respect to the shaft. In one embodiment, the region comprises substantially an entire length of the shaft and is made from flexible material, such as a mesh, onto which the member and the head are molded. In another embodiment, the shaft comprises generally rigid material, and the region comprises a flexible joint between the shaft and the head. The flexible joint comprises a breakable (e.g., frangible) section of the shaft, and a flexible member (e.g., a plurality of filaments or a flexible tube) extends between the shaft and the head past the breakable section.

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.