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: An abrading device consists of 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: 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.

Abstract: An implantable plate for providing support to a bone of a subject when affixed thereto includes a polymeric body of a biocompatible polymer having a desired amount of polymer molecule orientation in a first direction so that the plate can be bent to conform with a contour of the bone of the subject. The polymeric body includes a top surface, a bottom surface, and at least one fastener portion. The fastener portion includes a recess and a fastener hold that is configured for receiving a fastener when affixed to the bone of the subject. A method of manufacturing the implantable plate includes: (1) injection molding a biocompatible polymeric composition into a polymeric body within an injection mold; (2) removing the polymeric body from the injection mold; and (3) forming at least one fastener hole within polymeric body.

Abstract: A method for forming an acetabular shell includes providing a working surface such as a mandrel, and spraying the working surface with a first layer of material having a first composition such as aluminum oxide. After a suitable thickness is generated, the spray composition is gradually changed to other compositions having desired particle sizes and distribution. In one example, the composition is changed to a mixture of aluminum oxide and titanium oxide and/or titanium. As thickness builds up, the relative amount of aluminum oxide is decreased such that the composition is all titanium and titanium oxide. After a desired thickness is generated, the acetabular shell is extracted off the mandrel.

Abstract: The presently disclosed subject matter describes acid-derivatized perfluoropolyether (PFPE) materials and their use as coatings, sealants, and flexible fillers for devices, apparatuses, and structural parts for a variety of medical applications, and as coatings, sealants, flexible fillers, and structural parts for vessels, structures, and machinery exposed to a marine environment.

Abstract: A barrier is placed across a portion of or across the totality of a spinal implant. The barrier can serve a variety of purposes, including, for example: (1) to keep tissue away from the implant and minimize or eliminate the likelihood of tissue adhesion with the spine or implant; (2) to decrease or eliminate the likelihood of tissue growth, migration, invasion and/or interaction with the implant; (3) to decrease or eliminate the likelihood of the dissemination of implant wear debris and particles away from the implant and into body cavities; and (4) to decrease or eliminate the likelihood of calcification, ossification, and/or bone formation adjacent to the implant.

Abstract: Ceramic precursor compositions and chemically bonded ceramic (CBC) materials, especially Ca-based, and a composite biomaterial suitable for orthopaedic applications. The CBC-system includes a binding phase (chemical cement) and additional phases with specified chemistry imparting to the biomaterial the ability of initial strength followed by interaction with the body tissue including body liquid, to form a resorbable or partly resorbable biomaterial. The ceramic precursor composition includes at least one silicate with Ca as the main cation with a resorption rate less or equal to that of the bone in-growth rate. The silicate will form the binding phase of the cured material. Implants and surface coated devices are also disclosed. The cured material exhibits a compressive strength exceeding 100 MPa.

Abstract: An antimicrobial coating is provided for use on textiles, medical devices, packaging materials, and the like. The antimicrobial coating includes a halogenated furanone.

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: This invention relates to the discovery of functionalized triclosan monomers and oligomers that, when incorporated into a substrate of, or applied as part of a coating to, medical devices and/or consumer products may extend the duration of antimicrobial properties to the medical devices and/or consumer products.

Abstract: A spinal fusion device including a selectively applied bone growth promoting agent is disclosed. In particular, a bone growth promoting agent is selectively applied to spinal implants, spinal plugs, spinal wedges and other implantable devices.

Abstract: A force diffusion hook includes a hook element and a connecting member receiving portion for receiving a connecting member to stabilize a spinal column segment. The hook element defines a receptacle for receiving a bony portion. A force diffusion member extends along the receptacle between the hook element and the bony portion. The force diffusion member is deformable to distribute load between the bony portion and the hook element.

Abstract: The present disclosure provides substrates having a lubricious coating thereon. The substrate may be flexible and include, in embodiments, a medical device. The lubricious coating, in embodiments, is applied in a pattern so that the coating avoids delamination and/or fracturing which might otherwise occur as the substrate flexes and/or stretches.

Abstract: A prosthesis having an oxidized zirconium surface and a porous textured surface is described. A major advantage of the prosthesis is increased service life. Additionally, a process of manufacturing the prosthesis is described.

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: Novel orthopaedic bone screws/spinal pedicle screws and implants that include coatings to help promote a structurally stable interface between the implant and the patient's bone/tissue, and methods of coating such screws and implants are provided. The implants and methodologies described involve at least a coating that facilitates osseous integration, and additionally at least one coating that either reduces the risk of infection in immunologically suppressed patients and/or for utilization in patients who have infection, but who require stabilization, or coatings that permit the use of dissimilar metals and prevent galvanic corrosive reactions.

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: Systems and methods are provided for fixation of a fractured bone with an intramedullary bone fixation device. During an implantation procedure, the fixation device may be guided by a removable guidewire which is not coupled to the fixation device. The guidewire and device may be inserted into an intramedullary canal along a pathway which is not parallel to the intramedullary canal. The fixation device may be composite, formed of a support structure and a matrix material. The matrix material may be thermo-chemically activated, transformable from a deformable first thermo-chemical state to a hardened second thermo-chemical state. The fixation device may be radially expandable to deform to the shape of the intramedullary canal, to provide support to the fractured bone.

Abstract: A biocompatible fastener particularly well-suited for use in fundoplication procedures. In a preferred embodiment, the fastener is designed to break within the span of approximately three to six months after implantation and comprises a male portion and a female portion. The male portion includes a first base member, the first base member being generally flat and oval. A pair of male members are mounted on the bottom surface of the first base member, each male member comprising a cylindrical post extending downwardly from the bottom surface of the first base member and a conical head disposed at the bottom end of the post. The female portion includes a second base member, the second base member being generally flat and oval. A pair of sleeves are mounted on the top surface of the second base member and extend upwardly therefrom. Each sleeve defines a bore adapted to receive a head from a corresponding male member and has an inner flange formed thereon.

Abstract: A spinal implant including an at least one screw disposed within a wedge body is herein provided. The implant can be configured for placement with a facet joint in an intra-facet delivery. Furthermore, the implant can include a fusion-promoting bioactive material thereby providing a single device capable of spinal stabilization and/or fusion. Furthermore, a method of placing such an implant within a facet joint in an intra-facet orientation is hereby provided.

Abstract: In one aspect, the invention relates to coated substrates comprising a substrate having a surface, a cationic polymer layer adjacent the surface of the substrate, an anionic polymer layer adjacent the cationic polymer layer and methods for producing and using same. In one aspect, the cationic polymer layer comprises at least one residue of a first compound having the structure: In a further aspect, the anionic polymer layer comprises at least one residue of a compound having the structure: In a yet further aspect, at least one nanoparticle or microparticle is positioned within one or both of the anionic polymer layer and the cationic polymer layer. In a still further aspect, the outermost polymer layer has a surface having fractal characteristics. This abstract is intended as a scanning tool for purposes of searching in the particular art and is not intended to be limiting of the present invention.

Abstract: In one aspect a device is disclosed for use as a bone implant comprising, a body having a pre-implantation shape and a post-implantation shape different from the pre-implantation shape. The body is configured to change from the pre-implantation shape to the post-implantation shape in response to the body being activated. The body is configured to be inserted in a bone recess while the body is in the pre-implantation shape. In another aspect a method is disclosed comprising inserting a cable member into a recess in a bone, inserting a retention device into the recess, the retention device containing a shape memory material, and activating the shape memory material.

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: Orthopedic implant devices are positioned at a desired in vivo site by positioning a device that is non-rigid, i.e., flexible and/or malleable, in a first form, and then transformable after insertion to the in vivo site into a rigid, or hardened, form for providing a load-bearing function or providing other structural and/or mechanical function after implant. The device includes a biocompatible sheath and a curable material sealed within the sheath. The curable material is provided in a first form that provides flexibility to the device and is structured to rigidize in a second form after application of a quantity of an initiating energy to the material.

Abstract: A device is provided that is non-rigid, i.e., flexible and/or malleable, in a first form, and then transformable after insertion to an in vivo site into a rigid, or hardened, form; a cure-initiating energy is applied to the device; and the device is then positioned in the in vivo site where it hardens to provide a load-bearing function or other structural and/or mechanical function. The device includes a biocompatible sheath and a curable material sealed within the sheath. The curable material is provided in a first form that provides flexibility to the device and is structured to rigidize in a second form after application of a quantity of an initiating energy to the material.

Abstract: A bone anchoring nail is provided having a threadless shaft with a free end, a head opposite to the free end, the head having a substantially U-shaped recess for accommodation of a rod or a rod-shaped element, a longitudinal bore extending through the shaft and opening towards any one of the head and the free end and a plurality of openings extending through the wall of the shaft and being in communication with the bore. The bone anchoring nail allows quick insertion and reliable fixation enhanced by the in-growth of blood vessels.

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: The present invention relates to a multi-purpose bio-material useful as a bone filler, bio-adhesive, bone cement and bone graft. One preferred embodiment of the present invention generally comprises: potassium phosphate, a metal oxide (i.e. MgO), a calcium containing compound, a sugar and an aqueous solution. Exemplary calcium containing compounds include but are not limited to tri-calcium phosphates. The present invention is particularly useful as a bio-adhesive for bone, ligament, and other soft tissue and has surprising and unexpected osteoproliferative effects. The composition can be used for a variety of other uses.

Abstract: A medical device is constructed from a polymeric composition having properties such as increased visibility of the device and the ability to deliver therapeutic and other agents. The device is constructed with additives incorporated into the polymeric structure, such as a material that increases visibility of the device, while still maintaining desired mechanical characteristics such as high radial stiffness, minimized recoil values, and improved flexibility. The device can assume a wide range of geometries that are adaptable to various loading conditions In order to include performance-enhancing additives to the medical device without affecting mechanical performance, the additives are localized in discrete regions of a polymer structure from which a medical device will be formed. For example, a medical device can be prepared from a polymer form such as a tube containing radiopaque agent localized at its ends or in a desired pattern along the device.

Abstract: The present invention provides an implant for use in fusing adjacent bony structures. The implant comprises at least one structural member combined with at least one flexible planar member to retain the at least one structural member to form the implant.

Abstract: Disclosed are medical prosthetic devices or medical implants which exhibit improved biocompatitibly. The devices or implants include a metal material, e.g. titanium, in which the metal surface parts are coated with a corresponding hydride material that contains one or more biomolecule substance. This biomolecule substance may contain one or more biologically active molecules, e.g. bio-adhesives, biopolymers, blood proteins, enzymes, extra cellular matrix proteins, extra cellular matrix biomolecules, growth factors and hormones, peptide hormones, deoxyribonucleic acids, ribonucleic acids, receptors, enzyme inhibitors, drugs, biologically active anions and cations, vitamins, adenosine monophosphate (AMP), adenosine diphosphate (ADP), adenosine triphosphate (ATP), marker biomuolecules, amino acids, fatty acids, nucleotides (RNA and DNA bases), or sugars.

Abstract: A method of addressing a condition of a living body comprising the steps of using an energy beam to form a set of pores in a work piece biocompatible membrane. The pores should have a mean area of less than 500 ?m through the biocompatible membrane, thereby producing a microporous membrane adapted to facilitate tissue in growth. This membrane is placed at least partially about an article that is adapted to be implanted in a living body, which is implanted into the living body, thereby addressing the condition.

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: 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: Surface coating method for deposition of a chemically bonded ceramic coating on a substrate, includes the steps of preparing a curable coating slurry, depositing a coating of the slurry on at least a section of the substrate surface, and hardening the slurry. The step of preparing a curable coating slurry includes mixing calcium aluminate powder with water and at least one water-reducing-agent, such that a water-to-cement ratio in the range of 0.1 to 0.9 is achieved.

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 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: To change a spatial relationship between two or more bones in a patient's body, a wedge member is moved into a joint between the bones. As the wedge member enters the joint, pivotal movement occurs between the bones to change the orientation of the bones relative to each other. The wedge member may have a circular cross sectional configuration and be moved into the joint by rotating the wedge member about an axis which extends between a thin leading edge portion and a thick trailing edge portion of the wedge member. Alternatively, the wedge member may have a cam-shaped configuration and be rotated through less than a revolution to apply force against the bones. The wedge member may have a porous construction which enables bone to grow through the wedge member and immobilize the joint. The wedge member may be coated with and/or contain bone growth promoting material. The wedge member may be connected to only one of the bones or may be connected to two adjacent bones.

Abstract: The above-discussed and other problems and deficiencies of the prior art are overcome or alleviated by the improved bone connective prosthesis and method of forming the same of the present invention, comprising the addition of at least one biocompatible metal coupling agent to a prosthetic element, and then adding the biocompatible copolymerizer 2-hydroxyethyl methacrylate (“HEMA”) to the PMMA film and/or cement in an amount effective to enhance the cohesion between the prosthetic and the bone cement. In general, a PMMA/HEMA film is applied to the prosthetic element in the presence of a silane coupling agent by dipping, painting, spraying, etc.

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: The subject invention relates to a material for magnetic resonance imaging, and apparatus incorporating such material. The subject material can comprise cobalt, nickel, and chromium and can be used in nuclear spin tomography MRI. In specific embodiments, the subject material can be used in stents, mechanical springs, and guide wires.

Abstract: A method of producing a biocompatible microporous membrane comprising the steps of providing a biocompatible membrane and using an energy beam to form a set of pores having a minor axis of less than 15 ?m through the biocompatible membrane. One embodiment includes the steps of producing a first layer of material, defining a first set of pores; producing a second layer of material, defining a second set of pores and wherein the second set of pores is defined so as to cooperatively engage the first set of pores; and aligning and joining the first layer of material to the second layer of material to form a laminated membrane, having through-passageways formed by the first set of pores at least partially aligned with the second set of pores.

Abstract: Several embodiments of an implant sleeve are shown for use with implants inserted through a wound into a surgical site. In some embodiments, the sleeve is useful to protect mating implant components from contamination during insertion through the wound. In other embodiments, the sleeve is useful to clean components that have become contaminated during insertion.

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.