Abstract: Demineralized bone matric (DBM) and native bone morphogenetic protein (nBMP) are complex mixtures of non-collagenous bone proteins. These mixtures contain many of the BMPs that are available as recombinant molecules. Information regarding the presence in these materials of molecules that may affect the availability and activity of the BMPs is very limited. A chemical extraction of DBM, such as using alkali-urea produces a water soluble extractate which inhibits the osteogenic activity of DBM. Noggin, an extracellular BMP ligand antagonist is found in the water soluble extractate from DBM. Differential chemical extraction is a useful means of removing non-osteogenic, or osteogenic inhibitory molecules from DBM and nBMP.

Abstract: The present invention is directed to a composition comprising a matrix suitable for implantation in humans, comprising defatted, shredded, allogeneic human muscle tissue that has been combined with an aqueous carrier and dried in a predetermined shape. Also disclosed is a tissue graft or implant comprising a matrix suitable for implantation in humans, comprising defatted, shredded, allogeneic human muscle tissue that has been combined with an aqueous carrier and dried in a predetermined shape. The composition and/or tissue graft or implant of the invention is usable in combination with seeded cells, a tissue growth factor, and/or a chemotactic agent to attract a desired cell.

Abstract: A micro-alloyed porous metal is disclosed having an optimized chemical composition to achieve targeted mechanical properties for use as an orthopaedic implant and a cell/soft tissue receptor. The porous metal may achieve a targeted compressive strength and a targeted ductility, for example. These targeted mechanical properties may allow the porous metal to be densified to a low relative density.

Abstract: Described is an implantable medical material comprising a malleable, cohesive, shape-retaining putty including mineral particles, insoluble collagen fibers and soluble collagen. The medical material can be used in conjunction with biologically active factors such as osteogenic proteins to treat bone or other tissue defects in patients.

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

Abstract: The present disclosure in a broad aspect provides for diazeniumdiolated phosphorylcholine polymers and associated methods for achieving nitric oxide release. The present polymers have superior biocompatibility and are useful for coating or fabricating medical devices such as a vascular stent.

Abstract: Provided are methods of delivering at least one pharmaceutical agent to the central nervous system (CNS) of a subject, methods of treating a neurological disorder or pain in a subject that include administering at least one pharmaceutical agent onto a SEM graft in the skull base of the subject. Also provided are methods of treating a neurological disorder or pain in a subject that include forming a SEM graft in the skull base of the subject and administering at least one pharmaceutical agent onto the SEM graft in the skull base of the subject. Also provided are methods of forming a SEM graft in the skull base of a subject, compositions for administration onto a SEM graft in the skull base or into an endonasal reservoir or endonasal reservoir device in a subject, and devices for administering such compositions onto a SEM graft in the skull base of a subject.

Abstract: An antioxidant combined with UHMWPE prior to subjecting the UHMWPE to crosslinking irradiation. In one exemplary embodiment, the antioxidant is tocopherol. After the antioxidant is combined with the UHMWPE, the resulting blend may be formed into slabs, bar stock, and/or incorporated into a substrate, such as a metal, for example. The resulting product may then be subjected to crosslinking irradiation. In one exemplary embodiment, the UHMWPE blend is preheated prior to subjecting the same to crosslinking irradiation. Once irradiated, the UHMWPE blended product may be machined, packaged, and sterilized in accordance with conventional techniques.

Abstract: The present invention relates to devices, articles, coatings, and methods for controlled active agent release and/or for providing a hemocompatible surface. More specifically, the present invention relates to copolymer compositions and devices, articles, and methods regarding the same for controlled active agent release. In an embodiment, the present invention includes a copolymer composition. The copolymer composition can include a copolymer and an active agent. In an embodiment, the copolymer includes an effective portion of a monomeric unit including a polar moiety. The active agent can be polar. The active agent can be charged. The active agent can be non-polar. In an embodiment, the copolymer composition includes a random copolymer. In an embodiment, the random copolymer includes butyl methacrylate-co-acrylamido-methyl-propane sulfonate copolymer, which can provide reduced platelet adhesion.

Abstract: An antioxidant combined with UHMWPE prior to subjecting the UHMWPE to crosslinking irradiation. In one exemplary embodiment, the antioxidant is tocopherol. After the antioxidant is combined with the UHMWPE, the resulting blend may be formed into slabs, bar stock, and/or incorporated into a substrate, such as a metal, for example. The resulting product may then be subjected to crosslinking irradiation. In one exemplary embodiment, the UHMWPE blend is preheated prior to subjecting the same to crosslinking irradiation. Once irradiated, the UHMWPE blended product may be machined, packaged, and sterilized in accordance with conventional techniques.

Abstract: A manufacturing system for a surgical kit includes surgical tools and an implant for cartilage repair in an articulating surface of a joint. The design system includes the basic blocks of: I. Receiving design parameters for a surgical kit in a computer controlled manufacturing system, the design parameters for the surgical kit representing a model for a medical implant and a guide tool for implanting the implant; II. Manufacturing a medical implant dependent on the design parameters; and III. Manufacturing a guide tool for implanting the implant dependent on design parameters.

Abstract: A cell culture growth substrate comprising submucosal tissue of a warm-blooded vertebrate and a method for culturing fastidious organisms is described. Submucosal tissue used in accordance with the present invention supports the proliferation of cells when said cells are contacted with submucosal tissue under conditions conducive to cell proliferation.

Abstract: A design system for a surgical kit includes surgical tools and an implant. The design system includes the basic blocks of: I. Determining physical parameters for cartilage damage in a joint; II. Generating design parameters of a medical implant; and III. Generating design parameters of a set of tools for implanting the implant.

Abstract: The invention provides methods of making hydrolyzed cross-linked polyvinyl alcohol (PVA) hydrogels by polymerizing vinyl acetate (VAc) monomers to polyvinyl acetate (PVAc) polymer network by chemical-crosslinking and hydrolysis. The invention also provides methods for including pendant chains in the hydrogel during the polymerization process. Materials produced and use of the cross-linked hydrolyzed PVA hydrogels also are disclosed herein.

Abstract: A biologic diarthrodial joint includes an artificial subchondral bone shaped in the form of a joint replacement member and formed of an artificial fiber material. The artificial fiber material includes synthetic fibers formed in a fibrous network with the synthetic fibers arranged in multiple orientations. The artificial subchondral bone includes a polymer receiving component. An artificial cartilage polymer is cooperable with the artificial subchondral bone and engages the polymer receiving component. The artificial cartilage polymer has physical properties similar to that of native articular cartilage.

Abstract: A prosthetic assembly and a method of assembling same. The prosthetic assembly includes a base component with at least one engagement surface. A pyrolytic carbon component includes at least one engagement surface. The pyrolytic carbon component is elastically deformed to mechanically interlock with the engagement surface on the base component. The pyrolytic carbon component retains at least a portion of the deformation stress created during coupling with the base component.

Abstract: Bioprosthetic tissues are treated by immersing or otherwise contacting fixed, unfixed or partially fixed tissue with a glutaraldehyde solution that has previously been heat-treated or pH adjusted prior to its contact with the tissue. The prior heat treating or pH adjustment of the glutaraldehyde solution causes its free aldehyde concentration to decrease by about 25% or more, preferably by as much as 50%, and allows a “stabilized” glutaraldehyde solution to be obtained at the desired concentration and pH for an optimal fixation of the tissue at high or low temperature. This treatment results in a decrease in the tissue's propensity to calcify after being implanted within the body of a human or animal patient.

Abstract: This invention includes malleable, biodegradable, fibrous compositions for application to a tissue site in order to promote or facilitate new tissue growth. One aspect of this invention is a fibrous component that provides unique mechanical and physical properties. The invention may be created by providing a vessel containing a slurry, said slurry comprising a plurality of natural or synthetic polymer fibers and at least one suspension fluid, wherein the polymer fibers are substantially evenly dispersed and randomly oriented throughout the volume of the suspension fluid; applying a force, e.g., centrifugal, to said vessel containing said slurry, whereupon said force serves to cause said polymer fibers to migrate through the suspension fluid and amass at a furthest extent of the vessel, forming a polymer material, with said polymer material comprising polymer fibers of sufficient length and sufficiently viscous, interlaced, or interlocked to retard dissociation of said polymer fibers.

Abstract: Vertebral body replacements are provided, including at least one vertebral body replacement in the shape of an oblong object. The oblong vertebral body replacement includes a nose shape to provide as minimally invasive an installation as possible, serrations formed in the side wall of the body replacement's body to prevent expulsion once the body replacement is in place, a tapered asymmetric shape to provide spinal lordosis, and an integral protrusion for stability and to increase the bearing area to reduce contact pressure between the body replacement and the vertebral plate. Hollow passages are typically filled with bone tissue. The body is also provided with holes passing therethrough to promote tissue growth.

Abstract: The invention is directed to an ion plasma deposition (IPD) method adapted to coat polymer surfaces with highly adherent antimicrobial films. A controlled ion plasma deposition (IPD) process is used to coat a metal or polymer with a selected metal/metal oxide. Exposing the coated surface to ultraviolet light significantly improves the antimicrobial properties of the deposited coatings.

Abstract: Custom moldable cushions for covering medical implants fastened to a bone are provided. Such cushions inhibit irritation of the surrounding soft tissue by covering the bone-implant interface and by reducing friction caused by movement of soft tissue adjacent the implant. Such cushions may also be employed to spread and absorb forces reducing patient discomfort and risk of injury and infection associated with such implants.

Abstract: A medical system (10) is provided having a pulling device (20) and an active substance chain (50). The active substance chain (50) has at least two storage units (51) arranged like a chain, and at least one of the storage units (51) is loaded with a medicinal active substance. The pulling device (20) has a grip element (30) and a coupling element (40), and the coupling element (40) has at least one recess (41, 41?). In a free position (100) the active substance chain (50) is arranged separated from the pulling device (20), while in an inserted position (110) at least one of the storage units (51) is arranged form-fitting in a recess (41, 41?). The active substance chain (50) can be moved reversibly from the free position (100) into the inserted position (110).

Abstract: A deployment device, system, and method for deploying a prosthesis. The deployment device includes a housing, a rod disposed within the housing and adapted to rotate relative to the housing, and one or more support members (e.g., bushings, bearings, etc.) rotatably supporting the rod within the housing. An elongate slit is disposed in and entirely through the housing and is positioned in a way that enables the prosthesis to pass therethrough from a loaded, rolled configuration on the rod. The deployment device is generally flexible, e.g., has a bending stiffness of at most about 0.87 N/mm (e.g., about 0.05 N/mm to about 0.87 N/mm). Furthermore, the deployment device enables a user to deploy (e.g., unroll) a prosthesis therefrom at a rate determined manually by the user and in a piece-by-piece fashion.

Abstract: The present invention is directed to implantable bioabsorbable non-woven self-cohered web materials having a high degree of porosity. The web materials are very supple and soft, while exhibiting proportionally increased mechanical strength in one or more directions. The web materials often possess a high degree of loft. The web materials can be formed into a variety of shapes and forms suitable for use as implantable medical devices or components thereof.

Abstract: Disclosed are embodiments of an improved joint prosthesis that can provide the option to improve initial stability without removing the implant or altering the preparation. Embodiments of improved joint implant components can comprise one or more expandable, hollow segmented posts. Methods of implant fixation are also disclosed. Disclosed methods can provide the opportunity for establishing initial biologic fixation (bone ingrowth), and can also provide an adjunct fixation through injecting cement down the center of the post if initial stability is not achieved or is questionable.

Abstract: The present invention relates to use of a medical implant as an adhesion barrier. The medical implant is a sheet material which comprises at least one layer of a non-woven fabric of fibres of a crosslinked gelatin material.

Abstract: The present disclosure relates to implantable medical devices which include at least one mesh and at least one film pivotably attached to the mesh.

Abstract: The present invention relates to methods for making cross-linked oxidation-resistant polymeric materials and preventing or minimizing in vivo elution of antioxidant from the antioxidant-containing polymeric materials. The invention also provides methods of doping polymeric materials with a spatial control of cross-linking and antioxidant distribution, for example, vitamin E (?-Tocopherol), and methods for extraction/elution of antioxidants, for example, vitamin E (?-tocopherol), from surface regions of antioxidant-containing polymeric materials, and materials used therewith also are provided.

Abstract: A medical prosthesis for use within the body which is formed of radiation treated ultra high molecular weight polyethylene having substantially no detectable free radicals, is described. Preferred prostheses exhibit reduced production of particles from the prosthesis during wear of the prosthesis, and are substantially oxidation resistant. Methods of manufacture of such devices and material used therein are also provided.

Abstract: We describe herein biocompatible single crystal Cu-based shape memory alloys (SMAs). In particular, we show biocompatibility based on MEM elution cell cytotoxicity, ISO intramuscular implant, and hemo-compatibility tests producing negative cytotoxic results. This biocompatibility may be attributed to the formation of a durable oxide surface layer analogous to the titanium oxide layer that inhibits body fluid reaction to titanium nickel alloys, and/or the non-existence of crystal domain boundaries may inhibit corrosive chemical attack. Methods for controlling the formation of the protective aluminum oxide layer are also described, as are devices including such biocompatible single crystal copper-based SMAs.

Abstract: A prosthetic device may comprise an insert having a first surface configured to contact a first prosthetic component and a bearing surface configured to articulate against a second prosthetic component. The insert comprises an ultra-high molecular weight polyethylene and vitamin E. The vitamin E may have a concentration in the range of 0.02 to 0.12 wt % first mixed with the ultra-high molecular weight polyethylene and then molded with the ultra-high molecular weight polyethylene at a temperature greater than the melting point of the ultra-high molecular weight polyethylene. The ultra-high molecular weight polyethylene and vitamin E may be gamma irradiated with a dosage of radiation between 5 and 20 Mrad. The insert may be machined prior to gamma irradiating the insert in air such that the gamma irradiation, at suitably high dosages, may also sterilize the insert.

Abstract: A medical device that includes a coating of a composite material that includes a polymeric material having a void structure and particulate ceragenin material (i.e., ceragenin particles) associated with the void structure. The average particle size of the ceragenin particles in the composite is in a range from 5 nm to 20 ?m, 50 nm to 10 ?m, 100 nm to 5 ?m, or 1 ?m to 10 ?m. The composite has a high loading of ceragenin particles (e.g., about 10% to about 25%, by weight). The composite has good polymer stability, the ability to release ceragenins from the ceragenin particles disposed in the composite over a sustained period of time at a characteristic elution rate, and the ability to kill large numbers of bacteria and other susceptible microbes over the sustained period of time.

Abstract: This invention provides, in certain aspects, unique devices and methods for treating fistulae. In one embodiment, an inventive device includes an elongate graft body having a proximal end and a distal end. The graft body is configurable to a first condition and a second condition, the second condition including the distal end deflected laterally relative to its position in the first condition of the body. The device also includes a tether, which is connected to the graft body, and is configured to traverse proximally along the body. The tether is manipulable to convert the graft body from the first condition to the second condition. Such a device may also include one or more additional tethers connected to the graft body. For instance, a second tether can be configured to extend distally from the distal end of the graft body, and may be effective in pulling the graft body along a fistula tract.

Abstract: A method for coating an object (1). The object (1) is positioned in contact with holding means and the coating (4) is applied in such a way that contact parts (3, 8, 10) of the holding means form part of the coating (4). Contact parts (3, 8, 10) are made from a material having corrosion properties being substantially identical to the corrosion properties of the coating material, preferably from the same material. Thereby the contact parts (3) can form a natural part of the resulting coating (4). The contact parts (3, 8, 10) may subsequently be detached from the holding means and remain attached to the object (1) as part of the coating (4). Provides a substantially full coating (4) to the object (1) in one coating step. Avoids or reduces problems relating to pinholes in coatings. Further an object (1) having a coating (4) which has been provided using the method.

Abstract: Disclosed herein is an implantable medical device including an antimicrobial layer. The antimicrobial layer may include a first distinct size of silver nanoparticles, a second distinct size of silver nanoparticles, and a third distinct size of silver nanoparticles. The antimicrobial layer extends over a surface of the implantable medical device, and, in some instances, the surface of the implantable medical device may serve as a substrate on which the antimicrobial layer is deposited.

Abstract: A method of designing, presenting, generating, and fabricating custom implants by obtaining a 3D image of a site to receive an implant, simulating volumetric changes of the site, generating a virtual 3D implant, and fabricating a real 3D implant. A method of implanting a custom implant in a patient, by obtaining a 3D image of a site to receive an implant, simulating volumetric changes of the site, generating a virtual 3D implant, fabricating a real 3D implant, and implanting the implant in the patient. A method of correcting disfigurement in a patient. A method of replacing a disc in a patient's back. The present invention also provides for an implant fabricated by this method.

Abstract: An implant system for imparting vibratory massage to tissue of a patient from within the body of the patient is disclosed. The system comprises an implant device configured to produce and communicate a vibration to body tissue located adjacent to the implant device. The device may include a case forming at least a portion of an exterior of the device, and a vibration generator configured to vibrate the portion of the exterior. The device may include a power supply to supply power to the vibration generator and a switch to selectively permit power from the power supply to be supplied to the vibration generator. The device may include a power receiver to receive electrical energy from a location external to the body of the patient and a signal receiver to receive signals from a location external to the body of the patient when the receiver is located in the body of the patient.

Abstract: The construct described herein allows opposing tissues to form adhesions with either side of the construct, as part of the natural healing process. The construct however is multi-layered, wherein the space between the layers provides the protection from unwanted adhesions forming between and bonding separate tissues. In one embodiment, this space between layers of the construct may be developed spontaneously, that is the multiple layers are released by design after a finite time and the opposing tissues are free to move independent of each other, free of adhesions.

Abstract: This invention provides a new class of medical devices and implants comprising amorphous metal alloys. The medical devices and implants may be temporary or permanent and may comprise other materials as well, such as polymers, ceramics, and conventional crystalline or polycrystalline metal alloys. Specifically, this invention provides implantable surgical fabrics comprising amorphous metal alloys. The presence of amorphous metal alloys in these fabrics can serve a variety of purposes, including structurally reinforcing the surgical fabric and/or imparting to the fabric the ability to shield against harmful radiation. The fabric may be used inside or outside the body during medical procedures. Further, the implantable surgical fabrics may be woven or non-woven fabrics.

Abstract: Disclosed is a method for producing an implant coating that has a defined toxicity. The method is characterized by the following steps: i. a sol is produced from a biotoxic solution containing precious metal ions and a precursor solution for a titanium oxide; ii. an implant is coated by applying the sol in a sol-gel process; iii. the coating is pyrolyzed and sintered without admitting any light, the precious metal ion concentration in the dried coating ranging from 10 to 60 percent relative to the total weight of the dried coating; and iv. at least subareas of the coating produced without admitting any light are illuminated in order to reduce the toxicity of the dried coating to a predetermined measure.

Abstract: An antenna system for an implantable device like a cardiac pacemaker or a cochlear implant. The antenna system includes at least two coil units coupled with their terminals to a control circuit which can selectively connect the coil units in series or in anti-series, corresponding to a “operational mode” and a “safety mode”, respectively. In the operational mode, magnetically induced voltages in the coil units add, while they subtract and therefore completely or partially compensate in the safety mode. Thus the implantable device can be protected from damage due to extraordinarily large changing rates of external magnetic fields as they exist for example during MRI examinations.

Abstract: The invention relates to an endoprosthesis, particularly for the at least partial replacement of a long bone, comprising a plug-in connection for connecting a shaft (2) to another part (1) of the prosthesis, wherein the plug-in connection (3) comprises an axial projection (33) and a socket (34). According to the invention, provision is made that a radial transverse channel (53) is provided on one part of the plug-in connection (3), said radial transverse channel (53) engaging behind the plug-in connection and having a center axis (55) that is offset (d) relative to the axis (56) of a transverse bore (52) arranged on the other part of the plug-in connection, and a clamping element (6) which is to be inserted into the transverse channel (53) and whose point (62), in the inserted state, engages in the transverse bore (52). In this way, it is possible to achieve an effective securing action even in the event of an unfavorable tolerance pairing, without adversely affecting the sensitive projection itself.

Abstract: Implants comprising cartilage and trabecular metal, and methods of making the implants are disclosed. Further disclosed are therapeutic uses of the implants, which include methods of treatment or repair of an chondral or osteochondral defect, such as a chondral or osteochondral injury, lesion or disease. An implant comprises cartilage or chondrocytes and a subchondral base comprising trabecular metal. An implant can comprise a geometric shape such as a cylinder or an anatomical shape such as a condyle, and can be used in conjunction with a positioning structure.

Abstract: Implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the implantable or insertable medical devices include at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents.

Abstract: A partial-length catheter, or an extendable tube or sleeve member of the catheter, is selectively movable within the prostatic urethra to open a urine drainage passageway through and obstructed portion of the prostatic urethra or to open the external urinary sphincter muscle and thereby discharge urine from the bladder. A control element is manipulated at a position exterior of the urinary canal to selectively move the catheter or the extendable tube or sleeve member, thereby selectively controlling urine discharge.

Abstract: Described herein are apparatus, compositions, systems and associated methods to occlude structures and malformations with radiopaque hydrogel filaments with delayed controlled rates of expansion permitting the repositioning of the device once inside the structure or malformation. Further described is a device for implantation in an animal comprising a difunctional, low molecular weight ethylenically unsaturated shapeable macromer; an ethylenically unsaturated monomer; and a radiopaque element, wherein said device contains no support members. Methods of forming such devices are also disclosed.

Abstract: Embodiments of apparatuses, and methods and systems including apparatuses, configured to be magnetically coupled to a medical device within a body cavity of a patient. Some embodiments include one or more elements comprising at least one of a magnetically-attractive and magnetically-chargeable material; and a bumper extending around the one or more elements and configured to reduce the strength of a magnetic field of the one or more elements.

Abstract: Embodiments of apparatuses and/or medical devices, and systems and methods including apparatuses and/or medical devices, comprising one or more elements configured to define a U-shaped magnetic flux path and/or magnetic field.

Abstract: The biocompatible, biodegradable materials in the solid and/or liquid form are based on segmented linear polyurethanes and/or segmented crosslinked polyurethanes based on A) one or more biocompatible polyols susceptible to hydrolytic and/or enzymatic degradation having a molecular weight of 100 to 20,000 dalton and a number of active hydroxyl groups per molecule (functionality) of at least two or higher; B) one or more diisocyanates and/or triisocyanates; and C) one or more low molecular weight chain extenders having a molecular weight of 18 to 1000 dalton and the functionality of at least two or higher.

Abstract: A hydromagnetic joint includes a first joint part having a first magnetic element with a magnetically charged surface, and a first buoyant element coupled with the first magnetic element, and a second joint part including a second magnetic element having a second magnetically charged surface that opposes the first magnetically charged surface of the first magnetic element, and a second buoyant element coupled with the second magnetic element. The hydromagnetic joint has a liquid disposed between the first and second joint parts. The first and second joint parts are moveable relative to one another and are in fluid communication with the liquid. The first and second magnetically charged surfaces have a common polarity and repel one another.