Abstract: The present invention relates to an RDID tag enabled needle shield assembly that provides a sterile enclosure of an injection needle and that can be fixedly attached to a pre-filled syringe for administering an injection of medicament to a patient after removal of the needle shield assembly. The RFID tag is fixedly attached to the needle shield through co-molding or another form of permanent attachment. The present invention also relates to a method of tracking the life cycle of a medicament injection device where the RFID tag enabled needle shield assembly is attached to an injection needle that is connected to a syringe barrel that is part of an injection device. Data is written to or read from the RFID tag during the entire life cycle of the injection device, including assembly, packaging, storing, distribution and use.

Abstract: The root canal filling material marker is a tool for marking a desired length on root canal filling material, such as a conventional gutta percha point. In use, the gutta percha point is inserted into a hollow housing through an aperture formed in a front wall thereof. The gutta percha point is releasably gripped between spring-biased clamp jaws. A shaft is longitudinally positioned to a desired marking point at a desired length of the gutta percha point and then laterally pulled. Laterally pulling the shaft slides an applicator, which is secured to the shaft within the housing, across a marking agent and the gutta percha point to make a laterally extending mark on the gutta percha point at the desired length.

Abstract: Disclosed herein is a cleaning system (30) for a dental implant part (2) that has been introduced into the jaw bone of a patient. For this purpose, in an advantageous embodiment of the invention, a securing element, which is adapted on the end side to connect to a corresponding connection element in the dental implant part, particularly preferably which can be screwed into a thread of the dental implant part by the end side, and to which a distribution element for a cleaning fluid as well as an electrical contact element can be attached, which distribution element can be connected to an external media reservoir via a media channel, and via which electrical contact element, a power source that is connectable to an external power source can be electrically connected to the dental implant part.

Abstract: A process for preparing a body having an osseointegrative topography formed on its surface. The process includes the steps of providing a primary body made of a titanium-zirconium alloy containing 13 to 17 wt-% of zirconium, sandblasting the primary body, and etching the sandblasted primary body with an etching solution including hydrochloric acid, sulfuric acid and water at a temperature of above 80° C. to obtain the body, said etching being performed for a duration of 350 seconds at least.

Abstract: The present invention relates to a dental implant replica (10) for a physical dental model (36), the dental implant replica including: a coronal end (14); an apical end (18); a coronal portion (12) extending to the coronal end; an cylindrical apical portion (16) extending to the apical end and including a circumventing indentation (20); an anti-rotation portion (26) located between the coronal portion and the apical portion and including at least one external convex element (28; 28a-c) extending in a longitudinal direction of the dental implant replica; and a prosthetic connection interface (34) located at the coronal end. The present invention also relates to a system including a dental implant replica and a physical dental model, a 3D printed or milled dental model, and a method of installing a dental implant replica in a dental model.

Abstract: A method including modifying a known upper denture to form a final upper denture by a series of steps which may include making holes in a gums section made of a first material of the known upper denture, cutting away a palate section, and applying a gold and silicon mixture to make a new palate section, to insert into the holes in the gums section, and to cover the first material. The method may also include modifying a known lower denture to form a final lower denture by a series of steps which may include making holes in a gums section made of a first material of the known lower denture, and applying a gold and silicon mixture to insert into the holes, and to cover the first material. The first material may be nylon.

Abstract: A refill for an electric toothbrush comprises a generally tubular structure formed by refill walls defining an interior space for accepting thereinto a coupling stem of a toothbrush handle. The refill includes a motion transmitter functionally connected to the brush head for driving it. The refill has a coupling device including a pair of mutually opposite and resiliently deformable cantilevered arms disposed in the interior space of the refill and adjacent to the refill walls. Each of the arms terminates with a coupling surface for engaging a coupling pin extending from the handle's coupling stem for secure and disengageable connection therewith.

Abstract: The present invention relates to a rotating electric toothbrush comprising: a main body having a receiving space formed therein, a driving means received in the interior of the main body and providing a rotational force, a toothbrush handle having one end detachably coupled to the driving means, and receiving a rotational force of the driving means to be rotated, a support means coupled to the outer peripheral surface of the other end of the toothbrush handle and having plate-shaped support bodies made of a ductile material and radially formed to be spaced apart from each other, and a plurality of toothbrush bristles implanted between the support bodies.

Abstract: Bodily fluid collection systems are described where the system may be used for collecting and transferring sperm into a syringe. The syringe is configured to have a distal collection tip which is gently tapered or radiused to present a smooth and atraumatic surface and which is specifically configured and shaped to be inserted within and received by the collection receptacle. The distal collection tip has a shape which corresponds directly to a tapered reservoir defined at the bottom of the collection receptacle such that a distal opening defined through the tip is optimally positioned within the concentrated bodily fluid pooled within the reservoir for collection. Moreover, the gentle taper of the collection tip may present an atraumatic surface for inhibiting damage to the sperm contained within the ejaculate as the sperm is suctioned into the distal opening for insemination into the female.

Abstract: A hernia repair device, comprising: an inflatable balloon having an inflation tube, the inflation tube having a proximal end attached to said balloon and a distal end adapted to be extracted from the body, separately from the balloon, via an opening which is smaller than a laparoscopic opening, and a mesh removably attached to said balloon, wherein the inflation tube passes through the mesh.

Abstract: This disclosure is directed primarily to a stent for use in the trachea. The stent has a nominally deployed state, an axially extended state and an axially compressed state. The stent has a length. In the axially extended state, the length is at least 20% greater than in the nominally deployed state.

Abstract: Thin PTFE layers are described having little or no node and fibril microstructure and methods of manufacturing PTFE layers are disclosed that allow for controllable permeability and porosity of the layers. In some embodiments, the PTFE layers may act as a barrier layer in an endovascular graft or other medical device.

Abstract: Stent graft comprising a stent (1) having a plurality of ring segments (3) arranged side by side and connected with each other by connecting webs (7) having a meandering pattern, and at least one membrane (2), characterized in that a plurality of connecting webs (7) between adjacent ring segments (3) are provided with flexible tongues (6), which are arranged in a form-closed manner in the connecting webs (7) and which are resiliently movable against the connecting webs (7), wherein the membrane (2) being clamped between flexible tongues (6) and connecting webs (7).

Abstract: A tendon repair implant for treatment of a partial thickness tear in the supraspinatus tendon of the shoulder is provided. The implant may incorporate features of rapid deployment and fixation by an arthroscopic approach that compliment current procedures; tensile properties that result in desired sharing of anatomical load between the implant and native tendon during rehabilitation; selected porosity and longitudinal pathways for tissue in-growth; sufficient cyclic straining of the implant in the longitudinal direction to promote remodeling of new tissue to tendon-like tissue; and, may include a bioresorbable construction to provide transfer of additional load to new tendon-like tissue and native tendon over time.

Abstract: Fixation assemblies having a button captured by a continuous (i.e., closed) loop of thread, such as ultra high molecular weight polyethylene (UHMWPE) fiber are disclosed herein. Preferred assemblies are constructed such that the intact button cannot be detached from the continuous loop without breaking or opening the loop of fiber. The closed fiber advantageously contains at least one or two stitched, or otherwise secured or reinforced, sections positioned on the loop.

Abstract: An ophthalmic visualization system includes a rear illumination system, to generate and to project a rear illumination light onto a retina of an eye that has an intraocular lens (IOL) implanted into the eye, so that the rear illumination light reflects from the retina as a reflected illumination light, wherein a central portion of the reflected illumination light propagates through the IOL to form an IOL-focused illumination light, and a peripheral portion of the reflected illumination light propagates around the IOL to form a peripheral illumination light; an optic, to receive the IOL-focused illumination light and the peripheral illumination light from the eye, and to transmit the received illumination lights; an aperture slop, to stop the transmitted peripheral illumination light, and to allow the IOL-focused illumination light to pass through; and an imaging system, to form an isolated IOL image based on the transmitted IOL-focused illumination light.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having an outflow end and an inflow end, a plurality of commissure features attached to the stent, a plurality of anchoring features disposed on legs of the stent, the plurality of anchoring features being coupleable to a delivery device for repositioning, and a valve assembly disposed within the stent. The anchoring features may be configured to attach to heart tissue to help secure the prosthetic heart valve in an operating position.

Abstract: Methods and apparatus for holding and maneuvering a valve during preparation and attachment to patient, providing increased visibility of the prosthetic valve and the sewing ring to prevent suture entanglement. A handle attachment is spaced from the valve for improved visibility of the sewing ring and the outlet end of the valve during attachment. Commissure posts are bent inward at the tips while preventing crashing of the commissure posts into each other causing damage. A release force needed to remove the holder and unthread the holder sutures is reduced. The holder and related methods can provide a kink free holder suture path to reduce suture entanglement and prevent damage to the implanted valve during holder removal by reducing the release force needed to remove the holder sutures by up to 30%.

Abstract: Prosthetic valves and methods of use of prosthetic valves may be provided. In one implementation, a method of implanting a prosthetic valve within a native heart valve may be provided. The method may include delivering the prosthetic valve into a heart chamber while the prosthetic valve is constrained in a radially-contracted delivery configuration. The method may also include unconstraining ventricular tissue anchors and atrial tissue anchors of the prosthetic valve while maintaining an annular valve body of the prosthetic valve in the delivery configuration. The method may also include unconstraining the annular valve body from the delivery configuration while the unconstrained atrial tissue anchors and ventricular tissue anchors are positioned within an atrium and a ventricle, respectively. Unconstraining the annular valve body may decrease a longitudinal distance between the ventricular tissue anchors and atrial tissue anchors to secure the prosthetic valve within the native heart valve.

Abstract: Devices and methods for the repair of the functioning of heart valves are provided. A device may comprise a ventricular winding having a generally spiral shape, wherein the device is free of any atrial stabilizing section. A method involves positioning the device such that chords associated with the heart valve are positioned within the path of the generally spiral shape of the ventricular winding and turning the ventricular winding such that the chords move closer to the center of the ventricular winding. The ventricular winding draws the chords closer together, thereby pulling the valve leaflets closer together in order to facilitate their coaptation and proper closing. A delivery system for maneuvering and releasing a heart valve repair device comprises an applicator tube and internal rod.

Abstract: In some embodiments, an apparatus includes a handle, an actuator, a pusher device, and a puncture member. A distal anchor is disposed at a distal end portion of an artificial chorda, or suture, and is in a delivery configuration. The artificial chorda, or suture, is coupled to the actuator and extends through a lumen of the puncture member. The actuator can be actuated to move the puncture member distally a preset distance, and to move the pusher device distally such that at least a portion of the distal anchor is moved distal to the distal end of the puncture member and the distal anchor is moved from its delivery configuration to a deployed configuration.

Abstract: An orthopedic implant system includes a wedge implant. The implant includes a body having an upper surface extending generally in a first plane. The upper surface has a first plurality of longitudinal grooves and a second plurality of transverse grooves extending therealong. Portions of the upper surface extend between adjacent longitudinal grooves and transverse grooves form individual peaks. A lower surface extends generally in a second plane, parallel to the first plane. The lower surface has a third plurality of longitudinal grooves and a fourth plurality of transverse grooves extending therealong. Portions of the lower surface extend between adjacent longitudinal grooves and transverse grooves form individual peaks.

Abstract: An improvised anthroplastic prosthetic implant having, in some embodiments, secondary screws with threaded shafts for forming pilot holes into the resected cancellous bone surface, such as the tibia, and primary screws with tapered heads for replacing the secondary screws and forming a Morse friction fit with the implant and seating the implant in close apposition to, and at less than 150 um in, resected bone thereby facilitating implant stability, wherein the heads of the primary screws are recessed into a counterbore in the baseplate to improve axial postoperative stability of the implant.

Abstract: A system and method for further improving upon an ability of a surgeon to reduce or eliminate impaction forces when installing or assembling a prosthesis. An implant includes a surface treatment for aiding operations with the implant. For example, some surface treatments provide an asymmetry in installation versus removal to bias the associated implant deeper into an installation site.

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: Coiled spinal implants for disc, vertebral body, and spinal motion segment replacement or reconstruction comprise a plurality of loops and spaces between the loops, with the loops formed of a hollow material and having a plurality of apertures or a longitudinal gap that extend(s) through the sidewalls of the loops and into the hollow center. The coiled implants include one or more balloons within the hollow center, the spaces between the coil loops, and/or within the central void that the coil surrounds. Filling the balloon expands the loops and thereby increases the height of the coil. Bone graft material or bone cement may be deployed from the apertures or gap.

Abstract: An expandable intervertebral spacer has a plurality of arms. The arms can be retracted or extended. The spacer has a width that is narrower than the width between the nerve roots near the posterior approach to an intervertebral space. Once inserted into the intervertebral space, the arms can be deployed. The deployed arms expand the height and width of the spacer. Once deployed, the spacer stabilizes two adjacent vertebrae. The arms are interconnected mechanically to deploy simultaneously.

Abstract: Embodiments herein are generally directed to expandable spinal implants, systems, apparatuses, and components thereof that can be used in spinal fusion and/or stabilization procedures, as well as methods of installation. The expandable spinal implants may be configured for lateral insertion.

Abstract: The present invention provides a cup positioning guide which has a mechanical link from a cup introducer connection distal to the hip socket, to one or more landmarks on the pelvis. It facilitates intra-operative checks and adjustments to be made to reamed hip socket depth, cup anteversion and cup rotation with the aid of a cup trial component.

Abstract: A surgical instrument comprises a first member defining a cavity configured for disposal of a plurality of implants and including a distal portion that retains the implants with the first member. An element is configured to urge the implants in a first, release direction and the first member having at least one tab movable to prevent movement of at least one of the implants in a second direction. A second member is engageable with the at least one tab. Systems, spinal implants and methods are disclosed.

Abstract: A bone fastener includes a receiver defining an implant cavity and having an inner surface defining a slot. A band is disposable within the slot. A spacer disposable within the slot. A crown is rotatable relative to the receiver to translate the spacer relative to the inner surface such that the spacer orients the band in a capture orientation with the shaft. A screw shaft connectable with the receiver by the band and configured to penetrate tissue. Implants, systems, instruments and methods are disclosed.

Abstract: A prosthetic knee having a passive knee locking mechanism that uses the same four-bar mechanics found in a natural knee. The flexible four-bar mechanism guides the motion of the knee, aids in the return of the knee from full flexion to extension, and connects a femoral gear to a tibial gear. The gears have a circular radius and are connected using parallel links to keep the femur and tibia together when the knee is active. The knee stays locked throughout the stance phase. At toe off, no weight is applied on the prosthetic knee allowing the knee to flex. The flexible links are stretched, thereby increasing the stiffness in the springs, and at terminal swing phase, moments before heel strike, the flexible links in the four-bar mechanism snap back to the extended/locking position and lockout once the user applies his/her weight on the knee.

Abstract: An attachment for a prosthetic foot comprising an attachment surface that couples to the edges of a foot plate of a prosthetic foot and an outer surface that functionally or cosmetically alters the foot plate of the prosthetic foot in order to adapt the prosthetic foot to the needs of the user. In another embodiment, a toe attachment for a prosthetic foot comprising a cavity that can receive the toe end of an elongate foot element of a prosthetic foot, the toe attachment that can functionally or cosmetically alter the elongate foot element in order to adapt the prosthetic foot to the needs of the user. In yet another embodiment, a seal cover that can removably engage a prosthetic foot and a cosmetic cover for a prosthetic foot, resulting in a substantially watertight connection between the seal cover and the prosthesis and the seal cover and the cosmesis.

Abstract: A hydraulic system for adjusting a prosthetic limb. The hydraulic system may include an expandable pad mounted onto an interior surface of a socket of the prosthetic limb. The hydraulic system may further include a hydraulic cylinder and a plunger mechanism. The hydraulic cylinder may be filled with a hydraulic oil. The hydraulic system may be configured to expand the expandable pad by pumping the hydraulic oil from the hydraulic cylinder into the expandable pad responsive to a volume decrease of the residual limb being more than a threshold.

Abstract: The subject invention is directed to devices and methods for producing devices for regulating blood flow in the venous system. In particular, the invention provides for artificial valves designed to regulate the flow of blood in human vessels, wherein such artificial valves include superior properties including fatigue resistance, biocompatibility, and ease of manufacture.

Abstract: A stent that has a reduced state, an expanded state, and a delivery state, includes helical windings, a bridge, and a sacrificial bridge. The helical windings define a cylinder with a helical axis including a strut having a straight portion connected to a curved portion, wherein the straight portion aligns with the helical axis. The bridge connects adjacent windings. The sacrificial bridge connects adjacent windings and is configured for removal in the expanded state.

Abstract: A method of manufacturing three-dimensional thin-film nitinol (NiTi) devices includes: depositing multiple layers of nitinol and sacrificial material on a substrate. A three-dimensional thin-film nitinol device may include a first layer of nitinol and a second layer of nitinol bonded to the first layer at an area masked and not covered by the sacrificial material during deposition of the second layer.

Abstract: A method of releasing a bare stent of a stent graft includes moving a lumen, to which a proximal apex capture portion of an apex capture device is fixed, the proximal apex capture portion defining a radial restraint, along a major axis between a first position, in which tines of the proximal apex capture portion are mated with slots of a distal apex capture portion and overlie bosses extending radially from a major axis of the apex capture device, and a second position, in which the tines are not mated with the slots and do not overlie the bosses, to thereby release apices of a bare stent from a space defined by the tines, the bosses and the distal apex capture portion.

Abstract: Embodiments provide methods and systems for treating aneurysms using filling structures filled with a curable medium. An embodiment of a method comprises positioning at least one double-walled filling structure across the aneurysm and filling the structure(s) with a filling medium so that an outer wall conforms to the inside of the aneurysm and an inner wall forms a generally tubular lumen to provide for blood flow. The lumen is supported with a balloon or other expandable device while and/or after filling. The pressure within the structure and/or in the space between an external wall of the structure and the aneurysm wall is monitored and a flow of the medium into the structure is controlled responsive to the pressure. The pressure can also be used to determine a filling endpoint. The medium is hardened while the lumen remains supported by the balloon. The balloon is then removed after the medium hardens.

Abstract: This invention relates to a method for manufacturing an individualized immobilization element for the non-invasive immobilization and/or mobilization of at least a segment of a body part of a patient in a predetermined position relative to a reference and/or in a pre-certain configuration. The method comprises the steps of (i) providing a data set that comprises a three-dimensional image of an outer contour of at least a part of the segment of the body part to be immobilized and/or mobilized and (ii) the manufacture of at least a part of the immobilization element by rapid manufacturing of a shape on the basis of said data set using a polymeric material containing a thermoplastic polymer having a melting point less than or equal to 100° C., wherein the polymer material contains a nucleating agent for enhancing the of the crystallization of the thermoplastic polymer.

Abstract: Orthopedic devices may include rigid members for coupling to portions of a limb that includes a joint, and a cable that couples to the rigid members and extends up to a powered element. The orthopedic devices are configured to produce beneficial forces using the rigid member and the cable, which beneficial forces are translated to the wearer. The orthopedic devices include control systems that generate control signals for controlling the powered element.

Abstract: A garment, containing a tubular joint supporter section, the section including: a central region in an axial direction of the tubular joint supporter section, which includes a wear pressure applying region for applying wear pressure to a joint site of a body, a one-end side region positioned at one end, and an other-end side region positioned at another end side, in which the wear pressure of the wear pressure applying region is higher than an average wear pressure of the one-end and other-end side regions, and regions other than the wear pressure applying region in the section include a concave-convex structure region formed from a concave-convex structure; and a knee supporter, in which an average wear pressure A of the knee support section is higher than an average wear pressure B of the thigh side support section and the shin side support section.

Abstract: A human interface device is configured to be coupled to a trunk of a person and comprises a frame, a fabric coupled to said frame configurable to be under tensile forces, and a belt configured to be coupled to two side edges of said frame wherein when said belt is worn by said person, an area of said fabric will be pushed against the person's lower back conforming to the shape of the lower back of said person. In operation when said human interface device is worn by said person, the weight of any load coupled to or supported by said frame will be partially supported by the friction force between the area of said fabric which is pushed against the person's lower back, and the person's lower back allowing said person to carry said load.

Abstract: A vest-type maternity belt according to the present invention includes: a maternity belt body provided in the shape of a vest; size adjusting VELCRO members configured such that female VELCRO members and a male VELCRO member are fixedly disposed on both sides of the front part of the maternity belt body and a fastening function is provided; hook fastener members configured such that hooks and loops are fixedly and oppositely disposed on both sides of the lower end portion of the front part of the maternity belt body and the abdominal load of the pregnant woman can be borne; and spine correction elastic bands formed as elastic members contained in the back part of the maternity belt body, and configured to support and correct the spine of the pregnant woman.

Abstract: Method of using a shape-formable apparatus. A shape-formable apparatus can include an envelope defining a chamber, a port positioned to fluidly couple the chamber with ambience, and at least two locking sheets positioned in the chamber in an at least partially overlapping configuration. Each locking sheet can include a major surface, and at least a portion of each locking sheet can be patterned to include solid regions and open regions, the solid regions being movable with respect to one another within the major surface. The method can include providing the shape-formable apparatus in a first state; forming the apparatus into a desired shape; and reducing the pressure in the chamber to change the apparatus from the first state to a second state in which the apparatus is substantially less formable than in the first state.

Abstract: An orthopedic cock-up wrist brace and splint for people with arthritis, carpal tunnel syndrome, sprains, fractures, tendonitis, repetitive strain injury, osteoporosis, or other wrist injury. The splint having a specially designed hourglass shape formed using medical fit data in addition to established sizing data and refined after comprehensive studies and testing. The splint supplied as a stand-alone product or as part of a wrist brace system.

Abstract: An device including a proximal portion adapted for placement intermediately within a hollow body cavity to capture and divert contents; the proximal portion being expandable from an initial state with an initial diameter, into an expanded state with a diameter greater than the initial diameter for engaging the proximal portion with an inner wall of the hollow body cavity; and a distal portion, connected to the proximal portion, adapted to extend through the abdominal wall or into the intestine to conduct the hollow body cavity contents out of the proximal portion.

Abstract: A stoma extender includes a first end for insertion into a stoma for diverting stomal effluent into the stoma extender before the effluent exits the stoma; a second end for remaining external of the stoma, for providing a discharge exit for stomal effluent; and a conduit portion coupled between the first and second ends for communicating stomal effluent through the stoma extender, wherein the length of the conduit portion is adjustable stably, to permit adaptation of the stoma extender to an individual's stoma.

Abstract: A flange extender for an ostomy bag comprises honey. In a preferred embodiment, the flange extender comprises a composition of hydrocolloid and medical grade Manuka honey and at least one release liner. Incorporation of honey into a flange extender provides additional adhesion to the skin of an ostomate and to a flange of an ostomy bag, increased wear time may possible and there may be reduced peristomal skin irritation. These advantages provide increased comfort for a user as well as reduced risk of infection through the antibacterial properties of honey.

Abstract: A system and method for reducing the likelihood of colorectal cancer in a human being includes the modification of an individual's gut microbes by employing a Clustered Regularly Interspaced Short Palindromic Repeats-CRISPR-associated system (CRISPR-Cas) or Clustered Regularly Interspaced Short Palindromic Repeats from Prevotella and Francisella 1 (CRISPR/Cpf1) system to modify only bacterial genes of bacteria that reside in the human gut that are non-homologous to those encompassed in the human genome, and in particular, to administer a therapeutically effective amount of a bacterial formulation comprising F. prausnitzii that has been modified to produce one of alliin or butyrate.