Abstract: A hard tissue stent, including an access hole formed in one side, may be placed over one or more of the patient's teeth where the access hole is accurately aligned at a location for drilling to, for example, remove infection. A soft tissue stent may be placed over one or more of the patient's teeth, where the stent can include a mark to cut to create an access flap in the soft tissue. By keeping the flap attached, the surgeon can more easily return the flap to the proper position. The attached surgical guide permits access any area of the jaw and tooth and implanted device. With insertion of a sleeve with custom bores into the guide, the dental surgeon can work in a dry field and accurately manipulate the bony crypt and tooth for many different purposes including root-end preparation, filling and repair of local perforations and cracks.

Abstract: A system for generating a desired result of an orthodontic treatment plan may include an orthodontic decision support system and a scanning system. The orthodontic decision support system generates orthodontic data that details the final desired position and orientation of the teeth of a user as part of a treatment plan for the user. The scanning system may gather orthodontic data for the user to input to the orthodontic decision support system in order to generate the final output.

Abstract: A method includes determining, from a first image of a mouth, a first region of the first image comprising a representation of teeth; generating one or more parametric functions associated with tooth color based on color data from the first region; receiving image data comprising new contours of the mouth, wherein one or more of the teeth have a different position in the image data than in the first image; determining a second region comprising the teeth in the image data; and generating a new image based on the image data and the one or more parametric functions, wherein a shape of the teeth is based on the image data and a color of the teeth is based on applying the one or more parametric functions to the second region of the image data.

Abstract: Interproximal reduction guides apparatuses and methods of making and using them are described herein. These interproximal reduction guides apparatuses may include a body that fits over the patient's dental arch and one or more guide slots formed in them configured to limit the motion of an interproximal reduction cutting tool in a defined manner.

Abstract: Systems and methods for moving a tooth using a light, continuous force are disclosed. In examples, a bracket has a surface which is mounted to a tooth, and a pair of wings defining a slot having oppositely disposed upper and lower surfaces that converge at an apex. A wire runs through the slot at a distance from the apex. And a tensioning device presses the wire against a surface of the slot, the system is configured so that the wire gradually moves toward the apex of the slot.

Abstract: This invention is directed to a shaped block, a dental implant abutment comprising an implant, an abutment and a shaped block, wherein the shaped block comprises a dried collagen matrix; and a method of preparation thereof.

Abstract: A method of forming a prosthetic tooth element (104) is disclosed, the method comprising depositing a first hardenable fluid material (101) at a bottom of a cavity (111) of a female mould (110) to a first level (113) , the first material having a first translucency when hardened; depositing in the cavity (111), over the first material (101), a second hardenable fluid material (102) to a second level (114), the second material having a second translucency when hardened, the second translucency being less translucent than the first translucency; and inserting a male mould (120) into the cavity (111), the insertion of the male mould displacing at least a portion of the second material (102) within the cavity (111).

Abstract: A method of treating teeth and gums within an oral cavity including treating the accessible surfaces and hard-to-reach surfaces of the teeth and gums. The method includes providing an oral care composition including a therapeutic amount of sodium bicarbonate, providing a tool that generates hydrodynamic power, and applying the oral care composition to the accessible surfaces and the hard-to-reach surfaces of the teeth and gums and generating hydrodynamic power within the oral cavity. The combination of the oral care composition and the hydrodynamic power more effectively removes biofilm from the accessible surfaces and the hard-to-reach surfaces of the teeth and gums.

Abstract: The present invention relates to a container (100) for producing a self-curing or dual-curing dental synthetic material composition (200), which container comprises a deformable wall (101), having a first synthetic material component (103-1); and a second synthetic material component (103-2) for curing the synthetic material composition (200) or starting a curing reaction.

Abstract: A system (10) and method for selecting a mouthpiece (25) for a user. The method includes receiving a signal with a personal care system (10) to initiate oral arch measurements using a personal care device (12). Data is collected from a position sensor (16) related to a location of a probe (14) of the personal care device as the probe is moved about an oral arch of the user. A controller (18) of the personal care system determines a dimension of the oral arch from the data. The controller selects a mouthpiece for the user based on the dimension of the oral arch. Information identifying the mouthpiece is transmitted to the user or other intended recipient.

Abstract: A method of treating stress urinary incontinence includes moving a vaginal fornix of a female patient adjacent to a pectineal ligament of the female patient and securing the vaginal fornix to the pectineal ligament. The method may include inserting a fastener applier into a female patient to secure the vaginal fornix to the pectineal ligament. The method may include positioning a fastener applier adjacent to the vaginal fornix before moving the vaginal fornix.

Abstract: Disclosed herein are medical devices comprising biocompatible substrates and one or more fixation elements, and methods for making and using the same.

Abstract: A method is disclosed for removing a vascular occlusion, such as a clot, from a blood vessel. A tubular sheath is inserted into the vessel and a self-expanding Nitinol mesh filter is deployed from a distal end of the tubular sheath at a location proximal to a clot. An inner catheter is advanced through the tubular sheath and through the mesh filter for contacting the clot. An expandable agitation element is provided along a distal end portion of the inner catheter for cutting or chopping the clot, thereby facilitating removal of the clot and improving blood flow through the vessel. Resulting clot particles are captured by the mesh filter. Negative pressure may be applied along a proximal end portion of the sheath for aspirating remaining particles. Certain embodiments of the method are well-suited for treating deep vein thrombosis and do not require the use of thrombolytic drugs.

Abstract: A catheter device and method are disclosed for transvascular delivery of a medical device to a cardiac valve region of a patient. The catheter device comprises an elongate sheath with releasable locking members for controllably locking the elongate sheath in a shape at least partly along its length from a relaxed state to a locked state when positioned in relation to a cardiac valve. Furthermore, alignment members are provided to provide for a desired positioning in relation to the cardiac valve. Embolic protection is further provided.

Abstract: Devices, systems and methods for filtering embolic particles that may be generated from a medical procedure including protection of the major branching vessels from the aorta, and catches and filters emboli that may be generated during the TAVR procedure. The filter devices disclosed herein form an improved seal against the vessel wall that is activated by flowing blood. Devices described herein also allow for the closing of the ends of the filter device after capture of emboli, providing further security against accidental loss of emboli post capture.

Abstract: An implantable containment apparatus for receiving and retaining a plurality of cells for insertion into a patient, such as into a tissue bed, is disclosed. The device includes a chamber having structural spacers therein to maintain an average distance between the first interior surface and the second interior surface of the chamber and to define at least one reservoir space for the placement of cells within the chamber.

Abstract: A stent for treating a physical anomaly. The stent includes a skeletal support structure for expanding in the physical anomaly and a shape memory material coupled to the skeletal support structure.

Abstract: Soft tissue repair grafts are provided for supporting, covering, and/or retaining an implant positioned in the body of a subject. The grafts are particularly suitable for use for pre-pectoral breast reconstruction with a breast implant or tissue expander. The grafts include positional notches for more accurate positioning in a subject. The grafts also include at least one cuff element which is folded to form a reinforced folded edge for suturing the graft more securely to adjacent tissues than previously known grafts. The grafts also include a plurality of arcuate slots which form a plurality of circular patterns arranged concentrically about a focal point, thereby enabling the grafts to expand without tearing and to conform more closely to the implant and/or adjacent body tissues such as the breast pocket, than previously known grafts. Acellular dermal matrices are particularly suitable for making the soft tissue repair grafts.

Abstract: The present disclosure provides devices and methods for treating the breast. The devices can include an acellular tissue matrix having a predefined shape. The shape can include a first edge with an S-shaped configuration and a second arcuate-shaped edge. The shape alternatively can include a first concave edge and a second convex edge.

Abstract: A clip for immobilizing leaflets of a cardiac or venous valve includes a hub having a pair of tangle resistant spring-biased outer arms coupled to an inferior end of the hub. A pair of tangle-resistant spring-biased inner arms lies adjacent to the outer arms and is coupled to a superior end of the hub. The clip may incorporate adjustable spacers and retrievable post implantation. A delivery catheter is used to position the valve clip adjacent a target valve while the outer and inner arms are biased in an opened position relative to each other. After the valve leaflets are located between the opened outer and inner arms, the biasing forces may be released to allow the clip to self-close over the valve leaflets.

Abstract: The disclosure relates to a device for supporting functions of a heart valve and methods for making and using the same. The device includes a flow optimizer configured to be located in the valve and having a cross sectional area that reduces a regurgitation orifice of the valve during systole. The device includes an anchoring mechanism coupled to the flow optimizer and configured to fix a position of the flow optimizer relative to the valve. The flow optimizer allows hemodynamic flow during diastole, minimizing risk of inducing atrioventricular pressure gradient and thrombogenesis, and seals or minimizes the regurgitation orifice during systole and reinstates efficacy of the valve. The anchoring system requires no traumatic interaction with the valve, atrium and ventricle. Implantation of the device can be achieved without invasive surgery. The device permits intra-procedural optimization of the positioning of the flow optimizer.

Abstract: A docking device includes a hollow cylindrical body portion having an internal surface and an outer surface. The hollow cylindrical body portion is formed of a three-dimensional (3D) woven fabric comprising a plurality of different types of fibers.

Abstract: A device for implanting a heart prosthesis including a central body, a containment portion having one or more sub-components, and a release device for the central body capable of being inserted into a catheter. A device for assisting the connection operation between the central body and the sub-components of the containment portion includes an assembly of catheters, of which there are at least two catheters for each sub-component of the containment portion, the catheters being joined to each other over a portion thereof and having at least one free end for each catheter.

Abstract: A valve stent and a valve prosthesis. The valve stent is in the shape of a mesh tube, and has a compressed state and an expanded state. The valve stent includes an inflow tract structure, a transition tract structure, an outflow tract structure, and a barb structure. The transition tract structure has a fifth end portion, a sixth end portion, and a first middle section. In the expanded state, the diameters of the radial sections of the fifth end portion and the sixth end portion are greater than the diameter of the radial section of the first middle section of the transition tract structure. The outflow tract structure has a seventh end portion and an eighth end portion. The seventh end portion of the outflow tract structure is fixedly connected to the sixth end portion of the transition tract structure, and the eighth end portion is a free end.

Abstract: Apparatus and methods are described herein for a secondary valve apparatus that can be deployed within an existing implanted prosthetic heart valve. In some embodiments, a secondary prosthetic heart valve apparatus is implanted in series with an existing deteriorating implanted prosthetic valve. The secondary valve apparatus can restore proper valve function without disruption to the failing previously implanted valve. In some embodiments, the secondary valve apparatus can be positioned on an atrial portion of the existing valve, and be delivered transseptally. In other embodiments, the secondary valve apparatus can be positioned at a ventricular portion of the existing valve and delivered transapically. Devices and methods to prepare the existing valve to receive a secondary valve apparatus are also described herein. In some embodiments, a balloon expansion device can be used to expand an inner diameter of the existing valve to provide space for the secondary valve to be disposed.

Abstract: A method for heart valve replacement comprises forming an incision in a wall of a ventricle of a heart and inserting a delivery apparatus and a prosthetic heart valve through the incision and into the ventricle of the heart. The prosthetic valve comprises a self-expanding frame having an annular main body and a valve member disposed within the annular main body. The prosthetic valve further comprises an atrial sealing member formed by an annular metal ring and a fabric, wherein only the fabric of the atrial sealing member is connected to the main body for enhancing the flexibility and conformability of the atrial sealing member. The method further comprises deploying the prosthetic valve from the delivery apparatus such that the atrial sealing member extends radially outwardly from the main body within an atrium of the heart and the main body self-expands to a deployed state within a native heart valve.

Abstract: The present invention is directed to prostheses including a support structure having a proximal end and a distal end, and a motion limiting member attached to the distal end of the support structure, wherein the motion limiting member is configured to restrict radial expansion of the distal end of the support structure. Methods for delivering the prosthesis are also provided.

Abstract: An implantable prosthetic device for repairing a native valve includes a first clip, a second clip, a first cord, and a second cord. The first clip has a first arm and a second arm and is moveable between an open position and a closed position. The second clip has a third arm and a fourth arm and is moveable between an open position and a closed position. The first cord is operatively coupled to the first clip for moving the first clip between the open and closed position. The second cord is operatively coupled to the second clip for moving the second clip between the open and closed position. The device is configured to clamp a first leaflet of the native mitral valve between the first arm and the second arm and to clamp a second leaflet of the native mitral valve between the third arm and the fourth arm.

Abstract: A delivery device includes a handle, a sheath distally extending from the handle, a capsule distally extending from the sheath, and a pull wire having a proximal end attached to the handle and a distal end attached to the capsule. The sheath defines a central lumen there-through and has a longitudinally-extending lumen formed within a wall of the sheath. The capsule has a tubular body with an intermediate region having a plurality of ribs and a plurality of slots defined therein. The capsule includes an indented segment defined on the tubular body, the indented segment being disposed radially inward relative to the tubular body. The pull wire is tensioned to bend the capsule. The pull wire is slidably disposed within the longitudinally-extending lumen of the sheath and along an inner surface of the tubular body of the capsule with a portion of the pull wire crossing over an outer surface of the indented segment.

Abstract: A delivery system for percutaneously delivering a heart valve prosthesis to a site of a native heart valve includes a delivery catheter and a heart valve prosthesis. The delivery catheter includes an outer sheath, an inner shaft, and an orifice restriction mechanism. The heart valve prosthesis has a valve member and a docking member. When the orifice restriction mechanism is positioned within the docking member within an annulus of the native heart valve, the orifice restriction mechanism temporarily replicates the operation of the native heart valve until the valve member is positioned within the docking member.

Abstract: A guide wire introduction device for positioning at least one guide wire around a heart valve. The device includes a first catheter provided with a distal deflection system, a second catheter inserted inside the first catheter, at least one lumen capable of causing a guide wire to slide therein and provided with a distal deflection system for deflecting the end thereof through an angle greater than 90°, and a third catheter inserted inside the first catheter. The third catheter has a guide wire capturing device therein is provided with a distal deflection system.

Abstract: A prosthetic heart valve holder system includes a prosthetic heart valve having a base at an inflow end, a plurality of commissure posts extending from the base toward an outflow end, and valve leaflets secured to the commissure posts to permit flow through the heart valve. A deflector is provided at the outflow end having a central hub and a plurality of arms extending from the central hub secured to and covering the tips of respective commissure posts. A valve support body is secured to the base and a post connects the valve support body to the hub of the deflector.

Abstract: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. The steerable delivery system can contain a steerable rail configured for multi-plane bending to direct a distal end of the delivery system.

Abstract: Anchors for securing an implant within a body organ and/or reshaping a body organ are provided herein. Anchors are configured for deployment in a body lumen or vasculature of the patient that are curved or conformable to accommodate anatomy of the patient. Such anchors can include deformable or collapsible structures upon tensioning of a bridging element in a lateral direction, or segmented tubes that can be adjusted by tightening of one or more tethers extending therethrough. Such anchors can be used as a posterior anchor in a blood vessel in implant systems having a tensioned bridging element extending between the posterior anchor and an anterior anchor deployed at another location within or along the body organ. Methods of deploying such anchors and use of multiple anchors or multiple bridging elements to a single anchor are also provided.

Abstract: A method for transcatheter delivery to a native heart valve needing replacement. A first component is attached to the native annulus upstream of the native leaflets maintaining native leaflet function, and is held to the native annulus by barbs that are activated by a torus balloon after the first component is fully expanded. The torus balloon can be implanted along with the support frame. A limiting cable restricts further expansion of the first component and holds a second component that contains the replacement leaflets.

Abstract: A sutureless implant for replacing damaged natural chordae tedineae of a human or possibly animal heart, the implant including a distal implant part, a proximal implant part, and an artificial chord. The distal implant part is configured to fit in a lumen of an implant delivery device and includes a self-spreading portion spreading radially outside when the distal implant part is released from the lumen, the self-spreading portion being capable of anchoring the distal implant part in human muscle tissue. The proximal implant part is configured to fit in the lumen of the implant delivery device and comprises a self-spreading portion spreading radially outside when the proximal implant part is released from the lumen, the self-spreading portion being capable of bearing on a tissue portion of leaflet tissue. The distal implant part and the proximal implant part are connected by the chord.

Abstract: An implantable composition, method of making and using the implantable composition is provided. The implantable composition comprising a first set of fibers and a second set of fibers, the first set of fibers manufactured to have a first binding surface, the second set of fibers manufactured to have a second binding surface, the first binding surface of the first set of fibers configured to bind at least at or near the second binding surface of the second set of fibers and the second set of fibers configured to bind at least at or near the first binding surface of the first set of fibers.

Abstract: Formable mesh implants suitable for correcting bone implants are disclosed. A formable mesh may include a plurality of node plates that define a lattice, where connecting arms extend from each node plate. Each connecting arm associated with a given node plate connects with a plurality of adjacent connecting arms at a respective intermediate connection region, such that each connecting arm associated with the given node plate is connected to a different intermediate connection region, and such that neighboring node plates are indirectly connected through multiple connecting arms. At least a subset of the node plates may respectively include a screw-receiving aperture, and the intermediate connection regions may be absent of screw-receiving apertures. In another example embodiment, a formable mesh is disclosed in which each connecting arm of a given node plate connects with an adjacent node plate, where adjacent node plates are directly connected through at least two connecting arms.

Abstract: A lubrication device for lubricating a joint of a human or mammal patient, which is entirely implantable in a patient's body, comprises a reservoir for storing a lubricating fluid and a fluid connection for introducing the lubricating fluid into the joint when the device is implanted in the patient's body. Further, the fluid connection comprises a fluid connection device connecting the reservoir with the joint such that a lubricating fluid flow is established from the reservoir into the joint. The fluid connection comprises either an infusion needle adapted to be intermittently placed into the joint for injecting the lubricating fluid, or a tube adapted to be permanently placed into the joint for continuously injecting the lubricating fluid.

Abstract: A build-plate with integrally-formed spinal implant constructs and a method used in forming spinal implant constructs on the build plate and machining the spinal implant constructs formed on the build plate to manufacture spinal implants is provided. The spinal implant constructs can be formed via additive manufacturing processes by adding material to an upper surface of the build plate, and then the spinal implant constructs can be subjected to subtractive manufacturing processes to form the spinal implants.

Abstract: The present disclosure relates to a three-dimensionally (3D) printed tissue engineering scaffold for tissue regeneration and a method for manufacturing the 3D printed tissue engineering scaffold. The 3D printed tissue engineering scaffold may be fabricated at least in part from a composite material having an insoluble component and soluble component. The three-dimensional tissue scaffolds of the disclosure may be fabricated via a rapid prototyping machine. In some instances, the three-dimensional shape of the fabricated tissue engineering scaffold may correspond to a three-dimensional shape of a tissue defect of a patient.

Abstract: A system, device/implant, method and processes for manufacturing a filament and an implant having at least one or a plurality of areas in the implant comprised of selectively-place bone to facilitate osteoconductivity and, potentially, osteoinductivity after the implant is implanted into a patient.

Abstract: A bone screw implant is provided for immobilizing the articular surfaces of two bone segments by securing, fusing, or compression the two segments. The implant may be fabricated from a porous biocompatible metal and have a cylindrical shape and fully or partially threaded and may have variable pitch threads and a variable diameter of the shaft. The implant may include a blunt tip or a fluted self-drilling tip and a headless screwdriver socket. Large pitch cancellous threads may be in the leading-end portion of the cylinder shaft, and smaller pitch cortical threads may be at the trailing edge portion of the shaft. The implant may be fenestrated, it may have a roughened surface, and it may be coated with an osteoconductive material. The implant may be cannulated. In a specific embodiment, the implant is used for immobilizing the articular surfaces of a sacroiliac joint.

Abstract: Embodiments of a system and method for assessing hip arthroplasty component movement are generally described herein. A method may include receiving data from a sensor embedded in a femoral head component, the femoral head component configured to fit in an acetabular component, determining information about a magnetic field from the data, and outputting an indication of an orientation, coverage, or a force of the femoral head component relative to the acetabular component.

Abstract: According to one example, a posterior-stabilized femoral prosthesis for a knee arthroplasty. The femoral prosthesis can include medial and lateral condyles, a femoral cam and a recess. The medial and lateral condyles can be shaped to articulate with a tibial articular surface of a tibial bearing component through a range of motion, in which full extension corresponds to zero degrees flexion of a knee joint and positive flexion corresponds to greater than zero degrees flexion of the knee joint. In a sagittal plane, the medial and lateral condyles can define medial and lateral multi-radius curves, respectively. The medial multi-radius curve can have a single common radius swept through a first angular extent to define a single arc length that extends from between substantially ?20 degrees flexion to substantially 90 degrees flexion, inclusive.

Abstract: A system and method for sharing and absorbing energy between body parts. In one particular aspect, the system facilitates absorbing energy between members forming a joint such as between articulating bones.

Abstract: A medical device includes an implant anchor comprising first and second opposing end portions. The implant anchor may also include a fixation element to configured to couple the implant anchor to an implant, and an anchor element configured to couple the implant anchor to bone. At least a portion of the implant anchor has a porous structure.

Abstract: The invention concerns a prosthesis comprising: a stem part comprising: a rod, configured for being inserted into a medullary cavity of a diaphyseal fragment of a fractured long bone, for securing the stem part to the diaphyseal fragment, and an epiphyseal end, fixedly secured to the rod by means of at least one linker leg of the stem part, so that a gap is formed between the epiphyseal end and the rod along said at least one linker leg; and an implant distinct from the stem part and comprising: an internal part located at least partially within the gap, and at least one fastener for fastening epiphyseal fragments of the fractured long bone to the stem part, said at least one fastener being secured to the internal part.

Abstract: An improved surgical system and procedure for correcting a deformity between first and second bones using an alignment guide based on a correction factor. The correction factor can be based on a virtual model of the first and second bones in a deformed configuration and a corrected configuration. In the virtual corrected configuration, first and second virtual axes can be fixed in the respective first and second bones. When reverted to the virtual deformed configuration, the orientation of the first and second axes can be used to determine the correction factor. The alignment guide is used to insert one or more k-wires into each of the first and second bones in a deformed configuration. A correction guide is passed along the k-wires to rotate and/or translate the first bone relative to the second bone into the corrected configuration.

Abstract: A partial endoprosthesis device preserves the motion of a vertebral joint for implant into a spinal segment and includes an articular portion having a thickness that increases in the direction of introduction between the articular facets. The articular portion is elongated along a longitudinal axis with a opposite first and second faces. The first face has a central protrusion that is configured so that, by implanting the device with the articular portion inserted between an upper articular facet of a lower vertebra and a corresponding lower articular facet of upper vertebra adjacent to the lower vertebra, and with the first face in contact with either the upper or lower articular facet, and with the second face in contact with the other articular facet, the articular portion, with the first face, pushes against the first articular facet and finally becomes integral by osteointegration with the lower articular facet.