Abstract: An assembly for guiding a medical apparatus within a patient includes an elongated shaft and a balloon affixed to the shaft and movable between a collapsed condition and an expanded condition. A mesh material may be affixed to the shaft and movable between a collapsed condition and an expanded condition. The balloon may project away from the shaft when the balloon is in the expanded condition. The mesh material may project away from the shaft when the mesh material is in the expanded condition.

Abstract: A method of delivery a prosthetic heart valve includes inserting a delivery apparatus and a prosthetic heart valve into a patient's vasculature. The delivery apparatus includes a steerable guide catheter, a balloon catheter, and a flex indicator. The balloon catheter extends coaxially through the guide catheter, the prosthetic heart valve is mounted on a distal end portion of the balloon catheter, and the flex indicator is movably coupled to a handle of the guide catheter. The method further includes adjusting flexion of a steerable section of the guide catheter to position the prosthetic heart valve. The flex indicator moves relative to the handle of the guide catheter as the flexion of the steerable section is adjusted, and the handle comprises one or more visual indicators adjacent the flex indicator to provide visual indication of an amount of flexion of the steerable section of the guide catheter.

Abstract: The present disclosure relates to numerous devices and methods for transcatheter stented prosthetic heart valve loading and delivery. Such devices and methods reduce suture tangling and also provide the ability to adjust the stented prosthetic heart valve expansion and contraction prior to the final release of the stented prosthetic heart valve from the delivery device.

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a stent having a collapsed condition, an expanded condition, and cells arranged in circumferential rows. The stent has an anterior side configured to be disposed adjacent an anterior native valve leaflet and a posterior side configured to be disposed adjacent a posterior native valve leaflet. A valve assembly having a plurality of leaflets is disposed within the stent and a flange is disposed about the stent. The flange includes a flared portion adjacent the inflow end and a body portion extending from the flared portion to the outflow end, the flange extending between a first set of attachment points adjacent the inflow end, and a second set of attachment points adjacent the outflow end.

Abstract: A prosthetic device for treating a mitral valve includes a prosthetic insert member insertable between leaflets of mitral valve. The insert member has an elongated cross-sectional profile for conforming to gap between leaflets of a mitral valve. The device also includes an anchoring member for attachment to heart tissue for maintaining the insert member in the mitral valve. The insert member includes a valve that permits one-way blood flow therethrough. An anchoring member secures the prosthetic insert member to a heart wall.

Abstract: The invention is a gauge for the reconstruction of a cusp of an aortic valve, with the gauge (10) being made from a material that can be deformed in a plastic fashion using manual force.

Abstract: Computer implemented methods of producing a mesh implant having a compartment to enclose a bone material therein are provided. These methods include generating a 3D digital model of the mesh implant having the compartment, the 3D digital model including a virtual volume of the compartment and a virtual depth, thickness and volume of the mesh implant; generating a 3D digital model of a covering configured for closing the compartment of the mesh implant, the 3D digital model including a virtual volume of the covering for closing the compartment of the mesh implant; and instructing a 3D printer coupled to a computer to generate the mesh implant based on the 3D digital models. A computer system for making a mesh implant and a delivery system including the mesh implant are also provided.

Abstract: The present invention relates to an artificial joint comprising a first joint portion (101), a second joint portion (105) and an intermediate portion (103). The first joint portion and the second joint portion each comprise an electrically conductive material and the intermediate portion comprises a non-conductive material and is arranged in between the first joint portion and the second joint portion such that the first joint portion is electrically isolated from the second joint portion. The artificial joint further comprises an internal electronic unit (110) provided inside of the isolating portion being connected to the first joint portion via at least one first electrode (111) and to the second joint portion via at least one second electrode (113). Thus, a first voltage can be applied to the first joint portion and a second electric voltage can be applied to the second joint portion, the voltages being with reference to a common reference potential.

Abstract: A replacement knee implant has a femoral implant and a tibial implant, each of which are inset in a bone surface. The tibial implant is generally elongated with one end rounded and an opposite end conforming to the shape of the tibia, and is made of a metal alloy or a ceramic. The upper surface is dished while the lower surface is planar and can be parallel or sloped relative to the upper surface, and can have a keel for fixation. The femoral implant for implementation in a femoral condyle is rounded such that, when implemented, the femoral implant is flush at the anterior and posterior sides and protruding away from the femur between the anterior and posterior ends. The femoral implant can have an elongated keel for extending into the femur, and can be made from a highly cross-linked polyethylene.

Abstract: An orthopaedic knee prosthesis includes a femoral component which exhibits enhanced articular features, minimizes removal of healthy bone stock from the distal femur, and minimizes the impact of the prosthesis on adjacent soft tissues of the knee.

Abstract: A spinal implant has proximal and distal regions, and includes upper and lower bodies. A proximal adjustment assembly is disposed between the upper and lower bodies in the proximal region of the spinal implant and is adjustably coupled to the upper and lower bodies, and a distal adjustment assembly is disposed between the upper and lower bodies in the distal region of the spinal implant and is adjustably coupled to the upper and lower bodies. The proximal and distal adjustment assemblies are independently movable with respect to each other, both concurrently and alternately, to change a vertical height of at least one of the proximal or distal regions of the spinal implant. A set screw is removably disposed within the proximal region of the spinal implant to lock the vertical height of the proximal and distal regions of the spinal implant.

Abstract: An intervertebral disc includes a superior endplate having an upper vertebral contacting surface and a lower bearing surface, wherein the upper vertebral contacting surface of the superior endplate has a central portion that is raised relative to a peripheral portion of the superior endplate, and wherein the lower bearing surface has a concavity disposed opposite the raised central portion. The disc includes an inferior endplate having a lower vertebral contacting surface and an upper surface, wherein the lower vertebral contacting surface of the inferior endplate has a central portion and wherein the upper bearing surface has a concavity disposed opposite the central portion. A core is positioned between the superior and inferior endplates, the core having upper and lower core bearing surfaces configured to mate with the bearing surfaces of the superior and inferior endplates.

Abstract: An intervertebral prosthetic implant having a first endplate having a first surface configured to substantially engage with a first vertebral body and a second surface having an extension with a concave contact surface, the concave contact surface being spaced apart from the second surface. A second endplate is provided with a first surface configured to substantially engage with a second vertebral body and a second surface comprising a convex contact surface, and the second endplate having a securing element positioned along and above the second surface defining a first and second window on opposing sides of the second surface. The securing element extends along the width and length of the lower endplate and configured with an access hole. An extension portion extends from the first surface of the first endplate through the access hole of the securing element and contacts the second surface of the second endplate.

Abstract: A stand-alone interbody fixation system having a cage, anterior fixation blade and posterior fixation blade. The cage includes an annular side wall with an open interior and upper and lower surfaces, the cage being configured to fit between end plates of adjacent vertebrae. The anterior fixation blade includes an anterior alignment boss with two opposing outward extending anterior blades with end plate penetrating tips configured to fit within the open interior of the cage. The posterior fixation blade includes a posterior alignment boss with two opposing outward extending posterior blades with end plate penetrating tips configured to fit within the open interior of the cage. The anterior alignment boss and posterior alignment boss being rotatably coupled to each other and with a first opening and a second opening in the annular side wall opposite the first opening.

Abstract: Methods, devices and systems for the planning and execution of computer-assisted robotic surgery are provided. The methods include methods to collect information about bones and prostheses, use the information to create virtual models and simulations, optionally receive input based on user discretion in generating the cut file, and to generate instruction for the execution of cut paths during the surgery. The system and devices include computers and peripherals and set-ups to link the components together into functional systems.

Abstract: A method and system for determining the orientation of a surgical tool with respect to a bone of a patient are disclosed. The method includes defining a bone reference plane using a processor; receiving first information at the processor from a first active sensor attached to the bone at a location having a predetermined relationship with the plane, the first information relating to a movement of the first sensor and wherein changes in orientation to the plane are trackable through changes in orientation of the first sensor; receiving second information from a second active sensor attached to the surgical tool, the second information relating to a movement of the second sensor; and determining a three-dimensional orientation of the surgical tool with respect to the plane based on the first and second information. The reference plane may be defined from distances between at least three predetermined reference locations on the bone.

Abstract: A surgical tool and method used to extract an acetabular cup from an acetabulum with minimal or no bone damage even if there has been significant bone ingrowth prior to the extraction process. The tool is designed for use with a reverse hip prosthesis wherein the acetabular cup comprises a stem extending from its concave surface and an acetabular ball is affixed to the stem. The tool is rotated on the ball and a blade is thereby caused to rotate adjacent or in close proximity to a convex surface of the cup in a position between the acetabular bone and the cup, thereby separating the cup from the bone.

Abstract: The present application provides an apparatus and method for determining a position of a joint prosthesis using a computer assisted orthopedic surgery system in support of an arthroplasty surgery. The apparatus and method includes attaching a first locatable element to a first bone on one side of a joint, providing a sensor having a second locatable element and moving the sensor in proximity of the joint to locate a plurality of positions of the sensor relative to the first locatable element using a tracking devise. The apparatus and method further includes selecting a generic model of a joint, determining the generic model in response to the plurality of positions located using the tracking device to generate a deformed model, determining a position for a joint prosthesis on the deformed model, and outputting on a display the determined position upon the deformed model.

Abstract: A method according to one embodiment includes locating distal lateral and medial condyles and posterior lateral and medial condyles a femoral bone model, and determining a posterior resection plane based on locations of the distal lateral and medial condyles, one or more dimensions of a prospective femoral implant, and one or more surgical preferences. The method may further include determining a first distance between the posterior medial condyle and the posterior resection plane and a second distance between the posterior lateral condyle and the posterior resection plane, determining a difference between a target value and an average of the first distance and the second distance, wherein the target value is associated with a thickness of the prospective femoral implant, and selecting a desired femoral implant size based on the difference between the target value and the average determined for each of a plurality of possible femoral implant sizes.

Abstract: Systems and methods of operating a lower limb device having at least a powered joint are provided. A method includes configuring the device to a first state in a finite state model for a current activity mode including a stair ascent mode or a stair descent mode. The method also includes, based on real-time sensor information, transitioning the device between different states in the finite state model when pre-defined criteria for transitioning among the different states are met. In the method, the finite state model for stair ascent includes lifting and swing phases, where the lifting phase includes a powered knee extension and a powered ankle push-off. The finite state model for stair descent includes yielding and swing states, where the swing states include providing a powered plantarflexion of the powered ankle joint and the yielding states include providing a resistive and passive plantarflexion of the powered ankle joint.

Abstract: A prosthesis with a lower limb attachment part, a foot part, a connection element with a joint function that connects the lower limb attachment part with the foot part, and a release device which can be brought into a locking position in which the foot part and the lower limb attachment part are connected to each other in a rotationally fixed manner at least relative to a dorsal extension movement, and into a release position in which the foot part can be rotated relative to the lower limb attachment part. The release device is designed to passively switch from the locking position into the release position when a variable which correlates to an ankle torque (M) in the connection element lies above a pre-set threshold.

Abstract: Driving modules, motion assistance apparatuses including at least one of the driving modules, and methods of controlling at least one of the motion assistance apparatus may be provided. For example, a driving module including a driving source on one side of a user and configured to transmit power, an input side rotary body connected to the driving source and configured to rotate, and a first decelerator and a second decelerator configured to operate using the power received from the driving source through the input side rotary body, wherein a gear ratio from the input side rotary body to an output terminal of the first decelerator differs from a gear ratio from the input side rotary body to an output terminal of the second decelerator, may be provided.

Abstract: A battery pack including a case, a battery included in the case and relatively movable with respect to the case, a generator attached to the battery and including a generation axis, and a rotation member connected to the generation axis, wherein the rotation member is configured to act a torque enabling the generation axis to be rotatable when the battery is in motion.

Abstract: Methods and systems to interface between physiological devices and a prosthetic device, including to receive a plurality of types of physiological activity signals from a user, decode a user movement intent from each of the plurality of signals types, and fuse the movement intents into a joint decision to control moveable elements of the prosthetic device.

Abstract: There is provided a motion reproducing system and a motion reproducing apparatus that store human motions and reproduce them. The motion reproducing system includes a data acquiring apparatus acquiring body motion data representing a motion of a subject during the motion, and transmitting the body motion data, a data managing apparatus receiving the body motion data from the data acquiring apparatus, the data managing apparatus including a memory storing the body motion data, and a motion reproducing apparatus receiving the body motion data stored in the memory from the data managing apparatus, and allowing a reproducer to reproduce the motion of the subject using the body motion data, the motion being performed at the time of acquisition of the body motion data.

Abstract: Embodiments are directed to radiopaque implantable structures (e.g., stents) formed of cobalt-based alloys that comprise cobalt, chromium and one or more platinum group metals, refractory metals, precious metals, or combinations thereof. Platinum group metals include platinum, palladium, ruthenium, rhodium, osmium, and iridium. Refractory metals include zirconium, niobium, rhodium, molybdenum, hafnium, tantalum, tungsten, rhenium, and precious metals include silver and gold. In one embodiment, the one or more included platinum group or refractory metals substitute at least partially for nickel, such that the alloy exhibits reduced nickel content, or is substantially nickel free. The stents exhibit improved radiopacity as compared to similar alloys including greater amounts of nickel.

Abstract: A prosthesis includes a first wire bent into a first waveform and spirally wrapped into a first helix having a plurality of windings that form a hollow cylindrical shape and a second wire bent into a second waveform and spirally wrapped into a second helix having a plurality of windings that form a hollow cylindrical shape. The first and second wires are disposed relative to each other such that the plurality of windings of the first wire and the plurality of windings of the second wire are disposed about a common longitudinal axis and the plurality of windings of the first wire and the plurality of windings of the second wire are axially offset from each other, with windings of the plurality of windings of the first wire alternating or interwoven between windings of the plurality of windings of the second wire along a length of the prosthesis.

Abstract: The present disclosure describes intraluminal support devices having high radial stiffness regions with smaller diameter and low radial stiffness regions with larger diameter. When deployed to the vasculature of a patient in need of treatment, the high radial stiffness region is sized such that it has approximately the diameter of the vessel in need of treatment, so that it produces substantially zero chronic radial force when the vessel is not being subjected to external compression. The low radial stiffness regions anchor the device to the vessel wall and provide a less-abrupt transition from the high radial stiffness structure. Methods of making and using such devices are also described.

Abstract: An apparatus and method for controlling inflation pressure, pressurization rate, and volumetric flow rate of a balloon during deployment of a stent or scaffold is disclosed.

Abstract: A delivery device according to principles described herein includes a catheter having three concentric shafts including an inner core, an outer sheath over the inner core and an outer support shaft at least partially extending over the inner core and the outer sheath. A timing belt having a plurality of belt teeth on a surface of the timing belt is coupled to an outer sheath over a medical device or stent on the inner core such that movement of the timing belt link causes movement of the outer sheath from its position over the medical device or stent. The delivery device is actuated by rotation of a thumbwheel a thumbwheel coupled to a barrel having a plurality of teeth such that rotation of the thumbwheel causes movement of the barrel such that the barrel teeth engage the belt teeth to cause movement of the timing belt causing movement of the outer sheath.

Abstract: In apparatus and methods for rapid deployment of tissue anchors, a tissue manipulation assembly has a pivoting jaw. A needle assembly can be advanced through the launch tube across tissue received between the jaw members of the tissue manipulation assembly. Tissue anchors can be advanced through the needle assembly for securing received tissue. The tissue anchors can be positioned within a reloadable chamber of a control handle disposed outside the patient, then advanced through the needle assembly.

Abstract: An ankle brace which is positioned on an ankle of a person which incorporates a tensioning structure which permits full range of motion to the ankle joint but which prevents the ankle joint from moving past its normal range of motion to protect the ankle joint. An optional ankle strap system is also provided.

Abstract: A therapy aid device for improving rotation of shoulder complex is provided. The device includes an upper portion and a lower portion joined together by an angled connector. The upper portion is configured to attach to a user's upper arm and the lower portion is configured to attach to the user's lower arm. The lower portion may also be configured to keep a user's hand in a flexed angled position. Using the device, the user may rotate the shoulder and move while keeping the upper and lower arms and wrist in specific positions. For example, the user may rotate his shoulder such that the user's hand and forearm move away from the torso while the elbow generally remain in the same location.

Abstract: An arm restraint system is provided for restraining movement of an arm of a patient's body lying over a top surface of a table. The system includes a rigid support frame located at a lateral edge of said table and a padded restraint configured to at least partially receive the arm of said patient. The padded restraint is securely fixed to the rigid support frame, via a repositionable fastener, to inhibit movement of the patient's arm relative to the rigid support frame and thereby maintain the arm at a position laterally adjacent to the patient's body without the arm being restrained by tucking.

Abstract: A urinary catheter is provided as a package, where the package is an enclosed intermittent urinary catheter having a distal section and a proximal section. The distal section includes a urine exit port and the proximal section includes a urine entrance port and has a closed and rounded tip that is adapted to be inserted into a bladder.

Abstract: Methods and materials related to ostomy devices, and particularly to valves for use with continent ostomies (e.g., ileostomies) are provided herein.

Abstract: The invention relates to an implant for a palate, in particular a human palate. The implant comprises a proximal portion, a distal portion and a middle portion. The proximal portion is dimensioned in such a way that it can be fixed to a hard palate. The distal portion is arranged at an angle in relation to the proximal portion and is dimensioned in such a way that it can be accommodated completely in a soft palate. The middle portion extends between the proximal portion and the distal portion. In a sectional plane extending through the proximal portion and the distal portion, the curvature of the middle portion at each of its points is greater than the curvature of the proximal portion at each of its points and greater than the curvature of the distal portion at each of its points.

Abstract: A medical appliance for the treatment of one or more sleep disorders such as obstructive sleep apnea in a patient, the appliance comprising: a biasing member for inserting behind and exerting a force upon the patient's soft palate or tongue, wherein the biasing member is inserted in a reduced or minimized form and then expanded or firms once in place to exert the force. The appliance may be nasally inserted or be placed through the mouth. In a particular configuration, both the soft palate and tongue are biased to prevent obstruction of the flow of air in the nasopharyngeal airway.

Abstract: An improved medical pad for contact thermal exchange with a patient includes a fluid circulation layer for containing a thermal exchange fluid circulatable therethrough, a first port and a second port for circulating the thermal exchange fluid in to and out of the fluid circulation layer, and a hydrogel layer interconnected to and extending across one side of the fluid circulation layer to define an adhesive surface for adherence to a patient's skin. The hydrogel layer comprises an ultra violet light-cured composition that includes a cross-linking copolymer in an amount of between about 15% to 30% by weight of the composition, water in an amount of between about 15% to 40% by weight of the composition, and glycerol in an amount of between about 25% to 35% by weight of the composition. The hydrogel layer is provided to have a thermal conductivity of at least about 1.9 ca/hr-cm-° C.

Abstract: Methods and devices are provided for activating brown adipose tissue (BAT) with cooling. Generally, the methods and devices can activate BAT to increase thermogenesis, e.g., increase heat production in the patient, which over time can lead to weight loss and/or improved metabolic function. In one embodiment, a medical device is provided that activates BAT by cooling tissue having a high density of cold sensitive thermoreceptors and/or by cooling BAT depots directly, thereby increasing thermogenesis in the BAT and inducing weight loss and/or improved metabolic function through energy expenditure.

Abstract: A tissue removal device includes a hollow needle, an ultrasonic transducer for mechanically vibrating the needle, an aspiration line communicating with the needle, and a vacuum pulsing device for generating vacuum pulses in the needle. The device may be utilized for breaking up tissue by phacoemulsification, vacuum pulsing, or both.

Abstract: Devices, systems, and methods interface a cassette with an eye treatment system console to provide coupling between the console and an eye treatment probe. The console may receive the cassette using a driven axial translation linkage that inhibits rotation of the cassette. The cassette may facilitate accurately positioning of a pressure sensor relative to a the console by allowing sliding movement between the sensor and a cassette body. Multiple peristaltic drives may be mounted to the console so that their rotors rotate about a common axis. An integrated mount structure may support and/or position components of the console which will interface with cassette, and an axially compressible vacuum connector of the console seal to a tapered vacuum coupler of the cassette.

Abstract: An ophthalmic surgical instrument includes a housing and a snare operably coupled to the housing. The snare is configured to transition between an insertion configuration and a deployed configuration, in which the snare is sized to encircle lenticular tissue. The ophthalmic surgical instrument is designed to prevent elevation and/or tilting of the lenticular tissue as the snare transitions toward the insertion configuration to divide the lenticular tissue.

Abstract: A method of reversibly separating an imaging assembly from an optical path in a laser surgical system includes generating an electromagnetic beam, propagating the electromagnetic beam from the beam source to a scanner along an optical path, the optical path comprising a first optical element that attenuates the electromagnetic beam, reversibly inserting a confocal bypass assembly into the optical path, diverting the electromagnetic beam along a diversion optical path around the first optical element, wherein the confocal bypass assembly automatically exits the optical path when a power loss occurs to one or more components of the system.

Abstract: Systems and methods automatically locate optical surfaces of an eye and automatically generate surface models of the optical surfaces. A method includes OCT scanning of an eye. Returning portions of a sample beam are processed to locate a point on the optical surface and first locations on the optical surface within a first radial distance of the point. A first surface model of the optical surface is generated based on the location of the point and the first locations. Returning portions of the sample beam are processed so as to detect second locations on the optical surface beyond the first radial distance and within a second radial distance from the point. A second surface model of the optical surface is generated based on the location of the point on the optical surface and the first and second locations on the optical surface.

Abstract: A method and surgical system including a laser source for generating a pulsed laser beam, an imaging system including a detector, shared optics configured for directing the pulsed laser beam to an object to be sampled and confocally deflecting back-reflected light from the object to the detector, a patient interface, through which the pulsed laser beam is directed, the patient interface having, a cup with a large and small opening, and a notched ring inside the cup; and a controller operatively coupled to the laser source, the imaging system and the shared optics, the controller configured to align the eye for procedure.

Abstract: Disclosed are goggles. The goggles are provided so that they comprise: a main body unit worn on the face of a user; a lens unit that is coupled to the main body unit and has a fastening protrusion formed to protrude toward the main body unit; and a fastening unit that has a fastening recess formed therein and is coupled to the main body to lock and unlock the fastening protrusion, wherein the fastening unit includes a body part movably coupled to the main body unit and a guide protrusion for guiding the moving direction of the body part, the main body unit has a guide hole formed at a position corresponding to the guide protrusion, the guide protrusion being received in the guide hole, and the fastening unit further included a protrusion part coupled to the body part to push the fastening protrusion outward such that the lens unit is separated from the main body unit when the fastening protrusion is unlocked according to the movement of the body part into the main body unit.

Abstract: Embodiments are directed to a high performance safety goggle that permits a wide field of view for the user.

Abstract: A sport goggle strap for affixing sport goggles to the face of a user with first and second end portions, each having a connection member for attaching the first and second end portions to opposite sides of sports goggles, and an intermediate portion between the first and second end portions having an elongated opening disposed substantially in line between the first and second end portions. The first end portion, second end portions and the intermediate portion are comprised of a unitary piece of an elastomeric material, and preferably neoprene.

Abstract: An apparatus and a method of making a corded earplug, including a flexible cord material having a particular cross-section. An earplug having a nose portion for insertion into the ear and a handle portion extending from the nose portion and lying outside of the ear when the nose portion is inserted into the ear. The handle portion including at least two openings physically displaced from each other. At least one of the openings extends within the handle portion and with at least one of the openings having a cross-section different than the cross-section of the cord material. An end portion of the flexible cord material is inserted into the at least one opening extending within the handle portion.