Abstract: Devices and methods for providing protection from embolisms and microembolisms in a subject undergoing catheter-based intravascular procedures. The embolic protection devices have an expandable support frame comprising U-shaped members and leg members which facilitate proper placements in a defective valve annulus. The filtering devices expand in the vessels and allow blood flow to continue through the vessels, thereby catching and removing debris of the flowing blood. Also disclosed are embolic protection devices for use with a sutureless valve prosthesis which is implanted via catheter-based methods.

Abstract: The vascular prosthesis includes a luminal graft component having at least one fenestration. At least one fenestration ring borders the at least one fenestration and is fixed to the luminal graft component. The fenestration ring includes a main component with two opposing ends and a connecting component. The diameter of the fenestration ring can expand upon insertion of a branch prosthesis through the fenestration ring during implantation at a surgical site. The vascular prosthesis can be implanted in a patient to thereby treat, for example, an arterial aneurysm, spanning a region of an aneurysm that includes at least one arterial branch.

Abstract: A self-expanding stent-graft provided in a diametrically compacted state for implantation and retained preferably by a constraining sheath, useful for the temporary or permanent repair of injured, partially or entirely transected body conduits including blood vessels. It may be used under direct visualization to quickly stop or substantially reduce loss of blood from such damaged vessels and to quickly re-establish perfusion distal to the injury site. The device would typically be implanted under emergency room conditions but also be used in field situations by trained medical technicians. After an end of the device is inserted into a blood vessel through the injury access, deployment preferably initiates from the device end in a direction moving toward the middle of the length of the device by directionally releasing the constraining sheath.

Abstract: Hair Graft Placement Apparatus Used for Hair Transplantation. This invention is related to a hair graft placement apparatus that enables the placement of previously obtained hair grafts into incisions made on a bald scalp during the hair transplantation process. The invention consists of wall thickness (1), end region (2), narrow channel (3), wide channel (4), metal tube (5), handle grip (6) and finger slot (7).

Abstract: The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance element for implantation across the valve; a system including the coaptation assistance element and anchors for implantation; a system including the coaptation assistance element and delivery catheter; and a method for transcatheter implantation of a coaptation element across a heart valve.

Abstract: Heart valve replacement often involves complications associated with paravalvular leaks. Vascular plug and occlusive devices, as well as heart valves particularly beneficial in treating the phenomenon of paravalvular leaks are described to address this issue.

Abstract: Various features and associated advantages are described for diametrically adjustable support structures, adjustable valve structures, removable/replaceable valve structures, and associated systems and methods. Although some examples are directed toward prosthetic valve that is a conduit having a valve structure, or a “valved conduit” (e.g., used to replace a pulmonary valve and a portion of the corresponding pulmonary artery or an aortic valve and the aortic root), and other examples are directed toward prosthetic valves implanted native valve orifices (e.g., to replace an aortic or mitral valve), the features and advantages of the structures associated with those examples are interchangeable regardless of a particular application for which the examples are described.

Abstract: Mitral valve prolapse and mitral regurgitation can be treating by implanting in the mitral annulus a transvalvular intraannular band. The band has a first end, a first anchoring portion located proximate the first end, a second end, a second anchoring portion located proximate the second end, and a central portion. The central portion is positioned so that it extends transversely across a coaptive edge formed by the closure of the mitral valve leaflets. The band may be implanted via translumenal access or via thoracotomy.

Abstract: A percutaneous valve delivery system may include an outer sheath and an inner catheter disposed within the outer sheath. The inner catheter may include a plurality of lumens formed therein. A tubular extension may extend distally from a distal end of the inner catheter, wherein the tubular extension is axially movable relative to the inner catheter. A nose cone may be attached to the tubular extension. A handle may be attached to the outer sheath, wherein the handle is configured to shift the outer sheath between a first position and a second position relative to the inner catheter. A valve replacement implant may be releasably coupled to the inner 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: The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance devices for implantation across the valve; a system including the coaptation enhancement element and anchors for implantation; a system including the coaptation enhancement element, and one or more of the following: transseptal sheath, anchor delivery catheter, implant delivery catheter, and clip delivery catheter; and methods for transcatheter implantation of a coaptation element across a heart valve.

Abstract: A continuous compression fixation device for coupling a first bony structure to a second bony structure, including: a body structure; and a plurality of arm structures extending from the body structure, wherein at least one of the plurality of arm structures is configured to be coupled to the first bony structure and at least one opposed one of the plurality of arm structures is configured to be coupled to the second bony structure; wherein the body structure and the plurality of arm structures are manufactured from a shape memory material; and wherein tips of the at least one of the plurality of arm structures and the at least one opposed one of the plurality of arm structures are biased towards one another such that a desired compressive force is applied to an intercalary structural augment disposed between the first bony structure and the second bony structure.

Abstract: A modular variable blade augment including an augment component and a blade component. The blade component includes a buttress portion and a neck portion, with the neck portion having a body segment and a face segment that is contoured for mating engagement with an outer surface of the acetabular shell. The augment component has a first opening sized and shaped to receive insertion of the body segment, and which is also sized to accommodate selective adjustment of linear and angular orientations of the blade component relative to the augment component when the body segment is positioned in the first opening. Additionally, the body segment has a length that is sized to facilitate direct contact of the face segment with the acetabular shell when the modular variable blade augment is in an assembled configuration. Further, cement can be injected into the internal cavity to unitize the connection between the acetabular shell and the blade component.

Abstract: An interbody implant system for use in the spine includes a base comprising two or more bone contacting surfaces, at least one recess in at least one of the two or more bone contacting surfaces, the recess configured for containing a tooth, a deployable tooth to provide fixation between the base and the anatomy of a subject, a break-away bridge between the tooth and the base for providing a first relative position between the tooth and the base, and a locking mechanism for providing a second relative position between the tooth and the base.

Abstract: An orthopaedic prosthesis including a tibial tray is disclosed. The tibial tray includes a distal pocket and a plurality of inner pockets. Each inner pocket includes a channel sized to receive bone cement. The tibial tray includes distal-facing surfaces that have a surface roughness (Ra) equal to about 5.0 microns.

Abstract: Prosthesis for the knee joint including a tibial component, adapted to be fixed to one end of the tibial bone in proximity to the knee joint, and a femoral component, adapted to be fixed to one end of the femoral bone in proximity to the knee joint, wherein the tibial component is adapted to come into contact and be articulated with the femoral component, wherein the tibial component includes a protrusion adapted to be inserted in an opening present in the femoral component; method for the assembly of the prosthesis.

Abstract: A surgical balloon composed of an aseptically recovered umbilical cord vessel is provided. Methods of preparing a balloon and methods of using the same are also provided.

Abstract: A bi-directional fixating transvertebral (BDFT) screw/cage apparatus is provided. The BDFT apparatus includes an intervertebral cage including a plurality of internal angled screw guides, a plurality of screw members, and a cage indentation adjacent to the screw guides that independently or supplemented by other screw locking mechanisms prevents the screw members from pulling out of the internal angled screw guides. The internal angled screw guides orient a first screw member superiorly and a second screw member inferiorly. The intervertebral cage is adapted for posterior lumbar intervertebral placement, anterior lumbar intervertebral placement, anterio-lateral thoracic intervertebral placement, or anterior cervical intervertebral placement.

Abstract: An implant, comprising a body having a superior surface and an inferior surface, a superior-inferior axis, and a lateral axis. The implant further includes a first blade having a first retracted position in the body and a first extended position where the first blade extends outwardly from the body. In addition, the implant may include a blade actuating member that can translate through the body in directions parallel to the lateral axis. When the blade actuating member is moved in a first direction along the first axis, the first blade moves towards the first extended position. When the blade actuating member is moved in a second direction opposite the first direction, the first blade moves towards the first retracted position. Further, in the first extended position, the first blade extends from the superior surface at a first non-zero angle with respect to the superior-inferior axis.

Abstract: An expandable implant system is disclosed in which the system comprises an implant with: (1) top and bottom plates, (2) ramp surfaces formed on inner surfaces of the plates, and (3) an expansion member situated between the plates. An actuator also forms part of the system, the actuator being removable from between the top and bottom plates after implantation of the implant. The expansion member has a set of angled surfaces for mating with the ramp surfaces of the plates and, upon movement of the expansion member along a longitudinal axis of the implant, the top and bottom plates expand from a first dimension to a second greater dimension. The top and bottom plates are also securable at varying angles to one another depending on the amount of movement of the expansion member along the ramp surfaces.

Abstract: Medical devices suitable for implantation in spaces between bones are described. An example medical device suitable for use as an intervertebral spacer includes a main body having an exterior proximal wall, an exterior distal wall, a first exterior lateral wall, a second exterior lateral wall, an upper surface, a lower surface, an interior proximal wall, an interior distal wall, a first interior lateral wall, a second interior lateral wall, and a longitudinal axis. The interior proximal wall, the interior distal wall, the first interior lateral wall, and the second interior lateral wall cooperatively define an interior cavity. The first and second exterior lateral walls are outwardly directed at an angle from the lower surface to the upper surface relative to the longitudinal axis.

Abstract: A surgical instrument for implanting a semi-rigid medical implant. The surgical instrument includes a shaft, an accessory shaft, an actuation mechanism and an implant engagement mechanism. The shaft has a channel formed therein. The shaft has a proximal end and a distal end. The accessory shaft is slidably mounted in the channel. The accessory shaft has a proximal end and a distal end. The actuation mechanism is mounted to the shaft proximate the proximal end thereof. The actuation mechanism is capable of causing the accessory shaft to slide with respect to the shaft. The implant engagement mechanism is attached to the distal end of the accessory shaft. The implant engagement mechanism is capable of engaging a semi-rigid surgical implant.

Abstract: An instrument assembly and method for use in hip joint replacement surgery are described. The instrument assembly comprises a guide arm (102) having first (104) and second (106) ends, with a mount (108) at its first end (104) for locating the guide arm (102) relative to a landmark on the patient's back. An instrument (110) is provided at or towards the second end (106) of the guide arm (102) for modifying a patient's acetabulum. The guide arm (102) is arched to accommodate the patient's torso between its first and second ends (102, 104), and defines a reference axis extending between its first and second ends (102, 104) relative to which the instrument (110) is orientated. A surgical method is also described in which the instrument assembly is used in hip joint replacement surgery.

Abstract: An expandable device for expanding and supporting body tissue comprises an inferior endplate having an outer surface configured to contact one body tissue surface and a superior endplate having an outer surface configured to contact an opposing body tissue surface. The inferior endplate and the superior endplate are movable relative to each other in a direction of expansion. The device includes an elevator captively supported between the inferior endplate and the superior endplate for independent movement along the direction of expansion. In the first direction the elevator is moved toward said superior endplate to lift the superior endplate and expand the device. In the second direction the elevator moves away from said superior endplate toward said inferior endplate to create a space for insertion of an insert into the expanded device.

Abstract: A trial system for determining a suitable proximal body implant for hip replacement surgery comprises a separator instrument, a trial body attachable to a distal stem, and an insert. The insert is positioned within the trial body to receive the separator instrument. As the separator instrument is rotated about its axis, a ramp element of the insert guides a pin of the separator instrument, so as to separate the trial body from the distal stem. Additional apparatus, methods, and systems are disclosed.

Abstract: A polycentric knee joint including an adjustment-free multi-stage prosthesis air cylinder. The air cylinder has an air cylinder body, a piston assembly slidably mounted on the air cylinder body, a first check valve mounted in the piston, and a multi-stage air pressure valve mounted inside a lower air way of the air cylinder body. The multi-stage air pressure valve automatically cushions movements of the piston assembly without being adjusted whenever a user of the prosthesis joint walks slowly or quickly, for improved comfort.

Abstract: An acoustic muffler sock for use with a prosthetic device liner or with a socket of a prosthetic device includes a first sock opening at one end and sound absorbing material designed to inhibit noises that are often created from the liner/amputated limb interaction. The acoustic muffler sock is configured to be positioned over the liner before the liner and the acoustic muffler sock thereon is inserted into the socket for the prosthetic device. The acoustic muffler sock may further comprise a sound barrier material. The muffler can also be part of a sock that goes over the prosthetic device.

Abstract: A plaque tack can be used for holding plaque against blood vessel walls such as in treating atherosclerotic occlusive disease. The plaque tack can be formed as a thin, annular band for holding loose plaque under a spring or other expansion force against a blood vessel wall. Focal elevating elements and/or other features, such as anchors, can be used to exert a holding force on a plaque position while minimizing the amount of material surface area in contact with the plaque or blood vessel wall and reducing the potential of friction with the endoluminal surface. This approach offers clinicians the ability to perform a minimally invasive post-angioplasty treatment and produce a stent-like result without using a stent.

Abstract: The present disclosure relates to a wire-mesh stent having a radius of the outmost boundary defined by the following Formula 1 and consisting of a combination of a hook and a cross, a method for manufacturing the same and a method for patterning a multi-alterable structure thereof: Rob=Rtb/(COS(180/Nxo))??Formula 1 The present disclosure microscopically analyzes and quantifies a basic structure of a wire-mesh stent from a viewpoint of integrating, rather than separating, a stent and a delivery device which are main components of a stent system, especially in order to ensure the loadability that can be applied to the delivery device, which is a practical necessity. Moreover, the present disclosure forms a multi-alterable structure pattern that is transformable to various application structures in order to realize a required specific performance, instead of one specific stent structure.

Abstract: A vascular prosthesis is described, having blunted wire ends. The blunted wire ends can take on a variety of configurations including end caps, bent ends, curved ends, or eyelets. The novel ends provide a smooth surface to contact the blood vessel walls thereby reducing the risk of trauma during placement of the prosthesis.

Abstract: In some examples, a catheter defines a longitudinal axis and includes an inner member, a retaining member, and a support member. The inner member has an outer wall, and a portion of the inner member has a first stiffness. The retaining member defines a pocket configured to receive a connecting member of an expandable medical device. The retaining member has a second stiffness that is different from the first stiffness. The support member extends distally from the retaining member. In some examples, the support member is configured to be received radially within the expandable medical device when the connecting member is received within the pocket. The support member is configured to provide a gradual transition between the first stiffness of the inner member and the second stiffness of the retaining member.

Abstract: The present disclosure describes systems for endoluminal devices utilizing a sleeve for constraining an expandable device toward a constrained configuration suitable for endoluminal delivery to a treatment site along vasculature; and a mechanism for retracting at least a portion of the sleeve.

Abstract: A low profile stepped delivery system for retracting trigger wires from a prosthesis to release the prosthesis from a delivery device. A rod is disposed within an axial bore of a handle. The rod has a first longitudinal surface and a second longitudinal surface. A first engagement mechanism is disposed on the first longitudinal surface and a second engagement mechanism disposed on the second longitudinal surface. A wire coiling assembly is disposed at an end of the of the handle and comprises a first rotary gear that is adapted to be rotated by the first engagement mechanism, a second rotary gear that is adapted to be rotated by the second engagement mechanism, a first wire spool that is coupled to a rotation of the first rotary gear, and a second wire spool that is coupled to the rotation of second rotary gear. The first wire spool is configured to secure a first trigger wire and the second wire spool is configured to secure a second trigger wire.

Abstract: A minimally invasive system and method for providing weight loss by inducing the feeling of satiety whereby an intragastric device is inserted into the gastric lumen via the esophagus and an external magnetic device is used as needed to magnetically attract the intragastric device towards the inner wall of the stomach and impart tactile stimulation sufficient to stimulate the vagus nerve.

Abstract: Provided is an device for stabilizing the center of gravity and/or correcting distortion of the body simply through wearing of the appliance on a toe and conducting normal activities. The following invention is provided by the present invention. A cylindrical correction device that corrects distortion of the body, wherein: the correction device has inward-facing triangular-prism-shaped protrusions on the inner circumference; the triangles are inclined in one direction with respect to the circumference; and the correction device comprises a cylindrical elastic material having a diameter of 7-20 mm, a width of 5-10 mm, a thickness of 1-3 mm, and a hardness of 4-6.

Abstract: A spine support device includes a support plate having front and rear faces, a central opening, and a pair of stabilizing stirrups formed on the rear face of the support plate in spaced parallel relationship to augment the support provided by the support plate when positioned at its front face in contact with a portion of a person's back surrounding a region of spinal vertebra visible through the central opening in the support plate. The support plate has opposing inner side edge portions at opposing sides of the central opening and opposite peripheral side edge portions spaced outwardly therefrom with the stabilizing stirrups therebetween. The opposing inner side edge portions and the opposite peripheral side edge portions of the support plate have respective alternating peak and valley shapes for accommodating interconnecting facets of the spinal vertebra region visible through the central opening in the support plate.

Abstract: A rhinoplasty appliance is provided that may be custom-molded to a patient's nasal anatomy, including the nostrils, to maintain the corrected contour of the nostrils after rhinoplastic surgery. The rhinoplasty appliance may include a support wire; a first and second wire flanges; a first and second nostril insertion portions, each having a passage and an aperture to permit flow of air and drainage; a connecting structure to maintain the position of the nostril insertion portions in relation to each other, and to provide support and protection for the columella. The first and second wire flange may help to secure the rhinoplasty appliance in position on the patient's face, and improve retention of the first and second nostril insertion portions in the patient's nostrils. The support wire may be provided as added support for the connecting structure.

Abstract: A system suitable for collecting and transporting urine away from the body of a person or animal may include a urine collecting assembly having a body, a sealing flange, and a reservoir within the body and partially defined by the sealing flange. The sealing flange can define an opening such that the interior of the body is accessible via the opening. A peripheral edge of the opening can be configured to seal around a shaft of a penis of a user disposed through the opening. The urine collecting assembly can also include an outlet in fluidic communication with the reservoir. The urine collecting assembly can be arranged such that a fluid can flow into the body from the urethral opening of the user's penis, collect in the reservoir, and flow out of the outlet.

Abstract: An oral appliance includes an upper arch, a lower arch, and an electronic device. The upper arch is configured to be positioned within a user's mouth proximate the user's maxillary dentition when the upper arch is positioned in the user's mouth. The lower arch is configured to be positioned proximate the user's mandibular dentition when the lower arch is positioned in the user's mouth. The electronic device is coupled to one or more of the upper arch and the lower arch, the electronic device configured to monitor a feature of the environment proximate one or more of the upper arch and the lower arch.

Abstract: The cryogenic chamber has a treatment cabin (12) cooled by a cooling factor in the form of liquid air or liquid nitrogen distributed through the nozzle system (17). The treatment cabin (12), which can be open at the top or equipped with a roof, is available in a stationary or mobile version, namely it can be placed on a trailer and is transitional, namely it has a rear door (2) and a front door (1) and its side walls have outlet openings (8, 11) and a grid (7) intended for introducing the cooling factor from the cooling chamber (16), whereas in the treatment cabin (12) at the front and at the back there are elements (18) blocking the animal taking the treatment. The shape of the treatment cabin (12) is based on a rectangle. The chamber is equipped with roller blinds (4, 5) and its operation is controlled by a panel with a monitor as well as a power supply and control system (3).

Abstract: Devices for therapeutic interaction with an Abreu brain thermal tunnel (ABTT) terminus. Such devices provide heat to or remove heat from the ABTT terminus, and may also provide heat to or remove heat from veins connected to the ABTT. Therapeutic devices for engaging with the ABTT terminus benefit from diagnostics obtained at the ABTT terminus, or from other locations on the body.

Abstract: A thermal pack having a pouch, the pouch having a first wall and a second wall coupled to the first wall to form an interior volume. The interior volume configured to retain a thermal means. A thermal resistivity of the first wall is greater than a thermal resistivity of the second wall such that heat flow into, or out of, the interior volume is primarily through the second wall.

Abstract: A medical device includes: a shaft having a distal end and an associated exhaust channel; a first balloon configured to be attached to the distal end of the shaft, the first balloon having an outer surface that is substantially conformal to an inner surface of a uterine cavity; and a second balloon configured to be received within the first balloon and forming an intermediary space between the first balloon and an outer surface of the second balloon. The second balloon includes at least one rupture valve configured to rupture at a predefined pressure in the intermediary space.

Abstract: An apparatus includes a shaft having a proximal end and a distal end; a stem extending from the distal end of the shaft and comprising a first cover and a second cover, the, first cover and the second cover being configured to inhibit access to fallopian tubes of a patient; and a plurality of temperature sensors disposed on the shaft and on the stem. At least one of the temperature sensors is positioned between the proximal end of the shaft and the distal end of the shaft and at least one of the temperature sensors is positioned on the stem.

Abstract: A therapeutics delivery system, and methods of making and using same, are disclosed for environments that rapidly clear any injected therapeutics, such as a patient's eye. The therapeutics delivery system releases the drug in a therapeutically effective concentration for a desired duration of time with a predefined drug kinetics. In one embodiment, the embodiments of the present disclosure release a therapeutically effective concentration for a longer time period than other delivery systems, for instance from a day to a week. Certain embodiments comprise a therapeutics dispensing device comprising a biodissolvable hydrogel matrix for long term drug release that allows the device to be placed directly at the injured site, e.g., onto the surface at or near the injury, and retained there rather than through injection, whether locally or systematically.

Abstract: An ophthalmic device comprises an ultrasonic transducer, an accommodation actuator, and a controller. When the ophthalmic device is mounted in or on an eye of a user, the ultrasonic transducer is positioned to direct ultrasonic signals towards ciliary processes in the eye and the accommodation actuator is positioned to focus light entering the eye. The controller is coupled to the ultrasonic transducer and the accommodation actuator. The controller includes logic that when executed by the controller causes the ophthalmic device to perform operations including emitting the ultrasonic signals from the ultrasonic transducer towards the ciliary processes, receiving reflected ultrasonic signals from the ciliary processes with the ultrasonic transducer, calculating a time of flight between emitting the ultrasonic signals and receiving the reflected ultrasonic signals, and adjusting an optical power of the accommodation actuator based on the time of flight.

Abstract: A method, system, and device for magnetically pushing agents into an eye.

Abstract: Various arrangements of fluidics systems are disclosed. In one arrangement, an aspiration circuit for a fluidics system is disclosed that selectively controls aspiration. The aspiration circuit comprises an aspiration line operatively connected to a surgical instrument, an aspiration exhaust line operatively connected to a waste receptacle; an aspiration vent line connected at a first end to the aspiration line; and a selectively variable vent valve operatively connected to the aspiration vent line. The variable vent valve may be selectively moved to vary aspiration pressure within the aspiration line. Other fluidics systems are disclosed that include a selectively positionable irrigation valve that may also be incorporated into a fluidics system that includes a variable vent valve.

Abstract: Devices and methods for cutting a lens in the eye are provided with a specific application being for cutting a lens while contained within the capsular bag. The device has an elongate element which forms a loop. The loop is advanced into a space between the lens and the capsular bag. The device may be used with, or incorporated into, fluid handling devices such as irrigation and aspiration devices and phacoemulsification hand pieces and disposables.

Abstract: An ophthalmic laser system for generating a first beam at a first wavelength on a first beam path and a second beam at a second wavelength on a second beam path, and directing optics to selectively direct the first beam or the second beam to a treatment beam path. The ophthalmic laser system incorporates a reflex coaxial illuminator comprising a reflex mirror movable on an axis from a position out of the treatment beam path to a position in the treatment beam path to direct illumination into an illumination path coaxial with the treatment beam path. The reflex mirror is adapted to transmit a beam that follows the second beam path.