Abstract: Systems, apparatuses, and methods are described for providing visualization inside an ear of a subject before, during, or after an otologic procedure. An apparatus (100) includes a light source (140), a sensor (130), a processor (152, 170), and a display (154, 172, 972). The light source (140) can be configured to provide incident light to a target area (TM), and the sensor (130) can be configured to capture reflected light from the target area (TM) to generate image data based on the reflected light. The processor (152, 170) can process the image data to produce an image of the target area (TM), and the display (154, 172, 972) can display the image of the target area (TM).

Abstract: A myringotomy device includes a housing; an elongated tube extending from the housing; and a retractable cutting tool extendable through the elongated tube, the cutting tool comprising a blade. The cutting tool is configured such that when advanced, the blade of the cutting tool extends beyond a distal end of the elongated tube. The cutting tool is also configured such that when retracted, the blade is retracted into the elongated tube and a fluid conduit is created from the distal end of the elongated tube to the housing.

Abstract: A tympanostomy tube placement device has a needle with a tip, and a retainer at the needle tip. The retainer is within and retains by pulling radially inwardly a tympanostomy tube distal flange in a folded configuration extending distally. Movement of the needle tip in the proximal direction causes the adhesive bond to break and the distal flange releases to an unconstrained deployed position. Due to the axial folding of the distal flange its radial dimension does not affect deployment through the membrane.

Abstract: Surgical devices and methods of using the surgical devices are disclosed. The surgical devices generally include a trocar, a cannula releasably mounted on the trocar, and a propulsion system operatively connected to the trocar. The cannula includes a hub, and has a central opening through which the trocar extends. The propulsion system is operable to drive the trocar axially in a forward direction away from a proximal end of the surgical device.

Abstract: A prosthesis for implantation at a native semilunar valve includes a prosthetic distal valve, which includes a pliant material configured to collapse inwardly towards a longitudinal axis of the prosthesis during diastole, and to open outwardly during systole, and a distal fixation member configured to be positioned in a downstream artery of the subject. The apparatus also includes a proximal fixation member coupled to the distal fixation member, and configured to be positioned at least partially on a ventricular side of the native semilunar valve. The proximal fixation member is shaped so as to define a lattice that is shaped so as to define an intermediary portion that is coupled to the pliant material of the valve and diverges outwardly from the longitudinal axis, and a distal portion that is distal to the intermediary portion and diverges outwardly from the intermediary portion of the lattice. Other embodiments are also described.

Abstract: A loading device is configured to load a ventilation tube into an inserter device. The loading device includes a main body and at least one protruding member extending from the main body and terminating at a loading tip. An elongated hollow body has a first end, a second end, an inner wall and an outer wall. The elongated hollow body surrounds the at least one protruding member such that at least a portion of an outer facing surface of the protruding member engages with an inner wall of the elongated hollow body. A ventilation tube engages with the loading tip of the protruding member and is at least partially located within the elongated hollow body.

Abstract: An instrument comprises a handpiece, a boss member, a cylindraceous cam body, a linearly movable member, a cam follower, and a braking member. The cam body is rotatably supported in the handpiece and includes an exterior cam feature. The cam follower couples the linearly movable member with the cam feature of the cam body. The cam feature and the cam follower cooperatively drive the linearly movable member linearly in response to rotation of the cam body within the handpiece. The braking member extends about at least a portion of the exterior of the cam body and is positioned to progressively engage the boss member as the cam body rotates within the handpiece. The braking member and the boss member thus cooperate to provide gradual braking of the cam body. The instrument is operable to deploy a pressure equalization tube in the tympanic membrane of a patient.

Abstract: An insertion system includes a handle assembly and a nose assembly removably attached to the handle assembly and including an insertion end. The handle assembly includes a main body, a nose interface and an actuating element. The nose assembly includes a nose, a positioning rod extending from the nose to a distal end, a cutting sheath surrounding a distal end of the positioning rod and including a cutting edge, an actuation member having a proximal end coupled to the actuating element when the nose assembly is attached to the handle assembly and a distal end attached to the cutting sheath, a ventilation tube positioned distal to the distal end of the positioning rod and proximal to the insertion end. The cutting sheath retracts from around the ventilation tube and along the positioning rod when the actuating element on the handle assembly is moved.

Abstract: A myringotomy device includes a housing; an elongated tube extending from the housing; and a retractable cutting tool extendable through the elongated tube, the cutting tool comprising a blade. The cutting tool is configured such that when advanced, the blade of the cutting tool extends beyond a distal end of the elongated tube. The cutting tool is also configured such that when retracted, the blade is retracted into the elongated tube and a fluid conduit is created from the distal end of the elongated tube to the housing.

Abstract: A control system for controlling movement of a stent delivery system, a stent delivery system and a method for controlling movement of a stent delivery system are provided. The control system includes a housing having a chamber formed therein, a first drive at least partially positioned within the housing and operably connected to the first shaft of the delivery system and a second drive at least partially positioned within the housing and operably connected to the second shaft. The control system also includes a pressure controller operably connected to the housing and configured to change the pressure within the chamber. The first drive and the second drives are movable in response to the pressure change within the chamber and movement of the second drive relative to the first drive causes the second shaft to move relative to the first shaft to expand or constrain a stent operably connected thereto.

Abstract: A device for dispensing medication to the ear with a tympanic membrane sensor and medication dispenser which dispenses medication upon identification of the tympanic membrane by the sensor is provided. Also provided are methods for using the device to dispense medications to the ear.

Abstract: A tympanostomy tube for insertion into and residence in a tympanic membrane of a mammal, is disclosed. The tympanostomy tube includes a body including a first end portion, a second end portion, a central portion dispensed between the first and second end portions. An axially extending passageway has a first open end disposed adjacent the first end portion, and a second open end disposed adjacent the second end portion, and an axis extending between the first open end and second open end. The first end portion includes a relatively enlarged diameter, generally radially extending flange. The central portion includes a reduced diameter portion sized for extending through and residing in tissue of the tympanic membrane. The second end portion includes a relatively enlarged diameter second flange disposed adjacent the second end portion.

Abstract: A ventilation device includes a hollow body having a main portion, at least one distal member coupled to a distal end of the main portion and at least one proximal member coupled to a proximal end of the main portion. The at least one distal member is formed of a shape memory material. The hollow body includes a deployed state for maintaining an opening in an anatomical structure and an undeployed state. The shape memory material forms the at least one distal member into a deployed position. The shape memory material is reversibly deformed from the deployed state into the undeployed state such that at least the distal member changes in shape to an undeployed position, while the main portion of the hollow body remains unchanged.

Abstract: A kit is provided comprising a stent, an introducer and a bender. The stent is constructed for insertion into a Eustachian tube of a human. The stent includes a member having a preinsertion form that includes opposing exterior surfaces, means for immobilizing the stent within the Eustachian tube, and means for providing fluid communication between the opposing surfaces to effect pressure equilibration therebetween. The introducer includes a guide, an engager, and a sliding mechanism. A Eustachian tube method is also provided. The method involves using the above-described kit.

Abstract: An adaptor for a powered surgical instrument includes a casing, a cam drum, a first linear driver, and a second linear driver. The cam drum defines and is translatable along a longitudinal axis of the adaptor between a retracted position and an advanced position. The cam drum is being supported for rotation about the longitudinal axis. The cam drum defines first and second radial cam grooves about an outer surface thereof. The first cam groove defines a first profile and the second cam groove defines a second profile. The first linear driver includes a first cam follower disposed in the first cam groove and the second linear driver includes a second cam follower disposed in the second cam groove. The first and second linear drivers are supported for movement between advanced and retracted positions in response to rotation of the cam drum.

Abstract: Improved ear ventilation tubes and spring loaded insertion devices for use with the ventilation tubes whereby perforation and insertion steps take place substantially simultaneously with an aspiration step following.

Abstract: An insertion system includes a handle assembly and a nose assembly removably attached to the handle assembly and including an insertion end. The handle assembly includes a main body, a nose interface and an actuating element. The nose assembly includes a nose, a positioning rod extending from the nose to a distal end, a cutting sheath surrounding a distal end of the positioning rod and including a cutting edge, an actuation member having a proximal end coupled to the actuating element when the nose assembly is attached to the handle assembly and a distal end attached to the cutting sheath, a ventilation tube positioned distal to the distal end of the positioning rod and proximal to the insertion end. The cutting sheath retracts from around the ventilation tube and along the positioning rod when the actuating element on the handle assembly is moved.

Abstract: Intraocular stents and applicators are disclosed for treating glaucoma. The stents are configured to extend between the anterior chamber of the eye and Schlemm's canal for enhancing outflow of aqueous from the anterior chamber so as to reduce intraocular pressure. The stents can have features for anchoring the stent into Schlemm's canal as well as preventing the walls of Schlemm's canal from closing the outlet of the stents. The applicators can be steerable so as to make implantation easier. Additionally, the applicators can be configured to hold a plurality of stents so that multiple stents can be implanted through one incision without removing the applicator from the incision between serial implantations.

Abstract: An endovascular implantable shunt device for draining cerebrospinal fluid from a patient's subarachnoid space includes a shunt having opposed first and second ends, a one-way valve is located at the first end of the shunt, a helical tip is disposed at the second end, and a hollow passageway extends between the helical tip and one-way valve. The helical tip is constructed to penetrate a patient's sinus wall. Cerebrospinal fluid drains through the helical tip and out through the valve.

Abstract: A ventilation device includes a hollow body having a main portion, at least one distal member coupled to a distal end of the main portion and at least one proximal member coupled to a proximal end of the main portion. The at least one distal member is formed of a shape memory material. The hollow body includes a deployed state for maintaining an opening in an anatomical structure and an undeployed state. The shape memory material forms the at least one distal member into a deployed position. The shape memory material is reversibly deformed from the deployed state into the undeployed state such that at least the distal member changes in shape to an undeployed position, while the main portion of the hollow body remains unchanged.

Abstract: The foreign object extractor has an elongated hollow tube with a central lumen through its entire length providing fluid connection between an engaging end and a vacuum source. The engaging end has a nominally round transverse cross-section and is shaped to engage a foreign object to be removed from the human body. The engaging end flares so as to expose the internal surface of the elongated hollow tube for engagement with the foreign object. An adhesive is disposed on the exposed internal flared surface of the distal end. Pneumatic suction is applied through the lumen of the extractor and the suction serves to bring the foreign object into contact with the adhesive coated surface of the extractor to form a bond between the extractor and the object to be extracted.

Abstract: Devices, systems, methods, and kits for treating the tissue structures of the ear make use of a guide structure that can mechanically register a treatment probe with a target region of a target tissue, the guide structure being fittingly received in an auditory canal and often comprising a conformable body such as a compressible foam, or the like. The guide structure may include an articulating mechanism for selectively orienting the treatment probe toward the target region of, for example, a tympanic membrane. The guide structure may also support a videoscopic image capture device, illumination transmitting optical fibers, an aiming beam transmitter, and the like. Such structures facilitate myringotomy, tympanostomy tube placement, and the like, under local anesthesia in a doctor's office.

Abstract: A device performs a myringotomy and includes a main body oriented along a central axis. The main body includes an attachment hub for receiving components that provide suction. A hollow positioning member extends at least partially along the central axis, is coupled to the main body and includes a distal end. A cutting edge is located at the distal end of the hollow positioning member and is configured to pierce a tympanic membrane of a body. A sampling chamber is coupled to the main body for collecting at least a portion of the fluid located behind the tympanic membrane of the body using the components that provide suction at the attachment hub. A diagnostic indicator is housed in the sampling chamber and includes a visible indication of a test outcome when exposed to the fluid collected in the sampling chamber.

Abstract: The purpose of the “Dissolvable on-command Implant” is to act as a pressure equalizer tube in the eardrum, which has the unique characteristic that the tube can be dissolved with a specially formulated drop solution on-command. This tube can have various shapes and sizes, although the tube is usually a cylindrical tube with a hollow center, which maintains a ventilatory port for the middle ear space. With this design, the ear tube promotes drainage of middle ear fluid, lets air enter the middle ear, and allows for instillation of antibiotic drops.

Abstract: An indwelling catheter device and a method of treatment using the indwelling catheter device are provided. The indwelling catheter device includes an elongate shaft having a proximal portion, a distal portion, a first lumen extending longitudinally therethrough and an inflation lumen extending at least partially through the shaft. The distal portion of the shaft includes a first opening connected to the first lumen. The catheter device further includes a balloon operably connected to an outer surface of the shaft proximal to the first opening wherein the balloon at least partially surrounds the shaft. The inflation lumen is connected to the balloon for selective inflation and deflation of the balloon for disrupting migration of the occluding material and inhibiting the material from occluding the first opening when the catheter device is indwelling.

Abstract: Systems and methods are provided for automatically forming an incision in a tympanic membrane of an ear and placing a tympanic membrane pressure equalization tube into the incision. The systems include a housing with a shaft extending therefrom. A mechanism is disposed within the housing. A distal end of the shaft is placed against a tympanic membrane, and the mechanism is triggered to causes the tympanic membrane to be automatically incised and dilated and a tympanic membrane pressure equalization tube to be placed in the dilated incision.

Abstract: Improved ear ventilation tubes and spring loaded insertion devices for use with the of tubes whereby perforation and insertion steps take place substantially simultaneously with an aspiration step following.

Abstract: Improved ear ventilation tubes and spring loaded insertion devices for use with the ventilation tubes whereby perforation and insertion steps take place substantially simultaneously with an aspiration step following.

Abstract: An endoscope assembly has a tip that includes at least one front-pointing camera and at least one front illuminator associated therewith, at least one side-pointing camera and at least one side illuminator associated therewith, a first front service channel with a first exit point, and a second front service channel with a second exit point where the first and the second service channel exit points are located in close proximity on the front distal end of the tip. Further, an interior volume of the tip is in a range of 2.75 cm3 to 3.5 cm3, wherein each of the at least two viewing elements is configured to generate a field of view ranging from 120 to 180 degrees, a depth of field ranging from 3 to 100 mm, and a peripheral distortion of less than 80%.

Abstract: A tympanostomy tube delivery device comprises a shaft assembly, a pressure equalization tube, and a sensor. The shaft assembly comprises a cannula and a pusher operable to translate relative to the cannula. The pressure equalization tube is positioned within the shaft assembly. The pusher is operable to drive the pressure equalization tube out of the shaft assembly. The sensor is operable to detect a physical parameter associated with engagement between the distal end of the shaft assembly and a tympanic membrane. A controller may activate a feedback device to inform an operator that the distal end of the shaft assembly has achieved suitable apposition with the tympanic membrane, based on information from the sensor.

Abstract: Improved ear ventilation tubes and spring loaded insertion devices for use with the ventilation tubes whereby perforation and insertion steps take place substantially simultaneously with an aspiration step following.

Abstract: Systems and methods for treating a patient having a head with a first ear and a second ear, function by aligning a first device with a tympanic membrane of the first ear; inputting a command to an input device operatively coupled to the first device to generate a signal; and actuating the first device in response to the signal so as to drive a penetrator of the device through the tympanic membrane.

Abstract: Systems and methods for treating a patient having a head with a first ear and a second ear, function by aligning a first device with a tympanic membrane of the first ear; inputting a command to an input device operatively coupled to the first device to generate a signal; and actuating the first device in response to the signal so as to drive a penetrator of the device through the tympanic membrane.

Abstract: Systems, devices, and methods are provided for orthopedic implants. The implants may include a base member, such as an acetabular shell or an augment, that is configured to couple with an augment, flange cup, mounting member, or any other suitable orthopedic attachment. Any of the implantable components may be include one or more porous surfaces. The porous surface may be textured by protrusions that connect to and extend from the surface. The sizes and concentration of the protrusions may be varied for specific applications to accommodate different implants and patient anatomies. A porous implant may also include one or more internal or external solid portions that strengthen the implant.

Abstract: Improved ear ventilation tubes and spring loaded insertion devices for use with the ventilation tubes whereby perforation and insertion steps take place substantially simultaneously with an aspiration step following.

Abstract: A tympanostomy tube for insertion into and residence in a tympanic membrane of a mammal, is disclosed. The tympanostomy tube includes a body including a first end portion, a second end portion, a central portion dispensed between the first and second end portions. An axially extending passageway has a first open end disposed adjacent the first end portion, and a second open end disposed adjacent the second end portion, and an axis extending between the first open end and second open end. The first end portion includes a relatively enlarged diameter, generally radially extending flange. The central portion includes a reduced diameter portion sized for extending through and residing in tissue of the tympanic membrane. The second end portion includes a relatively enlarged diameter second flange disposed adjacent the second end portion.

Abstract: An insertion system includes a handle assembly and a nose assembly removably attached to the handle assembly and including an insertion end. The handle assembly includes a main body, a nose interface and an actuating element. The nose assembly includes a nose, a positioning rod extending from the nose to a distal end, a cutting sheath surrounding a distal end of the positioning rod and including a cutting edge, an actuation member having a proximal end coupled to the actuating element when the nose assembly is attached to the handle assembly and a distal end attached to the cutting sheath, a ventilation tube positioned distal to the distal end of the positioning rod and proximal to the insertion end. The cutting sheath retracts from around the ventilation tube and along the positioning rod when the actuating element on the handle assembly is moved.

Abstract: A device stenting the Eustachian tube is inserted through the nasopharynx and provides enhanced ventilation and drainage to the middle ear. Also provided is a method for inserting the device into the Eustachian tube and through the isthmus of a human subject.

Abstract: A device performs a myringotomy and includes a main body, a hollow positioning member, a cutting edge for piercing a tympanic membrane, a protective sheath and an actuator. The main body is oriented along an axis and has a proximal end, a distal end and an outer surface. The main body includes an attachment hub for receiving components that provide suction. The hollow positioning member extends at least partially along the axis, is coupled to the main body and includes a distal end. The actuator is located on the main body and is configured to move the protective sheath from a first position that surrounds the cutting edge to a second position that exposes the cutting edge and from the second position back to the first position.

Abstract: The surgical grasping instrument having U-shaped jaws has a pair of handles connected to a pair of U-shaped jaws by a pair of elongated arms. The lower jaw is rigidly connected to the anterior end of the lower elongated arm. The upper jaw is pivotally connected to the anterior ends of the upper and lower elongated arms. The upper and lower arms are held together in sliding contact so that sliding the upper arm pivots the upper jaw. Both handles have finger loops. The rearward handle is rigidly attached to the lower arm, and is pivotally attached to the forward handle. The forward handle is attached to the upper arm by a ball and socket joint so that pivoting the handles pivots the upper jaw. The U-shaped jaws are designed to grasp round or semi round objects, such as a tympanostomy tube.

Abstract: Systems and methods for treating a patient having a head with a first ear and a second car, function by mounting a support structure to the head of the patient; aligning the support structure with a target tissue in an ear canal of the first ear; stabilizing the support structure relative to the target tissue by injecting a material into the canal and hardening the material; and actuating a device while the device is supported by the support system so that the device therapeutically remodels the target tissue of the first ear.

Abstract: Systems for detecting one or more central auditory potentials include an implantable cochlear stimulator configured to be implanted within a patient and to generate a stimulation current in accordance with one or more stimulation parameters, a signal processing unit configured to be located external to the patient and to be communicatively coupled to the implantable cochlear stimulator, and one or more electrodes configured to be removably coupled to the signal processing unit. The electrodes are configured to detect the one or more central auditory potentials and the signal processing unit is configured to process the detected central auditory potentials.

Abstract: Systems and methods for treating a patient having a head with a first ear and a second ear function by mounting a support system to the head of the patient so that the support system is aligned with a target tissue of the first ear; applying a therapeutic agent to the first car by energizing an iontophoresis electrode supported by the support system; and actuating a device while the device is supported by the support system so that the device therapeutically remodels the target tissue of the first ear.

Abstract: Provided is an introducer for use with otolaryngological devices such as Eustachian tube stents. The introducer includes a guide, a stopper, an engager, and a release mechanism. An otolaryngological device having a first surface and a second surface that is nonparallel to the first surface may be loaded on the introducer by frictionally engaging the first surface of the device to a distal terminus of the engager. The device may be unloaded from the introducer by actuating the release mechanism. Upon actuation, the release mechanism slides the distal terminus of the engager toward the guide while the stopper abuts the second surface of the device. As a result, the relative motion between the engager and the stopper slides the device off the engager. Also provided are kits that include the introducer and methods for using the introducer.

Abstract: A kit is provided comprising a stent, an introducer and a bender. The stent is constructed for insertion into a Eustachian tube of a human. The stent comprises a member having a preinsertion form that includes opposing exterior surfaces, means for immobilizing the stent within the Eustachian tube, and means for providing fluid communication between the opposing surfaces to effect pressure equilibration therebetween. The introducer includes a guide, an engager, and a sliding mechanism. A Eustachian tube method is also provided. The method involves using the above-described kit.

Abstract: The present invention provides for fitting a multimodal hearing system to a recipient. Such fitting may include determining a desired perception for an input signal, receiving a measurement of a perception evoked by applying to the recipient one or more stimulation signals that correspond to the input signal, wherein the one or more stimulation signals applied using two or more stimulation modes, and each stimulation signal is determined using stimulus mode weighting, and adjusting one or more of the stimulus mode weightings based on the difference between the measured evoked perception and the desired perception. A multimodal hearing system is able to stimulate using an acoustic, electrical, mechanical mode and/or photo effect mode.

Abstract: Systems and methods for treating a patient having a head with a first ear and a second ear function by mounting a support system to the head of the patient so that the support system is aligned with a target tissue of the first ear; applying a therapeutic agent to the first ear by energizing an iontophoresis electrode supported by the support system; and actuating a device while the device is supported by the support system so that the device therapeutically remodels the target tissue of the first ear.

Abstract: Devices are provided for insertion into a Eustachian tube of an animal, e.g., a human being. The devices include an insertable member. The member has opposing surfaces and is formed at least in part from a biocompatible material that is degradable. The device may comprise a hole that is effective to provide sufficient fluid communication between the opposing surfaces of the insertable member to effect pressure equilibration therebetween. The device is able to be immobilized within the Eustachian tube for a predetermined period. Also provided are kits that include the device and methods for inserting the device into a Eustachian tube.

Abstract: The invention provides a flexible ear tube (10) for draining and ventilating the middle ear, the tube (10) having a flexible substantially tubular stem (12) with a lumen (14), the stem (12) being sized to be inserted through an incision in the eardrum (16) and the tube having at least two separate flexible contact surfaces (18) extending from the stem (12) and adapted to engage different spaced-apart inner surfaces of the eardrum 16, each of the contact surfaces (18) having a first axis XX extending substantially perpendicularly to the central axis of the stem and a second axis YY extending substantially perpendicularly to the first axis wherein one of the axes is between 0.6 and 3 mm and the second of the axes is between 1 and 7 mm in length.

Abstract: Systems and methods for treating ocular disorders are disclosed. One system has an implant and a delivery device. The implant has inlet and outlet portions, a lumen extending therebetween and communicating with inlet and outlet ports. The implant is sized so that in use aqueous humor flows from an anterior chamber of an eye through the implant and into a uveal scleral outflow path of the eye. The delivery device is configured to advance the implant from within the anterior chamber, with the outlet portion leading the inlet portion, to a location where the outlet and inlet ports respectively communicate with the uveal scleral outflow path and the anterior chamber. One method involves advancing an implant from within the anterior chamber, and draining fluid from therein such that fluid flows into an implant inlet port and out through an implant outlet port and into the uveal scleral outflow path.