Abstract: Methods and apparatus for treating disorders of the ear, nose, throat or paranasal sinuses, including methods and apparatus for dilating ostia, passageways and other anatomical structures, endoscopic methods and apparatus for endoscopic visualization of structures within the ear, nose, throat or paranasal sinuses, navigation devices for use in conjunction with image guidance or navigation system and hand held devices having pistol type grips and other handpieces.

Abstract: An irrigation catheter for the treatment of the sinus anatomy is described. The catheter comprises a proximal portion, a rigid middle portion, and a flexible distal portion. The flexible distal portion comprises an irrigation tip and the proximal portion has a stiffness that is intermediate the stiffness of the rigid middle portion and the flexible distal portion. The irrigation tip has a tip opening and one or more radially facing openings. A method for irrigating or suctioning the sinus anatomy includes inserting an irrigation catheter into a patient's anatomy and irrigating or suctioning a target space.

Abstract: A dilation catheter device and system for dilating an opening in a paranasal sinus and/or other passageways within the ear, nose or throat is disclosed. A dilation catheter device and system is constructed in a manner that facilitates ease of use by the operator and, in at least some cases, allows the dilation procedure to be performed by a single operator. Additionally, the dilation catheter device and system may be useable in conjunction with an endoscope and/or a fluoroscope to provide for easy manipulation and positioning of the devices and real time visualization of the entire procedure or selected portions thereof. In some embodiments, shaft markers are disposed on a shaft of the dilation catheter and have a light color to contrast with a dark color of the dilation catheter shaft. The high contrast between the markers and catheter shaft allows for easy viewing of the markers in low light and operation conditions.

Abstract: An array of sensors may be used to perform touchless registration of landmarks of a patient's face before an ENT procedure in order to associate those landmarks with pre-operative images in three-dimensional space, which is required for image guided surgery features such as navigation. Touchless or light-touch registration may improve accuracy by avoiding the need for substantial pressing against a patient's skin, which may deform and thereby introduce erroneous registration data. A sensor may also be implemented in forms other than an array such as handheld probe having a single sensor as opposed to an array.

Abstract: Guidewires and methods useable in conjunction with image guidance systems to facilitate performance of diagnostic or therapeutic tasks at locations within the bodies of human or animal subjects.

Abstract: An apparatus includes a navigational guidewire and a connector assembly. The navigational guidewire includes a sensing element, an outer member, and a conductor. The sensing element is configured to respond to positioning within an electromagnetic field. The conductor is in communication with the sensing element. The connector assembly is configured to couple the navigational guidewire with a navigation system. The connector assembly includes a body and a ferrule. The ferrule is coupled with the body. The navigational guidewire is coupled with the ferrule. The ferrule is rotatable relative to the body to thereby enable rotation of the navigational guidewire relative to the body.

Abstract: Apparatus, including a guidewire having a distal end, that is configured to be inserted into proximity with a nasal sinus of a patient, the guidewire having a lumen. The apparatus also includes an optic fiber, traversing the lumen, configured to illuminate the distal end, and a coil, wound around the optic fiber and located within the lumen at the distal end, configured to generate a signal in response to a magnetic field interacting with the coil. A processor is configured to receive the signal and to evaluate a location of the distal end in response to the signal.

Abstract: A dilation catheter includes a catheter shaft, an expandable element, and a navigation sensor. The catheter shaft has a proximal shaft portion defining a proximal shaft end, a distal shaft portion defining a distal shaft end, and a working lumen extending between the proximal and distal shaft ends. The expandable element is disposed on the distal shaft portion proximally of the distal shaft end, and is configured to expand to dilate an anatomical passageway of a patient. The navigation sensor is arranged at the distal shaft portion, and is configured to generate a signal corresponding to a location of the distal shaft portion within the patient. In various examples, the dilation catheter may further include a bulbous distal tip, and the navigation sensor may be arranged within the bulbous distal tip.

Abstract: A system effectively narrows a patulous Eustachian tube (ET) of a patient with a guide catheter, instrument, and insert. The guide catheter includes a shaft, a lumen and a distal end configured to provide access the ET when the guide catheter is inserted into a head of the patient. The instrument comprises a shaft. The insert comprises a body configured to radially expand and retract between a non-expanded state and an expanded state. The insert is sized and shaped to be received within the first lumen when in the non-expanded state and is operable to expand to the expanded state to substantially reduce an effective diameter of the ET.

Abstract: An apparatus includes a power source, a pulse generator, a light source, a guidewire, an optical fiber, and a connector. The pulse generator is in electrical communication with the power source. The pulse generator is also capable of generating an electric pulse. The light source is in electrical communication with the pulse generator in such a way that the light source turns on and off in response to the electric pulse received from the pulse generator. The guidewire includes a proximal end and a distal end. The optical fiber extends through the guidewire from the proximal end of the guidewire towards the distal end of the guidewire. The connector couples with the guidewire while allowing the light source to communicate with the optical fiber.

Abstract: Devices and methods for visually confirming the positioning of a distal end portion of an illuminating device placed within a patient include inserting a distal end portion of an illuminating device internally into a patient, emitting light from the distal end portion of the illuminating device, observing transillumination resulting from the light emitted from the distal end portion of the illuminating device that occurs on an external surface of the patient, and correlating the location of the observed transillumination on the external surface of the patient with an internal location of the patient that underlies the location of observed transillumination, to confirm positioning of the distal end portion of the illuminating device.

Abstract: A method is disclosed for clearing effusion from an ear. The method may include applying liquid to an ear canal, which is proximal to a perforated tympanic membrane, which is proximal to a middle ear containing effusion, applying an ear device to seal and pressurize the liquid inside the ear canal, the ear device regulating the amount of pressure inside the ear canal, and inducing a Eustachian tube, which is distal to the middle ear, to open, which causes the fluid to displace the effusion into the Eustachian tube.

Abstract: A dilation catheter system is provided to dilate the ostium of a paranasal sinus or some other anatomical passageway (e.g., within the ear, nose, or throat, etc.). The system may include a dilation catheter, a dilator, a guide catheter, and an inflator. The dilation catheter may be positioned between the dilator and the inflator. The guide catheter is configured to guide the dilator into the affected passageway. The inflator may then be actuated to transfer fluid from the inflator, through the dilation catheter, and into the dilator. The transfer of fluid may inflate the dilator to an expanded state to open or dilate the affected passageway. The inflator may include a body, a plunger assembly, and locking features that selectively secure the position of the plunger assembly relative to the body by moving along a path that is transverse to a longitudinal axis defined by the plunger assembly.

Abstract: A device for dilating an ostium of a paranasal sinus of a human or animal subject may include: a handle; an elongate shaft having a proximal end coupled with the handle and extending to a distal end; a guidewire disposed through at least a portion of the shaft lumen; a dilator having a non-expanded configuration and an expanded configuration; and a slide member coupled with at least one of the guidewire or the dilator through the longitudinal opening of the shaft for advancing the guidewire and/or the dilator relative to the shaft.

Abstract: A method for dilating a stenotic region in an airway of a patient may include advancing a balloon catheter through the airway of the patient to position an inflatable balloon of the catheter within at least a portion of the stenotic region, maintaining a position of the catheter relative to the patient, and inflating the balloon of the catheter to dilate the stenotic region of the airway. A system for dilating a stenotic region in an airway of a patient may include a catheter shaft having an overall length of less than 70 cm, an inflatable balloon disposed along a distal portion of the catheter shaft, and a stylet.

Abstract: Sinusitis, enlarged nasal turbinates, tumors, infections, hearing disorders, allergic conditions, facial fractures and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies, endoscopic studies and transillumination studies. Access and occluder devices may be used to establish fluid tight seals in the anterior or posterior nasal cavities/nasopharynx and to facilitate insertion of working devices (e.g., scopes, guidewires, catheters, tissue cutting or remodeling devices, electrosurgical devices, energy emitting devices, devices for injecting diagnostic or therapeutic agents, devices for implanting devices such as stents, substance eluting devices, substance delivery implants, etc.

Abstract: A dilation catheter system comprises a guide member, a dilation catheter, and an image sensor. The guide member includes a shaft comprising a distal end and a proximal end. The shaft further defines a longitudinal axis. The dilation catheter is movable relative to the guide catheter member and comprises an expandable dilator. The expandable dilator is sized to fit within one or both of a Eustachian tube or a passageway associated with a paranasal sinus. The image sensor is configured to provide visualization within anatomy of a patient. The image sensor is integral with the guide member.

Abstract: A dilation catheter system comprises a guide member, a dilation catheter, and an image sensor. The guide member includes a shaft comprising a distal end and a proximal end. The shaft further defines a longitudinal axis. The dilation catheter is movable relative to the guide catheter member and comprises an expandable dilator. The expandable dilator is sized to fit within one or both of a Eustachian tube or a passageway associated with a paranasal sinus. The image sensor is configured to provide visualization within anatomy of a patient. The image sensor is integral with the guide member.

Abstract: A suctioning and irrigating sinus balloon catheter is provided for treating a patient's paranasal sinus system, including dilating prepared openings, and natural ostia and ducts and excising sinus cavities and choana. The catheter has a number of fluid carrying conduits to provide irrigation, suction and inflation/deflation to the distally mounted balloon. The catheters have sufficient stiffness and column strength that the balloon carrying distal segment of the catheter can be pushed into the prepared opening, natural ostium or duct, choana or sinus to be excised. Some catheters can be hand bendable by the surgeon. Some catheters provide the capability of threading an endoscope through one of the conduits. The methods use the balloon catheters to dilate prepared openings to selected parts of the sinus system, to dilate natural ostia and ducts of the sinus system, choana, and/or to dilate sinus cavities to remove them.

Abstract: A catheter includes an articulation assembly that enables the distal end of the catheter to bend away from the longitudinal axis of a proximal portion of the catheter. The catheter may include a dilation catheter or a guide catheter. The articulation assembly may provide bending in response to changes in electrical current and/or in response to changes in temperature. In addition, or in the alternative, the articulation assembly may provide bending in response to translation of a wire member.