Abstract: Substance delivering spacer devices may comprise expandable reservoirs that are implantable in paranasal sinuses and other cavities, openings and passageways of the body to maintain patency and to provide sustained local delivery of a therapeutic or diagnostic substance. Delivery apparatus including elongate tubular members as well as shapeable distal portions and atraumatic tips are provided. Also provided are sinus penetrator devices and systems for performing ethmoidotomy procedures or for creating other openings in the walls of paranasal sinuses or other anatomical structures.

Abstract: Methods and devices for providing a gas pathway between the nasopharynx and the Eustachian tube are provided. One device may include a lumen with a valve. A portion of the valve may be tethered to adjacent muscle. Another portion of the valve may be tethered to adjacent cartilage. When the muscle contracts the valve may open through movement of the tethers, and provide a gas pathway between the nasopharynx and the Eustachian tube.

Abstract: A dilation catheter system includes a body, a guidewire, and a dilation catheter having an elongate shaft. The dilation catheter system may include a locking mechanism to prevent the guidewire from moving relative to the elongate shaft or to lock the guidewire to the dilation catheter to form a fixed wire unit. The dilation catheter system may include a stabilizing tube extending from an actuator, to provide rigidity to the guidewire. The dilation catheter may include a grip element having a plurality of grip features disposed thereon. The dilation catheter may include a cap biased toward a first longitudinal position and movable to a second longitudinal position. A guide catheter secured to the cap is prevented from changing angular orientation in the first longitudinal position and is free to change angular orientation in the second longitudinal position.

Abstract: Devices, systems and methods wherein a dilator, such as a balloon or other expandable member, is positionable within the frontal sinus ostium and adjacent frontal recess and useable to dilate the frontal sinus ostium and substantially all of the frontal sinus recess without requiring repositioning and repeated re-expansion of the dilator. One balloon catheter device of the invention comprises a catheter body that is less than about 50 cm in length (and in some embodiments less than 25 cm in length and a semi-compliant or non-compliant balloon on the catheter body. The balloon may have a working length of about 12 mm to about 30 mm and a width at its widest point when fully inflated of about 2 mm to about 7 mm. Such balloon may be constructed to withstand inflation pressures of about 12 atmospheres. In some embodiments, the dilator is advanced through or over a guide (e.g., guidewire or guide catheter) that has a preformed shape.

Abstract: Devices, systems and methods useable for dilating the ostia of paranasal sinuses and/or other passageways within the ear, nose or throat. 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, an optional handle may be used to facilitate grasping or supporting a device of the present invention as well as another device (e.g., an endoscope) with a single hand.

Abstract: Substance delivering spacer devices may comprise expandable reservoirs that are implantable in paranasal sinuses and other cavities, openings and passageways of the body to maintain patency and to provide sustained local delivery of a therapeutic or diagnostic substance. Delivery apparatus including elongate tubular members as well as shapeable distal portions and atraumatic tips are provided. Also provided are sinus penetrator devices and systems for performing ethmoidotomy procedures or for creating other openings in the walls of paranasal sinuses or other anatomical structures.

Abstract: A dilation catheter includes a shaft and an expandable element. The shaft includes a proximal portion and a distal portion. The distal portion includes a tip and a bend. The tip is sized and configured to pass through an isthmus of a Eustachian tube (ET). The bend is proximal to the tip. The bend is formed at an angle configured to provide insertion of the tip into the isthmus of the ET via an ear canal associated with the ET. The expandable element is disposed at the distal portion of the shaft. The expandable element is configured to transition between a non-expanded state and an expanded state. The expandable element in the non-expanded state is configured for insertion into the ET via the isthmus. The expandable element in the expanded state is configured to dilate the ET.

Abstract: A system for dilating a Eustachian tube (ET) of a patient includes a guide member and a dilation catheter. The guide member includes a bent distal portion that is configured to provide access to an opening in the ET. The dilation catheter is slidable relative to the guide member. The dilation catheter includes a shaft, an expandable element, and an actuator. The expandable element is disposed at the distal portion of the shaft. The actuator includes a grasping portion and an actuating member. The expandable element is configured to transition to an expanded configuration in response to actuation of the actuating member. The grasping portion and actuating member are configured to be grasped in a single hand of an operator to enable the operator to advance the dilation catheter relative to the guide member and to transition the expandable element between expanded and unexpanded configurations with the single hand.

Abstract: A system for delivering a fluid to a Eustachian tube (ET) of a patient includes a guide member and a tubular member. The guide member includes a shaft having a proximal portion, a distal portion, and a bend at the distal portion. The bend is configured to provide access to an opening in the ET. The system further includes a tubular member comprising a proximal end, a distal end, and a lumen extending therebetween. The tubular member is sized to fit within the ET. One or both of the tubular member and the guide member comprises a first stop member configured to engage the other of the tubular member or the guide member. The first stop member is configured to restrict a distal advancement of the tubular member relative to the guide member.

Abstract: A method of dilating a first Eustachian tube (ET) and a second ET of a patient using a dilation catheter includes directing the dilation catheter into the mouth of the patient and advancing the dilation catheter into a first ET on one side of the patient's head while a proximal portion of the dilation catheter is disposed in the mouth of the patient. The method further includes expanding the expandable member to thereby dilate the first ET. The method may further include repositioning the dilation catheter relative to a second ET on another side of the patient's head and advancing the dilation catheter into the second ET while a proximal portion of the dilation catheter is disposed in the mouth of the patient. The method may further include expanding the expandable member to thereby dilate the second ET.

Abstract: Methods and devices for providing a gas pathway between the nasopharynx and the Eustachian tube are provided. One device may include a lumen with a valve. A portion of the valve may be tethered to adjacent muscle. Another portion of the valve may be tethered to adjacent cartilage. When the muscle contracts the valve may open through movement of the tethers, and provide a gas pathway between the nasopharynx and the Eustachian tube.

Abstract: Devices and methods wherein an adapter is used to attach an electromagnetic image guidance component to a medical device such that an electromagnetic image guidance system may be used to track the location of the medical device within the body of a human or animal subject.

Abstract: Devices, systems and methods wherein a dilator, such as a balloon or other expandable member, is positionable within the frontal sinus ostium and adjacent frontal recess and useable to dilate the frontal sinus ostium and substantially all of the frontal sinus recess without requiring repositioning and repeated re-expansion of the dilator. One balloon catheter device of the invention comprises a catheter body that is less than about 50 cm in length (and in some embodiments less than 25 cm in length and a semi-compliant or non-compliant balloon on the catheter body. The balloon may have a working length of about 12 mm to about 30 mm and a width at its widest point when fully inflated of about 2 mm to about 7 mm. Such balloon may be constructed to withstand inflation pressures of about 12 atmospheres. In some embodiments, the dilator is advanced through or over a guide (e.g., guidewire or guide catheter) that has a preformed shape.

Abstract: A dilation system includes a balloon catheter and a puncturing assembly. The balloon catheter includes a shaft, a dilator coupled to a distal end of the shaft, and a lumen extending through the shaft and the dilator. The dilator is expandable from a collapsed state to an expanded state. The puncturing assembly includes at least one cutting member. The puncturing assembly is positionable within the lumen of the balloon catheter or along an exterior of the shaft when the puncturing assembly is in a first position. The puncturing assembly transitions to a second position to puncture the lumen of the balloon catheter and/or to puncture the dilator, to thereby drain fluid from the dilator.

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: A method for cleaning an isthmus of a Eustachian tube (ET) of a patient includes using an instrument. The instrument includes a proximal portion, a distal portion, and a shaft extending therebetween, and a treatment feature disposed at the distal portion. The method includes directing the instrument into an oro-nasal cavity of the patient and advancing at least the distal portion of the instrument into an opening of the ET. The method further includes further advancing the instrument within the ET so that the treatment feature is disposed past, or is coincident with, the isthmus. The method further includes moving the treatment feature relative to the isthmus to clean the isthmus.

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 defines a longitudinal axis. The dilation catheter comprises an expandable dilator and is movable relative to the guide member. 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 dilation catheter.

Abstract: A dilation system includes a handle, a guide member, a balloon dilation member, an actuator, and an endoscope. The handle is configured to provide single-handed use to a user. The guide member is coupled with a distal end of the handle and extends distally therefrom. The balloon dilation member is slidably disposed within the body and the guide member and includes an expandable balloon. The actuator is configured to translate and/or rotate to thereby cause translation and/or rotation of the balloon dilation member. The handle may include a guide member actuator configured to cause translation of the guide member. The handle may further include a rotation mechanism configured to impart rotation upon the guide member. The handle may also include a housing configured to receive and selectively retain the endoscope. The housing is configured to translate and/or rotate to thereby cause translation and/or rotation of the endoscope.

Abstract: A dilation system includes a handle, guide member, balloon dilation member, balloon, dilation member movement actuator, and endoscope. The handle is configured to provide single-handed use to a user. The handle includes a first and second body member pivotably coupled together such that the first body member and the second body member are configured to pivot toward and away from one another. The handle includes a rotation mechanism configured to impart rotation upon the guide member. The handle further includes a locking feature configured to lock endoscope in position relative to the handle. The handle may further include a rotation limiting feature configured to limit rotation of the guide member and or the body members. The dilation member movement actuator is configured to translate to thereby cause translation of the balloon dilation member. One or more components of the dilation system may include a plurality of measure markings.

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.