Abstract: A medical device and method for the treatment of a sinus opening includes a handle, a guide catheter, a guide wire, a balloon catheter, a guide wire movement mechanism and a balloon catheter movement mechanism. The handle has proximal and distal ends and a longitudinal axis along the length of the handle. The guide catheter is attached to the distal end of the handle and has a catheter lumen. The guide wire and balloon catheter are both disposed at least partially in the handle and catheter lumen. The guide wire movement mechanism and the balloon catheter movement mechanism are both operatively disposed on the handle. In addition, the guide wire movement mechanism is configured for advancement and retraction of the guide wire through the handle and catheter lumen by user operation of the guide wire movement mechanism.

Abstract: Devices and methods for locating sinus ostia and positioning a guide wire within the sinus ostia. The subject devices include a shaft having a distal end, a proximal end, a curved region located between the distal and proximal ends, and an interior channel, an extensible and retractable guide wire movably mounted within the interior channel and a probe tip joined to the guide wire. Certain devices further include expandable portions for engaging and treating body anatomy.

Abstract: Systems, apparatus, and methods are described for delivering a therapeutic substance to a target area within or proximate to a nasal cavity of a subject, including a reservoir configured to contain the therapeutic substance and a delivery interface by which the therapeutic substance is delivered to the target area. In some embodiments, systems, apparatus, and methods described herein can deliver a therapeutic substance using iontophoresis and/or electroosmosis.

Abstract: Deflectable guide catheters and methods, including methods for using deflectable guide catheters to perform transnasal procedures within the ear, nose, throat, paranasal sinuses or cranium. Some deflectable guide catheters of the present invention comprise a substantially rigid tube, a helical spring attached to and extending from the distal end of the substantially rigid tube, a tubular plastic inner jacket, an outer plastic jacket substantially covering at least the helical spring member. The spring member is deflectable to cause the distal portion of the guide catheter to deflect to a curved configuration. In embodiments for transnasal use the deflectable guide catheter may have a length of less than 25 cm.

Abstract: Systems, apparatus, and methods are described for transporting and delivering a therapeutic substance to an ear of a subject, including a tubular element (216) configured for deployment in a tympanic membrane (TM) and a fluid transport element (230). The fluid transport element can be configured to transport the therapeutic substance from a proximal side to a distal side of the tubular element. Systems, apparatus, and methods further can include a fluid dispenser including a reservoir configured to contain a therapeutic substance, and a tubular element defining a lumen in fluid communication with an outlet in which the lumen and the outlet are configured to deliver the therapeutic substance from the reservoir to a region proximal to the tympanic membrane. Systems, apparatus, and methods further can include an electrode device.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, a second arm moveable between a closed position and an open position.

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: Systems, apparatus, and methods are described for delivering a therapeutic substance to the tympanic membrane of an ear of a subject, including a reservoir configured to contain the therapeutic substance and a delivery interface by which the therapeutic substance is delivered to the tympanic membrane.

Abstract: Medical devices, systems and methods that are useable to facilitate transnasal insertion and positioning of guidewires and various other devices and instruments at desired locations within the ear, nose, throat, paranasal sinuses or cranium.

Abstract: Systems, apparatus, and methods are described for delivering a therapeutic substance, such as an anesthetic, to a tympanic membrane of a subject. Such systems can include an earset with a valve configured to control flow of a fluid, such as air, into and out of a reservoir. In some embodiments, systems, apparatus, and methods described herein can include additional valves and features for relieving negative pressure within the reservoir.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, a second arm moveable between a closed position and an open position.

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: 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: Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

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: Systems, apparatus, and methods are described for delivering a therapeutic substance to a target area within or proximate to a nasal cavity of a subject, including a reservoir configured to contain the therapeutic substance and a delivery interface by which the therapeutic substance is delivered to the target area. In some embodiments, systems, apparatus, and methods described herein can deliver a therapeutic substance using iontophoresis and/or electroosmosis.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, a second arm moveable between a closed position and an open position.

Abstract: The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation.

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.