Abstract: A medical device for the treatment and irrigation of a sinus opening is described. The device allows for single-handed operation to access, dilate and irrigate a sinus opening. The device includes a sinus guide catheter, a guiding element, a balloon dilation catheter, a balloon catheter movement mechanism and a guiding element movement mechanism. A method for treating a sinus opening and irrigating a sinus is also described.

Abstract: A lavage catheter for the treatment of a maxillary sinus is described. The catheter comprises a proximal portion and a distal portion. The distal portion comprises an irrigation tip. The irrigation tip has a tip opening through which fluid may be delivered by one handed operation of the catheter. A method for lavaging the maxillary sinus includes inserting the lavage catheter into a patient's anatomy and advancing the irrigation tip into the maxillary sinus using one hand.

Abstract: A surgical navigation system includes an endoscope having a body, a shaft having a distal shaft end, an optical conduit, and a moveable optical element. The moveable optical element is configured to provide a field of view defining a line of sight, and is operable to capture an image within the field of view. The system further includes a drive mechanism operable to move the movable optical element to adjust a direction of the line of sight, a navigation sensor operable to generate a signal corresponding to a location of the distal shaft end within a patient, and a processor. The processor is operable to determine a location of the distal shaft end within the patient based on the signal, and command the drive mechanism to position the movable optical element so the line of sight is directed toward a selected point of interest within the patient.

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: Apparatus, including a patient tracker, attached to a subject, having magnetic field sensors and optical landmarks with known spatial relationships to each other. A camera acquires a 3D optical image, in a first frame of reference (FOR), of the subject's face. A magnetic radiator assembly generates magnetic fields at the subject's head, thereby defining a second FOR. A processor: processes field sensor signals to acquire location coordinates of the sensors in the second FOR; segments a tomographic image of the subject, having a third FOR, to identify the subject's face in the third FOR; computes a first transformation between the third and first FORs to map the tomographic face image to the 3D optical image; maps the optical landmarks to the third FOR; maps the respective location coordinates of the sensors to the first FOR; and computes a second transformation between the second FOR and the third FOR.

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: Physicians performing invasive procedures utilize instruments inserted into a human body to perform the procedures. Such procedures typically involve actions to be performed on specific targeted anatomical structures. During the procedure, nearby anatomical structures unrelated to the procedure should generally be avoided. A system and techniques are provided herein for monitoring the position of such unrelated nearby anatomical structures relative to one or more surgical instruments. The system emits a warning to a human operator such as a surgeon if one of the instruments is too close to a monitored anatomical structure.

Abstract: Variations of integral navigation controls may be used in conjunction with a medical instrument to provide navigation functions for an image guided surgery (IGS) system that is in communication with the integral navigation controls. In some variations, a medical instrument with integrated navigation wheels allows movement of a cursor of the IGS system along the x and y axis by scrolling the wheel, or allows selection, zooming, or other controls by combined clicking and/or scrolling of wheels, and may be sterilized or discarded along with the device. In some other variations, a control overlay may be temporarily attached to the medical instrument to provide additional controls, such as buttons or a pointing stick, and then removed and sterilized or discarded after a procedure. In each variation, inputs may be communicated via wire or wirelessly to an IGS system to provide navigation of images during a surgical procedure.

Abstract: A surgical instrument for cutting a first tissue and detecting a second tissue includes a shaft, a cutting member, and a tissue monitor system. The shaft extends along a longitudinal axis and includes a shaft lumen and a shaft opening. The cutting member is disposed within the shaft lumen and configured to cyclically move from a first position to a second position relative to the shaft. The cutting member is further configured to cut a tissue portion of the first tissue for removal therefrom. The tissue monitor system is associated with at least one of the shaft or the cutting member configured to detect the second tissue distinct from the first tissue for selectively cutting and removing the first tissue relative to the second tissue.

Abstract: A dilation catheter comprises a handle, a guidewire, a dilation catheter, a guidewire movement mechanism, and dilation catheter movement actuator. The guidewire movement mechanism is configured to translate to thereby cause translation of the guidewire relative to the handle. The dilation catheter movement mechanism is configured to translate to thereby cause translation of the dilation catheter relative to the handle. The guidewire movement mechanism also includes a rotation mechanism configured to impart rotation upon the guidewire. The rotation mechanism may include features configured to limit the amount that the guidewire may rotate. The rotation mechanism may also include features configured to convert linear movement of an actuator into rotational movement of the guidewire. The dilation catheter may include features configured to provide for side entry of the guidewire into the dilation catheter.

Abstract: Devices, systems and methods for performing image guided interventional and surgical procedures, including various procedures to treat sinusitis and other disorders of the paranasal sinuses, ears, nose or throat.

Abstract: Physicians performing invasive procedures require accuracy and precision when working with surgical tools. Surgical procedures are increasingly becoming minimally invasive, with physicians operating using cameras to view the surgery site and directing their tools through oculars or video displays. Ideally, the physician should be able to perform the invasive procedure while simultaneously observing both the real-time image of the patient and additional data critical for his medical decisions about the manipulation of the surgical tool and the next surgical step. The augmented reality navigation system of the present disclosure provides tool location visibility for invasive procedures through the use of location sensors included on a camera and/or on the tools used during a procedure. A location tracking system determines and monitors the locations of the tools and camera based on the characteristics of signals detected by the sensors and displays informational overlays on images obtained with a camera.

Abstract: A guidewire includes a guidewire shaft and an inflatable element arranged at a distal end of the guidewire shaft. At least a portion of the guidewire shaft is formed of metal, and the guidewire shaft includes a lumen that fluidly communicates with an interior of the inflatable element. The inflatable element is operable to transition between a deflated state in which the inflatable element is configured to pass through an isthmus of a Eustachian tube (ET), and an inflated state in which the inflatable element is configured to dilate the ET.

Abstract: An apparatus includes an instrument body, a shaft assembly, a dilation catheter, a guidewire, and a proximal deflection actuation assembly. The dilation catheter includes an expandable dilator and is slidable relative to the shaft assembly to thereby position the dilator distally relative to the distal end of the shaft assembly. The proximal deflection actuation assembly is positioned at the proximal end of the shaft assembly and is operable to selectively deflect the length of the shaft assembly relative to the longitudinal axis of the instrument body to thereby deflect the longitudinal axis of the shaft assembly away from the longitudinal axis of the instrument body.

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: 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 apparatus includes a grounding member and an actuator. The grounding member includes a first grounding feature and a bending channel. The first grounding feature is configured to engage a dilation instrument. The bending channel is configured to receive a malleable member of the dilation instrument. The actuator is pivotably coupled with the grounding member. The actuator has a bearing surface. The bearing surface is configured to cooperate with the bending channel to thereby bend the malleable member of the dilation instrument as the actuator is pivoted relative to the grounding member.

Abstract: A device and method for dilating a Eustachian tube of a patient is disclosed. The device includes a guide catheter and a balloon dilation catheter. The balloon dilation catheter has an actuator that prevents injury to the middle ear. The balloon dilation catheter is slidably coupled with the guide catheter through the guide catheter lumen and is fully inserted into the guide catheter lumen when the distal side of the actuator is adjacent to the proximal end of the guide catheter. The method involves advancing the guide catheter and balloon dilation catheter through a nasal passage of the patient to dilate a portion of the Eustachian tube.

Abstract: A dilation apparatus includes a shaft, a dilation balloon, and a standoff member. The shaft includes a first lumen and a second lumen. The distal end of the second lumen is proximal to the distal end of the first lumen. The dilation balloon encompasses the second distal end of the second lumen such that the dilation balloon defines an interior in fluid communication with the second lumen. A distal portion of the standoff member is positioned within the interior of the dilation balloon. The distal portion of the standoff member is distal to the second distal end of the second lumen. The standoff member provides a pathway for fluid communication between the interior of the dilation balloon and the second lumen. The standoff member may include a tube, a thread, polymeric beading, or other structures.