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: 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 surgical instrument and method of tracking the surgical instrument includes a shaft, a cutting member, and navigation system. The shaft has a shaft lumen, a shaft window, and a shaft edge. The cutting member is disposed within the shaft lumen and is configured to cyclically move from a first position to a second position relative to the shaft. The cutting member includes a cutting window opening, a cutting edge, and a suction lumen to cut the tissue portion with the cutting member in the first position. The navigation system includes a navigation sensor positioned on at least one of the shaft or the cutting member that is configured to be tracked within a patient for identifying a positional movement of the shaft or the cutting member within the patient.

Abstract: An apparatus includes a handle, an elongate shaft assembly, an adjustment feature, and a position sensor. The shaft assembly includes an outer tube and an inner shaft. The outer tube is slidably disposed within an elongate body of the handle. The outer tube extends distally from the elongate body to an outer tube distal end. The inner shaft is coaxially disposed within the outer tube and extends distally through the outer tube end to an inner shaft distal tip. The inner shaft is sized and configured to pass through passageways within an ear, nose, or throat of a patient. The adjustment feature is slidably disposed relative to the body of the handle and is configured to translate at least the outer tube relative to the handle. The position sensor is configured to generate signals indicating a real-time position of the distal tip of the inner shaft.

Abstract: A surgical instrument includes a handle assembly and a shaft assembly extending distally from the handle assembly and having a distal end sized to be inserted into the nasal cavity of a patient. The shaft assembly includes a cutting member configured to cut tissue within the nasal cavity, and a translating member slidably disposed over the cutting member. A navigation sensor is disposed within the distal end of the shaft assembly and is operable to generate a signal corresponding to a position of the distal end within the patient.

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: A dilation instrument includes a body, a dilation catheter, a guide member, and a force sensor. The dilation catheter has an expandable dilator. The guide member extends distally from the body and is configured to guide movement of the expandable dilator. The force sensor is operatively connected to the guide member and is configured to sense a force imparted against the guide member for monitoring engagement with an anatomy of a patient.

Abstract: A surgical instrument and method of tracking the surgical instrument includes a shaft, a cutting member, and navigation system. The shaft has a shaft lumen, a shaft window, and a shaft edge. The cutting member is disposed within the shaft lumen and is configured to cyclically move from a first position to a second position relative to the shaft. The cutting member includes a cutting window opening, a cutting edge, and a suction lumen to cut the tissue portion with the cutting member in the first position. The navigation system includes a navigation sensor positioned on at least one of the shaft or the cutting member that is configured to be tracked within a patient for identifying a positional movement of the shaft or the cutting member within the patient.

Abstract: An endoscopic camera has two or more cameras positioned at a distal end, positioned to provide partially overlapping fields of view. The cameras communicate captured digital images the length of the flexible endoscope, where they may be saved and processed to provide additional imaging features. With partially overlapping images from two or more cameras, image processing can provide panoramic images, super resolution images, and three-dimensional images. One or more of these image modes may also be enhanced to provide a virtualization window that displays a portion of a larger or higher resolution image. The virtualization window displays the selected area of the image, and may be moved or zoomed around the image to provide a virtual endoscope repositioning experience, where the endoscope remains statically positioned but the virtualization window presents a sense of movement and navigation around the surgical area.

Abstract: A method of treating a patulous Eustachian tube includes forming a first pocket in a wall of a nasopharynx region proximate to a pharyngeal ostium, inserting a resiliently biased implant within the first pocket, and allowing the resiliently biased implant to expand within the first pocket to thereby urge the Eustachian tube towards a closed state. The wire implant may include a resilient stent or other resilient wire structure. In some versions, a deployment device having a balloon is used to deploy a malleable implant. This deployment device has a malleable implant disposed around the balloon, which is disposed around a guide catheter. The balloon is inflated and expands the malleable implant. The malleable implant retains the expanded shape and urges the Eustachian tube toward a closed state.

Abstract: A method of protecting an ear canal of a patient during a surgical procedure using a protective sheath includes forming the protective sheath using additive manufacturing based on a digital model of anatomy of the patient, where the protective sheath includes a passageway extending therethrough. The method may further include inserting the protective sheath into the patient so that the passageway extends at least partially within the ear canal of the patient. The method may further include inserting at least one instrument during the surgical procedure through the passageway of the protective sheath and into the middle ear of the patient.

Abstract: A dilation instrument and method of imaging an anatomy within a patient includes a dilation catheter having a catheter body, a fluid conduit extending along the catheter body, a dilator, and at least one ultrasonic transducer. The catheter body is configured to distally extend from an instrument body and move relative to the instrument body. The dilator is connected to the catheter body in fluid communication with the fluid conduit and configured to receive a fluid from the fluid conduit and thereby inflate from a contracted state to an expanded state. The at least one ultrasonic transducer positioned on the catheter body and configured to electrically connect to an ultrasonic generator. The at least one ultrasonic transducer is configured to emit a source ultrasonic signal toward an anatomy within a patient for producing a diagnostic or a therapeutic effect.

Abstract: A surgical system and method for determining insertion depth of a cutting member includes a body assembly, a securement mechanism, a base position sensor, and a cutting member sensor. The body assembly defines a longitudinal axis and is configured to receive the cutting member. The securement mechanism is operatively connected to the body assembly and configured to releasably secure the cutting member relative to the body assembly. The base position sensor is configured to be detected as a base position by a navigation system. The cutting member sensor is positioned a predetermined longitudinal sensor distance from the base position sensor and configured to detect an adjustable longitudinal position of the cutting member. The sensors are configured to communicate with the navigation system for determining a position of the distal reference feature within an anatomical passageway of a patient in any selected adjustable longitudinal position of the cutting member.

Abstract: A method of treating epistaxis includes inserting a distal end of an endoscope into a nasal cavity of a patient. At least the distal end of the endoscope includes a working channel. The method includes advancing a distal end of an RF ablation catheter through the working channel of the endoscope. The method also includes ablating tissue in a posterior nasal region of the nasal cavity using RF energy transmitted by the RF ablation catheter.

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: A surgical instrument includes an elongate shaft having a proximal shaft portion and a malleable distal shaft portion. The elongate shaft is configured to be secured to a supporting surgical instrument. An ablation head is coupled to the malleable distal shaft portion and includes at least one electrode operable to deliver RF energy to tissue for ablating the tissue. The ablation head is sized to fit within the nasal cavity of a patient with a distal end of the supporting surgical instrument. The proximal shaft portion is configured to operatively couple with an RF energy source operable to energize the at least one electrode with RF energy. The malleable distal shaft portion is configured to bend relative to a longitudinal shaft axis defined by the proximal shaft portion for selectively orienting the ablation head relative to the longitudinal shaft axis.

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: An apparatus includes a shaft, an imaging head, and a processor. The shaft includes a distal end sized to fit through a human nostril into a human nasal cavity. The imaging head includes an image sensor assembly, a plurality of light sources, and a plurality of collimators. At least some of the light sources are positioned adjacent to the image sensor assembly. Each collimator is positioned over a corresponding light source of the plurality of light sources. The processor is configured to activate the light sources in a predetermined sequence. The image sensor assembly is configured to capture images of a surface illuminated by the light sources as the light sources are activated in the predetermined sequence.

Abstract: An endoscopic camera has two or more cameras positioned at a distal end, positioned to provide partially overlapping fields of view. The cameras communicate captured digital images the length of the flexible endoscope, where they may be saved and processed to provide additional imaging features. With partially overlapping images from two or more cameras, image processing can provide panoramic images, super resolution images, and three-dimensional images. One or more of these image modes may also be enhanced to provide a virtualization window that displays a portion of a larger or higher resolution image. The virtualization window displays the selected area of the image, and may be moved or zoomed around the image to provide a virtual endoscope repositioning experience, where the endoscope remains statically positioned but the virtualization window presents a sense of movement and navigation around the surgical area.