rotary trimmer

Abstract

The present disclosure relates generally to instruments for neuro-otological surgical procedures, and more particularly to an instrument for shearing hair in the ear canal with combined shearing, illumination, and vacuum suction functions. In certain embodiments, the instrument can further facilitate visualization of the ear canal during shearing of the hair in the ear canal.

Description

[Background technology]

[0001] Anatomically, the human ear is divided into three distinct regions: the outer ear, the middle ear, and the inner ear. The outer and middle ear are separated by the tympanic membrane (i.e., eardrum). The outer ear portion of the ear includes the pinna or auricle and the external auditory canal or tube (i.e., ear canal). The middle ear, also known as the tympanic cavity, includes the ossicles and the Eustachian tube. Meanwhile, the inner ear portion of the ear includes the cochlea, the vestibule, and the semicircular canals.

[0002] An otoscope is typically used to aid in viewing and examining the ear canal and tympanic membrane, which may be performed prior to performing a neuro-otological surgical procedure. An otoscope is typically utilized in conjunction with an otoscope or other ear viewing device. One of the reasons for utilizing an otoscope when examining the ear is to aid in obtaining a direct and clear view of the tympanic membrane, which may often be obstructed by hair (among other things) in the ear canal.

[0003] Transcanal endoscopic ear surgery (TEES) is a neuro-otological procedure performed within the middle ear portion of the human ear. Such procedures are minimally invasive and differ from traditional ear procedures in that the surgeon accesses the middle ear through the ear canal rather than through an incision behind the ear. TEES procedures can be used to treat conditions such as acoustic neuroma, cholesteatoma, cholesterol granuloma, congenital or acquired ossicular chain fixation, congenital or acquired ossicular chain disruption, paraganglioma, tympanic membrane rupture, tympanosclerosis, and other otorhinolaryngological conditions.

[0004] In a TEES procedure, an endoscope is inserted through the ear canal to access the middle ear. The surgeon uses the endoscope to visualize the surgical area within the middle ear while performing the procedure using microsurgical instruments. One of the risks associated with a TEES procedure is the risk that hairs in the ear canal may be dislodged or unintentionally cut during the procedure and enter the middle ear. Because hairs in the ear canal are used to keep dust and debris away from the eardrum, such hairs entering the middle ear can cause infection and / or inflammation.

[0005] Due to the size of conventional endoscopes and the size of the average ear canal, it is not feasible to use an otoscope in combination with an endoscope and any associated surgical instruments to secure hair within the ear canal. Furthermore, with the addition of a speculum, there are at least three or more instruments used simultaneously at one or more points during a TEES procedure (e.g., an endoscope, a speculum, and a microsurgical instrument), while the surgeon only has two hands to perform the procedure.

[0006] To minimize the risks associated with TEES procedures, preoperative procedures are often performed to cut and remove hair within the ear canal. Traditionally, cutting and removing hair from the ear canal has been done manually using scissors, which can be time-consuming and tedious. Furthermore, manual removal of clipped hairs may not always be complete, thereby increasing the likelihood that clipped hairs will be missed and accidentally travel into the middle ear during the surgical procedure. Summary of the Invention [Means for solving the problem]

[0007] The present disclosure relates generally to instruments for neuro-otological surgical procedures, and more particularly to an instrument for shearing hair in the ear canal that combines trimming, lighting, and vacuum suction functions.

[0008] In certain embodiments, a rotary trimmer is provided. The rotary trimmer includes a base unit configured to be held by a user. The base unit has an opening at a distal end and a cover coupled to the opening. The cover has a plurality of slits formed near the distal end of the cover. The rotary trimmer includes a shearing assembly disposed within the base unit. The shearing assembly includes a blade at least partially disposed within the cover, a rotor coupled to the blade, and a driver configured to rotate the rotor, such that rotation of the rotor causes rotation of the blade. The rotary trimmer also includes one or more optical fibers disposed within the base unit and a port disposed at a proximal end of the base unit. The optical fiber may be configured for use in visualization of an external space distal to the cover. The port may be configured to be in fluid communication with a vacuum line. In certain embodiments, the vacuum line fluidly couples the port of the rotary trimmer to a vacuum source.

[0009] In certain embodiments, at least one of the one or more optical fibers in the rotary trimmer is configured to provide illumination light, while in other embodiments, at least one of the one or more optical fibers in the rotary trimmer is optically coupled to a camera at a distal end of the at least one optical fiber.

[0010] In certain embodiments, the one or more optical fibers comprise one or more illumination fibers configured to propagate illumination light and one or more image fibers configured to capture light and propagate an image to a visualization system.

[0011] In certain embodiments, at least one of the one or more optical fibers is configured as a proximity sensor to detect one or more sensitive surfaces within the ear canal space and monitor the distance between the distal end of the cover and the one or more detected sensitive surfaces.

[0012] In certain embodiments, the rotary trimmer includes a safety feedback feature that provides an audible and / or visual notification to the user when the proximity sensor detects that the distal end of the cover is within a minimum threshold distance to one or more sensitive surfaces within the ear canal space. In some other embodiments, the rotary trimmer includes a safety feedback feature that disables the shear assembly when the proximity sensor detects that the distal end of the cover is within a minimum threshold distance to one or more sensitive surfaces within the ear canal space.

[0013] In certain embodiments, the cover further comprises one or more regions formed from a translucent or transparent material that facilitates the transmission of light therethrough.

[0014] In certain embodiments, the blade of the rotary trimmer comprises a cylindrical body having a proximal end and a distal end, the proximal end of the cylinder coupled to the rotor, and the distal end of the cylinder comprising a cutting surface formed along a circumference of an opening at the distal end of the cylinder. In certain embodiments, the blade further comprises a hollow cavity extending from the proximal end of the cylinder to the opening at the distal end of the cylinder, and the one or more optical fibers are disposed within the hollow cavity concentrically with respect to the cutting surface of the cylinder.

[0015] In certain embodiments, the rotary trimmer blade comprises a cylindrical body and one or more lateral blades extending laterally from an outer surface of the cylindrical body, each of the one or more lateral blades including a lateral cutting surface disposed parallel to the outer surface of the cylindrical body. In certain embodiments, each of the one or more lateral blades further comprises a distal cutting surface at a distal end of each of the one or more lateral blades, the distal cutting surface extending perpendicular to the outer surface of the cylindrical body.

[0016] So that the above-mentioned features of the present disclosure can be understood in detail, a more particular description of the present disclosure briefly summarized above can be had by reference to embodiments, some of which are illustrated in the accompanying drawings. It should be noted, however, that the accompanying drawings illustrate only exemplary embodiments and therefore should not be considered as limiting the scope of the invention, as other equally effective embodiments are possible. [Brief explanation of the drawings]

[0017] [Figure 1A] 1A-1C illustrate perspective and top views of an exemplary rotary trimmer, according to some embodiments of the present disclosure. [Figure 1B] 1A-1C illustrate perspective and top views of an exemplary rotary trimmer, according to some embodiments of the present disclosure. [Figure 1C] 1A and 1B show first and second side views of a portion of the rotary trimmer shown in FIGS. 1A and 1B, according to some embodiments of the present disclosure. [Figure 1D] 1A and 1B show first and second side views of a portion of the rotary trimmer shown in FIGS. 1A and 1B, according to some embodiments of the present disclosure. [Figure 2A] 1A-1D show partial cross-sectional side views of a portion of an exemplary configuration of the rotary trimmer shown in FIGS. 1A-1D, according to some embodiments of the present disclosure. [Figure 2B] 2B shows a partial cross-sectional side view of a portion of the rotary trimmer configuration shown in FIG. 2A in use, according to some embodiments of the present disclosure. [Figure 2C] 1A-1D show partial cross-sectional side views of a portion of another exemplary configuration of the rotary trimmer shown in FIGS. 1A-1D, according to some embodiments of the present disclosure. [Figure 2D] FIG. 2D shows a partial cross-sectional side view of a portion of the rotary trimmer configuration shown in FIG. 2C in use, according to some embodiments of the present disclosure. [Figure 3A] 3A-3D show front views of an exemplary configuration of the rotary trimmer shown in FIGS. 1A-1D, as referenced from section line 3A-5 of FIG. 1D, according to some embodiments of the present disclosure. [Figure 3B] 3A-3D, as referenced from section line 3A-5 of FIG. 1D, show front views of another exemplary configuration of the rotary trimmer shown in FIGS. 1A-1D, according to some embodiments of the present disclosure. [Figure 4A] 3A-3D show front views of an exemplary configuration of the rotary trimmer shown in FIGS. 1A-1D, as referenced from section line 3A-5 of FIG. 1D, according to some embodiments of the present disclosure. [Figure 4B] 3A-3D, as referenced from section line 3A-5 of FIG. 1D, show front views of another exemplary configuration of the rotary trimmer shown in FIGS. 1A-1D, according to some embodiments of the present disclosure. [Figure 5] 3A-3D show front views of an exemplary configuration of the rotary trimmer shown in FIGS. 1A-1D, as referenced from section line 3A-5 of FIG. 1D, according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0018] For ease of understanding, the same reference numerals have been used, where possible, to refer to the same elements common to the figures, and it is contemplated that elements and features of one embodiment may be incorporated into other embodiments as appropriate without further elaboration.

[0019] The present disclosure relates generally to instruments for neuro-otological surgical procedures, and more particularly to an instrument for shearing hair in the ear canal that combines shearing, illumination, and vacuum suction functions.

[0020] In certain embodiments, the rotary trimmer includes a base unit including a shearing assembly, a vacuum source coupled to a port at the proximal end of the base unit, and a cover disposed at the distal end of the base unit and having a plurality of slits for receiving ear canal hair for shearing by the shearing assembly. In certain embodiments, the base unit may further include a semi-rigid bending shaft near the distal end of the base unit to adapt the distal end to a plurality of different diameters and angles of the ear canal. In certain embodiments, the base unit may further include one or more optical fibers. In certain embodiments, the one or more optical fibers may include an image fiber having a camera or other image sensor at its distal end to facilitate imaging of the interior of the ear. In certain embodiments, the one or more optical fibers may include an illumination fiber configured to illuminate the patient's outer ear (e.g., ear canal).

[0021] According to certain aspects of the present disclosure, a rotary trimmer can be inserted by a user into a patient's ear canal to shear and remove hair within the ear canal leading to the eardrum. In certain embodiments, one or more optical fibers provide otoscope (e.g., imaging) functionality for viewing the ear canal when the rotary trimmer is inserted into the ear canal. In certain embodiments, the one or more optical fibers can also transmit illuminating light into the ear canal to enhance visualization during examination and hair removal. Thus, the one or more optical fibers can facilitate improved guidance of the distal end of the rotary trimmer through the ear canal by the user when shearing hair therein.

[0022] In certain embodiments, the one or more optical fibers may be components of a safety or feedback mechanism to prevent inadvertent contact or damage to the tympanic membrane. For example, in certain embodiments that may be combined with other embodiments herein, the one or more optical fibers may comprise a fiber optic proximity sensor to detect a sensitive surface of the ear, such as the tympanic membrane (e.g., via light), and alert the user when the distal end of the rotary trimmer is within a predetermined distance of the detected sensitive surface. In certain embodiments, upon detecting that the distal end of the rotary trimmer is within a minimum threshold distance of the detected sensitive surface, the blade of the rotary trimmer may be automatically disabled by a controller or actuator in communication therewith. In certain embodiments, the rotary trimmer may be further configured to automatically re-activate upon detecting that the distal end of the rotary trimmer has moved outside the minimum threshold distance of the detected sensitive surface.

[0023] According to some embodiments, once a hair in the ear canal is cut by the blade of the rotary trimmer (e.g., immediately), the hair is sucked in to prevent the cut, free hair strand from falling toward the eardrum. After the hair is cut by the rotating blade in the rotary trimmer, the cut hair may be sucked toward the base unit by a vacuum source coupled to the rotary trimmer.

[0024] Referring now to FIG. 1A , a perspective view of an exemplary rotary trimmer 100 is shown, according to certain embodiments described herein. As shown, the rotary trimmer 100 includes a cover 110 removably coupled to a base unit 120. The cover 110 is disposed at a distal end 121 of the base unit 120 and includes a plurality of slits 112 disposed near the distal tip 111 of the cover 110. In the example of FIG. 1A , the cover 110 is substantially dome-shaped, although other configurations are contemplated. When the cover 110 is coupled to the base unit 120, an interior region of the cover 110 is in fluid communication with an interior chamber of the base unit 120 such that some components within the base unit 120 can extend partially into the interior region of the cover 110. Note that, as described herein, a distal end or distal portion of a component refers to an end or portion that is closer to a patient's body during use of the component. Conversely, a proximal end or proximal portion of a component refers to an end or portion that is farther away from the patient's body.

[0025] In certain embodiments, the base unit 120 comprises a handpiece near its distal end having an outer surface 128 configured to be held by a user, such as a surgeon or a member of surgical staff. For example, the base unit 120 can be ergonomically contoured to substantially fit and / or be held by a user. In certain embodiments, the outer surface may be textured or have one or more gripping features formed therein, such as one or more grooves and / or ridges. The base unit may further comprise a switch 133 or toggle for activating the rotary trimmer 100. The base unit 120 may be made from any material commonly used for such instruments and suitable for neuro-otological surgical procedures. For example, the base unit 120 may be formed from a lightweight metallic material, such as aluminum, a thermoplastic polymer material, or other suitable material. In certain embodiments, the base unit 120 and / or components attached to the base unit 120 may be sterilized and used in more than one surgical procedure. In other embodiments, the base unit 120 and / or components attached to the base unit 120 may be disposable devices or components. In certain aspects, the cover 110 comprises a disposable, single-use component that can be replaced each time the rotary trimmer 100 is used.

[0026] In certain embodiments, the base unit 120 may further comprise one or more ports 123 at its proximal end 125 through which one or more supply lines and / or cables may be routed to or coupled to an internal chamber of the base unit 120 (e.g., one port 123 is shown in FIGS. 1A and 1B ). For example, the port 123 may provide a connection between the base unit 120 and a vacuum line 301 fluidly coupled to a vacuum source 129 for sucking loose hair cut by the rotary trimmer 100. In certain embodiments, the port 123 may also provide a connection point for connecting an optical fiber to a visualization system or to a light source for providing illumination light. In certain embodiments, the one or more ports 123 may provide a connection point for connecting the base unit 120 to a pneumatic power source or power supply that drives the rotary trimmer 100. In certain embodiments, the one or more ports 123 may provide a connection point for connecting the base unit 120 to a console, such as a surgical console, which may include a pneumatic or power source for driving the rotary trimmer 100 and / or a controller for controlling one or more functions of the rotary trimmer 100. In further embodiments, the rotary trimmer 100 may be configured as a portable handheld device separate from any console or system. In such embodiments, the components necessary to facilitate hair trimming and suction, as well as imaging and / or illumination, may be integrated within the base unit 120 to form a portable handheld device.

[0027] 1B shows a top view of the rotary trimmer 100 of FIG. 1A in accordance with certain embodiments described herein. As shown, the base unit 120 includes a portion 126 configured to be held by a user adjacent a proximal end 125 of the base unit 120. The base unit 120 further includes an elongated shaft 119 adjacent a distal end 121 to which the cover 110 removably couples.

[0028] The shaft 119 and the cover 110, which is removably coupled to the shaft 119, may be sized and configured to be inserted into a patient's ear canal and trim any hair therein. For example, the elongated shaft 119 and the cover 110 may together have a longitudinal length 127 sized to substantially match or be greater than the typical depth of the outer ear. When the shaft 119 and the cover 110 are inserted into the outer ear, the length 127 may be sufficient for the shaft 119 to extend across the entire ear canal so that the cover 110 can be positioned adjacent the patient's eardrum. In certain embodiments, the longitudinal length 127 of the shaft 119 and the cover 110 may be sized from about 3 cm to about 15 cm, e.g., from about 3 cm to about 8 cm and from about 9 cm to about 15 cm. In certain embodiments, the shaft 119 and / or the cover 110 may further have a cross-sectional dimension (e.g., diameter) sized to be slightly smaller than the typical diameter of the ear canal of the outer ear. In certain embodiments, the shaft 119 may have a diameter 131 of about 2 mm (millimeters) to about 6 mm, e.g., about 2 mm to about 4 mm, about 4 mm to about 5 mm, and about 5 mm to about 6 mm. In other embodiments, the rotary trimmer 100 may have a greater or lesser length 127 and a diameter 131 that is still insertable into a patient's ear canal.

[0029] In certain embodiments, the elongate shaft 119 may be formed with a semi-ridged, flexible structure to allow the elongate shaft 119 to conform to the diameter and non-linear path of the ear canal in the outer ear. For example, the elongate shaft 119 may comprise a low-density plastic, a medium-density plastic, a polyurethane elastomer, a polyester elastomer, a polyimide, or a flexible metallic material such as Nitinol.

[0030] 1C and 1D show side views of a base unit 120 with a cover 110 attached and a distal end 121 of the base unit 120 with the cover 110 removed, respectively, in accordance with certain embodiments described herein. Figures 1C and 1D are described together herein for clarity. As shown, the cover 110 is removably coupled to the distal end 121 of the base unit 120 and disposed over an opening 122 thereof. The cover 110 may have a tapered, dome-shaped profile between an opening 116 at a proximal end 117 of the cover 110 and a distal tip 111 of the cover 110 to allow the rotary trimmer 100 to better traverse the ear canal and bring the cover 110 into contact with hair growing therein.

[0031] In certain embodiments, the distal tip 111 of the cover 110 may include a blunt or rounded end surface 118 (e.g., the most distal outer surface) to protect against inadvertent puncture of the surface of the outer ear and tympanic membrane by the distal tip 111 when the rotary trimmer 100 is used inside the ear. As described above, the cover 110 is generally sized to allow the rotary trimmer 100 to be advanced through the ear canal. Accordingly, the cover 110, like the shaft 119, has a diameter 131 of about 2 mm to about 5 mm, e.g., about 2 mm to about 3 mm, about 3 mm to about 4 mm, and about 4 mm to about 5 mm. In other embodiments, the cover 110 may have a larger or smaller diameter while still being able to cover insertion into a patient's ear canal.

[0032] The cover 110 includes a plurality of slits 112 formed near the distal tip 111 for receiving hair for cutting by the rotary trimmer 100 within the cover 110. Each of the plurality of slits 112 may extend substantially from near the distal tip 111 to the proximal end 117 of the cover 110. In certain embodiments, the plurality of slits 112 may be arranged in stages along the entire circumference of the cover 110 to receive hair for cutting from all sides and angles of the cover 110 without having to reorient the position of the rotary trimmer 100. In certain embodiments, each of the plurality of slits 112 may include a width 114 dimensioned from about 200 μm (micrometers) to about 500 μm, for example, from about 300 μm to about 400 μm. Each of the plurality of slits 112 may also include a length 115 dimensioned from about 1 mm to about 3 mm. In one embodiment, the plurality of slits 112 may be disposed about 1 mm to about 3 mm from the distal tip 111 of the cover 110 .

[0033] 1D , in certain embodiments, at least a portion of the tubular shearing body 202 and a portion of the optical fiber 302 extend from the opening 122 of the base unit 120 and are partially disposed within an interior portion of the cover 110 when the cover 110 is secured onto the distal end 121 of the base unit 120. The shearing body 202 is configured to rotate to cut / shear hair in the ear canal as it passes through the multiple slits 112 in the cover 110. Meanwhile, the optical fiber 302 may generally comprise an image fiber and / or an illumination fiber in optical communication with a visualization system and / or a light source, respectively, to assist a user in guiding the rotary trimmer 100 toward hair in the ear canal for cutting, as described below.

[0034] In certain embodiments, the optical fiber 302 may be operably coupled at its proximal end to a camera 304 or other image sensor of a visualization system and may be fitted with a lens or window at its distal end 303 to enable visualization of a digital image of the ear canal for the user while using the rotary trimmer 100. In certain embodiments, the optical fiber 302 and camera 304 (or other image sensor) may comprise components of a videoscope or endoscope to facilitate a live video feed of the external space in front of (e.g., distal to) the distal tip 111, such as the space within the patient's ear canal. Thus, in such embodiments, the optical fiber 302 and camera 304 enable the user to locate and direct the distal tip 121 of the rotary trimmer 100 toward the hair in the ear canal for shearing. After the hair in the ear canal has been cut, the camera 304 may also be used to examine the cleaned space to ensure that no uncut or loose hair remains.

[0035] In certain embodiments, the optical fiber 302 may be an illumination fiber coupled to the light source 306 and configured to relay illumination light. The illumination light may be used to enhance visualization of the ear canal for a user when using the rotary trimmer 100. In certain embodiments, the optical fiber 302 is configured to function as both an illumination fiber and an image fiber, and the illumination light relayed by the optical fiber 302 is used to enhance its imaging function. In certain other embodiments, the optical fiber 302 is configured to function as only one of an illumination fiber or an image fiber. For example, hair growth in the ear canal may be somewhat accessible and, under certain conditions, visible to the naked eye, so only illumination of the ear canal may be necessary. In still other embodiments, the rotary trimmer 100 may include more than one optical fiber 302 for imaging, illumination, or simultaneous performance of both functions via separate or the same fiber.

[0036] In certain embodiments in which the optical fiber 302 is coupled to the camera 304, the camera 304 and the optical fiber 302 may function as components of a safety feedback mechanism to prevent inadvertent contact with and / or puncture of sensitive surfaces in the ear canal, including the surface of the tympanic membrane. For example, the camera 304 and the optical fiber 302 may together comprise an optical proximity sensor for automatically detecting, based on an image captured by the camera 304, when the distal tip 111 of the cover 110 is within a minimum threshold distance of the sensitive surface of the ear canal. In certain embodiments, when the distal tip 111 is within the minimum threshold distance, an audible or visual warning notice or alert may be provided to the user, and / or the shearing assembly 200 may be automatically shut off to prevent contact of the rotary trimmer 100 with the sensitive surface and any damage caused to the sensitive surface. In certain embodiments, the feedback mechanism may further be configured to automatically re-activate the shearing assembly 200 when the rotary trimmer 100 is repositioned by the user such that the distal tip 111 is no longer within the minimum threshold distance of the detected sensitive surface in the ear canal.

[0037] 1D , the optical fiber 302 may be suspended within the shearing body 202 and extend through the opening 207 of the shearing body 202 such that the optical fiber 302 is disposed concentrically with respect to the shearing body 202 and is substantially centered within the base unit 120 of the rotary trimmer 100. Thus, in use, the shearing body 202 may rotate or oscillate about the optical fiber 302 suspended within and through the opening 207 of the shearing body 202.

[0038] In certain embodiments, the optical fiber 302 may be fixed or slidably coupled within the base unit 120. For example, the optical fiber 302 may be slidably coupled to the base unit 120 such that the optical fiber 302 extends from and retracts into the base unit 120. Thus, a user may selectively adjust the distance between the distal end 303 of the optical fiber 302 and the distal tip 111 of the cover 110. In certain aspects, the adjustability of the position of the distal end 303 of the optical fiber 302 may be used to position the distal end 303 of the optical fiber 302 in contact with the inner surface of the cover 110 proximate the distal tip 111.

[0039] In embodiments having optical fibers 302, cover 110 may include one or more sections formed from a translucent or transparent material to allow illumination and / or imaging of light from optical fibers 302 through cover 110. In certain embodiments, distal tip 111 of cover 110 may be formed from a translucent or transparent material, while the remainder of cover 110 is formed from an opaque metal or plastic material. In other embodiments, cover 110 may be formed entirely from a translucent or transparent material.

[0040] 1C and 1D , the distal tip 111 of the cover 110 may be configured with an opening 135 formed therein to allow illumination light from the distal end 303 of the optical fiber 302 to shine therethrough or to allow an image to be received by the optical fiber 302. Thus, the opening 135 in the distal tip 111 of the cover 110 may be used to facilitate illumination or imaging by the optical fiber 302 with an unobstructed view or access to an external space distal to the distal tip 111 of the cover 110.

[0041] 2A illustrates a partial cross-sectional side view of an exemplary configuration of a portion of a rotary trimmer 100, according to some embodiments of the present disclosure. As shown, the rotary trimmer 100 includes a rotor 212 operably coupled to a shear body 202 at a distal end of the rotor 212, and a drive device 214, such as an electromechanical motor, at a proximal end of the rotor 212. The drive device 214, rotor 212, and shear body 202 may collectively be referred to as a shear assembly 200. In this configuration, the drive device 214, when activated, rotates or oscillates the rotor 212, which is disposed within the base unit 120, which in turn rotates or oscillates the shear body 202.

[0042] At least a portion of the shearing body 202 extends within an interior portion of the cover 110 when the cover 110 is mounted on the base unit 120. As noted above, in certain embodiments, the shearing body 202 may comprise a generally tubular geometry. In such embodiments, the shearing body 202 may have an annular cutting surface 203 disposed about an opening 207 at a distal end 209 of the shearing body 202. The cutting surface 203 may extend perpendicular to the longitudinal axis of the shearing body 202 (e.g., parallel to axis X). The cutting surface 203, in certain embodiments, may include one or more teeth or sharp edges shaped to cut / shear hair strands when the cutting surface 203 is rotated.

[0043] 2B shows a partial cross-sectional side view of the rotary trimmer configuration shown in FIG. 2A in use, according to some embodiments of the present disclosure. Once the rotary trimmer 100 is introduced into a patient's outer ear, the driver 214 of the shearing assembly 200 may be activated by a user pressing a switch 133 on the exterior surface 128 of the base unit 120. When the rotary trimmer 100 is activated, the driver 214 of the shearing assembly 200 is configured to rotate or oscillate (either unidirectionally or bidirectionally) the shearing body 202 about the longitudinal axis of the rotary trimmer 100, which is parallel to the X-axis. The rotation or oscillation of the shearing body 202 causes the cutting surface 203 to move, or pivot, in a circular motion about the longitudinal X-axis. While the drive device 214 is activated and the cutting surface 203 is pivoting, the user may advance the rotary trimmer 100 toward the outer ear and / or into the ear canal (indicated by arrow 242), causing ear hair 240 to pass through the slit 112 in the cover 110 and enter the space inside the cover 110 where the ear hair 240 is sheared by the cutting surface 203 of the shearing body 202.

[0044] While or after the ear hair 240 is being sheared by the shearing body 202, the resulting free (e.g., severed) hair fragments may be collected by the rotary trimmer 100 to prevent such hair fragments from entering the patient's middle ear during a subsequent surgical procedure. In certain embodiments, the hair fragments may be collected via application of vacuum suction by the rotary trimmer 100. In such embodiments, as described above with reference to FIG. 1A , the rotary trimmer 100 may be in fluid communication with a vacuum source 129 via a vacuum line 301 coupled to one or more ports 123 at the proximal end 125 of the base unit 120 for generating and applying vacuum suction. In certain embodiments, the vacuum source 129 may be activated constantly and / or automatically when the shearing assembly 200 of the rotary trimmer 100 is activated. In other embodiments, the vacuum source 129 may be manually and separately activated by a user when using the rotary trimmer 100, for example, by pressing a switch or toggle on the exterior of the base unit 120.

[0045] When activated, vacuum source 129 may generate a vacuum force that can act on loose bristle strands through base unit 120 and cover 110, resulting in the bristle strands being pulled through the interior of cover 110 and / or base unit 120, through one or more ports 123, and through vacuum line 301 to vacuum source 129 for removal. In certain embodiments, loose bristle strands may be sucked and collected by a catch disposed within base unit 120. In such embodiments, the catch may comprise a removable collection chamber.

[0046] 2C illustrates a partial cross-sectional side view of a portion of another exemplary configuration of a rotary trimmer 100, according to some embodiments of the present disclosure. Some aspects of the configuration of the rotary trimmer 100 illustrated in FIG. 2C are similar or substantially similar to aspects of the configuration illustrated in FIGS. 2A and 2B. Accordingly, similar or substantially similar aspects are omitted from the following description for the sake of brevity.

[0047] 2C , in certain embodiments, in addition to or instead of the cutting surface 203, the shearing assembly 200 may include one or more lateral blades 204 extending from the outer surface 205 of the shearing body 202. Each of the one or more lateral blades 204 may comprise at least one of a lateral cutting surface 206 and / or a distal cutting surface 208. The lateral cutting surface 206 may extend parallel to the longitudinal axis of the shearing body 202 and the rotary trimmer 100 (e.g., parallel to axis X). Thus, the lateral cutting surface 206 may be configured to cut hair extending laterally from the slit 112 into or toward the outer surface 205 of the shearing body 202. Meanwhile, the distal cutting surface 208 may be disposed at a distal end of the lateral blade 204 substantially near the distal end 209 of the shearing body 202. The distal cutting surface 208 may extend perpendicular to the longitudinal axis of the rotary trimmer 100 and may therefore be used to cut a portion of hair that extends into the slit 112 parallel to the shearing body 202 of the rotary trimmer 100. In yet another embodiment, each of the side blades 204 may include a proximal cutting surface on a surface opposite the distal cutting surface 208, and in certain embodiments, parallel to the distal cutting surface 208.

[0048] 2D illustrates a partial cross-sectional side view of the rotary trimmer configuration shown in FIG. 2C in use, according to some embodiments of the present disclosure. As shown, when the driver 214 of the shearing assembly 200 is activated and the shearing body 202 rotates, a user may advance the rotary trimmer 100 toward the outer ear and / or into the ear canal (indicated by arrow 242), causing ear hair 240 to pass through the slit 112 in the cover 110 and enter the interior space of the cover 110. There, the ear hair 240 comes into contact with the cutting surfaces 203, 206, and / or 208, which shear the ear hair 240. Similar to the example of FIG. 2B, the severed hair pieces may be sucked and / or collected by the rotary trimmer 100 via application of a vacuum force by a vacuum source 129 fluidly coupled to the base unit 120.

[0049] 3A and 3B, front views of the distal end 121 of the base unit 120 of the rotary trimmer 100 are shown. In such an embodiment, the optical fiber 302 is disposed concentrically with respect to the cutting surface 203 of the shearing assembly 200. The optical fiber 302 may be centrally disposed within the shearing body 202 such that the radial distance between a point on the outer surface of the optical fiber 302 and the inner surface 210 of the shearing body 202 is uniform around the entire circumference of the optical fiber 302. In the example of FIG. 3A, the optical fiber 302 is an illumination fiber configured to relay and illuminate illumination light from the distal end 303 of the optical fiber 302. The optical fiber 302 may be a multimode end-emitting optical fiber, a single-mode end-emitting optical fiber, or the like. An illumination light source 306 may be optically coupled to the optical fiber 302 and may generate illumination light for transmission through the optical fiber 302.

[0050] In certain embodiments, the optical fiber 302 may extend through one or more ports 123 of the base unit 120 for connection to the illumination source 306. Alternatively, the optical fiber 302 may be disposed in an optical cable and connected to the illumination source 306, for example, via a second optical fiber connected to the optical fiber 302 at one or more ports 123. In certain other embodiments, the illumination source 306 may be integrated into the base unit 120. The illumination source 306 may comprise any suitable type of illumination source, including a violet light source, a blue light source, a white light source, or any other type of light source that produces visible light. For example, an LED-based (light-emitting diode-based) illumination source 306 may be utilized. In further examples, a xenon- or halogen-based illumination source 306 may be utilized.

[0051] In certain embodiments, the optical fiber 302 has a diameter of about 20 μm to about 120 μm, such as about 40 μm to about 100 μm. For example, the optical fiber 302 has a diameter of about 50 μm to about 80 μm. However, smaller or larger diameters are also contemplated.

[0052] 3B , the optical fiber 302 is an image fiber coupled to a camera 304 to facilitate visualization and imaging, including digital visualization and imaging, from within the rotary trimmer 100 through the distal end 303 of the optical fiber 302. The camera 304 integrated with the optical fiber 302 may be communicatively coupled to an external display to facilitate a user viewing the imaging feed captured by the camera 304 and relayed through the optical fiber 302. The external display may be connected to the camera 304 and optical fiber 302 wirelessly or via a wired connection for transmission of the image feed from the camera 304.

[0053] 3B , the optical fiber 302 may be further disposed within a sleeve 308. The sleeve 308 may be directly or indirectly coupled to the exterior of the optical fiber 302. The sleeve 308 may act as a tubular structure to provide structural support and alignment for the optical fiber 302 within the base unit 120. In embodiments in which the sleeve 308 is directly coupled to the optical fiber 302, the inner surface of the sleeve 308 may have an inner diameter substantially similar to the outer diameter of the optical fiber 302. In certain embodiments, the additional rigidity provided by the sleeve 308 enables suspension of the optical fiber 302 within / through the shear body 202.

[0054] 4A and 4B show exemplary front views of the distal end 121 of the base unit 120 having at least two optical fibers housed therein. Accordingly, a first optical fiber 440a may be configured as an illumination fiber utilized to relay and project illumination light for illumination of the ear canal space, while a second optical fiber 440b may be configured as an image fiber utilized to provide digital visualization and imaging of the ear canal space, or vice versa.

[0055] In certain embodiments, the first optical fiber 440a and the second optical fiber 440b may be the same size (e.g., have the same diameter). An example of the first optical fiber 440a and the second optical fiber 440b formed to be substantially the same size is shown in FIG. 4A for reference. In such an embodiment, the first optical fiber 440a and the second optical fiber 440b may both have a diameter of about 20 μm to about 120 μm, such as about 40 μm to about 100 μm. For example, the first optical fiber 440a and the second optical fiber 440b may both have a diameter of about 50 μm to about 80 μm. However, in still other embodiments, the optical fibers 440a, 440b may each have different dimensions.

[0056] In certain embodiments, the optical fibers 440a, 440b may be coupled together within the base unit 120, for example, by adhesive bonding. In other embodiments, the optical fibers 440a, 440b may be separated and insulated from one another within the base unit 120. As shown in FIG. 4A , the first optical fiber 440a and the second optical fiber 440b may, in certain embodiments, be centered within the base unit 120 by being disposed within the opening 207 of the shearing body 202. However, in other embodiments, only one of the first optical fiber 440a and the second optical fiber 440b may be disposed through the shearing body 202, with the other optical fiber disposed on the outside.

[0057] As shown in FIG. 4B , one or both of the first optical fiber 440 a and the second optical fiber 440 b may optionally be disposed within a sleeve 408. Similar to the sleeve 308, the sleeve 408 may provide structural support and containment for the first optical fiber 440 a and / or the second optical fiber 440 b within the rotary trimmer 100. In certain embodiments, a transparent filler material may be used within the sleeve 408 to prevent movement of the first optical fiber 440 a and / or the second optical fiber 440 b therein. For example, an adhesive may fill all areas within the sleeve 408 that are not occupied by the optical fibers 440 a, 440 b. In other embodiments, one or both of the optical fibers 440 a, 440 b are disposed within the sleeve 408 without the use of a filler material.

[0058] 5 shows an exemplary front view of the distal end 121 of the base unit 120 having a first optical fiber 550 and multiple second optical fibers 540 surrounding the first optical fiber 550. In the embodiment shown, the single first optical fiber 550 may be configured as an image fiber to provide digital visualization, while each of the multiple second optical fibers 540 may be configured as an illumination fiber to emit illumination light.

[0059] 5 , a single first optical fiber 550 is disposed within the shearing body 202 and is circumferentially surrounded by a plurality of second optical fibers 540 along the circumference of the optical fiber 550. In other words, a ring of second optical fibers 540 is disposed around and in contact with the first optical fiber 550 such that the center of the fiber 550 is equidistant, or at least substantially equidistant, from the center of the fiber 540. As shown, the single first optical fiber 550 and the plurality of second optical fibers 540 may all be centrally suspended within the shearing body 202.

[0060] In certain embodiments, the dimensions of each of the second optical fibers 540 may be smaller than the dimensions of the first optical fiber 550 to allow the optical fibers 540, 550 to fit within the space inside the shear body 202. In another embodiment, the plurality of second optical fibers 540 may be disposed outside the shear body 202, such as along the inner surface 124 of the base unit 120. In a further embodiment, an optional sleeve 548 may be disposed around the plurality of second optical fibers 540 and configured to firmly hold the second optical fibers 540 relative to the first optical fiber 550. The sleeve 548 may have any suitable thickness and dimensions to ensure that the second fibers 540 are tightly packed and do not have room for the second fibers 540 to loosen or move. The arrangement of the first optical fiber 550 and the second optical fiber 540 shown in FIG. 5 can improve illumination of the outer ear space during use of the rotary trimmer 100 due to the 360-degree arrangement of the second optical fiber 540 around the first optical fiber 550.

[0061] In addition to utilizing different arrangements and numbers of optical fibers within the base unit 120 of the rotary trimmer 100, the relay of illumination light by the illumination fibers through the cover 110 into the patient's ear canal space and / or the clarity of imaging obtained by the imaging fibers disposed within the rotary trimmer 100 may be modified by utilizing different materials for the cover 110. In one aspect, the cover 110 may be formed from a material suitable for insertion into a human ear. As described above, the cover 110 may include one or more sections formed from a translucent or transparent material to enable illumination and / or imaging through the cover 110. In certain embodiments, the distal tip 111 of the cover 110 may be formed from a translucent or transparent material, while the remainder of the cover 110 is formed from an opaque metal or plastic material. In other embodiments, the cover 110 may be formed entirely from a translucent or transparent material.

[0062] In summary, embodiments of the present disclosure include instruments for use in neuro-otological surgical procedures, and more particularly, shearing instruments for shearing hair in the ear canal and combining shearing, illumination, and vacuum suction functions. In particular, the described instruments are configured to shear and suction hair in the ear canal and may be used prior to performing a TEES procedure to prevent ear canal hair from entering the middle ear during the TEES procedure and causing middle ear infection and / or inflammation. Furthermore, the delivery of illumination light by the described instruments allows for enhanced visualization of the ear canal during inspection and removal of hair from the ear canal. Still further, in certain embodiments described herein, the instruments can facilitate digital visualization and imaging functions to assist in inspection and removal of hair from the ear canal. Digital visualization and imaging functions may also be implemented as part of the instrument's safety or feedback mechanism to prevent inadvertent contact and damage to the tympanic membrane when using the shearing instruments on a patient.

[0063] Thus, utilization of the instruments described herein allows for efficient, safe, and complete removal of hair from the ear canal prior to a TEES procedure, allowing surgeons to perform the TEES procedure without the need for an otoscope. Eliminating the need for an otoscope reduces the number of instruments the surgeon needs to hold during the TEES procedure and also provides the surgeon with more space within the ear canal to work in. Thus, the described embodiments allow for the performance of more efficient, less invasive, and safer neuro-otological surgical procedures.

[0064] Although neuro-otological surgery is discussed as an example of a surgical procedure that can benefit from the described embodiments, other surgical procedures can benefit from the advantages of the instruments described herein as well.

[0065] While the foregoing relates to embodiments of the present disclosure, other and further embodiments of the disclosure may be devised without departing from the basic scope thereof, which scope is determined by the claims that follow.

Claims

1. a base unit configured to be held by a user, the base unit comprising an opening at a distal end of the base unit; a cover removably coupled to the opening, the cover including a plurality of slits near a distal end of the cover; a shear assembly at least partially disposed within the base unit, blade, a rotor coupled to the blades; and a drive configured to rotate the rotor; a shear assembly for rotating the rotor to cause rotational movement of the blades; one or more optical fibers disposed within the base unit and configured to facilitate visualization of an exterior space distal to the cover; a port disposed at a proximal end of the base unit configured to be in fluid communication with a vacuum line; A rotary trimmer.

2. The rotary trimmer of claim 1 , wherein at least one of the one or more optical fibers is configured to emit illumination light.

3. 10. The rotary trimmer of claim 1, wherein at least one of the one or more optical fibers is optically coupled to a camera at a distal end of the at least one of the one or more optical fibers.

4. 2. The rotary trimmer of claim 1, wherein the one or more optical fibers comprise one or more illumination fibers configured to transmit illumination light to the exterior space and one or more image fibers configured to capture and transmit images to a visualization system.

5. 4. The rotary trimmer of claim 3, wherein at least one of the one or more optical fibers is configured as a proximity sensor to detect one or more sensitive surfaces within an ear canal space and monitor a distance between the distal end of the cover and the one or more sensitive surfaces.

6. 6. The rotary trimmer of claim 5, further comprising a safety feedback feature that provides an audible and / or visual notification to a user when the proximity sensor detects that the distal end of the cover is within a minimum threshold distance to the one or more sensitive surfaces in the ear canal space.

7. 6. The rotary trimmer of claim 5, further comprising a safety feedback feature that disables the shearing assembly when the proximity sensor detects that the distal end of the cover is within a minimum threshold distance to the one or more sensitive surfaces in the ear canal space.

8. 8. The rotary trimmer of claim 7, wherein the rotary trimmer is configured to automatically re-activate the shear assembly when the proximity sensor detects that the distal end of the cover is outside the minimum threshold distance after the shear assembly has been disabled by the safety feedback feature.

9. 10. The rotary trimmer of claim 1, wherein the cover further comprises one or more areas formed from a translucent or transparent material that facilitates the transmission of light therethrough.

10. 2. The rotary trimmer of claim 1, wherein the blade comprises a cylindrical body having a proximal end and a distal end, the proximal end of the cylindrical body being coupled to the rotor, and the distal end of the cylindrical body comprising a cutting surface formed along a periphery of an opening in the distal end of the cylindrical body.

11. 11. The rotary trimmer of claim 10, wherein the blade further comprises a hollow cavity extending from the proximal end of the cylinder to the opening at the distal end of the cylinder, and wherein the one or more optical fibers are disposed concentrically within the hollow cavity relative to the cutting surface of the cylinder.

12. 2. The rotary trimmer of claim 1, wherein the blade comprises a cylindrical body and one or more lateral blades extending laterally from an outer surface of the cylindrical body, each of the one or more lateral blades including a lateral cutting surface disposed parallel to the outer surface of the cylindrical body.

13. 13. The rotary trimmer of claim 12, wherein each of the one or more side blades further comprises a distal cutting surface at a distal end of each of the one or more side blades, the distal cutting surface extending perpendicular to the outer surface of the cylinder.

14. The rotary trimmer of claim 1 further comprising the vacuum line for fluidly coupling the port to a vacuum source.

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