Surgical Microscope System

Abstract

The devices, systems, and methods can be used to facilitate indirect viewing into cavities, such as, but not limited to, the middle ear cavity. Some embodiments have applications, such as, but not limited to, facilitating visualization and procedures in the outer ear, middle ear, and / or inner ear to diagnose and / or treat disorders, including, but not limited to, hearing loss and other ear disorders. In certain implementations, a surgical microscope is used in conjunction with an inverter lens and a distal lens. In some cases, the distal lens traverses a thin membrane or septum, such as, but not limited to, the tympanic membrane. In some embodiments, the distal lens can be an assembly combining two or more lenses. For example, in some cases, the distal lens can use a wide-angle lens, a zoom lens, other variously shaped lenses, and / or a prism.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. Provisional Application No. 62 / 965,481, filed January 24, 2020, U.S. Provisional Application No. 63 / 024,183, filed May 13, 2020, which is incorporated by reference in its entirety, U.S. Provisional Application No. 63 / 040,495, filed June 17, 2020, which is incorporated by reference in its entirety, U.S. Provisional Application No. 63 / 051,568, filed July 14, 2020, which is incorporated by reference in its entirety, and U.S. Provisional Application No. 63 / 077,448, filed September 11, 2020, which is incorporated by reference in its entirety. No. 63 / 082,996, filed September 24, 2020 (which is incorporated by reference in its entirety), which claims the benefit of priority to U.S. Provisional Application No. 63 / 078,141, filed September 14, 2020 (which is incorporated by reference in its entirety), U.S. Provisional Application No. 63 / 080,510, filed September 18, 2020 (which is incorporated by reference in its entirety), U.S. Provisional Application No. 63 / 081,015, filed September 21, 2020 (which is incorporated by reference in its entirety), and U.S. Provisional Application No. 63 / 082,996, filed September 24, 2020 (which is incorporated by reference in its entirety).

[0002] This document relates to devices, systems, and methods for facilitating visualization and procedures in the outer, middle, and inner ear to diagnose and / or treat conditions, including, but not limited to, hearing loss and other ear disorders. In some examples, the systems and methods include instruments and techniques that facilitate indirect viewing into cavities, such as, but not limited to, the middle ear cavity. [Background technology]

[0003] The human ear is subject to a variety of disorders including, but not limited to, hearing loss, tinnitus, imbalance including vertigo, Meniere's disease, vestibular neuritis, vestibular schwannoma, labyrinthitis, otosclerosis, ossicular chain disruption, cholesteatoma, outer ear infection, middle ear infection, schwannoma, and tympanic membrane perforation, to name a few.

[0004] In one example, conductive hearing loss (CHL) involves the obstruction of the normal mechanical pathway for sound to reach the hair cells in the cochlea, for example, due to malformations, fluid accumulation in the middle ear, a disrupted eardrum, the presence of a tumor, and / or damage to the canaliculus. Sensorineural hearing loss (SNHL) results from the absence or damage of hair cells in the cochlea, or damage to the auditory nerve. SNHL is usually associated with exposure to loud noise, head trauma, aging, infection, inherited disorders such as Meniere's disease, tumors, ototoxicity, Usher's disease, and the like.

[0005] Over the last few years, the use of endoscopes has increased and is of great appeal because they allow wide-angle viewing into the middle ear and adjacent spaces; however, endoscopes require one of the surgeon's hands to operate and usually eliminate binocular vision, making it difficult to assess depth and therefore making the procedure more difficult and potentially compromising consideration of delicate structures in the middle ear. Summary of the Invention [Means for solving the problem]

[0006] This document describes devices, systems, and methods for uses including, but not limited to, facilitating visualization and procedures in the outer ear, middle ear, and / or inner ear to diagnose and / or treat conditions, including, but not limited to, hearing loss and other ear disorders. For example, this document describes devices, systems, and methods including instruments and techniques that facilitate indirect viewing into cavities, such as, but not limited to, the middle ear cavity.

[0007] In certain implementations, a surgical microscope is used in conjunction with an inverter lens (which may include one or more lenses) and a distal lens (which may include one or more lenses). In some embodiments, the inverter lens is located outside the body, such as outside the ear. In certain embodiments, the inverter lens is located inside the body, such as in the ear canal. In some embodiments, a portion of the inverter lens is outside the body and another portion of the inverter lens is located inside the body.

[0008] In some cases, the distal lens traverses a thin membrane or septum, such as, but not limited to, the tympanic membrane ("TM"). In certain cases, the distal lens is positioned in a manner to allow visualization through an opening in a thin membrane or septum, such as, but not limited to, the TM. In some embodiments, the distal lens can be an assembly combining two or more lenses. For example, in some cases, wide-angle lenses, zoom lenses, lenses of various shapes, and / or prisms can be used in the distal lens, as described further below. Additionally, in some embodiments, optical fibers can be used to transmit images.

[0009] Although the devices, systems, and methods for facilitating visualization and procedures are described herein in the exemplary context of visualizing the middle and / or inner ear via the outer ear, it should be understood that the inventive concepts described herein are not limited to such applications. For example, in some embodiments, the devices, systems, and methods for facilitating visualization and procedures described herein can be used for other middle and / or inner ear procedures, such as, but not limited to, canal tympanic flap, transmastoid access, transcanal access via intraaural, postauricular, postauricular, and others. Furthermore, the devices, systems, and methods for facilitating visualization and procedures described herein are well suited for use in other cavities or spaces within the body, as well as in other procedures, in addition to visualizing the middle and / or inner ear. For example, the devices, systems, and methods are well suited for visualization and procedures related to the Eustachian tube, mastoid sinus, and others.

[0010] The devices, systems, and methods described herein can be used in conjunction with additional therapeutic techniques. For example, the devices, systems, and methods described herein can be used in conjunction with therapeutic techniques, such as, but not limited to, delivery of therapeutic agents (which may be in the form of gels, liquids, or solids), antibiotic delivery, gene delivery, device or implant delivery, diagnostic procedures, and surgical procedures, among others.

[0011] In some aspects, the present disclosure is directed to a surgical microscope system including a surgical microscope, a stereoscopic inverter lens system, and a distal lens.

[0012] Such a surgical microscope system may optionally include one or more of the following features: The distal lens may be dimensioned for placement against the tympanic membrane to facilitate visualization of the middle ear site. The distal lens may include a prism at a proximal end of the distal lens. The distal lens may include a wide field lens at a distal end of the distal lens. The distal lens may include a zoom lens or an objective lens disposed between the prism and the wide field lens. The distal lens may define a waist having a smaller outer diameter than immediately adjacent proximal and distal portions of the distal lens. In some embodiments, the distal lens includes a first prism at a proximal end of the distal lens and a second prism at a distal end of the distal lens. Such a distal lens may also include a zoom lens or an objective lens disposed between the first prism and the second prism. In some embodiments, the distal lens includes two or more stabilization arms extending radially outward from a body of the distal lens. In certain embodiments, the distal lens includes a focusing lens coupled to the housing at a proximal end of the distal lens and a second lens coupled to the housing at a distal end of the distal lens. The housing can define an interior space between the focusing lens and the second lens. The interior space can be filled with a gas. The interior space can be filled with a liquid. The housing can include a radially extending flange or arm. In some embodiments, the system also includes a port device attached to the distal lens. In some embodiments, at least a portion of the stereoscopic inverter lens system includes a speculum. (otoscope)In certain embodiments, the portion of the stereoscopic inverter lens system mounted within the speculum is positionally adjustable relative to the speculum. A cavity may be defined within the speculum and to the side of the portion of the stereoscopic inverter lens system mounted within the speculum. In some embodiments, the system also includes a light pipe coupled to the distal lens. The distal lens can include an elongated tubular member and a plurality of lenses coupled to the tubular member to define a light path through the tubular member. Such a tubular member can include a plurality of sections, the plurality of sections allowing angling between the sections. In some embodiments, the distal lens includes an elongated tubular member encasing an optical fiber configured to relay an image from a distal end of the distal lens to a proximal lens of the distal lens.

[0013] In a further aspect, the present disclosure is directed to a method for indirectly viewing into a patient's middle ear cavity. The method includes providing a surgical microscope system comprising: (i) a surgical microscope, (ii) a stereoscopic inverter lens system, and (iii) a distal lens. The method also includes placing the distal lens in contact with the patient's tympanic membrane and viewing an image of the middle ear cavity captured by the distal lens and relayed by the stereoscopic inverter lens system to the surgical microscope.

[0014] Such a method for indirectly viewing into a patient's middle ear cavity can optionally include one or more of the following features: The stereoscopic inverter lens system can be external to the patient's ear. The stereoscopic inverter lens system can be within the patient's ear canal. The method can include use of a surgical microscope system using any combination of any of the embodiments and / or features described herein. Effect of the Invention

[0015] Some or all of the embodiments described herein may provide one or more of the following advantages. First, current visualization of the middle ear cavity, inner ear, and nearby sites is generally challenged due to the constraints of direct access paths, such as through the ear canal, through the ear canal via a post-auricular trans-canal access created by invasively lifting the ear, or through highly invasive trans-canal access created with bone drills and other instruments. In these situations, it is challenging to see around the complex and delicate structures that create shadows and hidden corners that still need to be navigated around for many procedures. Furthermore, the access paths are small in diameter due to the congenital dimensions and curvature of the ear canal, or due to the desire to minimize bone and tissue removal, such as during trans-canal access. Using the surgical microscope system described herein has the advantage of allowing binocular vision by the surgeon, allowing for largely hands-free operation.

[0016] Second, using a surgical microscope system for visualizing the middle and / or inner ear as described herein provides the added advantage of allowing the surgeon to comfortably utilize the surgical microscope, as surgical microscopes are typically used, to easily look down into the ear canal and easily switch to a wide field of view within the middle ear (e.g., to achieve a field-of-view). Additionally, the surgical microscope system described herein provides a large depth of focus and high resolution at its periphery.

[0017] Third, the devices, systems, and methods described herein are advantageous because they allow instruments to be threaded to the operating site and function in liquid-filled spaces in addition to air-filled spaces.

[0018] Fourth, the devices, systems, and methods described herein facilitate minimally invasive procedures. Such minimally invasive techniques may tend to reduce recovery time, patient discomfort, disease recurrence, surgical complications, and treatment costs. Furthermore, the methods described herein can be performed using local anesthesia rather than requiring general anesthesia. Therefore, advantageously, treatment costs, patient risks, and recovery times are further reduced.

[0019] Fifth, the systems described herein can also be used for diagnostic purposes, which can aid in planning procedures, alter the location of treatment, and potentially improve patient outcomes.

[0020] The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims. [Brief description of the drawings]

[0021] [Figure 1] 1 is a schematic diagram of a medical procedure for visualizing a middle ear site using an exemplary surgical microscopy system according to some embodiments. [Diagram 2] A diagram showing an exemplary distal lens assembly that may be included as part of some embodiments of the surgical microscope system of FIG. [Diagram 3] A figure showing another exemplary distal lens assembly that may be included as part of some embodiments of the surgical microscope system of Figure 1. [Figure 4] A figure showing another exemplary distal lens assembly that may be included as part of some embodiments of the surgical microscope system of Figure 1. [Diagram 5] FIG. 2 illustrates another exemplary distal lens assembly that may be included as part of some embodiments of the surgical microscopy system of FIG. 1. The distal lens assembly is shown as traversing the TM. [Figure 6] A figure showing another exemplary distal lens assembly that may be included as part of some embodiments of the surgical microscope system of Figure 1. [Figure 7] A figure showing another exemplary distal lens assembly that may be included as part of some embodiments of the surgical microscope system of Figure 1. [Figure 8] FIG. 2 illustrates another exemplary distal lens assembly that may be included as part of some embodiments of the surgical microscopy system of FIG. 1. The distal lens assembly is shown adjacent an opening in the TM. [Figure 9] A longitudinal cross-sectional view of another exemplary distal lens assembly that may be included as part of some embodiments of the surgical microscopy system of Figure 1. [Figure 10] FIG. 2 is a plan view from the perspective of the outer ear of another exemplary distal lens assembly that may be included as part of some embodiments of the surgical microscopy system of FIG. 1. The distal lens assembly is shown in position over the TM and includes a connected TM port device that allows various types of instruments to pass into the middle ear. [Figure 11] 1 is a schematic diagram of a medical procedure for visualizing a middle ear region using another exemplary surgical microscopy system according to some embodiments. [Figure 12] 1 is a schematic diagram of a medical procedure for visualizing a middle ear region using another exemplary surgical microscopy system according to some embodiments. [Figure 13] 13 illustrates the use of a surgical instrument in conjunction with the use of the surgical microscope system of FIG. 12. [Figure 14] 1 illustrates the use of an exemplary distal lens assembly, light source, and surgical instrument for a TM. [Figure 15] 1 is a schematic diagram of a medical procedure for visualizing a middle ear region using another exemplary surgical microscopy system according to some embodiments. [Figure 16] FIG. 16 is a longitudinal cross-sectional view of the distal lens assembly of FIG. [Figure 17]16 is a proximal end view of the distal lens assembly of FIG. 15 with a peripheral structure for supporting the distal lens assembly within the outer ear. [Figure 18] 1 is a schematic diagram of a medical procedure for visualizing a middle ear region using another exemplary surgical microscopy system according to some embodiments. [Figure 19] 1 is a schematic diagram of a medical procedure for visualizing a middle ear region using another exemplary surgical microscopy system according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] Like reference numbers in the various drawings indicate like elements.

[0023] 1, certain embodiments of devices, systems, and methods for treating a patient 10 can include an exemplary surgical microscope system 100. The surgical microscope system 100 can be used to facilitate viewing structures in recessed spaces, such as, but not limited to, the middle ear 40.

[0024] In the illustrated embodiment, the surgical microscope system 100 includes a surgical microscope 110 (and / or camera), a stereoscopic inverter lens system 120, and a distal lens 130. An image at the middle ear site 40 is captured by the distal lens 130, which in this embodiment is located within an opening in the TM 30. From the distal lens 130, the image is transferred through the ear canal 20 to the stereoscopic inverter lens system 120. The surgical microscope 110 receives images from the stereoscopic inverter lens system 120 and presents them for the surgeon 12 to see. The surgical microscope 110 allows for binocular or stereoscopic vision and allows for primarily hands-free operation by the surgeon 12.

[0025] The stereoscopic inverter lens system 120, in this embodiment, is external to the ear canal 20. In some embodiments, the stereoscopic inverter lens system 120 is a prism inverter, which can also be a stereoscopic diagonal inverter, or a stereo reinverter. It transforms the image to make it easier for the surgeon or clinician to relate the direction of visualization to the object being viewed (e.g., moving an instrument to the right will appear to move to the right through the system). In certain embodiments, the stereoscopic inverter lens system 120 can include multiple parts, such as a beam splitter, a stereo inverter, and an objective lens.

[0026] In some embodiments, the surgical microscope system 100 includes a mount 112 by which the stereoscopic inverter lens system 120 is adjustably mounted to the framework of the surgical microscope 110 (or camera). Thus, the stereoscopic inverter lens system 120 can be aligned with the object of the surgical microscope 110. Additionally, in some embodiments, the mount 112 can be adjusted to allow for longitudinal adjustment.

[0027] Light for visualization with the surgical microscope system 100 may be provided externally via a light pipe or other source, as described further below, or may be projected coaxially through the system. The surgical microscope system 100 has the advantage that the surgeon can have binocular or stereoscopic vision using both hands during a treatment or diagnostic procedure, and can easily look down the ear canal 20, as is typical for surgical microscopes. Additionally, the surgical microscope system 100 allows the surgeon to easily switch to a wide field of view (e.g., to achieve a field of view within a field) within the middle ear 40 while still having a large depth of focus and high resolution at its periphery. Additionally, the surgical microscope system 100 further utilizes a surgical microscope that is comfortable for the surgeon, allowing the surgeon to pass instruments for treatment or diagnostic procedures, and can function within fluid-filled or air-filled spaces, among other advantages, as described further below. The surgical microscope system 100 facilitates therapeutic methods and devices for treating the patient 10 using minimally invasive techniques.

[0028] While many of these exemplary embodiments provided herein are described in combination with or for use with a surgical microscope, it is contemplated that the concepts may also work with a digital viewing modality, or endoscope. Digital viewing is well suited to display an image heads up on an external monitor, which may be high definition, 3D, curved, etc. Heads up viewing is also well suited to simultaneously display a picture-in-picture of the ear canal, e.g., showing a wide-field view from the distal tip of one of the previously mentioned assemblies. This would be surprisingly advantageous, as it would improve navigation of the assembly down the ear canal, as well as passage of instruments down the ear canal, while simultaneously allowing (e.g.) a wide-field view into the middle ear cavity.

[0029] When the concepts disclosed herein are used in a digital viewing system that enables a heads-up display, embodiments of the lens system can facilitate interaction with supporting personnel and training of new surgeons. Heads-up displays, virtual reality ("VR"), 3D, and similar systems can dramatically improve ergonomics.

[0030] The systems and concepts described herein also work well in combination with navigational tracking and other robotic-assisted surgical modalities.

[0031] In some embodiments, the light source used in the systems described herein can be replaced from a typical visual spectrum source to infrared or other specific spectrum. A specific spectrum such as infrared can be useful in itself for tissue or blood vessel identification. Infrared is useful for identifying blood vessels and vasculature. The long wavelengths of infrared (>700 nm) can penetrate tissues more easily than visible light and can allow for excellent illumination of the middle ear through the eardrum, but the reflection and scattering of short wavelengths can be problematic. To identify blood vessels and specific tissues, fluorescent colorants and other dyes or colorants such as ICG are useful in combination with specific wavelength light sources and / or specific filters. Examples include ICG (indocyanine green: near infrared with an excitation peak around 810 nm) suitable for blood vessel identification, and 5-aminolevulinic acid (5-ALA) or fluorescein for tumor identification. In the middle ear, for example, these non-standard light sources would be particularly advantageous when used to identify cholesteatomas growing on top of bony structures, or other soft tissue lesions.

[0032] 2-10 show various non-limiting examples of distal lenses 130. As shown in some of the figures, distal lenses 130 allow visualization of the middle ear through the TM 30. Any of the distal lenses 130 may be configured to traverse the TM 30 (e.g., as shown in FIG. 5) and / or be configured to be positioned adjacent to an opening in the TM 30 (e.g., as shown in FIG. 8).

[0033] The distal lens 130 can be a simple or compound lens assembly and can have a wide field or wide angle lens, a zoom lens, a prism or reflector element, a focusing lens, alone or in any combination. In some embodiments, the distal lens 130 is a lens with a prism element immediately adjacent to the lens or away from the lens. The lens or lenses comprising the distal lens 130 can be biconvex, biconcave, plano-convex, plano-concave, concave-convex, achromatic, multi-lens, focusing, etc., in any combination. The lenses comprising the distal lens 130 can be constructed from materials such as, but not limited to, flint glass, hardened glass, polycarbonate, acrylic, or other materials, and combinations thereof. In some embodiments, the lens or assembly comprising the distal lens 130 can be an injection molded polymeric optical element. It would be beneficial to have the distal lens 130 made from disposable components to eliminate the difficulties associated with sterilization and maintenance of the lens, as well as to reduce OR turnaround time. In some embodiments, the lens includes a coating to reduce the likelihood of fogging.

[0034] The distal lens 130 can be made in a variety of sizes and focal lengths to accommodate the ear canal length of an individual patient. For example, and without limitation, three sizes are available for ear canal lengths: 19-23 mm, 23-27 mm, and 27-31 mm, to maintain consistent microscope positioning for optimal instrument maneuverability and surgeon comfort.

[0035] FIG. 2 shows an exemplary distal lens assembly 130a. In the illustrated embodiment, the distal lens assembly 130a has a wide field lens 132a at its most distal end, followed by a zoom lens or objective lens 134a with an air gap of 1-2 mm, followed by a prism element 136a for varying the image angle going proximally, all mechanically coupled. The outer diameters of the lenses 132a and 134a can range, without limitation, from about 1 mm to 3 mm, 1 mm to 5 mm, 1 mm to 7 mm, 3 mm to 8 mm, 2 mm to 4 mm, or 3 mm to 6 mm. These outer diameter dimensions can be applied to any of the distal lens assemblies described herein. The prism 136a can have an angle (relative to the central longitudinal axis of the distal lens assembly 130a) of about 42 degrees to match the typical angle of the tympanic membrane relative to the main longitudinal axis of the ear canal. In some embodiments, the angle of the prism 136a is in the range of about 40 degrees to 50 degrees, 30 degrees to 60 degrees, or 20 degrees to 70 degrees, without limitation. These angle parameters may apply to any of the prisms described herein. The main objective lens 134a may be part of the distal assembly 130a and may be, for example, a biconvex lens (e.g., 60-120D). For these exemplary lenses, in some cases it may be preferable for them to be less than about 10 mm from the object of interest.

[0036] 3 shows another exemplary distal lens assembly 130b. In the illustrated embodiment, the distal lens assembly 130b has a wide field lens 132b at its most distal end, followed by a prism element 136b to change the image angle going proximally. In some embodiments, the dimensions and other parameters of the distal lens assembly 130b can be the same as the distal lens assembly 130a.

[0037] 4 shows another exemplary distal lens assembly 130c. In the illustrated embodiment, distal lens assembly 130c has a wide field lens 132c at its most distal end, then a 1-2 mm air gap, then a prism element 136c to change the image angle going proximally out. In some embodiments, the dimensions and other parameters of distal lens assembly 130c can be the same as distal lens assembly 130a.

[0038] 5 illustrates another exemplary distal lens assembly 130d positioned through the tympanic membrane 30. As shown in this example, any of the distal lenses 130 described herein can have form factors / features that facilitate maintaining the position of the distal lens 130 within the TM 30 for the duration of a surgical or diagnostic procedure. Such factors can include having a waist 138d (or waisted outer contour shape) that allows for a friction fit of the distal lens 130 within the opening in the TM 30, thereby providing longitudinal stability.

[0039] Any of the distal lenses 130 described herein may optionally include other elements to facilitate stabilization of the distal lens 130 relative to the TM 30. For example, the distal lens 130 may include arm members such as arm members 139da and 139db as shown in FIG. 5. Alternatively or in addition, the distal lenses 130 described herein may optionally include, without limitation, rings, interconnections with other elements, and / or other types of stabilization devices. Furthermore, in addition to stabilization relative to the illustrated TM 30, it is also contemplated that the stabilization members of the distal lenses 130 described herein may be stabilized relative to the ear canal wall, the tympanic annulus, other instruments or access sites, and / or other adjacent structures. It is also contemplated that these arm members 139da and 139db may be malleable or otherwise adjustable to allow fine adjustment of the direction and / or focus of the proximally "outgoing" image from any of the distal lenses 130 described herein.

[0040] 6 illustrates another exemplary distal lens assembly 130e that includes a distal prism member 132e, a zoom or objective lens 134e, and a proximal prism member 136e. Prism members 132e and 136e, as previously described, allow visualization of objects off-axis, distal to the plane of the tympanic membrane, and allow proximal images to be viewed off-axis from distal lens assembly 130e.

[0041] 7 shows another exemplary distal lens assembly 130f with a distal prism member 132f, a zoom or objective lens 134f, and a proximal prism member 136f. In addition, the distal lens assembly 130f includes an extension member 133f to provide a view deep inside the middle ear. Thus, the distal lens assembly 130f is a periscope-like distal lens assembly that can view typical structures in the middle ear that would be prevented from viewing directly through the eardrum.

[0042] 8 illustrates an exemplary distal lens assembly 130e that presents through an opening 31, or other hole, in the TM 30. By way of example, the opening 31 can be a hole or incision into the TM 30 made prior to placement of the distal lens assembly 130e. In such an implementation, since the distal lens assembly 130e does not have stabilization associated with penetrating the TM 30 (as opposed to the implementation shown in FIG. 5, for example), it may be particularly advantageous to have arm members 139ea and 139eb (as shown), rings, or other stabilization devices to facilitate stabilization of the distal lens assembly 130e relative to the surface or TM 30.

[0043] FIG. 9 illustrates another exemplary distal lens assembly 130g. In this embodiment, the proximal portion of the distal lens assembly 130g is a strong focusing lens 132g (e.g., about 60-130D). In some embodiments, the diameter of the focusing lens 132g is about 3 mm. This proximal focusing lens 132g is mechanically connected to a port in a housing 134g that defines an inner chamber 133g between the strong focusing lens 132g and a distal-most lens 136g (which may be a flat lens, a concave lens, a convex lens, etc.). In some embodiments, the diameter of the distal-most lens 136g is about 2 mm.

[0044] In some embodiments, the inner chamber 133g may be air / gas filled or liquid filled and sealed. In some embodiments, the inner chamber 133g itself may be glass, polymer, or the like. The combination of the contents of the inner chamber 133g and the focusing lens 132g, as well as the desired viewing result (e.g., degree of wide field of view and / or zoom, etc.) may dictate which most distal lens 136g is most appropriate. The housing 134g may have flanges 135g or wings as exemplary stabilizing members to hold the distal lens assembly 130g consistently and well-placed within the TM.

[0045] FIG. 10 shows a top-down (or plan view) of the TM 30 (from the perspective of the outer ear) with another exemplary distal lens assembly 130h disposed therein. The distal lens assembly 130h includes a lens portion 132h (which can be any type of distal lens assembly described herein and variations thereof). The distal lens assembly 130h also includes an integrated port 134h for passing instruments, lighting, therapy, needles, etc. through the TM 30 and into the middle ear. The lens portion 132h and the port 134h are coupled by a connecting member 136h, which can be of any suitable length. In some embodiments, two or more ports 134h can be included. In some embodiments, the distal lens assembly 130h can optionally include one or more fixation mechanisms for attaching the distal lens assembly 130h to the fibrous tympanic annulus 32 for improved stability.

[0046] If the stabilization mechanism can fit securely within the ear canal, the distal lens 130 described herein may be implemented in surgical procedures where the ear canal tympanic flap has already been created to provide wide-field visualization directly into the middle ear cavity (e.g., not just "transtympanic" viewing). Similarly, it is contemplated to use the distal lens described herein in transmastoid procedures by having the stabilization mechanism attached to structures relevant to establishing transmastoid access (such as the mastoid bone, posterior ear canal wall, etc.). In some embodiments, it is contemplated to have a stabilization member that extends proximally out of the ear canal, outer ear, microscope, speculum, inverter, relay lens, or even hand-held.

[0047] FIG. 11 shows another surgical microscope system 200 including a surgical microscope 110 (and / or camera), a stereoscopic inverter lens system 220, and a distal lens 130. The image at the middle ear site 40 is captured by the distal lens 130, which in this embodiment is located at an opening in the TM 30. From the distal lens 130, the image is transmitted to the stereoscopic inverter lens system 220 via the ear canal 20. The surgical microscope 110 receives the images from the stereoscopic inverter lens system 220 and presents them for the surgeon 12 to see. The surgical microscope 110 allows for binocular or stereoscopic viewing and also primarily allows for hands-free operation by the surgeon 12. This schematic example shows that the stereoscopic inverter lens system 220 (which may include prisms and / or other lenses, as required) can be present at various locations within the outer ear 20, and that there can be zero, one, or multiple stereoscopic inverter lens systems 220. Image quality typically decreases as the number of lenses or prisms increases, so it is preferable to have as few as possible. Additionally, each stereoscope inverter lens system 220 can invert the image (depending on power), so the design of the stereoscope inverter lens system 220 will be adjusted to compensate.

[0048] 12 shows another surgical microscope system 300 including a surgical microscope 110 (and / or camera), a stereoscopic inverter lens system 320, and a distal lens 130. In the illustrated embodiment, the stereoscopic inverter lens system 320 is attached to a speculum 330 or an outer ear stabilizer. The stereoscopic inverter lens system 320 may be in the center of the speculum 330 or stabilizer, or may be mounted off-center or to one side.

[0049] In some embodiments, an arm member, mechanism, or anchor can mechanically couple the stereoscopic inverter lens system 320 to the speculum 300, and such mechanism can be adaptive or adjustable (as indicated by the arrows) to align the position of the image from the stereoscopic inverter lens system 320 with the microscope 110 and / or the distal lens assembly 130. In some embodiments, the stereoscopic inverter lens system 320 can have multiple lenses or prisms to facilitate simultaneous alignment with the distal lens assembly 130 and the microscope 110 or camera, thus the elements can also be individually adjustable. In some embodiments, the assembly 320 can be a relay lens and / or prism. It should be understood that when the stereoscopic inverter relay lens, or prism lens system 320 is attached to the speculum 330, the inverter lens can be attached adjacent to the microscope 110 if desired.

[0050] With further reference to FIG. 13, in some embodiments, such arm members, mechanisms, or anchors mechanically coupling the stereoscopic inverter lens system 320 to the speculum 330 can provide sufficient lateral space or ports to allow one or more instruments, delivery cannulas, light pipes, chandelier lighting, etc., to simultaneously access the outer ear 20, and in some cases through the TM 30, and in some cases into the middle ear 40 (shown diagrammatically in FIG. 13 by an exemplary instrument 400).

[0051] Additionally, in some embodiments, an illumination source or element can be attached to the speculum 330. In another embodiment, a light pipe passes through the speculum 330 and adjacent to the TM 30 or into the middle ear cavity 40. Chandelier lighting can be attached to the TM 30. In some embodiments, the TM 30 can be treated with a solution such as glycerol to increase transparency and allow for external illumination through the TM 30. In certain embodiments, the distal lens assembly 130 itself can have a light source attached to it, similar to those found on endoscopes (see, e.g., FIG. 14).

[0052] In some embodiments, the light source will be distal to the most distal collecting lens 130 to minimize light scattering from the ear canal walls, as will other light sources for the stereoscopic inverter lens system 320. This would ideally be accomplished with a chandelier light source distal to the TM 30, or with an internally illuminated fixture in the middle ear 40. Alternatively, the stereoscopic inverter lens system 320 could be shielded within a tubular member, with the light source located distal to the most proximal stereoscopic inverter lens system 320.

[0053] It should further be appreciated that with appropriate middle ear illumination and enhanced transparency of the TM 30 (such as that achieved by pre-treatment with glycerol or saline, or with a refractive index matching material), the distal lens assembly 130 can be positioned proximally relative to the TM 30 without the need for additional incisions or openings in the TM 30. This would have the added benefit of improved image stability, with the distal lens assembly 130 fixed to the posterior ear canal wall or external speculum such that movement of the TM 30 during instrument passage is not transferred to the distal lens assembly 130. With fine (e.g., 25 gauge) or smaller fiber optic light sources, such a system would enable minimally invasive binocular office-based visualization of the middle ear 40 (currently unattainable) and allow for a host of office-based procedures.

[0054] FIG. 14 illustrates a distal end portion of another implementation of a surgical microscope system according to some embodiments. That is, an exemplary distal lens assembly 130 is shown in a position across the TM 30. In the illustrated embodiment, the distal lens assembly 130 includes an attached light pipe 132 that can illuminate the middle ear 40 and the anatomical structures at the site. Shown for further understanding is an exemplary injector instrument 410 that can pass through a port or opening in the TM 30. Such an injector instrument 410 can be used to deliver various therapeutic agents to various anatomical structures, such as, but not limited to, the round window pit, the oval window, the walls or entrances of the mastoid sinus, soft tissue lesions, etc. Also shown is an exemplary light pipe 420. Such a light pipe 420 can pass through a port or opening in the TM 30 and can be used to illuminate the middle ear 40 and the anatomical structures at the site.

[0055] 15-17 show another surgical microscope system 500 including a surgical microscope 110 (and / or camera), a stereoscopic inverter lens system 120, and a distal lens assembly 530. In the illustrated embodiment, the stereoscopic inverter lens system 120 resides outside the ear 10. The distal lens assembly 530 includes a tubular member that maintains the position and alignment between the distal lens assembly 530 and the stereoscopic inverter lens system 120.

[0056] FIG. 16 shows an exemplary light path or ray tracing showing a wide field view of an object at the distal end of the distal lens assembly 530 and the output of an image at the proximal end of the distal lens assembly 530 as seen through the surgical microscope 110. This approach would have the advantage of maintaining light path alignment between the lenses and keeping instruments from interfering with visualization. It could also have other mechanisms, such as a light shield, rod lenses, or others, to reduce coherent or stray light and improve image quality. The closed system or sealed assembly of the distal lens assembly 530 has the added advantage of minimizing fogging / sticking of the intermediate lens surfaces. It also allows the procedure to be performed partially in water with the distal lens assembly 530 submerged, and various fluid levels in the ear canal do not impede image or light transmission. Such a distal lens assembly 530 can also have an attached or integrated light source so that light is projected onto the object of interest, or light can be projected coaxially through the system.

[0057] This tubular embodiment of the distal lens assembly 530 can also have anchors, arm members 532, and / or other mechanisms that stabilize it in position and aid in alignment in the outer ear 20. For example, FIG. 15 shows an exemplary configuration of arm members 532 that hold the tubular outer member or light tube of the distal lens assembly 530 in position along the length of the ear canal 20.

[0058] FIG. 17 is an end view of an exemplary arm member embodiment of the distal lens assembly 530, with three arm members 532 extending radially from the distal lens assembly 530 to allow other instruments to pass by / pass. It is contemplated that there may be ports or other stabilizing mechanisms to aid in passing the instrument without disturbing the light tube, while also improving the stability of the instrument itself relative to the ear canal 20. In some embodiments, the arm members 532 may be rigidly attached to a flexible ring 534, as an exemplary method to minimize trauma or pressure against the walls of the ear canal 20. In some embodiments, the arm members 532 may be malleable or otherwise adjustable (e.g., having a threaded section that can be rotated within a threaded portion of the flexible ring 534 to shorten or lengthen the distance between the light tube and the flexible ring 534 by rotating the threaded portion, and being rotatably attached to the light tube). The proximal end of the distal lens assembly 530 may terminate in a relay lens, a prism, an inverter, and / or the like.

[0059] 18 shows another surgical microscope system 600 including a surgical microscope 110 (and / or camera), a stereoscopic inverter lens system 120, and a distal lens assembly 630. In the illustrated embodiment, the stereoscopic inverter lens system 120 is external to the ear 10. The distal lens assembly 630 includes a tubular member that maintains the position and alignment between the distal lens assembly 630 and the stereoscopic inverter lens system 120.

[0060] In the illustrated embodiment, the distal lens assembly 630 includes an optical tube or outer tubular member having multiple sections and relay lenses or prisms to allow for angulation between the sections. In such a configuration, the distal lens assembly 630 may include one or more intermediate relay lenses and may also include a prism or other reflective member to compensate for the angulation between the sections. Again, one or more arm members 632 may be used to stabilize or secure the tubular member of the distal lens assembly 630 against the wall of the ear canal 20. Such embodiments, or others, that can accommodate angulation in the optical path may be advantageous due to the angulation often encountered in situations such as trans-ear canal access.

[0061] 19 shows another surgical microscope system 700 that includes a surgical microscope 110 (and / or camera), a stereoscopic inverter lens system 120, and a distal lens assembly 730. In the illustrated embodiment, the stereoscopic inverter lens system 120 is external to the ear 10.

[0062] The distal lens assembly 730 includes a tubular member that utilizes optical fibers to "relay" an image from the distal end of the distal lens assembly 730 to the proximal lens 732, which can then be viewed by the surgical microscope 110 via the stereoscopic inverter lens system 120.

[0063] In some embodiments, the distal lens assembly 730 includes an integrated light source similar to a typical endoscope. In certain embodiments, the distal lens assembly 730 may be stabilized in place within the outer ear 20 using the arm members or mechanisms previously described. Such an angled assembly may provide increased space and freedom over more conventional straight shaft or slightly curved instruments, allowing for adjacent laterally passing of the distal lens assembly 730 toward the TM 30.

[0064] Although the instruments disclosed herein are primarily described in the context of otological procedures in the outer ear, or using a transauricular, transtympanic approach to the middle or inner ear, it should be understood that the instruments are not limited to such applications and may be used for other cavities or spaces within the body, and for other approaches. For example, in some embodiments, the instruments described herein may be used for other approaches and techniques to the middle ear, inner ear, Eustachian tube, mastoid sinus, including, but not limited to, transmastoid access, transcanal via canal tympanic flap, intraauricular, postauricular, postauricular, and others. Such systems and methods may be used for drug delivery, gel delivery, antibiotic delivery, gene delivery, graft placement, device or implant delivery, tissue removal, diagnostic procedures, sampling procedures, surgical procedures, among others.

[0065] It should be noted that any of the embodiments or features of the embodiments described herein may be combined in any combination and permutation, all within the scope of the present disclosure.

[0066] The devices, systems, and methods described herein can be used in the process of treating any disorder of the middle and / or inner ear, including, but not limited to, hearing loss, tinnitus, imbalance including vertigo, Meniere's disease, vestibular neuritis, vestibular schwannoma, labyrinthitis, otosclerosis, ossicular chain disruption, cholesteatoma, otitis media, middle ear infection, and tympanic membrane perforation, to name a few. In some embodiments, the devices, systems, and methods described herein can be used in the process of precisely delivering therapeutic agents to the round window pit and / or other target sites, such as the oval window or other portions of the middle ear cavity, and to provide access to other functions or sites of the middle ear. For example, the systems and methods described herein can be used for minimally invasive surgical reconstruction of the ossicular chain, for removal of cholesteatoma, for diagnostic evaluation, and for other procedures. Any and all such techniques for using the systems and methods described herein are within the scope of the present disclosure.

[0067] The devices and systems described herein may be constructed from metals, such as, but not limited to, aluminum, stainless steel, or polymers, such as, but not limited to, ABS, PEEK, PET, HDPE, injection molded components, and the like. Components such as flexible rings may be constructed from elastic materials, gels, and the like.

[0068] The devices, systems, materials, compounds, compositions, products, and methods described herein can be understood by referring to the above detailed description of specific aspects of the disclosed subject matter. However, it should be understood that the above-described aspects are not limited to specific devices, systems, methods, or specific agents, and thus may vary. It should also be understood that the terminology used herein is for the purpose of describing particular aspects only, and is not intended to be limiting.

[0069] Although several embodiments have been described, it will be understood that various modifications can be made without departing from the scope of the claims herein. Accordingly, other embodiments are within the scope of the following claims. [Explanation of symbols]

[0070] 10 Patient, Ear 12 Surgeon 20 Ear canal 30 TM, tympanic membrane 31 Opening 32 Tympanic ring 40 Middle ear, middle ear cavity 100 Surgical Microscope System 110 Surgical Microscope 112 Mounting part 120 Stereoscopic Inverter Lens System 130 Distal Lens 130a-130h Distal lens assembly 132 Light Pipe 132a, 132b, 132c Wide field lens 132e, 132f distal prism member 132g Condenser lens 132h Lens part 133f extension member 133g inner chamber 134a, 134e, 134f Zoom lenses or objective lenses 134g housing 134h port 135g flange or wing 136a, 136b, 136c, 136e, 136f Prism elements, prism members 136g most distal lens 136h Connection material 138d waist 139da, 139db, 139ea, 139eb Arm parts 200 Surgical Microscope System 220 Stereoscopic Inverter Lens System 300 Surgical Microscope System 320 Stereoscopic Inverter Lens System 330 Speculum 400 Equipment 410 Syringe equipment 420 Light Pipe 500 Surgical Microscope System 530 Distal Lens Assembly 532 Arm parts 534 Flexible Ring 600 Surgical Microscope System 630 Distal Lens Assembly 632 Arm parts 700 Surgical Microscope System 730 Distal Lens Assembly 732 Proximal Lens

Claims

1. A surgical microscope; a stereoscopic inverter lens system positionable externally relative to the tympanic membrane and positionally adjustably attached to said surgical microscope; a distal lens spaced from the stereoscopic inverter lens system and mountable within a portion of the tympanic membrane to facilitate visualization of a middle ear region through the tympanic membrane, the distal lens being positionable relative to the stereoscopic inverter lens system such that an image of the middle ear region captured by the distal lens can be transferred to the stereoscopic inverter lens system external to the tympanic membrane for presentation at the surgical microscope; Equipped with the distal lens includes a tubular member that is positioned along the length of the ear canal and maintains position and alignment between the distal lens and the stereoscopic inverter lens system; The stereoscopic inverter lens system has a plurality of lenses or prisms and transforms the image of the middle ear site to facilitate relating an orientation of visualization to the image of the middle ear site.

2. The distal lens comprises: a prism at a proximal end of the distal lens; a wide field lens at a distal end of the distal lens; and The system of claim 1 , comprising:

3. at least a portion of the stereoscopic inverter lens system is mounted within an otoscope; 3. The system of claim 2, wherein the otoscope is inserted into the ear canal and positioned between the surgical microscope and the distal lens.

4. The system of claim 3 , wherein the distal lens further comprises a zoom lens or an objective lens disposed between the prism and the wide field lens.

5. The system of claim 4 , wherein the distal lens comprises two or more stabilizing arms extending radially outward from a body of the distal lens.

6. The system of claim 3 , wherein the distal lens defines a waist having a smaller outer diameter than proximal and distal portions of the distal lens.

7. 4. The system of claim 3, wherein the distal lens includes an air gap of 1-2 mm between the wide field lens and the objective lens, the objective lens is positioned between the wide field lens and the prism, and the wide field lens, the objective lens, and the prism are all mechanically coupled together.

8. 8. The system of claim 7, wherein the wide field lens and the objective lens each have an outer diameter of 1 mm to 3 mm.

9. 8. The system of claim 7, wherein the prism has a proximal face that is angled from 30 degrees to 60 degrees with respect to a central longitudinal axis of the distal lens.

10. 4. The system of claim 3, wherein the portion of the stereoscopic inverter lens system mounted within the otoscope is positionally adjustable relative to the otoscope.

11. 4. The system of claim 3, wherein a cavity is defined within the otoscope and to the side of the portion of the stereoscopic inverter lens system mounted within the otoscope.

12. The system of claim 3 , further comprising a light pipe coupled to the distal lens.

13. 4. The system of claim 3, wherein the distal lens comprises an elongated tubular member and a plurality of lenses coupled to the tubular member for defining an optical path through the tubular member, the tubular member comprising a plurality of sections, the plurality of sections allowing angulation between the sections.

14. 4. The system of claim 3, wherein the distal lens comprises an elongated tubular member enclosing an optical fiber configured to relay an image from a distal end of the distal lens to a proximal end of the distal lens.

15. The distal lens comprises: a first prism at a proximal end of the distal lens; a second prism at a distal end of the distal lens; and a zoom lens or an objective lens disposed between the first prism and the second prism; The system of claim 1 , comprising:

16. The distal lens comprises: a focusing lens at a proximal end of the distal lens and coupled to a housing; and a second lens at a distal end of the distal lens and coupled to the housing; Equipped with The system of claim 1 , wherein the housing defines an interior space between the collecting lens and the second lens.

17. The system of claim 16 , wherein the housing includes a radially extending flange or arm.

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