Visualizing devices, systems, and methods for otology and other uses

Abstract

Devices, systems, and methods can be employed to facilitate indirect viewing of a cavity, such as, but not limited to, a middle ear space. Some embodiments have uses such as, but not limited to, facilitating visualization and surgery in the outer ear, middle ear, and / or inner ear, in order to diagnose and / or treat conditions, including but not limited to hearing loss and other ear conditions. In particular implementations, a surgical microscope is used in conjunction with a reversing lens and a distal lens. In some cases, the distal lens traverses a membrane or septum, such as, but not limited to, the tympanic membrane. In some embodiments, the distal lens can be an assembly that combines two or more lenses. For example, in some cases, wide angle lenses, zoom lenses, other variously shaped lenses, and / or prisms can be used in the distal lens.

Description

[0001] Cross-references to related applications

[0002] This application claims 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 herein by reference in its entirety); U.S. Provisional Application No. 63 / 040,495, filed June 17, 2020 (which is incorporated herein by reference in its entirety); U.S. Provisional Application No. 63 / 051,568, filed July 14, 2020 (which is incorporated herein by reference in its entirety); and U.S. Provisional Application No. 63 / 077,481, filed September 11, 2020. Priority interests in 48 (which are fully incorporated herein by reference), U.S. Provisional Application No. 63 / 078,141 filed September 14, 2020 (which are fully incorporated herein by reference), U.S. Provisional Application No. 63 / 080,510 filed September 18, 2020 (which are fully incorporated herein by reference), U.S. Provisional Application No. 63 / 081,015 filed September 21, 2020 (which are fully incorporated herein by reference), and U.S. Provisional Application No. 63 / 082,996 filed September 24, 2020 (which are fully incorporated herein by reference). Technical Field

[0003] This document relates to devices, systems, and methods for facilitating visualization and surgery in the outer, middle, and inner ear for the diagnosis and / or treatment of conditions including, but not limited to, hearing loss and other ear disorders. In some examples, systems and methods include instruments and techniques that facilitate indirect visualization of cavities (e.g., but not limited to, the middle ear space). Background Technology

[0004] The human ear is susceptible to a variety of conditions, including but not limited to hearing loss, tinnitus, balance disorders (including vertigo), Meniere's disease, vestibular neuritis, vestibular schwannoma, labyrinthitis, otosclerosis, ossicular chain dislocation, cholesteatoma, external ear infection, middle ear infection, schwannoma, and tympanic membrane perforation, to provide a few examples.

[0005] In one example, conductive hearing loss (CHL) involves the loss of the normal mechanical pathway for sound to reach the hair cells in the cochlea, such as due to malformation, fluid buildup in the middle ear, damage to the tympanic membrane, the presence of a tumor, and / or damage to the ossicles. Sensorineural hearing loss (SNHL) is caused by the absence or damage of cochlear hair cells or the absence or damage of the auditory nerve. SNHL is often associated with exposure to loud noise, head trauma, aging, infection, Meniere's disease, tumors, ototoxicity, genetic diseases (such as Usher's disease), etc.

[0006] While the use of endoscopes has increased over the past few years and is largely attractive because it allows for wide angle viewing of the middle ear and adjacent spaces, the use of endoscopes requires one hand of the surgeon to operate and often cannot be binocular, which makes it difficult to assess depth, which in turn makes the procedure more challenging and potentially damaging given the delicate structures of the middle ear. SUMMARY

[0007] This document describes devices, systems, and methods for, for example but not limited to, facilitating visualization and surgical procedures in the outer ear, middle ear, and inner ear, in order to diagnose and / or treat diseases including but not limited to hearing loss and other ear diseases. For example, this document describes devices, systems, and methods, including instruments and techniques that facilitate indirect viewing of cavities, such as but not limited to middle ear spaces.

[0008] In particular embodiments, a surgical microscope is used in conjunction with an inverting lens, which can include one or more lenses, and a distal lens, which can include one or more lenses. In some embodiments, the inverting lens is located outside of the body, such as outside of the ear. In particular embodiments, the inverting lens is located inside of the body, such as inside of the ear canal. In certain embodiments, a portion of the inverting lens is located outside of the body and another portion of the inverting lens is located inside of the body.

[0009] In some cases, the distal lens passes through a membrane or septum, such as but not limited to the tympanic membrane (“TM”). In particular cases, the distal lens is positioned to enable visualization through an opening in the membrane or septum, such as but not limited to the TM. In some embodiments, the distal lens can be an assembly that incorporates 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 further described below. In addition, in some embodiments, optical fibers can be used to transmit images.

[0010] While the devices, systems, and methods for facilitating visualization and surgery are described herein in the exemplary context of visualizing the middle ear and / or inner ear via the outer ear, it should be understood that the inventive concepts described herein are not limited to such use. For example, in some embodiments, the devices, systems, and methods for facilitating visualization and surgery described herein can be used in other middle ear and / or inner ear approaches, such as but not limited to transmastoid approaches, trans-tympanic flap trans-ear canal, intra-aural, retroaural, postaural, etc. In addition, in addition to middle ear and / or inner ear visualization, the devices, systems, and methods for facilitating visualization and surgery described herein are well suited for use in other cavities or spaces in the body and other approaches. For example, the devices, systems, and methods are well suited for visualization and surgical procedures related to the Eustachian tube, mastoid sinus space, etc.

[0011] The devices, systems, and methods herein can be used in conjunction with additional therapeutic techniques. For example, the devices, systems, and methods herein can be used in conjunction with therapeutic techniques such as, but not limited to, therapeutic agent delivery (which can be in the form of a gel, liquid, or solid), antibiotic delivery, gene delivery, device or implant delivery, diagnostic and surgical procedures, and the like.

[0012] In some aspects, the disclosure relates to a surgical microscope system including a surgical microscope, a stereoscopic inverter lens system, and a distal lens.

[0013] Such a surgical microscope system can optionally include one or more of the following features. The distal lens can be sized for placement in a tympanic membrane to facilitate visualization of a middle ear region. The distal lens can include a prism at a proximal end of the distal lens. The distal lens can include a wide-field lens at a distal end of the distal lens. The distal lens can include a zoom lens or objective lens disposed between the prism and the wide-field lens. The distal lens can define a waist having an outer diameter that is less than proximal and distal portions of the distal lens that are immediately adjacent. 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 can also include a zoom lens or objective lens disposed between the first prism and the second prism. In some embodiments, the distal lens includes two or more stabilizing arms extending radially outward from a body of the distal lens. In particular embodiments, the distal lens includes a condenser 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. The housing can define an interior space between the condenser 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 radially extending flanges or arms. In some embodiments, the system further includes a port device attached to the distal lens. In some embodiments, at least a portion of the stereoscopic inverter lens system is mounted within a speculum. In particular embodiments, the portion of the stereoscopic inverter lens system mounted within the speculum can be positionally adjusted relative to the speculum. An open space can 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 further includes a light pipe coupled to the distal lens. The distal lens can include an elongate tubular member and a plurality of lenses coupled to the tubular member to define an optical path through the tubular member. Such a tubular member can include a plurality of segments that allow for an angle between the segments. In some embodiments, the distal lens includes an elongate tubular member enclosing an optical fiber configured to relay an image from a distal end of the distal lens to a proximal lens of the distal lens.

[0014] In further aspects, the present disclosure is directed to a method for indirectly viewing a middle ear space of a patient. The method includes providing a surgical microscope system including: (i) a surgical microscope; (ii) a stereoscopic inverting lens system; and (iii) a distal lens. The method further includes placing the distal lens in contact with a tympanic membrane of the patient, and viewing images of the middle ear space captured by the distal lens and relayed to the surgical microscope by the stereoscopic inverting lens system.

[0015] Such a method for indirectly viewing a middle ear space of a patient can optionally include one or more of the following features. The stereoscopic inverting lens system can be located outside of the patient's ear. The stereoscopic inverting lens system can be within the patient's ear canal. The method can include using the surgical microscope system with any of the embodiments and / or features herein in any combination.

[0016] Some or all of the embodiments described herein can provide one or more of the following advantages. First, current visualization of middle ear spaces, inner ear, and nearby regions is challenging due to limitations of access paths, which are typically or directly via the ear canal, via a passage through a post-auricular trans-mastoid pathway created by invasively elevating the auricle, or through a highly invasive mastoid pathway created by using a bone drill and other instruments. In this context, it is difficult to make observations around complex and delicate structures that create shadows and blind angles that still need to be navigated in many surgeries. Additionally, either due to the natural size and curvature of the ear canal, or due to a desire to minimize removal of bone and tissue, for example during trans-mastoid entry, the diameter of the access path is small. Use of the surgical microscope systems herein has the benefit of allowing binocular observation and substantially hands-free operation by the surgeon.

[0017] Second, use of the surgical microscope systems for visualizing middle ear and / or inner ear herein provides the additional advantage of allowing the surgeon to utilize their familiar surgical microscope in order to be able to easily look down the ear canal in the manner that surgical microscopes are typically used, and to easily switch to a wide field view within the middle ear (e.g., to enable views within views). Moreover, the surgical microscope systems described herein provide large depth of focus and high resolution in the periphery.

[0018] Third, the devices, systems, and methods described herein advantageously allow the ability to pass instruments to the field of operation, and the ability to operate in a fluid-filled space in addition to an air-filled space.

[0019] Fourth, the devices, systems, and methods described herein facilitate treatment in a minimally invasive manner. Such minimally invasive techniques can tend to reduce recovery time, patient discomfort, disease recurrence, surgical complications, and treatment costs. Moreover, the methods described herein can be performed using local anesthetics without the need for general anesthesia. Thus, treatment costs, patient risk, and recovery time are further advantageously reduced.

[0020] Fifth, the systems described herein can also be used for diagnostic purposes. These uses can aid in surgical planning, change care sites, and potentially improve patient treatment outcomes.

[0021] The details of one or more embodiments of the application are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the application will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF DRAWINGS

[0022] Figure 1 is a schematic illustration of a medical procedure to visualize a middle ear region using an exemplary surgical microscope system in accordance with some embodiments.

[0023] Figure 2 shows an exemplary distal lens assembly that can be included as part of some embodiments of the surgical microscope system of Figure 1 .

[0024] Figure 3 shows another exemplary distal lens assembly that can be included as part of some embodiments of the surgical microscope system of Figure 1 .

[0025] Figure 4 shows another exemplary distal lens assembly that can be included as part of some embodiments of the surgical microscope system of Figure 1 .

[0026] Figure 5 shows another exemplary distal lens assembly that can be included as part of some embodiments of the surgical microscope system of Figure 1 , the distal lens assembly is shown traversing the TM.

[0027] Figure 6 shows another exemplary distal lens assembly that can be included as part of some embodiments of the surgical microscope system of Figure 1 .

[0028] Figure 7 shows another exemplary distal lens assembly that can be included as part of some embodiments of the surgical microscope system of Figure 1 .

[0029] Figure 8Another example distal lens assembly is shown, which can be included as part of some embodiments of the surgical microscope system of Figure 1 is shown adjacent to an opening in the TM.

[0030] Figure 9 is a longitudinal cross-sectional view of another example distal lens assembly, which can be included as part of some embodiments of the surgical microscope system of Figure 1

[0031] Figure 10 is a perspective plan view from the external ear of another example distal lens assembly, which can be included as part of some embodiments of the surgical microscope system of Figure 1 is shown in position on the TM and includes a connected TM port device through which various types of instruments can pass into the middle ear.

[0032] Figure 11 is a schematic illustration of a medical procedure to visualize a middle ear region using another example surgical microscope system in accordance with some embodiments.

[0033] Figure 12 is a schematic illustration of a medical procedure to visualize a middle ear region using another example surgical microscope system in accordance with some embodiments.

[0034] Figure 13 shows use of a surgical instrument in conjunction with the surgical microscope system of Figure 12

[0035] Figure 14 shows use of an example distal lens assembly, a light source, and a surgical instrument relative to the TM.

[0036] Figure 15 is a schematic illustration of a medical procedure to visualize a middle ear region using another example surgical microscope system in accordance with some embodiments.

[0037] Figure 16 is a longitudinal cross-sectional view of the distal lens assembly of Figure 15

[0038] Figure 17 is a proximal view of the distal lens assembly of Figure 15

[0039] Figure 18 is a schematic illustration of a medical procedure to visualize a middle ear region using another example surgical microscope system in accordance with some embodiments.

[0040] Figure 19 ​​​​is a schematic illustration of a medical procedure to visualize a middle ear region according to some embodiments using another example surgical microscope system.

[0041] Like reference numbers in different drawings represent the same element. DETAILED DESCRIPTION

[0042] Reference is now made to Figure 1 a schematic illustration of particular embodiments of apparatuses, systems, and methods for treating a patient 10 can include an example surgical microscope system 100. The surgical microscope system 100 can be used to facilitate viewing structures in a recessed space, such as but not limited to a middle ear 40.

[0043] In the described embodiment, the surgical microscope system 100 includes a surgical microscope 110 (and / or camera), a stereoscopic inverting lens system 120, and a distal lens 130. An image in the middle ear region 40 is captured by the distal lens 130, which in this embodiment is positioned in an opening in the TM 30. From the distal lens 130, the image is relayed to the stereoscopic inverting lens system 120 via the ear canal 20. The surgical microscope 110 receives the image from the stereoscopic inverting lens system 120 and presents the image for viewing by the surgeon 12. The surgical microscope 110 allows for binocular or stereoscopic viewing by the surgeon 12 and is substantially hands-free.

[0044] In this embodiment, the stereoscopic inverting lens system 120 is external to the ear canal 20. In some embodiments, the stereoscopic inverting lens system 120 is a prismatic inverter, which can also be a stereoscopic diagonal inverter or a stereo reinverter. It inverts the image so that the surgeon or clinician more easily relates the directionality of the visualization to the object being viewed (e.g., moving the instrument to the right is perceived as moving to the right in the system). In particular embodiments, the stereoscopic inverting lens system 120 can include multiple parts, such as a beam splitter, a stereo reinverter, and an objective lens, among others.

[0045] In some embodiments, the surgical microscope system 100 includes a mount 112 by which the stereoscopic inverting lens system 120 is adjustably mounted to the frame of the surgical microscope 110 (or camera). Thus, the stereoscopic inverting lens system 120 is alienable from the objective lens of the surgical microscope 110. Additionally, in some embodiments, the mount 112 can be adjusted to allow for longitudinal adjustment.

[0046] Light for visualization using the surgical microscope system 100 can be provided externally by a light pipe or other light source as further described below, or can be projected coaxially by the system. This surgical microscope system 100 has the advantage of allowing the surgeon to use both hands during a therapeutic or diagnostic procedure, to have binocular or stereoscopic viewing, and to be able to look down the ear canal 20 as easily as a typical surgical microscope. In addition, the surgical microscope system 100 allows the surgeon to easily switch to a wide field view (e.g., to enable a view within a view) within the middle ear 40, while still having a large depth of focus and high resolution in the periphery. In addition, the surgical microscope system 100 allows the surgeon to be able to deliver instruments for a therapeutic or diagnostic procedure (as further described below), still utilize a surgical microscope that the surgeon is familiar with, and function in a fluid-filled or air-filled space, among other advantages. This surgical microscope system 100 facilitates therapeutic methods and devices for treating a patient 10 using minimally invasive methods.

[0047] While many of these example embodiments provided herein are described in combination with or used with a surgical microscope, it is contemplated that these concepts are also applicable to digital viewing modalities or to an endoscope. Digital viewing is well suited for head-up display of the image on an external display, which can be high definition, 3D, curved, etc. Head-up viewing is also well suited for simultaneous display of a picture-in-picture of the external ear canal, along with a wide field view from the distal end of one of the aforementioned components, for example. This would be surprisingly advantageous as it would enhance navigation of the components over the ear canal and passage of the instruments over the ear canal, while allowing the wide field view into the middle ear space (as an example).

[0048] When the concepts disclosed herein are used with a digital viewing system that is capable of head-up display, the lens system embodiments can facilitate interaction with an assistant and training of new surgeons. Head-up displays, virtual reality (“VR”), 3D, and similar systems can significantly improve ergonomics.

[0049] The systems and concepts described herein also work well in combination with navigational tracking and other robotic-assisted surgical modalities.

[0050] In some embodiments, the light source used with the systems described herein can be substituted from a typical visual spectrum source to an infrared spectrum or other specific spectrum. Specific spectrums such as infrared can be used for tissue or vessel identification on their own. Infrared helps to identify blood vessels and vasculature. Longer wavelength infrared (>700 nm) is able to penetrate tissue more easily than visible light and enable superior illumination of the middle ear through the tympanic membrane where shorter wavelengths can be problematic with reflection and scattering. Fluorescent stains and other dyes or stains such as ICG in combination with specific wavelength light sources and / or specific filters can be used to identify blood vessels and specific tissue. Examples are ICG (indocyanine green; near infrared, excitation peak near 810 nm) for vessel identification and 5-aminolevulinic acid (5-ALA) or fluorescein for tumor identification. As an example, in the middle ear, these non-standard light sources would be particularly advantageous for identifying cholesteatoma or other soft tissue lesions growing on top of the bony structures.

[0051] Figure 2 -10 Various non-limiting examples of distal end lenses 130 are shown. As shown in some of the figures, the distal end lenses 130 allow visualization of the middle ear via the TM 30. Any of the distal end lenses 130 can be configured to traverse the TM 30 (e.g., as shown in Figure 5 ) and / or be positioned adjacent to an opening in the TM 30 (e.g., as shown in Figure 8 ).

[0052] The distal end lenses 130 can be simple or compound lens assemblies and can have wide field or wide angle lenses, zoom lenses, prismatic or reflective elements, condenser lenses, individually or in any combination. In some embodiments, the distal end lenses 130 are lenses with prismatic elements directly adjacent or spaced apart from the lens. The one or more lenses making up the distal end lenses 130 can be any combination of biconvex, biconcave, plano-convex, plano-concave, meniscus, achromatic, multi-lens, condenser, etc. The lenses comprising the distal end lenses 130 can be constructed of materials such as, but not limited to, flint glass, hardened glass, polycarbonate, acrylic, or other materials and combinations thereof. In some embodiments, the lenses or assemblies comprising the distal end lenses 130 can be injection molded polymer optics. It would be beneficial for the distal end lenses 130 to be made of disposable components to eliminate the difficulties associated with sterilization and maintenance of the lenses and to reduce OR turnover time. In some embodiments, the lenses include a coating to reduce the likelihood of fogging.

[0053] The distal end lenses 130 can be made in various sizes and focal lengths to accommodate the length of each patient’s ear canal. For example, but not limited to, three sizes can be provided for ear canal lengths of 19-23 mm, 23-27 mm, and 27-31 mm to maintain consistent microscope positioning for optimal instrument maneuverability and surgeon comfort.

[0054] Figure 2 An example distal lens assembly 130a is shown. In the described embodiment, the distal lens assembly 130a has a wide field lens 132a at its distal-most end, and then a 1-2 mm air gap to a zoom lens or objective lens 134a, and then a prism element 136a to redirect the proximal output image angle, all mechanically coupled. The outer diameter of the lenses 132a and 134a can range from about 1 mm to 3 mm, or 1 mm to 5 mm, or 1 mm to 7 mm, or 3 mm to 8 mm, or 2 mm to 4 mm, or 3 mm to 6 mm, but is not limited thereto. These outer diameter dimensions can apply to any distal lens assembly described herein. The prism 136a can have an angle of about 42 degrees (relative to the central longitudinal axis of the distal lens assembly 130a) to match the typical angle of the eardrum relative to the main longitudinal axis of the ear canal. In some embodiments, the angle of the prism 136a ranges from about 40 degrees to 50 degrees, or 30 degrees to 60 degrees, or 20 degrees to 70 degrees, but is not limited thereto. These angle parameters can apply to any prism described herein. The main objective lens 134a can be part of the distal assembly 130a and can be, for example, a double convex lens (e.g., 60-120 D). For these example lenses, it is preferred in some cases that their distance from the object of interest is less than about 10 mm.

[0055] Figure 3 Another example distal lens assembly 130b is shown. In the described embodiment, the distal lens assembly 130b has a wide field lens 132b at its distal-most end, and then a prism element 136b to redirect the proximal output image angle. In some embodiments, the size and other parameters of the distal lens assembly 130b can be the same as the distal lens assembly 130a.

[0056] Figure 4 Another example distal lens assembly 130c is shown. In the described embodiment, the distal lens assembly 130c has a wide field lens 132c at its distal-most end, and then a 1-2 mm air gap, and then a prism element 136c to redirect the proximal output image angle. In some embodiments, the size and other parameters of the distal lens assembly 130c can be the same as the distal lens assembly 130a.

[0057] Figure 5Another example distal lens assembly 130d is shown positioned to penetrate the tympanic membrane 30. As described in this example, any of the distal lenses 130 described herein can have shape elements / features to facilitate maintaining the position of the distal lens 130 in the TM 30 for the duration of a surgical or diagnostic procedure. Such elements can include a waist portion 138d (or hourglass outer profile shape) that allows the distal lens 130 to friction fit within the opening in the TM 30 and thereby provide longitudinal stability.

[0058] Any of the distal lenses 130 described herein can optionally include other elements to facilitate stabilization of the distal lens 130 relative to the TM 30. For example, the distal lens 130 can include arm members, such as the arm members 139da and 39db shown. Figure 5 Alternatively or additionally, the distal lenses 130 described herein can optionally include loops, interconnections with other elements, and / or other types of stabilization devices, without limitation. Further, in addition to stabilization relative to the TM 30 as shown, it is contemplated that the stabilization members of the distal lenses 130 described herein can stabilize against the ear canal wall, the tympanic membrane annulus, other instruments or access sites, and / or other adjacent structures. It is also contemplated that these arm members 139da and 139db can be retractable or otherwise adjustable to allow fine tuning of the directionality and / or focus of the proximal "output" image from any of the distal lenses 130 described herein.

[0059] Figure 6 Another example distal lens assembly 130e is shown having a distal prism member 132e, a zoom lens or objective 134e, and a proximal prism member 136e. The prism members 132e and 136e allow visualization of distal and off-axis objects of the tympanic membrane plane and viewing of the proximal image off-axis from the distal lens assembly 130e, as previously described.

[0060] Figure 7 Another example distal lens assembly 130f is shown having a distal prism member 132f, a zoom lens or objective 134f, and a proximal prism member 136f. In addition, the distal lens assembly 130f includes an extension member 133f to provide a view at depth inside the middle ear. Thus, the distal lens assembly 130f is a periscope-like distal lens assembly and it is possible to see around typical structures in the middle ear that would obstruct viewing directly through the tympanic membrane.

[0061] Figure 8An exemplary distal lens assembly 130e is shown positioned over an opening 31 or other aperture in the TM 30. As an example, the opening 31 can be a puncture or incision made to the TM 30 prior to positioning the distal lens assembly 130e. In such an embodiment, it is contemplated that it would be advantageous to have arm members 139ea and 139eb (as shown), a loop or other stabilizing device to facilitate stabilization of the distal lens assembly 130e relative to the surface or TM 30, as the distal lens assembly 130e does not have stabilization associated with puncturing the TM 30 (e.g., as opposed to the Figure 5

[0062] Figure 9 Another exemplary distal lens assembly 130g is shown. In this embodiment, the proximal portion of the distal lens assembly 130g is a strong condenser lens 132g (e.g., about 60-130 D). In some embodiments, the condenser lens 132g is about 3 mm in diameter. This proximal condenser lens 132g is mechanically connected to a port of a housing 134g that defines an internal cavity chamber 133g between the strong condenser lens 132g and a distal-most lens 136g (which can be a flat lens, a concave lens, a convex lens, etc.). In some embodiments, the distal-most lens 136g is about 2 mm in diameter.

[0063] In some embodiments, the internal cavity chamber 133g can be air / gas-filled or liquid-filled and sealed. In some embodiments, and the internal cavity chamber 133g itself can be glass, polymer, etc. The combination of the internal cavity chamber 133g contents and the condenser lens 132g, and the desired viewing outcome (e.g., the degree of, for example, wide field and / or zoom) can determine which distal-most lens 136g is most suitable. The housing 134g can have a flange 135g or wings as exemplary stabilizing members to keep the distal lens assembly 130g well positioned in the TM.

[0064] Figure 10 A top-down (or plan view) of a TM 30 (from the perspective of the outer ear) is shown with another exemplary distal lens assembly 130h positioned therein. The distal lens assembly 130h includes a lens portion 132h (which can be any of the types of distal lens assemblies herein and variations thereof). The distal lens assembly 130h also includes an integrated port 134h for passage of an instrument, illumination, therapeutic agent, needle, 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 securing features to attach the distal lens assembly 130H to the fibrous tympanic ring 32 for enhanced stabilization.​

[0065] With stable features allowing a secure fit within the ear canal, the distal lens 130 described herein can be implemented in a surgical procedure in which a tympanic membrane flap has been created to provide wide field visualization directly into the middle ear cavity (e.g., not just a “trans-tympanic” view). Similarly, it is envisioned that the distal lens herein can be used in a trans-tympanic procedure by having a secure feature that attaches to a structure associated with establishing a trans-tympanic passageway (e.g., a mastoid bone, a tube wall, etc.). In some embodiments, it is envisioned to have a stabilizing member that extends proximally out to the ear canal, the external ear, a microscope, a speculum, an inverter, a relay lens, or even handheld.

[0066] Figure 11 Another surgical microscope system 200 is shown, which includes a surgical microscope 110 (and / or camera), a stereoscopic inverter lens system 220, and a distal lens 130. The image in the middle ear region 40 is captured by the distal lens 130, which in this embodiment is positioned in an opening in the TM 30. From the distal lens 130, the image is relayed via the ear canal 20 to the stereoscopic inverter lens system 220. The surgical microscope 110 receives the image from the stereoscopic inverter lens system 220 and presents the image for viewing by the surgeon 12. The surgical microscope 110 allows for binocular or stereoscopic viewing by the surgeon 12, and is substantially hands-free. This illustrative example shows that the stereoscopic inverter lens system 220 (which can include prisms and / or other lenses as needed) can be located at various positions within the external ear 20, and there can be zero, one, or multiple stereoscopic inverter lens systems 220. Image quality generally decreases with an increase in the number of lenses or prisms, so it is preferable to have as few as possible. Additionally, each stereoscopic inverter lens system 220 can invert the image (depending on the power), so the design of the stereoscopic inverter lens system 220 will be adjusted to compensate.

[0067] Figure 12 Another surgical microscope system 300 is shown, which includes a surgical microscope 110 (and / or camera), a stereoscopic inverter lens system 320, and a distal lens 130. In the described embodiment, the stereoscopic inverter lens system 320 is mounted to a speculum 330 or an external ear stabilizer. The stereoscopic inverter lens system 320 can be located at the center of the speculum 330 or stabilizer, or mounted off-center or to one side.

[0068] In some embodiments, the arm members, features, or anchors can mechanically couple the stereoscopic inverter lens system 320 to the speculum 300, and such features can be extendable or adjustable (as represented by the arrows) in order to align 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 in order to facilitate simultaneous alignment with the distal lens assembly 130 and the microscope 110 or camera, and thus elements can be individually adjustable. In some embodiments, the assembly 320 can be a relay lens and / or prism. It can be appreciated that if the stereoscopic inverter relay lens or prism system 320 is mounted to the speculum 330, then the inverter lens can be mounted adjacent to the microscope 110 if desired.

[0069] Also with reference to Figure 13 In some embodiments, such arm members, features, or anchors mechanically couple the stereoscopic inverter lens system 320 to the speculum 330, can provide sufficient lateral space or porting to allow one or more instruments, delivery cannula, light pipe, overheard lighting, etc. to simultaneously enter the external ear 20, and in some cases through the TM 30, and in some cases into the middle ear 40 (as Figure 13 widely represented by exemplary instrument 400).

[0070] Additionally, in some embodiments, a light source or element can be mounted 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. Overhead lighting can be mounted to the TM 30. In some embodiments, the TM 30 can be treated with a solution (e.g. glycerin) to increase transparency and allow external lighting to pass through the TM 30. In particular embodiments, the distal lens assembly 130 itself can have a light source attached to it (e.g. with reference to Figure 14 ), similar to what is seen on endoscopes.

[0071] In some embodiments, the light source is distal to the distal-most collection lens 130 in order to minimize light scatter from the channel walls and other light sources to the stereoscopic inverter lens system 320. This would ideally be accomplished by overhead lighting distal to the TM 30 or by an endo-illumination instrument in the middle ear 40. Alternatively, the stereoscopic inverter lens system 320 can be shielded within a tubular member with the light source positioned distal to the proximal-most stereoscopic inverter lens system 320.

[0072] With proper middle ear illumination and enhanced transparency of the TM 30 (e.g., achieved by pre-treatment with a glycerol or saline solution or pre-treatment with a refractive index matching material), it can also be appreciated that the distal lens assembly 130 can be located proximal to the TM 30 without requiring additional incisions or openings in the TM 30. This would have the added benefit of improved image stabilization, where the distal lens assembly 130 is anchored to the channel wall or external speculum such that movement of the TM 30 during instrument passage is not transmitted to the distal lens assembly 130. Using a fine (e.g., 25 gauge) or smaller fiber optic light source, such a system can enable office-based, minimally invasive binocular visualization of the middle ear 40 (not currently possible) and enable a range of office-based procedures.

[0073] Figure 14 A distal portion of another implementation of a surgical microscope system is shown in accordance with some embodiments. That is, an exemplary distal lens assembly 130 is shown in a position that traverses the TM 30. In the described embodiment, the distal lens assembly 130 includes an attached light tube 132 that can illuminate the anatomy in the middle ear 40 and region. To additionally appreciate, an exemplary injection instrument 410 is also shown that can pass through a port or opening in the TM 30. Such an injection instrument 410 can be used to deliver various therapeutic agents to various anatomical structures, such as but not limited to the round window niche, oval window, walls or entrance of the mastoid sinus, soft tissue lesions, etc. Further, an exemplary light tube 420 is also described. Such a light tube 420 can pass through a port or opening in the TM 30 and can be used to illuminate the anatomy in the middle ear 40 and region.

[0074] Figures 15-17 Another surgical microscope system 500 is shown that includes a surgical microscope 110 (and / or camera), a stereoscopic inverter lens system 120, and a distal lens assembly 530. In the described embodiment, the stereoscopic inverter lens system 120 resides external to 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.

[0075] Figure 16An exemplary light path or ray trace showing a wide field view of an object at the distal end of the distal lens assembly 530, as well as the output of the image at the proximal end of the distal lens assembly 530 that can be observed through the surgical microscope 110. This approach would have the advantage of maintaining the alignment of the light path between the lenses and preventing instrument interference with the visualization. It can also reduce interference or stray light and can have other features such as baffles, rod lenses, or other features that improve image quality. The closed system or sealed assembly of the distal lens assembly 530 would have the additional advantage of minimizing fogging / fouling of the intermediate lens surfaces. It would also allow for the performance of the procedure partially underwater, with the distal lens assembly 530 submerged underwater and the variable fluid level in the ear canal not interfering with the image or light transmission. This 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 coaxially projected through the system.

[0076] This tubular embodiment of the distal lens assembly 530 can also have anchors, arm members 532, and / or other features that secure it in place in the external ear 20 and help with alignment. For example, Figure 15 An exemplary arrangement showing the arm members 532 holding the tubular outer member or optical tube of the distal lens assembly 530 in place along the length of the ear canal 20.

[0077] Figure 17 An end-on view showing 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 through. It is contemplated that there can be ports or other stabilizing features to help pass instruments without interfering with the optical tube, while also improving the stability of the instruments themselves relative to the ear canal 20. In some embodiments, the arm members 532 can be fixedly attached to a flexible ring 534 as an exemplary way of minimizing trauma or pressure on the walls of the ear canal 20. It is contemplated that in some embodiments the arm members 532 are telescoping or otherwise adjustable (e.g. rotatably attached to the optical tube while having a threaded section that can be rotated within a threaded portion of the flexible ring 534, such that rotating them shortens or lengthens the distance between the optical tube and the flexible ring 534). The proximal end of the distal lens assembly 530 can end in a relay lens, prism, inverter, and / or the like.

[0078] Figure 18 Another surgical microscope system 600 is shown, including the surgical microscope 110 (and / or camera), the stereoscopic inverter lens system 120, and a distal lens assembly 630. In the depicted embodiment, the stereoscopic inverter lens system 120 resides outside of 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.

[0079] In the described embodiment, the distal lens assembly 630 includes an optical tube or outer tubular member having multiple segments and relay lenses or prisms that allow for the presence of angles between segments. In such an arrangement, the distal lens assembly 630 can include one or more intermediate relay lenses and can include prisms or other reflective members to compensate for the angles between segments. Again, one or more arm members 632 can be used to secure or anchor the tubular member of the distal lens assembly 630 relative to the walls of the ear canal 20. Such an embodiment or other embodiments that can accommodate the presence of angles in the optical path can be advantageous because the presence of angles is frequently encountered in, for example, transcanal access situations.

[0080] Figure 19 Another surgical microscope system 700 is shown, which includes a surgical microscope 110 (and / or camera), a stereoscopic inverter lens system 120, and a distal lens assembly 730. In the described embodiment, the stereoscopic inverter lens system 120 resides outside of the ear 10.

[0081] 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 a proximal end lens 732, where the image can then be viewed by the surgical microscope 110 through the stereoscopic inverter lens system 120.

[0082] In some embodiments, the distal lens assembly 730 includes an integrated light source similar to a typical endoscope. In particular embodiments, the distal lens assembly 730 can be secured in place within the external ear 20 using one or more arm members or features as above. Such an angled assembly can potentially increase space and freedom for more conventional straight or slightly curved instruments to be passed transversely adjacent to the TM 30 of the distal lens assembly 730.

[0083] While the instruments disclosed herein are primarily described in the context of otologic surgery, either in the external ear or using a transcanal trans-tympanic approach to access the middle or inner ear, it should be understood that these instruments are not limited to these uses and can be used in other cavities or spaces in the body and other approaches. For example, in some embodiments, the instruments herein can be used for other approaches and techniques to the middle ear, inner ear, Eustachian tube, mastoid cavity space (including but not limited to trans-mastoid approach, trans-tympanic membrane transcanal, intra-aural, post-aural, post-aural point, etc.). Such systems and methods can be used for drug delivery, gel delivery, antibiotic delivery, gene delivery, graft placement, device or implant delivery, tissue resection, diagnostic procedures, sampling procedures, surgical procedures, etc.

[0084] It should be noted that any of the embodiments or features of the embodiments described herein can be in any combination or permutation, and all are within the scope of the present disclosure.

[0085] The devices, systems, and methods described herein can be used in the treatment of any disorder of the middle and / or inner ear, including but not limited to hearing loss, tinnitus, balance disorders (including dizziness), Meniere's disease, vestibular neuronitis, vestibular aqueduct ectasia, labyrinthitis, otosclerosis, ossicular chain dislocation, cholesteatoma, otitis media, middle ear infection, and tympanic membrane perforation, to provide a few examples. In some embodiments, the devices, systems, and methods described herein can be used in the precise delivery of therapeutic agents to round window sites and / or other target sites (such as oval window or other portions of the middle ear cavity), and for providing access to other features or regions of the middle ear. For example, the systems and methods described herein can be used in the microinvasive surgical reconstruction of the ossicular chain, for removal of cholesteatoma, for diagnostic evaluation, and other procedures. Any and all such techniques for using the systems and methods described herein are included within the scope of the present disclosure.

[0086] The devices and systems described herein can be constructed from metals (such as, but not limited to, aluminum, stainless steel, and the like) or polymers (such as, but not limited to, ABS, PEEK, PET, HDPE, and the like), injection molded parts, and the like. Portions such as the flexible ring can be constructed from elastomeric materials, gels, and the like.

[0087] The devices, systems, materials, compounds, compositions, articles, and methods described herein can be understood by reference to the foregoing detailed description of specific aspects of the disclosed subject matter. It should be understood, however, that the foregoing is not limited to the particular devices, systems, methods, or specific reagents, and thus can 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.

[0088] A number of embodiments have been described. Nevertheless, it will be understood that various modifications can be made without departing from the scope of the present disclosure. Accordingly, other embodiments are within the scope of the following claims.

Claims

1. A surgical microscope system, comprising: a surgical microscope; a stereoscopic inverting lens system; and a distal lens sized for placement in a tympanic membrane to facilitate visualization of a middle ear region, wherein an arm member, feature, or anchor mechanically couples the stereoscopic inverting lens system to the speculum, the arm member, feature, or anchor being telescoping or adjustable. the distal lens includes:

2. The system of claim 1, wherein, a prism at a proximal end of the distal lens; and a wide field lens at a distal end of the distal lens. the distal lens further includes a zoom lens or objective lens disposed between the prism and the wide field lens.

3. The system of claim 2, wherein, the distal lens defines a waist having an outer diameter that is less than proximal and distal portions immediately adjacent to the distal lens.

4. The system of claim 2, wherein, the distal lens includes:

5. The system of claim 1, wherein, 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 objective lens disposed between the first prism and the second prism. the distal lens includes two or more stabilizing arms extending radially outward from a body of the distal lens.

6. The system of claim 1, wherein, the distal lens includes:

7. The system of claim 1, wherein, a condenser 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, wherein the housing defines an interior space between the condenser lens and the second lens. the housing includes a radially extending flange or arm.

8. The system of claim 7, wherein, 9. The system of any of claims 1-8, further comprising a port device attached to the distal lens. an open space is defined within the speculum and to the side of the portion of the stereoscopic inverting lens system that is installed within the speculum.

10. The system of claim 1, wherein, 11. The system of any of claims 1-8, further comprising a light pipe coupled to the distal lens. the distal lens includes an elongated tubular member and a plurality of lenses coupled to the tubular member to define a light path through the tubular member, and wherein the tubular member includes a plurality of segments that allow for an angle between segments.

12. The system of any one of claims 1-8, wherein, the distal lens includes an elongated tubular member enclosing an optical fiber configured to relay an image from a distal end of the distal lens to a proximal lens of the distal lens.

13. The system of any one of claims 1-8, wherein, ​

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