Method and apparatus for film characterization using ultrasound and optical illumination

Abstract

An apparatus for measuring reflected ultrasonic and optical signals may include: a light source; an optical assembly including at least one lens configured to focus reflected optical illumination from the target onto the detector; and an ultrasonic transducer aligned to transmit and receive ultrasonic radiation coaxially with the reflected optical illumination, and wherein the ultrasonic transducer at least partially blocks a path of the reflected optical illumination. The obstacle may be away from the focus of the optical component. Devices for measuring reflected ultrasonic and optical signals may be particularly useful for characterizing fluids behind the ear tympanic membrane to diagnose otitis media.

Description

[0001] This application is a divisional application of a Chinese patent application with an application date of October 3, 2019, application number 201980079648.3, and invention name “Method and apparatus for membrane characterization using ultrasound and optical illumination” (the corresponding PCT application with an application date of October 3, 2019 and application number PCT / US2019 / 054571).

[0002] Cross-references

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 740,862 (Attorney Docket No. 45102-710.101), filed on October 3, 2018, the entire disclosure of which is incorporated herein by reference. Background Art

[0004] Acute otitis media (AOM) is an inflammatory process of the middle ear and is the most common clinical condition seen by pediatricians in children 15 years of age and younger. AOM is often associated with middle ear effusion and is considered an inflammation of the middle ear. Complications of undiagnosed AOM can include hearing loss. Recurrent AOM can also lead to delays in the development of speech and language skills if the child is not treated.

[0005] The probability of obtaining an accurate diagnosis using existing non-invasive methods is no more than 50%. Furthermore, existing non-invasive methods can only be used to identify the presence of an effusion, and they generally do not provide information about the type of effusion. Due to the risks associated with undiagnosed AOM and the recognized unreliability of existing diagnostic tests, patients are often prescribed antibiotics, which may not effectively treat viral effusions. In addition to the added cost burden of unnecessary antibiotic treatment, patients are also faced with the side effects of antibiotics and the attendant significant risk of developing antibiotic resistance.

[0006] The following well-known references may be of interest: U.S. Patent Publication No. 2018 / 0310917 and U.S. Patent Publication No. 2017 / 0014053, each of which is incorporated by reference in its entirety.

[0007] The following references may be of interest: US Patent 5,345,926. Summary of the invention

[0008] The apparatus and methods described herein can improve existing non-invasive techniques by measuring ultrasound data reflected from a biomembrane, which occurs simultaneously with pneumatic excitation. The size of the diagnostic target may be small, and the ultrasound is invisible to the human eye. A light source and a detection system may be provided. The light source and the detection system may facilitate alignment of the ultrasound beam. Since the size of the biological cavity may be small, the light source and the detection system may be space efficient. The present disclosure provides improvements in delivering optical illumination to a target. The present disclosure provides improvements in receiving optical illumination from a target in the presence of obstacles.

[0009] In one aspect, the present disclosure provides a speculum operably disposed within an ear of a subject. The speculum may include: a housing including a light-guiding element, wherein transmitted optical illumination is conducted by total internal reflection via the light-guiding element, wherein the housing has an inner cavity therein, and wherein the housing is configured to allow reflected optical illumination to propagate therethrough; and an obstruction disposed in the inner cavity proximate a distal end of the housing, the obstruction at least partially blocking the reflected optical illumination, wherein a maximum dimension of the obstruction is less than 75% of a minimum diameter of the inner cavity.

[0010] In some embodiments, the obstruction comprises an ultrasonic transducer. In some embodiments, the ultrasonic transducer is centered relative to the distal end of the housing. In some embodiments, the transmission axis of the ultrasonic transducer is coaxial with the axis of symmetry of the housing. In some embodiments, the housing is shaped as a truncated cone. In some embodiments, the transmission axis of the ultrasonic transducer is coaxial with the optical path of the reflected optical illumination. In some embodiments, the maximum dimension is the diameter. In some embodiments, the diameter is in the range of 20% to 60% of the minimum diameter of the lumen.

[0011] In some embodiments, the light-guiding element comprises one or more optical fibers adjacent to the housing. In some embodiments, a portion of the housing is configured to transmit light by total internal reflection, such that the portion of the housing is a light-guiding element. In some embodiments, the housing comprises a light-guiding core. In some embodiments, the housing comprises an opaque shell. In some embodiments, the speculum is disposable.

[0012] In some embodiments, the speculum is removably attached to the otoscope. In some embodiments, the speculum is removably connected to a device for measuring reflected optical and ultrasonic signals. In some embodiments, the speculum is axially aligned with the focal axis of the optical assembly when connected to the device. In some embodiments, the optical assembly includes a focal point within a range of 12-25 mm from the distal end of the otoscope. In some embodiments, the optical assembly includes a depth of field greater than 0.5 mm at a distance of 12-25 mm from the distal end of the otoscope.

[0013] In some embodiments, the optical assembly includes at least one lens. In some embodiments, the at least one lens is a relay lens. In some embodiments, the relay lens includes one or more concave lenses, convex lenses, plano-concave lenses, or plano-convex lenses. In some embodiments, the relay lens includes one or more achromatic doublet lenses. In some embodiments, the relay lens includes one or more gradient index lenses. In some embodiments, the relay lens includes a rod lens relay. In some embodiments, the at least one lens includes at least two lenses forming a first telescope.

[0014] In some embodiments, the ultrasonic transducer is mounted on the transducer mounting assembly. In some embodiments, the transducer mounting assembly includes one or more apertures to allow the transmission of pneumatic excitation around the ultrasonic transducer. In some embodiments, the transducer mounting assembly is press-fitted into the housing of the speculum. In some embodiments, the distal end of the transducer mounting assembly is operably connected to a transparent plate. In some embodiments, the transparent plate includes an ultrasonic transducer mounted on its surface. In some embodiments, a portion of the transducer mounting assembly is conductive. In some embodiments, the maximum dimension of the ultrasonic transducer is less than 2 mm. In some embodiments, a metal shield is arranged around the ultrasonic transducer, wherein the metal shield is radially displaced away from the transmission axis of the ultrasonic transducer. In some embodiments, the speculum includes a pressure gauge configured to measure the internal pressure of the speculum.

[0015] In another aspect, the present disclosure provides an apparatus for measuring reflected optical and ultrasonic signals. The apparatus may include: a light source; an optical assembly including at least one lens configured to focus reflected optical illumination from a target onto a detector; and an ultrasonic transducer aligned to transmit and receive ultrasonic radiation coaxially with the reflected optical illumination, and wherein the ultrasonic transducer at least partially blocks the path of the reflected optical illumination; wherein the optical assembly includes a focal point within a range of 12-25 mm from the distal tip of the otoscope and a depth of field greater than 0.5 mm at a distance of 12-25 mm from the distal tip of the otoscope.

[0016] In some embodiments, the device comprises a reflex device of any aspect or embodiment. In some embodiments, the ultrasonic transducer is centered relative to the focal axis of the optical assembly. In some embodiments, the transmission axis of the ultrasonic transducer is coaxial with the focal axis of the optical assembly. In some embodiments, the transmission axis of the ultrasonic transducer is coaxial with the optical path of the reflected optical illumination. In some embodiments, the ultrasonic transducer comprises a relative size of 20%-50% of the aperture of the optical assembly. In some embodiments, the light source comprises one or more optical fibers.

[0017] In some embodiments, the light source is configured to transmit light to the speculum. In some embodiments, a portion of the speculum is configured to transmit light by total internal reflection. In some embodiments, the speculum includes a light-guiding core. In some embodiments, the speculum includes an opaque shell. In some embodiments, the speculum is disposable. In some embodiments, the device is an otoscope. In some embodiments, the speculum is removably connected to the device.

[0018] In some embodiments, the reflex device is aligned axially with the focal axis of the optical assembly when connected to the device. In some embodiments, the optical assembly includes at least one lens. In some embodiments, the at least one lens is a relay lens. In some embodiments, the relay lens includes one or more concave lenses, convex lenses, plano-concave lenses, or plano-convex lenses. In some embodiments, the relay lens includes one or more achromatic doublet lenses. In some embodiments, the relay lens includes one or more gradient refractive index lenses. In some embodiments, the relay lens includes a rod lens relay. In some embodiments, the at least one lens includes at least two lenses forming a first telescope.

[0019] In some embodiments, the ultrasonic transducer is mounted on a transducer mounting assembly. In some embodiments, the transducer mounting assembly includes one or more holes to allow transmission of pneumatic excitation around the ultrasonic transducer. In some embodiments, the transducer mounting assembly is press-fitted into the housing of the speculum. In some embodiments, the distal end of the transducer mounting assembly is operably connected to a transparent plate. In some embodiments, the transparent plate includes an ultrasonic transducer mounted on its surface. In some embodiments, a portion of the transducer mounting assembly is conductive. In some embodiments, the maximum dimension of the ultrasonic transducer is less than 2 mm. In some embodiments, a metal shield is arranged around the ultrasonic transducer, wherein the metal shield is radially displaced away from the transmission axis of the ultrasonic transducer. In some embodiments, the device also includes a pressure gauge configured to measure the internal pressure of the speculum.

[0020] In another aspect, the present disclosure provides a method of using an otoscope. The method may include: directing optical illumination at a target; directing pneumatic excitation at the target; directing ultrasound at the target, wherein the ultrasound co-propagates with the optical illumination; receiving the optical illumination reflected from the target at a detector; measuring the response of the target to the pneumatic excitation in the reflected ultrasound; and determining a state or condition of the subject based on the reflected optical illumination and the response.

[0021] In some embodiments, the method further comprises providing an apparatus of any aspect or embodiment. In some embodiments, the method further comprises providing a speculum of any aspect or embodiment.

[0022] In another aspect, the present disclosure provides a speculum operably disposed within an ear of a subject. The speculum may include: a frustoconical housing configured to be disposed within an ear canal and including an inner cavity; one or more optical fibers adjacent to the frustoconical housing and extending from a proximal opening of the frustoconical housing to a distal tip; and an ultrasonic transducer mounted within the frustoconical housing proximal to the distal tip and aligned to transmit and receive ultrasonic radiation coaxially with reflected optical illumination, and wherein the ultrasonic transducer at least partially blocks the path of the reflected optical illumination.

[0023] In some embodiments, the retractor also includes the retractor of any aspect or embodiment, wherein the obstruction includes at least an ultrasonic transducer, and wherein one or more optical fibers include a light-guiding element. In some embodiments, the retractor is removably attached to the equipment of any aspect or embodiment. In some embodiments, the ultrasonic transducer is centered relative to the distal end of the housing. In some embodiments, the ultrasonic transducer is coaxial with the housing. In some embodiments, the retractor includes a quick release fitting. In some embodiments, the diameter of the ultrasonic transducer is less than 50% of the housing lumen at the distal end opening of the housing. In some embodiments, the retractor is disposable.

[0024] In another aspect, the present disclosure provides a speculum operably disposed within an ear of a subject. The speculum may include: a frustoconical housing configured to be disposed within an ear canal and configured to transmit light by total internal reflection; an ultrasonic transducer mounted within the frustoconical housing near a distal end of the frustoconical housing, wherein the ultrasonic transducer is sufficiently small to allow reflected light to pass through an interior cavity of the housing.

[0025] In some embodiments, the speculum also includes the speculum of any aspect or embodiment, wherein the obstruction includes at least an ultrasonic transducer, and wherein the housing includes a light-guiding element. In some embodiments, the speculum is removably attached to the device of any aspect or embodiment. In some embodiments, the ultrasonic transducer is centered relative to the distal end of the housing. In some embodiments, the ultrasonic transducer is coaxial with the housing. In some embodiments, the speculum is disposable.

[0026] In another aspect, the present disclosure provides an otoscope. The otoscope may include: an interface releasably coupled to a speculum; an optical assembly including at least one lens having an aperture, wherein the optical assembly includes a focal point within a range of 12-25 mm from a distal tip of the otoscope and a depth of field greater than 0.5 mm at a distance of 12-25 mm from the distal tip of the otoscope; a central obstruction along an optical path from the optical assembly to a target, wherein a diameter of the central obstruction is less than 50% of the aperture. In some embodiments, the speculum further includes the speculum of any aspect or embodiment.

[0027] In another aspect, the present disclosure provides an otoscope. The otoscope may include: a speculum having an inner cavity therein and including a light-guiding element, wherein the transmitted optical illumination is conducted by total internal reflection of the light-guiding element, and wherein the reflected optical illumination propagates through the inner cavity of the speculum; a central obstruction disposed within the speculum near the distal end, the central obstruction at least partially blocking the reflected optical illumination; and an optical assembly including at least one lens having a focal length longer than the distance from the lens to the central obstruction. In some embodiments, the speculum further includes the speculum of any aspect or embodiment.

[0028] In another aspect, the present disclosure provides a method of using an optical and ultrasonic device. The method may include: directing optical illumination at a target; directing ultrasound at a target; receiving ultrasound reflected from the target; and adjusting the focus of the optical illumination based on the received reflected ultrasound, wherein the adjustment is performed substantially in real time. In some embodiments, the method further includes: calculating image clarity, calculating a derivative of image clarity, and adjusting the focus based on image clarity.

[0029] In another aspect, the present disclosure provides a method of manufacturing a speculum operably disposed within an ear. The method may include: mounting an ultrasound transducer on a substrate; mounting the substrate on a support including a conductive portion, wherein the support has a pneumatically clear path when the support is mounted; and assembling the support in an inner cavity of the speculum, wherein the transducer is centered in the inner cavity of the speculum, wherein the speculum has an optically clear path when the transducer is located in the inner cavity.

[0030] Incorporation by reference

[0031] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The novel features of the present disclosure are particularly set forth in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description which sets forth illustrative embodiments and the accompanying drawings, wherein the illustrative embodiments utilize the principles of the present invention, wherein the accompanying drawings are:

[0033] Figure 1 is a side cross-sectional view of an optical assembly for measuring optical and ultrasonic signals according to some embodiments.

[0034] Figure 2A is a side cross-sectional view of another optical assembly for measuring optical and ultrasonic signals according to some embodiments.

[0035] Figure 2B Shows Figure 2A A light diagram of a device according to some embodiments.

[0036] Figure 3 is a side cross-sectional view of another optical assembly for measuring optical and ultrasonic signals according to some embodiments.

[0037] Figure 4A is a transparent side perspective view of an exemplary speculum including a light guide according to some embodiments.

[0038] Figure 4B yes Figure 4A A transparent isomorphic view of a speculum according to some embodiments.

[0039] Figure 5A is an elevational view of a distal tip of an exemplary speculum including one or more optical fibers, according to some embodiments.

[0040] Figure 5B yes Figure 5A A transparent side view of a speculum according to some embodiments.

[0041] Fig. 6A is an elevation view of a distal end of a transducer mounting assembly according to some embodiments.

[0042] Figure 6B yes Fig. 6A A side cross-sectional view of a transducer mounting assembly according to some embodiments.

[0043] Fig. 7A is a side cross-sectional view of an exemplary detector assembly according to some embodiments.

[0044] Figure 7B yes Fig. 7A A side view of a detector assembly according to some embodiments.

[0045] Fig. 8A is a side cross-sectional view of an exemplary interface for receiving a speculum, according to some embodiments.

[0046] Figure 8B yes Fig. 8A A side view of an interface according to some embodiments.

[0047] Fig. 9 is a side cross-sectional view of an exemplary speculum coupled to an interface according to some embodiments.

[0048] Fig. 10A is a side view of an exemplary device body and speculum coupled to an interface according to some embodiments.

[0049] Fig. 10B yes Fig. 10A Schematic diagram of an apparatus according to some embodiments.

[0050] Fig.11 is a side view of an exemplary device including an interface for receiving a speculum including a light guide according to some embodiments.

[0051] Fig.12 is a side view of an exemplary device connected to a speculum including a light guide and a light insertion point according to some embodiments.

[0052] Fig.13 is a perspective view of an exemplary interface to a pneumatic subsystem according to some embodiments.

[0053] Fig.14 is a transparent perspective view of an exemplary device body including an eyepiece according to some embodiments.

[0054] Reference Fig.15A and Fig. 15B Perspective and rear views, respectively, of various exemplary housings are shown according to some embodiments.

[0055] Fig.16 Exemplary shapes of specula of the present disclosure are shown according to some embodiments.

[0056] Fig.17 is a flow chart of an exemplary method of making a speculum, according to some embodiments.

[0057] Fig.18 is a schematic diagram of an exemplary system for measuring reflected ultrasonic and optical signals, including a digital processing device and a user-viewable display, according to some embodiments.

[0058] Fig.19 is a flow chart of an exemplary method of using an otoscope, according to some embodiments.

[0059] Fig. 20 is a flow chart of an exemplary method of using optical and ultrasonic devices according to some embodiments. DETAILED DESCRIPTION

[0060] Devices, otoscopes, specula, and methods of use and manufacture thereof as disclosed herein can solve problems associated with devices for measuring optical and ultrasonic information. Embodiments of the present disclosure can improve the transmission of light and / or the collection of light from a biofilm, which can be characterized simultaneously with ultrasonic excitation. Devices, otoscopes, specula, and methods of use and manufacture thereof as disclosed herein can solve difficulties in the field of alignment of devices for measuring reflected ultrasonic signals. In some cases, the present disclosure solves problems in the field of otoscopy.

[0061] For example, surface characterization using reflection ultrasound analysis in the presence of aerodynamic excitation can be improved if transmitting optical illumination, aerodynamic excitation, and ultrasound signals is spatially efficient. For example, surface characterization using reflection ultrasound analysis in the presence of aerodynamic excitation can be improved if the measurement of reflected ultrasound signals and reflected optical illumination is spatially efficient.

[0062] For example, surface characterization using reflected ultrasound in the presence of pneumatic excitation can be improved if the ultrasound is directed at the surface at an angle that causes the ultrasound signal to return to the transducer. Since the ultrasound excitation is invisible to the eyes, especially the eyes of the device operator, the alignment of the ultrasound is not simple. In one approach, the light source can be directed at the surface to allow the user to better adjust the alignment of the device. The light source can be substantially aligned with the ultrasound propagation. In the ear, the user can aim the light source into the ear canal to reflect the light off the eardrum. Good reflection can produce a "light cone". However, since the user may not look directly through the center of the lens and / or since the transducer may block the reflected light, the ultrasound and light may not propagate in the same direction.

[0063] The devices, otoscopes, specula, and methods of use and manufacture thereof disclosed herein may be used in conjunction with, for example, devices and methods for characterizing tough membrane, surface, and sub-surface properties, such as those described in the well-known U.S. Patent Publication No. 2018 / 0310917 and U.S. Patent Publication No. 2017 / 0014053, the entire contents of which are incorporated by reference.

[0064] The devices, otoscopes, specula, and methods of use and manufacture thereof as disclosed herein can be used to characterize a variety of biological tissues to provide various diagnostic information. The biological tissues can include patient organs. The speculum can be arranged in a body cavity to characterize patient tissues. The patient organs or body cavities can include, for example, muscles, tendons, ligaments, oral cavity, tongue, pharynx, esophagus, stomach, intestines, anus, liver, gallbladder, pancreas, nose, larynx, trachea, lungs, kidneys, bladder, urethra, uterus, vagina, ovaries, testicles, prostate, heart, arteries, veins, spleen, glands, brain, spinal cord, nerves, etc., to name a few.

[0065] Devices, otoscopes, specula, and methods of use and manufacture thereof as disclosed herein can be used to characterize the tympanic membrane. For example, the membrane can be characterized to determine a condition of the ear, such as acute otitis media (AOM). Characterization that the ear exhibits AOM can include detecting the presence of an effusion and characterizing the type of effusion as one of serous, mucoid, purulent, or a combination thereof. In AOM, middle ear effusion (MEE) can be caused by an infectious agent and can be thin or serous in the case of viral infection and thicker and purulent in the case of bacterial infection. Therefore, determining various properties of the fluid adjacent to the tympanic membrane can provide information that can be used to characterize the membrane.

[0066] Devices, otoscopes, specula, and methods of use and manufacture thereof as disclosed herein can be used to characterize food. For example, pneumatic excitation can apply pulsed pressure to the surface of a food, such as vegetables, fruits, meat, dairy products, cereals, etc., and ultrasonic energy can be applied to the food to measure the surface response of the food over time. For example, the surface response of a fruit or vegetable can be used to measure elasticity or other physical properties that can be related to the maturity of the fruit or vegetable. For example, the presence of mold on the surface of bread can change the surface response of the crust. For example, the surface properties of yogurt or cheese can be measured to evaluate the hardness of a fermented milk product. For example, the surface response of meat or meat products can be related to the degree of its cooling. For example, the food can be placed in a holder and the surface can be excited with a beam of gas (e.g., air), and the surface deflection response (surface deflection response) estimates maturity or other properties. For example, the excitation can be a gas transmitted at supersonic speed and / or at a grazing angle relative to the surface of the food, or one or more foods can be placed in a chamber with a variable pressure to measure low-frequency surface responses to pressure, such as the relationship between deflection and pressure. For example, an excitation may be applied to one surface and the response measured on a different surface of the same article, such as measuring propagating surface waves or shear waves propagating through the article being characterized.

[0067] The devices, otoscopes, specula, and methods of use and manufacture thereof as disclosed herein can be used to characterize industrial processes. For example, pneumatic excitation can apply pulsed pressure to the surface of a manufactured part to determine the consistency of a viscous fluid (e.g., a lubricant), and ultrasonic energy can be applied to the part to measure the surface response of the viscous fluid over time to determine elasticity or other physical properties that can be related to the quality of the lubricant. Other industrial examples may include range finding applications, ultrasonic transit time gas flow meters for metering dynamic airflow, anemometer applications, and various other ultrasound-based sensing applications.

[0068] Reference will now be made in detail to various embodiments, examples of which are illustrated in the accompanying drawings. In the detailed description below, many specific details are set forth to provide a thorough understanding of the present disclosure and the described embodiments. However, the embodiments of the present disclosure are optionally practiced without these specific details. In other cases, known methods, steps, components and circuits are not described in detail to avoid unnecessarily making the various aspects of the embodiments unclear. In the accompanying drawings, the same reference numerals refer to the same or similar steps or components.

[0069] The terms used herein are only for describing specific embodiments and are not intended to limit the claims. As used in the description of the embodiments and the appended claims, unless otherwise expressly stated in the text, the singular forms "one", "a kind of" and "the" are also intended to include plural forms. It should also be understood that the term "and / or" as used herein refers to and covers any and all possible combinations of one or more associated listed items. It will be further understood that when the terms "including" and / or "comprising" are used in this specification, it specifies the presence of the features, integers, steps, operations, elements and / or components, but does not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0070] As used herein, the term "if" is optionally interpreted to mean "when", "after..." or "in response to determination" or "according to determination" or "in response to detection", the precondition is true, depending on the context. Similarly, the phrase "if it is determined that [the precondition is true]" or "if [the precondition is true]" or "when [the precondition is true]" is optionally interpreted to mean "after determination" or "in response to determination" or "according to determination" or "according to detection" or "in response to detection", the conditional precondition is true, depending on the context.

[0071] As used herein, and unless otherwise indicated, the term "about" or "approximately" means an acceptable error for a particular value determined by one of ordinary skill in the art, which may depend in part on how the value is measured or determined. In certain embodiments, the term "about" or "approximately" means within 1, 2, 3, or 4 standard deviations. In certain embodiments, the term "about" or "approximately" means within 30%, 25%, 20%, 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, or 0.05% of a given value or range. In certain embodiments, the term "about" or "approximately" means within 40.0 mm, 30.0 mm, 20.0 mm, 10.0 mm, 5.0 mm, 1.0 mm, 0.9 mm, 0.8 mm, 0.7 mm, 0.6 mm, 0.5 mm, 0.4 mm, 0.3 mm, 0.2 mm, or 0.1 mm of a given value or range.

[0072] As used herein, the terms "comprises," "comprising," or any other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements includes not only the elements stated but may also include other elements not expressly listed or inherent to such process, method, article, or apparatus.

[0073] As used herein, the terms "subject" and "patient" are used interchangeably. As used herein, the term "subject" refers to animals (e.g., birds, reptiles, and mammals), including primates (e.g., monkeys, chimpanzees, and humans) and non-primates (e.g., camels, donkeys, zebras, cattle, pigs, horses, cats, dogs, rats, and mice). In certain embodiments, the mammal is 0 to 6 months old, 6 to 12 months old, 1 to 5 years old, 5 to 10 years old, 10 to 15 years old, 15 to 20 years old, 20 to 25 years old, 25 to 30 years old, 30 to 35 years old, 35 to 40 years old, 40 to 45 years old, 45 to 50 years old, 50 to 55 years old, 55 to 60 years old, 60 to 65 years old, 65 to 70 years old, 70 to 75 years old, 75 to 80 years old, 80 to 85 years old, 85 to 90 years old, 90 to 95 years old, or 95 to 100 years old.

[0074] Figure 1 1 is a side cross-sectional view of an optical assembly for measuring optical and ultrasonic signals according to some embodiments. As shown, the optical assembly includes a first lens 122 and a second lens 124. The first and second lenses may include focal axes that are substantially coaxially aligned. Figure 1 The focal axis 102 of the first lens 122 and the second lens 124 is shown. As shown, the device includes an ultrasonic transducer 110 on a plate 112. The ultrasonic transducer 110 may be configured to transmit ultrasonic signals and / or receive ultrasonic signals along the ultrasonic axis 104. The ultrasonic transducer 110 may be located on the focal axis 102. In some cases, the ultrasonic transducer 110 may block light propagating along 102. The plate 112 may be located on the focal axis 102. The plate 112 may be transparent or partially transparent to light propagating along the focal axis 102. In some cases, the device may include a detector 130. The detector may be positioned along the focal axis 102. The size and shape of the detector may be configured to receive light collected by the first lens 122 and the second lens 124. The detector may be sensitive to a range of wavelengths propagating along the optical path 102. In some cases, the device may include a light source, not shown. In other cases, the device may not include a light source. In some cases, the light propagating along the focal axis 102 may include light scattered along the focal axis 102. In some cases, focal axis 102 and ultrasonic axis 104 may also be co-linear with aerodynamic axis 106. Aerodynamic disturbances may propagate along axis 106.

[0075] As described herein, an optical assembly may include one or more optical components, which may include one or more lenses, one or more mirrors, one or more beam splitters, one or more prisms, one or more filters, one or more polarizers, one or more diffusers, one or more apertures, one or more beam pipes, one or more wave plates, or other optical components. In some cases, the optical assembly includes beam pipe 142. In some cases, the optical assembly includes exit aperture 140.

[0076] In some cases, the first lens 122 and the second lens 124 may work together to collect and / or transmit light. In some cases, the lens 122 and the lens 124 include an optical telescope. In some cases, the optical telescope is a reflecting telescope, a refracting telescope, or a combination thereof. The lens as described herein may include a focal length and an aperture. The magnification of the telescope may be related to the ratio of the first lens 122 and the second lens 124. As the magnification increases, the field of view may decrease. Similarly, as the aperture of the lens increases, the field of view may increase. The focal length may also affect the depth of focus of the optical assembly. For example, a longer focal length may result in a longer depth of field. The focal length and aperture may be adjusted to image the target at a certain distance from the first lens and the second lens. Similarly, the focal length and aperture may be adjusted to image around a central obstacle. Obstacles positioned along the focal axis may cause spatial aberrations of the image. The farther the obstacle is from the focal area, the less obvious the spatial aberration caused by the central obstacle. As the depth of focus increases, the obstacle is closer to the focal area. The size may also be limited by the intended use and access to the target area. For example, if the target is within a body cavity, a small diameter and smaller aperture lens may be desired.

[0077] Lenses as described herein may include a single lens or a composite lens. A composite lens may be a relay lens. A relay lens may include one or more pairs of optical substrates having different optical properties, for example, one substrate may be flint glass and one substrate may be Schott glass. A relay lens may include one or more single lenses. A relay lens may include one or more achromatic doublet lenses. Achromatic doublet lenses may include low chromatic aberration. In some cases, the relay lens includes one or more gradient index lenses. In some cases, the relay lens includes a rod lens relay. Although a first lens 122 and a second lens 124 are shown, the optical assembly may include additional lenses. For example, the third and fourth lenses and / or the relay lens may be used as an "erector" (e.g., a lens may invert an image, which may be inverted by a refracting telescope).

[0078] The lenses described herein may include one or more optical substrates. The optical substrates may include glass and / or crystals. For example, the optical substrates disclosed herein may include silicate glass, sapphire, quartz, etc.

[0079] The apparatus as described herein may include an ultrasonic transducer. The ultrasonic transducer may be a capacitive micromachined ultrasonic transducer. In some cases, the ultrasonic transducer may be a piezoelectric transducer. The ultrasonic transducer may transmit ultrasonic radiation. The ultrasonic transducer may be configured to receive ultrasonic radiation. In some cases, the apparatus may include a drive circuit. The drive circuit may provide an electrical waveform to the transducer, which may transmit a waveform in response to the waveform. In some cases, the transducer may receive ultrasonic radiation and may convert the received radiation into an electrical waveform. The received electrical waveform may be converted into a digital signal and / or stored by a digital processing device as disclosed elsewhere herein.

[0080] Ultrasonic transducers can generally be very small. For example, an ultrasonic transducer can be configured to be mounted in a body cavity of a subject. The body cavity can be an ear canal. The ultrasonic transducer can also be configured to allow light to propagate coaxially with ultrasound. Because the ultrasonic transducer can hinder the transmission of light. Smaller transducers can produce images with smaller aberrations. The ultrasonic transducer can include an effective area with a diameter of less than 5 millimeters (mm), less than 2 mm, less than 1 mm, or less. The ultrasonic transducer can include an effective area with a diameter of 2 mm to 0.5 mm. The ultrasonic transducer can include an effective area of ​​1.5 mm to 0.5 mm. The ultrasonic transducer can include a housing or base with a maximum dimension of less than 5 millimeters (mm), less than 2 mm, less than 1 mm, or less.

[0081] The ultrasonic transducer can be configured to transmit ultrasonic signals within a specific frequency band. For example, the ultrasonic transducer can transmit ultrasound at 0.1 megahertz (MHz) to 10 MHz, 1 MHz to 2 MHz, or 1.2 MHz to 1.8 MHz. In one example, the ultrasonic transducer can have an angular beam propagating between 10 and 20 degrees within a bandwidth of 1.2 to 1.8 MHz and an edge length of 0.6 to 1.0 mm.

[0082] Ultrasonic transducers 110 , 210 , 210 , 410 , and 510 may include any embodiment, variation, or example of an ultrasonic transducer disclosed herein.

[0083] The ultrasonic transducer may be mounted on a plate 112. The plate may be partially transparent to light propagating along the focal axis 102. The plate 112 may be partially transparent. For example, the substrate may be 95% transparent to light propagating along the path 102. For example, the substrate may be 85%, 75%, 50% transparent to light propagating along the path 102, or less. For example, the substrate may include substantially transparent portions and other opaque portions. For example, the plate may be transparent to certain wavelengths and absorb other wavelengths. The plate may act as a color filter. The plate may include one or more coatings that may affect the transparency of the substrate. The plate 112 may include a glass substrate, a quartz substrate, or the like.

[0084] In some cases, the optical assembly may include a detector 140. The detector may be a two-dimensional detector. The detector may be a CCD, a CMOS, a photodiode, a photodiode array, a thermal sensor, an optical sensor, etc. The detector may be sensitive to light within a spectrum. For example, the detector may be sensitive to light in a range of at least 400 to 800nm, 200 to 1000nm, 200 to 2500nm, or more. The detector may be operably connected to a digital processing device, as described elsewhere herein. In some cases, the detector may form an image from the received light signal. The digital processing device may perform one or more storage, analysis, and / or image processing functions. In some cases, the image may be transmitted to a display. The display may be on the device or external to the device.

[0085] In an embodiment without a detector, the user's eyes may not be fully aligned with the transmission axis of the ultrasonic energy. This is not ideal in the case where the user manually aligns the device with the target. If the user's eyes are not aligned with the transmission axis of the ultrasound, the ultrasound may be improperly aimed. The detector installed in the device can center the focal axis along the ultrasound transmission axis. The detector installed in the device can improve the alignment of the ultrasound and optical excitation on the target. For example, a detector installed and centered on the focal axis of the optical component can be used as a reference, and / or can be used as a sufficient reference for the propagation axis of the ultrasonic excitation. The ultrasound can be aimed by placing the target at the center of the detected optical image, which can be coaxial with the focal axis. The optical image can be used as an indicator (surrogate) of ultrasonic propagation. In addition to aligning the amplitude of the reflected ultrasonic signal, the optical image can also be used. Alignment aids on a display visible to the user can further help align the ultrasonic excitation. Since the ultrasonic excitation is not visible to the user, improved alignment is important.

[0086] Figure 2A is a side cross-sectional view of another optical assembly for measuring optical and ultrasonic signals according to some embodiments. Figure 2AAn optical assembly including a pair of telescopes for measuring optical and ultrasonic signals according to some embodiments is shown. As shown, the optical assembly includes a first lens 222, a second lens 224, a third lens 226, a fourth lens 228, and a fifth lens 229. The lenses may include focal axes that are substantially coaxially aligned. As shown, the device includes an ultrasonic transducer 210 on a plate 212. The ultrasonic transducer 210 may be configured to transmit ultrasonic signals and / or receive ultrasonic signals along an ultrasonic axis. The ultrasonic transducer 210 may be located on the focal axis of the optical assembly. For example, the axis of the ultrasonic beam emitted from the ultrasonic transducer may be the axis of ultrasonic propagation. The axis of ultrasonic propagation may be coaxial with the focal axis. In some cases, the ultrasonic transducer 210 may block light propagating along the focal axis of the optical assembly. The plate 212 may be located on the focal axis of the assembly. The plate 212 may be transparent or partially transparent to light propagating along the focal axis of the device. The plate may be mounted on a mounting assembly 214. The ultrasonic transducer 210 may include embodiments, variants, or examples of transducers disclosed herein.

[0087] In some cases, the device may include an imaging plane 230. In some cases, the imaging plane may be at the surface of the detector. In some cases, the imaging plane may be at the user's eye. The detector may be positioned along the focal axis of the device. The detector may be sized and shaped to receive light collected by a plurality of lenses. The detector may be sensitive to a range of wavelengths propagating along the optical path. In some cases, the device may include a light source, not shown. In other cases, the device may not include a light source. In some cases, light propagating along the focal axis may include light scattered along the focal axis. In some cases, the focal axis and the ultrasonic axis may also be colinear with the pneumatic axis. Pneumatic disturbances may propagate along the pneumatic axis.

[0088] The first and second lenses may form a first telescope. The first telescope may invert the image magnified by the first telescope. The third, fourth, and fifth lenses may include erectors. In some cases, the lenses may be mounted on a mechanical actuator. The mechanical actuator may be configured to translate one or more lenses to adjust the focus of the optical assembly. For example, the mechanical actuator may include a motor. The motor may include a stepper motor. The motor may turn a screw that translates the lens. In some cases, the mechanical actuator may be controlled by a user. In some cases, the mechanical actuator is automatically controlled (e.g., by a computer program configured to find focus). In some embodiments, the fifth lens 229 may be a fine focus lens that can translate along axis 221.

[0089] The sensor 210 may be operably attached to a mounting assembly 214. The mounting assembly 214 may provide an attachment mechanism for the sensor 210. For example, the mounting assembly 214 may include a surface to which the plate 212 is attached. For example, the mounting assembly 214 may center the transducer 210 within the focal axis. The mounting assembly may include a conductive portion. The conductive portion may be electrically connected to the ultrasonic transducer and the digital processing device described herein. The mounting assembly may include one or more holes that allow transmission of pneumatic excitation. In some cases, there may be a gap between the mounting assembly and the wall of the device and / or optical assembly that allows transmission of pneumatic excitation. In some cases, the first lens 222 may be connected to the mounting assembly 214. In other cases, the first lens 222 may not be connected to the mounting assembly 214.

[0090] Figure 2B Shows Figure 2A A light diagram of a device according to some embodiments. Figure 2B Target TM and exit aperture 240 are shown. Although the optical assembly includes a central obstruction, the optical assembly includes a wide collection angle. As shown, first lens 222 and second lens 224 comprise a first telescope. Along the light gray line, the image collected by the first telescope is inverted between second lens 224 and third lens 226. Third lens 226, fourth lens 228, and fifth lens 229 may form a second telescope. As shown, fifth lens 229 may be translated along axis 221, which may be colinear with the focal axis of the optical assembly. Continuing along the light gray line, the image transmitted to the imaging plane by the second telescope may not be inverted.

[0091] Figure 3 is a side cross-sectional view of another optical assembly for measuring optical and ultrasonic signals according to some embodiments. Figure 3 An exemplary optical assembly for measuring optical and ultrasonic signals using a removable camera assembly according to some embodiments is shown. As shown, the optical assembly includes a first lens 322, a second lens 324, a third lens 326, a fourth lens 328, and a fifth lens 329. The lenses may include focal axes that are substantially coaxially aligned. As shown, the device includes an ultrasonic transducer 310 on a plate 312. The ultrasonic transducer 310 may be configured to transmit ultrasonic signals and / or receive ultrasonic signals along an ultrasonic axis. The ultrasonic transducer 310 may be located on the focal axis of the optical assembly. In some cases, the ultrasonic transducer 310 may block light propagating along the focal axis of the optical assembly. The plate 312 may be located on the focal axis of the assembly. The plate 312 may be transparent or partially transparent to light propagating along the focal axis of the device. The ultrasonic transducer 310 may include an embodiment, variant, or example of an ultrasonic transducer disclosed herein.

[0092] In some cases, the device may have an imaging plane 330. In some cases, the imaging plane may be at the surface of the detector. In some cases, the imaging plane may be at the user's eye. The detector may be positioned along the focal axis of the device. In some cases, the device may include a second imaging plane. In some cases, the device may include a camera mounting assembly 700. In some cases, the camera mounting assembly may be removable. For example, the mounting assembly may be removed for prototyping, assembly, and / or alignment. The camera mounting assembly 700 may include a detector 730. The detector 730 may be movable along the focal axis 701. The detector may be movable along the image axis to improve image quality, for example, by improving image focus. In some cases, the third lens 326, the fourth lens 328, and the fifth lens 329 may not be used. For example, the optical assembly may include a first lens 322 and a second lens 324, which may project an image on the detector 730.

[0093] The detector 730 may be sized and shaped to receive light collected by a plurality of lenses. The detector may be sensitive to a range of wavelengths propagating along the optical path. In some cases, the device may include a light source, not shown. In other cases, the device may not include a light source. In some cases, light propagating along the focal axis may include light scattered along the focal axis. In some cases, the focal axis and the ultrasonic axis may also be colinear with the pneumatic axis. Pneumatic disturbances may propagate along the pneumatic axis. In some cases, the optical assembly includes an exit aperture 340. The transducer 310 may block the path of the optical illumination; however, light may be transmitted through the aperture 340 in an annular region around the transducer.

[0094] Figure 4A A transparent side perspective view of an exemplary retractor 400 including a light guide according to some embodiments is shown. The retractor of the present disclosure may include a transparent portion. The transparent portion may be configured to function as a light guide. For example, the retractor may include a transparent core 452 that may function as a light guide. The transparent portion may be configured to conduct light by total internal reflection.

[0095] As shown, the speculum may include a housing or shell. The housing or shell may be truncated conical in shape. The shell may include a light transmitting core 452. In some cases, the speculum may include a light-tight or substantially opaque shell 451. Light may be incident at the proximal portion of the truncated conical shell 454. The light may be incident at different insertion points of the circular proximal portion, or may be incident over an extended area. In some cases, one or more optical fibers or one or more tubular light guides may be used to direct the light to the insertion point.

[0096] At the insertion point, the light-guiding core may intersect the incident light at a large angle. When selecting the angle of the insertion point, the refractive index of the transmission core may be considered. Such an incident angle may be selected so that the incident light will be totally internally reflected between the walls of the transparent core. The light may be radially divergent within the transparent core. Therefore, although the number of insertion points may be limited, the light may be emitted from the entire area of ​​the distal end of the speculum. The core may include an optical grade plastic that may be substantially free of cracks or bubbles. The core may include an optical material designed to support total internal reflection, which is integral with the light input and light output portions. Surface treatments (e.g., polishing or reflective coatings) and continuous air gaps may be used to support total internal reflection. Any suitable surface treatment (e.g., polishing, reflective coatings, anti-reflective (AR) coatings, and / or dielectric coatings) may be used to support total internal reflection. The light-guiding housing may include a core-cladding interface configured to limit light leakage.

[0097] Fig.16 Exemplary shapes of specula of the present disclosure according to some embodiments are shown. The housing of the speculum may include a shape having a tapered distal portion and a larger proximal portion. The housing of the speculum may be conical. The housing may have a conical distal end 1602. The housing of the speculum may include a cone, a cone with a concave surface, or a cone with a convex surface. The housing may include an elbow fitting (e.g., 1603) in the body of the housing. The housing may taper to a tip (1604), or may have a truncated tip (1601).

[0098] Figure 4A In addition, exemplary positions of optical components and central obstacles are shown. For example, the exemplary scope 400 may include a transducer mounting assembly 414. The transducer mounting assembly 414 may facilitate fixation of the transducer 410 within the scope. The transducer mounting assembly 414 may provide an attachment mechanism for the transducer 410. For example, the mounting assembly 414 may include a surface on which a plate 412 is attached. In some cases, the plate 412 may be further connected to the transducer package base 411. The ultrasonic transducer 410 may be a capacitive micromachined ultrasonic transducer, which may be mounted on the package base 411. For example, the mounting assembly 414 may center the transducer 410 within the focal axis. The mounting assembly may include a conductive portion. The conductive portion may be electrically connected to the ultrasonic transducer and a digital processing device as described herein. The mounting assembly may include one or more holes that may allow transmission of pneumatic excitation. In some cases, there may be a gap between the mounting assembly and the wall of the device and / or optical component that may allow transmission of pneumatic excitation. In some cases, first lens 422 can be coupled to mounting assembly 414. In other cases, first lens 422 can be uncoupled from mounting assembly 414.

[0099] The scope may include an inner shell on the inside of the housing. The inner shell may include a shield. The shield may prevent ultrasound signals from the transducer from being transmitted to the outside of the scope. The shield may prevent electrical signals from being transmitted to the outside of the scope. The shield may be a metal shield. The shield may be a conductive material. The metal shield may be arranged around the ultrasound transducer. For example, the metal shield may be radially displaced away from the transmission axis of the ultrasound transducer. The scope may include an inner metal coating or foil. The inner metal coating or foil may be an electromagnetic shield for the transducer. In some cases, the shield may include a portion of an opaque shell. Figure 4A An exemplary arrangement of optical components within a retractor of the present disclosure is shown. For example, the first lens 422 and the second lens 424 may be aligned on a co-linear focal axis. The focal axis of the optical components may be substantially aligned with the central axis of the retractor. The retractor may include an exit aperture 440. In some cases, the diameter of the exit aperture may be less than 10 mm. The diameter of the exit aperture may be 2 mm to 8 mm. In some cases, the transducer may be located near the distal end of the retractor. For example, the transducer may be between 1.5 cm and 1 mm from the exit aperture 440.

[0100] In some cases, the speculum of the present disclosure may be disposable. A disposable speculum may facilitate cleaning. For example, a disposable speculum may allow for the prevention of pathogens from being transmitted from a first subject to a second subject. The apparatus of the present disclosure may include a durable portion and a disposable portion. The speculum, transducer mounting assembly, and transducer may include a disposable portion. In some cases, the optical assembly may be a portion of the durable portion. In some cases, all or a portion of the optical assembly may include a durable portion.

[0101] The speculum may have limited use. For example, the limited use may be for hygiene, such as to limit the spread of infection. For example, the speculum disclosed herein may be single-use. The speculum may be used rarely. For example, the speculum may be used less than 20 times, less than 10 times, less than 5 times, or less. The speculum may be used multiple times for a single subject or for a single body cavity of a subject. For example, the speculum may include an accessory that deforms or otherwise changes shape to limit it to a single use. The speculum may include a physical and / or electronic tag that can be registered by a digital processing device and is valid for a single use. The components of the speculum disclosed herein may be cheap enough to allow the speculum to be discarded after a single or several uses.

[0102] The speculum may include an interface for connecting to the durable portion. The interface may be light-tight. The interface may be airtight. Airtightness may help transmit pneumatic excitation from a pressure source to a target along a pneumatic axis. The interface may include one or more alignment guides. The alignment guide may include a raised portion or a lowered portion that may be used to align the speculum radially with the durable portion. Axial alignment may help form an electrical connection and / or an optical connection. The alignment guide may include a raised portion or a lowered portion that may be used to align the speculum axially with the durable portion. Example 400 includes an axial alignment guide 456 and a radial alignment guide.

[0103] Figure 4B A transparent isomorphic view of an exemplary speculum 400 including a light guide is shown according to some embodiments. Figure 4B A detailed view of the distal tip of an exemplary scope 400 is shown. The distal tip may include an ultrasound transducer 410 on a transducer package base 411. The package base may be mounted on a plate 412. The plate 412 may include an optically transparent portion. The distal end of the transducer mounting assembly 414 may include one or more electrical contact pads 413. The electrical contact pads may be electrically connected to electrical contacts on a surface of the transducer 410. The plate 412 may be substantially insulated. The electrical contact pads may be connected to a conductive portion of the transducer mounting assembly, which may be releasably electrically connected to a digital processing device as described elsewhere herein.

[0104] Figure 4B The distal end of the speculum is shown. The distal end may include a transparent core 452 and an opaque shell 451. The shell of the speculum may transmit light from the proximal portion of the speculum to the distal end of the speculum. The light may propagate to a target. The light may be reflected from the target into the central lumen of the speculum through the exit holes 440. The light may be received from the target through the exit holes 440 around the transducer 410 and through the transparent portion of the plate 412. A pneumatic excitation may be transmitted from the lumen of the speculum through one or more pneumatic holes 415. The pneumatic excitation may be small enough not to cause separation of the plate 412.

[0105] The speculum of the present disclosure may include an outer surface 451. In some cases, the outer surface may be opaque. The outer surface may be coated to provide a seal relative to the wall of the lumen to be measured. For example, the outer surface may include a soft coating or film that can provide improved airtightness to a biological lumen (e.g., an ear canal).

[0106] Figure 5BA transparent side view of an exemplary reflexoscope 500 including one or more optical fibers according to some embodiments is shown. A reflexoscope of the present disclosure may include one or more optical fibers. For example, in the illustrated embodiment, the reflexoscope may include one or more optical fibers 560. In the illustrated embodiment, the reflexoscope may include 4 optical fibers; however, the reflexoscope may include a plurality of optical fibers from 1 to 1000, from 1 to 100, or from 1 to 10. The one or more optical fibers may be configured to conduct light by total internal reflection.

[0107] As shown, the speculum 500 may include a housing or shell. The housing or shell may be frustoconical in shape. The housing or shell may include a body portion 552. The housing may include an outer shell 551 outside the body portion 552. The housing may include an inner shell 553. The inner shell 553 and the body portion 552 may secure one or more optical fibers 560 within the housing. In some cases, the body portion may be transparent, as disclosed elsewhere herein. In some cases, the body portion may be opaque. The body portion may be plastic or glass.

[0108] Inner shell 553 may include attachment elements 561. In some cases, inner shell 553 may be removable from body portion 552. Inner shell 553 and body portion 552 may be glued, press-fitted, welded, etc. Inner shell 553 may include attachment elements that may snap inner shell 553 into place or may friction fit inner shell 553 into place. In some cases, inner shell 553 may help secure transducer mounting assembly 600.

[0109] The inner shell 553 may include an electromagnetic shield. The shield may prevent the ultrasonic signal from the transducer from being transmitted to the outside of the scope. The shield may prevent the electrical signal from being transmitted to the outside of the scope. The shield may be a metal shield. The shield may be a conductive material. The metal shield may be arranged around the ultrasonic transducer. For example, the metal shield may be radially displaced away from the transmission axis of the ultrasonic transducer. The scope may include an inner metal coating or foil. The inner metal coating or foil may be an electromagnetic shield for the transducer. In some cases, the shield may include a portion of the opaque shell 551.

[0110] The speculum of the present disclosure may include an outer surface 551. In some cases, the outer surface may be opaque. The outer surface may be coated to provide a seal relative to the wall of the lumen to be measured. For example, the outer surface may include a soft coating or film that can provide improved airtightness to a biological lumen (e.g., an ear canal).

[0111] In some cases, the speculum can include a light-tight or substantially opaque housing. Light can be incident at a proximal portion of one or more optical fibers near the proximal end of the frustoconical portion. Light can be incident on all or a subset of the one or more optical fibers. In some cases, light from the device body can be directed to an insertion point near the proximal end of the frustoconical portion using one or more optical fibers or one or more tubular light guides.

[0112] Figure 5B Additionally shown is a transducer mounting assembly 600. The transducer mounting assembly 600 can facilitate fixation of the transducer 510 within the scope. The transducer mounting assembly 600 can provide an attachment mechanism for the transducer 510. For example, the mounting assembly 600 can include a surface on which a plate 512 is attached. In some cases, the plate 512 can also be connected to the transducer package base 511. The ultrasonic transducer 510 can be a capacitive micromachined ultrasonic transducer, which can be mounted on the package base 511. For example, the mounting assembly 600 can center the transducer 510 within the focal axis. The mounting assembly 600 can include a conductive portion 614. The conductive portion can be electrically connected to the ultrasonic transducer and the digital processing device described herein. The electrical connection can include one or more wires 516. The mounting assembly 600 can include one or more holes 515, which can allow the transmission of pneumatic excitation. In some cases, there can be a gap between the mounting assembly and the wall of the device and / or optical assembly, which can allow the transmission of pneumatic excitation.

[0113] The speculum can include an exit hole 540. In some cases, the diameter of the exit hole can be less than 10 mm. The diameter of the exit hole can be 2 mm to 8 mm. In some cases, the transducer can be located near the distal end of the speculum. For example, the transducer can be between 1.5 cm and 1 mm from the exit hole 540. The speculum can include an outer diameter that is sized and shaped to fit the patient's external auditory canal.

[0114] The speculum 500 may include an interface 554 for connecting to the durable portion. The interface may be light-tight. The interface may be airtight. Airtightness may help transmit pneumatic excitation from a pressure source to a target along a pneumatic axis. The interface may include one or more alignment guides (e.g., 556, 557, 558, 559). The alignment guide may help form an electrical connection and / or an optical connection. The radial alignment guide may include a raised portion or a lowered portion that may be used to align the speculum radially with the durable portion. For example, the radial alignment guide 557 may provide an external indication of the radial alignment of the speculum. For example, the radial alignment guide 556 may provide an internal, releasable stop for rotation. The radial alignment guide 558 may help to quickly release the speculum. The quick release may be engaged and / or disengaged by an external mechanism such as a twisting mechanism or a pulling mechanism. The axial alignment guide may include a raised portion or a lowered portion that may be used to align the speculum axially with the durable portion. For example, axial alignment guide 559 may fit into a groove in the durable portion to facilitate tactile sensing of the seal. For example, alignment guide 556 may also serve as an axial alignment guide.

[0115] Figure 5A A detailed view of an exemplary distal tip of a speculum 500 is shown according to some embodiments. The distal tip may include an ultrasonic transducer 510 on a transducer package base 511. The package base may be mounted on a plate 512. The plate 512 may include an optically transparent portion. One or more optical fibers with the speculum may transmit light from the proximal portion of the speculum to the distal tip of the speculum. The light may propagate to a target. The light may be reflected from the target into the central lumen of the speculum through the exit hole 540. The light may be received from the target through the exit holes 540 around the transducer 510 and through the transparent portion of the plate 512. The pneumatic excitation may be transmitted from the lumen of the speculum through one or more pneumatic holes 515. The pneumatic excitation may be small enough to avoid causing separation of the plate 512.

[0116] Figure 5ADimensions 501 and 503 are also shown. Dimension 501 may include the distance spanned by the central obstacle measured perpendicular to the optical axis. The central obstacle may be a transducer package base. In some embodiments, the substrate is arranged on a carriage material, which may be part of the base. The base may allow the ultrasonic transducer to be mounted on a device of the present disclosure. For example, the base may be mounted on the tip of a speculum described elsewhere herein. The base may include electrical connections, such as wiring, through holes, etc., to conduct electrical signals from the ultrasonic transducer to a digital processing device. The base may protect the ultrasonic transducer. The base may reinforce the substrate of the ultrasonic transducer and / or provide additional support for the substrate of the ultrasonic transducer. The base may include a portion of a wafer on which the ultrasonic transducer is manufactured. The package base may be a square with a size of 0.1 to 3 mm on each side. The package base may be a rectangle with sides of 0.1 to 4 mm and 0.1 to 4 mm. The package base may be a circle with a diameter of 0.1 to 3 mm.

[0117] Dimension 503 may comprise a maximum dimension of aperture 550. Aperture 550 may comprise a circle, an ellipse, a regular polygon, an irregular shape, etc. Aperture 550 may comprise a maximum distance of 0.2 to 10 mm, 1 mm to 8 mm, or 2 mm to 5 mm, measured along an axis perpendicular to the focal axis. Dimension 503 may be less than 5 mm. Dimension 503 may be sized and shaped to fit within an ear of a subject.

[0118] Dimension 501 may be smaller than dimension 503. The central obstruction may subtend a solid angle within aperture 550 that is less than 90% of the solid angle subtended by aperture 550, measured from the farthest lens of the optical assembly. In some cases, dimension 501 is approximately 75% of dimension 503. In some cases, dimension 501 is approximately half of dimension 503. In some cases, dimension 501 is 20% to 80% of dimension 503. In some cases, the exit aperture has an active area of ​​approximately 70% and a blockage area of ​​approximately 30%. In some cases, the blockage area of ​​the exit aperture is less than approximately 75%. In some cases, the transducer may be set back from the exit aperture by approximately 2 mm or less. The blockage area at the exit aperture may include a projection of the blockage area on the aperture plane.

[0119] Figure 6BA side cross-sectional view of a transducer mounting assembly 600 according to some embodiments is shown. The transducer mounting assembly 600 may provide an attachment mechanism for the transducer 510. The mounting assembly 600 may include a body portion 616. The mounting assembly 600 may include a surface on which a plate 512 is attached and may include a portion of the body 616. In some cases, the plate 512 may also be connected to the transducer package base 511. The ultrasonic transducer 510 may be a capacitive micromachined ultrasonic transducer, which may be mounted on the package base 511. In the example shown, the mounting assembly 600 may center the transducer 510 within the focal axis. The mounting assembly 600 may include one or more holes 515, which may allow the transmission of pneumatic excitation. In some cases, there may be a gap between the mounting assembly and the wall of the device and / or optical assembly, which may allow the transmission of pneumatic excitation. The conductive portion may be electrically connected to the ultrasonic transducer and the digital processing device described herein. The electrical connection may include one or more wires 516.

[0120] Fig. 6A A front view of the distal end of a transducer mounting assembly 600 according to some embodiments is shown. In the illustrated embodiment, the transducer mounting assembly 600 may include a body portion 616. The body portion 616 may include a fixture 630 on its outer surface. One or more fixtures may hold the transducer mounting assembly in place within the speculum. The body portion 616 may include one or more grooves 661. For example, a distal portion of one or more optical fibers may be disposed within the groove 661. Light may be transmitted from the distal end of one or more optical fibers near the distal end of the transducer mounting assembly. The body portion 616 may include a conductive portion. The assembly 600 shows an extended tail portion having an electrical interface 614. The interface 614 may make electrical contact with a durable portion of the device disclosed herein. The interface 614 may include contacts 614a and 614b.

[0121] Fig. 6AA view of an ultrasonic transducer 510 on a transducer package base 511 is also shown. The transducer 510 may include a plurality of ultrasonic transducer elements arranged in a circle on the package base 511. The package base may include one or more electrical contact pads (e.g., 613a, 613b, 613c, 613d). The electrical contact pads may be connected to one or more electrical contact pads of the transducer mounting assembly via conductors (e.g., 516a and 516b). The transducer mounting assembly 600 may include one or more electrical contact pads (e.g., 621a, 621b, 621c, 621d). The electrical contact pads may be electrically connected to electrical contacts on the surface of the transducer 610. The plate 512 may be substantially insulated. The electrical contact pads may be connected to a conductive portion of the transducer mounting assembly, which may be releasably electrically connected to a digital processing device as described elsewhere herein. The plate 512 may not completely cover the distal end of the transducer mounting assembly. As shown, the transducer mounting assembly may include pneumatic apertures 515 that may allow a gas (eg, air) to pass around the ultrasound transducer.

[0122] Fig. 7A A side cross-sectional view of a detector assembly 700 is shown according to some embodiments. Figure 7B Shows Fig. 7A 700 is a side view of a detector assembly according to some embodiments. Detector assembly 700 may include detector 730. Detector 730 may be aligned to receive an image from an optical assembly of the present disclosure. Detector 730 may translate along axis 701. Axis 701 may be parallel and / or coaxial with the focal axis of the optical assembly. Detector 730 may be mounted on a detector board 732. Detector board 732 may provide a mechanical and electrical interface between the detector and a digital processing device as described elsewhere herein. Conductor 734 may conduct electrical signals between detector 730 and the digital processing device.

[0123] Detector 730 can be mechanically translated. In some cases, detector 730 can be mounted on a mechanical actuator. The mechanical actuator can be configured to translate detector 730 to adjust the focus of the optical assembly. For example, the mechanical actuator can include a motor 752. The motor can include a stepper motor. The motor can turn screw 742, which translates the detector. In some cases, the mechanical actuator can be controlled by a user. In some cases, the mechanical actuator is automatically controlled (e.g., by a computer program configured to find the focus). A translatable detector can be used with an optical assembly having a fixed lens; however, a translatable detector can also be used in a system having a movable lens. The image from detector 730 can be processed, modified, or corrected by a digital processing device.

[0124] In some cases, the detector 730 cannot be removed from the device. In an embodiment without a detector, the user's eyes may not be fully aligned with the transmission axis of the ultrasonic energy. In the case where the user manually aligns the device with the target, this is not ideal. If the user's eyes are not aligned with the transmission axis of the ultrasound, the ultrasound can be improperly aimed. The detector installed in the device can center the focal axis along the ultrasound transmission axis. The detector installed in the device can improve the alignment of the ultrasound and optical excitation on the target. For example, a detector installed and centered on the focal axis of the optical component can be used as a reference and / or can be a sufficient reference for the propagation axis of the ultrasound excitation. The ultrasound can be aimed by placing the target at the center of the detected optical image, and the ultrasound can be coaxial with the focal axis. The optical image can be used as an indicator of ultrasound propagation. In addition to aligning the amplitude of the reflected ultrasound signal, the optical image can also be used. Alignment aids on a display visible to the user can further help align the ultrasound excitation. Since the ultrasound excitation is not visible to the user, improved alignment is important. The detector 730 can be removably coupled to the device disclosed herein using an accessory 754. In some cases, detectors may be removed for prototyping, alignment, etc., and replaced for long-term use.

[0125] Fig. 8A A side cross-sectional view of an interface 800 for receiving a speculum is shown according to some embodiments. Figure 8B Shows Fig. 8A 800 is a side view of an interface for receiving a speculum according to some embodiments. The interface 800 may include a tapered distal end sized and shaped to receive a speculum of the present disclosure. The interface 800 may include a proximal end 810 engageable with a device body (not shown). The interface 800 includes a surface 851 engageable with a speculum of the present disclosure. In some cases, there may be a gap between the interface surface and the speculum surface to facilitate transmission of pneumatic excitation.

[0126] Interface 800 can facilitate removable coupling of a speculum. Interface 800 includes actuator 860. Actuator 860 can rotate along axis 861 to lock and / or release the speculum. Interface 800 can include one or more alignment guides (e.g., 859, 861) that can facilitate attachment of the speculum. For example, groove 859 can engage with alignment guide 559 of speculum 500 to axially align the speculum. For example, groove 861 can engage with an elevated portion of the speculum corresponding to one or more optical fibers. Groove 861 can provide rotational alignment of the speculum.

[0127] The interface 800 can allow for the transmission of pneumatic excitation from the device body to the distal end of the speculum. The interface 800 shows a tube fitting 870 that can be connected to a pressure source within the device body. In some cases, the pneumatic excitation is transmitted from the fitting 870 to the interior of the interface and out through the distal end of the interface. In some cases, the pneumatic excitation is transmitted through the housing 810, through the passage behind the groove 859, along the inner surface of the speculum and partially through the hole 873 toward the distal tip of the speculum.

[0128] The interface 800 can allow for the transmission of electrical signals to and from the device body and the speculum. In the illustrated embodiment, the distal end of the interface 800 includes a communication nose cone and an electrical connector 814. For example, the electrical connector 814 can receive the electrical interface 614 of the transducer mounting assembly 600. The electrical connector 814 can be connected to a digital processing device via a wire 815.

[0129] As disclosed herein, the interface 800 can provide mechanical support for one or more mirrors of the optical assembly. In the illustrated embodiment, the interior of the interface 800 includes a socket 822 and a socket 824. The sockets 822 and 824 can receive the first and second lenses of the optical assembly. Fig. 8A Also shown is a display attachment 754, which can allow the detector assembly 700 to be connected to the interface 800. Also shown are guide posts 756, which can help stabilize the translation of the detector 730.

[0130] Fig. 9 is a side cross-sectional view of an exemplary speculum coupled to an interface according to some embodiments. Fig. 9 A speculum 500 is shown connected to an interface 800 according to some embodiments. The speculum 500 can be releasably connected to the interface 800. The locking and / or release of the speculum 500 can be actuated by an actuator 860. The interface 800 can be mechanically connected to the device body at a proximal portion 810. The interface 800 can be electrically connected to the device body at 815, and the interface 800 can be pneumatically connected to the device body at 870. Light, ultrasound, and gas can be transmitted from the device body to the target through the distal end 550. Light, ultrasound, and gas can be received from the target to the device body through the distal end 550.

[0131] Fig. 9 An exemplary arrangement of optical components in an interface of the present disclosure is shown. For example, the first lens 322 and the second lens 324 can be aligned on a co-linear focal axis. The focal axis of the optical component can be substantially aligned with the central axis of the retractor. Fig. 9Optional lenses 326, 328, and 329 and an image plane 330 are shown. As shown, the reflex device includes an ultrasonic transducer 310 on a plate 312. The ultrasonic transducer 310 may be configured to transmit ultrasonic signals and / or receive ultrasonic signals along an ultrasonic axis. The ultrasonic transducer 310 may be located on the focal axis of the optical assembly. In some cases, the ultrasonic transducer 310 may block light propagating along the focal axis of the optical assembly. The plate 312 may be located on the focal axis of the assembly. The plate 312 may be transparent or partially transparent to light propagating along the focal axis of the device. The ultrasonic transducer 310 may include an embodiment, variant, or example of an ultrasonic transducer disclosed herein.

[0132] Fig.11 1 is a side view of an exemplary device 1100 including an interface 1300 for receiving a speculum 400 according to some embodiments. The speculum 400 may include a transparent core that may be used as a light guide. The transparent portion may be configured to conduct light by total internal reflection. Light may be incident at a proximal portion of the frustoconical shell. As shown, the optical assembly includes a first lens 422, a second lens 424, a third lens 426, a fourth lens 428, and a fifth lens 429. The lenses may include focal axes that are substantially coaxially aligned. As shown, the device includes an ultrasonic transducer 410. Fig.13 An interface 1300 is shown connected to a pneumatic subsystem 1360 according to some embodiments. The pneumatic subsystem 1360 can be within a body portion of the device. In some examples, the interface 1300 can be connected to the speculum 400.

[0133] Fig.12 1 is a side view of an exemplary device 1200 connected to a speculum including a light guide and a light insertion point according to some embodiments. As shown, the speculum 400a may include a transparent core that can be used as a light guide. The transparent portion may be configured to conduct light by total internal reflection. Light may be incident at an injection point on the interior of the frustoconical shell. Optical fiber 1260 may connect a light source inside the device to the insertion point. As shown, the device includes an ultrasonic transducer 1210. As shown, the optical assembly includes a first lens 1222, a second lens 1224, and a relay lens assembly 1220. The lenses may include focal axes that are substantially coaxially aligned. The relay lens assembly may invert images from the first lens 1222 and the second lens 1224. The relay lens may include a viewing port 1221 that allows a user to observe an image transmitted by the optical assembly. Fig.12 Also shown is a port 1270 that can allow pressure stimulation to be conducted to the distal tip of the speculum 400a.

[0134] Fig. 10AA side view of an example of a device body coupled to an interface and a speculum according to some embodiments is shown. Device 1000 may include a handle portion 1010. Device 1000 may include and / or be attached to interface 800. Speculum 500 may be connected to interface 800. Actuator 860 may lock and / or release speculum 500. Device 1000 may include a control mechanism within handle portion 1010, which may include a digital processing device. Reference Fig. 10B The control mechanisms of the various components of the device are described in more detail.

[0135] Fig. 10B A schematic diagram of a device body 1000 according to some embodiments is shown. The device 1000 may include a pneumatic driver 1071 in the device body. In some instances, the pneumatic driver may be an excitation generator. The excitation generator may be operated by an operator to apply force to a membrane or surface, an air bag, an exhaust generator that generates alternating pressure, a step pressure, or an air puff. The output of the excitation generator may be a gas, such as the atmosphere or other suitable gas. In some instances, the excitation generator or the pneumatic driver is a voice coil actuator. In some instances, the excitation generator may generate acoustic excitation, infrasonic excitation, or ultrasonic excitation. For example, the excitation generator may generate an infrasonic frequency lower than 20 Hz, an audio frequency of 20 Hz to 20 kHz, or an ultrasonic frequency higher than 20 kHz. In one instance, acoustic excitation, infrasonic excitation, or ultrasonic excitation may be generated by a piezoelectric transducer. The piezoelectric transducer may convert an electrical signal into a physical displacement, which in turn may cause a pressure wave. In one example, sonic excitation, infrasonic excitation, or ultrasonic excitation may be generated by a capacitive micromachined ultrasonic transducer.

[0136] The device 1000 may include a pressure sensor 1073. The pressure sensor may be used to track the frequency and / or intensity of the pneumatic excitation. The pressure sensor may be used to determine whether the pneumatic excitation is occurring. The pressure sensor may be used to determine whether the pressure in the body cavity is becoming too high and / or to prevent the pressure in the body cavity from becoming too high. Excessive pressure may be an unsafe pressure for the subject. The pressure sensor may include quality control parameters. For example, if the pressure around the pneumatic excitation increases below a threshold, the digital processing device may remind the user to re-measure.

[0137] Device 1000 may include light source 1061. The light source may include an LED. The light source may include a laser. The light source may include a light bulb. The light source may include an optical fiber that terminates outside the housing and collects ambient light. Device 1000 may include a drive circuit for an optical assembly 1063. The drive circuit for the optical assembly may include a motor controller for a movable lens and / or a display assembly. The drive circuit for the optical assembly may include a display control circuit.

[0138] The device 1000 may include a transducer drive circuit 1050. In some cases, the transducer drive circuit may be integrated with an onboard digital processing device 1090 or a microprocessor 1091 as described herein. The transducer drive circuit 1050 may control the transducer elements and the ultrasonic transducer as described in various aspects herein. For example, the transducer drive circuit 1050 may provide a drive waveform for the ultrasonic transducer. For example, the transducer drive circuit 1050 may provide a drive waveform for the excitation device. For example, the transducer drive circuit 1050 may receive a waveform from the transducer corresponding to an ultrasonic signal reflected from the device.

[0139] The device 1000 may include a digital processing device 1090 as described elsewhere herein. For example, 1000 may include a microprocessor 1092 that may control various aspects of the device 1000, including the pneumatic driver 1071, the pressure sensor 1073, the optical driver 1063, the light source 1061, and the transducer driver 150. The microprocessor 1092 may be connected to an analog front end 1091 that may include an onboard PCB that includes connectors for various components. The digital processing device 1090 may be connected to a display 1080 that is viewable by a user.

[0140] Fig.14 A transparent perspective view of an exemplary device body 1400 that may include an eyepiece according to some embodiments is shown. The device 1400 may include an interface 1200 as described above. The interface 1200 may include an optical relay system 1220. The interface 1200 may be releasably connected to the speculum 400a. The device 1400 may include a Fig. 10B The various subsystems described in .

[0141] The device 1400 may include a pneumatic driver 1472 and an associated drive circuit 1471 within the device body. In some instances, the pneumatic driver may be an excitation generator. The excitation generator may be an airbag that is operated by an operator to apply force to a membrane or surface, an exhaust generator that produces alternating pressure, step pressure, or an air puff. The output of the excitation generator may be a gas, such as atmosphere or other suitable gas. In some instances, the excitation generator or pneumatic driver is a voice coil actuator. In some instances, the excitation generator may generate acoustic excitation, infrasonic excitation, or ultrasonic excitation. For example, the excitation generator may generate an infrasonic frequency below 20 Hz, an audio frequency between 20 Hz and 20 kHz, or an ultrasonic frequency above 20 KHz. In one instance, acoustic excitation, infrasonic excitation, or ultrasonic excitation may be generated by a piezoelectric transducer. A piezoelectric transducer may convert an electrical signal into a physical displacement, which in turn may cause a pressure wave. In one instance, acoustic excitation, infrasonic excitation, or ultrasonic excitation may be generated by a cMUT transducer. The device 1400 may include a pressure sensor 1473. The pressure may be used to track the frequency and / or intensity of the pneumatic excitation.

[0142] Device 1400 may include a light source 1461. The light source may include an LED. The light source may include a light bulb. The light source may include an optical fiber that terminates outside the housing and collects ambient light. Device 1400 may include a driver circuit for the optical assembly. The driver circuit for the optical assembly may include a motor controller for the movable lens and / or display assembly.

[0143] The device 1400 may include a transducer drive circuit. In some cases, the transducer drive circuit may be integrated with an onboard digital processing device 1490 or a microprocessor 1491 as described herein. The transducer drive circuit may control the transducer elements and ultrasonic transducers of various aspects as disclosed herein. For example, the transducer drive circuit may provide a drive waveform for an ultrasonic transducer. For example, the transducer drive circuit may provide a drive waveform for an excitation device. For example, the transducer drive circuit may receive a waveform from the transducer corresponding to an ultrasonic signal reflected from the device.

[0144] The device 1400 may include a digital processing device 1490 as described elsewhere herein. For example, 1400 may include a microprocessor that may control various aspects of the device 1400. The microprocessor may be connected to an analog front end 1491 that may include an onboard PCB that includes connectors for various components.

[0145] Fig.15A and Fig. 15BPerspective and rear views of various examples of housings according to some embodiments are shown, respectively. Device 1000 is shown as exemplary devices 1001, 1002, and 1003. The device may include a screen that can display a real-time image of a target to a user. The screen may display a crosshair or aiming aid. The screen may display real-time ultrasound data. The screen may display real-time optical data. The display may include one or more buttons. The display may include a touch screen. The housing may include a variety of profiles and shapes.

[0146] The devices, otoscopes, specula, and methods of use and manufacture thereof as disclosed herein can be used to characterize a surface. The surface can be a biological membrane, such as a tympanic membrane. Pneumatic excitation can change the response of the membrane to ultrasonic excitation. For example, pneumatic excitation can cause the membrane to deflect, which can change the phase of the reflected ultrasound relative to a membrane not exposed to the pneumatic excitation. The deflection of the membrane can include damped simple harmonic motion. The motion can be affected by changes in the elasticity of the membrane. For example, if water, bacterial growth, or other foreign matter is adjacent to the membrane, the membrane elasticity may change.

[0147] Surface characterization methods applicable to the present invention are also described in U.S. Patent Publication No. 2018 / 0310917 and U.S. Patent Publication No. 2017 / 0014053, the entire contents of which are incorporated herein by reference.

[0148] In some examples, pneumatic excitation can produce movement of a surface or membrane within a certain time interval. The interval can be consistent with the sound wave transmitted to the surface or membrane by the ultrasonic transmitter. Pneumatic excitation can be continuous, can be pulsed, and so on. The ultrasound reflected from the surface can be received at the transducer. The transducer can be the same transducer that produces the incident sound wave. The displacement of the surface or membrane can be related to the phase change of the received signal (compared with the transmitted signal). The movement of the membrane can affect the phase change of the received ultrasound. The displacement can change with time. Analysis of the time displacement of the surface or membrane can be used to determine the mechanical properties of the surface or membrane, such as measured by the phase shift of the reflected ultrasound in response to the pneumatic excitation coupled to the surface or membrane.

[0149] Analysis of the time information can be used in conjunction with time displacements measured from templates of other membrane responses to create comparisons. Analysis of the time information can be used in conjunction with other metrics associated with the delay of the reflected ultrasound amplitude that characterizes the response of the surface or membrane. The measured mechanical properties can include ductility, elasticity, hardness, etc. Non-contact measurements of mechanical properties of the membrane surface or fluid below the membrane surface can be determined.

[0150] In some embodiments, the elasticity of the surface can be measured. The phase and / or amplitude of the ultrasound reflected from the membrane can be analyzed to generate elasticity metrics. Elasticity measurements can characterize a series of measurements in response to an applied excitation. Elasticity metrics can be derived from the response of the surface and can provide one or more indications of several different phenomena. For example, elasticity metrics can indicate whether the surface adjacent to the membrane has a gaseous boundary or a fluid boundary. For example, if the membrane has a fluid boundary, the membrane may move less, move slower, or not move at all. In one example, for the case of characterizing the fluid behind the membrane, elasticity metrics can indicate the extent or characteristics of the fluid boundary, fluid. In some examples, elasticity metrics can be used to measure the characteristics of elastic fluids with or without response hysteresis. In a fluid with a hysteresis response, the fluid may exhibit an offset in the displacement response or "memory" so that the response behavior in one direction is similar to the response behavior in the opposite direction, but only after a specific displacement distance. For a hysteresis response, it may be necessary to characterize the linear behavior of the response after a specific measured displacement associated with the system hysteresis. Fluid elasticity metrics can be determined based on the characteristic response of the surface or membrane to the surface excitation and the ultrasonic characterization of the reflection.

[0151] In some embodiments, the surface deflection can be estimated. For example, the estimate of the surface deflection can be derived from an estimate measured by velocity, acceleration, or any other relevant measure of the change in deflection over time. For example, a displacement of the surface will cause the path from the transducer to the surface to be shortened, and the reflected signal from the surface back to the transducer will return with a phase shift. Therefore, the phase shift of the reflected ultrasound relative to the excitation gives information about the amount of deflection. Using the estimate of the force applied by the excitation, an estimate of the elasticity of the membrane can be estimated.

[0152] In one example, the excitation is a step or impulse response with a rising edge, a falling edge, or an impulse excitation. The impulse excitation causes an oscillatory deflection of the membrane. The reflected ultrasound can be measured based on the time from the excitation to the damping period of the membrane oscillation. In some embodiments, the elasticity or viscosity can be estimated by examining the ringing characteristics. For example, the ringing characteristics can include at least one of an exponential decay time or a ringing period interval or frequency, for example, decomposing the response into a ringing characteristic, such as:

[0153] φ(t)=e -t / τ cos(2πft)

[0154] in:

[0155] φ(t) is the capture phase of a series of measurements;

[0156] τ is the exponential decay coefficient;

[0157] f is the ringing cycle frequency; and

[0158] t is time.

[0159] The damping constant of the oscillator may be related to the energy lost from the membrane to the surrounding environment. In one example, if the membrane is adjacent to a fluid, the fluid may dampen the oscillations of the membrane. The viscosity of the fluid may be related to the damping of the oscillator. The ringing cycle frequency may be related to the restitution constant of the elastic membrane. The restitution constant may be related to the elasticity of the membrane. The restitution constant may be related to the viscosity of the fluid adjacent to the membrane. The lower the viscosity of the fluid adjacent to the membrane, the higher the ringing cycle frequency may be.

[0160] Each excitation event may cause a new deflection of the membrane. For example, a pulse excitation may pull the membrane in or push it out for a limited time. For example, a square wave excitation may pull the membrane in or push it out for a longer time. For example, a sine wave or other more complex excitation may be applied, and the ringing observed at the transducer may be the cross-correlation of the excitation field and the response field.

[0161] Fig.19 is a flow chart of an exemplary method of using an otoscope according to some embodiments. In operation 1910, the method 1900 of using an otoscope may include directing optical illumination at a target. In operation 1920, the method 1900 of using an otoscope may include directing pneumatic excitation at a target. In operation 1930, the method 1900 of using an otoscope may include directing ultrasound at a target, wherein the ultrasound co-propagates with the optical illumination. In operation 1940, the method 1900 of using an otoscope may include a detector receiving the optical illumination reflected from the target. In operation 1950, the method 1900 of using an otoscope may include measuring the response of the target to the pneumatic excitation in the reflected ultrasound. In operation 1960, the method 1900 of using an otoscope may include determining a state or condition of a subject based on the reflected optical illumination and the response.

[0162] Operation 1960 of the film may include using one or more optical characteristics of the film, such as the color of the film, the presence of visible fluid or bubbles behind the surface, visible effusion, visible inflammation, etc.

[0163] Although the above operations illustrate method 1900 of using an otoscope according to some embodiments, those of ordinary skill in the art will recognize many variations based on the teachings described herein. These steps can be completed in any order. Steps can be added or deleted. Some steps may include sub-steps. Multiple steps may be repeated as much as is beneficial to the characterization of the surface.

[0164] One or more steps of method 1900 may be performed using circuits described herein, such as one or more of a digital processing device or processor or logic circuits (e.g., programmable array logic for a field programmable gate array). The circuits may be programmed to provide one or more steps of method 1900, and the programming may include program instructions stored on a computer readable memory or programming steps of logic circuits (e.g., programmable array logic or a field programmable gate array).

[0165] Fig. 20 is a flow chart of an exemplary method of using optical and ultrasonic devices according to some embodiments. In operation 2010, the method 2000 of using an otoscope may include directing optical illumination at a target. In operation 2020, the method 2000 of using an otoscope may include directing ultrasound at a target. In operation 2030, the method 2000 of using an otoscope may include receiving ultrasound reflected from a target. In operation 2040, the method 2000 of using an otoscope may include adjusting the focus of the optical illumination based on the received reflected ultrasound, wherein the adjustment is performed substantially in real time.

[0166] For example, Fig. 20 The illustrated method 2000 may further include calculating image sharpness, calculating a derivative of the image sharpness, and adjusting focus based on the image sharpness. The operation of adjusting the focus may include translating one or more reflectors. The operation of adjusting the focus may include translating a detector. Calculating the image sharpness may include calculating a gradient. Calculating the image sharpness may include an edge finding algorithm. The image sharpness may include part of a feedback loop for image focusing. The calculation of the image sharpness may include calculating a derivative and then calculating the square or magnitude of the derivative. The calculation of the image sharpness metric may include an average of the derivative values ​​at edge boundaries and / or the magnitude of the derivative.

[0167] Although the above operations illustrate the method 2000 using optical and ultrasonic devices according to some embodiments, those of ordinary skill in the art will recognize many variations based on the teachings described herein. These steps can be completed in any order. Steps can be added or deleted. Some steps may include sub-steps. Multiple steps may be repeated as much as possible, as long as it is beneficial to the characterization of the surface.

[0168] One or more steps of method 2000 may be performed using circuits described herein, such as one or more of a digital processing device or processor or logic circuits (e.g., programmable array logic for a field programmable gate array). The circuits may be programmed to provide one or more steps of method 2000, and the programming may include program instructions stored on a computer readable memory or programming steps of logic circuits (e.g., programmable array logic or a field programmable gate array).

[0169] Fig.171 is a flow chart of an exemplary method of manufacturing a speculum according to some embodiments. Aspects of the present disclosure provide a method 1700 of manufacturing a speculum. The speculum may be disposable in the ear. Operation 1710 of the method may include providing a transducer. Operation 1720 may include providing a plate or substrate. Operation 1730 may include mounting the transducer on the plate or substrate. Operation 1740 may include providing a support. Operation 1750 may include mounting the plate or substrate on a support including a conductive portion, wherein when the support is mounted, the support has a pneumatically clear path. The support may be a transducer mounting assembly as disclosed herein. Operation 1760 may include providing a speculum. Operation 1770 may include assembling the support in an inner cavity of the speculum, wherein the transducer is centered in the inner cavity of the speculum, wherein when the transducer is located in the inner cavity, the speculum has an optically clear path.

[0170] A method of manufacturing a speculum may include: mounting an ultrasonic transducer on a substrate; mounting the substrate on a support including a conductive portion, wherein the support has a pneumatically clear path when the support is mounted; and mounting the support in an inner cavity of the speculum, wherein the transducer is centered in the inner cavity of the speculum, wherein the speculum has an optically clear path when the transducer is located in the inner cavity.

[0171] Although the above operations illustrate a method 1700 of manufacturing a speculum according to some embodiments, those of ordinary skill in the art will recognize many variations based on the teachings described herein. These steps can be completed in any order. Steps can be added or deleted. Some steps may include sub-steps. Multiple steps may be repeated as much as possible, as long as it is beneficial to the characterization of the surface.

[0172] One or more steps of method 1700 may be performed using circuits described herein, such as one or more of a digital processing device or processor or logic circuits (e.g., programmable array logic for a field programmable gate array). The circuits may be programmed to provide one or more steps of method 1700, and the programming may include program instructions stored on a computer readable memory or programming steps of logic circuits (e.g., programmable array logic or a field programmable gate array).

[0173] In some embodiments, the devices, specula, otoscopes, and their use and manufacture described herein include digital processing devices or their uses. For example, digital processing devices can be used to control the devices and methods of various aspects disclosed herein. For example, the digital processing device can adjust the position of one or more optical elements; can control the operation of the transducer, such as analog-to-digital conversion of the received ultrasound signal, provide waveforms, etc.; can process one or more images received by the detector; can provide instructions to the user to adjust the steering of the device; can control the application of pneumatic excitation; can measure the pressure of the biological cavity; can provide an indication of the quality of the airtightness; and so on.

[0174] The digital processing device may include an onboard microprocessor.In some cases, the digital processing device may be connected to the onboard digital processing device via a wireless link.

[0175] Digital processing devices 1090 and 1490 may include embodiments, variations, or examples of digital processing devices disclosed herein, including, for example, Fig.18 Device 1801 in.

[0176] In other embodiments, the digital processing device includes one or more hardware central processing units (CPUs), general purpose graphics processing units (GPGPUs), or field programmable gate arrays (FPGAs) that perform the functions of the device. In other embodiments, the digital processing device also includes an operating system configured to execute executable instructions. In some embodiments, the digital processing device may be optionally connected to a computer network. In other embodiments, the digital processing device is optionally connected to the Internet so that it can access the World Wide Web. In other embodiments, the digital processing device is optionally connected to a cloud computing infrastructure. In other embodiments, the digital processing device is optionally connected to an intranet. In other embodiments, the digital processing device is optionally connected to a data storage device.

[0177] According to the description herein, suitable digital processing devices include, as non-limiting examples, server computers, desktop computers, portable computers, notebook computers, sub-notebook computers, netbook computers, online tablet computers, set-top box computers, media streaming devices, handheld computers, Internet devices, mobile smart phones, tablet computers, personal digital assistants, video game consoles and vehicles. Those skilled in the art will recognize that a variety of smart phones are suitable for the system described herein. Those skilled in the art will also recognize that selected televisions, video players and digital music players with optional computer network connectivity are suitable for the system described herein. Suitable tablet computers include those with flip cover (booklet) construction, plate construction and convertible construction known to those skilled in the art.

[0178] In some embodiments, the digital processing device includes an operating system configured to execute executable instructions. The operating system is software, including programs and data, that manages the hardware of the device and provides services for executing application programs.

[0179] In some embodiments, the device includes a storage and / or memory device. A storage and / or memory device is one or more physical devices for temporarily or permanently storing data or programs. In some embodiments, the device is a volatile memory, and power is required to maintain the stored information. In some embodiments, the device is a non-volatile memory, and the stored information is retained when the digital processing device is not powered. In other embodiments, the non-volatile memory includes flash memory. In some embodiments, the non-volatile memory includes a dynamic random access memory (DRAM). In some embodiments, the non-volatile memory includes a ferroelectric random access memory (FRAM). In some embodiments, the non-volatile memory includes a phase change random access memory (PRAM). In other embodiments, as a non-limiting example, the device is a storage device including a CD-ROM, a DVD, a flash memory device, a disk drive, a tape drive, an optical drive, and a cloud computing-based memory. In other embodiments, the storage and / or memory device is a combination of devices such as those disclosed herein.

[0180] In some embodiments, the digital processing device includes a display to send visual information to a user. In some embodiments, the display is a cathode ray tube (CRT). In some embodiments, the display is a liquid crystal display (LCD). In other embodiments, the display is a thin film transistor liquid crystal display (TFT-LCD). In some embodiments, the display is an organic light emitting diode (OLED) display. In various other embodiments, the OLED display is a passive matrix OLED (PMOLED) or an active matrix OLED (AMOLED) display. In some embodiments, the display is a plasma display. In other embodiments, the display is a video projector. In other embodiments, the display is a combination of devices such as those disclosed herein.

[0181] In some embodiments, the digital processing device includes an input device for receiving information from a user. In some embodiments, the input device is a keyboard. In some embodiments, the input device is a pointing device, which includes, as a non-limiting example, a mouse, a trackball, a trackpad, a joystick, a game controller, or a stylus. In some embodiments, the input device is a touch screen or a multi-touch screen. In other embodiments, the input device is a microphone to capture voice or other sound input. In other embodiments, the input device is a camera or other sensor to capture motion or visual input. In other embodiments, the input device is a Kinect, Leap Motion, etc. In other embodiments, the input device is a combination of devices such as those disclosed herein.

[0182] Reference Fig.18In a specific embodiment, the exemplary digital processing device 1801 is programmed or otherwise configured to control the imaging components and / or instruments described herein. The device 1801 can adjust the imaging components and / or instruments of various aspects of the present disclosure, such as performing processing steps. In this embodiment, the digital processing device 1801 includes a central processing unit (CPU, also referred to herein as a "processor" and "computer processor") 1805, which can be a single-core or multi-core processor, or a plurality of processors for parallel processing. The digital processing device 1801 also includes a memory or memory location 1810 (e.g., random access memory, read-only memory, flash memory), an electronic storage unit 1815 (e.g., a hard disk), a communication interface 1820 (e.g., a network adapter) for communicating with one or more other systems, and a peripheral device 1825 (e.g., a cache, other memory, data storage, and / or an electronic display adapter). The memory 1810, the storage unit 1815, the interface 1820, and the peripheral device 1825 communicate with the CPU 1805 via a communication bus (solid line) (e.g., a motherboard). Storage unit 1815 may be a data storage unit (or data repository) for storing data. Digital processing device 1801 may be operably coupled to a computer network ("network") 1830 by means of communication interface 1820. Network 1830 may be the Internet, an internetwork and / or an extranet, or an intranet and / or an extranet in communication with the Internet. In some cases, network 1830 is a telecommunications and / or data network. Network 1830 may include one or more computer servers, which may implement distributed computing, such as cloud computing. In some cases, network 1830 may implement a peer-to-peer network by means of device 1801, which may enable a device coupled to device 1801 to act as a client or a server.

[0183] Continue to refer Fig.18 , CPU 1805 can execute a series of machine-readable instructions that can be embodied in a program or software. The instructions can be stored in a memory location, such as memory 1810. The instructions can be directed to CPU 1805, which can then be programmed to perform the methods of the present disclosure or otherwise configured to perform the methods of the present disclosure. Examples of operations performed by CPU 1805 may include acquisition, decoding, execution, and writeback. CPU 1805 may be part of a circuit (such as an integrated circuit). One or more other components of device 1801 may be included in the circuit. In some cases, the circuit is an application specific integrated circuit (ASIC) or a field programmable gate array (FPGA).

[0184] Continue to refer Fig.18, storage unit 1815 may store files, such as drivers, libraries, and saved programs. Storage unit 1815 may store user data, such as user preferences and user programs. In some cases, digital processing device 1801 may include one or more additional external data storage units, such as located on a remote server communicating via an intranet or the Internet. Digital processing device 1801 may communicate with one or more remote computer systems via network 1830. For example, device 1801 may communicate with a user's remote computer system.

[0185] Examples of remote computer systems include personal computers (e.g., laptop PCs), tablet computers (e.g., iPad, Galaxy Tab), phones, smartphones (e.g. iPhone, Android-enabled devices, ) or a personal digital assistant.

[0186] The methods described herein may be performed by machine (e.g., computer processor) executable code stored on an electronic storage location (e.g., memory 1810 or electronic storage unit 1815) of digital processing device 1801. Machine executable code or machine readable code may be provided in the form of software. During use, the code may be executed by processor 1805. In some cases, the code may be retrieved from storage unit 1815 and stored in memory 1810 for ready access by processor 1805. In some cases, electronic storage unit 1815 may be excluded and machine executable instructions may be stored in memory 1810.

[0187] The digital processing device 1801 may include or communicate with an electronic display 1835, which includes a user interface (UI) 1840. Examples of UIs include, but are not limited to, graphical user interfaces (GUIs) and web-based user interfaces. In some cases, the electronic display 1835 may be connected to the computer system 1801 via a network (e.g., via network 1830).

[0188] In some embodiments, the platforms, systems, media, and methods disclosed herein include one or more non-transitory computer-readable storage media, which use program coding including instructions that can be executed by an operating system of an optionally networked digital processing device. In other embodiments, the computer-readable storage medium is a tangible component of the digital processing device. In other embodiments, the computer-readable storage medium is optionally removable from the digital processing device. In some embodiments, the computer-readable storage medium includes, as a non-limiting example, a CD-ROM, a DVD, a flash memory device, a solid-state memory, a disk drive, a tape drive, an optical drive, a cloud computing system, and a server, etc. In some cases, the program and instructions are permanently, substantially permanently, semi-permanently, or non-temporarily encoded on the medium.

[0189] In some embodiments, the platform, system, medium and method disclosed herein include at least one computer program, or its use. The computer program includes an instruction sequence that can be executed in the CPU of a digital processing device, and the instruction sequence is written to perform a specified task. Computer-readable instructions can be implemented as program modules that perform specific tasks or implement specific abstract data types, such as functions, objects, application programming interfaces (APIs), data structures, etc. According to the disclosure provided herein, those skilled in the art will recognize that computer programs can be written in various versions of various languages.

[0190] The functionality of the computer-readable instructions may be combined or distributed as desired in various environments. In some embodiments, the computer program comprises an instruction sequence. In some embodiments, the computer program comprises a plurality of instruction sequences. In some embodiments, the computer program is provided from one location. In other embodiments, the computer program is provided from a plurality of locations. In various embodiments, the computer program comprises one or more software modules. In various embodiments, the computer program comprises, in part or in whole, one or more web applications, one or more mobile applications, one or more stand-alone applications, one or more web browser plug-ins, extensions, add-ons or attachments, or a combination thereof.

[0191] The present invention provides embodiments including but not limited to the following:

[0192] 1. A speculum operable to be placed within an ear of a subject, the speculum comprising:

[0193] a housing comprising a light-guiding element, wherein the transmitted optical illumination is by total internal reflection via the light-guiding element, wherein the housing has an internal cavity therein, and wherein the housing is configured to allow reflected optical illumination to propagate therethrough; and

[0194] An obstruction is disposed in the lumen proximate the distal end of the housing, the obstruction at least partially blocking the reflected optical illumination, wherein a maximum dimension of the obstruction is less than 75% of a minimum diameter of the lumen.

[0195] 2. The speculum of embodiment 1, wherein the obstacle comprises an ultrasonic transducer.

[0196] 3. The speculum of embodiment 2, wherein the ultrasound transducer is centered relative to the distal end of the housing.

[0197] 4. The speculum according to embodiment 2, wherein the transmission axis of the ultrasonic transducer is coaxial with the axis of symmetry of the shell.

[0198] 5. The speculum according to embodiment 1, wherein the shell is shaped like a frustoconical cone.

[0199] 6. The retractor of embodiment 1, wherein the transmission axis of the ultrasound transducer is coaxial with the optical path of the reflected optical illumination.

[0200] 7. The speculum of embodiment 1, wherein the maximum dimension is a diameter.

[0201] 8. The speculum of embodiment 7, wherein the diameter is in the range of 20% to 60% of the smallest diameter of the lumen.

[0202] 9. The speculum of embodiment 1, wherein the light-guiding element comprises one or more optical fibers adjacent to the housing.

[0203] 10. The speculum of embodiment 1, wherein a portion of the housing is configured to transmit light by total internal reflection such that the portion of the housing is a light-guiding element.

[0204] 11. The speculum of embodiment 10, wherein the housing comprises a light-guiding core.

[0205] 12. The speculum of embodiment 11, wherein the housing comprises an opaque shell.

[0206] 13. The speculum of embodiment 1, wherein the speculum is disposable.

[0207] 14. The speculum of embodiment 1, wherein the speculum is removably attached to an otoscope.

[0208] 15. The speculum of embodiment 1, wherein the speculum is removably connected to a device for measuring reflected optical and ultrasonic signals.

[0209] 16. The retractor of embodiment 15, wherein the retractor is axially aligned with the focal axis of the optical assembly when connected to the device.

[0210] 17. The speculum of embodiment 15, wherein the optical assembly includes a focal point within 12-25 mm from the distal tip of the otoscope.

[0211] 18. The speculum of embodiment 15, wherein the optical assembly comprises a depth of field greater than 0.5 mm at a distance of 12-25 mm from the distal tip of the otoscope.

[0212] 19. The speculum of embodiment 15, wherein the optical assembly comprises at least one lens.

[0213] 20. The speculum of embodiment 19, wherein the at least one lens is a relay lens.

[0214] 21. A speculum according to embodiment 20, wherein the relay lens comprises one or more concave lenses, convex lenses, plano-concave lenses or plano-convex lenses.

[0215] 22. A speculum according to embodiment 21, wherein the relay lens comprises one or more achromatic doublet lenses.

[0216] 23. A speculum according to embodiment 21, wherein the relay lens comprises one or more gradient index lenses.

[0217] 24. The speculum of embodiment 21, wherein the relay lens comprises a rod lens relay.

[0218] 25. The speculum of embodiment 19, wherein the at least one lens comprises at least two lenses forming a first telescope.

[0219] 26. The speculum of embodiment 2, wherein the ultrasound transducer is mounted on a transducer mounting assembly.

[0220] 27. The speculum of embodiment 26, wherein the transducer mounting assembly comprises one or more holes to allow transmission of pneumatic excitation around the ultrasound transducer.

[0221] 28. The speculum of embodiment 26, wherein the transducer mounting assembly is press-fit into a housing of the speculum.

[0222] 29. The speculum of embodiment 26, wherein the distal end of the transducer mounting assembly is operably connected to the transparent plate.

[0223] 30. The speculum of embodiment 29, wherein the transparent plate comprises an ultrasonic transducer mounted on a surface thereof.

[0224] 31. The speculum of embodiment 26, wherein a portion of the transducer mounting assembly is electrically conductive.

[0225] 32. The speculum of embodiment 1, wherein the maximum dimension of the ultrasound transducer is less than 2 mm.

[0226] 33. A speculum according to embodiment 4, wherein a metal shield is arranged around the ultrasound transducer, wherein the metal shield is radially displaced away from the transmission axis of the ultrasound transducer.

[0227] 34. The speculum according to embodiment 14 or 15 further comprises a pressure gauge configured to measure the internal pressure of the speculum.

[0228] 35. An apparatus for measuring reflected optical and ultrasonic signals, the apparatus comprising:

[0229] light source;

[0230] an optical assembly including at least one lens configured to focus reflected optical illumination from the target onto the detector; and

[0231] an ultrasonic transducer aligned to transmit and receive ultrasonic radiation coaxially with the reflected optical illumination, and wherein the ultrasonic transducer at least partially blocks a path of the reflected optical illumination;

[0232] Wherein the optical assembly includes a focal point within the range of 12-25 mm from the distal tip of the otoscope and a depth of field greater than 0.5 mm at a distance of 12-25 mm from the distal tip of the otoscope.

[0233] 36. The apparatus of embodiment 35, further comprising a speculum of any one of embodiments 1-32.

[0234] 37. An apparatus according to embodiment 35, wherein the ultrasound transducer is centered relative to the focal axis of the optical component.

[0235] 38. An apparatus according to embodiment 35, wherein the transmission axis of the ultrasound transducer is coaxial with the focal axis of the optical component.

[0236] 39. An apparatus according to embodiment 35, wherein the transmission axis of the ultrasound transducer is coaxial with the optical path of the reflected optical illumination.

[0237] 40. The apparatus of embodiment 35, wherein the ultrasound transducer comprises a relative size of 20%-50% of the aperture of the optical component.

[0238] 41. The apparatus of embodiment 35, wherein the light source comprises one or more optical fibers.

[0239] 42. The apparatus of embodiment 35, wherein the light source is configured to transmit light to a speculum.

[0240] 43. An apparatus according to embodiment 42, wherein a portion of the speculum is configured to transmit light by total internal reflection.

[0241] 44. The apparatus of embodiment 43, wherein the speculum comprises a light-guiding core.

[0242] 45. The apparatus of embodiment 44, wherein the speculum comprises an opaque shell.

[0243] 46. ​​The apparatus of embodiment 42, wherein the speculum is disposable.

[0244] 47. The device of embodiment 35, wherein the device is an otoscope.

[0245] 48. The device of embodiment 36, wherein the speculum is removably connected to the device.

[0246] 49. The device of embodiment 48, wherein the retractor is axially aligned with the focal axis of the optical assembly when connected to the device.

[0247] 50. An apparatus according to embodiment 35, wherein the optical component includes at least one lens.

[0248] 51. An apparatus according to embodiment 50, wherein at least one of the lenses is a relay lens.

[0249] 52. An apparatus according to embodiment 51, wherein the relay lens comprises one or more concave lenses, convex lenses, plano-concave lenses or plano-convex lenses.

[0250] 53. An apparatus according to embodiment 52, wherein the relay lens comprises one or more achromatic doublet lenses.

[0251] 54. An apparatus according to embodiment 52, wherein the relay lens comprises one or more gradient refractive index lenses.

[0252] 55. An apparatus according to embodiment 52, wherein the relay lens comprises a rod lens relay.

[0253] 56. An apparatus according to embodiment 50, wherein the at least one lens includes at least two lenses forming a first telescope.

[0254] 57. The apparatus of embodiment 35, wherein the ultrasonic transducer is mounted on a transducer mounting assembly.

[0255] 58. The apparatus of embodiment 57, wherein the transducer mounting assembly comprises one or more holes to allow transmission of pneumatic excitation around the ultrasonic transducer.

[0256] 59. The apparatus of embodiment 57 wherein the transducer mounting assembly is press fit into a housing of the speculum.

[0257] 60. The apparatus of embodiment 57, wherein the distal end of the transducer mounting assembly is operably connected to the transparent plate.

[0258] 61. An apparatus according to embodiment 60, wherein the transparent plate includes the ultrasonic transducer mounted on its surface.

[0259] 62. The apparatus of embodiment 57, wherein a portion of the transducer mounting assembly is electrically conductive.

[0260] 63. The apparatus of embodiment 35, wherein the maximum dimension of the ultrasonic transducer is less than 2 mm.

[0261] 64. An apparatus according to embodiment 35, wherein a metal shield is arranged around the ultrasonic transducer, wherein the metal shield is radially displaced away from the transmission axis of the ultrasonic transducer.

[0262] 65. The apparatus of embodiment 36 or 42 further comprising a pressure gauge configured to measure the internal pressure of the speculum.

[0263] 66. A method of using an otoscope, the method comprising:

[0264] Directing optical illumination to the target;

[0265] directing a pneumatic actuation toward the target;

[0266] directing ultrasound toward the target, wherein the ultrasound co-propagates with the optical illumination;

[0267] receiving reflected optical illumination from the target at a detector;

[0268] measuring the response of the target to the aerodynamic excitation in the reflected ultrasound; and

[0269] A state or condition of the subject is determined based on the reflected optical illumination and the response.

[0270] 67. A method according to embodiment 66, wherein the method further comprises providing an apparatus according to any one of embodiments 35 to 65.

[0271] 68. The method of embodiment 66, wherein the method further comprises providing a speculum according to any one of embodiments 1 to 34.

[0272] 69. A speculum operable to be placed within an ear of a subject, the speculum comprising:

[0273] a frustoconical shell configured to be disposed within an ear canal and comprising an interior cavity;

[0274] one or more optical fibers adjacent to the frustoconical housing and extending from a proximal opening of the frustoconical housing to a distal tip; and

[0275] An ultrasonic transducer is mounted within the frustoconical housing proximate the distal tip and aligned to transmit and receive ultrasonic radiation coaxially with the reflected optical illumination, and wherein the ultrasonic transducer at least partially blocks the path of the reflected optical illumination.

[0276] 70. The speculum according to embodiment 66 further comprises the speculum according to embodiment 1, wherein the obstruction comprises at least the ultrasound transducer, and wherein one or more optical fibers comprise a light-guiding element.

[0277] 71. The speculum according to embodiment 70 further comprises a speculum according to any one of embodiments 2-34.

[0278] 72. The speculum of any one of embodiments 69 to 71, wherein the speculum is removably attached to the device of any one of embodiments 35 to 65.

[0279] 73. The speculum of any one of embodiments 69 to 71, wherein the ultrasound transducer is centered relative to the distal end of the housing.

[0280] 74. The speculum of embodiment 73, wherein the ultrasound transducer is coaxial with the housing.

[0281] 75. The speculum of any one of embodiments 69 to 71, wherein the speculum comprises a quick release fitting.

[0282] 76. The speculum of any one of embodiments 69 to 71, wherein the diameter of the ultrasound transducer is less than 50% of the lumen of the housing at the distal opening of the housing.

[0283] 77. The speculum of any one of embodiments 69 to 71, wherein the speculum is disposable.

[0284] 78. A speculum operable to be placed within an ear of a subject, the speculum comprising:

[0285] a frustoconical shell configured to be disposed within an ear canal and configured to transmit light by total internal reflection;

[0286] An ultrasonic transducer is mounted within the frustoconical housing proximate the distal end of the frustoconical housing, wherein the ultrasonic transducer is small enough to allow reflected light to pass through the lumen of the housing.

[0287] 79. The speculum according to embodiment 78 further comprises the speculum according to embodiment 1, wherein the obstacle comprises at least the ultrasound transducer, and wherein the housing comprises a light-guiding element.

[0288] 80. The speculum according to embodiment 79 further comprises a speculum according to any one of embodiments 2-34.

[0289] 81. The speculum of any one of embodiments 78 to 80, wherein the speculum is removably attached to the device of any one of embodiments 35 to 65.

[0290] 82. The speculum of any one of embodiments 78 to 80, wherein the ultrasound transducer is centered relative to the distal end of the housing.

[0291] 83. The speculum of any one of embodiments 78 to 80, wherein the ultrasound transducer is coaxial with the housing.

[0292] 84. The speculum of any one of embodiments 78 to 80, wherein the speculum is disposable.

[0293] 85. An otoscope, comprising:

[0294] an interface releasably coupled to the speculum;

[0295] An optical assembly comprising at least one lens having an aperture, wherein the optical assembly comprises a focal point within a range of 12-25 mm from a distal tip of the otoscope and a depth of field greater than 0.5 mm at a distance of 12-25 mm from the distal tip of the otoscope;

[0296] A central obstruction along the optical path from the optical assembly to the target, wherein the central obstruction has a diameter less than 50% of the aperture.

[0297] 86. The otoscope of embodiment 85, wherein the speculum is the speculum of any one of embodiments 1-34 or 69-84.

[0298] 87. An otoscope, comprising:

[0299] a speculum having a lumen therein and comprising a light-guiding element, wherein the transmitted optical illumination is by total internal reflection via the light-guiding element, and wherein the reflected optical illumination propagates through the lumen of the speculum;

[0300] a central obstruction disposed within the speculum proximate the distal end, the central obstruction at least partially blocking reflected optical illumination; and

[0301] An optical assembly includes at least one lens having a focal length that is longer than a distance from the lens to the central obstacle.

[0302] 88. The otoscope of embodiment 87, wherein the speculum is the speculum of any one of embodiments 1-34 or 69-84.

[0303] 89. A method of using an optical and ultrasonic device, the method comprising:

[0304] Directing optical illumination to the target;

[0305] directing ultrasound toward the target;

[0306] receiving ultrasound reflected from the target; and

[0307] The focus of the optical illumination is adjusted based on the received reflected ultrasound, wherein the adjustment is performed substantially in real time.

[0308] 90. The method according to embodiment 89 also includes calculating image clarity, calculating the derivative of the image clarity, and adjusting the focus based on the image clarity.

[0309] 91. A method of manufacturing a speculum operable to be disposed within an ear, the method comprising:

[0310] mounting an ultrasonic transducer on a substrate;

[0311] mounting the substrate on a support including a conductive portion, wherein the support has a pneumatically clear path when the support is mounted; and

[0312] The support is mounted in a lumen of the speculum, wherein the transducer is centered in the lumen of the speculum, wherein the speculum has an optically clear path when the transducer is located in the lumen.

[0313] Although preferred embodiments of the present disclosure have been shown and described herein, it is readily understood by those skilled in the art that these embodiments are provided by way of example only. Without departing from the present disclosure, those skilled in the art will now expect many variations, changes and substitutions. It should be understood that various alternatives to the embodiments of the present disclosure described herein can be used to implement the embodiments of the present disclosure. It is intended that the scope of the invention be limited by the following claims, and methods and structures and their equivalents within the scope of these claims are thus covered.

Claims

1. A speculum operable to be placed within an ear of a subject, the speculum comprising: a housing including a light-guiding element, wherein the transmitted optical illumination occurs via the light-guiding element by total internal reflection, wherein the housing has an internal cavity therein, and wherein the housing is configured to allow reflected optical illumination to propagate therethrough; as well as An obstruction is disposed in the lumen proximate the distal end of the housing, the obstruction at least partially blocking the reflected optical illumination, wherein a maximum dimension of the obstruction is less than 75% of a minimum diameter of the lumen.

2. The speculum of claim 1, wherein the obstruction comprises an ultrasound transducer.

3. A device for measuring reflected optical and ultrasonic signals, the device comprising: light source; an optical assembly including at least one lens configured to focus reflected optical illumination from the target onto the detector; as well as an ultrasonic transducer aligned to transmit and receive ultrasonic radiation coaxially with the reflected optical illumination, and wherein the ultrasonic transducer at least partially blocks a path of the reflected optical illumination; Wherein the optical assembly includes a focal point within the range of 12-25 mm from the distal tip of the otoscope and a depth of field greater than 0.5 mm at a distance of 12-25 mm from the distal tip of the otoscope.

4. A method of using an otoscope, the method comprising: Directing optical illumination to the target; directing a pneumatic actuation toward the target; directing ultrasound toward the target, wherein the ultrasound co-propagates with the optical illumination; receiving reflected optical illumination from the target at a detector; measuring the target's response to the aerodynamic excitation in the reflected ultrasound; as well as A state or condition of the subject is determined based on the reflected optical illumination and the response.

5. A speculum operable to be placed within an ear of a subject, the speculum comprising: a frustoconical shell configured to be disposed within an ear canal and comprising an interior cavity; one or more optical fibers adjacent to the frustoconical housing and extending from a proximal opening of the frustoconical housing to a distal tip; as well as An ultrasonic transducer is mounted within the frustoconical housing proximate the distal tip and aligned to transmit and receive ultrasonic radiation coaxially with the reflected optical illumination, and wherein the ultrasonic transducer at least partially blocks the path of the reflected optical illumination.

6. A speculum operable to be placed within an ear of a subject, the speculum comprising: a frustoconical shell configured to be disposed within an ear canal and configured to transmit light by total internal reflection; An ultrasonic transducer is mounted within the frustoconical housing proximate the distal end of the frustoconical housing, wherein the ultrasonic transducer is small enough to allow reflected light to pass through the lumen of the housing.

7. An otoscope, comprising: an interface releasably coupled to the speculum; An optical assembly comprising at least one lens having an aperture, wherein the optical assembly comprises a focal point within a range of 12-25 mm from a distal tip of the otoscope and a depth of field greater than 0.5 mm at a distance of 12-25 mm from the distal tip of the otoscope; A central obstruction along the optical path from the optical assembly to the target, wherein the central obstruction has a diameter less than 50% of the aperture.

8. An otoscope, comprising: a speculum having a lumen therein and comprising a light-guiding element, wherein the transmitted optical illumination is by total internal reflection via the light-guiding element, and wherein the reflected optical illumination propagates through the lumen of the speculum; a central obstruction disposed within the speculum proximate the distal end, the central obstruction at least partially blocking reflected optical illumination; and An optical assembly includes at least one lens having a focal length that is longer than a distance from the lens to the central obstruction.

9. A method of using an optical and ultrasonic device, the method comprising: Directing optical illumination to the target; directing ultrasound toward the target; receiving ultrasound reflected from the target; as well as The focus of the optical illumination is adjusted based on the received reflected ultrasound, wherein the adjustment is performed substantially in real time.

10. A method of manufacturing a speculum operable to be disposed within an ear, the method comprising: Mounting the ultrasonic transducer on the substrate; mounting the substrate on a support including a conductive portion, wherein the support has a pneumatically clear path when the support is mounted; and The support is mounted in a lumen of the speculum, wherein the transducer is centered in the lumen of the speculum, wherein the speculum has an optically clear path when the transducer is located in the lumen.

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