Systems and methods for simulating a tympanic membrane

Abstract

A device for modeling characteristics of an ear is disclosed herein. The device includes an artificial eardrum and a housing coupled to the artificial eardrum. The housing defines an interior portion coupled to an interior surface of the artificial eardrum. The interior portion has an adjustable volume or adjustable type of fluid and an adjustable gas pressure. Adjustment of the fluid volume or type and gas pressure changes membrane movement to produce selected movement characteristics according to an activity scale.

Description

[0001] Cross-references

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 840,829, filed April 30, 2019, which is incorporated herein by reference in its entirety.

[0003] Statement Regarding Federally Funded Research

[0004] This invention was made with support from the U.S. Government through the Small Business Innovation Research (SBIR) program under Grant No. 1853244 (Phase II Award) from the National Science Foundation. Background Art

[0005] Otitis media (OM) is a group of inflammatory diseases of the inner ear and is the most common cause of childhood health care problems, commonly referred to as "ear infections". OM is defined as the presence of fluid accumulation in the middle ear and has the following main types: acute otitis media (AOM), otitis media with effusion (OME), chronic otitis media (COM), and chronic suppurative otitis media (CSOM). The rapid onset of infection, often accompanied by ear pain, is the hallmark of AOM middle ear effusion (MEE), while OME is not usually associated with symptoms because MEE fluid is non-infectious.

[0006] The accuracy of OM diagnosis depends on the equipment and the skill of the physician. The average misdiagnosis rate may be between 30%-50%. For example, OME may be misdiagnosed as AOM, and a retracted tympanic membrane without associated middle ear effusion may be misdiagnosed as OME. Given the misdiagnosis rate, improved devices, systems, and methods are needed for diagnosing OM. As new devices are developed, direct testing in humans may not be feasible or safe, or both.

[0007] Therefore, there is a need for improved devices, systems and methods for simulating a tympanic membrane, such as a diseased tympanic membrane, a disordered tympanic membrane or a healthy tympanic membrane.

[0008] References that may be relevant to the disclosure herein may include U.S. Patent Nos. 5,997,307, 7,771,356, 7,859,455, 10,043,415, and 10,097,923; U.S. Patent Publication No. 2019 / 0142258; Taiwan Application No. 1447681; and non-patent publications Shelton et al., Quantitative Pneumatic Otoscopy Using a Light-Based Ranging Technique, Journal of The Association for Research in Otolaryngology 18(4):555–568, 2017; Morris et al., Development and Validation of a Novel Ear Simulator To Teach Pneumatic Otoscopy, 7(1):22-26, 2012; and Diagnostic and Procedural Ear Trainer w / Pneumatic Otoscopy Kit, www.GTsimulators.com. Summary of the invention

[0009] The present disclosure relates to systems and methods for simulating a tympanic membrane. The simulated membrane can approximate the activity of the tympanic membrane during various biological states of the ear (such as a disease state or a healthy state). Implementations of the present disclosure can help develop tools for diagnosing ear disorders, such as, for example, otitis media.

[0010] In one aspect, an apparatus for modeling the characteristics of an ear including an eardrum is provided. The apparatus may include: an artificial eardrum having an ultrasonic reflectivity that mimics the ultrasonic reflectivity of a biological eardrum; and an outer shell coupled to the artificial eardrum and further defining an inner portion coupled to an inner surface of the artificial eardrum, the inner portion having an adjustable volume of fluid or an adjustable type of fluid, and the inner portion having an adjustable gas pressure.

[0011] In some embodiments, adjustment of one or more of the fluid volume, the fluid type, or the gas pressure changes membrane deflection or membrane movement to controllably mimic a disease state of the ear. In some embodiments, the adjustment of the fluid type comprises changing the viscosity of the fluid. In some embodiments, the disease state of the ear is a bacterial or viral ear infection.

[0012] In some embodiments, the shape of the artificial eardrum exhibits optical reflections from the surface of the artificial eardrum, thereby enabling positioning of the artificial eardrum and alignment of an otoscope. In some embodiments, the optical reflections are exhibited on the anterior inferior quadrant of the artificial eardrum. In some embodiments, the artificial eardrum has one or more visual cues, wherein the visual cues include at least partially exhibiting the shape of the umbilicus or malleus of the eardrum.

[0013] In some embodiments, the artificial eardrum is one or more of expandable or contractible, and is also configured to move in response to a change in applied pneumatic pressure. In some embodiments, the movement of the artificial eardrum can be adjusted according to a set of ordinal values. In some embodiments, the movement of the artificial eardrum can be adjusted according to a continuous scale. In some embodiments, the adjustment of one or more of the fluid volume, the fluid type, or the gas pressure changes the rate at which the membrane moves to controllably simulate a disease state of the ear. In some embodiments, the shell further defines an external portion, wherein the external portion includes an artificial ear canal having an approximate geometry of a human child subject or a human adult subject. In some embodiments, the internal portion includes a simulated ossicular chain coupled to the eardrum. In some embodiments, the simulated ossicular has a controllable tension. In some embodiments, the shape and hardness of the artificial eardrum are configured to simulate the presence of an ossicular chain.

[0014] In some embodiments, the interior portion includes a fluid syringe or an opening for a fluid syringe. In some embodiments, the interior portion includes an inner air valve and an inner air pump or an opening for an inner air valve and an inner air pump. In some embodiments, the interior portion includes an inner pressure gauge or an opening for an inner pressure gauge. In some embodiments, the shell also defines an outer portion that is coupled to the outer surface of the artificial eardrum. In some embodiments, the outer portion includes an outer pressure gauge or an opening for an outer pressure gauge. In some embodiments, the outer portion includes an outer air pump or an opening for an outer air pump.

[0015] In some embodiments, the apparatus of any aspect or embodiment further comprises a processor configured to control operation of one or more of: the fluid injector, the inner air valve, the inner air pump, the inner pressure gauge, the outer pressure gauge, the outer air pump, or a user-visible display. In some embodiments, the processor is configured to receive pressure data from one or more of the inner pressure gauge or the outer pressure gauge. In some embodiments, the pressure data is used to adjust one or more of: the volume of the fluid proximate the inner surface; the gas pressure proximate the inner surface; and the gas pressure proximate the outer surface.

[0016] In another aspect, a method for testing an otoscope using a model ear including an artificial eardrum is provided. The method includes: providing an artificial eardrum having an ultrasonic reflectivity that mimics the ultrasonic reflectivity of a biological eardrum; adjusting the volume or type of fluid proximate to the interior surface of the artificial eardrum; and adjusting the pressure of a gas proximate to the interior surface of the artificial eardrum.

[0017] In some embodiments, the adjustment of one or more of the fluid volume, the fluid type, or the gas pressure changes membrane deflection or membrane movement to controllably mimic a disease state of the ear. In some embodiments, adjusting the fluid type comprises changing the viscosity of the fluid. In some embodiments, the disease state of the ear is a bacterial or viral ear infection.

[0018] In some embodiments, the method further comprises aligning an otoscope to position the artificial tympanic membrane based on an optical reflection from a surface of the artificial tympanic membrane. In some embodiments, the optical reflection is presented on an anterior inferior quadrant of the artificial tympanic membrane. In some embodiments, the artificial tympanic membrane has one or more visual cues, wherein the visual cues include at least partially presenting the shape of a tympanic membrane umbilicus or a malleus.

[0019] In some embodiments, the method further comprises regulating the movement of the artificial eardrum according to a set of ordinal values. In some embodiments, the method further comprises regulating the movement of the artificial eardrum according to a continuous scale. In some embodiments, the method further comprises directing a speculum of an acoustic otoscope toward the artificial eardrum, wherein the artificial eardrum is at least one of expandable or contractible and is configured to move in response to a change in applied pneumatic pressure. In some embodiments, the regulation of one or more of the fluid volume, the fluid type, or the gas pressure changes the rate at which the membrane moves to controllably mimic a disease state of the ear.

[0020] In some embodiments, the method further comprises providing an artificial ear canal having an approximate geometry of a human child subject or a human adult subject. In some embodiments, the method further comprises adjusting tension in a simulated ossicular chain coupled to the artificial eardrum. In some embodiments, the shape and stiffness of the artificial eardrum are configured to simulate the presence of an ossicular chain.

[0021] In some embodiments, the method further comprises injecting a fluid proximate to the inner surface using a fluid injector. In some embodiments, regulating the gas pressure proximate to the inner surface comprises opening or closing an inner air valve and starting an inner air pump. In some embodiments, the method further comprises measuring the gas pressure proximate to the inner surface using an inner pressure gauge. In some embodiments, the method further comprises measuring the gas pressure proximate to the outer surface of the artificial eardrum using an outer pressure gauge. In some embodiments, the method further comprises regulating the gas pressure proximate to the outer surface of the artificial eardrum using an outer air pump.

[0022] In some embodiments, the method further comprises controlling operation of one or more of the fluid injector, the inner air valve, the inner air pump, the inner pressure gauge, the outer pressure gauge, the outer air pump, or a user-visible display using a processor. In some embodiments, the method further comprises receiving pressure data from one or more of the inner pressure gauge or the outer pressure gauge at a processor. In some embodiments, the method further comprises using the pressure data to adjust one or more of: the volume of the fluid proximate the inner surface; the gas pressure proximate the inner surface; and the gas pressure proximate the outer surface.

[0023] In another aspect, an apparatus for modeling properties of an ear including an eardrum is provided. The apparatus may include: an artificial eardrum; an outer shell coupled to the artificial eardrum and further defining an inner portion coupled to an inner surface of the artificial eardrum, the inner portion having an adjustable volume of fluid and an adjustable gas pressure; wherein adjustment of the fluid volume and the gas pressure changes membrane movement to produce selected movement properties according to a mobility scale.

[0024] In some embodiments, the activity scale is a set of ordinal values. In some embodiments, the activity scale is a continuous scale. In some embodiments, the artificial eardrum is expandable or contractible and is configured to move in response to applied pneumatic pressure changes. In some embodiments, the regulation of one or more of the fluid volume, the fluid type, or the gas pressure changes membrane deflection or membrane movement to controllably mimic a disease state of the ear. In some embodiments, the regulation of the fluid type includes changing the viscosity of the fluid. In some embodiments, the disease state of the ear is a bacterial or viral ear infection.

[0025] In some embodiments, the shape of the artificial eardrum exhibits optical reflections from the surface of the artificial eardrum, thereby enabling the artificial eardrum to be positioned and aligned with an otoscope. In some embodiments, the optical reflections are exhibited on the anterior-inferior quadrant of the artificial eardrum. In some embodiments, the artificial eardrum has one or more visual cues, wherein the visual cues include at least partially exhibiting the shape of an umbilicus or a malleus of the eardrum. In some embodiments, the shell further defines an external portion, wherein the external portion includes an artificial ear canal having an approximate geometry of a human child subject or a human adult subject. In some embodiments, the internal portion includes a simulated ossicular chain coupled to the eardrum. In some embodiments, the simulated ossicular has controllable tension. In some embodiments, the shape and hardness of the artificial eardrum are configured to mimic the presence of an ossicular chain.

[0026] In some embodiments, the interior portion includes a fluid syringe or an opening for a fluid syringe. In some embodiments, the interior portion includes an inner air valve and an inner air pump or an opening for an inner air valve and an inner air pump. In some embodiments, the interior portion includes an inner pressure gauge or an opening for an inner pressure gauge. In some embodiments, the shell also defines an outer portion that is coupled to the outer surface of the artificial eardrum. In some embodiments, the outer portion includes an outer pressure gauge or an opening for an outer pressure gauge. In some embodiments, the outer portion includes an outer air pump or an opening for an outer air pump.

[0027] In some embodiments, the device further comprises a processor configured to control operation of one or more of: the fluid injector, the inner air valve, the inner air pump, the inner pressure gauge, the outer pressure gauge, the outer air pump, or a user-visible display. In some embodiments, the processor is configured to receive pressure data from one or more of the inner pressure gauge or the outer pressure gauge. In some embodiments, the pressure data is used to adjust one or more of: the volume of the fluid proximate the inner surface; the gas pressure proximate the inner surface; and the gas pressure proximate the outer surface.

[0028] In another aspect, a method of testing an otoscope using a model ear including an artificial eardrum is provided. The method includes: providing an artificial eardrum; adjusting a volume or type of fluid proximate an interior surface of the artificial eardrum; adjusting a pressure of a gas proximate an interior surface of the artificial eardrum; wherein the adjustment of the volume or type of the fluid and the adjustment of the pressure of the gas alter membrane movement to produce a selected movement characteristic according to an activity scale.

[0029] In some embodiments, the modulation of one or more of the fluid volume, the fluid type, or the gas pressure changes membrane deflection or membrane movement to controllably mimic a disease state of the ear. In some embodiments, the disease state of the ear is a bacterial or viral ear infection. In some embodiments, the disease state of the ear is a bacterial or viral ear infection. In some embodiments, the activity scale comprises a set of ordinal values. In some embodiments, the activity scale comprises a continuous scale.

[0030] In some embodiments, the method further comprises aligning an otoscope to position the artificial tympanic membrane based on an optical reflection from a surface of the artificial tympanic membrane. In some embodiments, the optical reflection is presented on an anterior inferior quadrant of the artificial tympanic membrane. In some embodiments, the artificial tympanic membrane has one or more visual cues, wherein the visual cues include at least partially presenting the shape of a tympanic membrane umbilicus or a malleus.

[0031] In some embodiments, the method further comprises directing a speculum of an acoustic otoscope toward the artificial eardrum, wherein the artificial eardrum is at least one of expandable or contractible and is configured to move in response to a change in applied pneumatic pressure. In some embodiments, the regulation of one or more of the fluid volume, the fluid type, or the gas pressure changes the rate at which the membrane moves to controllably mimic a disease state of the ear. In some embodiments, the method further comprises providing an artificial ear canal having an approximate geometry of a human child subject or a human adult subject. In some embodiments, the internal portion comprises a simulated ossicular chain coupled to the eardrum. In some embodiments, the method further comprises adjusting the tension in the simulated ossicular chain coupled to the artificial eardrum. In some embodiments, the shape and hardness of the artificial eardrum are configured to simulate the presence of an ossicular chain.

[0032] In some embodiments, the method further comprises injecting a fluid proximate to the inner surface using a fluid injector. In some embodiments, regulating the gas pressure proximate to the inner surface comprises opening or closing an inner air valve and starting an inner air pump. In some embodiments, the method further comprises measuring the gas pressure proximate to the inner surface using an inner pressure gauge. In some embodiments, the method further comprises measuring the gas pressure proximate to the outer surface of the artificial eardrum using an outer pressure gauge. In some embodiments, the method further comprises regulating the gas pressure proximate to the outer surface of the artificial eardrum using an outer air pump.

[0033] In some embodiments, the method further comprises controlling, using a processor, operation of one or more of the fluid injector, the inner air valve, the inner air pump, the inner pressure gauge, the outer pressure gauge, the outer air pump, or a user-visible display. In some embodiments, the method further comprises receiving pressure data from one or more of the inner pressure gauge or the outer pressure gauge. In some embodiments, the method further comprises using the pressure data to adjust one or more of: the volume of the fluid proximate the inner surface; the gas pressure proximate the inner surface; and the gas pressure proximate the outer surface.

[0034] In another aspect, an apparatus for modeling characteristics of an ear including a tympanic membrane is provided. The apparatus may include: an artificial tympanic membrane; and a housing coupled to the artificial tympanic membrane and further defining an interior portion coupled to an interior surface of the artificial tympanic membrane, the interior portion having an adjustable volume or type of fluid and an adjustable gas pressure. Wherein adjustment of two or more of the fluid volume or the fluid type and the gas pressure changes membrane deflection or membrane movement to controllably mimic a disease state of the ear.

[0035] In another aspect, a method for testing an otoscope using a model ear including an artificial eardrum is provided. The method includes: providing an artificial eardrum; adjusting a volume or type of fluid proximate an interior surface of the artificial eardrum; adjusting a pressure of a gas proximate an interior surface of the artificial eardrum, wherein adjusting one or more of the fluid volume, the fluid type, or the gas pressure changes membrane deflection or membrane movement to controllably simulate a disease state of the ear.

[0036] In another aspect, a system for simulating an eardrum is provided. The system comprises: a main cavity; a membrane, wherein the membrane is supported within the main cavity, wherein the membrane separates the interior of the main cavity from the exterior of the main cavity, and wherein the membrane is secured by a membrane clip; and an elastomeric spring, wherein the elastomeric spring is coupled to the membrane and wherein the elastomeric spring is secured by a spring clip; wherein at least one of the mass of the membrane, the damping of the elastomeric spring, the spring stiffness, the pressure in the interior of the main cavity, and the amount of fluid in the interior of the main cavity is selectively controlled to simulate conditions within an ear.

[0037] Incorporation by reference

[0038] All publications, patents, and patent applications mentioned in this specification are incorporated herein 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. In the event that publications and patents or patent applications incorporated by reference conflict with the disclosure contained in this specification, this specification is intended to supersede and / or take precedence over any such conflicting material. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] The novel features of the present invention are particularly set forth in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by referring to the following detailed description and accompanying drawings (also referred to herein as "figures") which set forth illustrative embodiments in which the principles of the present invention are utilized, in which:

[0040] Figure 1A A schematic diagram of an apparatus for modeling properties of an ear is illustrated, according to some embodiments, the apparatus comprising an inner portion having a simulated ossicular chain.

[0041] Figure 1B A schematic diagram of a device for modeling properties of an ear is illustrated, the device comprising an inner portion having a simulated ossicular chain and an outer portion having a seal, according to some embodiments.

[0042] Figure 1C A schematic diagram of an apparatus for modeling characteristics of an ear is illustrated, the apparatus comprising an inner portion and an outer portion having a seal, according to some embodiments.

[0043] Figure 2 Some underlying principles related to membrane mimicry according to some embodiments are illustrated.

[0044] Figure 3A An exploded view of an example device for modeling characteristics of an ear is illustrated, the device including an inner portion and an outer portion with a seal, according to some embodiments.

[0045] Figure 3B Illustrated is a method for modeling the characteristics of an ear according to some embodiments. Figure 3A External isometric view of an example device.

[0046] Figure 3C Illustrated is a method for modeling the characteristics of an ear according to some embodiments. Figure 3A External front view of an example device.

[0047] Figure 4 Illustrated is a transparent isometric view of an example device including an interior portion having a simulated ossicular chain, according to some embodiments.

[0048] Figure 5A , Figure 5B and Figure 5C An isometric view, a front view, and a side view, respectively, of an artificial eardrum according to some embodiments are shown.

[0049] Figure 5D is an image of the exterior surface of an example artificial eardrum of the present disclosure.

[0050] Figure 6 is an illustration of an example air-liquid subsystem of an apparatus for modeling characteristics of an ear, according to some embodiments.

[0051] Figure 7 is a diagram of an example electrical subsystem of an apparatus for modeling characteristics of an ear, according to some implementations.

[0052] Figure 8 Illustrated is a top view of an example air-liquid subsystem of an apparatus for modeling properties of an ear, according to some embodiments.

[0053] Fig. 9 is a photograph of a device connected to an air-liquid subsystem for modeling properties of an ear, according to some embodiments.

[0054] Fig.10 Illustrated is an external isometric view of an example apparatus with an artificial ear canal and pinna for modeling characteristics of an ear in accordance with some embodiments.

[0055] Fig.11A Illustrated is a cross-sectional view of an example apparatus having an artificial ear canal and pinna for modeling characteristics of an ear, according to some embodiments.

[0056] Fig. 11B Illustrated according to some embodiments Fig.11A Isometric cross-sectional view of an artificial ear canal and auricle of an example device.

[0057] Fig. 12A The speculum of an otoscope of the present disclosure is illustrated positioned within the ear of a subject.

[0058] Fig. 12B , Fig. 12C , Fig.12D and Fig.12E Example experimental data are illustrated, showing how the output of an example otoscope may vary with varying viscosities of post-membranous fluid.

[0059] Fig.13 Example experimental data is illustrated, showing that various types of effusions can be identified based on vibration frequency and amplitude.

[0060] Fig.14is a flow chart of an example method for testing an otoscope using a model ear, according to some embodiments.

[0061] Fig.15 is a flow chart of another example method for testing an otoscope using a model ear in accordance with some embodiments.

[0062] Fig.16 is a schematic diagram illustrating an example apparatus for modeling characteristics of an ear, including a digital processing apparatus and a display visible to a user, according to some embodiments. DETAILED DESCRIPTION

[0063] The present disclosure relates to devices, methods and systems for modeling the characteristics of an ear using an artificial ear model (also referred to herein as a "phantom"). The devices, methods and systems herein can be used in conjunction with a pneumatic or other otoscope. A pneumatic otoscope can apply a pressure challenge to the tympanic membrane, and the characteristics of the tympanic membrane can be measured in response to the pneumatic challenge. Improved devices, methods and systems for simulating a tympanic membrane can allow otoscope devices (e.g., acoustic otoscope devices) to be tested without the need for a subject, etc. before use with a subject. The devices, methods and systems disclosed herein can allow for faster prototyping, safer prototype testing, etc. The artificial model of the ear can fully simulate various characteristics of the ear, such as membrane movement, membrane displacement, optical reflectivity, ultrasonic reflectivity, etc., to allow testing of otoscope devices, such as acoustic otoscope devices and / or pneumatic otoscope devices. The artificial model of the ear can be adjustable to simulate a specific disease state of the ear. The artificial model of the ear can be adjustable to simulate the membrane movement or displacement characteristics of the tympanic membrane. The artificial tympanic membrane can be adjustable according to the activity scale. Clinical diagnostic tests can use ordinal scales to classify membrane characteristics. Therefore, it may be beneficial to design an artificial tympanic membrane that mimics specific movement characteristics according to clinical scales.

[0064] The apparatus, methods and systems as disclosed herein can be used, for example, in combination with apparatus and methods for characterizing ductile films, surfaces and subsurface properties, such as those described in commonly owned U.S. Patent No. 7,771,356 and U.S. Patent Publication Nos. 2019 / 0365292, 2018 / 0310917 and 2017 / 0014053, each of which is incorporated by reference in its entirety. The methods, systems and media disclosed herein can be used, for example, in combination with apparatus and methods using optical coherence tomography (OCT), such as those disclosed in commonly assigned U.S. Patent Publication No. 2019 / 0200873 and U.S. Patent Publication No. 2017 / 0360302, each of which is incorporated by reference in its entirety.

[0065] Devices, methods and systems as disclosed herein can use the ear as an example membrane. In some cases, devices, methods and systems disclosed herein can be used to mimic a variety of biological tissues to provide various diagnostic information. Biological tissues can include patient organs. The speculum can be arranged in a body cavity to characterize patient tissues. 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., just to name a few.

[0066] Devices, methods and systems as disclosed herein can be used to simulate one or more characteristics of tympanic membranes. Devices, methods and systems as disclosed herein can include artificial tympanic membranes. For example, artificial tympanic membranes can simulate various conditions of the ear, such as acute otitis media (AOM), chronic otitis media, otitis media with effusion and / or chronic suppurative otitis media. The classification of ear manifestations of AOM can include detecting the presence of effusion and characterizing the type of effusion as one of serous, mucous, purulent or a combination of these. In AOM, middle ear effusion (MEE) can be induced by infectious agents, and may be thin or serous under bacterial infection, and thicker and purulent under bacterial infection. Therefore, simulating the diseased state or healthy state of the ear can include simulating various characteristics of the fluid near the tympanic membrane, such as the type of fluid, the viscosity of the fluid, etc. Simulating the diseased state or healthy state of the ear can include simulating the pressure in the ear. Simulating the diseased state or healthy state of the ear can include simulating the tension or shape of the tympanic membrane. For example, the membrane can be expanded or contracted.

[0067] Reference will now be made in detail to various embodiments, examples of which are illustrated in the accompanying drawings. In the detailed description that follows, 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.

[0068] 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, the singular forms "one", "a kind of" and "the" are also intended to include plural forms unless otherwise expressly stated herein. It should also be understood that the term "and / or" as used herein refers to and encompasses any and all possible combinations of one or more associated listed items. It will be further understood that when the terms "include" and / or "comprising" are used in this specification, they specify the presence of the features, integers, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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, 6 to 12 months, 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.

[0073] Disclosed herein is a device for modeling characteristics of an ear. The device can model characteristics of an ear, including characteristics of a tympanic membrane. In some embodiments, the device includes an artificial tympanic membrane. The artificial tympanic membrane can have an ultrasonic reflectivity that mimics the ultrasonic reflectivity of a biological tympanic membrane. The artificial tympanic membrane can have an optical reflectivity that mimics the biological tympanic membrane. The device can include a housing coupled to the artificial tympanic membrane. The housing can define an interior portion that can be coupled to an interior surface of the artificial tympanic membrane. The interior portion can have an adjustable volume of fluid or an adjustable type of fluid. The interior portion can have an adjustable gas pressure.

[0074] Disclosed herein is a device for modeling characteristics of an ear. The device may include a tympanic membrane. The device may include an artificial tympanic membrane. The device may include a housing coupled to the artificial tympanic membrane. The housing may define an interior portion coupled to an interior surface of the artificial tympanic membrane. The interior portion may have an adjustable volume or type of fluid and an adjustable gas pressure. Adjustment of two or more of the fluid volume or type and the gas pressure changes membrane deflection or membrane movement to controllably mimic a disease state of the ear.

[0075] Disclosed herein is a device for modeling characteristics of an ear. The device may include a tympanic membrane. The device may include an artificial tympanic membrane. The device may include a housing coupled to the artificial tympanic membrane. The housing may define an interior portion coupled to an interior surface of the artificial tympanic membrane. The interior portion may have an adjustable volume or type of fluid and an adjustable gas pressure. Adjustment of the fluid volume or type and gas pressure changes membrane movement to produce selected movement characteristics according to an activity scale.

[0076] Also disclosed herein is a system comprising a device for modeling the characteristics of an ear including a tympanic membrane. The system disclosed herein may include the device of the present disclosure and one or more additional components, such as a digital processing device, an air subsystem, a liquid subsystem, an electrical system, an artificial external ear, an interrogation device (e.g., an otoscope), and any combination thereof.

[0077] A system for simulating an eardrum is disclosed herein. The system may include a main cavity. The system may include a membrane. The membrane may be supported within the main cavity. The membrane may separate the interior of the main cavity from the exterior of the main cavity. The membrane may be secured within the main cavity by a clamp. The system may include an elastomeric spring. The elastomeric spring may be coupled to the membrane and secured by a spring clamp. In some cases, at least one of the mass of the membrane, the damping of the elastomeric spring, the spring stiffness, the pressure within the interior of the main cavity, and the amount of fluid within the interior of the main cavity may be selectively controlled to simulate conditions within the ear.

[0078] Figure 1A A schematic diagram of an apparatus 100 for modeling characteristics of an ear according to some embodiments is illustrated, the apparatus 100 including an inner portion having a simulated ossicular chain. The apparatus may include a housing 170. The housing 170 may include an inner portion 120. The housing 170 may include an elastic material 130, which may act as a simulated ossicular chain. The housing 170 may include a fluid injector 150 coupled to the housing. The housing 170 may include an air valve or air pump 140 coupled to the housing. The housing may include a main cavity separated by an artificial eardrum and including at least an inner portion and an optional outer portion.

[0079] The housing 170 may include an artificial eardrum 110. The membrane 110 may include a material having properties that mimic a biological eardrum. For example, the membrane 110 may mimic the tension and / or shape of a biological eardrum. For example, the membrane 110 may expand or contract to mimic a biological eardrum. The membrane may expand or contract to mimic a healthy state or a diseased state of the ear. The membrane may move in response to an applied pneumatic challenge. The rate of membrane movement in response to an applied pneumatic challenge may mimic a diseased state or a healthy state of the ear. The membrane 110 may have a shape that displays visual cues that mimic the visual appearance of a biological eardrum. For example, the surface of the artificial eardrum may have the visual shape of a malleus or an eardrum or both. The membrane may have an ultrasonic reflectivity that mimics biological ultrasonic reflectivity.

[0080] The inner portion can include a liquid. The liquid volume 122 can be adjustable to simulate the amount of fluid behind the tympanic membrane. In some cases, the fluid type can be adjustable to simulate the properties of a biological fluid. For example, the fluid type can be changed to increase or decrease the viscosity of the fluid behind the membrane. Changing the viscosity of the fluid can change the movement or rate of movement of the tympanic membrane. For example, a more viscous fluid may reduce the effective elasticity of the tympanic membrane. In some cases, the inner portion includes a fluid injector or an opening for a fluid injector. The fluid injector can be used to increase or decrease the volume of the liquid. The fluid injector can be used to change the type of liquid.

[0081] In some cases, the type of liquid can be water. In some cases, the type of fluid can be a solution. In some cases, the type of fluid can be an aqueous solution. The viscosity of the aqueous solution can be changed by controlling the amount of solute in the solvent. For example, sodium chloride, potassium iodide, sugar, etc. can be added to water to change the viscosity. In some cases, the type of liquid can be honey. In some cases, the type of liquid can be oil, such as olive oil, linseed oil, castor oil, motor oil, mineral oil, silicone oil, etc. In some cases, the type of liquid can be a suspension of two immiscible liquids. In some cases, the type of liquid can be a suspension of oil and water. In some cases, the fluid can be a paste, a gel, or another semisolid. In some cases, the fluid can be a viscoelastic polymer. The viscosity of the fluid can vary with temperature. For example, at room temperature, the viscosity of the fluid can vary between 100 micropascal seconds of, for example, a light fluid and 5000 pascal seconds of, for example, honey.

[0082] The inner portion 120 may include an adjustable air volume. The air volume may be adjusted to simulate the pressure behind the eardrum. The pressure behind the eardrum may adjust the movement or rate of movement of the eardrum. For example, a higher pressure behind the eardrum may reduce the movement or rate of movement of the eardrum. In some cases, the inner portion includes an internal air valve. The device 100 may include an internal air pump. The device 100 may include an opening for the internal air valve. The device 100 may include an opening for the internal air pump. In some cases, the inner portion includes an internal pressure gauge or an opening for the internal pressure gauge. The pressure in the inner portion may be adjusted by a pump. The pressure in the inner portion may be adjusted by raising or lowering the pressure with a pump and sealing the inner portion with a valve. The pressure in the inner portion may be monitored with a meter. The pressure in the inner portion may be monitored continuously or periodically.

[0083] In some cases, the type of gas can be air. The gas can include nitrogen, oxygen, helium, hydrogen, carbon dioxide, helium, krypton, argon, etc., and any combination thereof. The gas can include an inert gas. The gas can include an elemental gas. The pressure of the gas can vary from a few millitorr to 100 kilotorr. The biological ear pressure can typically be about 760 torr.

[0084] In some cases, the inner portion 120 can include an elastic material 130 coupled to the artificial eardrum. In some cases, the inner portion includes a simulated ossicular chain coupled to the eardrum. In some cases, the elastic material coupled to the artificial eardrum is a spring, such as an elastomeric spring. In some cases, the elastic material coupled to the artificial eardrum has a controllable tension. The simulated ossicles may have a controllable tension. Figure 1A A spring adjuster 160 is shown coupled to the elastic material 130. The spring adjuster can control tension to adjust the elasticity of the artificial eardrum 110.

[0085] Figure 1B A schematic diagram of an apparatus 100' for modeling characteristics of an ear according to some embodiments is illustrated, the apparatus 100' comprising an inner portion having a simulated ossicular chain and an outer portion having a seal. The apparatus may include a housing 170'. The housing 170' may include an inner portion 120'. The housing 170' may include an elastic material 130', which may act as a simulated ossicular chain. The housing 170' may include a fluid syringe 150' coupled to the housing. The housing 170' may include an inner air valve or inner air pump 140' coupled to the housing. The housing may include a main cavity separated by an artificial eardrum and including at least an inner portion and an outer portion 125'. The housing 170' may include an outer air valve or outer air pump 145' coupled to the housing. The housing 170' may include a seal 180' coupled to the housing.

[0086] The housing 170' may include an artificial eardrum 110'. The membrane 110' may include a material having properties that mimic a biological eardrum. For example, the membrane 110' may mimic the tension or shape of a biological eardrum. For example, the membrane 110' may expand or contract to mimic a biological eardrum. The membrane may expand or contract to mimic a healthy state or a diseased state of the ear. The membrane may move in response to an applied pneumatic challenge. The rate of membrane movement in response to an applied pneumatic challenge may mimic a diseased state or a healthy state of the ear. The membrane 110' may have a shape that displays visual cues that mimic the visual appearance of a biological eardrum. For example, the surface of the artificial eardrum may have the visual shape of the malleus or the eardrum or both. The membrane may have an ultrasonic reflectivity that mimics biological ultrasonic reflectivity.

[0087] The inner portion can include a liquid. The liquid volume 122' can be adjustable to simulate the amount of fluid behind the tympanic membrane. In some cases, the fluid type can be adjustable to simulate the properties of a biological fluid. For example, the fluid type can be changed to increase or decrease the viscosity of the fluid behind the membrane. Changing the viscosity of the fluid can change the movement or rate of movement of the tympanic membrane. For example, a more viscous fluid may reduce the effective elasticity of the tympanic membrane. In some cases, the inner portion includes a fluid injector or an opening for a fluid injector. The fluid injector can be used to increase or decrease the volume of the liquid. The fluid injector can be used to change the type of liquid.

[0088] In some cases, the type of liquid can be water. In some cases, the type of fluid can be a solution. In some cases, the type of fluid can be an aqueous solution. The viscosity of the aqueous solution can be changed by controlling the amount of solute in the solvent. For example, sodium chloride, potassium iodide, sugar, etc. can be added to water to change the viscosity. In some cases, the type of liquid can be honey. In some cases, the type of liquid can be oil, such as olive oil, linseed oil, castor oil, motor oil, mineral oil, silicone oil, etc. In some cases, the type of liquid can be a suspension of two immiscible liquids. In some cases, the type of liquid can be a suspension of oil and water. In some cases, the fluid can be a paste, a gel, or another semisolid. In some cases, the fluid can be a viscoelastic polymer. The viscosity of the fluid can vary with temperature. For example, at room temperature, the viscosity of the fluid can vary between 100 micropascal seconds of, for example, a light fluid and 5000 pascal seconds of, for example, honey.

[0089] The internal portion 120' may include an adjustable air volume. The air volume may be adjusted to simulate the pressure behind the eardrum. The pressure behind the eardrum may adjust the movement or rate of movement of the eardrum. For example, a higher pressure behind the eardrum may reduce the movement or rate of movement of the eardrum. In some cases, the internal portion includes an internal air valve. The device 100' may include an internal air pump. The device 100' may include an opening for the internal air valve. The device 100' may include an opening for the internal air pump. In some cases, the internal portion includes an internal pressure gauge or an opening for the internal pressure gauge. The pressure in the internal portion may be adjusted by a pump. The pressure in the internal portion may be adjusted by raising or lowering the pressure with a pump and sealing the internal portion with a valve. The pressure in the internal portion may be monitored with a meter. The pressure in the internal portion may be monitored continuously or periodically.

[0090] In some cases, the type of gas can be air. The gas can include nitrogen, oxygen, helium, hydrogen, carbon dioxide, helium, krypton, argon, etc., and any combination thereof. The gas can include an inert gas. The gas can include an elemental gas. The pressure of the gas can vary from a few millitorr to 100 kilotorr. The biological ear pressure can typically be about 760 torr.

[0091] In some cases, the inner portion 120' can include an elastic material 130' coupled to the artificial eardrum. In some cases, the inner portion includes a simulated ossicular chain coupled to the eardrum. In some cases, the elastic material coupled to the artificial eardrum is a spring, such as an elastomeric spring. In some cases, the elastic material coupled to the artificial eardrum has a controllable tension. The simulated ossicles may have a controllable tension. Figure 1B A spring adjuster 160' is shown coupled to the elastic material 130'. The spring adjuster can control tension to adjust the elasticity of the artificial eardrum 110'.

[0092] The device 100' may include an external portion 125' coupled to the interior surface of the artificial eardrum. The external portion 125' may include an adjustable air volume or pressure. The air volume or pressure may be adjusted to simulate pressure applied to the eardrum. The pressure applied to the eardrum may be a pneumatic challenge. For example, the pneumatic challenge may cause the membrane to move, which may be measured by an interrogation device, such as an otoscope. In some cases, the external portion includes an external air valve. The device 100' may include an external air pump. The device 100' may include an opening for an external air valve. The device 100' may include an opening for an external air pump. In some cases, the external portion includes an external pressure gauge or an opening for an external pressure gauge. The pressure within the external portion may be adjusted by a pump. The pressure in the external portion may be adjusted by raising or lowering the pressure with a pump and sealing the external portion with a valve.

[0093] The pressure within the external portion can be monitored with an instrument. The pressure within the external portion can be monitored continuously or periodically. Monitoring the pressure within the external portion can be used to monitor applied pressure, such as an applied pneumatic challenge. Knowing the pressure applied by the interrogation device may be beneficial, for example, to prevent over-pressurization of the patient's ear.

[0094] Device 100' may include a seal 180' coupled to outer portion 125'. Under clinical conditions, the interrogation device may include a seal to a subject's orifice. For example, the speculum of an otoscope may include a size and shape that fits within a biological ear canal (such as, the ear canal of an adult or infant subject). Seal 180' may simulate a biological seal between the interrogation device and the subject's orifice. In some cases, an external pressure gauge may be used to monitor the quality of the seal when the interrogation device is in place or in use.

[0095] Figure 1CA schematic diagram of an apparatus 100" for modeling characteristics of an ear according to some embodiments is illustrated, the apparatus comprising an internal portion and an external portion with a seal. The apparatus may include a housing 170". The housing 170" may include an internal portion 120". The housing 170" may include a fluid syringe 150" coupled to the housing. The housing 170" may include an internal air valve or an internal air pump 140" coupled to the housing. The housing may include a main cavity separated by an artificial eardrum and comprising at least an internal portion and an external portion 125". The housing 170" may include an external air valve or an external air pump 145" coupled to the housing. The housing 170" may include a seal 180" coupled to the housing.

[0096] Figure 1C An example may include an artificial eardrum 110'', wherein the shape and hardness of the artificial eardrum are configured to simulate the presence of an ossicular chain. The membrane 110'' may be used in combination with or in place of an elastic material (e.g., simulating an ossicular chain) described elsewhere herein.

[0097] The housing 170" may include an artificial eardrum 110". The membrane 110" may include a material having properties that mimic a biological eardrum. For example, the membrane 110" may mimic the tension or shape of a biological eardrum. For example, the membrane 110" may expand or contract to mimic a biological eardrum. The membrane may expand or contract to mimic a healthy state or a diseased state of the ear. The membrane may move in response to an applied pneumatic challenge. The rate of membrane movement in response to an applied pneumatic challenge may mimic a diseased state or a healthy state of the ear. The membrane 110" may have a shape that displays visual cues that mimic the visual appearance of a biological eardrum. For example, the surface of the artificial eardrum may have the visual shape of a malleus or an eardrum or both. The membrane may have an ultrasonic reflectivity that mimics biological ultrasonic reflectivity.

[0098] The inner portion can include a liquid. The liquid volume 122" can be adjustable to simulate the amount of fluid behind the tympanic membrane. In some cases, the fluid type can be adjustable to simulate properties of a biological fluid. For example, the fluid type can be changed to increase or decrease the viscosity of the fluid behind the membrane. Changing the viscosity of the fluid can change the movement or rate of movement of the tympanic membrane. For example, a more viscous fluid may reduce the effective elasticity of the tympanic membrane. In some cases, the inner portion includes a fluid syringe or an opening for a fluid syringe. The fluid syringe can be used to increase or decrease the volume of the liquid. The fluid syringe can be used to change the type of liquid.

[0099] In some cases, the type of liquid can be water. In some cases, the type of fluid can be a solution. In some cases, the type of fluid can be an aqueous solution. The viscosity of the aqueous solution can be changed by controlling the amount of solute in the solvent. For example, sodium chloride, potassium iodide, sugar, etc. can be added to water to change the viscosity. In some cases, the type of liquid can be honey. In some cases, the type of liquid can be oil, such as olive oil, linseed oil, castor oil, motor oil, mineral oil, silicone oil, etc. In some cases, the type of liquid can be a suspension of two immiscible liquids. In some cases, the type of liquid can be a suspension of oil and water. In some cases, the fluid can be a paste, a gel, or another semisolid. In some cases, the fluid can be a viscoelastic polymer. The viscosity of the fluid can vary with temperature. For example, at room temperature, the viscosity of the fluid can vary between 100 micropascal seconds of, for example, a light fluid and 5000 pascal seconds of, for example, honey.

[0100] The internal portion 120" may include an adjustable air volume. The air volume may be adjusted to simulate a pressure behind an eardrum. The pressure behind the eardrum may regulate the movement or rate of movement of the eardrum. For example, a higher pressure behind the eardrum may reduce the movement or rate of movement of the eardrum. In some cases, the internal portion includes an internal air valve. The device 100" may include an internal air pump. The device 100" may include an opening for an internal air valve. The device 100" may include an opening for an internal air pump. In some cases, the internal portion includes an internal pressure gauge or an opening for an internal pressure gauge. The pressure within the internal portion may be regulated by a pump. The pressure within the internal portion may be regulated by raising or lowering the pressure with a pump and sealing the internal portion with a valve. The pressure within the internal portion may be monitored with a meter. The pressure within the internal portion may be monitored continuously or periodically.

[0101] In some cases, the type of gas can be air. The gas can include nitrogen, oxygen, helium, hydrogen, carbon dioxide, helium, krypton, argon, etc., and any combination thereof. The gas can include an inert gas. The gas can include an elemental gas. The pressure of the gas can vary from a few millitorr to 100 kilotorr. The biological ear pressure can typically be about 760 torr.

[0102] The device 100" may include an external portion 125" coupled to an interior surface of an artificial tympanic membrane. The external portion 125" may include an adjustable air volume or pressure. The air volume or pressure may be adjusted to simulate pressure applied to the tympanic membrane. The pressure applied to the tympanic membrane may be a pneumatic challenge. For example, the pneumatic challenge may cause the membrane to move, which may be measured by an interrogation device, such as an otoscope. In some cases, the external portion includes an external air valve. The device 100" may include an external air pump. The device 100" may include an opening for an internal air valve. The device 100" may include an opening for an external air pump. In some cases, the external portion includes an external pressure gauge or an opening for an external pressure gauge. The pressure within the external portion may be adjusted by a pump. The pressure in the external portion may be adjusted by raising or lowering the pressure with a pump and sealing the external portion with a valve.

[0103] The pressure within the external portion can be monitored with an instrument. The pressure within the external portion can be monitored continuously or periodically. Monitoring the pressure within the external portion can be used to monitor applied pressure, such as an applied pneumatic challenge. Knowing the pressure applied by the interrogation device may be beneficial, for example, to prevent over-pressurization of the patient's ear.

[0104] Device 100" may include a seal 180" coupled to external portion 125". In clinical conditions, the interrogation device may include a seal to a subject's orifice. For example, the speculum of an otoscope may include a size and shape that fits within a biological ear canal (such as the ear canal of an adult or infant subject). Seal 180" may simulate a biological seal between the interrogation device and the subject's orifice. In some cases, an external pressure gauge may be used to monitor the quality of the seal while the interrogation device is in place or in use.

[0105] Figure 2 Some underlying principles related to membrane mimicry according to some embodiments are illustrated. Figure 2 Figure 1 is an acoustic-mechanical diagram of the middle ear, which includes the ear canal (EAM), the middle ear cavity (MEC), the tympanic membrane (TM), the ossicular connections (M, I, SFP), and the fluid-filled inner ear. The ossicular connections, also known as the ossicular chain, include the malleus M, the incus I, and the stapes base plate SFP. The round window RS and the Eustachian tube ET are also shown. As the external air pressure P T , such as aerodynamic challenges or sound in the ear canal, TM movement causes middle ear P MEC Volume displacement V U The anterior-posterior movement of the TM also causes the concomitant displacement of the ossicular chain and the stapes baseplate, which in turn causes the baseplate P CPressure changes in the medial vestibule. The umbilicus is the hammer head sometimes visible on the TM. For additional description of the acoustic mechanics of the ear, see, e.g., Acoustics of Speech & Hearing MIT 6.551 J / HST.714 J, http: / / web.mit.edu / 6.551j / www / , which is incorporated herein by reference in its entirety.

[0106] OM is characterized by the presence of fluid behind the TM. Bacterial ear infections can be treated with antibiotics; however, viral ear infections may not respond to antibiotics. Bacterial and viral OM are characterized by different types of effusions; however, effusions behind the TM are not usually visible from the outer ear. Identification of the type of effusion can be aided by various interrogation devices that detect movement of the tympanic membrane. These indirect methods may help to correctly and earlier identify the infection rather than biopsy a subject's TM or prescribing medication without diagnosis. For example, viral effusions are often more watery (e.g., less viscous) than bacterial infections, which may be more viscous (e.g., more viscous).

[0107] Examples of methods for detecting membrane movement include applying pneumatic challenge U T And monitor the membrane movement before and after the challenge. The movement can be monitored by visual inspection or using more complex methods (such as using an ultrasound system or optical coherence tomography). These techniques are described in more detail elsewhere in this article, for example in the "Interview Device" section.

[0108] Detecting membrane movement can include measurement of membrane contraction or expansion, measurement of movement speed, measurement of membrane movement damping time, measurement of membrane movement frequency, etc. A simple model of membrane movement in response to aerodynamic challenges is the model of a simple resonator. The spring force can be related to the elasticity of the TM, the compression of the cochlea (via the ossicular chain), the compression of the air in the middle ear, etc. The damping of the oscillator can be related to the damping of the TM, the air pressure balance via the ET, the pressure balance in the cochlea, etc. The mass of the oscillator can be related to the mass of the TM, the mass of the fluid in the ear, and the mass of the ossicles. Accurate membrane simulation should use simple and adjustable components to capture many or all of these parameters.

[0109] The device of the present disclosure can be selectively adjusted to produce movement characteristics that simulate disease states. In some cases, at least one of the mass of the membrane, the tension of the elastomeric spring, the pressure in the inner part, and the amount of fluid in the inner part can be selectively controlled to simulate the condition in the ear. In some cases, the elastomeric spring may not be needed. In some cases, the type or volume and pressure of the fluid in the inner part can be adjustable parameters. A single membrane type can be used to controllably simulate multiple disease states. In some cases, the adjustment of one or more of the fluid volume, fluid type, or gas pressure changes the membrane deflection or membrane movement to controllably simulate the disease state of the ear. In some cases, the adjustment of the fluid type includes changing the viscosity of the fluid. In some cases, the movement of the artificial eardrum can be adjusted according to a set of ordinal values ​​or a continuous scale. In some cases, the adjustment of one or more of the fluid volume, fluid type, or gas pressure changes the rate at which the membrane moves to controllably simulate the disease state of the ear.

[0110] Figure 3A An exploded view of an example device 300 for modeling characteristics of an ear is illustrated, the device including an inner portion and an outer portion with a seal, according to some embodiments. Figure 3B Illustrated is a method for modeling the characteristics of an ear according to some embodiments. Figure 3A An isometric view of the exterior of an example device. Figure 3C Illustrated is a method for modeling the characteristics of an ear according to some embodiments. Figure 3A The device 300 may include: Figure 1C An example implementation of the illustrative apparatus 100" presented in FIG.

[0111] The device may include a housing. The housing may include an inner portion 320. The housing may include an opening for a fluid syringe. The housing may include an opening for an inner air valve or an inner air pump coupled to the inner portion 320. The housing may include a main cavity separated by an artificial eardrum and including at least the inner portion 320 and an outer portion 325. The outer portion may include an opening for an outer air valve or an outer air pump coupled to the outer portion. The device may include a seal 380 coupled to the housing.

[0112] Device 300 may include an artificial eardrum 310, wherein the shape and hardness of the artificial eardrum are configured to simulate the presence of the ossicular chain. Membrane 310 may be used in combination with or in place of the elastic material described elsewhere herein (e.g., simulating the ossicular chain). As shown, membrane 310 may include a seal 312 to assist in the pressure separation between the inner portion and the outer portion. Membrane 310 may include an orientation feature.

[0113] Device 300 may include an artificial eardrum 310. Membrane 310 may include a material having properties that mimic a biological eardrum. For example, membrane 310 may mimic the tension or shape of a biological eardrum. For example, membrane 310 may expand or contract to mimic a biological eardrum. The membrane may expand or contract to mimic a healthy state or a diseased state of the ear. The membrane may move in response to an applied pneumatic challenge. The rate of membrane movement in response to an applied pneumatic challenge may mimic a diseased state or a healthy state of the ear. Membrane 310 may have a shape that displays visual cues that mimic the visual appearance of a biological eardrum. For example, the surface of the artificial eardrum may have the visual shape of a malleus or an eardrum or both. The membrane may have an ultrasonic reflectivity that mimics biological ultrasonic reflectivity.

[0114] The inner portion 320 may include a liquid. The volume of the liquid may be adjustable to simulate the amount of fluid behind the tympanic membrane. In some cases, the type of fluid may be adjustable to simulate the properties of a biological fluid. For example, the type of fluid may be changed to increase or decrease the viscosity of the fluid behind the membrane. Changing the viscosity of the fluid may change the movement or rate of movement of the tympanic membrane. For example, a more viscous fluid may reduce the effective elasticity of the tympanic membrane. In some cases, the inner portion includes an opening for a fluid syringe. The fluid syringe may be used to increase or decrease the volume of the liquid. The fluid syringe may be used to change the type of liquid.

[0115] In some cases, the type of liquid can be water. In some cases, the type of fluid can be a solution. In some cases, the type of fluid can be an aqueous solution. The viscosity of the aqueous solution can be changed by controlling the amount of solute in the solvent. For example, sodium chloride, potassium iodide, sugar, etc. can be added to water to change the viscosity. In some cases, the type of liquid can be honey. In some cases, the type of liquid can be oil, such as olive oil, linseed oil, castor oil, motor oil, mineral oil, silicone oil, etc. In some cases, the type of liquid can be a suspension of two immiscible liquids. In some cases, the type of liquid can be a suspension of oil and water. In some cases, the fluid can be a paste, a gel, or another semisolid. In some cases, the fluid can be a viscoelastic polymer. The viscosity of the fluid can vary with temperature. For example, at room temperature, the viscosity of the fluid can vary between 100 micropascal seconds of, for example, a light fluid and 1000 pascal seconds of, for example, tar.

[0116] The inner portion 320 may include an adjustable air volume. The air volume may be adjusted to simulate the pressure behind the eardrum. The pressure behind the eardrum may adjust the movement or rate of movement of the eardrum. For example, a higher pressure behind the eardrum may reduce the movement or rate of movement of the eardrum. In some cases, the inner portion includes an internal air valve. The device 300 may include an opening for an internal air pump. The device 300 may include an opening for an internal air valve. In some cases, the inner portion includes an opening for an internal pressure gauge. The pressure in the inner portion may be adjusted by a pump. The pressure in the inner portion may be adjusted by raising or lowering the pressure with a pump and sealing the inner portion with a valve. The pressure in the inner portion may be monitored with a meter. The pressure in the inner portion may be monitored continuously or periodically.

[0117] In some cases, the type of gas can be air. The gas can include nitrogen, oxygen, helium, hydrogen, carbon dioxide, helium, krypton, argon, etc., and any combination thereof. The gas can include an inert gas. The gas can include an elemental gas. The pressure of the gas can vary from a few millitorr to 100 kilotorr. The biological ear pressure can typically be about 760 torr.

[0118] The inner portion 320 may be adhered to the outer portion by attachment means 324. The inner and outer portions may be attached by screws, bolts, a screw fit, a snap fit, etc. The inner and outer portions may be fluidly and pneumatically sealed to each other.

[0119] The device 300 may include an external portion 325 coupled to the interior surface of the artificial eardrum. The external portion 325 may include an adjustable air volume or pressure. The air volume or pressure may be adjusted to simulate pressure applied to the eardrum. The pressure applied to the eardrum may be a pneumatic challenge. For example, the pneumatic challenge may cause the membrane to move, which may be measured by an interrogation device, such as an otoscope. In some cases, the external portion includes an opening for an external air valve. The device 300 may include an opening for an external air pump. In some cases, the external portion includes an opening for an external pressure gauge. The pressure within the external portion may be adjusted by a pump. The pressure in the external portion may be adjusted by raising or lowering the pressure with a pump and sealing the external portion with a valve.

[0120] The pressure within the external portion can be monitored with an instrument. The pressure within the external portion can be monitored continuously or periodically. Monitoring the pressure within the external portion can be used to monitor applied pressure, such as an applied pneumatic challenge. Knowing the pressure applied by the interrogation device may be beneficial, for example, to prevent over-pressurization of the patient's ear.

[0121] Device 300 may include a seal 380 coupled to outer portion 325. In clinical conditions, the interrogation device may include a seal to the subject's orifice. For example, the speculum of an otoscope may include a size and shape that fits within a biological ear canal (such as, the ear canal of an adult or infant subject). Seal 380 may simulate a biological seal between the interrogation device and the subject's orifice. In some cases, an external pressure gauge may be used to monitor the quality of the seal when the interrogation device is in place or in use.

[0122] The seal 380 may include an opening 382 for inserting the interrogation device. The seal 380 may form a fluid-pneumatic seal between the outer portion of the device and the exterior. The seal 380 may be attached to the outer portion by a panel 384. The panel 384 may be adhered to the outer portion by an attachment device 386. The panel and the outer portion may be attached by screws, bolts, a screw fit, a snap fit, etc.

[0123] Figure 4 A transparent isometric view of an example device including an interior portion having a simulated ossicular chain is illustrated according to some embodiments. The device 400 may include Figure 1A . The device may include a housing 470. The housing 470 may include an inner portion. The housing 470 may include an elastic material 430, which may act as a simulated ossicular chain. The housing 470 may include a fluid syringe connection 450 coupled to the housing. The housing 470 may include an air valve connection 440 coupled to the housing. The housing may include a main cavity that is divided by an artificial tympanic membrane and includes at least an inner portion and an optional outer portion.

[0124] The housing 470 may include an artificial eardrum 410. The membrane 410 may include a material having properties that mimic a biological eardrum. For example, the membrane 410 may mimic the tension or shape of a biological eardrum. For example, the membrane 410 may expand or contract to mimic a biological eardrum. The membrane may expand or contract to mimic a healthy state or a diseased state of the ear. The membrane may move in response to an applied pneumatic challenge. The rate of membrane movement in response to an applied pneumatic challenge may mimic a diseased state or a healthy state of the ear. The membrane 410 may have a shape that displays visual cues that mimic the visual appearance of a biological eardrum. For example, the surface of the artificial eardrum may have the visual shape of a malleus or an eardrum or both. The membrane may have an ultrasonic reflectivity that mimics biological ultrasonic reflectivity.

[0125] As shown, the membrane 410 includes a seal 412 to assist in pressure separation between the interior portion of the device and the exterior. The panel 472 can engage the interior portion of the housing 474. The interior portion and the panel can be attached by screws, bolts, screw fit, snap fit, etc.

[0126] The inner portion may include a liquid. The volume of the liquid may be adjustable to simulate the amount of fluid behind the tympanic membrane. In some cases, the type of fluid may be adjustable to simulate the properties of a biological fluid. For example, the type of fluid may be changed to increase or decrease the viscosity of the fluid behind the membrane. Changing the viscosity of the fluid may change the movement or rate of movement of the tympanic membrane. For example, a more viscous fluid may reduce the effective elasticity of the tympanic membrane. In some cases, the inner portion includes an opening for a fluid syringe. The inner portion may include a fluid syringe connection 450. The inner portion may include a valve 452 and a fluid outlet 454. The fluid syringe may be used to increase or decrease the volume of the liquid. The fluid syringe may be used to change the type of liquid.

[0127] In some cases, the type of liquid can be water. In some cases, the type of fluid can be a solution. In some cases, the type of fluid can be an aqueous solution. The viscosity of the aqueous solution can be changed by controlling the amount of solute in the solvent. For example, sodium chloride, potassium iodide, sugar, etc. can be added to water to change the viscosity. In some cases, the type of liquid can be honey. In some cases, the type of liquid can be oil, such as olive oil, linseed oil, castor oil, motor oil, mineral oil, silicone oil, etc. In some cases, the type of liquid can be a suspension of two immiscible liquids. In some cases, the type of liquid can be a suspension of oil and water. In some cases, the fluid can be a paste, a gel, or another semisolid. In some cases, the fluid can be a viscoelastic polymer. The viscosity of the fluid can vary with temperature. For example, at room temperature, the viscosity of the fluid can vary between 100 micropascal seconds of, for example, a light fluid and 5000 pascal seconds of, for example, honey.

[0128] The inner portion 474 may include an adjustable air volume. The air volume may be adjusted to simulate the pressure behind the eardrum. The pressure behind the eardrum may adjust the movement or rate of movement of the eardrum. For example, a higher pressure behind the eardrum may reduce the movement or rate of movement of the eardrum. In some cases, the inner portion includes an inner air valve. The device 400 may include an inner air pump connection 440. The device 400 may include an opening for an inner air valve 442 and an outlet 444.

[0129] In some cases, the inner portion includes an opening for an internal pressure gauge. The pressure in the inner portion can be adjusted by a pump. The pressure in the inner portion can be adjusted by raising or lowering the pressure with a pump and sealing the inner portion with a valve. The pressure in the inner portion can be monitored with a meter. The pressure in the inner portion can be monitored continuously or periodically.

[0130] In some cases, the type of gas can be air. The gas can include nitrogen, oxygen, helium, hydrogen, carbon dioxide, helium, krypton, argon, etc., and any combination thereof. The gas can include an inert gas. The gas can include an elemental gas. The pressure of the gas can vary from a few millitorr to 100 kilotorr. The biological ear pressure can typically be about 760 torr.

[0131] In some cases, the inner portion 474 can include an elastic material 430 coupled to the artificial eardrum. In some cases, the inner portion includes a simulated ossicular chain coupled to the eardrum. In some cases, the elastic material coupled to the artificial eardrum is a spring, such as an elastomeric spring. In some cases, the elastic material coupled to the artificial eardrum has a controllable tension. The simulated ossicles may have a controllable tension. Figure 4 A spring adjuster 460 is shown coupled to the elastic material 430. The spring adjuster can control tension to adjust the elasticity of the artificial eardrum 410.

[0132] Artificial eardrum

[0133] Figure 5A , Figure 5B and Figure 5C An isometric view, a front view, and a side view of an artificial eardrum according to some embodiments are shown, respectively. The membrane 510 may include a flexible surface 511. The membrane 510 may include a material having properties that mimic a biological eardrum. For example, the membrane 510 may mimic the tension or shape of a biological eardrum. For example, the membrane 510 may expand or contract to mimic a biological eardrum. The membrane may expand or contract to mimic a healthy state or a diseased state of the ear. The membrane may move in response to an applied pneumatic challenge.

[0134] Membrane 510 can include a shape and / or hardness configured to mimic the presence of an ossicular chain. Membrane 510 can be used in combination with or in place of an elastic material described elsewhere herein (e.g., simulating an ossicular chain). The rate of membrane movement in response to an applied pneumatic challenge can mimic a diseased state or a healthy state of the ear. Membrane 510 can have a shape that displays visual cues that mimic the visual appearance of a biological tympanic membrane. For example, the surface of the artificial tympanic membrane can have the visual shape of a malleus or a tympanic membrane or both. The membrane can have an ultrasonic reflectivity that mimics biological ultrasonic reflectivity.

[0135] Various parameters can be adjusted to approximate conditions within the ear, such as a diseased state or a healthy state. In some cases, one or more of the mass of the membrane, the damping of the elastomeric spring, the spring stiffness, the pressure within the interior of the main cavity, and the amount or type of fluid within the interior of the main cavity can be selectively controlled to simulate conditions within the ear.

[0136] The membrane may include a flexible material. The membrane may include an elastomer. The membrane may include an elastomer. The elastomer may include natural rubber, chloroprene rubber, styrene-butadiene rubber, nitrile rubber, elastic polymer, silicone rubber, polyisoprene, polybutadiene, chloroprene, butyl rubber, styrene rubber, butadiene-acrylonitrile rubber, ethylene-propylene rubber, epichlorohydrin rubber, polyacrylic rubber, fluorosilicone rubber, fluoroelastomer, perfluoroelastomer, polyether block amide, chlorosulfonated polyethylene, ethylene-vinyl acetate, etc. The membrane may include silicone. In some cases, the membrane includes a seal 512 to assist in attachment to the device of the present disclosure.

[0137] Figure 5D 511 is an image of an outer surface of an example artificial eardrum of the present disclosure. The visual appearance of the eardrum may be an important consideration because an otoscope can often be aimed by eye. The membrane of the present disclosure may be designed to present one or more visual cues. For example, the membrane may at least partially present the shape 514 of the eardrum umbilicus or the malleus.

[0138] In some embodiments, the shape of the membrane of the present disclosure exhibits optical reflections from the surface of the artificial tympanic membrane, thereby enabling the positioning of the artificial tympanic membrane and alignment of the otoscope. In some cases, the membrane of the present disclosure exhibits a light cone. In some cases, the optical reflection is exhibited on the anterior lower quadrant of the artificial tympanic membrane.

[0139] A cone of light, or light reflection, is a visible phenomenon that may occur during a visual examination of the eardrum. Shining light onto the eardrum may cause a cone-shaped reflection of light to appear. The apex of the cone is located at the most concave part of the eardrum, the umbilicus. This may be located in the anterior-inferior quadrant of the eardrum. The cone of light can be used as an alignment aid during an examination of the eardrum. In the ear, the user can aim a light source within the ear canal so that the cone of light is visible. Figure 5D , the light cone is shown as a bright spot near the umbilicus 514 of the tympanic membrane.

[0140] Gas-liquid subsystem

[0141] Figure 6 6 is an illustration of an example air-liquid subsystem of an apparatus for modeling properties of an ear according to some embodiments. The example air-liquid subsystem can be used in conjunction with any variant, embodiment, or example of the apparatus for modeling properties of an ear disclosed herein. As shown, the air-liquid subsystem includes a control unit 650 and a measurement unit 610. The measurement unit 610 may include an embodiment, variant, or example of an apparatus for modeling properties of air. The apparatus may include a housing. The housing may include a main cavity that is separated by an artificial eardrum 310 and includes at least an inner portion 320 and an outer portion 325.

[0142] The measuring unit 610 may include controls for components of the internal portion 320. The internal portion may include an opening for a fluid injector 660. The housing may include an opening for an internal air valve 614. As shown, a first valve 614 may separate the measuring unit from the control unit. A digital pressure gauge P / S1 may be fluidly connected to the air handling line. One or more syringes 622 and 624 may be fluidly connected to the internal air system for fine pressure control.

[0143] The measuring unit 610 may include controls for components of the outer portion 325. The outer portion 325 may include an opening for an inner air valve 612. The outer air valve 612 may be used as an exhaust valve. A digital pressure gauge P / S2 may be fluidly connected to the outer air handling line. As shown, an outer air pump 672 may be connected to the outer portion. The device may include a seal coupled to the housing. An interrogation device 640 within the seal is also shown.

[0144] The control unit 650 may include Figure 7 The electrical subsystem described in more detail. The control unit may include an internal air pump 652 coupled to the internal portion 320. The internal air pump may be a micro-diaphragm pump. The internal air line may include a vent 654 and a vent valve 656. The internal air line may include a direction control 658. The control unit may also include a meter 680 on the internal air line. The meter may be visible to the user. The meter may be an analog meter. The control unit may include a fluid injector 660 coupled to the internal fluid line. The fluid injector may include a syringe pump. The control unit may include an external air pump 672. The external air pump may include a bulb having a bulb compressor 670 and a control 674. The bulb compressor may include a solenoid. The bulb may mimic the action of a manually controlled pneumatic otoscope.

[0145] Figure 7 is a diagram of an example electrical system of an apparatus for modeling characteristics of an ear according to some embodiments. The digital pressure gauge P / S1 and the digital pressure gauge P / S2 can provide electrical signals to an analog-to-digital converter (DAC) 715. The DAC can provide at least two channel outputs to a digital processing device 710. The digital processing device can be a microprocessor, such as an Arduino microprocessor. The digital processing device can be connected to one or more secondary processors via an output 712 (such as a USB or Ethernet port). The digital processing device 710 can be connected to a display 690 visible to a user.

[0146] The processor may be connected to control various aspects of the apparatus and methods disclosed herein. The pump 652 may include a motor M. The motor M may be controlled by a power switch 750 and a direction control 658. The processor may be configured to control the operation of the motor M, the power switch 750, and the direction control 658. The processor may be configured to control the operation of the solenoid control switch 772 to move the solenoid 670 to compress the bulb 672.

[0147] Figure 8 Illustrated is a top view of an example air-liquid subsystem of an apparatus for modeling properties of an ear, according to some embodiments. Figure 8 The lower portion of the control unit 650 is shown. The control unit 650 may include a digital processing device 710. The digital processing device 710 may be connected to a display 690 visible to a user. The control unit may also include a meter 680 on the inner air line, which may be visible on the outer surface of the control unit. The control unit may include an outer air pump 672. The outer air pump may include a bulb having a bulb compressor 670 and controls 674. The control unit may include a fluid injector 660 coupled to the inner fluid line. Figure 8 The upper portion of shows the external air valve 612 and one or more syringes 622 and 624.

[0148] Fig. 9 The measurement unit of the device for modeling the characteristics of the ear connected to the air-liquid subsystem according to some embodiments is illustrated. The measurement unit 610 may include a bracket for the device of the present disclosure. The measurement unit may include a digital pressure gauge P / S1 and a digital pressure gauge P / S2. The measurement unit may include an internal air valve 614.

[0149] Artificial outer ear

[0150] Fig.10 An external isometric view of an example system with an artificial ear canal and auricle for modeling characteristics of an ear according to some embodiments is illustrated. The system may include a head model of a subject 1000. The system may include a base 1620 of a device for modeling characteristics of an ear. The base 1620 may be connected to the auricle 1610. The auricle may include an ear canal 1615. The ear canal 1615 may approximate the geometry of the ear canal of the subject. For example, the ear canal 1615 may include the geometry of a human adult subject or a human child subject.

[0151] Fig.11A Illustrated is a cross-sectional view of an example apparatus having an artificial ear canal and pinna for modeling characteristics of an ear, according to some embodiments. Fig. 11B Illustrated according to some embodiments Fig.11AAn isometric cross-sectional view of an artificial ear canal and auricle of an example device of the present invention. The system may include a base 1620 of a device for modeling characteristics of an ear. The base 1620 may be connected to the auricle 1610. The auricle may include an ear canal 1615. The base 1620 may be connected to a corresponding mounting portion 1025 of a device 1200 including a tympanic membrane 1100. The device 1200 may include any embodiment, variation, or example of a device as disclosed herein. The auricle 1610 may extend into the interior portion to form a seal 1012 with the device.

[0152] Medical consultation device

[0153] Fig. 12A The speculum of an otoscope of the present disclosure disposed in an ear of a subject is illustrated. The speculum of the otoscope may be an embodiment of the interrogation device disclosed herein. The interrogation system may collect data in response to a pneumatic excitation. The interrogation system may collect data related to membrane movement, for example, in response to a pneumatic excitation. The pneumatic excitation may include a pressure excitation, such as a gust of air. The pneumatic excitation may change the response of the membrane to an ultrasonic excitation. For example, the pneumatic excitation may cause the membrane to deflect, which may change the phase of the reflected ultrasound relative to a membrane not exposed to the pneumatic excitation. The deflection of the membrane may include a damped simple harmonic motion. The motion may be affected by a change 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.

[0154] 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.

[0155] 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.

[0156] 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 produce an elasticity metric. The elasticity measurement can characterize a series of measurements in response to an applied excitation. The elasticity metric can be derived from the response of the surface and can provide one or more indications of several different phenomena. For example, the elasticity metric 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, the elasticity metric can indicate the extent or characteristics of the fluid boundary, the fluid. In some examples, the elasticity metric 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. The fluid elasticity metric can be determined based on the ultrasonic characterization of the characteristic response and reflection of the surface or membrane to the surface excitation.

[0157] 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 shorten, 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.

[0158] Fig. 12B , Fig. 12C , Fig.12D and Fig.12E Example experimental data are illustrated showing how the output of an example otoscope may vary with different viscosities of fluid behind the membrane. 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 may be measured based on the time from the excitation to the damping period of the membrane oscillation. In some embodiments, an estimate of position, elasticity, or viscosity may be made by examining ringing properties. For example, the ringing properties may include at least one of an exponential decay time or a ringing period interval or frequency, such as decomposing the response into ringing properties, such as:

[0159] φ(t)=e -t / τ cos(2πft)

[0160] in:

[0161] φ(t) is the capture phase of a series of measurements;

[0162] τ is the exponential decay coefficient;

[0163] f is the ringing cycle frequency; and

[0164] t is time.

[0165] 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.

[0166] Each excitation event may cause a new deflection of the membrane. For example, a pulse excitation may pull the membrane in or push the membrane out for a limited time. For example, a square wave excitation may pull the membrane in or push the membrane 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 with the response field. Pneumatic excitation may be applied at a frequency of less than 100kHz, less than 1kHz, less than 100Hz, less than 10Hz, less than 1Hz or less, or within a range given by any two of the aforementioned values. Pneumatic excitation may be applied at a frequency greater than 1Hz, greater than 10Hz, greater than 100Hz, greater than 1kHz, greater than 100kHz or greater, or within a range given by any two of the aforementioned values. Pneumatic excitation may be applied in the range of 10Hz to 100Hz.

[0167] In an example, a consultation system as disclosed herein may include implementations, variations, or embodiments of the methods and systems disclosed in U.S. Patent No. 7,771,356 and U.S. Patent Publication Nos. 2019 / 0365292, 2018 / 0310917, and 2017 / 0014053, each of which is incorporated herein by reference in its entirety. The methods and systems disclosed in the incorporated references for obtaining information about tympanic membrane motion using ultrasonic echo signals can be used to generate one or more parameters related to the dynamic properties of the tympanic membrane. A system for measuring ultrasonic echo signals can cause movement of the tympanic membrane by applying a system pressure pulse, and then extracting a Doppler shift signal from the ultrasound to analyze the displacement of the TM and / or classify the viscosity of the ear effusion.

[0168] In an example, a medical consultation system as disclosed herein may include embodiments, variations or examples of the methods and systems disclosed in commonly assigned U.S. Patent Publication No. 2019 / 0200873 and U.S. Patent Publication No. 2017 / 0360302, each of which is incorporated herein by reference in its entirety. The methods and systems for characterizing membranes using optical coherence tomography (OCT) as disclosed in U.S. Patent Publication No. 2019 / 0200873 and U.S. Patent Publication No. 2017 / 0360302 can be used to generate one or more parameters related to the dynamic properties of the tympanic membrane. For example, the dynamic properties of the tympanic membrane may include a phase delay or time delay of a reflected light signal in response to an applied pneumatic excitation. OCT can be used to collect depth-related data related to the tympanic membrane. OCT can be used to collect frequency-related data, such as the absorption wavelength of a membrane or a fluid adjacent to the membrane.

[0169] Fig.14 is a flow chart of an example method 1400 for testing an otoscope using a model ear according to some embodiments. The method 1400 may include providing an artificial eardrum. According to operation 1410, the artificial eardrum may have an ultrasonic reflectivity that mimics the ultrasonic reflectivity of a biological eardrum. According to operation 1420, the method 1400 may include adjusting a volume or type of fluid proximate an interior surface of the artificial eardrum. According to operation 1430, the method 1400 may include adjusting a pressure of a gas proximate an interior surface of the artificial eardrum.

[0170] In some cases, adjusting one or more of the fluid volume, fluid type, or gas pressure can change the membrane deflection or membrane movement to controllably simulate a disease state of the ear. In some cases, adjusting the fluid type includes changing the viscosity of the fluid. In some cases, wherein the disease state of the ear is a bacterial or viral ear infection.

[0171] In some cases, method 1400 also includes aligning an otoscope to position the artificial tympanic membrane based on an optical reflection from a surface of the artificial tympanic membrane. In some cases, the optical reflection is presented on an anterior inferior quadrant of the artificial tympanic membrane. In some cases, the artificial tympanic membrane has one or more visual cues, wherein the visual cues include at least partially presenting the shape of the umbilicus or the malleus of the tympanic membrane.

[0172] In some cases, method 1400 also includes adjusting the movement of the artificial eardrum according to a set of ordinal values ​​or according to a continuous scale.

[0173] In some cases, method 1400 also includes directing a speculum of the acoustic otoscope toward an artificial tympanic membrane, wherein the artificial tympanic membrane is at least one of expandable or contractible and configured to move in response to applied pneumatic pressure changes. In some cases, adjustment of one or more of the fluid volume, fluid type, or gas pressure changes the rate at which the membrane moves to controllably simulate a disease state of the ear.

[0174] In some cases, method 1400 also includes providing an artificial ear canal having an approximate geometry of a human child subject or a human adult subject. In some cases, method 1400 also includes adjusting tension in a simulated ossicular chain coupled to the artificial eardrum. In some cases, the shape and hardness of the artificial eardrum are configured to simulate the presence of the ossicular chain.

[0175] In some cases, method 1400 also includes injecting fluid near the internal surface using a fluid injector. In some cases, regulating the gas pressure near the internal surface includes opening or closing the internal air valve and starting the internal air pump. In some cases, method 1400 also includes using an internal pressure gauge to measure the pressure of the gas near the internal surface. In some cases, method 1400 also includes using an external pressure gauge to measure the pressure of the gas near the external surface of the artificial eardrum. In some cases, method 1400 also includes using an external air pump to regulate the pressure of the gas near the external surface of the artificial eardrum.

[0176] In some cases, the method 1400 also includes controlling the operation of one or more of a fluid injector, an internal air valve, an internal air pump, an internal pressure gauge, an external pressure gauge, an external air pump, or a user-visible display using a processor. In some cases, the method 1400 also includes receiving pressure data from one or more of the internal pressure gauge or the external pressure gauge at the processor. In some cases, the method 1400 also includes using the pressure data to adjust one or more of: a fluid volume proximate to the internal surface; a gas pressure proximate to the internal surface; and a gas pressure proximate to the external surface.

[0177] Although the above operations illustrate a method 1400 for modeling an ear according to some embodiments, one of ordinary skill in the art will recognize many variations based on the teachings described herein. The steps can be completed in any order. Steps can be added or deleted. Many steps can include sub-steps. Many steps can be repeated as often as is beneficial to the method.

[0178] Fig.15is a flow chart of another example method 1500 for testing an otoscope using a model ear according to some embodiments. According to operation 1510, method 1500 may include providing an artificial eardrum. According to operation 1520, method 1500 may include adjusting a volume or type of fluid proximate an interior surface of the artificial eardrum. According to operation 1530, method 1500 may include adjusting a pressure of a gas proximate an interior surface of the artificial eardrum. According to operation 1540, method 1500 may adjust a volume or type of fluid and a pressure of a gas to produce a selected movement characteristic according to an activity scale by changing membrane movement.

[0179] In some cases, adjusting one or more of the fluid volume, fluid type, or gas pressure changes the membrane deflection or membrane movement to controllably simulate a disease state of the ear. In some cases, the disease state of the ear is a bacterial or viral ear infection. In some cases, adjustment of the fluid type includes changing the viscosity of the fluid.

[0180] In some cases, method 1500 also includes aligning an otoscope to position the artificial tympanic membrane based on an optical reflection from a surface of the artificial tympanic membrane. In some cases, the optical reflection is presented on an anterior inferior quadrant of the artificial tympanic membrane. In some cases, the artificial tympanic membrane has one or more visual cues, wherein the visual cues include at least partially presenting the shape of the umbilicus or the malleus of the tympanic membrane.

[0181] In some cases, the activity scale includes a set of ordinal values ​​or a continuous scale.

[0182] In some cases, method 1500 also includes directing a speculum of the acoustic otoscope toward an artificial tympanic membrane, wherein the artificial tympanic membrane is at least one of expandable or contractible and is configured to move in response to a change in applied pneumatic pressure.

[0183] In some cases, adjustment of one or more of fluid volume, fluid type, or gas pressure changes the rate at which the membrane moves to controllably simulate a disease state of the ear.

[0184] In some cases, method 1500 also includes providing an artificial ear canal having an approximate geometry of a human child subject or a human adult subject. In some cases, the inner portion includes a simulated ossicular chain coupled to the tympanic membrane. In some cases, method 1500 also includes adjusting tension in the simulated ossicular chain coupled to the artificial tympanic membrane. In some cases, the shape and hardness of the artificial tympanic membrane are configured to mimic the presence of the ossicular chain.

[0185] In some cases, method 1500 also includes injecting fluid near the internal surface using a fluid injector. In some cases, method 1500 also includes regulating the gas pressure near the internal surface including opening or closing the internal air valve and starting the internal air pump. In some cases, method 1500 also includes using an internal pressure gauge to measure the pressure of the gas near the internal surface. In some cases, method 1500 also includes using an external pressure gauge to measure the pressure of the gas near the external surface of the artificial eardrum. In some cases, method 1500 also includes using an external air pump to regulate the pressure of the gas near the external surface of the artificial eardrum.

[0186] In some cases, the method 1500 also includes controlling the operation of one or more of a fluid injector, an internal air valve, an internal air pump, an internal pressure gauge, an external pressure gauge, an external air pump, or a user-visible display using a processor. In some cases, the method 1500 also includes receiving pressure data from one or more of the internal pressure gauge or the external pressure gauge at the processor. In some cases, the method 1500 also includes using the pressure data to adjust one or more of: a fluid volume proximate to the internal surface; a gas pressure proximate to the internal surface; and a gas pressure proximate to the external surface.

[0187] Although the above operations illustrate a method 1500 for modeling an ear according to some embodiments, one of ordinary skill in the art will recognize many variations based on the teachings described herein. The steps can be completed in any order. Steps can be added or deleted. Many steps can include sub-steps. Many steps can be repeated as often as is beneficial to the method.

[0188] Disclosed herein is a method for testing an otoscope using a model ear including an artificial eardrum. In some cases, the method includes providing an artificial eardrum. In some cases, the method includes adjusting the volume and / or type of fluid proximate to an interior surface of the artificial eardrum. In some cases, the method includes adjusting the pressure of a gas proximate to the interior surface of the artificial eardrum. In some cases, adjusting two or more of the fluid volume, fluid type, or gas pressure changes membrane deflection or membrane movement to controllably simulate a disease state of the ear.

[0189] Digital processing device

[0190] Fig.16 is a schematic diagram illustrating an example apparatus for modeling characteristics of an ear, including a digital processing apparatus and a display visible to a user, according to some embodiments.

[0191] In some embodiments described herein, the apparatus, system, machine, and method of use described herein include a digital processing device or its use. For example, a digital processing device can be used to control various aspects of the apparatus, method, and system disclosed herein. For example, a digital processing device can be used to perform one or more operations of a method of testing an otoscope using a model ear including an artificial tympanic membrane. The digital processing device may include a computing system, for example, a computing system including a memory, which includes one or more steps for performing a method of testing a tympanic membrane. The digital processing device may be configured to perform one or more steps of method 1400 or method 1500, as disclosed herein. The digital processing device may be configured to control the operation of one or more of the following: a fluid syringe, an internal air valve, an internal air pump, an internal pressure gauge, an external pressure gauge, an external air pump, or a user-visible display. The digital processing device may be configured to receive pressure data from one or more of the internal pressure gauge or the external pressure gauge. The digital processing device may receive and / or retrieve one or more data sets from the apparatus or system disclosed herein. The digital processing device may be configured to use pressure data to adjust one or more of the following: a fluid volume close to an internal surface; a gas pressure close to an internal surface; and a gas pressure close to an external surface. The digital processing apparatus may include a database management system for one or more data sets.

[0192] 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.

[0193] 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.

[0194] In some embodiments, the digital processing apparatus includes an operating system configured to execute executable instructions. An operating system is software, such as programs and data, that manages the hardware of the device and provides services for executing application programs.

[0195] 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 requires power to maintain the stored information. In some embodiments, the device is a non-volatile memory and retains the stored information 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.

[0196] 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.

[0197] In some embodiments, the digital processing apparatus 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 non-limiting examples, 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.

[0198] refer to Fig.16In certain embodiments, the example digital processing device 710 is programmed or otherwise configured to control or implement the apparatus and methods as described herein. The device 710 can adjust various aspects of the disclosed systems and methods for classifying tympanic membranes, and systems and methods for training computer-implemented classifiers, such as, for example, performing processing steps. In this embodiment, the digital processing device 710 includes a central processing unit (CPU, also referred to herein as a "processor" and "computer processor") 1605, which can be a single-core or multi-core processor, or a plurality of processors for parallel processing. The digital processing device 710 also includes a memory or memory location 1610 (e.g., random access memory, read-only memory, flash memory), an electronic storage unit 1615 (e.g., a hard disk), a communication interface 1620 (e.g., a network adapter) for communicating with one or more other systems, and peripheral devices 1625 (e.g., cache, other memory, data storage, and / or an electronic display adapter). Memory 1610, storage unit 1615, interface 1620 and peripheral device 1625 communicate with CPU 1605 via a communication bus (solid line) (such as a motherboard). Storage unit 1615 may be a data storage unit (or data repository) for storing data. Digital processing device 710 may be effectively coupled to a computer network ("network") 1630 by means of communication interface 1620. Network 1630 may be the Internet, the Internet and / or an extranet, or an intranet and / or extranet that communicates with the Internet. In some cases, network 1630 is a telecommunications and / or data network. Network 1630 may include one or more computer servers, which may implement distributed computing, such as cloud computing. In some cases, network 1630 may implement a peer-to-peer network by means of device 710, which may enable devices coupled to device 710 to act as clients or servers.

[0199] Continue to refer Fig.16 , CPU 1605 may execute a series of machine-readable instructions that may be embodied in a program or software. The instructions may be stored in a memory location, such as memory 1610. The instructions may be directed to CPU 1605, which may 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 1605 may include acquisition, decoding, execution, and writeback. CPU 1605 may be part of a circuit such as an integrated circuit. One or more other components of device 710 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).

[0200] Continue to refer Fig.16, storage unit 1615 may store files, such as drivers, libraries, and saved programs. Storage unit 1615 may store user data, such as user preferences and user programs. In some cases, digital processing device 710 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 710 may communicate with one or more remote computer systems via network 1630. For example, device 710 may communicate with a user's remote computer system.

[0201] Examples of remote computer systems include personal computers (e.g., portable PCs), tablet computers (e.g., iPad, GalaxyTab), phones, smartphones (e.g. iPhone, Android-enabled devices, ) or a personal digital assistant.

[0202] The methods described herein may be performed by machine (e.g., computer processor) executable code stored on an electronic storage location (e.g., memory 1610 or electronic storage unit 1615) of digital processing device 710. Machine executable code or machine readable code may be provided in the form of software. During use, the code may be executed by processor 1605. In some cases, the code may be retrieved from storage unit 1615 and stored in memory 1610 for ready access by processor 1605. In some cases, electronic storage unit 1615 may be excluded and machine executable instructions may be stored in memory 1610.

[0203] The digital processing device 710 may include or communicate with an electronic display 690, which includes a user interface (UI) 1640. Examples of UIs include, but are not limited to, graphical user interfaces (GUIs) and web-based user interfaces. In some cases, the electronic display 690 may be connected to the computer system 710 via a network (e.g., via network 1630).

[0204] 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 non-limiting examples, CD-ROMs, DVDs, flash memory devices, solid-state memories, disk drives, tape drives, optical drives, cloud computing systems and servers, etc. In some cases, the programs and instructions are permanently, substantially permanently, semi-permanently, or non-temporarily encoded on the medium.

[0205] In some embodiments, the platforms, systems, media, and methods disclosed herein include at least one computer program, or its use. The computer program includes a sequence of instructions that can be executed in a CPU of a digital processing device, and the sequence of instructions 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. Based on the disclosure provided herein, those skilled in the art will recognize that computer programs can be written in various versions of various languages.

[0206] The functionality of the computer readable instructions may be combined or distributed as desired in various environments. In some embodiments, the computer program comprises one sequence of instructions. In some embodiments, the computer program comprises multiple sequences of instructions. In some embodiments, the computer program is provided from one location. In other embodiments, the computer program is provided from multiple 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 accessories, or a combination thereof.

[0207] In some embodiments, the platform, system, medium and method disclosed herein include software modules, server modules and / or database modules, or use thereof. In view of the disclosure provided herein, the software module is created by using machines, software and languages ​​known in the art through techniques known to those skilled in the art. The software modules disclosed herein are implemented in a variety of ways. In various embodiments, the software module includes a file, a piece of code, a programming object, a programming structure or a combination thereof. In further various embodiments, the software module includes multiple files, multiple pieces of code, multiple programming objects, multiple programming structures or a combination thereof. In various embodiments, the one or more software modules include, by way of non-limiting example, a network application, a mobile application and a standalone application. In some embodiments, the software module is in a computer program or application. In other embodiments, the software module is in more than one computer program or application. In some embodiments, the software module is hosted on a machine. In other embodiments, the software module is hosted on more than one machine. In further embodiments, the software module is hosted on a cloud computing platform. In some embodiments, the software module is hosted on one or more machines located in one location. In other embodiments, the software module is hosted on one or more machines located in more than one location.

[0208] In some embodiments, the platform, system, medium and method disclosed herein include one or more databases or their use. In view of the disclosure provided herein, those skilled in the art will recognize that many databases are suitable for storing and retrieving data sets from the medical inquiry system, storing classified databases, determining parameters from one or more databases, storing parameters associated with classified databases, etc. In various embodiments, suitable databases include, for example, relational databases, non-relational databases, object-oriented databases, object databases, entity relationship model databases, associated databases, and XML databases. Further non-limiting examples include SQL, PostgreSQL, MySQL, Oracle, DB2, and Sybase. In some embodiments, the database is based on the Internet. In further embodiments, the database is based on a network. In further embodiments, the database is based on cloud computing. In other embodiments, the database is based on one or more local computer storage devices.

[0209] Example

[0210] Fig.13Example experimental data obtained using Doppler ultrasound measurements in response to a pneumatic challenge are illustrated. The data show that various types of effusions can be identified based on the vibration frequency and amplitude. The data points in the upper left corner are from samples with air behind the membrane (e.g., no effusion) and show high vibration frequency and high amplitude. The data points in the lower left corner are from samples with high viscosity effusions and show high frequency and very low amplitude. The data points in the upper right corner are from samples with medium and lower viscosity fluids and show high amplitude and low frequency vibrations.

[0211] The following data table shows example experimental data, which shows that the device of the present disclosure is adjusted according to the activity scale to produce selected movement characteristics. We used artificial eardrums of different hardnesses from Shore hardness 20A to Shore hardness 70A. We arranged for clinicians to view the artificial eardrum using a standard otoscope equipped with a manual inflatable bulb for pneumatic otoscopy. Our clinicians are pediatricians who often use pneumatic otoscopes in practice. The ear body model is also configured to open the external auditory canal to the environment (i.e., open seal), so that the blowing effect is slightly weakened due to leakage, or the external auditory canal is closed to the environment ("closed seal"). A needle valve is used to adjust the damping of the system. The entrance to the external auditory canal has an elastomeric covering above the entrance aperture, and the elastomeric covering has a hole with a diameter of 2 mm. This allows the outer surface of the speculum to be fully sealed with the external auditory canal.

[0212] The scale of tympanic membrane mobility in response to air insufflation was based on clinician observation of the expected movement of the tympanic membrane in vivo, with "3" being normal, "2" being somewhat hypermobile, "1" being hypermobile, "4" being somewhat too stiff, and "5" being too stiff. Based on the data, we determined that the average closest to normal was 70 A. We also determined that the open condition introduced too much uncertainty in tympanic membrane mobility and represented an excessively leaky state. We presented tympanic membrane stiffness in a random order to reduce observation bias caused by pattern recognition.

[0213] We repeated the same method with artificial eardrums in the range of values ​​around Shore 70A. For this kit, we did not use the "open" position on the ear canal seal. We found that values ​​close to the normal average measurements were for Shore 70A and 80A artificial eardrums.

[0214]

[0215]

[0216] Table 1: Test 1

[0217]

[0218] Table 2: Test 2

[0219] Although preferred embodiments of the present invention have been shown and described herein, it will be readily understood by those skilled in the art that such embodiments are provided by way of example only. Those skilled in the art will now appreciate that many modifications, changes, and substitutions will be appreciated without departing from the present invention. It should be understood that various alternatives to the embodiments of the present invention described herein may be employed in the practice of the present invention. The following claims are intended to define the scope of the present invention and therefore cover methods and structures within the scope of these claims and their equivalents.

Claims

1. An apparatus for modeling characteristics of an ear including an eardrum, the apparatus comprising: an artificial eardrum having an ultrasonic reflectivity that mimics the ultrasonic reflectivity of a biological eardrum; a housing coupled to the artificial eardrum and further defining an interior portion coupled to an interior surface of the artificial eardrum, the interior portion having an adjustable volume of fluid or an adjustable type of fluid, and the interior portion having an adjustable gas pressure; and An air valve and an air pump are operably connected to the internal portion and are configured to change the gas pressure within the internal portion by opening or closing the air valve and starting the air pump so as to controllably change the movement rate of the artificial eardrum, thereby controllably simulating a disease state of the ear.

2. The device of claim 1, wherein modulation of one or more of the fluid volume or the fluid type changes membrane deflection or membrane movement to controllably mimic a disease state of the ear.

3. The device of claim 1, wherein modulation of the fluid type changes membrane deflection or membrane movement to controllably mimic a disease state of the ear, and modulation of the fluid type comprises changing the viscosity of the fluid.

4. The device of claim 1, wherein the disease state of the ear is a bacterial or viral ear infection.

5. The device of claim 1, wherein the shape of the artificial eardrum exhibits optical reflections from a surface of the artificial eardrum, thereby enabling positioning of the artificial eardrum and alignment of an otoscope.

6. The apparatus of claim 1, wherein the artificial eardrum has one or more visual cues, wherein the visual cues include at least partially representing the shape of the umbilicus or the malleus of the eardrum.

7. The device of claim 1, wherein the artificial tympanic membrane is one or more of expandable or contractible and is further configured to move in response to changes in applied pneumatic pressure.

8. The device of claim 1, wherein modulation of one or more of the fluid volume or the fluid type changes the rate at which the membrane moves, thereby controllably mimicking a disease state of the ear.

9. The device of claim 1, wherein the housing further defines an exterior portion, wherein the exterior portion includes an artificial ear canal having an approximate geometry of a human pediatric subject or a human adult subject.

10. The apparatus of claim 1, wherein the inner portion comprises a simulated ossicular chain coupled to the artificial eardrum. The device according to claim 10 , wherein the simulated ossicular chain has controllable tension.

12. The device of claim 1, wherein the shape and stiffness of the artificial eardrum are configured to mimic the presence of an ossicular chain.

13. The device of claim 1, wherein the interior portion comprises an opening for a fluid syringe or the fluid syringe.

14. The device of claim 1, wherein the interior portion includes the air valve and the air pump or openings for the air valve and the air pump.

15. The apparatus of claim 1, wherein the housing further defines an outer portion coupled to an outer surface of the artificial tympanic membrane.

16. The device of claim 1, further comprising a processor configured to control operation of one or more of: a fluid injector, the air valve, the air pump, an internal pressure gauge, an external pressure gauge, an external air pump, or a user-visible display.

17. The apparatus of claim 16, wherein the processor is configured to receive pressure data from one or more of the internal pressure gauge or the external pressure gauge.

18. The apparatus of claim 16, wherein the pressure data is used to adjust one or more of: the adjustable volume of fluid proximate the interior surface; said adjustable gas pressure proximate said interior surface; and The pressure of the gas proximate the exterior surface.

19. A method of testing an otoscope using a model ear including an artificial eardrum, the method comprising: providing the artificial eardrum having an ultrasonic reflectivity that mimics the ultrasonic reflectivity of a biological eardrum; adjusting the volume or type of fluid proximate to the interior surface of the artificial eardrum; as well as The gas pressure near the inner surface of the artificial eardrum is adjusted by opening or closing an air valve and starting an air pump so as to controllably change the movement rate of the artificial eardrum, thereby controllably simulating a disease state of the ear, wherein the air valve and the air pump are operably connected to the inner portion of the model ear.

20. An apparatus for modeling properties of an ear including an eardrum, the apparatus comprising: Artificial eardrum; a housing coupled to the artificial eardrum and further defining an interior portion coupled to an interior surface of the artificial eardrum, the interior portion having an adjustable volume or type of fluid and an adjustable gas pressure; and an air valve and an air pump operably connected to the inner portion and configured to change the gas pressure within the inner portion by opening or closing the air valve and activating the air pump so as to controllably change the movement rate of the artificial eardrum to controllably simulate a diseased state of the ear, Adjustment of the fluid volume or type and the gas pressure alters membrane movement to produce selected movement characteristics based on the activity scale.

21. A method of testing an otoscope using a model ear including an artificial eardrum, the method comprising: Providing artificial eardrums; adjusting the volume or type of fluid proximate to the interior surface of the artificial eardrum; as well as regulating the pressure of gas proximate the inner surface of the artificial eardrum by opening or closing an air valve and activating an air pump so as to controllably vary the rate of movement of the artificial eardrum to controllably mimic a diseased state of the ear, wherein the air valve and the air pump are operably connected to the inner portion of the model ear; Wherein said adjustment of said fluid volume or type and said adjustment of said gas pressure alters membrane movement to produce selected movement characteristics based on an activity scale.

22. An apparatus for modeling properties of an ear including an eardrum, the apparatus comprising: Artificial eardrum; a housing coupled to the artificial eardrum and further defining an interior portion coupled to an interior surface of the artificial eardrum, the interior portion having an adjustable volume or type of fluid and an adjustable gas pressure; as well as an air valve and an air pump operably connected to the inner portion and configured to change the gas pressure within the inner portion by opening or closing the air valve and activating the air pump so as to controllably change the movement rate of the artificial eardrum to controllably simulate a diseased state of the ear, Wherein modulation of two or more of the fluid volume or the fluid type and the gas pressure changes membrane deflection or membrane movement to controllably mimic a disease state of the ear.

23. A method of testing an otoscope using a model ear including an artificial eardrum, the method comprising: Providing artificial eardrums; adjusting the volume or type of fluid proximate to the interior surface of the artificial eardrum; as well as regulating the pressure of gas proximate the inner surface of the artificial eardrum by opening or closing an air valve and activating an air pump so as to controllably vary the rate of movement of the artificial eardrum to controllably mimic a diseased state of the ear, wherein the air valve and the air pump are operably connected to the inner portion of the model ear; The modulation of two or more of the fluid volume, the fluid type, or the gas pressure changes membrane deflection or membrane movement to controllably mimic a disease state of the ear.

Images