Systems and methods for optical illumination within a speculum tip - Patents.com

Abstract

The speculum, operable to be placed within the ear of a subject, may include a housing. The housing may include a light-guiding element. The transmitted optical illumination may be conducted through the light-guiding element by total internal reflection. The housing may include a lumen. The housing may be configured to allow the reflected optical illumination to propagate through the lumen. The speculum may include one or more coupling portions that couple the transmitted optical illumination from the light source to the light-guiding element. The one or more coupling portions may be shaped as a conical section.

Description

[Background technology]

[0001] (Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 214,938, filed June 25, 2021, which is incorporated by reference in its entirety.

[0002] Acute otitis media (AOM) is an inflammatory process in the middle ear and is the most common clinical condition seen by pediatricians in children aged 15 years and younger. AOM is generally associated with the presence of middle ear effusion and is considered a middle ear inflammation. Complications of undiagnosed AOM can include hearing loss. If left untreated in children, recurrent AOM can also lead to delays in the development of speech and language skills.

[0003] Using existing non-invasive methods, the likelihood of obtaining an accurate diagnosis may not exceed 50%. Furthermore, existing non-invasive methods may only be useful in identifying the presence of an effusion, and they often do not provide information regarding the type of effusion. Due to the risks associated with undiagnosed AOM and the perceived unreliability of existing diagnostic tests, patients are often prescribed antibiotics, which may be ineffective in treating viral effusions. In addition to the increased cost burden of unnecessary antibiotic treatment, patients are exposed to antibiotic side effects and the concomitant and significant risk of developing antibiotic resistance. Summary of the Invention [Means for solving the problem]

[0004] The devices and methods described herein may improve upon existing non-invasive techniques by measuring ultrasound data reflected from a biological membrane that coincides with a pneumatic excitation. The size of the diagnostic target may be small and the ultrasound is invisible to the human eye. An optical source and detection system may be provided. The optical source and detection system may facilitate alignment of the ultrasound beam. Because the size of the biological lumen may be small, the optical source and detection system may be space efficient. The present disclosure provides improvements for delivering optical illumination to a target. The present disclosure provides improvements for receiving optical illumination from a target even in the presence of obstructions.

[0005] In one aspect, the present disclosure provides a speculum operable to be placed within an ear of a subject. The speculum may comprise a housing comprising a light-guiding element, where the transmitted optical illumination is conducted through the light-guiding element by total internal reflection, the housing having a lumen therein, the housing configured to allow the reflected optical illumination to propagate through the lumen, and one or more coupling portions that couple the transmitted optical illumination from a light source to the light-guiding element, the one or more coupling portions shaped as conical sections.

[0006] In another aspect, the present disclosure provides an otoscope, the otoscope may include a speculum having a lumen therein and comprising a light-guiding element, where transmitted optical illumination is conducted by the light-guiding element by total internal reflection and where reflected optical illumination is propagated through the lumen of the speculum, and one or more coupling portions that couple the transmitted optical illumination from a light source to the light-guiding element, the one or more coupling portions being shaped as a conical section.

[0007] In another aspect, the disclosure provides a method of using an otoscope, which may include directing optical illumination of a light source to one or more coupling portions, where the one or more coupling portions are shaped as conical sections, collimating the optical illumination using the one or more coupling portions, directing the optical illumination from the one or more coupling portions to a light-guiding element, where the optical illumination is conducted by the light-guiding element by total internal reflection, and collecting reflected optical illumination from a target within a lumen of a housing, where the housing forms a portion of a speculum of the otoscope.

[0008] In some embodiments, the method further includes directing the pneumatic excitation towards the target. In some embodiments, the method further includes directing ultrasound and / or illumination towards the target. In some embodiments, the method further includes measuring a response of the target to the pneumatic excitation in a reflected ultrasound signal. In some embodiments, the method further includes determining a state or condition of the object based on the reflected optical illumination and the response.

[0009] In another aspect, the present disclosure provides a speculum operable to be placed in an ear of a subject, the speculum comprising a housing comprising a light-guiding element, wherein the transmitted optical illumination is conducted through the light-guiding element by total internal reflection, the housing having a lumen therein, the housing configured to allow the reflected optical illumination to propagate through the lumen, and one or more coupling portions coupling the transmitted optical illumination from the light source to the light-guiding element, the one or more coupling portions shaped as conical sections. In some embodiments, the device further comprises an insert, the insert configured to be mechanically coupled to the housing. In some embodiments, the insert comprises a lens, an ultrasound transducer, one or more electrical leads electrically coupled to the ultrasound transducer, one or more electrical leads and one or more wires electrically coupled to the ultrasound transducer, or any combination thereof. In some embodiments, the ultrasound transducer comprises a capacitive micromachined ultrasound transducer. In some embodiments, the light-guiding element comprises an elliptical shape. In some embodiments, the light-guiding element is configured to be a parabolic mirror when the light beam of the light source interacts with the light-guiding element. In some embodiments, the light-guiding element comprises a launch point. In some embodiments, the light-guiding element comprises one or more launch points. In some embodiments, the launch point comprises a geometric shape, the geometric shape comprising a flat, circular, oval, concave, rectangular, flat, or V-shape. In some embodiments, the housing comprises a proximal seal member, a distal seal member, or any combination thereof. In some embodiments, the proximal seal member and the distal seal member comprise an elastomeric material configured to seal the housing within the ear of the subject. In some embodiments, the ultrasound transducer is electrically coupled to one or more electrical leads of the insert by one or more wires. In some embodiments, the insert comprises a spacer structure configured to space the insert from an inner surface of the lumen of the housing.In some embodiments, the insert comprises a structure configured to releasably couple to the housing when inserted into the housing. In some embodiments, the structure comprises a groove, hole, or hook configured to snap-fit ​​to the structure of the housing. In some embodiments, the housing is partially or entirely steam polished, aluminum coated, chrome coated, or any combination thereof. In some embodiments, the insert comprises an electrical coupling interface comprising an electromechanical structure configured to releasably couple to and electrically communicate with the receptacle. In some embodiments, the electromechanical structure comprises one or more electrical pads adjacent a surface of the one or more mechanical coupling interfaces. In some embodiments, the one or more mechanical coupling interfaces comprise a hook configured to couple with the clasp receptacle.

[0010] In another aspect, the present disclosure provides an otoscope having a lumen therein and comprising a light-guiding element, where the transmitted optical illumination is conducted by the light-guiding element by total internal reflection and the reflected optical illumination is propagated through the lumen of the speculum, and one or more coupling portions coupling the transmitted optical illumination from a light source to the light-guiding element, the one or more coupling portions being shaped as conical sections. In some embodiments, the otoscope further comprises an insert, the insert configured to mechanically couple to the speculum. In some embodiments, the insert comprises a lens, an ultrasound transducer, one or more electrical leads electrically coupled to the ultrasound transducer, one or more electrical leads and one or more wires electrically coupled to the ultrasound transducer, or any combination thereof. In some embodiments, the ultrasound transducer comprises a capacitive micromachined ultrasound transducer. In some embodiments, the light-guiding element comprises an elliptical shape. In some embodiments, the light-guiding element is configured to be a parabolic mirror when the light beam of the light source interacts with the light-guiding element. In some embodiments, the light-guiding element comprises an emission point. In some embodiments, the light-guiding element comprises at least two emission points. In some embodiments, the emission point comprises a geometric shape, the geometric shape comprises a flat, a circular, an oval, a concave, a rectangular, a flat, or a V-shape. In some embodiments, the speculum comprises a proximal seal member, a distal seal member, or any combination thereof. In some embodiments, the proximal seal member and the distal seal member comprise an elastomeric material configured to seal the housing within the ear of the subject. In some embodiments, the ultrasound transducer is electrically coupled to one or more electrical leads of the insert by one or more wires. In some embodiments, the insert comprises a spacer structure configured to space the insert from an interior surface of the lumen of the speculum. In some embodiments, the insert comprises a structure configured to releasably couple to the speculum when inserted into the speculum.In some embodiments, the structure comprises a groove, hole, or hook configured to snap-fit ​​onto the structure of the speculum. In some embodiments, the speculum is partially or entirely steam polished, aluminum coated, chrome coated, or any combination thereof. In some embodiments, the insert comprises an electrical coupling interface comprising an electromechanical structure configured to releasably couple to and electrically communicate with the receptacle. In some embodiments, the electromechanical structure comprises one or more electrical pads adjacent a surface of the one or more mechanical coupling interfaces. In some embodiments, the one or more mechanical coupling interfaces comprise a hook configured to couple with the clasp receptacle.

[0011] In another aspect, the disclosure provides a method of using an otoscope, comprising: directing optical illumination of a light source to one or more coupling portions, the one or more coupling portions being shaped as conical sections; collimating the optical illumination using the one or more coupling portions; directing the optical illumination from the one or more coupling portions to a light-guiding element, the optical illumination propagating through the light-guiding element by total internal reflection; and collecting reflected optical illumination from a target within a lumen of a housing, the housing forming a part of a speculum of the otoscope. In some embodiments, the method further comprises directing a pneumatic excitation toward the target. In some embodiments, the method further comprises directing ultrasound or illumination toward the target. In some embodiments, the method further comprises measuring a response of the target to the pneumatic excitation in a reflected ultrasound signal. In some embodiments, the method further comprises determining a state or condition of the subject based on the reflected optical illumination and the response.

[0012] Another aspect of the disclosure provides a system comprising one or more computer processors and, coupled thereto, a computer memory comprising machine executable code that, upon execution by the one or more computer processors, implements any of the methods described above or anywhere herein.

[0013] Additional aspects and advantages of the present disclosure will become readily apparent to those skilled in the art from the following detailed description, in which only illustrative embodiments of the present disclosure are shown and described. As will be realized, the present disclosure is capable of other and different embodiments, and its several details are capable of modification in various obvious respects, all without departing from the present disclosure. Thus, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

[0014] (Incorporated by reference) All publications, patents, and patent applications mentioned herein are incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. To the extent that the publications, patents, and patent applications incorporated by reference do not conflict with the disclosure contained herein, the present specification is intended to supersede and / or take precedence over any such conflicting material. [Brief description of the drawings]

[0015] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings (also referred to herein as figures ("Figures", "FIGs", and "FIGS")).

[0016] [Figure 1] FIG. 1 illustrates an exploded view of an exemplary speculum tip, according to an embodiment.

[0017] [Figure 2A] FIG. 2A illustrates a lateral view of an exemplary speculum tip, according to an embodiment.

[0018] [Figure 2B] FIG. 2B illustrates a cross-sectional view of an exemplary speculum tip, according to an embodiment.

[0019] [Figure 3A] FIG. 3A illustrates a view of the proximal end of an exemplary speculum tip, according to an embodiment.

[0020] [Figure 3B] FIG. 3B illustrates an enlarged side view of the distal end of an exemplary speculum tip, in accordance with an embodiment.

[0021] [Figure 4A] FIG. 4A illustrates a view of the distal end of an exemplary speculum tip insert (e.g., transducer-mounted core (XMC)), according to an embodiment.

[0022] [Figure 4B] FIG. 4B illustrates an enlarged isometric view of the distal end of an exemplary speculum tip, according to an embodiment.

[0023] [Diagram 5] FIG. 5 illustrates another example of a speculum tip with a triangular projection point, according to an embodiment.

[0024] [Figure 6A] FIG. 6A illustrates a truncated conical section comprising half an ellipse, according to an embodiment.

[0025] [Figure 6B] FIG. 6B illustrates an example of a petal shape as a segmented truncated cone section, according to an embodiment.

[0026] [Figure 7A]FIG. 7A shows an image of an illuminated, manually sharpened speculum tip, according to an embodiment.

[0027] [Figure 7B] FIG. 7B shows an image of an illuminated vapor-polished speculum tip, according to an embodiment.

[0028] [Figure 7C] FIG. 7C illustrates experimental data regarding optical transmission through an exemplary speculum with varying polishing of the exterior surface of the speculum.

[0029] [Figure 8A] 8A-8B show images of commercial Welsch Allyn illumination patterns for a speculum tip with only a conical section and a speculum tip with one or more petals obtained at varying distances from the speculum exit tip. [Figure 8B] 8A-8B show images of commercial Welsch Allyn illumination patterns for a speculum tip with only a conical section and a speculum tip with one or more petals obtained at varying distances from the speculum exit tip.

[0030] [Figure 8C] FIG. 8C illustrates experimental data regarding the intensity of light transmitted through an exemplary speculum as the optical source coupling method is changed.

[0031] [Figure 9A] FIG. 9A illustrates a speculum tip with fiber optic coupling, according to an embodiment.

[0032] [Figure 9B] FIG. 9B illustrates a speculum tip with a conical section, according to an embodiment.

[0033] [Figure 9C] FIG. 9C illustrates a speculum tip with a conical cross section in addition to one or more light-guiding elements ("petals"), according to an embodiment.

[0034] [Figure 9D] FIG. 9D shows experimental data regarding the intensity of light transmitted through an exemplary speculum as the geometry and / or method of light coupling from the light source is changed.

[0035] [Figure 10] 10A-10D illustrate the results of modeling the coupling angle of light into the speculum tip.

[0036] [Figure 11] FIG. 11 illustrates the results of modeling the collimation properties of light coupled into the light-guiding element of a speculum tip, according to an embodiment.

[0037] [Figure 12A] FIG. 12A illustrates an image of light transmitted from an exemplary speculum tip at zero millimeter (mm) offset from the speculum tip.

[0038] [Figure 12B] FIG. 12B illustrates an image of light transmitted from an exemplary speculum tip at a 25 mm offset from the speculum tip.

[0039] [Figure 12C] FIG. 12C shows images of the illuminated speculum tip for speculum tips with and without elliptical light guide features (eg, petals) attached to a speculum cone section.

[0040] [Figure 13] FIG. 13 illustrates a computer system that is programmed or otherwise configured to implement the methods provided herein.

[0041] [Figure 14] FIG. 14 illustrates an exploded view of an exemplary speculum tip, according to an embodiment.

[0042] [Figure 15A]FIG. 15A illustrates a lateral view of an exemplary speculum tip, according to an embodiment.

[0043] [Figure 15B] FIG. 15B illustrates a cross-sectional view of an exemplary speculum tip, according to an embodiment.

[0044] [Figure 15C] FIG. 15C illustrates an isometric view of the proximal end of an exemplary speculum tip, in accordance with an embodiment.

[0045] [Figure 16A] FIG. 16A illustrates a view of the distal end of an exemplary speculum tip insert (e.g., XMC), according to an embodiment.

[0046] [Figure 16B] FIG. 16B illustrates an example of a speculum tip with a circular firing point, according to an embodiment.

[0047] [Figure 17A] FIG. 17A shows an image of a vapor-polished speculum tip, according to an embodiment.

[0048] [Figure 17B] FIG. 17B shows an image of a chrome coated speculum tip, where the chrome coating is removed on the emission and exit surfaces of the speculum tip, according to an embodiment.

[0049] [Figure 17C] FIG. 17C shows an image of a chrome coated speculum tip, according to an embodiment, where the chrome coating is removed on the speculum tip sidewall near the emission point and exit tip.

[0050] [Figure 18] 18A-18C show images of an experimental setup for measuring the light transmission and irradiance of light emitted from a speculum tip, according to an embodiment.

[0051] [Figure 19] FIG. 19 shows experimental results for the measured optical irradiance transmitted through a vapor-polished and chrome-coated speculum tip compared to the power of an illumination light-emitting diode (LED) provided at the proximal end of the speculum tip.

[0052] [Figure 20] FIG. 20 shows experimental results for the measured irradiance falloff as a function of distance away from the distal tip of a vapor-polished and chrome-coated speculum tip.

[0053] [Figure 21] FIG. 21 shows the measured experimental irradiance results over the course of five tests, where the irradiance was measured at a distance of 10 mm distal from the vapor polished and chrome coated speculum tip.

[0054] [Figure 22A] FIG. 22A shows an image of the experimental setup for measuring the transmitted optical power and / or irradiance of the speculum tip without the presence of tissue medium external to the speculum tip.

[0055] [Figure 22B] FIG. 22B shows an image of the experimental setup for measuring the transmitted optical power and / or irradiance of the speculum tip with tissue medium present external to the speculum tip.

[0056] [Figure 22C] FIG. 22C shows experimental results of absolute irradiance measured at the distal end of a vapor-polished and chrome-coated speculum tip with and without the presence of tissue medium on the exterior of the speculum tip.

[0057] [Figure 23] FIG. 23 shows images of the distal emitting tip of a vapor polished and chrome coated speculum measured at varying distances away from the distal emitting tip.

[0058] [Figure 24A] FIG. 24A shows a schematic diagram of a flat firing point geometry for a speculum tip, according to an embodiment.

[0059] [Figure 24B] FIG. 24B shows a schematic diagram of an oval firing point geometry for a speculum tip, according to an embodiment.

[0060] [Figure 24C] FIG. 24C shows a schematic diagram of a rectangular firing point geometry for a speculum tip, according to an embodiment.

[0061] [Figure 24D] FIG. 24D shows a schematic diagram of a rounded firing point geometry for a speculum tip, according to an embodiment.

[0062] [Figure 24E] FIG. 24E shows a schematic diagram of a concave firing point geometry for a speculum tip, according to an embodiment.

[0063] [Figure 24F] FIG. 24F shows a schematic diagram of a V-shaped firing point geometry for a speculum tip, according to an embodiment.

[0064] [Diagram 25] FIG. 25 shows experimental results of optical power at various distances from the speculum exit tip for various launch point geometries.

[0065] [Figure 26A] FIG. 26A shows experimentally simulated ray tracings for a speculum tip with a variable flat emission point geometry.

[0066] [Figure 26B] FIG. 26B shows experimentally simulated ray tracings for a speculum tip with a variable oval emission point geometry.

[0067] [Figure 26C] FIG. 26C shows experimentally simulated ray tracings for a speculum tip with a variable round emission point geometry.

[0068] [Figure 26D] FIG. 26D shows experimentally simulated ray tracings for a speculum tip with a variable rectangular emission point geometry.

[0069] [Figure 26E] FIG. 26E shows experimentally simulated ray tracing for a speculum tip with a V-shaped emission point geometry.

[0070] [Figure 26F] FIG. 26F shows experimentally simulated ray tracing for a speculum tip with a concave emission point geometry.

[0071] [Figure 27A] FIG. 27A shows images of various aluminum coated speculum tips, according to an embodiment.

[0072] [Figure 27B] FIG. 27B shows images of a patient's tympanic membrane, vapor polished and illuminated by various chrome and aluminum coated speculum tips.

[0073] [Figure 28] FIG. 28 shows a workflow diagram for a method of using an otoscope, according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0074] Detailed Description The devices, otoscopes, specula, and methods of use and manufacture as disclosed herein may address problems associated with devices for measuring optical and ultrasonic information. The embodiments of the present disclosure may improve the delivery and / or collection of light from biological membranes that may be characterized simultaneously with ultrasonic excitation. The devices, otoscopes, specula, and methods of use and manufacture as disclosed herein may address difficulties in the field of alignment of devices for measuring reflected ultrasonic signals. In some cases, the present disclosure addresses problems in the field of otoscopes.

[0075] For example, surface characterization using analysis of reflected ultrasound in the presence of pneumatic excitation may be improved if the delivery of optical illumination, pneumatic excitation, and ultrasound signals are space efficient. For example, surface characterization using analysis of reflected ultrasound in the presence of pneumatic excitation may be improved if the measurements of reflected ultrasound signals and reflected optical illumination are space efficient.

[0076] For example, surface characterization using analysis of reflected ultrasound in the presence of pneumatic excitation may be improved if the ultrasound is directed to the surface at an angle that will result in an ultrasound signal being returned to the transducer. Since the ultrasound excitation is invisible to the eye, particularly to the eye of the device operator, alignment of the ultrasound may be important. In one solution, a light source may be directed toward the surface, allowing the user to better adjust the alignment of the device. The light source may be substantially aligned with the ultrasound propagation. In the ear, the user may align the light source in the ear canal and reflect the light off the eardrum. A good reflection may result in a "cone of light". However, the ultrasound and light may not propagate in the same direction because the user cannot see directly through the center of the lens and / or the transducer may block the reflected light.

[0077] The devices, otoscopes, specula, and methods of use and manufacture thereof as disclosed herein may be used in combination with devices and methods for characterizing ductile membrane, surface, and subsurface properties, such as those described in, for example, commonly owned U.S. Patent Publication No. 2020 / 0107813, U.S. Patent Publication No. 2018 / 0310917, and U.S. Patent Publication No. 2017 / 0014053 (each of which is incorporated by reference in its entirety).

[0078] The devices, otoscopes, specula, and methods of use and manufacture thereof as disclosed herein may be used to characterize a number of biological tissues and provide various diagnostic information. The biological tissues may comprise patient organs. The specula may be placed within a body cavity to characterize the patient tissue. The patient organs or body cavities may comprise, for example, muscles, tendons, ligaments, mouth, tongue, pharynx, esophagus, stomach, intestines, anus, liver, gallbladder, pancreas, nose, larynx, trachea, lungs, kidneys, bladder, urethra, uterus, vagina, ovaries, testes, prostate, heart, arteries, veins, spleen, glands, brain, spinal cord, nerves, etc., or any combination thereof, to name a few.

[0079] The devices, otoscopes, specula, and methods of use and manufacture thereof as disclosed herein may be used to characterize the tympanic membrane. For example, the tympanic membrane may be characterized to determine ear conditions such as acute otitis media (AOM). If the ear exhibits AOM, characterization may include detection of the presence of effusion and characterization of the type of effusion as one of serous, mucous, purulent, or combinations thereof. In AOM, the middle ear effusion (MEE) may be induced by a pathogen and may be thin or serous in viral infections and thicker and purulent in bacterial infections. Thus, determining various properties of the fluid adjacent to the tympanic membrane (shape or thickness of the liquid, viscosity, or and / or other mechanical properties) may provide information that may be used to characterize the membrane and / or provide a diagnosis to the patient.

[0080] While various embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the invention. It is understood that various alternatives to the embodiments of the present invention described herein may be employed.

[0081] Each time the term "at least," "greater than," or "greater than or equal to" precedes a first number in a series of two or more numerical values, the term "at least," "greater than," or "greater than or equal to" applies to each and every numerical value in the series. For example, "greater than or equal to 1, 2, or 3" is equivalent to "greater than or equal to 1," "greater than or equal to 2," or "greater than or equal to 3."

[0082] Each time the term "less than", "less than", or "less than or equal to" precedes a first number in a series of two or more numerical values, the term "less than", "less than", or "less than or equal to" applies to each and every numerical value in the series. For example, "less than or equal to 3, 2, or 1" is equivalent to "less than or equal to 3", "less than or equal to 2", or "less than or equal to 1".

[0083] Certain invention embodiments herein contemplate numerical ranges. When a range exists, the range includes the range endpoints. In addition, all subranges and values ​​within the range exist as if explicitly stated. The term "about" or "approximately" may mean within an acceptable error range for a particular value, which will depend in part on how the value is measured or determined, e.g., the limitations of the measurement system. For example, "about" may mean within 1 or more than 1 standard deviation, according to the practice in the art. Alternatively, "about" may mean within a range of up to 20%, up to 10%, up to 5%, or up to 1% of a given value. When a particular value is described in the present application and claims, the term "about" may be assumed to mean within an acceptable error range for the particular value, unless otherwise stated. device

[0084] A speculum, such as one that houses a camera module, may be shaped like a conical section funnel, which in the limit mimics hyperbolic rotation. These hyperbolic funnels are often used to teach physics students about orbits and gravity due to the properties they exhibit. It may be difficult to send something through one of these funnels without a lot of swirling and friction. It may be difficult to approach the center of the funnel on a radial path of the funnel's optical axis, which may be advantageous to avoid swirling. In the case of optics, excessive swirling may result in many rays swirling around and exiting from the launch surface instead of the tip, which may result in light loss.

[0085] It may be advantageous to direct the light beam on a radial path of the optical axis of the funnel, leading from the LED to a direct route through the funnel, thus avoiding swirls. Methods that launch the light beam radially through the funnel may accomplish this goal to a certain extent. However, since LEDs are extended sources, there may be limitations to the efficiency of this scheme. Not all light beams can be controlled well enough to efficiently pass through the funnel, for example, due to the etendue nature of the source.

[0086] It may be advantageous to provide a shape substantially similar to an elliptical cross section attached to a funnel-shaped speculum. Such a shape may act as an elliptical mirror cross section and direct light rays along radial lines of the speculum, thus improving the coupling efficiency between the light source and the light rays exiting the speculum tip for illumination.

[0087] In some cases, the devices 200 and 600 described herein may include a speculum tip (207, 633) and an insert (e.g., XMC) (224, 602), as shown in Figures 1-5 and 14-16B. In some cases, the speculum tip may be configured to illuminate a biological surface or tissue of a patient or subject by redirecting a light source located on the proximal end of the device to the distal exit tip (202, 630) of the speculum tip. In some cases, the speculum tip described elsewhere herein may be configured such that light rays exiting the distal exit tip (202, 630) may reflect off surrounding surfaces (e.g., the inner surface of the subject's or patient's ear canal) and diffusely illuminate the subject's or patient's tympanic membrane. In some cases, the diffusely reflected illumination may increase the total amount of illumination on the subject's or patient's tympanic membrane, thereby enabling visualization and alignment of the device. In some cases, the speculum tip (207, 633) and the insert (e.g., XMC) (224, 602) may be made of the same or different materials. The speculum tip may be manufactured from a material that transmits light from the light source (e.g., visible, near infrared, etc.) with minimal loss. In some cases, the insert may be manufactured from a material that is electrically insulating and mechanically robust to retain the optical and ultrasonic components for precise, reproducible measurements. The biological surface may comprise the tympanic membrane of a patient or subject. In some cases, the illumination may comprise uniform and / or diffuse illumination that uniformly illuminates the biological surface and / or tissue. In some cases, the uniform and / or diffuse illumination may be generated by one or more light-guiding elements (212, 622) described elsewhere herein.

[0088] In some cases, the speculum tip (207, 633) may comprise a distal seal member (204, 628), an emission tip (202, 630), a speculum cone section (206, 632), one or more light-guiding elements (212, 622), a proximal seal member (208, 626), one or more light source alignment features (227, 620), one or more emission points (214, 618), or any combination thereof, as seen in Figures 1-5 and 14-16B.

[0089] In some cases, the light-guiding element (212, 622) may form part of an elliptical shape 316, as seen in FIG. 6B. The contour and shape of the light-guiding element may collimate to a point light source 314 or a vicinity of a point light source located on a distal launch point. In some cases, the light source may comprise a light emitting diode (LED). In some cases, the point source has an emission angle of up to about 50 degrees, about 60 degrees, about 70 degrees, about 80 degrees, about 90 degrees, about 100 degrees, about 120 degrees, about 130 degrees, about 140 degrees, about 150 degrees, about 160 degrees, about 170 degrees, or about 180 degrees. In some cases, the point source has an emission angle of at least about 50 degrees, about 60 degrees, about 70 degrees, about 80 degrees, about 90 degrees, about 100 degrees, about 120 degrees, about 130 degrees, about 140 degrees, about 150 degrees, about 160 degrees, about 170 degrees, or about 180 degrees.

[0090] As described elsewhere herein, the elliptical shape of the light-guiding element may prevent secondary and tertiary reflections at or near the coupled point source in a manner that causes the light rays to be reflected back out of the light-guiding element as they are coupled into the conical section, for example, as shown in FIG. 6A. The light-guiding element collimates the input light source in a manner that would prevent the light rays from exiting the light-guiding element with an angled path relative to the optical axis of the light-guiding element. Such an angled path would contribute to a loss in the total power of light transmitted to the speculum tip. In some cases, the shape or profile of the light-guiding element may comprise a petal shape of a flower. Minimizing angled reflections of light exiting relative to the optical axis of the light-guiding element may be important, especially when considering coupling of the light-guiding element with a conical section, as shown in FIG. 6A and described elsewhere herein. A light ray may exit a "collimated" portion of the speculum (e.g., a light-guiding element or petal) and enter the conical section of the speculum with a propagation direction that follows the radial plane of the conical section. In some cases, the exterior surface of the light-guiding element and / or the conical section may comprise a surface by which the light ray propagating within the light-guiding element and / or the conical section will undergo total internal reflection. In some cases, the total internal reflection may direct the light ray toward a radial path of the conical section and / or the light-guiding element. In some cases, the difference between the refractive index of the material of the conical section and / or the light-guiding section and the refractive index of air or a sample provided adjacent to the exterior surface of the conical section and / or the light-guiding section may modify the total internal reflection. The present principles may be utilized to increase the total internal reflection, for example, by coating or polishing that surface or region on the cone or the light-guiding element. In some cases, the surface or region may be coated with aluminum, chromium, platinum, gold, or any combination thereof. In some cases, the surface or region may be steam or hand polished. In some cases, the steam or hand polished surface is intended to simulate or model the effect of molding or stamping a part when manufacturing a speculum tip.

[0091] The light-guiding element (212, 622) may be bonded to, mated with, molded with, or connected to the speculum tip's speculum cone section (206, 632). The intersection geometry between the light-guiding element and the speculum cone section may be a function of both production (molding properties) and efficiency concerns. For example, FIG. 5 illustrates a cylindrical section of a petal light-guiding element assembly with a draft angle for one or more launch points (618) for molding efficiency. A triangular launch point may be efficient for the example shown in FIG. 5.

[0092] In some cases, the exit tip aperture distribution pattern can be affected by changes in the light-guiding element cone section design. Varying the number of light-guiding elements (i.e., petals) or the type of launch point geometry described elsewhere herein can change the illumination pattern at the exit tip. The examples of petal launch geometries and numbers provided herein can provide sufficient illumination patterns while maintaining satisfactory efficiency.

[0093] In some cases, the light directing element (212, 622) may collimate or redirect the light source such that the output light out of the speculum exit tip (202, 630) is at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or at least 95% of the light source's output power coupled into the one or more launch points (214, 618). In some cases, the light source may comprise a light emitting diode, a surface emitting diode, a superluminescent diode, a laser, a supercontinuum diode laser, a pulsed laser, or any combination thereof. In some cases, the light source may comprise coupling optics between the light source and the one or more launch points (214, 618). In some cases, the coupling optics between the light source and the one or more launch points (214, 618) may comprise one or more lenses and / or index matching materials between the one or more lenses and the one or more launch points (214, 618). In some cases, the one or more launch points (214, 618) may be optically coupled to one or more light-guiding elements (212, 622), the speculum cone section (206, 632), and / or the exit tip (202, 630) of the speculum tip. In some cases, the light-guiding element (212, 622) may comprise one or more light source matching features (227, 620), which are configured to match the placement of the light source relative to the one or more launch points (214, 618). One or more light source matching features (227, 620) may protrude out and away from a surface of the one or more light-guiding elements.

[0094] In some cases, the one or more launch points (214, 618) may be configured to interface and / or couple the light source into one or more light-guiding elements (212, 622). In some cases, the one or more launch points (214, 618) may comprise a geometric shape. The geometric shape may comprise a flat, circular, oval, concave, triangular, rectangular, or V-shaped geometric shape, as seen in Figures 1-5, 14-16B, and 24A-24F. Each geometric shape may comprise variable dimensions, which may affect the coupling efficiency of coupling emitted light from the light source into one or more light-guiding elements (212, 622), as seen in the ray tracing simulations of Figures 26A-26F.

[0095] In some cases, the flat launch point geometry may comprise a length 700, as seen in FIG. 24A. In some cases, the length 700 may comprise between about 200 micrometers (μm) and about 1,000 μm. In some cases, the length 700 may comprise between about 200 μm and about 300 μm, between about 200 μm and about 400 μm, between about 200 μm and about 500 μm, between about 200 μm and about 600 μm, between about 200 μm and about 800 μm, between about 200 μm and about 1,000 μm, between about 300 μm and about 400 μm, between about 300 μm and about 500 μm, between about 300 μm and about 600 μm, between about 300 μm and about 800 μm, between about 300 μm and about 1,000 μm. In some cases, length 700 may comprise about 200 μm, about 300 μm, about 400 μm, about 500 μm, about 600 μm, about 800 μm, about 400 μm to about 1,000 μm, about 500 μm to about 600 μm, about 500 μm to about 800 μm, about 500 μm to about 1,000 μm, about 600 μm to about 800 μm, about 600 μm to about 1,000 μm, or about 800 μm to about 1,000 μm. In some cases, the length 700 may comprise at least about 200 μm, about 300 μm, about 400 μm, about 500 μm, about 600 μm, or about 800 μm. In some cases, the length 700 may comprise at most about 300 μm, about 400 μm, about 500 μm, about 600 μm, about 800 μm, or about 1,000 μm.

[0096] In some cases, the circular firing point geometry may comprise a diameter 712, as seen in FIG. 24D. In some cases, the diameter 712 may comprise between about 0.5 millimeters (mm) and about 3 mm. In some cases, the diameter 712 may comprise between about 0.5 mm and about 0.7 mm, between about 0.5 mm and about 0.8 mm, between about 0.5 mm and about 0.9 mm, between about 0.5 mm and about 1 mm, between about 0.5 mm and about 1.2 mm, between about 0.5 mm and about 1.4 mm, between about 0.5 mm and about 1.5 mm, between about 0.5 mm and about 1.8 mm, between about 0.5 mm and about 2 mm, between about 0.5 mm and about 2.5 mm, between about 0.5 mm and about 3 mm, between about 0.7 mm and about 0.8 mm, between about 0.7 mm and about 0.9 mm, between about 0.7 mm and about 1 mm, between about 0.7 mm and about 1.2 mm, between about 0.7 mm to about 1.4 mm, about 0.7 mm to about 1.5 mm, about 0.7 mm to about 1.8 mm, about 0.7 mm to about 2 mm, about 0.7 mm to about 2.5 mm, about 0.7 mm to about 3 mm, about 0.8 mm to about 0.9 mm, about 0.8 mm to about 1 mm, about 0.8 mm to about 1.2 mm, about 0.8 mm to about 1.4 mm, about 0.8 mm to about 1.5 mm, about 0.8 mm to about 1.8 mm, about 0.8 mm to about 2 mm, about 0.8 mm to about 2.5 mm, about 0.8 mm to about 3 mm, about 0.9 mm to about 1 mm, about 0.9 mm to about 1.2 mm , about 0.9mm to about 1.4mm, about 0.9mm to about 1.5mm, about 0.9mm to about 1.8mm, about 0.9mm to about 2mm, about 0.9mm to about 2.5mm, about 0.9mm to about 3mm, about 1mm to about 1.2mm, about 1mm to about 1.4mm, about 1mm to about Approximately 1.5mm, approximately 1mm to approximately 1.8mm, approximately 1mm to approximately 2mm, approximately 1mm to approximately 2.5mm, approximately 1mm to approximately 3mm, approximately 1.2mm to approximately 1.4mm, approximately 1.2mm to approximately 1.5mm, approximately 1.2mm to approximately 1.8mm, approximately 1.2mm to approximately 2mm, approximately 1.2m may be about 1.5 mm to about 2.5 mm, about 1.2 mm to about 3 mm, about 1.4 mm to about 1.5 mm, about 1.4 mm to about 1.8 mm, about 1.4 mm to about 2 mm, about 1.4 mm to about 2.5 mm, about 1.4 mm to about 3 mm, about 1.5 mm to about 1.8 mm, about 1.5 mm to about 2 mm, about 1.5 mm to about 2.5 mm, about 1.5 mm to about 3 mm, about 1.8 mm to about 2 mm, about 1.8 mm to about 2.5 mm, about 1.8 mm to about 3 mm, about 2 mm to about 2.5 mm, about 2 mm to about 3 mm, or about 2.5 mm to about 3 mm.In some cases, diameter 712 may comprise about 0.5 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.2 mm, about 1.4 mm, about 1.5 mm, about 1.8 mm, about 2 mm, about 2.5 mm, or about 3 mm. In some cases, diameter 712 may comprise at least about 0.5 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.2 mm, about 1.4 mm, about 1.5 mm, about 1.8 mm, about 2 mm, or about 2.5 mm. In some cases, diameter 712 may comprise at most about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.2 mm, about 1.4 mm, about 1.5 mm, about 1.8 mm, about 2 mm, about 2.5 mm, or about 3 mm.

[0097] In some cases, the oval firing point geometry may comprise a major diameter 708 and a minor diameter 710, as seen in Figure 24B. In some instances, the major diameter 708 may comprise between about 1 mm and about 2.6 mm. In some cases, the major diameter 708 is between about 1 mm and about 1.2 mm, between about 1 mm and about 1.4 mm, between about 1 mm and about 1.6 mm, between about 1 mm and about 1.8 mm, between about 1 mm and about 2 mm, between about 1 mm and about 2.2 mm, between about 1 mm and about 2.4 mm, between about 1 mm and about 2.6 mm, between about 1.2 mm and about 1.4 mm, between about 1.2 mm and about 1.6 mm, between about 1.2 mm and about 1.8 mm, between about 1.2 mm and about 2 mm, between about 1.2 mm and about 2.2 mm, between about 1.2 mm and about 2.4 mm, between about 1.2 mm and about 2.6 mm, between about 1.4 mm and about 1.6 mm, between about 1.4 mm and about 1.8 mm, between about 1.4 mm and about 2 mm, between about 1. may comprise about 0.4 mm to about 2.2 mm, about 1.4 mm to about 2.4 mm, about 1.4 mm to about 2.6 mm, about 1.6 mm to about 1.8 mm, about 1.6 mm to about 2 mm, about 1.6 mm to about 2.2 mm, about 1.6 mm to about 2.4 mm, about 1.6 mm to about 2.6 mm, about 1.8 mm to about 2 mm, about 1.8 mm to about 2.2 mm, about 1.8 mm to about 2.4 mm, about 1.8 mm to about 2.6 mm, about 2 mm to about 2.2 mm, about 2 mm to about 2.4 mm, about 2 mm to about 2.6 mm, about 2.2 mm to about 2.4 mm, about 2.2 mm to about 2.6 mm, or about 2.4 mm to about 2.6 mm. In some cases, the major diameter 708 may comprise about 1 mm, about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, about 2 mm, about 2.2 mm, about 2.4 mm, or about 2.6 mm. In some cases, the major diameter 708 may comprise at least about 1 mm, about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, about 2 mm, about 2.2 mm, or about 2.4 mm. In some cases, the major diameter 708 may comprise at most about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, about 2 mm, about 2.2 mm, about 2.4 mm, or about 2.6 mm. In some cases, the minor diameter 710 may comprise between about 1 mm and about 2.6 mm.In some cases, minor diameter 710 is between about 1 mm and about 1.2 mm, between about 1 mm and about 1.4 mm, between about 1 mm and about 1.6 mm, between about 1 mm and about 1.8 mm, between about 1 mm and about 2 mm, between about 1 mm and about 2.2 mm, between about 1 mm and about 2.4 mm, between about 1 mm and about 2.6 mm, between about 1.2 mm and about 1.4 mm, between about 1.2 mm and about 1.6 mm, between about 1.2 mm and about 1.8 mm, between about 1.2 mm and about 2 mm, between about 1.2 mm and about 2.2 mm, between about 1.2 mm and about 2.4 mm, between about 1.2 mm and about 2.6 mm, between about 1.4 mm and about 1.6 mm, between about 1.4 mm and about 1.8 mm, between about 1.4 mm and about 2 mm, between about 1.4 may be about 1.6 mm to about 2.2 mm, about 1.4 mm to about 2.4 mm, about 1.4 mm to about 2.6 mm, about 1.6 mm to about 1.8 mm, about 1.6 mm to about 2 mm, about 1.6 mm to about 2.2 mm, about 1.6 mm to about 2.4 mm, about 1.6 mm to about 2.6 mm, about 1.8 mm to about 2 mm, about 1.8 mm to about 2.2 mm, about 1.8 mm to about 2.4 mm, about 1.8 mm to about 2.6 mm, about 2 mm to about 2.2 mm, about 2 mm to about 2.4 mm, about 2 mm to about 2.6 mm, about 2.2 mm to about 2.4 mm, about 2.2 mm to about 2.6 mm, or about 2.4 mm to about 2.6 mm. In some cases, minor diameter 710 may comprise about 1 mm, about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, about 2 mm, about 2.2 mm, about 2.4 mm, or about 2.6 mm. In some cases, minor diameter 710 may comprise at least about 1 mm, about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, about 2 mm, about 2.2 mm, or about 2.4 mm. In some cases, minor diameter 710 may comprise at most about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, about 2 mm, about 2.2 mm, about 2.4 mm, or about 2.6 mm.

[0098] In some cases, the rectangular firing point geometry may comprise a length 702, a width 706, and an interior angle 704, as seen in Figure 24C. In some cases, the interior angle 704 may comprise an angle of about 90 degrees or about 91 degrees. In some cases, the length 702 may comprise between about 1 mm and about 2.6 mm. In some instances, the length 702 may be between about 1 mm and about 1.2 mm, between about 1 mm and about 1.4 mm, between about 1 mm and about 1.6 mm, between about 1 mm and about 1.8 mm, between about 1 mm and about 2 mm, between about 1 mm and about 2.2 mm, between about 1 mm and about 2.4 mm, between about 1 mm and about 2.6 mm, between about 1.2 mm and about 1.4 mm, between about 1.2 mm and about 1.6 mm, between about 1.2 mm and about 1.8 mm, between about 1.2 mm and about 2 mm, between about 1.2 mm and about 2.2 mm, between about 1.2 mm and about 2.4 mm, between about 1.2 mm and about 2.6 mm, between about 1.4 mm and about 1.6 mm, between about 1.4 mm and about 1.8 mm, between about 1.4 mm and about 2 mm, between about 1 may comprise about 0.4 mm to about 2.2 mm, about 1.4 mm to about 2.4 mm, about 1.4 mm to about 2.6 mm, about 1.6 mm to about 1.8 mm, about 1.6 mm to about 2 mm, about 1.6 mm to about 2.2 mm, about 1.6 mm to about 2.4 mm, about 1.6 mm to about 2.6 mm, about 1.8 mm to about 2 mm, about 1.8 mm to about 2.2 mm, about 1.8 mm to about 2.4 mm, about 1.8 mm to about 2.6 mm, about 2 mm to about 2.2 mm, about 2 mm to about 2.4 mm, about 2 mm to about 2.6 mm, about 2.2 mm to about 2.4 mm, about 2.2 mm to about 2.6 mm, or about 2.4 mm to about 2.6 mm. In some cases, the length 702 may comprise about 1 mm, about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, about 2 mm, about 2.2 mm, about 2.4 mm, or about 2.6 mm. In some cases, the length 702 may comprise at least about 1 mm, about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, about 2 mm, about 2.2 mm, or about 2.4 mm. In some cases, the length 702 may comprise at most about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, about 2 mm, about 2.2 mm, about 2.4 mm, or about 2.6 mm. In some cases, the width 706 may comprise between about 0.2 mm and about 1.2 mm.In some cases, the width 706 is about 0.2 mm to about 0.3 mm, about 0.2 mm to about 0.4 mm, about 0.2 mm to about 0.5 mm, about 0.2 mm to about 0.6 mm, about 0.2 mm to about 0.8 mm, about 0.2 mm to about 1 mm, about 0.2 m m ~ about 1.2mm, about 0.3mm - about 0.4mm, about 0.3mm - about 0.5mm, about 0.3mm - about 0.6mm, about 0.3mm - about 0.8mm, about 0.3mm - about 1mm, about 0.3mm - about 1.2mm, about 0.4mm - about 0 In some cases, width 706 may comprise about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.4 mm, about 0.8 mm, about 0.4 mm, about 1 mm, about 0.4 mm, about 1.2 mm, about 0.5 mm, about 0.6 mm, about 0.5 mm, about 0.8 mm, about 0.5 mm, about 1.2 mm, about 0.6 mm, about 0.8 mm, about 0.6 mm, about 1 mm, about 0.8 mm, about 1.2 mm, or about 1 mm, about 1.2 mm. In some cases, width 706 may comprise about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.8 mm, about 1 mm, or about 1.2 mm. In some cases, width 706 may comprise at least about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.8 mm, or about 1 mm, In some cases, width 706 may comprise at most about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.8 mm, about 1 mm, or about 1.2 mm.

[0099] In some cases, the concave firing point geometry may comprise a length 714, a width 716, an inner fillet radius 719, and an interior angle 718, as seen in Figure 24E. In some cases, the interior angle 718 may comprise an angle of about 115 degrees, up to about 115 degrees, or at least about 115 degrees. In some cases, the length 714 may comprise between about 1 mm and about 2.4 mm. In some cases, the length 714 is between about 1 mm and about 1.2 mm, between about 1 mm and about 1.4 mm, between about 1 mm and about 1.6 mm, between about 1 mm and about 1.8 mm, between about 1 mm and about 2 mm, between about 1 mm and about 2.2 mm, between about 1 mm and about 2.4 mm, between about 1.2 mm and about 1.4 mm, between about 1.2 mm and about 1.6 mm, between about 1.2 mm and about 1.8 mm, between about 1.2 mm and about 2 mm, between about 1.2 mm and about 2.2 mm, between about 1.2 mm and about 2.4 mm, between about 1.4 mm and about 1.6 mm, between about 1 2.2 mm, or about 2.4 mm. In some cases, length 714 may comprise about 1 mm, about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, about 1.6 mm, about 2 mm, about 1.6 mm, about 2.2 mm, about 1.6 mm, about 2.4 mm, about 1.8 mm, about 2 mm, about 1.8 mm, about 2.2 mm, about 2 mm, about 2.4 mm, or about 2.2 mm, about 2.4 mm. In some cases, length 714 may comprise at least about 1 mm, about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, about 2 mm, or about 2.2 mm. In some cases, length 714 may comprise at most about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, about 2 mm, about 2.2 mm, or about 2.4 mm. In some cases, width 716 may comprise between about 0.5 mm and about 1.4 mm.In some cases, the width 716 is about 0.5 mm to about 0.6 mm, about 0.5 mm to about 0.7 mm, about 0.5 mm to about 0.8 mm, about 0.5 mm to about 0.9 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.2 mm, about 0.5 mm to about 1.4 mm, about 0.6 mm to about 0.7 mm, about 0.6 mm to about 0.8 mm, about 0.6 mm to about 0.9 mm, about 0.6 mm to about 1 mm, about 0.6 mm to about 1.2 mm, about 0.6 mm to about 1.4 mm, about 0.7 mm to about The width 716 may comprise about 0.8 mm, about 0.7 mm to about 0.9 mm, about 0.7 mm to about 1 mm, about 0.7 mm to about 1.2 mm, about 0.7 mm to about 1.4 mm, about 0.8 mm to about 0.9 mm, about 0.8 mm to about 1 mm, about 0.8 mm to about 1.2 mm, about 0.8 mm to about 1.4 mm, about 0.9 mm to about 1 mm, about 0.9 mm to about 1.2 mm, about 0.9 mm to about 1.4 mm, about 1 mm to about 1.2 mm, about 1 mm to about 1.4 mm, or about 1.2 mm to about 1.4 mm. In some cases, the width 716 may comprise about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.2 mm, or about 1.4 mm. In some cases, width 716 may comprise at least about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, or about 1.2 mm. In some cases, width 716 may comprise at most about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.2 mm, or about 1.4 mm. In some cases, inner fillet radius 719 may comprise a radius of about 0.1 mm to about 0.3 mm.In some cases, the inner fillet radius 719 is between about 0.1 mm and about 0.15 mm, between about 0.1 mm and about 0.18 mm, between about 0.1 mm and about 0.2 mm, between about 0.1 mm and about 0.22 mm, between about 0.1 mm and about 0.25 mm, between about 0.1 mm and about 0.3 mm, between about 0.15 mm and about 0.18 mm, between about 0.15 mm and about 0.2 mm, between about 0.15 mm and about 0.22 mm, between about 0.15 mm and about 0.25 mm, between about 0.15 In some cases, the inner fillet radius 719 may comprise a radius of about 0.1 mm, about 0.15 mm, about 0.18 mm, about 0.2 mm, about 0.22 mm, about 0.25 mm, or about 0.3 mm. In some cases, the inner fillet radius 719 may comprise a radius of at least about 0.1 mm, about 0.15 mm, about 0.18 mm, about 0.2 mm, about 0.22 mm, or about 0.25 mm. In some cases, the inner fillet radius 719 may comprise a radius of at most about 0.15 mm, about 0.18 mm, about 0.2 mm, about 0.22 mm, about 0.25 mm, or about 0.3 mm.

[0100] In some cases, the V-shaped firing point geometry may comprise a length 720, an interior angle 722, and an interior fillet radius 724, as seen in FIGURE 24F. In some cases, the interior angle 722 may comprise up to about 90 degrees, 90 degrees, or at least about 90 degrees. In some cases, the interior fillet radius 724 may comprise a radius of about 0.1 mm to about 0.3 mm. In some cases, the inner fillet radius 724 is between about 0.1 mm and about 0.15 mm, between about 0.1 mm and about 0.18 mm, between about 0.1 mm and about 0.2 mm, between about 0.1 mm and about 0.22 mm, between about 0.1 mm and about 0.25 mm, between about 0.1 mm and about 0.3 mm, between about 0.15 mm and about 0.18 mm, between about 0.15 mm and about 0.2 mm, between about 0.15 mm and about 0.22 mm, between about 0.15 mm and about 0.25 mm, between about 0.15 The inner fillet radius 724 may comprise a radius of about 0.1 mm, about 0.15 mm, about 0.18 mm, about 0.2 mm, about 0.22 mm, about 0.25 mm, or about 0.3 mm. In some cases, the inner fillet radius 724 may comprise a radius of at least about 0.1 mm, about 0.15 mm, about 0.18 mm, about 0.2 mm, about 0.22 mm, or about 0.25 mm. In some cases, the inner fillet radius 724 may comprise a radius of at most about 0.15 mm, about 0.18 mm, about 0.2 mm, about 0.22 mm, about 0.25 mm, or about 0.3 mm. In some cases, the length 720 may comprise between about 1.2 mm and about 2.4 mm.In some cases, the length 720 is between about 1.2 mm and about 1.4 mm, between about 1.2 mm and about 1.6 mm, between about 1.2 mm and about 1.8 mm, between about 1.2 mm and about 2 mm, between about 1.2 mm and about 2.2 mm, between about 1.2 mm and about 2.4 mm, between about 1.4 mm and about 1.6 mm, between about 1.4 mm and about 1.8 mm, between about 1.4 mm and about 2 mm, between about 1.4 mm and about 2.2 mm, between about 1. The length 720 may comprise about 4 mm to about 2.4 mm, about 1.6 mm to about 1.8 mm, about 1.6 mm to about 2 mm, about 1.6 mm to about 2.2 mm, about 1.6 mm to about 2.4 mm, about 1.8 mm to about 2 mm, about 1.8 mm to about 2.2 mm, about 1.8 mm to about 2.4 mm, about 2 mm to about 2.2 mm, about 2 mm to about 2.4 mm, or about 2.2 mm to about 2.4 mm. In some cases, the length 720 may comprise about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, about 2 mm, about 2.2 mm, or about 2.4 mm. In some cases, the length 720 may comprise at least about 1.2 mm, about 1.4 mm, about 1.6 mm, about 1.8 mm, about 2 mm, or about 2.2 mm. In some cases, the length 720 may comprise a maximum of about 1.4 mm, about 1.6 mm, about 1.8 mm, about 2 mm, about 2.2 mm, or about 2.4 mm.

[0101] In some cases, the distal seal member (204, 628) and / or the proximal seal member (208, 626) may be made of a material configured to provide a seal between the device (200, 600) tip and a tubular cavity or orifice of a patient and / or subject into which the speculum tip (207, 633) is inserted. In some cases, the proximal seal member 208 and / or the distal seal member 204 may comprise one or more circular ring structures, as seen in Figures 1-5. In some cases, the proximal seal member 626 may comprise one or more circular ring structures, as seen in Figures 14-16B, while the distal seal member 628 may comprise a single elongated ring structure that follows the contour of the speculum tip cone section. The seal may be created to allow for pneumatic excitation of a biological surface or tissue and recording of mechanical deformation of the biological surface and / or tissue. In some cases, the mechanical deformation of the biological surface and / or tissue may provide information regarding the mechanical properties of the tissue, the presence of abnormalities and / or heterogeneity in the mechanical properties of the biological tissue, the presence or absence of fluid adjacent to or in contact with the biological tissue and / or surface, or any combination thereof of the biological surface and / or tissue. In some cases, measuring the presence or absence of fluid adjacent to or in contact with the biological tissue and / or surface may provide diagnostic information to distinguish between acute otitis media, bacterial otitis media, viral otitis media, or any combination thereof. In some cases, the mechanical deformation of the biological surface may be measured by an ultrasound transducer (222, 614).

[0102] In some cases, the insert (224, 602) may comprise an ultrasonic transducer (222, 614) (e.g., a cMUT), one or more wires (225, 616) in electrical communication with one or more leads of the ultrasonic transducer (222, 614) and the insert (226, 606), a lens (216, 612), one or more mechanical coupling structures (220, 604) configured to couple the speculum tip cone section (206, 632) at one or more mechanical fastening features (624), one or more electromechanical structures (210, 634) configured to interact with a corresponding receptacle, one or more mechanical support structures (228, 610), or any combination thereof, as can be seen in Figures 1-5 and 14-16B. In some cases, the one or more leads (226, 606) may comprise traces of deposited gold or silver conductor material adjacent to the exterior and / or interior surface of the insert body. In some cases, the one or more leads may comprise a sheet of conductor inlaid into the exterior surface of the insert (224, 602). In some cases, the electromechanical structure (210, 634) may comprise pad contacts, areas, or regions (608) of the electromechanical structure in electrical communication with the one or more leads (226, 606), the one or more wires (225, 616), the ultrasound transducer (222, 614), or any combination thereof. In some cases, the electromechanical structure (210, 634) may be configured to mechanically and electrically couple to a receptacle of the otoscope, provide mechanical stability, conduct electrical signals between the transducer and the base system, and drive and receive signals from the ultrasound transducer. In some cases, the one or more mechanical support structures (228, 610) may comprise rib-like protrusion structures on the XMC insert (224, 602). The mechanical support structures may be configured to position the insert (224, 602) within the speculum cone section (206, 632) such that the light emission from the speculum emission tip (630, 202) and the ultrasound transducer (222, 614) and the lens (216, 612) of the insert are concentric.

[0103] In some cases, the one or more mechanical coupling structures (220, 604) may include hooks or protrusions that may couple to one or more mechanical fastening features (624). The one or more fastening features may include corresponding features that mate with the one or more mechanical coupling structures (220, 604), e.g., cut-out features into which the hooks may snap.

[0104] In some cases, the insert (224, 602) may include a lens (216, 612) coupled to the insert. In some cases, the lens may be in contact with or adjacent to the ultrasound transducer (222, 614). In some cases, the lens may be configured to focus light reflected from the biological surface and / or tissue of the light source for viewing by an operator of an otoscope that is matched with the device (200, 600). In some cases, the lens may be located proximal to the ultrasound transducer. In some cases, the lens may focus light reflected from the biological surface and / or tissue of the light source onto an image sensor of a system, described elsewhere herein, that may convert the reflected light beam into a still image or video of the biological surface and / or tissue. In some cases, the lens may include an anti-reflective coating that transmits a first spectrum and reflects a second spectrum. In some cases, the first spectrum may comprise a visible spectrum and the second spectrum may comprise an infrared spectrum.

[0105] In some cases, the one or more wires (225, 616) may be configured to transmit and / or relay electrical signals from the one or more leads (226, 606) to the ultrasound transducer (222, 614). In some cases, the one or more wires (225, 616) may connect the one or more leads (226, 606) to the ultrasound transducer (222, 614) through wire bonding techniques.

[0106] In some cases, devices of the present disclosure may include an ultrasound transducer (222, 614) that may be electrically coupled to one or more leads via surface mount pads of the ultrasound transducer (222, 614). In some cases, the ultrasound transducer (222, 614) may include a capacitive micromachined ultrasound transducer (cMUT). method

[0107] The present disclosure provides methods of using the devices and associated speculum tips described elsewhere herein. In some cases, the methods include the use of an otoscope with a speculum tip, as shown in FIG. 28. The methods may include (a) directing optical illumination of a light source to one or more coupling portions (i.e., launch points, described elsewhere herein), where the one or more coupling portions are shaped as conical sections 800; (b) collimating the optical illumination using one or more coupling portions 802; (c) directing the collimated optical illumination from the one or more coupling portions to a light-guiding element (i.e., one or more light-guiding elements or petals, described elsewhere herein), where the collimated optical illumination propagates through the light-guiding element by total internal reflection 804; and (d) collecting the reflected optical illumination from a target within a lumen of a housing, where the housing constitutes a portion of the otoscope's speculum 806. In some embodiments, the method may further include directing the pneumatic excitation toward the target. In some cases, the method may further include directing ultrasound or illumination toward the target. In some cases, the method may further include measuring a response of the target to the pneumatic excitation in a reflected ultrasound signal. In some cases, the method may further include determining a state or condition of the object based on the reflected optical illumination and the response. Computer Systems

[0108] The present disclosure provides a computer system that is programmed to implement the methods of the present disclosure. FIG. 13 shows a computer system 1301 that is programmed or otherwise configured to control the otoscope system and method of the present disclosure. The computer system 1301 can regulate various aspects of the optical or ultrasonic illumination system of the otoscope of the present disclosure, such as turning off or on various aspects of the device, analyzing data, acquiring data, providing drive signals to the light source and / or ultrasonic transducer, etc. The computer system 1301 can be a user's electronic device or a computer system that is remotely located relative to the electronic device. The electronic device can be a mobile electronic device. The electronic device can be built into the otoscope.

[0109] The computer system 1301 includes a central processing unit (CPU, also referred to herein as "processor" and "computer processor") 1305, which may be a single-core or multi-core processor, or multiple processors for parallel processing. The computer system 1301 also includes memory or memory locations 1310 (e.g., random access memory, read-only memory, flash memory), an electronic storage unit 1315 (e.g., hard disk), a communication interface 1320 (e.g., network adapter) for communicating with one or more other systems, and peripheral devices 1325, such as cache, other memory, data storage devices, and / or electronic display adapters. The memory 1310, the storage unit 1315, the interface 1320, and the peripheral devices 1325 communicate with the CPU 1305 through a communication bus (solid lines) such as a motherboard. The storage unit 1315 may be a data storage unit (or data repository) for storing data. The computer system 1301 can be operatively coupled to a computer network ("network") 1330 with the aid of the communication interface 1320. The network 1330 can be the Internet, an intranet and / or an extranet, or an intranet and / or an extranet in communication with the Internet. The network 1330, in some cases, is a telecommunications and / or data network. The network 1330 can include one or more computer servers, which may enable distributed computing, such as cloud computing. The network 1330 can, in some cases, implement a peer-to-peer network, which may enable devices coupled to the computer system 1301 to behave as clients or servers with the aid of the computer system 1301.

[0110] CPU 1305 can execute sequences of machine-readable instructions, which may be embodied in a program or software. The instructions may be stored in a memory location, such as memory 1310. The instructions can be directed to CPU 1305, which can subsequently program or otherwise configure CPU 1305 to implement methods of the present disclosure. Examples of operations performed by CPU 1305 can include fetch, decode, execute, and writeback.

[0111] The CPU 1305 may be part of a circuit such as an integrated circuit. One or more other components of the system 1301 may be included in the circuit. In some cases, the circuit is an application specific integrated circuit (ASIC).

[0112] The storage unit 1315 can store files such as drivers, libraries, and saved programs. The storage unit 1315 can store user data, such as user preferences and user programs. The computer system 1301 can include one or more additional data storage units that are external to the computer system 1301, in some cases, such as located on a remote server that communicates with the computer system 1301 through an intranet or the Internet.

[0113] Computer system 1301 can communicate with one or more remote computer systems through network 1330. For example, computer system 1301 can communicate with a user's remote computer system. Examples of remote computer systems include a personal computer (e.g., a portable PC), a slate or tablet PC (e.g., Apple® iPad®, Samsung® Galaxy Tab), a phone, a smartphone (e.g., Apple® iPhone®, Android®-enabled devices, Blackberry®), or a personal digital assistant. A user can access computer system 1301 via network 1330.

[0114] Methods as described herein can be implemented using machine (e.g., computer processor) executable code stored on electronic storage locations of the computer system 1301, such as, for example, on the memory 1310 or electronic storage unit 1315. The machine executable or machine readable code can be provided in the form of software. During use, the code can be executed by the processor 1305. In some cases, the code can be read from the storage unit 1315 and stored on the memory 1310 for quick access by the processor 1305. In some circumstances, the electronic storage unit 1315 can be omitted and the machine executable instructions are stored on the memory 1310.

[0115] The code can be pre-compiled and configured for use with a machine having a processor adapted to execute the code, or can be compiled during run-time. The code can be provided in a programming language that can be selected to allow the code to be executed in a pre-compiled or immediately compiled manner.

[0116] Aspects of the systems and methods provided herein, such as the computer system 1301, can be embodied in programming. Various aspects of the technology can be considered as a "product" or "article of manufacture" typically in the form of machine (or processor) executable code and / or associated data carried on or embodied in some type of machine-readable medium. The machine executable code can be stored on an electronic storage unit, such as a memory (e.g., read-only memory, random access memory, flash memory) or a hard disk. A "storage" type medium can include any or all of the tangible memory of a computer, processor, or equivalent, or its associated modules, such as various semiconductor memories, tape drives, disk drives, and the like, that can provide non-transitory storage at any time for software programming. All or a portion of the software may be communicated from time to time over the Internet or various other telecommunications networks. Such communication may, for example, enable loading of the software from one computer or processor to another, for example, from a management server or host computer to a computer platform of an application server. Thus, other types of media that may bear software elements include optical, electrical, and electromagnetic waves, such as those used across physical interfaces between local devices, through wired and optical fixed networks, and via various air links. Physical elements that carry such waves, such as wired or wireless links, optical links, or the like, may also be considered media bearing the software. As used herein, unless limited to non-transitory tangible "storage" media, terms such as computer or machine "readable medium" refer to any medium that participates in providing instructions to a processor for execution.

[0117] Thus, a machine-readable medium such as a computer executable code may take many forms, including, but not limited to, a tangible storage medium, a carrier wave medium, or a physical transmission medium. Non-volatile storage media include optical or magnetic disks, such as any of the storage devices in any computer or equivalent, such as those that may be used to implement the databases, etc., shown in the figures. Volatile storage media include dynamic memory, such as the main memory of such a computer platform. Tangible transmission media include coaxial cables, copper wire and optical fibers, including the wires that comprise a bus in a computer system. Carrier wave transmission media may take the form of electric or electromagnetic signals, or acoustic or light waves, such as those generated during radio frequency (RF) and infrared (IR) data communications. Common forms of computer readable media thus include, for example, floppy disks, flexible disks, hard disks, magnetic tape, any other magnetic media, CD-ROMs, DVDs or DVD-ROMs, any other optical media, punch cards, paper tape, any other physical storage media with patterns of holes, RAM, ROM, PROMs and EPROMs, FLASH-EPROMs, any other memory chips or cartridges, carrier waves that transmit data or instructions, cables or links that transmit such carrier waves, or any other medium from which a computer may read programming code and / or data. Many of these forms of computer readable media may be involved in carrying one or more sequences of one or more instructions to a processor for execution.

[0118] The computer system 1301 can include or communicate with an electronic display 1335 that provides a user interface (UI) 1340 for providing, for example, alignment information, providing diagnostic information, etc. Examples of a UI include, but are not limited to, a graphical user interface (GUI), i.e., a monitor screen or device display, and a web-based user interface.

[0119] The methods and systems of the present disclosure can be implemented using one or more algorithms. The algorithms can be implemented using software upon execution by the central processing unit 1305. The algorithms can implement, for example, a method for characterizing the tympanic membrane. Embodiment

[0120] Numbered embodiment 1 comprises a speculum operable to be placed in the ear of a subject, the speculum comprising a housing comprising a light-guiding element, the transmitted optical illumination being conducted through the light-guiding element by total internal reflection, the housing having a lumen therein, the housing configured to allow the reflected optical illumination to propagate through the lumen, and one or more coupling portions coupling the transmitted optical illumination from the light source to the light-guiding element, the one or more coupling portions being shaped as conical sections. Numbered embodiment 2 comprises the device of embodiment 1, further comprising an insert, the insert configured to be mechanically coupled to the housing. Numbered embodiment 3 comprises the device of embodiment 2, the insert comprising a lens, an ultrasound transducer, one or more electrical leads electrically coupled to the ultrasound transducer, one or more electrical leads and one or more wires electrically coupled to the ultrasound transducer, or any combination thereof. Numbered embodiment 4 comprises the device of embodiment 3, in which the ultrasonic transducer comprises a capacitive micromachined ultrasonic transducer. Numbered embodiment 5 comprises the device of any one of embodiments 1-4, in which the light-guiding element comprises an elliptical shape. Numbered embodiment 6 comprises the device of any one of embodiments 1-5, in which the light-guiding element is configured to be a parabolic mirror when the light beam of the light source interacts with the light-guiding element. Numbered embodiment 7 comprises the device of any one of embodiments 1-6, in which the light-guiding element comprises a launch point. Numbered embodiment 8 comprises the device of any one of embodiments 1-6, in which the light-guiding element comprises one or more launch points. Numbered embodiment 9 comprises the device of embodiment 7 or 8, in which the launch point comprises a geometric shape, the geometric shape comprising a flat, round, oval, concave, rectangular, or V-shape. Numbered embodiment 10 includes the device of embodiment 1, wherein the housing includes a proximal seal member, a distal seal member, or any combination thereof.Numbered embodiment 11 comprises the device of any one of embodiments 1-10, in which the proximal and distal sealing members comprise an elastomeric material configured to seal the housing in the ear of the subject. Numbered embodiment 12 comprises the device of embodiment 3, in which the ultrasound transducer is electrically coupled to one or more electrical leads of the insert by one or more wires. Numbered embodiment 13 comprises the device of embodiment 3 or 12, in which the insert comprises a spacer structure configured to space the insert from an inner surface of the lumen of the housing. Numbered embodiment 14 comprises the device of embodiment 3, 12, or 13, in which the insert comprises a structure configured to releasably couple to the housing when inserted into the housing. Numbered embodiment 15 comprises the device of embodiment 14, in which the structure comprises a groove, hole, or hook configured to snap-fit ​​into the structure of the housing. Numbered embodiment 16 comprises the device of any one of embodiments 1-14, in which the housing is partially or entirely steam polished, aluminum coated, chrome coated, or any combination thereof. Numbered embodiment 17 comprises the device of any one of embodiments 1-16, in which the insert comprises an electrical coupling interface comprising an electromechanical structure configured to releasably couple with and electrically communicate with the receptacle. Numbered embodiment 18 comprises the device of embodiment 17, in which the electromechanical structure comprises one or more electrical pads adjacent a surface of the one or more mechanical coupling interfaces. Numbered embodiment 19 comprises the device of embodiment 18, in which the one or more mechanical coupling interfaces comprise hooks configured to couple with the clasp receptacle.

[0121] Numbered embodiment 20 comprises an otoscope having a lumen therein and comprising a light-guiding element, where the transmitted optical illumination is conducted by the light-guiding element by total internal reflection and the reflected optical illumination is propagated through the lumen of the speculum, and one or more coupling portions coupling the transmitted optical illumination from a light source to the light-guiding element, the one or more coupling portions being shaped as conical sections. Numbered embodiment 21 comprises the device of embodiment 20, further comprising an insert, the insert configured to mechanically couple to the speculum. Numbered embodiment 22 comprises the device of embodiment 21, where the insert comprises a lens, an ultrasound transducer, one or more electrical leads electrically coupled to the ultrasound transducer, one or more electrical leads and one or more wires electrically coupled to the ultrasound transducer, or any combination thereof. Numbered embodiment 23 comprises the device of embodiment 22, in which the ultrasonic transducer comprises a capacitive micromachined ultrasonic transducer. Numbered embodiment 24 comprises the device of any one of embodiments 20-23, in which the light-guiding element comprises an elliptical shape. Numbered embodiment 25 comprises the device of any one of embodiments 20-24, in which the light-guiding element is configured to be a parabolic mirror when the light beam of the light source interacts with the light-guiding element. Numbered embodiment 26 comprises the device of any one of embodiments 20-25, in which the light-guiding element comprises a launch point. Numbered embodiment 27 comprises the device of any one of embodiments 20-25, in which the light-guiding element comprises at least two launch points. Numbered embodiment 28 comprises the device of embodiment 26 or 27, in which the launch point comprises a geometric shape, the geometric shape comprising a flat, round, oval, concave, rectangular, or V-shape. Numbered embodiment 29 includes a device according to any one of embodiments 20-28, wherein the speculum includes a proximal sealing member, a distal sealing member, or any combination thereof.Numbered embodiment 30 comprises the device of embodiment 29, in which the proximal and distal sealing members comprise an elastomeric material configured to seal the housing in the ear of the subject. Numbered embodiment 31 comprises the device of any one of embodiments 22-27, in which the ultrasound transducer is electrically coupled to one or more electrical leads of the insert by one or more wires. Numbered embodiment 32 comprises the device of any one of embodiments 22-27 or 31, in which the insert comprises a spacer structure configured to space the insert from an inner surface of the lumen of the speculum. Numbered embodiment 33 comprises the device of any one of embodiments 22-27, 31, or 32, in which the insert comprises a structure configured to releasably couple to the speculum when inserted into the speculum. Numbered embodiment 34 comprises the device of embodiment 33, in which the structure comprises a groove, hole, or hook configured to snap-fit ​​to the structure of the speculum. Numbered embodiment 35 comprises the device of any one of embodiments 20-34, in which the speculum is partially or entirely steam polished, aluminum coated, chrome coated, or any combination thereof. Numbered embodiment 36 comprises the device of any one of embodiments 22-27 or 31-33, in which the insert comprises an electrical coupling interface comprising an electromechanical structure configured to releasably couple with and electrically communicate with the receptacle. Numbered embodiment 37 comprises the device of embodiment 36, in which the electromechanical structure comprises one or more electrical pads adjacent a surface of the one or more mechanical coupling interfaces. Numbered embodiment 38 comprises the device of embodiment 37, in which the one or more mechanical coupling interfaces comprise hooks configured to couple with the clasp receptacle.

[0122] Numbered embodiment 39 includes a method of using an otoscope, comprising: directing optical illumination of a light source to one or more coupling portions, the one or more coupling portions being shaped as conical sections; collimating the optical illumination using one or more coupling portions; directing the optical illumination from the one or more coupling portions to a light-guiding element, the optical illumination propagating through the light-guiding element by total internal reflection; and collecting reflected optical illumination from a target within a lumen of a housing, the housing forming a part of a speculum of the otoscope. Numbered embodiment 40 includes the method of embodiment 39, further comprising directing a pneumatic excitation toward the target. Numbered embodiment 41 includes the method of embodiment 39 or 40, further comprising directing ultrasound or illumination toward the target. Numbered embodiment 42 includes the method of embodiment 40, further comprising measuring a response of the target to the pneumatic excitation in a reflected ultrasound signal. Numbered embodiment 43 includes the method of any one of embodiments 39-42, further including determining a state or condition of the object based on the reflected optical illumination and the response. EXAMPLES

[0123] Example 1 Determine the optimal coupling angle for light rays incident on the conical section of the speculum tip

[0124] 10A-10D show experimental ray tracing modeling data performed using Monte Carlo modeling methods. Various take-off angles of 16 degrees (FIG. 10A), 18 degrees (FIG. 10B), 20 degrees (FIG. 10C), and 40 degrees (FIG. 10D) were tested with a fixed cone section. Note that take-off angles are in degrees, which is half angle in air. From the results of the ray tracing modeling experiments, smaller take-off angles, e.g., 16 degrees, were more efficient in passing rays toward the tip of the cone section, with no to minimal rays exhibiting back reflection from the inner wall of the cone section, as seen with the larger take-off degrees. This finding suggests that rays of light incident at very small angles to the cone section optical axis will exit with low to no insertion loss as they enter the cone section. The light-guiding elements described elsewhere herein may address this issue, particularly with regard to coupling to an external light source.

[0125] Example 2 Simulated ray tracing of petal light guide elements

[0126] A ray tracing analysis of light coupling from a light source into and out of an elliptical (i.e., "petal") light-guiding structure was performed using Zemax, as seen in FIG. 11. From the ray tracing results, it appears that the "petal" elliptical structure of the light-guiding element functions to collimate the coupled emission of the light source in a manner similar to a parabolic mirror, focusing the light rays parallel along the optical axis of the light-guiding element. When viewed from a cross section through the light-guiding element, it can be observed that the light rays reflect back and forth between the inner and outer surfaces of the light-guiding element, instead of reflecting back towards the illumination source. By reducing and / or eliminating the back-reflected light rays, the light-guiding element reduces the swirling pattern trajectory that the light rays would otherwise follow without traveling through the light-guiding element.

[0127] Example 3 Comparison of transmission performance between speculum tips with and without light-guiding elements

[0128] Optical power transfer was compared between a speculum tip with a conical section (FIG. 9B), a speculum tip with a conical section plus light-guiding elements (i.e., "petals") (FIG. 9C), and a speculum tip with optical fiber coupling (FIG. 9A). The speculum tip with optical fiber coupling (hereafter referred to as "C0") was designed to couple illumination light from a light source through multiple 250 μm diameter optical fibers onto the proximal end of the speculum tip. Optical power intensity measurements were made for C0, a speculum tip with only a conical section, and a speculum tip with a conical section and one or more light-guiding elements, as described elsewhere herein, at variable displacements (10 mm, 25 mm, 100 mm) from the exit tip of the speculum tip and variable light source output currents (50 mA, 100 mA, and 123 mA), and the results are shown in the table of FIG. 9D. From the measured optical power, the speculum tip consisting of both a light-guiding element and a conical section can couple and transmit more optical power of the light source compared to a speculum tip with only a conical section. In addition, the speculum tip consisting of a conical section plus one or more light-guiding elements shows significant efficiency in the measured illumination by producing a comparable illumination of 840 μW power at 19.1 mA compared to the 840 μW power delivered by C0 at 734 mA and the 380 μW optical power delivered by a light-guiding element with only a conical section at 50 mA. The present results show that the combination of a conical section and one or more light-guiding elements efficiently couples a distal light source to a proximal reduced geometry.

[0129] An experiment showing the visual brightness variation between the speculum tip C0 508 and a cone section 504 with one or more light-guiding elements ("petals") can be seen in Figure 12C. At the same light source drive current, a 5-fold increase in brightness was measured and observed in the image shown.

[0130] Example 4 Comparison of manually and steam-polished speculum tips

[0131] Speculum tips were hand polished (FIG. 7A) and steam polished (FIG. 7B) to determine whether post-treatment of the speculum tip would improve transmission from the light source through one or more light-directing elements and the conical section of the speculum tip. Optical power intensity measurements were performed on clinical prototype C_0, hand polished speculum tip, and steam polished speculum tip described in Example 3 at variable displacements (10 mm, 25 mm, 100 mm) and variable light source output currents (50 mA, 100 mA, and 123 mA), the results of which are summarized in FIG. 7C. The clinical prototype speculum tip (C_0) included four 250 μm outer diameter fibers coupled to the inner lumen of the speculum tip. The four 250 μm fibers were, however, coupled on the proximal end of the speculum tip to four corresponding 500 μm outer diameter optical fibers that provided illumination. The hand-polished and steam-polished speculum tips comprised a waveguide cone section as described elsewhere herein, but were configured to couple to a light source on the proximal end of the speculum tip, as shown in Figures 7A-7B. Measurement results showed that the steam-polished speculum tip outperformed the hand-polished speculum tip at 100 mA light source current, with a difference of approximately 400 μW of power at 10 mm displacement from the emitting tip, 46 μW of power at 100 mA, and 4 μW of power at 100 mm displacement from the emitting tip.

[0132] Example 5 The influence of biological tissue placed adjacent to the speculum tip on various post-processing approaches

[0133] Baseline (μW / cm 2 ) versus absolute irradiance (μW / cm 2The effect of an adjacent biological surface held against the outer surface of the speculum tip on irradiance, as shown in Figures 22A-C, was determined. For the purposes of this experiment, both vapor polished (VP_1-VP_5) and chrome coated (CHR_1 and CHR_2) speculum tips were compared when a finger biological surface or a white seal was placed adjacent to the outer surface of the speculum tip cone section. The white seal, for the purposes of this experiment, was a piece of white pigmented elastomeric material configured to mimic a human biological surface, e.g., human skin, which would allow for the measurement of light "leakage" or light refraction from the speculum tip (i.e., light conduit or light pipe) when such material is present adjacent to the surface of the speculum tip. To obtain irradiance measurements, each speculum tip distal surface, however, is coupled to a combined light source otoscope receptacle interface, as shown in Figure 18A. Prior to placing each speculum tip into the light source otoscope receptacle, a 2.5 mm pin was placed on the distal tip of the otoscope receptacle, as seen in FIG. 18A, to prevent detection of stray light traveling from the proximal light source through the center of the speculum tip. After the speculum tip was seated in the light source otoscope receptacle, as seen in FIG. 18B, a paper baffle was placed around the periphery of the proximal tip of the speculum, as shown in FIG. 18C and FIGS. 22A-B, to further block stray light from the light source and limit measurements to light transmitted by the speculum tip. Measurements of light emitted from the speculum tip were taken at 1 cm. 2 The efficiency was measured using a Model 818-SL silicon detector head with area and a Model 1830-C power meter with wavelength calibration set for 550 nm. The light source utilized for this measurement was driven by an HP E3631A DC power supply in current control mode. From the results shown in FIG. 22C, an approximately 3-4% decrease in efficiency was observed when a white seal was placed in contact with the exterior surface of the vapor-polished speculum tip, and an approximately 5-7% decrease in efficiency was observed when the speculum tip was pressed between the thumb and index finger near the tip, as shown in FIG. 22B. No change in efficiency was observed when the chrome-coated speculum tip was exposed to the white seal or the thumb and index finger as presented to the vapor-polished speculum tip.

[0134] Example 6 Comparison of the illumination performance of vapor-polished and chrome-coated speculum tips

[0135] Illumination performance experiments between a vapor polished speculum tip (FIG. 17A) and a chrome coated speculum tip (FIGS. 17B-C) were conducted to determine any differences between the two types of speculum tip finishing processes. A representative vapor polished speculum tip is shown in FIG. 17A, where the vapor polish was applied to all surfaces of the speculum tip except for the light source emission point and the speculum exit tip, as described elsewhere herein. The vapor polished speculum tips will be referred to as VP_1-VP_15 in the corresponding figures. The chrome coated speculum tips consisted of variable areas of chrome coating. FIG. 17B shows a chrome coated speculum tip, where the chrome coating was applied to all internal and external surfaces of the speculum tip, without coating the multiple light source emission points and the distal exit tip of the speculum, as described elsewhere herein. Such chrome coated speculum tips will be referenced with the identifiers CHR_1-CHR_3 in the corresponding figures. 17C shows a chrome coated speculum tip where the chrome coating was applied to all internal and external surfaces of the speculum tip, without coating the multiple light source emission points, the distal exit tip of the speculum, and the masked area on the sidewall proximate the distal exit tip of the speculum. Such chrome coated speculum tips will be referenced with the identifiers CwM_1-CwM_3 in the results referenced in the corresponding figures.

[0136] Each speculum tip was placed into the experimental illumination receptacle outlined in Example 5 to prevent stray light from adding noise to the illumination measurements. Illumination measurements (FIGS. 19-21) were made by varying both the current of the light source (an LED light source in current controlled power mode) and the distance between the detector and the distal emitting tip of the speculum.

[0137] Figure 19 shows the measured irradiance percent change versus power for the speculum tip at three detector distances (5, 10, and 15 mm) from the distal emitting tip of the speculum. From the results shown in Figure 19, optical irradiance and power share a linear relationship, are similar across different types of speculum tips, and are independent of detector measurement distance.

[0138] Figure 20 shows the measured irradiance percent change versus detector distance from the distal emitting tip of the speculum. The results show that the irradiance drop as a function of detector measurement distance is the same for both the vapor polished and chrome coated speculum tips. In addition, the relationship of irradiance drop as a function of detector measurement distance is independent of power.

[0139] FIG. 21 shows the measured irradiance for various types of speculum tips at a distance of 10 mm from the distal emitting tip of the speculum. The irradiance was measured over five time-distinct tests. From the results shown in FIG. 21, the best performing vapor polished speculum tip performed approximately 16 times more efficiently than any of the various chrome coated speculum tips.

[0140] Example 7 Simulated ray tracing and lighting transfer efficiency of launch point geometry

[0141] Simulated ray tracing and optical illumination transmittance were performed for various launch point geometries as shown in FIG. 25 and FIG. 26A-26F and described elsewhere herein. The launch point geometries included flat (FIG. 26A), oval (FIG. 26B), round (FIG. 26C), rectangular (FIG. 26D), concave (FIG. 26F), and V-shaped (FIG. 26E). Each launch point geometry was tested with at least two sets of dimensional parameters describing the launch point geometry as described elsewhere herein. The simulated ray tracing and optical illumination transmittance results are shown in FIG. 25 and FIG. 26A-26E, respectively. From FIG. 25, the V-shaped geometry illumination uniformity outperformed all other launch point geometries with approximately 33-34% of the source power injected at a point in front of the exit tip of the speculum. In terms of power transfer, the oval (FIG. 26B) geometry performed best.

[0142] Example 8 Comparison of in vivo illumination of the speculum tip with different post-processing approaches

[0143] Intra-aural videos were taken using illuminated speculum tips that were chrome coated (FIG. 17B), steam polished (FIG. 17A), or aluminum coated (FIG. 27A). For the purposes of this experiment, various aluminum coated geometries shown in FIG. 27A were analyzed: the coating of the speculum exit tip and the lead wire traces of the XMC insert (tip and trace), the coating of the outer surface of the conical section of the speculum tip (outer, no petals), the coating of all inner and outer surfaces of the speculum tip except the exit tip surface and light source emission point (inner and outer), and the coating of the entire outer surface of the speculum tip (outer only).

[0144] A Hawkeye Pro Super Slim borescope and iPhone 12 camera were used to capture video of the subject's illuminated tympanic membrane as the drive current to the illumination LED was varied. The iPhone 12 camera exposure settings were locked to the following set points: ISO 100, EV 0, Color Temp 4000K, shutter speed 1 / 60 sec, manual focus 50. The Hawkeye focus was adjusted to give the sharpest image while the live in-ear video was recorded. Representative images from each of the experimental conditions (i.e., variable current light source supply values) are shown in FIG. 27B for the various speculum tips.

[0145] From the images shown in FIG. 27B, image brightness and clarity of the tympanic membrane at low current and power was highest for the steam polished, tip and trace aluminum coated speculum tip.

[0146] Example 9 Comparison of illumination patterns and power of petal and commercial speculum tips

[0147] 8A-8C show a comparison of the spatial illumination patterns and transmitted power of a petal speculum tip (404), a conical speculum tip without distal petal structures (405), and a commercial (Welsch Allyn) speculum tip (402) as described elsewhere herein. An LED light source was utilized as the illumination source for purposes of analysis. For the petal speculum tip, the LED light source was coupled to the petal speculum tip by placing the LED light source in contact or near contact with the contoured petal emission point as described elsewhere herein. For the conical speculum tip without distal petal structures, the LED light source was coupled into the conical speculum tip by a parabolic mirror configured to collimate the LED light source as it stands incident on the conical speculum tip. The spatial illumination patterns were measured for each speculum tip at a distance of 100 mm from the speculum tip emission surface as shown in FIGS. 8A and 8B, respectively. From the images in Figures 8A and 8B, the spatial illumination patterns for the petal speculum tip (404) and the conical speculum tip without distal petal structures (405) appear to have a larger area of ​​illumination compared to the Welsch Allyn illumination pattern 402. In addition, the petal speculum tip illumination 404 appears to produce an illumination pattern with greater spatial illumination uniformity compared to the other speculum tips (402, 405). Such improvements in illumination area and uniformity may provide advantages for improving ultrasound transducer alignment and subsequent acquisition of data, as described elsewhere herein.

[0148] Turning to Figure 8C, the optical power measurements at 100 mm from the speculum tip can be seen. The optical power data shown in Figure 8C highlights and clearly demonstrates the superior performance and light coupling efficiency of the "petal" speculum tip, with light directing elements combined with a conical cross section, compared to the conical speculum tip without the distal petal structure and the Welsch Allyn speculum tip.

[0149] 12A-12B compare the diffuse illumination patterns of the petal (504) and commercial Welsch Allyn speculum tip (502) at the distal emitting tip (FIG. 12A) and 25 mm from the distal emitting tip (FIG. 12B). From the images shown, the petal speculum tip 504 has a more spatially uniform and diffuse pattern compared to the Welsch Allyn 502 speculum tip. In addition, as seen in FIG. 12B, at 25 mm from the distal tip of the Welsch Allyn 502, an artifactual dark spot can be seen in the center of the illumination 502 that would otherwise limit the uniformity of the illumination and overall optical power delivered to the surface being imaged.

[0150] 12C shows macro perspective images taken of an illuminated C0 (508) and petal-shaped speculum tip (504) as described elsewhere herein. From the images, it can be seen that the illumination of the petal-shaped speculum tip (504) is five times brighter than the illumination of the C0 speculum tip (508) under the same light source drive current settings.

[0151] Example 10 Comparison of illumination patterns of coated speculum tips

[0152] FIG. 23 shows images of various treated speculum tips at various distances (e.g., 10 mm, 17.5 mm, 25 mm, or 100 mm) from the speculum tip distal exit tip, as described elsewhere herein, e.g., in Example 6. For purposes of interpreting the data in FIG. 23, VP_1 corresponds to a vapor polished speculum tip intended to mimic or model the performance of a speculum tip from a tooled manufactured speculum tip. CHR_1 indicates a speculum tip with a chrome coating on all surfaces except one or more emission points and the exit tip distal surface. CwM_1 corresponds to a speculum tip where a chrome coating is applied to all internal and external surfaces of the speculum tip, without coating the multiple light source emission points, the distal exit tip of the speculum, and the mask area on the sidewall near the distal exit tip of the speculum. From FIG. 23, it appears that the vapor polished speculum tip provides the most uniform illumination pattern compared to the chrome coated speculum tip and the partially chrome coated speculum tip.

[0153] While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. The present invention is not intended to be limited by the specific examples provided herein. Although the present invention has been described with reference to the foregoing specification, the description and illustration of the embodiments herein are not meant to be construed in a limiting sense. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the present invention. Furthermore, it should be understood that all aspects of the present invention are not limited to the specific depictions, configurations, or relative proportions set forth herein, which depend upon a variety of conditions and variables. It should be understood that various alternatives to the embodiments of the present invention described herein may be employed in practicing the present invention. It is therefore contemplated that the present invention shall cover any such alternatives, modifications, variations, or equivalents. The following claims define the scope of the present invention, and methods and structures within the scope of these claims and their equivalents are intended to be covered thereby.

[0154] Although the above steps illustrate each of the methods according to the embodiments, one of ordinary skill in the art will recognize many variations based on the teachings described herein. Steps may be completed in different orders. Steps may be added or omitted. Some of the steps may include sub-steps. Many of the steps may be repeated as many times as is useful.

[0155] One or more of the respective steps of the method may be implemented using one or more of a processor or logic circuitry, such as, for example, programmable array logic for a field programmable gate array, as described herein. The circuitry may be programmed to provide one or more of the respective steps of the method, and the program may include program instructions stored on a computer readable memory or programmed steps of logic circuitry, such as, for example, programmable array logic or a field programmable gate array.

Claims

1. 1. A speculum operable to be placed in an ear of a subject, the speculum comprising: a housing comprising a light-guiding element, wherein transmitted optical illumination is conducted through the light-guiding element by total internal reflection, the housing having a lumen therein, the housing configured to allow reflected optical illumination to propagate through the lumen; one or more coupling portions for coupling the transmitted optical illumination from a light source to the light-guiding element, the one or more coupling portions being shaped as conical sections; A speculum.

2. The speculum of claim 1 , further comprising an insert, the insert configured to be mechanically coupled to the housing.

3. 3. The speculum of claim 2, wherein the insert comprises a lens, an ultrasound transducer, one or more electrical leads electrically coupled to the ultrasound transducer, one or more wires electrically coupled to the one or more electrical leads and the ultrasound transducer, or any combination thereof.

4. The speculum of claim 3 , wherein the ultrasound transducer comprises a capacitive micromachined ultrasound transducer.

5. The speculum of claim 3 , wherein the ultrasound transducer is electrically coupled to the one or more electrical leads of the insert by the one or more wires.

6. The speculum of claim 2 , wherein the insert comprises a spacer structure configured to space the insert from an interior surface of the lumen of the housing.

7. The speculum of claim 2 , wherein the insert comprises structure configured to releasably couple to the housing when inserted into the housing.

8. The speculum of claim 7 , wherein the formations comprise grooves, holes, or hooks configured to snap-fit ​​into formations on the housing.

9. 3. The speculum of claim 2, wherein the insert comprises an electrical coupling interface comprising an electromechanical structure configured to releasably couple to and electrically communicate with a receptacle.

10. 10. The speculum of claim 9, wherein the electromechanical structure comprises one or more electrical pads adjacent a surface of one or more mechanical coupling interfaces.

11. The speculum of claim 10 , wherein the one or more mechanical coupling interfaces comprise a hook configured to mate with a clasp receptacle.

12. The speculum of claim 1 , wherein the light-guiding element comprises an elliptical shape.

13. The speculum of claim 1 , wherein the light-guiding element is configured to become a parabolic mirror when light rays of the light source interact with the light-guiding element.

14. The speculum of claim 1 , wherein the light directing element comprises an emission point.

15. 15. The speculum of claim 14, wherein the projection point comprises a geometric shape, the geometric shape comprising flat, round, oval, concave, rectangular, or V-shaped.

16. The speculum of claim 1 , wherein the housing comprises a proximal seal member, a distal seal member, or any combination thereof.

17. 17. The speculum of claim 16, wherein the proximal and distal sealing members comprise an elastomeric material configured to seal the housing within the ear of the subject.

18. 10. The speculum of claim 1, wherein the housing is partially or wholly steam polished, aluminum coated, chrome coated, or any combination thereof.

19. The speculum of claim 1, wherein the housing and the one or more coupling portions are part of a speculum, the speculum being operably and releasably coupled to an otoscope.

20. 1. A method of using an otoscope, the method comprising: directing optical illumination of a light source to one or more coupling portions, the one or more coupling portions being shaped as conical sections; directing the optical illumination from the one or more coupling portions to a light-guiding element, the optical illumination propagating through the light-guiding element by total internal reflection; collecting reflected optical illumination from a target within a lumen of a housing, said housing forming a portion of an otoscope speculum; A method comprising:

21. 21. The method of claim 20, further comprising directing the pneumatic excitation towards a target.

22. 22. The method of claim 21, further comprising directing ultrasound toward the target.

23. 22. The method of claim 21, further comprising measuring a response of the target to the pneumatic excitation in a reflected ultrasonic signal.

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