Methods and devices for film property evaluation using ultrasonic and optical illumination

Abstract

The device for measuring reflected ultrasound and optical signals may include an optical source, an optical assembly having at least one lens and configured to focus reflected optical illumination from a target onto a detector, and an ultrasound transducer aligned to transmit and receive ultrasound radiation coaxially with the reflected optical illumination, the ultrasound transducer at least partially obstructing the path of the reflected optical illumination. The obstruction may be far from the focal point of the optical assembly. The device for measuring reflected ultrasound and optical signals may be particularly useful for characterizing fluid behind the tympanic membrane to diagnose otitis media.

Description

Technical Field

[0001] (Cross - reference) This application claims the benefit of U.S. Provisional Patent Application No. 62 / 740,862, filed Oct. 3, 2019 [Attorney Docket No. 45102 - 710.101], which is hereby incorporated by reference in its entirety.

Background Art

[0002] Acute otitis media (AOM) is an inflammatory process in the middle ear and is the most common clinical condition in children under 15 years old diagnosed by pediatricians. AOM is generally associated with the presence of middle ear effusion and is considered an inflammation of the middle ear. Complications of AOM with uncertain diagnosis 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] The possibility of obtaining an accurate diagnosis using existing non - invasive methods can be less than 50%. Furthermore, existing non - invasive methods may be useful only in identifying the presence of effusion and, in many cases, do not provide any information regarding the type of effusion. Due to the risks associated with AOM with uncertain diagnosis and the recognized low reliability of existing diagnostic tests, patients are often prescribed antibiotics, which may not be effective in treating viral effusions. In addition to the increased cost burden of unnecessary antibiotic treatment, patients are exposed to the side effects of antibiotics and a significant associated risk of developing antibiotic resistance.

[0004] The following co - owned references may be of interest: U.S. Patent Publication No. 2018 / 0310917 (Patent Document 1) and U.S. Patent Publication No. 2017 / 0014053 (Patent Document 2) (each of which is hereby incorporated by reference in its entirety). The following reference may be of interest: U.S. Patent No. 5,345,926 (Patent Document 3).

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

Problems to be Solved by the Invention

[0006] The devices and methods described herein can improve existing non-invasive techniques by measuring ultrasonic data reflected from a biological membrane simultaneously with pneumatic excitation. The size of the diagnostic target can be small and the ultrasonic waves are not visible to the human eye. An optical source and a detection system can be provided. The optical source and the detection system can facilitate the alignment of the ultrasonic beam. Since the size of the biological lumen can be small, the optical source and the detection system can be space-efficient. The present disclosure provides improvements in delivering optical illumination to a target. The present disclosure provides improvements in receiving optical illumination from a target in the presence of obstacles.

Means for Solving the Problems

[0007] In one aspect, the present disclosure provides an otoscope operable to be disposed within the ear of a subject. The otoscope is a housing having an optical conduction element, wherein transmission optical illumination is conducted through the optical conduction element by total internal reflection, the housing has a lumen therein, and the housing is configured to allow reflected optical illumination to propagate therethrough, and an obstacle disposed within the lumen near the distal end of the housing, the obstacle at least partially obstructs the reflected optical illumination, and the obstacle has a largest dimension less than 75% of the smallest diameter of the lumen.

[0008] In some embodiments, the obstacle is provided with an ultrasonic transducer. In some embodiments, the ultrasonic transducer is centered with respect to the distal end of the housing. In some embodiments, the transmission axis of the ultrasonic transducer is coaxial with the Name axis of symmetry of the housing. In some embodiments, the housing is frustoconical in shape. In some embodiments, the transmission axis of the ultrasonic transducer is coaxial with the optical path of the reflective optical illumination. In some embodiments, the largest dimension is the diameter. In some embodiments, the diameter is in the range of 20% to 60% of the smallest diameter of the lumen.

[0009] In some embodiments, the light conducting element comprises one or more optical fibers adjacent to the housing. In some embodiments, a part of the housing is configured to transmit light by total internal reflection such that a part of the housing is a light conducting element. In some embodiments, the housing comprises a light conducting core. In some embodiments, the housing comprises an impermeable shell. In some embodiments, the endoscope is disposable.

[0010] In some embodiments, the endoscope is removably attachable to an otoscope. In some embodiments, the endoscope is removably connected to a device for measuring reflective optical signals and ultrasonic signals. In some embodiments, when the endoscope is connected to the device, it is axially aligned with the focal axis of the optical assembly. In some embodiments, the optical assembly has a focus within the range of 12 to 25 mm from the distal tip of the otoscope. In some embodiments, the optical assembly has a depth of field greater than 0.5 mm at a distance of 12 to 25 mm from the distal tip of the otoscope.

[0011] In some embodiments, the optical assembly comprises at least one lens. In some embodiments, the at least one lens is a relay lens. In some embodiments, the relay lens comprises one or more concave lenses, convex lenses, plano-concave lenses, or plano-convex lenses. In some embodiments, the relay lens comprises one or more achromatic doublets. In some embodiments, the relay lens comprises one or more gradient index lenses. In some embodiments, the relay lens comprises a rod lens relay. In some embodiments, the at least one lens comprises at least two lenses forming a first telescope.

[0012] In some embodiments, the ultrasonic transducer is mounted on a transducer-mounted assembly. In some embodiments, the transducer-mounted assembly comprises one or more apertures to enable the transmission of pneumatic excitation around the ultrasonic transducer. In some embodiments, the transducer-mounted assembly is press-fitted into the housing of the ophthalmoscope. In some embodiments, the distal end of the transducer-mounted assembly is operably coupled to a transmissive plate. In some embodiments, the transmissive plate comprises an ultrasonic transducer mounted on its surface. In some embodiments, a portion of the transducer-mounted assembly is conductive. In some embodiments, the ultrasonic transducer has a largest dimension of less than 2 mm. In some embodiments, a metal shield is disposed around the ultrasonic transducer and the metal shield is displaced radially away from the transmission axis of the ultrasonic transducer. In some embodiments, the ophthalmoscope comprises a pressure gauge configured to measure the internal pressure within the ophthalmoscope.

[0013] In another aspect, the present disclosure provides a device for measuring reflected optical signals and ultrasonic signals. The device includes an optical source, an optical assembly comprising at least one lens configured to focus reflected optical illumination from a target onto a detector, and an ultrasonic transducer aligned to transmit and receive ultrasonic radiation coaxially with the reflected optical illumination, wherein the ultrasonic transducer may comprise an ultrasonic transducer that at least partially obstructs the path of the reflected optical illumination, and the optical assembly has a focus within a range of 12 to 25 mm from the distal tip of the otoscope and a depth of field greater than 0.5 mm at a distance of 12 to 25 mm from the distal tip of the otoscope.

[0014] In some embodiments, the device comprises an otoscope of any aspect or embodiment. In some embodiments, the ultrasonic transducer is centered with respect to the focal axis of the optical assembly. In some embodiments, the transmission axis of the ultrasonic transducer is coaxial with the focal axis of the optical assembly. In some embodiments, the transmission axis of the ultrasonic transducer is coaxial with the optical path of the reflected optical illumination. In some embodiments, the ultrasonic transducer has a relative size of 20% to 50% of the aperture of the optical assembly. In some embodiments, the optical source comprises one or more optical fibers.

[0015] In some embodiments, the optical source is configured to deliver light to the otoscope. In some embodiments, a portion of the otoscope is configured to transmit light by total internal reflection. In some embodiments, the otoscope comprises an optical conducting core. In some embodiments, the otoscope comprises an impermeable shell. In some embodiments, the otoscope is disposable. In some embodiments, the device is an otoscope. In some embodiments, the otoscope is removably connected to the device.

[0016] In some embodiments, when connected to the device, the endoscope is axially aligned with the focal axis of the optical assembly. In some embodiments, the optical assembly comprises at least one lens. In some embodiments, the at least one lens is a relay lens. In some embodiments, the relay lens comprises one or more concave lenses, convex lenses, plano - concave lenses, or plano - convex lenses. In some embodiments, the relay lens comprises one or more achromatic doublets. In some embodiments, the relay lens comprises one or more gradient index lenses. In some embodiments, the relay lens comprises a rod lens relay. In some embodiments, the at least one lens comprises at least two lenses forming a first telescope.

[0017] In some embodiments, the ultrasonic transducer is mounted on a transducer - mounted assembly. In some embodiments, the transducer - mounted assembly comprises one or more apertures to enable the transmission of pneumatic excitation around the ultrasonic transducer. In some embodiments, the transducer - mounted assembly is press - fit into the housing of the endoscope. In some embodiments, the distal end of the transducer - mounted assembly is operably coupled to a transmissive plate. In some embodiments, the transmissive plate comprises an ultrasonic transducer mounted on its surface. In some embodiments, a portion of the transducer - mounted assembly is conductive. In some embodiments, the ultrasonic transducer has a largest dimension of less than 2 mm. In some embodiments, a metal shield is disposed around the ultrasonic transducer and the metal shield is radially displaced away from the transmission axis of the ultrasonic transducer. In some embodiments, the device further comprises a pressure gauge configured to measure the internal pressure within the endoscope.

[0018] In another aspect, the present disclosure provides a method of using an otoscope. The method includes directing optical illumination toward a target, directing pneumatic excitation toward the target, directing ultrasonic waves toward the target, where the ultrasonic waves propagate with the optical illumination, receiving reflected optical illumination from the target at a detector, measuring a response of the target to the pneumatic excitation in the reflected ultrasonic waves, and determining a condition or state of the subject based on the reflected optical illumination and the response.

[0019] In some embodiments, the method further includes providing a device of any aspect or embodiment. In some embodiments, the method further includes providing an otoscope of any aspect or embodiment.

[0020] In another aspect, the present disclosure provides an otoscope operable to be disposed within a subject's ear. The otoscope includes a frustoconical housing configured to be disposed within the ear canal and having a lumen, one or more optical fibers adjacent to the frustoconical housing and extending from a proximal opening of the frustoconical housing to a distal tip, and an ultrasonic transducer mounted within the frustoconical housing near the distal tip and aligned to transmit and receive ultrasonic radiation coaxially with the reflected optical illumination, where the ultrasonic transducer at least partially obstructs a path of the reflected optical illumination.

[0021] In some embodiments, the endoscope further comprises an endoscope of any aspect or embodiment, the obstacle comprises at least an ultrasonic transducer, and the one or more optical fibers comprise an optical conduction element. In some embodiments, the endoscope is removably attached to a device of any aspect or embodiment. In some embodiments, the ultrasonic transducer is centered relative to the distal end of the housing. In some embodiments, the ultrasonic transducer is coaxial with the housing. In some embodiments, the endoscope comprises a quick-release joint. In some embodiments, the diameter of the ultrasonic transducer is less than 50% of the lumen of the housing that opens at the distal end of the housing. In some embodiments, the endoscope is disposable.

[0022] In another aspect, the present disclosure provides an endoscope operable to be disposed within the ear of a subject. The endoscope comprises a frustoconical housing configured to be disposed within the ear canal and configured to transmit light by total internal reflection, and an ultrasonic transducer mounted within the frustoconical housing near the distal tip of the frustoconical housing, the ultrasonic transducer being small enough to allow passage of reflected light through the lumen of the housing.

[0023] In some embodiments, the endoscope further comprises an endoscope of any aspect or embodiment, the obstacle comprises at least an ultrasonic transducer, and the housing comprises an optical conduction element. In some embodiments, the endoscope is removably attached to a device of any aspect or embodiment. In some embodiments, the ultrasonic transducer is centered relative to the distal end of the housing. In some embodiments, the ultrasonic transducer is coaxial with the housing. In some embodiments, the endoscope is disposable.

[0024] In another aspect, the present disclosure provides an otoscope. The otoscope includes an interface for releasably coupling to an endoscope, and an optical assembly having at least one lens with an aperture, wherein the optical assembly has a focal point within a range of 12 to 25 mm from the distal tip of the otoscope and a depth of field greater than 0.5 mm at a distance of 12 to 25 mm from the distal tip of the otoscope, and a central obstacle along the optical path from the optical assembly to the target, the central obstacle having a diameter less than 50% of the aperture. In some embodiments, the endoscope further includes an endoscope of any aspect or embodiment.

[0025] In another aspect, the present disclosure provides an otoscope. The otoscope includes an endoscope having a lumen therein and a light conducting element, wherein transmission optical illumination is conducted by total internal reflection by the light conducting element and reflective optical illumination is propagated through the lumen of the endoscope, a central obstacle disposed within the endoscope near the distal end, the central obstacle at least partially obstructing the reflective optical illumination, and an optical assembly having at least one lens with a focal length longer than the distance from the lens to the central obstacle. In some embodiments, the endoscope further includes an endoscope of any aspect or embodiment.

[0026] In another aspect, the present disclosure provides a method of using an optical and ultrasonic device. The method can include directing optical illumination toward a target, directing ultrasonic waves toward the target, receiving reflected ultrasonic waves from the target, and adjusting the focus of the optical illumination based on the received reflected ultrasonic waves, wherein the adjusting is performed substantially in real time. In some embodiments, the method further includes calculating image sharpness, calculating a derivative of the image sharpness, and adjusting the focus based on the image sharpness.

[0027] In another aspect, the present disclosure provides a method of manufacturing an endoscope operable to be disposed within an ear. The method includes mounting an ultrasonic transducer on a substrate, mounting the substrate on a support having a conductive portion, the support having an air-pressure clear path when the support is mounted, and housing the support within the lumen of the endoscope, the transducer being centered within the lumen of the endoscope, the endoscope having an optically clear path when the transducer is within the lumen. (Incorporation by reference)

[0028] All publications, patents, and patent applications mentioned in this specification are hereby incorporated by reference to the same extent as if each individual publication, patent, or patent application had been specifically and individually indicated to be incorporated by reference. The present invention further provides, for example, the following. (Item 1) An endoscope operable to be disposed within an ear of a subject, the endoscope comprising a housing having an optical conduction element, transmission optical illumination being conducted through the optical conduction element by total internal reflection, the housing having a lumen therein, the housing being configured to allow reflective optical illumination to propagate therethrough, an obstacle disposed within the lumen near a distal end of the housing, and comprising wherein the obstacle at least partially obstructs the reflective optical illumination, the obstacle having a largest dimension less than 75% of the smallest diameter of the lumen. (Item 2) The endoscope according to item 1, wherein the obstacle comprises an ultrasonic transducer. (Item 3) The endoscope according to item 2, wherein the ultrasonic transducer is centered with respect to the distal end of the housing. (Item 4) The transmission axis of the ultrasonic transducer is opposite to the NameThe endoscope according to item 2, which is coaxial with the shaft. (Item 5) The endoscope according to item 1, wherein the housing has a frustum of a cone shape. (Item 6) The endoscope according to item 1, wherein the transmission axis of the ultrasonic transducer is coaxial with the optical path of the reflective optical illumination. (Item 7) The endoscope according to item 1, wherein the largest dimension is the diameter. (Item 8) The endoscope according to item 7, wherein the diameter is in the range of 20% to 60% of the smallest diameter of the lumen. (Item 9) The endoscope according to item 1, wherein the light guiding element includes one or more optical fibers adjacent to the housing. (Item 10) The endoscope according to item 1, wherein a part of the housing is configured to transmit light by total internal reflection such that the part of the housing is the light guiding element. (Item 11) The endoscope according to item 10, wherein the housing includes a light conducting core. (Item 12) The endoscope according to item 11, wherein the housing includes an impermeable shell. (Item 13) The endoscope according to item 1, which is disposable. (Item 14) The endoscope according to item 1, which is removably attachable to an otoscope. (Item 15) The endoscope according to item 1, which is removably connected to a device for measuring reflective optical signals and ultrasonic signals. (Item 16) The endoscope according to item 15, which is axially aligned with the focal axis of the optical assembly when connected to the device. (Item 17) The endoscope according to item 15, wherein the optical assembly has a focus within the range of 12 to 25 mm from the distal tip of the otoscope. (Item 18) The ophthalmoscope according to item 15, wherein the optical assembly has a depth of field greater than 0.5 mm at a distance of 12 to 25 mm from the distal tip of the ophthalmoscope. (Item 19) The ophthalmoscope according to item 15, wherein the optical assembly includes at least one lens. (Item 20) The ophthalmoscope according to item 19, wherein the at least one lens is a relay lens. (Item 21) The ophthalmoscope according to item 20, wherein the relay lens includes one or more concave lenses, convex lenses, plano-concave lenses, or plano-convex lenses. (Item 22) The ophthalmoscope according to item 21, wherein the relay lens includes one or more achromatic doublets. (Item 23) The ophthalmoscope according to item 21, wherein the relay lens includes one or more gradient index lenses. (Item 24) The ophthalmoscope according to item 21, wherein the relay lens includes a rod lens relay. (Item 25) The ophthalmoscope according to item 19, wherein the at least one lens includes at least two lenses forming a first telescope. (Item 26) The ophthalmoscope according to item 2, wherein the ultrasonic transducer is mounted on a transducer-mounted assembly. (Item 27) The ophthalmoscope according to item 26, wherein the transducer-mounted assembly includes one or more openings for enabling transmission of pneumatic excitation around the ultrasonic transducer. (Item 28) The ophthalmoscope according to item 26, wherein the transducer-mounted assembly is press-fitted into the housing of the ophthalmoscope. (Item 29) The ophthalmoscope according to item 26, wherein the distal end of the transducer-mounted assembly is operably coupled to a transmissive plate. (Item 30) The inspection mirror according to item 29, wherein the permeable plate includes the ultrasonic transducer mounted on its surface. (Item 31) The inspection mirror according to item 26, wherein a part of the transducer mounting assembly is conductive. (Item 32) The inspection mirror according to item 1, wherein the ultrasonic transducer has a largest dimension of less than 2 mm. (Item 33) The inspection mirror according to item 4, wherein a metal shield is disposed around the ultrasonic transducer, and the metal shield is displaced radially away from the transmission axis of the ultrasonic transducer. (Item 34) The inspection mirror according to item 14 or 15, further comprising a pressure gauge configured to measure the internal pressure within the inspection mirror. (Item 35) A device for measuring reflected optical signals and ultrasonic signals, the device comprising: an optical source; an optical assembly comprising at least one lens, the optical assembly being configured to focus reflected optical illumination from a target onto a detector; an ultrasonic transducer aligned to transmit and receive ultrasonic radiation coaxial with the reflected optical illumination; and the ultrasonic transducer at least partially obstructs the path of the reflected optical illumination; the optical assembly has a focal point within a range of 12 to 25 mm from the distal tip of the otoscope and a depth of field greater than 0.5 mm at a distance of 12 to 25 mm from the distal tip of the otoscope. (Item 36) The device according to item 35, further comprising the inspection mirror according to any one of items 1 - 32. (Item 37) The ultrasonic transducer is centered with respect to the focal axis of the optical assembly, the device according to item 35. (Item 38) The transmission axis of the ultrasonic transducer is coaxial with the focal axis of the optical assembly, the device according to item 35. (Item 39) The transmission axis of the ultrasonic transducer is coaxial with the optical path of the reflective optical illumination, the device according to item 35. (Item 40) The ultrasonic transducer has a relative size of 20% to 50% of the opening of the optical assembly, the device according to item 35. (Item 41) The optical source comprises one or more optical fibers, the device according to item 35. (Item 42) The optical source is configured to deliver light to a beam splitter, the device according to item 35. (Item 43) A part of the beam splitter is configured to transmit light by total internal reflection, the device according to item 42. (Item 44) The beam splitter comprises an optical conducting core, the device according to item 43. (Item 45) The beam splitter comprises an impermeable shell, the device according to item 44. (Item 46) The beam splitter is disposable, the device according to item 42. (Item 47) The device is an otoscope, the device according to item 35. (Item 48) The beam splitter is removably connected to the device, the device according to item 36. (Item 49) When the beam splitter is connected to the device, it is axially aligned with the focal axis of the optical assembly, the device according to item 48. (Item 50) The device according to item 35, wherein the optical assembly comprises at least one lens. (Item 51) The device according to item 50, wherein the at least one lens is a relay lens. (Item 52) The device according to item 51, wherein the relay lens comprises one or more concave lenses, convex lenses, plano - concave lenses, or plano - convex lenses. (Item 53) The device according to item 52, wherein the relay lens comprises one or more achromatic doublets. (Item 54) The device according to item 52, wherein the relay lens comprises one or more gradient - index lenses. (Item 55) The device according to item 52, wherein the relay lens comprises a rod - lens relay. (Item 56) The device according to item 50, wherein the at least one lens comprises at least two lenses forming a first telescope. (Item 57) The device according to item 35, wherein the ultrasonic transducer is mounted on a transducer - mounted assembly. (Item 58) The device according to item 57, wherein the transducer - mounted assembly comprises one or more openings for enabling transmission of pneumatic excitation around the ultrasonic transducer. (Item 59) The device according to item 57, wherein the transducer - mounted assembly is press - fitted into the housing of the ophthalmoscope. (Item 60) The device according to item 57, wherein a distal end of the transducer - mounted assembly is operably coupled to a transmissive plate. (Item 61) The device according to item 60, wherein the transmissive plate comprises the ultrasonic transducer mounted on its surface. (Item 62) The device according to item 57, wherein a part of the transducer-mounted assembly is conductive. (Item 63) The device according to item 35, wherein the ultrasonic transducer has a largest dimension of less than 2 mm. (Item 64) The device according to item 35, wherein a metal shield is disposed around the ultrasonic transducer, and the metal shield is displaced radially away from the transmission axis of the ultrasonic transducer. (Item 65) The device according to item 36 or 42, further comprising a pressure gauge configured to measure the internal pressure within the endoscope. (Item 66) A method of using an otoscope, the method comprising: directing optical illumination towards a target; directing pneumatic excitation towards the target; directing ultrasonic waves towards the target, wherein the ultrasonic waves propagate together with the optical illumination; receiving reflected optical illumination from the target at a detector; measuring the response of the target to the pneumatic excitation in the reflected ultrasonic waves; determining a state or condition of an object based on the reflected optical illumination and the response. A method comprising the above. (Item 67) The method according to item 66, further comprising providing a device according to any one of items 35 - 65. (Item 68) The method according to item 66, further comprising providing an endoscope according to any one of items 1 - 34. (Item 69) An endoscope operable to be disposed within an ear of a subject, the endoscope comprising: a frustoconical housing configured to be disposed within the external auditory canal and having a lumen; One or more optical fibers adjacent to the frustoconical housing and extending from the proximal opening to the distal tip of the frustoconical housing, An ultrasonic transducer mounted within the frustoconical housing near the distal tip Comprising, The ultrasonic transducer is aligned to transmit and receive ultrasonic radiation coaxial with the reflective optical illumination, and the ultrasonic transducer is an endoscope that at least partially obstructs the path of the reflective optical illumination. (Item 70) The endoscope according to item 1, further comprising the endoscope according to item 66, wherein the obstacle comprises at least the ultrasonic transducer, and the one or more optical fibers comprise the optical conduction element. (Item 71) The endoscope according to item 70, further comprising the endoscope according to any one of items 2 - 34. (Item 72) The endoscope according to any one of items 69 - 71, wherein the endoscope is removably attached to the device according to any one of items 35 - 65. (Item 73) The endoscope according to any one of items 69 - 71, wherein the ultrasonic transducer is centered with respect to the distal end of the housing. (Item 74) The endoscope according to item 73, wherein the ultrasonic transducer is coaxial with the housing. (Item 75) The endoscope according to any one of items 69 - 71, wherein the endoscope comprises a quick-release joint. (Item 76) The endoscope according to any one of items 69 - 71, wherein the diameter of the ultrasonic transducer is less than 50% of the lumen of the housing that opens at the distal end of the housing. (Item 77) The endoscope according to any one of items 69 - 71, wherein the endoscope is disposable. (Item 78) An endoscope operable to be placed within the ear of a subject, the endoscope comprising, A frustoconical housing configured to be disposed within the external auditory canal and configured to transmit light by total internal reflection, and an ultrasonic transducer mounted within the frustoconical housing near the distal tip of the frustoconical housing comprising The ultrasonic transducer is an endoscope that is small enough to allow the reflected light to pass through the lumen of the housing. (Item 79) An endoscope further comprising the endoscope according to item 1, wherein the obstacle comprises at least the ultrasonic transducer, and the housing comprises the light guiding element, the endoscope according to item 78. (Item 80) The endoscope according to item 79, further comprising the endoscope according to any one of items 2-34. (Item 81) The endoscope according to any one of items 78-80, wherein the endoscope is removably attached to the device according to any one of items 35-65. (Item 82) The ultrasonic transducer is centered with respect to the distal end of the housing, the endoscope according to any one of items 78-80. (Item 83) The ultrasonic transducer is coaxial with the housing, the endoscope according to any one of items 78-80. (Item 84) The endoscope according to any one of items 78-80 is disposable. (Item 85) An otoscope, wherein the otoscope an interface for releasably coupling to an endoscope, and an optical assembly comprising at least one lens, the optical assembly having an aperture, the optical assembly having a focal point within a range of 12 to 25 mm from the distal tip of the otoscope and a depth of field greater than 0.5 mm at a distance of 12 to 25 mm from the distal tip of the otoscope, an optical assembly, and a central obstacle along the optical path from the optical assembly to the target comprising an otoscope, wherein the central obstacle has a diameter less than 50% of the opening. (Item 86) The otoscope according to Item 85, wherein the endoscope is the endoscope according to any one of Items 1-34 or 69-84. (Item 87) An otoscope, comprising an endoscope having a lumen therein and comprising a light conducting element, wherein transmission optical illumination is conducted by total internal reflection by the light conducting element and reflective optical illumination is propagated through the lumen of the endoscope; a central obstacle disposed within the endoscope near the distal end, the central obstacle at least partially obstructing the reflective optical illumination; and an optical assembly comprising at least one lens having a focal length wherein the focal length is longer than the distance from the lens to the central obstacle. (Item 88) (Item 88) The otoscope according to Item 87, wherein the endoscope is the endoscope according to any one of Items 1-34 or 69-84. (Item 89) A method of using an optical and ultrasonic device, the method comprising: directing optical illumination towards a target; directing ultrasonic waves towards the target; receiving reflected ultrasonic waves from the target; adjusting the focus of the optical illumination based on the received reflected ultrasonic waves; wherein the adjusting is performed substantially in real time. (Item 90) (Item 90) The method according to Item 89, further comprising calculating an image sharpness, calculating a derivative of the image sharpness, and adjusting the focus based on the image sharpness. (Item 91) A method of manufacturing an endoscope operable to be disposed in an ear, the method comprising: mounting an ultrasonic transducer on a substrate; mounting the substrate on a support having a conductive portion, the support having an air-pressure-clear path when the support is mounted; receiving the support within the lumen of the endoscope; and wherein the transducer is centered within the lumen of the endoscope and the endoscope has an optically-clear path when the transducer is within the lumen. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The novel features of the present disclosure are particularly set forth in the appended claims. A more complete understanding of the features and advantages of the present disclosure will be obtained from the following detailed description of the illustrative embodiments in which the principles of the invention are utilized, along with the accompanying drawings.

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[0057] Devices, otoscopes, otoscopes, and methods of using and manufacturing the same as disclosed herein can address problems associated with devices for measuring optical and ultrasonic information. Embodiments of the present disclosure can improve the delivery of light and / or the collection of light from biological membranes that can be characterized simultaneously with ultrasonic excitation. Devices, otoscopes, otoscopes, and methods of using and manufacturing the same as disclosed herein can address difficulties in the field related to the alignment of devices for measuring reflected ultrasonic signals. In some cases, the present disclosure addresses problems in the field of otoscopy.

[0058] For example, surface property evaluation using the analysis of reflected ultrasound in the presence of pneumatic excitation can be improved if the delivery optical illumination, pneumatic excitation, and ultrasound signal are spatially efficient. For example, surface property evaluation using the analysis of reflected ultrasound in the presence of pneumatic excitation can be improved if the measurement of the reflected ultrasound signal and reflected optical illumination are spatially efficient.

[0059] For example, surface property evaluation using the analysis of reflected ultrasound in the presence of pneumatic excitation can be improved if the ultrasound is directed at the surface at an angle that will cause the ultrasound signal to be returned to the transducer. Since ultrasound excitation is not visible to the eye, particularly the eye of the device operator, aligning the ultrasound can sometimes be difficult. In one solution, a light source can be directed towards the surface such that the user can better adjust the alignment of the device. The light source can be substantially aligned with the ultrasound propagation. In the ear, the user can align the light source within the ear canal to reflect light from the eardrum. Good reflection can result in a "light cone". However, since the user may not be looking directly through the center of the lens and / or the transducer may block the reflected light, the ultrasound and the light may not propagate in the same direction.

[0060] Devices, otoscopes, endoscopes, and methods of using and manufacturing them as disclosed herein can be used in combination with devices and methods for characterizing ductile films, surfaces, and subsurface properties such as those described in co-owned U.S. Patent Publication Nos. 2018 / 0310917 and 2017 / 0014053, each of which is incorporated by reference in its entirety.

[0061] Devices, otoscopes, endoscopes, and methods of using and manufacturing the same as disclosed herein can be used to characterize several biological tissues and provide various diagnostic information. The biological tissue can comprise a patient organ. The endoscope can be disposed within a body cavity to characterize a patient tissue. The patient organ or body cavity can comprise, for example, muscle, tendon, ligament, mouth, tongue, pharynx, esophagus, stomach, intestine, anus, liver, gallbladder, pancreas, nose, larynx, trachea, lung, kidney, bladder, urethra, uterus, vagina, ovary, testis, prostate, heart, artery, vein, spleen, gland, brain, spinal cord, nerve, etc.

[0062] Devices, otoscopes, endoscopes, and methods of using and manufacturing the same as disclosed herein can be used to characterize the tympanic membrane. For example, the membrane can be characterized to determine ear conditions such as acute otitis media (AOM). The characterization of the ear for AOM can include the detection of the presence of exudate and the characterization of the type of exudate as one of serous, mucous, purulent, or a combination thereof. In AOM, middle ear effusion (MEE) can be induced by pathogens and can be thin or serous in viral infections and thicker and purulent in bacterial infections. Thus, determining the various characteristics of the fluid adjacent to the tympanic membrane can provide information that can be used to characterize the membrane.

[0063] Devices, otoscopes, endoscopes, and methods of use and manufacture as disclosed herein can be used to characterize food items. For example, pneumatic excitation can apply an impact pressure to the surface of food items such as vegetables, fruits, meats, dairy products, grains, etc., and ultrasonic energy can be applied to the food item to measure the time-dependent surface response of the food item. For example, the surface response of a fruit or vegetable can be used to determine elastic or other physical properties that may be related to the ripeness of the fruit or vegetable. For example, the presence of mold on the surface of a bread item can change the surface response of the bread crust. For example, the surface properties of yogurt or cheese can be determined to assess the firmness of the cultured dairy product. For example, the surface response of a meat or meat product can be related to the degree to which it has been cooled. For example, the food item is placed in a holder, the surface is excited by blowing a gas such as air, and the surface deflection response can estimate ripeness or other properties. For example, the excitation can be a gas delivered to the surface of the food item at supersonic speeds and / or at an angle of incidence, or one or more food items can be placed in a chamber with variable pressure to measure the low-frequency surface response to pressure such as deflection versus pressure. For example, the excitation is applied to one surface and the response can be measured on a different surface of the same item (such as measuring propagating surface waves or shear waves traveling through the item being characterized).

[0064] Devices, otoscopes, endoscopes, and methods of use and manufacture as disclosed herein can be used to characterize industrial processes. For example, pneumatic excitation can apply an impact pressure to the surface of a manufactured part, such as to determine the viscosity of a viscous fluid such as a lubricant, and ultrasonic energy can be applied to the part to measure the time-dependent surface response of the viscous fluid and determine elastic or other physical properties that may be related to the quality of the lubricant. Other industrial examples can include ranging applications, ultrasonic transit time gas flow meters for measuring dynamic gas flows, anemometry applications, and various other ultrasonic-based sensing applications.

[0065] Here, various embodiments are referred to in detail, and examples thereof are illustrated in the accompanying drawings. In the following modes for carrying out the invention, numerous specific details are set forth in order to provide a thorough understanding of the disclosed and described embodiments. However, the embodiments of the present disclosure may be practiced optionally without these specific details. In other instances, well-known methods, procedures, components, and circuits are not described in detail so as not to unnecessarily obscure aspects of the embodiments. In the drawings, like reference numerals designate like or similar things or components.

[0066] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be a limitation of the claims. As used in the description of the embodiments and the appended claims, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. It should also be understood that the term "and / or" as used herein refers to and encompasses any and all possible combinations of one or more of the listed items associated therewith. The terms "comprises" and / or "comprising", as used herein, specify the presence of the features, integers, steps, operations, elements, and / or components described, and do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0067] As used herein, the term "when" optionally, depending on the context, is interpreted to mean "when", or "in response to", or "in accordance with", or "in response to determining", or "in accordance with a determination", or "in response to detecting" that the stated precondition applies. Similarly, the phrases "when it is determined that [the stated precondition applies]", or "when [the stated precondition applies]", or "when [the stated precondition applies]" optionally, depending on the context, are interpreted to mean "in response to determining", or "in response to detecting", or "in accordance with a determination", or "in response to detecting", or "in accordance with a detection" that the stated precondition applies.

[0068] As used herein and unless otherwise specified, the term "about" or "approximately" means, in part, an acceptable error with respect to a particular value as determined by one of ordinary skill in the art, which depends in part on the manner in which the value is measured or determined. In certain embodiments, the term "about" or "approximately" means within 1, 2, 3, or 4 standard deviations. In certain embodiments, the term "about" or "approximately" means within 30%, 25%, 20%, 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, or 0.05% of a given value or range. In certain embodiments, the term "about" or "approximately" means within 40.0 mm, 30.0 mm, 20.0 mm, 10.0 mm, 5.0 mm, 1.0 mm, 0.9 mm, 0.8 mm, 0.7 mm, 0.6 mm, 0.5 mm, 0.4 mm, 0.3 mm, 0.2 mm, or 0.1 mm of a given value or range.

[0069] As used herein, the term "comprises," "comprising," or any other variation thereof is intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

[0070] As used herein, the terms "subject" and "patient" are used synonymously. As used herein, the terms "subject" and "a plurality of subjects" refer to animals (e.g., birds, reptiles, and mammals), and mammals include primates (e.g., monkeys, chimpanzees, and humans) and non-primates (e.g., camels, donkeys, zebras, cows, pigs, horses, cats, dogs, rats, and mice). In certain embodiments, the mammal is from 0 to 6 months old, 6 to 12 months old, 1 to 5 years old, 5 to 10 years old, 10 to 15 years old, 15 to 20 years old, 20 to 25 years old, 25 to 30 years old, 30 to 35 years old, 35 to 40 years old, 40 to 45 years old, 45 to 50 years old, 50 to 55 years old, 55 to 60 years old, 60 to 65 years old, 65 to 70 years old, 70 to 75 years old, 75 to 80 years old, 80 to 85 years old, 85 to 90 years old, 90 to 95 years old, or 95 to 100 years old.

[0071] FIG. 1 is a side cross-sectional view of an optical assembly for measuring optical and ultrasonic signals, according to some embodiments. As shown, the optical assembly includes a first lens 122 and a second lens 124. The first and second lenses may have substantially coaxial and aligned focal axes. FIG. 1 illustrates the focal axis 102 of the first lens 122 and the second lens 124. As shown, the device includes an ultrasonic transducer 110 on a plate 112. The ultrasonic transducer 110 may be configured to transmit and / or receive ultrasonic signals along an ultrasonic axis 104. The ultrasonic transducer 110 may be located on the focal axis 102. In some cases, the ultrasonic transducer 110 may obstruct light propagating along 102. The plate 112 may be located on the focal axis 102. The plate 112 may be transparent or partially transparent to light propagating along the focal axis 102. In some cases, the device may include a detector 130. The detector may be located along the focal axis 102. The detector may be sized and shaped to receive light collected by the first lens 122 and the second lens 124. The detector may be sensitive to a wavelength range propagating along the optical path 102. In some cases, the device may include an optical source (not shown). In other cases, the device may not include an optical source. In some cases, the light propagating along the focal axis 102 may include light scattered along the focal axis 102. In some cases, the focal axis 102 and the ultrasonic axis 104 may also be collinear with a pneumatic axis 106. A pneumatic perturbation may propagate along the axis 106.

[0072] An optical assembly as described herein may include one or more optical components, such components may include one or more lenses, one or more mirrors, one or more beam splitters, one or more prisms, one or more filters, one or more polarizers, one or more diffusers, one or more apertures, one or more beam tubes, one or more wave plates, or other optical components. In some cases, the optical assembly includes a beam tube 142. In some cases, the optical assembly includes an exit aperture 140.

[0073] In some cases, the first lens 122 and the second lens 124 may function together to collect and / or transmit light. In some cases, the lenses 122 and 124 comprise an optical telescope. In some cases, the optical telescope is a reflecting telescope, a refracting telescope, or a combination thereof. The lenses as described herein may comprise a focal length and an aperture. The magnification of the telescope may be related as a ratio of the first lens 122 to the second lens 124. As the magnification increases, the field of view may decrease. Similarly, as the aperture of the lens increases, the field of view may increase. The focal length may also affect the depth of focus of the optical assembly. For example, a longer focal length may result in a longer depth of field. The focal length and aperture may be adjusted to image a target at a distance from the first and second lenses. Similarly, the focal length and aperture may be adjusted to image around a central obstacle. An obstacle located along the focal axis may result in a spatial aberration of the image. The farther the obstacle is from the focal band, the less prominent the spatial aberration due to the central obstacle becomes. As the depth of focus increases, the obstacle is closer to the focal band. The size may also be limited by the intended use and access to the target area. For example, if the target is within a body lumen, lenses with a smaller diameter and a smaller aperture may be desirable.

[0074] Lenses as described herein may comprise individual lenses or compound lenses. Compound lenses may be relay lenses. Relay lenses may comprise one or more pairs of optical substrates with different optical properties. For example, one substrate may be flint glass and one substrate may be schott glass. Relay lenses may comprise one or more individual lenses. Relay lenses may comprise one or more achromatic doublets. Achromatic doublets may have low chromatic aberration. In some cases, relay lenses comprise one or more gradient index lenses. In some cases, relay lenses comprise rod lens relays. A first lens 122 and a second lens 124 are shown, but the optical assembly may comprise additional lenses. For example, third and fourth lenses and / or relay lenses may function as an "erector" (e.g., the lens may invert the image, which may be inverted by a refractive telescope).

[0075] Lenses as described herein may comprise one or more optical substrates. Optical substrates may include glass and / or crystals. For example, optical substrates disclosed herein may comprise silicate glass, sapphire, quartz, etc.

[0076] Devices as described herein may comprise ultrasonic transducers. Ultrasonic transducers may be capacitive microfabricated ultrasonic transducers. In some cases, ultrasonic transducers may be piezoelectric transducers. Ultrasonic transducers may transmit ultrasonic radiation. Ultrasonic transducers may be configured to receive ultrasonic radiation. In some cases, the device may comprise a drive circuit. The drive circuit may provide an electrical waveform to the transducer, which may transmit a certain waveform in response to that waveform. In some cases, the transducer may receive ultrasonic radiation and convert the received radiation into an electrical waveform. The received electrical waveform may be converted into a digital signal and / or stored by a digital processing device as disclosed elsewhere herein.

[0077] An ultrasonic transducer can typically be small. For example, the ultrasonic transducer can be configured to fit within a target body lumen. The body lumen can be the external auditory canal. The ultrasonic transducer can also be configured to enable light to propagate coaxially with the ultrasonic waves. Since the ultrasonic transducer can interfere with the transmission of light, a smaller transducer can result in an image with less aberration. The ultrasonic transducer can have an active area with a diameter of less than 5 millimeters (mm), less than 2 mm, less than 1 mm, or less. The ultrasonic transducer can have an active area with a diameter of 2 mm to 0.5 mm. The ultrasonic transducer can have an active area of 1.5 mm to 0.5 mm. The ultrasonic transducer can have a housing or base with a largest dimension of less than 5 millimeters (mm), less than 2 mm, less than 1 mm, or less.

[0078] The ultrasonic transducer can be configured to transmit ultrasonic signals within a defined band. For example, the ultrasonic transducer can transmit ultrasonic waves in the range of 0.1 megahertz (MHz) to 10 MHz, 1 MHz to 2 MHz, or 1.2 MHz to 1.8 MHz. In one example, the ultrasonic transducer can have an angular beam spread of 10 to 20 degrees within a 1.2 to 1.8 MHz bandwidth and with respect to an edge length of 0.6 to 1.0 mm.

[0079] The ultrasonic transducers 110, 210, 210, 410, and 510 can comprise any embodiment, variation, or example of an ultrasonic transducer disclosed herein.

[0080] The ultrasonic transducer can be mounted on the plate 112. The plate can be partially transmissive to light propagated along the focal axis 102. The plate 112 can be partially transmissive. For example, the substrate can be 95% transmissive to light propagated along the path 102. For example, the substrate can be 85%, 75%, 50%, or less transmissive to light propagated along the path 102. For example, the substrate can include a substantially transmissive portion and other sections that are non-transmissive. For example, the plate can be transmissive to some wavelengths and absorptive with respect to others. The plate can function as a chromatic filter. The plate can include one or more coatings that can affect the transmissivity of the substrate. The plate 112 can include a glass substrate, a quartz substrate, etc.

[0081] In some cases, the optical assembly can include a detector 140. The detector can be a two-dimensional detector. The detector can be a CCD, CMOS, photodiode, photodiode array, thermal sensor, optical sensor, etc. The detector can be sensitive to light within a certain optical spectrum. For example, the detector can be sensitive to light within at least 400 - 800 nm, 200 - 1,000 nm, 200 - 2,500 nm, or a wider range. The detector can be operatively connected to a digital processing device as described elsewhere in this specification. In some cases, the detector can form an image from the received optical signal. The digital processing device can perform one or more storage, analysis, and / or image processing functions. In some cases, the image can be transmitted to a display. The display can be on-board the device or external to the device.

[0082] In embodiments without a detector, the user's eye may not be perfectly aligned with the transmission axis of the ultrasonic energy. This may not be ideal when the user manually aligns the device to the target. When the user's eye is not aligned with the transmission axis of the ultrasonic wave, the ultrasonic wave may be directed inaccurately. The detector mounted in the device may be centered along the focus axis along the ultrasonic transmission axis. The detector mounted in the device may improve the alignment of the ultrasonic and optical excitations on the target. For example, a detector mounted on and centered on the focus axis of the optical assembly may be used as a reference and / or it may be a sufficient reference regarding the propagation axis of the ultrasonic excitation. The ultrasonic wave, which may be coaxial with the focus axis, may be aimed by placing the target at the center of the detected optical image. The optical image may be used as a surrogate for the propagation of the ultrasonic wave. The optical image may be used in addition to the alignment regarding the amplitude of the reflected ultrasonic signal. Alignment assistance on a display visible to the user may further assist in the alignment of the ultrasonic excitation. Since the ultrasonic excitation is not visible to the user, improved alignment may be important.

[0083] Figure 2A is a side cross-sectional view of another optical assembly for measuring optical and ultrasonic signals according to some embodiments. Figure 2A illustrates an optical assembly for measuring optical and ultrasonic signals with a pair of telescopes according to some embodiments. As shown, the optical assembly includes a first lens 222, a second lens 224, a third lens 226, a fourth lens 228, and a fifth lens 229. The lenses may have a focal axis that is substantially coaxial and aligned. As shown, the device includes an ultrasonic transducer 210 on a plate 212. The ultrasonic transducer 210 may be configured to transmit ultrasonic signals along an ultrasonic axis and / or to receive ultrasonic signals. The ultrasonic transducer 210 may be located on the focal axis of the optical assembly. For example, the axis of the ultrasonic beam emitted from the ultrasonic transducer may be the axis of ultrasonic propagation. The axis of ultrasonic propagation may be coaxial with the focal axis. In some cases, the ultrasonic transducer 210 may interfere with light propagating along the focal axis of the optical assembly. The plate 212 may be located on the focal axis of the assembly. The plate 212 may be transparent or partially transparent to light propagating along the focal axis of the device. The plate may be mounted on a mounting assembly 214. The ultrasonic transducer 210 may comprise some embodiments, variations, or examples of the transducers disclosed herein.

[0084] In some cases, the device may include an imaging surface 230. In some cases, the imaging surface may be on the surface of a detector. In some cases, the imaging surface may be in the user's eye. The detector may be located along the focal axis of the device. The detector may be sized and shaped to receive light collected by the plurality of lenses. The detector may be sensitive to a wavelength range propagating along the optical path. In some cases, the device may include an optical source (not shown). In other cases, the device may not include an optical source. In some cases, the light propagating along the focal axis may include light scattered along the focal axis. In some cases, the focal axis and the ultrasonic axis may also be collinear with a pneumatic axis. Pneumatic perturbations may propagate along the pneumatic axis.

[0085] The first and second lenses can form a first telescope. The first telescope can invert the image magnified by the first telescope. The third, fourth, and fifth lenses can include an actuator. In some cases, the lens can be mounted on a mechanical actuator. The mechanical actuator can be configured to translate one or more lenses to adjust the focus of the optical assembly. For example, the mechanical actuator can include a motor. The motor can include a stepper motor. The motor can rotate a screw, and the screw translates the lens. In some cases, the mechanical actuator can be controlled by a user. In some cases, the mechanical actuator is automatically controlled (e.g., by a computer program configured to find the focus). In some embodiments, the fifth lens 229 can be a high-precision focus lens, and it can be translated along the axis 221.

[0086] The transducer 210 can be operably attached to the mounting assembly 214. The mounting assembly 214 can provide a mounting mechanism for the transducer 210. For example, the mounting assembly 214 can include a surface on which a plate 212 is attached. For example, the mounting assembly 214 can center the transducer 210 within the focus axis. The mounting assembly can include a conductive portion. The conductive portion can be electrically connected to the ultrasonic transducer and to a digital processing device as described herein. The mounting assembly can include one or more apertures that allow for the transmission of pneumatic excitation. In some cases, a gap can exist between the mounting assembly and the wall of the device and / or the optical assembly, which can allow for the transmission of pneumatic excitation. In some cases, the first lens 222 can be connected to the mounting assembly 214. In other cases, the first lens 222 may not be connected to the mounting assembly 214.

[0087] Figure 2B illustrates a ray diagram of the device of Figure 2A according to some embodiments. Figure 2B illustrates a target TM and an emission aperture 240. The optical assembly includes a central obstacle, but the optical assembly has a wide collection angle. As shown, the first lens 222 and the second lens 224 include a first telescope. Following the gray line of light, the image collected by the first telescope is inverted between the second lens 224 and the third lens 226. The third lens 226, the fourth lens 228, and the fifth lens 229 may form a second telescope. As shown, the fifth lens 229 may be translated along an axis 221 that may be collinear with the focal axis of the optical assembly. Continuing to follow the gray line of light, the image transmitted to the imaging plane by the second telescope may not be inverted.

[0088] Figure 3 is a side cross-sectional view of another optical assembly for measuring optical and ultrasonic signals according to some embodiments. Figure 3 illustrates an exemplary optical assembly for measuring optical and ultrasonic signals with a removable camera assembly according to some embodiments. As shown, the optical assembly includes a first lens 322, a second lens 324, a third lens 326, a fourth lens 328, and a fifth lens 329. The lenses may have a focal axis that is substantially coaxial and aligned. As shown, the device includes an ultrasonic transducer 310 on a plate 312. The ultrasonic transducer 310 may be configured to transmit ultrasonic signals along an ultrasonic axis and / or to receive ultrasonic signals. The ultrasonic transducer 310 may be located on the focal axis of the optical assembly. In some cases, the ultrasonic transducer 310 may interfere with light propagating along the focal axis of the optical assembly. The plate 312 may be located on the focal axis of the assembly. The plate 312 may be transparent or partially transparent to light propagating along the focal axis of the device. The ultrasonic transducer 310 may include some embodiments, variations, or examples of the ultrasonic transducers disclosed herein.

[0089] In some cases, the device may have an imaging surface 330. In some cases, the imaging surface may be on the surface of the detector. In some cases, the imaging surface may be in the user's eye. The detector may be positioned along the focal axis of the device. In some cases, the device may include a second imaging surface. In some cases, the device may include a camera-mounted assembly 700. In some cases, the camera-mounted assembly may be removable. For example, the mounted assembly may be removed for prototyping, assembly, and / or alignment. The camera-mounted assembly 700 may include a detector 730. The detector 730 may be moved along the focal axis 701. The detector may be moved along the image axis, for example, to improve the quality of the image by improving the image focus. In some cases, the third lens 326, the fourth lens 328, and the fifth lens 329 may not be used. For example, the optical assembly may include a first lens 322 that projects an image onto the detector 730 and a second lens 324.

[0090] The detector 730 may be sized and shaped to receive light collected by a plurality of lenses. The detector may be sensitive to a wavelength range propagating along the optical path. In some cases, the device may include an optical source (not shown). In other cases, the device may not include an optical source. In some cases, the light propagating along the focal axis may include light scattered along the focal axis. In some cases, the focal axis and the ultrasonic axis may also be collinear with the pneumatic axis. Pneumatic perturbations may be propagated along the pneumatic axis. In some cases, the optical assembly includes an exit aperture 340. The transducer 310 may obstruct the path of the optical illumination; however, the light may be transmitted through the aperture 340 within an annular region around the transducer.

[0091] FIG. 4A illustrates a transparent side perspective view of an exemplary endoscope 400 with an optical waveguide according to some embodiments. The endoscope of the present disclosure may include a transmissive portion. The transmissive portion may be configured to function as an optical waveguide. For example, the endoscope may include a transmissive core 452 that can function as an optical waveguide. The transmissive portion may be configured to conduct light by total internal reflection.

[0092] As shown, the endoscope may include a housing or shell. The housing or shell may be frustoconical in shape. The shell may include an optical transmission core 452. In some cases, the endoscope may include a light-shielding or substantially non-transmissive shell 451. Light may be incident at the proximal portion of the frustoconical shell 454. Light may be incident at different insertion points around the circular proximal portion or may be incident over an extended region. In some cases, one or more optical fibers or one or more tubular optical waveguides may be used to direct light to the insertion points.

[0093] At the insertion point, the optical conduction core may contact the incident light at a steep angle. The refractive index of the transmission core may be considered when selecting the angle of the insertion point. The incident angle may be selected such that the incident light will be totally internally reflected between the walls of the transmissive core. The light may diverge radially within the transmissive core. Thus, the number of insertion points may be finite, but the light may emerge from the entire area of the distal tip of the endoscope. The core may comprise an optically graded plastic that may be substantially free of cracks or bubbles. The core may comprise an optical material designed to assist total internal reflection that is integral with the light input and light output portions. Surface treatments, such as polishing or reflective coatings, and continuous voids may be used to assist total internal reflection. For example, any suitable surface treatment such as polishing, reflective coating, anti-reflection (AR) coating, and / or dielectric coating may be used to assist total internal reflection. The optical conduction housing may include a core-cladding interface configured to limit light leakage.

[0094] FIG. 16 illustrates an exemplary shape of an endoscope according to some embodiments. The endoscope housing may have a shape with a tapered distal portion and a larger proximal portion. The endoscope housing may be conical. The housing may have a distal end 1602 that is conical. The endoscope housing may comprise a tapered cone, a cone with a concave surface, or a cone with a convex surface. The housing may comprise an elbow joint within the body of the housing (e.g., 1603). The housing may taper to a fine tip (1604) or may have a truncated tip (1601).

[0095] FIG. 4A additionally illustrates an exemplary location of an optical assembly and a central obstruction. For example, an exemplary endoscope 400 may comprise a transducer-mounted assembly 414. The transducer-mounted assembly 414 may facilitate the fixation of a transducer 410 within the endoscope. The transducer-mounted assembly 414 may provide a mounting mechanism for the transducer 410. For example, the mounting assembly 414 may comprise a surface on which a plate 412 is mounted. In some cases, the plate 412 may be further connected to a transducer package base 411. The ultrasonic transducer 410 may be a capacitive micromachined ultrasonic transducer that may be mounted on the package base 411. For example, the mounting assembly 414 may center the transducer 410 within the focus axis. The mounting assembly may comprise a conductive portion. The conductive portion may be electrically connected to the ultrasonic transducer and to a digital processing device as described herein. The mounting assembly may comprise one or more apertures that may enable the transmission of pneumatic excitation. In some cases, a gap may exist between the mounting assembly and the wall of the device and / or the optical assembly, which may enable the transmission of pneumatic excitation. In some cases, a first lens 422 may be connected to the transducer-mounted assembly 414. In other cases, the first lens 422 may not be connected to the transducer-mounted assembly 414.

[0096] The endoscope may include an inner shell on the inside of the housing. The inner shell may include a shield. The shield may prevent ultrasonic signals from the transducer from being transmitted outside the endoscope. The shield may prevent electrical signals from being transmitted outside the endoscope. The shield may be a metal shield. The shield may be a conductive material. The metal shield may be disposed around the ultrasonic transducer. For example, the metal shield may be displaced radially away from the transmission axis of the ultrasonic transducer. The endoscope may include an inner metal coating or foil. The inner metal coating or foil may be an electromagnetic shield for the transducer. In some cases, the shield may include a part of an impermeable shell. FIG. 4A illustrates an exemplary installation of an optical assembly within the endoscope of the present disclosure. For example, the first lens 422 and the second lens 424 may be aligned on the same focal axis. The focal axis of the optical assembly may be substantially aligned with the central axis of the endoscope. The endoscope may include an exit aperture 440. In some cases, the exit aperture may have a diameter of less than 10 mm. The exit aperture may have a diameter of 2 mm to 8 mm. In some cases, the transducer may be located near the distal end of the endoscope. For example, the transducer may be 1.5 cm to 1 mm from the exit aperture 440.

[0097] In some cases, the endoscope of the present disclosure may be disposable. The disposable endoscope may promote cleanliness. For example, the disposable endoscope may enable prevention of transmission of pathogens from a first subject to a second subject. The device of the present disclosure may include a durable portion and a disposable portion. The endoscope, the transducer-mounted assembly, and the transducer may include a disposable portion. In some cases, the optical assembly may be part of the durable portion. In some cases, all or part of the optical assembly may include a durable portion.

[0098] The endoscope may have a limited number of uses. For example, the limited use may be useful for hygiene purposes, for example, to limit the spread of infection. For example, an endoscope as disclosed herein may be for single use. The endoscope may be used several times. For example, the endoscope may be used less than 20 times, less than 10 times, less than 5 times, or less than that. The endoscope may be used multiple times for a single subject or a single body lumen of a subject. For example, the endoscope may be provided with a joint that deforms or otherwise changes shape to limit it to single use. The endoscope may be provided with physical and / or electronic markings that are registered by a digital processing device and verified for single use. The components of the endoscope disclosed herein may be inexpensive enough to allow for the disposal of the endoscope after single or multiple uses.

[0099] The endoscope may be provided with an interface for connecting to a durable portion. The interface may be optically sealed. The interface may be air sealed. The air seal may assist in the transmission of pneumatic excitation from a pressure source along a pneumatic axis to a target. The interface may be provided with one or more alignment guides. The alignment guides may be provided with raised or recessed portions that may serve to radially align the endoscope with the durable portion. Axial alignment may assist in forming electrical and / or optical connections. The alignment guides may be provided with raised or recessed portions that may serve to axially align the endoscope with the durable portion. Example 400 includes an axial alignment guide 456 and a radial alignment guide.

[0100] Figure 4B illustrates a transparent isometric view of an exemplary endoscope 400 with an optical waveguide, according to some embodiments. Figure 4B illustrates a detailed view of the distal tip of the exemplary endoscope 400. The distal tip may include an ultrasonic transducer 410 on a transducer package base 411. The package base may be mounted on a plate 412. The plate 412 may include an optically transmissive portion. The distal end of the transducer mounting assembly 414 may include one or more electrical contact pads 413. The electrical contact pads may be electrically connected to electrical contacts on the surface of the transducer 410. The plate 412 may be substantially insulating. The electrical contact pads may be connected to a conductive portion of the transducer mounting assembly that can be releasably electrically connected to a digital processing device as described elsewhere in this specification.

[0101] Figure 4B illustrates the distal tip of the endoscope. The distal tip may include a transmissive core 452 and an opaque shell 451. The housing of the endoscope may transmit light from the proximal portion of the endoscope to the distal tip of the endoscope. The light may be propagated to the target. The light may be reflected from the target into the central lumen of the endoscope through an exit aperture 440. The light may be received from the target through the exit aperture 440 surrounding the transducer 410 and through the transmissive portion of the plate 412. Pneumatic excitation may be transmitted from the lumen of the endoscope through one or more pneumatic apertures 415. The pneumatic excitation may be small enough not to cause delamination of the plate 412.

[0102] The endoscope of the present disclosure may include an outer surface 451. In some cases, the outer surface may be opaque. The outer surface may be coated to provide a seal against the wall of the lumen to be measured. For example, the outer surface may include a soft coating or membrane that can provide an improved air seal against a biological lumen (e.g., the ear canal).

[0103] FIG. 5B illustrates a transparent side view of an exemplary endoscope 500 comprising one or more optical fibers, according to some embodiments. The endoscopes of the present disclosure may comprise one or more optical fibers. For example, in the illustrated embodiment, the endoscope may comprise one or more optical fibers 560. In the example shown, the endoscope may comprise four optical fibers, however, the endoscope may comprise some optical fibers in the range of 1 to 1,000, 1 to 100, or 1 to 10. The one or more optical fibers may be configured to conduct light by total internal reflection.

[0104] As shown, the endoscope 500 may comprise a housing or shell. The housing or shell may be frustoconical in shape. The housing or shell may comprise a body portion 552. The housing may comprise an outer shell 551 external to the body portion 552. The housing may comprise an inner housing 553. The inner housing 553 and the body portion 552 may secure one or more optical fibers 560 within the housing. In some cases, the body portion may be transparent, as disclosed elsewhere in this specification. In some cases, the body portion may be opaque. The body portion may be plastic or glass.

[0105] The inner housing 553 may comprise a mounting member 561. In some cases, the inner housing 553 may be removable from the body portion 552. The inner housing 553 and the body portion 552 may be, for example, glued, press-fitted, or welded. The inner housing 553 may comprise a mounting member that may snap the inner housing 553 into position or friction fit the inner housing 553 into position. In some cases, the inner housing 553 may assist in securing the transducer-mounted assembly 600.

[0106] The inner housing 553 may comprise an electromagnetic shield. The shield may prevent ultrasonic signals from the transducer from being transmitted outside the endoscope. The shield may prevent electrical signals from being transmitted outside the endoscope. The shield may be a metal shield. The shield may be a conductive material. The metal shield may be disposed around the ultrasonic transducer. For example, the metal shield may be displaced radially away from the transmission axis of the ultrasonic transducer. The endoscope may comprise an inner metal coating or foil. The inner metal coating or foil may be an electromagnetic shield for the transducer. In some cases, the shield may comprise a part of the impermeable shell 551.

[0107] The endoscope of the present disclosure may comprise an outer surface 551. In some cases, the outer surface may be impermeable. The outer surface may be coated to provide a seal against the wall of the lumen to be measured. For example, the outer surface may comprise a soft coating or membrane that may provide an improved air seal against a biological lumen (e.g., the ear canal).

[0108] In some cases, the endoscope may comprise an outer shell that is light-shielding or substantially impermeable. Light may be incident on the proximal portion of one or more optical fibers near the proximal end of the frustoconical portion. Light may be incident on all or a subset of the one or more optical fibers. In some cases, one or more optical fibers or one or more tubular light guides may be used to direct light from the body of the device to an insertion point near the proximal end of the frustoconical portion.

[0109] FIG. 5B additionally illustrates a transducer-mounted assembly 600. The transducer-mounted assembly 600 can facilitate the fixation of the transducer 510 within the endoscope. The transducer-mounted assembly 600 can provide a mounting mechanism for the transducer 510. For example, the mounting assembly 600 can include a surface on which a plate 512 is mounted. In some cases, the plate 512 can be further connected to the transducer package base 511. The ultrasonic transducer 510 can be a capacitive micromachined ultrasonic transducer that can be mounted on the package base 511. For example, the mounting assembly 600 can center the transducer 510 within the focal axis. The mounting assembly can include a conductive portion 614. The conductive portion can be electrically connected to the ultrasonic transducer and to a digital processing device as described herein. The electrical connection can include one or more wires 516. The mounting assembly 600 can include one or more apertures 515 that can allow for the transmission of pneumatic excitation. In some cases, a gap can exist between the mounting assembly and the walls of the device and / or the optical assembly, which can allow for the transmission of pneumatic excitation.

[0110] The endoscope can include an exit aperture 540. In some cases, the exit aperture can have a diameter of less than 10 mm. The exit aperture can have a diameter of 2 mm to 8 mm. In some cases, the transducer can be located near the distal end of the endoscope. For example, the transducer can be located 1.5 cm to 1 mm from the exit aperture 540. The endoscope can be sized and shaped to fit within a patient's ear canal and can have an outer diameter.

[0111] The inspection mirror 500 may include an interface 554 for connecting to the durable portion. The interface may be optically sealed. The interface may be air sealed. The air seal may assist in the transmission of pneumatic excitation from a pressure source along the pneumatic axis to the target. The interface may include one or more alignment guides (e.g., 556, 557, 558, 559). The alignment guides may assist in forming electrical and / or optical connections. The radial alignment guide may include a raised or recessed portion that may serve to radially align the inspection mirror with the durable portion. For example, the radial alignment guide 557 may provide an external indication of the radial alignment of the inspection mirror. For example, the radial alignment guide 556 may provide an internal releasable stop against rotation. The radial alignment guide 558 may assist in the rapid release of the inspection mirror. The rapid release portion may be engaged and / or disengaged by an external mechanism such as a twisting or pulling mechanism. The axial alignment guide may include a raised or recessed portion that may serve to axially align the inspection mirror with the durable portion. For example, the axial alignment guide 559 may fit into a groove on the durable portion to assist in the tactile feel of the seal. For example, the alignment guide 556 may also serve as an axial alignment guide.

[0112] FIG. 5A illustrates a detailed view of the distal tip of an example of the inspection mirror 500 according to some embodiments. The distal tip may include an ultrasonic transducer 510 on a transducer package base 511. The package base may be mounted on a plate 512. The plate 512 may include an optically transmissive portion. One or more optical fibers within the inspection mirror may transmit light from the proximal portion of the inspection mirror to the distal tip of the inspection mirror. The light may be propagated to the target. The light may be reflected from the target into the central lumen of the inspection mirror through an exit aperture 540. The light may be received from the target through the exit aperture 540 around the transducer 510 and through the transmissive portion of the plate 512. Pneumatic excitation may be transmitted from the lumen of the inspection mirror through one or more pneumatic apertures 515. The pneumatic excitation may be small enough not to cause delamination of the plate 512.

[0113] Figure 5A also shows dimensions 501 and 503. Dimension 501 may comprise the distance that a central obstacle, measured perpendicular to the optical axis, extends. The central obstacle may be the transducer package base. In some embodiments, the substrate is disposed on a carriage material that may be part of the base. The base may enable mounting of the ultrasonic transducer on the device of the present disclosure. For example, the base may be mounted on the tip of the otoscope described elsewhere in this specification. The base may comprise electrical connections such as wiring, vias, etc. to conduct electrical signals from the ultrasonic transducer to the digital processing device. The base may protect the ultrasonic transducer. The base may stiffen the substrate of the ultrasonic transducer and / or provide additional support thereto. The base may comprise a portion of the wafer on which the ultrasonic transducer is fabricated. The package base may be a square with dimensions of 0.1 to 3 mm per side. The package base may be a rectangle with sides of 0.1 to 4 mm and 0.1 to 4 mm. The package base may be a circle with a diameter of 0.1 to 3 mm.

[0114] Dimension 503 may comprise the largest dimension of the aperture 550. The aperture 550 may have a circular shape, an elliptical shape, a regular polygon shape, an irregular shape, etc. The aperture 550 may have a largest distance measured along an axis normal to the focal axis of 0.2 to 10 mm, 1 mm to 8 mm, or 2 mm to 5 mm. Dimension 503 may be less than 5 mm. Dimension 503 may be sized and shaped to fit within the ear of the subject.

[0115] Dimension 501 can be less than dimension 503. The central obstacle can define a solid angle within aperture 550 that is less than 90% of the solid angle defined by aperture 550 as measured from the farthest lens of the optical assembly. In some cases, dimension 501 is about 75% of dimension 503. In some cases, dimension 501 is about half of dimension 503. In some cases, dimension 501 is 20% - 80% of dimension 503. In some cases, the exit aperture has a clear area of about 70% and an obstructed area of about 30%. In some cases, the exit aperture has an obstructed area of less than about 75%. In some cases, the transducer may be placed about 2 mm or less away from the exit aperture. The obstructed area at the exit aperture can comprise a projection of the obstructed area onto the plane of the aperture.

[0116] FIG. 6B illustrates a side cross-sectional view of a transducer-mounted assembly 600 according to some embodiments. The transducer-mounted assembly 600 can provide a mounting mechanism for transducer 510. The mounting assembly 600 can comprise a body portion 616. The mounting assembly 600 can have a surface on which plate 512 is mounted and which comprises a part of body 616. In some cases, plate 512 can be further connected to transducer package base 511. The ultrasonic transducer 510 can be a capacitive microfabricated ultrasonic transducer that can be mounted on package base 511. In the example shown, the mounting assembly 600 can center transducer 510 within the focus axis. The mounting assembly 600 can comprise one or more apertures 515 that can allow for the transmission of pneumatic excitation. In some cases, a gap can exist between the mounting assembly and the walls of the device and / or the optical assembly, which can allow for the transmission of pneumatic excitation. The conductive portion can be electrically connected to the ultrasonic transducer and to a digital processing device as described herein. The electrical connection can comprise one or more wires 516.

[0117] Figure 6A illustrates a front view of a distal end of a transducer-mounted assembly 600 according to some embodiments. In the illustrated embodiment, the transducer-mounted assembly 600 may include a body portion 616. The body portion 616 may include a securing device 630 on its outer surface. One or more securing devices may hold the transducer-mounted assembly in place within an endoscope. The body portion 616 may include one or more grooves 661. For example, the distal portions of one or more optical fibers may be disposed within the grooves 661. Light may be transmitted from the distal ends of the one or more optical fibers near the distal end of the transducer-mounted assembly. The body portion 616 may include a conductive portion. Assembly 600 illustrates an extension tail with an electrical interface 614. Interface 614 may form an electrical contact with a durable portion of a device as disclosed herein. Interface 614 may include contacts 614a and 614b.

[0118] Figure 6A also illustrates a view of an ultrasonic transducer 510 on a transducer package base 511. The transducer 510 may include a plurality of ultrasonic transducer elements arranged in a circle on the package base 511. The package base may include one or more electrical contact pads (e.g., 613a, 613b, 613c, 613d). The electrical contact pads may be connected by conductors (e.g., 516a and 516b) to one or more electrical contact pads of the transducer-mounted assembly. The transducer-mounted assembly 600 may include one or more electrical contact pads (e.g., 621a, 621b, 621c, 621d). The electrical contact pads may be electrically connected to electrical contacts on the surface of the transducer 610. Plate 512 may be substantially insulating. The electrical contact pads may be connected to a conductive portion of the transducer-mounted assembly that may be releasably electrically connected to a digital processing device as described elsewhere herein. Plate 512 may incompletely cover the distal end of the transducer-mounted assembly. As shown, the transducer-mounted assembly may include an air pressure opening 515 that may allow a gas such as air to pass around the ultrasonic transducer.

[0119] FIG. 7A illustrates a side cross-sectional view of a detector assembly 700 according to some embodiments. FIG. 7B illustrates a side view of the detector assembly of FIG. 7A according to some embodiments. The detector assembly 700 may include a detector 730. The detector 730 may be aligned to receive an image from the optical assembly of the present disclosure. The detector 730 may be translated along an axis 701. The axis 701 may be parallel and / or coaxial with the focal axis of the optical assembly. The detector 730 may be mounted on a detector board 732. The detector board 732 may provide a mechanical and electrical interface between the detector and a digital processing device as described elsewhere herein. Conductors 734 may conduct electrical signals between the detector 730 and the digital processing device.

[0120] The detector 730 may be mechanically translated. In some cases, the detector 730 may be mounted on a mechanical actuator. The mechanical actuator may be configured to translate the detector 730 to adjust the focus of the optical assembly. For example, the mechanical actuator may include a motor 752. The motor may include a stepper motor. The motor may rotate a screw 742, which translates the detector. In some cases, the mechanical actuator may be controlled by a user. In some cases, the mechanical actuator may be automatically controlled (e.g., by a computer program configured to find the focus). The translatable detector may be used in conjunction with an optical assembly with a fixed lens, however, the translatable detector may also be used in a system with a movable lens. The image from the detector 730 may be processed, modified, or corrected by a digital processing device.

[0121] In some cases, the detector 730 may not be removable from the device. In embodiments without a detector, the user's eye may not be perfectly aligned with the transmission axis of the ultrasonic energy. This may not be ideal when the user manually aligns the device to the target. When the user's eye is not aligned with the ultrasonic transmission axis, the ultrasonic waves may be inaccurately directed. The detector mounted within the device is positioned about the focal axis along the ultrasonic transmission axis. The detector mounted within the device may improve the alignment of the ultrasonic and optical excitations on the target. For example, a detector mounted and centered on the focal axis of the optical assembly may be used as a reference and / or it may be a sufficient reference regarding the propagation axis of the ultrasonic excitation. Ultrasonic waves that may be coaxial with the focal axis may be aimed by placing the target at the center of the detected optical image. The optical image may be used as a surrogate for the propagation of the ultrasonic waves. The optical image may be used in addition to the alignment regarding the amplitude of the reflected ultrasonic signal. Alignment assistance on a display visible to the user may further assist in the alignment of the ultrasonic excitation. Since the ultrasonic excitation is not visible to the user, improved alignment may be important. The detector 730 may be removably coupled to a device as disclosed herein using an attachment 754. In some cases, the detector may be removed for prototyping, alignment, etc., and the detector may be replaced for long-term use.

[0122] FIG. 8A illustrates a side cross-sectional view of an interface 800 for receiving an endoscope according to some embodiments. FIG. 8B illustrates a side view of the interface of FIG. 8A for receiving an endoscope according to some embodiments. The interface 800 may be sized and shaped to receive an endoscope of the present disclosure and may include a tapered distal end. The interface 800 may include a proximal end 810 that may interface with the body of the device (not shown). The interface 800 includes a surface 851 that may interface with an endoscope of the present disclosure. In some cases, a gap may exist between the surface of the interface and the surface of the endoscope to facilitate the transfer of pneumatic excitation.

[0123] Interface 800 can facilitate the removable coupling of the endoscope. Interface 800 includes an actuator 860. Actuator 860 can be rotated along axis 861 to lock and / or release the endoscope. Interface 800 can include one or more alignment guides (e.g., 859, 861) that can facilitate the attachment of the endoscope. For example, groove 859 can interface with alignment guide 559 of endoscope 500 to axially align the endoscope. For example, groove 861 can interface with a raised portion of the endoscope corresponding to one or more optical fibers. Groove 861 can provide rotational alignment of the endoscope.

[0124] Interface 800 can enable the transmission of pneumatic excitation from the body of the device to the distal end of the endoscope. Interface 800 illustrates a tube fitting 870 that can be connected to a pressure source within the body of the device. In some cases, pneumatic excitation is transmitted from fitting 870, into the interior of the interface, and out through the distal tip of the interface. In some cases, pneumatic excitation is transmitted, in part, through housing 810, through a channel behind groove 859, along the inner surface of the endoscope, and through opening 873 toward the distal tip of the endoscope.

[0125] Interface 800 can enable the transmission of electrical signals to and from the body of the device and the endoscope. In the illustrated embodiment, the distal tip of interface 800 includes a conductive nose cone with an electrical connection 814. For example, electrical connection 814 can receive electrical interface 614 of transducer-mounted assembly 600. Electrical connection 814 can be connected to a digital processing device by wire 815.

[0126] Interface 800 may provide mechanical support for one or more mirrors of an optical assembly as disclosed herein. In the illustrated embodiment, the interior of interface 800 includes socket 822 and socket 824. Sockets 822 and 824 may receive the first and second lenses of the optical assembly. FIG. 8A also illustrates display attachment 754 that may enable connection of detector assembly 700 to interface 800. Also shown is guide post 756 that may assist in stabilizing the translation of detector 730.

[0127] FIG. 9 is a side cross-sectional view of an exemplary endoscope connected to an interface, according to some embodiments. FIG. 9 illustrates endoscope 500 connected to interface 800, according to some embodiments. Endoscope 500 may be releasably connected to interface 800. Locking and / or releasing of endoscope 500 may be actuated by actuator 860. Interface 800 may be mechanically connected to the body of the device at proximal portion 810. Interface 800 may be electrically connected to the body of the device at 815. Interface 800 may be pneumatically connected to the body of the device at 870. Light, ultrasound, and gas may be transmitted from the body of the device through distal tip 550 to a target. Light, ultrasound, and gas may be received from the target through distal tip 550 into the body of the device.

[0128] FIG. 9 illustrates an exemplary installation of an optical assembly within the interface of the present disclosure. For example, the first lens 322 and the second lens 324 can be aligned on a focal axis on the same line. The focal axis of the optical assembly can be substantially aligned with the central axis of the inspection mirror. FIG. 9 illustrates optional lenses 326, 328, and 329, and an image plane 330. As shown, the inspection mirror includes an ultrasonic transducer 310 on a plate 312. The ultrasonic transducer 310 can be configured to transmit ultrasonic signals along an ultrasonic axis and / or receive ultrasonic signals. The ultrasonic transducer 310 can be located on the focal axis of the optical assembly. In some cases, the ultrasonic transducer 310 can interfere with light propagating along the focal axis of the optical assembly. The plate 312 can be located on the focal axis of the assembly. The plate 312 can be transparent or partially transparent to light propagating along the focal axis of the device. The ultrasonic transducer 310 can comprise certain embodiments, variations, or examples of the ultrasonic transducers disclosed herein.

[0129] FIG. 11 is a side view of an exemplary device 1100 comprising an interface 1300 for receiving an inspection mirror 400 according to some embodiments. The inspection mirror 400 can comprise a transmissive core that can function as an optical waveguide. The transmissive portion can be configured to conduct light by total internal reflection. Light can be incident at a proximal portion of a frustoconical shell. As shown, the optical assembly includes a first lens 422, a second lens 424, a third lens 426, a fourth lens 428, and a fifth lens 429. The lenses can have a focal axis that is substantially coaxial and aligned. As shown, the device includes an ultrasonic transducer 410. FIG. 13 illustrates an interface 1300 connected to a pneumatic subsystem 1360 according to some embodiments. The pneumatic subsystem 1360 can be within a body portion of the device. In some examples, the interface 1300 can be connected to the inspection mirror 400.

[0130] FIG. 12 is a side view of an exemplary device 1200 connected to an endoscope having an optical guide and an optical insertion point, according to some embodiments. As shown, the endoscope 400a can include a transmissive core that can function as an optical guide. The transmissive portion can be configured to conduct light by total internal reflection. Light can be incident at an incident point on the interior of the frustoconical shell. The optical fiber 1260 can connect a light source within the interior of the device to the insertion point. As shown, the device includes an ultrasonic transducer 1210. As shown, the optical assembly includes a first lens 1222, a second lens 1224, and a relay lens assembly 1220. The lenses can have focal axes that are substantially coaxial and aligned. The relay lens assembly can invert the images from the first lens 1222 and the second lens 1224. The relay lens can include a viewing port 1221 that can enable a user to view the image transmitted by the optical assembly. FIG. 12 also illustrates a port 1270 that can enable pressure excitation to be conducted to the distal tip of the endoscope 400a.

[0131] FIG. 10A illustrates a side view of an example of a device body coupled to an interface and an endoscope, according to some embodiments. The device 1000 can include a handle portion 1010. The device 1000 can include an interface 800 and / or be attached thereto. The endoscope 500 can be connected to the interface 800. An actuator 860 can lock and / or release the endoscope 500. The device 1000 can include a control mechanism that can include a digital processing device within the handle portion 1010. The control mechanism for the various components of the device is described in further detail with reference to FIG. 10B.

[0132] Figure 10B illustrates a schematic view of the device body 1000 according to some embodiments. The device 1000 may include a pneumatic drive device 1071 within the body of the device. In some examples, the pneumatic drive device may be an excitation generator. The excitation generator may be an air bladder, alternating pressure, step pressure, or air jet that is operated by an operator to apply a force to a membrane or surface, generating an air displacement. The excitation generator output may be a jet of gas such as ambient air or other suitable gas. In some examples, the excitation generator or the pneumatic drive device is a voice coil actuator. In some examples, the excitation generator may generate sonic excitation, subsonic excitation, or supersonic excitation. For example, the excitation generator may generate a sub-audio frequency below 20 Hertz (Hz), an audio frequency between 20 Hz and 20 kilohertz (kHz), or a super-audio frequency above 20 kHz. In one example, sonic excitation, subsonic excitation, or supersonic excitation may be generated by a piezoelectric transducer. The piezoelectric transducer may convert an electrical signal into a physical displacement, which may then induce a pressure wave. In one example, sonic excitation, subsonic excitation, or supersonic excitation may be generated by a capacitive microfabricated ultrasonic transducer.

[0133] The device 1000 may include a pressure sensor 1073. The pressure sensor may be used to track the frequency and / or intensity of the pneumatic excitation. The pressure sensor may be used to determine whether pneumatic excitation is occurring. The pressure sensor may be used to determine whether the pressure within the body lumen is too high and / or to prevent the pressure within the body lumen from becoming too high. An overly high pressure may be a dangerous pressure for the subject. The pressure sensor may include quality control parameters. For example, if the pressure increase around the pneumatic excitation is below a certain threshold, the digital processing device may alert the user to perform the measurement again.

[0134] Device 1000 may include an optical source 1061. The optical source may include an LED. The optical source may include a laser. The optical source may include an incandescent bulb. The optical source may include an optical fiber that terminates outside the housing and collects ambient light. Device 1000 may include a drive circuit for the optical assembly 1063. The drive circuit for the optical assembly may include a movable lens and / or a motor controller for the display assembly. The drive circuit for the optical assembly may include a display control circuit.

[0135] Device 1000 may include a transducer drive circuit 1050. In some cases, the transducer drive circuit may be integrated with an on-board digital processing device 1090 or a microprocessor 1091 as described herein. The transducer drive circuit 1050 may control various aspects of the transducer element and the ultrasonic transducer as disclosed herein. For example, the transducer drive circuit 1050 may provide a drive waveform for the ultrasonic transducer. For example, the transducer drive circuit 1050 may provide a drive waveform for the excitation device. For example, the transducer drive circuit 1050 may receive a waveform corresponding to the reflected ultrasonic signal from the device from the transducer.

[0136] Device 1000 may include a digital processing device 1090 as described elsewhere herein. For example, 1000 may include a microprocessor 1092 that can control various aspects of device 1000, including a pneumatic actuator 1071, a pressure sensor 1073, an optical drive 1063, an optical source 1061, and a transducer drive 150. The microprocessor 1092 may be connected to an analog front end 1091 that includes an on-board PCB with connections for various components. The digital processing device 1090 may be connected to a display 1080 that may be visible to the user.

[0137] FIG. 14 illustrates a transparent perspective view of an exemplary device body 1400 that may include an eyepiece. The device 1400 may include an interface 1200 as described above herein. The interface 1200 may include an optical relay system 1220. The interface 1200 may be releasably connected to the inspection mirror 400a. The device 1400 may include various subsystems as described with respect to FIG. 10B.

[0138] The device 1400 may include a pneumatic drive device 1472 and an associated drive circuit 1471 within the body of the device. In some examples, the pneumatic drive device may be an excitation generator. The excitation generator may be an air bladder, alternating pressure, step pressure, or air displacement generator that is operated by an operator to apply a force to a membrane or surface. The excitation generator output may be a blast of gas such as ambient air or other suitable gas. In some examples, the excitation generator or pneumatic drive device may be a voice coil actuator. In some examples, the excitation generator may generate sonic excitation, subsonic excitation, or supersonic excitation. For example, the excitation generator may generate a sub-audio frequency below 20 Hz, an audio frequency between 20 Hz and 20 kHz, or a super-audio frequency above 20 kHz. In one example, sonic excitation, subsonic excitation, or supersonic excitation may be generated by a piezoelectric transducer. The piezoelectric transducer may convert an electrical signal into a physical displacement, which may then induce a pressure wave. In one example, sonic excitation, subsonic excitation, or supersonic excitation may be generated by a cMUT transducer. The device 1400 may include a pressure sensor 1473. The pressure may be used to track the frequency and / or intensity of the pneumatic excitation.

[0139] Device 1400 may include an optical source 1461. The optical source may include an LED. The optical source may include an incandescent bulb. The optical source may include an optical fiber that terminates outside the housing and collects ambient light. Device 1400 may include a drive circuit for the optical assembly. The drive circuit for the optical assembly may include a movable lens and / or a motor controller for the display assembly.

[0140] Device 1400 may include a transducer drive circuit. In some cases, the transducer drive circuit may be integrated with an on-board digital processing device 1490 or a microprocessor 1491 as described herein. The transducer drive circuit may control various aspects of the transducer elements and ultrasonic transducers as disclosed herein. For example, the transducer drive circuit may provide a drive waveform for the ultrasonic transducer. For example, the transducer drive circuit may provide a drive waveform for the excitation device. For example, the transducer drive circuit may receive from the transducer a waveform corresponding to the reflected ultrasonic signal from the device.

[0141] Device 1400 may include a digital processing device 1490 as described elsewhere herein. For example, 1400 may include a microprocessor that may control various aspects of device 1400. The microprocessor may be connected to an analog front end 1491 that may include an on-board PCB with connections for various components.

[0142] Figures 15A and 15B respectively show perspective views and rear views of various examples of the housing according to several embodiments. Device 1000 is shown as exemplary devices 1001, 1002, and 1003. The device may comprise a screen capable of displaying a live image of a target to the user. The screen may display a crosshair or targeting assistance. The screen may display live ultrasound data. The screen may display live optical data. The display may comprise one or more buttons. The display may comprise a touch screen. The housing may have a wide variety of outer shapes and forms.

[0143] Devices, otoscopes, endoscopes, and methods of using and manufacturing the same as disclosed herein may be used to characterize a surface. The surface may be a biological membrane such as the tympanic membrane. Air pressure excitation may change the response of the membrane to ultrasonic excitation. For example, air pressure excitation may deflect the membrane, which may change the phase of the reflected ultrasonic wave relative to a membrane not exposed to air pressure excitation. The deflection of the membrane may include damped harmonic motion. This motion may be affected by changes in the elasticity of the membrane. Changes in membrane elasticity may occur, for example, when water, bacterial growth, or other foreign substances are adjacent to the membrane.

[0144] Surface characterization methods that may be applicable herein are also described in 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.

[0145] In some instances, pneumatic excitation can cause movement of a surface or membrane over a period of time. This period can coincide with an acoustic wave delivered to the surface or membrane by an ultrasonic transmitter. The pneumatic excitation can be continuous or can be pulsed, etc. Ultrasonic waves reflected from the surface can be received at a transducer. The transducer can be the same transducer that generated the incident acoustic wave. The displacement of the surface or membrane can be related to a phase change of the received signal when compared to the transmitted signal. Movement of the membrane can affect the phase change of the received ultrasonic wave. The displacement can vary over time. Analysis of the temporal displacement of the surface or membrane, as measured by a phase shift of the reflected ultrasonic wave in response to pneumatic excitation coupled to the surface or membrane, can be used to determine the mechanical properties of the surface or membrane.

[0146] Analysis of the temporal information can be used in combination with the measured temporal displacement from templates of other membrane responses to create a comparison. The analysis of the temporal information can be used in combination with other metrics related to a delay in the amplitude of the reflected ultrasonic wave that characterizes the response of the surface or membrane. The mechanical properties measured can include ductility, elasticity, hardness, etc. A non-contact measurement of the mechanical properties of the surface, or alternatively, the fluid below the surface of the membrane, can be determined.

[0147] In some embodiments, the surface elasticity can be measured. The phase and / or amplitude of the reflected ultrasound from the membrane can be analyzed to generate an elasticity metric. The elasticity measurement can characterize a series of measurements in response to an applied excitation. The elasticity metric can be derived from the response of the surface and can provide an indication of one or more of several different phenomena. For example, the elasticity metric can indicate whether the surface adjacent to the membrane has a gaseous boundary or a fluid boundary. For example, the membrane may move less, move more slowly, and / or not move at all if the membrane has a fluid boundary. In one example, the elasticity metric can indicate the extent or properties of the fluid with respect to characterizing the fluid behind the fluid boundary of the membrane. In some examples, the elasticity metric can be used to measure the properties of an elastic fluid, with or without a hysteresis in the response. In a fluid with a hysteresis response, the fluid can exhibit an offset in the displacement response, i.e., a “memory,” such that the response behavior in one direction is similar to the response behavior in the opposite direction only after a specific displacement distance has been traveled. With respect to the hysteresis response, it may be necessary to characterize the linear behavior of the response after a specific measured displacement associated with the hysteresis of the system. The fluid elasticity metric can be determined from the characteristic response of the surface or membrane to surface excitation and reflected ultrasound characterization.

[0148] In some embodiments, the surface deflection can be estimated. For example, an estimated value of the surface deflection can be derived from the measured estimated values of velocity, acceleration, or any other metric associated with deflection over time. For example, the displacement of the surface results in a shortened path from the transducer to the surface, and the reflected signal returning from the surface to the transducer will return with a phase shift. The phase shift of the reflected ultrasound with respect to the excitation thus provides information about the amount of deflection. Using an estimated value of the force applied by the excitation, an estimated value of the elasticity of the membrane can be estimated.

[0149] In one example, the excitation is a step or impulse response with a rising edge, a falling edge, or an impulse excitation. The impulse excitation initiates the vibration deflection of the membrane. The reflected ultrasonic wave can be measured through the decay period of the membrane vibration from the time of excitation. In some embodiments, the estimation of elasticity or viscosity can be performed by verifying the ring-down characteristics. For example, the ring-down characteristics can include at least one of an exponential decay time such as the decomposition of a response into the ring-down characteristics, a ring cycle interval, or a frequency.

Number

[0150] The damping constant of the oscillator can be related to the energy lost from the membrane to the surrounding environment. In one example, when the membrane is adjacent to a fluid, the fluid can damp the vibration of the membrane. The viscosity of the fluid can be related to the damping of the oscillator. The ring cycle frequency can be related to the restoring constant of the elastic membrane. The restoring constant can be related to the elasticity of the membrane. The restoring constant can be related to the viscosity of the fluid adjacent to the membrane. The ring cycle frequency can be higher as the viscosity of the fluid adjacent to the membrane is lower.

[0151] Each excitation event can initiate a new deflection of the membrane. For example, an impulse excitation can pull in or push out the membrane over a limited period. For example, a square wave excitation can pull in or push out the membrane over a longer time. For example, a sine wave or other more complex excitation can be applied, and the ring-down observed in the transducer can be the cross-correlation between the excitation field and the response field.

[0152] Figure 19 is a flowchart of an exemplary method of using an otoscope, according to some embodiments. In operation 1910, method 1900 of using an otoscope may include directing optical illumination towards a target. In operation 1920, method 1900 of using an otoscope may include directing pneumatic excitation towards the target. In operation 1930, method 1900 of using an otoscope may include directing ultrasonic waves towards the target, where the ultrasonic waves are propagating with the optical illumination. In operation 1940, method 1900 of using an otoscope may include receiving reflected optical illumination from the target at a detector. In operation 1950, method 1900 of using an otoscope may include measuring the target's response to the pneumatic excitation in the reflected ultrasonic waves. In operation 1960, method 1900 of using an otoscope may include determining the state or condition of the subject based on the reflected optical illumination and the response.

[0153] Operation 1960 may include using one or more optical characteristics of the membrane. For example, the color of the membrane, the presence of a visible fluid or bubble behind the surface, a visible exudate, a visible inflammation, etc.

[0154] The operations above illustrate method 1900 of using an otoscope, according to some embodiments, but those skilled in the art will recognize many variations based on the teachings described herein. The steps may be completed in any order. Steps may be added or removed. Some of the steps may include sub-steps. Many of the steps may be repeated any number of times if beneficial for evaluating the characteristics of the surface.

[0155] One or more steps of method 1900 may be implemented using one or more of the circuits as described herein, such as a digital processing device or a processor or a programmable array logic for a field programmable gate array, etc. The circuit may be programmed to provide one or more steps of method 1900, and the program may include, for example, program instructions stored on a computer-readable memory or programmed steps of a programmable array logic or a field programmable gate array or other logic circuit.

[0156] FIG. 20 is a flowchart of an exemplary method of using optical and ultrasonic devices, according to some embodiments. In operation 2010, method 2000 of using an otoscope may include directing optical illumination towards a target. In operation 2020, method 2000 of using an otoscope may include directing ultrasonic waves towards the target. In operation 2030, method 2000 of using an otoscope may include receiving reflected ultrasonic waves from the target. In operation 2040, method 2000 of using an otoscope may include adjusting the focus of the optical illumination based on the received reflected ultrasonic waves, and the adjusting is performed substantially in real time.

[0157] For example, method 2000 as illustrated in FIG. 20 may further include calculating an image sharpness, calculating a derivative of the image sharpness, and adjusting the focus based on the image sharpness. The operation of adjusting the focus may include translating one or more mirrors. The operation of adjusting the focus may include translating a detector. Calculating the image sharpness may include calculating a gradient. Calculating the image sharpness may include an edge detection algorithm. The image sharpness may be part of a feedback loop for image focusing. Calculating the image sharpness may include calculating the square or magnitude of the derivative following the calculation of the derivative. Calculating the image sharpness metric may include an average of the derivative values and / or the magnitude of the derivative at the edge boundary.

[0158] The above operations illustrate method 2000 of using optical and ultrasonic devices according to some embodiments, and those skilled in the art will recognize many variations based on the teachings described herein. The steps may be completed in any order. Steps may be added or deleted. Some of the steps may include sub-steps. Many of the steps may be repeated as many times as beneficial for the evaluation of the target characteristics.

[0159] One or more steps of method 2000 may be implemented using one or more of the circuits as described herein, such as a digital processing device or a processor or a programmable array logic for a field programmable gate array, among other logic circuits. The circuit may be programmed to provide one or more steps of method 2000, and the program may include, for example, program instructions stored on a computer-readable memory or programmed steps of a programmable array logic or a field programmable gate array or other logic circuits.

[0160] FIG. 17 is a flowchart of an exemplary method of manufacturing an endoscope according to some embodiments. Aspects of the present disclosure provide a method 1700 of manufacturing an endoscope. The endoscope may be configured to be disposed within the ear. Operation 1710 of the method may include providing a transducer. Operation 1720 may include providing a plate or substrate. Operation 1730 may include mounting the transducer on the plate or substrate. Operation 1740 may include providing a support. Operation 1750 may include mounting the plate or substrate on a support having a conductive portion, and the support has an air-pressure clear path when the support is mounted. The support may be a transducer mounting assembly as disclosed herein. Operation 1760 may include providing an endoscope. Operation 1770 may include housing the support within the lumen of the endoscope, and the transducer is centered within the lumen of the endoscope, and the endoscope has an optically clear path when the transducer is within the lumen.

[0161] A method of manufacturing an endoscope includes mounting an ultrasonic transducer on a substrate, mounting the substrate on a support having a conductive portion, the support having an air-pressure clear path when the support is mounted, and enclosing the support within the lumen of the endoscope, the transducer being centered within the lumen of the endoscope, the endoscope having an optically clear path when the transducer is within the lumen.

[0162] The above operations illustrate a method 1700 of manufacturing an endoscope according to some embodiments, and those skilled in the art will recognize many variations based on the teachings described herein. The steps can be completed in any order. Steps can be added or deleted. Some of the steps can include sub-steps. Many of the steps can be repeated as many times as beneficial to the manufacturing method.

[0163] One or more steps of method 1700 can be implemented using one or more of a circuit as described herein, such as a digital processing device or a processor or a programmable array logic for a field programmable gate array, among other logic circuits. The circuit can be programmed to provide one or more steps of method 1700, and the program can include, for example, program instructions stored on a computer-readable memory or programmed steps of a programmable array logic or a field programmable gate array or other logic circuit.

[0164] In some embodiments, the devices, endoscopes, otoscopes, and methods of use and manufacture described herein include a digital processing device or the use thereof. For example, a digital processing device can be used to control various aspects of the devices and methods disclosed herein. For example, a digital processing device can adjust the position of one or more optical elements; control the operation of a transducer such as analog-to-digital conversion of received ultrasonic signals and provide waveforms and the like; process one or more images received at a detector; provide instructions to a user to adjust the steering of a device; control the application of pneumatic excitation; measure pressure using a biological lumen; provide an indication of the quality of an air seal, and the like.

[0165] The digital processing device can comprise an on-board microprocessor. In some cases, the digital processing device can be connected to an on-board digital processing device by a wireless link.

[0166] The digital processing devices 1090 and 1490 can comprise embodiments, variations, or examples of the digital processing devices disclosed herein, including, for example, the device 1801 of FIG. 18.

[0167] In a further embodiment, the digital processing device includes one or more hardware central processing units (CPUs), general-purpose graphics processing units (GPGPUs), or field-programmable gate arrays (FPGAs) that execute the functions of the device. In yet a further embodiment, the digital processing device further comprises an operating system configured to execute executable instructions. In some embodiments, the digital processing device may optionally be connected to a computer network. In a further embodiment, the digital processing device may optionally be connected to the Internet so that it can access the World Wide Web. In yet a further embodiment, the digital processing device may optionally be connected to a cloud computing infrastructure. In other embodiments, the digital processing device may optionally be connected to an intranet. In other embodiments, the digital processing device may optionally be connected to a data storage device.

[0168] According to the description herein, suitable digital processing devices include, by way of non-limiting example, server computers, desktop computers, laptop computers, notebook computers, subnotebook computers, netbook computers, netpad computers, set-top computers, media streaming devices, handheld computers, Internet appliances, mobile smartphones, tablet computers, personal digital assistants, video game consoles, and vehicles. Those skilled in the art will recognize that many smartphones are suitable for use in the systems described herein. Those skilled in the art will also recognize that select televisions, video players, and digital music players with optional computer network connectivity are suitable for use in the systems described herein. Suitable tablet computers include those with convertible, slate, and booklet configurations known to those skilled in the art.

[0169] In some embodiments, the digital processing device includes an operating system configured to execute executable instructions. The operating system is software, for example, that manages the device's hardware and provides services for the execution of applications, including programs and data.

[0170] In some embodiments, the device includes a storage and / or memory device. The storage and / or memory device is one or more physical devices used to store data or programs temporarily or permanently. In some embodiments, the device is volatile memory and requires power to maintain stored information. In some embodiments, the device is non-volatile memory and retains stored information when the digital processing device is not powered. In further embodiments, the non-volatile memory comprises flash memory. In some embodiments, the non-volatile memory comprises dynamic random access memory (DRAM). In some embodiments, the non-volatile memory comprises ferroelectric random access memory (FRAM (registered trademark)). In some embodiments, the non-volatile memory comprises phase change random access memory (PRAM). In other embodiments, the device is a storage device including, by way of non-limiting example, CD-ROMs, DVDs, flash memory devices, magnetic disk drives, magnetic tape drives, optical disk drives, and cloud computing-based storage devices. In further embodiments, the storage and / or memory device is a combination of devices such as those disclosed herein.

[0171] In some embodiments, the digital processing device includes a display for sending visual information to the user. In some embodiments, the display is a cathode ray tube (CRT). In some embodiments, the display is a liquid crystal display (LCD). In further embodiments, the display is a thin film transistor liquid crystal display (TFT-LCD). In some embodiments, the display is an organic light emitting diode (OLED) display. In various further embodiments, there is a passive matrix OLED (PMOLED) or an active matrix OLED (AMOLED) display on the OLED display. In some embodiments, the display is a plasma display. In other embodiments, the display is a video projector. In still further embodiments, the display is a combination of devices such as those disclosed herein.

[0172] In some embodiments, the digital processing device includes an input device for receiving information from the user. In some embodiments, the input device is a keyboard. In some embodiments, the input device is a pointing device including, by way of non-limiting example, a mouse, trackball, trackpad, joystick, game controller, or stylus. In some embodiments, the input device is a touch screen or multi-touch screen. In other embodiments, the input device is a microphone for capturing voice or other audio input. In other embodiments, the input device is a video camera or other sensor for capturing motion or visual input. In further embodiments, the input device is a Kinect, Leap Motion, or the like. In still further embodiments, the input device is a combination of devices such as those disclosed herein.

[0173] Referring to FIG. 18, in certain embodiments, an exemplary digital processing device 1801 is programmed or otherwise configured to control an imaging component and / or apparatus as described herein. The device 1801 can adjust various aspects of the imaging components and / or apparatus of the present disclosure, such as performing processing steps. In this embodiment, the digital processing device 1801 includes a central processing unit (CPU, also referred to herein as a “processor” and a “computer processor”) 1805, which can be a single-core or multi-core processor or multiple processors for parallel processing. The digital processing device 1801 also includes a memory or memory location 1810 (e.g., random access memory, read-only memory, flash memory), an electronic storage unit 1815 (e.g., hard disk), a communication interface 1820 (e.g., network adapter) for communicating with one or more other systems, and peripheral devices 1825 such as a cache, other memory, data storage devices, and / or an electronic display adapter. The memory 1810, storage unit 1815, interface 1820, and peripheral devices 1825 communicate with the CPU 1805 through a communication bus (solid line), such as a motherboard. The storage unit 1815 can be a data storage unit (or data repository) for storing data. The digital processing device 1801 can be operatively coupled to a computer network (“network”) 1830 using the communication interface 1820. The network 1830 can be the Internet, an intranet and / or an extranet, or an intranet and / or extranet that communicates with the Internet. In some cases, the network 1830 is a telecommunications and / or data network. The network 1830 can include one or more computer servers that enable distributed computing, such as cloud computing. In some cases, the network 1830 can implement a peer-to-peer network that enables a device coupled to the device 1801 to act as a client or server using the device 1801.

[0174] Continuing to refer to FIG. 18, the CPU 1805 can execute a sequence of machine-readable instructions that can be embodied in a program or software. The instructions can be stored within a memory location such as the memory 1810. The instructions can be directed to the CPU 1805, which can in turn program or otherwise configure the CPU 1805 to implement the methods of the present disclosure. Examples of operations performed by the CPU 1805 can include fetch, decode, execute, and write-back. The CPU 1805 can be part of a circuit such as an integrated circuit. One or more other components of the device 1801 can be included within the circuit. In some cases, the circuit is an application specific integrated circuit (ASIC) or a field programmable gate array (FPGA).

[0175] Continuing to refer to FIG. 18, the storage unit 1815 can store files such as drivers, libraries, and saved programs. The storage unit 1815 can store user data, such as user preferences and user programs. In some cases, the digital processing device 1801 can include one or more additional data storage units external to the device, such as located on a remote server that communicates through an intranet or the Internet. The digital processing device 1801 can communicate with one or more remote computer systems through the network 1830. For example, the device 1801 can communicate with a user's remote computer system.

[0176] Examples of remote computer systems include personal computers (e.g., portable PCs), slates or tablet PCs (e.g., Apple® iPad®, Samsung® Galaxy Tab), telephones, smartphones (e.g., Apple® iPhone®, Android-enabled devices, Blackberry®), or personal digital assistants.

[0177] A method as described herein can be implemented using machine (e.g., computer processor) executable code stored on an electronic storage location of a digital processing device 1801, such as, for example, on the memory 1810 or the electronic memory unit 1815. 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 1805. In some cases, the code can be read from the memory unit 1815 and stored on the memory 1810 for rapid access by the processor 1805. In some situations, the electronic memory unit 1815 can be excluded and the machine executable instructions can be stored on the memory 1810.

[0178] The digital processing device 1801 can include, or communicate with, an electronic display 1835 that includes a user interface (UI) 1840. Examples of UIs include, but are not limited to, graphical user interfaces (GUIs) and web-based user interfaces. In some cases, the electronic display 1835 can be connected to the computer system 1801 via a network, such as, for example, via the network 1830.

[0179] In some embodiments, the platforms, systems, media, and methods disclosed herein include one or more non-transitory computer-readable storage media encoded with a program comprising instructions executable by an operating system of an optionally networked digital processing device. In further embodiments, the computer-readable storage media are tangible components of the digital processing device. In still further embodiments, the computer-readable storage media are optionally removable from the digital processing device. In some embodiments, the computer-readable storage media include, by way of non-limiting example, CD-ROMs, DVDs, flash memory devices, solid state memories, magnetic disk drives, magnetic tape drives, optical disk drives, cloud computing systems and services, and the like. In some cases, the program and instructions are encoded on the media permanently, substantially permanently, semi-permanently, or non-transitorily.

[0180] In some embodiments, the platforms, systems, media, and methods disclosed herein include at least one computer program or use thereof. The computer program includes a sequence of instructions executable in a CPU of a digital processing device written to perform a specified task. The computer-readable instructions may be implemented as program modules such as functions, objects, application programming interfaces (APIs), data structures, and the like that perform a particular task or implement a particular abstract data type. In light of the disclosure provided herein, one of ordinary skill in the art will recognize that the computer program may be written in various versions of various languages.

[0181] The functionality of the computer-readable instructions can be combined or distributed as desired in various environments. In some embodiments, the computer program comprises one sequence of instructions. In some embodiments, the computer program comprises a plurality of sequences of instructions. In some embodiments, the computer program is provided from one location. In other embodiments, the computer program is provided from a plurality of locations. In various embodiments, the computer program includes one or more software modules. In various embodiments, the computer program includes, in part or whole, one or more web applications, one or more mobile applications, one or more stand-alone applications, one or more web browser plugins, extensions, add-ins, or add-ons, or combinations thereof.

[0182] Preferred embodiments of the present disclosure have been shown and described herein, but it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, modifications, and substitutions will occur to those skilled in the art without departing from the scope of the present disclosure. It should be understood that various alternatives to the embodiments of the present disclosure described herein may be employed in practicing the present disclosure. The following claims define the scope of the invention and are intended to cover methods and structures within the scope of these claims and their equivalents.

Claims

1. An otoscope operable to be disposed within an ear of a subject, the otoscope comprising: a housing having an optical waveguide element, wherein transmission optical illumination is conducted through the optical waveguide element by total internal reflection, the housing having a lumen therein, the housing being configured to allow reflective optical illumination to propagate within the lumen from a distal end of the housing to a proximal portion of the housing and toward a proximal detector of the housing; an obstruction disposed within the lumen near a distal end of the housing and centered with respect to the distal end of the housing; and; the obstruction at least partially obstructs the reflective optical illumination, the obstruction having a largest dimension less than 75% of the smallest diameter of the lumen, the lumen being configured to transmit the reflective optical illumination within an annular region around the obstruction such that the reflective optical illumination is operable to form an image of a target on the detector beyond the obstruction.

2. The otoscope according to claim 1, wherein the obstruction comprises an ultrasonic transducer.

3. The otoscope according to claim 2, wherein a transmission axis of the ultrasonic transducer is coaxial with a symmetry axis of the housing.

4. The otoscope according to claim 1, wherein the housing has a frustoconical shape.

5. The otoscope according to claim 1, wherein a transmission axis of the ultrasonic transducer is coaxial with an optical path of the reflective optical illumination.

6. The largest dimension of the obstruction is a diameter of the obstruction, and the diameter of the obstruction is in a range of 20% to 60% of the smallest diameter of the lumen. The otoscope according to claim 1.

7. The otoscope according to claim 1, wherein the optical waveguide element comprises one or more optical fibers adjacent to the housing.

8. The otoscope according to claim 1, wherein a portion of the housing is configured to transmit light by total internal reflection such that the portion of the housing is the optical waveguide element.

9. The otoscope according to claim 1, wherein the otoscope is disposable.

10. The otoscope according to claim 1, wherein the otoscope is removably attachable to an otoscope.

11. The otoscope according to claim 10, wherein when the otoscope is connected to the otoscope, it is axially aligned with a focal axis of an optical assembly.

12. The ophthalmoscope according to claim 11, wherein the optical assembly has a focus within a range of 12 to 25 mm from the distal tip of the otoscope.

13. The ophthalmoscope according to claim 12, wherein the optical assembly has a depth of field greater than 0.5 mm at a distance of 12 to 25 mm from the distal tip of the otoscope.

14. The ophthalmoscope according to claim 2, wherein the ultrasonic transducer is mounted on a transducer-mounted assembly, and the transducer-mounted assembly has one or more openings for enabling transmission of pneumatic excitation around the ultrasonic transducer.

Images