Method and system for automated pneumatic otoscopy - Patent Application 20070123633

Abstract

An exemplary method for characterizing the quality of the membrane measurement may include receiving a reflected signal from the tympanic membrane in response to an air pressure load, characterizing the quality of the seal in response to the reflected signal, where the quality of the seal is characterized based on a leak rate, and providing an indication that the leak rate is sufficiently small to continue the measurement. In one embodiment, the method is implemented by a computer including a processor, and the characterizing and providing are performed in the processor in response to the reflected signal.

Description

[Background technology]

[0001] (cross reference) This application claims priority to U.S. Provisional Patent Application No. 63 / 192,661, filed May 25, 2021, which application is incorporated herein by reference in its entirety for all purposes.

[0002] Acute otitis media (AOM) is an inflammatory process within the middle ear and is the most common clinical condition seen by pediatricians in children under the age of 15. AOM is generally associated with the presence of middle ear effusion and is considered an inflammation of the middle ear. Complications of undiagnosed AOM can include hearing loss. If left untreated in children, recurrent AOM can also lead to delayed development of speech and language skills. Summary of the Invention [Means for solving the problem]

[0003] Aspects of the present disclosure provide a method for characterizing the quality of a membrane measurement, which may include receiving a reflected signal from a tympanic membrane in response to an air pressure load, characterizing a quality of a seal in response to the reflected signal, where the quality of the seal is characterized based on a leak rate, and providing an indication that the leak rate is small enough to continue the measurement.

[0004] In some embodiments, the method is implemented by a computer including a processor, and the characterizing and providing are performed in the processor in response to the reflected signal.

[0005] In another aspect, the present disclosure provides a system for characterizing the quality of a membrane measurement, which may include a processor comprising instructions configured, when executed, to process a signal reflected from the tympanic membrane in response to an air pressure load, characterize a quality of a seal in response to the reflected signal, where the quality of the seal is characterized based on a leak rate, and provide an indication that the leak rate is sufficiently small to continue measuring.

[0006] In some embodiments, the processor is mounted on an otoscope. In some embodiments, the processor is mounted on a pneumatic otoscope.

[0007] In another aspect, the present disclosure provides a system comprising a pressure source configured to provide a plurality of pressure profiles to a pneumatic volume comprising a target object or area, one or more sensors configured to detect or measure (i) the pressure within the pneumatic volume and / or (ii) the leak rate of the pneumatic volume, and a control unit configured to implement a closed-loop control scheme to adjust or modulate the operation, position, and / or movement of the pressure source based on one or more measurements obtained using the one or more sensors.

[0008] In some embodiments, the system may further comprise a valve configured to equalize or reset the pressure of the pneumatic volume. In some embodiments, the control unit may be configured to regulate the operation or movement of the valve based on one or more measurements obtained using the one or more sensors.

[0009] In some embodiments, the control unit may be configured to select or modify a pressure profile provided by the pressure source. In some embodiments, the control unit may be configured to select or modify the pressure profile based on input provided by a user or operator. In some embodiments, the input may comprise a selection of one or more operating modes. In some embodiments, the one or more operating modes may comprise a pressure scouting mode or a seal quality assessment mode. In some embodiments, the one or more operating modes may comprise a tympanic membrane load mode or a tympanic membrane response measurement mode. In some embodiments, the multiple pressure profiles may comprise (i) a first pressure profile for the pressure scouting mode or the seal quality assessment mode, and (ii) a second pressure profile for the tympanic membrane load mode or the tympanic membrane response measurement mode. In some embodiments, the first pressure profile and the second pressure profile may be different.

[0010] In some embodiments, the control unit may include a pressure monitor configured to disable operation or movement of a relief valve for a pneumatic manifold in pneumatic communication with the pressure source based on one or more measurements. In some embodiments, the pressure monitor may be configured to control or modulate operation or movement of the pressure source based on one or more measurements. In some embodiments, the control unit and / or pressure monitor may be configured to determine a seal quality for the pneumatic volume based on (i) the one or more measurements or (ii) the amount of movement or displacement required for the pressure source to achieve or maintain a threshold pressure for the pneumatic volume.

[0011] In some embodiments, the system may further comprise an indicator to provide an indication of the seal quality to a user or operator, hi some embodiments, the indication may comprise an audio, visual, or tactile alert or feedback.

[0012] In some embodiments, the pressure source comprises an electroacoustic device, hi some embodiments, the electroacoustic device comprises a speaker, hi some embodiments, the electroacoustic device comprises an air impulse generator or air pump configured to displace a volume of air within the pneumatic volume.

[0013] In some embodiments, the pneumatic volume comprises a sealed or partially sealed volume or region between the pressure source and the target object or region, hi some embodiments, the pneumatic volume extends from the pressure source to at least the ear canal of the patient or subject.

[0014] In some embodiments, the system may further comprise one or more additional sensors configured to detect (i) one or more signals received, transmitted, or reflected from the target object or region, and / or (ii) a behavior or movement of the target object or region in response to one or more of the plurality of pressure profiles. In some embodiments, the one or more additional sensors may comprise a microphone.

[0015] In some embodiments, the target object or region may comprise a biological membrane. In some embodiments, the biological membrane may comprise a tympanic membrane.

[0016] In another aspect, the disclosure provides a method that includes: (a) using a pressure source to provide a plurality of pressure profiles to a pneumatic volume that includes a target object or area; (b) using one or more sensors to detect or measure (i) the pressure in the pneumatic volume and / or (ii) the leak rate of the pneumatic volume; and (c) using a control unit configured to implement a closed-loop control scheme to adjust or modulate the operation, position, and / or movement of the pressure source based on the one or more measurements obtained using the one or more sensors.

[0017] In some embodiments, the method may further include, subsequent to (c), measuring a behavior or movement of the target object or region based at least in part on one or more signals received, transmitted, or reflected from the target object or region in response to one or more of the plurality of pressure profiles. In some embodiments, (c) may further include equalizing or resetting the pressure of the pneumatic volume using a valve. In some embodiments, the method may further include adjusting the operation or movement of the valve based on one or more measurements obtained using the one or more sensors.

[0018] In some embodiments, the method may further include, subsequent to (a), selecting or modifying a pressure profile to be provided by the pressure source. In some embodiments, the multiple pressure profiles may correspond to one or more operational modes. In some embodiments, the one or more operational modes may comprise a pressure scouting mode or a seal quality assessment mode. In some embodiments, the one or more operational modes may comprise a tympanic membrane loading mode or a tympanic membrane response measurement mode. In some embodiments, the multiple pressure profiles may comprise (i) a first pressure profile for the pressure scouting mode or the seal quality assessment mode, and (ii) a second pressure profile for the tympanic membrane loading mode or the tympanic membrane response measurement mode. In some embodiments, the first pressure profile and the second pressure profile may be different.

[0019] In some embodiments, the method may further include disabling operation or movement of a relief valve for a pneumatic manifold in pneumatic communication with the pressure source based on the one or more measurements.

[0020] In some embodiments, the method may further include determining a seal quality for the pneumatic volume based on (i) the one or more measurements or (ii) an amount of movement or displacement required for the pressure source to achieve or maintain a threshold pressure for the pneumatic volume. In some embodiments, the method may further include providing an indication of the seal quality to a user or operator. In some embodiments, the indication may comprise an audio, visual, or tactile alert or feedback.

[0021] In some embodiments, the pneumatic volume may comprise a sealed or partially sealed volume or region between the pressure source and the target object or region, hi some embodiments, the pneumatic volume may extend from the pressure source to at least the ear canal of the patient or subject. (Cited by reference)

[0022] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. [Brief description of the drawings]

[0023] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings.

[0024] [Figure 1A] FIG. 1A illustrates an exemplary system for characterizing a membrane according to some embodiments.

[0025] [Figure 1B] FIG. 1B illustrates an example of a pneumatic tympanic loading system (TCS) according to some embodiments.

[0026] [Figure 1C]FIG. 1C illustrates an example of a TCS including a pressure monitoring system according to some embodiments.

[0027] [Figure 2A] FIG. 2A illustrates an example of a pressure transient profile for evaluating the behavior or response of a TM according to some embodiments.

[0028] [Figure 2B] FIG. 2B illustrates an example of a pressure transient profile for implementing a pressure reconnaissance function according to some embodiments.

[0029] [Diagram 3] FIG. 3 illustrates an example configuration for an earbud style ear canal seal according to some embodiments.

[0030] [Figure 4A] FIG. 4A illustrates an example user interface showing the quality of the seal according to some embodiments.

[0031] [Figure 4B] FIG. 4B illustrates an additional example user interface indicating the quality of the seal according to some embodiments.

[0032] [Diagram 5] FIG. 5 diagrammatically illustrates a computer system configured to implement the methods of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] In systems with manual gas injection valves, a trained practitioner (clinician) elicits sudden pressure transients of both negative and positive pressure into a lightly sealed ear canal to observe dampened tympanic membrane (TM) movement in patients with suspected otitis media (OM). A healthy middle ear (without any OM and without any effusion) will exhibit "active" movement in response to the pressure transients. In patients with middle ear effusion, the TM has lost some of its active movement.

[0034] The clinician may use an external elastomeric valve-style seal about 5 mm distal to the open end of the speculum to seal the ear canal. Any leaks in the system may be overcome by the clinician squeezing harder on the valve, generating pressures as high as 520 mm water column to 748 mm water column to the TM. See, e.g., Clarke L, Wiederhold M, Gates G. Quantitation of pneumatic otoscopy. Otolaryngol Head Neck Surg. Feb 1987; 96(2): 119-24. PMID: 3120084, and Cavanaugh R. Pediatricians and the pneumatic otoscope: are we playing it by ear? Pediatrics. Aug 1989; 84(2): 362-4. PMID: 2748268, each of which is incorporated herein by reference in their entirety. This pressure approaches the threshold for patient injury. The pressure differential across the TM required for rupture varies from 17 to 100 kPa. See, e.g., Cameron J, Skofronick J, Grant R., Physics of the Body (Medical Physics Series). Madison WI: Medical Physics Publishing; 1999, and Richmond D, Yelverton J, Phillips Y, Fletcher E., Physical correlates of eardrum rupture. Ann Otol Rhinol Laryngol Suppl. May 1989;140:35-41, each of which is incorporated herein by reference in their entirety. Assuming the worst case pressure differential from this publication, 17 kPa is assumed to be the lower threshold for TM rupture, which is approximately 1,734 mm of water.

[0035] The systems and methods of the present disclosure may improve upon these methods by automating the process of adjusting for leakage in pneumatic otoscopic measurements. The systems and methods described herein may provide highly reproducible low pressure transients on the TM and measure TM motion. The systems and methods disclosed herein may be used with a variety of sensors, including, but not limited to, air-coupled ultrasound, coherent optical or infrared light, or non-coherent optical or infrared light. (Pneumatic Tympanic Loading System (TCS))

[0036] 1A shows an exemplary system 100 for characterizing the response of a membrane. The system 100 may include an electroacoustic device 101 configured to generate a signal 102 that is transmitted to a target area 103. The signal 102 may include a pressure transient profile. The target area 103 may include, for example, the tympanic membrane (TM).

[0037] In some cases, the pressure transient profile may include two or more cycles of negative, neutral, and positive pressure components. Cycles in both pressure directions may allow for a measurement of the degree of symmetry or asymmetry of TM motion in response to the pressure transient profile.

[0038] In some cases, the signal 102 may interact with the target region 103 and induce movement of the target region 103. The signal 102 may be reflected back towards the system 100 as a reflected signal 104. The reflected signal 104 may be produced by (and / or received from) the tympanic membrane in response to an air pressure load that accompanies (or is initiated by) an interaction between a pressure transient profile associated with the signal 102 and the target region 103.

[0039] In some cases, the reflected signal 104 may be received at a detector 105. The detector 105 may comprise, for example, a pressure sensor or a microphone. The detector 105 may be configured to detect and / or characterize a response or movement of the membrane following an interaction between the signal 102 and the membrane. In some cases, the detector 105 may be configured to determine and / or characterize the quality of a seal formed between the speculum and the patient's or subject's ear canal. The speculum may be provided as part of the system 100 or may be a separate additional accessory or any part or component thereof that is coupleable or attachable to the system 100.

[0040] FIG. 1B illustrates an example of a pneumatic tympanic loading system (TCS) according to some embodiments. The pneumatic TCS may comprise an electroacoustic device, e.g., an audio speaker 201, which acts as a positive displacement air impulse generator (air pump) that may be finely adjusted to regulate the volume or pressure of a pneumatic volume that includes a target object or region (e.g., TM membrane). In some cases, the pneumatic volume may comprise a continuous pneumatic volume that includes at least the speaker 201, the interior volume of any manifolds, conduits, channels, or pneumatic tubing 202 provided between the speaker 201 and the speculum 203, the interior volume of the speculum 203, and the ear canal of the subject or patient. The speculum 203 may be used to create an ear canal seal 204. In some cases, the pneumatic volume may comprise a sealed (or partially sealed) volume or region between a pressure source (e.g., an electroacoustic device) and a target object or region (e.g., TM membrane). In some cases, the air pressure volume may extend from the pressure source to at least the patient's or subject's ear canal.

[0041] In some embodiments, the position, direction of travel, rate of travel, pressure profile, and / or total displacement of the TCS (e.g., an audio speaker) may be adjusted manually or automatically (e.g., using closed loop control as described elsewhere herein). The speaker may be controlled by an analog drive voltage, which may in turn be controlled by a digital-to-analog conversion device 208 controlled by a microprocessor 207.

[0042] In some cases, the TCS system may operate in a closed loop mode using one or more pressure sensors 205 to measure pressure and / or leak rate within the pneumatic volume and adjust the operation or configuration of the TCS system according to the measured pressure or leak rate. The one or more pressure sensors 205 may be operably coupled to a proportional integral derivative controller 206 and / or a microprocessor 207 configured to adjust the operation of the TCS or one or more components or subsystems of the TCS. Pressure measurements obtained using the one or more pressure sensors may be used to control the motion of an audio speaker through a proportional integral derivative control (PID) scheme to maintain a required or desired pressure profile. In some cases, the proportional integral derivative controller 206 and / or the microprocessor 207 may be configured to control the operation of an audio driver 209 configured to move or displace the speaker 201.

[0043] 1C diagrammatically illustrates a block diagram of an exemplary tympanic loading system (TCS). The system may include an electroacoustic device 110 (e.g., an audio speaker) configured to operate as a positive displacement air impulse generator (air pump), which is connected and / or sealed to an air manifold 111.

[0044] In some embodiments, the system can be fine-tuned to adjust the continuous air pressure volumes between the speaker 110, the air manifold 111, the plumbing between the air manifold and the speculum 112, the interior portion or region of the speculum 112, and the subject's or patient's ear canal. In some cases, the position, direction of travel, rate of travel, pressure profile, and / or total displacement of the electroacoustic device 110 can be adjusted manually or automatically (e.g., using closed loop control).

[0045] In some embodiments, the system may include an equalization valve 113. The equalization valve 113 may be connected to or integrated with the air manifold 111. The equalization valve 113 may be configured to regulate the pressure within the successive pneumatic volumes and allow the successive pneumatic volumes to be returned to a desired pressure or atmospheric pressure (i.e., zero gauge pressure) at the end of a fully positive or fully negative displacement limit of the electroacoustic device 110 (e.g., when the electroacoustic device 110 is maximally displaced in a particular direction, such as toward or away from a center or starting location of the electroacoustic device 110). The equalization valve 113 may be configured to reset (or restore) the pressure volume of the electroacoustic device 110.

[0046] In some embodiments, the TCS system may be configured to operate in a closed-loop pressure mode. The closed-loop pressure mode may utilize feedback from a pressure sensor 114. The pressure sensor 114 may be configured to measure a pressure, which in turn feeds a signal indicative of the measured pressure through a serial engine sample processing unit 115, a pressure interpretation module 116, and a proportional-integral-derivative (PID) control 117, with the PID configured to output one or more control signals based on the feedback received from the pressure sensor 114.

[0047] In some cases, pressure interpretation module 116 may be configured to process raw data values ​​received from serial engine sample processing unit 115 and calculate a pressure value (e.g., pressure in millibars) that can be used by pressure monitor subsystem 118 to control operation of valve 113 and / or electroacoustic device 110. In some cases, pressure monitor subsystem 118 may be used to control or implement valve state override 121 or speaker shutoff 122.

[0048] In some embodiments, the pressure monitor subsystem 118 may be a separable software block that operates outside of the pressure control logic associated with the PID control 117. The pressure monitor subsystem 118 may be configured to check the measured pressure for proximity to any safety limits (e.g., proof or burst limits) and (i) disable the valve state to "open" and / or (ii) block any further speaker movement until the limits are cleared.

[0049] In some embodiments, the PID control 117 may reside in a common software block with pressure control logic, which may configure the system or electroacoustic device / speaker / pressure source to generate a preprogrammed time-varying square wave pressure profile (e.g., as shown in FIG. 2A or 2B). The pressure control logic and the PID control signal may be provided as inputs for both the speaker control 119 and the valve control 120. The speaker control 119 and the valve control 120 may be used to modulate the operation of the valve 113 and / or the operation or movement of the electroacoustic device 110 (e.g., using the valve driver 123 or the motor controller 124).

[0050] FIG. 2A illustrates an example pressure transient profile 301 according to some embodiments. The pressure transient profile may include two or more cycles of negative, neutral, and positive pressure components. Cycles in both pressure directions may allow for measurement of the degree of symmetry or asymmetry of TM motion, which may reveal aspects of effusion behind the TM inside the middle ear. In some cases, the pressure transient profile may comprise a pressure profile cycling at ±80 mm of water. In some cases, different pressure transient profiles may be used for pressure scouting purposes, as described in more detail below.

[0051] For measurements of TM mobility, the pre-programmed pressure transient profile applied to the TM may include multiple cycles of negative, neutral, and positive pressure components. The multiple cycles of negative, neutral, and positive pressure components may interact with the TM and elicit a response or behavior (e.g., TM movement). In some cases, the elicited response or behavior may indicate a degree of symmetry or asymmetry that may indicate the presence or absence of effusion behind the TM inside the patient's or subject's inner ear.

[0052] The pressure transient profile may allow observation of the impeded movement (damping) of the TM that may be caused by effusion behind the TM. A healthy TM without effusion in the middle ear will show a TM displacement showing a profile with a high degree of similarity to the pressure profile. In contrast, a middle ear with effusion may show a dampened profile that allows diagnosis of disease states and the type of effusion inside the middle ear.

[0053] The disclosed systems and methods may overcome at least some limitations of conventional systems and methods for pneumatic otoscopy. For example, the disclosed systems and methods may provide a consistent air pressure profile applied to the TM regardless of the patient's ear canal volume, volume leakage (subject to pressure reconnaissance actions, as described in more detail below), and operator technique. The consistent pressure profile may allow for inter-patient baselining of middle ear effusion status. The disclosed systems and methods may also provide a greater margin for safety limits in the TM, since there is no need to over-pressurize the patient's ear canal volume to observe TM movement. Furthermore, the disclosed systems and methods do not require the operator to squeeze the gas insufflation valve and apply positive and negative air pressure to the TM, thereby allowing the operator to make more efficient use of the patient's time, particularly with very young pediatric patients, who may not provide long-term compliance for pneumatic otoscopy.

[0054] FIG. 2B illustrates an example pressure transient profile 302 that may be used for pressure reconnaissance purposes. In some embodiments, the TCS or electroacoustic device or audio speaker may be operated in a pressure reconnaissance mode and / or configured to implement a pressure reconnaissance function. In some cases, the pressure reconnaissance function may move or operate the electroacoustic device or audio speaker using a pressure profile that is different from the pressure profile used to stimulate or probe the TM. For example, instead of using a pressure profile of ±80 mm water, the system may cycle at ±20 mm water to perform pressure reconnaissance. The pressure reconnaissance function may maintain a pressure profile that is entirely tolerable or even barely detectable by the patient while allowing continuous monitoring of pressure, leak rate, and / or pressure changes in response to movement or movement of the electroacoustic device or audio speaker. In some cases, the TCS may predict the extent to which a detected or estimated leak rate will be successful during a measurement cycle utilizing a pressure profile that includes, for example, a ±80 mm water measurement cycle.

[0055] In some cases, the TCS may be configured to use a first pressure transient profile to measure TM movement or response. In some cases, the TCS may be configured to use a second pressure transient profile for pressure reconnaissance. The second pressure transient profile may include a maximum or minimum value having an absolute value that is less than the absolute value of the maximum or minimum value of the first pressure transient profile.

[0056] In some cases, the first pressure transient profile and / or the second pressure transient profile may be pre-set, pre-programmed, or otherwise predetermined. In other cases, the first pressure transient profile and / or the second pressure transient profile may be adjustable (e.g., based on patient needs or operator preferences). In some cases, the first pressure transient profile and / or the second pressure transient profile may be adjusted automatically or autonomously by the TCS using a control loop, as described elsewhere herein. (seal)

[0057] The disclosed systems and methods may be integrated with and / or compatible with a wide range of speculum seal designs. In some non-limiting embodiments, a speculum seal comprising multiple flanges of elastomeric material may be used to form a seal between the TCS system and the subject's or patient's ear canal. A speculum seal with multiple flanges may conform to the variability of ear canal shapes, provide a tortuous path for air to escape from / to the ear canal, and reduce contact forces on highly innervated portions of the ear canal, thus reducing discomfort for any patient. The seal may be designed based on numerous pediatric radiological data of the ear canal from the helix to the tympanic membrane.

[0058] In some alternative embodiments, an earbud style ear canal seal may be used to form a seal between the TCS system and the subject's or patient's ear canal. FIG. 3 illustrates an example configuration for an earbud style ear canal seal. In some cases, the seal may be placed over or on the tip of a speculum. As shown in the cutaway view, the earbud style ear canal seal may comprise multiple surfaces, including an outer surface 401 and an inner surface 402. The inner surface 402 may seal against the outside of the speculum shell, and the outer surface 401 may seal against the skin in the subject's or patient's ear canal. In some cases, the two seal surfaces 401, 402 may articulate independently of one another while still remaining connected. In some cases, the earbud style ear canal seal may comprise an elastomer (e.g., a low durometer elastomer). The elastomer may provide a relatively high coefficient of friction to firmly grip and seal over both the speculum shell and the skin in the subject's or patient's ear canal.

[0059] In some cases, the outer surface 401 and the inner surface 402 may be at least partially joined. For example, the outer surface 401 and the inner surface 402 may be joined at one or more locations. The one or more locations may correspond to an intersection between an area or portion of the outer surface 401 and an area or portion of the inner surface 402. In some cases, the seal may comprise a gap, cavity, recess, or interior volume between the outer surface 401 and the inner surface 402. The gap, cavity, recess, or interior volume may extend between the outer surface 401 and the inner surface 402. The perimeter or boundary of the gap, cavity, recess, or interior volume may coincide with one or more locations where the outer surface 401 and the inner surface 402 are joined. The gap, cavity, recess, or interior volume may allow the outer surface 401 and the inner surface 402 to articulate independently of one another while still remaining connected.

[0060] An earbud-style ear canal seal design may be used in combination with a closed loop pressure control scheme described elsewhere herein to allow accurate monitoring of pressure in situ and precise control and / or modulation of an electroacoustic device or speaker in response to the sensed pressure. As described elsewhere herein, control and / or modulation of an electroacoustic device or speaker may include controlling or modulating the position, direction of travel, rate of travel, pressure profile, and / or total displacement of the electroacoustic device or speaker.

[0061] The earbud style ear canal seal design may also be used in combination with a pressure reconnaissance function or mode, as described in more detail below. The pressure reconnaissance may assist the operator in assessing the seal quality and establishing or re-establishing an acceptable seal on the patient's or subject's ear canal. (Pressure Reconnaissance)

[0062] When using the TCS or pressure profile to assess TM characteristics or response, there may be instances where the operator does not obtain a sufficient seal or is not aware of excessive leakage until attempting to perform a TM mobility measurement with the TCS. If the leakage is significant, the pressure PID control may respond by moving, displacing, or otherwise modulating the operation of the electroacoustic device or audio speaker to recapture the lost volume of air between the TM and the speculum. In some embodiments, for example, in extreme cases of excessive leakage, the electroacoustic device or audio speaker may reach its physical displacement limit before the entire TCS measurement cycle can be completed (even with the action of the equalization valve). In such cases, the operator may not know of the leakage until the TCS voice coil warning times out. The systems and methods of the present disclosure may provide the operator with a proactive pressure indication, referred to herein as a pressure scout function or mode.

[0063] In some embodiments, the TCS or electroacoustic device or audio speaker may be operated in a pressure reconnaissance mode and / or configured to implement a pressure reconnaissance function. In some cases, the pressure reconnaissance function may move or operate the electroacoustic device or audio speaker using a pressure profile different from the pressure profile used to stimulate or probe the TM. For example, instead of using a pressure profile of ±80 mm water column, the system may cycle at ±20 mm water column to perform pressure reconnaissance. The pressure reconnaissance function may maintain a pressure profile that is entirely tolerable or even barely perceptible by the patient or subject while allowing continuous monitoring of pressure, leak rate, and / or pressure changes in response to movement or movement of the electroacoustic device or audio speaker. The software and / or processing module of the TCS may predict the degree to which the ear canal is sealed based on the degree to which additional speaker movement is required. For example, if very little movement is required, a good seal is present. Above some threshold of a "good seal" (which may correspond, for example, to the amount of movement required for the electroacoustic device or audio speaker to achieve a desired leak rate or pressure), the TCS may predict the extent to which a detected or estimated leak rate will be successful during a measurement cycle utilizing a pressure profile including, for example, a ±80 mm water column measurement cycle. In some cases, the system may also infer or determine whether the electroacoustic device or audio speaker may have sufficient margin to affect the measurement cycle without approaching audio speaker displacement limits. If the system infers or determines that the electroacoustic device or audio speaker may have sufficient margin to affect a partial or full measurement cycle without approaching audio speaker displacement limits, the system may output an indication to the operator that an acceptable seal has been formed. Conversely, if there is too much air leakage beyond the capabilities or capacity of the TCS to maintain the desired pressure for a particular air pressure volume, the operator may be presented with an indication of an unacceptable seal.

[0064] In any of the embodiments described herein, the instructions may include audio, visual, or tactile instructions. In some cases, the instructions for an acceptable seal may be different from the instructions for an unacceptable seal.

[0065] FIG. 4A illustrates an exemplary user interface showing the quality of the seal according to some embodiments. Information regarding the quality of the seal may be presented in the form of a sliding sphere 501 that may move up and down on an arc-shaped scale. When the sphere 501 is in a high position on the scale, it may turn green, indicating to the operator that the ear canal leakage condition is acceptable for making a measurement. If the sphere 501 is in a lower position on the scale with a yellow color, there may be a sufficient seal and the pressure scout function may prompt the operator to make one or more adjustments to obtain the desired air pressure or leak rate for the pneumatic volume. In some cases, if the sphere 501 is located toward the lower region of the scale and colored red, the pressure scout function may indicate that the leak rate is too excessive for a measurement to be made accurately. In this way, the system may proactively notify the operator on-site about the pneumatic seal condition.

[0066] 4B illustrates an additional exemplary user interface showing the quality of the seal according to some embodiments. The quality of the seal may be presented in the form of two concentric rings superimposed on the periphery of the otic display.

[0067] In some cases, the two concentric rings may consist of an inner ring 502 and an outer ring 503. The outer ring 503 may correspond to a pressure recon indication. The inner ring 502 may correspond to a beam recon indication. The beam recon indication may be based on the ultrasound return and / or the signal or wave characteristics of the ultrasound return and may indicate whether a portion of the TM is moving in phase or out of phase with the TCS pressure waveform. Movement of the TM in phase with the TCS pressure waveform may indicate that the TM is being interrogated rather than another nearby tissue region, such as the skin inside the patient's ear canal wall. In some cases, movement of the TM out of phase with the TCS pressure waveform may indicate that another nearby tissue region, rather than the TM, is being interrogated.

[0068] In some cases, when the inner ring 502 and the outer ring 503 are displayed in a first color (e.g., orange), the conditions required for TM mobility measurement may not be met. In such cases, the TCS may prompt the user to adjust the seal formed for the patient's or subject's ear canal. In some cases, when the inner ring 502 is displayed in a first color (e.g., orange) and the outer ring 503 is displayed in a second color (e.g., green), the conditions required for TM mobility measurement may not be met and the TCS may prompt the user to adjust its aim for light reflection. In some non-limiting embodiments, when the outer ring 503 is displayed in a first color (e.g., orange) and the inner ring 502 is displayed in a second color (e.g., green), the conditions required for TM mobility measurement may not be met (e.g., because the leak rate may be excessive even if the TM is within the ultrasound field of view), in which case the TCS may prompt the user to reposition the speculum tip inside the patient's ear canal to obtain a better seal. In some cases, when both rings 502, 503 are displayed in a second color (e.g., green), the rings may indicate that the conditions for measuring TM mobility are met. In some cases, when both rings 502, 503 are displayed in a third color (e.g., gray), the TCS may prompt the user to remain still, and the TCS may begin or continue recording data. In some embodiments, software control may be implemented to not change the beam scout (inner ring) to green until the pressure scout (outer ring) has already changed to green. This may encourage the operator to first establish an acceptable seal, as repositioning the speculum tip to achieve an acceptable seal may or may not place the TM within the ultrasound view of the TCS.Once the speculum tip is positioned to achieve an acceptable seal, the software controls can enable the TCS to assess whether the TM is moving in phase with the TCS pressure waveform and whether the TM is within the ultrasound field of view, which can then indicate to the operator that they can proceed with pneumatic otoscopy.

[0069] In some embodiments, when the TCS is initiated for clinical operation outside the subject's ear, both the inner ring 502 and the outer ring 503 may be displayed in orange on the display screen. As the user (e.g., physician or clinician) navigates the speculum with the integrated ear canal seal into the ear canal and forms a sufficient seal, the pressure scout (outer ring 503) may change to green. When a light reflection is brought within view and ultrasound Doppler indicates that TM motion is in phase with the pressure perturbation, the beam scout (inner ring 502) may change to green. Once both rings 502, 503 are colored green, the TCS may begin automatically and / or autonomously taking and recording pressure measurements and / or measurements related to TM mobility. As the system processes and records the measurement data (e.g., using the control system or closed loop control described above and referenced in Figures 1B and / or 1C), rings 502, 503 may turn gray as an indication to the operator to hold the system in place.

[0070] This pressure reconnaissance may overcome various limitations of existing systems and methods for pneumatic otoscopy. For example, an operator's normal hand tremor, nominally about 8-23 Hz, may affect the position of the speculum tip inside the ear canal, fluctuating the pneumatic seal, air pressure, and / or leak rate. The pressure reconnaissance feature may detect when such tremors result in a pneumatic seal, air pressure, and / or leak rate that is unacceptable or insufficient to measure the response or behavior of the TM, thereby allowing the operator to take corrective action.

[0071] The disclosed systems and methods may provide numerous advantages over existing systems and methods for pneumatic otoscopy. For example, while not all ear canals have the same volume, the disclosed systems and methods may utilize closed-loop pressure control, in addition to pressure scouting capabilities, to allow the operator to adjust or improve the seal between the speculum and the ear canal to accommodate different sized ear canals. The disclosed systems and methods may provide real-time, easy-to-interpret feedback to the operator preparing (or performing) a pneumatic otoscopy, thereby allowing the operator to use their time more efficiently with younger, non-compliant pediatric patients who may not be inclined to comply with the operator's commands or requests over an extended period of time.

[0072] The TCS systems disclosed herein can be of sufficient volume to provide sufficient air pressure inside the tip of the speculum (e.g., at the narrowest point of the tip of the speculum) so that the corresponding Reynolds number within that volume remains well below the transition boundary from laminar to turbulent flow (Re<1,000), which ensures that turbulent airflow does not interfere with the air-coupled ultrasound sensing methods disclosed herein. (Computer Systems)

[0073] In an aspect, the present disclosure provides a computer system programmed (or otherwise configured) to implement any of the methods of the present disclosure, e.g., the subject methods for pneumatic otoscopy. FIG. 5 shows a computer system 1001 programmed (or otherwise configured) to implement a method for pneumatic otoscopy. The computer system 1001 may be configured to control, regulate, or modulate, for example, the operation of (i) a valve driver for resetting the air pressure of a pneumatic volume, and / or (ii) a motor controller for moving or displacing an electroacoustic device or speaker. The pneumatic volume may include the electroacoustic device or speaker, an air manifold, tubing between the air manifold and the speculum, an inner portion or region of the speculum, and a sealed ear canal of a patient or subject. The computer system 1001 may be a user's electronic device or a computer system located remotely relative to the electronic device. The electronic device may be a mobile electronic device.

[0074] The computer system 1001 may include a central processing unit (CPU, also referred to herein as "processor" and "computer processor") 1005, which may be a single-core or multi-core processor, or multiple processors for parallel processing. The computer system 1001 also includes a memory or memory location 1010 (e.g., random access memory, read-only memory, flash memory), an electronic storage unit 1015 (e.g., hard disk), a communication interface 1020 (e.g., network adapter) for communicating with one or more other systems, and peripheral devices 1025, such as cache, other memory, data storage devices, and / or electronic display adapters. The memory 1010, the storage unit 1015, the interface 1020, and the peripheral devices 1025 communicate with the CPU 1005 through a communication bus (solid lines), such as a motherboard. The storage unit 1015 may be a data storage unit (or data repository) for storing data. The computer system 1001 may be operatively coupled to a computer network ("network") 1030 with the aid of the communication interface 1020. The network 1030 can be the Internet, an Internet and / or an extranet, or an intranet and / or an extranet in communication with the Internet. The network 1030 is, in some cases, a telecommunications and / or data network. The network 1030 can include one or more computer servers, which may enable distributed computing, such as cloud computing. The network 1030 can, in some cases, implement a peer-to-peer network, which may enable devices coupled to the computer system 1001 with the help of the computer system 1001 to behave as clients or servers.

[0075] The CPU 1005 can execute sequences of machine-readable instructions, which may be embodied in a program or software. The instructions may be stored in a memory location, such as the memory 1010. The instructions may be directed to the CPU 1005, which may then program or otherwise configure the CPU 1005 to implement the methods of the present disclosure. Examples of operations performed by the CPU 1005 may include fetch, decode, execute, and writeback.

[0076] The CPU 1005 may be part of a circuit, such as an integrated circuit. One or more of the other components of the system 1001 may be included in the circuit. In some cases, the circuit is an application specific integrated circuit (ASIC).

[0077] The storage unit 1015 can store files such as drivers, libraries, and saved programs. The storage unit 1015 can store user data, such as user preferences and user programs. The computer system 1001 can include one or more additional data storage units, in some cases located outside the computer system 1001 (e.g., on a remote server in communication with the computer system 1001 through an intranet or the Internet).

[0078] The computer system 1001 can communicate with one or more remote computer systems through the network 1030. For example, the computer system 1001 can communicate with a remote computer system of a user (e.g., a doctor, clinician, physician, medical professional or assistant, medical provider, imaging technician, etc.). Examples of remote computer systems include a personal computer (e.g., a portable PC), a slate or tablet PC (e.g., Apple® iPad®, Samsung® Galaxy Tab), a phone, a smartphone (e.g., Apple® iPhone®, Android®-enabled device, Blackberry®), or a personal digital assistant. A user can access the computer system 1001 via the network 1030.

[0079] Methods as described herein may be implemented using machine (e.g., computer processor) executable code stored on electronic storage locations of the computer system 1001, such as, for example, on the memory 1010 or electronic storage unit 1015. The machine executable or machine readable code may be provided in the form of software. In use, the code may be executed by the processor 1005. In some cases, the code may be read from the storage unit 1015 and stored on the memory 1010 for quick access by the processor 1005. In some circumstances, the electronic storage unit 1015 may be omitted and the machine executable instructions are stored on the memory 1010.

[0080] The code can be pre-compiled and configured for use with a machine having a processor adapted to execute the code, or can be compiled during run-time. The code can be provided in a programming language that can be selected to allow the code to be executed in a pre-compiled or as-compiled manner.

[0081] Aspects of the systems and methods provided herein, such as the computer system 1001, can be embodied in programming. Various aspects of the technology can be thought of as a "product" or "article of manufacture" that is typically in the form of machine (or processor) executable code and / or associated data carried on (or embodied in) some type of machine-readable medium. The machine executable code can be stored on an electronic storage unit, such as a memory (e.g., read-only memory, random access memory, flash memory) or a hard disk. A "storage" type medium can include any or all of the tangible memory of a computer, processor, etc., or their associated modules, such as various semiconductor memories, tape drives, disk drives, etc., that can provide non-transitory storage at any time for software programming. All or a portion of the software can be communicated over the Internet or various other telecommunications networks from time to time. Such communication can enable, for example, loading of the software from one computer or processor to another (e.g., from a management server or host computer to the computer platform of an application server). Thus, other types of media that may bear software elements include optical, electrical, and electromagnetic waves, such as those used across physical interfaces between local devices, through wired and optical fixed networks, and by various air links. The physical elements that carry such waves, such as wired or wireless links, optical links, etc., may also be considered media bearing the software. As used herein, unless limited to non-transitory tangible "storage" media, terms such as computer or machine "readable medium" refer to any medium that participates in providing instructions to a processor for execution.

[0082] Thus, a machine-readable medium such as a computer executable code may take many forms, including, but not limited to, a tangible storage medium, a carrier wave medium, or a physical transmission medium. For example, non-volatile storage media, including optical or magnetic disks or any storage device in any computer or the like, may be used to implement the databases, etc., shown in the figures. Volatile storage media include dynamic memory, such as the main memory of such a computer platform. Tangible transmission media include coaxial cables, copper wire, and optical fibers, including the wires that comprise a bus in a computer system. Carrier wave transmission media may take the form of electric or electromagnetic signals, or acoustic or light waves, such as those generated during radio frequency (RF) and infrared (IR) data communications. Common forms of computer readable media thus include, for example, a floppy disk, a flexible disk, a hard disk, a magnetic tape, any other magnetic medium, a CD-ROM, a DVD or DVD-ROM, any other optical medium, punch cards, paper tape, any other physical storage medium with a pattern of holes, RAM, ROM, PROM and EPROM, FLASH-EPROM, any other memory chip or cartridge, a carrier wave transporting data or instructions, a cable or link transporting such a carrier wave, or any other medium from which a computer may read programming code and / or data. Many of these forms of computer readable media may be involved in carrying one or more sequences of one or more instructions to a processor for execution.

[0083] The computer system 1001 may include or communicate with an electronic display 1035 with a user interface (UI) 1040 to provide a portal for a medical provider or imaging technician to monitor or track seal quality for various measurements, such as targeted air pressure volume and / or pressure scout measurements and / or TM response measurements, for example. The portal may be provided through an application programming interface (API). A user or entity may also interact with various elements within the portal via the UI. Examples of UIs include, but are not limited to, graphical user interfaces (GUIs) and web-based user interfaces.

[0084] The methods and systems of the present disclosure can be implemented using one or more pressure control logic algorithms. The pressure control logic algorithms can be implemented using software when executed by the central processing unit 1005. For example, the pressure control logic algorithms can be configured to adjust the operation of a valve or an electroacoustic device or a speaker based on one or more pressure measurements obtained for a target air pressure volume.

[0085] While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It is understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention, and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

1. 1. A system for automated pneumatic otoscopy, the system comprising: a pressure source configured to provide a plurality of pressure profiles to a pneumatic volume comprising a target object or region; one or more sensors configured to detect or measure (i) the pressure within said pneumatic volume and / or (ii) the leak rate of said pneumatic volume; Control unit and Equipped with The system, wherein the control unit is configured to implement a closed-loop control scheme for regulating or modulating the operation, position, and / or movement of the pressure source based on one or more measurements obtained using the one or more sensors.

2. The system of claim 1 , further comprising a pneumatic valve configured to equalize or reset the pressure in the pneumatic volume.

3. The system of claim 2 , wherein the control unit is configured to adjust operation or movement of the pneumatic valve based on the one or more measurements obtained using the one or more sensors.

4. The system of claim 2 , wherein the control unit is configured to select or modify a pressure profile provided by the pressure source.

5. the control unit is configured to select or modify the pressure profile based on input provided by a user or operator; the input comprises a selection of one or more operating modes; the one or more operating modes comprising a pressure reconnaissance mode or a seal quality assessment mode; The system of claim 4 , wherein the one or more operational modes comprise a tympanic membrane loading mode or a tympanic membrane response measurement mode.

6. 2. The system of claim 1, wherein the plurality of pressure profiles comprises: (i) a first pressure profile for a pressure reconnaissance mode or a seal quality assessment mode; and (ii) a second pressure profile for a tympanic membrane load mode or a tympanic membrane response measurement mode.

7. The system of claim 6 , wherein the first pressure profile and the second pressure profile are different.

8. the control unit includes a pressure monitor configured to disable operation or movement of a relief valve for a pneumatic manifold in pneumatic communication with the pressure source based on the one or more measurements; The system of claim 1 , wherein the pressure monitor is configured to control or modulate operation or movement of the pressure source based on the one or more measurements.

9. 9. The system of claim 8, wherein the control unit and / or the pressure monitor are configured to determine a seal quality for the pneumatic volume based on (i) the one or more measurements or (ii) an amount of movement or displacement required for the pressure source to achieve or maintain a threshold pressure for the pneumatic volume.

10. The system of claim 9, further comprising an indicator for providing an indication of the seal quality to a user or operator.

11. The system of claim 10 , wherein the indication comprises an audio, visual, or tactile alert or feedback.

12. The system of claim 1 , wherein the pressure source comprises a speaker.

13. the pressure source comprises an air impulse generator or air pump configured to displace a volume of air within the pneumatic volume; The system of claim 1 , wherein the pneumatic volume comprises a sealed or partially sealed volume or region between the pressure source and the target object or region.

14. The system of claim 1 , wherein the air pressure volume extends from the pressure source to at least an ear canal of a patient or subject.

15. 2. The system of claim 1, further comprising one or more additional sensors configured to detect (i) one or more signals received, transmitted, or reflected from the target object or area, and / or (ii) behavior or movement of the target object or area in response to one or more of the plurality of pressure profiles.

16. 1. A method for automated pneumatic otoscopy, the method comprising: (a) providing a plurality of pressure profiles to a pneumatic volume comprising a target object or region using a pressure source; (b) using one or more sensors to detect or measure (i) the pressure within said pneumatic volume and / or (ii) the leak rate of said pneumatic volume; (c) using a control unit; Including, The method, wherein the control unit is configured to implement a closed-loop control scheme for regulating or modulating the operation, position, and / or movement of the pressure source based on one or more measurements obtained using the one or more sensors.

17. 17. The method of claim 16, further comprising, subsequent to (c), measuring a behavior or movement of the target object or region based at least in part on one or more signals received, transmitted, or reflected from the target object or region in response to one or more of the plurality of pressure profiles.

18. 17. The method of claim 16, wherein (c) further comprises equalizing or resetting the pressure in the pneumatic volume using a pneumatic valve.

19. The method of claim 16 , further comprising adjusting operation or movement of a pneumatic valve based on the one or more measurements obtained using the one or more sensors.

20. The method of claim 16 , further comprising, subsequent to (a), selecting or modifying a pressure profile to be provided by the pressure source.

21. the plurality of pressure profiles correspond to one or more operating modes; the one or more operating modes comprising a pressure reconnaissance mode or a seal quality assessment mode; the one or more operating modes include a tympanic membrane loading mode or a tympanic membrane response measurement mode; 17. The method of claim 16, wherein the plurality of pressure profiles comprises: (i) a first pressure profile for a pressure reconnaissance mode or a seal quality assessment mode; and (ii) a second pressure profile for a tympanic membrane load mode or a tympanic membrane response measurement mode.

22. The method of claim 16 , further comprising disabling operation or movement of a relief valve for a pneumatic manifold in pneumatic communication with the pressure source based on the one or more measurements.

23. 17. The method of claim 16, further comprising determining a seal quality for the pneumatic volume based on (i) the one or more measurements or (ii) an amount of movement or displacement required for the pressure source to achieve or maintain a threshold pressure for the pneumatic volume.

24. 24. The method of claim 23, further comprising providing an indication of the seal quality to a user or operator.

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