WO2020161712A1 - Méthode et dispositif de détection de contenu et/ou d'état d'oreille moyenne - Google Patents

Méthode et dispositif de détection de contenu et/ou d'état d'oreille moyenne Download PDF

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Publication number
WO2020161712A1
WO2020161712A1 PCT/IL2020/050140 IL2020050140W WO2020161712A1 WO 2020161712 A1 WO2020161712 A1 WO 2020161712A1 IL 2020050140 W IL2020050140 W IL 2020050140W WO 2020161712 A1 WO2020161712 A1 WO 2020161712A1
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WIPO (PCT)
Prior art keywords
tympanic membrane
light
imager
fluid
light sources
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PCT/IL2020/050140
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English (en)
Inventor
Rabei’ IBRAHIM
Nasrallah NAGIB
Zvi Friedman
Michael SHHADEH
Evgeny Belov
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Hrm Smart Technologies & Services Ltd.
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Application filed by Hrm Smart Technologies & Services Ltd. filed Critical Hrm Smart Technologies & Services Ltd.
Publication of WO2020161712A1 publication Critical patent/WO2020161712A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/12—Audiometering
    • A61B5/121—Audiometering evaluating hearing capacity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00002—Operational features of endoscopes
    • A61B1/00004—Operational features of endoscopes characterised by electronic signal processing
    • A61B1/00009—Operational features of endoscopes characterised by electronic signal processing of image signals during a use of endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00097—Sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00163—Optical arrangements
    • A61B1/00186—Optical arrangements with imaging filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00163—Optical arrangements
    • A61B1/00194—Optical arrangements adapted for three-dimensional imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/043—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances for fluorescence imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/227—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for ears, i.e. otoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0075—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6814—Head
    • A61B5/6815—Ear
    • A61B5/6817—Ear canal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 

Definitions

  • the present invention in some embodiments thereof, relates to ear examination and, more particularly, but not exclusively, to a device and method for detecting middle ear content and/or condition.
  • US Patent 8602971B2 to Farr discloses“Various embodiments for providing removable and pluggable opto-electronic modules for illumination and imaging for endoscopy or borescopy are provided.
  • various medical or industrial devices can include one or more solid state or other compact electro-optic illuminating elements located thereon.
  • opto electronic modules may include illuminating optics, imaging optics, image capture devices, and heat dissipation mechanisms.
  • the illumination elements may have different wavelengths and can be time synchronized with an image sensor to illuminate an object for imaging or detecting purpose or otherwise conditioning purpose.
  • the optoelectronic modules may include means for optical and/or wireless communication.
  • the removable opto-electronic modules may be plugged in on the exterior surface of a device, inside the device, deployably coupled to the distal end of the device, or otherwise disposed on the device” (Abstract).
  • a device for assessing middle ear content or condition comprising: a cone shaped body comprising a cylindrical extension at its tapered end, the cylindrical extension having a diameter small enough to be introduced into an external ear canal; a head configured at a wide end of the cone shaped body, the head comprising a plurality of light sources positioned to emit light towards the tympanic membrane when the cylindrical extension is positioned within the external ear canal; the plurality of light sources arranged peripherally around the wide end of the cone shaped body and directed such that the emitted light is transmitted through a solid portion of the cone shaped body; the plurality of light sources configured to emit light independently and sequentially; each of the light sources emitting light at a single wavelength; the cylindrical extension comprising a distally facing imager, the imager equipped with per pixel wide bandpass filters; the device being in communication with circuitry configured to analyze spectral images obtained by the imager to assess middle ear content or condition.
  • the imager occupies a volume within the cylindrical extension such that light emitted by the plurality of light sources travels around the imager in a ring shaped pattern.
  • the circuitry is configured to generate a 2D image of the tympanic membrane using the spectral images.
  • the circuitry is programmed to detect fluoroscopic fingerprints of pathogens in the 2D image.
  • the imager comprises a CMOS sensor matrix.
  • the plurality of light sources comprise between 4-16 LEDs peripherally arranged around the wide end of the cone shaped body.
  • each LED emits light at a single wavelength selected from the range of 200-1000 nm, and wherein different LEDs emit light at different wavelengths.
  • the circuitry comprises a processor programmed to analyze the spectral images using machine learning techniques.
  • the processor is pre-programmed with at least one known fluorescence fingerprint of a pathogen and is configured to compare the spectral image acquired by the imager to the known fluorescence fingerprint.
  • the wide bandpass filters are RGB filters and wherein the fluorescence fingerprint is defined by a set of wavelengths that are within wavelength ranges detectable by the RGB filters.
  • the device comprises 4 light sources, each positioned to illuminate a quadrant area of the tympanic membrane.
  • simultaneous activation of all 4 light sources produces a uniform illumination of the tympanic membrane.
  • the solid portion of the cone shaped body is formed of a transparent material.
  • the circuitry is configured for transferring data to one or more of: a clinician, a database, cloud storage, external memory, a remote server.
  • the device comprises a handle extending proximally from the wide end of the cone shaped body.
  • the circuitry is in communication with a screen display.
  • the cylindrical extension further comprises a set of radio frequency coils and circuity configured for measuring a magnetic field detected in response to passing of electrical current through the coils, the magnetic field indicative of presence of fluid behind the tympanic membrane.
  • a method for assessing middle ear content or condition comprising: emitting light from a plurality of light sources sequentially towards the tympanic membrane; detecting the light returning from the tympanic membrane via an imager equipped with per pixel wide bandpass filters; and processing spectral images acquired by the imager to assess middle ear content or condition.
  • the filters comprise RGB filters.
  • processing comprises comparing wavelengths of the light returning from the tympanic membrane to expected wavelength ranges.
  • comparing comprises comparing to a known set of wavelength values which define a pathogen fingerprint.
  • processing comprises generating 2D images of the tympanic membrane from the spectral images.
  • each pixel of the 2D image is generated as a combination of K*N spectral images, N being the number of independent light sources from which the light is emitted and K being the number of different wide bandpass filters used.
  • processing comprises determining one or more of: a transparency level of the tympanic membrane, a color of the tympanic membrane.
  • processing comprises detecting one or both of a fluid level and a viscosity of the fluid behind the tympanic membrane.
  • the method comprises diagnosing at least one of: acute otitis media (AOM) and otitis media with effusion (OME) according to the pathogen fingerprint.
  • AOM acute otitis media
  • OME otitis media with effusion
  • the method comprises dividing the tympanic membrane into separately illuminated segments and using a corresponding number of light sources to illuminate the segments.
  • a method for identifying pathogens in the middle ear in real time comprising: illuminating the tympanic membrane using multiple single wavelength light sources; capturing light returning from the tympanic membrane using an imager comprising per-pixel RGB filters; determining presence of one or more pathogens in at least one of middle ear fluid behind the tympanic membrane and the tympanic membrane itself as a function of the light detected by the RGB filters.
  • illuminating comprises illuminating at wavelengths which are not detectable by the filters.
  • determining comprises comparing a set of wavelengths detected by the filters to a known set of wavelengths that characterizes a pathogen.
  • determining comprises comparing to a known fluorescence spectra of enzymes and/or coenzymes and/or amino acids of one or more of: H Influenza, M Cataralis, S Pneumoniae, S. Aureas.
  • the method further comprises indicating if a tympanic membrane condition was caused or effected by bacterial growth.
  • the method further comprising displaying an image of the tympanic membrane captured by the imager and marking a pathogen distribution on the image.
  • the pathogen distribution includes a location of one or more pathogen colonies.
  • only light characterized by wavelengths which are detectable by at least one of the RGB filters are characterized by wavelengths which are detectable by at least one of the RGB filters.
  • a method for identifying pathogens in the middle ear in real time comprising: illuminating the tympanic membrane using multiple single wavelength light sources; capturing light returning from the tympanic membrane using an imager comprising per-pixel RGB filters; wherein if light returning from the tympanic membrane is detected by at least one of the RGB filters, pathogen presence is indicated.
  • light returning from the tympanic membrane is detected due to presence of one or more of the following amino acids: Tryptophan, Tyrosine and Phenyloalanine which are characterized by emittance at wavelengths within wavelength ranges detectable by at least one of the RGB filters.
  • presence of Tryptophan alone is detected and is indicative of pathogen presence.
  • a device for assessing middle ear effusion comprising: a cone shaped body comprising a cylindrical extension at its tapered end, the cylindrical extension having a diameter small enough to be introduced into an external ear canal; the cylindrical extension comprising co-axial RF coils separated by a diamagnetic insert; and circuitry configured to pass an electrical current through the RF coils and measure a resulting magnetic field; the magnetic field indicative of presence of middle ear fluid.
  • a device for assessing middle ear content or condition comprising: a body which tapers towards a narrow end having a diameter small enough to be introduced into an external ear canal; a plurality of light sources arranged peripherally around the wide end of the body and directed such that the emitted light is transmitted through a solid portion of the body; a distally facing imager for obtaining images of the tympanic membrane; the device being in communication with circuitry configured to analyze spectral images obtained by the imager to assess middle ear content or condition.
  • the plurality of light sources are configured to emit light independently and sequentially; each of the light sources emitting light at a single wavelength.
  • the imager is equipped with per pixel wide bandpass filters.
  • the imager occupies a volume within the cylindrical extension such that light emitted by the plurality of light sources travels around the imager in a ring shaped pattern.
  • the circuitry is configured to generate a 2D image of the tympanic membrane using the spectral images.
  • the circuitry is programmed to detect fluoroscopic fingerprints of pathogens in the 2D image.
  • the imager comprises a CMOS sensor matrix.
  • the plurality of light sources comprise between 4-16 LEDs peripherally arranged around the wide end of the cone shaped body, each LED emitting light at a single wavelength selected from the range of 200-1000 nm.
  • the circuitry comprises a processor which is pre-programmed with at least one known fluorescence fingerprint of a pathogen and is configured to compare the spectral image acquired by the imager to the known fluorescence fingerprint.
  • the wide bandpass filters are RGB filters and wherein the fluorescence fingerprint is defined by a set of wavelengths that are within wavelength ranges detectable by the RGB filters.
  • the device comprises 4 light sources, each positioned to illuminate a quadrant area of the tympanic membrane.
  • simultaneous activation of all 4 light sources produces a uniform illumination of the tympanic membrane.
  • the solid portion of the cone shaped body is formed of a transparent material.
  • the circuitry is configured for transferring data to one or more of: a clinician, a database, cloud storage, external memory, a remote server.
  • the device comprises a handle extending proximally from the wide end of the cone shaped body.
  • the circuitry is in communication with a screen display.
  • the cylindrical extension further comprises a set of radio frequency coils and circuity configured for measuring a magnetic field detected in response to passing of electrical current through the coils, the magnetic field indicative of presence of fluid behind the tympanic membrane.
  • a method for assessing middle ear content or condition comprising: emitting light from a plurality of light sources sequentially towards the tympanic membrane; detecting the light arriving from the tympanic membrane via an imager equipped with per pixel wide bandpass filters; and processing spectral images acquired by the imager to assess middle ear content or condition.
  • the filters comprise RGB filters.
  • processing comprises comparing wavelengths of the light arriving from the tympanic membrane to expected wavelength ranges.
  • comparing comprises comparing to a known set of wavelength values which define a pathogen fingerprint.
  • processing comprises generating 2D images of the tympanic membrane from the spectral images.
  • each pixel of the 2D image is generated as a combination of K*N spectral images, N being the number of independent light sources from which the light is emitted and K being the number of different wide bandpass filters used.
  • processing comprises determining one or more of: a transparency level of the tympanic membrane, a color of the tympanic membrane.
  • processing comprises detecting one or both of a fluid level and a viscosity of the fluid behind the tympanic membrane.
  • the method comprises diagnosing at least one of: acute otitis media (AOM) and otitis media with effusion (OME) according to the pathogen fingerprint.
  • AOM acute otitis media
  • OME otitis media with effusion
  • the method comprises dividing the tympanic membrane into separately illuminated segments and using a corresponding number of light sources to illuminate the segments.
  • a method for identifying pathogens in the middle ear in real time comprising: illuminating the tympanic membrane using multiple single wavelength light sources; capturing light arriving from the tympanic membrane using an imager comprising per-pixel RGB filters; determining presence of one or more pathogens in at least one of middle ear fluid behind the tympanic membrane and the tympanic membrane itself as a function of the light detected by the RGB filters.
  • illuminating comprises illuminating at wavelengths which are not detectable by the filters.
  • determining comprises comparing a set of wavelengths detected by the filters to a known set of wavelengths that characterizes a pathogen.
  • determining comprises comparing to a known fluorescence spectra of enzymes and/or coenzymes and/or amino acids of one or more of: H Influenza, M Cataralis, S Pneumoniae, S Aureas.
  • the method comprises indicating if a tympanic membrane condition was caused or effected by bacterial growth.
  • the method comprises displaying an image of the tympanic membrane captured by the imager and marking a pathogen distribution on the image.
  • the pathogen distribution includes a location of one or more pathogen colonies.
  • only light characterized by wavelengths which are detectable by at least one of the RGB filters are characterized by wavelengths which are detectable by at least one of the RGB filters.
  • a method for identifying pathogens in the middle ear in real time comprising: illuminating the tympanic membrane using multiple single wavelength light sources; capturing light arriving from the tympanic membrane using an imager comprising per-pixel RGB filters; wherein if light arriving from the tympanic membrane is detected by at least one of the RGB filters, pathogen presence is indicated.
  • light arriving from the tympanic membrane is detected due to presence of one or more of the following amino acids: Tryptophan, Tyrosine and Phenyloalanine which are characterized by emittance at wavelengths within wavelength ranges detectable by at least one of the RGB filters.
  • presence of Tryptophan alone is detected and is indicative of pathogen presence.
  • a device for assessing middle ear effusion comprising: a body tapering towards a narrow end having a diameter small enough to be introduced into an external ear canal; at least two RF coils spaced apart from each other; and circuitry configured to pass an electrical current through the RF coils, measure at least one property of each of the coils, and generate an output based on a difference in the measured property between the two coils.
  • the at least one property includes: a voltage that develops across the coil, an electromagnetic field generated by the coil, an impedance of the coil.
  • the output comprises indicating presence of middle ear fluid based on the difference in the measured at least one property.
  • a diamagnetic insert is positioned in between the at least two RF coils along a similar long axis.
  • a method for assessing presence of middle ear fluid comprising: introducing a probe comprising at least two electrically conductive elements into the external ear canal; conducting current through the elements; measuring one or more properties selected from: voltage across each of the elements, an electromagnetic field produced by each of the elements ; and determining a difference in the one or more properties as measured for each of the elements to determine presence of middle ear fluid.
  • the method comprises, prior to the introducing, conducting a calibration measurement in which the probe is not in proximity to fluid, and then comparing an electromagnetic field measured inside the external ear canal to the electromagnetic field measured during the calibration measurement.
  • the electrically conductive elements comprise coils and wherein the introducing comprises positioning the coils such that one is axially closer to the tympanic membrane than the other.
  • a method for assessing presence of middle ear fluid comprising: introducing a probe comprising a ultrasound transducer into the external ear canal; excitating the ultrasound transducer to emit ultrasound signals; receiving echoes of the ultrasound signals; and analyzing the echoes to determine a change in echo signal which is indicative of presence of fluid.
  • the ultrasound transducer comprises a piezoelectric transducer, the emitting and the receiving are performed using the same piezoelectric transducer.
  • introducing comprises positioning the probe such that the ultrasound transducer is in contact with the tympanic membrane or in contact with a liquid or gel medium contacting the tympanic membrane.
  • a device for assessing middle ear content or condition comprising: a body extending between proximal and distal ends, the body sized for insertion, at least in part, into an external ear canal; a plurality of light sources configured at the proximal end of the body, the plurality of light sources facing distally to emit light towards the tympanic membrane when the device is inserted into the external ear canal; a distally facing imager equipped with one or more light filters; and a radio-frequency assembly incorporated within the body and including at least two electrically conductive elements spaced apart from each other.
  • Implementation of the method and/or system of embodiments of the invention can involve performing or completing selected tasks manually, automatically, or a combination thereof.
  • several selected tasks could be implemented by hardware, by software or by firmware or by a combination thereof using an operating system.
  • hardware for performing selected tasks according to embodiments of the invention could be implemented as a chip or a circuit.
  • selected tasks according to embodiments of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system.
  • one or more tasks according to exemplary embodiments of method and/or system as described herein are performed by a data processor, such as a computing platform for executing a plurality of instructions.
  • the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage, for example, a magnetic hard-disk and/or removable media, for storing instructions and/or data.
  • a network connection is provided as well.
  • a display and/or a user input device such as a keyboard or mouse are optionally provided as well.
  • FIG. 1 is a flowchart of a general method for diagnosing a middle ear content and/or condition, according to some embodiments
  • FIG. 2 is a flowchart of a method for diagnosing a middle ear content and/or condition based on spectral images of the tympanic membrane and/or of middle ear fluid behind the tympanic membrane, according to some embodiments;
  • FIGs. 3A-B are a schematic drawing of a system for diagnosing a middle ear content and/or condition (3A), and a schematic drawing of the path of light through the system (3B), according to some embodiments.
  • FIG. 4 is a schematic diagram of the process of acquiring and analyzing images of the tympanic membrane, according to some embodiments.
  • FIG. 5 is a schematic drawing of the human ear
  • FIGs. 6A-B are a flowchart of a method for indicating existence of pathogens in the ear using RGB based detection (figure 6A) and a schematic graphic representation of RGB wavelength sensitivity (figure 6B), according to some embodiments;
  • FIGs. 7A-B are examples of images displayed to a user, separately or in combination, according to some embodiments;
  • FIGs. 8A-F are schematic representations of a device comprising RF coils for diagnosing middle ear effusion, according to some embodiments.
  • FIG.8G is a flowchart of a method for detecting presence of fluid behind the tympanic membrane using a radio-frequency mechanism, according to some embodiments.
  • FIGs. 9A-C are images of different views of a 3D-printed model of a human ear used in an experiment performed in accordance with some embodiments.
  • FIGs. 10A-C are images of the three device probes being tested, arranged on a platform constructed for an experiment performed in accordance with some embodiments;
  • FIGs. 11A-B show an example of circuitry connecting between the RF and ultrasound modules (11A) and an example of a digital acquisition assembly (11B) for transferring and/or processing of data obtained by the device probe, in accordance with some embodiments;
  • FIGs. 12A-D show structural and functional details of an ultrasound device probe, according to some embodiments.
  • FIGs. 13A-B show examples of echo signals recorded by a digital scope when no fluid was injected in the model (FIG. 13A) and when fluid was present (FIG. 13B), in the experiment performed according to some embodiments;
  • FIG. 13C shows an exemplary screen of a user interface, showing the recorded echo signal and a Fourier transformation of the signal performed in accordance with some embodiments
  • FIGs. 14A-E show structural and functional details of a light based device probe, according to some embodiments.
  • FIGs. 15A is an image of the device and the user interface screen as used in the experiment performed in accordance with some embodiments.
  • FIGs. 15B-C show examples of the images captured by the light based probe, where in FIG. 15A there was no fluid in the model, and in FIG. 15B fluid was injected in the model;
  • FIGs. 16A-D show structural and functional details of a radio-frequency based device probe, according to some embodiments.
  • FIGs. 17A-D show an exemplary experimental setup and results in which an RF probe was tested in accordance with some embodiments
  • FIG. 18 is a block diagram of an integrated device, according to some embodiments.
  • FIG. 19 shows an exemplary light based probe structure, according to some embodiments
  • FIG. 20 shows an exemplary ultrasound probe structure, according to some embodiments.
  • FIG. 21 shows an exemplary RF probe structure, according to some embodiments.
  • the present invention in some embodiments thereof, relates to ear examination and, more particularly, but not exclusively, to a device and method for detecting middle ear content and/or condition.
  • a broad aspect of some embodiments relates to detection of middle ear content, for example assessment of the presence of middle ear fluid, by measurements obtained from the tympanic membrane.
  • An aspect of some embodiments relates to detecting middle ear content and/or condition by illuminating the tympanic membrane and detecting the light returning from the tympanic membrane using wide bandpass filters.
  • the tympanic membrane is illuminated by a plurality of independent light sources.
  • each light source is operated to emit light at a distinct wavelength, selected for example from the range of 200-1000 nm.
  • light returning from the tympanic membrane in response to the illumination is captured.
  • light is captured by an imager comprising a sensor matrix, for example a CMOS sensor matrix, in which each pixel-sensor is equipped with wide bandpass filters.
  • each sensor is equipped with RGB filters.
  • an image of the tympanic membrane is generated and further processed for determining, for example, characteristics of the tympanic membrane (color, structure (e.g. bulging), transparency level, rupturing, and/or others); middle ear fluid (e.g. fluid level and/or fluid viscosity); and/or other middle ear conditions.
  • processing involves comparing wavelengths of the light returning from the tympanic membrane to expected wavelength ranges.
  • non-matching wavelengths are filtered, potentially improving a sensitivity of detection.
  • the imager properties are suitable for capturing of images of the tympanic membrane, optionally from within the ear canal.
  • properties such as a focal length of the imager, a depth of field of the imager and/or other are selected according to an expected distance range between the imager, when positioned in the ear canal, and the tympanic membrane and/or its surroundings (such as a distance from middle ear fluid, if present).
  • a depth of field of the imager is between 0.1-4 mm, 0.05- 2 mm, 0.5mm-9 mm, or intermediate, longer or shorter distance.
  • the generated image of the tympanic membrane is displayed to a user (e.g. a physician).
  • the displayed image includes markings for the findings that were automatically identified during processing.
  • markings that can be laid out onto the image of the tympanic membrane may include: bacterial growth and/or distribution; an indication of rupturing of the membrane; an indication of discoloring of the membrane.
  • An aspect of some embodiments relates to detecting existence of pathogens in the middle ear as a function of light arriving from the tympanic membrane in response to illumination.
  • the arriving light is detected by an imager comprising per-pixel wide bandpass filters, such as RGB filters.
  • the light arriving from the tympanic membrane may be characterized by a set of wavelengths that fall within wavelength ranges that are detectable by the filters, so that detection itself may provide an indication for pathogen presence.
  • pathogen presence is indicated if light of specific characteristics arrived from the tympanic membrane and detected by the imager with the per-pixel wide band pass filters, such as RGB filters. In the example of RGB filters, detection of light arriving from the tympanic membrane by one, two or all three filters may itself provide a sufficient indication for existence of pathogens.
  • the spectra is compared to one or more known sets of wavelengths which are associated with respective one or more pathogens.
  • pathogens such as H. Influenzae, S. pneumoniae, S. aureus, M. catarrhalls are detected and optionally differentiated according to their known spectra.
  • the spectra is of one or more amino acids which are present in bacteria, such as Tryptophan, Tyrosine and/or Phenyloalanine.
  • the same amino acid found in different pathogen types may be characterized not by a specific wavelength but rather by a wavelength range; optionally, when at least a portion of that wavelength range is detected after the light had passed through the one or more filters, an indication of pathogen existence is provided. In some embodiments, if the spectra is characterized by wavelengths that are above a minimal threshold and below a maximal threshold - detection itself may be indicative of pathogen presence.
  • wavelengths of the illumination light are selected from within ranges that are not detectable by the filters, so that the filters are“blind” to the illumination wavelengths. Additionally or alternatively, one or more filters are applied to the light sources (such as on the light source end and not on the imager).
  • pathogen detection and optionally identification is carried out by comparing a spectral image obtained by the filter-equipped imager to a database or library of known spectral images associated with specific pathogens.
  • An aspect of some embodiments relates to a device for examining the middle ear, the device comprising a cone shaped body through which light travels distally to illuminate the tympanic membrane, when the device is introduced into the external ear canal.
  • a plurality of independent light sources e.g. LEDs
  • monochromatic are positioned at or proximally to a proximal wide end of the cone shaped body.
  • an extension shaped and/or sized to be introduced into the ear canal extends distally from the distal (tapered) end of the cone shaped body.
  • an imager is positioned within the extension at a location suitable to capture the light arriving from the direction of the tympanic membrane.
  • the imager occupies a certain volume of the extension such that the transmitted light bypasses the imager, for example travelling around the imager in a ring shaped pattern.
  • light emitted sequentially by the plurality of light sources is transmitted directly through the solid material from which the peripheral walls of the cone body are formed of.
  • the material is transparent.
  • light is transmitted through the solid material such that less than 10%, less than 5%, less than 2% of the emitted light is scattered or reflected.
  • a device extension (also referred to as probe) is tapering, for example, being shaped as a hollow cone.
  • the device extension includes a light conducting channel extending along the length of the cone, optionally along a central axis of the cone.
  • the cone is shaped and configured to prevent light emitted by the plurality of light sources from exiting the side walls of the cone, for example, the cone is coated by a black light-blocking layer on its inner walls.
  • the light conducting channel is semitransparent.
  • a light conducting channel is not used, and light is transferred through the cone itself (for example, through a center of the cone and/or through walls of a transparent or semi-transparent cone).
  • the cone is not coated by an inner light-blocking layer.
  • An aspect of some embodiments relates to identifying pathogens in the middle ear in real time.
  • an image of the tympanic membrane is generated (for example using devices as described herein) and analyzed for existence of fluoroscopic fingerprints of pathogens, for example of pathogens that exist in the middle ear fluid behind the tympanic membrane and/or on the tympanic membrane. Parameters such as pathogen type, concentration, location, may be assessed.
  • inflammation of the middle ear is determined.
  • generation of an image and analysis of the image are performed in real time, so that during examination of the ear, a user (e.g.
  • a potential advantage of immediate identification of pathogens in the ear may include assisting the physician in deciding on suitable treatment. For example, prescribe antibiotics according to type of bacteria found, avoid prescribing unneeded medication (for example if no pathogens are found), and decide on quantities and/or duration of medication needed as a function of the amount of bacterial growth.
  • An aspect of some embodiments relates to a device and/or method for detection of middle ear effusion using radio-frequency.
  • current is conducted through electrically conductive elements, such as coils, and one or more parameters are assessed for determining or estimating presence of fluid behind the tympanic membrane.
  • electrically conductive elements such as coils
  • parameters may include, for example, an electromagnetic field generated by the coil(s) and/or voltage across each of the coils and/or a voltage difference between the coils.
  • detection of middle ear effusion using RF comprises positioning spaced apart conductive elements such that a first conductive element is positioned at distance from the tympanic membrane which is shorter than a distance between the second conductive element and the tympanic membrane.
  • parameters of the electric field produced by each of the elements are affected by the distance from the tympanic membrane, and/or affected by the presence of fluid behind the tympanic membrane.
  • a capacitive coupling between the conductive elements is measurable.
  • a permittivity and/or permeability of electromagnetic field(s) produced by the conductive element(s) are assessed.
  • a cylindrical extension of a device comprises a set of RF coils separated apart from each other, optionally by a diamagnetic insert.
  • the cylindrical extension is positioned adjacent the tympanic membrane, and electrical current is passed through the coils.
  • an indication of existence of middle ear fluid can be provided.
  • one or more calibration measurements are performed when the device extension (also referred to as“probe”) is positioned at a location in which no fluid is present, for example outside of the ear or at only entry to the external ear canal. Then, in some embodiments, a measurement obtained from adjacent the tympanic membrane is compared to the calibration measurement, and differences in the measured electromagnetic fields may be indicative of presence of fluid.
  • the two coils along a similar long axis, optionally being a long axis of the probe inserted into the ear.
  • current is conducted through each of the coils.
  • a voltage difference develops along each of the coils (between a first end of the coil and the second opposite end of the coil), and that voltage is measured.
  • presence of fluid in proximity of the coil affects the voltage, so that upon measuring, a voltage measured for the coil which is at a more distal position and closer to the tympanic membrane would be different from the voltage measured for the more proximal coil, which is positioned further away from the tympanic membrane.
  • the proximal coil is used as a reference for defining a baseline electromagnetic field measured in a surrounding in which no fluid exists.
  • a diamagnetic insert configured in between the two coils is suitable for electrically isolating the coils and/or for reducing or preventing an effect of ear fluid, if present, on the more proximal (reference) coil.
  • an RF probe may be moved axially within the external ear canal (e.g. back and forth) to adjust a distance of the coils from the tympanic membrane.
  • an RF probe may be moved laterally along the tympanic membrane external surface.
  • lateral movement may provide for mapping a plurality of electric fields to potentially assess an amount of fluid (e.g. a fluid level) behind the membrane.
  • an antenna of a size small enough to be inserted into the external ear canal is provided.
  • the antenna is configured to transmit and receive radio waves to and from the tympanic membrane, when inserted into the ear.
  • An aspect of some embodiments relates to a device and/or method for detection of middle ear effusion using ultrasound.
  • ultrasound signals are emitted towards the tympanic membrane, for example by an ultrasound emitter such as a piezoelectric transducer.
  • the piezoelectric transducer is configured within a device extension insertable into the external ear canal, allowing for positioning the transducer in contact with the tympanic membrane.
  • excitation of the transducer causes ultrasound signals to be emitted towards the membrane.
  • the returning echo signals are received and analyzed for detecting the presence of fluid, amount of fluid, and/or a viscosity of the fluid.
  • a time delay in the returning echo is correlated with an amount of fluid: optionally, a longer delay is indicative of a larger amount of fluid. In some embodiments, a higher signal attenuation coefficient of the fluid is indicative of a higher viscosity of the fluid.
  • a single transducer is used for both emitting the ultrasound signals and for receiving the returning echoes. Alternatively, multiple transducers are used, optionally at least one transducer for emitting signals and at least one transducer for receiving returning echoes.
  • the emitted signals are returned only by the tympanic membrane. If fluid is present, the emitted signals travel through the fluid medium and are optionally reflected back by the one or more bones behind the tympanic membrane (the malleus, incus and stapes).
  • the attenuation of the signals by the fluid medium may be indicative of the presence of fluid, type of fluid, amount of fluid and/or viscosity of the fluid.
  • the ultrasound signals are emitted in pulses.
  • a pulse is as short as possible yet sufficient for reaching beyond the tympanic membrane.
  • the reflected signals (echoes) are characterized by different pattern: in a first pattern, only a single reflection is returned by the tympanic membrane, potentially indicating that no fluid exists behind the membrane.
  • two reflections occur, optionally with a time delay between them: a first reflection from the tympanic membrane, and a second reflection from one or more structures beyond the tympanic membrane, such as bones.
  • the second reflection is obtained only if a fluid medium is present intermediate the tympanic membrane and the bones.
  • fluid e.g. gel
  • the probe itself comprises fluid or gel at its distal tip for providing a fluid medium coupling between the ultrasound element and the tympanic membrane.
  • an aspect of some embodiments relates to an integrated device for detection of middle ear content and/or condition.
  • the integrated device incorporates an RF module and a fluorescence module.
  • the RF module is used for preliminary detection of presence of fluid behind the tympanic membrane. Then, in some embodiments, lighting is applied (e.g. by one or more light sources) towards the tympanic membrane. Images of the tympanic membrane are then acquired by an imager, and a fluorescence spectra is optionally analyzed for detection of pathogens.
  • a potential advantage of an integrated device may include performing initial screening using the RF module; then, only if fluid is present, the fluorescence spectra is collected. The described operation scheme may simplify usage, reduce the time required for diagnosing and optionally improve sensitivity.
  • data collected and/or analyzed by the integrated device is presented to a user, for example on a display.
  • data includes an indication from the RF module as to whether or not fluid is present within the ear.
  • data includes an image of the tympanic membrane, optionally a colored image, obtained by the imager.
  • data includes a processed image of the tympanic membrane, for example having applied image processing algorithms, for example for facilitating detection of fluid, pathogens in the fluid, and/or other phenomena, such as bulging of the tympanic membrane.
  • data includes an estimation (for example, a probability) of existence of pathogens, and optionally classification of the types of pathogens.
  • data is presented using visual representations or models, such as graphs, tables, etc.
  • a“device extension”,’’probe”, or“head” may refer to a distal portion of the device (such as a distal portion of an otoscope device) shaped and sized for insertion, at least in part, into an external ear canal.
  • the distal portion is tapering, for example, conical.
  • the distal portion is tubular.
  • light arriving from the tympanic membrane may include light reflected, returned, and/or emitted by the tympanic membrane and/or its surroundings.
  • FIG. 1 is a flowchart of a general method for diagnosing a middle ear content and/or condition, according to some embodiments.
  • examination of the ear is performed for patients suffering from ear-related symptoms and/or as a regular check-up examination.
  • a physician or other suitable health care provider screens the ear to search for illness, for example inflammation.
  • a non-invasive examination is performed, in which the internal ear canal and/or the tympanic membrane are viewed.
  • middle ear conditions are diagnosed based on characteristics of the tympanic membrane, for example as further discussed hereinbelow.
  • a device configured for examination of the ear such as an otoscope, is provided.
  • at least a portion of the device, for example a distal extension of the device is inserted at least in part into the external ear canal (101).
  • the tympanic membrane is illuminated, while a plurality of spectral images are acquired (103).
  • the tympanic membrane is illuminated via a plurality of light sources, for example LEDs, directed towards the tympanic membrane.
  • different light sources are configured to emit light at different wavelengths.
  • different light sources are positioned to emit light at different directions or angles.
  • different light sources are operable independently. In an example, light is emitted from the different light sources sequentially, in a serial manner.
  • a plurality of spectral images are acquired (103), for example using an imager of the device.
  • the imager comprises per pixel wide band pass filters.
  • the imager comprises a TV-camera.
  • the imager comprises a matrix of CMOS sensors, each equipped with wide band pass filters, for example, RGB filters.
  • processing comprises obtaining a multi spectral image of the tympanic membrane. In some embodiments, processing comprises detecting wavelengths of the light emitted by (returning from) the tympanic membrane.
  • a middle ear diagnosis is provided (107).
  • diagnosis is provided based on one or more 2D images of the tympanic membrane.
  • a 3D representation of the tympanic membrane is constructed and analyzed.
  • the 3D representation is constructed by lighting the tympanic membrane from multiple directions, for example from at least 4 directions, and observing for shadowed and/or lighted areas in the obtained images.
  • characteristics of the tympanic membrane such as color, translucency level, bulging of the membrane and/or other shape deformations are searched for.
  • a level of middle ear fluid and optionally its viscosity are searched for.
  • visibility of the malleus bone is searched for.
  • a presence and optionally amount of cerumen (ear wax) is searched for.
  • findings are associated with a specific condition.
  • Various conditions that may be determined by analyzing the acquired images may include: inflammation (acute otitis media (AOM) and/or otitis media with effusion (OME), cholesteatoma, perforation or rupture of the tympanic membrane, and/or other conditions (see also FIG. 5).
  • AOM acute otitis media
  • OME otitis media with effusion
  • cholesteatoma cholesteatoma
  • perforation or rupture of the tympanic membrane and/or other conditions (see also FIG. 5).
  • examination of the ear for example from initial positioning of the device in the ear canal to obtaining at least one image of the tympanic membrane and optionally indicating significant findings within the image is performed within a time period of less than 10 minutes, less than 5 minutes, less than 2 minutes, less than 30 seconds or intermediate, longer or shorter time periods.
  • diagnosis is provided immediately following examination.
  • examination is carried out in a similar manner to standard ear examination using an otoscope.
  • FIG. 2 is a flowchart of a method for diagnosing a middle ear content and/or condition based on spectral images of the tympanic membrane and/or of middle ear fluid behind the tympanic membrane, according to some embodiments.
  • fluorescence spectra arriving from the tympanic membrane is measured.
  • light is emitted towards the tympanic membrane from a plurality of light sources (201).
  • light is emitted sequentially, such that each of the light sources is activated independently in a serial manner.
  • light is emitted simultaneously from two or more of the light sources.
  • the plurality of light sources are activated such that each light source emits light at a different wavelength.
  • the excitation (illumination) wavelength is selected from between 200 nm-1000 nm.
  • the light sources are activated sequentially.
  • the first light source e.g. a LED
  • the second light source emits at 405-450 nm, and so forth.
  • near- infrared and/or infrared ranges may be used, including wavelengths of between 780 nm to 2500 nm, 700 nm- 1000 nm, or intermediate, higher or lower ranges.
  • near infra-red or infra-red wavelengths are emitted in combination with visible light spectra, for example: NIR(810nm 750-950 nm), IR(940nm 750-1000nm), Red(660nm 620-750nm), white(390-700 nm).
  • wavelengths at emission are selected according to expected emission spectra of certain pathogens.
  • the illumination wavelengths can be selected to increase a likelihood of detecting the pathogen fingerprints, in cases in which pathogens, such as bacteria, are present.
  • spectrographs are generated for various pathogens.
  • illumination wavelengths that best distinguish between different bacteria are identified.
  • the device is pre-programmed with different illumination wavelength sets that can be implemented for detecting specific pathogens.
  • a fluorescence spectra of the tympanic membrane is detected, optionally via an imager equipped with per pixel wide bandpass filters (203).
  • the filters comprise RGB color filters.
  • a color filter array in the form of a Bayer filter mosaic is used.
  • RGB-IR (infrared) filtering may be applied at image detection.
  • the process of illuminating the tympanic membrane and capturing light arriving from the tympanic membrane in response to the illumination is repeated (205).
  • the process is repeated until a sufficient number of spectral images are acquired for generating a 2D image of the tympanic membrane (207).
  • the 2D image is analyzed for detection of one or more of: pathologies of the middle ear, a specific anatomy of the middle ear, general content of the middle ear (including, for example, tympanic membrane characteristics such as color, translucency level, rupturing if exists, existence of visible patterns or shapes, and/or other characteristics.
  • the 2D image is analyzed for detection of fluoroscopic fingerprints of pathogens (209). Based on in-vitro evidence (see for example Spector, Brian C., Lou Reinisch, Dana Smith, and Jay A. Werkhaven. "Noninvasive fluorescent identification of bacteria causing acute otitis media in a chinchilla model.” The Laryngoscope 110, no.
  • pathogen existence is indicative of inflammation (acute otitis media (AOM) and/or otitis media with effusion (OME).
  • AOM acute otitis media
  • OME otitis media with effusion
  • a 3D model of the tympanic membrane is constructed (211).
  • a plurality of 2D images are analyzed for generating a 3D model from which a topography of the tympanic membrane can be assessed.
  • one or more bulges and/or depressions of the tympanic membrane are detected from the 3D model (213). Such bulging may be indicative, for example, of acute otitis media.
  • FIGs. 3A-B are a schematic drawing of a system for diagnosing a middle ear content and/or condition (3A), and a schematic drawing of the path of light through the system (3B), according to some embodiments.
  • a device 301 for ear examination comprises a conical body 303.
  • body 303 is comprised of a solid material, such as clear medical grade plastic, for example polycarbonate.
  • the solid material forming the cone allows for light to pass through without causing scattering of the light.
  • the solid material transmits the emitted light such that less than 10%, less than 5%, less than 2% or intermediate, higher or smaller percentage of the emitted light is scattered, reflected and/or absorbed by the solid material of the cone.
  • the solid material is transparent.
  • device 301 comprises a plurality of light sources 305, such as 2, 4, 6, 8, 10, 12, 16 light sources or an intermediate, larger or smaller number of light sources.
  • light sources 305 are mounted at a proximal head portion 307 at the wide end of the cone body 303.
  • the light sources are peripherally arranged around the circular head.
  • the light sources are distributed such that a central angle a of between 20-60 degrees, such as 30 degrees, 45 degrees, 55 degrees or intermediate, larger or smaller angle separates between adjacent light sources.
  • separation angle a is selected according to the number of light sources being used.
  • each of the light sources is activated to emit light at a distinct wavelength.
  • the number of light sources and/or a spatial arrangement of the light sources are selected so that all portions of the tympanic membrane (schematically illustrated at 331) will be illuminated, optionally uniformly.
  • the tympanic membrane is divided into 4 quadrants, and 4 LEDs are used for illuminating the 4 quadrants.
  • the tympanic membrane is lighted substantially uniformly.
  • the tympanic membrane may be divided into a different number of segments, and a corresponding amount of LEDs used for lighting it. For example, 3 segments illuminated by 3 LEDs, 5 segments illuminated by 5 LEDs, etc).
  • a number and/or arrangement of light sources is selected to be sufficient to illuminate the tympanic membrane from a plurality of directions.
  • a potential advantage of illuminating the membrane from multiple directions is producing lit areas as well shaded areas.
  • light/shade differences may be used as basis for determining a shape and/or structural characteristics of the tympanic membrane, such as bulging of the membrane.
  • light sources may be used, for example: lasers, intense pulsed light (IPL), flashlamps, and discharge lamps.
  • IPL intense pulsed light
  • flashlamps flashlamps
  • discharge lamps discharge lamps
  • an axial lumen 311 extends throughout the cone body 303, from the proximal end to the distal end of the body.
  • a distal extension 315 extends from a distal (tapered) end of the cone body.
  • the distal extension or at least a portion of it is shaped and sized to fit within the external ear canal.
  • extension 315 is positioned within the ear such that a distal end 319 of the extension is located adjacent the tympanic membrane.
  • distal end 319 of the extension is positioned at a distance of between 1-5 mm, 3-10 mm, 1-3 mm or intermediate, longer or shorter distances from the tympanic membrane.
  • extension 315 comprises a sensor, for example a pressure sensor, for determining a location of the extension relative to the tympanic membrane.
  • the sensor is a pressure gauge inserted between the distal end of the extension and the tympanic membrane.
  • the pressure level rises.
  • the extension is substantially cylindrical.
  • the extension is axially aligned with the lumen 311.
  • a diameter 333 of cylindrical extension 315 is small enough so that at least a portion of the extension can be easily introduced into the external ear canal.
  • diameter 333 ranges between 1-5 mm, 2-4 mm, 3-6 mm or intermediate, larger or smaller diameters.
  • an imager 313 is positioned within extension 315 and/or within lumen 311, at a location suitable to capture light arriving from the tympanic membrane.
  • imager 313 comprises a standard TV camera.
  • imager 313 comprises a CMOS sensor matrix, and/or a CCD sensor matrix.
  • Each of the sensors of the matrix includes one or more wide bandpass filters.
  • each sensor includes RGB (red-green- blue) colors filters.
  • imager 313 captures spectral images of the tympanic membrane in response to illumination of the tympanic membrane by the plurality of light sources.
  • images are captured during a time period of between, for example, 30 seconds to 3 minutes, 10 seconds to 1 minute, 1-3 minutes or intermediate, longer or shorter time periods.
  • a number of acquired images is associated with the number of light sources being used, optionally being equal to the number of light sources being used. In some embodiments, even a single image is enough for detecting a spectra which is indicative of pathogen presence.
  • imager 313 is synched with the rate of light emission so that capturing is coincident with the excitation by each of the light sources.
  • light emitted by one or more of the light sources travels distally through the solid material portions of the cone body, optionally into axial lumen 311 and then around imager 313. In some embodiments, light passes in a ring-shaped pattern around the imager.
  • device 301 includes optical components, such as lenses, diffusers, beam collimators and/or other optical components.
  • a diffuser since the emitted light is transmitted directly through the solid (optionally transparent) material forming the cone body, a diffuser may not be needed.
  • device 301 comprises a handle 321 for manipulation by a user, such as a physician.
  • handle 321 extends proximally from the proximal end of the cone body.
  • device 301 comprises or is in communication with a processor 323.
  • processor 323 is configured for analyzing the spectral images acquired by the imager.
  • processor 323 is configured for storing the images.
  • processor 323 comprises a communication module 325.
  • Communication module may be configured for sending and/or receiving data to or from one or more of: an external memory, cloud storage, clinical database, cellular phone, and/or others.
  • communication module 325 connects to a dedicated cell phone application, suitable for analyzing and/or storing and/or displaying the acquired images and/or diagnosis.
  • device 301 comprises or is in communication with a color screen display 327.
  • screen display 327 is located on handle 321.
  • images and/or analysis results and/or recommendations e.g. guidance for improving a positioning of the device when in the ear
  • images and/or analysis results and/or recommendations are presented on the screen.
  • an image displayed to the user e.g. physician
  • device 301 is compact enough so that it can be held and/or operated single handedly by the user.
  • a total length 329 of cone shaped body and the extension is short enough to be suitable for manipulation by a user’s hand.
  • FIG. 3B an example of the path of light through device 301 is shown.
  • light 341 rays travel from a proximal end of cone body 303 in a distal direction.
  • the light passes through the walls of the cone body, travelling around imager 313 such that it forms a ring shaped pattern.
  • FIG. 4 is a schematic diagram of the process of acquiring and analyzing images of the tympanic membrane, according to some embodiments.
  • “N” independent light sources (401) are activated to emit light towards the tympanic membrane.
  • each sensor comprises“K” different wide band pass filters (403).
  • each sensor comprises RGB filters, for generating 3 spectral combinations of the light arriving from the tympanic membrane.
  • the process of emitting light and capturing spectral images of the tympanic membrane is repeated.
  • the process is repeated until the tympanic membrane had been illuminated by all independent light sources.
  • the captured images are recorded and stored (for example in a device memory).
  • a 2D image of the tympanic membrane is generated (405).
  • each pixel of the generated image is calculated as a combination of“N”*”K” spectral images that were captured.
  • an RGB image of the tympanic membrane is generated based on the collected data and displayed to the user (e.g. a physician) (407).
  • additional processing is performed to determine the original wavelengths of the light arriving from the tympanic membrane (409).
  • the calculated wavelengths are filtered as noise.
  • a potential advantage of filtering based on expected wavelengths ranges may include improving a signal to noise ratio, allowing image detection of higher sensitivity.
  • FIG. 5 is a schematic drawing of the human ear.
  • a distal device extension 501 is advanced within the external ear canal 503, until being positioned in proximity to the tympanic membrane 505.
  • movement of the device is compensated for by using a high resolution imager and/or a high frame rate.
  • a mechanism for holding the device in a fixed position relative to the tympanic membrane is used, for example, an air filled balloon which positions the device extension against the walls of the external ear canal.
  • characteristics of the tympanic membrane 505 such as a structure, translucency level, color, smoothness, and/or others are examined.
  • existence and/or a level of and/or a viscosity of inner ear fluid 507 is examined.
  • a condition of the ossicles 509 is examined.
  • the following conditions are tested for using devices and/or method for example as described herein: Tympanosclerosis, Perforation of the tympanic membrane, Acute otitis externa, Serous otitis media, Exostosis Atrophic otitis media, Keratosis Obturans, Red reflex, Otomycosis, cholesteatoma.
  • a spectra which is indicative of this condition may be detected by the filters, for example by the green filter (G), as it is characterized by wavelengths detectable by the filters, for example between 405 nm and 450 nm.
  • G green filter
  • FIGs. 6A-B are a flowchart of a method for indicating existence of pathogens in the ear using RGB based detection (figure 6A) and a schematic graphic representation of RGB wavelength sensitivity (figure 6B), according to some embodiments.
  • light is emitted towards the tympanic membrane at wavelengths which are not detectable by RGB filters (601). In some embodiments, light is emitted sequentially by a plurality of light sources which are independently controlled.
  • light arriving from the tympanic membrane in response to illumination is captured via an imager equipped with RGB filters (603). Based on that in some cases the spectra of certain pathogens falls within wavelength ranges which are detectable by the RGB filters, detection itself is, in some embodiments, an indication for the presence of these pathogens. (605).
  • the spectra of enzymes and/or coenzymes and/or amino acids and/or other proteins of certain pathogens is characterized by wavelengths higher than a minimal wavelength detected by the RGB filters, for example, higher than 375 nm which is the shortest wavelength detectable by the blue filter.
  • the ability to detect such spectra is indicative, in some embodiments, of the presence of one or more of these pathogens.
  • existence of amino acids such as Tryptophan, Tyrosine and/or Phenyloalanine affects the spectra such that it is characterized by wavelengths which are detected by one or more of the RGB filters.
  • the presence of bacteria is indicated.
  • only tryptophan is detected, characterized by a wavelength range of between 230-350 nm.
  • the emittance of Tryptophan is detected by the blue or green filters.
  • one or more of the light sources are excited to emit light at wavelengths shorter than, for example, 350 nm.
  • a pathogen type is indicated based on the spectra.
  • the system for example as described herein above (for example, the system processor) is programmed with known pathogen fingerprints (an expected fluorescence spectra of one or more pathogens) and upon detection of a similar or like spectra by the imager, an indication regarding the presence of the one or more pathogens is provided.
  • the processor is configured to compare a current spectra (for example, the wavelength ranges obtained) to a database and/or table of known expected wavelength ranges correlated with the presence of pathogens.
  • the user e.g. physician
  • an alert for example a screen displayed message, a light indication, a sound indication, and/or other; additionally or alternatively, the acquired image is displayed to the user along with markings showing a location and/or distribution of pathogens behind the tympanic membrane.
  • one or more specific types of pathogens are recognized and indicated (607), for example by comparing to known fluorescent fingerprints associated with each pathogen.
  • one or more thresholds are set (for example to wavelength values) to determine whether a currently obtained spectra is sufficiently correlated with a known pathogen fingerprint.
  • FIG. 6B is a schematic graphic representation of RGB wavelength sensitivity, in accordance with some embodiments.
  • each pixel-sensor of the imager includes RGB filters.
  • each of the RGB filters passes a selected wavelength range, for example: the blue filter passes wavelengths between“A” and“B, the green filter passes wavelengths between“C” and “D”; and the red filter passes wavelengths between“E” and“F”.
  • the illumination wavelengths are selected from within ranges that are not passed by the filters (e.g. wavelengths that are shorter than“A” and/or wavelengths that are longer than“F”), so that detection is“blind” to the illumination wavelengths.
  • spectra of a specific pathogen is characterized by a specific set of RGB wavelength values.
  • FIGs. 7A-B are examples of images displayed to a user, separately or in combination, according to some embodiments.
  • the image of 7A shows a distribution of bacteria one or both of the tympanic membrane and behind the tympanic membrane, e.g. in the ear fluid.
  • the images of 7B show three tympanic membrane conditions: a normal tympanic membrane 701; a tympanic membrane in which bulging and erythematous are exhibited 703; and a tympanic membrane in which otitis media with effusion is exhibited 705.
  • an image for example as shown in 7A is overlaid on the tympanic membrane image, for example as shown in figure 7B.
  • markings are made onto the combined image to indicate pathogen characteristics such as: the pathogen type(s); distribution 707; size of colony and/or other.
  • markings are made to point out conditions such as rupture of the tympanic membrane, discoloring of the membrane.
  • combining and marking of the image is carried out by designated software.
  • FIGs. 8A-E schematically illustrates a device comprising a radio-frequency mechanism for detection of middle ear effusion, according to some embodiments.
  • the RF mechanism is configured for detection of fluid behind the tympanic membrane, by measuring an effect on the electric field and/or magnetic field, such as: absorbance of electromagnetic waves, phase polarization, reflection, impedance, and/or other effects or phenomena associated with electrical conduction.
  • cylindrical extension 801 comprises a set of RF coils 803, coaxially aligned, and separated by a diamagnetic insert 805, for example an aluminum insert.
  • a diamagnetic insert 805 for example an aluminum insert.
  • an insulating core 807 for example formed of plastic, extends axially throughout a center of the cylindrical extension. The described construction is schematically illustrated at a cross section in figure 8D, and photographed in figure 8C.
  • the coils are electrically connected to each other via an AC measurement bridge scheme, as shown for example in FIG. 8F.
  • cylindrical extension 801 is introduced into the patient’s ear canal, and advanced such that its distal end is in proximity to the tympanic membrane.
  • the cylindrical extension is advanced as close as possible to the tympanic membrane.
  • an electrical current is passed through the coils (supplied by a power source), and a resulting magnetic field is detected.
  • FIG. 8E2 different voltage values will be measured for each of the coils, changing the magnetic field (as schematically shown in FIG. 8E2). If no fluid is present, a similar voltage will be measured (as schematically shown in FIG. 8E1).
  • some voltage difference (e.g. below a threshold) may be measured.
  • the power source is configured to generate a square wave signal, at a selected frequency (in an example, 7MHz).
  • a current source is connected to port 1.
  • Potentiometers R1 and R2 are calibrated such that in the absence of middle ear fluid, a voltage difference between point 3 and point 4 does not exist (equals to zero). In the case of middle ear effusion, the voltage difference between point 3 and point 4 will be different than zero.
  • the voltage difference is amplified and optionally filtered, and the resulting signal is digitized.
  • each of the two RF coils may comprise of an insulated copper wire, optionally rotated 160 turns, and having a diameter of 0.15 mm; a length 809 (thickness) of each coil (as measured along the long axis of the cylindrical extension, see FIG. 8D) may range between 1.5-3 mm, such as 2.40 mm, 2 mm, 3 mm or intermediate, longer or shorter length; a length 811 (thickness) of the diamagnetic insert (as measured along the long axis of the cylindrical extension, see FIG. 8D) may range between 0.5-2 mm, for example 0.7 mm, 1 mm, 1.5 mm or intermediate, longer or shorter length; a total length 813 of the cylindrical extension (see FIG.
  • an external diameter 815 of the cylindrical extension may range between 2.5-4 mm, such as 3 mm, 3.5 mm, 3. 9 mm or intermediate, longer or shorter diameter
  • an internal diameter 817 of the cylindrical extension may range between 2-3.5 mm, such as 2 mm, 2.5 mm, 3.2 mm or intermediate, longer or shorter diameter.
  • the electrical current is in the form of a square wave, at a frequency of 7MHz and an amplitude of about 100mA; and the resulting voltage difference (if detected) is band-pass filtered at a frequency of 7MHz, and digitized at a frequency of at least 15MHz (optionally according to the Nyquist frequency).
  • an effect on the electric and/or magnetic field is detected and/or measured using an antenna, such as a printed antenna.
  • an antenna such as a printed antenna.
  • a near field behavior of the electromagnetic field (close to the antenna) is detected and measured.
  • a look-up table e.g. a table stored on the device controller memory and/or on a remote server
  • a property e.g. voltage, waveform, frequency
  • a physical condition associated with that property such as existence of inner ear fluid, rupturing of the tympanic membrane, and/or other conditions.
  • the look-table links between various applied waveforms and an expected measured waveform.
  • FIG.8G is a flowchart of a method for detecting presence of fluid behind the tympanic membrane using a radio-frequency mechanism, according to some embodiments.
  • a device probe comprising two or more conductive coils is introduced into the ear canal.
  • the coils are arranged with a space therebetween.
  • a diamagnetic insert or ring is positioned intermediate the coils, for example as further described herein.
  • the coil includes a wound wire or a printed wire.
  • electrical current is conducted through the coils.
  • an alternating current is applied.
  • the electromagnetic field and/or differences in the electromagnetic field are measured.
  • a voltage difference which develops between two opposite ends of each of the coils is a function of the electrical impedance of the coil.
  • approximation of the RF probe to the tympanic membrane results in changes to the measured electromagnetic field, as a result of the differences in impedances.
  • a calibration measurement is performed for measuring the electromagnetic field when the probe is a distance away from the tympanic membrane. Then, a measurement of the electromagnetic field performed in proximity (e.g. adjacent) the tympanic membrane is compared to the calibration measurement to detect presence of fluid.
  • measurements e.g. of voltage, electromagnetic field and/or other parameters
  • a coil positioned at a proximal position are used as reference or baseline for measurements obtained from a coil positioned at a more distal position, closer to the tympanic membrane (and thereby potentially closer to any fluid, if present, behind the membrane).
  • the two coils are positioned with a space between them (e.g. axial space) which, on the one hand, is large enough to reduce or prevent a mutual effect on the electromagnetic field of each of the coils; and, on the other hand, is short enough to maintain a total length of the probe as small as possible to facilitate its insertion, at least in part, into the external ear canal).
  • a space between them e.g. axial space
  • FIGs. 9A-17C describe an experiment setup and results in which device probes constructed according to three different techniques were tested using an artificial model of the human ear.
  • the probes included an ultrasound based probe, a light based probe, and a radio frequency probe. Data obtained by each of the probes was analyzed and processed using designated software.
  • the different probes were tested for the ability to detect presence of fluid behind the tympanic membrane and for the ability to identify the type of fluid and/or viscosity of the fluid based on the data acquired by the probe. The different probes were further assessed for determining ease of use and cost aspects.
  • two or all three techniques may be implemented in the same single otoscope device.
  • FIGs. 9A-C are images of different views of a 3D-printed model of the human ear 901 used in an experiment performed in accordance with some embodiments.
  • Colon tissue obtained from swine was used in the model for imitating the tympanic membrane (the tissue is not observable in the image, as it was inserted into the model).
  • a hydraulic system 903 was used for injection of various types of fluids into a space located behind the swine tissue. Calibration and initial testing were performed using an NaCl physiologic solution, and other fluids used in the experiment included water, salted water, gelatin, and animal blood. The hydraulic system provided for gradually injecting the fluid to the space behind the swine tissue.
  • FIGs. 10A-C are images of the three device probes tested, arranged on a platform constructed for an experiment performed in accordance with some embodiments. The images show an RF based probe 1001; an ultrasound based probe 1003; and a light based probe 1005.
  • FIGs. 11A-B show an example of circuitry connecting between the RF and ultrasound modules (11A) and an example of a digital acquisition assembly (11B) for transferring and/or processing of data obtained by the device probe, in accordance with some embodiments.
  • the RF device probe 1101 and the ultrasound device probe 1103 are connected via switch circuitry 1105 to a digital acquisition assembly 1107.
  • the digital acquisition assembly is directly connected or is in communication with a computer 1109 (in the experiment, a USB type connection was used).
  • Other connections may include wireless connections such as Bluetooth, wi-fi, etc.
  • data may be transferred to a remote server.
  • data collected from a plurality of measurements and/or from a plurality of patients is stored and/or analyzed by a remote server.
  • the digital acquisition assembly includes an analog to digital converter (ADC), optionally high-speed; a configurable chip such as a field programmable gate array chip (FPGA); a microprocessor control unit (MCU) and an interface for connecting with the computer 1109 on which the proprietary software is installed.
  • ADC analog to digital converter
  • FPGA field programmable gate array chip
  • MCU microprocessor control unit
  • FIGs. 12A-D show structural and functional details of an ultrasound device probe, according to some embodiments.
  • the ultrasound probe comprises a piezoelectric transducer suitable for emitting and/or receiving signals.
  • the piezoelectric transducer was used for both emitting of ultrasound signals and for receiving returning echoes. Additionally or alternatively, in some embodiments, signals may be emitted or received by different piezoelectric transducers.
  • analysis of the echoes is performed to assess a location from which the signal was reflected.
  • analysis of the echoes is configured to indicate presence of fluid behind the tympanic membrane.
  • an amount and/or volume of fluid are detected or estimated based on the returning echoes.
  • analysis of the echoes for example, assessment of a time delay or difference between the emitted signal and the returning echo is correlated with a viscosity of the fluid.
  • FIGs. 12A-B show an example of an ultrasound probe constructed for use in the experiment.
  • FIGs. 12C and 12D show exemplary parameters used in the experiment, including, for example:
  • Echo sampling frequency 510 KHz (exemplary range: 100 KHz-2500 KHz)
  • Echo sampling delay 151 psec (exemplary range: 0-500 psec)
  • FIGs. 13A-B show examples of echo signals recorded by a digital scope when no fluid was injected in the model (FIG. 13A) and when fluid was present (FIG. 13B), in the experiment performed according to some embodiments.
  • the presence of fluid caused a change in the echo signal amplitude(s).
  • FIG. 13C shows an exemplary screen of a user interface, showing the recorded echo signal and a Fourier transformation of the signal performed in accordance with some embodiments.
  • FIGs. 14A-E show structural and functional details of a light based device probe, according to some embodiments.
  • the light based device probe 1400 comprises a light guiding cone 1402; one or more light sources 1404, and a light conductor (not shown) optionally extending through the cone.
  • the light guiding cone is sealed to prevent surrounding light from entering and/or to prevent from light from exiting the cone radially outwards.
  • the light guiding cone is shaped to converge the emitted light towards a selected area or location, such as towards the tympanic membrane.
  • the light guiding cone comprises a black coating on the inside.
  • a reflective coating is applied onto an inner wall of the cone.
  • the light conductor comprises a tube or channel which extends along the light guiding cone.
  • the light conductor is formed of a semi-transparent material, for example a plastic, for example polycarbonate.
  • the probe was connected to a digital microscope 1406 used for capturing the images. In some embodiments, a live streaming of the field of view is obtained.
  • FIG. 14E lists details of the components used in the experiment. For example, a digital microscope having a sensor resolution of 5 mega pixel and a lens of 13 inch FOV was used.
  • FIGs. 15A is an image of the device and the user interface screen as used in the experiment performed in accordance with some embodiments.
  • FIGs. 15B-C show examples of the images captured by the light based device, where in FIG. 15A there was no fluid in the model, and in FIG. 15B fluid was injected in the model, filling about a half of the available space behind the tissue portion.
  • color analysis of the acquired images is indicative of the type and/or amount of fluid behind the membrane.
  • a color analysis is performed by comparing two or more selected points on the image.
  • one point is used as a reference or baseline for the other point.
  • a color analysis of the images is presented (e.g. to a user, such as a physician) using an RGB representation model and/or using an HSV (hue, saturation, value) representation model.
  • values of the actual images are normalized according to these models and/or others for analysis purposes.
  • a transparency level of the tympanic membrane is estimated or calculated from the acquired images.
  • image processing algorithms are applied for detection of 3-dimenional phenomena such as bulging of the tympanic membrane.
  • FIGs. 16A-D show structural and functional details of a radio-frequency based device probe, according to some embodiments.
  • the RF probe comprises two coils 1601, 1603 separated by a diamagnetic insert 1605.
  • the coils are wrapped around a core 1607, for example formed as a tube.
  • the coils and the diamagnetic insert are arranged along the similar long axis. In some embodiments, the coils are co-axial.
  • the coils are formed of a wounded wire, such as a copper wire.
  • the diamagnetic insert is formed of aluminum.
  • the core is formed of a plastic tube.
  • a diameter of each of the coils and of the insert is small enough to fit within a diameter of the external ear canal.
  • Exemplary dimensions and construction include:
  • Each coil having a wire diameter of 0.15mm, 160 turns of the wire, and a thickness (e.g. as measured along the long axis of the core) of 4.5 mm; an inner diameter of the core is, for example, 5 mm; an outer diameter of the core is, for example, 8 mm; a thickness of the diamagnetic insert positioned in between the coils is, for example, 1 mm.
  • each coil comprises 100 turns of the wire and a thickness of 2 mm; optionally used with a ring shaped aluminum diamagnetic insert having a thickness of 0.6mm.
  • each coil has a wire diameter of between 0.15-0.2 mm; between 10- 15 turns of the wire; an inner diameter of between 1.4- 1.8mm.
  • a diamagnetic insert may have a thickness of, for example, 0.3-0.8mm.
  • the coil inductance is between 3mH- 10 pH. In some embodiments, the working frequency is between 2MHz-12MHz.
  • FIG. 16C shows an example of an RF probe constructed for use in the experiment.
  • the coils are powered by an AC source.
  • FIG. 16D shows examples of operation parameters for the RF probe, including for example:
  • a sampling rate of 25000 KHz (exemplary range: 100-25000 KHz).
  • a probe excitation frequency of 7025 KHZ (exemplary range: 10 KHz-12500 KHz).
  • FIG. 17A shows one of the experiment setups for testing the RF probe, in accordance with some embodiments.
  • the recorded signal will change based on the absorbance of electromagnetic waves within body fluid, e.g. within fluid behind the tympanic membrane. Therefore, in the experiment setup, the probe was tested in two conditions: when held in the air (imitating insertion into a human air having no fluid behind the tympanic membrane, and under the assumption that within the ear itself the probe will be surrounded mostly by air and/or optionally ear wax). In the second tested condition, the probe was held in proximity to fluid, using a 0.5cm A 3 volume of fluid.
  • FIG. 17B is an image of a recording obtained when the probe was held in the air
  • FIG. 17C is an image of a recording obtained when the probe was held in proximity to the fluid.
  • the results of measurement are presented by the graph of FIG. 17D- as can be observed, the signal intensity rises as the probe is moved closer to the fluid (i.e. closer to the tympanic membrane, behind which the fluid is located).
  • the signal is low and remains relatively constant.
  • even a single measurement including, for example, conducting of current to the coils and measurement of voltage differences between the two coils
  • the measurement takes less than 5 seconds, less than 3 seconds, less than 2 seconds or intermediate, longer or shorter duration.
  • the experiment results may indicate that in some embodiments, by positioning the RF probe at a distance of 4 mm or less, 5 mm or less, 7 mm or less, or intermediate, longer or shorter distances from the tympanic membrane, the received signal may be indicative of presence of fluid behind the membrane.
  • a distance for positioning the probe is selected taking into account the sensitivity of the probe, the operation frequency, and/or other parameters.
  • the signal intensity changes in response to the location of the probe relative to the fluid.
  • the probe itself may include fluid at an amount and/or arrangement which produces a desired baseline electromagnetic field, such as for calibration purposes.
  • an otoscope device may include: an RF module and an ultrasound module, an RF module and light based module, a light based module and an ultrasound module.
  • all three modules are implemented in the same device.
  • the device circuitry is configured for independent control of each of the modules.
  • one or more switches provide for automatic and/or user instructed selection of a module.
  • modules are actuated simultaneously or consecutively.
  • a module is selected for use according to type of parameter to be detected and/or estimated. For example, for detection of presence of fluid, an RF module may be most advantageous; for detection of fluid type, a light based module may be most advantageous; for detection of fluid viscosity, an ultrasound module may be most advantageous.
  • FIG. 18 is a block diagram of an integrated device, according to some embodiments.
  • device 1800 comprises an RF module 1802, for example as describe herein; one or more light sources 1804, positioned and configured for emitting light towards the tympanic membrane; an imager 1806 configured for capturing light returning from the tympanic membrane; and optionally one or more filters 1808, such as an RGB filter.
  • the device comprises powering means 1810, for example, a battery.
  • the device comprises control circuitry 1812 for activating the device modules and components.
  • the device comprises or is in communication with a user interface 1814, optionally including a display.
  • the user interface is configured on a computer, tablet computer, cellular phone (optionally using a designated cell phone application) and/or other suitable means.
  • the RF module is activated first, to detect if fluid is at all present behind the tympanic membrane. Then, in some embodiments, optionally only if fluid exists, the one or more light sources are activated to illuminate the tympanic membrane. In some embodiments, the imager is activated to capture one or more images of the illuminated membrane. Optionally, imaging is performed via one or more filters, such as an RGB filter. Optionally, the filter is positioned in the imager itself.
  • the captured images are analyzed, for example as described hereinabove.
  • a fluorescence spectra of the tympanic membrane is detected and analyzed for the presence of pathogens, such as bacteria.
  • FIGs. 19-21 show exemplary structures (shown at a cross-section) of a device probe, including a light-based probe (FIG. 19), an ultrasound probe (FIG.20) and an RF based probe (FIG. 21), for example as used in the experiments described hereinabove.
  • At least a distal portion of each of the probes described is narrow enough to enable its insertion, at least in part, into the external ear canal.
  • a diameter of a distal portion of the probe is between 0.5mm-5 mm, 2mm-6mm, 5mm- 12mm, or intermediate, larger or smaller diameter.
  • FIG. 19 shows an exemplary light based probe structure, according to some embodiments.
  • probe 1900 comprises a tapering body 1902, optionally cone shaped.
  • the body is solid.
  • a cylindrical extension 1904 extends from the narrow end of the body.
  • a light conducting channel 1906 extends axially along the length of the body and the cylindrical extension.
  • an imager (not shown) is positioned at a proximal end of the body.
  • the probe comprises one or more light sources 1908, for example, LEDs.
  • the light sources are mounted on a proximal portion of the body, and are directed towards the distal end.
  • a plurality of light sources e.g. 2, 3, 4, 6, 8, 12, 16 or intermediate, higher or smaller number
  • the light sources are arranged at selected intervals from one another.
  • the intervals may be constant, as shown in this example (where 4 LEDs are configured such that each pair of LEDS are located on diametrically opposing positions); or, in some embodiments, the light sources are arranged with non-constant intervals.
  • a light conducting channel 1910 extends from each of the light sources to the distal end of the probe, for illumination of the tympanic membrane.
  • light is transferred via the probe body itself, for example via walls of a body comprising or formed of transparent or semitransparent material(s).
  • the probe includes no designated light conducting channels.
  • only a central channel extends axially along the body, for example through which imaging is performed.
  • FIG. 20 shows an exemplary ultrasound probe structure, according to some embodiments.
  • ultrasound probe 2000 comprises a tubular body 2002 ending with a tapering geometry, such as a cone 2004.
  • the cone is separable from the body, for example attached to the body via a rotatable nut 2008 and/or other separable coupling.
  • one or more ultrasound elements 2006 are placed within the tubular body.
  • the ultrasound element comprises a piezoelectric transducer.
  • a UST-40T ultrasonic ceramic piezoelectric transducer was used.
  • the ultrasound element is configured for emitting and/or receiving signals to and/or from the ear, such as to and/or from the tympanic membrane.
  • properties of the emitted ultrasound such as intensity, frequency, duration of emission and/or others are suitable for producing a reflection (returning echoes) from the tympanic membrane and/or from other middle and/or inner structures, such as one or more bones inside the ear.
  • the probe comprises circuitry (not shown) for excitation of the ultrasound element and/or for transferring of the signals received by the ultrasound element.
  • more than one ultrasound element is used.
  • one element is used for emitting ultrasound signals, and another element is used for receiving ultrasound signals.
  • the probe is introduced to the ear such that contact with the tympanic membrane is made. Additionally or alternatively, a liquid or gel medium is placed intermediate the ultrasound element and the tympanic membrane.
  • the probe itself comprises a liquid, for example contained at a distal tip of the probe. Additionally or alternatively, a liquid or gel are inserted into the ear prior to introducing of the probe, to provide a fluid medium suitable for transferring of the ultrasound signals through.
  • FIG. 21 shows an exemplary RF probe structure, according to some embodiments.
  • probe 2100 comprises a body 2102 tapering towards an extension 2104, optionally cylindrical, at its distal end.
  • an inner channel or lumen 2108 extends along the body and the extension.
  • an RF assembly 2110 of the probe comprises conductive elements, for example conductive coils 2106.
  • the coils are disposed circumferentially around the cylindrical extension 2104, for example, surrounding the extension.
  • a diamagnetic insert 2112 is positioned in between the two coils.
  • the diamagnetic insert is shaped as a ring.
  • the diamagnetic insert comprises or is formed of a material suitable for reducing or preventing an electric effect of one coil on the other.
  • the diamagnetic insert is formed of aluminum.
  • the coils and the insert are arranged externally to extension 2104, for example positioned radially outwardly to the walls of extension 2104 (and thereby radially outwardly to the inner channel 2108).
  • an imager (not shown) may be mounted at a proximal position and directed towards the distal end of the probe.
  • images of the tympanic membrane are obtained by the imager via the inner channel 2108.
  • one or more light sources are positioned and directed towards the distal end of the probe, for illumination of the ear, such as for the purpose of examination and/or for positioning of the probe and/or for enabling acquiring of images.
  • compositions, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.
  • a compound or “at least one compound” may include a plurality of compounds, including mixtures thereof.
  • various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range.
  • method refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.
  • the term“treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

Abstract

L'invention, selon certains modes de réalisation, concerne un dispositif d'évaluation de contenu ou d'état d'oreille moyenne, comprenant : un corps qui va en diminuant en direction d'une extrémité étroite ayant un diamètre suffisamment petit pour être introduit dans un conduit auditif externe; une pluralité de sources de lumière disposées de manière périphérique autour de l'extrémité large du corps et orientées de façon à transmettre la lumière émise à travers une partie solide du corps; un imageur orienté de manière distale servant à obtenir des images de la membrane tympanique; le dispositif étant en communication avec des circuits conçus pour analyser des images spectrales obtenues par l'imageur de façon à évaluer un contenu ou un état d'oreille moyenne.
PCT/IL2020/050140 2019-02-05 2020-02-05 Méthode et dispositif de détection de contenu et/ou d'état d'oreille moyenne WO2020161712A1 (fr)

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