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WO2009157825A1 - Procédé et dispositif pour diagnostiquer des pathologies auriculaires - Google Patents

Procédé et dispositif pour diagnostiquer des pathologies auriculaires Download PDF

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Publication number
WO2009157825A1
WO2009157825A1 PCT/SE2008/050761 SE2008050761W WO2009157825A1 WO 2009157825 A1 WO2009157825 A1 WO 2009157825A1 SE 2008050761 W SE2008050761 W SE 2008050761W WO 2009157825 A1 WO2009157825 A1 WO 2009157825A1
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WO
WIPO (PCT)
Prior art keywords
detector
light
accordance
tympanic membrane
probe
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/SE2008/050761
Other languages
English (en)
Inventor
Mikael Sundberg
Anders Johansson
Åke ÖBERG
Tomas STRÖMBERG
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Atos Medical AB
Original Assignee
Atos Medical AB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Atos Medical AB filed Critical Atos Medical AB
Priority to PCT/SE2008/050761 priority Critical patent/WO2009157825A1/fr
Publication of WO2009157825A1 publication Critical patent/WO2009157825A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61B1/2275—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 with controlled air pressure
    • 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
    • A61B1/00096—Optical elements
    • 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
    • A61B1/00165—Optical arrangements with light-conductive means, e.g. fibre optics
    • A61B1/00167—Details of optical fibre bundles, e.g. shape or fibre distribution
    • 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
    • A61B1/06—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 with illuminating arrangements
    • A61B1/0607—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 with illuminating arrangements for annular illumination
    • 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
    • A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
    • A61B5/0086—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters using infrared radiation
    • 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
    • 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
    • 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
    • A61B1/06—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 with illuminating arrangements
    • A61B1/07—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 with illuminating arrangements using light-conductive means, e.g. optical fibres
    • 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
    • A61B5/0071—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by measuring fluorescence emission
    • 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
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/1459—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter

Definitions

  • the invention relates to a device and a method for measuring physical properties in general and physical properties of human tissues in the ear.
  • the device in accordance with the invention can be used in connection with diagnosing ear conditions such as acute otitis media (AOM).
  • AOM acute otitis media
  • AOM is one of the most common infectious diseases of childhood. In- cidence figures vary greatly in the current literature. This probably reflects different threshold through time for seeking medical attention for earache and different diagnostic criteria between researchers rather than a true difference in incidence. AOM can in general terms be defined as purulent inflammation in the middle ear which starts abruptly, is of short duration and can be clinically verified.
  • Antibiotics have for long been recommended in the treatment of AOM but indefinite diagnostic criteria, a high percentage of spontaneous healing and an increasing awareness of microbial resistance have led to revision of the therapeutic guidelines in several European countries Myringotomy with demonstration of purulent middle ear fluid, as a proof of bacterial infection, is considered the gold standard of AOM identification. In practice however, the diagnosis is often based on the combination of symptoms, such as earache, rubbing of the ear, fever, and changes of the characteristics of tympanic membrane (TM). An otoscopic assessment of the TM can be challenging even for the most experienced clinician because of overlapping findings with other conditions where antibiotics are not needed.
  • OME otitis media with effusion
  • otoscopes have been used for diagnosis of otitis media, the standard device being used for a subjective assessment of tympanic membrane characteristics.
  • a conventional pneumatic otoscope will allow subjective assessment of tympanic membrane mobility.
  • a video otoscope can be used for a Quasi-objective assessment of tympanic membrane characteristics that allow for post-examination as the video signal can be recorded on analog/digital media.
  • a tympanometer is used for measurement of acoustic immittance of the ear canal and middle ear and will allow an objective assessment of tympanic membrane mobility.
  • Acoustic immittance is a general term used to refer either to acoustic impedance or acoustic admittance measurements. At present most of the devices are based on admittance measurement. Acoustic admittance is the ease with which acoustic energy is transferred from one system to another, which is the opposite of acoustic impedance. If the air in the ear canal is easily set into a vibration, the admittance is high. If the air is difficult to set into a vibration, the admittance of the system is low.
  • Tympanometry is the measurement of acoustic admittance as a function of ear canal pressure and the resulting graph is a tympanogram.
  • Positive or nega- tive pressure introduced to the sealed ear canal decreases the admittance of the air in the ear canal by stiffening the tympanic membrane.
  • the effect of air pressure on acoustic admittance measured in the ear canal is systematically altered by the middle ear disease.
  • An acoustic reflectometer can be used for an objective assessment of tympanic membrane mobility and a spectroscopic otoscope provides an ob- jective assessment of tympanic membrane color.
  • Fluorescence spectroscopy has been utilized by Sorrel et al Bacteria identification of otitis media with fluorescence spectroscopy, Lasers in surgery and medicine 1994;14:155-163, and Spector et al, Noninvasive fluorescent identification of bacteria causing acute otitis media in a chinchilla model.
  • US Patent US 7,058,441 discloses a device capable of obtaining a spectrum of reflected light from an ear of a subject and a processing unit in connection with said device, which is capable of translating the obtained spectrum of reflected light to one or more output values related to the condition of the ear.
  • a method for detecting and diagnosing ear related conditions comprising the steps of illuminating inside the ear; inserting a device to the ear canal capable of conveying at least one spectrum of reflected light from said ear to a processing unit; and activating said processing unit thereby translating at least one spectrum of reflected light provided at the time of activating to one or more output values related to the condition of the ear.
  • An object of the invention is to provide a device that will improve the possibilities to perform diagnosis of acute otitis media.
  • the device is provided with means for applying diffuse reflectance spectroscopy in combination with a pressure provocation of the tym- panic membrane.
  • the invention combines the subjective assessment of tympanic membrane appearance and the objective measures of tympanic membrane mobility and effusion characterization.
  • the device in accordance with the invention comprises an elongated probe, a first end of which being operatively connected to a housing and a second end of which is designed to be inserted in the external auditory canal to a position close to the TM.
  • the spectral analytical instrument includes at least one amplitude- or frequency-modulated light source in form of a light emitting diode (LED) or a laser diode (LD) and at least one photodetector (e.g., a photo diode, photo transistor, CCD or CMOS detector) where the detector is sensitive to electromagnetic radiation in the range 200-2000 nm.
  • LED light emitting diode
  • LD laser diode
  • photodetector e.g., a photo diode, photo transistor, CCD or CMOS detector
  • the housing there is provided light generating means and at least one detector means.
  • the light generating means are operatively connected to a plurality of optical fibers that extend through the probe to a position in the vicinity of the second end of the probe.
  • means for producing air pressure variations allowing quantification of physiological properties of the tympanic membrane.
  • a pressure transducer for measuring pressure variations in the external auditory canal caused either by a manually controlled pneumatic bulb or by a pneumatic control unit.
  • the optical fibers can be divided into at least two sets of fibers.
  • a first set of the optical fibers is used to convey light from the light sources to the TM.
  • a second set of fibres is used to convey light reflected from the TM and the ear to a photodetector arranged in the housing.
  • Said second set of fibres can be divided further into subsets if different detectors are used. It is also possible to use the same set of fibers for conveying light in both directions, for instance by using so called fiber couplers.
  • the light from the light sources is directed towards the tissue in front of the probe and is used for diffuse reflectance spectroscopy.
  • a minor por- tion of the light is specularly reflected from the surface and will have basically the same properties as the generated light.
  • a major part of the light will penetrate into the tissue and interact with different objects such as red blood cells.
  • the light reflected will be diffuse and due to different properties of the objects also properties of the light will change.
  • the diffuse reflected light will have different intensities at different wavelengths.
  • the light from the light sources will also penetrate the TM and be reflected from the middle ear and through the TM back to the light detector means.
  • Light reflected from the middle ear will indicate existence of purulent middle ear fluid, as a proof of bacterial infection.
  • the detecting means is arranged to receive the reflected light and to detect intensities at different wavelengths, preferably within an interval of 200-2000 nm.
  • the detecting means comprises separate sensors for detecting different wavelengths.
  • reflected light is received in a single detector and then analyzed with regard to intensity at different wavelengths. It is possible also to use a combination of the detector embodiments.
  • the mobility of the TM can be assessed by measuring the intensity of the reflected light as a function of the pressure variations caused by the associated means. It is further possible to assess the presence of fluid in the middle ear by arranging the detector means for measuring reflected light at wavelengths in the interval 800-2000 nm.
  • the detector means will be arranged for measuring presence and/or concentration of various chromophores by specifically analyzing the reflected light in the wavelength interval 200-2000 nm. By specifically ar- ranging the detector means for analyzing the reflected light in the interval 450-900 nm the oxygen saturation of the blood in the inspected area can be measured.
  • the diffuse reflectance spectroscopy arrangement in accordance with the invention also will allow identification of a purulent effusion as opposed to a serous effusion. A combination of two or more analyzing steps described above will highly improve the diagnosis of acute otitis media.
  • the pressure provocation of the tympanic membrane is performed through an air channel that can be included in the probe and extend along the fibers.
  • a pressure transducer for measuring pressure variations during pressure provocation can be included in the air channel or be arranged elsewhere in air contact with the TM.
  • detected backscattered light from the tympanic membrane during pressure provocation either via a manual bulb or via an automatic pneumatic control system, allow for quantification of tympanic membrane mobility.
  • the present invention will allow an objective quantification of physio- logical properties of the tympanic membrane and the middle ear related to acute otitis media, myringitis and otitis media with effusion.
  • the ear speculum is replaceable, making it possible to fit the speculum to the size of the external auditory canal of the individuals).
  • the light sources could be of various wavelengths, where the different wavelengths are chosen to allow for separable detection and quantification of the mentioned chromophores.
  • the different light sources could be modulated in frequency or amplitude to allow for parallel detection from all light sources.
  • the light sources are activated in sequence, allowing for time-gated detection of the backscattered light.
  • a broad spectrum light source is chosen, and the chromophore quantification is made possible by introducing wavelength separating devices on the detector side (e.g., filters, gratings, spec- trometers etc.)
  • the invention can be equipped with a starting trigger allowing the operator to decide when a measurement is to be recorded.
  • the instrument records the signals continuously.
  • Fig. 1 is a schematic side elevational view of a first embodiment of a device in accordance with the invention including a control apparatus and a probe,
  • Fig. 2 is a schematic view showing components of the control apparatus of Fig. 1 ,
  • Fig. 3 is a cross sectional view from ///-/// in Fig. 1 of a first configuration of optical fibres in the tip of the probe
  • Fig. 4 is a cross sectional view from ///-/// in Fig. 1 of a second configuration of optical fibres in the tip of the probe
  • Fig. 5 is a schematic block diagram of the device in accordance with the invention.
  • Fig. 6 is a schematic side elevational view of a second embodi- ment of a device in accordance with the invention including a probe and a manually operated bladder, and
  • Fig. 7 is a schematic block diagram showing components of a pneumatic means.
  • a device in accordance with the invention comprises an instrument 10 designed as a modified sinuscope suitable for visual inspection of narrow body cavities, such as the auditory canal.
  • the instrument 10 is T-shaped with a vertical grip section 11 supporting a probe 12 and an eyepiece 13 extending in opposite directions.
  • the probe is inserted in the external auditory canal 14.
  • a tip 15 of the probe 12 is positioned 5-10 mm from the tympanic membrane 16.
  • the instrument 10 is operatively connected to a control apparatus 17 through a cable 18.
  • the cable 18 holds a plurality of optical fibres as will be described below.
  • the optical fibres extend from a lower section of the vertical grip section to the probe 12. In the probe the optical fibres extend together with an ocular channel (c.f. Fig. 3 and Fig. 4) that connects to the eyepiece 13.
  • the control apparatus 17 comprises a power supply 27 that is con- nected to other devices and components of the control apparatus in a conventional manner.
  • a light source 20 is operatively connected to a light source control 28 that will turn on and turn of the light source 20 in line with a control sequence.
  • a detector unit 29 comprises at least two detectors, one for optical measurements and one for pressure measurements.
  • a signal processing means 30 receives detected signals from the detector unit 29 and analyzes the signals on the basis of different criteria. The result of the analyze is presented on a presentation panel, or display unit, 34.
  • the pressure provocation of the TM is caused by pneumatic means 36.
  • the pneumatic means comprises a manually operated bladder or bulb 37.
  • the pneumatic means 36 comprises a pump, a control processor, a motor and a sensor or transducer.
  • a first light source 20 generates white light that is used for illuminating the TM.
  • the light source serves both the visual inspection via the otoscope and as light for the diffuse reflectance spectroscopy as will be described below.
  • the first light source can be similar to an Avantes HL-2000-LL, 7 W output, VIS-NIR spectral range, Eerbeek, Netherlands).
  • Light from the first light source is directed into a first set of optical fibres 21 that is embedded in said cable 18 and extends to the end of the probe 12.
  • the fibres in said first set of optical fibres are distributed in the end of the probe to provide an appropriate inten- sity level and a suitable distribution of light over the TM.
  • the light from the first set of optical fibres 21 is reflected from the TM and received in a second set of optical fibres 22 that extends also from the tip of the probe to the control apparatus 17.
  • the fibres in the second set of optical fibres 22 are connected to a first detector means 23 that can be con- figured basically in different ways.
  • the first detector means 23 is a single detector that is connected to a signal processor 24 in the control apparatus 17.
  • the single detector produces data corresponding to the intensity of the diffuse reflected light.
  • the signal processor 24 in this embodiment is configured to apply an erythema detection algorithm on the acquired data.
  • a novel algorithm utilizes the fact that the photon absorption in the Q-band of various blood chromophores is different in erythymatous and in normal tissue.
  • R 650 and R ⁇ are the reflectivity at 650 nm and ⁇ nm, respectively. Normalization was performed by dividing every sample in each spectrum with its reflectivity at 650 nm. A variety of ⁇ :s were tested. ⁇ :s were selected in the absorption peak of bilirubin and the Q-band of oxyhemoglobin (HbO 2 ) (460 nm, 542 nm and 576 nm). In addition, ⁇ -values were chosen based on measurements of Q ⁇ in normal and erythematous TM, .in order to maximize discrimination. It was observed that Qx discriminated well at ⁇ :s near 490 nm and 576 nm.
  • the first detector means can include discrete detectors for each specific frequency. Each detector can be combined with a narrow filter, to achieve the desired frequency characteristics. Appropriate centre wavelengths are 460 nm, 490 nm, 542 nm, 576 nm and 650 nm.
  • the detectors are connected to the signal processor 24 in the control apparatus 17. In such an embodiment the signal processor 24 can have a less complicated design.
  • a second light source 25 is also included.
  • the second light source emits light that is directed towards the target tissue as a visual reference when the probe is positioned in the external auditory canal.
  • a separate optical fibre, or a set of fibres, 26 is provided for conveying the light to the end of the probe.
  • the second light source 25 is a laser diode that emits light at the wavelength 632 nm.
  • the detector means for analyzing the reflected light in the interval 450-900 nm information about the oxygen saturation of the blood in the inspected area can be measured.
  • the diffuse reflectance spectroscopy arrangement in accordance with the invention also will allow identification of a purulent effusion as opposed to a serous effusion.
  • the control apparatus 17 also comprises a control unit 31 operatively connected to other units of the control apparatus, such as the signal processor 24 and a memory unit 46.
  • the light sources are driven by a driver unit 32, which is operated by the control unit.
  • Data, such as operating commands, can be fed in by an input device 33, such as a keyboard or other appropriate means.
  • the input device comprises a single trigger that will operate the control apparatus 17 when set into different positions.
  • the trigger or any other suitable input device can be arranged on the instrument 10, for instance on the vertical grip section 11.
  • Data produced by the signal processor 24 and the imaging system can be displayed on a display unit 34, which also may include or consist of other audiovisual means, such as light diodes and loudspeakers.
  • the data can also be transferred to further computing, analyzing and monitoring means (not shown).
  • the display unit 34 is arranged to display an indication of the physical status of the TM.
  • the display indicates the medical status of the TM.
  • several units of the control apparatus 17, such as the control unit 31 , the input device 33 and the display unit 34 can be part of a conventional personal computer or an application specific computer.
  • the tip 15 of the probe is covered by a protective and optically neutral cap 38, c.f. Fig. 7.
  • the cap 38 is disposable.
  • the tip 15 of the probe comprises a plurality of optical fibres and an ocular channel 35.
  • the fibres are gathered in a semicircular section in the embodiment shown in Fig. 3.
  • the number of individual fibres is chosen so as to supply each of the detectors in the first detector means 23 with a sufficient amount of reflected light. Normally, at least five individual fibres are used for each detector and each detector frequency.
  • a pressure sensor 54 is provided in the ocular channel in this embodiment, c.f. Fig. 7.
  • Fig. 4 an embodiment comprising an annular configuration of the fibre carrying part of the probe head is shown.
  • a circular outer section of the probe head is used for the first set of optical fibres 21 and the second set of optical fibres 22.
  • a central part of the probe head forms the ocular channel 35.
  • a plurality of channels are formed in the probe head and in each channel a plurality of fibres are arranged. Every second channel holds elements of the first set of optical fibres 21 and every second channel holds elements of the second set of optical fibres 22.
  • These fibres and the corre- sponding detector means are operated in correspondence with the description with reference to Fig. 3 and Fig. 4. All sets of fibres are arranged along a semicircular line outside the ocular channel 35.
  • a pressure sensor 54 is provided in the ocular channel in this embodiment, c.f. Fig. 7.
  • Two separate optical fibres, or set of fibres, 26' arranged opposite each other are provided for facilitating the positioning of the probe head in the ear of a patient.
  • the second light source 25 produces a collimated light that will be directed from the optical fibres 26' in two intersecting beams. After intersecting the light beams will hit the tympanic membrane in two separate and distinctive positions. By adjusting the distance between the probe and the tympanic membrane until target areas of the light beams are located at opposite side edges of the tympanic membrane it is possible position the probe at an appropriate distance from the tympanic membrane.
  • a basic block diagram illustrating the function of the device in accor- dance with the invention is shown in Fig. 5.
  • a light source section 39 comprises first light source 20 and in some embodiments also second light source 25.
  • Light from the light source section 39 is directed through a waveguide section 40 comprising a plurality of fibers or similar light guiding means.
  • the pneumatic means 36 generates the air pressure variations used for the pressure provocation of the TM.
  • the light source section 39 can comprise a plurality of light emitting elements operating at different wavelengths.
  • the elements can be frequency or amplitude modulated to allow a parallel detection from all elements. They can also be activated in sequence, so as to obtain a time-gated detection of the backscattered light.
  • a plurality of detectors is included in a detector section 41.
  • the detector section 41 comprises light detectors and preferably a pressure detector.
  • the device can have an appearance similar to a conventional otoscope or endoscope 42. Signals detected by the different detectors are transferred to the signal processing means 30 capable of analyzing pressure signals and light signals. Data indicative of the status of the TM is presented at a presentation unit 43.
  • the light sources used in different embodiments can be either light emitting diodes, laser diodes or other suitable light sources.
  • the detectors can be photodiodes, phototransistors, CCD-detectors, CMOS-detectors, a spectrometer or other suitable light detecting devices.
  • the light source(s) can be provided at or in the vicinity of the distal end of the device. Such device could also be fitted using optical fibers for conveying light from the device to the tympanic membrane and vice versa. It is preferred that the ear speculum is replaceable, making it possible to fit the speculum to the size of the external auditory canal of the individuals).
  • the light sources could be of various wavelengths, where the different wavelengths are chosen to allow for separable detection and quantification of the mentioned chromophores.
  • the different light sources could be modulated in frequency or amplitude to allow for parallel detection from all light sources.
  • the light sources are activated in sequence, allowing for time-gated detection of the backscattered light.
  • a broad spectrum light source is chosen, and the chromophore quantification is made possible by introducing wavelength separating devices on the detector side (e.g., filters, gratings, spectrometers etc.)
  • the invention could be equipped with a starting trigger allowing the operator to decide when a measurement is to be recorded.
  • the instrument records the signals continuously.
  • An illustrative example of a basic embodiment of the invention is shown in Fig. 6. The appearance is similar to a conventional otoscope with a handle 44, an otoscope head 45, an ear speculum 47 and a lens 48.
  • a striking difference as compared to a conventional otoscope is bladder or bulb 37 used for generating air pressure pulses during the provocation of the TM.
  • An optical fiber cord 49 extends from the handle 44 to the control apparatus.
  • the pneumatic means 36 shown in Fig. 7 comprises a pump 50 driven by a motor 51.
  • a pressure control unit 52 generates control signals for the pump and the motor, so as to provide the required air pressure pulses.
  • a sensor unit 53 is provided for obtaining a signal indicative of the generated air pressure variations.
  • the sensor unit 53 can comprise a pressure sensor 54 which can be provided in the ocular channel as shown in Fig. 3 and Fig. 4.
  • the pressure sensor also can be provided in the otoscope head 45 or in any other location where a relevant air pressure signal can be obtained.
  • the sensor unit 53 can comprise a positional sensor or similar device capable of obtaining a signal indicative of the position of a valve that is opened when the air pulse is transferred to the TM.
  • the sensor unit 53 also can be implemented as a an output of the pressure control unit 52 indicative of the generation and transfer of an air pulse.

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  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Optics & Photonics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Otolaryngology (AREA)
  • Signal Processing (AREA)
  • Audiology, Speech & Language Pathology (AREA)
  • Acoustics & Sound (AREA)
  • Multimedia (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

La présente invention concerne un dispositif pour mesurer les propriétés physiques de la membrane tympanique (TM), comprenant une sonde allongée (12) avec une extrémité distale (15) pour l’inspection de l’oreille, où une pluralité de fibres optiques sont agencées dans ladite sonde allongée. Lesdits premiers moyens formant détecteur (23) sont conçus pour mesurer l’intensité de lumière réfléchie par la membrane tympanique. Le dispositif comprend en outre des moyens pour produire une provocation par pression de la membrane tympanique et des moyens pour analyser la mobilité de la membrane tympanique pendant la provocation.
PCT/SE2008/050761 2008-06-24 2008-06-24 Procédé et dispositif pour diagnostiquer des pathologies auriculaires Ceased WO2009157825A1 (fr)

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PCT/SE2008/050761 WO2009157825A1 (fr) 2008-06-24 2008-06-24 Procédé et dispositif pour diagnostiquer des pathologies auriculaires

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CN103340594A (zh) * 2013-06-18 2013-10-09 深圳市古安泰自动化技术有限公司 体表检查仪
EP2762056A1 (fr) * 2013-02-04 2014-08-06 Helen of Troy Procédé pour identifier des objets dans l'oreille d'un sujet
WO2014117955A3 (fr) * 2013-02-04 2014-11-27 Helen Of Troy Limited Procédé d'identification d'objets dans l'oreille d'un sujet
CN104605861A (zh) * 2015-01-08 2015-05-13 山东大学 一种光束整形对光诱发听觉影响的测试系统和方法
EP2635174A4 (fr) * 2010-11-04 2015-05-20 Cleveland Clinic Foundation Dispositif et méthode permettant de déterminer la présence de liquide dans l'oreille moyenne
CN104814744A (zh) * 2014-02-04 2015-08-05 Gn尔听美公司 听力测试探针
WO2015169435A1 (fr) * 2014-05-05 2015-11-12 Helen Of Troy Limited Otoscope et procédé otoscopique basé sur l'analyse spectrale
CN105324063A (zh) * 2013-02-04 2016-02-10 特洛伊海伦有限公司 识别受试者的耳朵中的对象的方法
CN105996995A (zh) * 2016-05-03 2016-10-12 华南师范大学 一种基于光谱技术的中耳炎诊断系统和仪器
WO2017049000A1 (fr) * 2015-09-15 2017-03-23 Massachusetts Institute Of Technology Systèmes et méthodes de diagnostic de troubles de l'oreille moyenne et de détection d'analytes dans la membrane du tympan
US10004386B2 (en) 2013-02-04 2018-06-26 Helen Of Troy Limited Otoscope
EP2901916B1 (fr) * 2014-02-04 2018-10-10 Natus Medical Incorporated Sonde de test auditif
US10172513B2 (en) 2013-02-04 2019-01-08 Helen Of Troy Limited Otoscope
US10213098B2 (en) 2013-11-08 2019-02-26 Welch Allyn, Inc. Laser configured otoscope
WO2019226701A1 (fr) * 2018-05-22 2019-11-28 The Regents Of The University Of California Outil de spectroscopie optique diffuse basé sur une diode électroluminescente
WO2019231485A1 (fr) * 2018-06-01 2019-12-05 Otonexus Medical Technologies, Inc. Otoscope acoustique
US11058286B2 (en) 2013-02-04 2021-07-13 Helen Of Troy Limited Ear inspection device and method of determining a condition of a subject's ear
US11206971B2 (en) 2018-08-16 2021-12-28 Cactus Medical, LLC Optical spectroscopy circuitry for assessing ear health
US11361434B2 (en) 2019-01-25 2022-06-14 Otonexus Medical Technologies, Inc. Machine learning for otitis media diagnosis
US20220257107A1 (en) * 2019-07-26 2022-08-18 University Of Florida Research Foundation Calibrated pneumatic otoscope
US11647902B2 (en) 2019-04-05 2023-05-16 University Of Utah Research Foundation Otoscope

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EP2635174A4 (fr) * 2010-11-04 2015-05-20 Cleveland Clinic Foundation Dispositif et méthode permettant de déterminer la présence de liquide dans l'oreille moyenne
US9918622B2 (en) 2010-11-04 2018-03-20 The Cleveland Clinic Foundation Device and method for determining the presence of middle ear fluid
US9788712B2 (en) 2010-11-04 2017-10-17 The Cleveland Clinic Foundation Device and method for determining the presence of middle ear fluid
JP2019093167A (ja) * 2013-02-04 2019-06-20 ヘレン オブ トロイ リミテッド 耳検査装置及び被験体の耳の状態を決定する方法
US9931021B2 (en) 2013-02-04 2018-04-03 Helen Of Troy Limited Method for identifying objects in a subject's ear
CN105324063B (zh) * 2013-02-04 2018-03-02 特洛伊海伦有限公司 识别受试者的耳朵中的对象的方法
EP3539448A3 (fr) * 2013-02-04 2019-11-06 Helen of Troy, Limited Procédé pour identifier des objets dans l'oreille d'un sujet
WO2014117955A3 (fr) * 2013-02-04 2014-11-27 Helen Of Troy Limited Procédé d'identification d'objets dans l'oreille d'un sujet
CN105324063A (zh) * 2013-02-04 2016-02-10 特洛伊海伦有限公司 识别受试者的耳朵中的对象的方法
US11058286B2 (en) 2013-02-04 2021-07-13 Helen Of Troy Limited Ear inspection device and method of determining a condition of a subject's ear
US10172513B2 (en) 2013-02-04 2019-01-08 Helen Of Troy Limited Otoscope
EP2762056A1 (fr) * 2013-02-04 2014-08-06 Helen of Troy Procédé pour identifier des objets dans l'oreille d'un sujet
US10004386B2 (en) 2013-02-04 2018-06-26 Helen Of Troy Limited Otoscope
CN105324063B9 (zh) * 2013-02-04 2018-04-20 特洛伊海伦有限公司 识别受试者的耳朵中的对象的方法
CN103340594B (zh) * 2013-06-18 2014-12-17 深圳市古安泰自动化技术有限公司 体表检查仪
CN103340594A (zh) * 2013-06-18 2013-10-09 深圳市古安泰自动化技术有限公司 体表检查仪
US10213098B2 (en) 2013-11-08 2019-02-26 Welch Allyn, Inc. Laser configured otoscope
EP2901916B1 (fr) * 2014-02-04 2018-10-10 Natus Medical Incorporated Sonde de test auditif
CN104814744A (zh) * 2014-02-04 2015-08-05 Gn尔听美公司 听力测试探针
CN106455987A (zh) * 2014-05-05 2017-02-22 特洛伊海伦有限公司 基于光谱分析的耳镜及耳镜检查的方法
KR102378345B1 (ko) * 2014-05-05 2022-03-23 헬렌 오브 트로이 리미티드 검이경 및 스펙트럼 분석에 기반한 이경검사 방법
JP2017514609A (ja) * 2014-05-05 2017-06-08 ヘレン オブ トロイ リミテッド 耳鏡及びスペクトル解析に基づく耳鏡検査方法
JP2017514610A (ja) * 2014-05-05 2017-06-08 ヘレン オブ トロイ リミテッド 耳鏡及びスペクトル解析に基づく耳鏡検査方法
US20170049310A1 (en) 2014-05-05 2017-02-23 Helen Of Troy Limited Otoscope and otoscopic method based on spectral analysis
US20170049309A1 (en) * 2014-05-05 2017-02-23 Helen Of Troy Limited Otoscope and otoscopic method based on spectral analysis
US11147440B2 (en) 2014-05-05 2021-10-19 Helen Of Troy Limited Otoscope and otoscopic method based on spectral analysis
CN106455964A (zh) * 2014-05-05 2017-02-22 特洛伊海伦有限公司 基于光谱分析的耳镜及耳镜检查的方法
KR20160149206A (ko) * 2014-05-05 2016-12-27 헬렌 오브 트로이 리미티드 검이경 및 스펙트럼 분석에 기반한 이경검사 방법
AU2015258114B2 (en) * 2014-05-05 2019-11-21 Helen Of Troy Limited Otoscope and otoscopic method based on spectral analysis
US10307048B2 (en) 2014-05-05 2019-06-04 Helen Of Troy Limited Otoscope and otoscopic method based on spectral analysis
WO2015169436A1 (fr) * 2014-05-05 2015-11-12 Helen Of Troy Limited Otoscope et procédé otoscopique basé sur une analyse spectrale
WO2015169435A1 (fr) * 2014-05-05 2015-11-12 Helen Of Troy Limited Otoscope et procédé otoscopique basé sur l'analyse spectrale
AU2015258115B2 (en) * 2014-05-05 2019-11-21 Helen Of Troy Limited Otoscope and otoscopic method based on spectral analysis
CN104605861A (zh) * 2015-01-08 2015-05-13 山东大学 一种光束整形对光诱发听觉影响的测试系统和方法
US10874333B2 (en) 2015-09-15 2020-12-29 Massachusetts Institute Of Technology Systems and methods for diagnosis of middle ear conditions and detection of analytes in the tympanic membrane
WO2017049000A1 (fr) * 2015-09-15 2017-03-23 Massachusetts Institute Of Technology Systèmes et méthodes de diagnostic de troubles de l'oreille moyenne et de détection d'analytes dans la membrane du tympan
CN105996995B (zh) * 2016-05-03 2018-09-07 华南师范大学 一种基于光谱技术的中耳炎诊断系统和仪器
CN105996995A (zh) * 2016-05-03 2016-10-12 华南师范大学 一种基于光谱技术的中耳炎诊断系统和仪器
WO2019226701A1 (fr) * 2018-05-22 2019-11-28 The Regents Of The University Of California Outil de spectroscopie optique diffuse basé sur une diode électroluminescente
CN112512400A (zh) * 2018-06-01 2021-03-16 沃德诺希斯医疗技术有限公司 声学耳镜
WO2019231485A1 (fr) * 2018-06-01 2019-12-05 Otonexus Medical Technologies, Inc. Otoscope acoustique
US11445942B2 (en) 2018-06-01 2022-09-20 Otonexus Medical Technologies, Inc. Acoustic otoscope
US11206971B2 (en) 2018-08-16 2021-12-28 Cactus Medical, LLC Optical spectroscopy circuitry for assessing ear health
US11361434B2 (en) 2019-01-25 2022-06-14 Otonexus Medical Technologies, Inc. Machine learning for otitis media diagnosis
US12137871B2 (en) 2019-01-25 2024-11-12 Otonexus Medical Technologies, Inc. Machine learning for otitis media diagnosis
US11647902B2 (en) 2019-04-05 2023-05-16 University Of Utah Research Foundation Otoscope
US20220257107A1 (en) * 2019-07-26 2022-08-18 University Of Florida Research Foundation Calibrated pneumatic otoscope
US12256903B2 (en) * 2019-07-26 2025-03-25 University Of Florida Research Foundation, Inc. Calibrated pneumatic otoscope

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