EXHIBIT 2118
`EXHIBIT 2118
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`(12) United States Patent
`US 6,358,216 B1
`(10) Patent N0.:
`Kraus et al.
`Mar. 19, 2002(45) Date of Patent:
`
`
`U8006358216B1
`
`(54) APPARATUS FOR TAKING
`MEASUREMENTS IN THE EAR
`
`(75)
`
`Inventors: Bernhard Kraus, Braunfels; Elke
`Kahler, Griesheim; Alexander Klijs,
`Hofheim; Horst Mannebach, Butzbach,
`all of (DE)
`
`(73) Assignee: Braun Aktiengesellschaft, Frankfurt
`am Main (DE)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) Appl. No.: 09/335,141
`
`(22)
`
`Filed:
`
`Jun. 17, 1999
`
`(30)
`
`Foreign Application Priority Data
`
`Jan. 19, 1998
`
`(DE)
`
`......................................... 198 27 343
`
`(51)
`Int. Cl.7 .................................................. A61B 5/00
`
`(52) US. Cl. .................... 600/549; 600/559
`(58) Field of Search ................................. 600/549, 559;
`73/585
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`2/1986 Heller
`4,567,881 A
`7/1994 Pompei
`5,325,863 A
`5/1995 Arenberg
`5,419,312 A
`10/1997 Schulze
`5,673,692 A
`8/1998 Hilton, Jr.
`5,790,586 A
`.............. 600/549
`6/1999 Jenkins et al.
`5,919,143 A *
`FOREIGN PATENT DOCUMENTS
`
`JP
`JP
`WO
`WC
`
`07286905
`09005167
`9623442
`9801730
`
`10/1995
`1/1997
`8/1996
`1/1998
`
`OTHER PUBLICATIONS
`
`PCT search report in German.
`
`* cited by examiner
`
`Primary Examiner—Max Hindenburg
`(74) Attorney, Agent, or Firm—Hopgood, Calimafde,
`Judlowe & Mondolino LLP
`
`(57)
`
`ABSTRACT
`
`The invention is directed to an apparatus for taking mea-
`surements in the ear, having a positioning aid enabling a
`probe head (10) of the apparatus to be properly aligned in a
`user’s auditory canal (12). The apparatus of the present
`invention comprises a source of radiation (24) emitting
`energy particularly in the visible region, a photodetector (30)
`suitable for sensing this radiation, and an associated evalu-
`ation unit and, where applicable, an indicating unit for
`representing the alignment of the probe head in the auditory
`canal (12). This canal receives the radiation from the radia-
`tion source (24), with part of the radiation being scattered
`back into the probe head (10) and sensed by the photode-
`tector (30). In this arrangement, the radiant power sensed is
`dependent on the mean distance between the reflecting tissue
`and the probe head (10), with a minimum radiant power
`corresponding to a correct alignment of the probe head (10)
`to the rear auditory canal (12) and hence to the tympanic
`membrane (38). The output signal of the photodetector (30)
`preferably controls the frequency and/or volume of an
`audible signal informing the user of the optimal alignment of
`the probe head (10), so that the repeat accuracy of the
`measurement results is improved.
`
`EP
`
`0 588 631
`
`3/1994
`
`60 Claims, 3 Drawing Sheets
`
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`US. Patent
`
`Mar. 19, 2002
`
`Sheet 1 013
`
`US 6,358,216 B1
`
`F ig. 1
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`28
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`US. Patent
`
`Mar. 19, 2002
`
`Sheet 2 0f3
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`US 6,358,216 B1
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`US. Patent
`
`Mar. 19, 2002
`
`Sheet 3 0f3
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`US 6,358,216 B1
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`23
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`g#1
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`10
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`28
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`

`US 6,358,216 B1
`
`1
`APPARATUS FOR TAKING
`MEASUREMENTS IN THE EAR
`
`This invention relates to an apparatus for taking mea-
`surements in the ear, having a probe head insertable into the
`ear canal and an indicating unit. Measuring apparatus of this
`type which include, for example, infrared radiation ther-
`mometers or ear reflectometers, are known in the art.
`From WO 98/01730 an infrared thermometer having a
`visual marking system is known, which enables a user
`during a temperature measurement
`to maintain a given
`distance between the probe head and the object of measure-
`ment.
`However, the art also knows of infrared radiation ther-
`mometers for determining the temperature of a human body,
`whose probe head which is equipped with a radiation inlet
`is insertable into the ear canal and capable of measuring the
`infrared radiation emitted by the tympanic membrane. Con-
`sidering that blood supply to the tympanic membrane is the
`same as to the temperature center in the brain, this radiation
`is representative of the true core temperature of the human
`body.
`Because a difference typically exists between the tym-
`panic temperature to be measured and the temperature of the
`surrounding ear canal tissue, it is necessary for the probe
`head to be correctly aligned relative to the tympanic mem-
`brane for temperature measurement precision. However, this
`is not always ensured because bends in the ear canal or
`frequently occurring natural irregularities (exostoses) may
`block the free view at the tympanic membrane. Hence the
`measurement result is appreciably affected by the geometry
`of the respective ear canal so that more or less significant
`errors may be introduced. Even a subjectively correct seat of
`the probe head is no guarantee of a correct alignment to the
`tympanic membrane, because in the worst case a partial
`obstruction of the radiation inlet by a skin fold is suflicient
`to make the measured temperature severely dependent on
`the direction, producing conventionally an erroneous read-
`ing not noticeable by the user with a poor repeatability.
`When the probe head is accidentally placed directly on the
`ear canal tissue, errors may also be introduced which pretend
`an excessively low body temperature.
`To solve this problem, it is proposed in US. Pat. No.
`5,325,863 to provide the user with an audible reply indica-
`tive of the quality of positioning. Thus the known ear canal
`thermometer invariably takes several measurements, and it
`possesses an audible signal detector delivering a tone as the
`probe head is inserted in the ear canal whenever the mea-
`sured temperature value is higher than a previous measure-
`ment value. In this arrangement, however, the evaluation of
`the regions whose temperature is sensed depends on chance,
`and there is no possibility of checking whether the tympanic
`membrane as the region with the overall highest temperature
`has been included in the evaluation and the body core
`temperature correctly detected. Furthermore, errors intro-
`duced due to direct placement of the probe head onto tissue
`cannot be detected and, accordingly, cannot be corrected
`either when a measurement is taken.
`
`The problems involved in properly aligning the probe
`head in the ear canal are precisely the same when the
`impedance of the tympanic membrane is measured using an
`ear reflectometer capable of determining accumulations of
`liquid in the tympanum. To this end, sound waves are
`emitted at different frequencies, and the sound waves
`reflected by the tympanic membrane are recorded and evalu-
`ated.
`
`invention to
`is therefore an object of the present
`It
`provide an apparatus for taking measurements in the ear,
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`with which erroneous readings due to an insuflicient align-
`ment of the probe head to the tympanic membrane can be
`avoided.
`
`According to the present invention, this object is accom-
`plished by an apparatus having a device for determining the
`alignment of the probe head in the ear canal.
`This device comprises a source of radiation emitting
`electromagnetic radiation to be passed to the measurement
`spot targeted by the probe head of the apparatus, a detector
`responding in the corresponding wavelength region for
`sensing the radiation scattered by the measurement spot, and
`an evaluation unit arranged downstream of the detector for
`determining the alignment of the probe head in the ear canal.
`The device may further include an indicating unit to repre-
`sent the alignment.
`In a preferred embodiment of an apparatus of the present
`invention, the source of radiation is a light source emitting
`energy preferably in the visible region or in the near infrared
`region, the detector then being a photodetector.
`To preclude the effects of the radiation passed into the ear
`canal on the measurement, the mean intensity of the radia-
`tion source is selected suitably low so that in particular
`heating of the ear canal is prevented. This is accomplishable
`preferably by the use of a pulsed radiation source and a
`detector circuit synchronized with it. The power consump-
`tion of a pulsed radiation source is less than that of a source
`which is not pulsed, which presents an advantage particu-
`larly where battery-powered apparatus are used. In addition,
`a pulsed radiation source also enables the radiation back-
`ground to be determined.
`An apparatus of the present invention advantageously
`includes a first radiation guide, in the above embodiment a
`light guide, which directs the radiation emitted from the
`radiation source to the measurement spot, that is, the radia-
`tion is given off at the end of the radiation guide close to the
`measurement spot, radiating into the ear canal. The radiation
`may be focused or, alternatively, it may form a widening
`radiation cone. Upon striking tissue, the radiation is reflected
`diffusely, causing part of it to be passed to the detector either
`via the same or a second radiation guide. The intensity of the
`radiation sensed by the detector is dependent on the mean
`distance between the reflecting tissue and the probe head.
`Therefore, when the probe head is improperly aligned, a
`relatively high percentage of the radiation, upon diffusion on
`the walls of the ear canal, is again coupled in the probe head
`and sensed in the detector, whilst in the presence of a correct
`alignment of the probe head to the rear auditory canal and
`the tympanic membrane, only a minimum amount of radia-
`tion is sensed. This enables severe erroneous readings to be
`detected as they may occur, for example, when the probe
`head is placed directly onto the tissue.
`In the above-described use of two radiation guides, the
`occurrence of indicating errors due to direct overcoupling of
`the emitted radiation to the detector is precluded.
`In another embodiment of a measuring apparatus of the
`present invention, the first radiation guide is omitted. In this
`arrangement the radiation source is disposed at the extreme
`forward end of the probe head.
`To instruct the user with regard to a proper alignment of
`the probe head, it is possible for the probe head alignment
`to be indicated visually and/or audibly. For this purpose, the
`device of the present invention measures the amount of
`diffuse radiation continuously, that is, preferably as early as
`the moment when the probe head is inserted into the ear
`canal. Preferably, the indicating unit comprises a device for
`producing an audible signal whose volume and/or frequency
`is/are controlled by the output signal of the detector. Shortly
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`US 6,358,216 B1
`
`3
`upon inserting the probe head into the auditory canal, the
`user of an apparatus of the present invention receives a direct
`reply indicative of the optimum alignment of the probe head
`to the tympanic membrane or at least to the region of the rear
`auditory canal. This indication causes the user to align the
`probe head nearly alike for each measurement, so that good
`repeatability of the measurement results is obtained.
`The indicating unit comprises, for example, a voltage-
`controlled oscillator driven by the output signal of the
`detector and having a loudspeaker connected thereto. Any
`variation of the detected radiant power then effects an
`increase or decrease in the oscillation frequency and/or
`oscillation amplitude, so that the user hears a correspond-
`ingly changing tone when aligning the thermometer in the
`ear canal. Proper alignment of the probe head is achieved
`when the tone with the lowest (or highest) frequency and/or
`amplitude sounds.
`To facilitate a measurement by third persons, another
`embodiment makes provision for the indicating unit
`to
`comprise a visual display, in particular an LED line or a
`pointer instrument providing the user with a visual indica-
`tion of the proper alignment of the probe head to the rear
`auditory canal and to the tympanic membrane. This way of
`representation enables measurements to be taken on sleeping
`persons without having to disturb them by an audible signal.
`In a preferred embodiment,
`the evaluation unit of an
`apparatus of the present invention includes the added pro-
`vision of a threshold value device which activates the
`
`indicating unit for the measurement values and/or the indi-
`cating unit for representing the alignment not until
`the
`radiant power sensed in the detector has fallen below a
`predetermined threshold value. This enables the indication
`of a measurement value to be suppressed until the evaluation
`unit has sensed a satisfactory alignment of the probe head.
`Still further, the end of measurement can be indicated to the
`user when the threshold value is reached. The threshold
`
`value is fixed at a level ensuring the requisite measurement
`accuracy also with differently shaped ear canals.
`In a particularly advantageous configuration of the mea-
`suring apparatus,
`the threshold value is adapted to the
`individual diffusivity of the individual ear canal already the
`moment when the probe head is inserted into the ear canal.
`This succeeds particularly well when the user initially
`moves the probe head to and fro in the ear canal, thereby
`aligning the probe head in different directions. The threshold
`value device senses the to-and-fro movement by correspond-
`ing fluctuations in the output signal of the detector, and it
`varies the threshold value when the threshold value is not
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`reached within a predetermined measuring period in spite of
`this movement.
`
`50
`
`Wrong manipulation by placing the probe head directly
`on the tissue is assumed to be the case when the output signal
`of the detector reaches a correspondingly predetermined
`second threshold value.
`
`Two preferred embodiments of a measuring apparatus of
`the present invention involve an infrared radiation thermom-
`eter having an infrared sensor, particularly for measuring the
`temperature of the tympanic membrane, and an ear reflec-
`tometer having a sound source and a microphone, in par-
`ticular for measuring the impedance of the tympanic mem-
`brane.
`
`Infrared radiation thermometers known in the art typi-
`cally include a housing with a radiation inlet for the infrared
`radiation to be measured, and a waveguide extending from
`the radiation inlet
`to the infrared sensor. In an infrared
`
`the
`invention,
`radiation thermometer of the present
`waveguide serves the function of conveying both the infra-
`
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`4
`red radiation emitted from the tympanic membrane to the
`infrared sensor and the radiation source’s radiation reflected
`
`in the auditory canal to the detector. Therefore the infrared
`sensor and the detector are preferably disposed at the end of
`the waveguide (which hence also assumes the function of
`the second radiation guide referred to in the foregoing).
`In another aspect, provision is made for two separate
`radiation guides for passing the infrared radiation and the
`reflected radiation. Alternatively, it is possible for the infra-
`red radiation needing to be measured, for the emitted radia-
`tion and the reflected radiation to be guided in a single
`radiation guide. It is also possible to substitute an optic
`system having lenses and/or mirrors for the radiation guide
`(s).
`
`The detector is preferably arranged laterally in the end
`area of the waveguide in order to minimize its effect on the
`viewing angle and the sensitivity of the infrared sensor.
`However, the detector may also be integrated in the housing
`of the infrared sensor in which case the window material of
`
`the sensor housing is selected so that the window is trans-
`missive both to the infrared radiation and in the wavelength
`region utilized by the radiation source.
`In a particular
`configuration, the detector with the infrared sensor is inte-
`grated in a microsystem on a chip. Similarly, an integration
`of infrared sensor, detector and radiation source on a chip or
`in a housing is also possible.
`the
`invention,
`In an ear reflectometer of the present
`detector and the microphone may have a common housing.
`In a particular configuration, the detector and the micro-
`phone are integrated in a microsystem on a chip. Similarly,
`an integration of microphone, detector and radiation source
`on a chip or in a housing is also possible.
`The present invention will be described in the following
`with reference to preferred embodiments in connection with
`the accompanying drawing. Further embodiments are dealt
`with in the description. The drawing shows schematically in
`FIG. 1 a probe head of an infrared radiation thermometer
`of the present invention which is improperly aligned in a
`user’s auditory canal;
`FIG. 2 the probe head of FIG. 1 but properly aligned;
`FIG. 3 the components of the device of the present
`invention for determining the alignment of the probe head of
`an infrared radiation thermometer;
`FIG. 4 a probe head of an ear reflectometer of the present
`invention which is improperly aligned in a user’s auditory
`canal;
`FIG. 5 the probe head of FIG. 4 but properly aligned; and
`FIG. 6 the components of the device of the present
`invention for determining the alignment of the probe head
`and the components for the ear reflectometry.
`FIGS. 1 and 2 show schematically a probe head of an
`infrared radiation thermometer of the present invention as
`introduced into a user’s ear canal 12 for taking the patient’s
`temperature. As is known,
`the probe head comprises a
`housing 16 tapering conically in the direction of a radiation
`inlet 14 for the infrared radiation needing to be measured.
`The radiation inlet 14 is sealed by a radiation inlet window
`18 to protect the interior of the housing from contamination
`and damage.
`The forward end of the probe head may be covered by an
`exchangeable protective cover (not shown) to prevent in
`particular cross contamination between patients. It is made,
`for example, from a thin foil of polyethylene material.
`The infrared radiation incident in the radiation inlet 14 is
`
`conveyed in a manner known in the art through a waveguide
`20 to an infrared sensor 22. The infrared sensor 22 is
`
`connected to an electronic evaluation unit (not shown)
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`US 6,358,216 B1
`
`5
`which converts the sensed infrared radiation into tempera-
`ture information indicated by means of an indicating unit
`(not shown either) for the measurement values.
`In addition, the probe head comprises according to the
`present invention a device for determining the alignment of
`the probe head in the ear canal, said device including a light
`source 10 (FIG. 3) emitting light, for example, in the visible
`range or in the near infrared, which light 24 is directed
`through a first radiation guide 26 surrounding the waveguide
`20 concentrically to the radiation inlet 14. From there it
`radiates upon the ear canal 12 and is diffusely reflected by
`the ear canal’s walls 28, as illustrated by arrows in the
`Figures. Part of this diffuse radiation is coupled back into the
`probe head through the radiation inlet 14 and directed,
`through the waveguide 20, to a photodetector 30 disposed
`laterally in the rear part of the waveguide 20 and issuing a
`corresponding electrical signal. This signal is delivered to an
`evaluation unit
`(not shown) and,
`in an alternative
`embodiment, also to an indicating unit presenting visual
`and/or audible information to the user about the alignment of
`the probe head in the ear canal in the manner subsequently
`described. In another embodiment, the first radiation guide
`26 is at least partially disposed in the waveguide 20.
`In order to preclude an appreciable heating of the ear
`canal 12 and an attendant effect on the temperature
`measurement, the mean intensity of the light 24 radiated into
`the ear canal 12 is selected correspondingly low. To this end,
`the light source 10 is operated in the pulse mode in a manner
`known in the art, and the photodetector 30 is synchronized
`with it.
`
`In another embodiment, the photodetector 30 is arranged
`in the housing of the infrared sensor 22, with the window
`material of the sensor housing being selected such as to be
`transmissive to both the infrared radiation needing to be
`measured and the light 24 emitted by the light source 10. In
`a further configuration,
`the infrared sensor 22 and the
`photodetector 30 are integrated in a microsystem on a chip.
`In other variants, the light source 10 with the infrared sensor
`and/or detector are integrated on a chip or arranged in a
`housing.
`In a further embodiment not illustrated in the Figures, the
`light coupled into the radiation inlet 14 of the probe head,
`rather than being conveyed through the waveguide 20, is
`conveyed through an additional radiation guide to the pho-
`todetector 30 in order to avoid that the field of view of the
`
`infrared sensor 22 is possibly affected by the photodetector
`30.
`
`Because the light 24 emitted from the light source 10 in
`the probe head is conveyed in the first radiation guide 26
`separately from the radiation emitted from the ear canal in
`the waveguide 20, it is ensured that light emitted from the
`light source and reflected at the radiation inlet window 18 or
`at
`the protective cover (not shown)
`is prevented from
`reaching the photodetector 30. Therefore, even in the event
`of wrong manipulation of the clinical infrared thermometer
`of the present invention due to direct placement of the probe
`head upon tissue, its transparency to the light emitted by the
`light source operates to couple back to the photodetector 30
`only light reflected on the tissue in suflicient intensity, so that
`any misalignment of the probe head can be detected and
`avoided.
`
`Because the light radiated into the ear canal 12 is
`reflected there diffusely, the intensity of the radiation sensed
`by the photodetector 30 is dependent on the mean distance
`between the probe head and the ear canal 12. When the
`probe head is misaligned as illustrated, for example, in FIG.
`1, a relatively high percentage of the light radiated into the
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`ear canal, following diffusion on the walls 28 of the ear canal
`12, is coupled back into the probe head to be sensed in the
`photodetector 30. By contrast, with the probe head properly
`aligned in the ear canal 12 as illustrated in FIG. 2, only a
`small percentage of the light scattered on the walls 28 of the
`ear canal 12 is sensed in the photodetector 30. In this event,
`the probe head of the infrared thermometer is directed
`toward the rear ear canal 12 and the tympanic membrane 38
`so that the infrared sensor 22 receives predominantly the
`radiation from the tympanic membrane and the user’s cor-
`rect body core temperature is measured.
`the radiation
`As illustrated schematically in FIG. 3,
`source 10 emits radiation which is scattered on the walls 28
`
`of the ear canal and is passed at least in part to the detector
`30 whose output signal is amplified in an amplifier 32 and
`supplied to a voltage-controlled oscillator (VCO) 34. The
`output signal of the oscillator 34 is converted into an audible
`signal via a loudspeaker 36. Considering that a higher
`detected radiant power results in a higher-level signal of the
`photodetector 30, a correspondingly different oscillation
`frequency of the oscillator results as well. The user,
`in
`moving the probe head in his ear to and fro, then hears a tone
`of a higher and lower loudness level which is attributable to
`the resultant variation of the radiant power measured. The
`correct alignment of the probe head shown in FIG. 2 is
`achieved when the tone with the lowest or highest frequency
`sounds.
`
`On any variation of the alignment of the probe head in
`the ear the user thus receives a direct audible response
`enabling him to properly align the probe head to the rear area
`of the auditory canal 12, whose temperature corresponds to
`the temperature of the tympanic membrane 38 or departs
`from this temperature only a small amount. The device of the
`present invention thus assists the user in finding the correct
`alignment of the probe head in the ear canal and ensures,
`independently of the individual size and shape of the ear
`canal, an optimum alignment of the probe head for each
`measurement so that a good repeat accuracy of the mea-
`surement results is obtained.
`
`FIGS. 4 and 5 illustrate schematically a probe head of an
`ear reflectometer equipped with a device of the present
`invention for determining the alignment of the probe head
`inserted into an ear canal. The probe head is of a structure
`similar to the one illustrated in FIGS. 1 and 2, substituting
`however in a manner known in the art a sound source 40 and
`
`a microphone 42, which are both aligned in the direction of
`a radiation inlet 14, for the infrared sensor 22. Moreover, this
`probe head does not have a waveguide 20 but only the first
`radiation guide 26 through which radiation emitted from the
`light source 10 is guided to the radiation inlet 14. In another
`embodiment of the present invention, provision is made for
`a second radiation guide through which radiation reflected
`from the ear canal is passed to the detector 30. Alternatively,
`the emitted and reflected radiation may be guided in a single
`radiation guide. Otherwise in FIGS. 4, 5 and 6 the same
`reference characters are applied to like parts as those used in
`the FIGS. 1, 2 and 3 so that these need not be described
`again.
`FIG. 4 shows schematically a probe head improperly
`positioned in the ear canal, as a result of which the detector
`30 senses a reflected radiation of correspondingly high
`intensity illustrated symbolically by a thick arrow 48, whilst
`FIG. 5 shows a probe head in proper alignment whose
`detector 30 senses only a comparatively low radiant power
`illustrated symbolically by a thin arrow 46.
`As shown schematically in FIG. 6, in an ear reflectometer
`of the present invention a processor 44 is used for processing
`
`IPR2017—003 15
`
`CONDITIONAL MOTION TO AMEND
`
`VALENCELL, INC.
`EXHIBIT 2118 — PAGE 8
`
`IPR2017-00315
`CONDITIONAL MOTION TO AMEND
`
`VALENCELL, INC.
`EXHIBIT 2118 - PAGE 8
`
`

`

`US 6,358,216 B1
`
`7
`both the output signal of the amplifier 32 arranged down-
`stream of the detector 30 and the output signals of the
`microphone 42 which are amplified in an amplifier 32'. The
`result of the reflectance measurement is preferably shown on
`a display 50 connected to the processor 44.
`What is claimed is:
`
`1. An apparatus for taking measurements in the ear having
`a probe head insertable into the ear canal and an indicating
`unit for measured values, wherein the apparatus includes a
`device for determining the alignment of the probe head in
`the ear canal.
`
`2. The apparatus as claimed in claim 1, wherein further
`includes an indicating unit to represent the alignment of the
`probe head in the ear canal.
`3. The apparatus as claimed in claim 1 wherein the device
`for determining the alignment comprises the following com-
`ponents: a source of radiation (10) for radiating electromag-
`netic radiation of a given wavelength onto the measurement
`spot; a detector (30) for sensing the radiation scattered by the
`measurement spot; and an evaluation unit arranged down-
`stream of the detector (30) for determining the alignment of
`the probe head in the ear canal.
`4. The apparatus as claimed in claim 3, wherein the
`evaluation unit includes a threshold value device which
`
`activates one or both indicating units not until the output
`signal of the detector (30) has exceeded or fallen below a
`predetermined threshold value.
`5. The apparatus as claimed in claim 4, wherein the
`threshold value is adapted to be varied by the threshold value
`device.
`
`6. The apparatus as claimed in claim 3, wherein the source
`of radiation (10) is a light source, and the detector is a
`photodetector (30).
`7. The apparatus as claimed in claim 3, wherein the
`radiation source (10) emits pulsed radiation, and the detector
`(30) is synchronized with the radiation source (10).
`8. The apparatus as claimed in claim 3, wherein it includes
`a radiation guide, in particular a light guide (26), for the
`radiation emitted from the radiation source (10).
`9. The apparatus as claimed in claim 3, wherein it includes
`a radiation guide, in particular a light guide (20), for the
`radiation emitted from the measurement spot.
`10. The apparatus as claimed in claim 2, wherein the
`indicating unit for representing the alignment comprises a
`device for producing an audible signal whose volume and/or
`frequency is/are controlled by the output signal of a detector
`(30) for sensing radiation scattered by the measurement
`spot.
`11. The apparatus as claimed in claim 2, wherein the
`indicating unit comprises a visual display, in particular an
`LED line or a pointer instrument.
`12. The apparatus as claimed in claim 1, wherein it is an
`infrared radiation thermometer having an infrared sensor
`(22), particularly for measuring the temperature of the
`tympanic membrane, or an ear refiectometer having a sound
`source (40) and a microphone (42), in particular for mea-
`suring the impedance of the tympanic membrane.
`13. The infrared radiation thermometer as claimed in
`
`claim 12, wherein a detector (30) for sensing radiation
`scattered by the measurement spot and the infrared sensor
`(22) are disposed at the end of a second radiation guide (20).
`14. The infrared radiation thermometer as claimed in
`
`claim 12, wherein a detector (30) for sensing radiation
`scattered by the measurement spot and the infrared sensor
`(22) have a common housing.
`15. The infrared radiation thermometer as claimed in
`
`claim 12, wherein a detector (30) for sensing radiation
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`8
`scattered by the measurement spot and the infrared sensor
`(22) are integrated on the same chip.
`16. The infrared radiation thermometer as claimed in
`
`claim 12, wherein a detector (30) for sensing radiation
`scattered by the measurement spot and the microphone (42)
`have a common housing.
`17. The infrared radiation thermometer as claimed in
`
`claim 12, wherein a detector (30) for sensing radiation
`scattered by the measurement spot and the microphone (42)
`are integrated on te same chip.
`18. The apparatus as claimed in claim 14, wherein the
`radiation source (10) is arranged in the same housing as the
`detector (30).
`19. The apparatus as claimed in claim 14, wherein the
`radiation source (10) is integrated on the same chip as the
`detector.
`20. The apparatus as claimed in claim 2, wherein the
`device for determining the alignment comprises the follow-
`ing components: a source of radiation (10) for radiating
`electromagnetic radiation of a given wavelength onto the
`measurement spot; a detector (30) for sensing the radiation
`scattered by the measurement spot; and an evaluation unit
`arranged downstream of the detector (30) for determining
`the alignment of the probe head in the ear canal.
`21. The apparatus as claimed in claim 4, wherein the
`source of radiation (10) is a light source, and the detector is
`a photodetector (30).
`22. The apparatus as claimed in claim 5, wherein the
`source of radiation (10) is a light source, and the detector is
`a photodetector (30).
`23. The apparatus as claimed in claim 4, wherein the
`radiation source (10) emits pulsed radiation, and the detector
`(30) is synchronized with the radiation source (10).
`24. The apparatus as claimed in claim 5, wherein the
`radiation source (10) emits pulsed radiation, and the detector
`(30) is synchronized with the radiation source (10).
`25. The apparatus as claimed in claim 6, wherein the
`radiation source (10) emits pulsed radiation, and the detector
`(30) is synchronized with the radiation source (10).
`26. The apparatus as claimed in claim 4, wherein it
`includes a radiation guide, in particular a light guide (26), for
`the radiation emitted from the