throbber
United States Patent 5
`Haaret al.
`
`[54] APPARATUS FOR LIGHT REFLECTION
`MEASUREMENTS
`
`US005893364A
`
`(11) Patent Number:
`
`[45] Date of Patent:
`
`5,893,364
`Apr. 13, 1999
`
`5,598,843
`5,638,818
`
`
`..
`2/1997 Caisey et al.
`vase 600/476
`G/1997 Diab et al. ou... cecsesessesessesseeees 600/310
`
`(75]
`
`Inventors: Hans-Peter Haar, Wiesloch; Matthias
`4/1984
`0104772
`Essenpreis, Gauting; Rainer Fritsche.
`European Pat. Off.
`28 23 769 «12/1979
`Briihl, all of Germany
`Germany.
`2927814~~I/1981
`Germany .
`31 13248=3/1987
`Germany.
`Boehringer Mannheim GmbH.
`[73] Assignee:
`38 09 084AL
`9/1989
`Germany.
`Mannheim, Germany
`9103 974
`8/1991
`Germany.
`43 14 835
`11/1994
`Germany .
`[21] Appl. No.: 08/752,629
`0 631 137 A2
`12/1994
`Germany .
`43 37570=5/1995
`Germany.
`[22] Filed:
`Nov. 19, 1996
`1-138507
`5/1989
`Japan .
`2253 070=8/1992
`United Kingdom .
`[30]
`Foreign Application Priority Data
`
`FOREIGN PATENT DOCUMENTS
`
`.
`
`Nov. 29, 1995
`
`[DE]
`
`Germany ..........:.sccseene 195 44 501.5
`
`(SY) te C1. neeeeccccscccecorssecnnnnenenesenceneensens AGLB 5/00
`[52] U.S. C1. eeeeeeesecseenens 600/310; 600/476; 356/338
`[58] Field of Search 0... seein 600/3 10~317,
`600/322-324, 336. 473. 474. 476, 477;
`356/39-41, 337, 338; 435/4; 436/43
`
`[56]
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`Primary Examiner—Ruth S. Smith
`Attorney, Agent, or Firm—Nikaido, Marmelstein, Murray &
`Oram LLP
`
`[57]
`
`ABSTRACT
`
`An apparatus for light transport measurements on a test
`object with a measuring head which includes a contact
`surface for placing against an interface of the test object.
`light irradiation device with a light transmitterfor irradiating
`light through the contact surface and an interface into the test
`object, and detection device with a light receiver for detect-
`2,706,927—4195S Wo...ssseescseensnccseorssnsenenerenes 38/14
`ing light leaving the test object. The contact surface com-
`6/1987 Sakurai etal............
`350/96.27
`4,671,612
`
`ww. 357/471
`...
`4,942.48!
`7/1990 Yoshinouchi et al.
`prises at least one optically transparent light passage point
`
`5,030,000=F/1991 Kamda ou... eeesccessessessseeonsveneces 356/40
`for the light, on which a large number of rigid light-
`+. 385/120
`
`5,052,776 10/1991 Fukushimaet al.
`.
`conducting elements are arranged, wherein an optical con-
`e+. 600/316
`5,077,476 12/1991 Rosenthal .........
`
`nection with a light transmitter or light receiver assigned to
`--- 600/476
`5/1993 Gratton et al.
`a light passage point is produced by the whole of the
`wee 385/120
`11/1993 Cook ........ee
`light-conducting elements of the light passagesite.
`-- 600/476
`.
`2/1994 Dhadwal etal.
`
`-- 600/476
`9/1994 Tiemann etal. .....
`9/1996 Simonsen et al.
`........cece 128/633
`
`5,259,057
`3,284,149
`5,349,954
`5,551,422
`
`32 Claims, 5 Drawing Sheets
`
`19 18 21c
`
`21b 21a
`
`8
`
`SSSBSSSeTODLLLLA|
`re|
`
`27 16a iN 17
`RBSSESLbphSots
`NlTHAS
`TAAAAU.
`iba
`thd
`The
`8 23c
`23b 23a
`
`behhlod
`
`h
`
`26
`
`16b 22
`
`3
`aL
`
`15
`
`16
`
`on
`
`6
`
`APPLE 1015
`
`APPLE 1015
`
`1
`
`

`

`U.S. Patent
`
`Apr. 13, 1999
`
`Sheet 1 of 5
`
`5,893,364
`
`UNIT
`
`EVALU ATION
`
`LIGHT
`DETECTOR
`
`Fig. 2
`
`19 18 21 2b 20 8
`
`1
`
`S
`
`Br
`
`J
`4 ta } 20 2
`SAUESARSASSSTanWHamecniy
`MnIS
`LTrNEclheathaaththahathethanthrathnaifheleneRinseMeathMendelMhPhaiMeventeredMakadhallmyadhtheeslghha1NY
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`VAMAMMAK
`
`J
`
`L
`
`thb
`lhe
`23 3c 23b
`
`tha
`23a
`
`3
`26 6b 22 aL
`
`15
`
`16
`
`2
`
`

`

`U.S. Patent
`
`Apr. 13, 1999
`
`Sheet 2 of 5
`
`5,893,364
`
`
`
`Fig. 3 2ic=2b2Ta
`
`Fig. 4
`
`Fig. 6
`
`3
`
`

`

`U.S. Patent
`
`Sheet 3 of 5
`
`Apr. 13, 1999
`
`5,893,364
`
`4
`
`

`

`USS. Patent
`
`Apr. 13, 1999
`
`Sheet 4 of 5
`
`5,893,364
`
`Lore
`Zamnifeleeey
`
`
`
`

`
`
`ie}=COar=—s
`;TSLE=Yi}AASS
`
`
`
`
`
`
`
`
`aE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`04
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`NENUbeiol;ii1/WV,G:A61V/aWY}WYVz~LLL
`=53=j\Sor]7isoEER
`Aty/\AssC5a]=/)aacesZaee:SSCLSee)
`A,
`99Gg:eeMITTMTTToyareneoTLobelmn
`
`5
`
`
`
`
`
`

`

`U.S. Patent
`
`Apr. 13, 1999
`
`Sheet 5 of 5
`
`5,893,364
`
`
`
`Fig. 9
`
`6
`
`

`

`5.893.364
`
`1
`APPARATUS FOR LIGHT REFLECTION
`MEASUREMENTS
`
`FIELD OF THE INVENTION
`
`1. Background of the Invention
`The invention relates to an apparatus for light transport
`measurements with a measuring head which comprises a
`contact surface for placing against an interface of the test
`object.
`2. Description of the Related Art
`A particularly importantfield of application is light trans-
`port measurements on test objects which scatter the light
`strongly, in particularly on biological tissue, above all the
`skin of humansor animals. Light reflection measurements
`on the skin are mainly performed in medical-analytical
`investigations. A large number of methods have been pro-
`posed in which light of varying wavelengths (from the UV
`at about 200 nm up to the infrared at about 2500 nm) is used.
`Where methods of this kind are used for the analytical
`determination of the concentration of substances contained
`in the tissue (analytes). they are generally based on the
`principles of spectroscopy. Examples of such methods are
`described in EP-0 104 772 A2 and the printed publications
`cited there.
`
`A commonfeature of these methods is that light leaving
`a light transmitter (“primary light”) is irradiated through the
`contact surface of the measuring head andaninterface of the
`test object (in the case of the skin throughits surface) into
`the test object and light leaving the test object through an
`interface after interaction with said test object (“secondary
`light”) is detected. Thin test objects (for example the ear
`lobes) can be transilluminated by the light, i-e. the detection
`of the secondary light takes place at an interface which lies
`opposite the irradiation interface (“transport measurement”).
`A suitable light
`transport measuring instrument has two
`contact surfaces which are placed against the two opposite
`interfacesof the test object (cf. e.g. U.S. Pat. No. 2,706,927).
`The present invention can be realized on one or on both of
`the contact surfaces.
`
`The invention is particularly suitable for light transport
`measurements in which the irradiation of the primary light
`and the detection of the secondary light take place at the
`same interface. This is commonly called a measurement“in
`reflection”, although there is no reflection in the strict sense
`at the skin surface. Rather the light is also in this case
`irradiated into the inside of the test object where it travels
`from the irradiation site to a detection site, the light transport
`being determined by absorption and scattering in the test
`object. Such an apparatus can be designated as a contact
`reflectometer.
`In recent times contact reflectometers have also been used
`for methods which do not operate according to spectroscopic
`principles. For example, in WO 94/10901 a method and a
`corresponding contact reflectometer are described. which
`permit the analysis of glucose on the basis of the scattering
`properties in the tissue.
`The inventionis suitable for but is not limited to these and
`similar methods.
`It can in general be used successfully
`wherever light transport measurements have to be performed
`in direct contact with the test object and with particularly
`high accuracy. Non-biological test objects for which the
`invention is suitable are for example test strip surfaces
`whosecolor is characteristic of a particular analyte concen-
`tration.
`
`In order to permit the passage of the light. at least one
`partial area of the contact surface is optically transparent.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`45
`
`30
`
`55
`
`65
`
`2
`Sucha transparent section will be referred to here as the light
`passage site. In general separate light passage sites are
`provided in the contact surface for the irradiation of the
`primary light and for the detection of the secondary light.
`The accuracy requirements ofa suitable measuring device
`for the above-mentioned medical-analytical applications are
`extremely high. The total change in the secondary light as a
`function of the concentration of the analyte in the entire
`medically relevant concentration range is often only a few
`per cent. In order to determine the analyte concentration
`with sufficient accuracy from these small changes, a mea-
`suring accuracy of the reflectometer in the order of some
`0.1% is required. The main concern is the stability and
`long-term reproducibility of the measurement. Thusit is
`mostcritical that a particular light flux of the secondary light
`leaving the test object leads to the sameelectrical signal with
`maximum long term accuracy(at least over several hours, if
`possible over several days). In many cases such devices are
`to be provided to patients for the individual monitoring of a
`critical analyte (in particular glucose). Despite the high
`requirements, therefore, they must be manufactured at low
`cost.
`
`SUMMARY OF THE INVENTION
`
`The invention therefore addresses the problem to
`improve,
`in the case of an apparatus with the features
`explained above. the measuring accuracy in particular as
`regards the reproducibility of the link between the secondary
`light flux and the measured signal.
`The problem is solved for such a measuring device by the
`fact that the at least one light passage site in the contact
`surface comprises a large numberof rigid light-conducting
`elements, wherein the whole of the light-conducting ele-
`ments of a light passage site forms an optical connection
`with a particular light transmitter or light receiver assigned
`to the light passagesite.
`Thus the optical connection between the test object and a
`light receiver (detector) and/or between the test object and a
`light transmitter is produced in each case by a light passage
`site which is assigned to the respective transmitter/receiver.
`A plurality of light transmitters can be assigned to one light
`passagesite, as will be explained below. In certain circum-
`stances a plurality of receivers can also be assigned to one
`light passage site. This is expedient. for example, if a range
`of wavelength is used in which two different
`types of
`detector have to be used for different sections of the spec-
`trum (“tandem detector”).
`According to the invention the primary light leaving a
`particular light transmitter and/or the secondary light passed
`to a particular light receiver (detector) at the light passage
`site does not pass through an unsealed opening in the contact
`surface and is also not
`transmitted by a single light-
`conducting element, for example a light-conducting rod. but
`by a large number of light-conducting elements. Preferably
`at least 100, particularly preferably at
`least 1000.
`light-
`conducting elements are provided at a light passagesite. in
`particular at sites which are assigned to a light receiver. It is
`furthermore important that the light-conducting elements are
`rigid,
`i.e. no flexible light-conducting fibers shall be
`involved, as have been used on a large scale to date.
`In the known methodsthe light passage sites often have
`very small dimensions. A point-shaped light passage site of
`0.5 mm diameter can in the case of the invention neverthe-
`less comprise over 1000, possibly even about 10000. light-
`conducting elements. The elements preferably have a very
`small cross-section of less than 0.01 mm*. particularly
`preferably less than 0.002 mm*.
`
`7
`
`

`

`5,893,364
`
`3
`Suitable light-conducting elements which are packed
`closely parallel
`to one another, and are therefore rigid
`despite an extremely small cross-section. are manufactured
`as so-called fiber optic plates.
`The inventors have found that, when light-conducting
`elements according to the prior art are arranged between the
`opto-electronic converters (light
`transmitters and light
`receivers) and the test object, even extremely small
`mechanical changes in the sensor system or at the contact
`point with the interface of the test object (in particular of the
`skin surface) in many cases cause signal variations which
`are far higher than the desired measuring accuracy of about
`0.1%. Therefore it is often not possible to determine the
`desired analytical result in the medium with sufficient accu-
`racy or long term stability.
`The invention far better ensures that always the same
`fraction of the photons leaving the transmitter actually
`passes into the test object and—with the test object
`unchanged—-a likewise identical
`fraction passes to the
`detector after leaving the test object through the interface.
`Theoptical stability is in particular improved with respect to
`interference caused by minor irregularities at the surface of
`the test object (skin surface). At the same time the contact
`surface is closed, so that the interior of the measuring head
`is protected. Finally, the invention allows both the irradia-
`tion and the detection to be limited very precisely to par-
`ticular sections of the skin surface (“irradiation site” and
`“detection site” as defined in WO 94/10901).
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The invention will now be explained in detail by means of
`embodiments shown in the figures, where
`FIG. 1 showsa block diagram,partially in section, of an
`apparatus according to the invention,
`FIG. 2 showsa block diagram in cross-section of the main
`parts of a measuring head suitable for the invention,
`FIG. 3 shows a view onto a detector arrangement,
`FIG. 4 shows a highly magnified and abstract represen-
`tation explaining optical features critical for the invention,
`FIG. § shows an exploded view of the optical unit of a
`contact surface module for the invention,
`
`FIG. 6 showsa perspective view of a part of alternatively
`usable light irradiation means and
`FIG. 7 shows an exploded view of a contact surface
`module using a modified optical unit.
`FIG. 8 shows a cut-out view—partially in section and
`partially in perspective—of a further embodiment of the
`contact surface module.
`
`FIG. 9 shows a perspective view of the contact surface
`module of FIG. 8 in which the semi-conductor layer is
`shownin upright position to make its underside visible.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`
`The contact reflectometer shown in highly diagrammatic
`form in FIG. 1 consists essentially of a measuring head 1 and
`a signal processing and evaluation unit 2.
`The measuring head is in contact via contact surface 3 of
`a sample contact plate 4 with aninterface 5 of the test object
`6. Light irradiation means labeled overall as 7 and detection
`means 8 are located in the measuring head 1. They contain
`a light transmitter 20 (preferably a semiconductor light
`transmitter, in particular a light-emitting diode) and light
`detectors 21 (preferably semiconductor detectors, in particu-
`
`4
`lar photodiodes, phototransistors or avalanche-type
`photodiodes), which are connected to the signal processing
`and evaluation unit 2 via electrical leads 9 and 10 and a cable
`11.
`
`For the passage of the light the contact surface 3 (and the
`sample contact plate 4 as a whole) comprises light passage
`sites. wherein in the case shown onelight passagesite 13 is
`provided for the primary light irradiated into the test object
`6 and twolight passage sites 1da. 145 are provided for the
`detection of secondary light leaving the test object 6. The
`position and size of the respective primary light passage site
`13 (primary light passage location) and of the secondary
`light passage sites 1da and 14b (secondary light passage
`location} determines the site on the interface at which the
`light is irradiated into the test object (“irradiation site”) or
`from which emerging light is detected (“detection site”).
`The signal processing and evaluation unit 2 contains the
`electronic meansfor activating the light irradiation means 7
`and for deriving desired information concerning the inside
`of the test object 6 from theelectrical signals (test signals)
`generated by the detection means §. As already explained.
`the inventionis suitable for a large number of such methods
`and the signal processing and evaluation unit 2 contains the
`means respectively required for this purpose and explained,
`for example. in the publications mentioned above. Such
`means generally include electronic amplifier circuits (for
`example a lock-in amplifier) for the analog processing of the
`test signal of the detection means, together with a digital
`signal processing unit based on a microprocessor coupled
`thereto.
`
`FIG, 2 shows special features of the invention in highly
`abstract form. The contact plate 4 includes an optical fiber
`plate 16, which consists of a large number of closely packed.
`relatively short rigid light-conducting elements 15, in the
`form of optical fibers, running perpendicular to the contact
`surface 3. The length of the fibers. and hence the thickness
`of the optical fiber plate 16. preferably is not more than 5
`mm, particularly preferably not more than 2 mm. A thick-
`ness of about 1 mm has proven particular suitable.
`In the embodiment shown the optical fiber plate 16 is
`fitted directly between the walls of the housing 17 of the
`measuring head 1 in such a waythat it seals off the housing
`17 completely from thetest object 6. It is bonded directly to
`a semiconductor layer 19 by means of an index-adapted
`adhesive 18 said layer comprising at suitable points light-
`sensitive areas in the form of silicon detectors 21
`(photodiodes). This can be seen in overhead view in FIG.3.
`In the case shown,three detectors (light receivers) 21a, 21b
`and 21c are provided. Recesses are provided in alignment
`with these detectors. namely in a mask 22 which can be
`located optionally on the detector-side surface 16a or the
`sample-side surface 16b of the optical fiber plate 16. In the
`shown embodiment a covering layer 23 is provided on the
`sample-side surface 16b, which layer forms the mask 22 and
`comprises at
`the light passage sites 14a, 14b and 14c
`transparent partial areas 23a, 23b, 23c of an antireflection
`coating. while the remaining surface consists of black paint.
`The mask comprises a further transparent partial area 24,
`which defines the light passage site 13 for the irradiation of
`the light.
`The light irradiation means 7 and the detection means 8
`are carried by a printed circuit board 25 positioned between
`the walls of the housing 17. A recess 26 is provided in the
`fiber plate 16,
`through which connecting wires 27 are
`guided, which connect the detector contacts on the silicon
`layer 19 with the conductors of the printed circuit board 25.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`45
`
`50
`
`55
`
`65
`
`8
`
`

`

`5.893.364
`
`5
`In the context of the invention it has been found that a
`mechanically stable construction of the optical unit is critical
`for the desired high measuring accuracy. Consequently a
`compact type of design is particularly preferred in which the
`following construction elements shown in FIG.2 are real-
`ized individually or in combination with one another:
`At least the detection sites, but preferably also the irra-
`diation sites, are provided in a single. common fiber
`plate 16.
`The mask 22 is connected firmly to the fiber plate. As an
`alternative to the coating mentioned above, a selec-
`tively black-tinted glass plate. which is bonded to the
`optical fiber plate 16 by mastic or by a hot melt process
`is also suitable as the mask and as the test-object-side
`seal of the fiber plate 16.
`The detectors are connected firmly and immovably to the
`detector-side surface 16a of thefiber plate, in particular
`by bonding or a similar permanent fixing method.
`The detectors 21 are arranged on a common semiconduc-
`tor substrate 19. Thereby an identical characteristic
`curve of the detection sensitivity is obtained. Bonding
`of the semiconductor plate to the fiber plate in addition
`improves the mechanical and optical stability.
`Three light-conducting elements 15 can be seen in FIG. 4
`in a view which is highly magnified and not to scale. Two
`light beams are shown diagrammatically, wherein the light
`beam 29 symbolizes the path of photons which emerge at an
`angle a of virtually 90°. referred to the interface 5, and
`therefore impinge on the walls 30 of the light-conducting
`elements 15 at an acute angle B, while the light beam 31
`leaves the interface 5 at a more acute angle a. so that the
`angle of incidence B of the photons on the wall 3 is greater
`in this case. In the invention the optical conditions of the
`light
`transmission in the light-conducting elements 15
`should be such that the:light is fully reflected at the walls of
`the light-conducting elements 15 down to very small angles
`of emergence & (i.e. up to the highest possible angles of
`incidence B of the light beams on the walls 30). This
`property is termed the numerical aperture NA: NA=n-sin B.
`In technical terms the optical aperture is determined—in the
`case ofthe rigid light-conducting elements used according to
`the invention—by the reflection properties at the elements’
`walls, which in turn depend on the ratio of the refractive
`indices at the wall and the possible existence of an additional
`reflective layer on the wall. Preferably the light-conducting
`elements have a numerical optical aperture of more than 0.5.
`The photons emerge from a strongly scattering test object
`6 isotropically (ie. uniformly distributed across a wide
`angular range) through the contact surface 5. As a result of
`the optical conditions prevailing in the invention, all these
`photonsoratleast a fraction thereof, which is constantin the
`long term arrive at the respective detector 21.
`The light-conducting elements of a light passage site
`conduct the light separately from one another, and are thus
`essentially insulated optically from one another. If the opti-
`cal insulation is incomplete, the measuring accuracy and
`reproducibility is affected, although perfectly good results
`are achieved with an optical crosstalk of less than 20%,
`whereas on the other hand an optical crosstalk of less than
`1% can be obtained without any difficulty even with the
`extremely close arrangement of rigid light-conducting ele-
`ments in an optical fiber plate.
`The optical insulation of the light-conducting elements 15
`is symbolized in FIG. 4 by gaps 32. In an actual fiber plate
`16 the light-conducting elements 15 are packed far more
`densely than shownin FIG.4. and the gaps 32 are therefore
`much smaller.
`
`16
`
`20
`
`25
`
`30
`
`35
`
`45
`
`50
`
`55
`
`65
`
`6
`In the optical unit 39 shown in FIG. § which formsa part
`of a contact surface module and which is suitable in par-
`ticular for analytical investigations of human skin. an optical
`fiber plate 16 is sandwiched between two masks 40, 41.
`wherein both masks 40. 41 comprise at the same points of
`the surface of the fiber plate 16 (therefore in alignment with
`one another), transparent partial areas 23a, 23b, 23c for
`detectors 21@. 21d, 21c, and a transparent partial area 24 for
`the irradiation of light. The masks 40, 41 can consist of black
`ink which is applied by screen-printing. Particularly prefer-
`ably a photosensitive layer is used for the mask. in which the
`optical openings are produced by an exposure process (as
`with the manufacture of semiconductor boards). This
`method can be easily incorporated in the manufacturing
`process. No changeof the production tool is necessary after
`generating the mask layer. Therefore, precise assembly is
`facilitated.
`The use of two masks on both sides of the fiber plate 16
`is advantageous. The mask on the detector-side surface 16a
`of the fiber plate 16 can be generated with particular high
`precision and this method step can be incorporated in the
`manufacturing process as described. On the other hand a
`dark mask on the sample-side surface 16 of thefiber plate
`16 is often also advantageous—irrespective of the precise
`position of the light passage sites—in order to absorb light
`components which leave the sample surface between the
`irradiation and detection sites. Such a mask can be produced
`with slightly less precision and be applied for example by a
`printing method.
`In FIG. § the detector-side fiber plate 41 comprises an
`additional recess 42 for accommodatingthe electrical wiring
`for the connection between the detectors 21a, 21b. 21¢ and
`the measurementelectronics.
`In the embodiment shown in FIG. 5 the light irradiation
`means 7 are so constructed that light of a plurality of
`different wavelengths can be irradiated at a single point in
`the test object which is defined by the transparent point 24
`in the masks 40, 41. To this end four light-emitting diodes
`46 to 48 are arranged within an Ulbricht cylinder 44, which
`is closed in a downward direction (towards the fiber plate
`16) by a layer 45 silvered on its inside. The light emitting
`diodes radiate light of different wavelengths and are secured
`to a covering plate 50 closing the Ulbricht cylinder in an
`upward direction.
`Instead of the Ulbricht cylinder 44 another optical ele-
`ment can be used, which causes the light from the various
`light-emitting diodes 46 to 49 to impinge as isotropically as
`possible at the same point on the surface ofthefiber plate 16.
`An optical element of this kind is termed a “beam com-
`biner”. Preferably a beam-combiner element suitable for the
`invention should comprise an optical cavity whose walls
`reflect (diffusely or specularly), so that the light emerging
`from light transmitters which are attached at various points
`on the walls of the cavity is distributed isotropically in the
`cavity.
`The dimensionsof the cavity in relation to the maximum
`light exit distance (distance between the light exit points
`furthest from one another) of the light transmitters are
`important for a sufficiently isotropic light distribution. Pref-
`erably the minimum distance of the light transmitters from
`the light exit opening of the beam-combiner element(i.e.
`from the light entry opening of the assigned light passage
`site) should be three times as great and the minimum mean
`diameter of the cavity should be at least twice as great as the
`maximum light exit distance. The optical cavity of the
`beam-combiner element does not necessarily have to be
`empty. For example, a truncated-cone-shaped componentof
`
`9
`
`

`

`5,893,364
`
`7
`a transparent plastics material is suitable, which forms a
`conical light conductor 51 that is silvered on its generated
`surface 52 in order to achieve a diffusion effect. A beam
`combiner of this kind is shown in FIG.6.
`The embodiment shown in FIG. 5 with one light passage
`site for the primary light and a plurality of light passage sites
`for the secondary light makes it possible to determine the
`reflection properties of a test object for several differenttest
`distances between the respective irradiation site of the
`primary light and the respective detection site of the sec-
`ondary light. This is advantageous in particular with inves-
`tigations in which not only the optical absorption behaviour
`(absorption coefficient 1,). but also the scattering behaviour
`of the test object (scattering coefficient 1,) is to be investi-
`gated. Such methods are described in the international patent
`applications WO 94/10901, WO 95/12348 and WO
`95/324 16. It can alternatively also be advantageous to work
`with a plurality of inradiation sites and only one detection
`site or with a combination of several irradiation and several
`detection sites.
`In the contact plate module shown in FIG. 7 the optical
`unit 39 comprises for example two beam combiners as part
`of the light irradiation means 7a. 7b. Two transparent areas
`24a, 24b are provided accordingly for the primary light on
`the underside ofthe fiber plate 16, which define two different
`irradiation sites on the skin surface. In addition five trans-
`parent areas 23 are provided for the detection. corresponding
`to five different detection sites on the skin surface.
`FIG. 7 shows furthermore a suitable structural arrange-
`ment in which the fiber plate 16 is located in a corresponding
`recess 54 in a skin contact plate 55, which preferably is made
`from metal or glass. Such an arrangement, in which only a
`part of the skin contactplate consists of an optical fiber plate,
`is advantageous with respect to the cost. For example, the
`optical unit 39 may be connected as shown to the skin
`contact plate 54 in a firm and stable manner by means of a
`holding plate 56 and screws 57.
`In the embodiment of FIG. 7 two light sources (light
`irradiation means 7a and 7b) are assembled together with a
`plurality of detectors to a commonoptical fiber plate 16. The
`invention allows configurations of this kind with a plurality
`of irradiation sites and a plurality of detection sites which are
`of particularly compact design and simultaneously excellent
`measuring accuracy. In this way a chessboard-type arrange-
`ment of many irradiation sites and detectionsites is possible
`with a relatively simple design.
`Such an embodiment is shown in FIGS. $ and 9 which
`also show further preferred embodiments which can be used
`individually or in combination.
`FIG, $ showsa cout-out of a sample contact plate 4 which
`consists of an optical fiber plate 16 and a silicon semi-
`conductor layer 19 which is bonded to fiber plate 16 by
`means of a layer 18 of index-adapted adhesive. As in FIG.
`2, detectors 21 are integrated into semi-conducting layer 19.
`Aplurality of detectors 21 (in this case 6x6 detectors having
`a surface area of 0.25~0.25 mm each) are arranged on the
`underside 19a of layer 19 in a chessboard-type arrangement
`having a dimension of 10 mm.
`In this embodiment also light-transmitters 20 are fixed to
`semi-conducting substrate 19, namely by bonding to its
`upper surface 19d. They are contacted by a wirebond-
`method and connected via thin layer leads 60 and contacts
`61 to the signal processing and evaluation unit2. In a similar
`manner as in the embodimentof FIG.5 and 6, a plurality of
`light-transmitters of different wavelengths—embodied as
`light-emitting diodes—are provided for each light passage
`site 13 of the primary light. These radiate the light essen-
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`45
`
`50
`
`55
`
`65
`
`8
`irradiation is
`Isotropical
`tially sidewards and upwards.
`accomplished by means of a beam combiner element 62.
`The optical cavity of the beam combiner is in this case
`closed by a reflecting dome-shaped cover.
`At each light passage site 13 for the primary light, a light
`passage channel 63 between the surfaces of silicon layer 19
`is provided via which the primary light travels to the light
`passage site 13. The inner surface of channel 63 is light-
`reflecting by means of a metallization. Alternatively. also a
`light-guiding rod which is inserted into a bore of a silicon
`layer could be used. In this case, the inner side of the bore
`should have a light-absorbing coating.
`A further special feature of the embodiment shownrefers
`to the fact that at each light passage site a surface-light
`barrier 65 is provided. It is formed by an optical locking
`ditch. This is a ring-shaped groove which is provided (for
`example by engraving) in the upper surface offiber plate 16,
`the depression being preferably filled with an optically
`absorbing substance. Thereby. optical cross-talk of the pri-
`mary light at the surface of fiber plate 16 is eliminated.
`With such optical light barriers 65 no mask on the upper
`surface of fiber plate 16 is necessary whereas on the skin-
`side of fiber plate 16 a mask 46 should preferably be present.
`As a further means for minimizing any remaining optical
`cross-talk inside fiber plate 16, a jacket 68 surrounding light
`passage site 13 and consisting of an absorbing substance is
`provided which perferably has a cylindrical shape. For |
`example, during the production of fiber plate 16, glass fibers
`of black color can be incorporated to form the jacket surface
`surrounding the light passagesite.
`We claim:
`
`1. An apparatusfor light transport measurements on a test
`object for generating medical analysis data on a concentra-
`tion of an analyte in the test object. said apparatus compris-
`ing:
`a measuring head, said measuring head including a con-
`tact surface for contacting an interface of the test
`object;
`at least one light irradiation means connected to the
`measuring head for irradiating primary light into the
`test object through the contact surface and the interface,
`said irradiation means comprising a light transmitter;
`at least one detection means connected to the measuring
`head for detecting secondary light emerging from the
`test object through theinterface and the contact surface,
`said detection means comprising a light receiver; and
`a signal processing unit connected to the detection means
`for processing a signal which is output by the detection
`means to yield an analytical result, wherein said ana-
`lytical result corresponds to the concentration of the
`analyte in the test object,
`wherein said contact surface includes at least one opti-
`cally transparent primary light passage means for con-
`ducting light therethrough from said light transmitter to
`which it is optically connected, and at least one opti-
`cally transparent secondary light passage means for
`conducting light therethrough to said light receiver to
`which it is optically connected, wherein a size and
`position of a site on the int

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket