EP2557991A2 - Dispositif et procédé permettant de déterminer un paramètre biologique, chimique et/ou physique dans un tissu biologique vivant - Google Patents

Dispositif et procédé permettant de déterminer un paramètre biologique, chimique et/ou physique dans un tissu biologique vivant

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Publication number
EP2557991A2
EP2557991A2 EP11712536A EP11712536A EP2557991A2 EP 2557991 A2 EP2557991 A2 EP 2557991A2 EP 11712536 A EP11712536 A EP 11712536A EP 11712536 A EP11712536 A EP 11712536A EP 2557991 A2 EP2557991 A2 EP 2557991A2
Authority
EP
European Patent Office
Prior art keywords
tissue
sensor
measured value
unit
parameter
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.)
Withdrawn
Application number
EP11712536A
Other languages
German (de)
English (en)
Inventor
Arno Müller
Heinz-Peter Utz
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.)
Vivantum GmbH
Original Assignee
Vivantum GmbH
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 Vivantum GmbH filed Critical Vivantum GmbH
Publication of EP2557991A2 publication Critical patent/EP2557991A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • 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, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • 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, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14558—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters by polarisation
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/21—Polarisation-affecting properties
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/27—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration
    • G01N21/274—Calibration, base line adjustment, drift correction
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47—Scattering, i.e. diffuse reflection
    • G01N21/4738—Diffuse reflection, e.g. also for testing fluids, fibrous materials
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47—Scattering, i.e. diffuse reflection
    • G01N21/49—Scattering, i.e. diffuse reflection within a body or fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0233—Special features of optical sensors or probes classified in A61B5/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/046—Arrangements of multiple sensors of the same type in a matrix array
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47—Scattering, i.e. diffuse reflection
    • G01N2021/4704—Angular selective
    • G01N2021/4709—Backscatter
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47—Scattering, i.e. diffuse reflection
    • G01N2021/4704—Angular selective
    • G01N2021/4711—Multiangle measurement
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2201/00—Features of devices classified in G01N21/00
    • G01N2201/12—Circuits of general importance; Signal processing
    • G01N2201/128—Alternating sample and standard or reference part in one path
    • G01N2201/1281—Reflecting part, i.e. for autocollimation

Definitions

  • the invention relates to a device for determining biological, chemical and / or physical parameters in living biological tissue according to claim 1 and a method for determining biological, chemical and / or physical parameters in living biological tissue according to claim 15.
  • Determining biological, chemical and / or physical parameters in living biological tissue is a fundamental necessity in the field of physiological research and medical examination methods.
  • a particular example is the identification and monitoring of blood constituents and, in particular, the determination of the blood sugar concentration.
  • the tissue must be injured and a certain amount of blood withdrawn.
  • devices are nowadays available for such invasive procedures that allow for blood sampling with minimal effort and in a relatively safe manner, some people find this uncomfortable.
  • blood collection for persons with coagulation disorders must always be accompanied by special precautions to avoid unquenchable bleeding and thus major complications.
  • a continuous monitoring of blood sugar and other blood parameters is hardly possible for such persons or only under medical supervision.
  • US Pat. No. 5,383,452 discloses a method in which the concentration of sugar in the biological Tissue caused rotation of the polarization plane is measured.
  • Blood sugar level in a tolerance test the rotation of the polarization plane can be used as a measure of blood sugar concentration.
  • German laid-open specification DE 43 14835 A1 discloses a method and a device for analyzing glucose in a biological matrix, in which light is irradiated into the matrix at one location and the intensity of the light measured within the matrix is determined. The measured intensity is then used as a measure of the glucose concentration within the matrix.
  • the noninvasive determination of the blood sugar level is thus comparatively simple because of the physically known interaction between light and glucose.
  • the determination of physical values in living tissue or the determination of laboratory values in human blood is not confined exclusively to the determination of blood sugar levels, but involves a much larger amount of values to be measured.
  • the non-invasive methods known from the prior art no longer suffice.
  • the measurement methods mentioned above reach their limits.
  • the object is achieved with a device according to claim 1 and a method according to claim 13.
  • the respective subclaims contain expedient and / or advantageous embodiments of the device and method.
  • the device according to the invention for determining biological, chemical and / or physical parameters in living biological tissue contains a power supply unit, a laser operating unit with at least one laser source directed to the biological tissue, at least one sensor unit for detecting the backscattered and / or absorbed by the biological tissue Light, a control unit, a storage and processing unit and an interface for an external data processing unit.
  • the sensor unit is designed as a planar sensor array.
  • the first sensor section forms an inner subarray and the second sensor section forms an outer subarray surrounding the inner subarray.
  • the distribution of the scattered light can be detected as a function of location.
  • the inner sub-array has a
  • the sensor unit is formed as a photometer unit with a first photometer for determining an absolute intensity of the light of the laser source and a second photometer for measuring the light scattered by the tissue.
  • the sensor unit has a switching mechanism for the demand-directed deflection of the light from the laser source to the first photometer.
  • two laser sources are provided with mutually orthogonal beam directions. As a result, the properties of the scattered light can be detected as a function of the beam direction of the incident light.
  • the laser source is expediently arranged in a hole located on the sensor array and has a beam direction inclined with respect to the detection direction of the sensor array by a tilt angle. It is advantageous if the tilt angle has a value that can be adjusted by 45 °. Thus, the scattered light generated in the tissue at a certain depth, but not the light reflected on the tissue surface light is detected by the detector assembly.
  • the first sub-array consists of at least a first single diode and the second sub-array of at least four individual diodes, which are evenly distributed around the first single diode around.
  • the sensor unit has a pressure sensor for measuring a contact pressure between the sensor unit and the tissue and / or a temperature sensor for measuring a tissue temperature.
  • a pressure sensor for measuring a contact pressure between the sensor unit and the tissue
  • a temperature sensor for measuring a tissue temperature.
  • the pressure sensor and / or the temperature sensor form a control circuit cooperating with the control unit for setting a suitable contact pressure and / or a suitable temperature value.
  • the inventive method for determining a biological, chemical and / or physical parameter in a living biological Fabric is designed in the form of a self-learning process sequence with the following process steps:
  • the procedure is divided into two basic procedural blocks. This is on the one hand a calibration phase and on the other hand an interpolation phase.
  • Performing the calibration phase includes at least one conventional determination of the parameter in conjunction with at least one light scattering measurement performed on the tissue to determine optical measurements.
  • the at least one conventionally determined parameter is assigned to the respective optical measured values. This data is stored as a calibrating reference quantity.
  • the execution of the interpolation phase comprises at least one on the
  • the parameter to be determined is interpolated from the measured values of the light scattering measurement and the data of the reference quantity.
  • the interpolated parameter is stored in the reference set.
  • each reference vector consists of the conventionally determined parameter and a measured value vector containing the optical measured values.
  • a measured value vector with optical measured values is determined and the associated interpolated parameter is transferred together with the measured value vector into the reference set as a new reference vector.
  • the measured value vector determined during the execution of the calibration phase contains a light intensity influenced by the tissue in a first polarization direction and light intensity influenced by the tissue in a second polarization direction.
  • the measured value vector is combined with the independently determined parameter to the reference vector.
  • the measured value vector determined during the execution of the interpolation phase contains a light intensity influenced by the tissue in a first polarization direction and a light intensity influenced by the tissue in a second polarization direction.
  • the interpolated parameter is determined by the following steps:
  • the measured value vector is registered and a determination of the closest measured value vectors from the reference quantity takes place with a minimum distance to the measured value vector. Subsequently, the parameter assigned to the registered measured value vector is interpolated from the nearest measured value vectors and the respectively associated reference parameters.
  • the interpolated parameter is added to the reference set along with the metric vector after performing the interpolation.
  • FIGS. 1 to 15 are used for clarification.
  • the same reference numbers are used for identical and / or equivalent parts and method steps.
  • Fig. 1 is an exemplary block diagram of an inventive
  • 1 b is an exemplary circuit diagram for a central processing unit
  • FIG. 2 an exemplary representation of a sensor unit, a covering of the sensor unit shown in Fig. 2 with polarizers, a supplemented with other components sensor unit in a side view in section, a spacer and pressure and temperature sensors complemented sensor unit, provided for the sensor unit beam path in a first embodiment, an embodiment of a Sensor unit for an optional absolute measurement of the initially emitted laser intensity, an embodiment for a sensor unit with two laser light sources with mutually orthogonal beam directions, another exemplary sensor arrangement, a further embodiment for a combined
  • 13 is a schematic reference quantity
  • 14 is an interpolation performed on the reference set
  • FIG. 1 shows an exemplary block diagram for the device according to the invention
  • FIG. 1a in conjunction therewith an exemplary circuit diagram for measuring sensors
  • FIG. 1b an exemplary circuit diagram for realizing a central processing unit by means of integrated circuits.
  • This concept allows various components, sensors, data processing units and other devices to be combined in such a way that the largest possible amount of measured data can be recorded and processed on a case-by-case basis.
  • the device consists of a central unit 1, which is supplied with power via a power supply unit la.
  • a power supply unit both a mains connection with a downstream transformer and rectifier circuit, as well as an accumulator and battery unit can be used.
  • a laser operating unit 2 is provided within the central unit. This controls a connectable to the central unit laser source 3 or even contains a laser device, from which the laser light is guided via a fiber optic cable to the outside.
  • the laser source 3 is a mere, the optical fiber downstream radiation optics for aligning the beam on the tissue surface.
  • the usual driver hardware can be used.
  • This expediently allows a pulsed operation of the laser source with variably adjustable time intervals in the range of 100 ms to 800 ms and thus supports the execution of pulse programs.
  • the laser source suitably a laser diode with an emitted wavelength between 800 nm to 950 nm is used.
  • the power of the laser diode should desirably be limited to a few mW to avoid damage within the tissue. It is possible to use a P-type laser diode. Conveniently, the laser diode is protected by a capacitor circuit against overvoltages.
  • At least one sensor unit 4 is provided. This contains at least one measuring sensor 4a, which is that of the biological
  • Tissue scattered, reflected, attenuated or otherwise influenced laser light receives.
  • at least the emitting opening of the laser source 3 is combined with the measuring sensor 4a in the body of the sensor unit 4.
  • the sensor unit 4 thus forms a measuring module connected to the central unit 1 for emitting laser radiation and for
  • photodiodes can be used as measuring sensors. As appropriate, photodiodes have been found with a light-receiving diameter of about 2 to 5 mm. In the detection of scattered radiation in the infrared spectral range is a black covering the
  • Light receiving surface expedient to exclude any influence of the diode by the incidence of visible light.
  • FIG. 1a An example of this is shown in FIG. 1a.
  • the sensitivities of the photodiodes can be adjusted by means of corresponding resistors R1, R2, R3 and R4, which are integrated into the circuit at appropriate places.
  • the necessary circuitry and the arrangement of the photodiodes on a corresponding board forms an integral part of the sensor unit.
  • Control unit 5 is provided. This interacts with the laser operating unit 2.
  • the control unit provides switching signals to the laser operating unit and at the same time contains an amplifier for the measurement signals collected by the sensor unit and by the pressure and temperature sensors.
  • a standard amplifier circuit can be used in which the gain can be easily adjusted by a ratio of resistors used therein.
  • Different gain factors can be used for different sensor groups. For example, a gain factor of 10 in the conversion of the measuring signals of the temperature sensor and a gain factor of 1 in the conversion of the measuring signals from the measuring sensors of the sensor unit is possible.
  • These different amplification factors can usually be predetermined by setting jumpers on the circuit board of the amplifier circuit.
  • Both components are supplied with control signals by a storage and processing unit 6 and in the process convert a measurement program stored in the storage and processing unit.
  • additional sensors 5a can be connected to the control unit 5. This can be in particular pressure or temperature sensors.
  • a temperature sensor is useful to monitor a constant temperature in the tissue to be measured and thus to prevent adverse effects on the measurement method.
  • temperature sensors can be used.
  • connection between the individual components for example, by an 8-pin cable, in particular a network cable.
  • the physical effects and interactions of the light in the biological tissue detected by the optical measuring sensors can be very different. However, they are known to the person skilled in the art, although the exact effects of each individual effect on the measurement signals ultimately detected by the sensor arrangement as a whole can be very complex.
  • a diffraction or light scattering occurring within the tissue which can be both directional and diffuse, and in particular can be described as Rayleigh and Mie scattering and depends on the size of the scattering particles, and especially polarization effects, in particular rotations of polarization planes and others
  • Forms of optical activity, in particular caused by chiral centers of molecules present within the tissue can also be used as physical interaction processes for obtaining measured values.
  • the storage and processing unit 6 is programmable for this, the data stored in it and measurements can be read and processed externally and also changed.
  • an interface 7 is provided, via which an external data processing unit 8, for example a computer or an external network, can be connected.
  • the central unit acts as a data collection device that can be queried regularly. This can be done in particular via a USB interface.
  • the interface can also be designed in the form of an SD card. This can be inserted as a mobile memory module in a corresponding slot of the device and recorded with the measurement data. These data are then read out in a computer.
  • the components can all be housed and miniaturized in a housing. It is readily possible to carry out the arrangement as a device that can be worn on a body part, for example a bracelet.
  • the elements present in the central unit are sufficiently miniaturized and expediently even arranged on a circuit board of the sensor unit 4.
  • a hardware architecture using a microcontroller.
  • this executes an AD conversion with a processing width of 10 or 12 bits.
  • an AD converter with a processing width of 10 bits and an analog input signal with a maximum voltage of approximately 4000 mV a resolution of about 3.9 mV / unit is achieved. It is advantageous to ensure the largest possible voltage range for the input signal, because the level of the actually applied measurement signal is not known from the outset. An overflow of the AD converter is thereby avoided. However, this reduces the resolution of AD conversion.
  • An EEPROM for temporary storage of process data is an advantage.
  • As a clock frequency is depending on the specific design of the microcontroller
  • the microcontroller has a number of ports, via which the measuring signals of the sensor unit and other sensors are read in and via which a programming of the microcontroller can take place.
  • the programming takes place in particular via an integrated JTAG circuit.
  • ports for storing the measurement data, in particular on an SD card, and their transfer to an external data processing unit are provided.
  • a port is used for outputting control signals to the control unit and the laser operating unit for activating and deactivating the laser source and / or the sensor unit and the other measuring sensors.
  • a further suitable device may be a means for wireless data transmission, which is arranged in the central unit and with which it is possible to send the determined measurement data to an external receiver, for example to a medical facility or a monitoring center.
  • the entire device may externally have the shape of a mobile phone.
  • the entire device expediently has a display, not shown here. Both small and simple liquid crystal displays for miniaturized devices and larger displays for stationary configurations can be used as the display.
  • the display can be designed as standard hardware in conjunction with a corresponding driver library.
  • buttons are provided for a user guidance. These, in conjunction with an interface for user guidance, permit the setting and deletion of device parameters, for the storage and readout of measurement data and the like data.
  • four buttons are provided. These access the microcontroller via appropriate ports. When a key is pressed, the corresponding port is switched to ground, thus generating the digital input.
  • An internal program code for reading the keys counts the pending bytes and checks them for changes. According to the results obtained, corresponding menus are activated on the display, deactivated or executed within the menus scroll functions.
  • the sensor unit contains a planar sensor array 9 consisting of individual measuring sensors 4a.
  • the number of measuring sensors is basically arbitrary.
  • the sensor array 9 is subdivided into a first sensor section with an inner sub-array 10 of four measuring sensors and a second sensor section with an outer sub-array 11 of eight measuring sensors.
  • the outer subarray completely encloses the inner subarray.
  • the laser source 3 or a corresponding radiation optics embedded in the body of the sensor unit It is possible to exclude individual measurement sensors from each of the two sub-arrays from the measurement process or to combine them as desired. As a result, various configurations of the sub-arrays can be realized. In particular, it is possible to switch off the measuring sensors closest to the laser source or to weight their signals less by measurement than those of the other measuring sensors.
  • the inner subarray 10 is covered by a first polarizer 12 and the outer subarray 11 by a second polarizer 13. These have mutually orthogonal polarization directions A and B.
  • the light emitted by the laser source 3 is not affected by the polarizing coverage.
  • the polarizer 13 has for this reason an opening 14 through which the laser light can pass.
  • the diameter of the opening may be in the range of 1 to 3 mm.
  • the arrangement of a diaphragm with a variable opening cross-section is possible.
  • To cover the sub-arrays or the surface of the sensor unit expediently resorted to polarizing films, which are mounted on a glass substrate and thus cover the sensor surface plan.
  • Fig. 4 shows a related embodiment in a side view and Fig. 5 in a view of the sensor surface.
  • the additionally attached components should on the one hand ensure a sufficient distance between the sensor surface and the surface of the tissue and on the other hand detect parameters which are necessary for a smooth measuring process.
  • spacers 15 distributed uniformly around the sensor surface are provided between the sensor surface and the fabric.
  • the spacers attach to the tissue surface 16. If appropriate, they have a tacky contact surface, which slipping the entire assembly prevented and the sensor attached to the assigned place on the fabric.
  • the spacers are located within an arrangement of pressure sensors 17 and temperature sensors 18 surrounding the sensor surface.
  • the pressure sensors 17 register the contact pressure of the sensor unit on the tissue surface and are coupled to the previously explained control unit within the central unit.
  • the temperature sensors register the temperature directly on the tissue surface and, on the other hand, in the immediate external environment of the measuring site. They have a contact surface which ensures good thermal contact between the tissue surface and the sensor body.
  • the spacers 15 and the interposed pressure and temperature sensors 17 and 18 are partitioned from each other by air-permeable slots 19. These slots prevent a reading-distorting negative pressure between the sensor surface and the tissue surface and a resulting increased blood flow or a different falsifying change in the tissue.
  • FIG. 6 shows an exemplary beam path on the previously described sensor unit 4.
  • the laser light emitted by the laser source 3, optionally via a light guide cable 20, strikes the tissue surface 16 at a finite angle ⁇ within a beam spot of finite size and penetrates into the latter top tissue layers.
  • the scattered light generated within the tissue spreads from the beam spot within a scattering cone and is detected in a direction of detection oriented perpendicular to the tissue surface. In this case, the scattered light penetrates the polarizers 12 and 13 and is received by the sub-arrays 10 and 11 arranged behind it.
  • the angle of incidence ⁇ is about 45 ° and is adjustable around this angle by means of a tilting mechanism 21 arranged in the sensor unit.
  • FIG. 7 shows a further development of the arrangement shown in FIG. 6, in which, in addition to the relative measurement of the intensities falling on both subarrays, an absolute measurement of the intensity of the laser light initially emitted onto the tissue surface is possible.
  • two groups of measuring sensors are provided. At least one of the measuring sensors serves exclusively for the absolute intensity measurement. In the example shown here, this is a measuring sensor 22. Its detection direction is directed against the surface of a deflecting mirror 23, which can optionally be folded into the radiation direction of the laser source 3 and thereby deflects the emitted laser light directly onto the measuring sensor 22.
  • the switching mechanism for the deflection mirror is also addressed by the central unit, in particular by the control unit contained therein.
  • the sensor arrangement shown in FIG. 7 contains the usual measuring sensors sensitive to the light scattered by the tissue surface.
  • a single measuring sensor 24 is shown by way of example for this purpose.
  • the sub-arrays 10 and 11 shown in the previous figures can also be provided.
  • One of the measuring sensors of the outer sub-array 11 can be used as a measuring sensor 22 in the sense of the present embodiment and is accordingly tilted.
  • the 8 shows a further sensor surface with two laser light sources 25 and 26 in conjunction with the already described array arrangement 9 of the sub-arrays 10 and 11.
  • the laser light sources 25 and 26 have mutually orthogonally oriented beam directions and are at an angle of 45 ° relative to the Tissue surface inclined.
  • the array arrangement 9 therefore registers stray light which has been generated in the tissue by the laser light source 25 and, on the other hand, scattered light which is caused by the laser light source 26 in the tissue is detected with the same array arrangement.
  • the device shown in Fig.8 is suitably operated in a pulse mode.
  • the laser light source 25 is first activated by the laser operating unit 2 within the central unit, while the array arrangement in conjunction with it detects the scattered light from the tissue.
  • the laser operation unit 2 activates the laser light source 26 and the measurement process in the array arrangement is repeated, so that a total of four measurement values are obtained within this measurement cycle.
  • FIG. 9 shows a further example of a sensor arrangement.
  • This consists of an applied on the fabric surface 16 assembly of a ring detector 27, a photodetector 28 for an absorption measurement, a photodetector 29 for a refraction measurement, a photosensor 30 with a spectral resolution for determining a wavelength-dependent absorption and a photosensor 31 for determining the polarization state of in the tissue scattered light.
  • the light source is a laser source 32 with an angle of incidence ⁇ of about 45 °.
  • the already mentioned central unit 1 controls the operation of the laser source and the sensor arrangement.
  • the ring detector 1 receives the scattered light generated in the tissue and is optionally shielded laterally against any incident unwanted lights.
  • the light path passed through the middle of the tissue must be taken into account.
  • the distances a to d within the arrangement are to be chosen so that an optimum of the signals occurring at each detector is achieved.
  • the penetration depth within the tissue for the irradiated laser light can be varied by the power and the wavelength of the light. Since the penetration depth of the light in biological tissues changes with the wavelength, the distances a to d must then be changed accordingly.
  • FIG. 10 shows a further embodiment for a combined arrangement of sensor and light source.
  • the arrangement consists of a housing with an arrangement contained therein of a light source 33, in particular a laser source, and optically reflecting surfaces 34 and 35. These reflect the laser light several times and let it emerge from an opening 36 located on the underside of the arrangement.
  • the opening is covered with a polarizing film 37.
  • ring detectors 38 and 39 Around the opening 36 are concentrically arranged ring detectors 38 and 39, while the entire assembly is housed with a preferably black painted housing 40.
  • the ring detectors contain, for example, for the measurement of diffraction effects photo layers and / or solar layers and can also be formed as a unit.
  • the non-linearity between the measuring signal and the irradiated light intensity possibly present in the detectors can be compensated for by varying the irradiation power.
  • Pressure and / or temperature sensors may be present.
  • One or more sensors from the exemplary embodiment from FIG. 10, but also from the exemplary embodiments shown above, can also be used as reference detectors, which detect and correct errors in a repeated placement of the sensor arrangement.
  • the aforementioned laser sources expediently radiate in a wavelength range in which the penetration depth of the light into the tissue is maximum.
  • laser sources are expedient whose emitted light has a wavelength of about 650 nm to 1000 nm and therefore is in the near infrared.
  • Light of such a wavelength for example, penetrates into human skin up to 4 cm deep and there reaches an intensity which is 25% of the initial value.
  • laser diodes in the red and infrared spectral range in particular semiconductor lasers or color center lasers, have proven to be useful. In this case, relatively short laser pulses of about 200 ms suffice.
  • the wavelength of the light used also depends on the tissue fluids present in the examined tissue.
  • the wavelength of the light should be chosen so that the oxygen saturation given in the blood is irrelevant.
  • body cavities are considered as preferred locations of the measurement method. So it is possible to perform a measurement in the region of the navel.
  • the exact parameters for the design of a measurement program can be entered and adjusted in the central unit via input means there, in particular buttons, touch screens, but also via an external interface.
  • the first embodiment is particularly suitable for larger, stationary facilities, the latter option is useful for small mobile devices and miniaturized measuring arrangements.
  • the user of the measuring arrangement is provided with means for a user guidance, which are embodied, for example, in the form of signal tones, speech output, displayed font and character representations, menu sequences and the like, further signaling.
  • a user guidance which are embodied, for example, in the form of signal tones, speech output, displayed font and character representations, menu sequences and the like, further signaling.
  • the basic idea of the method is to initially determine, by means of a self-learning measuring arrangement in an empirical manner, a relationship between a series of different and fundamentally any desired measurement data on the one hand and the parameter to be measured within the tissue on the other hand to accumulate sufficient data first and finally to use the determined empirical relationship between measured data and measured parameter to finally determine the parameter to be determined only optically. It should be emphasized that the physical relationship that determines the behavior of the incident light in the tissue and the resulting intensity or polarization effects, which are then ultimately measured by the sensor array, does not have to be known in detail and often not clarified in detail can.
  • the process is divided into two major process sections.
  • a first process section the calibration phase
  • a series of so-called measurement vectors are determined and related to the parameter determined by other means.
  • so-called reference vectors are generated.
  • Interpola- tion phase the entirety of measured value and reference vectors determined during the calibration phase is used to determine from the newly determined measured value vectors now by way of interpolation the sought tissue parameters
  • the dimension of the measured value vectors, d. H. the number of components can be any size. It is essentially determined by the number of measured values supplied by the sensor arrangements.
  • the sensor arrangement shown in FIG. 2 provides a first intensity measurement for tissue scattered light in a first polarization direction and a second intensity measurement for scattered light in a second polarization direction.
  • Each individual measured value vector is thus two-dimensional.
  • a multiplicity of measured value vectors, together with a tissue parameter assigned to the measured values, thus describes a two-dimensional surface in a three-dimensional space.
  • each individual measured value vector consists of four components.
  • the first two components result from the light intensities for the mutually perpendicular polarization directions in the first active laser light source
  • the third and fourth components of the measured value vector are formed by the polarization-dependent light intensities in the case of the second active laser light source.
  • the totality of the measured value vectors thus determined thus form a four-dimensional hypersurface in a five-dimensional space.
  • the measured value vectors determined from the sensor arrangement according to FIG. 9 form a five-dimensional hypersurface in a six-dimensional space. If one assumes that the pressure and / or the temperature can be added to each sensor arrangement as a further measured value, the dimension of the respective hypersurfaces increases by one or two.
  • the basic idea of the method explained below is to first of all determine the n-dimensional hypersurface of the measured value vectors with sufficient accuracy by means of calibration procedures and then to perform interpolations on this hypersurface.
  • the procedure starts with a calibration phase.
  • An exemplary flowchart for this is shown in FIG. 11.
  • the measured values provided by the sub-array 10 are hereinafter referred to as the variable P and an index
  • the measured values supplied by the sub-array 11 are denoted by the variable S and an index.
  • the indices each indicate the number of an executed measurement.
  • a measured value vector M is thus composed of the components (P; S).
  • the designation M, or M k stands for a measured value vector of the i-th or k-th measurement
  • the associated components P, and S, or P k and S k are the corresponding measured values P and S of the i or k-th measurement.
  • the index i denotes measured values and measured value vectors which were generated within the calibration phase and for which the tissue parameter has been independently determined
  • the index k denotes measured value vectors which are generated during the interpolation phase and for which the tissue parameter is to be interpolated.
  • variable BZ is subsequently used for the tissue parameter to be determined.
  • the designations BZ and BZ k stand for the tissue parameters determined independently or later interpolated in the i-th or k-th measurement.
  • the calibration phase begins with a method step 41 of an independent determination of a tissue parameter BZ,. If it is a Blood glucose measurement is performed, this is performed a blood sample and a corresponding blood analysis, which provides a clear blood glucose reading. Simultaneously with this, in a method step 42, a non-invasive measurement is carried out using the sensor arrangement according to FIG. 2.
  • the measured values S, and P which are determined thereby, form a measured value vector M, and are combined in a method step 43 with the independently determined tissue parameter BZ, to form a reference vector R, and stored in a database or memory 44.
  • the reference vectors stored there form the reference quantity R of the method.
  • a decision step 45 it is checked whether the number of reference vectors R, already acquired, is sufficient. If this is the case, the method goes into the interpolation phase 46.
  • the number of reference vectors R, required for the reference set R depends on the shape of the hypersurface described and on the degree of individuality thereof. For blood sugar measurements, it has been found that about 20 reference vectors later enable a sufficiently good interpolation. In general, the greatest possible number of reference vectors is of course advantageous, but it must be reasonably weighed in terms of reasonable effort.
  • the interpolation phase begins with a step 47, in which a measured value vector M k is determined using one of the aforementioned sensor arrangements. This consists in a use of the sensor arrangement according to FIG. 2 of two components S k and P k .
  • the reference set R contained in the memory 44 is called.
  • the measured value vectors M contained in the reference vectors R 1 stored there are compared with the measured value vector M k in a step 49. In this case, a predetermined number of measured value vectors M ', which are closest to the given measured value vector M k, are selected.
  • the reference vectors R 'belonging to these measured value vectors form the basis for a now following interpolation step 50.
  • the interpolation Step 50 is determined from the selected reference vectors R ', and the current measured value vector M k an interpolated parameter BZ k and output as now purely optically and non-invasively measured tissue parameters in a step 51.
  • FIG. 13 firstly shows an exemplary reference set R from a set of reference vectors Ri to Rio in the form of a surface embedded in a three-dimensional space.
  • the basis vectors of the three-dimensional space form the previously mentioned parameters P, S and BZ.
  • the reference quantity thus describes the dependence of the tissue parameter BZ as a function of the measured parameters S and P.
  • the Mi to M N form the previously described measured value vectors
  • distances d k i can be determined as follows:
  • This interpolation set I can be specified in matrix form as follows:
  • the parameters A, B and C must now be determined.
  • the parameter set I is used, resulting in a linear equation system with three equations and three unknowns:
  • a value of zero occasionally occurring in the denominator of equations (9) or (10) can be eliminated by interchanging the columns within the matrix of equation (3), i. be permuted.
  • FIGS. 13 and 14 show a detail of a reference quantity formed by the end points of reference vectors R 1 to R in a three-dimensional (S; P; BZ) space.
  • the reference quantity is a two-dimensional hypersurface.
  • FIG. 14 shows a measured value vector M k with an associated interpolated tissue parameter BZ k , in the vicinity of three nearest reference vectors R'i to R ' 3 . These form the interpolation set I selected in this case. These form an interpolation surface F.
  • Parameter BZ k be regarded as the value assigned to the measured value vector M k on the area of the interpolation surface F.
  • the interpolation becomes accurate, especially when the hypersurface is as flat and curvilinear as possible, and its accuracy increases even if measured value vectors of the reference set lie as close as possible to the measured value vector whose parameter BZ k is to be interpolated.
  • the references constant vectors for the otherwise unknown hypersurface. This is approximated at each new interpolation operation by a new interpolation area in a small area, with the interpolated tissue parameter being slightly above or below the true hypersurface. This is of importance for the subsequent interpolation processes, which in turn make use of interpolated tissue parameters BZ k and corresponding measured value vectors M k .
  • the interpolation can also be carried out with the aid of an interpolation network generated from the reference set R.
  • the value range for the values measured values S and P is subdivided into a network of, for example, 12 by 12 points, and the reference vectors R 1, ie the reference values BZ, are determined at these points in a first interpolation step.
  • the interpolation network makes it possible to find in the interpolation phase for each measured value vector M k in the vicinity reference measurement vectors M i , and thus to carry out the interpolation more securely.
  • the reference quantity ie the hypersurface formed by the reference vectors, can have a thoroughly complex shape.
  • FIG. 15 shows an example obtained from real calibration measurements.
  • blood glucose concentrations BZ are plotted against the measured values S and P in arbitrary units.
  • the reference quantity is shown in this example as a surface formed by maxima, minima and saddle points, which may well differ from tissue to tissue or from test person to test person and thus can also be regarded as an individual "fingerprint" for the subject or the examined tissue .
  • these evaluation procedures take the form of background processes for user-friendly menu navigation. This menu navigation is particularly advantageous when capturing measurement series that are to be personalized to a subject. The user can first select and confirm a subject name from a first menu.
  • a measurement is taken and the user is immediately prompted to enter the independently determined BZ value for the tissue parameter.
  • the inputs are confirmed by the device and stored in a personalized database.
  • the input of the corresponding numerical values for BZ can be done either via a numeric keypad or UP and DOWN menus in which the corresponding values are traversed within a sufficiently large selection range.
  • This browse function can take place both on the device itself and also on an external data processing unit via the mentioned interface and with the more extensive and more comfortable editing options there, for example corresponding evaluation programs and text editors.
  • the device When a certain amount of reference data is reached, the device issues a corresponding message via the display, signaling that the interpolation phase can be started.
  • the measurement is performed as during the calibration phase.
  • the instrument does not prompt to input a reference value, but displays on the display the execution of the above-described interpolation operation.
  • the interpolated tissue parameter BZ k is displayed and stored internally. Also in this case it is possible to transfer the data acquired during the measuring process via the interface to the external data processing unit and to perform further processing there. In principle, it is possible to modify the boundary conditions and specify under which criteria an interpolation is performed and under which criteria the interpolation should be omitted.
  • the user can specify certain maximum amounts via the menu, for example for the abovementioned distances d k i. If the distance d k i lies between the measured value vector M k and the measured value vector M, the reference quantity outside this predefined range, a corresponding indication is output and the interpolation is stopped or continued with the reservation of a potentially severely faulty determination of the tissue parameter.
  • the software contained in the device corresponds to a software component contained on the external data processing device.
  • This consists of a set of program tools for data analysis. It allows a representation of the hypersurface generated from the measured value vectors and the tissue parameters and thus enables an assessment of the quality of a possible interpolation.
  • the software comprises components for comparing the correct and independently determined tissue parameters BZ, with the calculated values BZ k on the basis of the optical measurements, and displays in a graph the quality of the optical measurements. It thus enables a possible additional quality check of the measurement.
  • the software further comprises means for calculating a correlation function between the independently determined tissue parameters BZ, and the interpolated values BZ k .
  • the corresponding measurement data is transferred to the external data processing unit.
  • a file with the corresponding results is generated and output.
  • a combination of a data processing software and already given means for displaying data and their output resorted.
  • the measured values are in the form of a file in an ASCII format and are subjected to a corresponding data analysis by a first software means.
  • the calculated results are transferred to a file, which in turn is accessed by means of a plot program, such as gnuplot.
  • the calculated data in particular the hypersurface for the interpolation or the correlation function, are now displayed by gnuplot and then converted into a LaTeX-compatible file format.
  • the LaTeX file is supplemented with corresponding text information and transferred by means of a compilation program to a DVI, PS or PDF file and displayed.
  • the corresponding values may also be converted to a graphical display program and viewed on a display.
  • the associated code includes, for example, five sections.
  • the first section defines the variables required to run the program.
  • configuration data are read.
  • the data is read out of a data file and in a fourth section the calculated data is written into an output file.
  • the fifth section represents the actual core of the code and is used to calculate the correlation values.
  • an already pre-stored configuration file is expediently used. Thereafter, the program outputs the read data files as information and sets the file names for the output values. This reserves the space for the output data.
  • the input file is checked for its proper format. Then, for each value BZ, the percentage deviation x between the correct value BZ and the value BZ k is determined:
  • Pearson's product moment or the Pearson coefficients are used. This is a dimensionless measure of the degree of linear relationship between two at least interval-scaled features. It can take values between -1 and +1. At a value of +1 or -1, there is a completely positive (or negative) linear relationship between the considered features. If the correlation coefficient is 0, the two features do not depend linearly on each other.
  • the Pearson coefficient is calculated for N values BZ, and N values BZ k as follows:

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Abstract

L'invention concerne un dispositif permettant de déterminer des paramètres biologiques, chimiques et/ou physiques dans un tissu biologique vivant, ledit dispositif comprenant une unité d'alimentation en énergie, une unité de fonctionnement au laser dotée d'au moins une source de laser orientée sur le tissu biologique, au moins une unité de détection destinée à détecter la lumière rétrodiffusée et/ou absorbée par le tissu biologique, une unité de commande, une unité de mise en mémoire et de traitement et une interface pour une unité de traitement de données externe. Le procédé selon l'invention consiste à mettre en œuvre une phase d'étalonnage destinée à déterminer une quantité de référence (R) à partir de vecteurs de référence (Ri), consistant respectivement à déterminer de manière indépendante un paramètre (BZi), à irradier le tissu biologique à l'aide d'une lumière laser non polarisée et à enregistrer un vecteur de valeur de mesure (Mi) à partir d'une série de grandeurs de mesure optiques. Le procédé consiste également à mettre en œuvre une phase d'interpolation destinée à déterminer une quantité d'interpolation (I) à partir de vecteurs d'interpolation (Ik), consistant respectivement à irradier le tissu biologique à l'aide d'une lumière laser non polarisée et à enregistrer un vecteur de valeur de mesure (Mk) à partir d'une intensité lumineuse rétrodiffusée avec détermination consécutive d'un paramètre interpolé (BKk) à partir de la quantité de référence (R).
EP11712536A 2010-04-13 2011-03-31 Dispositif et procédé permettant de déterminer un paramètre biologique, chimique et/ou physique dans un tissu biologique vivant Withdrawn EP2557991A2 (fr)

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PCT/EP2011/054977 WO2011128209A2 (fr) 2010-04-13 2011-03-31 Dispositif et procédé permettant de déterminer un paramètre biologique, chimique et/ou physique dans un tissu biologique vivant

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