WO2019185903A1 - Système de mesure pour réaliser des analyses spectroscopiques de tissu vivant - Google Patents

Système de mesure pour réaliser des analyses spectroscopiques de tissu vivant Download PDF

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Publication number
WO2019185903A1
WO2019185903A1 PCT/EP2019/058070 EP2019058070W WO2019185903A1 WO 2019185903 A1 WO2019185903 A1 WO 2019185903A1 EP 2019058070 W EP2019058070 W EP 2019058070W WO 2019185903 A1 WO2019185903 A1 WO 2019185903A1
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WO
WIPO (PCT)
Prior art keywords
housing
measuring system
radiation
radiation source
optical
Prior art date
Application number
PCT/EP2019/058070
Other languages
German (de)
English (en)
Inventor
Yoon Ok Kim
Ok-Kyung Cho
Original Assignee
Flore, Ingo
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 Flore, Ingo filed Critical Flore, Ingo
Priority to CN201980023664.0A priority Critical patent/CN111936049B/zh
Priority to EP19718581.2A priority patent/EP3773206A1/fr
Publication of WO2019185903A1 publication Critical patent/WO2019185903A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—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
    • A61B5/14551—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 for measuring blood gases
    • A61B5/14552—Details of sensors specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6825—Hand
    • A61B5/6826—Finger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0223—Operational features of calibration, e.g. protocols for calibrating sensors
    • A61B2560/0238—Means for recording calibration data
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0242—Operational features adapted to measure environmental factors, e.g. temperature, pollution
    • A61B2560/0247—Operational features adapted to measure environmental factors, e.g. temperature, pollution for compensation or correction of the measured physiological value
    • A61B2560/0252—Operational features adapted to measure environmental factors, e.g. temperature, pollution for compensation or correction of the measured physiological value using ambient temperature
    • 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
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/166—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted on a specially adapted printed circuit board
    • 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
    • A61B2562/18—Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
    • A61B2562/185—Optical shielding, e.g. baffles

Definitions

  • the invention relates to a measuring system for spectroscopic examinations of living tissue comprising a housing having two housing openings located on one side of the housing, one or more optical radiation sources arranged in the housing and one or more optical radiation detectors arranged in the housing wherein the radiation source and the optical radiation detector are each associated with a housing opening and wherein there is no optical connection within the housing between the radiation source and the radiation detector. Furthermore, the invention relates to a method for using the measuring system. Spectroscopic studies of living tissue provide insights into static and dynamic tissue properties and their underlying physiological processes. Known examples of the use of spectroscopic methods in the analytical and medical field are the oximetric and / or photoplethysmographic determination of various physiological parameters of humans.
  • Typical measuring systems for the applications mentioned have one or more radiation sources and one or more radiation detectors.
  • a concrete example of radiation sources and radiation detectors are LEDs and photodiodes.
  • the radiation sources illuminate the tissue to be examined and the radiation emitted by the radiation source (s) is absorbed, scattered, reflected or transmitted by the tissue.
  • the radiation detectors have the task to measure the absorption, reflection and / or transmission properties of the tissue.
  • US 2016/0061726 A1 discloses such a measuring system.
  • changes in the signal being measured are only caused by changes in the physiological properties of the tissue being examined.
  • other factors such as environmental parameters or operating conditions of the measuring system, can influence the detected measuring signal.
  • these changes in the measurement signal can be dynamic in nature, for example, when the radiation sources heat up during operation and thereby change the intensity of the emitted radiation.
  • the invention proposes, starting from a measuring system of the type mentioned above, that in the housing, an optical reference sensor is arranged and from the radiation source to the reference sensor, a direct optical connection channel for the transmission of a reference signal.
  • a largely undisturbed reference value can be determined simultaneously and continuously with the measured value of the radiation detector and used for the evaluation of the measurement result. Operating fluctuations in the intensity of the radiation source can thus be filtered out and no longer falsify the measurement results for analyzing the tissue.
  • the inner surface of the housing is provided with a light-absorbing black layer.
  • the housing openings are covered with an at least partially transparent layer. This prevents dirt from entering the housing. Furthermore, the area of the housing that comes into contact with the tissue is particularly easy to clean. Due to the transparently designed layer, the measurement itself is at most negligibly affected.
  • the transparent layer has optical filter elements.
  • the transparent layer may be designed such that it is transparent only in one direction. Thus, a defined optical radiation path can be forced, so that, for example, it is avoided that radiation from the tissue to the radiation source is reflected back.
  • the measuring system has one or more temperature sensors.
  • the temperature sensors can be realized, for example, as NTC thermistors.
  • NTC thermistors By this measure, further disturbances can be compensated and / or explained in more detail.
  • the influence of the heating of the measuring system by the overlying tissue and by the environment can be taken into account.
  • the radiation source is adapted to emit radiation in the visual and / or near-infrared wavelength range. Due to the radiation in this wavelength range, particularly meaningful measurement results can be achieved. At the same time, the tissue is not attacked.
  • the ratio of the height of the connection channel to the distance between the radiation source and the housing opening assigned to the radiation source is at most 0.5. This further ensures that the reference sensor only reflects the radiation of the radiation source and no incident ambient light or back from the tissue Light measures.
  • the housing e.g. is designed as a flexible band.
  • the measuring system can be flexibly adapted to different tissue surface structures.
  • the miniaturized measuring system can be integrated into a bracelet or a ring or a ring-like shape.
  • the direct optical connection between the radiation source and the reference sensor can be realized for example via an optical fiber cable, so that the reference measurement of the radiation intensity is possible even if, as in this embodiment, there is no straight optical path between the radiation source and the reference sensor.
  • Figure 1 Schematically a measuring system according to
  • Figure 2 Schematically a section through an inventive measuring system in a first embodiment
  • FIG. 3 shows a schematic section through an inventive measuring system in a second embodiment
  • Figure 4 Schematically a section through an inventive measuring system in a third embodiment
  • FIG. 5 shows a schematic section through an inventive measuring system in a fourth embodiment
  • Figure 6 Schematically a section through an inventive measuring system in a fifth embodiment.
  • Figure 7 Schematically a section through an inventive measuring system in a sixth embodiment.
  • a measuring system as known from the prior art, is designated by the reference numeral 1 in FIG.
  • the measuring system 1 has a housing 2, a radiation source 3 and a radiation detector 4.
  • the measuring system 1 is used for the spectroscopic examination of a living tissue 5.
  • In the reflection spectroscopy are radiation sources 3 and
  • Radiation detectors 4 often in a plane that is parallel to the tissue to be examined 5, as shown in Figure 1.
  • one or more LEDs can be used as the radiation source 3, and a photodiode can be used as the radiation detector 4.
  • the housing 2 has, on its side facing the fabric 5, two housing openings 2a, 2b, through which radiation can exit and exit the housing 2.
  • measuring system 1 can in principle be used at arbitrary locations of the body, since there are no geometrical restrictions, e.g. 5 with respect to the thickness of the tissue to be examined.
  • a possible path of the radiation from the radiation source 3 to the radiation detector 4 through the tissue 5 is symbolized by the directional arrows in the tissue 5.
  • a disadvantage of such a measuring system 1, however, is that, for example, it is much more difficult to determine the intensity of the radiation sources 3 in comparison to a transmission-based measuring system 1.
  • FIG. 2 schematically shows a first embodiment according to the invention.
  • an optical reference sensor 6 is provided in the housing 2.
  • the reference sensor 6 is set up to continuously measure the radiation intensity of the radiation source 3 during a measurement process.
  • a connection channel 2c between the radiation source 3 and the Reference sensor 6 is provided.
  • the connecting channel 2c is designed so that as far as possible no external interference influences the light signal of the radiation source 3, in particular it is designed such that no incident ambient light or light reflected back from the tissue to the radiation source influences the measured light signal.
  • the radiation detector 4 and the reference sensor 6 are read in parallel. In this way it is possible to determine the tissue properties and the radiation powers of the radiation source 3 simultaneously.
  • the signal of the radiation detector 4, which measures the tissue properties can then be normalized to the signal of the reference sensor 6, so that fluctuations in the radiation intensity of the radiation source 3 can be compensated for example due to temperature changes.
  • the reference sensor 6 can be as shown in Figure 2 between the radiation source 3 and radiation detector 4, but this is not absolutely necessary and other positioning of the reference sensor are possible, as far as a connection channel between the radiation source 3 and reference sensor 6 is given.
  • both the number and the arrangement of the radiation sources 3, radiation detectors 4 and reference sensors 5 can be adapted to the respective requirements.
  • An essential aspect that is relevant for the design of the measuring system is the distance between radiation sources 3 and radiation detectors 3, since this distance sets the typical penetration depth of the radiation into the tissue reaching the detector. If not only the near-surface tissue layers but also underlying layers are to be examined, then a certain distance between radiation source 3 and detector 4 is necessary.
  • the illustrated embodiment of the invention allows a particularly efficient use of the space occupied by the measuring system and thus a particularly compact design, since the reference sensor 6 can be placed between the radiation source 3 and radiation detector 4 to save space.
  • lasers eg in the form of laser diodes
  • the radiation sources 3 may be arranged in a row, in a plurality of rows (matrix-shaped), or in a semicircular manner.
  • Radiation detectors 4 and reference sensors 6 can be used in addition to photodiodes and a detector array or CMOS sensors. In the case of several radiation detectors 4, these can be used in various arrangements, e.g. be arranged linear, matrix-shaped or circular.
  • FIG. 3 shows a measuring system 1 according to the invention in a second embodiment.
  • the radiation detectors 4 and radiation sources 3 are located on a printed circuit board (PCB) 7 in the measuring system 1.
  • the housing 2 is arranged on the PCB 7.
  • the housing has two flea spaces 8a, 8b.
  • a plurality of LEDs 3a as radiation sources 3 and a photodiode as a reference sensor 6 are arranged.
  • the LEDs 3a and the reference sensor 6 are also arranged together in the cavity 8a.
  • Via the housing opening 2a of the housing 2 light can enter or leave the cavity 8a in the cavity 8a.
  • a shield 9 is provided, by means of which a narrow optical connecting channel 2c is formed between the radiation source 3 and the reference sensor 6.
  • the height H of the optical connection channel 2c is an important system parameter.
  • the height H must be substantially smaller than the distance A between the LEDs 3a and the housing opening 2a, because otherwise light that is reflected by the tissue 5 back to the LEDs 3a, could also reach the reference sensor 6.
  • the optical connection channel 2c is made as narrow as possible.
  • the ratio between the height H of the connection channel 9 and the distance A between LEDs 3a and the housing opening 2a is at most 0.5. In the embodiment shown here, the ratio is about 0.38.
  • the PCB 7 is coated with black solder resist, because this also ensures a very good light absorption due to its color.
  • the radiation detector 4 is arranged on the PCB 7. This is located in the cavity 8b. Light can enter or leave the cavity 8b via the housing opening 2b.
  • a flexible cable 10 is provided, via which the LEDs 3a are supplied with current or driven and the detectors 4, 6 can be read out.
  • the housing openings 2a, 2b of the cavities 8a, 8b are provided with windows 11a, 11b, which consist of a transparent material.
  • the windows 11 a, 11 b are separated by an opaque material 12, so that the light of the LEDs 3 a is prevented from being reflected multiple times within the windows and can reach the radiation detector 4 without having passed the tissue 5. Because of the windows 11a, 11b, the side of the housing 2 coming into contact with the fabric 5 is particularly easy to clean.
  • the windows 11 a, 11 b and the opaque material 12, via which the windows are connected 11 a, 11 b, biocompatible material is used, because thus the support surface of the module for the living tissue 5 is biocompatible.
  • the PCB 7 used in this embodiment is substantially larger than the housing 2.
  • the protruding part of the PCB can be used to fix the measuring system 1 in a measuring device, not shown here, using glue or screws. If a different mounting option is chosen, the size of the PCB 7 can also be reduced to the size of the housing 2.
  • the dimensions of the measuring system 1 shown in this embodiment are extremely compact.
  • the housing 2 is only 3.8 mm high and 7.5 mm wide.
  • the PCB 7 is 12.5 mm wide, so that the measuring system 1 can be integrated very well into higher-level measuring instruments due to its compactness.
  • the measuring system 1 is applied to the fabric 5, so that the housing openings 2 a, 2 b face the fabric 5.
  • the LEDs 3a are driven by a measuring control unit (MSR unit - not shown here) via the flexible cable 10, and the LEDs 3a emit radiation in the cavity 8a.
  • a first part of the radiation is conducted through the housing opening 2a and the window 11a into the fabric 5 and a second part of the radiation directly reaches the reference sensor 6.
  • the remaining radiation is essentially due to the black coating on the walls of the cavity 8a or absorbed on the PCB 7.
  • the radiation emitted into the tissue 5 propagates in it and is reflected many times.
  • the radiation detector 4 Part of the radiation will finally pass through the window 11b and the housing opening 2b into the cavity 8b and can be detected there by the radiation detector 4.
  • the radiation measured by the radiation detector 4 is detected by the MSR unit.
  • the MSR unit detects the values measured by the reference sensor 6 and can finally take them into account in the evaluation of the overall examination.
  • the third exemplary embodiment illustrated in FIG. 4 has, as an extension to the embodiment described in FIG. 3, optical filter elements on the windows 11 a, 11 b to the cavities 8 a, 8 b and in the optical connecting channel 2 c between the LEDs 3 a and reference sensor 6.
  • the optical filter elements 13 may be, for example, interference filters or mirrors including anti-reflection coatings for particular wavelengths or wavelength ranges.
  • the filter elements 13 may also be integrated directly into the windows 11 a, 11 b.
  • these filters or mirrors can be influenced, in which sub-elements of the measuring system 1 radiation of certain wavelengths or wavelength ranges can penetrate or which radiation from these can emerge.
  • disturbances for example due to ambient light, unwanted backscattering of light from the tissue 5 into the cavity 8a or penetration of thermal radiation (infrared) of the tissue 5 into the cavities 8a, 8b can be reduced.
  • the filter function is indicated by the directional arrows on the filter elements 13.
  • the measuring system 1 is supplemented with a further radiation detector 4a, so that transmission measurements are also possible with the measuring system 1.
  • the radiation power of the radiation sources 3 measured with the reference sensor 6 can likewise be taken into account.
  • the intensity of the LEDs 3a although in principle by the other radiation detector 4a would be determinable, but this can not be done parallel to the measurement of the fabric 5. Therefore, the use of the shielded reference sensor 6 is particularly favorable in this embodiment.
  • FIG. 6 shows a fifth embodiment according to the invention.
  • the invention is integrated into a higher-level measuring device which has two side parts 2c, 2d.
  • a total of three temperature sensors 14a, 14b, 14c are integrated in the measuring arrangement, of which two sensors directly into the measuring system 1.
  • temperature sensors 14 for example, NTC thermistors can be used.
  • the additional temperature sensors 14 inside and outside of the measuring system 1 can be used to compensate or to further break down further disturbing influences (for example, influence of the heating of the measuring system 1 by the overlying tissue 5 and by the environment).
  • the temperature sensor 14c the temperature of the laid-up tissue can be measured directly.
  • the measuring system 1 in FIG. 6 is designed to examine a finger 5 a:
  • the temperature sensor 14 a is placed in the cavity 8 a so that the temperature of the surroundings of the LEDs 3 a and of the radiation detector 4 can be determined. It should be noted that it is only a cross section in Figure 6 and the temperature sensor 14a is located at the edge of the housing, so that the channel between LEDs 3a and Reference sensor 6 remains largely free and thus the reference measurement is not affected.
  • the temperature measured with the temperature sensor 14a has several causes (radiation of the finger, heat conduction between fingers 5a and housing 2, heat radiation of the LEDs 3a, heating of the housing 2 by the operation of the electrical components).
  • the additional temperature sensor 14b is inserted into the housing wall, which measures only the housing temperature. If, in addition, one places the temperature sensor 14c on the outside of the measuring system 1 for direct temperature measurement on the finger 5a (heat conduction), the finger temperature can be determined directly and thus additional information about the heat sources occurring in the system can be obtained.
  • FIG. 7 illustrates a sixth exemplary embodiment, in which the measuring system 1 is realized with a flexible printed circuit (FPC 16) and is integrated in a ring 17 in which living tissue 5, for example a human finger, is located.
  • FPC 16 flexible printed circuit
  • FIG. 7 illustrates a sixth exemplary embodiment, in which the measuring system 1 is realized with a flexible printed circuit (FPC 16) and is integrated in a ring 17 in which living tissue 5, for example a human finger, is located.
  • FPC 16 flexible printed circuit
  • a key feature of the sixth embodiment is that the measuring system 1 in this implementation can be worn permanently on the body and thus continuous measurements or, for example, individual measurements at certain intervals are possible.
  • a comparable embodiment can for example be in the form of a bracelet.
  • the invention allows different modes of operation for the LEDs 3a used in the measuring system 1.
  • the LEDs 3a can be operated for example with any multiplexing or modulation method.
  • the signals measured at the radiation detector 4 and the reference sensor 6 can then be analyzed by the respective demultiplexing or demodulation methods. Concrete examples of such methods are the sequential activation of different LEDs 3a for one certain time interval or the parallel, pulsed operation of multiple LEDs 3a, wherein the pulse frequency for the individual LEDs 3a differs.
  • the cavities 8a, 8b in the housing 2, in which the radiation detector 4, reference sensor 6 and radiation sources 3 are located can be filled with ambient air, which is included in the manufacturing process.
  • the cavities 8a, 8b may contain a gas, gas mixture or a solid, for example epoxy resin, introduced during the production process.
  • a solid only a portion of the cavities 8a, 8b or individual optical elements may be encapsulated with a solid such as epoxy resin to protect these elements.
  • a nitrogen-impregnated and subsequently pressed porous material can be used to fill the cavities.
  • PCB Printed Circuit Board

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  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
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  • Veterinary Medicine (AREA)
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  • Heart & Thoracic Surgery (AREA)
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  • Optics & Photonics (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)

Abstract

La présente invention concerne un système de mesure (1) pour réaliser des analyses spectroscopiques de tissu vivant comprenant un boîtier (2) qui présente deux ouvertures (2a, 2b) situées sur un côté du boîtier, une source de rayonnement optique (3) agencée dans le boîtier (2) et un détecteur de rayonnement optique (4) agencé dans le boîtier (2), la source de rayonnement optique (3) et le détecteur de rayonnement optique (4) étant respectivement associés à une ouverture de boîtier (2a, 2b) et aucune liaison optique n'étant présente à l'intérieur du boîtier (2) entre la source de rayonnement (3) et le détecteur de rayonnement (4). Le but de l'invention est de minimiser les perturbations internes et externes et/ou de pouvoir les détecter et ainsi d'en tenir compte de manière fiable lors de l'évaluation des résultats de mesure, le système de mesure devant pouvoir être réglé de manière flexible en fonction des différentes personnes et des différents sites d'application et intégré dans d'autres systèmes de mesure. Selon l'invention, un capteur optique de référence (6) est agencé dans le boîtier et un canal de liaison optique directe (2c) consiste à transmettre un signal de référence de la source de rayonnement (3) au capteur de référence (6).
PCT/EP2019/058070 2018-03-29 2019-03-29 Système de mesure pour réaliser des analyses spectroscopiques de tissu vivant WO2019185903A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN201980023664.0A CN111936049B (zh) 2018-03-29 2019-03-29 用于光谱检查活组织的测量系统
EP19718581.2A EP3773206A1 (fr) 2018-03-29 2019-03-29 Système de mesure pour réaliser des analyses spectroscopiques de tissu vivant

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE102018002620 2018-03-29
DE102018002620.6 2018-03-29
DE102018003521 2018-05-02
DE102018003521.3 2018-05-02

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