WO2023067611A1 - Appareil et procédé de détermination de caractéristiques d'un fluide - Google Patents

Appareil et procédé de détermination de caractéristiques d'un fluide Download PDF

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Publication number
WO2023067611A1
WO2023067611A1 PCT/IN2021/051134 IN2021051134W WO2023067611A1 WO 2023067611 A1 WO2023067611 A1 WO 2023067611A1 IN 2021051134 W IN2021051134 W IN 2021051134W WO 2023067611 A1 WO2023067611 A1 WO 2023067611A1
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WO
WIPO (PCT)
Prior art keywords
heel
light
electrical signals
leds
optical sensor
Prior art date
Application number
PCT/IN2021/051134
Other languages
English (en)
Inventor
Partha Pratim Das MAHAPATRA
Chaitali ROY
Original Assignee
Ezerx Health Tech Pvt. Ltd.
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 Ezerx Health Tech Pvt. Ltd. filed Critical Ezerx Health Tech Pvt. Ltd.
Publication of WO2023067611A1 publication Critical patent/WO2023067611A1/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
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7264—Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems
    • A61B5/7267—Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems involving training the classification device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0075—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, 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
    • A61B5/14551—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
    • A61B5/6887—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient mounted on external non-worn devices, e.g. non-medical devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2503/00—Evaluating a particular growth phase or type of persons or animals
    • A61B2503/04—Babies, e.g. for SIDS detection
    • A61B2503/045—Newborns, e.g. premature baby monitoring
    • 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
    • A61B2562/0242—Special features of optical sensors or probes classified in A61B5/00 for varying or adjusting the optical path length in the tissue
    • 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
    • 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
    • A61B5/6829—Foot or ankle

Definitions

  • An apparatus and a method for determining characteristics of a fluid An apparatus and a method for determining characteristics of a fluid.
  • the present invention relates to a non-invasive portable device, more specifically, a non-invasive portable apparatus and method for measuring characteristics of a fluid in neonates, such as haemoglobin, bilirubin, lactate, sodium, potassium, calcium, vitamin D, blood glucose, cholesterol, thyroxin, and oxygen saturation from the neonatal’ s body.
  • characteristics of a fluid in neonates such as haemoglobin, bilirubin, lactate, sodium, potassium, calcium, vitamin D, blood glucose, cholesterol, thyroxin, and oxygen saturation from the neonatal’ s body.
  • the present invention provides a non- invasive portable apparatus and method for determining characteristics of a fluid.
  • the present invention discloses an apparatus for determining characteristics of a fluid.
  • the apparatus includes a heel bed at one end for resting heel of a foot. It also includes a light source covering the heel bed including an LED array placed at a predefined inclination to produce a concentrated light beam. It includes an optical sensor to detect light scattered and convert into electronic signal. It includes a switch on the apparatus to activate or deactivate the light source.
  • the LED array produces the concentrated light beam to irradiate peripheral venous blood, wherein a passage of the concentrated light beam is defined through the heel bed, anterior side of the resting heel of the foot and then heel epidermis
  • the optical sensor converts the light scattered from the irradiated venous blood into electrical signals.
  • the present disclosure discloses a method of determining characteristics of a fluid.
  • the method includes emitting light by a light source, covering a heel bed for resting heel of a foot, including an LED array placed at a predefined inclination to produce a concentrated light beam.
  • the method includes irradiating peripheral venous blood by the concentrated light beam, wherein a passage of the concentrated light beam is defined through the heel bed, anterior side of the resting heel of the foot and then heel epidermis.
  • the method detecting and converting by an optical sensor, light scattered from the irradiated venous blood into electrical signals.
  • Report generation is instant (within 60 seconds) thus saves time.
  • Figure 1 illustrates an apparatus for determining characteristics of a fluid, in accordance with the present disclosure
  • Figures 2 and 3 illustrate working of an optical system in the apparatus, in accordance with the present disclosure
  • Figure 4 illustrates a digital diagram of the electrical signals obtained as an output of the apparatus, in accordance with the present disclosure
  • Figure 5 illustrates a method of determining characteristics of a fluid, in accordance with the present disclosure
  • FIG. 6 illustrates the data processing steps for generation to output, in accordance with the present disclosure.
  • Figure 7 illustrates a sample architecture of the data model, in accordance with the present disclosure.
  • FIG. 1 illustrates an apparatus (100) is shown in the form of a device for determining characteristics of a fluid, in accordance with the present disclosure.
  • the apparatus (100) is in communication with an application on a mobile device.
  • the apparatus (100) includes a heel bed (102) at one end for resting heel of a foot. It also includes a light source (104) covering the heel bed including an LED array placed at a predefined inclination to produce a concentrated light beam. It includes an optical sensor to detect light scattered and convert into electronic signal. It includes a switch (106) to activate or deactivate the light source (104).
  • the LED array produces the concentrated light beam to irradiate peripheral venous blood, wherein a passage of the concentrated light beam is defined through the heel bed (102), anterior side of the resting heel of the foot and then heel epidermis
  • the optical sensor converts the light scattered from the irradiated venous blood into electrical signals.
  • the LED array corresponds to a white LED ring and a combination of 6 LEDs of luminous intensity of 18 med.
  • the combination of LEDs is of different wavelengths viz. two visible white LED (440-660 nm, typical color temperature 7000 K), two Infrared (IR) LED (940 nm) and two Ultraviolet (UV) LED (390 nm).
  • Figures 2 and 3 illustrate working of an optical sensor (200) in the apparatus, in accordance with the present disclosure.
  • the optical sensor (200) includes a linear image sensor (202), a focusing lens (204), a grating (206) and a collimator (208) to convert the scattered light into electrical signals.
  • the grating (206) to receive the scattered light through the collimator (208) and disperse the light into wavelengths.
  • the focusing lens (204) having the linear image sensor (202) arranged at a focal plane to convert the light by the grating (206) and focusing into electrical signals.
  • the grating is defined by a spectral analyzer of 310 to 980 nm, 288 pixels based with 15 nm resolution and configured to distribute the reflected light from the object to whole spectra from 310 to 980 nm.
  • the apparatus also includes a microcontroller connected to the optical sensor (200) to process the electrical signals and communicate the electrical signals digitally on the application on the mobile device.
  • the apparatus includes a remote server which collects the digital signals from microcontroller and processes the signals through digital signal processing (DSP) technique. Further, the remote server is trained on datasets to collect the processed signal and predict a value for the fluid defined by one or more of hemoglobin, bilirubin, creatinine, blood glucose, sodium, potassium, calcium, vitamin D, lactate, cholesterol, thyroxin and oxygen saturation.
  • DSP digital signal processing
  • Figure 4 illustrates a digital diagram of the electrical signals obtained as an output of the apparatus, in accordance with the present disclosure.
  • the image sensor (202) converts the light which were dispersed into wavelengths by the grating (206) and focused by the focusing lens, into electrical signals.
  • the electrical signals are then converted in digital form in a distributed spectrum as shown in Figure 4.
  • Figure 5 illustrates a method (500) of determining characteristics of a fluid, in accordance with the present disclosure.
  • the method (500) includes emitting light by a light source, covering a heel bed for resting heel of a foot, including an LED array placed at a predefined inclination to produce a concentrated light beam.
  • the method (500) includes irradiating peripheral venous blood by the concentrated light beam, wherein a passage of the concentrated light beam is defined through the heel bed, anterior side of the resting heel of the foot and then heel epidermis.
  • the method (500) includes detecting and converting by an optical sensor, light scattered from the irradiated venous blood into electrical signals.
  • the method of converting the scattered light into electrical signals includes receiving, by a grating, the scattered light through a collimator and dispersing the light into wavelengths.
  • the method includes converting, by a focusing lens having a linear image sensor arranged at a focal plane, the light by the grating and focusing into electrical signals.
  • the grating is defined by a spectral analyzer of 310 to 980 nm, 288 pixels based with 15 nm resolution and configured to distribute the reflected light from the object to whole spectra from 310 to 980 nm.
  • the method further includes connecting, by a microcontroller to the optical sensor to process the electrical signals and communicate the electrical signals digitally on the application on the mobile device.
  • the LED array corresponds to a white LED ring and a combination of 6 LEDs of luminous intensity of 18 med.
  • the combination of LEDs is of different wavelengths viz. two visible white LED (440-660 nm, typical color temperature 7000 K), two Infrared (IR) LED (940 nm) and two Ultraviolet (UV) LED (390 nm).
  • the method includes collecting, by a remote server, the digital signals from microcontroller and processing the signals through digital signal processing (DSP) technique.
  • the method further includes training the remote server on datasets to collect the processed signal and predict a value for the fluid defined by one or more of hemoglobin, bilirubin, creatinine, blood glucose, sodium, potassium, calcium, vitamin D, lactate, cholesterol, thyroxin and oxygen saturation.
  • Figure 6 illustrates the data processing steps for generation to output, in accordance with the present disclosure. All data was firstly validated, by checking for a few conditions. The training data was pre-processed by removing all the erroneous values, normalized between the maxima and the minima, and noise was removed by using rolling averages. The testing data was also pre-processed in a similar way. All of this was done to prevent erroneous values in data model output of the various parameters and to make sure that the outputs of the parameters fell within a valid range. This data model was then deployed in the mobile application and a cloud server for working with real-time data. The real-time data also went through the same validation and pre-processing steps just like the training and testing data to minimize errors. Only additional step in the real time data pre-processing, was the averaging of multiple data sets, which cleans the data further. This data is then processed by the cloud data model if internet connectivity is there in the smart phone otherwise the data is processed in the android application.
  • the data model for this device is based on a neural network architecture.
  • the neural network is created by defining an architecture of number of layers and the number of “neurons” in each layer.
  • a sample architecture has been shown in Figure 7, where N represents the neurons and L represents the layers.
  • Each neuron focusses on different portions of the data or all data at once, based on its position in the network and its connectivity.
  • a neuron is a matrix of number, and each neuron can have its own pre-processor/post-processor.
  • the matrices in these neurons are altered based on the input and output, such that the output of the data model has high accuracy, minimal bias, minimal variance and has a high tolerance to noisy input.
  • the process of altering the neurons is called “Learning”.
  • a neural network can have N-number of layers (the depth) and each layer can have N-number of neurons (the width). But a large neural network can be slower (depending upon the computational capability of the server running the neural network), so based on the server configuration, a neural network must be optimized and trained to generate accurate results in minimum time frame.
  • a neural network can also be customized to focus more on critical data, to have high sensitivity and specificity, which is especially important in case of neonates. In this case, the data model is tuned to focus more on the critical neonates and is highly optimized to generate results within 2 seconds on a nominal configuration server.
  • the output of the neural network are the various device parameters, such as haemoglobin, bilirubin etc.
  • a method of working of device of present invention includes, passing a light through the heel of the neonate and reflecting the light at 90 degrees back from the heel to the photo diode of the device. Thereafter, a spectrum reflected light is produced by the photo diode, for example, the photo diode captures more than hundreds of signals continuously with a minimum delay of 500 milliseconds. Then an average of the signals is determined by the microcontroller of the device and the signals are amplified through the ADC to obtain a spectrum of signal. Thereafter, a signal is sent to the platform by the device on the mobile device for further processing, say via Bluetooth.
  • the signal is compared with the reference spectrum of the database in the platform and then the compared result is fed into the data model. Accordingly, the value of the haemoglobin, bilirubin, sodium, potassium, calcium, vitamin D, lactate, cholesterol, thyroxin, oxygen saturation, creatinine and random blood glucose of the user’s blood (especially neonates) is determined from the signal using the data model having probability factors using existing calibrated data. Lastly, these values of user’s health parameters are stored in the cloud for future references.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
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  • Medical Informatics (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Spectroscopy & Molecular Physics (AREA)
  • Optics & Photonics (AREA)
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  • Emergency Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

Dans un mode de réalisation, la présente invention concerne un appareil permettant de déterminer les caractéristiques d'un fluide. L'appareil (100) comprend un lit de talon (102) à une extrémité pour reposer le talon d'un pied. Il comprend également une source de lumière (104) recouvrant le lit de talon comprenant un réseau de DEL placé à une inclinaison prédéfinie pour produire un faisceau de lumière concentré. Il comprend un capteur optique pour détecter la lumière diffusée et convertir en signal électronique. Il comprend un commutateur (106) pour activer ou désactiver la source de lumière (104). En outre, dans l'appareil (100), le réseau de DEL produit le faisceau de lumière concentré pour irradier le sang veineux périphérique, un passage du faisceau de lumière concentré étant défini à travers le lit de talon (102), le côté antérieur du talon au repos du pied puis l'épiderme du talon enfin, dans l'appareil (100), le capteur optique convertit la lumière diffusée par le sang veineux irradié en signaux électriques.
PCT/IN2021/051134 2021-10-19 2021-12-03 Appareil et procédé de détermination de caractéristiques d'un fluide WO2023067611A1 (fr)

Applications Claiming Priority (2)

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IN202131047390 2021-10-19
IN202131047390 2021-10-19

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WO2023067611A1 true WO2023067611A1 (fr) 2023-04-27

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5978691A (en) * 1996-07-19 1999-11-02 Mills; Alexander Knight Device and method for noninvasive continuous determination of blood gases, pH, hemoglobin level, and oxygen content
WO2003076883A2 (fr) * 2002-03-08 2003-09-18 Sensys Medical, Inc. Appareil compact de mesure non effractive du glucose par spectroscopie proche infrarouge
CA2875650A1 (fr) * 2012-06-05 2014-01-09 Hypermed Imaging, Inc. Procedes et appareil d'imagerie coaxiale de longueurs d'ondes multiples

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5978691A (en) * 1996-07-19 1999-11-02 Mills; Alexander Knight Device and method for noninvasive continuous determination of blood gases, pH, hemoglobin level, and oxygen content
WO2003076883A2 (fr) * 2002-03-08 2003-09-18 Sensys Medical, Inc. Appareil compact de mesure non effractive du glucose par spectroscopie proche infrarouge
CA2875650A1 (fr) * 2012-06-05 2014-01-09 Hypermed Imaging, Inc. Procedes et appareil d'imagerie coaxiale de longueurs d'ondes multiples

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