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
  • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
  • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
  • A61B5/02416—Detecting, measuring or recording pulse rate or heart rate using photoplethysmograph signals, e.g. generated by infrared radiation
  • A61B5/02427—Details of sensor
  • A61B5/02433—Details of sensor for infrared radiation
• • 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
  • A61B5/683—Means for maintaining contact with the body
  • A61B5/6831—Straps, bands or harnesses
• • 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
  • A61B5/683—Means for maintaining contact with the body
  • A61B5/6832—Means for maintaining contact with the body using adhesives
  • A61B5/6833—Adhesive patches
• • 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

Definitions

• the present invention relates to the field of medical measuring devices. It finds a particularly advantageous application in the field of oximeters. It may also apply to non-adhesive connected devices for measuring the heart rate and/or the rate of blood oxygen saturation (Sp02) and/or the temperature of a patient.
• the present invention lends itself in particular to the monitoring and control of physiological parameters of newborns and particularly of premature babies. Similar issues may also be felt for targets other than children, such as athletes, the elderly in general, EPHAD patients, the military or firefighters. STATE OF THE ART
• the monitoring of vital parameters in newborns and particularly in premature babies is essential for caregivers to monitor and ensure the health of the newborn.
• This monitoring is usually done using a pulse oximeter in the form of a clip around the finger or using a tape around the wrist, foot or leg.
• the classic hospital course for premature newborns, in particular those born before thirty-two weeks of gestation goes through neonatal resuscitation units, neonatal intensive care units and then neonatal medicine before finally leaving for home. Close monitoring of certain criteria, in particular cardiorespiratory stability, is necessary throughout this course.
• Discharge from hospital is particularly conditioned by thermal and cardio-respiratory stability and the capacity parent to take care of this fragile newborn. This involves sometimes very long hospitalizations in neonatology, often inducing a prolonged separation of the child and his family, at the origin of early developmental and sensory disorders, even parent-child attachment disorders and difficulties in learning. 'feeding with milk.
• the opening of a mobile neonatal care team at home within a neonatology service is fully integrated into developmental care strategies centered on the child and his family.
• the main objective of setting up mobile teams is to optimize developmental care and parental experience by caring for newborns at home whose condition no longer justifies full-time maintenance in a hospital unit. neonatology but requiring a quality and safety of care equivalent to that which they benefited from during their traditional hospital stay, thanks to nursing staff trained to ensure technical and relational continuity of care, adequate monitoring and long-term family support.
• GREEN Group of Reflections and Evaluations of the Neonatal Environment of the French Society of Neonatology
• the rate of re-hospitalizations remains very low (less than 10% in all the experiences reported). Added to this is better fluidity and a decongestion of neonatology services, particularly in this particular period of health crisis linked to Covid19.
• This type of organization is also the subject of recommendations on the follow-up of newborns at high risk of NDD (neurodevelopmental disorders) by the HAS published in February 2020. The need is expressed in particular for the follow-up and control of vital parameters, heart rate and oxygenation rate, in newborns and particularly in premature babies.
• An object of the present invention is therefore to propose a solution which makes it possible to eliminate or limit at least one of the aforementioned drawbacks.
• a device for measuring physiological data capable of being positioned on a part of the skin of the human body or of an animal, the device comprising a first dielectric support comprising a first surface on which is positioned a capture system comprising a plurality of light-emitting elements, and at least one photoreceptor, the device comprises a protective layer, made of parylene and/or polyurethane, comprising an exposed face capable of coming into contact with the part of skin and an internal face covering the plurality of light-emitting elements, and the at least one photoreceptor, the capture system being interposed between the first support and the protective layer.
• This device should be adaptable to all types of surfaces of the human body and be able to allow measurements comparable to those carried out using known devices of the state of the art such as those which are positioned at the end of the finger.
• the present invention makes it possible to optimize the comfort of use of the measuring device, thanks to a protective layer which improves the capture system to allow a soft contact between the device and the skin.
• the present invention proposes a means of optimizing an oximetry device comprising a plurality of luminescent elements and at least one photoreceptor.
• the present invention makes it possible to encapsulate a capture system between two layers in order to avoid injuries while guaranteeing a correct measurement of the Sp02 oxygenation rate and of the heart rate comparable to similar measurements recorded directly on the skin.
• a portable element comprising the device and a band forming a closed loop in at least a first configuration, the device being carried by at least one internal wall of the band.
• Figures 1A-1B show illustrations of a headband comprising the flexible oximeter device mounted on an infant's head.
• Figures 2A to 2D represent an illustration of the steps for mounting the device on a portable element, in this case a headband.
• FIGS. 3A to 3C represent the steps for mounting the device according to an embodiment with a band.
• Figure 4 shows different positions of a band comprising the device.
• FIG. 5 represents the capture system mounted on the first support according to a particular embodiment.
• Figure 6 shows in section an example of successive stacking of the first support, the capture system and finally the protective layer.
• FIG. 7 represents an example of connection by a flexible connection sheet between the device and a communication system.
• the protective layer 600 has a thickness of less than 10 ⁇ m. According to one example, the protective layer 600 has a thickness greater than 5 ⁇ m. According to one example, the first support 500 is made of polyethylene terephthalate PET and/or polyethylene naphthalate PEN.
• the plurality of light-emitting elements 201, 202 comprises a first light-emitting element 201 emitting electromagnetic waves whose wavelengths are between 600 nm and 750 nm and a second light-emitting element 202 emitting electromagnetic waves whose lengths waves are between 800 nm and 1000 nm.
• the 600 nm-750 nm range is advantageously conducive to the absorption of hemoglobin and the 800 nm-1000 nm range is advantageously conducive to the absorption of oxyhemoglobin.
• the first light-emitting element 201 and the second light-emitting element 202 are OLEDs.
• the photoreceptor 203 is an organic photodiode.
• the first support 500 and/or the protective layer 600 have a bending deformation capacity with a radius of curvature less than or equal to 1 m.
• the capture system 300 is connected by a flexible connection layer 103 to a communication system 700, the communication system 700 comprising a second support 520 on which is positioned an acquisition card to which elements are connected. allowing wireless transmission of data.
• the first support 500 and the second support 520 are two separate parts.
• the first support 500 has a thickness less than or equal to 50 ⁇ m and the second support 520 has a thickness less than or equal to 100 ⁇ m.
• the capture system 300 extends over a surface whose area is less than or equal to 4 cm 2 . According to this example, the capture system can operate in reflection.
• the light emitted by the system impacts tissues of the body and generates a reflection of part of the light, this part of the light being able to be captured by the at least photoreceptor 300.
• at least at least one of the plurality of light-emitting elements 201 , 202 and the at least photoreceptors 300 are arranged next to each other, preferably at a distance of less than 4 cm, preferably less than or equal to 2 cm.
• the band 100 is made of a flexible and elastic material.
• the strip 100 is made of a non-woven textile material.
• the capture system 300 includes a thermometer 800.
• the term "light-emitting element” means an electrical light source.
• photoreceptor or “photodiode” is understood to mean a component, preferably a semiconductor, having the capacity to capture radiation from the optical domain and to transform it into an electrical signal.
• the term "flexible” or “flexible” is used with regard to the first support 500 or the protective layer 600. It can be understood in a certain way, as a characteristic of materials that can deform according to the areas of the body and the directions of extension of the skin on which it is likely to be used.
• the soft or flexible character may be understood as a soft or flexible element alternatively or cumulatively:
• a bending deformation capacity of the element with a radius of curvature of less than one meter, preferably less than 200 mm.
• an "elastic” element will be understood to mean an element capable of deforming under mechanical stress from a first formal configuration to a second formal configuration in at least one direction, then once to return to its first configuration, once the constraint is lifted.
• the acronym “OLED” corresponds to the English term “Organic Light-Emitting Diode” which means an organic light-emitting diode.
• LED corresponds to an English term which means a light-emitting diode.
• the term “height” means a dimension located along the thickness of a layer, which may be the protective layer 600.
• the protective layer 600 generally has two opposite faces around its thickness.
• a direction substantially normal to a plane means a direction having an angle of 90 ⁇ 10° relative to the plane.
• the protective layer 600 can comprise several layers.
• a layer can also be composed of several sub-layers of the same material or of different materials.
• FIG. 1A and FIG. 1B there is shown schematically the head of a newborn baby respectively in profile and from the front wearing equipment in the form of a portable element 90 comprising a band 100 on which is positioned and attached a device according to the present invention.
• the present invention relates to a physiological data capture device configured to be able to be fixed to a band 100 in order to allow a measurement of physiological data in a stabilized manner, on a patient.
• a band 100 capable of being closed around the head of a child using fasteners 110, preferably made of VELCRO®, which can be positioned at the end of the band 100 .
• the band 100 comprises an adjustable fastening system making it possible to adapt the length of the band 100 to the morphology of the patient by allowing a modification of the place of closure of the closed loop that the band 100 forms.
• the portable element can be adjusted around a part of the patient's body so that the exposed face 601 is, in an optimized manner, in contact with the skin.
• the adjustable fastening system can comprise at least one of the following elements: a self-gripping tape, an adhesive tape, notches, a self-locking system, a fastening loop.
• the headband comprises an inner face 102 on which the device extends so that the device is in direct contact with a part of the skin 80.
• the device can be adapted to many parts of the body and for all types of morphologies. Indeed, it will not necessarily be limited to newborns, but will be able to adapt to adult human beings as well as to animal species.
• the band 100 is configured so as to be able to form a closed loop, at least in a first configuration, in order to allow optimized maintenance of the device in contact with the skin part 80.
• a method for positioning and maintaining the device in position with the strip 100 may comprise at least one of the following steps:
• the capture system 300 is inserted between the first support 500 and the protective layer 600.
• the method can be carried out with said steps carried out in the opposite direction.
• the device is capable of being placed in position on a strip 100 closing on itself in order to form a closed loop. Closing can be done using a fastener 110 which can be for example VELCRO® fasteners.
• the strip 100 may be a headband or an armband.
• the first support 500 and a second support 520 surmount an inner face 102 of the strip 100.
• the first support 500 is surmounted by the capture system 300 and a protective layer 600 covers the capture system 300 so that the capture system 300 is interposed between the first support 500 and the protective layer 600.
• the device associated with a headband can also be positioned at different locations on the human body.
• the device can be positioned on the arm, wrist, leg, ankle, around the foot, around the bust or abdomen.
• the device can be adapted to different fields such as portable technologies in monitoring in hospitals in general or in the management of patients in general. emergency outside the hospital.
• the device can also be associated with equipment such as clothing, glasses, connected watches, or jewelry.
• the device will therefore not only provide real-time monitoring of the vital parameters of premature and newborn babies, but it will also allow better comfort for the child and better freedom of movement at this age when motor development is essential and This will reduce stress for the baby and the parents when they return home.
• the first support 500 comprises a first surface 501 on which is mounted a first light-emitting element 201, a second light-emitting element 202, as well as two first photoreceptors 203 and two second photoreceptors 204.
• the photoreceptor elements 203, 204 are preferentially distributed in a homogeneous manner around a central point and preferably on either side and on the periphery of the light-emitting elements 201, 202.
• the distance between the first light-emitting element 201 and the first photoreceptor 203 is less than or equal to 5 mm.
• the distance between the second light-emitting element 202 and the second photoreceptor 204 is less than or equal to 5 mm.
• the sensing system 300 comprises a thermometer 800, preferably mounted on the first surface 501 and configured so as to be able to measure the temperature at the skin part 80.
• thermometer 800 is configured for a temperature measurement by contact of the device with the skin or without contact, preferably with an infrared measurement.
• the provision of the thermometer 800 below the protective layer 600 as described here makes it possible to preserve the effectiveness of the thermometer 800, whether it is a technique with or without contact.
• the thermometer 800 can be the subject of data acquisition combined with the oximetry data.
• the first support 500 comprises a first surface 501 on which is mounted the capture system 300 comprising the first light-emitting element 201, the second light-emitting element 202 as well as a first photoreceptor 203 and a second photoreceptor 204.
• the capture system 300 for its part, is covered by the protective layer 600.
• the first support 500 comprises a lower surface 502 distinct and distant from the first surfaces 501 and capable of being able to be in direct contact with the strip 100.
• the first surface 501 and the lower surface 502 are parallel.
• the first support 500 is fixed directly to the strip 100, preferably by an adhesive.
• the protective layer 600 comprises an internal face 602 and an exposed face 601 .
• the internal face 602 being configured to be fixed to the device, in contact with the capture system 300.
• the inner face 602 is configured to be able to be fixed to the device in contact with one of the first light-emitting element 201, the second light-emitting element 202, the first photoreceptor 203 and the second photoreceptor 204.
• the capture system 300 is connected to a communication system 700.
• this connection takes place via a flexible connection sheet.
• the first support 500 is separate and distant from the protection layer 600 so that the capture system 300 is inserted between the first support 500 and the protection layer 600.
• the portable element is configured so that the protective layer 600 presses the capture system against the first support.
• the protective layer covers and protects the dust collection system.
• the protective layer 600 is configured so as to hug the internal wall 81 of the strip 100. This allows optimized oximetry measurement to be taken when the portable element 90 is positioned against the patient's skin.
• the capture system 300 is in contact with the protective layer 600 in order to allow optimization of the oximetry measurements.
• the capture system 300 comprises a plurality of light-emitting elements 201, 202, preferably a first light-emitting element 201 and a second light-emitting element 202.
• the capture system 300 comprises at least one photoreceptor 203, preferably a first photoreceptor 203 and a second photoreceptor 204.
• the first light-emitting element 201 and the second light-emitting element 202 emit electromagnetic waves whose wavelengths extend along different ranges.
• the wavelengths of the first light-emitting element 201 extend into the visible red range and are greater than 600 nm and/or less than 750 nm, preferably equal to 630 nm.
• the first photodetector 203 is capable of detecting according to said range of wavelengths emitted by the first light-emitting element 201.
• the wavelengths of the second electroluminescent element 202 extend into the infrared range and are greater than 800 nm and/or less than 1000 nm, preferably equal to 850 nm.
• the second light-emitting element 201 is associated with at least one second photodetector 204 capable of detecting according to said range of wavelengths emitted by said second light-emitting element 202.
• the plurality of light-emitting elements 201, 202 comprises a first light-emitting element 201 emitting a red light source and a second light-emitting element 202 emitting an infrared wavelength source.
• the maximum spectral sensitivity of the first photoreceptor 203 is 650 nm.
• the maximum spectral sensitivity of the second photoreceptor 204 is 850 nm.
• the plurality of light-emitting elements can comprise OLEDs and/or LEDs and/or lasers.
• the second support 520 is surmounted by a communication system 700 preferably comprising an electronic acquisition card which comprises at least one element among: a microcontroller, an operational amplifier, a data transmission antenna and a power bank, preferably Li polymer
• the communication system 700 is configured so as to be able to connect to a computer program preferably accessible on a smartphone in order to preferentially allow digitization of the data and thus keep the nursing staff informed of the evolution of a baby's state of health in order to anticipate complications and thus improve the quality of care during hospital or home care.
• the capture system 300 can be connected to said communication system 700 via a flexible connection layer.
• the device is connected via a wireless connection element to an application on a smartphone, tablet or computer to allow the display of at least one of the following parameters: the PPG signal in order to detect changes blood volumetrics; an Sp02 blood oxygen level; heart rate; a visual and/or audible alarm.
• the measurement of arterial oxygen saturation can be calculated from the Photoplethysmography (PPG) signal and is given by the following formula:
• the application is configured so as to be able to ensure the real-time transmission of data to the medical profession.
• the communication system 700 includes a microprocessor configured to be able to process the data from the capture system 300.
• the spaces between the components of the communication system 700 may be filled by at least one component, one member or at least one electrically insulating layer.
• Electrically insulating should be considered as a property whose function is to prevent the passage of any electric current between two conductive parts subject to a difference in electric potential.
• the device comprises a wireless data transmission antenna (Bluetooth, WIFI, 4G, NFC, etc.).
• a wireless data transmission antenna Bluetooth, WIFI, 4G, NFC, etc.
• the quality of care for premature babies during hospital or home care can advantageously be improved.
• the second support 520 is advantageously flexible and preferably has a thickness of less than 100 micrometers.
• the capture system 300 will be covered by a protective layer 600.
• the protective layer 600 comprising one or more sub-layers.
• the capture system 300 and the communication system 700, the protective layer 600, the first support 500 and the second support 520 together have a mass less than or equal to 10 g.
• the device has a surface projected on the strip 100 of less than or equal to 10 cm 2 .
• the protective layer 600 is laminated on a part of the first surface 501 .
• the protective layer 600 is laminated over the entire first surface 501 .
• the capture element 300 is comprised in a shape with rounded corners, preferably an oval shape.
• the communication system 700 is comprised in a shape with rounded corners, preferably an oval shape.
• the protective film advantageously covers all the luminescent elements and all the photodiodes.
• layer 600 covers both first support 500 and second support 520.
• the strip 100 comprises a double thickness of fabric and the device is integrated between the two thicknesses and at least one of the two thicknesses comprises an opening so that the protective layer 600 can be in contact with the part of skin 80 in order to optimize the measurement.
• the protective layer 600 is made of a transparent material, so as to be able to let light waves pass.
• the material consists of parylene and/or polyurethane.
• the protective layer 600 comprises several sub-layers and at least one of the sub-layers consists of parylene and/or polyurethane.
• the first support 500 is advantageously flexible and is made of PEN or of PET and has a thickness and less than or equal to 50 micrometers.
• electrical connectors are printed by inkjet on the first support 500 in order to optimize the thickness of the device. This responds to the problem of lowering manufacturing costs. Indeed, inkjet printing of electrical connectors, and for example the use of CMOS packaging electronics, advantageously suggests an almost instantaneous implementation since the masking steps or the processes subtractive and preferably without spending excess raw material and thus lowering the manufacturing cost.
• the strip 100 is made of a lightweight non-woven textile, elastic and suitable for the medical environment.
• a non-woven fabric also allows optimized adhesion of the protective layer 600 to the strip 100 during its deposition. Indeed, the use of non-woven textile prevents, during the deposition of parylene and/or polyurethane, that portions of the protective layer 600 come to disperse in the meshes of the textile.
• the protective layer 600 is able to be easily sterilized.
• the protective layer 600 is made of a transparent material having a property allowing it to be flexible and extensible so as to be able to adapt to the surfaces of the skin part 80.
• a flexible, compact and light oximeter has the advantage of being comfortable to wear since it is almost imperceptible.
• the protective layer 600 comprises a protective surface film able to be in contact with the skin part 80 and able to be easily sterilized, this surface film is transparent and comprises parylene and/or polyurethane.
• connection cable 110 fastening

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Physics & Mathematics (AREA)
• Surgery (AREA)
• General Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Biophysics (AREA)
• Animal Behavior & Ethology (AREA)
• Pathology (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Cardiology (AREA)
• Spectroscopy & Molecular Physics (AREA)
• Optics & Photonics (AREA)
• Physiology (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Applications Claiming Priority (2)

Publications (1)

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Family Applications (1)

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• 2021
  • 2021-02-18 FR FR2101552A patent/FR3119753A1/fr active Pending
• 2022
  • 2022-02-14 WO PCT/EP2022/053471 patent/WO2022175193A1/fr active Application Filing
  • 2022-02-14 EP EP22705053.1A patent/EP4294270A1/de active Pending

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