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WO2024165947A1 - Dispositif adhésif flexible, élastique et équipé d'un capteur pour la surveillance à distance des paramètres physiologiques d'un patient - Google Patents

Dispositif adhésif flexible, élastique et équipé d'un capteur pour la surveillance à distance des paramètres physiologiques d'un patient Download PDF

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Publication number
WO2024165947A1
WO2024165947A1 PCT/IB2024/050908 IB2024050908W WO2024165947A1 WO 2024165947 A1 WO2024165947 A1 WO 2024165947A1 IB 2024050908 W IB2024050908 W IB 2024050908W WO 2024165947 A1 WO2024165947 A1 WO 2024165947A1
Authority
WO
WIPO (PCT)
Prior art keywords
patient
sensor
flexible
physiological parameters
elastic
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.)
Ceased
Application number
PCT/IB2024/050908
Other languages
English (en)
Inventor
Paolo Giorgi
Paolo Marini
Gianluca Testa
Marco URSITTI
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.)
Advanced Electronic Biosystem Srl
Original Assignee
Advanced Electronic Biosystem Srl
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 Advanced Electronic Biosystem Srl filed Critical Advanced Electronic Biosystem Srl
Priority to EP24703074.5A priority Critical patent/EP4661738A1/fr
Publication of WO2024165947A1 publication Critical patent/WO2024165947A1/fr
Anticipated expiration legal-status Critical
Ceased 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
    • A61B5/68—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
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A61B5/02055—Simultaneously evaluating both cardiovascular condition and temperature
    • 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
    • A61B5/6823—Trunk, e.g., chest, back, abdomen, hip
    • 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
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0406—Constructional details of apparatus specially shaped apparatus housings
    • A61B2560/0412—Low-profile patch shaped housings
    • 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
    • A61B2562/164—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier
    • 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
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/1112—Global tracking of patients, e.g. by using GPS
    • 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/251—Means for maintaining electrode contact with the body
    • A61B5/256—Wearable electrodes, e.g. having straps or bands

Definitions

  • the present invention has application in medical and pharmaceutical fields.
  • This generally refers to a system of digital electronic detection of clinical body parameters for medical use. More particularly, this is a flexible, adhesive, conductive and sensor-equipped device for medical use, which allows instantaneously measuring the clinical body values.
  • Telemonitoring consists of the remote detection of the parameters referable to the health state of an individual so as to correct, in a timely manner, the management of specific medical conditions or to identify new medical conditions that have not yet clinically manifested. This is a mode of delivering medical services, provided for in the field of telemedicine, that would allow considerably modifying the management of medical conditions, even complex ones.
  • telemonitoring when attained by means of wearable devices that are not overly cumbersome for the monitored subject, hence not interfering with the quality of life and the detections carried out, could be employed in many health contexts, allowing the facilitation of both the transition of the patient from recovery setting to hospital setting, which would mark the need to increase the intensity of the treatments to be delivered following the worsening of a specific condition.
  • the remote detection of the information referable to the health state if carried out by means of devices that are technologically reliable and not very cumbersome for the subject who must use it, will become an essential practice and will be made possible due to the technological innovations introduced by telemedicine, allowing the revolution of the clinical management protocols of numerous medical conditions.
  • Object of the present industrial patent application is therefore that of proposing a new and alternative solution to all these limits of the present technology, through a flexible and sensor- equipped adhesive device for the continuous and remote monitoring of the parameters referable to the health state of a subject, which is able to optimize the extension of the electric field through the thorax, reaching a measurement precision and a detectable quantity of physiological parameters that is much greater than that of the prior art.
  • the present device preferably made of polyamide, is thin, flexible and invisible, and can be comfortably worn, reducing the invasiveness to a minimum, not obstructing the performance of daily life activities.
  • a processing board is miniaturized thereon, based on a microprocessor; it has, in contact with the skin, a series of electrodes and sensors capable of detecting the physical parameters directly from the body surface of the subject who wears it without the aid of further external instruments; the electrodes and the sensors able to measure, and the processing board able to derive, a plurality of parameters referable to the health state such as, by way of a nonlimiting example: the recording of the cardiac biopotential (electrocardiogram), the heart rate, the blood pressure, the oxygen saturation of the arterial blood, the liquid content of the thorax, the respiratory rate, the position of the body, the body temperature; the data is then sent to a remote display device for the doctor evaluation.
  • the cardiac biopotential electrocardiogram
  • the device consists of electrodes and sensors connected together by a flexible rigid circuit, preferably printed on polyamide, a rubbery plastic polymer that is soft and twistable, i.e. on silicon paper which has an even greater extensibility, and is characterized by a particular crescent form that allows it to cross the surface of the human body, preferably but not necessary from the armpit to the heart.
  • the internal layer of the device that in contact with the skin, is coated by a special adhesive having specific zones with high electric conductivity at the electrodes, such that it is not necessary to use a conductive hydrogel.
  • the end is the terminal part of the flexible circuit in contact with the armpit, is composed of an external layer preferably made of polyamide, of an adhesive internal layer having a conductive zone, and houses at least: - an oximeter composed of an LED for phototransmission, at least a photoreceiver LED for the reception of the light variation and a lens designed so as to allow the correct focusing of the beams from the phototransmitter LED to the photoreceiver LED;
  • an electrode for detecting the cardiac biopotential and the detection of the bioimpedance.
  • the median segment is placed between the head and the end, houses at least a median electrode adapted for the detection of only the cardiac biopotential, the bio-impedance and is connected both to the head and to the end through the connection that runs along the flexible body of the device; a conductive zone of said adhesive being placed at the electrode.
  • the head of the device in contact with the area of the sternum in proximity to the heart, is composed of an external layer preferably made of polyamide that houses at least:
  • an electrode for detecting the cardiac biopotential and the bio-impedance and by an internal layer, in contact with the skin, constituted by a conductive zone of said adhesive.
  • Said adhesive being non-conductive in the adherence zones not close to said sensors and electrodes.
  • the head of the device also comprises a processing board composed of a flexible rigid miniaturized circuit preferably printed on polyamide having at least a microprocessor, a Bluetooth module, a battery preferably flat circular and contained within a suitable small carriage protected against accidental opening, an accelerometer, a system for detecting the GPS position and an antenna; said antenna being specifically developed for being used in proximity to the biological tissues without causing absorption or damage, through a particular geometry that allows directing the irradiation lobe outward; and said small carriage for the battery able to be thrust outward by means of the two first lateral elements adapted to apply a leverage when both are simultaneously pressed and having two second non-deformable rubber elements adapted to report the two first elements in initial position after the opening.
  • an altimeter in the processing board, such altimeter adapted to establish the altimetric height at which the measurement of the physiological parameters is carried out, such information being useful for the clinical evaluation of the cardiac health.
  • a functionally characterizing element of the device, object of the present industrial patent application is the presence of at least three electrodes capable of measuring the electric voltage and positioned in three different points of the thoracic cage, which allows a precise measurement both of the cardiac biopotential and of the bio-impedance: indeed, with regard to the biopotential, the electrodes at the two ends of the device measure the voltage generated by the heart by comparing it with the reference measurement detected by the median electrode; while, in the measurement of the bio-impedance, the two electrodes placed at the two ends (under the armpit and in proximity to the sternum) can generate an electric voltage in response to the injection of a current imposed in the two electrodes and obtain a transverse measurement that maximizes the value of the biopotential measured in the lung crossing zone, so as to be able to calculate also the respiratory rate, the possible presence of liquid in the lung and the possible nocturnal apnea.
  • the presence of the electrodes in three points also allows calibrating the electric detection specifically on the artificial biopotential emitted by a possible pacemaker, with the object of detecting the presence thereof and the possible malfunctioning.
  • the device Once correctly positioned on the human body, the device in its entirety is therefore able to detect the direct measurement of the cardiac biopotential, the presence and the correct operation of a pacemaker, the measurements of the bio-impedance, of the body temperature, of the oxygen level in the arteries, of the position and of the movement of the body of the patient.
  • the presence of liquid in the lungs is derived from the known values of the electrical resistance of the liquids: the presence of a liquid in the lung in fact increases the detected impedance; the respiratory rate is derived from the variation of the impedance relative to the greater/smaller presence of air in the lung; and the nocturnal apnea emerge from the observation of the respiratory rate, which in the case of stop simply indicates the temporary absence of breathing.
  • the presence of the accelerometer provides further information that is useful for the evaluation of the overall clinical picture, by showing the position of the patient and his/her physical activity, i.e. if he/she is lying down or standing, if still, walking or running.
  • a specific cardiac trace, together with the general clinical picture, can in fact be more or less worrying if the patient is at rest or moving.
  • the oximeter and the thermometer both positioned on the end of the device, finally accompany all the evaluations by making direct and programmed measurements of the body temperature and of the blood oxygenation.
  • the terminal portion comprising the median electrode and the end, can be substituted; in this case, said portion can be connected to the head through a flat miniature grip of male/female type and substituted with a new terminal portion, e.g. in case of malfunctioning or for use with a new patient.
  • the flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters is also capable of detecting the biopotential generated by the heart rate of a fetus, so as to allow the monitoring thereof without having to do an ultrasound or an electronic fetal monitor. In this manner, it becomes possible to execute the end-of-pregnancy clinical monitoring even from home.
  • the flexible, adhesive and sensor-equipped device for the detection and the display of clinical body parameters is integrated with a meter, i.e. a material that releases a pre- established dose of drug if stimulated by the sensor-equipped device or by the remote control and display system controlled by the doctor.
  • the adhesive layer that runs along the entire device, placing a conductive zone in contact with the electrodes and the sensors is substitutable for use with another patient.
  • the head has a button only for turning on, the turning off only being possible by remote application.
  • the external layer on which the sensors and the electrodes are printed is made with a support of silicon paper type, i.e. silicone printed with conductive ink, adapted to ensure the extensibility and the adaptability to any complex surface, such as that of the human body.
  • the head of the device comprises a sensor of “analog front end” type adapted to separate the wave spectrum and to cancel the noise due to the conducted noisiness, to the vicinity with other electronic apparatuses and disturbance sources.
  • the device can be attained for professional clinical purposes and be provided to the doctor, but it can also be attained in a commercial version designed specifically for athletes, gyms and all those who wish to keep their own physiological parameters under control.
  • FIGURE 1 shows the upper surface of a possible device 100, where the following are visible: the head 10, the median segment 20 and the end 30.
  • FIGURE 2 illustrates the lower surface of a possible device 100, that in contact with the skin of the patient, where the following are visible: the electrodes 11, 21 and 31, the various described sensors, the processing board 12 with several of its components and connections 110 between the parts.
  • FIGURE 3 shows the upper layer 200 on which the circuits and the sensors are printed, and the lower layer, composed of the particular adhesive 300 having conductive zones 310 at electrodes and sensors.
  • FIGURE 4 shows the head 10 of the device 100 where the system is visible for expelling a small carriage 18 containing the battery 16 and having first expulsion elements 18a and second non-deformable rubber elements 18b.
  • a possible embodiment of the device 100 is represented that is composed of a lower adhesive layer 300 having zones with high conductivity 310 at electrodes and sensors described hereinbelow; and of an upper layer of plastic polymer 200, preferably polyamide, having a thickness of 0.14 mm and comprising:
  • a head 10 comprising a processing board 12, at least an electrode 11 and an accelerometer 13.
  • Said processing board 12 comprising in turn at least a microprocessor 14, a Bluetooth device 15, a 3V battery 16 preferably of flat type capable of power supplying the device for an approximate time of 40 days and inserted within a small carriage 18 protected against accidental opening, a system for detecting the GPS position, a special antenna 17 optimized for the outward irradiation and a button 19 for turning on; said button 19 being prevented from the function of turning off, possible only by remote device;
  • an end 30, comprising at least an electrode 31, an oximeter 32 and a temperature sensor 33;
  • Said end 30 being intended to adhere, by means of the special adhesive 300, under the armpit of the patient; said head 10 being intended to adhere, by means of the same adhesive 300, on the sternum in proximity to the heart; and said median portion 20 adhering in an intermediate position on the thorax of the patient who wears the device 100.
  • Two said electrodes 11 and 31 being adapted for the measurement of the cardiac biopotential by means of the aid of a reference value provided by said electrode 21, positioned in contact with the body of the patient in a median position; two said electrodes 11 and 31 also being adapted for the measurement of the pulmonary bio-impedance since they are able to generate an electric voltage and obtain a transverse measurement that maximizes the bio-impedance measured through the thorax, so as to be able to calculate the respiratory rate together with the possible presence of liquid in the lung and the possible nocturnal apnea.
  • Said accelerometer 13 being adapted for the detection of the position and of the movement of the body of the patient; said oximeter 32 being adapted for the detection of the quantity of oxygen present in the arteries; said temperature sensor 33 being adapted for the detection of the body temperature.
  • Said Bluetooth device 15 being adapted to transmit the physiological parameters detected directly on the body of the patient towards a remote device adapted to process the further derived physiological parameters such as, by way of a non-binding example:
  • a remote device such as by way of example a cell phone and/or a computer and/or a tablet, provided with dedicated software; said remote device then able to send a visual alarm and/or sound alarm when the detected parameters exceed certain preset thresholds or in all the cases in which the doctor or the supervisor user has set the need to receive an alarm on the basis of the variation of the detected physiological data.

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

Abstract

L'invention concerne un dispositif adhésif flexible et équipé d'un capteur pour la surveillance continue et à distance des paramètres physiologiques d'un patient. Le dispositif, de préférence en polyamide, mince, flexible et invisible, sur lequel une carte de traitement est miniaturisée qui est basée sur un microprocesseur et une série d'électrodes et de capteurs, est capable de détecter, de manière non invasive, les paramètres physiques directement à partir du corps du patient sans l'aide d'autres dispositifs externes ; les électrodes et les capteurs pouvant mesurer, et la carte de traitement pouvant dériver, une pluralité de paramètres physiologiques tels que, au moyen d'un exemple non limitatif, la fréquence cardiaque, la pression, l'oxymétrie, la présence de liquides dans le poumon, la fréquence respiratoire, la position du corps, la température et l'apnée nocturne ; les données sont ensuite envoyées à un dispositif de traitement et d'affichage à distance pour l'évaluation du médecin.
PCT/IB2024/050908 2023-02-08 2024-02-01 Dispositif adhésif flexible, élastique et équipé d'un capteur pour la surveillance à distance des paramètres physiologiques d'un patient Ceased WO2024165947A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP24703074.5A EP4661738A1 (fr) 2023-02-08 2024-02-01 Dispositif adhésif flexible, élastique et équipé d'un capteur pour la surveillance à distance des paramètres physiologiques d'un patient

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102023000002124 2023-02-08
IT102023000002124A IT202300002124A1 (it) 2023-02-08 2023-02-08 Dispositivo adesivo flessibile, elastico e sensorizzato per il monitoraggio remoto dei parametri fisiologici di un paziente

Publications (1)

Publication Number Publication Date
WO2024165947A1 true WO2024165947A1 (fr) 2024-08-15

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Family Applications (1)

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PCT/IB2024/050908 Ceased WO2024165947A1 (fr) 2023-02-08 2024-02-01 Dispositif adhésif flexible, élastique et équipé d'un capteur pour la surveillance à distance des paramètres physiologiques d'un patient

Country Status (3)

Country Link
EP (1) EP4661738A1 (fr)
IT (1) IT202300002124A1 (fr)
WO (1) WO2024165947A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120108917A1 (en) * 2008-12-15 2012-05-03 Corventis, Inc. Patient monitoring systems and methods
US20150335288A1 (en) * 2013-06-06 2015-11-26 Tricord Holdings, Llc Modular physiologic monitoring systems, kits, and methods
US20160183794A1 (en) * 2014-12-31 2016-06-30 Blue Spark Technologies, Inc. Body temperature logging patch
US20180358119A1 (en) * 2016-06-03 2018-12-13 FOURTH FRONTIER TECHNOLOGIES, Pvt. Ltd. Method and system for continuous monitoring of health parameters during exercise
US20210345899A1 (en) * 2020-05-07 2021-11-11 GE Precision Healthcare LLC Multi-sensor patch

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120108917A1 (en) * 2008-12-15 2012-05-03 Corventis, Inc. Patient monitoring systems and methods
US20150335288A1 (en) * 2013-06-06 2015-11-26 Tricord Holdings, Llc Modular physiologic monitoring systems, kits, and methods
US20160183794A1 (en) * 2014-12-31 2016-06-30 Blue Spark Technologies, Inc. Body temperature logging patch
US20180358119A1 (en) * 2016-06-03 2018-12-13 FOURTH FRONTIER TECHNOLOGIES, Pvt. Ltd. Method and system for continuous monitoring of health parameters during exercise
US20210345899A1 (en) * 2020-05-07 2021-11-11 GE Precision Healthcare LLC Multi-sensor patch

Also Published As

Publication number Publication date
IT202300002124A1 (it) 2024-08-08
EP4661738A1 (fr) 2025-12-17

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