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WO2025169108A1 - Dispositif d'alerte pour la miction et/ou la défécation d'un utilisateur - Google Patents

Dispositif d'alerte pour la miction et/ou la défécation d'un utilisateur

Info

Publication number
WO2025169108A1
WO2025169108A1 PCT/IB2025/051259 IB2025051259W WO2025169108A1 WO 2025169108 A1 WO2025169108 A1 WO 2025169108A1 IB 2025051259 W IB2025051259 W IB 2025051259W WO 2025169108 A1 WO2025169108 A1 WO 2025169108A1
Authority
WO
WIPO (PCT)
Prior art keywords
sensors
user
alert device
bladder
alert
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.)
Pending
Application number
PCT/IB2025/051259
Other languages
English (en)
Inventor
Elisabeth TOCCA
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.)
Pipo Srl
Original Assignee
Pipo 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 Pipo Srl filed Critical Pipo Srl
Publication of WO2025169108A1 publication Critical patent/WO2025169108A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/20Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/202Assessing bladder functions, e.g. incontinence assessment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/01Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/20Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/202Assessing bladder functions, e.g. incontinence assessment
    • A61B5/204Determining bladder volume
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/74Details of notification to user or communication with user or patient; User input means
    • A61B5/746Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/48Devices for preventing wetting or pollution of the bed

Definitions

  • the present disclosure generally relates to the field of alert and physiological monitoring devices, particularly in the context of advanced management of human urination and defecation.
  • the present disclosure refers to a non-invasive alert device for the urination and/or defecation of a user or wearer, whether a newborn, a child, an adult, or an elderly individual, specifically designed to anticipate the user's need for evacuation, ensuring a dignified and sustainable management of physiological functions.
  • disposable diapers significantly contributes to environmental pollution. In many cases, this type of waste can take hundreds of years to fully degrade, as disposable diapers are largely composed of petroleum- derived plastic materials, such as polyethylene and polypropylene, along with traces of heavy metals. The materials used in traditional disposable diapers have a considerable impact on land and soil. Additionally, the use of disposable diapers creates complications related to waste management and storage, both in domestic and healthcare environments.
  • Another aspect to consider is the hygiene issues associated with the use of diapers, such as skin irritations caused by moisture trapped inside the diaper.
  • diapers Another alternative to diapers consists of training methods designed to improve a person’s perception of evacuation stimuli.
  • adoption of such methods or techniques remains particularly limited, as they often yield unsatisfactory results and require considerable time and effort to be effectively implemented.
  • medications are available to help control urination.
  • such medications are subject to prescription regulations and are mainly prescribed for incontinence-related issues.
  • the present disclosure is based on the recognition by the author of this disclosure that, as of today, no devices or systems are available that can anticipate the actual evacuation of feces or urine, thereby eliminating the need for diapers.
  • the present disclosure aims to provide an alert device for the urination and/or defecation of a user that overcomes the aforementioned drawbacks of the known technology and/or offers additional advantages.
  • the alert device for urination and/or defecation comprises a plurality of sensors and/or electrodes configured to measure the filling level of a user's bladder and/or anal ampulla.
  • the alert device includes a data processing unit configured to receive data from the plurality of sensors and determine whether the measured filling level of the user's bladder and/or anal ampulla exceeds a predetermined threshold. The data processing unit is also configured to send an alert signal to the user if the measured filling level exceeds the predetermined threshold.
  • the alert device allows a user to be warned before urination or defecation occurs, based on the filling level of the bladder and/or anal ampulla.
  • the use of this alert device eliminates the need for a user to wear diapers, such as disposable ones, since the user is notified of the need to urinate and/or defecate before the evacuation becomes urgent, even in cases of incontinence. Consequently, all the issues associated with the use of diapers, as discussed earlier, can be overcome through the use of the alert device according to this disclosure.
  • the plurality of sensors in the alert device includes primary sensors configured to measure the body impedance of a specific body area of a user.
  • various human body parts such as the bladder or anal ampulla, exhibit characteristic impedance that varies depending on the liquid content within these areas.
  • These primary impedance sensors therefore allow the determination of the amount of liquid present in the bladder and/or anal ampulla.
  • these primary sensors include or consist of at least one electrode.
  • these primary sensors are configured to measure the filling level of a user's bladder and/or anal ampulla.
  • the plurality of sensors includes second sensors configured to measure the body temperature of a portion of the user's body.
  • the temperature of a body portion measured by these second sensors may be influenced by physiological activities, including the need for fecal and/or urinary evacuation. Consequently, measuring these thermal variations provides a useful indicator of imminent physiological events.
  • these second sensors configured to measure the body temperature of a portion of a patient’s body, are preferably designed to, preferably in combination with the first sensors, measure the filling level of the user's bladder and/or anal ampulla.
  • a sudden change in body temperature has been observed in a body area near the bladder or anal ampulla before and after urination and/or defecation. This body temperature then gradually returns to nominal values as the bladder and/or anal ampulla refills. Therefore, advantageously, the presence of second temperature sensors contributes — preferably in combination with the first sensors — to significantly improving the accuracy of detecting an imminent need for urinary and/or fecal evacuation.
  • the second sensors are positioned at the pubic bone.
  • the plurality of sensors additionally includes third sensors configured to determine a user's posture and/or movements.
  • these third sensors include at least one accelerometer.
  • the presence of these third sensors further enhances the accuracy of predicting an imminent urinary and/or fecal evacuation event, as the readings from some sensors, such as impedance sensors, may be influenced by a user's posture and/or movements.
  • the first and second sensors and/or electrodes are positioned in the inguinal region of the user, as shown in Figure 2 in a triangular arrangement, in Figure 4 in a vertical arrangement, or in Figure 5, and/or at the coccyx, as shown in Figure 3 in a triangular arrangement, in Figure 4 in a vertical arrangement, or in Figure 5.
  • the first and second sensors and/or electrodes may be positioned at the user's feet, as shown in Figure 6.
  • placing the sensors in these body regions allows for accurate data collection regarding the filling state of the user's bladder and/or anal ampulla.
  • the alert device further includes an energy storage unit, such as a battery, configured to power at least the plurality of sensors, in particular, the first and second sensors.
  • an energy storage unit such as a battery, configured to power at least the plurality of sensors, in particular, the first and second sensors.
  • the alert device includes a support element.
  • this support element is designed to be worn by a user and to support at least the plurality of sensors, particularly the first and second sensors.
  • this support element ensures the correct placement of the sensors and/or electrodes in specific body areas of a user.
  • this support element is made of a flexible material for enhanced comfort during use.
  • the support element may also be configured to accommodate the energy storage unit.
  • the alert signal includes an audible signal and/or a notification to a user's portable device. Consequently, advantageously, audible signals and instant notifications ensure timely communication with the user. This is particularly crucial in the context of incontinence or use with infants, as it allows for a prompt response to the imminent need to urinate or defecate. This aspect also enables users to customize the alert signals, increasing the device’s adaptability to individual preferences and instant needs, which may also be determined by the context, ensuring optimal privacy management. Further advantages, features, and methods of use of the object of the present disclosure will become evident from the following detailed description of its embodiments, presented for illustrative and non-limiting purposes.
  • Figure 1 shows a schematic view of an alert device for urination and/or defecation of a user, according to a preferred aspect of the present disclosure
  • Figure 2 shows a schematic view of the arrangement of a plurality of sensors of an alert device for urination and/or defecation of a user, according to a preferred aspect of the present disclosure
  • Figure 3 shows a schematic view of the arrangement of a plurality of sensors of an alert device for urination and/or defecation of a user, according to another preferred aspect of the present disclosure
  • Figure 4 shows a schematic view of the arrangement of a plurality of sensors of an alert device for urination and/or defecation of a user, according to another preferred aspect of the present disclosure
  • Figure 5 shows a schematic view of the arrangement of a plurality of sensors of an alert device for urination and/or defecation of a user, according to another preferred aspect of the present disclosure
  • an embodiment of an alert device for urination and/or defecation of a user, or user is indicated with reference number 100.
  • the alert device 100 comprises a plurality of sensors 10, 20.
  • each sensor of this plurality of sensors 10, 20 is a non- invasive type.
  • the sensors in the plurality of sensors 10, 20 of the alert device 100 are configured to measure the filling level of a user's bladder and/or anal ampulla. Specifically, these sensors are designed to measure the degree of urine filling in the bladder and/or fecal matter in the anal ampulla.
  • the terms "sensor” or “sensors” generally refer to a device configured to measure a specific parameter, particularly, within this disclosure, the filling level of a user's bladder and/or anal ampulla.
  • the plurality of sensors 10, 20 includes first sensors 10 configured to measure a body impedance value of a user's body portion.
  • the first sensors 10 comprise or consist of at least one electrode, preferably an impedance electrode.
  • the first sensors 10 include an emitter and a receiver.
  • the emitter of the first sensors 10 is configured to generate currents within the user's body, preferably single-frequency sinusoidal currents or a combination of multiple frequencies.
  • the body parts through which this current passes have a characteristic impedance that transforms these currents into voltages. This characteristic impedance can be significantly influenced by the presence of liquid in the bladder or feces in the anal ampulla.
  • the receiver of the sensors 10 is configured to detect these voltages and sample them, for example, using an analog- to-digital converter.
  • the plurality of sensors and/or electrodes 10, 20 includes second sensors 20.
  • These second sensors 20 are configured to measure a body temperature value of a user's body portion.
  • These second sensors 20 may include, for example, a thermal sensor, such as an NTC sensor, which varies its resistance based on temperature.
  • the temperature measured by the second sensors 20 is influenced by bodily functions such as urination and defecation. Generally, the body temperature of a specific body portion may vary depending on the presence of urine or feces.
  • the second sensors may also include an emitter and a receiver.
  • the first sensors and/or electrodes 10 and the second sensors 20 are configured to continuously measure impedance and body temperature without interruption for 24 hours, providing continuous data.
  • the first sensors 10 and/or the second sensors 20 are preferably configured to be positioned on a user's skin surface and are therefore non-invasive.
  • the first sensors 10 and/or the second sensors 20 may include temperature sensors and/or impedance sensors and/or electrodes.
  • the first sensors 10 and/or the second sensors 20 may be tattooed, particularly on a user's skin surface.
  • the first sensors 10 and the second sensors 20 can be powered by body heat and/or the movement of the user's body.
  • the first sensors 10 and the second sensors 20 are configured to take measurements in a frequency range between 1 kHz and 500 kHz, ensuring comprehensive coverage of physiological variations.
  • the plurality of sensors 10, 20 of the alert device 100 comprises at least one first sensor 10 and at least one second sensor 20. Even more preferably, the plurality of sensors 10, 20 of the alert device 100 comprises at least two first sensors 10 and at least two second sensors 20.
  • the first sensors 10 and/or the second sensors 20 are positioned in the inguinal region of a user. In combination or alternatively, the first sensors 10 and/or the second sensors 20 are positioned in the coccyx region of a user. Furthermore, in combination or alternatively, the first sensors 10 and/or the second sensors 20 are positioned on the user's feet.
  • the plurality of sensors 10, 20 may include additional sensors configured to detect the filling level of the bladder and/or anal ampulla.
  • additional sensors configured to detect the filling level of the bladder and/or anal ampulla.
  • pressure sensors and/or electric potential sensors and/or sensors capable of measuring shape variations of the bladder and/or anal ampulla may be provided.
  • the alert device 100 further comprises an energy storage unit 80.
  • This energy storage unit 80 is specifically configured to power at least the plurality of sensors 10, 20, particularly at least the first sensors 10 and/or at least the second sensors 20.
  • the energy storage unit 80 may be a battery, preferably miniaturized.
  • the alert device 100 further comprises a support element 90.
  • This support element 90 is configured to be worn by a user.
  • the support element 90 is preferably designed to support the plurality of sensors 10, 20, in particular the first sensors 10 and the second sensors 20.
  • the support element 90 is further configured to support, in addition to the first sensors 10 and the second sensors 20, the energy storage unit 80.
  • the support element 90 is made of a flexible material to ensure maximum comfort for the user.
  • the support may be a wearable item, such as an undergarment, an elastic band to be applied to a user’s body portion, or an adhesive element to be attached to the user’s body.
  • the support element 90 may also include a microcontroller configured for an initial processing of the data detected by the plurality of sensors 10, 20.
  • the alert device 100 for urination and/or defecation of a user further comprises a data processing unit 30.
  • this data processing unit 30 is operatively associated with the plurality of sensors 10, 20. Specifically, the data processing unit 30 is configured to receive data collected by the plurality of sensors 10, 20, preferably wirelessly or via RTF.
  • the data processing unit 30 is preferably a server operatively associated, through a wireless connection, with the plurality of sensors 10, 20 and, preferably, with a portable and preferably wearable device, such as a smartwatch or a smartphone, belonging to the user.
  • the data processing unit 30 is configured to determine whether a user's bladder filling level and/or anal ampulla filling level, as measured by the plurality of sensors 10, 20, exceeds a predetermined filling threshold.
  • this predetermined filling threshold may be approximately 70% or 80% of the estimated maximum capacity of the user’s bladder and/or anal ampulla.
  • the data processing unit 30 is also configured to send an alert signal to a user if the bladder and/or anal ampulla filling level measured by the plurality of sensors exceeds the predetermined threshold.
  • this alert signal includes an audible signal.
  • the alert signal may include a notification sent to a user’s portable device, such as a smartphone, a smartwatch, or any other suitable portable or desktop device.
  • the data processing unit 30 may additionally rely on machine learning and artificial intelligence algorithms to send the alert signal.
  • this data processing unit 30 may also take into account behavioral data from a user and/or records and manual inputs from the user. Such data may, for example, be collected through an application interface installed on an electronic device of the user, such as a smartphone, smartwatch, or desktop computer.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physiology (AREA)
  • Urology & Nephrology (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

La présente divulgation concerne un dispositif d'alerte (100) pour la miction et/ou la défécation d'un utilisateur, comprenant une pluralité de capteurs (10, 20) configurés pour mesurer un niveau de remplissage de la vessie et/ou de l'ampoule rectale d'un utilisateur, et une unité de traitement de données (30) configurée pour recevoir les données détectées par la pluralité de capteurs (10, 20) et pour déterminer si le niveau de remplissage de la vessie et/ou de l'ampoule rectale de l'utilisateur, tel que mesuré par la pluralité de capteurs (10, 20), dépasse une valeur seuil de remplissage prédéterminée. L'unité de traitement de données (30) est en outre configurée pour envoyer un signal d'alerte à un utilisateur dans le cas où le niveau de remplissage de la vessie et/ou de l'ampoule rectale, tel que mesuré par la pluralité de capteurs (10, 20), dépasse une telle valeur seuil de remplissage prédéterminée.
PCT/IB2025/051259 2024-02-08 2025-02-06 Dispositif d'alerte pour la miction et/ou la défécation d'un utilisateur Pending WO2025169108A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT202400002638 2024-02-08
IT102024000002638 2024-02-08

Publications (1)

Publication Number Publication Date
WO2025169108A1 true WO2025169108A1 (fr) 2025-08-14

Family

ID=90810613

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2025/051259 Pending WO2025169108A1 (fr) 2024-02-08 2025-02-06 Dispositif d'alerte pour la miction et/ou la défécation d'un utilisateur

Country Status (1)

Country Link
WO (1) WO2025169108A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5058591A (en) * 1987-11-10 1991-10-22 The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration Rapidly quantifying the relative distention of a human bladder
US20190357836A1 (en) * 2018-05-24 2019-11-28 Verathon Inc. Bladder monitoring system
US11064924B2 (en) * 2014-11-27 2021-07-20 Novioscan B.V. Wearable ultrasound device for signalling changes in a human or animal body

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5058591A (en) * 1987-11-10 1991-10-22 The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration Rapidly quantifying the relative distention of a human bladder
US11064924B2 (en) * 2014-11-27 2021-07-20 Novioscan B.V. Wearable ultrasound device for signalling changes in a human or animal body
US20190357836A1 (en) * 2018-05-24 2019-11-28 Verathon Inc. Bladder monitoring system

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