WO2023052853A1 - Portable device and method for detecting and alerting of the accidental disconnection of a patient from a mechanical ventilation circuit - Google Patents

Portable device and method for detecting and alerting of the accidental disconnection of a patient from a mechanical ventilation circuit Download PDF

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Publication number
WO2023052853A1
WO2023052853A1 PCT/IB2022/054589 IB2022054589W WO2023052853A1 WO 2023052853 A1 WO2023052853 A1 WO 2023052853A1 IB 2022054589 W IB2022054589 W IB 2022054589W WO 2023052853 A1 WO2023052853 A1 WO 2023052853A1
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Prior art keywords
patient
disconnection
depressurization
mechanical ventilation
ventilation circuit
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PCT/IB2022/054589
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French (fr)
Inventor
David Alexander LEMOS MARTINEZ
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Fundación Valle Del Lili
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Publication of WO2023052853A1 publication Critical patent/WO2023052853A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes with alarm devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
    • A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
    • A61M2016/0024—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with an on-off output signal, e.g. from a switch
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/13—General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/18—General characteristics of the apparatus with alarm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3553—Range remote, e.g. between patient's home and doctor's office
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587—Lighting arrangements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00—Ancillary equipment
    • A61M2209/08—Supports for equipment
    • A61M2209/088—Supports for equipment on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/08—Limbs
    • A61M2210/083—Arms

Definitions

  • the present invention relates to devices and methods of monitoring patients receiving mechanical ventilation. Specifically, the invention relates to devices that detect the disconnection of a patient from the mechanical ventilation circuit and alert a caregiver of said disconnection.
  • Mechanical ventilation is a therapeutic strategy that consists of mechanically assisting a patient's spontaneous pulmonary ventilation when it is non-existent or ineffective for life.
  • a mechanical fan or artificial respirator can be used, or a person can manually pump the air by compressing an air bag or bellows.
  • a mechanical ventilator or artificial respirator is used, there are occasions when the patient is accidentally disconnected from the ventilation circuit, putting his or her life at risk.
  • Mechanical ventilators traditionally include a disconnection warning system, which is activated in real time when disconnection of the patient from the ventilation circuit is detected.
  • the alerts generated are not quickly detected by the patient's caregivers (such as, for example, healthcare staff in a hospital setting), as they are not always present in the patient's room.
  • the caregivers such as, for example, healthcare staff in a hospital setting
  • Alert systems and methods have been reported in the prior art that detect undesired events in mechanical ventilation circuits associated with a wide variety of ventilatory parameters and changes in vital signs. After detecting these types of events, these systems and methods send, by connecting to a network or server, an alert signal to a user interface where the patient's caregiver can receive an alarm indicating the detected event.
  • these systems and methods can be quite complex, measuring of a large number of variables simultaneously and subsequently processing these variables, which can result in a delay in the identification of unwanted events.
  • a network or server to send the alert to the caregiver, if there are failures in the connection to the network or server it is not possible to transmit the alert signal adequately and in time to the user interface, putting the patient's life at risk.
  • document IT102014902229662 relates to a system and method for remote monitoring of patients receiving home mechanical ventilation treatment, which allows continuous monitoring in real time of the main parameters of pulmonary ventilation, as well as the possibility of detecting any improvement in the patient's physical condition and their spontaneous inspiration attempts.
  • This system performs the measurement of the different ventilation parameters in a first unit, which are then sent to a remote monitoring unit where they are processed and compared against a set of acceptable values. Based on this comparison, information on the physical conditions of the monitored patients is provided.
  • the antecedent WO2017/033157 relates to a method and a system for detecting a malfunction in the gas supply in a spontaneous mechanical ventilation circuit. Detection is implemented by generating a test gas flow for delivery to a patient's airway, and monitoring a response gas flow at the patient interface. If one or more parameters associated with the responding gas flow show inconsistencies with a reference gas flow corresponding to the test flow under the condition that there is no malfunction of the gas supply, the system determines that there is a malfunction of the gas supply.
  • Application EP3839972A1 discloses a device and method for respiratory monitoring in mechanically ventilated patients.
  • the device comprises an input unit for receiving a respiratory signal comprising a pressure signal from the airways and/or a flow signal acquired during mechanical ventilation of a patient, and a data processing unit configured to calculate the entropy values of the sample of a plurality of time series data sets derived from each respiratory signal to obtain an entropy signal from the sample, extract one or more characteristics of each entropy signal from the sample, compare the characteristics with a reference condition, and detect a change in the breathing pattern and/or asynchrony groups based on the comparison.
  • the inventor of the present application has identified the need in the technical field for new devices and methods to detect the accidental disconnection of a patient from a mechanical ventilation circuit, which can also alert the patient's caregiver remotely to solve the disconnection problem in real time, and which do not require additional devices or units to carry out the processing of information, do not require a connection to networks or servers that in the event of a failure may delay or prevent the alert from reaching the caregiver, carry out a measurement of simple ventilation parameters that do not require delayed or complex processing and allows a historical record of the disconnection events to be kept.
  • the inventor provides a new device and method for detecting and alerting a caregiver of an accidental disconnection of a patient from a mechanical ventilation circuit, which addresses some of the above-mentioned needs.
  • This device comprises a depressurization identification unit in connection with the mechanical ventilation circuit to which the patient is connected, a wireless communication unit, a light source, a memory unit, a real-time clock, and a processing unit in connection with all the elements mentioned above.
  • the computer-implemented method which is executed by a processing unit, comprises determining whether there is disconnection of the patient from the mechanical ventilation circuit, and if so, turning on a light signal indicating the occurrence of the disconnection, sending a wireless alarm signal to a user's portable receiver, and recording the disconnection event with the date and time obtained from the real-time clock and storing it in a memory, where the control of the total number of disconnections detected is carried out.
  • Figure 1 shows a schematic view of an embodiment of the device for detecting and alerting of the accidental disconnection of a patient from a mechanical ventilation circuit of the present invention, which illustrates the different units that make it up and the connections existing between the device, the mechanical ventilation circuit to which the patient is connected, and the receiver of the caregiver.
  • Figure 2 shows a flowchart of a modality of the method of the present invention when executed by a modality of the device of the present invention, by which it is possible to send an alert signal to a portable receiver available to the patient's caregiver, notifying same when it is identified that the patient has been disconnected from the ventilation circuit.
  • the present invention relates to a device 1 for detecting and alerting of the accidental disconnection of a patient from a mechanical ventilation circuit, as illustrated by way of example in figure 1 , comprising: a depressurization identification unit 2 in connection with the mechanical ventilation circuit 8 to which the patient 9 is connected; a wireless communication unit 7; a light source 6; a memory unit 5; a real-time clock RTC 4; and a processing unit 3 in connection with all the aforementioned elements.
  • the processing unit 3 is in connection with a caregiver receiver 10, to which an alert signal is sent when disconnection of the patient is detected, by means of the wireless communication unit 7.
  • the depressurization identification unit 2 detects when the patient 9 is disconnected from the mechanical ventilation circuit 8 by detecting the depressurization of the circuit.
  • the depressurization identification unit 2 may have only two states, so that when depressurization of the system is detected, the depressurization identification unit changes from one state to another sending a signal to the processing unit 3. This configuration makes the detection of the patient disconnection from the circuit simple, fast and unequivocal, since it does not require the use of complex pressure sensors or the implementation of algorithms.
  • the depressurization identification unit 2 may be a pressure switch operating as a normally closed - normally open contactor.
  • the depressurization identification unit 2 can be connected to the expiratory arm or to the inspiratory arm of the mechanical ventilator.
  • the light source 6 may be an led light, although any light source known in the art may be employed for these purposes.
  • the memory unit 5 may be a memory card, particularly an SD memory card.
  • the memory unit 5 records the disconnection events, along with the date and time obtained from the RTC 4.
  • the memory 5 may subsequently be connected to a computer to access the log of disconnection events.
  • the receiver 10 of the caregiver can be any mobile device known in the technical field, by which the caregiver can receive an auditory, vibrational or visual alert indicating that an accidental disconnection of the patient from the mechanical ventilation circuit has occurred.
  • the receiver 10 is a watch.
  • the wireless communication unit 7 uses radio frequency to send the alert signal to the receiver 10, so it does not require connection to a Wi-Fi network or to a server in order to send the alarm signal.
  • all the elements described above are arranged inside a housing where a battery can also be housed to give energy autonomy to the device. In this way, the device can be portable and autonomous.
  • the processing unit 3 is configured to: identify the state change of the depressurization identification unit 2 to define if there is disconnection of the patient 9 from the mechanical ventilation circuit 8, and if there is disconnection of the patient 9, perform the following steps, and otherwise repeat this first step; turn on the light source 6; send a wireless alarm signal to the caregiver receiver 10 through the wireless communication unit 7; record the disconnection event with the date and time acquired from the RTC 4 and store it in the memory unit 5; iteratively perform the previous steps, verifying the state of the depressurization identification unit 2 to determine if there are changes in the state and consequently in the disconnection of the patient from the mechanical ventilation circuit.
  • the memory records the total number of disconnections detected and the time and date in which they occurred.
  • the state change of the depressurization identification unit 2 is identified by generating a depressurization of the mechanical ventilation circuit 8 when the patient is disconnected from same.
  • the wireless alarm signal that is sent to the receiver 10 of the caregiver via the wireless communication unit 7 is a radio frequency signal, which does not require connection to a network or server.
  • the receiver 10 of the caregiver upon receiving the signal from the device 1 , emits an alarm that can be auditory, vibratory or visual.
  • the present invention relates to a computer-implemented method for detecting and alerting a caregiver of the accidental disconnection of a patient from a mechanical ventilation circuit, executed by a processing unit 3 comprising: identifying the state change of a depressurization identification unit 2 to determine if there is disconnection of a patient 9 from a mechanical ventilation circuit 8; if there is disconnection, execute the following steps and, otherwise, repeat this first step; turn on a light signal indicating the occurrence of the disconnection; send a wireless alarm signal to a receiver 10 of the caregiver by means of a wireless communication unit 7; record the disconnection event with the date and time acquired from an RTC 4 and store it in the memory unit 5; iteratively perform the above steps, verifying the state of the depressurization identification unit 2 to determine if there are changes in the state and consequently in the disconnection of the patient from the mechanical ventilation circuit.
  • the depressurization identification unit 2 changes state if depressurization of the mechanical ventilation circuit 8 occurs when the patient is disconnected from it.
  • the wireless alarm signal is sent to the receiver 10 of the caregiver as a radio frequency signal, which does not require connection to a network or server.
  • the device and method of the present invention only detect a change of state of the depressurization identification unit 2 to identify that there has been an accidental disconnection of the patient from the mechanical ventilation circuit, without the need to measure more parameters, compare with acceptable values, or execute other types of complex algorithms to detect such disconnection. This makes detection much easier, faster and more efficient compared to other systems and methods.

Abstract

The present invention relates to a novel device and method for detecting and alerting a caregiver of the accidental disconnection of a patient from a mechanical ventilation circuit. The device comprises a depressurization identification unit in connection with the mechanical ventilation circuit to which the patient is connected, a wireless communication unit, a light source, a memory unit, a real-time clock, and a processing unit in connection with all the elements mentioned above. The method comprises determining whether the patient is disconnected from the mechanical ventilation circuit, and if so, turning on a light signal indicating the occurrence of the disconnection, sending a wireless alarm signal to a user receiver, and recording the disconnection event with the date and time obtained from the real-time clock and storing it.

Description

PORTABLE DEVICE AND METHOD FOR DETECTING AND ALERTING OF THE ACCIDENTAL DISCONNECTION OF A PATIENT FROM A MECHANICAL VENTILATION CIRCUIT
FIELD OF THE ART
[0001] The present invention relates to devices and methods of monitoring patients receiving mechanical ventilation. Specifically, the invention relates to devices that detect the disconnection of a patient from the mechanical ventilation circuit and alert a caregiver of said disconnection.
STATE OF THE ART
[0002] Mechanical ventilation is a therapeutic strategy that consists of mechanically assisting a patient's spontaneous pulmonary ventilation when it is non-existent or ineffective for life. To carry out the mechanical ventilation, a mechanical fan or artificial respirator can be used, or a person can manually pump the air by compressing an air bag or bellows. When a mechanical ventilator or artificial respirator is used, there are occasions when the patient is accidentally disconnected from the ventilation circuit, putting his or her life at risk.
[0003] Mechanical ventilators traditionally include a disconnection warning system, which is activated in real time when disconnection of the patient from the ventilation circuit is detected. However, the alerts generated are not quickly detected by the patient's caregivers (such as, for example, healthcare staff in a hospital setting), as they are not always present in the patient's room. Additionally, it is usual for patients' rooms to remain closed, which makes it difficult for the caregiver to hear the ventilator sound alarm outside the room in the event of accidental disconnection, increasing the risk of irreversible injury due to hypoxia or death.
[0004] There are also alert systems in hospital environments that are synchronized with the central monitors of intensive care units, but it is not possible to differentiate whether the alert was generated by the disconnection of the ventilator or by another device of the patient (EKG, saturation clamp, blood pressure, etc.), emitting the same sound upon disconnection of any element, thus increasing the auditory contamination in the environment and generating alarm fatigue, making it more difficult for caregivers to quickly solve the disconnection.
[0005] Alert systems and methods have been reported in the prior art that detect undesired events in mechanical ventilation circuits associated with a wide variety of ventilatory parameters and changes in vital signs. After detecting these types of events, these systems and methods send, by connecting to a network or server, an alert signal to a user interface where the patient's caregiver can receive an alarm indicating the detected event. However, these systems and methods can be quite complex, measuring of a large number of variables simultaneously and subsequently processing these variables, which can result in a delay in the identification of unwanted events. Additionally, by requiring a network or server to send the alert to the caregiver, if there are failures in the connection to the network or server it is not possible to transmit the alert signal adequately and in time to the user interface, putting the patient's life at risk.
[0006] For example, document IT102014902229662 relates to a system and method for remote monitoring of patients receiving home mechanical ventilation treatment, which allows continuous monitoring in real time of the main parameters of pulmonary ventilation, as well as the possibility of detecting any improvement in the patient's physical condition and their spontaneous inspiration attempts. This system performs the measurement of the different ventilation parameters in a first unit, which are then sent to a remote monitoring unit where they are processed and compared against a set of acceptable values. Based on this comparison, information on the physical conditions of the monitored patients is provided.
[0007] On the other hand, the antecedent WO2017/033157 relates to a method and a system for detecting a malfunction in the gas supply in a spontaneous mechanical ventilation circuit. Detection is implemented by generating a test gas flow for delivery to a patient's airway, and monitoring a response gas flow at the patient interface. If one or more parameters associated with the responding gas flow show inconsistencies with a reference gas flow corresponding to the test flow under the condition that there is no malfunction of the gas supply, the system determines that there is a malfunction of the gas supply.
[0008] Application EP3839972A1 discloses a device and method for respiratory monitoring in mechanically ventilated patients. The device comprises an input unit for receiving a respiratory signal comprising a pressure signal from the airways and/or a flow signal acquired during mechanical ventilation of a patient, and a data processing unit configured to calculate the entropy values of the sample of a plurality of time series data sets derived from each respiratory signal to obtain an entropy signal from the sample, extract one or more characteristics of each entropy signal from the sample, compare the characteristics with a reference condition, and detect a change in the breathing pattern and/or asynchrony groups based on the comparison.
SUMMARY OF THE INVENTION
[0009] The inventor of the present application has identified the need in the technical field for new devices and methods to detect the accidental disconnection of a patient from a mechanical ventilation circuit, which can also alert the patient's caregiver remotely to solve the disconnection problem in real time, and which do not require additional devices or units to carry out the processing of information, do not require a connection to networks or servers that in the event of a failure may delay or prevent the alert from reaching the caregiver, carry out a measurement of simple ventilation parameters that do not require delayed or complex processing and allows a historical record of the disconnection events to be kept.
[0010] In the present application, the inventor provides a new device and method for detecting and alerting a caregiver of an accidental disconnection of a patient from a mechanical ventilation circuit, which addresses some of the above-mentioned needs.
[0011] This device comprises a depressurization identification unit in connection with the mechanical ventilation circuit to which the patient is connected, a wireless communication unit, a light source, a memory unit, a real-time clock, and a processing unit in connection with all the elements mentioned above.
[0012] The computer-implemented method, which is executed by a processing unit, comprises determining whether there is disconnection of the patient from the mechanical ventilation circuit, and if so, turning on a light signal indicating the occurrence of the disconnection, sending a wireless alarm signal to a user's portable receiver, and recording the disconnection event with the date and time obtained from the real-time clock and storing it in a memory, where the control of the total number of disconnections detected is carried out.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 shows a schematic view of an embodiment of the device for detecting and alerting of the accidental disconnection of a patient from a mechanical ventilation circuit of the present invention, which illustrates the different units that make it up and the connections existing between the device, the mechanical ventilation circuit to which the patient is connected, and the receiver of the caregiver.
Figure 2 shows a flowchart of a modality of the method of the present invention when executed by a modality of the device of the present invention, by which it is possible to send an alert signal to a portable receiver available to the patient's caregiver, notifying same when it is identified that the patient has been disconnected from the ventilation circuit.
DETAILED DESCRIPTION OF THE INVENTION
[0013] In a first aspect, the present invention relates to a device 1 for detecting and alerting of the accidental disconnection of a patient from a mechanical ventilation circuit, as illustrated by way of example in figure 1 , comprising: a depressurization identification unit 2 in connection with the mechanical ventilation circuit 8 to which the patient 9 is connected; a wireless communication unit 7; a light source 6; a memory unit 5; a real-time clock RTC 4; and a processing unit 3 in connection with all the aforementioned elements. The processing unit 3 is in connection with a caregiver receiver 10, to which an alert signal is sent when disconnection of the patient is detected, by means of the wireless communication unit 7.
[0014] The depressurization identification unit 2 detects when the patient 9 is disconnected from the mechanical ventilation circuit 8 by detecting the depressurization of the circuit. The depressurization identification unit 2 may have only two states, so that when depressurization of the system is detected, the depressurization identification unit changes from one state to another sending a signal to the processing unit 3. This configuration makes the detection of the patient disconnection from the circuit simple, fast and unequivocal, since it does not require the use of complex pressure sensors or the implementation of algorithms. In an embodiment of the invention, the depressurization identification unit 2 may be a pressure switch operating as a normally closed - normally open contactor.
[0015] In an embodiment of the invention, the depressurization identification unit 2 can be connected to the expiratory arm or to the inspiratory arm of the mechanical ventilator.
[0016] In an embodiment of the invention, the light source 6 may be an led light, although any light source known in the art may be employed for these purposes.
[0017] In an embodiment of the invention, the memory unit 5 may be a memory card, particularly an SD memory card. The memory unit 5 records the disconnection events, along with the date and time obtained from the RTC 4. The memory 5 may subsequently be connected to a computer to access the log of disconnection events.
[0018] In an embodiment of the invention, the receiver 10 of the caregiver can be any mobile device known in the technical field, by which the caregiver can receive an auditory, vibrational or visual alert indicating that an accidental disconnection of the patient from the mechanical ventilation circuit has occurred. In an embodiment of the invention, the receiver 10 is a watch.
[0019] In an embodiment of the invention, the wireless communication unit 7 uses radio frequency to send the alert signal to the receiver 10, so it does not require connection to a Wi-Fi network or to a server in order to send the alarm signal.
[0020] In an embodiment of the invention, all the elements described above are arranged inside a housing where a battery can also be housed to give energy autonomy to the device. In this way, the device can be portable and autonomous.
[0021] The processing unit 3 is configured to: identify the state change of the depressurization identification unit 2 to define if there is disconnection of the patient 9 from the mechanical ventilation circuit 8, and if there is disconnection of the patient 9, perform the following steps, and otherwise repeat this first step; turn on the light source 6; send a wireless alarm signal to the caregiver receiver 10 through the wireless communication unit 7; record the disconnection event with the date and time acquired from the RTC 4 and store it in the memory unit 5; iteratively perform the previous steps, verifying the state of the depressurization identification unit 2 to determine if there are changes in the state and consequently in the disconnection of the patient from the mechanical ventilation circuit. Preferably, the memory records the total number of disconnections detected and the time and date in which they occurred.
[0022] In one embodiment of the invention, the state change of the depressurization identification unit 2 is identified by generating a depressurization of the mechanical ventilation circuit 8 when the patient is disconnected from same.
[0023] In one embodiment of the invention, the wireless alarm signal that is sent to the receiver 10 of the caregiver via the wireless communication unit 7 is a radio frequency signal, which does not require connection to a network or server.
[0024] In an embodiment of the invention, the receiver 10 of the caregiver, upon receiving the signal from the device 1 , emits an alarm that can be auditory, vibratory or visual.
[0025] In a second aspect, the present invention relates to a computer-implemented method for detecting and alerting a caregiver of the accidental disconnection of a patient from a mechanical ventilation circuit, executed by a processing unit 3 comprising: identifying the state change of a depressurization identification unit 2 to determine if there is disconnection of a patient 9 from a mechanical ventilation circuit 8; if there is disconnection, execute the following steps and, otherwise, repeat this first step; turn on a light signal indicating the occurrence of the disconnection; send a wireless alarm signal to a receiver 10 of the caregiver by means of a wireless communication unit 7; record the disconnection event with the date and time acquired from an RTC 4 and store it in the memory unit 5; iteratively perform the above steps, verifying the state of the depressurization identification unit 2 to determine if there are changes in the state and consequently in the disconnection of the patient from the mechanical ventilation circuit.
[0026] In one embodiment of the method of the invention, the depressurization identification unit 2 changes state if depressurization of the mechanical ventilation circuit 8 occurs when the patient is disconnected from it.
[0027] In one embodiment of the method of the invention, the wireless alarm signal is sent to the receiver 10 of the caregiver as a radio frequency signal, which does not require connection to a network or server.
[0028] As has been shown, the device and method of the present invention only detect a change of state of the depressurization identification unit 2 to identify that there has been an accidental disconnection of the patient from the mechanical ventilation circuit, without the need to measure more parameters, compare with acceptable values, or execute other types of complex algorithms to detect such disconnection. This makes detection much easier, faster and more efficient compared to other systems and methods.

Claims

7 CLAIMS
1 . A portable device 1 for detecting and alerting a caregiver of the accidental disconnection of a patient (9) from a mechanical ventilation circuit (8) comprising: a depressurization identification unit (2) in connection with the mechanical ventilation circuit (8) to which the patient (9) is connected; a wireless communication unit (7); a light source (6); a memory unit (5); a real-time clock RTC (4); and a processing unit (3) in connection with the depressurization identification unit (2), the wireless communication unit (7), the light source (6), the memory unit (5) and the real-time clock RTC (4); wherein the processing unit is configured to: identify the change of state in the depressurization identification unit (2) to determine if there is disconnection of the patient 9 from the mechanical ventilation circuit (8) and, if there is disconnection of the patient, perform the following steps and, otherwise, repeat this step; turn on the light source (6); send a wireless alarm signal to a receiver (10) of the caregiver via the wireless communication unit (7); record the disconnection event with the date and time acquired from the RTC (4) and store it in the memory unit (5); and iteratively perform the above steps, verifying the state of the depressurization identification unit (2) to determine if there are changes in the state and consequently in the patient's disconnection from the mechanical ventilation circuit.
2. The device according to claim 1 , wherein the depressurization identification unit (2) detects when the patient (9) is disconnected from the mechanical ventilation circuit (8), upon detecting the depressurization of the circuit, changing from a first state to a second state.
3. The device according to claim 2, wherein the depressurization identification unit (2) is a pressure switch operating as a normally closed - normally open contactor.
4. The device according to claim 1 , wherein the depressurization identification unit (2) is connected to the expiratory arm or the inspiratory arm of the mechanical ventilator. 8
5. The device according to claim 1 , wherein the memory unit (5) is a memory card that stores the number of disconnections detected and the time and date when they occurred.
6. The device according to claim 1 , wherein the receiver (10) of the caregiver is a mobile device.
7. The device according to claim 1 , wherein the wireless communication unit (7) is a radio frequency system.
8. A computer-implemented method for detecting and alerting a caregiver of the accidental disconnection of a patient from a mechanical ventilation circuit, executed by a processing unit (3), comprising: identifying the change of state of a depressurization identification unit (2) to define if there is disconnection of the patient (9) from the mechanical ventilation circuit (8) and, if there is disconnection of the patient (9), perform the following steps, and otherwise repeat this step; turning on a light signal indicating the occurrence of the disconnection; sending a wireless alarm signal to a receiver (10) of the caregiver via a wireless communication unit (7); recording the disconnection event with the date and time acquired from an RTC (4) and storing it in a memory unit (5); and iteratively performing the above steps, verifying the state of the depressurization identification unit (2) to determine if there are changes in the state and consequently in the patient's disconnection from the mechanical ventilation circuit.
9. The method of claim 8, wherein the depressurization identification unit (2) changes from a first state to a second state when a depressurization of the mechanical ventilation circuit (8) occurs upon disconnection of the patient therefrom.
10. The method of claim 8, wherein the wireless alarm signal is sent to the receiver (10) of the caregiver as a radio frequency signal.
PCT/IB2022/054589 2021-09-29 2022-05-18 Portable device and method for detecting and alerting of the accidental disconnection of a patient from a mechanical ventilation circuit WO2023052853A1 (en)

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CONC2021/0013026A CO2021013026A1 (en) 2021-09-29 2021-09-29 Portable device and method to detect and alert about accidental disconnection of a patient from a mechanical ventilation circuit

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2281513A (en) * 1993-08-31 1995-03-08 Ulco Eng Pty Ltd Indicating abnormal operation of a ventilator
WO2017027906A1 (en) * 2015-08-14 2017-02-23 Resmed Limited Monitoring respiratory pressure therapy
WO2017033157A1 (en) 2015-08-27 2017-03-02 Koninklijke Philips N.V. Detecting a malfunction during spontaneous mechanical ventilation
EP3839972A1 (en) 2019-12-16 2021-06-23 Consorci Corporació Sanitària Parc Taulí A device and method for respiratory monitoring in mechanically ventilated patients

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2281513A (en) * 1993-08-31 1995-03-08 Ulco Eng Pty Ltd Indicating abnormal operation of a ventilator
WO2017027906A1 (en) * 2015-08-14 2017-02-23 Resmed Limited Monitoring respiratory pressure therapy
WO2017033157A1 (en) 2015-08-27 2017-03-02 Koninklijke Philips N.V. Detecting a malfunction during spontaneous mechanical ventilation
EP3839972A1 (en) 2019-12-16 2021-06-23 Consorci Corporació Sanitària Parc Taulí A device and method for respiratory monitoring in mechanically ventilated patients

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