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EP4041357A1 - Connecteur pour système d'assistance respiratoire à un patient - Google Patents

Connecteur pour système d'assistance respiratoire à un patient

Info

Publication number
EP4041357A1
EP4041357A1 EP20789922.0A EP20789922A EP4041357A1 EP 4041357 A1 EP4041357 A1 EP 4041357A1 EP 20789922 A EP20789922 A EP 20789922A EP 4041357 A1 EP4041357 A1 EP 4041357A1
Authority
EP
European Patent Office
Prior art keywords
sensor
connector
breathing air
patient
control
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
EP20789922.0A
Other languages
German (de)
English (en)
Inventor
Thomas Ruhland
Ricardo Ehrenpfordt
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.)
Raumedic AG
Original Assignee
Raumedic AG
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
Priority claimed from DE102019215483.2A external-priority patent/DE102019215483A1/de
Priority claimed from DE102019216485.4A external-priority patent/DE102019216485A1/de
Application filed by Raumedic AG filed Critical Raumedic AG
Publication of EP4041357A1 publication Critical patent/EP4041357A1/fr
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/08Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816Joints or connectors
    • A61M16/0833T- or Y-type connectors, e.g. Y-piece
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/08Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816Joints or connectors
    • A61M16/0841Joints or connectors for sampling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/08Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816Joints or connectors
    • A61M16/0841Joints or connectors for sampling
    • A61M16/085Gas sampling
    • AHUMAN NECESSITIES
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    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/021Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes operated by electrical means
    • A61M16/022Control means therefor
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    • A61M16/08Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816Joints or connectors
    • AHUMAN NECESSITIES
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    • A61M16/08Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816Joints or connectors
    • A61M16/0841Joints or connectors for sampling
    • A61M16/0858Pressure sampling ports
    • AHUMAN NECESSITIES
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    • A61M16/10Preparation of respiratory gases or vapours
    • A61M16/1075Preparation of respiratory gases or vapours by influencing the temperature
    • A61M16/1095Preparation of respiratory gases or vapours by influencing the temperature in the connecting tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/08Measuring devices for evaluating the respiratory organs
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    • A61M15/0065Inhalators with dosage or measuring devices
    • A61M15/0068Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/0083Timers
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    • A61M16/10Preparation of respiratory gases or vapours
    • A61M16/14Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • A61M16/16Devices to humidify the respiration air
    • A61M16/161Devices to humidify the respiration air with means for measuring the humidity
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    • A61M16/0003Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
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    • A61M2016/003Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
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    • A61M2205/00General characteristics of the apparatus
    • A61M2205/02General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0227Materials having sensing or indicating function, e.g. indicating a pressure increase
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    • A61M2205/00General characteristics of the apparatus
    • A61M2205/14Detection of the presence or absence of a tube, a connector or a container in an apparatus
    • AHUMAN NECESSITIES
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    • A61M2205/18General characteristics of the apparatus with alarm
    • AHUMAN NECESSITIES
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    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3306Optical measuring means
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    • A61M2205/332Force measuring means
    • AHUMAN NECESSITIES
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    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • A61M2205/3334Measuring or controlling the flow rate
    • AHUMAN NECESSITIES
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    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3368Temperature
    • AHUMAN NECESSITIES
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    • A61M2205/3375Acoustical, e.g. ultrasonic, measuring means
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    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
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    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587Lighting arrangements
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    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6018General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
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    • A61M2205/6054Magnetic identification systems
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    • A61M2230/06Heartbeat rate only
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    • A61M2230/65Impedance, e.g. conductivity, capacity

Definitions

  • the invention relates to a connector for a patient ventilation system.
  • Such a connector is known from DE 202014 103 998 Ul.
  • WO 2007/051230 A1 discloses a sensory sleeve section for a ventilator.
  • EP 2062 531 A1 discloses a multifunctional airway adapter.
  • this object is achieved according to the invention by a connector having the features specified in claim 1.
  • a signal data memory can be used as part of the connector to store signal data for their later internal and / or external signal data processing.
  • the signal data memory can then, in the manner of a buffer, initially collect the signal data generated in particular by the at least one sensor of the connector in order to feed them for later processing.
  • a log file can be written in the signal data memory, which can be used to log the duration of the connector's service life.
  • the recorded signal data but also other information, such as B. acquisition times and other data, e.g. B. identification data on connector components and / or the sensors used and / or the data standards used can be stored.
  • the signal data memory can also be used for other data, for example to store a type designation of the connector and / or the patient ventilation system equipped with it, as well as other components, an operating manual for the connector and / or other components of the ventilation system, and safety instructions in relation to the connector and / or other components of the ventilation system.
  • the signal data memory can have its own interface for reading via an external component, for example via RFID or via NFC (Near Field Communication).
  • the breathing air hose section that is connected to the connector can be a heatable breathing air hose section.
  • the hose section can also be lead out of non-heatable manner.
  • a processing module enables internal signal data processing in the connector.
  • Examples of data processing that can take place in the processing module are data filtering, data volume reduction, feature extraction and feature selection, a classification of the data in a given classification scheme, a sensor data fusion and a sensor data standardization.
  • machine-running algorithms e.g. B. Tit-in, and / or decision trees / decision networks are used that are known in connection with neural networks and artificial intelligence (AI).
  • the processing module is in signal connection with the signal data memory.
  • the processing can be used to identify the status of the ventilation system and / or a patient connected to it. Corresponding status information and possibly warning signals can then be passed on to a display unit of the connector and / or to an external component.
  • Measures can be taken to respond to a corresponding status detection.
  • captured environmental parameters such as. B. temperature and air humidity
  • functions of the breathing system can be controlled or regulated, or an exchange of components of the breathing system can be prepared. Big data applications are possible by processing and / or forwarding the data that is saved with the signal data memory.
  • An identification data record stored in the memory according to claim 3 permits an unambiguous assignment, in particular at least one disposable component of the connector. Such a data record can be used to protect against plagiarism.
  • a plurality of sensors according to claim 4 increases the possible uses of the connector.
  • the processing module if it is provided for processing the recorded sensor data, can combine the raw signal data of several sensors recorded by the sensors with one another for processing. This can improve the quality, in particular, of a status recognition of the ventilation system and / or of a patient connected to it.
  • this can, for example, compress acquired sensor data and / or bring it into a further processable data format.
  • the processing module can be used to select recorded raw sensor data. This makes it possible, for example, to pass on maximum or minimum sensor values that are recorded by the sensor within a certain period of time.
  • a sensor according to claim 6, which measures at least one breathing air parameter in contact with the breathing air can be used for a precise measurement of the breathing air parameter.
  • the sensor can be designed in such a way that it measures more than one breathing air parameter.
  • the sensor can be a gas composition analysis sensor, a flow sensor and / or a humidity sensor.
  • At least one environment sensor helps to significantly improve the quality of a condition detection, in particular a patient condition, but also the ventilation system.
  • a condition detection in particular a patient condition, but also the ventilation system.
  • Such an ambient sensor can be a sensor for detecting an ambient brightness and / or a microphone.
  • a stress level for the patient can be assessed based on what can be responded to by appropriate control / regulation of the ventilation system.
  • a motion detection sensor helps, in particular, to allow additional patient movements to flow into a state detection. It is also possible to record a movement pattern, for example using a Fourier analysis of the data output by the movement detection sensor. This can also be used to draw conclusions about a patient's condition.
  • An acceleration sensor can be used as a motion detection sensor.
  • An analysis sensor makes it possible to readjust a breathing air source of the ventilation system accordingly.
  • the analysis sensor is arranged in the ventilation system, for example, in the area of a guide of exhaled breathing air, the patient's condition z. B. close via a measured CCE value of the exhaled breath.
  • a breathing gas pressure sensor enables breathing pattern recognition and a conclusion about the patient's condition.
  • An interface connection with an external sensor according to claim 11 enables additional external sensor data to flow into the signal data processing, for example the data of a heart rate measurement, a body temperature measurement and / or a measurement of a main surface resistance of the patient.
  • a contactless sensor measurement according to claim 12 enables the breathing air to be routed tightly in the area of the sensor. The requirements placed on the biocompatibility of the sensor are reduced.
  • the Connector can have both a sensor that measures the breathing air parameter in contact with the breathing air, and a sensor that measures the breathing air parameter without contact. This can be used to generate an error security in such an air measurement. A redundant measurement can be achieved.
  • a cover layer according to claim 13 can, if the sensor is designed as a temperature sensor, be designed as a heat coupling layer. If the sensor is designed as a pressure sensor, the cover layer can be designed as a pressure coupling layer.
  • a design of the cover layer according to claim 14 as an optical window enables the use of an optical sensor. This can be used to measure an absorption or scattering of the breathing air and / or a measurement of a reflection of an inner wall of a lumen of the connector carrying the breathing air, which in turn draws conclusions about breathing air parameters, the condition of the ventilation system and / or the condition of the patient allows.
  • the optical sensor can be designed as a spatially resolving sensor.
  • a measurement of moving particles, such. B. of flowing condensate or condensation droplets possible.
  • This also enables the status of the ventilation system to be recognized and, for example, allows a warning signal to be output if the flowing condensate threatens to flow into other areas of the ventilation system in an undesired manner.
  • the object mentioned at the beginning is achieved according to a further aspect in accordance with the invention by a connector having the features specified in claim 15.
  • control / regulating unit with several and, in particular, different signal transmission interfaces enables the connector to be flexibly expanded to include additional internal and / or external sensors.
  • Interfaces that can be used in this way are I 2 C (Inter-Integrated Circuit), SPI (Serial Peripherial Interface), RS232 and / or RS485.
  • FIG. 1 schematically shows the main components of a patient ventilation system including a main unit, a humidification device, a breathing mask and several heatable hose components connecting them and carrying the breathing air, including several connectors for the fluid-carrying connection of these components;
  • FIG. 2 is a perspective view of an end section of one of the hose components with a connection connector and a monitoring connector shown at a distance from it, i.e. not yet in the connection position
  • Fig. 3 is a further perspective view of the monitoring Konnek sector
  • 4 is an exploded view in which a reusable component of the monitoring connector is shown separately from a one-way component of the monitoring connector;
  • FIG. 5 shows a further exploded view of the monitoring connector, with a circuit board of the disposable component as an additional
  • Part of a start signal generator unit and a cover are shown for this purpose, which are used to generate a start signal to detect a useful life of the one-way component;
  • FIG. 6 shows an axial section through the monitoring connector, partially revealing internal details, wherein in particular components of a control / regulating unit, a light source and a start signal generator unit are shown;
  • FIG. 7 shows, in perspective, in a representation similar to FIG. 2, a further embodiment of a monitoring connector which at the same time has the function of a connection connector comparable to the embodiment according to FIG. 2;
  • thermochromic material 8 shows a further embodiment of a disposable component of the monitoring connector with a connector section made of a thermochromic material
  • 9 shows, in sections, an embodiment of a hose component of the ventilation system with a wall section made of a thermochromic material.
  • a patient ventilation system 1 the main components of which are shown in FIG. 1, is used to ventilate a patient in the clinical, otherwise stationary or domestic care sector.
  • the essential, air-conducting components of the ventilation system 1 are made of plastic.
  • the ventilation system has a main unit 2 for control / regulation, in particular a breathing air supply, air humidification and a Tem peration of the breathing air.
  • the main unit 2 can also be used to specify a breathing air composition.
  • the main unit 2 serves as a source of breathing air.
  • the main unit 2 is in fluid connection with a breathing air supply hose component 5 via a connection port 3 and a connection connector 4.
  • the latter like the other hose components, is shown very schematically in FIG. 1.
  • the tube components of the breathing system 1 are, as will be described below, controlled / regulated via the main unit 2 and can be heated.
  • the breathing air supply hose component 5 is in fluid connection with a connection port 7 of a breathing air humidifying device 8 via a further connection connector 6.
  • the moistening seimichtung 8 is in a manner not shown with the main unit 2 in Signalver connection.
  • the humidification device 8 is in fluid connection with a breathing air connection hose component 11 via a further connection port 9 and a further connection connector 10.
  • the breathing air connec tion hose component 11 is in fluid connection with a patient breathing mask 15 via a further connection connector 12, a monitoring connector 13 and a three-way connector 14.
  • the monitoring connector 13 is therefore used on the one hand to connect to the breathing air connection hose component 11, that is to say with a heatable breathing air hose section for guiding ventilation air from the main unit 2 to the patient, and on the other hand to connect this hose component 11 to the patient.
  • Breathing mask 15 as a patient air interface.
  • the monitoring connector 13 is integrally connected to the hose component 11, so it forms an integral part of it.
  • the breathing mask 15 is in fluid connection with a breathing air discharge hose component 17 via the three-way connector 14 and a further connection connector 16. This is in turn in fluid connection with the main assembly 2 via a further connection connector 18 and a further connection port 19.
  • the connection connector 12 has a receptacle which is not visible in FIG. 2 and which is designed to be complementary to a supply connection sleeve 21 of the monitoring connector 13.
  • the feed connector sleeve 21 is formed on a base body 22 of the monitoring connector 13. Opposite to the supply connection sleeve 21, a discharge connection sleeve 23 of the monitoring connector 13 is integrally formed on the base body 22.
  • An outside diameter of the supply connection sleeve 21 is smaller than an outside diameter of the discharge connection sleeve 23. A flow of breathing air through the monitoring connector 13 is ensured via the two connection sleeves 21, 23 and an opening in the base body 22 that is aligned therewith.
  • the feed connection sleeve 21 and also the connection connector 12 and the base body 22 of the monitoring connector 13 is molded directly onto the hose component 11, so that an air routing connector component of the monitoring connector 13, i.e. the Base body 22, an integral part with the breathing air hose component 11 forms.
  • FIGS. 3 to 6 show further details of the monitoring connector 13.
  • the main components of the monitoring connector 13 are a reusable component 24, which is also referred to as a reusable, and a disposable component 25, which is also referred to as a disposable. In principle, it is possible to use the disposable 25 several times after appropriate cleaning or sterilization.
  • the reusable 24 is detachably connected to the disposable 25 via an electrical plug connection 26.
  • the plug connection is multi-pole and eight-pole in the embodiment shown.
  • a plug 27 of the plug connection 26 is designed as part of the disposable 25.
  • the reusable 24 has a cuboid base body 28 from which two protruding components 29, 30 extend away which, when assembled with the disposable 25, cover two opposing walls of the disposable 25 in sections. Except for a cover 31 closing the base body 28 in the orientation according to FIG. 4 towards the top, visible sides of the base body 28 are made of transparent or opaque material.
  • the base body 28 also has a supply plug connection for connecting a supply line 32, via which an electrical supply and / or signal transmission from / to an external component, in particular the main assembly 2, is possible.
  • FIG. 5 shows in an additional exploded view the embedding of a circuit board 33 in a corresponding receiving space 34 in the base body 22 of the disposable 25.
  • the receiving space 34 is above a coupling wall, a window or a passage opening with one of the two connecting sleeves 21, 23 connecting inner lumen of the base body 22 in connection. This can be used for a sensory coupling of a sensor of the disposable 25 accommodated in the receiving space 34 to the breathing air conveyed through it.
  • the monitoring connector 13 has a control / regulating unit 35. This is accommodated in a receiving space 36 of the reusable 24.
  • Core The component of the control / regulating unit 35 is a microcontroller 37 which, along with other components, is accommodated on a circuit board 38 in the receiving space 36.
  • the control unit 35 also includes a real-time clock 39, which can have a quartz crystal timer, and a connection controller 40, which is also a microcontroller, and a data connection between the components on the circuit board 38 of the reusable 24 and the blocks on the board 33 of the disposable 25 controls.
  • a sensor controller 41 can be provided on the circuit board 38 as an additional component of the control / regulating unit 35.
  • the microcontroller 37 and the real-time clock 39 are housed on one side of the board 38 and the connection controller 40 and the sensor controller 41 on the opposite side of the board 38, on which a socket of the plug connection 26 is also arranged.
  • the electronic components arranged on the circuit boards 33 or 38 can be designed as SMD components.
  • the circuit boards 33, 38 can be two-layer PCBs. Internal communication between the components on the boards 33, 38 can take place via an I 2 C interface standard.
  • Two light sources 42 which are designed as RGB LEDs and are in signal connection with the control / regulating unit 35, are also arranged on the circuit board 38.
  • the respective light source 42 can, for example, emit red light, green light, blue light or also white light. This emitted light is visible through the transparent / opaque sections of the base body 28 of the reusable 24.
  • the number of light sources 42 can vary between 1 and 10 depending on the design of the monitoring connector 13.
  • the respective light source 42 has a plurality of individual light sources of different colors via these RGB LEDs. Controlled by the microcontroller 37, each of these colors is assigned to a state of the monitoring connector 13 or a state of the ventilation system 1. In addition, the microcontroller 37 can specify an activation frequency of the light source 42 so that, for example, further states of the monitoring connector 13 or the ventilation system 1 can be displayed via a blink sequence of the light source 42.
  • a light guide of the light emitted by the light sources 42 over the transparent / opaque sections of the base body 28 and the protruding components 29, 30 ensures that the light signal generated by the light sources 42 is visible from at least five spatial directions. Visibility directly from above, that is, from a viewing direction perpendicular to the plane of arrangement of the cover 31, is achieved in that the transparent / opaque base body 28 protrudes over the entire circumference of the cover 31.
  • the other four spatial directions from which a light signal from the light sources 42 are visible are the main directions assigned to the four side walls of the base body 28.
  • a memory module 43 is also arranged on the circuit board 33 of the disposable 25.
  • the memory module contains an identification data record as ROM data, which uniquely identifies the disposable 25.
  • the identification signal can be, for example, an individual identification number of the disposable 25 which is assigned when the disposable 25 is manufactured.
  • the memory module 43 represents a start signal generator unit 44 for generating a start signal from which the control / regulating unit 35 records a usage period of the disposable 25. For this purpose, a transfer of the identification data record between the memory module 43 and the microcontroller 37 generates the start signal.
  • the start signal generator unit can only have the microcontroller 37 and possibly the connection controller 40 and be designed so that an electrical contact between the reusable 24 and the disposable 25 via the plug connection 26 generates the start signal.
  • a trigger by the main unit 2 can also generate the start signal via a corresponding control signal connection.
  • the board 33 of the disposable 25 also carries a sensor 45 for detecting a breathing air parameter.
  • the sensor 45 is in signal connection with the microcontroller 37 of the control / regulating unit 35 via the plug connection 26.
  • the sensor 45 is a temperature sensor. This can be functional in a temperature range between -20 ° C and 90 ° C and, for example, in a range between
  • Signal data of the sensor 45 can be stored at least temporarily in the memory module 43 of the disposable 25 and / or in a memory of the microcontroller 37.
  • the microcontroller 37 and the memory module 43 can thus have the function of a signal data memory.
  • the microcontroller 37 contains a processing module 37a for processing the signal data.
  • the signal data memory of the microcontroller 37 can in turn have an identification data record as a ROM data record, via which the reusable 24 can be clearly identified.
  • the sensor 45 is in sensori-shear connection, in particular in thermal contact, via a coupling medium 46 and a thin sensor wall section 47 with the inner lumen 48 of the disposable 25.
  • the coupling medium 46 is accordingly a material that conducts heat very well.
  • a wall thickness of the sensor wall section 47 can be less than 1 mm, can be less than 0.5 mm, less than 0.25 mm and can also be less than 0.2 mm. As a rule, the wall thickness of the sensor wall section 47 is greater than 25 mth.
  • the sensor 45 is designed in such a way that it measures the breathing air parameter, that is to say the breathing air temperature, without contact, that is to say without direct contact with the breathing air.
  • the coupling medium 46 on the one hand and the sensor wall section 47 on the other hand represent a cover layer over which the sensor 45 is covered up to the lumen 48 of the disposable 25, that is to say to a breathing air guide lumen.
  • a window can also be inserted into the base body 22 of the disposable 25 as the cover layer 46, via which the sensor 45 is in sensory contact with the lumen 48 and thus with the breathing air.
  • the sensor 45 can then be an optical sensor and in particular a spatially resolving optical sensor.
  • the sensor 45a measures the respective breathing air parameter in contact with the breathing air.
  • a sensor window or a sensor recess 22a is designed, via which a sensor surface of the sensor 45a comes into direct contact with the breathing air in the lumen 48.
  • the sensitive sensor surface of the sensor 45a is arranged in such a way that there is no disruptive dead volume between it and the lumen 48.
  • the sensitive sensor surface of the sensor 45a preferably closes flush with a channel wall of the sensor window or the sensor recess 22a in the lumen 48.
  • Such a sensor 45a which measures the breathing air parameter in direct contact with the breathing air, can be, for example, an analysis sensor for determining a composition of the breathing gas, a sensor for measuring a flow rate of the breathing air or a humidity sensor for the breathing air act.
  • the monitoring connector 13 can additionally have an environmental sensor for detecting an environmental parameter, which is in signal connection with the control / regulating unit 35.
  • an environmental sensor for detecting an environmental parameter, which is in signal connection with the control / regulating unit 35.
  • Such a sensor can for example also be arranged on the circuit board 38, which is indicated in FIG. 6 at 49.
  • the environment sensor can, similarly to what was described above in connection with the sensor 45, be in sensor contact with the environment via a thin sensor wall section of the grand body 28 or via a window formed therein.
  • the environment sensor 49 can have a microphone.
  • the environment sensor 49 can be designed as a motion detection sensor for detecting a movement of the monitoring connector 13, for example as an acceleration sensor.
  • RS232 and / or RS485 can be used as interface standards.
  • Several signal transmission interfaces of the control unit 35 are realized via the plug connection 26 and the connection controller 40. Signal transmission according to several and, in particular, different interface standards is therefore possible. Internal communication between the components on the boards 33, 38 can take place via an I 2 C interface standard. At least one of these interfaces is designed for signal connection with the sensor 45 and is correspondingly connected to it. Another of these interfaces is prepared for Signalver connection with a sensor not yet installed in this monitoring connector 13. In this way, the monitoring connector can be expanded to include additional sensors that work with different interface standards than the sensor 45.
  • the monitoring connector 50 integrates the functions of the connection connector 12 and the monitoring connector 13 of the embodiment according to FIG Three-way connector 14 and on the other hand has the control and monitoring functions of the monitoring connector 13 explained above.
  • the monitoring connector 50 is designed as a connector that connects the hose component 11 with the patient breathing mask 15, i.e. the patient interface det.
  • the monitoring connector 50 has at least one basic sensor in the manner of the sensor 45 for detecting a breathing air measurement parameter.
  • the basic sensor 45 is indicated again in FIG. 7 by dashed lines.
  • the monitoring connector 50 is integrally connected to the hose component 11 and in particular encapsulated with this.
  • An air routing connector component of the monitoring connector 50 i.e. the base body 51 defining the inner lumen 48, forms an integral part with an inner lumen of the hose component 11.
  • the base body 51 of the monitoring connector 50 can have the sensor in the manner of the sensor 45.
  • An electronic connector component 52 of the monitoring connector 50 which has the control / regulating unit 35, is detachably connected to the base body 51 of the monitoring connector 50, for example via a mechanical plug connection.
  • the monitoring connector 50 can have an additional sensor connector component 53 which detects an expansion sensor 54 for detecting a further breathing air parameter, that is to say a different parameter than the basic sensor.
  • An RFID chip in particular for the transmission of an identification data record, can be part of the electronic connector component 52.
  • a supply line 56 in the manner of the supply line 32 is connected to the monitoring connector 50 via a connecting section 55.
  • the supply line 56 can be connected via a supply plug 57 to a supply device (not shown) for energy / signal transmission, for example to the main unit 2 of the ventilation system 1.
  • FIG. 8 A further embodiment of a monitoring connector 58 is described below with reference to FIG. 8. Components and functions that correspond to those that have already been explained above with reference to FIGS. 1 to 7 have the same reference numerals and who will not be discussed again in detail.
  • the monitoring connector 58 can be an integrated connector of the type of the monitoring connector 50.
  • a section 60 of a base body 59 of the monitoring connector 58 which at the same time forms a wall section of the inner lumen 48, is made of a thermochromic material.
  • a color change sensitivity of section 60 is adapted to a predetermined operating temperature range of the breathing air to be conveyed.
  • the section 60 can be divided into several sections 60i, 6O 2 , 6O 3 . These sections 6O 1 , 6O 2 , 6O 3 can each be made of thermochromic materia lien with different color change temperatures. Alternatively or additionally, at least one of these sections 6O 1 ,
  • 6O 2 , 6O 3 made of a reversible thermochromic material and at least one further of these sections 6O 1 , 6O 2 , 6O 3 made of a non-reversible thermochromic material.
  • a further embodiment of a hose component of the type of hose components 5, 11, 17 will be described below, which have already been explained above, in particular with reference to FIGS. 1 to 7.
  • Components and functions that correspond to those that have already been explained above with reference in particular to FIGS. 1 to 7 have the same reference numbers and are not discussed again in detail.
  • part of a hose wall is designed as a section 62 made of thermochromic material.
  • Section 62 made of thermochromic material.
  • thermochromic material can be a thermoplastic elastomer or silicone.
  • thermochromic mate rial a component or a portion of a component that is thermally coupled to the breathed air can be made of thermochromic mate rial.
  • the thermochromic material can be a material composition containing inorganic compounds of rutile and zinc oxide. Alternatively or additionally, components with bixanthylidene derivatives and / or bianthronylidene derivatives can be used. In principle, silver iodide compounds can also be used. Alternatively or in addition, bromothymol blue, embedded in a pH-dependent polymer matrix, can also be used. Further variants that can be components of the thermochromic material are a lithium chloride-containing polyether matrix, bis (diethylammonium) tetrachloridocuprate (II) and salvatochromic dyes.
  • the ventilation system 1 can be used as follows: In a ready state, the monitoring connector 13 is present with a reusable 24 separated from the disposable 25. When the hose components 5, 11 and 17 are connected to one another and to the main unit 2 in order to make the ventilation system 1 operational, the reusable 24 is connected to the disposable 25 shortly before the start of the first use, the start signal being the start signal Ge generator unit 37 or 37, 43 is generated, as explained above. From the then specified start time, the microcontroller 37 records the recorded period in signal connection with the real-time clock 39 and thus monitors the duration of use of the disposable 25 during ventilation. Assuming a maximum duration of use of seven days, the
  • Control / regulating unit 35 control the light source 42, for example, in such a way that the light sources 42 emit green light during the first six and a half days. The light can then switch from green to blue for the remaining 12 hours until the maximum operating time is reached, which is controlled by the control / regulating unit 35. If the seven-day operating time is exceeded, a blue flashing signal can then initially be generated which, after a waiting period has elapsed, changes to a red signal, in each case again controlled by the control / regulating unit 35. In any case, when the maximum duration of use is reached, the components of the ventilation system 1 that come into contact with the breathing air are exchanged. The reusable 24 is then reused and connected to the new disposable 25 of the exchanged breathing air guide components, so that the operating time cycle can begin again after the start signal generator unit 37 or 37, 43 has generated the start signal.
  • the monitoring connector 13 can also be used for temperature measurement and, in particular, for temperature threshold value recognition.
  • the breathing air temperature is detected via the sensor 45 and a corresponding temperature signal is passed on to the microcontroller 37.
  • a threshold value for example 40 ° C.
  • the control / regulating unit 35 controls the light sources 42 to output a visual warning signal, for example a red flashing light.
  • this visual display can be ended again, controlled by the control unit 35.
  • the storage units as part of the microcontroller 37 or 43 can also be used to store a digital business card of the monitoring connector 13 as a whole or also of the reusable 24 or the disposable 25.
  • Part of a corresponding business card data record can be the identification data record, a type designation of the monitoring connector 13 and of the entire ventilation system 1, Instructions for use for the monitoring connector and / or the ventilation system and other data, for example for relevant usage data.
  • the identification data record can be designed to protect against plagiarism.
  • the IDs of the disposables 25 used over the lifetime of the reusable 24 can be stored as usage data in the memory of the microcontroller 37 or measurement data of the sensor 45 over time and over the control sequences of the light signals 2 can be recorded by the control / regulating unit 35 Connector states, in particular alarm events (exceeding the maximum service life / exceeding the temperature threshold).
  • the sensor 45 can be designed with an integrated EEPROM. In particular, temperature threshold values can be specified by programming.
  • a separate identification data record of the disposable 25 can also be stored in the memory of the sensor 45, which can be stored there during the manufacture of the disposable 25. Alternatively, such an identification data record can be written to the memory of the sensor 45 by the microcontroller 37 of the reusable 24 when these two components are electrically connected or also when the service life starts.
  • the control / regulating unit 35 can be in signal connection with an external display unit, for example with a graphical user interface (GUI), via a wireless or wired interface.
  • GUI graphical user interface
  • This enables, for example, a display of the current temperature or a display of the current usage period and other sensor data.
  • a log file, which logs the status parameters of the monitoring connector 13, can be written in the memory module 43 or in the memory module of the microcontroller 37.
  • a humidity sensor e.g., a humidity sensor, a mass flow or flow sensor, a sensor for determining a condensation agglomeration or a gas analysis sensor for determining a gas composition of the breathing air and in particular for monitoring a contamination and / or a Be used when critical constituent thresholds are exceeded.
  • a breathing air pressure sensor is used in the monitoring connector 13, it can be used to regulate a breathing effort adjustment.
  • a pressure or strain sensor can be used to detect a mechanical load on the monitoring connector 13.
  • a sensor can have a membrane structure and / or a meander structure.
  • the application of pressure or force leads to structural strain that can be detected and converted into pressure and / or force values.
  • Such a pressure sensor can be in a portion of the monitoring connector 13, for. B. in Reusable 24 or in Disposable 25, be arranged.
  • such a pressure or strain sensor can be arranged as an external sensor, for example in the breathing air hose component 11, and be in signal connection with the monitoring connector 13 via appropriate interfaces.
  • Such a pressure or strain sensor can alternatively or additionally also monitor a pressure load on the hose components 5, 11 or 17.
  • sensors that can be either integrated into the monitoring connector or used as external sensors in the ventilation system 1 are a sensor for measuring the patient's skin temperature, a sensor for measuring the patient's skin moisture, a sensor for measuring the patient's skin color, a heart rate sensor, an oxygen saturation sensor, a gas analysis sensor, a fire alarm, an orientation sensor for determining a location of at least one component of the ventilation system 1 in the room, a motion sensor for determining a movement of at least one component of the ventilation system 1, a Sensor for monitoring drug delivery.
  • Processing, in particular pre-processing, of the sensor data transmitted to microcontroller 37 can take place in microcontroller 37.
  • the data can be averaged or filtered or compressed to reduce storage requirements.
  • These (pre-) processed data can then be forwarded for further external processing or display, for example to the main assembly 2 and / or to another external data processing component.
  • the components of the ventilation system 1 that carry breathing air can have an antimicrobial coating.
  • a gas flow measurement can be used to infer a leak in the ventilation system 1, in particular by appropriate processing in the microcontroller 37 and / or in the main unit 2.
  • the microcontroller 37 can be designed to be programmable.
  • the memory of the microcontroller 37 can contain a program library from which programs or program components can be selected.
  • the reusable 24 can also have further wireless interfaces for reading out, in particular, recorded measurement data, for example via RFID, via NFC, via Bluetooth or via WLAN.
  • the control / regulating unit 35 can be in signal connection with at least one sensor external to the connector 13, 50 or 58 via one of the interfaces described above.
  • a sensor is indicated schematically at 63 in FIG. 1, which is a sensor for measuring a patient's heart rate, a sensor for measuring a patient's body temperature and / or a Sensor for measuring a skin-surface resistance of the patient can act.

Landscapes

  • Health & Medical Sciences (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne un connecteur de surveillance (13) destiné à un système d'assistance respiratoire à un patient, qui sert à assurer la liaison avec une section de tube à air respiratoire pour prodiguer une alimentation en air respiratoire issu d'une source d'air respiratoire à un patient, et à relier la section de tube à air respiratoire à une interface air-patient. Le connecteur (13) présente une unité de commande/réglage (35) et au moins un capteur (45, 45a) qui sert à détecter un paramètre d'air respiratoire et est en liaison de signal avec l'unité de commande/réglage (35). Le connecteur (13) présente selon un aspect une mémoire de données de signal pour le stockage au moins temporaire de données de signal. Selon un autre aspect, le capteur (45a) est réalisé de telle sorte qu'il mesure le paramètre d'air respiratoire en contact avec l'air respiratoire. Selon un autre aspect, le connecteur (13) présente au moins un capteur environnemental qui est destiné à détecter un paramètre environnemental et est en liaison de signal avec l'unité de commande/réglage (35). Selon un autre aspect, le capteur (45) est réalisé de telle sorte qu'il mesure sans contact le paramètre d'air respiratoire. Selon un autre aspect, l'unité de commande/réglage (35) présente plusieurs interfaces de transmission de signal, l'une de ces interfaces étant réalisée pour assurer le traitement de signal avec le capteur (45, 45a), et une autre de ces interfaces étant préparée au traitement de signal avec un capteur qui n'est pas encore intégré au connecteur (13). Il en résulte un connecteur qui peut être utilisé de manière et adaptée à des exigences particulières.
EP20789922.0A 2019-10-09 2020-10-08 Connecteur pour système d'assistance respiratoire à un patient Pending EP4041357A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102019215483.2A DE102019215483A1 (de) 2019-10-09 2019-10-09 Überwachungs-Konnektor für ein Patienten-Beatmungssystem
DE102019216485.4A DE102019216485A1 (de) 2019-10-25 2019-10-25 Konnektor für ein Patienten-Beatmungssystem
PCT/EP2020/078219 WO2021069550A1 (fr) 2019-10-09 2020-10-08 Connecteur pour système d'assistance respiratoire à un patient

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EP4041357A1 true EP4041357A1 (fr) 2022-08-17

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US (1) US20240100286A1 (fr)
EP (1) EP4041357A1 (fr)
CN (1) CN114938635A (fr)
WO (1) WO2021069550A1 (fr)

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CN113273993A (zh) * 2021-05-13 2021-08-20 北京荣瑞世纪科技有限公司 一种带有测试功能的呼吸末端装置
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US12053584B1 (en) * 2023-02-15 2024-08-06 Telesair, Inc. Coupler

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US6910481B2 (en) * 2003-03-28 2005-06-28 Ric Investments, Inc. Pressure support compliance monitoring system
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EP2111248B1 (fr) * 2007-01-23 2016-04-20 Fisher & Paykel Healthcare Limited Humidicateur avec un capteur rfid
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DE102013208761A1 (de) * 2013-05-13 2014-11-13 Karl Küfner KG Vorrichtung zum Messen von strömenden Gasen bei Beatmungsgeräten oder Beatmungshilfen
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DE202014103998U1 (de) 2014-08-27 2014-09-16 Sensirion Ag Vorrichtung zum Messen eines Parameters eines Fluids, Steckerteil und Messanordnung

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CN114938635A (zh) 2022-08-23
WO2021069550A1 (fr) 2021-04-15

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