Classifications

• • 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
  • A61M15/00—Inhalators
  • A61M15/0065—Inhalators with dosage or measuring devices
  • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
  • A61M15/008—Electronic counters
• • 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
  • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
  • A61M11/02—Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
• • 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
  • A61M15/00—Inhalators
  • A61M15/0001—Details of inhalators; Constructional features thereof
  • A61M15/0021—Mouthpieces therefor
  • A61M15/0025—Mouthpieces therefor with caps
• • 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
  • A61M15/00—Inhalators
  • A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
• • 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
  • A61M15/00—Inhalators
  • A61M15/0001—Details of inhalators; Constructional features thereof
  • A61M15/0021—Mouthpieces therefor
• • 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
  • A61M2205/33—Controlling, regulating or measuring
  • A61M2205/332—Force measuring means
• • 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
  • A61M2205/33—Controlling, regulating or measuring
  • A61M2205/3375—Acoustical, e.g. ultrasonic, measuring means
• • 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
  • A61M2205/3546—Range
  • A61M2205/3561—Range local, e.g. within room or hospital
• • 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
  • A61M2205/3569—Range sublocal, e.g. between console and disposable
• • 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
  • A61M2205/82—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
  • A61M2230/00—Measuring parameters of the user
  • A61M2230/62—Posture
• • 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
  • A61M2230/00—Measuring parameters of the user
  • A61M2230/63—Motion, e.g. physical activity

Definitions

• the present invention relates to a fluid dispenser device, and more particularly to an aerosol type inhalation device.
• MDI Metal Dose Inhaler
• pMDI Pressure Metered Dose Inhaler
• the actuation must be done in the appropriate position, with the reservoir disposed above the valve, to ensure a reliable filling of the metering chamber when the valve returns to rest position, after actuation. For example, if the device is operated by a user lying down, the orientation of the device is not good, and there is a risk of incomplete dose at the next actuation.
• Another problem relates to the homogeneity and reproducibility of the dose at each actuation, especially in case of prolonged storage.
• the operating instructions of the device provides for shaking the device before operation, but nothing prevents the user from operating without shaking or reminds him before operation that he must shake the device. The risk therefore exists that the device is actuated without having been previously shaken.
• Yet another problem relates to remote monitoring of successive actuations of the device. If there are devices of the type connected to inform a third party that the device has been activated, it is not To date, it has not been possible to reliably identify the identity of the user or if the dose has been inhaled under the optimal conditions required.
• the present invention aims to provide a fluid dispensing device that does not reproduce the aforementioned drawbacks.
• the present invention also aims to provide a fluid dispensing device whose operating reliability is improved.
• the present invention also aims to provide a fluid dispenser device that improves the reproducibility of the dose dispensed at each actuation.
• the present invention also aims to provide a fluid dispenser device that reduces the risk of malfunction of electronic components.
• the present invention also aims to provide a fluid dispenser device that allows, at least partially, a remote identification of the user of the device and the quality of the dose issued.
• the present invention also aims to provide a fluid dispenser device that is simple and inexpensive to manufacture and assemble.
• the subject of the present invention is thus a fluid dispenser device, comprising a main body provided with a mouthpiece, a product reservoir containing a fluid and a propellant, a metering valve comprising a valve assembled on said reservoir for dispensing. selectively the fluid product, said valve being received in a valve well secured to said main body and said reservoir being slidably mounted in said main body between a rest position, in which said metering valve is closed, and a dispensing position, in which said metering valve is open to dispense a dose of fluid through said valve to said mouthpiece, said device comprising:
• At least one actuation sensor for detecting the actuation of the device and / or the dispensing of a dose of fluid product
• at least one orientation and / or motion sensor for detecting the orientation of the device and / or the movements of the device
• an electronic dose counter comprising a screen displaying the number of doses dispensed or still to be dispensed
• said orientation sensor comprises an accelerometer.
• said motion sensor comprises an accelerometer.
• said at least one accelerometer detects the movements of the arm and / or the hand of the user during actuation.
• said actuation sensor is disposed in the expulsion path of the fluid product.
• said actuation sensor is a membrane disposed in the valve well.
• said actuation sensor is disposed outside the expulsion path of the fluid product.
• said actuation sensor is a sound sensor, in particular for detecting the sound generated during the dispensing of the fluid product.
• said actuation sensor is a motion sensor, preferably comprising an accelerometer.
• said sensors are arranged on the main body.
• said sensors are arranged on the tank.
• said device further comprises a contact sensor or switch, in particular for passing at least one sensor from a "sleep" mode to an "awake” mode.
• said actuation sensor actuates said dose counter.
• FIG. 1 is a schematic perspective view of a fluid dispensing device, according to a first advantageous embodiment, in the rest position
• FIG. 2 is a diagrammatic cross-sectional view of the device of FIG. 1,
• FIG. 3 is an enlarged view of the detail D1 of FIG. 2,
• FIG. 4 is a view similar to that of FIG. 1, in the actuating position,
• FIG. 5 is a diagrammatic cross-sectional view of the device of FIG. 4,
• FIG. 6 is an enlarged view of the detail D2 of FIG. 5,
• FIG. 7 is a view in section from above, illustrating an example of a printed circuit used in the device of FIGS. 1 to 6,
• FIG. 8 is a view similar to that of FIG. 7, seen from below,
• FIG. 9 is a schematic view of an example of a system on a chip used in the device of FIGS. 1 to 6,
• FIG. 10 is a schematic view of an example of a sequence of signals generated by the device of FIGS. 1 to 6,
• FIG. 1 1 is a schematic perspective view of a fluid dispenser device, according to a second advantageous embodiment, in the rest position,
• FIG. 12 is an enlarged view of the electronic components of FIG.
• FIG. 13 is a diagrammatic perspective view of a fluid product distribution device, according to a third advantageous embodiment, in the rest position,
• FIG. 14 is an enlarged view of the electronic components of FIG. 13, and
• FIG. 15 is a variant of FIG. 14.
• the terms “upper”, “lower”, “high” and “low” refer to the straight position of the device shown in FIGS. 1, 2, 4 and 5.
• the terms “axial” and “radial” refer to the vertical central axis A shown in particular in Figure 2.
• the terms “proximal” and “distal” refer to the mouthpiece.
• the invention is applicable to aerosol valve type inhalation devices for oral delivery, as will be described in more detail below, generally referred to as MDI ("Metered Dose Inhaler", metered dose inhaler). or pMDI ("Pressurized Metered Dose Inhaler”, pressurized metered dose inhaler).
• MDI Metal Dose Inhaler
• pMDI Pressureurized Metered Dose Inhaler
• the device comprises a main body 10 provided with a mouthpiece 15.
• This mouthpiece 15 defines a dispensing orifice through which the user will inhale during the use of the device.
• the mouthpiece 15 can be made in one piece with the body 10, as in FIGS. 1, 5, 11 and 13, but it could also be formed on a lower part of the body which is fixed to said main body 10.
• a removable protective cover 150 may be provided on said mouthpiece 15, particularly during storage periods, that the user will remove before use.
• Figures 1 and 2 show such a protective cover 150, which could be of any shape.
• the main body 10 contains a reservoir 20, containing the product to be dispensed and a propellant, such as an HFA type gas, a metering valve 30 being mounted on said reservoir 20 to selectively dispense the product.
• a propellant such as an HFA type gas
• the metering valve 30 comprises a valve body 31 and a valve 32 axially displaceable upon actuation with respect to said valve body 31, and thus with respect to said reservoir 20.
• This metering valve 30 may be of any suitable type. It can be fixed to the reservoir 20 by a fixing element 5, preferably a crimped capsule, preferably with the interposition of a neck seal 4.
• the outlet port of the valve 32 of said metering valve 30 is connected via a channel 40 to said mouthpiece 15, through which the user inhales the dispensed product.
• said valve 32 is received in a valve well 50 which at least partially defines said channel 40.
• the valve well 50 can be integrally formed with the main body 10 (or a lower part of the body as mentioned previously), but it can also be formed by a separate piece which is fixed in said main body 10.
• the reservoir 20 is axially slidably mounted in the main body 10 between a rest position, in which the metering valve 30 is closed, and a dispensing position, in which the metering valve 30 is open to dispense a dose of fluid through the valve 32 to said mouthpiece 15.
• the device embeds electronic modules comprising different sensors.
• At least one actuation sensor may be provided to detect actuation of the device.
• This actuation sensor may be a membrane sensor 100, as visible in FIGS. 1 to 6, which detects the distribution of the dose of fluid product, for example in the valve well 50.
• the membrane 100 is passive and no signal is created.
• the membrane 100 deforms and then creates the event by contacting a contact plate 110 suitable for generating a signal.
• This signal can for example be used to change the display of an LCD screen of an electronic counter provided in the device.
• the actuation sensor could detect the movements of the reservoir 20, for example by means of a suitable contact sensor or switch 200, visible in particular in FIGS. 1 1, 12, 13 and 14.
• the movement of the reservoir 20 can be detected from the beginning of the actuating stroke.
• This contact sensor 200 can thus be used to pass the various electronic modules of a "sleep" energy saving mode in "waking" or “ready to be operated” mode.
• Other means of detecting the actuation of the device are also possible, for example the detection of the displacement of the valve 32 of the metering valve 30 with respect to the valve body 31.
• the actuation sensor is a sound sensor 300 adapted to detect the sound produced by the actuation of the device. Preferably, it is the sound generated by the expulsion of the dose out of the valve 30. In a variant, it would also be possible to detect other sounds characteristic of the actuation of the device and / or the dose distribution. as for example the sound generated by the displacement of the reservoir 20 in the body 10 or the sound generated by the displacement of the valve 32 in the valve body 31.
• At least one orientation sensor 400 may be provided to detect the orientation of the device, in particular when it is actuated.
• This orientation sensor 400 may comprise an accelerometer.
• Such an orientation sensor 400 makes it possible in particular to detect whether the device is in the correct orientation, in particular to ensure effective filling of the valve chamber when it returns to the rest position after each actuation.
• the orientation sensor 400 also makes it possible to detect whether the user shakes the device before use, as generally recommended in the instructions for use.
• At least one motion sensor 500 may be provided to detect the movements of the arm or the hand of the user during actuation.
• This motion sensor may include an accelerometer.
• Such a motion sensor 500 may in particular make it possible to identify the user with respect to his actuating movement, each user having a specific motion profile.
• the motion sensor 500 also makes it possible to detect whether the user shakes the device before use, as generally recommended in the instructions for use.
• the motion sensor 500 also makes it possible to detect the actuation of the device, instead of the sound sensor 400, as in the variant of FIG. 15.
• the orientation sensor 400 or the motion sensor 500 could also be used to switch the various electronic modules from a "sleep" energy saving mode to "awake” or "ready to be operated” mode.
• the device may include means for recording the date and time, in particular for time stamping each actuation of the device.
• a GPS sensor may be provided, in particular to geotag each actuation of the device.
• the device comprises storage means for storing at least some of the information detected by the various electronic modules, a microcontroller 800 for controlling the different electronic modules, and power supply means 900, such as a battery or an accumulator.
• the device may include a speaker or buzzer 1300. This may for example be used to indicate to the user that the device has been actuated and / or that the dose has been distributed. It can also serve as an alarm, for example in case of low battery, or to indicate to the user that he must operate the device.
• the device may also include an electronic dose counter with a display 1400 showing the number of doses dispensed or remaining to be distributed.
• This counter may be connected to the actuation sensor, in particular the membrane sensor 100 of FIGS. 1 to 6 or the contact sensor 200 of FIGS. 11 and 12.
• the documents WO2015150029 and WO2015010932 describe counters operating with a membrane sensor 100 .
• the device may also comprise signal transmission means 1500 for communicating information relating to the actuations of the device.
• the body 10 may comprise a signal transmission module for remote communication with any receiver. Suitable feeding means are advantageously provided.
• said 1500 signal emitting means are wireless, active or passive, such as Bluetooth (BLE), Wifi, NFC, RFID, etc., for sending the information on a peripheral device.
• BLE Bluetooth
• Wifi Wireless Fidelity
• NFC Near-Field Communication
• RFID Wireless Fidelity
• FIGS. 7 to 10 illustrate the electronic modules of the device of Figures 1 to 6. These modules are formed on a printed circuit board 1000, which can support all or part of the elements described above. It should be noted here that the example of FIGS. 7 to 10 is not limiting, and that other combinations of modules would be possible.
• the signal generated during the actuation by the membrane 100 is received on the plate 1000 at an input 120.
• An antenna 130 then transmits this signal to the controller 800, which will control one or more peripherals, such as the screen 1400 and / or the speaker 1300.
• the orientation sensor 400 and / or the motion sensor 500 are also connected (s) to said controller 800.
• FIG. 10 illustrates a possible sequence of the signals generated during the actuation.
• the detection of the actuation is performed by means of the membrane 100 disposed in the expulsion path of the fluid product. It is then the detection of the actual dose distribution.
• the sensors must be placed out of said path, as illustrated by the embodiments of FIGS. 1 1 to 15.
• the electronic modules are arranged laterally in the body 10.
• the device comprises a switch 200, a sound sensor 300 and an orientation sensor 400.
• the switch 200 When the user takes the device and presses the reservoir 20 to actuate it, the switch 200 is actuated, for example by an element integral with the reservoir, in particular the capsule 5, generating a signal. This signal can be used to activate or "wake up" other sensors.
• the sound detected by the sound sensor 300 is preferably that generated by the sputtering, i.e. expelling the fluid out of the valve.
• a motion sensor 500 could also be provided, for example by replacing the sound sensor 300.
• the acceleration signal of the orientation sensor 400 and / or the motion sensor 500 is mainly generated by the back pressure created during the spraying.
• the electronic modules are arranged on the bottom of the tank 20.
• FIGS. 13 and 14 illustrate a first variant, in which the device comprises a switch 200, a sound sensor 300, an orientation sensor 400, a capacitive sensor 600 and a positioning sensor 700.
• the capacitive sensor 600 is provided on a distal end surface of the body receiving the electronic modules, to detect the support of the fingers of the user.
• the positioning sensor 700 is provided to detect that the body receiving the electronic modules is fixed to the tank 20.
• the capacitive sensor 600 detects it and the orientation sensor 400 is activated to detect whether the user is shaking the device. Otherwise, a signal or message can be transmitted to the user via the speaker or the screen.
• the switch 200 is here provided in a user interface 250 loaded by a spring 255 whose resistance is lower than that of the valve 30, so that the switch 200 will be actuated before the reservoir 20 is moved in the body 10.
• the switch 200 When the patient actuates the device, the switch 200 is first actuated, generating a signal that will activate or "wake up" the sound sensor 300.
• valve is actuated and a dose of fluid is dispensed.
• the dose counter is actuated.
• the orientation sensor 400 checks whether the orientation of the device is correct. If this is not the case, the user may be informed, and may in particular be requested perform a priming operation to avoid incomplete dosing at the next actuation.
• the device At the end of actuation, the device, and in particular the electronic modules, returns to the standby mode, for example when the capacitive sensor 600 is no longer activated.
• FIG. 15 illustrates another variant, without the user interface 250, without the switch 200, and with a motion sensor 500 replacing the sound sensor.
• the device therefore comprises an orientation sensor 400, a motion sensor 500, a capacitive sensor 600 (optional here) and a positioning sensor 700.
• the capacitive sensor 600 When the user enters the apparatus, the capacitive sensor 600, if used, detects it and the orientation sensor 400 is activated to detect whether the user is shaking the device. Otherwise, a signal or message can be transmitted to the user via the speaker or the screen.
• the motion sensor 500 detects movement of the reservoir and generates a corresponding signal.
• the motion sensor can be actuated only after a certain predefined stroke of the reservoir 20 in the body 10.
• the orientation sensor 400 checks whether the orientation of the device is correct. If this is not the case, the user can be informed, and he may in particular be asked to perform a priming operation to avoid incomplete dosing at the next actuation.
• the electronic modules can be returned to the standby mode. If the capacitive sensor 600 is used, it can also be used for this purpose.
• the presence of the orientation sensor may be unnecessary, and it could be omitted.
• the motion sensor includes an accelerometer, it can perform both functions, motion detection and orientation detection.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Life Sciences & Earth Sciences (AREA)
• Anesthesiology (AREA)
• General Health & Medical Sciences (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Veterinary Medicine (AREA)
• Animal Behavior & Ethology (AREA)
• Public Health (AREA)
• Pulmonology (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Biophysics (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
• Nozzles (AREA)

Applications Claiming Priority (2)

Publications (1)

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• 2017
  • 2017-08-03 FR FR1757460A patent/FR3069762B1/fr active Active
• 2018
  • 2018-08-02 CN CN201880060401.2A patent/CN111163822A/zh active Pending
  • 2018-08-02 EP EP18780171.7A patent/EP3661578A1/de not_active Withdrawn
  • 2018-08-02 US US16/635,391 patent/US20200155775A1/en not_active Abandoned
  • 2018-08-02 WO PCT/FR2018/051993 patent/WO2019025738A1/fr unknown

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