EP4580708A1 - Injektionsvorrichtung und zusatzvorrichtung - Google Patents

Injektionsvorrichtung und zusatzvorrichtung

Info

Publication number
EP4580708A1
EP4580708A1 EP23761533.1A EP23761533A EP4580708A1 EP 4580708 A1 EP4580708 A1 EP 4580708A1 EP 23761533 A EP23761533 A EP 23761533A EP 4580708 A1 EP4580708 A1 EP 4580708A1
Authority
EP
European Patent Office
Prior art keywords
container
antenna
electronic
identifier
add
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
EP23761533.1A
Other languages
English (en)
French (fr)
Inventor
Stefan Alt
Michael Helmer
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.)
Sanofi SA
Original Assignee
Sanofi SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanofi SA filed Critical Sanofi SA
Publication of EP4580708A1 publication Critical patent/EP4580708A1/de
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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/18General characteristics of the apparatus with alarm
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3546Range
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3546Range
    • A61M2205/3569Range sublocal, e.g. between console and disposable
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic

Definitions

  • the present disclosure relates to the field of injection devices, such as hand-held pen-type injectors.
  • the disclosure further relates to add-on devices for such injection devices, in particular to add-on devices attachable to a pen-type injector.
  • the disclosure relates to an injection system comprising an injection device and an add-on device.
  • the disclosure relates to a method of monitoring operation or use of an injection device.
  • Drug delivery devices for setting and dispensing a single or multiple doses of a liquid medicament are as such well-known in the art. Generally, such devices have substantially a similar purpose as that of an ordinary syringe.
  • Drug delivery devices such as pen-type injectors
  • Suitable drug delivery devices especially intended for home medication therefore need to be robust in construction and should be easy to use.
  • manipulation and general handling of the device and its components should be intelligible and easy understandable.
  • injection devices should provide setting and subsequent dispensing of a dose of a medicament of equal or variable size.
  • a dose setting as well as a dose dispensing procedure must be easy to operate and has to be unambiguous.
  • a patient suffering from a particular disease may require a certain amount of a medicament to either be injected via a pen-type injection syringe.
  • Some drug delivery or injection devices provide selecting of a dose of a medicament of variable size and injecting a dose previously set.
  • Other injection devices provide setting and dispensing of a fixed dose.
  • the amount of medicament that should be injected in accordance to a given prescription schedule is always the same and does not change or cannot be changed over time.
  • an external electronic device such as a mobile electronic device, e.g. implemented as a smartphone, a tablet computer, or a smart watch.
  • a software application provided on such external electronic devices may interact with the user and may provide instructions or recommendations to the user of how to correctly use the injection device.
  • add-on devices or auxiliary devices can be detachably connected to an injection device.
  • An add-on device typically comprises a detector or detector arrangement operable to detect a date and/or time when the user sets or injects a dose of the medicament.
  • Some add-on devices also provide a quantitative measurement of a size of a dose currently set or dispensed.
  • Some add-on devices are intended for use with a series of injection devices. This may particularly apply with disposable injection devices, that are intended to become discarded after use or after the medicament located therein has been used up.
  • a container part containing the medicament container may be detachably connected to a body of the injection device, wherein the body comprises a drive mechanism operably engageable with the medicament container for expelling or withdrawing a dose of the medicament from the medicament container.
  • Some injection devices of reusable type may be operable for setting and dispensing of different medicaments, e.g. provided in different container parts and/or different medicament containers.
  • a specific container part and/or medicament container should only be used with a dedicated drive mechanism and/or body of an injection device. Hence, a correct pairing of a medicament container with a suitable drive mechanism has to be ensured.
  • the expelled dose volume per settable dose increment is usually determined and fixed by the device mechanics of the drive mechanism. Therefore, reusable injection devices are commonly dedicated to a single drug to avoid incorrect dosing. However, some drug type, like insulin, are provided in common unit/volume rations (e.g. U100, U300), so a reusable pen could potentially support multiple drugs of the same group. As this increases the risk of potentially dangerous mix-ups, there shoud be provided a technical solution to provide an enhanced mix-up prevention.
  • an injection device for injecting of a dose of a medicament.
  • the injection device comprises a housing comprising a body detachably connectable to a container part.
  • the container part is configured to accommodate a medicament container.
  • the injection device further comprises a drive mechanism arranged in the body and operable to expel and/or to withdraw the dose of the medicament from the medicament container.
  • the injection device further comprises a first antenna on or in a first portion of the body.
  • the antenna is configured for wireless signal transmission with an electronic container identifier provided on or in the container part.
  • the injection device further comprises a second antenna on or in a second portion of the body.
  • the second antenna is electrically connected to the first antenna and is further configured for wireless signal transmission with a transceiver of an electronic module of an add-on device connectable to the injection device.
  • the injection device further comprises an electronic device identifier on or inside the body and configured for wireless signal transmission with the transceiver of the electronic module of the add-on device.
  • the first antenna and the second antenna are separated from each other, e.g. along a longitudinal direction of the injection device.
  • the injection device may be implemented as a mechanically-implemented injection device, where a user has to exert a dispensing force required for expelling the medicament from the medicament container.
  • the injection device may be void of any further electric or electronic components.
  • the electronic identifier is likewise configured for wireless signal transmission with the transceiver.
  • the add-on device and hence its transceiver is operable to communicate with both, the electronic device identifier and the second antenna as provided on or inside the injection device.
  • the present injection device provides a twofold communication or signal transmission with an external electronic device.
  • the add-on device is assembled or connected to the injection device the electronic device identifier is operable to communicate with the add-on device.
  • This signal transmission is provided through a communication link formed or established between electronic container identifier and the first antenna, the electrical connection between the first antenna and the second antenna and by way of the wireless signal transmission between the second antenna and the add-on device.
  • the first and the second antennas and their mutual electrical interconnection there can be provided a twofold communication link with the add-on device.
  • the add-on device may become operable to read data or information from the electronic container identifier as well as to read or to obtain information from the electronic device identifier. This way, the add-on device will be enabled to read or to obtain information from both, the container part as well as from the body of the injection device, thus allowing to conduct a comparison and a checkup if the data being indicative of the medicament container matches with the data being indicative of the drive mechanism or body of the injection device.
  • Reading of the electronic container identifier is thus enabled through the electrical connection between first and second antennas of the injection device.
  • the add-on device is operable to wirelessly read or to wirelessly obtain information or data from the electronic device identifier.
  • all electronically readable information as provided in or on the injection device namely information or data as provided by the electronic container identifier and as provided by or in the electronic device identifier can be provided to the add-on device wirelessly with the add-on device being attached to a dedicated portion of the injection device, e.g. while being attached at or near the proximal end of the injection device.
  • the injection device comprises an electric transmission line interconnecting the first antenna and the second antenna.
  • the transmission line is configured to transmit electrical signals between the first and the second antennas.
  • the transmission line also provides electrical power between the first and the second antennas.
  • the transmission line may be provided as a power line operable to transfer and/or to provide electrical energy or electrical power from the second antenna to the first antenna.
  • the second antenna may be inductively coupled with the transceiver of the addon device when the add-on device is attached and/or connected to the injection device. This way, the electrical power induced by the add-on device into the second antenna can be transferred via the transmission line to the first antenna and can be used to wirelessly obtain or to wirelessly read respective information or data from the electronic container identifier, which is within the transmission range of the first antenna.
  • at least one or both identifiers, namely the electronic container identifier as well as the electric device identifier could be implemented as passive radiofrequency transmission devices, e.g. as a passive RFID tags, NFC tag or UWB tag.
  • the electric transmission line connected with the first antenna and connected with the second antenna forms or constitutes a bridge antenna, such as a NFC bridge antenna or RFID bridge antenna.
  • the bridge antenna includes the first antenna and the second antenna spaced apart from one another and coupled together by the electric transmission line, e.g. by an electric conductor.
  • the first antenna is located proximate to the electronic container identifier, which may be implemented as a passive RFID or passive NFC tag.
  • the second antenna is located proximate to the transceiver of the electronic module of the add-on device when the add-on device is connected to the injection device.
  • the transceiver forms or constitutes a RFID reader.
  • An electromagnetic signal transmitted by the transceiver is received by the second antenna and is transmitted via the electric transmission line to the second antenna, which then communicates with the electronic container identifier provided on or in the container part.
  • a response from the electronic container identifier may be then retransmitted via the first antenna to the second antenna and further to the transceiver of the electronic module of the add-on device.
  • the first antenna and the second antenna which are mutually interconnected by the transmission line, provide a wired range extension for the wireless signal transmission between the electronic container identifier and the transceiver of the add-on device.
  • the first antenna is matched or tuned to a respective antenna of the electronic container identifier.
  • the second antenna may be matched or tuned to the transceiver of the electronic module of the add-on device.
  • the first antenna and the second antenna may be mutually tuned to a common transmission frequency.
  • the electric transmission line interconnecting the first and the second antennas may be of passive type. It may provide a wired connection between the first and the second antennas.
  • the transmission range of the first antenna is extended through the longitudinal extension of the transmission line and the position of the second antenna relative to the first antenna; and vice versa.
  • the electronic device identifier comprises an integrated device circuit with a device memory configured to store at least one of a device information and a use related data.
  • the electronic container identifier may comprise an integrated circuit with a memory configured to store at least one of a container information and a use-related data.
  • the device information may comprise information or data with regard to the type of the injection device.
  • the device information may be specific about a type of an injection mechanism or drive mechanism of the injection device.
  • the device information may thus characterize the dose setting and/or dose dispensing operability of the respective injection device.
  • the device identification may further contain data or information about suitable medicaments or medicament containers to be exclusively used with the respective injection device.
  • the add-on device is typically provided with a wireless transmission collision handling function so as to distinguish between signal transmission with regards to the electronic container identifier by the first and the second antennas and signal transmission with the electronic device identifier, which takes place via the second antenna.
  • the injection device also comprises the container part.
  • the electronic container identifier is arranged on or in one of the container part and the medicament container accommodated by the container part.
  • the container part may be implemented as a cartridge holder configured for detachably connecting with a portion of the body. Typically, a proximal end of the container part is detachably connectable with a distal end of the body.
  • the medicament container comprises or constitutes a cartridge filled with a liquid medicament.
  • the medicament container is typically arranged inside the container part.
  • the container part and the medicament container may be preassembled and may be mutually fixed.
  • the medicament container inside the container part may constitute or form a container assembly of the injection device.
  • the electronic module is operable to induce and to transmit electric power to the first antenna via the second antenna and the transmission line electrically connecting the first antenna and the second antenna.
  • the electric power is effective to induce signal transmission between the first antenna and the electronic container identifier when the electronic container identifier is within the transmission range of the first antenna.
  • the electronic container identifier may be implemented as a passive radiofrequency communication tag, thus allowing to simplify the structure of the electronic container identifier and/or to reduce respective manufacturing costs.
  • the add-on device comprises a sensor operable to quantitatively determine at least one of a position and a movement of a movable component relative to at least one of the housing, the medicament container and the device body.
  • the sensor is operable to generate a respective sensor signal.
  • the module processor of the electronic module of the add-on device is further operable to determine or to calculate a size of the dose of the medicament, which is currently set or dispensed by the injection device. Determination or calculation of the dose size is conducted on the basis of the sensor signal and on the basis of data received from one of the electronic container identifier and the electronic device identifier.
  • the add-on device itself is capable to derive and/or to process medicament container specific information and/or device specific information, e.g. in the course of assembly to the injection device.
  • the add-on device may be configured to conduct a calibration routine. This way the measurable sensor signals as obtained by the sensor of the add-on device can be translated or re-calculated into correct dose size information.
  • the electronic module of the add-on device is operable to read at least one of a device information and a use-related data from the electronic device identifier.
  • the electronic module is further operable to read at least one of a container information and a use-related data from the electronic container identifier. This way, the electronic module may obtain both, device-related information as well as container related information being characteristic of the drive mechanism and being characteristic of the medicament container medicament contained therein.
  • the electronic module may be further operable to process respective device information and container information.
  • the electronic module may be particularly operable to compare the device information with the container information in order to reveal if the device information matches the container information and/or to assert that the container part and/or the medicament container and hence the medicament contained therein matches with the body and/or with the drive mechanism of the injection device.
  • the electronic module is operable to compare the device information with the container information and is further operable to determine, if the device information matches with the container information.
  • the electronic module is operable to activate a locking mechanism of the drive mechanism when the container information does not match the device information.
  • the locking mechanism is operable to block at least one of setting of the dose and dispensing of the dose.
  • the electronic module may comprise a locking controller operably engageable with the locking mechanism of the drive mechanism of the injection device when the add-on device is correctly assembled to the injection device.
  • the electronic module may be operable to keep the locking mechanism of the drive mechanism locked per default until a matching combination of container information and device information is obtained by the electronic module of the add-on device.
  • the locking mechanism of the drive mechanism may be also in a locking configuration per default. It may be unlocked or unlockable only and exclusively by the locking controller of the add-on device. Unlocking of the locking mechanism of the drive mechanism of the injection device may thus require a correct assembly of the add-on device to the injection device as well as acquisition and reading of matching data with regards to device information as provided by the electronic device identifier and container information as provided by the electronic container identifier. Both information or data, i.e. the device information and the container information can be acquired by a single transceiver of the add-on device when the add-on device is e.g. attached to proximal end of the injection device.
  • the present disclosure also relates to an injection system comprising an injection device as described above and further comprising an add-on device as described above.
  • the injection system may optionally comprise at least one or several external electronic devices, such as a smartphone, a smartwatch and a tablet computer or some other electronic device that is capable to communicate with the add-on device.
  • the present disclosure also relates to a method of monitoring operation of an injection device.
  • the method comprises the steps of attaching an add-on device as described above to an injection device.
  • the add-on device as described above is connected to an injection device as described above.
  • device information is obtained or read from the electronic body identifier by the electronic module of the add-on device.
  • container information is read or obtained from the electronic container identifier by the electronic module of the add-on device via the first and the second antennas of the injection device.
  • the device information and the container information obtained by reading of the electronic body identifier and by reading of the electronic container identifier is evaluated.
  • the respective information may be compared with each other and/or may be compared with predefined data e.g. stored in a module memory of the electronic module of the add-on device.
  • the medicament container as identified or characterized by the electronic container identifier matches the body or drive mechanism of the injection device as identified or characterized by the electronic device identifier.
  • Obtaining of the device information and the container information may not require any user interaction.
  • the add-on device upon installing the add-on device to the dedicated portion of the injection device the add-on device may be configured to autonomously conduct respective reading procedures in order to obtain the device information and the container information wirelessly.
  • the add-on device may not only limited to detect a matching between the type of a medicament container with a body or drive mechanism of an injection device. Reading and evaluating of device information and container information may also provide an effective counterfeiting drug prevention. It may be checked if the medicament as provided inside the medicament container has not expired. Moreover, it may be also checked if and in how far the medicament container has been stored and/or transported within a predefined temperature range.
  • Respective device information and/or container information can be stored and updated in the memory of the integrated circuit of at least one or both of the electronic container identifier and the electronic device identifier.
  • the electronic module and/or the module processor may be operable to process any of the device information, the use-related data and the container information so as to check if the respective information mutually match and represent an allowable and intended use or configuration of the injection device.
  • the present disclosure also relates to a computer program, e.g. a computer program product comprising computer readable instructions, which when executed by a module processor of an add-on device as described above cause the module processor to conduct the steps of the method as described above.
  • a computer program e.g. a computer program product comprising computer readable instructions, which when executed by a module processor of an add-on device as described above cause the module processor to conduct the steps of the method as described above.
  • the computer program is executable by an add-on device as described above. It is further operable to conduct a method of monitoring operation of the injection device with the add-on device as described above.
  • the computer program and its computer readable instructions are operable to cause a processor of the add-on device to conduct a method of monitoring or checking the injection device as described above.
  • the computer readable instructions may be executable by a processor of an add-on device as described above.
  • the computer program and its computer readable instructions may be at least in part executable by a processor of the external electronic device.
  • the computer program is to be executed by a processor of an add-on device as described above in order to monitor and/or record operation of the injection device when the add-on device is attached thereto.
  • a processor of an add-on device as described above in order to monitor and/or record operation of the injection device when the add-on device is attached thereto.
  • the present disclosure further discloses and proposes a computer program including computerexecutable instructions for performing the method according to the disclosed method / device I system in one or more of the examples enclosed herein when the program is executed on a processor, computer or computer network.
  • the computer program may be stored on a computer-readable data carrier.
  • one, more than one or even all of the method steps as indicated above may be performed by using a computer or a computer network, typically by using a computer program.
  • the present disclosure further discloses and proposes a computer program product having program code means, in order to perform the method according to the disclosed method / system in one or more of the embodiments enclosed herein when the program is executed on a computer or computer network.
  • the program code means may be stored on a computer-readable data carrier.
  • the present disclosure discloses and proposes a data carrier having a data structure stored thereon, which, after loading into a processor, computer or computer network, such as into a working memory or main memory of the processor, computer or computer network, may execute the method according to one or more of the examples disclosed herein.
  • the present disclosure further proposes and discloses a computer program product with program code means stored on a machine-readable carrier, in order to perform the method or parts thereof according to one or more of the examples disclosed herein, when the program is executed on a processor, computer or computer network.
  • a computer program product refers to the program as a tradable product.
  • the product may generally exist in an arbitrary format, such as in a paper format, or on a computer-readable data carrier.
  • the computer program product may be distributed over a data network.
  • the add-on device in particular its device body may comprise a receptacle to fit onto the dose dial and/or trigger.
  • a geometric distance between the machine-readable identification and a reader or transceiver of the add-on device for readout of the machine-readable identification can be reduced to a minimum thus allowing to implement the transceiver or reader of the add-on device as a wireless near field transceiver operable to read a respective near field communication tag of the machine-readable identification of the device. This way, readout of the machine-readable identifier can only take place when the add-on device is correctly mounted to the proximal end of the injection device.
  • the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region.
  • the term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and/or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).
  • TBTI tetravalent bispecific tandem immunoglobulins
  • CODV cross-over binding region orientation
  • An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems.
  • the container may be a replaceable container or an integrated non-replaceable container.
  • Fig. 1 schematically illustrates an example of an injection device
  • Fig. 2 shows the process of assembling an add-on device to a proximal end of the injection device
  • Fig. 3 shows an injection device in a longitudinal schematic cross-section
  • Fig. 4 shows a configuration of an injection system including the injection device, the addon device and at least one external electronic device,
  • Fig. 6 shows the add-on device of Fig. 5 when attached to the injection device
  • Fig. 7 shows a block diagram of one example of the injection device and the add-on device.
  • Fig. 13 shows a block diagram of one example of the injection device with the add-on device attached thereto
  • Fig. 14 shows a block diagram of another example of the injection device with the add-on device attached thereto
  • the sensor 48 of the add-on device 30 is capable or operable to generate a sensor signal or a sequence of sensor signals, which due to the coupling or connection to the module processor 44 can be processed by the module processor 44 in order to derive or to calculate a size of a dose currently set or dispensed.
  • the trigger 9, which comprises a reduced diameter compared to the dose dial 8 may protrude in proximal direction 3 through the flange portion 62 while the flange portion 62 may rest or abut against the proximal end face of the dose dial 8 when the add-on device 30 is suitably fastened to the dose dial 8.
  • the add-on device 30 further comprises a movable part 70 protruding in proximal direction from the device body 60.
  • the movable part 70 comprises or forms an auxiliary trigger or trigger button, which is configured to mechanically engage with the trigger 9 of the injection device 1 when the add-on device 30 is correctly assembled to the injection device 1.
  • the add-on device 30, in particular, the device body 60 is frictionally engageable with the dose dial 8.
  • a user may apply a dose setting torque onto the dose dial via the device body 60.
  • the user may simply rotate the device body 60 relative to the body 6 of the injection device 1 .
  • the dial extension 27 may become subject to a dose incrementing dialing or rotating motion.
  • a respective size of a dose currently set will then be displayed in the window 26 of the body 6 of the injection device 1 as illustrated in Fig. 2.
  • the user For dispensing of a dose the user has to depress the movable part 70, which may then be subject to a distally directed motion relative to the device body 60.
  • the movable part 70 which may be in direct or indirect mechanical engagement with the trigger 9, may then apply a respective dispensing force onto the trigger 9 thereby initiating a dose dispensing action of the injection device 1.
  • the add-on device 30 as schematically illustrated in Fig. 15 comprises an electronic module 34.
  • the electronic module 34 comprises a printed circuit board 36.
  • the electronic module 34 comprises a module processor 44, an electronic and hence digital module memory 40 and a clock 42.
  • the electronic module 34 comprises a power source 46 and the sensor 48.
  • the electronic module 34 also comprises a signal generator 52 coupled to the processor 44 and/or coupled to the power source 46.
  • the electronic module 34 further comprises at least one of a reader 37 and a wireless transceiver 38, 39.
  • the add-on device 30 may also comprise a user perceptible device identification 50.
  • the signal generator 52 is operable to generate at least one of a visual, an acoustic and a haptic signal or device identification and is hence operable to produce or to generate a visual identifier, an acoustic identifier or a haptic identifier or a respective alert signal.
  • the add-on device 30 comprises numerous signal generators 52 of equal or different type, e.g. optical, acoustic or haptic type.
  • the external device 100 is configured to set up a communication link, e.g. a wireless communication link with the add-on device 30.
  • a communication link e.g. a wireless communication link with the add-on device 30.
  • the local range transceiver 39 of the add-on device 30 may communicate wirelessly with the local range device transceiver 139 of the add-on device 100.
  • the electronic device 100 may be operable to visibly illustrate information or data of the injection device or medicament container 21 on the device display 151
  • the machine-readable identification 28, 88 may be implemented as a passive RF communication tag, such as a NFC tag.
  • the information e.g. the device information and/or the container information stored in at least one of the machine-readable identification 28, 88 is readable by the electronic module 34 and hence by any one of the transceivers 38, 39 of the add-on device 30 and/or by any of the transceivers 138, 139 of the external electronic device 100, 100’.
  • the transceiver 38 may be located inside the receptacle 63 of the device body 60 so as to minimize a spatial distance to the machine-readable identification 28 as provided at or near the proximal end 68 of the body 6.
  • the machine-readable a notification 28, 88 and the respective transceivers 38, 138 it can be ensured, that the machine-readable identification and the device information and/or container information stored therein can only be acquired or obtained when the add-on device 30 and/or the external electronic device 100, 100’ is within the near field transmission range.
  • the external electronic device 100 may permanently or regularly synchronize with the add-on device e.g. by local range communication interfaces as provided by the transceivers 39, 139. Insofar, any information gathered or read by the add-on device 30 can be instantly transmitted to and further processed, e.g. visualized, by the external electronic device 100, 100’.
  • Figs. 7-14 there are illustrated numerous examples of an injection the device 1 equipped with a first antenna 74 and a second antenna 76.
  • the first antenna 74 is electrically connected to the second antenna 76.
  • the first and the second antennas 74, 76 are separated in longitudinal direction.
  • the first antenna 74 is provided at or near a distal end 67 of the body 6.
  • the second antenna 76 is provided at or near a proximal end 68 of the body 6 or of the drive mechanism 20.
  • the second antenna 76 may be provided on or inside the trigger 9 or dose dial 8 of the drive mechanism 20.
  • the first antenna 74 and the second antenna 76 are connected by an electrical transmission line 75.
  • the transmission line 75 may comprise at least one or several sliding contacts for maintaining the electrical connection between the first antenna 74 and the second antenna 76.
  • the first antenna 74 interconnected to the second antenna 76 via the transmission line 75 may constitute a bridge circuit 172 effectively providing a kind of a range extender for the wireless transmission of the second antenna 76.
  • the first antenna 74 is operable to wirelessly communicate with the electronic container identifier 89 and hence with a machine-readable identification 88 as provided on one of the container part 7 and the medicament container 21.
  • the electronic container identifier 89 may be provided at or near the proximal end of the container part 7 or at or near a proximal end of the medicament container 21. When the container part 7 is correctly attached and connected to the body 6, the electronic container identifier 89 may radially overlap with the first antenna 74.
  • the electronic container identifier 89 and the first antenna 74 may be arranged concentrically.
  • the device transceiver 38 is implemented as a near field communication interface operable to wirelessly communicate with a complementary near field communication antenna 76.
  • the distance between the first antenna 74 and the transceiver 38 may be larger than the transmission range of the transceiver 38.
  • the first antenna 74 is connected to the second antenna 76 via the transmission line 74 extending between the first and the second antennas 74, 76.
  • the injection device 1 is further equipped with an electronic device identifier 28.
  • the electronic device identifier 28 comprises an electronic circuit 90 with an antenna 91 and an integrated circuit 93.
  • the antenna 91 is or represents an identifier antenna of the electronic device identifier 29.
  • the transceiver 38 may be operable to communicate with both, the second antenna 76 as well as with the antenna 91 of the machine- readable identification 28 and hence the electronic device identifier 29 of the injection device 1.
  • the electronic module 34 is operable to read or to obtain container information as provided by a memory 92’ of the electronic container identifier 89. Likewise, the electronic module 34 is operable to read and/or to obtain device related information from the memory 92 of the electronic device identifier 29. The electronic module 34 is operable to evaluate the device information and the container information and to compare the respective information in order to check or to assert if the medicament container 21 or the container part 7 matches with the drive mechanism 20 and/or with the body 6.
  • the electronic module 34 is operable to activate at least one of an alert and a locking mechanism 85 of the drive mechanism 20.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
EP23761533.1A 2022-08-30 2023-08-28 Injektionsvorrichtung und zusatzvorrichtung Pending EP4580708A1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP22315202 2022-08-30
PCT/EP2023/073459 WO2024046931A1 (en) 2022-08-30 2023-08-28 Injection device and add-on device

Publications (1)

Publication Number Publication Date
EP4580708A1 true EP4580708A1 (de) 2025-07-09

Family

ID=83439200

Family Applications (1)

Application Number Title Priority Date Filing Date
EP23761533.1A Pending EP4580708A1 (de) 2022-08-30 2023-08-28 Injektionsvorrichtung und zusatzvorrichtung

Country Status (4)

Country Link
EP (1) EP4580708A1 (de)
JP (1) JP2025528931A (de)
CN (1) CN119744188A (de)
WO (1) WO2024046931A1 (de)

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0304822D0 (en) 2003-03-03 2003-04-09 Dca Internat Ltd Improvements in and relating to a pen-type injector
EP2335755A1 (de) * 2009-12-17 2011-06-22 Sanofi-Aventis Deutschland GmbH Vorrichtung und Verfahren zur Abgabe von zwei oder drei Arzneimittelwirkstoffen
SG11201500322TA (en) 2012-08-31 2015-02-27 Sanofi Aventis Deutschland Drug delivery device
PL2890434T3 (pl) 2012-08-31 2020-11-02 Sanofi-Aventis Deutschland Gmbh Urządzenie do dostarczania leków
JP2017529918A (ja) * 2014-09-08 2017-10-12 メダクソール プロプライエタリー リミテッドMedaxor Pty Ltd 注射システム
US10898647B2 (en) * 2015-07-31 2021-01-26 Sanofi-Aventis Deutschland Gmbh Sensor, cartridge and drug delivery device
EP3476417A1 (de) * 2017-10-31 2019-05-01 Tecpharma Licensing AG Überwachung von wegwerfbaren injektionsvorrichtungen
JP7317835B2 (ja) * 2017-12-28 2023-07-31 サノフイ 注射デバイス用の取付けアダプタおよびアドオンデバイス

Also Published As

Publication number Publication date
CN119744188A (zh) 2025-04-01
WO2024046931A1 (en) 2024-03-07
JP2025528931A (ja) 2025-09-02

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