ACTIVATION AND DETECTION SYSTEM FOR A SUPPLEMENTAL DEVICE ATTACHED TO A MEDICAMENT DELIVERY DEVICE

Abstract

The present disclosure relates to an activation system for a supplemental device that is attached to an existing design of a medicament delivery device, where a movement applied on the protective cap or other covering of the medicament delivery device triggers the activation mechanism for re-establishing electrical contacts to close a circuit between a battery module and a power source, thus activating the battery module. The activation mechanism is configured to not intervene with the sterility of the dose delivery outlet. Thus, the supplemental device can be activated at any time before removal of the protective cap or other covering. The supplemental device can further have a transmitter for communicating information about the use of the medicament delivery device to an external device, such as a smart device. Memory storage elements can also be included having unique identification data. The present disclosure also relates to a medicament delivery device having the supplemental device attached.

Claims

1-14: (canceled)

15: A medicament delivery system comprising: a drug delivery device comprising a medicament container positioned within a housing, a dose delivery outlet accessible through a terminal end of the housing and a needle shield acting as a sterile barrier, coupled to a needle shield remover; a supplemental device comprising a battery module, an activation member and a communication module; a movable cap coupled to the needle shield remover wherein a cap movement acts on the activation member to activate the supplemental device; wherein the supplemental device is configured to determine if the cap has moved relative to the needle shield and wherein the communication module is configured to transmit data to an external device where the data comprises information directly related to the status of the activation member and/or the movement of the removable cap.

16: The medicament delivery system of claim 15, wherein the cap when coupled to the needle shield remover is configured to be movable in an axial and/or circumferential direction and wherein an initial motion sequence of the cap activates the supplemental device but does not move the needle shield remover.

17: The medicament delivery system of claim 15, wherein the dose delivery outlet is prevented from being accessible unless the cap is fully removed from the medicament delivery device, wherein a continued moving sequence of the cap subsequently to the initial moving sequence of the cap is required to remove of needle shield from the dose delivery outlet.

18: The medicament delivery system of claim 15, wherein the battery module or the communication module comprises one or more sensors configured to detect a motion of at least one of the components of the medicament delivery device.

19: The medicament delivery system of claim 15, wherein the system further comprises a sensor module connectable to any other module and wherein said sensor module comprises one or more sensors configured to detect a motion of at least one of the components of the medicament delivery device.

20: The medicament delivery system of claim 15, wherein the activation member is one of a switch or an insulating pad.

21: The medicament delivery system of claim 20, wherein the switch is initially in a first state where the communication module is prevented to receive power from the battery and where movement of the cap unit relative to a proximal end of the medicament delivery device changes the switch to a second state where the battery provides power to the communication module.

22: The medicament delivery system of claim 20, wherein the activation member is configured to activate the supplemental device only once, and wherein the switch being in the second state or the insulating pad being removed, indicates a potential breach of the sterile barrier of the medicament delivery device.

23: The medicament delivery system of claim 15, wherein the communication module or the battery module or supplemental device comprises a recorder (1d,3d) configured to obtain and store data information about the medicament delivery device.

24: The medicament delivery system of claim 15, wherein the data transmission by the communication module starts when the recorder receives power from the battery.

25: The medicament delivery system of claim 15, wherein any of the modules is removable from the housing and is reusable.

26: The medicament delivery system of claim 15, wherein the system further comprises a logging module connectable to any other module or included as part of any other module, and wherein the logging module is configured to start tracking motion of the medicament delivery device when the cap unit is removed.

27: The medicament delivery system of claim 15, wherein the system further comprises a memory module connectable to any other module or included as part of any other module, and wherein the memory module is configured to store the data and the communication module is configured to transmit the data wirelessly to the external device.

28: The medicament delivery system of claim 15, wherein the communication module comprises means for wireless data transfer and signaling means for the status of the activation member, and or the movement of the cap.

29: A medicament delivery system comprising: a drug delivery device having a medicament container positioned within a housing, a dose delivery outlet accessible through a terminal end of the housing and a needle shield surrounding the dose delivery outlet to provide a sterile barrier, where the needle shield is operatively associated with a needle shield remover; a supplemental device comprising a battery module, an activation member and a communication module; and a removable cap is operatively associated with the needle shield remover, where an initial movement of the cap causes the activation member to activate the supplemental device and where subsequent movement of the cap causes the needle shield to be removed from the dose delivery outlet, wherein the supplemental device is configured to determine if the cap has moved relative to the needle shield, and wherein the communication module is configured to transmit data to an external device where the data comprises information directly related to the status of the activation member or the movement of the removable cap.

30: The medicament delivery system of claim 29 further comprising a sensor module containing a sensor that detects a motion of the cap relative to the housing.

31: The medicament delivery system of claim 29, wherein the activation member comprises a switch or an insulating pad.

32: The medicament delivery system of claim 29, wherein the activation member comprises a switch that is initially in a first state that prevents a battery from energizing the communication module and where movement of the cap relative to the terminal end of the housing moves the switch to a second state where the battery provides power to the communication module.

33: The medicament delivery system of claim 29, wherein the cap can move axially relative to the needle shield remover a first distance that will activate the activation member, where further axial movement of the cap with cause axial movement of the needle shield remover which in turn will cause axial movement of the needle shield relative to the dose delivery outlet.

34: The medicament delivery system of claim 29, wherein the supplemental device is removable from the drug delivery device and is attachable to and reusable with a second drug delivery device.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0067] In the following detailed description of the present disclosure, reference will be made to the accompanying drawings, of which

[0068] FIG. 1A is a schematic representation of one possible embodiment of the present disclosure in a side view in an initial state of the activation member, where the housing of the cap and functional connections were not shown for clarity.

[0069] FIG. 1B is a schematic representation of one possible embodiment of the present disclosure in a side view in a final state of the activation member, where the housing of the cap and functional connections were not shown for clarity.

[0070] FIG. 2A schematically illustrates a configuration of the switch unit and the cap in a final state as shown in FIG. 1B without the cap housing for visibility.

[0071] FIG. 2B schematically illustrates a general circuit diagram according to the present disclosure, where the medicament delivery device is not shown for clarity.

[0072] FIG. 3A schematically shows the configuration of the activation member and the cap with the switch in an initial state before the movement of the cap where the part of the housing of the cap and the functional connections were not shown for clarity.

[0073] FIG. 3B is a partial cross-sectional view of FIG. 3A with the cap unit with a needle shield remover or closure member with the activation member in an initial state before the movement of the cap and the before any movement of the needle shield remover

[0074] FIG. 4A schematically shows the configuration of the activation member and the cap with the switch in an activated state after the movement of the cap, and before any movement of the needle shield, where part of the housing of the cap and the functional connections were not shown for clarity.

[0075] FIG. 4B is a partial cross-sectional view of FIG. 4A with the cap unit with a needle shield remover, or closure member before the sterile barrier is removed.

[0076] FIG. 5A schematically shows the configuration of the activation member and the cap with the switch in an activated state after the movement of the cap and after movement of the needle shield, where part of the housing of the cap and the functional connections were not shown for clarity.

[0077] FIG. 5B is a partial cross-sectional view of FIG. 5A with the cap unit with a needle shield remover, or closure member after the sterile barrier has been removed.

[0078] FIG. 6A illustrates an exploded view of the cap unit with the supplemental device.

[0079] FIG. 6B is a schematic view of an alternative embodiment with the supplemental device mounted on the housing and the activation member being an isolating pad in the initial state of the activation member.

[0080] FIG. 7 displays a functional scenario according to the present disclosure where the supplemental device integrates with the user and external devices.

DETAILED DESCRIPTION

[0081] In the following description, the wording smart device will be used. In this context, smart devices may include electronic devices that are provided with processors or processing circuitry that are capable of running computer programs as well as storage space to store programs as well as data retrieved from different external sources. The processing circuitry may for example use any combination of one or more of a suitable central processing unit (CPU), multiprocessor, microcontroller, digital signal processor (DSP), application specific integrated circuit (ASIC), field programmable gate arrays (FPGA) etc., capable of executing any herein disclosed operations concerning detection and or transmission of data. It is further to be understood that the smart devices are provided with communication systems that are capable of communicating with data networks in order to access different databases. It is to be understood that databases may be accessed via the internet, so called cloud services, and/or databases that are connected directly to and accessed via local area networks. It is further to be understood that the smart devices in this context comprise some sort of human-machine interface for two-way communication. The human-machine interface may comprise displays, keyboards, microphones, loudspeakers, I/O-ports for connection of peripherals. Further the smart devices may be provided with antennas for wireless communication with the networks. Also, the smart devices may be arranged with receiving and transmitting mechanisms capable of communicating with NFC tags as well as programs capable of establishing and handling the communication with the NFC tags. Also, the smart devices may be arranged with receiving and transmitting mechanisms capable of communicating via Li-Fi (light-fidelity) technology.

[0082] Further, in the following description, the wording medicament delivery device will be used. In this context, medicament delivery devices may include a number of devices capable of delivering certain doses of medicament to a user, such as e.g. injection devices with or without injection needles, inhalers of all kinds, such as powder, aerosol driven, gas, nebulizers having mouth or nasal pieces, dispensers for medicament in tablet form. The medicament delivery devices may be of either disposable type or re-usable type and may be provided with medicament containers suitably arranged for specific medicaments in specific forms.

[0083] Referring to FIG. 1A and FIG. 1B representing a possible configuration 10 of an activation system for a medical delivery device 20, where the supplemental device 1 is attached to the cap 21 of the medicament delivery device 20 having a housing 24 containing a medicament container 65 having a dose delivery outlet 60 i.e. a fixed needle that is covered by needle shield 62 Attached to protective cap 21 is needle shield remover 61, where the removal of the cap 21 from housing 24 necessarily causes removal of the needle shield 62 from needle as shown in FIGS. 3B, 4B and 5B. FIG. 1A shows a side view of the medicament delivery device with the activation member 8 attached to the supplemental device 1 mounted on the cap 21 where the housing surrounding the activation member 8 is not shown for clarity.

[0084] FIG. 1A further represents a configuration 10 when the activation member 8 preferably is initially in a first state where the recorder is prevented from/does not receive power from the battery 2 and where movement of the cap 21 proximally relative to the housing 24 changes the activation member 8 to a second state as shown in FIG. 1B where the battery provides power to the recorder and/or the communication module.

[0085] The activation member 8 can be configured such that it can be in the first state only once. This is best accomplished by configuring the activation member 8 such that it is prevented from/cannot transform from the second state back to the first state. One possible configuration that will prevent such a transformation involves the use of normally closed switch that is physically held in a temporary open position.

[0086] The activation member 8 is configured to be in contact with the housing 24 of the medicament delivery device 20 when the supplemental device 1 is mounted on the medicament delivery device 20. Stated differently, the activation member 8 is arranged to be slidably in contact with the surface of the proximal end of the medical delivery device 20 as represented in FIG. 1A and FIG. 3A. When the supplemental device 1 is mounted on an existing injection device, such as an auto-injector, that has a protective cap 21 that surrounds and encloses a separate needle cover or shield 62, and a pulling or twisting motion is applied to the cap 21 by a user, the cap will move towards the proximal end of the device 20.

[0087] This axial movement of the cap 21 towards the proximal end of the device 20 creates a gap 12 between the housing 24 and the cap 21 as illustrated in FIG. 1B, FIG. 4A and FIG. 5A The cap 21 abuts the proximal end of the housing 24 such that the activation member 8 being a switch in this example, is in mechanical contact with the housing 24 of the medicament delivery device 20 as shown in FIG. 1A and FIG. 3A. Upon movement of the cap 21 toward the proximal end of the delivery device, the switch 8, triggered by the movement of the cap 21, slides along the housing 24 of the medicament delivery device 20. When the switch 8 reaches the edge of the proximal end of the housing 24, the switch can slide vertically into the space 12 created by the distancing of the cap 21 from the housing 24 of the medical delivery device 20 as shown in FIG. 1B, FIG. 4A and FIG. 5A. This vertical movement with respect to the longitudinal axis of the medicament delivery device triggers the switch 8 back to its default position and closes the circuit, to form an electrical connection such that electricity from the battery will flow through and between the contacts, thus closing or energizing the electrical circuit connected to the other electrical components. The normally closed switch 8 may have alternative spatial or functional configurations, collectively referred to as activation member.

[0088] In one embodiment the coupling between the protective cap 21 and the needle shield remover 62 may be configured to allow a predefined axial displacement of the cap 12 with respect to the needle shield remover 62, and this axial movement does not act on the needle shield remover 62 to remove the needle shield.

[0089] One example may comprise an additional elongation between the gripping members of the cap and the needle shield remover. Stated differently the cap 21 may slide with an axial and/or rotational movement along the needle shield remover 62, defining an axial displacement 12, before gripping members of the needle shield and/or gripping members of the cap 21 can engage with each other. Upon coupling of the gripping members, any further axial and/or rotational movement of the cap 21 translates into a movement of the needle shield remover 62 and the attached rigid or flexible needle shield.

[0090] One embodiment may be configured to provide an additional external circumferential member 26 to the needle shield remover 62 or to the internal circumferential side of the cap 21. The circumferential member 26 comprises protrusions on the external or internal surface configured to engage with engagement members of the cap 21 or the needle shield remover 62. When assembling the cap 21 and the needle shield remover 62, the cap and the circumferential member 26 engage with the engagement members. When an axial and/or rotational movement is applied to the cap 21, a predefined axial displacement 12 of the cap 21 with respect to the needle shield is available as the circumferential member being engaged with the cap 21 slides along the needle shield removal until its engages with a gripping or engagement members of the needle shield. Thus, the sliding movement of the circumferential member with respect to the needles shield remover stops and any further movement applied to the cap 21 acts on the needle shield remover 62.

[0091] Alternatively, the circumferential member is coupled to the needle shield remover 62 and the cap 21 may slide on the circumferential member 26 until it abuts gripping or engagement members and the sliding movement of the circumferential member with respect to the cap 21 stops and any further movement applied to the cap 21 acts on the needle shield remover 62.

[0092] The activation of the supplemental device 1, 3 prior to the removal of the cap 21, 31 and the needle shield 62, may be used to check the status of the medicament delivery device with the external device. For example, information about the content and the administration can be stored and or displayed on the external device. When the supplemental device is activated and the data has been transmitted, wirelessly or via a wired connection, to the external device, the external device may verify the status of the content, i.e. the temperature if the sensors comprise temperature sensors, date of manufacturing, verifying if the content is safe to use, or if patient data is available, the personal administration plan may be displayed.

[0093] An advantage amongst others is the additional layer of safety, as sterility breaches or temperature breaches or safe use of the content may be verified and communicated from the external device to the user. For example, a temperature logging of the device over the lifetime can be transmitted wirelessly and the medicament shelf life calculated based on the transmitted data, and the external device may communicate to the user if the medicament is still safe to use and until when. Temperature conditions may in some cases accelerate or slowdown the degradation or contamination of some medicaments, accordingly the shelf life may be reduced or extendable. This might be a non-negligible advantage in regions where the medical delivery devices being stored in ambient environment with non-constant temperatures.

[0094] Another possible use of the activation mechanism is to verify before removal of the cap and thus whether there has been a breach of the sterility, if the medication is the intended one and if the administration is the right one. For example a user with visual and/or mental disabilities, who may not be able to distinguish visually or by tactile means between several medicament delivery devices containing different medicaments or medicament doses, or may not remember the personal administration plan, can activate the supplemental device and verify if it is the intended medication before self-administration of the medication.

[0095] For example, in a medical environment with a higher number of medicament delivery devices and users, the activation of the supplemental device may be coupled to an external device verifying and monitoring the administration plans for several users, thus minimizing accidental or erroneous administrations of the medication contained in the medicament delivery device.

[0096] As shown in FIG. 4B the axial displacement of the cap that triggered the activation member 8 in an initial default state A to move into a second state B which establishes a connection to the power supply and thus activates the supplemental device 1 as shown in FIG. 2A and FIG. 2B. This initial motion sequence of the cap activates the supplemental device 1 without inducing any movement of the needle shield remover. Stated differently the initial motion sequence activating the supplemental device is not projected as a sequence of motion onto the needle shield remover 62.

[0097] Especially in the case of a medicament delivery device that relies upon sterility of the dose delivery outlet, very little cap movement is tolerated before the supplemental device is activated. As illustrated in FIG. 4B relatively little cap movement, which translates into an axial displacement of the cap unit towards the proximal end of the medical device is required to activate the supplemental device 1 without triggering any needle shield remover 62 displacement or movement. Any additional displacement or movement of the cap beyond the motion sequence required for activating the supplemental device may trigger the needle shield remover 62. This is especially the case when the dose delivery outlet is an injection needle having its own separate flexible needle shield that is axially fixed to the protective cap. In other words, additional axial movement of the cap away from the device housing can result in axial movement of the needle shield away from the proximal end of the needle which can destroy the condition of sterility as illustrated in FIG. 5B.

[0098] FIG. 6A shows an embodiment including a number of electrical components, for instance a communication module 13 comprising a communication unit 1b, a recorder 1d having data storage, and a processor or control unit 1c. All these components/modules are in electrical communication through circuit board 1e and enclosed by cover 1a. Further a battery module 18 comprising the activation member being communicatively coupled to an energy source shown as a coin battery 2 is represented and the communication module 13 not shown in the Figures.

[0099] The communication unit 1b contained in the supplemental device 1 of the present disclosure may also make use of radio frequency identification technology, RFID. In particular, high frequency RFID provides a number of advantages regarding communication. The possibilities of using HF RFID are numerous and in particular provides the use of Near Field Communication, NFC. NFC is particularly suitable because it is a set of standards for smartphones and other smart devices to establish radio communication. NFC is a set of short-range wireless technologies, typically requiring a distance of 10 cm or less. NFC operates at 13.56 MHz on ISO/IEC 18000-3 air interface and at rates ranging from 106 kbit/s to 424 kbit/s. NFC always involves an initiator and a target; the initiator actively generates an RF field that can power a passive target. This enables NFC targets to take very simple form factors such as tags, stickers, key fobs, or cards that do not require batteries.

[0100] In the following description of the technology used the word NFC-tag may be used. In this context it is to be understood that an NFC-tag will comprise an NFC-chip connected to a circuit as well as an antenna. An NFC-tag is not limited to being integrated in a patch or label, but may be a stand-alone unit, or integrated in the material used for manufacturing medicament delivery devices. Further, the NFC-tag may include further features and components that are needed for the required or desired purposes and applications as will be apparent below.

[0101] NFC tags contain data and are typically read-only but may be rewriteable. They can be custom encoded by their manufacturers or use the specifications provided by the NFC Forum, an industry association charged with promoting the technology and setting key standards. The tags can securely store personal data such as debit and credit card information, loyalty program data, PINs and networking contacts, among other information.

[0102] Regarding medicament delivery devices, they can be arranged with NFC tags in order to perform a number of tasks. The NFC tags may be arranged as part of the above-mentioned supplemental devices of the present disclosure and conveniently incorporated in labels which are attached to an outer surface of a housing of a medicament delivery device.

[0103] The types of short-range wireless technology (SRWT) that may be utilized in the supplemental devices include ANT+, RFID, Zigbee and Bluetooth. One favourable technology is Bluetooth technology. Bluetooth technology operates in the unlicensed industrial, scientific and medical (ISM) band at 2.4 to 2.485 GHz, using a spread spectrum, frequency hopping, full-duplex signal at a nominal rate of 1600 hops/sec. The 2.4 GHz ISM band is available and unlicensed in most countries. Especially the Bluetooth low energy or Bluetooth Smart may be utilized in connection with medicament delivery devices and the functions that are requested. The Bluetooth circuit is provided with a transmitter that is capable of transmitting for instance a unique identification number or data as well as recording a time stamp. The Bluetooth circuit is preferably driven by the power source described above, e.g. the coin battery, and the Bluetooth circuit for activating the Bluetooth circuit only when there is an occurrence or change of status of the medicament delivery device.

[0104] Alternatively, Li-Fi technology which is based on light produced by LEDs instead of Radio frequency spectrum produced by Wi-Fi may be used in circumstances where Wi-Fi or other radiation may cause interference or disturb other equipment in specific areas like hospitals. The communication module 1b contained in the supplemental device 1 of the present disclosure may also make use of a photodetectors and LED light bulbs.

[0105] Turning to FIG. 2B, the basic circuit diagram of the supplemental device 1 that can be used in the present activation system is schematically shown. An energy source 2, shown as a coin battery, is electrically connected to a control module 1c, which may be connected or incorporated to the communication module 13. This communication module may contain one or more sensors/sensor module as described above, a communication unit 1b for transmitting data to an external device, a recorder or memory module, and a controller 1c (control unit). The sensors may include a magnetometer, a gyroscope, and/or an accelerometer. A magnetometer may be used to detect the position of an auto injector needle of the medicament delivery device with the supplemental device attached to it. A gyroscope may be used to detect the position of the medicament delivery device and the accelerometer may be used to detect movement in a particular direction. By use of a combination of a gyroscope and three accelerometers, a high precision tracking may be provided. The supplemental device of FIG. 2B also contains an energy isolation feature comprising a normally closed mechanical switch mechanism that is mechanically held open until the cap is removed which then causes the switch to close and completes the circuit.

[0106] The memory module, when present, can be a non-volatile memory to store data from the sensor(s)/sensor module and/or from a logging module. The non-volatile memory may e.g. be a read-only memory, flash memory, ferroelectric RAM (F-RAM), most types of magnetic computer storage devices (e.g. hard disks, floppy disks, and magnetic tape), optical discs. The non-volatile memory may be removable, to be inserted into a reader of an external device. The supplemental device may further be provided with a contact interface, allowing stored data to be uploaded to an external device through a cable connection. The communication module when present allows real data and/or stored data to be uploaded to the external device. The communication module is configured to transmit (wirelessly and/or by wire) real time data from the logging module or to transmit stored data from the memory module. The communication module may be provided with e.g. wi-fi, Bluetooth, BLE or Li-Fi.

[0107] Removal of cap 21 from housing 24 causes a movement with respect to the longitudinal axis of the medicament delivery device which triggers the switch 8 back to its default position, which represents the translation of the activation member. This will then close the circuit allowing the battery 2 to activate and energize the electrical components such as a communication module 1b, the recorder 1d having data storage, and the processor or control unit 1c.

[0108] In another possible embodiment of the presently disclosed activation system, the design of the supplemental device is such that it can be removed from the medical delivery device 20 and reused.

[0109] FIG. 6B illustrates an alternative activation system and embodiment representing a possible configuration 30 of an activation system for a medical delivery device 20, where the supplemental device 3 is attached to the cap 31 of the medicament delivery device 20 having a housing 24 containing a medicament container 65 having a dose delivery outlet 60 i.e. a fixed needle that is covered by needle shield 62. Attached to protective cap 31 is needle shield remover 61, where the removal of the cap 31 from housing 24 necessarily causes removal of the needle shield 62 from the needle. FIG. 6B shows a side view of the medicament delivery device 20 with the activation member 38 attached to the supplemental device 3 mounted on the housing 24 of the medicament delivery device 20 and coupled to the cap 31.

[0110] FIG. 6B further shows the supplemental device 3 including several electrical components for instance a communication module 3b, a recorder 3d having data storage, and a processor or control unit 3c. All these components/modules are in electrical communication through circuit board 3e and enclosed by cover 3a. Further a battery module shown as a coin battery 2. The battery module can include a contact pad 38 and a switch 48 operatively connected to the battery 2 and the contact pad 38, where a part of the switch 48 is directly connected to the removable cap 31 when the battery module is attached to the housing 24 or where a part of the switch is directly connected to the housing when the battery module is attached to the cap 31.

[0111] In another embodiment of the present disclosure a method of activating a supplemental device 3 is presented where transmitting data containing information relating to a medicament delivery device occurs when a protective a cap 31 or other cover that is attached to a proximal portion of the medicament delivery device 20 is moved axially relative to the proximal portion of the medicament delivery device housing or is completely removed from the medicament delivery device housing. This method involves the removal of an activation member, e.g., an insulating sheet or strip, from electrical contacts that are directly contacted to a battery that is part of an electrical circuit of the supplemental device 3 that can contain a switch 48 that is operatively connected to the battery 2 and to a contact pad 38, where a part of the switch 48 is directly connected to the cap 31. A recorder can be configured to obtain and store information about the medicament delivery device 20 and a communication module can be used to transmit data recorder by the recorder to an external device.

[0112] FIG. 7 illustrates one possible logical flow diagram representative of activation system of the present disclosure. Circuits may be connected to a number of modules or components within the supplemental device for providing status information. Such status information may comprise end of dose delivery. It may for example be important for a user to know when an injection sequence has ended and that it is safe to remove the device from the injection site. In this case a circuit may be affected by moving components at the end of dose delivery, wherein the circuit acts as a switch. The switch information detected by the SRWT is transmitted to the smart device, wherein the smart device is arranged to indicate to the user that the device may safely be removed. Also, this information confirms that the device is used.

[0113] The circuits and switches may further be used as interactive, step by step, instructions. For example, the smart device may be provided with an instruction application showing a user in a stepwise manner how a device should be handled. When one step has been performed, whereby a certain circuit has been affected and detected by the SRWT and transmitted to the smart device, an OK or positive response is provided by the smart device and displayed to the user. The instruction application then shows the subsequent handling step to be taken. In this manner, all steps affect different circuits that in turn provide the SRWT-chip with status information. This status information is successively transmitted to the smart device and appropriate information is displayed to the user by the instruction application.

[0114] In connection with the increased integration of the medicament delivery device and the smart device by the supplemental device, further information could be collected in order to increase the understanding of the effects of a certain treatment scheme, e.g. disease monitoring. The programs or applications that are used in the smart device in connection with the medicament delivery devices may further include questionnaires that are filled in by the user in connection with a dose delivery operation. The questionnaire may include a number of questions regarding the current status of the patient and may preferably be configurable depending on therapy, disease and user needs. The areas that might be handled may include quality of life, cognitive function, pain, fatigue, nausea, mental health, etc. The answers of the questionnaire may then be transmitted from the smart device to external databases together with information collected via the SWRT-tags for processing and evaluation to find positive or negative correlations between the treatment scheme and type of medicament in relation to the perceived condition of the patient.

[0115] Further, if the smart device is not equipped with an NFC-reader, the attachment could be provided with such an NFC-reader, thereby adding functionality to the smart device. The integration of the medicament delivery device and the smart device further provides real time interactive user instructions as well as correct injection times, dates and dose quantities because of the close connection between the medicament delivery device and the smart device because of real time reading of the NFC-tag. The injection times, dates and dose quantities can be recorded directly in the smart device for further processing or transmittal.

[0116] Many smart devices are arranged with motion sensors in three dimensions, which functionality could be used in connection with handling of the medicament delivery device. For instance, the smart device could detect how it, and thus the medicament delivery device, is being held. This may be important for some types of medicaments and for some types of medicament delivery devices in that the medicament delivery device has to be held in a certain way during some steps when used. This could for example be a medicament delivery device using a so-called dual chamber medicament container, where it can be important how the medicament container is held during mixing and priming. The motion sensors of the smart device could then be used to detect how the medicament delivery device is held and could inform a user on how to hold the device and alert the user if the device is not held according to instructions.

[0117] Further features of the smart device that could be used with the integrated medicament delivery device include the use of a camera that is often an integrated part of the smart device. The camera is used to receive the light fidelity or alternatively could then be used to take photographs of the content of the medicament container, which often is transparent, in order to obtain information regarding the status of the medicament. For example, colouring or opacity of a medicament may indicate that something adverse has happened to the medicament, such as exposure to temperatures outside the prescribed range, such that the medicament should not be used. The comparison of colour or opacity may be performed directly by the user in an application in the smart device, or the picture may be sent by the smart device to an external site where skilled personnel perform the comparison and alert the patient of any deficiencies of the medicament and advice as to how proceed.

[0118] Regarding adherence and patient responsibility, there are features and functions of the smart device that may be utilized. Some medicaments and treatment schemes are very expensive to the national healthcare authorities and a lot of responsibility is put on the users to really adhere to the treatment schemes. There has been discussions in several countries in the world that if patients do not adhere to an expensive treatment, they should be forced to pay for the continued treatment, fully or partly, the arguments being that those persons that are not interested enough in a treatment should have to pay for it. The information and medicament delivery history obtained from the NFC-tags could be used to monitor the adherence.

[0119] In that respect, biometrical sensors such as fingerprint sensors, eye and/or face recognition via cameras on the smart devices mat provide proof of a user of a certain medicament delivery device, providing proof that it is the legitimate user that has activated the medicament delivery device for delivering a dose. Biometrical sensors may further be used in order to ascertain that the device is prevented to/cannot be accidentally, or wilfully, used by a third person.

[0120] For example, if a larger battery is used, the NFC-tag could use the temperature sensor that is built into the NFC-chip. This may be an advantage because then the temperature of a medicament delivery device and/or a medicament container may be monitored and logged for instance during transport. This might be important for a number of medicaments that are temperature sensitive, whereby it can be ensured that the quality of the medicament has not been affected by temperature variations outside approved ranges. Also, the temperature sensor could be used to provide information when a medicament has reached a target temperature for delivery. The information is then communicated to the smart device, where the latter provides handling and temperature information to the user.

[0121] It is to be understood that the embodiments described above and shown in the drawings are to be regarded only as non-limiting examples of the present disclosure and that it may be modified in many ways within the scope of the patent protection.