Auxiliary Device for Drug Delivery Device - Patent application

Abstract

An auxiliary device attached to a removable cap of a medication delivery device, the auxiliary device including a housing (11) attachable to the removable cap (21), the housing (11) configured to accommodate a battery module (15) including batteries (14a, 14b) and a switch (16) operably connected to the battery module (15), and an activation clip (12) operably connected to the battery module (15), the activation clip (12) operably connected to the switch (16). The auxiliary device includes a communications module (13) connectable to the battery module (15) or included as part of the battery module and configured to transmit data to an external device, the data including information directly related to a status of the switch (16). The auxiliary device (1) further includes an insulating strip (113A, 113B), a first portion (1131) of the insulating strip (113A, 113B) slidably disposed between the switch (16) and the activation clip (12), and a second portion (1132) of the insulating strip (113A, 113B) is attachable to the housing (22) of the drug delivery device (20). The auxiliary device (1) is initially in a first state (S1), in which the communication module (13) is prevented from receiving power from the battery module (15), and a first movement (M1) or a second movement (M2) of the removable cap (21) relative to the housing (22) changes the auxiliary device (1) to a second state (S2), in which the batteries (14a, 14b) provide power to the communication module (13).

Description

[Technical Field]

[0001] The present invention relates to an auxiliary device that attaches to a medication delivery device and can function as an information provider that can transmit specific information about the medication delivery device. The auxiliary device is activated by the removal of a coating from the medication delivery device. The auxiliary device can monitor the use of the medication delivery device and can communicate with an external smart device. [Background technology]

[0002] Drug delivery devices, especially those designed for self-administered drug delivery, have been commercially available for many years. To allow non-professionals to use the devices, they must be easy to use and intuitive. Furthermore, because many medications are vital or at least highly important to patients, there is a demand from physicians and other professionals to obtain information that patients are taking their medications according to the prescribed schedule. Desired information can include the type of medication, delivery time, date, dose size, and safety information, such as sterility. It is also important to know whether the medication or the device itself is counterfeit or has been tampered with. Similarly, information that may be useful to physicians relates to whether the medication is being taken using the correct procedure and according to the instructions; that the medication is maintained at a predetermined temperature before and during drug delivery; and, when the drug delivery device is an injector, whether the correct injection depth and injection rate are being used.

[0003] Systems for obtaining information from a medication delivery device are known. For example, Patent Document 1 discloses a system for presenting and dispensing medication information, in which the medication delivery device is arranged with a communication mechanism that allows communication with an external device, such as, for example, a cellular or mobile phone or a personal digital assistant (PDA). A suitable communication standard is Bluetooth®. The medication delivery device is arranged with a number of sensors, for example, for monitoring and registering dose delivery sequences. The idea is then to use the functionality of the external device, such as, for example, its display, its processor, its keyboard, etc., instead of providing such features in the medication delivery device. The transfer of functionality to an external device reduces the cost of the medication delivery device compared to a medication delivery device provided with such functionality.

[0004] However, a drawback of the solution of Patent Document 1 is that the Bluetooth circuit or a similar wireless communication system, such as ANT or ZigBee, is integrated into the housing of the medication delivery device. The communication system, along with its battery for powering the circuit, requires dedicated space within the medication delivery device. Manipulating an existing device design to accommodate an add-on battery module may cause unexpected regulatory issues. Another problem with known data collection devices is that the power source is directly connected to the electronic circuit when the battery module is manufactured and attached to the medication delivery device. This may cause premature battery depletion. Additionally, such systems require the user to perform a separate, specific step to activate the battery module, which may not always be performed successfully.

[0005] Therefore, it is not so easy to modify existing designs or to easily provide them with the additional functionality that a communication system can provide. As such, there exists a need to provide an activation system that is automatic and that is performed prior to a breach of the sterility barrier as part of normal use of the medication delivery device, that provides a detection mechanism that is activated by the removal sequence of the protective unit before the sterility barrier is removed, thereby activating an auxiliary device for recording and signaling the breach of the sterility barrier of the medical delivery device. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] International Publication No. 2004 / 084116 Summary of the Invention [Means for solving the problem]

[0007] The present disclosure is applicable to a variety of medication delivery devices, including, for example, injection devices with or without an injection needle, all types of inhalers, such as powder inhalers, aerosol-driven inhalers, gas inhalers, nebulizers with mouthpieces or nosepieces, dispensers for medications in tablet form, and other devices capable of delivering a specific dose of medication to a user. The medication delivery devices can be either disposable or reusable and can be provided with a medication container appropriately positioned for a specific medication in a specific form. Furthermore, medical devices include, but are not limited to, devices that deliver one or more doses of medication automatically, semi-automatically, or manually.

[0008] In the following description, the term "smart device" will be used. In this context, a smart device may include an electronic device provided with a processor or processing circuitry capable of executing computer programs and storage space for storing programs and data imported from different external sources. The processing circuitry may use any combination of one or more suitable central processing units (CPUs), multiprocessors, microcontrollers, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), etc., capable of performing any of the operations disclosed herein, for example, related to data detection and / or transmission. It should further be understood that the smart device is provided with a communication system, which may communicate with a data network to access different databases. It should also be understood that the databases may be accessed via the Internet, so-called cloud services, and / or via databases directly connected to and accessed via a local area network. It should also be understood that a smart device in this context includes some kind of human-machine interface for two-way communication. The human-machine interface may include a display, keyboard, microphone, loudspeaker, and I / O ports for connecting peripheral devices. Furthermore, the smart device may be provided with an antenna for wireless communication with a network, may be configured with receiving and transmitting mechanisms capable of communicating with NFC tags, and programs capable of establishing and handling communications with NFC tags, and may be configured with receiving and transmitting mechanisms capable of communicating via light-fidelity (Li-Fi) technology.

[0009] It is an object of the present invention to provide an activation mechanism for an auxiliary device that can be attached to an existing medication delivery device, where attachment does not require the existing design of the medication delivery device to be modified or otherwise changed. A particularly suitable auxiliary device is an information provider device that can be used on and with a number of different medication delivery devices, and is particularly configured for use on a medication delivery device for self-administration of medication. Preferably, a medication delivery device configured with such an information provider can be used with a conventional external smart device, which is common on the market and used by the majority of patients who handle medication delivery devices for self-administration.

[0010] In the present disclosure, when the term "distal direction" is used, it refers to the direction facing away from the dose delivery site during use of the drug delivery device. When the term "distal part / end" is used, it refers to the part / end of the delivery device, or the part / end of a member thereof, that is positioned furthest away from the dose delivery site during use of the drug delivery device. Correspondingly, when the term "proximal direction" is used, it refers to the direction facing towards the dose delivery site during use of the drug delivery device. When the term "proximal part / end" is used, it refers to the part / end of the drug delivery device, or the part / end of a member thereof, that is positioned closest to the dose delivery site during use of the drug delivery device.

[0011] Additionally, the terms "longitudinal," "longitudinally," "axially," and "axial" refer to a direction extending from the proximal end to the distal end and extending along a device or component thereof, typically in the direction of the device and / or component's longest extension.

[0012] Similarly, the terms "transverse," "transverse," and "transversely" refer to a direction generally perpendicular to the longitudinal direction.

[0013] As used herein, the term "medicament" is meant to encompass any drug-containing flowable agent, e.g., a liquid, solution, gel, or fine suspension, that can be passed in a controlled manner through a delivery means, e.g., a cannula or hollow needle. Exemplary agents include, for example, pharmaceuticals such as peptides, proteins, and hormones; biologically derived drugs or active agents; hormonal and gene-based drugs; nutritional formulations; and other substances in both solid (dispensed) or liquid form. In describing exemplary embodiments, reference will be made to the use of insulin. Correspondingly, the term "subcutaneous" infusion or injection is meant to encompass any method of transcutaneous delivery to a subject.

[0014] In this disclosure, the term "module" is meant to encompass a self-contained unit or item, such as an electronic component or an assembly of electronic components and associated wiring, that by itself performs a defined task and that can be linked and connected with other such units to form a larger system.

[0015] In general, all terms used in the claims are to be interpreted according to their ordinary meaning in the art unless expressly defined otherwise herein. All references to elements, devices, members, components, means, etc. are to be openly interpreted as referring to at least one instance of the element, device, member, component, means, etc. unless expressly stated otherwise.

[0016] The term automatic in relation to a medical injection device means that the injector device is capable of performing the injection without the user of the device delivering the force required to expel the medication during delivery. The force is delivered automatically by a resilient force, such as a spring, or an electric motor, or any other suitable means for providing the delivery force.

[0017] A first aspect of the present invention relates to an auxiliary device attachable to a removable cap of a medication delivery device, the auxiliary device including a housing attachable to the removable cap, the housing configured to accommodate a battery module, an activation clip connected to the battery module, a switch having a first surface and a second surface, the first surface connected to the battery module and the second surface connectable to the activation clip, the switch generating a contact area when connected, and a communication module connectable to or included as part of the battery module and configured to transmit data to an external device, the data including information directly related to a status of the switch. The auxiliary device further includes an insulating strip having a first portion and a second portion, the first portion having a predetermined area larger than the contact area between the switch and the activation clip, and the second portion attachable to a housing of the medication delivery device extending along a longitudinal axis between a proximal end and a distal end, the auxiliary device is initially in a first state S1, in which the first portion of the insulating strip is slidably disposed between the switch and the activation clip to prevent the communication module from receiving power from the battery module, and the removable cap is removed toward the proximal end of the housing of the medication delivery device by a first movement M1 and / or a second movement M2, removing the removable cap changes the auxiliary device to a second state S2, in which the first portion of the insulating strip is removed from the contact area between the switch and the activation clip, after which the battery module provides power to the communication module.

[0018] An advantage of the auxiliary device is that any existing medication delivery device can be combined and upgraded with such a smart device. Furthermore, because the auxiliary device begins powering and consuming power only when the user removes the cap from the device, the battery size can be small and limited to the expected usage time of the device and is not designed for a long shelf life.

[0019] Optionally, the insulating strip is flexible or is adaptable to the shape of the outer and / or inner surface of the medication delivery device, or the insulating strip includes a shape that matches the outer and / or inner surface of the medication delivery device.

[0020] Optionally, the insulating strip extends along a longitudinal direction, with a first portion disposed within the housing of the auxiliary device and a second portion extending toward a distal end of the housing of the auxiliary device.

[0021] Optionally, the first movement is a linear movement of the removable cap relative to the housing of the medication delivery device towards the proximal end.

[0022] An advantage of the insulating strip being partially within the auxiliary device and partially attached to the housing is that the auxiliary device is activated only when the removable cap is completely removed from the device, i.e., when the removable cap performs a linear movement M1 in the proximal direction. Thus, slight longitudinal movements of the removable cap do not activate the auxiliary device.

[0023] Alternatively, the insulating strip extends circumferentially around the housing of the medication delivery device, with a first portion disposed within the housing of the auxiliary device and a second portion extending circumferentially from the housing of the auxiliary device.

[0024] Optionally, the second movement M2 is first a rotational movement and then a linear movement, or vice versa, or a spiral or linear movement of the removable cap toward the proximal end relative to the housing of the drug delivery device.

[0025] An advantage of the circumferentially arranged insulating strip is that medication delivery devices that uncap by twisting and pulling movements can be easily upgraded with auxiliary devices.

[0026] An advantage is that accidental breach of the sterility barrier can be detected by an auxiliary device. For example, a patient suffering from a psychiatric disorder who may forget to administer a prescribed dose of medication after removing the cap of a medical delivery device can be alerted by an external system receiving information from the communication module. Also, the sterility breach of individual medication delivery devices in a large stock of medication delivery devices can be monitored in this way.

[0027] Optionally, the auxiliary device further includes an adhesive pad configured to securely attach and hold the auxiliary device to the cap.

[0028] The advantages are high compatibility with many drug delivery devices and the facility to add smart devices to existing models.

[0029] Optionally, the battery module or the communication module includes one or more sensors configured to detect the movement or status of at least one of the components of the medication delivery device.

[0030] An advantage is monitoring the drug delivery and / or mixing process of drug components of a drug delivery device.

[0031] Optionally, the auxiliary device further includes a sensor module connectable to any other module, the sensor module including one or more sensors configured to detect the movement or status of at least one of the components of the medication delivery device.

[0032] An advantage of modularity is that the sensor components can be easily reused and relocated in other auxiliary devices. For example, when a battery module reaches end of life and must be discarded, the sensor module can be separated from the battery module from the auxiliary device and added to a new battery module.

[0033] Optionally, any of the modules are removable from the housing and reusable.

[0034] Optionally, the battery module or the communication module includes a recorder configured to obtain and store data information about the medication delivery device.

[0035] The advantage is that specific data about medications, details of a patient's medication, or environmental data can be collected and transmitted. For example, a patient's medication intake can be monitored, or the user can be notified if a medication must be stored or used at a specific temperature and this has not been applied to the medication delivery device. Or specific information about a batch or a patient's specific therapeutic regimen can be stored thereon.

[0036] Optionally, data transmission by the communication module begins when the recorder receives power from the battery.

[0037] Optionally, the auxiliary device further includes a logging module, which can be connected to or included as part of any other module, and which is configured to start tracking the movement of the medication delivery device when the removable cap is removed.

[0038] Optionally, the auxiliary device further includes a memory module, connectable to or included as part of any other module, the memory module configured to store data, and the communication module configured to wirelessly transmit data to an external device.

[0039] A second aspect relates to a medication delivery device comprising a housing, a medication container positioned within the housing, a dose delivery outlet accessible through a terminal end of the housing, a removable cap attached to the housing such that the dose delivery outlet is prevented from becoming accessible unless the removable cap is completely removed from the medication delivery device, and an auxiliary device according to any one of the preceding options.

[0040] These and other aspects of the present invention, as well as its attendant advantages, will become apparent from the following detailed description and accompanying drawings.

[0041] Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0042] [Figure 1A] FIG. 1 shows a medication delivery device with an auxiliary device attached to the medication delivery device. [Figure 1B] FIG. 1B is a side view of the auxiliary device of FIG. 1A. [Figure 1C]FIG. 1B shows a three-dimensional perspective view of the auxiliary device of FIG. 1A. [Figure 2A] FIG. 1B shows the drug delivery device of FIG. 1A in top view with an auxiliary device attached. [Figure 2B] FIG. 1B shows the drug delivery device of FIG. 1A in rear view with an auxiliary device attached. [Figure 2C] FIG. 1B shows the drug delivery device of FIG. 1A in side view with an auxiliary device attached. [Figure 3A] FIG. 10 shows a top view of an auxiliary device. [Figure 3B] FIG. 10 shows a side view of an auxiliary device. [Figure 3C] FIG. 10 is a perspective rear view of the auxiliary device. [Figure 3D] FIG. 10 shows a rear view of the auxiliary device. [Figure 4A] 13A-13C show alternative auxiliary devices with further division of parts. [Figure 4B] 13A-13C show alternative auxiliary devices with further division of parts. [Figure 4C] 13A-13C show alternative auxiliary devices with further division of parts. [Figure 4D] FIG. 10 is a distal top view of an auxiliary device. [Figure 4E] FIG. 13 is a proximal top view of an auxiliary device. [Figure 5] FIG. 1 is an exploded view of an auxiliary device. [Figure 6A] FIG. 10 shows an auxiliary module attached to a medication delivery device with the communication module removed. [Figure 6B] FIG. 10 shows the arrangement of the activation clip, insulating strip, switch and adhesive pad of the auxiliary device relative to the medication delivery device in a first state S1. [Figure 6C] 1 shows the arrangement of the activation clip, insulating strip, switch, and battery module in a first state S1. FIG. [Figure 7A]FIG. 1 shows an auxiliary device attached to a medication delivery device with insulating strips arranged circumferentially in a first state S1. [Figure 7B] FIG. 7B shows the device of FIG. 7A with twisting and pulling movements of the removable cap of the medication delivery device in a second state (S2). DETAILED DESCRIPTION OF THE INVENTION

[0043] Various modifications to the described embodiments are possible and will occur to those skilled in the art without departing from the invention as defined by the claims.

[0044] Exemplary methods and systems are described herein. It should be understood that the words “example,” “exemplary,” and “illustrative” are used herein to mean “serving as an example, instance, or illustration.” Any embodiment or feature described herein as “example,” “exemplary,” or “for illustrative purposes” is not necessarily to be construed as preferred or advantageous over other embodiments or features. The exemplary embodiments described herein are not meant to be limiting. It will be readily understood that aspects of the present disclosure, as generally described herein and illustrated in the Figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are expressly contemplated herein.

[0045] Moreover, the particular arrangements shown in the figures should not be seen as limiting. It should be understood that other embodiments may include more or less of each element shown in a given figure. Furthermore, some of the elements shown may be combined or omitted. Furthermore, example embodiments may include elements not shown in the figures.

[0046] Unless otherwise indicated, terms such as "first," "second," etc. are used herein merely as labels and are not intended to impose any hierarchical, positional, or other requirements on the items to which they refer. Moreover, a reference to, for example, a "second" item does not require or preclude the presence of, for example, a "first" or lower-numbered item, and / or, for example, a "third" or higher-numbered item.

[0047] As used herein, devices, elements, and methods that are "configured to" perform a particular function are in fact capable of performing the particular function without modification, rather than merely having the potential to perform the particular function after further modification. In other words, devices, elements, and methods that are "configured to" perform a particular function are specifically selected, generated, implemented, utilized, programmed, and / or designed for the purpose of performing the particular function. As used herein, "configured to" refers to existing characteristics of the devices, elements, and methods that enable them to perform the particular function without further modification. For purposes of this disclosure, devices, elements, and methods that are described as "configured to" perform a particular function can additionally or alternatively be described as "adapted to" and / or "operable to" perform that function.

[0048] Furthermore, in the following description, the term drug delivery device will be used. In this context, a drug delivery device can include multiple devices capable of delivering a specific dose of drug to a user. The drug delivery device can be either of the disposable or reusable type and can be provided with a drug container that is appropriately arranged for a specific drug in a specific form.

[0049] 1A and 2A-2C show the auxiliary device 1 when attached to a medication delivery device 20. In this example, the medication delivery device 20 has a tubular, elongated body extending from a distal end to a proximal end. The medication delivery device includes a housing 22, which is arranged to house a medication container, an activation mechanism, and a medication delivery member. The proximal end has a removable cap 21 that protects the medication delivery member. The auxiliary device 1 includes a housing 11 that extends longitudinally from the removable cap toward the distal end of the medication delivery device 20. In the example shown in FIGS. 1A and 2A-2C, the auxiliary device housing 11 extends partially above the longitudinal dimension of the removable cap 21, such that a portion of the housing 11 is positioned above the housing 22 of the medication delivery device 20.

[0050] In an alternative example not shown in the figures, the auxiliary device housing does not extend beyond the removable cap 21. For example, the auxiliary device housing can have a c-clip shape that circumferentially surrounds the removable cap. Alternatively, the housing can adopt the cross-sectional shape of the cap, i.e., it can be added to the proximal end or top of the cap.

[0051] Attaching the housing 11 of the auxiliary device 1 to the removable cap 21 of the medication delivery device 20 includes, in this example, an adhesive pad 111, as shown in Figures 3D, 5, and 6B. The auxiliary device is adhesively attached to the removable cap 21. The adhesive pad 111 preferentially includes an adhesive glue configured to reversibly or irreversibly glue to the cap. Alternatively, the adhesive pad 111 includes a surface with a suction mechanism, e.g., a micro-suction cup, for reversibly attaching the auxiliary device 1 to the removable cap 21. Still alternatively, the adhesive pad 111 is a magnetic pad, which magnetically attaches the auxiliary device to the cap.

[0052] In the alternative example above with a c-clip shaped housing for the auxiliary device, the mounting pad can have the form of an elastic c-clip that holds the auxiliary device in place attached to the cap by elastic force alone or in combination with any of the adhesive examples above.

[0053] In the above example with the cross-sectional cap shape of the auxiliary device, various versions of adhesive pads are applicable, i.e. glue, suction or magnetic type, and furthermore the auxiliary device can further comprise threaded means for attaching the auxiliary device to the cap, in this case the adhesive pad or the threaded means can be used alone or in combination.

[0054] The auxiliary device housing 11 is configured to receive various modules. As shown in FIG. 5 , the housing 11 receives a communications module 13, a battery module 15, a switch 16, and an activation clip 12. The battery module 15 includes a circuit board 151 disposed thereon, one or more batteries 14 a, 14 b, and, optionally, battery mounting structures 141 a, 141 b. Optionally, the auxiliary device includes a sensor module (not shown); for example, the sensor module may include sensors for temperature, humidity, movement, light, sound, or vibration, or an electric or magnetic field sensor.

[0055] Optionally, the auxiliary device comprises data storage means for storing data relating to the medication delivery device, the patient, the medication, or any other relevant useful data. For example, it may further store a computer program with instructions for the communication module 13.

[0056] For example, when the communication module 13 is designed for a wide variety of medication delivery devices and medications, each computer program associated with a particular medication delivery device, medication, or patient can be stored in a storage means specific to the medication delivery device type or medication contained therein. For example, a certain type of medication must be stored at a specific temperature but administered at a temperature different from the storage temperature. In this case, a temperature sensor transmits temperature data to a data storage device, which transmits the data and computer program to the communication module, which, upon execution of the computer program, notifies the user that the storage temperature has not been previously violated and that the temperature for administration has been reached. The notifications sent to the user can be sent, for example, via wireless communication to a smartphone, computer, or separate display device, or any other suitable display device.

[0057] Optionally, the communication module 13 further includes a display module for showing notifications to the user. A display module, not shown, can alternatively be attached to or integrated into the medication delivery device. The display module in this example can then be connected to the communication module 13 of the auxiliary device. Optionally, the display module further includes additional signaling elements for tactile, visual, and / or audible signaling, such as a vibration generator for tactile signaling and a speaker for audible signaling.

[0058] In some examples, the battery module 15 and the communication module 13 are designed as a single module that can be reused and reassembled with, for example, a new battery, switch, and activation clip.

[0059] 3A-3D, the auxiliary device is arranged with an insulating strip 113A, a first portion of which is disposed within the auxiliary device housing 11 as shown in FIGS. 3C and 3D, and a second portion of which is configured to be attached to the housing of the medication delivery device 20, as can be seen, for example, in FIGS. 2A and 6A. The activation clip 12 is shaped such that a first portion 121 of the clip is operably connected to the battery module 15, and further, a second portion 122 is formed such that it provides support for the insulating strips 113A, 113B, in this example, extending longitudinally from the connection to the battery module 15 toward a spaced-apart switch 16, which is also connected to the battery module 15 as shown in FIG. 6C. The first portion 1131 of the insulating strips 113A, 113B is disposed between the second portion 122 of the activation clip 12 and the switch 16, as shown in FIGS. 6B and 6C. In the first state (S1) of the auxiliary device 1, the insulating strips 113A, 113B prevent the communication module from receiving power from the battery module. To activate the communication module 13, the insulating strips 113A, 113B must be moved so that contact between the switch and the activation clip is established. This is achieved when the first portion 1131 of the insulating strip is removed from the contact area between the switch 16 and the activation clip 12, and a first movement M1 or second movement M2 of the removable cap 21 relative to the housing 22 of the medication delivery device changes the auxiliary device 1 to the second state S2, so that the batteries 14a, 14b provide power to the communication module 13. When the communication module 13 receives power from the battery, the communication module can send a notification, for example, to an external device or a display. Additionally, the battery module can provide power to the sensor module either directly or via the communication module.In the example shown in FIGS. 6A-6C, the connection of the activation clip 12 to the battery module 15 is longitudinally spaced from the switch 16, which provides a longitudinal travel distance for the insulating strips 113A, 113B prior to activation. Or, in other words, the removable cap 21 must move a certain distance (M1) in the proximal direction, the travel distance being set by the initial position of the insulating strips on the second portion 122 of the activation clip 12. Thus, the maximum travel distance is the distance between the position of the switch 16 and the position of the connection of the activation clip 12 to the battery module 15. The advantage is that the removable cap 21 can accidentally travel a certain distance in the proximal direction without the insulating strips 113A, 113B moving distally past the switch 16. As noted above in the first state S1 of the auxiliary device 1, the insulating strips 113A, 113B prevent the communications module from receiving power from the battery module. Removal of the removable cap 21 moves the attached auxiliary device 1 proximally, whereby the movements (M1, M2) can be any one of linear, circumferential, or spiral movements, or any combination thereof. Proximal displacement of the auxiliary device 1 moves the switch 16 and activation clip 12 proximally, whereby the insulating strips 113A, 113B move out of the contact area of ​​the switch and activation clip; in other words, the insulating strips 113A, 113B move beyond the position of the switch 16, allowing contact between the switch 16 and the activation clip 12. In this way, accidental activation cannot occur.The second portions 1132 of the insulating strips 113A, 113B have adhesive portions by which the insulating strips are attached to the housing 22 of the drug delivery device 20; in other words, when the auxiliary device 1 is attached to the drug delivery device 20, the housing 11 of the auxiliary device 1 is attached to the removable cap 21 via the adhesive pad 111, and the insulating strips 113A, 113B are attached to the housing 22 of the drug delivery device via the adhesive portions of the insulating strips 113A, 113B.

[0060] 7A and 7B, the insulating strip is wrapped circumferentially around the housing 22 of the medication delivery device 20, and the second portion 1132 of the insulating strip 113B is circumferentially attached at the housing 22 of the medication delivery device. The removable cap 21 can be twisted before activation occurs. Thus, a movement M2 is required to activate the auxiliary device 1, which includes a movement that first twists the removable cap 21 and then pulls the removable cap 21.

[0061] The second portion 1132 of the insulating strip may further include information on its external side that is visible to the user. For example, various tags may be envisaged, such as a QR code, an RFID tag, a temperature sensor (a sensor that changes color when a threshold temperature is reached), a hologram, a label, etc.

[0062] In an alternative example not shown in the figures, the auxiliary device is non-releasably coupled to the cap, and it can be integrated into the cap. In this example, the auxiliary device is arranged with an insulating strip. A first portion of the insulating strip is arranged in the auxiliary device housing 11, i.e., in the cap, and a second portion of the insulating strip is configured to be attached to the housing of the drug delivery device 20. In a further example, a battery module including one or more batteries and optionally a battery mounting structure is integrated into the removable cap, and the auxiliary device is electrically connected to the battery module in the removable cap. In this manner, the auxiliary device has a connection to an external battery module. The modular aspect of the auxiliary device described herein has the advantage of combining different modules for different needs, which allows for easy adaptation and modification of the device. Furthermore, any existing drug delivery device can be easily upgraded with smart device functions without changing the underlying drug delivery device. More functionality and safety can be added to existing devices without modifying the existing device. The modular structure also allows the auxiliary device to be reused in whole or in part. By having activation triggered by a removable cap, removal battery life and battery size can be optimized, which reduces the material cost of the device and allows for a more compact design of the auxiliary device.

[0063] In a further example not shown in the figures, the insulating strip is configured to be repositioned between the switch 16 and the activation clip 12 when the removable cap 21 is replaced onto the drug delivery member after the removable cap 21 has been pulled away and the communication module has been activated by contact between the switch 16 and the activation clip 12, such that the power supply is again interrupted. In this way, the activation mechanism is reusable, which may be an advantage for multi-dose or reusable devices.

[0064] While various aspects and embodiments have been disclosed herein, other aspects and embodiments will become apparent to those skilled in the art. All embodiments within and between different aspects of the devices and methods can be combined unless the context clearly dictates otherwise. The various aspects and embodiments disclosed herein are for illustrative purposes and are not intended to be limiting, with the true scope being indicated by the claims. [Explanation of symbols]

[0065] 1. Auxiliary Devices 11. Housing 12 Activation Clips 121 First Part 122 Second Part 13 Communication Module 14a, 14b battery 141a, 141b Battery mounting structure 15 Battery Module 151 Circuit Board 16 Switch 20 Drug Delivery Devices 21 Removable Cap 22 Housing 111 adhesive pad 113A, 113B Insulation Strips 1131 First Part 1132 Second Part M1 First Move M2 Second Move S1 First state S2 Second state

Claims

1. An auxiliary device (1) attached to a removable cap (21) of a medication delivery device (20), said auxiliary device (1) comprising a housing (11) attachable to said removable cap (21); The housing includes: a battery module (15), an activation clip (12) connected to said battery module (15), said activation clip (12) comprising a first part (121) operatively connected to said battery module (15) and a second part (122) extending longitudinally from said first part (121) and providing support for insulating strips (113A, 113B) of said auxiliary device (1); a switch (16) having a first surface and a second surface, the first surface being connected to the battery module (15) and the second surface being connectable to the second part (122) of the activation clip (12) to create a contact area when connected, the switch (16) being longitudinally spaced apart from the first part (121) of the activation clip (12); a communication module (13) connectable to or included as part of the battery module (15) and configured to transmit data to an external device, the data including information directly related to the status of the switch; configured to accommodate the insulating strip (113A, 113B) has a first portion (1131) and a second portion (1132), the first portion (1131) having a predetermined area greater than a contact area between the switch (16) and the second portion (122) of the activation clip (12), and the second portion (1132) is attachable to a housing (22) of the medication delivery device (20) extending along a longitudinal axis between a proximal end and a distal end; The auxiliary device (1) is initially in a first state (S1), in which the first portion (1131) of the insulating strip (113A, 113B) is slidably disposed between the switch (16) and the second portion (122) of the activation clip (12), preventing the communication module (13) from receiving power from the battery module (15), and the removable cap (21) is attached to the housing (20) of the medication delivery device (20). (22) toward the proximal end, removal of the removable cap (21) changes the auxiliary device (1) to a second state (S2), in which the first portion (1131) of the insulating strip (113A, 113B) is removed from the contact area between the switch (16) and the second portion (122) of the activation clip (12), after which the battery module (15) provides power to the communication module (13).

2. The auxiliary device (1) of claim 1, wherein the insulating strip (113A) is flexible or can conform to the shape of the outer and / or inner surface of the drug delivery device (20), or the insulating strip (113A) includes a shape that matches the outer and / or inner surface of the drug delivery device (20).

3. An auxiliary device (1) as described in claim 1 or 2, wherein the insulating strip (113A) extends along the longitudinal axis, the first portion (1131) is arranged within the housing (11) of the auxiliary device (1), and the second portion (1132) extends toward the distal end of the housing (11) of the auxiliary device.

4. The auxiliary device (1) of claim 3, wherein the cap (21) is configured to be removed relative to the housing (22) of the medication delivery device by linear movement of the removable cap (21) toward the proximal end relative to the housing of the medication delivery device.

5. The auxiliary device (1) of claim 1, wherein the insulating strip (113B) extends circumferentially around the housing (22) of the drug delivery device (20), the first portion (1131) is disposed within the housing (11) of the auxiliary device (1), and the second portion extends circumferentially from the housing (11) of the auxiliary device (1).

6. 6. The auxiliary device (1) of claim 5, wherein the cap (21) is configured to be removed relative to the housing (22) of the drug delivery device by an initial rotational movement and then a linear movement relative to the housing of the drug delivery device, or vice versa, or by a spiral or linear movement of the removable cap towards the proximal end.

7. 3. The auxiliary device (1) of claim 1 or 2, wherein the auxiliary device (1) further comprises an adhesive pad (111), the adhesive pad (111) configured to securely attach and hold the auxiliary device (1) to the removable cap (21).

8. The auxiliary device (1) of claim 1 or 2, wherein the battery module (15) or the communication module (13) includes one or more sensors configured to detect the movement or status of at least one of the components of the medication delivery device (20).

9. The auxiliary device (1) according to claim 1 or 2, further comprising a sensor module connectable to any other module, the sensor module comprising one or more sensors configured to detect the movement or status of at least one of the components of the medication delivery device (20).

10. 3. An auxiliary device (1) according to claim 1 or 2, wherein any of the modules is removable from the housing and reusable.

11. 3. The auxiliary device (1) according to claim 1 or 2, wherein the battery module or the communication module includes a recorder configured to acquire and store data information about the medication delivery device.

12. 12. The auxiliary device (1) according to claim 11, wherein data transmission by the communication module starts when the recorder receives power from the battery module.

13. The auxiliary device (1) of claim 1 or 2, further comprising a logging module, which is connectable to or included as part of any other module, and which is configured to start tracking the movement of the medication delivery device when the removable cap is removed.

14. 3. The auxiliary device (1) of claim 1 or 2, further comprising a memory module, the memory module being connectable to or included as part of any other module, the memory module being configured to store the data, and the communication module being configured to wirelessly transmit the data to the external device.

15. A drug delivery device (20) comprising a housing (22), a drug container positioned within the housing, a dose delivery outlet accessible through a terminal end of the housing, a removable cap (21) attached to the housing such that the dose delivery outlet is prevented from becoming accessible unless the removable cap is completely removed from the drug delivery device, and an auxiliary device (1) as described in claim 1 or 2.

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