Spacer for add-on device

Abstract

The present disclosure relates to an add-on device (30) of an injection device (1) and a spacer (80) for such an add-on device (30) wherein the spacer (80) is detachably secured to the add-on device (30) wherein the add-on device (30) comprises a device body (60) and a movable portion (70) movable relative to the device body (60) in a first direction (2, 3), the spacer (80) comprising:-a spacer body (81), the spacer body (81) comprises an engagement portion (83) detachably secured to one of the device body (60) and the movable portion (70),-wherein the spacer body (81) is operable to prevent movement of the movable portion (70) relative to the device body (60) with respect to the first direction (2, 3) when secured to the device body (60) or the movable portion (70).

Description

Technical Field

[0001] The present disclosure relates to an attachment for an injection device. In another aspect, the present disclosure relates to a spacer that is removably fastened to the attachment. In a further aspect, the present disclosure relates to an injection device that can be equipped with an attachment and can be equipped with a spacer for such an attachment. Furthermore, the present disclosure relates to a method of attaching an attachment to an injection device. Background Art

[0002] Drug delivery devices for setting and dispensing single or multiple doses of liquid medicaments are well known in the art per se. Typically, such devices have substantially similar uses to ordinary syringes.

[0003] Drug delivery devices such as pen-type injectors must meet many user-specific requirements. For example, in the case of patients suffering from chronic diseases such as diabetes, the patient may be physically weak and may also be visually impaired. Therefore, suitable drug delivery devices specifically intended for home medication need to be robust and should be easy to use. In addition, the manipulation and general handling of the device and its components should be clear and easy to understand. Such injection devices should provide for the setting and subsequent distribution of doses of equal or variable sizes. In addition, the dose setting and dose distribution procedures must be easy to operate and must be clear and unambiguous.

[0004] Patients with certain diseases may require a certain amount of medication to be injected via a pen-type syringe.

[0005] Some drug delivery devices or injection devices are capable of selecting variable-sized doses of medication and injecting a previously set dose. Other injection devices provide fixed dose setting and dispensing. In this case, the amount of medication that should be injected according to a given prescription schedule is always the same and does not change over time or cannot be changed.

[0006] Some injection devices are implemented as reusable injection devices, allowing users to replace medication containers (such as cartridges). Other injection devices are implemented as disposable injection devices. For disposable injection devices, it is intended that the entire injection device be discarded when the contents (i.e., medication) have been used up.

[0007] In order to control and monitor the administration of medicaments by users or patients themselves, it is desirable to provide automatic detection and recording of repeated and regular use of drug delivery devices. A fairly automated recording of doses injected by a user has significant advantages over manual dose recording in terms of safety and convenience.

[0008] There are many attachments configured for use with injection devices that provide electronic detection and monitoring of repeat dose injection procedures.

[0009] Typically, such an attachment or auxiliary device may be detachably connected to the injection device. The attachment typically includes a sensor, a detector or a detector arrangement that is operable to detect the date and / or time when a user sets or injects a dose of medicament. Some attachments also provide a quantitative measurement of the dose size currently set or dispensed. Some attachments are intended to be used with a range of injection devices. This may be particularly useful for disposable injection devices that are intended to be discarded after use or after the medicament therein has run out.

[0010] Removing and reattaching the attachment to the injection device may require some training and should not result in accidental operation of the attachment.

[0011] Some attachments include a device body configured to be removably fastened to a dose dial, which may be provided at the proximal end of an elongated injection device, such as a pen-type injection device. Here, the device body of the attachment should be securely attached to the dose dial, such as frictionally engaging with the dose dial. The attachment may further include a movable portion, such as forming or constituting an auxiliary trigger. The movable portion may be operably engaged with a trigger of the injection device when moved relative to the device body in a first direction.

[0012] In this case, for some attachments comprising a device body and a movable part, it may be necessary or intended that the movable part cannot move relative to the device body when the attachment is not attached to the injection device. Moreover, during installation or reattachment of the attachment to, for example, a dose dial of the injection device, the movable part should not move or be depressed relative to the device body. For some attachments, it may be necessary to perform a reset operation of the attachment after attaching or reattaching the attachment to another injection device.

[0013] Some users may have difficulty complying with these restrictions, for example when attempting to attach an additional device to an injection device. During assembly of the additional device to the injection device, the user may inadvertently move the movable portion relative to the device body, thereby causing or initiating a recording action or some other function of the additional device.

[0014] It would therefore be desirable to enhance and improve the usability of such attachments, particularly during detachment of the attachment from an injection device and reattachment to another injection device.

[0015] Therefore, the object is to simplify the use, in particular to simplify the removal and the attachment of the attachment to the injection device.A further object is to increase the user acceptance of such an attachment and to improve the intuitive handling of such a device. Summary of the invention

[0016] In one aspect, a spacer is provided, which is removably fastened to an attachment of an injection device. The attachment comprises a device body and a movable portion. The movable portion is movable relative to the device body in a first direction. The spacer comprises a spacer body. The spacer body comprises an engagement portion, which is removably fastened to one of the device body and the movable portion. The spacer body is operable to block or prevent movement of the movable portion relative to the device body about the first direction when the spacer body is fastened to the device body or the movable portion.

[0017] In this case, when the spacer is appropriately attached or fastened to the attachment, the spacer is used to inhibit or prevent movement of the movable part relative to the device body in the first direction. In this way, the spacer can be effectively used to prevent the attachment from being accidentally operated or activated, for example, during assembly of the attachment to the injection device. In this case, the spacer includes or constitutes a stop, such as a mechanical stop, which is operable to block movement of the movable part relative to the device body.

[0018] The spacer may be attached to the attachment device before the attachment device is removed from the injection device and / or attached to the injection device. When the attachment device is removed from the injection device, the spacer may remain fastened to at least one of the device body and the movable part, thereby preventing relative movement of the device body and the movable part about a first direction. During or during assembly of the attachment device to the same or another injection device, the spacer effectively prevents relative movement of the movable part relative to the device body at least about a first direction (which may be a longitudinal direction).

[0019] In this way, the process of (re)assembling the additional device to the injection device, such as the process of attaching the device body to, for example, a dose dial of the injection device, can be simplified. Here, the user can also apply a mounting force to the movable part, which force does not cause a relative movement between the movable part and the device body. Instead, due to the spacer (e.g. effectively located between the movable part and the device body), a corresponding mounting force (e.g. applied by the user not only to the device body but also to the movable part) can be transmitted from the movable part to the device body via the spacer. In fact, by the spacer, relative movement of the movable part and the device body about the first direction can be effectively prevented. Accidental activation or operation of the additional device during mounting or fastening of the additional device to the injection device can be effectively prevented.

[0020] After the attachment has been properly attached to the injection device, the spacer may be detached from the attachment, thereby enabling the intended movement of the movable portion relative to the device body in the first direction.

[0021] By means of the spacer, accidental operation or actuation of the attachment can be effectively prevented. In this case, it may become unnecessary to perform a reset operation on the attachment after the attachment is attached to another injection device. In this way, the overall handling of the attachment can be simplified and user satisfaction can be improved. According to another example, the engaging portion of the spacer includes a snap or a clamp that at least partially surrounds the side wall of the movable portion or at least partially surrounds the side wall of the device body.

[0022] In some examples, the device body has an elongated and / or tubular shape. Here, the longitudinal axis can extend in a first direction. Accordingly, the movable portion can be moved relative to the device body in a longitudinal direction, in particular for causing a dose injection procedure when the additional device is correctly attached or fastened to the injection device. In other examples, the engaging portion includes a clamp, or the snap-fit ​​of the engaging portion forms or constitutes a fastening clamp. In this way, the engaging portion is used to provide a forced engagement or a form-fit engagement between the spacer body and at least one of the side walls of the movable portion and the side walls of the device body.

[0023] In some examples, the snap or clamp of the engaging portion is configured to enter or at least partially fill the longitudinal gap, so that the gap has a gap size along the first direction. Here, the longitudinal width or thickness of the engaging portion can correspond to the longitudinal gap size to fill or occupy the corresponding gap. The engaging portion and therefore the spacer body, when arranged in the gap between the device body and the movable part, acts as a blocking element or stop element, which effectively prevents the movable part from moving in the longitudinal direction relative to the device body, otherwise the movement will cause the gap to decrease in size with respect to the longitudinal direction.

[0024] In another example, it is conceivable that the engaging portion frictionally engages and / or forcibly engages with a side wall of one of the movable portion and the device body, and wherein the engaging portion is configured to abut an end surface of the other of the movable portion and the device body, wherein the end surface faces a first direction.

[0025] In this manner, when the engaging portion is fixed to the side wall of one of the device body and the movable portion with respect to the first direction, the spacer can provide the same blocking effect when attached or fastened to one of the movable portion and the device body.

[0026] In some examples, the spacer or the catch or clamp of the spacer body is configured to at least partially surround the side wall of the movable portion. In some examples, the spacer or the catch or clamp of the spacer body is configured to at least partially surround the side wall of the device body. In other examples, the spacer or the catch or clamp of the spacer body is configured to at least partially surround both the side wall of the device body and the side wall of the spacer body.

[0027] In some examples, the extent of the catch or retainer of the spacer or spacer body along the first direction can be greater than the gap size along the first direction. In this way, the catch or retainer of the spacer or spacer body can engage with both at least a portion of the side wall of the device body and at least a portion of the side wall of the movable portion simultaneously. This configuration is particularly useful when the lateral or radial extent of the side wall of the movable portion is substantially the same as the lateral or radial extent of the side wall of the spacer body.

[0028] According to another example, the engaging portion of the spacer body includes an insertion opening that receives at least one of the movable portion and the device body. The size of the insertion opening of the engaging portion can be set to receive the side wall of the movable portion or the side wall of the device body. Both the side wall of the movable portion and the side wall of the device body can have a substantially tubular shape. The insertion opening of the engaging portion can include a circumferential width or size about the circumference of the side wall of the device body or the side wall of the movable portion, and the circumferential width or size is at least slightly smaller than the diameter of the side wall of the corresponding device body or the movable portion. In this way, a forced engagement of the engaging portion with at least one of the movable portion and the device body can be provided.

[0029] In some examples, the insertion opening is provided by a snap or a clamp. The size and configuration of the snap or the clamp of the engagement portion can be configured to surround at least a portion of the circumference of the side wall of the device body or the movable part. Typically, the configuration and size of the snap or the clamp are configured to surround a portion of the side wall of the movable part or the device body, which is greater than or at least equal to half of the circumference of the corresponding side wall. In this way, a forced fit between at least one of the side walls of the snap or the clamp and the movable part or the device body can be provided. This snap or the clamp connection provides installation or fastening of the tubular shape of the spacer in the radial direction about the side wall of the movable part or the device body and releases the installation or disassembly.

[0030] According to another example, the engagement portion includes a first arm portion and a second arm portion. The first arm portion and the second arm portion may extend radially opposite to each other to define a receiving portion, the size of which is configured to receive a side wall of the movable portion or a side wall of the device body. The first arm portion and the second arm portion may have a symmetrical shape. Their size and configuration may be configured to surround a portion of the outer circumference of the side wall of at least one of the movable portion and the device body.

[0031] The first arm portion may include a free end that faces the free end of the second arm portion. The first arm portion and the second arm portion may be connected to each other at ends opposite to their free ends. The first arm portion and the second arm portion may be formed integrally with the joining portion. In this case, an end section of the first arm portion that faces away from the free end of the first arm portion and an end section of the second arm portion that faces away from the free end of the second arm portion may be formed integrally or may be combined.

[0032] In another example, the spacer has a planar shape. The spacer may have a disc-like shape. The first arm portion and the second arm portion may extend in a common plane. In this way, the spacer may be designed in a rather compact and space-saving manner. Due to its shape, the manner in which the spacer and / or its engaging portion may be attached to the movable portion or the device body is quite clear and intuitive.

[0033] According to another example, the insertion opening of the engagement portion is formed between the free end section of the first arm portion and the free end section of the second arm portion. The circumferential distance between the free end section of the first arm portion and the free end section of the second arm portion is typically less than or smaller than half of the circumference of the side wall of the movable portion or the device body to which the spacer is configured to be fastened.

[0034] The free end segments of the first arm portion and the free end segments of the second arm portion may face each other. They may define an insertion opening and thus define a circumferential width of the insertion opening. In some examples, the free end segments of the first arm portion and the second arm portion may engage with corresponding portions of a side wall of at least one of the device body and the movable portion. By applying a radially inwardly directed pressure to the side wall of one of the device body or the movable portion, the free end segments may perform an evasive movement, thereby increasing the distance between the free end segments so that the side wall of one of the device body or the movable portion may snap into the receiving portion of the engaging portion.

[0035] In some examples, free end sections of the first arm portion and the second arm portion can protrude inwardly and therefore toward each other so as to engage with a recess of a complementary shape provided in a corresponding side wall of the device body or the movable portion. In this way, a forced fit can be provided between the arm portion of the engagement portion and a recessed structure on the outer side of the side wall of at least one of the movable portion and the device body. In this way, the engagement portion and therefore the entire spacer can be fixed to the side wall of one of the device body and the movable portion with respect to a first direction. When at least a portion of the spacer or the spacer body extends radially outward from the engagement portion, the radially outward extending portion can be in abutment with the other of the device body and the movable portion to prevent longitudinal movement.

[0036] According to another example, the first arm portion and the second arm portion have an arc shape. The inner edge or inner side wall of the first arm portion faces the inner edge or inner side wall of the second arm portion. The first arm portion and the second arm portion can form or constitute a semicircular receiving portion to surround or clasp at least a portion of the side wall of the movable portion or the device body.

[0037] The shape and / or contour of the inner edge or inner side wall of the arm portion can correspond to the outer contour or profile of the side wall of the device body or the movable part. In this way, a fairly firm and stable fixation can be provided between the engaging portion and the movable part or the device body.

[0038] According to another example, at least one of the first arm portion and the second arm portion and thus at least a part of the joint portion is elastically deformable to increase the distance between the first arm portion and the second arm portion. Typically, by elastic deformation, for example in the plane of the planar spacer body, the size of the insertion opening, for example formed between the free end sections of the first arm portion and the second arm portion, can be at least temporarily increased to receive the side wall of the movable part or the side wall of the device body. The elastic deformation of at least one of the first arm portion and the second arm portion can be easily achieved by manufacturing the joint portion and thus the spacer body from an elastically deformable material.

[0039] In some examples, the spacer body or at least its engaging portion is made of an elastically deformable plastic material. The spacer body may include a thermoplastic material. The spacer or the spacer body may include an injection molded plastic material. By implementing the spacer or the spacer body as a plastic part, such as an injection molded plastic part, the spacer can be produced at low or medium cost.

[0040] According to another example, the spacer body has a planar shape and / or a disc-like shape. The planar or disc-shaped spacer body is quite simple and intuitive to use. The thickness of the spacer body or the thickness of the engaging portion seen along the surface normal of the planar or disc-shaped spacer body can be suitable for or can conform to the recessed structure of the attached device. In this way, the recessed structure arranged on the outer surface of the side wall of the attached device can be effectively occupied by the spacer body. The size of the recessed structure along the first direction can be matched with the corresponding thickness of the spacer body. In this case, the spacer body, when correctly fastened or attached to the attached device, can occupy the recessed structure at least about the first direction, thereby effectively preventing the movement between the movable part and the device body, which is typically accompanied by a reduction in the size of the recessed structure along the first direction.

[0041] According to another example, the thickness of at least one of the spacer body and the engagement portion is adapted to or conforms to the recessed structure provided on the outer surface of the attachment device. In some examples, the thickness of the buckle may also be adapted to or conform to the recessed structure.

[0042] In some examples, the thickness or extent of the spacer body can be uniform across the plane of the spacer body. In other examples, the thickness of the spacer body can vary across the plane of the spacer body.

[0043] According to another example, the size of the recessed structure of the additional device along the first direction matches the thickness of at least one of the spacer body and the engaging portion of the spacer body. In this way, the spacer body and / or its engaging portion can enter the recessed structure and can effectively occupy at least a circumferential portion of the recessed structure, as seen along the first direction.

[0044] According to another example, when the spacer is properly fastened or attached to the attachment, at least one of the spacer body and the engagement portion at least partially occupies the recessed structure of the attachment, thereby preventing the movable part from moving relative to the device body. In fact, the portion of the spacer body or the engagement portion that enters the recessed structure of the attachment is operable to prevent or block the movement of the movable part relative to the device body along a first direction, which movement will result in a reduction in the size of the recessed structure along the first direction.

[0045] According to another example, the spacer body includes a gripping portion protruding from the engagement portion. Typically, the gripping portion protrudes outward from the engagement portion. In some examples, when the engagement portion includes a receiving portion whose size is set to a portion of the outer circumference of the side wall of the receiving device body or the movable portion, the gripping portion protrudes outward from the receiving portion. In this way, when the engagement portion is attached to, for example, a tubular side wall of the movable portion or the device body, the gripping portion protrudes radially outward. The gripping portion may include a gripping flange. The gripping flange may be positioned radially opposite to the insertion opening of the engagement portion. In another example, the gripping portion may be substantially located in the middle between the first arm portion and the second arm portion. The gripping portion facilitates user manipulation of the spacer. The user can grip the spacer body by and through the gripping portion to fasten the spacer to the attachment and remove the spacer from the attachment.

[0046] The gripping portion may include or constitute a gripping tab that protrudes outward or extends radially outward. Typically, the gripping portion may be gripped by a user's index finger and thumb.

[0047] In another example, the gripping portion includes at least one or more gripping ribs. The gripping ribs may protrude from, for example, the planar gripping portion in a first direction. Typically, the engagement portion and the gripping portion are positioned adjacent to each other in the plane of the spacer body. The gripping portion is typically located in the same plane as the first arm portion and the second arm portion.

[0048] The gripping ribs may protrude from the plane of the planar spacer body. The gripping ribs may extend parallel to each other. In some examples, the gripping ribs extend in a tangential or circumferential direction about the circular or semicircular shape of the receiving portion formed by the snap or clamp of the engagement portion. In this way, the friction fit between the user's fingers and the gripping portion of the spacer may be enhanced.

[0049] According to another example, the spacer comprises a through recess extending through the spacer body. The through recess may be located in the engagement portion or in the gripping portion. The through recess may be used as a fastening structure, for example, for a rope or a belt. In this way, the spacer may be connected to the rope or the belt when not fastened to the attachment device. The rope or the belt may be fastened to other locations of the attachment device or the injection device, for example to a pocket clip of the injection device. When not in use, the spacer may remain loosely fixed to the attachment device or the injection device even if it is not fastened to the body or the movable part.

[0050] In another example, the spacer body includes a proximal side and a distal side. The distal side is configured to abut the proximal side of the device body. The proximal side is configured to abut the distal side of the movable portion. The proximal side and the distal side of the spacer body are opposite sides of the spacer body. They can face opposite directions. The proximal side and the distal side can both have a plane or a disc-like shape. The respective faces extend parallel to each other, and the spacer can have a substantially constant thickness as seen along the first direction.

[0051] The proximal side of the device body of the additional device and the distal side of the movable part can define a recessed structure on the outer side of the additional device. When correctly assembled to the additional device, the corresponding recessed structure between the distal side of the movable part and the proximal side of the device body can be at least partially or even completely occupied by the spacer body, thereby inhibiting the reduction of the size of the recessed structure if the user attempts to move the movable part in the first direction relative to the device body.

[0052] Here, when the movable part is slidably supported relative to the device body, it is sufficient that only the circumferential portion of the recessed structure between the movable part and the device body is occupied by the corresponding portion of the spacer. As long as the spacer is fastened to at least one of the movable part and the device body, the movement of the movable part relative to the device body in the first direction is effectively blocked and prevented.

[0053] According to another example, the thickness of the spacer body is less than or equal to the longitudinal distance between the proximal side of the device body and the distal side of the movable part. In the case of a spacer body having a uniform thickness, a fairly uniform abutment can be provided between the spacer body, the distal side of the movable part and the proximal side of the device body. In this way, a fairly stable and strong abutment can be provided between the oppositely directed faces of the device body and the movable part, and thus the movement-blocking function of the spacer is provided when the spacer is appropriately attached to one of the device body and the movable part.

[0054] In another aspect, the present disclosure also relates to an attachment for detachably connecting to an injection device. The attachment comprises a device body and a movable portion. The movable portion is movable relative to the device body at least in a first direction. The attachment further comprises a spacer as described above. The spacer is detachably fastened to one of the device body and the movable portion. The spacer is configured to prevent movement of the movable portion relative to the device body at least about the first direction.

[0055] Since the additional device is equipped with the spacer as described above, all the features, effects and benefits described above in conjunction with the spacer are also applicable to the additional device; and vice versa.

[0056] In some examples, when the attachment is properly attached to the injection device, the movable portion may be moved relative to the device body in a first direction to cause a dose injection procedure. In this case, the movable portion may serve as an auxiliary trigger that may be operably engaged with a trigger of the injection device when the attachment is attached to the injection device.

[0057] The movable part may be configured to be detachably connected to a dose dial of the injection device. The movable part and the device body may be rotatable relative to each other, for example in a second direction. The spacer may be configured to specifically prevent movement in the first direction while allowing and / or supporting movement in the second direction, which movement may be a rotation about the longitudinal axis as the axis of rotation.

[0058] Typically, the first direction extends parallel to a cylindrical or longitudinal tubular axis of the device body or movable part, for example, with respect to the tubular shape of the device body or movable part. The second direction may extend in a circumferential direction with respect to the tubular shape of the device body or movable part. The movable part may slide longitudinally relative to the device body in the first direction. The movable part may rotate relative to the device body in the second direction, with the longitudinal axis of the device body being the rotation axis.

[0059] In this case, the spacer may be specifically intended to prevent longitudinal movement of the movable portion relative to the device body in order to prevent actuation of the attachment which typically accompanies a dispensing operation of the injection device when the attachment is properly attached to the injection device.

[0060] With the spacer fastened to the attachment, the user can even apply pressure or mounting force to the movable part, which is effectively transmitted to the device body via the spacer without substantially moving the movable part relative to the device body at least about the first direction (i.e. the longitudinal direction). In this way, the spacer facilitates and simplifies the mounting of the attachment to the injection device.

[0061] In another example, the device body of the attachment device comprises a receiving portion configured to receive a dose dial of an injection device. Typically, the receiving portion is configured to frictionally engage with the dose dial of the injection device. The dose dial of the injection device may have a substantially tubular or sleeve-like shape. The receiving portion of the device body may comprise one or several resilient fastening ribs to provide a non-slip frictional engagement between the interior of the receiving portion and the exterior of the dose dial of the injection device.

[0062] In a further example, the outer portion of the dose dial and / or the inner portion of the receiving portion may comprise one or several radial recesses or protrusions to provide a non-slip form fit or positive fit between the dose dial and the receiving portion of the device body.

[0063] The movable part may protrude from the device body proximally and therefore in a proximal longitudinal direction. The movable part may include a button that can be pressed by, for example, a thumb of a user. The movable part may include a rod that extends longitudinally into and / or through a receiving portion of the device body to mechanically engage with a trigger of the injection device when the additional device is correctly attached to the injection device. Since the movable part is movable relative to the device body at least in the longitudinal direction, the movable part may be operable to introduce a distally directed actuation force onto the trigger of the injection device when the device body is fastened to the dose dial. In this way, the movable part may act as an auxiliary trigger.

[0064] According to another example, the movable part may be operably engaged with a trigger of an injection device. The trigger of the injection device may be depressed or moved relative to the dose dial about a first direction. When the additional device is attached to the injection device, the trigger may be depressed or moved relative to the dose dial about the first direction by moving the movable part relative to the device body in the first direction. Since the device body is fixed to the dose dial, movement of the movable part relative to the device body in the first direction serves to cause a corresponding movement of the trigger relative to the dose dial.

[0065] In this case, the general operability of the injection device (i.e. for example rotating the dose dial and depressing the trigger to set and / or inject a dose of medication) can be maintained even when the additional device is attached to the dose dial and / or trigger of the injection device, thereby fully covering the dose dial and the trigger.

[0066] According to another example, the additional device includes an electronic module. The electronic module is arranged in the device body or in the movable part. The electronic module includes a processor, a memory and a transceiver. The electronic module is operable to detect and / or record injection-related information of the injection device. The electronic module may be further equipped with a detector and / or a sensor to detect the date and / or time when the user operates the injection device. In some examples, the detector or sensor is operable to quantitatively measure the size of the dose actually set or injected.

[0067] In another example, the electronic module includes a transceiver operable to establish a communication link with an external electronic device (such as a smart watch, smart phone or tablet). The electronic module may be further configured or operable to transmit the recorded injection-related data to the external electronic device for further data analysis.

[0068] According to another example, the attachment device includes a recessed structure on the outside of the side wall of the attachment device. The size of the recessed structure along the first direction can match the corresponding thickness of at least one of the snap member, the engaging portion and the spacer body of the spacer. Typically, the recessed structure is arranged between the device body and the movable part. The recessed structure can be a circumferentially extended recessed structure. It can have an annular or elliptical shape and can include, for example, a closed annular geometry between the movable part and the device body.

[0069] In some examples, the recessed structure may include an annular groove, for example, the annular groove is located in one of the sidewall of the device body and the movable part. In some examples, the recessed structure may be arranged as an annular groove defined by an annular surface of the movable part and an annular surface of the device body. In some examples, the recessed structure is defined by an annular surface of the device body facing the proximal side and an annular surface of the movable part facing the distal side along a first direction. Here, the corresponding faces of the movable part and the device body may include or may constitute an abutment surface for engaging or abutting with an engaging portion of a spacer body, a snap or a spacer.

[0070] According to another example, the recessed structure on the outside of the attachment is defined by the proximal side of the device body and the distal side of the movable portion. Typically, the distal side of the movable portion can be offset from the proximal side of the device body toward the proximal direction. In order to operate the attachment, it may be necessary to move the movable portion in the distal direction to reduce the size of the recessed structure along the first direction. When and as long as the recessed structure is occupied by the spacer, this movement is effectively blocked or blocked by the spacer.

[0071] According to another aspect, the present disclosure also relates to an injection device for setting and injecting a dose of a medicament. The injection device includes a housing for accommodating a medicament container. The medicament container, for example, contains a liquid injectable medicament. The injection device further includes a drive mechanism that is operably engaged with the medicament container for dispensing or injecting a dose of the medicament. The injection device further includes a dose dial that can be operated by a user to set a dose and a trigger that can be pressed by a user to inject or dispense a dose.

[0072] The dose dial and the trigger may both belong to the drive mechanism. In some examples, the drive mechanism includes a piston rod operable to apply longitudinally directed pressure on a stopper of the medication container to expel a dose of medication from a distally positioned outlet of the medication container. In some examples, the outlet of the medication container may be easily connected to an injection needle.

[0073] The injection device is further provided with an attachment as described above. The attachment is attachable to at least one of the dose dial and the trigger. Typically, the device body of the attachment is fastenable or attachable to the dose dial, and when the attachment is attached to the injection device, the movable portion of the attachment is operably engaged with the trigger of the injection device.

[0074] In this case, all features and effects as described above in conjunction with the spacer and the additional device also apply to the injection device; and vice versa.

[0075] In another aspect, the present disclosure also relates to a method of attaching and / or securing an additional device to an injection device. Here, the method utilizes a spacer as described above. In a first step, a spacer as described above is attached to the device. With the spacer attached to the additional device, the additional device is then attached or mounted to the injection device. After the additional device is attached or mounted to the injection device, the spacer is removed. The spacer is thus separated from at least one of the device body or the movable part of the device, thereby enabling the movable part to move relative to the device body about a first direction.

[0076] The method is particularly intended to be carried out using a spacer, an attachment and an injection device as described above. In this case, all effects, features and benefits described above in conjunction with the spacer, the attachment and the injection device are equally applicable to the method of attaching or fastening the attachment to the injection device; vice versa.

[0077] Generally, the scope of the present disclosure is defined by the content of the claims. The present disclosure is not limited to specific embodiments or examples, but includes any combination of elements of different embodiments or examples. In this case, the present disclosure covers any combination of claims and any technically feasible combination of features disclosed in combination with different examples or embodiments.

[0078] In this context, the term "distal" or "distal end" refers to the end of the injection device that faces the injection site of a human or animal. The term "proximal" or "proximal end" refers to the opposite end of the injection device that is farthest from the injection site of a human or animal.

[0079] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical preparation comprising one or more active pharmaceutical ingredients or a pharmaceutically acceptable salt or solvate thereof and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used to treat, cure, prevent, or diagnose disease or to otherwise enhance physical or mental health. A drug or medicament may be used for a limited duration, or periodically for a chronic disorder.

[0080] As described below, a drug or medicament may include at least one API or a combination thereof in different types of formulations for treating one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids (such as antisense DNA and RNA), small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also contemplated.

[0081] The drug or medicament can be included in a primary package or "drug container" suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, a syringe, a reservoir or other solid or flexible vessel, which is configured to provide a suitable chamber for storing (for example, short-term or long-term storage) one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (for example, 1 day to at least 30 days). In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. It can be stored at room temperature (for example, about 20 ° C) or refrigerated temperature (for example, about -4 ° C to about 4 ° C). In some cases, the drug container can be or can include a dual-chamber cartridge, which is configured to store two or more components (for example, API and diluent, or two different drugs) of the pharmaceutical preparation to be applied separately, and one is stored in each chamber. In such a case, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components before and / or during distribution to the human body or animal body. For example, the two chambers may be configured so that they are in fluid communication with each other (e.g., via a conduit between the two chambers) and allow the user to mix the two components if desired prior to dispensing. Alternatively or additionally, the two chambers may be configured to allow mixing when dispensing the components into a human or animal body.

[0082] The drugs or medicaments contained in the drug delivery devices as described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Further examples of disorders are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, tumors, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are examples as described in the following manuals: such as Rote Liste 2014 (for example, but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index, 15th edition.

[0083] Examples of APIs for treating and / or preventing type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixtures thereof. As used herein, the terms "analogs" and "derivatives" refer to polypeptides having a molecular structure that can be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deleting and / or exchanging at least one amino acid residue present in a naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residues can be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Alternatively, one or more amino acids present in the naturally occurring peptide may have been deleted and / or replaced by other amino acids (including non-encodable amino acids), or amino acids (including non-encodable amino acids) have been added to the naturally occurring peptide.

[0084] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and in which the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0085] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (degludec insulin, ); B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0086] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are e.g. lixisenatide Exendin-4 A 39-amino acid peptide produced by the salivary glands of the Gila monster), liraglutide Semaglutide, tasmoglutide, albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924 , NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA- 3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Telportide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0087] Examples of oligonucleotides are, for example: Mipomersen sodium Cholesterol reducing antisense therapeutics for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrome. Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0088] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory activity peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, tocopherol), growth hormone (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin.

[0089] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of a polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 A sodium hyaluronate.

[0090] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen binding portion thereof. Examples of antigen binding portions of immunoglobulin molecules include F (ab) and F (ab') 2 fragments, which retain the ability to bind antigens. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized antibody or a humanized antibody, a fully human antibody, a non-human (e.g., mouse) antibody or a single-chain antibody. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the ability of the antibody to bind to Fc receptors is reduced or there is no such ability. For example, the antibody can be an isotype or subtype, an antibody fragment or a mutant, which does not support binding to Fc receptors, for example, its Fc receptor binding region has been mutated or deleted. The term "antibody" also includes antigen binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with cross-binding region orientation (CODV).

[0091] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule, which does not include a full-length antibody polypeptide, but still includes at least a portion of a full-length antibody polypeptide that can bind to an antigen. Antibody fragments may include cleavage portions of full-length antibody polypeptides, but the term is not limited to such cleavage fragments. Antibody fragments that can be used in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies)), monovalent or multivalent antibody fragments (such as bivalent antibodies, trivalent antibodies, tetravalent antibodies and multivalent antibodies), mini antibodies, chelated recombinant antibodies, triabodies or biabodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and antibodies containing VHH. Other examples of antigen-binding antibody fragments are known in the art.

[0092] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequences to allow antigen binding. Although the framework region itself is typically not directly involved in antigen binding as known in the art, certain residues within the framework region of certain antibodies may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0093] Examples of antibodies are anti-PCSK-9 mAb (eg, alirocumab), anti-IL-6 mAb (eg, salilumab), and anti-IL-4 mAb (eg, dupilumab).

[0094] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0095] Those skilled in the art will appreciate that modifications (additions and / or removals) may be made to the various components, formulations, apparatuses, methods, systems and embodiments of the API described herein without departing from the overall scope and spirit of the invention, and that the invention encompasses such modifications and any and all equivalents thereof.

[0096] 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), needle-based injection systems can be broadly divided into multi-dose container systems and single-dose (partially or completely emptied) container systems. The container may be a replaceable container or an integral non-replaceable container.

[0097] As further described in ISO 11608-1:2014(E), a multiple-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container contains multiple doses, the sizes of which may be fixed or variable (pre-set by the user). Another multiple-dose container system may involve a needle-based injection device with an integral non-replaceable container. In such a system, each container contains multiple doses, the sizes of which may be fixed or variable (pre-set by the user).

[0098] As further described in ISO 11608-1:2014 (E), a single dose container system can relate to an injection device based on a needle with a replaceable container. In an example of such a system, each container holds a single dose, wherein the entire deliverable volume is discharged (completely emptied). In another example, each container holds a single dose, wherein a portion of the deliverable volume is discharged (partially emptied). Also as described in ISO 11608-1:2014 (E), a single dose container system can relate to an injection device based on a needle with an integral non-replaceable container. In an example of such a system, each container holds a single dose, wherein the entire deliverable volume is discharged (completely emptied). In another example, each container holds a single dose, wherein a portion of the deliverable volume is discharged (partially emptied). BRIEF DESCRIPTION OF THE DRAWINGS

[0099] In the following, several examples of data recording devices for monitoring the use of injection devices and corresponding injection devices will be described in more detail with reference to the accompanying drawings, in which:

[0100] Figure 1 An example of an injection device is schematically shown,

[0101] Figure 2 schematically illustrates an additional device for attachment to the proximal end of an injection device,

[0102] Figure 3 Schematically illustrates a cross section of an assembly of an injection device and an additional device, wherein the movable part is in an initial configuration,

[0103] Figure 4 Shows Figure 3An assembly in which the movable portion is depressed,

[0104] Figure 5 An additional device equipped with a spacer is shown,

[0105] Figure 6 schematically illustrates a spacer for removably fastening to an additional device,

[0106] Figure 7 Another example of an attachment device is shown in an initial configuration,

[0107] Figure 8 Shows Figure 7 An example in which the movable portion is depressed,

[0108] Fig. 9 Shown attached to Figure 7 Examples of additional devices for spacers,

[0109] Fig.10 Another example of a spacer is shown,

[0110] Fig.11 Another example of a spacer attached to an additional device is shown,

[0111] Fig.12 A flow chart showing a method of fastening an attachment to an injection device,

[0112] Fig.13 The schematic diagram shows a typical usage scenario of the injection device.

[0113] Fig.14 A block diagram showing an example of an additional device,

[0114] Fig.15 A schematic diagram showing an additional device mounted on an injection device before reaching the final assembled configuration,

[0115] Fig.16 Shows Fig.15 an assembly of said device wherein the attachment is in its final assembled configuration, and

[0116] Fig.17 Shows the removal of the spacer according to Fig.16 components. DETAILED DESCRIPTION

[0117] Figure 1An example of a drug delivery device 1 is shown, which is implemented as a handheld injection device. The injection device 1 may include or may be implemented as a pen-type injector. It may be implemented as a disposable injection device or a reusable injection device. In some examples, the injection device 1 is implemented as an autoinjector. The injection device 1 has an elongated shape. It may extend along a longitudinal direction. Towards the longitudinal distal direction 2, the drug delivery device 1 comprises a dispensing end for dispensing or injecting a medicament 24. Towards the proximal direction 3, the injection device 1 comprises at least one of a dose member 8 and a trigger 9, by which doses of equal size or individual or different sizes can be set and dispensed, respectively.

[0118] The injection device 1 comprises a housing 10. The housing 10 may comprise a plurality of housing components, such as a body 6 and a cartridge holder 7. The body 6 may be sized and configured to accommodate a drive mechanism 20. The cartridge holder 7 may be sized and configured to accommodate a medicament container 21, which may be implemented, for example, as a cartridge containing a liquid medicament 24. The medicament container 21 comprises a tubular barrel 22, which is sealed towards the distal end by a seal 23. The seal 23 may comprise a pierceable septum fixed to an outlet 25 of the medicament container 21. The interior of the barrel 22 is sealed towards the proximal end by a piston 18 or a stopper, which is slidably disposed within the barrel 22.

[0119] By advancing the piston 18 toward the distal direction 2, a dose of medicament 24 can be discharged from the medicament container 21. In use, the medicament container 21 is arranged inside the cartridge holder 7. The drive mechanism 20 of the injection device 1 includes a piston rod 19, which can be displaced in the distal direction 2 to advance the piston 18 toward the outlet 25 of the medicament container 21. The details of the drive mechanism are not further shown and described here. In some examples, the drive mechanism 20 can be implemented as a full mechanical drive mechanism, wherein the user must provide the piston rod 19 and therefore the piston 18 All the required dispensing forces are moved in the distal direction 2. For other examples, the drive mechanism includes a mechanical energy storage, which is configured to provide at least a portion of the dispensing force. Examples of drive mechanisms can be found in, for example, WO 2004 / 078241A1, WO 2014 / 033197 A1 or WO2014 / 033195 A1, and the entire contents of these documents are incorporated herein by reference.

[0120] In some examples, such as in Fig.13As described or shown in , the injection device 1 and thus the drive mechanism 20 may include a dial extension 27 that projects and moves in the proximal direction 3 from the proximal end of the body 6 when or during setting a dose, and returns to its initial distal position during a dose injection procedure. To this end, the user may use the thumb 114 of his hand 110 to exert distally directed pressure on the trigger 9, thereby pushing the dial extension 27 in the distal direction 2 during the dose injection procedure. During the injection procedure, the injection device 1 may be firmly held by the fingers 116, 117 and / or the palm of the hand 110.

[0121] In order to set or dial a dose, the user may, for example, twist or rotate the dose dial 8 in a dose incrementing direction 4, thus in a clockwise direction when viewed from the proximal end. In order to correct a previously set dose, the user may also rotate the dose dial 8 in an opposite dose decrementing direction 5. The size of the dose is typically displayed in a window 26 provided in or on the body 6 of the injection device 1. Before a dose of medicament 24 is injected, the distal end of the cartridge holder 7 must be connected to the needle assembly 12. To this end, the distal end of the cartridge holder 7 comprises a connector 11, for example in the form of a threaded interface, to engage with a complementary shaped threaded mating interface of the needle assembly 12.

[0122] The needle assembly 12 can be detachably or releasably fixed to the cartridge holder 7. It includes a double-pointed injection needle 13. The proximal end of the injection needle (not shown) is configured to enter the through opening at the distal end face of the connector 11 or the cartridge holder 7 so as to pierce or penetrate the seal 23 of the medicament container 21. The distal end of the injection needle 13 is usually covered by a detachable inner needle cap 14. The entire needle assembly 12 can be covered by a detachable outer needle cap 15.

[0123] The cartridge holder 7 and thus a part of the housing 10 will be received in a protective cap 16 which can be detachably connected to the cartridge holder 7 or the body 6 .

[0124] The additional device 30 used with the injection device 1 is Figures 2 to 12 and Fig.14 . The attachment 30 comprises a device body 60 having a substantially tubular shape. The device body 60 comprises a tubular side wall 61. The device body 60 comprises a receiving portion 63 towards the distal end. The receiving portion 63 is sized to receive a proximal portion of the injection device. In particular, the receiving portion 63 is configured and sized to receive a dose dial 8 as provided at the proximal end of the injection device 1. On the inner surface of the receiving portion 63 and therefore on the inner side of the side wall 61 a plurality of fastening ribs 31 are provided, which are made of, for example, an elastic or elastomeric material. The fastening ribs 31 of the receiving portion 63 may be configured to form a friction fit with the outer surface of the dose dial 8.

[0125] like Figures 3 to 5 As schematically illustrated in , the outer surface of the dose dial 8 and / or the inner surface of the receiving portion 63 may have a slightly conical shape to provide a friction fit and thus a clamping effect between the inner surface of the receiving portion 63 and the outer surface of the dose dial 8. In this way, a press-fit or form-fit configuration of the dose dial 8 and the device body 60 may be provided.

[0126] like Figures 3 to 5 As shown, the final assembly position of the device body 60 with respect to the dose dial 8 is reached when the radially inwardly extending flange portion 62 delimiting the receptacle 63 in the proximal direction 3 engages or abuts the proximal end face 28 of the dose dial 8 of the injection device 1 .

[0127] The attachment 30 comprises a movable portion 70 which is movable about a first direction, and thus about a longitudinal direction relative to the device body 60. The movable portion 70 can also be moved in a second direction relative to the device body 60. The second direction can define a rotational movement of the movable portion 70 relative to the device body 60 with the longitudinal axis of the sleeve-shaped device body 60 as the rotation axis. The movable portion 70 can be slidably displaced relative to the device body 60 about the first direction, as shown by comparing Figure 3 and Figure 4 The movable portion 70 is movable from the initial position along the first direction in the distal direction 2 to the triggered or depressed position. The movable portion 70 is also movable along the longitudinal axis but in the proximal direction 3 from the depressed position back toward the initial position.

[0128] In the final assembly position, when the device body 60 is securely attached to the dose dial 8 , it can be ensured that the movable part 70 , in particular the distal abutment face 74 thereof, is in a well-defined position relative to the trigger 9 of the injection device 1 .

[0129] Typically, the attachment 30 is configured for detachable fastening to the proximal end of the dial extension 27. The device body 60 engages with and covers the dose dial 8. The movable portion 70 is configured to engage with the trigger 9 or dose button. In this case, the movable portion 70 acts as an auxiliary trigger for transmitting a dispensing force, which is applied to the dial extension 27 by, for example, the thumb 114 of the user, and effectively depresses the trigger 9 relative to the dose dial 8. In this case, when the attachment 30 is attached to the dose dial 8 and / or the trigger 9, as described with respect to Fig.13 The typical usage scenarios shown and described are largely unaffected.

[0130] The movable portion 70 of the attachment 30 comprises a proximal portion 73 which protrudes in the proximal direction 3 from the proximal end or proximal face 69 of the device body 60. The movable portion 70 further comprises a rod 71 connecting the proximal portion 73 with a distal portion 72. The distal portion 72 is completely located within the device body 60. The distal portion 72 comprises a distally facing abutment surface 74 which is configured to engage with the proximal face of the trigger 9. Due to the longitudinal sliding displacement of the movable portion 70 relative to the device body 60, the user can exert a dispensing force on the proximal facing end face 76 of the movable portion 70, thereby causing a distally directed movement of the movable portion 70 relative to the device body 60.

[0131] In such Figure 3 In the initial configuration shown, when a distally directed force is applied to the movable part 70, a corresponding distally directed movement of the movable part 70 is caused in the distal direction 2, thereby transmitting the corresponding force action to the trigger 9, through which the dose dispensing or dose injection action of the injection device can be triggered or performed.

[0132] During such a dispensing action, the dose dial 8 may be rotated in the dose decrementing direction 5 for dose decrementing, while the trigger 9 and / or the movable part 70 longitudinally adjacent to the trigger 9 remain in a non-rotated state.

[0133] Due to the frictional engagement between the device body 60 and the dose dial 8, the device body 60 may also perform a corresponding rotation in the dose decrementing direction 5 and may therefore rotate relative to the movable part 70. In this case, during the dose dispensing phase, a rotation of the device body 60 relative to the movable part 70 may occur. This rotation and therefore the degree of rotation may indicate the size of the dose currently being dispensed or injected.

[0134] The additional device 30 may include an electronic module 34, such as Fig.14 The electronic module 34 may be operable to detect movement of the movable part 70 in the first direction 2, 3 and to detect movement of the movable part 70 relative to the device body 60 in the second direction, wherein the second direction is one of the dose increasing direction 4 and the dose decreasing direction 5.

[0135] In some examples, the device body 60 includes a proximal receiving portion 64, which is sized to receive the proximal portion 73 of the movable portion 70. The attachment 30 may further include a return element 65, for example in the form of a return spring, which is operable to push the movable portion 70 relative to the device body 60 into an initial configuration in which the movable portion 70 is in a proximal position. By means of the return element 65, the movable portion 70 can automatically return to the initial configuration.

[0136] In other examples, the attachment 30 may be free of such a return element 65. Here, the return movement of the movable part 70 in the proximal direction 3 towards and into the initial configuration or position may be caused by a return movement of the trigger 9 relative to the dose dial 8. The injection device 1 and therefore the trigger 9 may be depressed in the distal direction 2 against the action of the return element, in particular against the action of a return spring or trigger spring (not shown). At the end of the dose injection procedure, when the trigger 9 or the dose button is released, the trigger 9 or the dose button automatically returns to the initial configuration under the action of the return spring, such as, for example Figure 3 or Figure 5 shown.

[0137] In case the attachment 30 is correctly attached to the dose dial 8, a return movement of the trigger 9, e.g. caused by a spring, may cause a corresponding return movement of the movable part in the proximal direction 3, since the distal end face or abutment face 74 of the distal portion 72 of the movable part 70 is in permanent longitudinal abutment or engagement with the trigger 9 when the attachment 30 is correctly attached or assembled to the proximal end of the injection device 1.

[0138] In some examples, a radially inwardly extending protrusion 66 is provided in the region of the proximal receiving portion 64. The protrusion 66 may provide a proximally facing abutment surface 67 operable to engage or abut with a complementary shaped abutment portion or abutment surface 73a of the proximal portion 73 of the movable portion 70. In this way, distally directed movement of the movable portion 70 relative to the device body 60 may be limited or prevented.

[0139] The protrusion 66 or some other part within the proximal receiving portion 64 may be provided with a gauge 68 or a similar rotation encoding structure. The gauge 68 may cooperate with the sensors 48, 49, 50 of the electronic module 34 arranged on or within the movable portion 70. The sensor may be implemented as an acceleration sensor 48, a rotation sensor 49, or a position sensor 50. The sensor may include at least one of an optical sensor, a magnetic sensor, and a capacitive sensor arrangement to quantitatively measure the degree of rotation and / or longitudinal movement of the movable portion 70 relative to the device body 60. The gauge 68 cooperating with the sensors 48, 49, 50 may be optically, magnetically, or capacitively encoded.

[0140] The movable portion 70 may include a hollow structure to provide a construction space to receive or accommodate multiple components of the electronic module 34. The distal portion 72 and the proximal portion 73 may be implemented as a single piece. In some examples, the distal portion 72 and the proximal portion 73 may be detachably connected. In other examples, the proximal portion 73 may be covered by a cover 75, which may be detachable. A battery or power supply 46 may be provided below the cover 75, which may be replaceably arranged in the hollow interior of the proximal portion 73. The battery may provide a power supply for the electronic module 34.

[0141] Electronic module 34 (such as Fig.14 The electronic module may further include a transceiver 38, a memory 40, a clock 42, a processor 44, a power supply 46, an acceleration sensor 48, a rotation sensor 49, a position sensor 50, and a signal generator 52, for example, equipped with a light source. The electronic module may also include a microphone.

[0142] Additionally, the sidewall 77 of the movable portion may include windows that align with corresponding windows in the sidewall 61 of the device body 60. In this manner, visual signals that may be generated by a light source located within the movable portion 70 may be perceived and visually detected from outside of the attachment 30.

[0143] Such a light source may belong to the visual signal generator 52, which is operable to produce or generate visual signals of different colors and / or variable duration. The window may be provided with a light pipe or light-guiding structure. In this way, the device body 60 may be protected from dust or moisture ingress.

[0144] As shown in the block diagram of the electronic module 34 , the processor 44 may be mounted on a printed circuit board 36 , which may be fastened or secured within the removable portion 70 or the device body 60 .

[0145] Typically, the entire electronic module 34 can be mounted on a printed circuit board 36. The electronic module 34 can be configured to communicate with an external electronic device, which can be implemented as a mobile electronic device. It can include a smart watch, a smart phone, or a tablet computer. The electronic module 34 includes a transceiver 38, which is configured to establish or build a communication link between the external electronic device and the electronic module 34. The corresponding communication link can be implemented in a wireless or wired manner.

[0146] The electronic module 34 may be configured to exchange data with an external electronic device (not shown). Data indicative of the operation of the injection device and acquired or collected by the sensors 48, 49, 50 may be transmitted to the external electronic device via the transceiver 38. The transceiver 38 may be implemented as a Bluetooth transceiver or a BLE transceiver. The transceiver 38 may also be implemented as an NFC transceiver. A plurality of transceivers may be provided, which are distinguished from each other in terms of their communication protocols and / or in terms of their spatial range.

[0147] The electronic module 34 comprises a memory 40 configured to store a plurality of user interactions with the additional device. The electronic module 34 further comprises a clock 42 configured to provide a time index to each of the plurality of measurement data of the sensors 48, 49, 50, the time index indicating a detection time point and / or detection date of a corresponding operation of the injection device 1.

[0148] The electronic module 34 is further equipped with a power supply 46, which is configured to supply power to the processor 44 and the sensors 48, 49, 50. The power supply 46 may be implemented as a battery. The acceleration sensor 48 may be configured to detect an injection operation of the injection device 1 and / or to detect or classify a gesture of a user when using the attachment 30 and / or the injection device 1 provided with the attachment 30. For example, and when implemented as an automatic injector, the acceleration sensor may detect the acceleration of the needle of the automatic injector when performing a dispensing or injection procedure.

[0149] The position sensor 50 may be operable to detect the position or orientation of a dedicated component of the drive mechanism 20 of the injection device 1. The position sensor may be operable to detect, for example, the position of a last dose nut, a piston rod 19 or the like of the drive mechanism 20, which position indicates the amount of medicament located in the medicament container 21.

[0150] In addition, the electronic module 34 includes a signal generator 52, which can be implemented as a visual signal indicator including at least one light source. Additionally or alternatively, the signal generator 52 can be implemented as a tactile signal generator, for example, configured to generate a perceptible vibration of the electronic module 34. In another example, the signal generator 52 can include an audible signal generator configured to generate an audible sound.

[0151] Furthermore, in a further example, the electronic module 34 may comprise a microphone, by means of which a characteristic click sound of the injection device may be detected and processed, thereby allowing the size of the dose currently set or injected by the injection device 1 to be derived or measured.

[0152] In some examples, when depressed by a user, the outwardly facing sidewall 77 of the proximal portion 73 of the movable portion 70 can enter the proximal receiving portion 64 defined by the sidewall 61 of the device body 60. In some examples, the proximal portion 73 includes, for example, a radial protrusion 79 at the proximal end face 76 that protrudes slightly from the sidewall 77. The distally facing portion of the protrusion 79 includes a distal side 79a that faces the proximal end face 69 of the sidewall 61 of the device body 60.

[0153] In such Figure 4 In the depressed configuration shown, the distal side 79a can abut against the end surface 69, thereby limiting the distal movement of the movable portion 70 relative to the device body 60 in a first direction (e.g., distal direction 2). In some examples of the attachment 30, the depression or longitudinal sliding movement of the movable portion 70 relative to the device body 60 is automatically detected by at least one of the sensors 48, 49, 50 of the electronic module 34. Such automatic movement detection can trigger the recording of a dose injection or can cause a specific operation of the electronic module 34.

[0154] In some examples, by detecting depression of the movable portion 70 relative to the device body 60 in the longitudinal distal direction 2, the electronic module 34 and thus the processor 44 can begin to monitor and set or measure the degree of rotation of the device body 60 relative to the movable portion 70 with the longitudinal axis as the rotation axis. Here, the movement of the rotary encoder scale 68 can be detected and / or monitored by any one of the sensors 48, 49, 50.

[0155] In order to detach and / or attach the additional device 30 to the proximal end of the injection device 1, in particular, to securely attach the device body 60 to the dose dial 8, it may be advantageous not to cause relative movement between the movable part 70 and the device body 60. In particular, when the additional device 30 is mounted to the dose dial 8 of the injection device 1, the movable part 70 should not be depressed in the distal direction 2 relative to the device body 60.

[0156] In order to prevent unintentional longitudinal movement, and thus movement of the movable part 70 relative to the device body 60 in the first direction 2, 3 during assembly or attachment of the additional device 30 to the dose dial 8, a spacer 80 is provided, such as Figure 5 and Figure 6 shown.

[0157] The spacer 80 includes a planar and / or disc-shaped spacer body 81. The spacer body 81 includes an engagement portion 83 configured to be removably fastened to one of the device body 60 and the movable portion 70. When the spacer 80 is attached to one of the device body 60 and the movable portion 70, the spacer effectively blocks and / or prevents movement of the movable portion 70 relative to the device body 60 about a first direction (i.e., about the longitudinal directions 2, 3).

[0158] In particular, the spacer 80 and thus the engagement portion 83 are operable to prevent distal movement of the movable portion 70 relative to the device or body 60. The spacer 80 includes a catch 85 including a first arm portion 87 and a second arm portion 88. The catch 85 is configured for clip-on or snap-fit ​​fastening to the side wall 77 of the movable portion 70. Figure 5 and Figure 6 As shown, the first arm 87 and the second arm 88 surround at least most of the circumference of the side wall 77 of the movable part 70. In this way, the radial recessed structure 69a located between the protrusion 79 and the proximal end face 69 can be at least partially occupied or filled by the spacer body 81. The user will be blocked when trying to press the movable part 70 in the distal direction 2. Here, the spacer body 81 located between the distal side 79a of the protrusion 79 and the proximal side 69 of the device body 60 effectively blocks such distal movement. Any distal force applied to the end face 76 and therefore applied to the movable part 70 will be transmitted through the spacer 80 to the proximal end face 69 of the side wall 61 of the device body 60 or toward the proximal end face.

[0159] Therefore, a user trying to press the device body 60 onto the dose dial 8 in the distal direction 2 may even exert a distally directed force on the movable part 70 , which distal force may be directly transmitted to the device body 60 without causing a longitudinal relative movement between the movable part 70 and the device body 60 .

[0160] The first arm portion 87 and the second arm portion 88 each include a free end 87a, 88a. The free ends 87a, 88a define an insertion opening 86 in the circumferential direction. The size of the insertion opening 86 is set to receive and / or surround the side wall 77 of the movable part 70. In order to attach the spacer 80 to the side wall 77, the first arm portion 87 and the second arm portion 88 can be elastically deformed to a certain extent to at least temporarily increase the insertion opening 86 so as to receive the diameter of the tubular side wall 77 of the movable part 70, which protrudes proximally from the proximal end of the side wall 61 of the device body 60. As long as the spacer 80 is attached to the movable part 70, the movable part 70 is effectively blocked from being displaced in the distal direction 2 relative to the device body 60.

[0161] The spacer 80 and the spacer body 81 are substantially planar in shape. The arm portions 87, 88 define an arcuate or semicircular receiving portion 84. The inner circumference of the receiving portion 84 (typically formed by the inner edges 87b, 88b or the inner side walls of the first arm portion 87 and the second arm portion 88) includes a circumferential length that is at least slightly greater than half of the circumference of the side wall 77. In this way, a positively fitting radial engagement can be provided between the engagement portion 83 and the side wall 77 of the movable portion 70.

[0162] The circumferential extent of the receiving portion 84 is greater than 180° and typically less than 300°. More typically, the circumferential extent is greater than 200° and less than 270° relative to the circumference of the side wall 77. The circumferential extent of the receiving portion 84 is typically defined by an inner circumference extending from the free end 87a of the first arm portion 87 and the free end 88a of the second arm portion 88. The inner edge 93 of the receiving portion 84 of the engagement portion 83 may have a slightly semicircular or partially circular structure. The inner edge 93 formed by the first arm portion 87 and the second arm portion 88 may closely match the outer structure of the side wall 77 of the movable portion 70.

[0163] Due to the elasticity of the arm portions 87, 88 and / or the elasticity of the material of which the spacer body 81 is made, the insertion opening 86 can be slightly widened in the circumferential direction when an attempt is made to push the insertion opening 86 in the radial direction onto the side wall 77 of the movable part 70. In this way, when the maximum diameter of the side wall 77 passes through the insertion opening 86, the arm portions 87, 88 can relax or return to their original configuration, thereby forming a snap-fit ​​connection.

[0164] The spacer 80 further includes a gripping portion 82 that radially protrudes from the engagement portion 83. The gripping portion 82 includes or constitutes a gripping tab that facilitates manual manipulation and / or manual gripping of the spacer 80. The gripping portion 82, when attached to the movable portion 70, protrudes radially outward from the movable portion 70 and is easily gripped by, for example, a user's fingers to remove the spacer from the attachment 30.

[0165] like Figures 3 to 11 As further indicated in the figure, the disc-shaped or planar spacer body 81 comprises a proximal side 90 facing the proximal direction 3 when attached to the attachment device 30, and further comprises a distal side 91 facing the distal direction 2. The proximal side 90 and the distal side 91 extend substantially parallel to each other. In the region of the gripping portion 82, a plurality of gripping ribs 92 may be provided. The gripping ribs 92 may be provided equally on both the proximal side 90 and the distal side 91. The gripping ribs 92 protrude slightly from the plane of the spacer body 81 and facilitate the user's fingers to grip the gripping portion 82 non-slip and thus precisely.

[0166] As another option, the spacer body 81 may include a through recess 95. The through recess may provide for the fastening of a cord or a strap, by which the spacer 80 may be movably attached, for example to the protective cap 16 and / or to any other part of the injection device 1 or the attachment device 30, when the engagement portion 83 is released from the movable portion 70.

[0167] exist Figures 7 to 9 , another example of an attachment 30 is shown. Here, the movable portion 70 does not have a radially outwardly extending protrusion 79. Instead, the side wall 77 of the movable portion 70 includes a groove 78 that is sized to receive the engagement portion 83 of the spacer 80. Figure 7 The illustrated configuration corresponds to the initial configuration of the attachment 30, i.e. when the movable portion 70 has not yet been depressed by the user. Figure 8 In the illustration of , the movable part 70 is actually depressed by the user to cause a dose dispensing or dose injection procedure. With the spacer 80 attached to the movable part 70, and therefore when the catch of the spacer 80 engages with the groove 78, the spacer 80 and therefore at least one of the arm portions 87, 88 and the gripping portion 82 protrudes radially from the outer surface of the side wall 77 and effectively provides a stop to engage with the proximal end face 69 of the side wall 61 of the attachment 30.

[0168] The user attempts to depress the movable portion 70 (eg Fig. 9 ) will be hindered because the spacer 80 is in a shape-fitting longitudinal engagement with the movable portion 70 and blocks distal movement when its distal side 91 abuts the proximal end face 69 of the side wall 61 of the device body 60.

[0169] In another example, Fig.10 As shown, the spacer 80 includes a side wall 89, which protrudes in the distal direction from the planar arm portions 87, 88, for example. Here, the inner surface of the side wall 89 is configured to engage with the outer side of the side wall 61 of the device body 60. Here, the spacer 80 can be detachably connected to the proximal end of the side wall 61 of the device body 60, for example, and the spacer engages with the groove 78 provided in the outer surface of the side wall 77 of the movable part 70 through its radially inwardly extending arm portions 87, 88.

[0170] and Figures 3 to 5 Compared to the examples shown in Fig.10 The spacer 80 shown in the figure can be forcibly engaged with a recessed structure (for example, with a groove 78 provided on or in the side wall 77 of the movable part 70) and can block the distal movement of the movable part 70 relative to the side wall 61 of the device body 60.

[0171] In another example, Fig.10 As shown, the spacer 80 can be detachably connected to both the device body 70 and the movable part 70. The side wall 89 of the spacer 80 can be frictionally engaged or forcibly engaged with the side wall 61. The spacer 80 or the spacer body 81 can further be frictionally engaged and / or forcibly engaged with the side wall 77 of the movable part 70.

[0172] In another example, Fig.11 As shown, the spacer 80 may be removably connected or removably fastened to the proximal end of the side wall 61 of the device body 60. Here, the spacer body 81 may include a proximally extending protrusion 94 that abuts the distally facing surface 79a of the protrusion 79 of the proximal portion 73 of the movable part 70. As long as the spacer 80 is attached to the device body 60, the movable part 70 is effectively blocked from moving distally relative to the device body 60. Operating the attachment 30 and thus depressing the movable part 70 relative to the device body requires the spacer 80 to be removed from the device body 70.

[0173] Fig.12 The flowchart of FIG. 2 shows a method for attaching or fastening an additional device 30 to an injection device. Here, in a first step 200, it is intended to attach a spacer 80 as described above to the additional device 30. Here, the spacer 80 is attached to the movable part 70 and / or to the device body 60. In step 202, when the spacer 80 is correctly attached to the additional device 30, the additional device 30 and the spacer 80 attached thereto are connected or attached to the proximal end of the injection device 1. Here, the device body 60 and its receiving portion 63 are, for example, press-fitted onto the proximal end of the dose dial selection member 8 until, as shown in FIG. Figures 3 to 5 The flange portion 62 shown in FIG. 8 is in longitudinal or distal abutment with the end face 28 of the dose dial 8 .

[0174] During this tightening or installation operation, the user may even apply distally directed pressure on the movable portion 70. Any distally directed pressure applied to the movable portion 70 can or will be transferred to the device body 60 via the spacer 80 while avoiding relative longitudinal movement between the movable portion 70 and the device body 60. When a position such as Figures 3 to 5 When the spacer 80 is in the final assembled configuration shown in any of the figures in FIG. 20, the spacer 80 can be removed from the attachment 30 in step 204. To remove the spacer 80 from the attachment 30, the user can use the gripping portion 82 as a kind of pull tab.

[0175] Figures 15 to 17 The sequence further illustrates a typical scenario of installing the additional device 30 to the proximal end of the injection device 1. When the additional device 30 is assembled to the dose dial option 8 of the injection device 1, the following can be achieved: Fig.15Here, the device body 60 of the attachment device has not yet reached the final assembled configuration on the dose dial 8 or the trigger 9 of the injection device 1 .

[0176] In order to achieve Fig.16 The well-defined final assembly configuration shown, in which the abutment face 74 of the movable portion 70 is within a well-defined distance or even abuts against the proximal side of the trigger 9, may require the following Fig.15 The illustrated device body 60 is pushed further in the distal direction onto the dose dial 8. The frictional engagement between the outer surface of the dose dial 8 and the interior of the side wall 61 of the device body 60 may require that a considerable distally directed force be exerted on the device body 60 relative to the dose dial 8 such that the flange portion 62 of the device body 60 abuts the proximally facing end face 28 of the dose dial 8, thereby reaching the final assembly position.

[0177] To this end, the user may attempt to push the movable portion 70. Since the spacer 80 is located between the movable portion 70 and the device body 60, and since the spacer 80 substantially fills the gap between the proximal end face 69 of the device body 60 and the protrusion 79 of the movable portion 70, any distally directed force effect applied to the movable portion 70 will be directly transmitted to the side wall 61 of the device body 60 via the spacer 80 and its arm portions 87, 88 until a force such as Fig.16 Here, the flange portion 62 of the device body 60 is in longitudinal or axial abutment with the end face 28 of the dose dial 8 .

[0178] Thereafter, the spacer 80 can be detached from the attachment 30 and the movable part 70 can be moved relative to the device body 60. Here, after removal of the spacer 80, the movable part 70 is and remains in a well-defined position relative to the trigger 9 of the injection device 1. By means of the spacer 80, it can be ensured that, at least during the installation of the attachment 30 to the injection device 1, the movable part 70 is and remains in a predetermined position or configuration relative to the device body 60.

[0179] Otherwise, without the spacer, the movable part 70 may be longitudinally displaced relative to the device body 60, for example during installation of the attachment 30 to the injection device 1, and this relative movement may lead to unintended activation or use of the attachment 30. With the spacer 80 attached to the attachment 30, it can be ensured that the predetermined orientation position of the movable part 70 relative to the device body 60 can be maintained during assembly of the attachment 30 to the injection device 1.

[0180] exist Figures 15 to 17In the example shown, the attachment 30 may be without a return element 65. Here, the movable portion 70 may only be returned to the proximal position under the action or effect of the return trigger 9, which in turn is typically biased in the proximal direction 3 by a trigger spring (not shown). With such a configuration, in which the attachment 30 is without a return element 65, for example, the correct assembly and positioning of the movable portion 70 relative to the trigger 9 may be particularly important for the correct operation of the attachment 30.

[0181] Reference numerals

[0182] 1 Injection device

[0183] 2 Distal direction

[0184] 3 Proximal direction

[0185] 4 Dose escalation direction

[0186] 5 Dose reduction direction

[0187] 6 body

[0188] 7 Cartridge holder

[0189] 8-dose dial option

[0190] 9 Triggers

[0191] 10 Housing

[0192] 11 Connectors

[0193] 12-pin assembly

[0194] 13. Injection needle

[0195] 14 Inner needle cap

[0196] 15 Outer needle cap

[0197] 16 Protective cap

[0198] 18 Piston

[0199] 19 Piston rod

[0200] 20 Driving mechanism

[0201] 21 Medicine Container

[0202] 22 Cylinder

[0203] 23 Seals

[0204] 24 Pharmacy

[0205] 25 Exit

[0206] 26 Window

[0207] 27 Dial extension

[0208] 28 End face

[0209] 30 Additional devices

[0210] 34 Electronic modules

[0211] 36 Printed Circuit Board

[0212] 38 Transceiver

[0213] 40 Memory

[0214] 42 clock

[0215] 44 Processor

[0216] 46 Power Supply

[0217] 48 Acceleration Sensor

[0218] 49 Rotation Sensor

[0219] 50 Position Sensor

[0220] 52 Signal Generator

[0221] 60 Device body

[0222] 61 Sidewall

[0223] 62 flange part

[0224] 63 Reception Department

[0225] 64 Reception Department

[0226] 65 Return element

[0227] 66 Protrusion

[0228] 67 Adjacent surface

[0229] 68 Scale

[0230] 69 End face

[0231] 69a Depression structure

[0232] 70 Movable part

[0233] 71 shots

[0234] 72 Distal part

[0235] 73 Proximal part

[0236] 73a Adjacent surface

[0237] 74 Adjacent surfaces

[0238] 75 Cover

[0239] 76 End face

[0240] 77 Sidewall

[0241] 78 Grooves

[0242] 79 Protrusion

[0243] 79a Distal aspect

[0244] 80 Spacer

[0245] 81 Spacer body

[0246] 82 Grip

[0247] 83 Joint

[0248] 84 Reception Department

[0249] 85 Clip

[0250] 86 Insert opening

[0251] 87 Arm part

[0252] 87a Free end section

[0253] 87 Inside edge

[0254] 88 Arm part

[0255] 88a Free end section

[0256] 88b Inside edge

[0257] 89 Sidewall

[0258] 90 Near side

[0259] 91 Far side

[0260] 92 Grip Rib

[0261] 93 Inner Edge

[0262] 94 protrusion

[0263] 95 Through recess

[0264] 110 hands

[0265] 114 Thumb

[0266] 116 fingers

[0267] 117 fingers

Claims

1. A spacer (80) detachably fastened to an attachment (30) of an injection device (1), the attachment (30) comprising a device body (60) and a movable portion (70), the movable portion being movable relative to the device body (60) in a first direction (2, 3), the spacer (80) comprising: a spacer body (81) comprising an engagement portion (83) detachably fastened to one of the device body (60) and the movable part (70), - wherein the spacer body (81) is operable to prevent movement of the movable part (70) relative to the device body (60) about the first direction (2, 3) when fastened to the device body (60) or the movable part (70).

2. The spacer (80) according to claim 1, wherein: The engaging portion (83) includes a snap-fit ​​member (85) which at least partially surrounds the side wall (77) of the movable portion (70) or at least partially surrounds the side wall (61) of the device body (60).

3. The spacer (80) according to claim 2, wherein: The latch (85) is configured to at least partially surround the side wall (77) of the movable portion and the side wall (61) of the device body (60).

4. A spacer (80) according to any one of the preceding claims, wherein: The engaging portion (83) includes an insertion opening (86) that receives at least one of the movable portion (70) and the device body (60).

5. The spacer (80) according to any one of the preceding claims, wherein: The engaging portion (83) includes a first arm portion (87) and a second arm portion (88).

6. The spacer (80) according to claim 4 and 5, wherein: The insertion opening (86) is formed between a free end section (87a) of the first arm portion (87) and a free end section (88a) of the second arm portion (88).

7. The spacer (80) according to any one of the preceding claims 5 or 6, wherein: The first arm portion (87) and the second arm portion (88) have an arc shape, and wherein an inner edge (87b) of the first arm portion (87) faces an inner edge (88b) of the second arm portion (88).

8. The spacer (80) according to any one of the preceding claims 5 or 7, wherein: At least one of the first arm portion (87) and the second arm portion (88) is elastically deformable to increase the distance between the first arm portion (87) and the second arm portion (88).

9. The spacer (80) according to any one of the preceding claims, wherein: The spacer body (81) has a flat or disc-like shape.

10. The spacer (80) according to any one of the preceding claims, wherein The thickness of at least one of the spacer body (81) and the engaging portion (83) is adapted to or conforms to the recessed structure (69a) provided on the outer surface of the attachment (30).

11. The spacer (80) according to claim 10, wherein: The size of the recessed structure (69a) of the attachment device (30) along the first direction (2, 3) matches the thickness of at least one of the spacer body (81) and the engaging portion (83) of the spacer body (81).

12. The spacer (80) according to claim 10 or 11, wherein: When the spacer (80) is properly fastened or attached to the attachment (30), at least one of the spacer body (81) and the engaging portion (83) at least partially occupies the recessed structure (69a) of the attachment (30), thereby inhibiting or preventing the movable portion (70) from moving relative to the device body (60).

13. The spacer (80) according to any one of the preceding claims, wherein: The spacer body (81) includes a gripping portion (82) protruding from the engaging portion (83).

14. The spacer (80) according to claim 13, wherein: The gripping portion (82) includes a gripping flange.

15. The spacer (80) according to claim 13 or 14, wherein: The gripping portion (82) includes or constitutes a gripping tab that protrudes outward or extends radially outward.

16. The spacer (80) according to any one of claims 13 to 15, wherein the gripping portion (82) comprises at least one or more gripping ribs (92).

17. The spacer (80) according to claims 9 and 16, wherein: The at least one or more gripping ribs (92) protrude from the plane of the planar spacer body (81).

18. The spacer (80) according to any one of the preceding claims, further comprising a through recess (95) located in the engagement portion (83) or in a gripping portion (82) protruding from the engagement portion (83).

19. The spacer (80) according to any one of the preceding claims, wherein The spacer body (81) includes a proximal side (90) and a distal side (91), wherein the distal side (90) is configured to be adjacent to the proximal side (69) of the device body (60), and wherein the proximal side (91) is configured to be adjacent to the distal side (79a) of the movable portion (70).

20. An attachment device (30) for detachably attaching to an injection device (1), the attachment device comprising: -Device body (60), - a movable part (70) which is movable in a first direction (2, 3) relative to the device body (60), and - A spacer (80) according to any of the preceding claims, which is detachably fastened to the device body (60) and one of the movable parts (70), and is configured to prevent movement of the movable part (70) relative to the device body (60) at least about the first direction (2, 3).

21. The attachment (30) according to claim 20, wherein: The device body (60) comprises a receiving portion (63) configured to receive a dose dial (8) of the injection device (1).

22. The attachment (30) according to claim 20 or 21, further comprising an electronic module (34), which is arranged in the device body (60) or in the movable part (70), wherein: The electronic module (34) includes a processor (44), a memory (40), and a transceiver (38).

23. The attachment (30) according to any one of the preceding claims 20 to 22, further comprising a recessed structure (69a) located on the outer side of the side wall of the attachment (30), wherein: The size of the recessed structure (69a) along the first direction (2, 3) matches the corresponding thickness of the spacer body (81) of the spacer (80).

24. The attachment (30) according to claim 23, wherein: The recessed structure (69a) on the outer side of the attachment (30) is defined by the proximal side (69) of the device body (60) and the distal side (79a) of the movable portion (70).

25. An injection device (1) for setting and injecting a dose of a medicament, the injection device comprising: - a housing (10) which accommodates a medicament container (21), - a drive mechanism (20) operatively engaged with the medicament container (21) for injecting the dose of medicament, a dose dial (8) operable by a user to set the dose, - a trigger (9) which can be depressed by the user to inject the dose, and - An additional device (30) according to any of the preceding claims 20 to 24, which is attachable to at least one of the dose dial (8) and the trigger (9).

Images