Spacer for Add-on Device

Abstract

The present disclosure relates to an add-on device (30) for an injection device (1) and a spacer (80) for such an add-on device (30), the spacer (80) being removably attachable to the add-on device (30), the add-on device (30) including a device body (60) and a movable part (70) movable relative to the device body (60) along a first direction (2, 3), the spacer (80) being - including a spacer body (81) including an engagement part (83) for removably attaching to one of the device body (60) and the movable part (70), - the spacer body (81) being operable to prevent movement of the movable part (70) relative to the device body (60) in the first direction (2, 3) if attached to the device body (60) or the movable part (70).

Description

Technical Field

[0001] The present disclosure relates to an add-on device for an injection device. In a further aspect, the present disclosure relates to a spacer that can be removably attached to the add-on device. In a further aspect, the present disclosure relates to an injection device that can be equipped with an add-on device and a spacer for such an add-on device. Further, the present disclosure relates to a method of attaching an add-on device to an injection device.

Background Art

[0002] Drug delivery devices for setting and dispensing single or multiple doses of a liquid medicament are known in the art. Generally, such devices have a purpose similar to that of a normal syringe.

[0003] Drug delivery devices such as pen-type syringes must meet many requirements specific to the user. For example, in the case of a patient suffering from a chronic disease such as diabetes, the patient may be physically debilitated and have reduced vision. A drug delivery device particularly suitable for home care must therefore be robust and easy to use. Further, the operation and general handling of the device and its elements must be clear and easy to understand. Such an injection device must be able to set a fixed or variable dose of the medicament and then dispense it. Further, the dose setting and dose dispensing procedures must be easy and clear to operate.

[0004] A patient suffering from a particular disease may require the injection of a specific amount of a medicament via a pen-type syringe.

[0005] Some drug delivery devices or injection devices perform the selection of a variable dose of the medicament and the injection of a pre-set dose. Other injection devices perform the setting and dispensing of a fixed dose. Here, the amount of medicament to be injected according to a given prescription schedule is always the same and is invariant or cannot be changed over time.

[0006] Some infusion devices are implemented as reusable infusion devices where the user can replace the drug container, such as a cartridge. Other infusion devices are implemented as disposable infusion devices. In the case of disposable infusion devices, it is intended that the entire infusion device be discarded once the contents, i.e., the drug, have been used up.

[0007] To control and monitor drug administration by the user or the patient themselves, it is desirable to be able to automatically detect and log the repeated and regular use of the drug delivery device. Automating the recording of the doses injected by the user will provide greater advantages from the perspectives of safety and convenience than manual dose logging.

[0008] There are many add-on devices configured to be used in conjunction with infusion devices that perform electronic detection and monitoring of repeated dose infusion procedures.

[0009] Typically, such add-on devices or auxiliary devices can be detachably connected to the infusion device. The add-on device typically includes a sensor, detector, or detector configuration operable to detect the date and / or time when the user sets or infuses a dose of the drug. Some add-on devices also perform a quantitative measurement of the size of the currently set or dispensed dose. Some add-on devices are intended to be used in conjunction with a series of infusion devices. This may apply in particular to disposable infusion devices intended to be discarded after use or after the drug filled inside has been used up.

[0010] Attaching and detaching the add-on device to the infusion device may require some training and should not cause unintentional operation of the add-on device.

[0011] Some add-on devices include a device body configured to be removably attached to a dose dial that may be provided at the proximal end of an elongated injection device such as a pen-type syringe. Here, the device body of the add-on device should be firmly attached to the dose dial, for example, by frictional engagement. The add-on device may further include a movable part that forms or constitutes, for example, a kind of auxiliary trigger. The movable part can be operably engaged with the trigger of the injection device when it moves relative to the device body along a first direction.

[0012] Therefore, in some add-on devices including a device body and a movable part, when the add-on device is not attached to the injection device, it may not be necessary or intended to move the movable part relative to the device body. Also, for example, during the process of placing or re-attaching the add-on device on the dose dial of the injection device, the movable part should not be moved or pushed down relative to the device body. In some add-on devices, it may be necessary to perform a reset operation of the add-on device after attaching or re-attaching the add-on device to another injection device.

[0013] Some users may face difficulties in complying with these constraints, for example, when attempting to attach an add-on device to an injection device. During the process of assembling the add-on device to the injection device, the user may inadvertently induce or initiate a recording operation or some other function of the add-on device rather than moving the movable part relative to the device body by mistake.

[0014] Therefore, it is desirable to improve and enhance the usability of such add-on devices, especially during the process of removing the add-on device from an injection device and re-attaching it to another injection device.

[0015] Therefore, it is an object to simplify the use, especially the attachment and detachment of the add-on device to the injection device. A further object is to make such an add-on device more acceptable to the user and to improve the intuitive handling of such a device.

SUMMARY OF THE INVENTION

MEANS FOR SOLVING THE PROBLEM

[0016] In one aspect, a spacer is provided that can be detachably attached to an add-on device of an injection device. The add-on device includes a device body and a movable part. The movable part is movable relative to the device body along a first direction. The spacer includes a spacer body. The spacer body includes an engaging portion that is detachably attached to one of the device body and the movable part. The spacer body is operable to prevent or inhibit the movement of the movable part relative to the device body in the first direction if the spacer body is attached to the device body or the movable part.

[0017] Accordingly, if properly attached or mounted to the add-on device, the spacer serves to inhibit or prevent the movement of the movable part relative to the device body along the first direction. In this way, the spacer can be effectively useful in preventing an unintended operation or activation of the add-on device, for example, during the process of assembling the add-on device to the injection device. Accordingly, the spacer includes or constitutes a stopper, such as a mechanical stopper, that is operable to prevent the movement of the movable part relative to the device body.

[0018] The spacer may be attachable to the add-on device before removing the add-on device from the injection device and / or before attaching the add-on device to the injection device. While the add-on device is removed from the injection device, the spacer may remain attached to at least one of the device body and the movable part, thus preventing the relative movement of the device body and the movable part in the first direction. The spacer effectively prevents the relative movement of the movable part relative to the device body in the first direction, which may be the longitudinal direction, during or in the process of assembling the add-on device to the same or another injection device.

[0019] In this way, the process of reassembling the add-on device into the injection device, for example, the process of attaching the device body to the dose dial of the injection device, can be simplified. Here, the user may also apply a placement force to the movable part, but this force does not cause relative movement between the movable part and the device body. Rather, due to, for example, a spacer effectively arranged between the movable part and the device body, each placement force applied by the user to not only the device body but also the movable part can be transmitted from the movable part to the device body via the spacer. In fact, the spacer can effectively prevent relative movement of the movable part in the first direction with respect to the device body. Unintended activation or operation of the add-on device while the add-on device is placed or mounted on the injection device can be effectively prevented.

[0020] The spacer may be removed from the add-on device after the add-on device is properly attached to the injection device, so that intended movement of the movable part relative to the device body along the first direction becomes possible.

[0021] The spacer can effectively prevent unintended operation or activation of the add-on device. Therefore, it may not be necessary to perform a reset operation of the add-on device after attaching the add-on device to another injection device. In this way, the overall handling of the add-on device can be simplified and user satisfaction can be improved. According to a further example, the engaging portion of the spacer includes a fixture or clip that at least partially sandwiches the side wall of the movable part or at least partially sandwiches the side wall of the device body.

[0022] In some examples, the device body is in an elongated and / or tubular shape. Here, the longitudinal axis may extend along a first direction. Accordingly, the movable part may be movable relative to the device of the body along the longitudinal direction so as to cause a dosage injection treatment, particularly if the add-on device is correctly attached or mounted to the injection device. In a further example, the engaging part includes a clip or the fastener of the engaging part forms or constitutes a mounting clip. In this way, the engaging part functions to positively engage or conform to engage the spacer body with at least one side wall of the movable part and the device body.

[0023] In some examples, the fastener or clip of the engaging part is configured to enter or at least partially fill a longitudinal gap, i.e., a gap having a gap size along a first direction. Here, the longitudinal width or thickness of the engaging part may correspond to the longitudinal gap size to fill or occupy each gap. When disposed inside the gap between the device body and the movable part, the engaging part, and thus the spacer body, functions as a blocking element or a stop element, effectively blocking each longitudinal movement of the movable part relative to the device body, or else the size of the gap in the longitudinal direction would be reduced by this movement.

[0024] In a further example, it is considered that the engaging part frictionally engages and / or positively engages with one side wall of the movable part and the device body, and the engaging part is configured to abut against the other end face of the movable part and the device body, and the end face faces the first direction.

[0025] In this way, if the engaging part is fixed in the first direction to one side wall of the device body and the movable part, a similar restraining effect can be obtained by the spacer if it is attached or mounted to one of the movable part and the device body.

[0026] In some examples, the fastener or clip of the spacer or spacer body is configured to at least partially sandwich the side wall of the movable part. In some examples, the fastener or clip of the spacer or spacer body is configured to at least partially sandwich the side wall of the device body. In a further example, the fastener or clip of the spacer or spacer body is configured to at least partially sandwich both the side wall of the device body and the side wall of the spacer body.

[0027] In some examples, the fastener or clip of the spacer or spacer body may include a length along a first direction that is greater than the size of the gap along the first direction. In this way, the fastener or clip of the spacer or spacer body can engage with at least a part of the side wall of the device body and at least a part of the side wall of the movable part simultaneously. Such a configuration is particularly useful when the lateral or radial extent of the side wall of the movable part is substantially the same as the lateral or radial length of the side wall of the spacer body.

[0028] According to a further example, the engaging portion of the spacer body includes an insertion opening for receiving at least one of the movable part and the device body. The insertion opening of the engaging portion may be sized to receive the side wall of the movable part or to receive the side wall of the device body. The side walls of the movable part and the device body may both be substantially tubular. The insertion opening of the engaging portion may include a circumferential width or size around the side wall of the device body or the movable part that is at least slightly smaller than the diameter of the side wall of each device body or movable part. In this way, the engaging portion can be positively engaged with at least one of the movable part and the device body.

[0029] In some examples, the insertion opening is provided by a fastener or clip. The fastener or clip of the engaging portion may be sized and configured to sandwich at least a portion around the side wall of the device body or the movable part. Typically, the fastener or clip is configured and sized to sandwich a portion of the side wall of the movable part or the device body that is greater than or at least equal to half around each side wall. In this way, the fastener or clip can be properly fitted with at least one side wall of the movable part or the device body. By such a fastener or clip connection, the spacer can be placed or mounted, as well as removed or detached, radially along the tubular shape of the side wall of the movable part or the device body.

[0030] According to a further example, the engaging portion includes a first arm portion and a second arm portion. The first and second arm portions may extend in opposite directions from each other to enclose a receptacle sized to receive the side wall of the movable part or the side wall of the device body. The first and second arm portions may be of a symmetrical shape. They may be sized and configured to sandwich a part of the outer periphery of at least one of the side walls of the movable part and the device body.

[0031] The first arm portion may include a free end facing the free end of the second arm portion. The first and second arm portions may be connected to each other on the opposite sides of their respective free ends. The first arm portion and the second arm portion may be integrally formed with the engaging portion. The end of the first arm portion opposite to the free end as described above may be integrally formed or integrated with the end of the second arm portion opposite to the free end of the second arm portion.

[0032] In a further example, the spacer is planar. The spacer may be disc-shaped. The first arm portion and the second arm portion may extend in a common plane. In this way, the spacer can be designed in a fairly small and space-saving manner. How to attach the spacer and / or its engaging portion to the movable part or the device body is obvious and intuitive due to its shape.

[0033] According to a further example, the insertion opening of the engaging 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 half of the circumference around the movable part or the side wall of the device body, and the spacer is configured to be mounted on the side wall.

[0034] The free end sections of the first arm portion and the second arm portion may face each other. They may define the insertion opening and thus the circumferential width of the insertion opening. In some examples, it may be the free end sections of the first arm portion and the second arm portion that engage with each part of at least one side wall of the device body and the movable part. By applying a radially inward pressure to one side wall of the device body or the movable part, the free end sections may be displaced to avoid, so that the distance between the free end sections increases to such an extent that one side wall of the device body or the movable part fits into the receptacle of the engaging portion.

[0035] In some examples, the free end sections of the first arm portion and the second arm portion may project inwardly and thus towards each other to engage with recesses having complementary shapes provided on each side wall of the device body or the movable part. In this way, the arm portions of the engaging portion can be properly fitted with the concave structures on the outer sides of at least one of the side walls of the movable part and the device body. In this way, the engaging portion and thus the entire spacer can be fixed to one side wall of the device body and the movable part in the first direction. When at least a part of the spacer or the spacer body extends radially outward from the engaging portion, such a radially outward extending portion abuts against the other of the device body and the movable part to inhibit longitudinal movement.

[0036] According to a further example, the first connecting portion and the second connecting portion are arch-shaped. The inner edge or inner wall of the first arm portion faces the inner edge or inner wall of the second arm portion. The first and second arm portions may form or constitute a kind of semi-circular receptacle that sandwiches or wraps around at least a part of the side wall of the movable part or the device body.

[0037] The shape and / or contour of the inner edge or inner wall of the arm portion may correspond to the outer contour or outer shape of the side wall of the device body or the movable part. In this way, the engaging portion and the movable part or the device body can be fixed more firmly and stably.

[0038] According to a further example, at least one of the first arm portion and the second arm portion, and thus at least a part of the engaging portion, is elastically deformable to increase the distance between the first arm portion and the second arm portion. Typically, for example, by elastic deformation in the plane of a planar spacer body, the size of the insertion opening formed, for example, between the free end sections of the first arm portion and the second arm portion can be increased at least temporarily 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 realized by manufacturing the engaging 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 component, for example as an injection-molded plastic component, the spacer can be produced at low or medium cost.

[0040] According to a further example, the spacer body is planar and / or disc-shaped. A planar or disc-shaped spacer body is fairly easy and intuitive to use. The thickness of the spacer body or the engaging portion as seen along the surface normal of the planar or disc-shaped spacer body may be adapted to or match the concave structure of the add-on device. Thus, the concave structure provided on the outer surface of the side wall of the add-on device can be effectively occupied by the spacer body. The size of the concave structure along the first direction may match the thickness of each of the spacer bodies. As described above, if the spacer body is correctly mounted or attached to the add-on device, it can occupy the concave structure at least in the first direction, effectively preventing movement involving a reduction in the size of the concave structure typically along the first direction between the movable part and the device body.

[0041] According to a further example, the thickness of at least one of the spacer body and the engaging portion is adapted to or matches the concave structure provided on the outer surface of the add-on device. In some examples, this thickness may also be the thickness of a fastener adapted to or matching the concave structure.

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

[0043] According to another example, the size of the concave structure of the add-on device along the first direction matches the thickness of at least one of the spacer body and the engaging portion of the spacer body. Thus, the spacer body and / or its engaging portion can enter the concave structure and effectively occupy at least the peripheral portion of the concave structure as seen along the first direction.

[0044] According to another example, if the spacer is correctly attached or mounted to the add-on device, at least one of the spacer body and the engaging portion occupies the concave structure of the add-on device at least within the compartment, thereby preventing the movement of the movable part relative to the device body. In practice, the portion of the spacer body or the engaging portion that enters the concave structure of the add-on device is operable to prevent or deter the movement of the movable part relative to the device body along a first direction, and this movement leads to a reduction in the size of the concave structure along the first direction.

[0045] According to a further example, the spacer body includes a gripping portion that protrudes from the engaging portion. Typically, the gripping portion protrudes outwardly from the engaging portion. In some examples, if the engaging portion includes a receptacle sized to receive a side wall of the device body or a part of the outer periphery of the movable part, the gripping portion protrudes outwardly from the receptacle. Thus, if the engaging portion is attached to, for example, the movable part or the tubular side wall of the device body, the gripping portion protrudes radially outward. The gripping portion may include a gripping flange. The gripping flange may be disposed opposite to the insertion opening of the engaging portion. In a further example, the gripping portion may be disposed substantially midway between the first arm portion and the second arm portion. The gripping portion facilitates the handling of the spacer by the user. The user can grip the spacer body via the gripping portion to attach the spacer to the add-on device and remove the spacer from the add-on device.

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

[0047] In a further example, the gripping portion includes at least one or a plurality of gripping ribs. The gripping ribs can protrude, for example, along a first direction from a planar gripping portion. Typically, the engaging portion and the gripping portion are disposed adjacent to each other within the plane of the spacer body. The gripping portion is typically disposed in the same plane as the first and second arm portions.

[0048] The gripping ribs can project 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 with respect to the circular or semi-circular receptacle formed by the fastener or clip of the engaging portion. In this way, the frictional fit between the user's finger and the gripping portion of the spacer can be enhanced.

[0049] According to a further example, the spacer includes a through recess extending through the spacer body. The through recess may be disposed in the engaging portion or the gripping portion. The through recess can function as, for example, a mounting structure for a line or a leash. In this way, the spacer can be connected to a line or a leash if not attached to an add-on device. The line or leash can be attached to other locations on the add-on device or the infusion device, such as the pocket clip of the infusion device. When not in use, the spacer may remain loosely fixed to the add-on device or the infusion device even if not attached to the body or the movable part.

[0050] In a further example, the spacer body includes a proximal surface and a distal surface. The distal surface is configured to abut the proximal surface of the device body. The proximal surface is configured to abut the distal surface of the movable part. The proximal surface and the distal surface of the spacer body are opposing surfaces of the spacer body. They may face in opposite directions. The proximal surface and the distal surface may be either planar or disc-shaped. Each surface extends parallel to each other, and the thickness of the spacer may be substantially constant when viewed along a first direction.

[0051] The proximal surface of the device body and the distal surface of the movable part of the add-on device may enclose a concave structure on the outside of the add-on device. If correctly assembled to the add-on device, each concave structure between the distal surface of the movable part and the proximal surface of the device body allows the spacer body to at least partially or completely occupy it, so that the size of the concave structure does not decrease when the user attempts to move the movable part relative to the device body along the first direction.

[0052] Here, when the movable part is slidably supported with respect to the apparatus main body, it is sufficient that only the peripheral part of the concave structure is occupied by each part of the spacer between the movable part and the apparatus main body. As long as the spacer is attached to at least one of the movable part and the apparatus main body, the movement of the movable part relative to the apparatus main body along the first direction is effectively suppressed and blocked.

[0053] According to a further example, the thickness of the spacer body is not more than the longitudinal distance between the proximal surface of the apparatus main body and the distal surface of the movable part. Since the thickness of the spacer body is uniform, the spacer body, the distal surface of the movable part, and the proximal surface of the apparatus main body can be brought into contact with each other fairly uniformly. In this way, the surfaces of the apparatus main body and the movable part facing in opposite directions are brought into contact with each other fairly stably and firmly, and thus, if appropriately attached to one of the apparatus main body and the movable part, the function of preventing the movement of the spacer can be exerted.

[0054] In another aspect, the present disclosure also relates to an add-on device for detachably connecting to an injection device. The add-on device includes an apparatus main body and a movable part. The movable part is movable relative to the apparatus main body at least along a first direction. The injection device further includes a connector as described above. The spacer is detachably attachable to one of the apparatus main body and the movable part. The spacer is configured to prevent the movement of the movable part relative to the apparatus main body at least in the first direction.

[0055] Since the add-on device includes a spacer as described above, all of the above-described features, effects, and advantages related to the spacer equally apply to the add-on device, and vice versa.

[0056] In some examples, the movable part is movable relative to the apparatus main body along the first direction so as to cause a dosage injection treatment if the add-on device is correctly attached to the injection device. Accordingly, the movable part may function as an auxiliary trigger operably engageable with the trigger of the injection device if the add-on device is attached to the injection device.

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

[0058] Typically, for example, along the tubular shape of the device body or the movable part, the first direction extends parallel to the cylindrical or longitudinal tubular axis of the device body or the movable part. The second direction may extend circumferentially along the tubular shape of the device body or the movable part. The movable part may be longitudinally slidable relative to the device body along the first direction. The movable part may be rotatable relative to the device body along the second direction about the longitudinal axis of the device body as the axis of rotation.

[0059] Accordingly, the spacer serves to exclusively prevent the longitudinal movement of the movable part relative to the device body so as to prevent the activation of the add-on device typically occurring with the dispensing operation of the injection device if the add-on device is correctly attached to the injection device.

[0060] With the spacer attached to the add-on device, the user may apply pressure or a seating force to the movable part, and the pressure or seating force is effectively transmitted through the spacer to the device body without significantly moving the movable part relative to the device body, at least in the first, i.e., longitudinal, direction. In this way, the spacer facilitates and simplifies the seating of the add-on device on the injection device.

[0061] In a further example, the device body of the add-on device includes a receptacle configured to receive the dose dial of the infusion device. Typically, the receptacle is configured to frictionally engage the dose dial of the infusion device. The dose dial of the infusion device may be substantially tubular or sleeve-shaped. The receptacle of the device body may include one or more resilient mounting ribs to frictionally engage the inner side of the receptacle and the outer side of the dose dial of the infusion device without slipping.

[0062] In a further example, the outer side of the dose dial and / or the inner side of the receptacle may include one or more radial recesses or protrusions to achieve a non-slip form fit or positive fit between the dose dial and the receptacle of the device body.

[0063] The movable part can project proximally, and thus in the proximal longitudinal direction, from the device body. The movable part may include, for example, a button that can be depressed by the user's thumb. The movable part may include a stem that extends longitudinally within and / or through the receptacle of the device body so as to mechanically engage the trigger of the infusion device if the add-on device is correctly attached to the infusion device. Since the movable part is at least movable relative to the device body in the longitudinal direction, the movable part may be operable to generate a starting force in the distal direction against the trigger of the infusion device if the device body is attached to the dose dial. Thus, the movable part can function as an auxiliary trigger.

[0064] According to a further example, the movable part can be operably engaged with the trigger of the infusion device. The trigger of the infusion device is depressible or movable relative to the dose dial in a first direction. If the add-on device is attached to the infusion device, the trigger is depressible or movable relative to the dose dial in the first direction by moving the movable part relative to the device body along the first direction. Since the device body is fixed to the dose dial, the movement of the movable part along the first direction relative to the device body serves to cause each movement of the trigger relative to the dose dial.

[0065] Thus, the general operability of the injection device, i.e., for example, setting the dose of the drug and / or rotating the dose dial to inject and pressing the trigger, can be maintained even when the add-on device is attached to the dose dial and / or trigger of the injection device and thus the dose dial and trigger are completely covered.

[0066] According to a further example, the add-on device includes an electronic module. The electronic module is arranged inside the device body or inside 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 further include 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 actually set or injected dose.

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

[0068] According to a further example, the add-on device includes a concave structure on the outer side of the side wall of the add-on device. The size of the concave structure along the first direction may correspond to the thickness of at least one of the fastener, the engaging part, and the spacer body of the spacer. Typically, the concave structure is provided between the device body and the movable part. The concave structure may include a circumferentially extending concave structure. The concave structure may be annular or elliptical, for example, the space between the movable part and the device body may form a closed annular shape.

[0069] In some examples, the concave structure may include an annular groove, for example, on one of the side wall of the device body and the movable part. In some examples, the concave structure may be provided as an annular groove enclosed by the annular surface of the movable part and the annular surface of the device body. In some examples, the concave structure is enclosed along a first direction by the annular surface facing the proximal direction of the device body and by the annular surface facing the distal direction of the movable part. Here, each surface of the movable part and the device body may include or constitute a contact surface that engages or abuts with the spacer body, the fastener of the spacer, or the engaging part.

[0070] According to a further example, the recessed structure on the outside of the add-on device is enclosed by the proximal surface of the device body and the distal surface of the movable part. Typically, the distal surface of the movable part may be offset in the proximal direction from the proximal surface of the device body. To operate the add-on device, it may be necessary to reduce the size of the concave structure along the first direction by moving the movable part in the distal direction. Such movement is effectively blocked or inhibited by the spacer as long as the concave structure is occupied by the spacer.

[0071] According to a further aspect, the present disclosure further relates to an injection device for setting and injecting a dose of a drug. The injection device includes a housing that houses a drug container. The drug container contains, for example, a liquid injectable pharmaceutical. The injection device further includes a drive mechanism that is operably engagable with the drug container for dispensing or injecting a dose of the drug from the drug container. The injection device further includes a dose dial that is operable by a user to set the dose and a trigger that is depressable by the user to inject or dispense the dose.

[0072] Both the dose dial and the trigger may belong to the drive mechanism. In some examples, the drive mechanism includes a piston rod operable to apply longitudinal pressure to the stopper of the drug container to discharge the dose of the pharmaceutical from an outlet disposed distally of the drug container. In some examples, the outlet of the drug container can be easily connected to a syringe needle.

[0073] The injection device further comprises an add-on device as described above. The add-on device is attachable to at least one of the dose dial and the trigger. Typically, the body of the add-on device is attachable or mountable to the dose dial, and the movable part of the add-on device is operatively engageable with the trigger of the injection device if the add-on device is attached to the injection device.

[0074] Accordingly, all the features and effects described above with respect to the spacer and the add-on device apply equally to the injection device, and vice versa.

[0075] In another aspect, the present disclosure also relates to a method of attaching and / or mounting an add-on 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 add-on device, the add-on device is then attached or mounted to the injection device. After the add-on device is attached or mounted to the injection device, the spacer is removed. The spacer is thus removed from at least one of the body of the device or the movable part of the device, enabling movement of the movable part relative to the body of the device in a first direction.

[0076] The method is specifically tailored to be implemented using a spacer, an add-on device, and an injection device as described above. Accordingly, all the effects, features, and advantages described above in relation to the spacer, the add-on device, and the injection device apply equally to the method of attaching or mounting an add-on device to an injection device, and 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 and includes any combination of elements of different embodiments or examples. Accordingly, the present disclosure is directed to any combination of claims and any technically feasible combination of features disclosed in relation to different examples or embodiments.

[0078] In this context, the term "distal" or "distal end" relates to the end of the infusion device that is opposite to the infusion site of a human or animal. The term "proximal" or "proximal end" relates to the end of the infusion device that is on the opposite side and farthest from the infusion site of a human or animal.

[0079] The terms "drug" or "agent" are used synonymously herein and refer to a formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. A pharmaceutical active ingredient ("API") is, in the broadest sense, a chemical structure that has a biological effect on a human or animal. In pharmacology, a drug or agent is used for the treatment, cure, prevention, or diagnosis of a disease, or otherwise for the improvement of physical or mental health. A drug or agent may be used over a limited duration or, in the case of chronic diseases, periodically.

[0080] As described below, a drug or agent may contain at least one API or a combination thereof in various formulations to treat one or more diseases. Examples of APIs include small molecules with a molecular weight of 500 Da or less, i.e., 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 a molecular delivery system such as a vector, plasmid, or liposome. Mixtures of one or more drugs are also contemplated.

[0081] A drug or medicament may be contained within a primary package or “drug container” adapted for use in conjunction with a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storing one or more drugs (e.g., short-term or long-term storage). For example, in some instances, the chamber may be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some instances, the chamber may be designed to store the drug for from about one month to about two years. Storage may occur at room temperature (e.g., about 20° C.) or refrigerated temperature (e.g., about -4° C. to about 4° C.). In some instances, the drug container may be a dual-chamber cartridge configured to separately store one type each of two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs) in each chamber, or may include a dual-chamber cartridge. In such instances, the two chambers of the dual-chamber cartridge may be configured to enable mixing of two or more components before and / or during dispensing into a human or animal body. For example, the two chambers may be in fluid communication with each other (e.g., by a conduit between the two chambers) and configured to enable a user to mix the two components if desired before dispensing. Alternatively or additionally, the two chambers may be configured to enable mixing while the components are being dispensed into a human or animal body.

[0082] The drugs or agents included in a drug delivery device as described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes, or complications associated with diabetes such as diabetic retinopathy, and thromboembolic disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders include acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs include those described in handbooks such as the Rote Liste 2014, for example, but not limited to, main group 12 (antidiabetic drugs) or 86 (oncological drugs), and the 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, such as 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 mixture thereof. As used herein, the terms "analog" and "derivative" refer to polypeptides having a molecular structure formally derivable from the structure of a naturally occurring peptide, such as the structure of human insulin, by deletion and / or exchange of at least one amino acid residue occurring within the naturally occurring peptide and / or by addition of at least one amino acid residue. The amino acid residues added and / or exchanged may be either 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 formally derivable from the structure of a naturally occurring peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may be deleted and / or replaced by other amino acids containing non-codable amino acids or amino acids containing non-codable amino acids added to the naturally occurring peptide.

[0084] Examples of insulin analogs include 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 may be replaced with Asp, Lys, Leu, Val or Ala and the Lys at position B29 may be replaced with Pro, Ala(B26) human insulin, Des(B28-B30) human insulin, Des(B27) human insulin and Des(B30) human insulin.

[0085] Examples of insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir (registered trademark)), B29-N-palmitoyl-des(B30) human insulin, B29-N-myristoyl human insulin, B29-N-palmitoyl human insulin, B28-N-myristoyl LysB28ProB29 human insulin, B28-N-palmitoyl-LysB28ProB29 human insulin, B30-N-myristoyl-ThrB29LysB30 human insulin, B30-N-palmitoyl-ThrB29LysB30 human insulin, B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba (registered trademark)), B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin, B29-N-(omega-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(omega-carboxyheptadecanoyl) human insulin.

[0086] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary gland of the Gila monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), r exendin-4, CJC-1134-PC, PB-1023, TTP-054, langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, GLP-1 erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, nodexen, viadorl-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (pegapamodotide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tildesatide (LY3298176), bamaductide (SAR425899), exenatide-XTEN, and glucagon-Xten.

[0087] Examples of oligonucleotides include, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome. Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0088] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides such as gonadotropins (folitropin, lutropin, chorionic gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, tryptorelin, leuprorelin, buserelin, nafarelin, and goserelin, and their antagonists.

[0089] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or ultra-low molecular weight heparin, or their derivatives, or sulfated forms of the above polysaccharides, such as poly-sulfated forms and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of poly-sulfated low molecular weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives include Hylan G-F 20 (Synvisc (registered trademark)), 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 that retain the ability to bind to an antigen. Antibodies may be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the antibody has a reduced or no ability to bind to an Fc receptor. For example, the antibody may be an isotype or subtype, antibody fragment, or mutant that does not assist in binding to an Fc receptor, e.g., the Fc receptor binding region is mutated or deleted. The term "antibody" also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins having a crossover binding region orientation (CODV).

[0091] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding to an antigen. An antibody fragment may contain a cleavage portion of the full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab’)2 fragments, scFv (single-chain Fv) fragments, linear antibodies, single-specific or multispecific antibody fragments, such as bispecific, trispecific, tetra-specific and multispecific antibodies (e.g., diabodies, triabodies, tetra-bodies), monovalent or multivalent antibody fragments, such as divalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0092] The term "complementary determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both the heavy and light chain polypeptides that primarily play a role in mediating specific antigen recognition. The term "framework region" refers to the amino acid sequences within the variable regions of both the heavy and light chain polypeptides that are not CDR sequences but primarily play a role in maintaining the correct arrangement of the CDR sequences to permit antigen binding. The framework region itself is typically not directly involved in antigen binding, but as is known in the art, specific residues within the framework region of a particular antibody can be directly involved in antigen binding or can affect the ability of one or more amino acids within the CDR to interact with the antigen.

[0093] Examples of antibodies include anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

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

[0095] Those skilled in the art will understand that changes (additions and / or deletions) to the various elements of the APIs, formulations, devices, methods, systems, and embodiments described herein may be made without departing from the full scope and spirit of the invention, encompassing all such changes and their equivalents.

[0096] Exemplary drug delivery devices may include 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 classified into multi-dose container systems and single-dose (partial or full discharge) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0097] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, and its size may be fixed or variable (pre-set by the user). Other multi-dose container systems may include a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, and its size may be fixed or variable (pre-set by the user).

[0098] As further described in ISO11608-1:2014(E), a single-dose container system may include a needle-based injection device with an exchangeable container. In one example of such a system, each container holds a single-dose amount, and the entire deliverable amount is discharged (full discharge). In a further example, each container holds a single-dose amount, and a portion of the deliverable amount is discharged (partial discharge). Also as described in ISO11608-1:2014(E), a single-dose container system may include a needle-based injection device with an integrated non-exchangeable container. In one example of such a system, each container holds a single-dose amount, and the entire deliverable amount is discharged (full discharge). In a further example, each container holds a single-dose amount, and a portion of the deliverable amount is discharged (partial discharge).

[0099] Examples of injection devices and data logging devices for monitoring the use of each injection device will now be described in more detail with reference to the drawings.

Brief Description of the Drawings

[0100]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

DETAILED DESCRIPTION OF THE INVENTION

[0101] FIG. 1 shows an example of a drug delivery device 1 implemented as a pen-type syringe. The injection device 1 may include a pen-type injector or may be implemented as a pen-type injector. The injection device 1 may be implemented as a disposable injection device or a reusable injection device. In some examples, the injection device 1 is implemented as an auto-injector. The injection device 1 has an elongated shape. The injection device 1 may extend along the longitudinal direction. The drug delivery device 1 includes a dispensing end for dispensing or injecting a medicament 24 towards the longitudinal distal direction 2. Since the injection device 1 includes at least one of a dosing member 8 and a trigger 9 towards the proximal direction 3, doses of equal or separate or different sizes can be set and dispensed respectively.

[0102] The injection device 1 includes a housing 10. The housing 10 may include a number of housing elements such as a main body 6 and a cartridge holder 7. The main body 6 may be sized and configured to accommodate a drive mechanism 20. The cartridge holder 7 is sized and configured to accommodate a drug container 21 and is implemented as a cartridge for accommodating, for example, a liquid drug 24. The drug container 21 includes a tubular barrel 22 sealed towards the distal end by a seal 23. The seal 23 may include a pierceable septum fixed to the outlet 25 of the drug container 21. The interior of the barrel 22 is sealed towards the proximal end by a piston 18 or a stopper slidably disposed within the barrel 22.

[0103] By advancing the piston 18 in the distal direction 2, a dose of the drug 24 can be discharged from the drug container 21. The drug container 21 is disposed within the cartridge holder 7 during use. The drive mechanism 20 of the injection device 1 includes a piston rod 19 displaceable in the distal direction 2 to advance the piston 18 towards the outlet 25 of the drug container 21. Details of the drive mechanism are not further illustrated and described herein. In some examples, the drive mechanism 20 may be implemented as a fully mechanical drive mechanism where the user needs to apply all of the dispensing force required to move the piston rod 19, and thus the piston 18, in the distal direction 2. In other examples, the drive mechanism includes a mechanical energy storage configured to apply at least a portion of the dispensing force. Examples of drive mechanisms can be found, for example, in WO 2004 / 078241 A1, WO 2014 / 033197 A1 or WO 2014 / 033195 A1, the entire content of which is incorporated herein by reference.

[0104] In some examples, as described or shown for example in Figure 13, the injection device 1, and thus the drive mechanism 20, may include a dial extension 27 that projects from the proximal end of the body 6 and moves in the proximal direction 3 when setting or during the setting of the dose, and returns to its initial distal end position during the execution of the dose injection procedure. For this purpose, the user can move the dial extension 27 in the distal direction 2 during the execution of the dose injection procedure by applying pressure in the distal direction to the trigger 9 using the thumb 114 of his hand 110. The injection device 1 may be securely held by the fingers 116, 117 and / or the palm of the hand 110 during the execution of the injection procedure.

[0105] When setting or dialing the dose, the user may twist or turn the dose dial 8, for example, in the dose increment direction 4 and thus clockwise as seen from the proximal end. When correcting a previously set dose, the user may turn the dose dial 8 in the opposite dose reduction direction 5. The size of the dose is typically indicated in a window 26 within or on the body 6 of the injection device 1. Before injecting the dose of the medicament 24, it is necessary to connect the distal end of the cartridge holder 7 to the needle assembly 12. For this purpose, the distal end of the cartridge holder 7 includes a connector 11 in the form of a threaded interface that engages a threaded counter-interface having, for example, a complementary shape to the needle assembly 12.

[0106] The needle assembly 12 can be removably or separably fixed to the cartridge holder 7. The needle assembly 12 includes a double-tip injection needle 13. The proximal end of the injection needle (not shown) is configured to enter a through-opening at the distal end face of the connector 11 or the cartridge holder 7 to pierce or penetrate the seal 23 of the medicament container 21. The distal end of the injection needle 13 is typically covered by a removable inner needle cap 14. The entire needle assembly 12 may be covered by a removable outer needle cap 15.

[0107] The cartridge holder 7, and thus part of the housing 10, is received in a protective cap 16 that can be removably connected to the cartridge holder 7 or the body 6.

[0108] An add-on device 30 for use in combination with an infusion device 1 is shown in FIGS. 2-12 and 14. The add-on device 30 includes a generally tubular device body 60. The device body 60 includes a tubular side wall 61. The device body 60 includes a receptacle 63 at the distal end side. The receptacle 63 is sized to receive the proximal portion of the infusion device. Specifically, the receptacle 63 is configured and sized to receive the dose dial 8 provided at the proximal end of the infusion device 1. A number of mounting ribs 31 made of, for example, an elastic or elastomeric material are provided on the inner surface of the receptacle 63 and thus on the inside of the side wall 61. The mounting ribs 31 of the receptacle 63 may be configured to frictionally engage the outer surface of the dose dial 8.

[0109] As schematically shown in FIGS. 3-5, the outer surface of the dose dial 8 and / or the inner surface of the receptacle 63 may be slightly conical in shape to frictionally engage and thus produce a clamping effect between the inner surface of the receptacle 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 can be achieved.

[0110] As shown in FIGS. 3-5, if a radially inwardly extending flange portion 62 that divides the receptacle 63 in the proximal direction 3 engages or abuts against the proximal end face 28 of the dose dial 8 of the infusion device 1, the final assembly position of the device body 60 with respect to the dose dial 8 has been reached.

[0111] The add-on device 30 includes a movable portion 70 that is movable in a first direction and thus in the longitudinal direction relative to the device body 60. The movable portion 70 may also be movable relative to the device body 60 along a second direction. The second direction can define a rotational movement of the movable portion 70 relative to the device body 60 about the longitudinal axis of the sleeve-shaped device body 60 as the axis of rotation.

[0112] In a first direction, as can be seen from a comparison of FIGS. 3 and 4, the movable part 70 is displaceable relative to the device body 60 in a slidable manner. The movable part 70 is movable from an initial position along the first direction to a trigger position or a pressing position in the distal direction 2. The movable part 70 is also movable in the reverse direction from the pressing position to the initial position along the longitudinal axis, but in the proximal direction 3.

[0113] In a final assembled position, if the device body 60 is firmly attached to the dose dial 8, it can be ensured that the movable part 70, in particular its distal abutment surface 74, is arranged in a clearly defined position relative to the trigger 9 of the injection device 1.

[0114] Typically, the add-on device 30 is configured to be removably attached to the proximal end of the dial extension 27. The device body 60 engages and covers the dose dial 8. The movable part 70 is configured to engage the trigger 9 or the dose button. Thus, the movable part 70 functions as an auxiliary trigger that transmits a dispensing force effective to press the trigger 9 relative to the dose dial 8, for example, by the user's thumb 114 applying a force to the dial extension 27. Thus, a typical usage scenario as described while showing FIG. 13 is substantially unaffected even if the add-on device 30 is attached to the dose dial 8 and / or the trigger 9.

[0115] The movable part 70 of the add-on device 30 includes a proximal part 73 that protrudes in the proximal direction 3 from the proximal end or the proximal end face 69 of the device body 60. The movable part 70 further includes a stem 71 that connects the proximal part 73 to the distal part 72. The entire distal part 72 is arranged within the device body 60. The distal part 72 includes a distal surface abutment surface 74 configured to engage the proximal end face of the trigger 9. By a longitudinal sliding displacement of the movable part 70 relative to the device body 60, the user can induce the movement of the movable part 70 in the distal direction relative to the device body 60 by applying a dispensing force to the end face 76 facing the proximal side of the movable part 70.

[0116] In the initial configuration shown in FIG. 3, by applying a force in the distal direction to the movable part 70, the movement of each of the movable parts 70 in the distal direction is induced in the distal direction 2, so that each force effect capable of activating or executing the dose dispensing or dose injection operation of the injection device is transmitted to the trigger 9.

[0117] During the execution of such a dispensing operation, the dose dial 8 can be rotated in the dose decreasing direction 5 to decrease the dose, while the trigger 9 and / or the movable part 70 in longitudinal contact with the trigger 9 remain in a non-rotating state.

[0118] Due to the frictional engagement between the device body 60 and the dose dial 8, the device body 60 may also be rotated in the dose decreasing direction 5 and thus can rotate relative to the movable part 70. Therefore, rotation of the device body 60 relative to the movable part 70 can occur during the execution of the dose dispensing phase. Such rotation, and thus the degree of rotation, may indicate the size of the dose currently being dispensed or injected.

[0119] The add-on device 30 may include an electronic module 34 schematically shown in FIG. 14. The electronic module 34 is operable to detect movement of the movable part 70 along the first directions 2, 3 and movement of the movable part 70 relative to the device body 60 along the second direction, where the second direction is one of the dose increasing direction 4 and the dose decreasing direction 5.

[0120] In some examples, the device body 60 includes a proximal receptacle 64 sized to receive the proximal portion 73 of the movable part 70. The add-on device 30 may further include a return element 65, for example in the form of a return spring operable to return the movable part 70 to an initial configuration relative to the device body 60, in which the movable part 70 is in the proximal end position. By the return element 65, the movable part 70 can be automatically returned to the initial configuration.

[0121] In other examples, the add-on device 30 can disable such a return element 65. Here, the movement to return the movable part 70 to its initial configuration or position in the proximal direction 3 may be induced by the return movement of the trigger 9 relative to the dose dial 8. The injection device 1, and thus the trigger 9, may be pushable in the distal direction 2 against the action of the return element, in particular against the action of a return spring or a trigger spring (not shown). At the end of the dose injection procedure, if the trigger 9 or the dose button is released, the trigger 9 or the dose button automatically returns to its initial configuration under the influence of the return spring, as shown, for example, in FIGS. 3 or 5.

[0122] With the add-on device 30 correctly attached to the dose dial 8 and correctly attached or assembled to the proximal end of the injection device 1, the distal end face or contact surface 74 of the distal part 72 of the movable part 70 is in permanent and longitudinal contact or engagement with the trigger 9, so that, for example, the spring-induced return movement of the trigger 9 may result in a return movement of each of the movable parts in the proximal direction 3.

[0123] In some examples, a projection 66 extending radially inwards within the region of the proximal receptacle 64 is provided. The projection 66 can be provided with a contact surface 67 facing in the proximal direction operable to engage or contact a contact portion or contact surface 73a having a complementary shape to the proximal part 73 of the movable part 70. In this way, the distal movement 60 of the movable part 70 relative to the device body can be restricted or prevented.

[0124] A scale 68 or a similar rotational encoding structure may be provided on a protrusion 66 or some other part within the proximal receptacle 64. The scale 68 can cooperate with sensors 48, 49, 50 of the electronic module 34 disposed on or within the movable part 70. The sensors may be implemented as an acceleration sensor 48, a rotation sensor 49, or a position sensor 50. The sensors may include at least one of an optical sensor, a magnetic sensor, and a capacitive sensor mechanism to quantitatively measure the degree of rotation and / or longitudinal movement of the movable part 70 relative to the device body 60. The scale 68 cooperating with the sensors 48, 49, 50 may be optically, magnetically, or capacitively encoded.

[0125] The movable part 70 may include a hollow structure to provide a structural space for receiving or accommodating a number of elements of the electronic module 34. The distal part 72 and the proximal part 73 may be implemented as an integral structure. In some examples, the distal part 72 and the proximal part 73 may be detachably connected. In a further example, the proximal part 73 may be covered by a cover 75 that may be detachable. A battery or power source 46 that may be disposed interchangeably inside the hollow interior of the proximal part 73 may be provided under the cover 75. The battery can supply electrical energy to the electronic module 34.

[0126] The electronic module 34 schematically shown in FIG. 14 may include a printed circuit board 36. Further, it may include a transceiver 38, a memory 40, a clock 42, a processor 44, a power source 46, an acceleration sensor 48, a rotation sensor 49, a position sensor 50, and a signal generator 52 having, for example, a light source. It may also include a microphone.

[0127] Further, the side wall 77 of the movable part may include windows aligned with each window of the side wall 61 of the device body 60. Thus, visual signals that can be generated by a light source disposed inside the movable part 70 can be perceived and visually detected from outside the add-on device 30.

[0128] Such a light source may belong to a visual signal generator 52 operable to generate or produce visual signals with different colors and / or variable durations. The window may be provided with an optical pipe or a light guiding structure. In this way, the device body 60 can be protected from the intrusion of dust or humidity.

[0129] As shown in the block diagram of the electronic module 34, the processor 44 may be placed on a printed circuit board 36 that may be mounted or fixed inside the movable part 70 or the device body 60.

[0130] Generally, the entire electronic module 34 can be placed on the printed circuit board 36. The electronic module 34 may be configured to communicate with an external electronic device that may be implemented as a mobile electronic device. The external electronic device may include a smartwatch, a smartphone, or a tablet computer. The electronic module 34 includes a transceiver 38 configured to establish or build a communication link between the external electronic device and the electronic module 34. Each communication link can be realized wirelessly or wired.

[0131] The electronic module 34 may be configured to exchange data with an external electronic device (not shown). Data indicating the operation of the injection device, collected or retrieved 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 number of transceivers may be provided that distinguish each other with respect to their communication protocols and / or their spatial ranges.

[0132] The electronic module 34 includes a memory 40 configured to store interactions with add-on devices of multiple users. The electronic module 34 further includes a clock 42 configured to assign a time index indicating the detection time and / or the detection date of each operation of the injection device 1 to each of the multiple measurement data of the sensors 48, 49, 50.

[0133] The electronic module 34 further comprises a power supply 46 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 the injection operation of the injection device 1 and / or to detect or classify the gestures of the user when using the add-on device 30 and / or the injection device 1 provided with the add-on device 30. For example, when implemented as an auto-injector, the acceleration sensor can detect the acceleration of the needle of the auto-injector if a dispensing or injection procedure has been performed.

[0134] The position sensor 50 may be operable to detect the position or orientation of a dedicated element of the drive mechanism 20 of the injection device 1. The position sensor may be operable to detect the position of, for example, the end-dose nut, the piston rod 19 or a similar element of the drive mechanism 20, which indicates the amount of medicament present in the medicament container 21.

[0135] Furthermore, the electronic module 34 may include a signal generator 52 implemented as a visual signal indicator including at least one light source. Additionally or alternatively, the signal generator 52 may be implemented as a tactile signal generator configured to generate a perceptible vibration of the electronic module 34, for example. In a further example, the signal generator 52 may include an audible signal generator configured to generate an audible sound.

[0136] In yet a further example, the electronic module 34 may include a microphone capable of detecting and processing the characteristic click sound of the injection device to enable derivation or measurement of the size of the dose currently set or being injected by the injection device 1.

[0137] In some examples, if pressed by a user, the side wall 77 facing the outside of the proximal portion 73 of the movable part 70 may enter the proximal receptacle 64 defined by the side wall 61 of the device body 60. In some examples, the proximal portion 73 includes a radial protrusion 79 at a proximal end face 76 that protrudes slightly from, for example, the side wall 77. The portion of the protrusion 79 facing the distal direction includes a distal face 79a facing the proximal end face 69 of the side wall 61 of the device body 60.

[0138] In the pressed configuration shown in FIG. 4, since the distal face 79a may contact the end face 69, the distal movement of the movable part 70 relative to the device body 60 in the first, for example, distal direction 2 can be restricted. In some examples of the add-on device 30, the pressing or longitudinal sliding movement 60 of the movable part 70 relative to the device body is automatically detected by at least one of the sensors 48, 49, 50 of the electronic module 34. Such automatic movement detection can trigger a dosage injection record or induce a specific operation of the electronic module 34.

[0139] In some examples, by detecting the pressing of the movable part 70 relative to the device body 60 in the longitudinal distal direction 2, the electronic module 34, and thus the processor 44, can start monitoring, setting, or measuring the degree of rotation of the device body 60 relative to the movable part 70 with the longitudinal axis as the rotation axis. Here, the movement of the rotation encoding scale 68 may be detected and / or monitored by any of the sensors 48, 49, 50.

[0140] To attach and detach the add-on device 30 to the proximal end of the injection device 1, especially to firmly attach the device body 60 to the dosage dial 8, it may be beneficial not to induce relative movement between the movable part 70 and the device body 60. In particular, when the add-on device 30 is placed on the dosage dial 8 of the injection device 1, the movable part 70 should not be pressed distally relative to the device body 60 in the direction 2.

[0141] During the process of assembling or attaching the add-on device 30 to the dose dial 8, a spacer 80 is provided as shown in FIGS. 5 and 6 to prevent any unintended longitudinal movement of the movable part 70 relative to the device body 60, and thus movement along the first directions 2, 3.

[0142] 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 attached to one of the device body 60 and the movable part 70. When attached to one of the device body 60 and the movable part 70, the spacer 80 effectively prevents and / or inhibits movement of the movable part 70 relative to the device body 60 in the first direction, i.e., the longitudinal directions 2, 3.

[0143] In particular, the spacer 80, and thus the engagement portion 83, is operable to prevent distal movement of the movable part 70 relative to the device or body 60. The spacer 80 includes a fastener 85 including a first arm portion 87 and a second arm portion 88. The fastener 85 is configured to be attached to the side wall 77 of the movable part 70 by a clip or snap fit. As shown in FIGS. 5 and 6, the first and second arms 87, 88 surround at least a major portion around the side wall 77 of the movable part 70. Thus, the radially recessed structure 69a disposed between the projection 79 and the proximal end face 69 may be at least partially occupied or filled by the spacer body 81. A user attempting to push the movable part 70 distally in direction 2 encounters resistance. Here, the spacer body 81 disposed between the distal face 79a of the projection 79 and the proximal face 69 of the device body 60 effectively prevents such distal movement. The distal force applied to the end face 76, and thus to the movable part 70, is transmitted across the spacer 80 onto, or towards, the proximal end face 69 of the side wall 61 of the device body 60.

[0144] Accordingly, a user attempting to press the device body 60 distally 2 against the dose dial 8 may apply a distal force to the movable part 70, and this distal force can be transmitted directly to the device body 60 without causing longitudinal relative movement between the movable part 70 and the device body 60.

[0145] The first and second arm portions 87, 88 each include free ends 87a, 88a. The free ends 87a, 88a circumferentially delimit the insertion opening 86. The insertion opening 86 is sized to receive and / or sandwich the side wall 77 of the movable part 70. In order to attach the spacer 80 to the side wall 77, the first and second arm portions 87, 88 are somewhat elastically deformable to at least temporarily enlarge the insertion opening 86 to receive the diameter of the tubular side wall 77 of the movable part 70, and the side wall 77 projects 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 prevented from shifting distally 2 relative to the device body 60.

[0146] The spacer 80 and the spacer body 81 are substantially planar. The arm portions 87, 88 define arcuate or semi-circular receptacles 84. Typically, the inner circumference of the receptacle 84 formed by the inner edges 87b, 88b of the first and second arm portions 87, 88 or the inside of the side walls includes a circumference slightly larger than at least half of the circumference of the side wall 77. In this way, a radial engagement by shape fit can be achieved between the engaging portion 83 and the side wall 77 of the movable part 70.

[0147] The circumferential angle of the receptacle 84 is greater than 180° and typically less than 300°. More typically, it is greater than 200° and less than 270° with respect to the circumference of the side wall 77. The circumferential angle of the receptacle 84 is typically defined by the 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 receptacle 84 of the engaging portion 83 may have a somewhat semi-circular or partially circular structure. The inner edge 93 formed by the first and second arm portions 87, 88 may closely match the outer structure of the side wall 77 of the movable part 70.

[0148] Due to the elasticity of the arm portions 87, 88 and / or the elasticity of the material forming the spacer body 81, the insertion opening 86 can expand slightly circumferentially if tested when the insertion opening 86 is radially pushed to 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 relax and return to their initial configuration, thus forming a snap-fit connection.

[0149] The spacer 80 further includes a gripping portion 82 that projects radially from the engaging portion 83. The gripping portion 82 includes or constitutes a gripping tab that facilitates the manual operation and / or manual gripping of the spacer 80. When attached to the movable part 70, the gripping portion 82 projects radially outward from the movable part 70 and can be easily gripped by the user's finger, for example, when removing the spacer from the add-on device 30.

[0150] As further shown in FIGS. 3 to 11, the disk-shaped or planar spacer body 81 includes a proximal surface 90 facing in the proximal direction 3 and, if attached to the add-on device 30, further includes a distal surface 91 facing in the distal direction 2. The proximal surface 90 and the distal surface 91 extend substantially parallel to each other. A number of gripping ribs 92 may be provided in the region of the gripping portion 82. The gripping ribs 92 may be evenly provided on the proximal surface 90 and the distal surface 91. The gripping ribs 92 project slightly from the plane of the spacer body 81, making it difficult for the user's finger to slip on the gripping portion 82 and thus facilitating accurate gripping.

[0151] Furthermore, optionally, the spacer body 81 may include a through recess 95. The through recess can be used to attach a line or leash that can movably attach the spacer 80, for example, to a protective cap 16 and / or an injection device 1 or any other part of the add-on device 30 when the engaging portion 83 is disengaged from the movable part 70.

[0152] Figures 7 to 9 show further examples of the add-on device 30. In the figures, the movable part 70 lacks the radially outwardly extending protrusion 79. In contrast, the side wall 77 of the movable part 70 includes a groove 78 sized to receive the engaging portion 83 of the spacer 80. The configuration shown in FIG. 7 corresponds to the initial configuration of the add-on device 30, i.e., when the movable part 70 has not yet been depressed by the user. In FIG. 8, the movable part 70 is actually depressed by the user to initiate a dose dispensing or dose injection procedure. With the spacer 80 attached to the movable part 70 and thus the fastener of the spacer 80 engaged in the groove 78, at least one of the spacer 80, and thus the arm portions 87, 88 and the gripping portion 82, projects radially from the outer surface of the side wall 77 to form an effective fastener for engaging with the proximal end face 69 of the side wall 61 of the add-on device 30.

[0153] As shown in FIG. 9, even if the user attempts to depress the movable part 70, it is prevented because the spacer 80 is longitudinally engaged with the movable part 70 by shape fit, and when the distal face 91 abuts against the proximal end face 69 of the side wall 61 of the device body 60, the movement in the distal direction is suppressed.

[0154] In another example shown in FIG. 10, the spacer 80 includes, for example, a side wall 89 that projects distally from the planar arm portions 87, 88. Here, the inner surface of the side wall 89 is configured to engage with the outside of the side wall 61 of the device body 60. Here, the spacer 80 is, for example, detachably connectable to the proximal end of the side wall 61 of the device body 60 and engages with its radially inwardly extending arm portions 87, 88 having a groove 78 provided on the outer surface of the side wall 77 of the movable part 70.

[0155] In contrast to the examples shown in FIGS. 3 to 5, the spacer 80 shown in FIG. 10 can positively engage with a recessed structure, for example, a groove 78 provided on or inside the side wall 77 of the movable part 70, and can suppress the distal movement of the movable part 70 relative to the side wall 61 of the device body 60.

[0156] In a further example, as shown in FIG. 10, the spacer 80 may be detachably connectable to both the device body 70 and the movable part 70. The side wall 89 of the spacer 80 may be in frictional or positive engagement with the side wall 61. The spacer 80 or the spacer body 81 may further be in frictional and / or positive engagement with the side wall 77 of the movable part 70.

[0157] In a further example shown in FIG. 11, the spacer 80 is detachably connectable or detachably attachable to the proximal end of the side wall 61 of the device body 60. Here, the spacer body may include a protrusion 94 that extends in the proximal direction so as to abut against the surface 79a facing in the distal direction of the protrusion 79 of the proximal portion 81 of the proximal portion 73 of the movable part 70. As long as the spacer 80 is attached to the device body 60, the distalward movement of the movable part 70 relative to the device body 60 is effectively inhibited. To operate the add-on device 30, and thus press the movable part 70 relative to the device body, it is necessary to remove the spacer 80 from the device body 70.

[0158] A method of attaching or mounting the add-on device 30 to an injection device will be described with reference to the flowchart of FIG. 12. In the first step 200 of the flowchart, it is intended to attach the spacer 80 as described above to the add-on device 30. Here, the spacer 80 is attached to the movable part 70 and / or the device body 60. In step 202, if the spacer 80 is correctly attached to the add-on device 30, the add-on device 30 to which the spacer 80 is attached is connected or attached to the proximal end of the injection device 1. Here, the device body 60, together with its receptacle 63, is pressed against the proximal end of the dose dial 8 until the flange portion 62 is in a longitudinal or distal abutting state with the end face 28 of the dose dial 8, as shown in FIGS. 3 to 5, for example.

[0159] During this mounting or placement operation, the user can even apply a distal pressure to the movable part 70. The distal pressure applied to the movable part 70 can be transmitted or is transmitted to the device body 60 via the spacer 80 while avoiding relative longitudinal movement between the movable part 70 and the device body 60. For example, if the final assembled configuration shown in any of FIGS. 3 to 5 is reached, the spacer 80 can be removed from the add-on device 30 in step 204. To remove the spacer 80 from the add-on device 30, the user may use the gripping portion 82 as a kind of pull tab.

[0160] A typical scenario of placing the add-on device 30 at the proximal end of the injection device 1 is further shown by the sequences of FIGS. 15 to 17. During the assembly of the add-on device 30 to the dose dial 8 of the injection device 1, an intermediate configuration as shown in FIG. 15 may be reached. In the intermediate configuration, the device body 60 of the add-on device has not yet reached the final assembled configuration to the dose dial 8 or the trigger 9 of the injection device 1.

[0161] To reach the clearly defined final assembled configuration as shown in FIG. 16 where the contact surface 74 of the movable part 70 is at or in contact with the proximal surface of the trigger 9 at a clearly defined distance, it may be necessary to further push the device body 60 distally to the dose dial 8 as shown in FIG. 15. To frictionally engage the outer surface of the dose dial 8 with the inner side of the side wall 61 of the device body 60, a relatively strong distal force may be required to be applied to the device body 60 relative to the dose dial 8 so that the flange portion 62 of the device body 60 abuts the end face 28 facing the proximal direction of the dose dial 8 to reach the final assembled position.

[0162] For this purpose, the user may want to press on the movable part 70. Since the spacer 80 is located between the movable part 70 and the device body 60 and the spacer 80 substantially fills the gap between the proximal end face 69 of the device body 60 and the projection 79 of the movable part 70, if a distal direction force effect is applied to the movable part 70, it is directly transmitted to the side wall 61 of the device body 60 up to the final assembled configuration as shown in Fig. 16 via the spacer 80 and its arm portions 87, 88. Here, the flange portion 62 of the device body 60 is in contact with the end face 28 of the dose dial 8 in the longitudinal or axial direction.

[0163] Thereafter, the spacer 80 can be removed from the add-on device 30, and the movable part 70 becomes relatively movable with respect to the device body 60. Here, after removing the spacer 80, the movable part 70 is in a position clearly defined relative to the trigger 9 of the injection device 1 and stays there. The spacer 80 can ensure that the movable part 70 stays in a predetermined position or configuration relative to the device body 60 at least during the process of placing the add-on device 30 on the injection device 1.

[0164] On the other hand, in the case where there is no spacer, the movable part 70 may be longitudinally displaced relative to the device body 60, for example, while the add-on device 30 is being placed on the injection device 1, and such relative movement may result in an unintended activation or use of the add-on device 30. Since the spacer 80 is attached to the add-on device 30, it can be ensured that a predetermined position of the orientation of the movable part 70 relative to the device body 60 can be maintained while assembling the add-on device 30 to the injection device 1.

[0165] In the example shown in Figs. 15 to 17, the add-on device 30 may lack the return element 65. Here, since the movable part 70 can only return to the proximal end position by the action or effect of the return trigger 9, it is typically displaced in the proximal direction 3 by a trigger spring (not shown). In such a configuration, that is, when the add-on device 30 lacks the return element 65, for example, the correct assembly and positioning of the movable part 70 relative to the trigger 9 may be particularly important for the correct operation of the add-on device 30.

Description of Symbols

[0166] 1 Injector 2 Distal direction 3 Proximal direction 4 Dosage increment direction 5 Dosage reduction direction 6 Body 7 Cartridge holder 8 Dosage dial 9 Trigger 10 Housing 11 Connector 12 Needle connector 13 Hypodermic needle 14 Inner needle cap 15 Outer needle cap 16 Protective cap 18 Piston 19 Piston rod 20 Drive mechanism 21 Drug container 22 Barrel 23 Seal 24 Drug 25 Outlet 26 Window 27 Dial extension 28 End face 30 Add-on device 34 Electronic module 36 Circuit board 38 Transceiver 40 Memory 42 Clock 44 Processor 46 Power supply 48 Acceleration sensor 49 Rotation sensor 50 Position sensor 52 Signal generator 60 Device body 61 Side wall 62 Flange portion 63 Receptacle 64 Receptacle 65 Return element 66 Protrusion 67 Junction surface 68 Scale 69 End face 69a Concave structure 70 Movable part 71 Stem 72 Distal part 73 Proximal part 73a Junction surface 74 Junction surface 75 Cover 76 End face 77 Side wall 78 Groove 79 Protrusion 79a Distal face 80 Spacer 81 Spacer body 82 Gripping part 83 Engaging part 84 Receptacle 85 Fastener 86 Insertion opening 87 Arm part 87a Free end section 87 Inner edge 88 Arm part 88a Free end section 88b Inner edge 89 Side wall 90 Proximal face 91 Distal face 92 Gripping rib 93 Inner edge 94 Protrusion 95 Through recess 110 Hand 114 Thumb 116 Finger 117 Finger

Claims

1. A spacer (80) that can be detachably attached to an add-on device (30) of an injection device (1), wherein the add-on device (30) includes a device body (60) and a movable part (70) that can move relative to the device body (60) along a first direction (2, 3), and the spacer (80) - includes a spacer body (81) including an engaging portion (83) for detachably attaching to one of the device body (60) and the movable part (70), - the spacer (80) that is operable to prevent movement of the movable part (70) relative to the device body (60) in the first direction (2, 3) when the spacer body (81) is attached 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 fastener (85) that at least partially sandwiches a side wall (77) of the movable part (70) or at least partially sandwiches a side wall (61) of the device body (60).

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

4. The spacer (80) according to any one of claims 1 to 3, wherein the engaging portion (83) includes an insertion opening (86) for receiving at least one of the movable part (70) and the device body (60).

5. The spacer (80) according to any one of claims 1 to 4, 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 or 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 claim 5 or 6, wherein the first arm portion (87) and the second arm portion (88) are arched, and 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 claims 5 to 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 claims 1 to 8, wherein the spacer body (81) is planar or disc-shaped.

10. The spacer (80) according to any one of claims 1 to 9, wherein the thickness of at least one of the spacer body (81) and the engaging portion (83) is adapted to or matches a concave structure (69a) provided on the outer surface of the add-on device (30).

11. The spacer (80) according to claim 10, wherein the size of the concave structure (69a) of the add-on 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 if the spacer (80) is correctly mounted or attached to the add-on device (30), at least one of the spacer body (81) and the engaging portion (83) occupies at least a plurality of sections of the concave structure (69a) of the add-on device (30), thereby preventing or precluding relative movement of the movable part (70) with respect to the device body (60).

13. The spacer (80) according to any one of claims 1 to 12, 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 protruding outward or extending radially outward.

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

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

18. The spacer (80) according to any one of claims 1 to 17, further comprising a through recess (95) disposed within the engaging portion (83) or disposed within a gripping portion (82) protruding from the engaging portion (83).

19. The spacer (80) according to any one of claims 1 to 18, wherein the spacer body (81) includes a proximal surface (90) and a distal surface (91), the distal surface (90) being configured to abut against a proximal surface (69) of the device body (60), and the proximal surface (91) being configured to abut against a distal surface (79a) of the movable part (70).

20. An add-on device (30) for detachably connecting to an injection device (1), the add-on device comprising - a device body (60), - a movable part (70) movable relative to the device body (60) along a first direction (2, 3), - a spacer (80) according to any one of claims 1 to 19, which is detachably attachable to one of the device body (60) and the movable part (70) and is configured to prevent movement of the movable part (70) relative to the device body (60) at least in the first direction (2, 3). An add-on device (30) comprising

21. The add-on device (30) according to claim 20, wherein the device body (60) includes a receptacle (63) configured to receive a dose dial (8) of the injection device (1).

22. The add-on device (30) according to claim 20 or 21, further comprising an electronic module (34) disposed inside the device body (60) or inside the movable part (70), the electronic module (34) including a processor (44), a memory (40), and a transceiver (38).

23. The add-on device (30) according to any one of claims 20 to 22, further comprising a concave structure (69a) outside a side wall of the add-on device (30), the size of the concave structure (69a) along the first direction (2, 3) being equal to the thickness of each spacer body (81) of the spacer (80).

24. The add-on device (30) according to claim 23, wherein the concave structure (69a) outside the add-on device (30) is enclosed by a proximal surface (69) of the device body (60) and a distal surface (79a) of the movable part (70).

25. An infusion device (1) for setting and infusing a dose of a medicament, the infusion device comprising: - a housing (10) for accommodating a medicament container (21); - a drive mechanism (20) operably engageable with the medicament container (21) for infusing the dose of the medicament; - a dose dial (8) operable by a user for setting the dose; - a trigger (9) depressible by the user for infusing the dose; - an add-on device (30) according to any one of claims 20 to 24, attachable to at least one of the dose dial (8) and the trigger (9); and an infusion device (1) including the same.

Images