Injection unit and injection device

Abstract

In one aspect the present disclosure relates to an injection unit (10) for an injection device (1), the injection unit (10) comprising: - a unit housing (11) defining a longitudinal direction and configured to accommodate a medicament container (20) fluidically engageable with an injection needle (22), containing an injectable medicament (24) and sealed in a longitudinal proximal direction (3) by a movable stopper(23), the unit housing (11) comprising: - a distal end (12) with an orifice (14) for the injection needle (22), - a sidewall (15) defining a container receptacle (16) sized to receive the medicament container (20), - a mount (30) for the medicament container (20) located inside the container receptacle (16), - a proximal end (13) provided with a connecting portion (40) for detachably connecting the unit housing (11) to a drive unit (4) of the injection device (1), wherein the drive unit (4) comprises a drive mechanism (5) configured to operably engage with the stopper (23), - wherein the injection unit (10) is transferable from a pre-injection configuration into an injection configuration by moving at least one of the mount (30) and the medicament container (20) relative to the distal end (12) in the longitudinal direction to shift the injection needle (22) through the orifice (14).

Description

[0001] Injection Unit and Injection Device

[0002] Description

[0003] Field

[0004] The present disclosure relates to the field of injection devices and injection units to be used with such injection devices. Particularly, the present disclosure relates to the field of disposable injection units to be used with reusable injection devices, specifically for injection devices configured as so-called auto-injectors.

[0005] Background

[0006] Drug delivery devices allowing for multiple discrete or continuous dosing of a required dosage of a liquid medicinal product and further providing administration of such liquid drug to a patient, are as such well known in the prior art. Generally, such devices have substantially the same purpose as that of an ordinary syringe. Some medicaments require administration by way of infusion.

[0007] Drug delivery devices, such as pen-type injectors, have to meet a number of user-specific requirements. For instance, with patients suffering chronic diseases, such as diabetes, the patient may be physically infirm and may also have impaired vision. Suitable drug delivery devices especially intended for home medication therefore need to be robust in construction and should be easy to use. Furthermore, manipulation and general handling of the device and its components should be intelligible and easy understandable. Such injection devices should provide setting and subsequent dispensing of a dose of a medicament of equal or variable size. Moreover, a dose setting as well as a dose dispensing procedure must be easy to operate and has to be unambiguous.

[0008] Some drug delivery or injection devices provide selecting of a dose of a medicament of variable size and subsequent injecting of the dose previously set. Other injection devices provide setting and dispensing of a fixed dose. Here, the amount of medicament that should be injected in accordance to a given prescription schedule is always the same and does not change or cannot be changed over time. Some injection devices are implemented as reusable injection devices offering a user to replace a medicament container, such as a cartridge. Other injection devices are implemented as a disposable injection device. With disposable injection devices it is intended to discard the entirety of the injection device when the content, i.e. the medicament, has been used up. Disposable injection devices may be prefilled with the injectable medicament.

[0009] Medical devices, such as drug delivery devices or injection devices may have a limited lifetime. Due to regulatory provisions or for reasons of patient safety, medical devices or drug delivery devices may only be used for a rather limited number of times. Also, some medical devices, drug delivery devices or injection devices or parts thereof may be intended only for a one-time use. They may be designed or constructed as disposable devices or device components, which are intended to be discarded after use.

[0010] Medical devices, such as drug delivery devices or injection devices may have a limited lifetime. Due to regulatory provisions or for reasons of patient safety, medical devices or drug delivery devices may only be used for a rather limited number of times. Also, some medical devices, drug delivery devices or injection devices or parts thereof may be intended only for a one-time use. They may be designed or constructed as disposable devices or device components, which are intended to be discarded after use. Such medical devices or injection devices for single or multiple use may therefore represent or impose a comparatively high environmental burden.

[0011] Some medical devices, drug delivery devices or injection devices commercially distributed for home medication are typically made from injection moldable plastic material, which comes along with some drawbacks in terms of biocompatibility when the respective device has reached its end of lifetime. However, and nowadays injection moldable plastic materials seem to be without alternative in order to provide a cost efficient and lightweight drug delivery device or injection device, which is also easy and intuitive to handle.

[0012] It is therefore desirable to provide intelligent solutions to reduce the environmental burden or environmental footprint of drug delivery devices and their packaging. It is a particular aim to reduce waste and to reduce production costs and expenditure for commercially distributing drug delivery devices, such as hand-held injection devices, e.g. injection pens.

[0013] Summary

[0014] In one aspect the present disclosure relates to an injection unit for an injection device. The injection unit comprises a unit housing defining a longitudinal direction. The unit housing is configured or sized to accommodate a medicament container. The medicament container is fluidically engageable with an injection needle or is connected or provided with an injection needle for expelling an amount, i.e., a dose of a medicament into biological tissue.

[0015] The medicament container contains the injectable medicament and is sealed in a longitudinal proximal direction by a movable stopper. The unit housing of the injection unit comprises a longitudinal distal end with an orifice or through opening for the injection needle. The unit housing further comprises a sidewall defining a container receptacle, which is sized to receive the medicament container. The unit housing further comprises a mount or holder for the medicament container, which is located inside the container receptacle.

[0016] Moreover, the unit housing comprises a proximal end, which is longitudinally opposite the distal end. The proximal end is provided with a connecting portion for detachably connecting the unit housing to a drive unit of the injection device. The drive unit of the injection device comprises a drive mechanism, which is configured to operably engage with the stopper of the medicament container.

[0017] The injection unit is transferable from a pre-injection configuration into an injection configuration by moving at least one of the mount and the medicament container relative to the distal end in the longitudinal direction to shift or to expose the injection needle through the orifice, which is provided at the distal end of the unit housing.

[0018] In some examples it may be provided that the medicament container is displaceable relative to the unit housing towards the distal end so as to shift the injection needle in distal direction through the orifice. In other examples it is the distal end of the unit housing, which is moved relative to the mount or medicament container attached thereto in proximal direction, which in relation to the injection needle fixed or attached to the medicament container has more or less the same effect.

[0019] Also and by way of moving or displacing the distal end of the unit housing in proximal direction relative to the medicament container or relative to the mount for the medicament container the injection needle, which in the pre-injection configuration of the injection unit is entirely encapsulated or housed inside the container receptacle, can be at least partially exposed or shifted through the orifice such that a tipped distal end of the injection needle is allowed to penetrate or to pierce a puncture site of biological tissue of a patient.

[0020] In some examples the injection device is implemented as a so-called auto injector. Here, the drive mechanism of the injection device serves to displace the stopper of the medicament container in distal direction to expel the medicament from the medicament container through the injection needle into biological tissue.

[0021] The drive mechanism of the drive unit may comprise a piston rod or plunger to operably engage with the stopper of the medicament container. In this way the drive mechanism may exert a distally directed pressure by way of which the stopper can be moved or displaced in distal direction relative to a barrel of the medicament container, which is filled with the liquid injectable medicament.

[0022] The injection unit may be implemented as a disposable injection unit. By way of its proximal end and the connecting portion provided at the proximal end the injection unit can be detachably connected to a re-usable drive unit of the injection device. The drive unit of the injection device can be implemented as a reusable part of the injection device, e.g. as a reusable part of an auto-injector.

[0023] The injection unit may be implemented as a disposable part of the injection device. In some examples the injection unit is configured to provide a single dose of the medicament. Hence, the injection unit may be particularly designed for a single dose injection by way of which the entirety or almost the entirety of the liquid injectable medicament located inside the medicament container is injected or dispensed.

[0024] After use the injection unit may be replaced by another injection unit and may be discarded. In this way, there can be provided an auto-injector with a reusable drive unit to be selectively and repeatedly connectable with an injection unit of disposable type. The injection unit of disposable type may be implemented in a rather sustainable and ecologically friendly manner. Moreover, since parts of the injection device, namely the drive unit is intended and designed for multiple use or is implemented as a reusable device component, the overall ecological footprint of the injection device can be reduced. At the same time costs and expenditure for device manufacturing and device assembly can be reduced.

[0025] According to some examples the sidewall of the injection unit extends entirely between the distal end and the proximal end of the unit housing. Hence, the unit housing may comprise a kind of a unitary structure. The sidewall of the unit housing may entirely and / or unitarily extend from the distal end of the unit housing to the proximal end of the unit housing. In this way there can be provided a rather attractive and standardized design for the injection unit. Overall handling of the injection unit becomes rather intuitive and simple. According to a further example the mount for the medicament container is fixable or is fixed to the sidewall of the unit housing. The mount may be particularly configured and designed for fastening and fixing of the medicament container inside the container receptacle of the unit housing. It may frictionally engage with the medicament container or it may be configured to fix the medicament container inside the container receptacle by way of a positive fitting or positive fit connection. After use the entire unit housing and hence the entire injection unit may be discarded with the medicament container located therein.

[0026] According to a further example the mount is integrated into the sidewall or is unitarily shaped with the sidewall. Here, an inside surface of the sidewall may comprise at least in sections a radially narrowed neck portion by way of which there can be provided a firm fitting or firm fixing of the medicament container inside the container receptacle. Depending on the way of manufacturing the unit housing the mount can be easily integrated into the sidewall of the unit housing. For instance, with an injection molded unit housing the inside surface or inside structure of the container receptacle as confined by the sidewall of the unit housing may conform the outside shape or outside geometry of the medicament container. Hence, an inside surface or inside structure of the unit housing may conform the shape or geometry of the medicament container to provide a firm fitting and fixing of the medicament container inside the container receptacle. Instead of an injection molding the unit housing may be also provided by deep drawing a respective housing material.

[0027] In some examples the entire unit housing may be unitarily shaped or may be made from a single piece of material. In this way, the unit housing may be made of only one material or material composition. In some examples, the housing may be formed by folding a sheet of material into a sidewall structure confining or forming the container receptacle. This way, manufacturing costs and expenditure for assembly of the injection unit may be reduced.

[0028] In further examples the injection unit comprises numerous components that are assembled together. Here, the mount for the medicament container may be provided or may form a separate piece configured for fastening or fixing to the sidewall of the unit housing. In this way, the separate mount may provide a universal adaptation to differently sized or differently shaped medicament containers while making use of always one and the same unit housing. Here, the mount may provide or form a mounting adapter to enable a fixing and attachment of medicament containers of different size or different geometry inside the container receptacle.

[0029] According to a further example the mount comprises or constitutes a holder for the medicament container, which is fixable inside the container receptacle. Here, the holder may be provided as a separate piece that is to be separately provided and that is to be arranged inside the container receptacle. The holder may be configured for fastening or fixing inside the container receptacle, e.g. by fastening the holder to an inside surface of the sidewall of the unit housing.

[0030] The mount and / or the holder may provide a firm fitting with the medicament container and may provide a firm fastening and fixing of the medicament container inside the container receptacle.

[0031] According to a further example the mount comprises a first stop face defining a distal injection position for the medicament container. The first stop face may face in proximal direction and may be configured to engage with a complementary shaped distally facing abutment face or stop face of the medicament container. In this way it can be provided that any distally directed force applied to the stopper of the medicament container can be counteracted by the mutual abutment between the stop face of the mount and the complementary stop face or abutment face of the medicament container.

[0032] Hence, a distally directed displacement of the medicament container relative to the mount and / or relative to the sidewall or unit housing can be effectively prevented. In some examples and when in the pre-injection configuration the first stop face of the mount may not (yet) be engaged with the complementary shaped abutment or counter stop face of the medicament container. It may be only in the course of transferring the injection unit from the pre-injection configuration into the injection configuration that the medicament container is subject to a distally directed movement relative to at least one of the mount and the distal end or sidewall of the unit housing.

[0033] In other examples and when the injection unit is in the pre-injection configuration the stop face of the mount may be already in longitudinal abutment or longitudinal engagement with a complementary shaped counter stop face of the medicament container.

[0034] In some examples the medicament container comprises a prefilled syringe. Typically and near a proximal end of the medicament container the medicament container may comprise a radially outwardly extending flange portion, e.g. implemented as a barrel flange by way of which the medicament container may suitably abut in distal direction at the first stop face. Hence, a proximal side of the barrel flange of the medicament container may form or constitute the complementary shaped counter stop face to provide a suitable longitudinal fixing or abutment of the medicament container inside the container receptacle. According to a further example the mount of the injection unit comprises at least one clamp element to frictionally engage with an outside surface of a barrel of the medicament container. The at least one clamp element may provide a firm fitting and / or firm fastening or fixing of the medicament container inside the container receptacle of the unit housing. The clamp element may comprise a sleeve like or shell-like structure.

[0035] The at least one clamp element may comprise an annular structure with an inner diameter that is smaller than or equal to an outside diameter or cross-section of the barrel of the medicament container. In this way the medicament container may be securely and firmly fitted and fixed inside the container receptacle. The fitting or fixing of the medicament container inside the container receptacle may be accompanied with a resilient deformation or squeezing of the clamp element.

[0036] According to further examples there may be provided numerous clamp elements along the outer circumference of the medicament container. Hence, there may be provided first and second clamp elements at diametrically opposite positions of the medicament container. In further examples there may be provided three, four or even more clamp elements that may be equally and / or equiangularly distributed around the outer circumference of the medicament container. In this way, there can be achieved a similar clamping effect for fixing of firmly holding the medicament container inside the container receptacle.

[0037] According to some examples the mount is configured to support and / or to allow a proximally directed sliding movement of the medicament container relative to the mount. In this way, the mount may provide a proximally directed retraction of the medicament container such that a needle, which may protrude in distal direction through the orifice at the distal end of the injection unit, can be retracted back into the container receptacle. Such a retraction and / or proximal directed displacement relative to the distal end of the unit housing may be typically conducted in the course of transferring the injection unit from the injection configuration into a post-injection configuration. By retracting the medicament container in proximal direction relative to the distal end of the unit housing the distally located needle tip can be effectively concealed in the interior of the unit housing and hence in the container receptacle. In this way, a danger or risk of inadvertent stitching at the distal end of needle can be effectively reduced. This way, handling of the injection unit after conducting the injection procedure can become rather simple and failure safe.

[0038] According to some examples the proximally directed sliding displacement or displaceability of the medicament container relative to the mount enables a well-defined retraction of the medicament container and the needle attached thereto in proximal direction after conducting the injection procedure. In some examples the proximally directed displacement may be triggered or controlled by the drive mechanism and / or by a piston or plunger of the drive mechanism of the drive unit. Here, the plunger or piston rod may be connected to the stopper of the medicament container and may be configured to transmit or to transfer tensile forces.

[0039] Hence, by retracting or by moving the piston or plunger in proximal direction, e.g. as provided by the drive mechanism, there can be applied a respective proximally directed dragging force onto the stopper, which due to its frictional engagement with the barrel of the medicament containers may also serve to move the entire medicament container in proximal direction.

[0040] According to a further example the unit housing comprises a retention element to mechanically engage with a proximal end of the medicament container. The retention element is configured to prevent a proximally directed movement of the medicament container relative to at least one of the sidewall and the mount. The retention element may be of particular use when the injection unit is not (yet) connected to the drive unit. In this way, an uncontrolled or inadvertent proximally directed sliding displacement of the medicament container relative to the unit housing can be effectively prevented. This might be of particular benefit during transportation and storage of isolated injection units configured for use with a re-usable drive unit of the injection device.

[0041] The retention element may be configured to engage with a complementary shaped portion of the medicament container. In some examples the retention element may be arranged and configured at an inside of the sidewall of the unit housing to engage with a proximal end of the medicament container, e.g., with a proximal end of a barrel of the medicament container. In this way, and when the medicament container is arranged and fixed inside the container receptacle it can be effectively secured against uncontrolled displacement relative to the unit housing in longitudinal direction, i.e., in longitudinal distal direction as well as with respect to the longitudinal proximal direction.

[0042] According to a further example the retention element is transferable from an activated state into an inactive state through interaction with the drive mechanism of the drive unit. When in the activated state the retention element is configured to prevent the proximally directed movement of the medicament container relative to at least one of the sidewall and the mount. When in the inactive state the retention element is configured to allow or to support the proximally directed movement of the medicament container relative to at least one of the sidewall and the mount.

[0043] According to some examples it is upon final assembly of the injection device, namely in the course of connecting the injection unit to the drive unit that the retention element is transferred from the activated state into the inactive state. In this way, the retention functionality of the retention element can be abrogated as soon the injection unit is duly attached or connected to the drive unit of the injection device. It may be then that the plunger or piston rod of the drive mechanism provides a respective retention function by way of which a proximally directed movement of the medicament container relative to the mount or distal end of the unit housing is effectively prevented.

[0044] It may be only upon transferring of the injection unit from the injection configuration into the post-injection configuration that the medicament container is allowed to move proximally, i.e., in proximal direction relative to the unit housing, relative to the sidewall and / or relative to the distal end of the unit housing, e.g., in order to withdraw the needle attached to the medicament container into the container receptacle or container compartment of the unit housing.

[0045] According to a further example a longitudinal distance between the distal end and the proximal end of the unit housing is variable. Such a variable distance may be obtained by making use of a particular housing material for the unit housing. Hence, there may be used and provided a resilient or deformable material to form or to constitute the unit housing and / or the sidewall of the unit housing. In this way, the longitudinal distance between the distal end and the proximal end of the unit housing can be varied in a rather simple and elegant manner.

[0046] According to a further example the sidewall of the unit housing comprises a resilient portion, which is located between the distal end and the mount for the medicament container. The resilient portion is compressible in longitudinal direction. In some examples it may be compressible in longitudinal direction against an elastic restoring force. With an inherent elasticity and when compressed the resilient portion may return into an initial uncompressed state when a force effect configured to compress the resilient portion is no longer applied to the unit housing.

[0047] By way of providing a resilient portion at or in the sidewall of the unit housing there can be provided a proximally directed displacement of the distal end of the unit housing or sidewall of the unit housing relative to the mount and / or relative to the medicament container attached, held or fixed to the mount of the injection unit. In this way the medicament container may remain in the distal injection position when transferring the injection unit from the pre-injection configuration into or towards the injection configuration. Rather, it may be that distal end of the unit housing and / or of the sidewall of the unit housing is subject to a proximally directed displacement relative to the mount and hence relative to the medicament container or relative to the needle attached to the medicament container. In this way there can be provided a shifting of the injection needle through the orifice as provided at the distal end of the unit housing.

[0048] In some examples and when the resilient portion of the sidewall is compressible in longitudinal direction against a restoring force, the unit housing may automatically return into the preinjection configuration or may transfer into the house-injection configuration upon completion of a medicament injection procedure. Generally, the resilient portion of the sidewall may be subject to a compression when a proximally directed force effect is applied to the distal end of the unit housing relative to the proximal end of the unit housing.

[0049] Due to the proximally directed force effect, which may arise by urging the entire unit housing or injection unit in distal direction against a skin of a patient the injection needle may be displaced in distal direction relative to the distal end of the unit housing. Vice versa, the unit housing may be subject to a proximally directed displacement relative to the needle. As soon as a respective force effect is no longer applied to the distal end of the unit housing the unit housing may relax into or towards its initial configuration by way of which the injection unit is either transferred into the pre-injection configuration or is transferred into a post-injection configuration. In either configuration the distal end of the tipped needle may be securely concealed or held inside the interior of the unit housing, e.g. inside the container compartment or container receptacle as provided by the sidewall of the unit housing.

[0050] According to a further example the resilient portion comprises a bellow section through which the distal end of the unit housing is connected to the proximal end of the unit housing. In this way, the longitudinal distance between the distal end and the proximal end of the unit housing can be easily varied, namely by longitudinally comperssing the bellow section. The bellow section may comprise an alternating sequence of slanted or beveled sidewall sections, which support a kind of a dilatation and compression of the resilient portion of the sidewall of the unit housing in longitudinal direction.

[0051] With a bellow section entirely surrounding the circumference of the elongated unit housing a large variety of different materials can be used for implementing the sidewall. Here, even comparatively stiff or non-resilient materials may be used for the sidewall. It is then due to the geometry and the intrinsic deformability of the bellow section that there can be provided a sufficient and suitable longitudinal compression or longitudinal dilatation of the sidewall of the unit housing.

[0052] According to a further example the injection unit is transferable from the injection configuration into a post-injection configuration by moving at least one of the mount and the medicament container relative to the distal end of the unit housing in the longitudinal direction in order to retract the injection needle into the container receptacle or into the interior as confined by the sidewall of the unit housing.

[0053] The post- injection configuration may distinguish from the pre-injection configuration in that when the injection unit is in the post-injection configuration a repeated displacement of at least one of the mount and the medicament container relative to the distal end along the longitudinal direction for shifting the injection needle through the orifice is no longer possible and may be prevented or blocked as soon as post-injection configuration has been reached.

[0054] In this way, the post-injection configuration may be characterized by a lockout feature or by a lockout functionality of the injection unit. Hence, after conducting an injection procedure and after transferring the injection unit from the pre-injection configuration into the injection configuration and further into the post-injection configuration a repeated use of the injection unit may be no longer possible. In this way, an unintended or unauthorized use of the injection unit can be effectively prevented. The patient or user of the injection unit or of the injection device is rather obliged to replace the used injection unit by another injection unit for conducting a further injection procedure.

[0055] According to another example the injection unit comprises a lockout mechanism comprising a lockout element, which is configured to block transferring of the injection unit from the postinjection configuration into the injection configuration. The lockout element may be activated of may be transferred into an activated state in the course of transferring the injection unit from the pre-injection configuration into or towards the injection configuration. Here, the lockout element and hence the lockout mechanism may be activated through or upon transferring the injection unit from the pre-injection configuration into the injection configuration. The lockout element may be subject to a longitudinal displacement or movement relative to at least one of the mount and the unit housing when transferring the injection unit from the pre-injection configuration towards or into the injection configuration.

[0056] Upon reaching or prior to reaching the injection configuration the lockout element may be in a locking position by way of which the lockout mechanism is activated and provides an effective pre-use prevention of the injection units. Even when disconnected from the drive unit of the injection device the lockout mechanism may remain activated. In this way it will be impossible or prevented that the needle may repeatedly protrude through the orifice at the distal end of the unit housing. In this way and when detaching a used injection unit in a post-injection configuration from the drive unit it can be effectively prevented that the needle by accident protrudes through the orifice. A danger or risk of an inadvertent needle stitch can be thus effectively reduced.

[0057] According to a further example the lockout element is longitudinally movable inside the container receptacle. The lockout element comprises a distal fastener to connect to a complementary shaped counter fastener, which is provided at or near the distal end of at least one of the unit housing and the sidewall of the unit housing. The distal fastener is configured to connect to the counter fastener when or upon reaching the injection configuration. In the preinjection configuration the fastener may be still disconnected from the counter fastener. When and upon reaching the injection configuration the distal fastener may be releasably or detachably connect to the respective counter fastener.

[0058] In this way, the lockout element can be attached or connected and hence mechanically engaged with the distal end of the unit housing. It may be displaced towards the distal end of the unit housing in the course of transferring the injection unit from the pre-injection configuration into the injection configuration.

[0059] According to a further example the lockout element is displaceable in longitudinal distal direction relative to the sidewall by transferring the injection unit from the injection configuration into the post-injection configuration. Here, the lockout element, which may comprise a lockout sleeve may be displaced in distal direction relative to the medicament container and / or relative to the needle of the medicament container. In this way, a distal end of the needle may be encapsulated by the hollow structure of the lockout element and hence by the hollow interior of the lockout sleeve. The lockout element may comprise of conforming a kind of a needle sheath thus protecting the distal end of the needle against inadvertent mechanical contact.

[0060] According to a further example the lockout element is rigid in compression. It is configured to abut with a distally facing lockout abutment of the unit housing and to abut with a proximally facing abutment section of the distal end when reaching the post-injection configuration. Since the lockout element, e.g., the lockout sleeve, is rigid in compression and when the lockout element is located longitudinally between the proximally facing abutment section of the distal end of the unit housing and the lockout abutment of the unit housing it may prevent a proximally directed displacement of the distal end of the unit housing relative to at least one of the mount and the proximal end of the unit housing.

[0061] Here, the proximally facing abutment section of the distal end of the unit housing may get in longitudinal abutment with a distal end or with a respective distally facing abutment face of the lockout element. A proximal end or a respective proximally facing abutment section of the lockout element may get in a respective longitudinal abutment with the distally facing lockout abutment provided on or inside the unit housing.

[0062] The distally facing lockout abutment may be provided proximally from resilient portion and hence at a side of the resilient portion that is opposite to the distal end. Hence, the lockout element may serve as a bridge extending across the resilient portion of the sidewall. It may be in longitudinal abutment with the lockout abutment of the unit housing with a proximal end and may be further in longitudinal abutment with the proximally facing abutment section of the distal end of the unit housing with a distal and.

[0063] In this way, the lockout element may effectively prevent a repeated or an overly proximally directed displacement of the distal end of the unit housing or sidewall relative to mount or medicament container connected or engaged therewith.

[0064] According to a further example the resilient portion of the sidewall is located longitudinally between the lockout abutment and the distal end. In this way it can be provided that the lockout element, hence the lockout sleeve effectively bridges the resilient portion of the sidewall and prevents a compression of the sidewall due to its inherent stiffness or its rigidity in compression. A proximally directed force effect as applied to the distal end of the unit housing will transfer into the lockout element and a respective force effect may further transfer through the lockout element into the distally facing lockout abutment of the unit housing, which is located proximal to the resilient portion of the sidewall of the unit housing.

[0065] In some examples it may be provided that the distal end of the unit housing with its counter fastener engages the distal fastener of the lockout element when the resilient portion of the sidewall is subject to compression. It may be then due to the inherent restoring force of the resilient portion of the sidewall that the distal end of the sidewall is subject to a distally directed displacement relative to the mount and / or relative to the injection needle when a respective proximally directed force effect is no longer applied to the distal end of the unit housing. Since the distal end of the unit housing may be then operably connected to the lockout element the lockout element will be dragged or shifted automatically in distal direction relative to the mount and / or relative to the medicament container in the course of a relaxation of the resilient portion. It may be then that the proximal end or a proximally facing abutment section of the lockout element gets in longitudinal abutment with the lockout abutment of the unit housing thereby automatically activating the lockout mechanism. According to a further example the lockout element may be engaged with a return element, e.g. with a spring element. The spring element may be located between the mount and the lockout element. The spring may be configured to provide a distally directed restoring force onto the lockout element in order to support an automatic activation of the lockout mechanism when the injection process has terminated and / or when the injection unit is transferred from the injection configuration towards or into the post-injection configuration.

[0066] According to further examples the unit housing comprises or is made of at least one of the following materials: polypropylene, polyethylene, polyethylene terephthalate, polyurethane, polystyrene, polyvinyl chloride, polyether ether ketone, polycarbonate, polyethylenimine, polysulfone, polylactide, lignin-derived composite materials, cardboard, molded pulp material or molded fiber material and mixtures or composites thereof.

[0067] At least some or all of these materials exhibit a comparatively small ecological footprint. They may be classified to be ecologically friendly or may exhibit a comparatively beneficial decomposition rate after discarding. They may be biocompatible.

[0068] Hence, by making use of any one of these above-mentioned materials for manufacturing the unit housing and / or the mount an environmental burden or ecological footprint emanating from the injection unit can be effectively reduced. The overall sustainability assessment of the injection device can be improved by making use of at least one of the above mentioned materials.

[0069] According to a further example the unit housing comprises one of a circular, an oval, a triangular, a rectangular, a quadratic cross or polygonal cross section. Depending on the choice of materials for manufacturing the unit housing, one or several of the above mentioned cross- sectional geometries may be beneficial. For instance, with lignin-derived composite materials or molded pulp material or molded fiber material, such as paper based or cardboard based materials the mechanical stability or rigidity of the respective unit housing may be improved when implementing one of a circular, an oval, a triangular, a rectangular, a quadratic cross or polygonal cross section.

[0070] Moreover and since the injection unit is configured to be of disposable type a rather large variety of materials for manufacturing the unit housing can be used to reduce the ecological footprint arising from the injection unit. According to a further example the sidewall of the unit housing comprises at least a first elongated sidewall section and a second elongated sidewall section. The first elongated sidewall section is pivotable relative to the second sidewall section with regard to a pivot axis extending substantially parallel to the longitudinal direction. In further examples there may be provided three or more elongated sidewall sections that are arranged parallel and which may comprise a substantially equal size. In this way there may be provided a sidewall with a triangular like or triangular cross-section. With further examples there may be provided four or even more elongated sidewall sections that are arranged parallel to each other and which are mutually connected by respective pivot or folding axes, which all extend substantially parallel to each other. In this way, there can be provided a rectangular, a quadratic or a polygonal crosssection of the sidewall of the unit housing. This may be of particular benefit to wrap or to arrange the medicament container radially inside the unit housing.

[0071] Moreover, also the mount may be easily arranged and fixed inside the unit housing when the unit housing may be manufactured by providing a sidewall made from a wrappable or foldable sheet material, which is folded or wrapped into a closed, i.e., into a circumferentially closed configuration to form a triangular, rectangular, quadratic or polygonal cross-sectional sidewall.

[0072] According to a further example the sidewall comprises at least one inspection window to visually inspect the container receptacle. The sidewall may comprise two inspection windows located at diametrically opposite side wall sections. This may allow to provide an improved visual inspection of the content located inside the container receptacle.

[0073] In further examples and when the mount is implemented as a separate piece or part and / or when the mount comprises a separate holder configured for attachment or arrangement inside the unit housing also the mount or holder may comprise at least one mount window. Typically, the mount window of the mount may be aligned with the inspection window of the sidewall of the injection unit. Also here, the mount may comprise at least two diametrically oppositely located mount windows, which may provide an unobstructed visual inspection of the medicament container readily assembled inside the mount and / or inside the container receptacle or container compartment of the unit housing.

[0074] According to a further example the medicament container is arranged and fixed inside the container receptacle. The medicament container may comprise a tubularly-shaped barrel, which is sealed in proximal longitudinal direction by a movable stopper. Towards the distal longitudinal direction the medicament container may comprise an outlet. The outlet of the container may be provided with an injection needle. According to some examples the medicament container comprises a pre-filled syringe.

[0075] According to another aspect the present disclosure also relates to an injection device comprising a drive unit and comprising an injection unit as described above. The drive unit comprises the drive mechanism and a body to house the drive mechanism. The body is detachably connectable to the proximal end of the unit housing. Accordingly, the body comprises a counter connecting portion, which is complementary shaped to the connecting portion of the proximal end of the unit housing. In this way, there can be provided a standardized and detachable or releasable connection between the body of the drive unit and the unit housing of the injection unit.

[0076] According to some examples the body of the drive unit comprises a receptacle sized and configured to receive at least the proximal end of the injection unit. Here, an inside surface of the sidewall of the receptacle of the body is provided with the counter connecting portion, which is sized and configured to detachably or releasably connect with the connecting portion provided at the proximal end of the injection unit.

[0077] The drive mechanism of the drive unit may be resettable. It may be controllable by at least one control or actuating element. Hence, the drive unit may be triggered by a user to displace the plunger or piston rod in distal direction for expelling a dose of the medicament and / or for driving or urging the stopper of the medicament container in distal direction. The drive mechanism may be resettable while the injection unit is and remains connected to the drive unit. Resetting of the drive mechanism may include a proximally directed longitudinal displacement of the plunger or piston rod into an initial or intermediate longitudinal position, by way of which there may be also provided a retraction of the medicament container relative to the mount and / or by way of which the needle protruding from the distal end of the injection unit when in the injection configuration is withdrawn into the interior of the unit housing when transferring the injection unit from the injection configuration into the post-injection configuration.

[0078] Accordingly, and since the injection device comprises an injection unit as described above all features, effects and benefits as described above in connection with the injection unit equally apply to the injection device; and vice versa.

[0079] According to another aspect the present disclosure also relates to a method of manufacturing an injection unit as described herein. For this, there are provided a unit housing and a medicament container. In a further step the medicament container is arranged and fixed in the unit housing and in a further step the so-formed injection unit with the unit housing and the medicament container arranged therein is optionally sealed or wrapped inside a foil to protect the inside and the interior of the unit housing against environmental influences.

[0080] The method may also relate to the manufacturing or assembly of the injection device as described herein.

[0081] Insofar, all features, effects and benefits as described herein with respect to the injection unit and the injection device equally apply to them method of manufacturing or assembling the injection unit answers or the injection device; and vice versa.

[0082] Generally, the scope of the present disclosure is defined by the content of the claims. The disclosure is not limited to specific embodiments or examples but comprises any combination of elements of different embodiments or examples. Insofar, the present disclosure covers any combination of claims and any technically feasible combination of the features disclosed in connection with different examples or embodiments.

[0083] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0084] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0085] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0086] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0087] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0088] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0089] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); 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®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(co-carboxyheptadecanoyl) human insulin.

[0090] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1 Eligen, GRMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1 , ZYD-1, GSK-2374697, DA-3091 , MAR-701 , MAR709, ZP- 2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA- 15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide- XTEN and Glucagon-Xten. An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom. Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0091] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0092] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0093] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0094] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0095] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0096] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0097] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0098] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0099] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0100] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

[0101] As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0102] Brief description of the drawings

[0103] In the following, some examples of an injection unit and an injection device will be described in greater detail by making reference to the drawings, in which:

[0104] Fig. 1 schematically shows an example of an injection unit,

[0105] Fig. 2 schematically shows a drive unit of an injection device configured for use with the injection unit,

[0106] Fig. 3 shows a further example of an injection unit in a perspective illustration,

[0107] Fig. 4 shows a further example of an injection unit,

[0108] Fig. 5 shows a further longitudinal cross-section through another example of an injection unit,

[0109] Fig. 6 shows a further example of an injection unit in a longitudinal cross-section,

[0110] Fig. 7 shows a side view of an injection unit with an inspection window covered by a cover,

[0111] Fig. 8 shows the injection unit of Fig. 7 with the cover removed,

[0112] Fig. 9 shows another example of the injection unit,

[0113] Fig. 10 shows a further example of an injection unit, Fig. 11 shows another example of an injection unit,

[0114] Fig. 12 shows an assembly of numerous injection units interconnected via a packaging, Fig. 13 shows a longitudinal cross-section through the injection unit equipped with a medicament container in the pre-injection configuration,

[0115] Fig. 14 shows the injection unit according to Fig. 13 after removal of a needle cap,

[0116] Fig. 15 shows the injection unit of Figs. 13 and 14 after transferring the injection unit into the injection configuration,

[0117] Fig. 16 shows the injection unit after completion of an injection procedure,

[0118] Fig. 17 shows the injection unit after transferring into a post-dispensing configuration,

[0119] Fig. 18 shows the injection unit after disconnection from the drive unit or drive mechanism,

[0120] Fig. 19 shows an enlarged view of one possible solution for mutually connecting the plunger and the piston,

[0121] Fig. 20 shows a further example for connecting the plunger and the stopper,

[0122] Fig. 21 shows a further example of connecting the plunger or piston rod with the stopper of the medicament container,

[0123] Fig. 22 shows a further example of the injection unit provided with a cover at the distal end,

[0124] Fig. 23 shows the injection unit according to Fig. 22 after removal of the cover,

[0125] Fig. 24 shows the injection unit of Fig. 23 after transferring into the injection configuration,

[0126] Fig. 25 shows the injection unit after transferring into the post-injection configuration,

[0127] Fig. 26 shows a further example of the injection unit in the pre-injection configuration or post-dispensing configuration,

[0128] Fig. 27 shows the example of an injection unit according to Fig. 26 in the injection configuration,

[0129] Fig. 28 shows a further example of the injection unit,

[0130] Fig. 29 shows one example of a unit housing, and

[0131] Fig. 30 shows an isolated example of the medicament container and the mount before assembly inside the unit housing,

[0132] Fig. 31 shows a preassembly of the mount and the medicament container,

[0133] Fig. 32 illustrates an assembly or mounting process for manufacturing the injection unit,

[0134] Fig. 33 shows the injection unit according to Figs. 32 in its final assembly configuration and

[0135] Fig. 34 is a flowchart of a method of assembling an injection unit as described herein.

[0136] Detailed description

[0137] In Figs. 1 and 2 there is illustrated one example of an injection device 1 comprising a drive unit 4 and further comprising an injection unit 10 as separately illustrated in Fig. 1 . The drive unit 4 comprises a drive mechanism 5. The drive mechanism 5 may be operated or triggered by a user. The drive mechanism 5 comprises a plunger 6, which is displaceable in longitudinal distal direction 2 to engage with a stopper 23 of a medicament container 20 as e.g. shown in Figs. 14- 17. The drive unit 4 comprises a body 7 and hence a drive unit housing. The plunger 6 is longitudinally displaceable inside the body 7. It may extend into a receptacle 8, which may be open towards a distal direction 2. The receptacle 8 may be sized and configured to receive or to engage with a proximal end 13 of the injection unit 10. Hence, the injection unit 10 may be at least partially inserted in longitudinal direction into the receptacle 8 and may engage with the receptacle 8 in a releasable or detachable manner.

[0138] The injection unit 10 as e.g. described in greater detail in Figs. 1-21 comprises a unit housing 11. The unit housing 11 comprises a distal end 12. The distal end 12 comprises an orifice 14 or through opening for an injection needle 22 of a medicament container 20, which is located inside the unit housing 11. The unit housing 11 comprises a sidewall 15 confining or defining a container receptacle 16. At the proximal end 13 the unit housing 11 comprises a connecting portion 40 in order to detachably connect to a counter fastener 46 as provided on or inside the body 8 of the drive unit 4. The connecting portion 14 may comprise at least one fastening element 41 complementary shaped to a counter fastener 46 or counter fastening element.

[0139] In addition, there may be provided a guiding structure 42 at the proximal end 13 to engage with a complementary shaped counter fixing structure or counter guiding structure 47 as provided on or inside the body 7. The fastening element 41 and the complementary shaped counter fixing structure 46 may comprise, e.g., one of a snap fit connection, a threaded connection or a bayonet connection by way of which the connecting portion 40 can be detachably or releasably connected to the body 7 of the drive unit 4.

[0140] In this way, the drive unit 4 may be implemented as a reusable unit or reusable part of the injection device 1 and the injection unit 10 can be implemented as a disposable unit or disposable part of the injection device 1. The sidewall 15 of the injection unit 10 may comprise one or two or even more inspection window 35 by way of which the content inside the container receptacle 16 can be visually inspected from outside the unit housing 11.

[0141] The distal end 12 of the unit housing 11 may be connected to the proximal end 13 of the unit housing 11 via a resilient portion 18. As illustrated in the numerous examples of Figs. 1-21 the resilient portion 18 comprises a bellow section 19, which enables and provides a longitudinal compression of the entire unit housing 11 in longitudinal direction. Hence, by way of the compressibility of the bellow section 19 and hence the resilient portion 18 the longitudinal distance between the distal end 12 and the proximal end 13 can be varied.

[0142] The overall design of the unit housing 11 may be of rather arbitrary shape. In the example according to Fig. 3 the geometry of the unit housing and hence of the sidewall is rather rectangular or quadratic. Here, the unit housing comprises numerous sidewall section 15a, 15b, 15c, 15d, which may extend at a predefined angle relative to each other. Each one of the sidewall sections 15a, 15b, 15c, 15d may be of a slat-profiled shape and may be rather even shaped. In the alternative example as shown in Fig. 4, the sidewall 15 is of substantially tubular shape.

[0143] Inside the unit housing 11 there is provided a mount 30 for the medicament container 20. The mount 30 may comprise at least one clamp element 32 featuring a reduced diameter compared to residual or longitudinally adjoining portions of the sidewall 15. The clamp element 32 may provide a firm fitting of firm fastening of the medicament container 20 and / or of its barrel 21 inside the hollow interior as confined in circumferential or radial direction by the at least one clamp elements 32.

[0144] In the example of Fig. 5, the mount 30 is formed by a radially narrowed neck portion forming the clamp element 32. Here, there is provided a radially narrowed neck portion and hence a clamp element 32 in the sidewall 15. The clamp element 32 is located between the proximal end 13 and the resilient portion 18. When the medicament container 20 is assembled inside the container receptacle 16 it is firmly held by the clamp element 32 and hence by the radially narrowed neck portion of the sidewall 15 of the unit housing 11.

[0145] With the example according to Fig. 5 the mount 30 is somewhat integrally formed or integrated into the sidewall 15 of the unit housing 11. In the example of Fig. 6 the mount 30 is provided as a separate part. Here, the mount 30 comprises or forms a holder 36 that is be assembled separately inside the unit housing 11. lt may be fixed inside the unit housing with regard to the longitudinal direction. Also here, the mount 30 and hence the holder 36 comprises a sidewall 37, e.g., of tubular shape. Yet the sidewall 37 may form or comprise an aperture 39 sized to receive the medicament container 20 there through or therein.

[0146] The inspection window 35 as provided in the sidewall 15 may be initially covered by a cover 75. The cover 75 may comprise a non-transparent and hence opaque foil 76, which may be peeled away immediately before use of the injection unit 10 or before use of the injection device 1. In the illustration of Fig. 8 the cover 75 or foil 67 has been peeled away and hence detached from the housing 15. Thus, there is provided an unobstructed view into the interior of the unit housing 11 through the inspection window 35.

[0147] In the example of Fig. 9 the proximal end 13 may be additionally provided with a mechanical coding 43. The mechanical coding 43 may be complementary shaped to a respective mechanical counter coding as provided on or inside the body 7 of the drive unit 4 (not illustrated).

[0148] By way of the mechanical coding 43 it can be prevented that an injection unit 10 unsuitable for a particular drive unit 4 can be assembled in an unauthorized or non-intended way to such a drive unit. By way of the mechanical coding 43 and by way of a complementary shaped mechanical counter coding on the side of the drive unit 4 it can be provided that only and exclusively such injection units 10 can be used with a drive unit 4 which the injection unit 10 is intended for. Unintended or unauthorized cross use of non-matching injection units 10 and drive units 4 can be effectively prevented.

[0149] In the example of Fig. 10 there is provided a sleeve-shaped cover 75 surrounding at least a portion of the unit housing 11. The cover 75 may be provided with a label or with printed information being indicative about the properties or content of the injection unit 10. The cover 75 or the cover sleeve 75 may support user convenience and may contribute to the outer design language of the injection unit. Eventual recesses as provided on the outside surface of the sidewall 15 may be covered or "pasted over" by the cover 75.

[0150] In the example of Fig. 11 at least a portion or the entirety of the unit housing 11 is wrapped inside a foil 76. Here, the foil 76 may comprise a shrink foil and may be laminated or adhered to the outside surface of the unit housing 11 . The foil 76 may also support fixing of a closure cap 77 to the unit housing 11 , typically to the distal end 12 of the unit housing 11. By destroying or by detaching the foil 76 the closure cap 77 may be removed from the injection unit 10. In some examples the closure cap 77 may be provided with a gripping structure 78, which may comprise an eyelet for ease of gripping and detaching the closure cap 77 from the distal end 12 of the unit housing 11 of the injection unit 10.

[0151] In Fig. 11 there is shown a kit of numerous injection units 10, 10', 10". Here, each injection unit may be readily equipped or provided with a medicament container 20 assembled therein (not shown). The the individual injection unit 10, 10', 10" may be mutually mechanically connected via their foil 76. The foil, e.g. implemented as a laminated or shrink foil may mutually connect the various injection units 10, 10', 10". Here, the foil 76 may cover at least a portion of all the injection units 10, 10', 10" which be hence mutually connected via a perforation 79 to one another. Hence the foil 76 engaged with the injection unit 10 may be detachably connected to the foil 76'. In the same way, the foil 76' may be connected to another foil or foil portion 76" via another perforation or score line 79', wherein the further foil 76" at least partially covers or encloses a portion of the further injection unit 10". By way of the lamination or by way of the arrangement of the foils 76, 76', 76" a comparatively large number of injection units 10 can be mutually attached and bundled as a commercially distributable unit, e.g. as a kit or as an assembly of individual injection units 10.

[0152] A user may simply detach a single injection unit 10 from such a kit by disconnecting the injection unit 10 with its foil 76 along the perforation 79.

[0153] In the sequence of Figs. 13-18 one mode of operation of the injection unit 10 is exemplary shown and illustrated. In Fig. 13 the injection unit 10 is in an initial configuration. The medicament container 20 comprises a barrel 21, which is sealed in proximal direction 3 by a movable stopper 23. Between a distal end of the barrel 21 and the stopper 23 there is provided the injectable medicament 24 inside the barrel 21 . The distal outlet end of the barrel 21 and hence the distal outlet of the medicament container 20 is provided with a tipped injection needle 22. In the initial configuration as shown in Fig. 13 the injection needle 22 is entirely covered by a protective needle cap 70. The needle cap 70 protrudes through the orifice 14 as provided at the end face of the distal end 12 of the unit housing 11 . For initiating a dispensing or dose injection procedure a user may grip a portion of the needle cap 70 protruding outwardly through the orifice 14. The medicament container 20 may be secured inside the container receptacle 16 of the unit housing 11 in the initial and hence in the pre-dispensing configuration as shown in Fig. 13. Here, there may be provided a retention element 17 at a well-defined position on an inside surface of the sidewall 15 of the unit housing 11.

[0154] The retention element 17 may be radially deformable. It may comprise a radially displaceable or radially deformable latch element, which in the initial configuration as shown in Fig. 13 is in longitudinal abutment with the proximal end 26 and / or with a radially outwardly protruding barrel flange 25 of the syringe-like medicament container 20. In this way, the medicament container 20 can be secured against a proximally directed displacement relative to the mount 30, which in the presently illustrated example is attached or integrally formed with an inside of the sidewall 15.

[0155] The mount 30 may comprise a proximally facing stop face 31 , which in the example of Fig. 13 may be in longitudinal abutment or longitudinal engagement with the barrel flange 25 of the medicament container 20. In this way and as illustrated in Fig. 13 the medicament container 20 is secured against a distally directed displacement relative to the mount 30. Hence, in the initial configuration and hence in the pre-injection configuration as shown in Figs. 13 and 14 the medicament container 20, e.g., implemented as a prefilled syringe 29, is fixed to the mount 30 and hence to the unit housing 11 with regard to both longitudinal directions, i.e., with respect to the longitudinal distal direction 2 and with respect to the longitudinal proximal direction 3.

[0156] In the illustration of Fig. 14 the injection unit 10 has been duly connected or attached to the drive unit 4. Accordingly, the plunger 6 has entered into the container receptacle 16 via the open proximal end 13. The plunger 6 is only partially illustrated in Figs. 14 and 15. Plunger insertion 6 may deactivate or inactivate the retention element 17. It may fold away the retention element 17 and may thus liberate a proximally displaceability of the medicament container 20 relative to the sidewall 15 or unit housing 11. However, and as long as the plunger 6 is in a longitudinal abutment with the stopper 23 of the medicament container 20 a proximally directed displacement of the medicament container 20 is effectively blocked.

[0157] Now and when turning to the illustration of Fig. 15 there may be applied a proximally directed force effect to the distal end 12 of the unit housing 11 . Due to the resilient portion 18 the distal end 12 is allowed to move in proximal direction 3. Since the medicament container 20 is firmly held in longitudinal position, either by way of its engagement with the plunger 6 or by the firm fixing to the mount 30 the proximally directed displacement of the distal end 12 leads to an exposure of the injection needle 22, which may then be shifted accordingly through the aperture or orifice 14. Such a proximally directed displacement of the distal end 12 may be obtained by urging the sidewall 11 against the skin of a patient.

[0158] In Fig. 16 termination of and dispensing procedure is schematically illustrated. Here, the drive mechanism 5 of the drive unit 4 has been triggered to displace the plunger 6 in distal direction 2 thereby expelling the entirety of the medicament 24 from the interior of the medicament container 20. Thereafter and as shown in Fig. 17 the plunger 6 may be subject to a retractive motion. The plunger 6 may move in proximal direction 3 relative to at least one of the body 7 and the unit housing 11 . Since the distal end of the plunger 6 may be firmly or rigidly attached to the stopper 23, also the stopper experiences a respective force effect or a movement in proximal direction 3. Due to the friction between the stopper 23 and the sidewall of the barrel 21 also the barrel 21 and hence the medicament container 20 in its entirety experiences a respective proximally directed force effect.

[0159] Since the medicament container 20 may be slidably displaceable relative to the mount 30 in proximal direction 3, the medicament container 20 can be withdrawn into the post-dispensing position as shown in Fig. 17. When reaching the post-dispensing configuration configuration as shown in Fig. 17 the barrel flange 25 may engage with at least one further retention element 17', 17" by a way of which the longitudinal position of the medicament container 20 can be fixed relative to the unit housing 11. lt may be then that the plunger 6 can be detached or disconnected from the stopper 23 and is allowed to disconnect from the medicament container 20 as shown in Fig. 18. In this terminal and hence post-injection configuration the medicament container 20 can be detached from the drive unit 4 and can be discarded and / or replaced by another injection unit 10.

[0160] In the example according to Figs. 19-21 there are shown different and conceivable mutual connecting mechanism for connecting the plunger 6 with the stopper 23. The stopper 23 comprises an engagement structure 27, which is complementary shaped to a counter engaging structure 28 provided at the distal end of the plunger 6. In the example of Fig. 19 the engagement structure 27 and the counter engagement structure 28 may form or constitute a friction fit. Here, the mutual connection may be abrogated by applying a force to the plunger 6 in proximal direction 3 above a predefined connecting threshold.

[0161] In Fig. 20 the engagement structure 27 and the counter engagement structure 28 are implemented to form a form fitting engagement. Here, the receptacle as provided at the proximal side of the stopper 23 comprises an undercut or undercut structure to form a form fitting engagement with a complementary shaped insert section of the counter engagement structure 28 of the plunger 6. In the further example of Fig. 21 the engagement structure 27 and the counter engagement structure 28 form or constitute a threaded engagement, which can be released or disconnected by inducing a torque to the plunger 6 relative to the stopper 23.

[0162] In the further example of the injection unit 10 as shown in Figs. 22-25 the injection unit 10 is further provided with a lockout mechanism 50. The lockout mechanism 50 comprises a lockout element 51 , which is located between the mount 30 and the distal end 12 of the unit housing 11. The lockout element 51 comprises a distal fastener 55 to mechanically engage with a complementary shaped counter fastener 65 provided at or near the distal end 12 of the unit housing 11.

[0163] In an initial configuration as shown in Fig. 22, the distal end 12 is covered or provided with a cover 75, which serves as a closure for the distal end 12. The cover 75 may comprise a cupshaped receptacle and may entirely enclose the distal end 12 of the unit housing 11. The cover 75 may be in engagement with the needle cap 70, which in the embodiment of Fig. 22 may be entirely located inside the container receptacle 16. The cover 75 may be provided with a gripping structure 78, e.g. in form of an eyelet for an easy gripping and for providing a rather intuitive and easy detachment of the cover 75 from the distal end 12. By detaching the cover 75 from the distal end 12 also the needle cap 70 will be detached from the injection needle 22. By detaching the cover 75 from the injection unit 10, the orifice 14 is revealed and the injection unit 10 is in principle ready to use.

[0164] In the pre-injection configuration as shown in Fig. 23 the fastener 55 of the lockout element 51 is located at a predefined or initial longitudinal distance from the complementary shaped counter fastener 65 protruding longitudinally inwardly from the distal end 12. It is upon transferring the injection unit 10 from the pre-injection configuration as shown in Fig. 23, into the injection configuration as shown in Fig. 24 that the distal end 12 of the unit housing 11 is subject to a proximally directed movement thereby reducing the distance between the counter fastener 65 and the fastener 55.

[0165] When reaching the injection configuration as shown in Fig. 24 the counter fastener 65 engages the fastener 55. By way of this engagement the lockout element 51 is mechanically connected to the distal end 12 of the unit housing 11. In the course of transferring the injection unit into the injection configuration the resilient portion 18 of the sidewall 50 is subject to a compression. As soon a compressive force is no longer applied to the unit housing 11 the inherent elasticity of the bellow section 19 and hence the inherent elasticity of the resilient portion 18 may serve to return the resilient portion 18 into its initial configuration as shown in Fig. 23.

[0166] Now and since the lockout element 51 , e.g. in form of a lockout sleeve 54, is connected or fixed to the counter fastener 65 the distally directed movement of the distal end 12 relative to the mount 30 and hence relative to the medicament container 20 leads to a longitudinal distally directed displacement of the lockout element 51. When reaching the post-injection configuration as shown in Fig. 25 a proximal end 53 of the lockout element 51 gets in longitudinal abutment with a lockout abutment 61 provided on the inside surface of the sidewall 15 of the unit housing 11. Moreover, and since the lockout element 51 is rigid in longitudinal compression the lockout element 51 effectively prevents a repeated proximally directed displacement of the proximal end 12 of the unit housing 11 after having reached the post-injection configuration as shown in Fig. 25.

[0167] The fastener 55 and the counter fastener 65 may comprise mutually corresponding snap features, which enables to establish a mutual connection of suitable tensile strength by way of which the lockout element 51 can be displaced in distal direction 2 as the resilient portion 18 of the sidewall 15 relaxes into its initial configuration. The lockout abutment 61 may comprise a resiliency deformable latch element, which in the initial configuration as shown in Fig. 24 may slide along an outside surface of the lockout element 51. However, when reaching the post-injection configuration as shown in Fig. 25 the proximal end 53 of the lockout element 51 have passed the lockout abutment 61, which may then engage with the proximally facing end face of the proximal end 53 of the lockout element 51 or lockout sleeve 54. Hence, when reaching the post-injection configuration as shown in Fig. 25 the lockout element 51 cannot be displaced in proximal direction 3. It is locked in this distal activated or lockout position.

[0168] With the example of Fig. 25 it is required that the resilient portion 18 provides a restoring force sufficiently high to move the lockout element 51 in distal direction 2. In the further example of Fig. 26 there may be provided a supplemental spring element 56 located between a distally facing abutment 33 of the mount 30 and the proximal end 53 of the lockout element 51. Here, the distally directed movement of the lockout element 51 into the lockout configuration may be supported or entirely provided by the relaxing spring 56.

[0169] Moreover and as shown in the example of Figs. 26 and 27 the lockout element 51 may comprise a counter snap element 58, e.g. in form of a recess to mechanically engage with a complementary-shaped snap element 57 as provided on the inside of the sidewall 15 or as provided on the mount 30. In the example of Figs. 26 and 27 it may be provided that the lockout element 51 is initially connected to the distal end 12. The lockout element 51 may move in proximal direction 3 relative to the medicament container 20 when transferring the injection unit 10 from the pre-injection configuration into the injection configuration. However, this motion may be delimited by an abutment 59 as provided on the lockout element 51 to abut with a distally facing stop face 33' of the mount 30 or to abut with a stop face as provided on the inside of the sidewall 15 of the unit housing 11.

[0170] In a further example of Fig. 28 the unit housing 11 is void of a resilient portion 18. Rather and as illustrated in Fig. 28 the distal end 12 of the unit housing 11 comprises a needle shield 80 comprising a tubular sleeve 81 forming or constituting the distal end 12 of the unit housing 11. Here, the unit housing 11 is not of unitary shape and comprises at least two components, namely a proximal housing component 82 and the sleeve 81 , which is longitudinally displaceable relative to the proximal housing component 82. The sleeve 81 forms or constitutes a distal housing component. The sleeve 81 and hence the needle shield 80 is provided with the orifice 14 at its distal end and is movable in proximal direction relative to the proximal housing component 82 against the action of the spring element 56. In this way, the distal end 12 of the unit housing 11, which is provided with the orifice 14 for the injection needle 22 can be displaced relative to the proximal end 13. In Figs. 29-33 there is illustrated one example of an injection unit 10, wherein the unit housing 11 is made of a sheet of material comprising numerous sidewall sections 15a, 15b, 15c, 15d, each of which comprising a slat-like profile. They may be made from an ecologically friendly material, such as cardboard or molded pulp material or molded fiber material.

[0171] The individual sidewall sections 15a-d may be mutually connected and may be foldable relative to each other along pivot axes A, A', A", which may form respective film hinges between the individual sidewall section 15a-d of the unitary or single sheet of material.

[0172] The sidewall sections 15b and 15 d are provided with an inspection window 35, 35'. In the final assembly configuration the sidewall sections 15b, 15d will be located diametrically opposite to each other. Some of the sidewall sections 15a-d may comprise the fastening element 41. Other sidewall sections 15a-d may comprise the guiding structure 42 or may contribute to the guiding structure 42.

[0173] One of the sidewall sections, e.g. sidewall section 15c comprises a counter fixing structure 47, e.g. in form of a recess or recessed portion or a through opening in the sidewall section to engage with a complementary-shaped fixing element 74 as provided on an outside surface of the mount 30 separately illustrated in Figs. 30, 31. The fixing element 74 may protrude radially outwardly from a sidewall 37 of the separate mount 30.

[0174] The fixing element 74 may engage the counter fixing structure 47. In this way, the mount 30 can be fixed in longitudinal direction inside the sidewall 15. The further sidewall section 15 may comprise another counter fixing structure 47' to engage with another fixing element 74' provided at another sidewall section of the sidewall 37 of the mount 30. The mount 30 may also be made of cardboard, a molded pulp material or some other ecologically friendly of biocompatible material.

[0175] The mount 30 may comprise or constitute a separate holder 36 configured for mounting inside the unit housing 11. The mount 30 can comprises four sidewall sections and may resemble the geometric structure of the unit housing 11. Towards the proximal direction 3 the sidewall 37 may be closed or delimited by a stop face 31 which is formed by an end face 38 covering the interior as confined by the surrounding sidewall 37. The end face 38 may be provided with an aperture 39 sized to receive the medicament container 20.

[0176] The mount 30 further comprises at least one mount window 34 through which the interior of the mount 30 and hence the medicament container 20 located therein can be visually inspected. In the course of mounting the mount 30 inside the unit housing 11 the mount window 34 is aligned with the inspection window 35 to provide unhindered visual inspection of the content of the medicament container 20 when assembled inside the injection unit 10.

[0177] As shown in the examples of Figs. 30 and 31 the medicament container 30 may be longitudinally inserted through the aperture 39 and the radially outwardly protruding barrel flange 25 may engage or abut with the end face 38 and hence with the stop face 31 as provided or defined by the end face 38. Now and with the preassembly of having the medicament container 20 assembled inside the mount 30 the preassembly of the mount 30 with the medicament container 20 located therein can be placed e.g. on one of the sidewall sections 15 a, 15b, 15c, 15d and the residual sidewall sections may be folded in a way as indicated in Fig. 32.

[0178] Here, the individual sidewall section 15a-d may be folded along or with respect to the folding lines or hinge axes A, A', A" to obtain a final assembly configuration as shown in Fig. 33. When in the final assembly configuration 33 the mount 30 or holder 36 is firmly fixed inside the interior of the sidewall 15.

[0179] The fastening element 41 , configured for fastening the injection unit 10 to the drive unit 4 may comprise a through opening or through recess extending all through the structure of the respective sidewall 15 or sidewall section 15a. When reaching a final assembly configuration with the drive unit 4, the complementary shaped counter fixing structure or counter fastener 46 may reach through the fastening element 41 and may form or constitute the retention element 17, which gets in longitudinal abutment with the proximally facing side of the barrel flange 25 upon fastening the injection iunit 10 to the drive unit 4.

[0180] The medicament container 20 may be firmly held inside the mount 30 by a frictional engagement between an inside surface of the mount 30, e.g., its clamp element 32 and an outside surface of the barrel 21 of the medicament container 20.

[0181] In the flowchart of Fig. 34 there are illustrated numerous steps of manufacturing an injection unit 10 as described herein. Here and in a first step 100 there is provided a sidewall structure as shown in Fig. 29. The medicament container 20 prefilled with the liquid injectable medicament 24 may be provided in step 102. In step 104 the medicament container 20 may be placed inside the unit housing 11 and in step 106 the medicament container 20 may be fixed or firmly connected to the unit housing. In the optional step 108 the injection unit 10 may be at least partially wrapped in a protective foil 76 as e g. shown in Figs. 11 or 12.

[0182] Reference Numbers

[0183] 1 injection device

[0184] 2 distal direction

[0185] 3 proximal direction

[0186] 4 drive unit

[0187] 5 drive mechanism

[0188] 6 plunger

[0189] 7 body

[0190] 8 receptacle

[0191] 10 injection unit

[0192] 11 unit housing

[0193] 12 distal end

[0194] 13 proximal end

[0195] 14 orifice

[0196] 15 sidewall

[0197] 15a,b,c,d sidewall section

[0198] 16 container receptacle

[0199] 17 retention element

[0200] 18 resilient portion

[0201] 19 bellow section

[0202] 20 medicament container

[0203] 21 barrel

[0204] 22 injection needle

[0205] 23 stopper

[0206] 24 medicament

[0207] 25 barrel flange

[0208] 26 proximal end

[0209] 27 engagement structure

[0210] 28 counter engagement structure

[0211] 29 prefilled syringe

[0212] 30 mount

[0213] 31 stop face

[0214] 32 clamp element

[0215] 33 stop face

[0216] 34 window

[0217] 35 window 36 holder

[0218] 37 sidewall

[0219] 38 end face

[0220] 39 aperture

[0221] 40 connecting portion

[0222] 41 fastening element

[0223] 42 guiding structure

[0224] 43 mechanical coding

[0225] 46 counter fastener

[0226] 47 counter fixing structure

[0227] 50 lockout mechanism

[0228] 51 lockout element

[0229] 52 distal end

[0230] 53 proximal end

[0231] 54 lockout sleeve

[0232] 55 fastener

[0233] 56 spring element

[0234] 57 snap element

[0235] 58 counter snap element

[0236] 59 abutment

[0237] 61 lockout abutment

[0238] 62 abutment section

[0239] 65 counter fastener

[0240] 70 needle cap

[0241] 74 fixing element

[0242] 75 cover

[0243] 76 foil

[0244] 77 closure cap

[0245] 78 gripping structure

[0246] 79 perforation

[0247] 80 needle shield

[0248] 81 sleeve

[0249] 82 housing component

Claims

Claims1. An injection unit (10) for an injection device (1), the injection unit (10) comprising: a unit housing (11) defining a longitudinal direction and configured to accommodate a medicament container (20) fluidically engageable with an injection needle (22), containing an injectable medicament (24) and sealed in a longitudinal proximal direction (3) by a movable stopper(23), the unit housing (11) comprising: a distal end (12) with an orifice (14) for the injection needle (22), a sidewall (15) defining a container receptacle (16) sized to receive the medicament container (20), a mount (30) for the medicament container (20) located inside the container receptacle (16), a proximal end (13) provided with a connecting portion (40) for detachably connecting the unit housing (11) to a drive unit (4) of the injection device (1), wherein the drive unit (4) comprises a drive mechanism (5) configured to operably engage with the stopper (23), wherein the injection unit (10) is transferable from a pre-injection configuration into an injection configuration by moving at least one of the mount (30) and the medicament container (20) relative to the distal end (12) in the longitudinal direction to shift the injection needle (22) through the orifice (14).

2. The injection unit (10) according to claim 1, wherein the mount (30) is fixable or is fixed to the sidewall (15).

3. The injection unit (10) according to claim 1 or 2, wherein the mount (30) comprises a first stop face (31) defining a distal injection position for the medicament container (20).

4. The injection unit (10) according to any one of the preceding claims, wherein the mount (30) comprises at least one clamp element (32, 33) to frictionally engage with an outside surface of a barrel (21) of the medicament container (20).

5. The injection unit (10) according to any one of the preceding claims, wherein the unit housing (11) comprises a retention element (17) to mechanically engage with a proximal end (26) of the medicament container (20), wherein the retention element (17) is configured toprevent a proximally directed movement of the medicament container (20) relative to at least one of the sidewall (15) and the mount (30).

6. The injection unit (10) according to any one of the preceding claims, wherein a longitudinal distance between the distal end (12) and the proximal end (13) of the unit housing (11) is variable.

7. The injection unit (10) according to any one of the preceding claims, wherein the sidewall (15) extends entirely from the distal end (12) to the proximal end (13) of the unit housing (11).

8. The injection unit (10) according to any one of the preceding claims, wherein the unit housing (11) is unitarily shaped or is made from a single piece of material.

9. The injection unit (10) according to any one of the preceding claims, wherein the sidewall (15) comprises a resilient portion (18) located between the distal end (12) and the mount (30), wherein the resilient portion (18) is compressible in longitudinal direction against a restoring force.

10. The injection unit (10) according to claim 9, wherein the resilient portion (18) comprises a bellow section (19) through which the distal end (12) of the unit housing (11) is connected to the proximal end (13) of the unit housing (11).

11. The injection unit (10) according to any one of the preceding claims, wherein the injection unit (10) transferable from the injection configuration into a post-injection configuration by moving at least one of the mount (30) and the medicament container (20) relative to the distal end (12) in the longitudinal direction (3) to retract the injection needle (22) into the container receptacle (16).

12. The injection unit (10) according to claim 11 , further comprising a lockout mechanism (50) comprising a lockout element (51), which is configured to block transferring of the injection unit (10) from the post-injection configuration into the injection configuration.

13. The injection unit (10) according to claim 12, wherein the lockout element (51) is longitudinally movable inside the container receptacle (16) and comprises a distal fastener (55) to connect to a complementary shaped counter fastener (65) provided at the distal end (12),wherein the distal fastener (55) configured to connect to the counter fastener (65) when or upon reaching the injection configuration.

14. The injection unit (10) according to claim 12 or 13, wherein the lockout element (51) is displaceable in longitudinal distal direction (2) relative to the sidewall (15) by transferring the injection unit (10) from the injection configuration into the post-injection configuration.

15. The injection unit (10) according to any one of the preceding claims 12 - 14, wherein the lockout element (51) is rigid in compression and is configured to abut with a distally facing lockout abutment (61) of the unit housing (11) and to abut with a proximally facing abutment section (62) of the distal end (12) when reaching the post-injection configuration.

16. The injection unit (10) according to any one of the preceding claims, wherein the unit housing (11) comprises or is made of at least one of the following materials: polypropylene, polyethylene, polyethylene terephthalate, polyurethane, polystyrene, polyvinyl chloride, polyether ether ketone, polycarbonate, polyethylenimine, polysulfone, polylactide, lignin-derived composite materials, molded pulp material or molded fiber material.

17. The injection unit (10) according to any one of the preceding claims, wherein the unit housing (11) comprises one of a circular, an oval, a triangular, a rectangular or quadratic crosssection.

18. The injection unit (10) according to any one of the preceding claims, wherein the sidewall (15) of the unit housing (11) comprises at least a first elongated sidewall section (15a) and a second elongated sidewall section (15b), wherein the first elongated sidewall section (15a) is pivotable relative to the second sidewall section (15b) with regard to a pivot axis (A) extending parallel to the longitudinal direction (z).

19. The injection unit (10) according to any one of the preceding claims further comprising the medicament container (10) arranged and fixed inside the container receptacle (16).

20. An injection device comprising a drive unit (4) and comprising an injection unit (10) according to any one of the preceding claims, wherein the drive unit (4) comprises the drive mechanism (5) and a body (7) to house the drive mechanism (5) and wherein the body (7) is detachably connectable to the proximal end (13) of the unit housing (11).

Images