Packaging for an injection device

Abstract

In one aspect the present disclosure relates to a packaging (50; 150) for an injection device (1), wherein the injection device (1) comprises an elongated housing (10) extending along a longitudinal direction, wherein the housing (10) comprises a container part (7) and a device body (6) adjoining the container part (7) along the longitudinal direction, the packaging (50; 150) comprising: - an elongated body (51; 151) extending along the longitudinal direction, the elongated body (51; 151) comprises a distal body portion (52; 152) and a proximal body portion (53; 153) adjoining the distal portion (52; 152) along the longitudinal direction, - a receptacle (60; 160) located in the distal body portion (52; 152) and configured to receive the container part (7) of the injection device (1), - an extension (70; 170) located in the proximal body portion (53; 153) adjoining the receptacle (60; 160) or prolonging the receptacle (60; 160) and being configured to extend along at least a part of the device body (6) of the injection device (1) when the container part (7) is located inside the receptacle (60; 160).

Description

[0001] Packaging for an Injection Device

[0002] Description

[0003] Field

[0004] The present disclosure relates to the field of medical devices, particularly to injection devices. In one aspect the present disclosure relates to a packaging for an injection device and to a kit comprising such a packing and an injection device.

[0005] Background

[0006] Drug delivery devices for setting and dispensing a single or multiple doses of a liquid medicament are as such well-known in the art. Generally, such devices have substantially a similar purpose as that of an ordinary syringe.

[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.

[0009] 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.

[0010] Disposable injection devices may be prefilled with the injectable medicament.

[0011] 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.

[0012] Such 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.

[0013] Medical devices, specifically injection devices, such as hand-held injectors are typically commercially distributed in a packaging, such as an outer packaging. Some injection devices are individually enclosed in a card box like packaging or in a polymer-based packaging, e.g. a plastic packaging. In some user scenarios the packaging is only used during shelf-life or storage and commercial distribution. A patient commencing to use the drug delivery device or injection device typically opens the outer packaging and discards the outer packaging and then uses the injection device multiple times thereafter. Noteworthy, it is not only the drug delivery device or injection device but also the packaging thereof that may represent a significant environmental burden in terms of its ecological compatibility.

[0014] 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.

[0015] Summary

[0016] In one aspect there is provided a packaging for an injection device, such as a hand-held injection pen. The injection device comprises an elongated housing extending along a longitudinal or axial direction. The housing comprises a container part and a device body. The device body adjoins the container part along the longitudinal direction. Hence, the container part is a longitudinal extension of the device body; and vice versa.

[0017] The packaging comprises an elongated body extending along the longitudinal direction. The elongated body comprises a distal body portion and a proximal body portion adjoining the distal body portion along the longitudinal direction. The elongated body may be a single or unitary component. It may be single-pieced. The packaging further comprises a receptacle located in the distal body portion and configured to receive at least the container part of the injection device. Furthermore, the packaging comprises an extension located in the proximal body portion, adjoining the receptacle or prolonging the receptacle and being configured to extend along at least a part of the device body of the injection device when the container part of the injection device is located inside the receptacle.

[0018] The packaging is particularly designed and configured for pen-type injection devices comprising a housing, wherein the housing of the injection device comprises a distally located container part, e.g. configured or implemented as a cartridge holder, and a device body connected or integrally or unitarily formed with the container part. The device body is sized and configured to accommodate a drive mechanism of the injection device, e.g. comprising a piston rod operable to engage with a stopper of a medicament container located inside the container part of the injection device. The receptacle of the elongated body of the packaging is typically sized and configured to receive the entirety of the container part of the injection device.

[0019] The receptacle and / or the elongated body is typically made of a non-transparent material so as to protect the container part of the injection device against light or the like electromagnetic radiation. The extension of the elongated body and hence the extension of the packaging is particularly suitable and configured to extend along at least a part of the device body so as to protect a respective part of the device body and / or to engage with the device body, e.g. to fix the injection device to the packaging. Moreover, the extension may provide an additional surface, such as a sidewall, which is suitable for providing readable and / or visual information, e.g. related the injection device and / or the associated medicament.

[0020] By way of the extension also the body portion of the housing of the injection device can be effectively protected against environmental influences, such as radiation, dust and / or humidity.

[0021] In some examples the packaging substitutes a protective cap covering the distal end of the housing of the injection device. The packaging may substitute a protective cap sized and configured to receive the container part of the injection device. In this way, the injection device may be void of a protective cap but may be equipped with a packaging instead as described herein. The packaging combines the function of an outer packaging and the function of a protective cap of the injection device. On the one hand the packaging, e.g. the receptacle in the distal body portion of the packaging may provide or constitute a cap portion resembling a protective cap conventionally used with such hand-held injection pens. On the other hand the packaging as described herein may represent or constitute an outer packaging for the injection device, such that an additional packaging for commercially distributing the injection device may become superfluous. This way, an environmental burden of the injection device and the packaging can be reduced and the ecological compatibility of the injection device and the packaging can be improved.

[0022] In further aspects the packaging as described herein is a functional combination of a protective cap and an outer packaging in which the injection device is accommodated at least during shelflife, storage and / or commercial distribution or retail.

[0023] In some examples the packaging represents an outer packaging for the injection device, which is directly commercially distributable without a necessity to wrap the packaging with the injection device therein in a further protective cover or supplemental outer packaging.

[0024] In in this way, the packaging, in particular the elongated body thereof serves a multiple purpose. It may provide a packaging for the injection device for and during the shelf-life of the injection device as well as for and during its commercial distribution. After a first use, i.e. when a patient or user has removed the injection device from the packaging, e.g. by removing the container part of the injection device from the receptacle of the elongated body, the packaging, i.e. the elongated body may be repeatedly used as a kind of a protective cap.

[0025] After an initial use of the injection device the injection device may be re-inserted into the receptacle of the elongated body of the packaging, which then serves as a protective cap for the container part and compartment for a distal injection end of the injection device. In this way, the injection device can be produced and distributed without a supplemental or additional outer packaging around the presently proposed packaging. As a consequence, the environmental burden and the environmental footprint of the injection device can be reduced. At the same time, manufacturing costs can be reduced.

[0026] According to a further example a longitudinal extent EB of the elongated body is larger than a longitudinal extent EC of the container part of the injection device by a ratio R > 1.2, R > 1.4, R > 1.6, R > 1.8, R > 2, R > 2.2 > 2.4, or R > 2.6, wherein R = EB / EC. In other words, the longitudinal extent of the elongated body may be much larger than a longitudinal extent of the container part of the injection device. Typically, the elongation of the container part of the injection device is defined by the elongation of the medicament container to be accommodated inside the container part. Hence, a proximal end of a medicament container accommodated inside the container part may substantially coincide with a proximal end of the container part.

[0027] With a ratio R larger than 1.2 or larger than any of the above-mentioned ratios the elongated body, at least in some examples, may comprise a longitudinal extent that is larger than or equal to the longitudinal extent of the housing of the injection device. In this way, the packaging may provide a complete packaging for the entire injection device. Here, some parts of the packaging, e.g. the receptacle may be configured to entirely enclose a part of the injection device whereas other parts of the packaging, such as the extension or the proximal body part may only align or extend along a sidewall of the housing of the injection device towards the proximal end.

[0028] Here, the proximal end of the packaging, e.g. a proximal end of the extension may mechanically engage with the device body of the injection device or even with a proximal end of the device body of the injection device, thus allowing to securely fasten or to securely fix the injection device to the packaging. In some examples the extension of the packaging is a longitudinal prolongation or longitudinal extension of the receptacle such that the receptacle may be provided along the entire longitudinal elongation of the elongated body of the packaging. Here, the elongated body of the packaging may provide an elongated shaft, which is sized to receive not only the container part but also a longitudinal portion or even the entirety of the device body of the housing of the injection device. In this way, the entirety of the housing of the injection device can be effectively protected against environmental influences when the injection device is received inside the receptacle of the packaging.

[0029] According to a further example the receptacle is configured to receive at least a portion of the device body when receiving the container part of the injection device. Here, the receptacle of the packaging comprises a longitudinal extent or a longitudinal extension that is larger than the longitudinal extent of the container part of the injection device. Here, the receptacle, e.g. a sidewall of the receptacle may be configured to mechanically engage, e.g. to mechanically fix or to mechanically fasten to a portion of the device body of the injection device when the container part of the injection device has been received inside the receptacle. In this way, the receptacle may receive the container part without getting in mechanical contact with the container part.

[0030] This is particularly suitable for injection devices, where the container part comprises a reduced diameter or reduced transverse cross-section compared to the device body. In some examples the injection device comprises a tubularly or sleeve - shaped device body and also a respective tubularly or sleeve - shaped container part, wherein a diameter of the container part is smaller than a diameter of the device body. Here, the housing of the injection device may comprise a radial step in the interface formed by a proximal end of the container part and a distal end of the device body. With the receptacle of the packaging comprising an elongation being larger than a longitudinal extent of the container part at least a proximal end of the receptacle, e.g. a proximal end of a sidewall of the receptacle may mechanically engage exclusively with the device body while receiving the container part in a contactless manner. This helps to avoid any mechanical damage or scratches on the sidewall of the container part, which may otherwise be caused by a repeated insertion of the container part into and out of the receptacle.

[0031] In some examples, the container part of the injection device is made of or at least in sections comprises a transparent material, e.g. a transparent plastic material that allows to visually inspect the medicament inside a medicament container accommodated inside the container part of the injection device. With the receptacle of the packaging configured to mechanically engage exclusively with the device body the likelihood of producing any scratches on a sidewall of the container part when removing and inserting the container part of the injection device into the receptacle of the packaging can be reduced.

[0032] According to another example the receptacle of the packaging is configured to receive a proximal end of the device body when receiving the container part of the injection device. Here, the receptacle may comprise a longitudinal extent that is substantially equal or only slightly less than the longitudinal extent of the housing of the injection device. Here, the receptacle may be sized and configured to receive the entirety of the housing of the injection device. The receptacle may provide or comprise a longitudinal shaft, which is accessible from a proximal end thus allowing to insert the injection device from the proximal end of the receptacle towards a distal end of the receptacle.

[0033] In an assembly configuration, when the injection device is located inside the packaging the distal end of the container part of the injection device may be located in a distal portion of the receptacle of the packaging and the proximal end of the device body of the injection device may be received in a proximal end of the receptacle of the packaging. Here, the extension of the elongated body of the packaging corresponds to an elongation of the receptacle. In other words, the receptacle forms or constitutes the extension. The extension may be integrated into an longitudinally extended receptacle. The elongated receptacle receiving at least a portion or even the entirety of the device body of the housing of the injection device may provide a mechanically stable and long-lasting protective cover for the entire injection device. Here, the packaging may not only provide a protective cap for the container part of the injection device but may provide a complete packaging for the entire injection device, which might be beneficial to protect the injection device against mechanical impact or shock.

[0034] In a further example at least one of the distal body portion and the proximal body portion comprises a surrounding sidewall portion confining the receptacle at least partially in a circumferential direction. In some examples, the distal body portion forms or constitutes the receptacle and the proximal body portion forms or constitutes the extension. In some examples it is the distal body portion that comprises a surrounding and substantially closed sidewall portion confining the receptacle at least partially or completely in a circumferential direction. In other examples it is the proximal body portion that comprises a surrounding sidewall portion confining a prolongation of the receptacle at least partially or completely in a circumferential direction.

[0035] In further examples, both, the distal body portion and the proximal body portion of the elongated body comprise a surrounding sidewall portion confining the receptacle and the prolongation of the receptacle either partially or completely in a circumferential direction. Providing a surrounding sidewall portion, e.g. being void of through recesses and comprising a substantially closed sidewall structure can be beneficial to improve a sealing or protection effect of the packaging for the injection device.

[0036] Moreover, and in some examples the surrounding sidewall portion may be provided with a fastener configured to engage with a complementary shaped counter fastener of the injection device. The fastener may be provided on an inside surface of the surrounding sidewall portion and the counter fastener may be provided on an outside surface of at least one of the container part and the device body of the housing of the injection device. The fastener and the counter fastener may comprise or provide at least one of a snap fit connection, a clip connection and a frictional engagement between the sidewall portion and a portion of the housing of the injection device. In this way, there can be provided a well-defined fastening and fixing of the injection device to the packaging; and vice versa.

[0037] According to another example the surrounding sidewall portion comprises a proximal end confining an insert opening through which the housing of the injection device is insertable into the receptacle. This way, the receptacle may comprise a cup-like shape. It may be only accessible through the insert opening provided at a proximal end of the surrounding sidewall portion. This provides an unequivocal, intuitive and straightforward use of the packaging. An end section of the surrounding sidewall portion longitudinally opposite to the insert opening may be closed so as to provide a kind of a seal for the container part and / or for the distal end of the injection device when the container part is received inside the receptacle.

[0038] In some examples the surrounding sidewall portion with its proximal end terminates in proximal direction in the transitional region between the container part and the device body of the injection device when the container part of the injection device is received inside the receptacle. In other examples the surrounding sidewall portion terminates in proximal direction at or near a proximal end of the device body of the injection device. Here, the surrounding sidewall may belong to an elongated shaft as provided by the elongated body of the packaging sized to receive at least a portion or even the entirety of the housing and hence of the device body of the injection device.

[0039] In another example the surrounding sidewall portion comprises a first through recess adjoining the proximal end of the surrounding sidewall portion. Such a through recess adjoining the proximal end of the surrounding sidewall portion may comprise a U-shaped recess as seen from a proximal end of the surrounding sidewall portion. Such a through recess may help and facilitate gripping of the housing of the injection device for removing the injection device from the packaging. This is of particular use when the injection device may be in frictional engagement with an inside of the surrounding sidewall portion when located or accommodated inside the packaging or the receptacle thereof.

[0040] Providing of a first through recess adjoining the proximal end of the surrounding sidewall portion may facilitate and enable a direct gripping of the injection device, typically of a proximal part or portion of the device body when the injection device is located inside the receptacle of the packaging. Typically, the through recess is sized to receive a finger of a user therethrough thus allowing and enabling a direct and immediate gripping of the injection device when located inside the packaging.

[0041] According to another example the surrounding sidewall portion comprises a second through recess also adjoining the proximal end of the surrounding sidewall portion. Typically, the second through recess is circumferentially offset from the first through recess. The first through recess and the second through recess may be provided at opposite sides of the surrounding sidewall portion. Providing not only one but providing two or even more through recesses adjoining the proximal end of the surrounding sidewall portion may further help to grip the injection device when located inside the packaging for removing the injection device from the packaging, e.g. for withdrawing of pulling the injection device from the packaging towards a proximal direction.

[0042] In a further example the distal body portion comprises the surrounding sidewall portion and the extension comprises an extension sidewall portion adjoining the surrounding sidewall portion in proximal direction. Here, the distal body portion may comprise or may coincide with a receptacle comprising or constituting the surrounding sidewall portion whereas the extension is void of a surrounding sidewall portion but only comprises an extension sidewall portion that has an extension in circumferential direction that is less than a completed circumference of the receptacle of the surrounding sidewall portion.

[0043] In some examples the extension sidewall portion is of elongated shape. It may comprise a slatlike profile. In other examples the extension sidewall portion may comprise a shell - like geometric structure, such as a half shell structure, which is extending axially along the circumference of the housing of the injection device, which may be of tubular or sleeve - like shape.

[0044] The extension sidewall portion may provide a mechanical stabilization for receiving or fixing the injection device inside the packaging, e.g. for receiving the container part of the housing of the injection device inside the receptacle of the packaging. The extension sidewall portion may also mechanically engage with the device body of the injection device when the injection device is assembled in or to the packaging.

[0045] Moreover, the extension sidewall portion may provide additional space or an additional surface for receiving or providing readable or visual information belonging to or related to the injection device and / or the associated medicament.

[0046] According to a further example the extension sidewall portion comprises an inside surface provided with at least one of a label and a printed information. Thus, an inside surface of the extension sidewall portion may be particularly dedicated to provide readable or visual information such as a label and / or printed information related to the injection device or medicament. In some examples the label and / or the visual information may be detachably provided on the inside of the extension sidewall portion. The inside surface may be provided with a foldable label or leaflet, which may be either permanently attached to the inside surface of the extension sidewall portion of which may be detachably fastenable to the inside surface of the extension sidewall portion. In some examples the label and / or the printed information may be provided in the form of a kind of a booklet or foldable leaflet.

[0047] When the injection device and / or at least the container part thereof is received inside the receptacle of the packaging the device body of the injection device may align with the inside surface of the extension sidewall portion. The label and / or the printed information provided on the inside surface may be then covered and / or fixed by the injection device. This is of particular benefit when the label or leaflet comprises a foldable substrate, such as a booklet provided on paper.

[0048] In another example of the packaging there is provided a retainer at a proximal end of the proximal body portion. The retainer is configured to engage a proximal end of the injection device when the container part of the injection device is located or accommodated inside the receptacle. The retainer serves to mechanically engage the proximal end of the injection device. In this way, the retainer serves to prevent an uncontrolled separation or removal of the injection device from the packaging. The retainer helps to fix the injection device to the packaging or vice versa, to fix the packaging to the injection device. In either way, the retainer helps to provide a mutual fixing of the injection device and the packaging, thus allowing to commercially distribute the injection device only with the packaging without providing a separate protective cap for the container part or for a distal injection end of the injection device.

[0049] According to a further example, the retainer is provided at a proximal end of the extension sidewall portion of the packaging.

[0050] In further examples the retainer is integrally formed with the proximal end of the proximal body portion or with a proximal end of the extension sidewall portion. It may be movable relative to the proximal body portion or relative to the extension sidewall portion between a fixing or fastening configuration and a release configuration. In the fixing or fastening configuration the retainer provides a fixing or fastening of the proximal end of the elongated housing of the injection device to the elongated body. In the release configuration the retainer enables and provides a removal or detachment of the elongated body of the injection device from them body of the packaging.

[0051] According to a further example the retainer comprises a retaining bracket, which is one of flexible deformable or pivotally attached to the proximal end of the proximal body portion. The retaining bracket is configured to releasably engage the proximal end of the injection device.

[0052] The retainer as described above is typically provided at or near a proximal end of the extension of the proximal body portion of the elongated body of the packaging. The retaining bracket is of particular use to provide a detachable or releasable mutual fixing between the proximal body portion of the elongated body of the packaging with a proximal end of the injection device. The retaining bracket may be configured to engage with a proximal end of the device body of the housing of the injection device. In other examples and specifically when the injection device is provided with a dose dial and / or with an injection button at a proximal end, which dose dial or injection button may proximally protrude from a proximal end of the device body, the retaining bracket may be configured to engage, i.e. to mechanically engage, with at least one of the dose dial and the injection button of the injection device.

[0053] By providing a flexible deformable retaining bracket the proximal end of the injection device may be repeatedly engageable with the retaining bracket so as to reversibly and repeatedly fix the injection device to the packaging.

[0054] Towards a distal direction the container part or device body may get in longitudinal abutment or in frictional engagement with at least one of the receptacle and the surrounding sidewall portion of the receptacle provided at the distal body portion of the elongated body. In this way, the injection device can be clamped or fixed to the packaging with regard to both longitudinal directions, i.e. in distal direction as well as in proximal direction.

[0055] According to another example the distal body portion of the elongated body comprises a distally facing end face with a through opening. The through opening may be configured to provide access to the container part, e.g. to the distal end of the container part of the injection device received in the packaging.

[0056] The through opening at or in the distal body portion may provide attachment or assembly of an auxiliary tool for preparing for deploying the injection device upon removal of the injection device from the packaging. In one example, the through opening may serve to receive an auxiliary tool, such as a needle cap remover or needle grabber configured to detach or to remove at least one of an outer or inner needle cap from a needle provided at a distal end of the container part of the injection device.

[0057] Accordingly, and with another example the packaging comprises a needle cap remover comprising an elongated sleeve portion, wherein the elongated sleeve portion extends longitudinally into an interior of the receptacle of the elongated body. The elongated sleeve portion is configured to engage with a needle cap of the injection device located inside the receptacle of the elongated body of the packaging. The elongated sleeve portion may be fixed or fastened to the distal body portion, e.g. to the distally facing end face of the distal body portion, e.g. to a distally facing end face of the receptacle of the distal body portion.

[0058] In the course of removing the injection device in proximal direction and out of the receptacle the elongated sleeve portion may remain in engagement with the needle cap of the injection device such that the injection device can be removed from the receptacle of the elongated body with an unprotected needle provided at the distal end of the container part. This way and by removing the injection device from the packaging the needle cap of the injection device may be detached from the injection needle. This way, the injection device may be ready to use or readily prepared for executing injection of a dose of a medicament into biological tissue. Here, the user may no longer have to manually detach a needle cap from a needle as provided at a distal end of the injection device.

[0059] According to a further example the needle cap remover comprises a flange portion extending radially outwardly from a distal end of the elongated sleeve portion. The flange portion is configured to abut a complementary shaped flange portion around the through opening of the distally facing end face of the distal body portion of the elongated body. In this way, and when moving the packaging in distal direction relative to the injection device the complementary shaped flange portion may be configured to exert a respective distally directed force effect onto the flange portion of the elongated sleeve portion thereby transferring a respective force effect onto the elongated sleeve portion, which is engaged or attached to the needle cap of the injection device. In this way the needle cap can be directly removed upon removal of the injection device out of the packaging.

[0060] In some examples the needle cap remover and / or its elongated sleeve portion may be made of a dimensionally stable material, such as a metallic material or it may be made from a plastic material providing a sufficient mechanical stability to engage with the needle cap of the injection device and to transfer a respective force to the needle cap upon for removing of the needle cap from the injection device. Here, providing a through opening in the distally facing end face of the distal body portion of the elongated body of the packaging allows for a straightforward assembly and fixing of the needle cap remover to the elongated body of the packaging. A respective force transfer can be provided by the mutually engaging flange portions of the elongated sleeve portion and of the distally facing end face of the distal body portion.

[0061] The elongated sleeve portion and the distal body portion may be made of or may comprise different materials. In some examples the elongated sleeve portion and hence the needle cap remover is made of a material being more stable and less deformable than the material from which the distal body portion is made of. In some examples the elongated sleeve portion and / or the needle cap remover is made of a metal or metal alloy. While the distal body portion is made of plastic or a polymeric material.

[0062] According to another example the elongated body comprises a first shell section extending from the distal body portion to the proximal body portion and further comprises a second shell section extending from the distal body portion to the proximal body portion. The receptacle is confined by the first shell section and by the second shell section. The second shell section is movable relative to the first shell section for at least one of opening and closing the receptacle.

[0063] The first shell section and the second shell section may complement each other to provide a closed receptacle, which may be hermetically closed or sealed with regard to an exterior. In some examples the first shell section and the second shell section complement each other to provide a completely surrounding and / or closed sidewall portion of the receptacle.

[0064] In some examples the first shell section and the second shell section are transferable between an open configuration and a closed configuration. In the open configuration the interior of the receptacle is accessible, e.g. for arranging the injection device inside the receptacle and / or for removing the injection device from the receptacle. In the closed configuration the receptacle is effectively inaccessible from outside. Here, the receptacle is completely enclosed by the mutually complementing first and second shell sections of the elongated body.

[0065] According to some examples the first and second shell sections are shaped substantially identical. They may both comprise or constitute a shell section, e.g. enclosing about 50% of the outside surface of the injection device as seen in circumferential direction. In some examples the first shell section and the second shell section are mutually connected in a movable manner. In some examples the first shell section and the second shell section are hingedly attached. Here, a lateral end of the first shell section may be hingedly attached to a lateral end of the second shell section thereby enabling a pivoting motion of the first shell section relative to the second shell section to transfer the receptacle as provided or formed by the first and second shell sections between an open configuration and a closed configuration. The hinge axis may extend in longitudinal direction.

[0066] In some examples the first shell section is provided in the distal body portion and in the proximal body portion. The first shell section may extend all along the distal body portion and the proximal body portion. The same may apply to the second shell section. In some examples the first shell section and the second shell section are of substantially equal longitudinal extent. In other examples one of the first and second shell sections is larger with regard to its longitudinal extent than the other one of the first shell section and the second shell section. Here, one of the first and second shell sections being longer than the other one of the first and the second shell sections may be provided with a supplemental receptacle or with a supplemental appendix at one longitudinal end, e.g. to receive and / or to store auxiliary devices or auxiliary components or for the injection device, such as a needle assembly.

[0067] According to another example the elongated body of the packaging comprises a molded body comprising a molding material including cellulose fibers and a binder.

[0068] The first molding material comprises cellulose fibers and a binder. Cellulose fibers and the binder may exhibit an excellent degree of biodegradability. Thus, the molded body of the packaging may exhibit a large degree of environmental compatibility or sustainability. At the same time, the cellulose fibers in connection with the binder may exhibit an excellent mechanical stability, thus allowing to manufacture the molded body from such lightweight and rather cost-efficient material.

[0069] Cellulose fibers used for the molded body may be manufactured or obtained from a biological source, such as wood or wood pulp. Also, the binder may be made or derived from a natural source. The binder may comprise starch or proteins or the like binding material, which may be per se biodegradable. In this way the molded body may easily decompose or rot after disposal, particularly when exposed to humidity and / or thermal energy.

[0070] In some examples the binder may be water soluble. Hence, and after use of the packaging, i.e. when the packaging is discarded, the binder may dissolve or disintegrate when getting in contact with water or the like liquid media. In this way, the molded body may chemically and / or mechanically decompose thus allowing and supporting for a rather fast and complete biological decomposition of the molded body.

[0071] The molded body of the packaging may conform any conceivable moldable form or structure. In this way, the molded body may comprise or may constitute a three-dimensional structure. The molded body may comprise a bulk effectively filled with cellulose fibers and binder.

[0072] In some examples the molded body is of unitary three-dimensional structure. The cellulose fibers and the binder may be homogeneously distributed inside the bulk of the molded body. Due to a manufacturing by way of molding the molded body may conform any conceivable moldable shape. This allows to provide different examples of packagings featuring different geometries or shapes.

[0073] By way of the molded body, the packaging may substitute a prior art packaging made of or comprising a plastic material. In this way the biodegradability of the packaging and / or of a kit comprising the injection device and the packaging can be enhanced.

[0074] In some examples the molded body is dimensionally stable. It may be operable to transfer forces or momentum between a hand of a user and a device component, such as a needle cap remover.

[0075] According to another example the molded body is at least partially covered or coated with a waterproof layer. Typically, an outside surface of the molded body may be at least partially covered or coated with such a waterproof layer. In some examples the entirety of the outside surface of the molded body may be covered or coated with the waterproof layer. Since the bonding material may be susceptible to water and / or since the integrity and / or stability of the molding material or of the body may be harmed when getting in contact with water, providing of a waterproof coating or layer on or with the molded body may improve the molded body's resistivity against humidity and liquid in general.

[0076] With a waterproof coating or layer the packaging and / its molded body can be used for a large variety of application scenarios, wherein the packaging may be exposed to water or the like dissolving liquid.

[0077] The waterproof layer or coating may comprise a plastic material. It may comprise a plastic foil, such as cellophane, cellulose, epoxy, lacquer, nitrocellulose, nylon, plastic, polyester, polylactide, polyolefin, polyvinyl alcohol, polyvinylchloride, silicone, wax, and any combinations thereof. These materials or material mixture provides an excellent barrier property against liquids, such as water, and are rather easy to adhere or to fix to the surface of the molded body.

[0078] According to another example the waterproof layer comprises a shrinkable foil, e.g a heat shrinkable foil. The heat shrinkable foil may be easily applied to an outside surface of the molded body. In an original state, i.e. before applying heat to the heat shrinkable foil, the foil may be wrapped around the molded body or may be applied to at least a portion of the molded body. By subsequently applying heat to the arrangement of the heat shrinkable foil and the molded body, the heat shrinkable foil typically shrinks due to the thermal impact and may thus conform to the shape of the molded body. This way, there can be provided a high degree of adhesion between the heat shrinkable foil and an outside surface of the molded body. By way of the heat shrinkable foil even portions of the molded body, which may be difficult to reach, can be effectively covered and sufficiently coated and protected with the waterproof layer.

[0079] In some examples the heat shrinkable foil comprises a polyethylene foil. It may comprise a low- density polyethylene foil (LDPE). The heat shrinkable foil may be produced by extrusion of LDPE. In further examples, the heat shrinkable foil comprises at least one of polyvinylchloride (PVC), polyolefin, polyethylene, polypropylene or mixtures thereof.

[0080] In other examples the molded body is compression molded. Here, the mold may be transferred into an open state for filling the cavity of the mold with the first molding material and optionally also with the second molding material. After filling the cavity of the mold with the first and / or second molding materials the mold is closed and the molding material(s) is / are cured under the effect of heat and / or pressure.

[0081] Compression molded bodies can exhibit an excellent surface quality. In some examples the molded body of the medical device component is a compression molded body comprising cellulose fibers and a binder. The molded body is compression molded, which means that the raw material, e.g. a pulp comprising cellulose fibers and the binder, is provided in a mold in which the raw material is molded, i.e. press molded under the application of pressure and heat. Here, at least one or both of the pressing tool and the mold is heated so as to deposit thermal energy into the raw material during the molding or pressing step.

[0082] The compression molded body may be compression molded in a single stage or in a multistage procedure. Hence, the molded body may be molded in a first mold and / or by a first pressing tool, e.g. under the application of heat and pressure. Thereafter, an intermediate product obtained from such a first molding process may be demolded or removed from the first mold and may be subject to a second step of thermal energy deposition and / or compression to improve the quality of its surface finish. This second step may be conducted by making use of a further compression molding tool, which may operate at a different temperature or pressure compared to the first compression molding tool. This way, cellulose fiber based raw materials, such as paper or cardboard can be used to produce a molded body of a medical device component as described herein.

[0083] Compression molded bodies, which have been subject to deposition of heat during and / or after the molding or pressing operation may exhibit a kind of a densified surface structure, which is less prone for ingress of humidity. Such compression molded bodies may therefore comprise an intrinsic water- or liquid-repellent surface finish. At the same time and due to the application of pressure and / or heat during the molding or press-molding step, the mechanical stability of such compression molded bodies, which are based on or comprise cellulose fibers, may be enhanced.

[0084] According to another example, the molded body comprises a first body component and a second body component adjoining the first body component. The first body component is made of the first molding material and the second body component is made of a second molding material. The second molding material comprises a plastic material. In some examples the plastic material of the second molding material is selected from one of: Polyvinylchloride, Polyethylene, Polyether ether ketone (PEEK), Polycarbonate, Polyethylenimine (PEI), Polysulfone, Polypropylene and Polyurethane, Cyclic Olefin Copolymer (COC), Polylactide (PLA) and any combinations thereof. Polylactides for instance comprise an excellent biodegradability. They are typically produced from renewable raw materials.. They may comprise or contain biodegradable thermoplastic polyester.

[0085] Here, the molded body may comprise a two-component or more-component body, which may be manufactured in a variety of different ways. Due to the choice of molding material, the second body component may exhibit a higher degree of stiffness and rigidity compared to the first body component. In this way, the molded body may be mechanically stabilized by the second body component. The second body component, which is made of a plastic material, may exhibit a lower degree of elasticity or mechanical deformability compared to the material of the first body component. By making use of an at least two-component or more-component molded body any potential disadvantages due to a comparatively low mechanical rigidity of the first body component may be compensated due to the combination and / or composite with the second body component.

[0086] Insofar, the molded body may comprise a composite article composed of the first body component and the second body component. In some examples the first body component and the second body component form a solid composite and thus form a mechanically stable and rather rigid compound structure. The mechanical properties of the first body component and the second body component may mutually complement each other. In examples wherein the first body component exhibits a lower degree of mechanical stability or mechanical rigidity compared to the second body component this disadvantage can be easily compensated in the compound structure of the first and second body components of the molded body.

[0087] In detail, the second body component may mechanically stabilize the molded body. The first body component may enhance the biodegradability of the molded body. According to a further example the second body component is at least in portions overmolded by the first body component. Here, the molded body may be insert molded with the second body component constituting or forming an inlay or insert. The second body component may be completed by the first body component. Here, the first body component may entirely form or constitute an outside surface and may thus dominate the outer appearance of the molded body and hence of the medical device component.

[0088] According to a further example the first molding material comprises 50 wt.-% - 80 wt.- % of the binder, 5 wt.- % - 20 wt.-% of cellulose fibers and 10 wt.-% - 30 wt.-% of water.

[0089] According to another example the first molding material comprises: 60 wt.-% - 75 wt.- % of the binder, 10 wt.- % - 15 wt.-% of cellulose fibers and 10 wt.-% - 30 wt.-% of water.

[0090] These examples of molding material compositions are particularly suitable to provide an injection moldable molded body. The molding material composition may be suitable as a basis for a molded body made of injection molded paper.

[0091] The first molding material may be provided in a slurry containing water, the binder and the cellulose fibers. The slurry may be injection moldable thus forming a molded body, which may be regarded as a paper-based injection molded body.

[0092] The molded body, e.g. in form of so-called injection molded paper or formed by injection molded paper, may exhibit a comparatively high degree of mechanical stability. It may also comprise or exhibit a high-quality surface finish, which may be obtained by the injection molding process. In particular, the surface of the molded body may precisely conform to the inside surface of the injection mold. The surface finish may be particularly smooth and even and may exhibit a comparatively low degree of roughness thus providing the molded body with a smooth surface finish.

[0093] According to a further example the second molding material comprises at least one of Polyvinylchloride, Polyethylene, Polyether ether ketone (PEEK), Polycarbonate, Polyethylenimine (PEI), Polysulfone, Polypropylene, Polyurethane, Cyclic Olefin Copolymer (COC), Polylactide (PLA) and any combinations thereof and any mixtures thereof. Also, the second molding material may be injected moldable. Specifically, the second molding material may enhance the structural and mechanical stability or rigidity of the molded body and hence of the medical device component. In a further example the elongated body of the packaging comprises an outside surface and at least one of a distal fastener and a proximal fastener protruding from the outside surface for fixing a leaflet to the packaging. At least one of the distal fastener and the proximal fastener may comprise a movable or deformable clamp or clip by way of which the leaflet can be fixed by clamping to the outside surface of the elongated body. At least one of the distal fastener and the proximal fastener may comprise a L-shaped structure with a first branch protruding outwardly from the outside surface of the elongated body and with a second branch extending substantially parallel to the outside surface but in a well-defined distance from the outside surface of the elongated body. The distance between the second branch and the outside surface of the elongated body may correspond to a thickness of the leaflet to be fixed to the outside surface of the packaging. This distance may further correspond to the radial or outwardly extending elongation of the first branch.

[0094] In some examples the elongated body comprises both, a distal fastener and a proximal fastener located proximally offset from the distal fastener by a longitudinal distance that corresponds to a longitudinal extent of the leaflet. In this way, the leaflet can be securely fastened by both, the distal and the proximal fastener. Here, at least one of the proximal fastener and the distal fastener may comprise a movable clamp or clip by way of which the leaflet can be clamped or clipped and hence fixed to the outside surface of the elongated body.

[0095] According to another aspect the present disclosure also relates to a kit. The kit comprises a packaging as described above and an injection device. The injection device comprises an elongated housing extending along a longitudinal direction. The housing comprises a container part and a device body adjoining the container part along the longitudinal direction. The container part is configured for insertion into the receptacle of the packaging. The kit comprises a packaging as described above. Insofar, all features, effects and beneficial aspects as described above in connection with the packaging equally apply to the kit.

[0096] According to a further example the kit further comprises a cover comprising a pliable cover sheet configured to wrap around a portion of the elongated body of the packaging and the injection device received in the receptacle of the elongated body along a circumferential direction. By way of the pliable cover sheet, e.g. implemented as a pliable foil, the injection device can be further fixed to the packaging, until it is used for a first time. Since the packaging may not entirely cover the housing of the injection device the pliable cover sheet may provide a further protection against ingress of dust or humidity. In further examples, the pliable sheet may comprise a shrink foil, e.g. of tubular shape, which comprises a diameter that exceeds the circumferential dimension or diameter of the kit. In this configuration the shrink foil may be arranged around a portion of the kit and may be then shrinked to a reduced dimension, e.g. by applying heat or radiation, until it fits tightly to an exterior of the kit. In this way, the injection device may be securely and non-movably fastened to the packaging at least for transportation and storage.

[0097] Typically, the pliable cover sheet is transparent or translucent so that the patient or user is enabled to visually inspect the integrity of the injection device and the packaging upon delivery or during commercial distribution.

[0098] In further example of the kit the cover comprises a first cover sheet configured to extend along an upper side of the elongated body of the packaging and a second cover sheet configured to extend along a lower side of the elongated body of the packaging. The upper side and the lower side may be opposite sides of the elongated body. The first and second cover sheets are connected to each other along at least one seam. The at least one seam is typically provided in a transition or transitional area between the lower side of the elongated body and the upper side of the elongated body. Typically, the at least one seam extends in longitudinal direction along a side or sidewall of the elongated packaging.

[0099] According to a further example the kit comprises a first packaging and a first injection device as well as a second packaging and a second injection device. Here, the first injection device is located or arranged inside the receptacle of the first packaging. The second injection device is arranged or located inside the receptacle of the second packaging. First and second packagings as well as first and second injection devices may be identically shaped and may be identically arranged relative to each other.

[0100] In a further example the cover with a pliable cover sheet is configured to wrap around a portion of the first packaging with a first injection device and to wrap around a portion of the second packaging with the second injection device. In this way, the pliable cover sheet may provide a mechanical fastening of the first packaging with a first injection device and the second packaging with the second injection device.

[0101] In further examples the kit may be also extended to comprise a third packaging with a third injection device, and / or a fourth packaging with a fourth injection device and so on. In some examples the pliable cover sheet provides a mutual fastening of the numerous packagings or kits each of which equipped with a respective injection device. The cover may comprise first and second pliable cover sheets, which are mutually connected along a side edge of the packagings of the injection device.

[0102] The pliable cover sheet may extend across at least first and second packagings each of which provided with an injection device and arranged next to each other. By wrapping the pliable cover sheet around the elongated body of the packagings the numerous packagings and injection devices can be mutually attached or grouped together. Typically, the pliable cover sheet comprises first and second cover sheets configured to extend along an upper side of the lateral arrangement of numerous packagings and injection devices and further comprises a second cover sheet extending along the lower side of the arrangement of the numerous packagings and injection devices.

[0103] Here, the first and second cover sheets may be connected, e.g. welded or adhesively attached along a seam extending in longitudinal direction between the first packaging with the first injection device and the second packaging equipped with the second injection device and optionally also between the second packaging and a further adjoining third packaging provided with a third injection device.

[0104] The at least one seam or connection structure between first and second cover sheets may be provided with a frangible portion or with a predetermined breaking structure so as to facilitate a separation of the first packaging with the first injection device from a second packaging with a second injection device.

[0105] The cover and / or the pliable cover sheet may provide a disposable package of minimum waste and minimal environmental burden. It may be discarded after opening or unwrapping the packaging and the injection device from the cover or cover sheet.

[0106] 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.

[0107] In the present context the term ‘distal’ or ‘distal end’ relates to an end of the injection device that faces towards an injection site of a person or of an animal. The term ‘proximal’ or ‘proximal end’ relates to an opposite end of the injection device, which is furthest away from an injection site of a person or of an animal. 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.

[0108] 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.

[0109] 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. 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.

[0110] 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.

[0111] 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.

[0112] 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. 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-(w-carboxyheptadecanoyl) human insulin.

[0113] 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, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701 , MAR709, ZP- 2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA- 15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide- XTEN and Glucagon-Xten.

[0114] 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.

[0115] 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.

[0116] 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. 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 antigenbinding 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).

[0117] 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.

[0118] 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.

[0119] 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).

[0120] 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.

[0121] 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.

[0122] 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.

[0123] 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).

[0124] 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). Brief description of the drawings

[0125] In the following, various examples of packagings for numerous injection devices will be described in greater detail by making reference to the drawings, in which:

[0126] Fig. 1 is a perspective illustration of an example of a packaging for an injection device,

[0127] Fig. 2 shows a kit comprising a packaging according to Fig. 1 and an injection device for inserting into a receptacle of the packaging,

[0128] Fig. 3 is a perspective illustration of the kit comprising the packaging with the injection device assembled therein,

[0129] Fig. 4 shows a further example of a packaging,

[0130] Fig. 5 shows an example of the a according to Fig. 4 with the injection device arranged inside the receptacle of the packaging,

[0131] Fig. 6 shows a further example of a packaging,

[0132] Fig. 7 shows a kit comprising an injection device and a packaging according to Fig. 6,

[0133] Fig. 8 is a schematic cross-section through a distal end of the packaging,

[0134] Fig. 9 is an illustration of the kit according to Fig. 7 with the injection device arranged inside the receptacle of the packaging,

[0135] Fig. 10 shows the kit according to Fig. 9 with a supplemental proximal closure,

[0136] Fig. 11 shows a further example of a packaging,

[0137] Fig. 12 shows a further configuration of the packaging according to Fig. 11 ,

[0138] Fig. 13 shows the packaging according to Figs. 11 and 12 in an open configuration,

[0139] Fig. 14 is an isolated view of an injection device provided with an auxiliary or or add-on device,

[0140] Fig. 15 shows a further example of the packaging,

[0141] Fig. 16 shows a further configuration of the packaging according to Fig. 15 with a label or leaflet attached to an outside surface of the packaging,

[0142] Fig. 17 shows a further variation of the packaging of Figs. 15 and 16 with a further cover comprising a pliable cover sheet,

[0143] Fig. 18 shows an assembly of numerous kids fastened or assembled together by way of a cover or by way of numerous cover sheets, and

[0144] Fig. 19 schematically illustrates one example of an injection device and some of its components.

[0145] Detailed Description

[0146] Fig. 19 shows an example of an injection device 1 comprises a housing 10. The housing 10 may comprise numerous housing components, such as a device body 6 and a container part 7, e.g. implemented as a cartridge holder 7. The device body 6 may be sized and configured to accommodate a drive mechanism 20. The container part 7 is sized and configured to accommodate a medicament container 21, e.g. implemented as a cartridge containing a liquid medicament 24. The medicament container 21 comprises a tubular-shaped barrel 22 sealed towards the distal end by a seal 23. The seal 23 may comprise a pierceable septum fixed to an outlet 25 of the medicament container 21. Towards a proximal end the interior of the barrel 22 is sealed by a piston 18 or stopper, which is slidably disposed inside the barrel 22.

[0147] By advancing the piston 18 towards the distal direction 2, e.g. by the drive mechanism 20, a dose of the medicament 24 can be expelled from the medicament container 21. In use, the medicament container 21 is arranged inside the container part 7. The drive mechanism 20 of the injection device 1 comprises a piston rod 19, which is displaceable in distal direction 2 for advancing the piston 18 towards the outlet 25 of the medicament container 21. Details of the drive mechanism 20 are not further illustrated and described here. In some examples, the drive mechanism 20 may be implemented as an all-mechanical drive mechanism, where a user provides the entirety of a dispensing force required to move the piston rod 19 and hence the piston 18 in distal direction 2. In other examples, the drive mechanism comprises a mechanical energy storage configured to provide at least a portion of the dispensing force. Examples of drive mechanisms can be found e.g. in W02004 / 078241 A1 , WO 2014 / 033197 A1 or WO 2014 / 033195 A1 the entirety of which are herein incorporated by reference.

[0148] In some examples, the injection device 1 and hence the drive mechanism 20 may comprise a dial extension, which projects and moves in proximal direction 3 from a proximal end of the body 6 during setting a dose and which returns into its initial distal end position during a dose injection procedure. For this, a user may use a thumb of his hand to exert a distally directed pressure onto the trigger 9 thereby urging the dial extension in distal direction 2 during and / or for a dose injection procedure.

[0149] For setting or dialing of a dose a user may twist or rotate the dose dial 8, e.g. in a dose incrementing direction 4, hence in a clockwise sense as seen from the proximal end. For correcting a dose previously set the user may also rotate the dose dial 8 in an opposite dose decrementing direction 5. The size of the dose is typically illustrated in a window 26 provided in or on the body 6 of the injection device 1. Prior to inject a dose of the medicament 24 the distal end of the container part 7 or cartridge holder has to be connected with a needle assembly 12. For this, the distal end of the cartridge holder 7 comprises a connector 11 , e.g. in form of a threaded interface to engage with a complementary shaped threaded counter interface of the needle assembly 12. The housing 10 of the injection device 1 may comprise 2 separate housing components, namely the container part 7 and the device body 6. At a distal end 35 of the container part 7 there is typically provided the connector 11 for receiving and / or fixing the injection needle 13. The connector 11 may form or constitute a dispensing end 31 of the injection device 1. At an opposite proximal end 36 of the container part 7 the container part 7 is connected or fixed to a distal end 37 of the device body 6. At an opposite longitudinal end 38 the device body 6 is terminated by a proximal end 38. At or near the proximal end 38 there is typically provided at least one of a dose dial 8 and a trigger 9. The arrangement of the dose dial 8 and / or trigger 9 may constitute or form a proximal end 33 of the injection device 1.

[0150] The needle assembly 12 is detachably or releasably fixable to the container part 7. It comprises a double-tipped injection needle 13. A proximal end of the injection needle (not shown) is configured to enter into a through opening at the distal end face of the connector 11 or container part 7 so as to pierce or to penetrate the seal 23 of the medicament container 21. The distal end of the injection needle 13 is typically covered by a detachable inner needle cap 14. The entirety of the needle assembly 12 may be covered by a detachable outer needle cap 15.

[0151] In Figs. 1-3 there is shown one example of a packaging 50 for an injection device 1. The packaging 50 comprises an elongated body 51 extending along the longitudinal direction, hence along the distal direction 2 and the opposite proximal direction 3. The elongated body 51 comprises a distal body portion 52 and a proximal body portion 53. The proximal body portion 53 adjoins the distal body portion 52 along the longitudinal direction.

[0152] The packaging 50 further comprises a receptacle 60 located in the distal body portion 52. The receptacle 60 is configured to receive the container part 7 of the injection device 1. The receptacle 60 is sized and configured to receive at least the container part 7 of the injection device 1. In some examples the receptacle 60 may be sized to receive not only the container part 7 but also a distal portion of the device body 6 adjoining the container part 7 in proximal direction 3.

[0153] The packaging 50 further comprises an extension 70 located in the proximal portion 53 of the elongated body 51 and adjoining the receptacle 60 or prolonging the receptacle 60 in the proximal direction 3. The extension 70 is configured to extend along at least a part of the device body 6 of the injection device 1 when the container part 7 of the injection device 1 is located inside the receptacle 60. The receptacle 60 is formed or constituted by a surrounding sidewall portion 58 of the distal body portion 52. The sidewall portion 58 may be of somewhat tubular or cylindrical shape.

[0154] The surrounding sidewall portion 58 comprises an insert opening 61 at or near a proximal end of the surrounding sidewall 58. The insert opening 61 faces in proximal direction 3 and is configured to receive the container part 7 in longitudinal direction. Hence, the container part 7 can be inserted into the receptacle 60 by displacing or moving the container part 7 in distal direction 2 through the insert opening 61.

[0155] The distal body portion 52 may be entirely formed by the receptacle 60. Insofar, the extension 70 may form or constitute the proximal body portion 53. The extension 70 also comprises an extension sidewall portion 71 , adjoining the proximal end of the receptacle 60 and e.g. prolonging the receptacle 60 at least in parts in the proximal direction 3. The extension sidewall portion 71 may be of a slat-like profile or may be of a half-shell or partial shell-like profile so as to conform to the shape of the device body 6. Hence, the extension sidewall portion 71 may comprise a kind of a shell-like recess 72 on an inside surface 73, which is sized to receive at least a portion of an outer surface of the container part 7 of the injection device 1.

[0156] As further illustrated in Fig. 1 the distal body portion 52 comprises a distal end 54, which coincides with a distal end of the receptacle 60 and which further coincides with a distal end of the packaging 50 and the elongated packaging body 51. The distal body portion 52 further comprises a proximal end 55. The proximal end 55 of the distal body portion 52 adjoins the distal end 56 of the proximal body portion 53. The distal end 56 may be unitarily shaped with the proximal end 55. Hence, the distal body portion 52 and the proximal body portion 53 may be made from a single pieced part or material.

[0157] In some examples the entire packaging 50 may be a single pieced molded packaging 50 and may comprise a respective molded single-pieced packaging body 51. In the example as shown in Fig. 1 the distal body portion 52 somewhat coincides with or constitutes the sidewall portion 58 of the receptacle 60. Hence, a proximal end 59 of the surrounding sidewall portion 58 may coincide or may form or constitute the proximal end of the receptacle 60.

[0158] The extension sidewall portion 71 may comprise a somewhat constant profile as it extends from the proximal end 55 of the distal body portion 52 towards the proximal end 57 of the elongated body 51 of the packaging 50.

[0159] As further illustrated in Fig. 1 the distal body portion 52, e.g. an outside surface of the surrounding sidewall portion 58 of the receptacle 60 is provided with a fastening clip 62, which allows for a detachably fastening or clipping the packaging 50 to a piece of cloth or the like support structure. The receptacle 60, and hence the surrounding sidewall portion 58 may comprise or constitute a cap portion 65 of the packaging 50 sized and configured to receive at least the container part 7 of the injection device 1.

[0160] The surrounding sidewall portion 58 may also comprise at least one of an engaging portion 63 and a fastener 64. The engaging portion 63 may be provided at or near the proximal end 59 of the surrounding sidewall portion 58 of the receptacle 60. The engaging portion 63 may be provided at an inside of the surrounding sidewall portion 58. The engaging portion 63 may be configured and sized to engage with at least one of an outside surface of the device body 6 and the container part 7.

[0161] The fastener 64 may be also provided on an inside surface of the surrounding sidewall portion 58. The fastener 64 may comprise at least one of a clip or snap feature to engage with a complementary shaped counter fastener 28, e.g. provided on the outside surface of at least one of the device body 6 and the container part 7. In this way, there may be provided a form fitting or positive fitting engagement between the fastener 64 and the counter fastener 28 when the injection device 1 is received at least with a container part 7 inside the receptacle 60 of the packaging 50. In some examples, at least one of the fastener 64 and the counter fastener 28 comprises a closed and continuous structure in circumferential direction. This way, there can be provided a mutual fastening of the injection device with the packaging 50 that is invariant to an rotational orientation of the injection device 1 with regard to its longitudinal axis.

[0162] In the example of Figs. 1-3 the extension 70 comprises an inside surface 73, which may be provided with at least one of readable or visual information. The inside surface 73 may be provided with a tutorial or with printed information 78, which may be detachably stored in the recess 72 of the inside of the sidewall portion 71.

[0163] The recess 72 may comprise a first recessed section 74 sized and configured to receive the device body 6 and may further comprise a second recessed section 75 longitudinally and proximally adjacent to the first recessed section 74. The second recessed section 75 may be sized and configured to receive at least one of the dose dial 8 and the trigger 9 of the injection device 1.

[0164] At or near the proximal end 57 of the proximal body portion 53 there is optionally provided a retainer 80 which is configured to engage with a proximal end 38 of the injection device 1 when the container part 7 of the injection device 1 is received in the receptacle 60. The retainer 80 comprises a retainer bracket 81, which is at least one of flexible deformable or pivotally attached to the proximal end 57 of the proximal body portion 53.

[0165] As illustrated in Fig. 2, the retaining bracket 81 is foldable into an open configuration, in which the injection device 1 can be assembled inside the receptacle 60 of the packaging 50. Here, the retainer bracket 81 is in a folded away configuration and does not interfere with the injection device 1. This allows for an unhindered insertion of the injection device 1 into the receptacle 60 of the packaging 50. When reaching a final assembly configuration, e.g. in which the container part 7 is at least partially or entirely received in the receptacle 60, retaining bracket 81 may be folded or pivoted back into its original configuration as illustrated in Fig. 1.

[0166] Then, the engaging parts 83, 84 of the retaining bracket 81 may engage with the proximal end 38 of the injection device 1. As illustrated, the retaining bracket 81 comprises a hinge 82 by way of which the L-shaped retaining bracket 81 is pivotally attached to the proximal end 57 of the proximal body portion 53. The engaging part 83 is sized and configured to abut in longitudinal direction, e.g. to abut in distal direction 2 with the proximal end face of the proximal end 38 of the injection device 1. The engaging part 84 is configured to clasp around a portion of the outer circumference of the proximal end 38 of the injection device 1.

[0167] In the example as shown in Figs. 1-3 the injection device 1 is provided with the dose dial 8 and / or with the trigger 9 at its proximal end 38. Accordingly, the retaining bracket 81 is configured to engage with the dose dial 8 and the trigger 9.

[0168] As further illustrated in Figs. 2 and 3 the longitudinal extent EB of the elongated body 51 is larger than a longitudinal extent EC of the container part of the injection device 1 by a ratio R > 1.2, R > 1.4, R > 1.6, R > 1.8, R > 2, R > 2.2 > 2.4, or R > 2.6, wherein R = EB / EC. In this way, the packaging 50 covers at least the container part 7 of the injection device 1 and at least some components or portions of the housing 10 of the injection device 1 adjoining the distal container part 7 in proximal direction 3. In this way, there can be provided an effective packaging 50 for the injection device 1 , which replaces or substitutes a conventional protective cap of such an injection device.

[0169] Rather, the packaging 50 serves to provide both, a durable outer packaging for protecting the injection device during 1 shelf - life, storage and commercial distribution as well as during a repeated use of the injection device. The injection device 1 may be void of a separate protective cap. Rather, the packaging 50 providing a commercially distributable packaging to be handed out directly to patients or consumers comprises an integrated protective cap portion 65 configured and designed for directly receiving the container part 7 of the injection device 1.

[0170] In Fig. 4 and 5 there is shown another example of a packaging 50. Unless mentioned otherwise the same or like components of the packaging 50 as shown in Figs. 4 and 5 are provided with the same reference numbers as used in the example of Figs. 1-3.

[0171] The packaging 50 of Figs. 4 and 5 also comprises an elongated body 51 with a distal body portion 52 and a proximal body portion 53. Here, the distal body portion 52 comprises a proximal end 55 directly adjoining a distal end 56 of the proximal body portion 53. The proximal body portion 53 comprises a proximal end 57 that coincides with the proximal end 59 of the surrounding sidewall portion 58. Compared to the packaging 50 of Fig. 1 the packaging 50 of Figs. 4 and 5 comprises an extension 70 that is an elongation of the receptacle 60 towards the proximal direction 3. Accordingly, the receptacle 60 may extend from a distal end 54 of the elongated body 51 towards the proximal end 57 of the elongated body 51.

[0172] The receptacle 60 is likewise confined by the surrounding sidewall portion 58. As becomes immediately apparent from a comparison of Figs. 4 and 5 the receptacle 60 is sized to receive the entirety of the container part 7 and the device body. It may be only the dose dial 8 and / or the trigger 9 that protrudes proximally from the proximal end 57 of the elongated body 51. Insofar, the packaging 50 may comprise an elongated sheath 90 with an insert opening 91 at the proximal end 57 of the proximal body portion 53. The insert opening 91 of the sheath 90 may coincide with the insert opening 61 of the receptacle 60. The proximal body portion 53 is a elongation of the distal body portion 52. Both, the proximal body portion 53 and the distal body portion 52 comprise a unitary surrounding sidewall portion 58.

[0173] The packaging 50 provides an excellent protection for the injection device 1 when assembled inside the receptacle 60. The insert opening 61 of the receptacle 60 coincides with the proximal end 59 of the surrounding sidewall portion 58.

[0174] As it is further apparent from Figs. 4 and 5 the surrounding sidewall portion 58 comprises a first through recess 92 adjoining the proximal end 59 of the surrounding sidewall portion 58. Optionally, there may be also provided a second through recess 93 adjoining the proximal end 59 of the surrounding sidewall portion 58. The second through recess 93 may be located circumferentially offset from the first through recess 92. In some examples the second through recess 93 may be located diametrically opposite to the first through recess 92. The through recesses 92, 93 provide a direct and immediate gripping of an outside surface of the device body 6 when the injection device 1 is assembled inside the receptacle 60. Here, and when at least one of the container part 7 and the device body 60 should fixed or fastened to and inside surface of the sidewall portion 58, e.g. by a friction fit, the at least one through recess 92, 93 allows for a direct gripping and application of a force effect onto the injection device 1 for removing the same from the packaging 50.

[0175] Optionally, an outside surface of the sidewall portion 58 of the receptacle 60 may be provided with a label 17, which may be provided with readable or visual information being indicative of the injection device 1 and / or the medicament located therein. The label 17 may comprise or provide readable information, such as a regulatory information about the injection device 1 and / or about the medicament 24 located inside the medicament container 21 of the injection device 1.

[0176] In Figs. 4 and 5 there is illustrated a kit 30 comprising the injection device 1 and comprising the packaging 50. As further shown in Fig. 4, the container part 7 of the injection device 1 may be provided with a window 32. Alternatively, the entirety of the container part 7 may be made from a transparent material, e.g. from a translucent plastic material that is allowing to visually inspect the content of the container part 7, e.g. the content of the medicament container 21. Also, the window 32 provides visual inspection of the interior of the container part 7. The window 32 may be covered by the opaque surrounding sidewall portion 58 of the receptacle 60 when the injection device 1 is located inside the packaging 50.

[0177] Specifically, the extension 70 and hence the proximal part of the receptacle 60 and / or the proximal body portion 53 provides an enlarged outer surface of the packaging 50, which is therefore suitable to provide a basis for applying or for providing readable or visual information, e.g. in form of the label 17.

[0178] In the further example according to Fig. 6-10 the packaging 50 also comprises an elongated body 51 comprising a distal body portion 52 and a proximal body portion 53. Also here, the proximal body portion 53 provides and forms a proximal extension of the distal body portion 52. The distal body portion 52 is particularly dedicated and configured to receive the container part 7 of the injection device 1 whereas the proximally located device body 6 of the elongated housing 10 of the injection device 1 may protrude in proximal direction 3 from the proximal end 57 of the proximal body portion 53 as indicated in Fig. 9.

[0179] Here, the injection device 1 may be implemented as a so-called auto-injector. It may comprise and provide a single dose of the medicament, which is automatically injected when the injection device is urged against the skin of a patient. Also here, reference numbers used before in connection with the examples of Figs. 1-5 are equally used with the example of Fig. 6-10 unless described otherwise.

[0180] The packaging 50 according to Figs. 6-10 also comprises a tubular-shaped receptacle 60 with an insert opening 61 provided at the proximal end and facing in proximal direction 3. The distal body portion 52 of the elongated body 51 comprises a distally facing end face 66 at its distal end 54. It may also form a closed cap portion 65 to receive the container part 6 of the injection device 1. The distally facing end face 66 is provided with a through opening 69, which is sized to receive a needle cap remover 100 shown separately in Fig. 6. The needle cap remover 100 comprises an elongated sleeve portion 101 extending through the through opening 69. Towards a distal end the needle cap remover 100 comprises a flange portion 102 extending radially outwardly from a distal end of the sleeve portion 101. The flange portion 102 is sized to engage with a complementary shaped flange portion 68 provided at or along the outer circumference of the through opening 69. Insofar, the needle cap remover 100 with its sleeve portion 101 and flange portion 102 is configured to be inserted into a receptacle 67 as provided at the distal end 54 and hence in the distally facing end face 66 of the elongated body 51.

[0181] Generally, the elongated body 51 may be made from a plastic material or from a molded material, e.g. comprising a molding material including cellulose fibers and a binder as described above. The needle cap remover 100 is particularly suitable to remove a needle cap 14 as provided at the distal end of the injection device 1 and covering the injection needle 13. The needle cap remover 100 may be made from a different material compared to the material of the elongated body 51. The needle cap remover 100 may be made from a metal or metal alloy. The needle cap remover 100 may be provided in form of an insert 109 for insertion into and at least partially through the through opening 69 provided at the distally facing end face 66 of the distal body portion 51.

[0182] In this way, at least a portion of the sleeve portion 101 extends longitudinally in proximal direction into the interior of the receptacle 60. The elongated sleeve portion 101 comprises an engaging section 103, which is configured to engage with a sidewall of the needle cap 14. For this, the engaging section 103 as provided in or on the sleeve portion 101 may be provided with radially inwardly extending engaging flaps 104, which positively engage with a counter abutment portion 108 as provided on an outside surface of the needle cap 14. The counter abutment portion 108 may face in proximal direction 3 and the engaging flap 104 may longitudinal engage with the counter abutment portion 108 to exert a force effect in distal direction 2 onto the counter abutment portion 108. The engaging flaps 104 may be formed by a U-shaped through recess 105 extending through the e.g. tubular shaped sleeve portion 101 of the needle cap remover 100. Insofar, a longitudinal end of the engaging flap 104 is provided with an abutment portion 106 complementary shaped to the counter abutment portion 108 as provided on the outside surface of the needle 14. In in an initial configuration and when inserting the injection device 1 into the receptacle 60 of the packaging 50 as shown in Fig. 6 and 7 a final assembly configuration may be reached, in which the abutment section 106 of the engaging section 103 of the needle cap remover 100 gets in longitudinal abutment with the proximally facing counter abutment portion 108 of the respective needle cap 14.

[0183] By applying a distally directed force effect onto the needle cap remover 100, e.g. upon removing or separating the packaging 50 in distal direction 2 from the injection device 1, the needle cap remover 100 will apply a respective distally directed effect onto the needle cap 14, thereby removing the needle cap 14 from the injection needle 13. Accordingly, and upon removing the packaging 50 from the injection device 1 as shown in Fig. 7, the injection device 1 may be in a configuration ready to use.

[0184] As further indicated in Fig. 7, the injection device 1 may be provided with an identifier 34, e.g. in form of an electronic identifier, which is electronically readable by a reading device. In some examples the identifier 34 comprises a wireless electronic identifier, which is suitable for wireless reading, e.g. by RF radiation. In some examples the identifier 34 is one of a NFC chip and a RFID chip allowing to encode and / or to identify the injection device 1.

[0185] In the example according to Figs. 6-10, the proximal body portion 53 is provided with at least one or even with two through recesses 92, 93 at or near the proximal end 57 of the proximal body portion 53. Here, the through recesses 92, 93 may be also located opposite to each other or at least circumferentially offset. The through recesses 92, 93 may comprise an elongated groove-like shape sized and configured to receive a complementary shaped extension 116 of a supplemental closure 110.

[0186] In the example of Fig. 6-10 the total elongation of the packaging 50 and hence of the elongated body 51 may be slightly shorter than the respective elongation of the injection device 1. Hence when the injection device 1 is inserted in the receptacle 60 of the packaging 50 at least a portion of the device body 6, e.g. a proximal end 33 of the injection device 1 may protrude proximally from the proximal end 57 of the packaging 50. Here, the supplemental closure 110 comprising a body 112 with a cap portion 114 may be attached to the proximal end 57 of the packaging 50 to completely enclose and to completely cover the proximal end 33 of the injection device and 1. Here, the longitudinally and distally protruding extension 116 may slidably engage with the groove-shaped through recess 92 as provided in the surrounding sidewall portion 58 of the elongated body 51 of the packaging 50.

[0187] The extension 116 may comprise a slat-like profile and may provide a well-defined fastening of the supplemental closure 110 to the packaging 50. It may provide a mutual fastening between the supplemental closure 110 and the packaging 50. Generally, the supplemental closure 110 may complement the packaging 52 and may thus provide a completely closed packaging structure for the injection device 1.

[0188] In Figs. 11-14 there is shown another example of a packaging 150. The packaging 150 comprises an elongated body 151 extending along the longitudinal direction. Also here, the elongated body 151 comprises a distal body portion 152 and a proximal body portion 153 adjoining the distal body portion 152 along the longitudinal direction. The elongated body 151 also comprises an extension 170 located in the proximal body portion 153 and adjoining or constituting a receptacle 160 provided in the distal body portion 152. As shown in Fig. 13 the proximal body portion 153 prolongs the receptacle 160 and is configured to receive at least the device body 6 of the injection device. The receptacle 160 located in the distal body portion 152 is configured to receive the container part 7 of the injection device 1.

[0189] Here, the reference numbers as used for the packaging 150 according to Figs. 11-14 are equivalent or identical to the reference numbers as used in connection with the packaging 50 according to Figs. 1-10 except that some of the reference numbers are increased by a numeral 100. Unless described otherwise the reference numbers as used in the example of Figs. 11-14 denote the same or like components as the reference numbers used in connection with the examples as shown in Figs. 1-10 and might be increased by the numeral 100.

[0190] The packaging 150 comprises or forms a receptacle 160 which is sized to receive the entirety of the injection device 1. The receptacle 160 extends from the distal end 154 of the elongated body 151 and hence from the distal end 154 of the distal body portion 152 to the proximal end 157 of the proximal body portion 153. The distal end 156 of the proximal body portion 153 adjoins the proximal end 155 of the distal body portion 152. Here, the proximal end 155 of the distal body portion 152 may be characterized by a proximal end 36 of the container part 7 of the injection device 1. Its longitudinal position may be defined by the respective longitudinal position of the proximal end 36. The distal end 156 of the proximal body portion 153 may coincide or may be defined by the distal end 37 of the device body 6. The receptacle 160 is void of a proximally facing insert opening 61 as described in connection with the examples according to Figs. 1-10. Rather, the receptacle 150 is accessible by moving first and second shell sections 172, 174 of the elongated body 151. The first shell section 172 and the second shell section 174 a each comprise a kind of a half-shell structure comprising an elongated sidewall portion 173, 175, respectively. The shell sections 172, 174 may comprise a somewhat constant cross-section as seen in longitudinal direction. They may comprise a half shell cross-section so as to form a tubular-shaped hollow interior when the first and second shell sections 172, 174 are folded or arranged onto one another.

[0191] In the example of Fig. 13 the second shell section 174 is hingedly attached to the first shell section 172 by a hinge 171. The hinge 171 may be implemented as a film hinge and may allow for a pivoting motion of the second shell section 174 relative to the first shell section 172. This way, and in an open configuration as shown in Fig. 13 the first and second shell sections 172, 174 are arranged next to each other. When transferring the shell sections 172, 174 into a closed configuration, wherein the side wall portions of 173, 175 of the first and second shell sections 172, 174 are folded onto each other the respective shell sections 172, 174 form or constitute a closed interior and thus form a closed receptacle 160 which is sized to accommodate and / or to receive the injection device 1 in its entirety.

[0192] The receptacle 160 comprises a radially narrowed neck portion 166 at or near the proximal end 33 of the injection device 1. The radially stepped down neck portion 166 may be particularly sized to receive at least one of the dose dial 8 and the trigger 9 as protruding from the proximal end of the housing 10 of the injection device 1. The receptacle 160 may be further provided with a head portion 167 adjoining the neck portion 166 in proximal director. The head portion 167 may be directly connected to the neck portion 166 and may comprise a slightly enlarged crosssection compared to the radially narrowed neck portion 166. The head portion 167 is particularly sized and configured to receive an auxiliary device 200 or add-on device, which is designed and configured for detachably fastening to the proximal end 33 of the injection device 1.

[0193] In some examples the auxiliary device 200 is configured for attachment to the dose dial 8 in order to record and / or to quantitatively measure a size of a dose actually set or dispensed, e.g. injected by the injection device 1. The auxiliary device 200 may comprises a tubular-shaped device body 201 and an optional display 202. The auxiliary device 200 may further comprise an actuation element 203 at a proximal end of the device body 201 of the auxiliary device 200. The actuation element 203 may be movable in longitudinal direction relative to the auxiliary device body 201 and may operably engage with the trigger 9 to depress the trigger 9 of the injection device 1 when the auxiliary device 200 is assembled or fixed to the dose dial 8 of the injection device 1.

[0194] The packaging 150 is sized and configured to receive or to accommodate the injection device 1 with the auxiliary device 200 assembled or attached to the proximal end 33 of the injection device 1. Insofar, the head portion 167 of the receptacle 160 forms or constitutes a receptacle 181 for the auxiliary device 200.

[0195] As becomes further apparent from the illustration of Fig. 13 at least one of the first and second shell sections 172, 174 is provided with a longitudinal appendix 184 protruding from the other one of the first and the second shell sections 172, 174 in the proximal direction 3. The second shell section 174 is terminated or delimited in proximal direction 3 by an end face 168. Also, the first shell section 172 may be provided with a respective end face (not visible). Proximally from this end face 168 there may be provided the appendix 184 comprising a further receptacle 185 to receive an auxiliary device component for the injection device 1.

[0196] The receptacle 185 comprises an insert opening 186 accessible in radial direction. The insert opening 186 is delimited in transverse and / or circumferential direction by two oppositely located flange-like portions 187, 188 so as to provide a longitudinal extending through opening 189 between the flange portions 187, 188. The receptacle 185 may be particularly designed and configured to receive a needle assembly 12, e.g. comprising an injection needle 13 and a respective needle hub for fastening to the connector 11 of the injection device 1. The needle assembly 12 comprises the injection needle 13 and at least one of an inner needle cap 14 and an outer needle cap 15. The outer needle cap 15, which may be sealed by a detachable or tearable seal 16 may be sized to fit into the receptacle 185, such that a distal end of the outer needle cap 15 protrudes through the through opening 189 of the appendix 185.

[0197] In Figs. 15 and 16 there is shown another example of the packaging 150 according to Figs. 11- 14. However, this example is not limited to the implementation of the packaging 150 as shown in Figs. 11-14. It may be also implemented with any of the packaging 50 as shown and described in connection with Figs. 1-10. Here, the elongated body 151 comprises an outside surface 176, which is provided with at least one holder 194 to detachably hold or to detachably fix at least one of a label 17 and a leaflet 210 associated with the injection device 1 and / or medicament 34. The leaflet 210 may comprise a printed substrate or layer, such as a paper or paper-based layer, which is provided with readable or visual information.

[0198] The leaflet 210 may comprise numerous folded sheets of a printable material and may be attached to the outside surface 176 by way of the holder one and 94. In the example as illustrated, the holder(s) 194 comprises a distal fastener 192 and a proximal fastener 193. The longitudinal distance between the distal fastener 192 and the proximal fastener 193 may correspond or may be equal to a respective longitudinal extent of the leaflet 210. In this way, the leaflet 210 may be clamped or otherwise fixed to the outside surface 176 of the packaging 150 by the distal fastener 192 and the proximal fastener 193. In the example as shown in Figs. 15 and 16 at least one of the distal fastener 192 and the proximal fastener 193 comprises a L- shaped holder 194 allowing to receive at least one longitudinal end of the leaflet 210. The other one of the distal fastener 192 and the proximal fastener 193 may comprise a movable clamp 195, which may be resiliently movable, deformable or pivotably to a predefined extent so as to receive the leaflet 210 and / or to fix the leaflet 210 to the outside surface 176 of the packaging 150.

[0199] In the further examples as shown in Figs. 17 and 18 the packaging 150 is further provided with a cover 220. The cover 220 may comprise a pliable cover sheet 221 suitable for wrapping around at least a portion of the packaging 150. The pliable cover sheet 221 may be configured to enclose or to wrap around the packaging 150 and the leaflet 210 attached to the outside surface 176 of the packaging 150. The pliable cover may comprise a first and a second cover sheet 221 , 222. The first cover sheet 221 may be configured to extend along an upper side of the body 151 as seen in transverse or circumferential direction and the second cover sheet 222 may be configured to cover a opposite lower side of the elongated body 151. First and second cover sheets 221 222 may be joined together, e.g. along a seam 223, 224 extending along the longitudinal direction. In this way, the first and second cover sheets 221, 222 may be attached to the packaging 150 with the injection device 1 located inside the receptacle 160. The cover 220 may also support or provide a fixing of the leaflet 210 to the outside surface 176 of the packaging 150.

[0200] By way of the cover 220 also numerous kits 30, 30', 30" each of which comprising a packaging 150, 150', 150" and each of which being provided with an injection device 1 may be combined or assembled together. As shown in Fig. 18, numerous packagings 150, 150', 150", optionally provided with a leaflet 210 and an outside surface 176 may be covered with first and second cover sheets 221 222, wherein the first cover sheet 221 extends across a number of packagings 150, 150', 150" arranged next to each other.

[0201] Likewise, the second cover sheet may extend across the lower sides of the numerous packagings 150, 150', 150". Between the individual packagings 150, 150', 150" the first and second cover sheet 221, 222 may be joined together, e.g. welded or adhesively joined together to form a seam 224, 224', 224" by way of which the individual packagings 150, 150', 150" with a respective injection device 1 disposed therein are mutually connected or fixed. In some examples at least one of the seams 224, 224', 224" may be provided with a predetermined breaking structure, e.g in form of a perforation, so as to facilitate separation of at least one kit 30 or packaging 150 from another kit 30', 30" or packaging 150', 150".

[0202] Reference Numbers

[0203] 1 injection device

[0204] 2 distal direction

[0205] 3 proximal direction

[0206] 4 dose incrementing direction

[0207] 5 dose decrementing direction

[0208] 6 body

[0209] 7 container part

[0210] 8 dose dial

[0211] 9 trigger

[0212] 10 housing

[0213] 11 connector

[0214] 12 needle assembly

[0215] 13 injection needle

[0216] 14 inner needle cap

[0217] 15 outer needle cap

[0218] 16 seal

[0219] 17 label

[0220] 18 piston

[0221] 19 piston rod

[0222] 20 drive mechanism

[0223] 21 medicament container

[0224] 22 barrel

[0225] 23 seal

[0226] 24 medicament

[0227] 25 outlet

[0228] 26 window

[0229] 28 counter fastener

[0230] 30 kit

[0231] 31 dispensing end

[0232] 32 window

[0233] 33 proximal end

[0234] 34 identifier

[0235] 35 distal end

[0236] 36 proximal end

[0237] 37 distal end 38 proximal end

[0238] 50 packaging

[0239] 51 packaging body

[0240] 52 distal body portion

[0241] 53 proximal body portion

[0242] 54 distal end

[0243] 55 proximal end

[0244] 56 distal end

[0245] 57 proximal end

[0246] 58 sidewall portion

[0247] 59 proximal end

[0248] 60 receptacle

[0249] 61 insert opening

[0250] 62 fastening clip

[0251] 63 engaging portion

[0252] 64 fastener

[0253] 65 cap portion

[0254] 66 end face

[0255] 67 receptacle

[0256] 68 flange portion

[0257] 69 through opening

[0258] 70 extension

[0259] 71 sidewall portion

[0260] 72 recess

[0261] 73 inside surface

[0262] 74 recessed section

[0263] 75 recessed section

[0264] 78 printed information

[0265] 80 retainer

[0266] 81 retainer bracket

[0267] 82 hinge

[0268] 83 engaging part

[0269] 84 engaging part

[0270] 90 sheath

[0271] 91 insert opening

[0272] 92 through recess

[0273] 93 through recess 100 needle cap remover

[0274] 101 sleeve portion

[0275] 102 flange portion

[0276] 103 engaging section

[0277] 104 engaging flap

[0278] 105 through recess

[0279] 106 abutment portion

[0280] 108 counter abutment portion

[0281] 109 insert

[0282] 110 closure

[0283] 112 body

[0284] 114 cap portion

[0285] 116 extension

[0286] 150 packaging

[0287] 151 packaging body

[0288] 152 distal body portion

[0289] 153 proximal body portion

[0290] 154 distal end

[0291] 155 proximal end

[0292] 156 distal end

[0293] 157 proximal end

[0294] 160 receptacle

[0295] 166 neck portion

[0296] 167 head portion

[0297] 168 end face

[0298] 170 extension

[0299] 171 hinge

[0300] 172 shell section

[0301] 173 sidewall portion

[0302] 174 shell section

[0303] 175 sidewall portion

[0304] 176 outside surface

[0305] 181 receptacle

[0306] 184 appendix

[0307] 185 receptacle

[0308] 186 insert opening

[0309] 187 flange portion 188 flange portion

[0310] 189 through opening

[0311] 192 distal fastener

[0312] 193 proximal fastener 194 holder

[0313] 195 clamp

[0314] 200 auxiliary device

[0315] 201 device body

[0316] 202 display 203 actuation element

[0317] 210 leaflet

[0318] 220 cover

[0319] 221 cover sheet

[0320] 222 cover sheet 223 seam

[0321] 224 seam

[0322] 225 shrink foil

Claims

Claims1. A packaging (50; 150) for an injection device (1), wherein the injection device (1) comprises an elongated housing (10) extending along a longitudinal direction, wherein the housing (10) comprises a container part (7) and a device body (6) adjoining the container part (7) along the longitudinal direction, the packaging (50; 150) comprising: an elongated body (51 ; 151) extending along the longitudinal direction, the elongated body (51 ; 151) comprises a distal body portion (52; 152) and a proximal body portion (53; 153) adjoining the distal portion (52; 152) along the longitudinal direction, a receptacle (60; 160) located in the distal body portion (52; 152) and configured to receive the container part (7) of the injection device (1), an extension (70; 170) located in the proximal body portion (53; 153) adjoining the receptacle (60; 160) or prolonging the receptacle (60; 160) and being configured to extend along at least a part of the device body (6) of the injection device (1) when the container part (7) is located inside the receptacle (60; 160).

2. The packaging (50; 150) according to claim 1 , wherein a longitudinal extent EB of the elongated body (51 ; 151) is larger than a longitudinal extent EC of the container part (7) of the injection device (1) by a ratio R > 1 .2, R > 1.4, R > 1 .6, R > 1.8, R > 2, R > 2.2 > 2.4, or R > 2.6, wherein R = EB / EC.

3. The packaging (50; 150) according to any one of the preceding claims, wherein the receptacle (60; 160) is configured to receive at least a portion of the device body (6) when receiving the container part (7) of the injection device (1).

4. The packaging (50; 150) according to any one of the preceding claims, wherein the receptacle (60; 160) is configured to receive a proximal end (38) of the device body (6) when receiving the container part (7) of the injection device (1).

5. The packaging (50; 150) according to any one of the preceding claims, wherein at least one of the distal body portion (52; 152) and the proximal body portion (53; 153) comprises a surrounding sidewall portion (58; 173, 175) confining the receptacle (60; 160) at least partially (60; 160) in a circumferential direction.

6. The packaging (50; 150) according to claim 5, wherein the surrounding sidewall portion (58) comprises a proximal end (59) confining an insert opening (61) through which the housing (10) of the injection device (1) is insertable into the receptacle (60; 160).

7. The packaging (50; 150) according to claim 6, wherein the surrounding sidewall portion (58) comprises a first through recess (92) adjoining the proximal end (59) of the surrounding sidewall portion (58).

8. The packaging (50; 150) according to any one of the preceding claims 5 to 7, wherein the distal body portion (52) comprises the surrounding sidewall portion (58) and wherein the extension (70) comprises an extension sidewall portion (71) adjoining the surrounding sidewall portion (58) in proximal direction.

9. The packaging (50; 150) according to claim 8, wherein the extension sidewall portion (71) comprises an inside surface (73) provided with at least one of a label (17) and a printed information (78).

10. The packaging (50; 150) according to any one of the preceding claims, further comprising a retainer (80) at a proximal end (55) of the proximal body portion (53), wherein the retainer (80) is configured to engage a proximal end (33) of the injection device (1) when the container part (7) of the injection device (1) is located inside the receptacle (60).

11. The packaging (50; 150) according to claim 10, wherein the retainer (80) comprises a retaining bracket (81), which is flexible deformable or pivotally attached to the proximal end (55) of the proximal body portion (53) and which is configured to releasably engage the proximal end (33) of the injection device (1).

12. The packaging (50; 150) according to any one of the preceding claims, wherein the distal body portion (52) comprises a distally facing end face (66) with a through opening (69).

13. The packaging (50; 150) according to claim 12, further comprising a needle cap remover (100) comprising an elongated sleeve portion (101), wherein the elongated sleeve portion (101) extends longitudinally into an interior of receptacle (60, 160) and is configured to engage with a needle cap (14) of the injection device (1).

14. The packaging (50; 150) according to any one of the preceding claims, wherein the elongated body (151) comprises a first shell section (172) extending from the distal body portion(152) to the proximal body portion (153) and a second shell portion (174) extending from the distal body portion (152) to the proximal body portion (153), wherein the receptacle (160) is confined by the first shell portion (172) and by the second shell portion (174), and wherein the second shell portion (174) is movable relative to the first shell portion (172) for at least one of opening and closing of the receptacle (160).

15. The packaging (50; 150) according to any one of the preceding claims, wherein the elongated body (51 ; 151) comprises a molded body (51 ; 151) comprising a molding material including cellulose fibers and a binder.16 The packaging (50; 150) according to claim 15, wherein the molded body (51) is at least partially covered or coated with a waterproof layer (66).

17. The packaging (50; 150) according to claim 15 or 16, wherein the molding material comprises:50 wt.-% - 80 wt.- % of the binder,5 wt.- % - 20 wt.-% of cellulose fibers and10 wt.-% - 30 wt.-% of water.

18. A kit (30) comprising: a packaging (50; 150) according to any one of the preceding claims and an injection device (1) comprising an elongated housing (10) extending along a longitudinal direction, wherein the housing (10) comprises a container part (7) and a device body (6) adjoining the container part (7) along the longitudinal direction, wherein the container part (7) is configured for insertion into the receptacle (60; 160) of the packaging (50; 150).

19. The kit (30) according to claim 18, further comprising a cover (220) comprising a pliable cover sheet (221 , 222) configured to wrap around a portion of the body (51; 151) and the injection device (1) received in the receptacle (60; 160) of the body (51 ; 151) along a surface circumferential direction.

20. The kit (30) according to claim 19, wherein the cover (220) comprises: a first cover sheet (221) configured to extend along an upper side of the body (51 ; 151), and a second cover sheet (222) configured to extend along a lower side of the body (51 ; 151) opposite to the upper side of the body (51; 151) and connected to the first cover sheet (221) along at least one seam (223, 224).

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