Blinding device for injecting devices

Abstract

Blinding Device for Injection Devices In one aspect the present disclosure relates to a blinding device (50) for concealing an injection device (1) in clinical trials, wherein the injection device (1) comprises a movable plunger (20) and an elongated barrel (10) extending in a longitudinal direction (2, 3) and filled with a medicament (8) or with a placebo, wherein the plunger (20) is longitudinally movable relative to the barrel (10) for expelling the medicament (8) or the placebo from the barrel (10) and wherein the injection device (1) comprises a flange portion (17, 18) at or near a proximal end of the barrel (10), the blinding device (50) comprising: - an opaque housing (52) to cover the barrel (10) and the plunger (20), the opaque housing (60) comprising: - a barrel cover portion (54) to receive and to cover the barrel (10), - a plunger cover portion (56) of variable longitudinal extent to receive and to cover the plunger (20), and - a housing flange portion (55) protruding outwardly from the barrel cover portion (54), wherein the housing flange portion (55) comprises a first flange part (61) and a second flange part (62), which are mutually connectable to form a flange assembly (66) connecting the barrel cover portion (54) with the plunger cover portion (56). (Fig. 1)

Description

[0001] PAT24300-WO-PCT

[0002] Blinding Device for Injecting Devices

[0003] Description

[0004] Field

[0005] The present disclosure relates to the field of medical devices, particularly to injection devices, such as syringes and in particular to pre-filled syringes and / or safety syringes. Specifically, the present disclosure relates to a blinding device and a blinding kit for concealing the outer appearance of an injection device or syringe for use in clinical trials.

[0006] Background

[0007] 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.

[0008] 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.

[0009] 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.

[0010] Some injection devices are implemented as reusable injection devices offering a user to replace a medicament container, such as a cartridge. Other injection devices are implemented as a disposable injection device. With disposable injection devices it is intended to discard the entirety of the injection device when the content, i.e. the medicament, has been used up. Disposable injection devices may be pre-filled with the injectable medicament.

[0011] Clinical trials for some pharmaceutical drugs require that the drug dosage and corresponding placebo dosage be delivered in a blinded study through the use of pre-filled syringes. Each syringe comprises a syringe barrel that houses the dosage, a needle projecting from the syringe barrel, and a plunger rod with a corresponding stopper that is used to dispense the dosage out of the syringe barrel through the needle. For safety reasons, a rigid needle shield or needle cap is removable attached to the syringe barrel and covers the needle when the syringe is not in use. At the time of injection, the needle shield or needle cap is simply pulled off of the syringe or syringe barrel to expose the needle.

[0012] As part of the protocols for blinded studies, a plurality of syringes are each preloaded with a single dose of the drug, comparator or placebo prior to shipping for use. The recipient and person delivering the dosage should be blind as to any visual properties of a dosage. This is particularly helpful in avoiding any perceived distinctions between the drug and either the comparator, the placebo or both.

[0013] Injection device or syringes are often filled at different facilities and / or in different batches.

[0014] Injection devices, such as pre-filled syringes may be provided and manufactured by numerous suppliers or pharmaceutical manufacturers. Pre-filled injection devices, such as pre-filled syringes, typically comprise a barrel filled with a liquid injectable medicament. The medicament may visually distinguish from a placebo, which may be also provided in a likewise barrel of a pre-filled syringe. Moreover, placebo-filled syringes and syringes filled with a pharmaceutical product or medicament may be originally labeled when provided by a respective pharmaceutical manufacturer or supplier.

[0015] Also, various features of injection devices, e.g., a geometric shape, color or texture of a plunger may vary. The plunger may be operable or actuatable by a user of the injection device for injecting the dose. Concealing the visual appearance of a plunger of an injection device is quite challenging since the plunger subject to a longitudinal or axial movement relative to the barrel of the injection device. Hence, for a proper operation of the injection device the plunger must remain manually operable or movable.

[0016] It is therefore necessary to provide an improved blinding device for concealing the injection device, at least for concealing the barrel and the plunger of the injection device during and / or for a clinical trial while at the same time providing a good and reliable handling thereof.

[0017] Summary

[0018] In one aspect there is provided a blinding device for concealing or blinding an injection device, wherein the injection device is configured for use in clinical trials. The injection device comprises a plunger and a barrel, wherein the barrel is filled with a medicament or with a placebo. The plunger is movable relative to the barrel for expelling of the medicament from the barrel. Typically, the barrel comprises a distally located outlet, e.g. provided or fluidically connected with an injection needle. By moving the plunger relative to the barrel a dose of the medicament or placebo can be expelled through the outlet of the barrel, typically through the injection needle and hence into biological tissue that has been punctured or pierced by the respective injection needle. The injection needle may comprise a cannula, which is in fluid communication with the outlet of the barrel or which forms the outlet of the barrel.

[0019] The injection device further comprises a flange portion at or near a proximal end of the barrel. The flange portion protrudes outwardly, e.g., transversely or radially outwardly from the elongated and / or longitudinally extending barrel. The outwardly extending flange portion provides a rather easy and intuitive handling, e.g., an easy and straightforward holding or mounting of the injection device.

[0020] The blinding device comprises an opaque housing to cover the barrel and to cover the plunger of the injection device. The opaque housing comprises a barrel cover portion to receive and to cover the barrel of the injection device. The opaque housing further comprises a plunger cover portion of variable longitudinal extent to receive and to cover the plunger of the injection device. The opaque housing further comprises a housing flange portion protruding outwardly from the barrel cover portion. The housing flange portion comprises a first flange part and a second flange part.

[0021] The first and the second flange parts may be mutually connectable to form a flange assembly connecting or interconnecting the barrel cover portion with the plunger cover portion.

[0022] With the plunger assembly comprising the first flange part and the second flange part there can be provided a mutual fastening between the barrel cover portion and the plunger cover portion. In this way, the opaque housing may be separated in numerous portions or parts. Hence, the barrel cover portion may be provided as a separate part compared to the plunger cover portion. The barrel cover portion may comprise a cover body made of a rather rigid and inflexible material. The barrel cover portion may comprise or constitute a sidewall configured to enclose the barrel of the injection device so as to conceal the barrel of the injection device.

[0023] The plunger cover portion comprises a variable longitudinal extent. This way, the plunger cover portion is configured to adapt to the movement of the plunger during expelling or injecting the dose of the medicament. The variable longitudinal extent may be provided in a variety of different ways. According to some examples, the plunger cover portion may comprise a flexible material, which allows and supports a variation of the longitudinal extent of the plunger cover portion. According to further examples the plunger cover portion may comprise numerous parts, which may be movable relative to each other so as to provide a variation of the longitudinal extent of the plunger cover portion. Moreover, by way of the variable longitudinal extent of the plunger cover portion a user of the blinding device blinding kit can apply an actuation force onto the plunger cover portion, which might be effective to compress or to reduce the longitudinal extent of the plunger cover portion and / or to induce a movement of the plunger relative to the barrel of the injection device. The plunger cover portion may comprise or may provide an opaque sidewall structure enclosing or accommodating the movable plunger of the injection device.

[0024] By way of the flange assembly the plunger cover portion can be fastened or connected, e.g., detachably fastened or connected to the barrel cover portion. This way, the opaque housing may be split or may be provided by numerous individual parts or portions that can be assembled and fixed together to form or to constitute the opaque housing, which entirely covers or conceals the visual appearance of the injection device. By way of the flange assembly, the plunger cover portion can be connected and fastened to the barrel cover portion; and vice versa. Hence, by way of the flange assembly the barrel cover portion can be fixed and fastened to the plunger cover portion.

[0025] According to some examples the plunger assembly is located longitudinally between the barrel cover portion and the plunger cover portion.

[0026] According to some examples, the flange assembly may be connected or fixed to at least one of the proximal longitudinal end of the barrel cover portion and may be fixed or fixable or fastenable to a distal end of the plunger cover portion.

[0027] According to some examples the plunger assembly may be implemented as an integral part of the barrel cover portion. Hence, the barrel cover portion may comprise a first barrel cover part and a second barrel cover part. Here, the first flange part may be integrally formed with the first barrel cover part and the second flange part may be connected or integrated into the second barrel cover part. The first and second barrel cover parts may be mutually assembled or connected to form or to constitute the barrel cover portion. Here, a mutual fastening and fixing of the respective first and second barrel cover parts may provide a fastening and fixing of the plunger cover portion to the proximal end of the plunger cover assembly.

[0028] According to another example the first and the second flange part may be integrally formed with a portion of a first and a second plunger cover part, respectively. Here, the plunger cover portion may comprise a first plunger cover part and a second plunger cover part, that may be integrally formed or unitarily shaped with the first and the second flange parts. By mutually fixing or mutually assembling the first and the second flange parts respective first and second plunger cover parts may be mutually attached thereby providing a mount or a fixing and fastening structure for residual parts, e.g. of proximal parts of the plunger cover portion. In either way, the first and the second flange parts provide and support a mutual mechanical fastening of the barrel cover portion, the flange assembly and the plunger cover portion. In this way, a rather easy assembly of the injection device inside the opaque housing of the blinding device can be provided.

[0029] The structure and composition of the opaque housing provides a rather easy and straightforward arrangement and assembly of the injection device inside the opaque housing. By way of example, the injection device with its plunger may be inserted or insertable into the plunger cover portion. In a separate step the barrel cover portion may be attached to the barrel of the injection device, or, the barrel of the injection device may be introduced into the barrel cover portion. In a further assembly step the flange assembly may be attached and / or fixed to the barrel cover portion and to the plunger cover portion, thereby mutually fixing and fastening the barrel cover portion and the plunger cover portion.

[0030] The flange assembly with first and second flange parts may provide and support a fastening in a transverse or radial direction thereby engaging with both, the proximal end of the barrel cover portion and the distal end of the plunger cover portion.

[0031] Accordingly, the first flange part and the second flange part are mutually fastenable or fixable along a transverse or radial fasting direction with respect to the elongation of the elongated barrel to form or to establish the flange assembly, thereby engaging with at least one of the proximal end of the barrel cover portion and the distal end of the plunger cover portion. According to some examples, and by way of a mutual assembly of the first and the second flange parts, there is provided both, establishing or forming of the flange assembly and a mutual fastening and fixing of the proximal end of the barrel cover portion with the distal end of the plunger cover portion via the flange assembly.

[0032] According to some examples of the blinding device, the first flange part comprises a first flange section, which protrudes outwardly, e.g., radially outwardly from the barrel cover portion and / or from the plunger cover portion when attached or fixed to at least one of the barrel cover portion of plunger cover portion.

[0033] The first flange part may also comprise or form a first receptacle, which is sized and configured to receive a flange portion of the elongated barrel of the injection device. The first receptacle may comprise or form a slit on an interior side of the first flange part, which is correspondingly or complementary shaped to an outside surface or outside facing structure of the flange portion of the elongated barrel of the injection device.

[0034] Likewise and according to a further example, also the second flange part comprises a second flange section, which protrudes outwardly, e.g., radially outwardly from the barrel cover portion and / or from the plunger cover portion when attached or fixed to at least one of the barrel cover portion of plunger cover portion.

[0035] Like the first flange part, also the second flange part may comprise or form a second receptacle, which is sized and configured to receive a flange portion or another flange portion of the elongated barrel of the injection device. The second receptacle may comprise or form another slit on an interior side of the second flange part, which is correspondingly or complementary shaped to an outside surface or facing structure of the flange portion of the elongated barrel of the injection device.

[0036] In this way, the first and second flange parts and hence the flange assembly may provide a twofold function. First of all, it is configured to receive a flange portion of the barrel of the injection device in order to provide a firm fitting or fixing of the injection device with respect to the longitudinal direction relative to the flange assembly and hence relative to the entire opaque housing. Second, and by way of first and / or second flange sections, the first and second flange parts can be used as a finger flanges for a user to apply a respective driving force to the blinding device in the course of or for injecting a placebo or a medicament from the injection device. Of course, the barrel cover portion, the plunger cover portion as well as the housing flange portion are made of an opaque material. In a final assembly configuration, wherein the flange assembly connects or interconnects the barrel cover portion with the plunger cover portion, the entirety of the injection device can be concealed by the housing of the blinding device.

[0037] According to a further example the housing flange portion comprises a proximally facing end face and a fastener at the proximally facing end face. The fastener is configured to mechanically engage with a complementary shaped counter fastener of the plunger cover portion for fastening the plunger cover portion to the housing flange portion. By way of the fastener provided at the proximally facing end face of the housing flange portion and by way of the complementary shaped counter fastener of the plunger cover portion there can be provided a well-defined mutual fixing and fastening between the plunger portion and the plunger cover portion.

[0038] According to some examples the fastener is provided at a proximal end face of the plunger assembly. The complete fastener may be only provided after and / or by attaching the first flange part and the second flange part to each other and / or by attaching the first flange part and the second flange part to the barrel cover portion of the opaque housing of the blinding device.

[0039] According to some examples the mutual fastening and fixing between the plunger cover portion and the housing flange portion or the flange assembly may be incomplete and may be inoperable as long as the first flange part and the second flange part are not mutually attached or interconnected and / or as long as the first flange part and the second flange part are not duly attached or connected to the barrel cover portion of the opaque housing. In this way, it becomes mandatory that the first flange part and the second flange part are either mutually connected or that the first flange part and the second flange part are connected to the barrel cover portion in order to provide or to constitute the fastener by way of which the complementary shaped counter fastener of the plunger cover portion can be fastened and fixed to the housing flange portion or flange assembly.

[0040] According to another example the first flange part comprises a first fastening structure. The second flange part comprises a second fastening structure. The first fastening structure and the second fastening structure complement each other to form the fastener. According to some examples neither the first fastening structure nor the second fastening structure alone will be sufficient and / or operable to provide a fastening between the flange assembly and the plunger cover portion. Rather, it may be required to establish the plunger assembly, by arranging the first flange part and the second flange part in a well-defined orientation or configuration, e.g., by mutually connecting or mutually attaching the first flange part and the second flange part. It may be then that the flange assembly is constituted by mutually attaching the first flange part and the second flange part and / or by attaching the first flange part and the second flange part to the barrel cover portion.

[0041] It may be only upon completion or constitution of the flange assembly that the first fastening structure of the first flange part and the second fastening structure of the second flange part mutually complement to form or to constitute the fastener of the housing flange portion or flange assembly. In this way it is mandatory and required that both flange parts are used to establish or to constitute the flange assembly thereby providing or constituting the fastener by way of which the plunger cover portion can be attached and fixed to the housing flange portion and hence to the barrel cover portion.

[0042] According to some examples the first and second fastening structures and hence the fastener provided by the first and second fastening structures of the first and the second flange parts may be configured to connect or to fasten to the complementary shaped counter fastener upon a completion of the flange assembly, hence, upon a mutual fastening of the first flange part and the second flange part. In this way, the mutual fastening of first and second flange part and the mutual fastening of the fastener and the complementary shaped counter fastener may be conducted simultaneously.

[0043] Hence, numerous mechanical interconnects and fastening structures may be established in a single or with a reduced number of assembly steps thereby facilitating and simplifying the mutual assembly of the opaque housing and the injection device.

[0044] According to some examples the plunger cover portion is attachable or fixable to the barrel cover portion by the housing flange portion. According to some examples the housing flange portion is fixable or attachable to the plunger cover portion and to the barrel cover portion. Here, the housing flange portion may provide a mechanical interconnect for fixing or fastening the barrel cover portion to the plunger cover portion.

[0045] According to some examples the housing flange portion, hence the flange assembly comprising first and second flange parts is configured to attach and to fix to both, to a proximal end of the barrel cover portion and to a distal end of the plunger cover portion thereby fixing and fastening the barrel cover portion and the plunger cover portion relative to each other.

[0046] According to a further example the fastener comprises a fastening profile, e.g., with a radially inwardly or radially outwardly protruding projection. The fastening profile may comprise a circumferentially closed structure, e.g., a kind of a profiled rim or ring provided at the proximally facing end face of the housing flange portion. The fastening profile may be provided or completed by mutually fastening the first flange part and the second flange part and / or by fastening the first flange part and by fastening the second flange part to the barrel cover portion.

[0047] According to some examples the fastening profile may comprise a barrel-shaped profile with a first leg protruding proximally from the proximally facing end face of the housing flange portion and with a second leg protruding inwardly or outwardly, e.g., transversely or radially inwardly or outwardly from the first leg. In this way there is provided a kind of an undercut for engaging with the complementary shaped counter fastener of the plunger cover portion.

[0048] According to another example the counter fastener of the plunger cover portion comprises a counter fastening profile with an outwardly or inwardly protruding projection. The counter fastening profile may be complementary shaped to the fastening profile of the fastener. The fastening profile with its outwardly or inwardly protruding projection may comprise a kind of an outwardly or inwardly protruding flange, which engages the undercut structure of the fastening profile of the fastener. Here, the counter fastening profile may comprise an outwardly or inwardly extending flange. A distal end of a sidewall or sidewall structure of the plunger cover portion, with a radially outwardly or inwardly protruding flange or projection, is sized to engage the fastening profile of the fastener.

[0049] The outwardly protruding projection may be sized and shaped to become inserted into the gap between the proximally facing end face of the housing flange portion and the second leg of the fastening profile of the fastener.

[0050] The counter fastening profile may be provided on an outside facing side at a distal end of a sidewall or sidewall structure of the plunger cover portion. The counter fastening profile may be a circumferential profile. It may comprise a closed circumference, which is sized to become inserted into the fastening profile of the fastener of the housing flange portion. The fastener of the housing flange portion and hence the fastener of the flange assembly may be provided and completed by mutually fastening the first and second flange part to each other and / or by fastening the first and the second flange parts in a radially inwardly facing direction to the barrel cover portion. In this way, the outwardly protruding projection of the counter fastener can be covered and / or engages with the fastening profile of the fastener, which is formed and / or completed by bringing the first and the second flange parts together into a final assembly position or final assembly configuration. According to a further example the first flange part comprises a first engaging section. The second flange part comprises a second engaging section. The first flange part and the second flange part are mutually connectable by a mechanical engagement of the first engaging section with the second engaging section. By way of first and second engaging sections the first and the second flange parts can mutually engage. By way of the first and the second engaging section the first flange part and the second flange part can be mutually attached and / or mutually fixed. The mutual fixing and fastening of the first flange part and the second flange part establishes or forms or constitutes the fastener by way of which the plunger cover portion can be fastened and fixed to the housing flange portion.

[0051] According to a further example the first engaging section comprises a connecting element. The second engaging section comprises a counter connecting element, which is complementary shaped to the connecting element. The first engaging section is mechanically engageable with the second engaging section by a mechanical engagement of the connecting element with the counter connecting element. In this way, the first and the second engaging sections can be mutually connected and fastened as well as mutually fixed relative to each other thereby establishing and maintaining a final assembly configuration of the first and second flange part to form or to constitute the plunger assembly and hence the housing flange portion.

[0052] According to further examples the first engaging section comprises another connecting element and the second engaging section comprises another counter connecting element. The another connecting element and the another counter connecting element may likewise mechanically engage to provide a another mutual fastening and / or fixing of the first and second engaging sections and hence of the first and the second flange parts.

[0053] By way of the connecting element and the another connecting element as well as by way of the counter connecting element and the another counter connecting element there can be provided a multiple mutual fastening and fixing of the first and second engaging sections and hence of the first and the second flange parts. By numerous mutually engaging connecting elements and counter connecting elements the mechanical stability of the mechanical interconnection between the first and the second flange parts can be improved and strengthened.

[0054] According to a further example at least one of the first engaging section and the second engaging section comprises a recess, which is configured to receive at least a portion of the barrel cover portion.

[0055] According to some examples the first engaging section and the second engaging section comprise mutually corresponding abutment faces, which get in direct mutual abutment when bringing the first and the second engaging sections into a final assembly configuration. The connecting element may protrude from the abutment face. The counter connecting element may comprise a recess in a complementary shaped counter abutment face of the first and the second engaging sections, respectively. In addition to the protruding or recessed structures of the connecting element and the counter connecting element the recess as provided in at least one of the first and the second engaging sections of the respective first or second flange part, provides a receptacle for receiving at least a portion of the barrel cover portion, e.g., for receiving a sidewall of the barrel cover portion. The recess of at least one of the first engaging section and the second engaging section may be sized to receive an outside surface of a sidewall of the barrel cover portion.

[0056] In some examples the recess may be sized and shaped to receive at least a fraction of an outer circumference of the sidewall of the barrel cover portion.

[0057] According to some examples the first flange part and the second flange part each comprises a recess configured to receive at least a portion of the barrel cover portion. Here, the first flange part may comprise a first recess. The second flange part may comprise a second recess. In the mutual assembly configuration, the first recess may align with and / or complement the second recess. The first and the second recess may form or constitute a through opening extending longitudinally through the mutual assembly of the first and the second flange parts.

[0058] Hence, the first and the second recesses of the first flange part and the second flange part and hence of the first and the second engaging sections thereof may form or constitute a through recess through the flange assembly, which through recess is configured and shaped to receive the barrel cover portion therein or therethrough.

[0059] According to some examples the first recess of the first flange part may be sized and configured to receive a first outside facing portion of a sidewall of the barrel cover portion. Likewise, the second recess of the second flange part and hence of the second engaging section may be sized and configured to receive an opposite second outside surface of the sidewall of the barrel cover portion.

[0060] The mutual assembly of the first and the second engaging sections with first and second recesses may entirely enclose or sandwich an outside surface of the sidewall of the barrel cover portion therebetween. In this way, there can be provided a rather firm, e.g., a rather robust mutual fastening between the barrel cover portion and the flange assembly. With some examples, an outside of a sidewall of the barrel cover portion can be clamped or squeezed inside the receptacle or through opening formed by the at least one recess or formed by first and second recesses of the first and second engaging sections of the first and second flange parts.

[0061] According to a further example the first flange part comprises a first barrel cover connector. By way of the first barrel cover connector the first flange part can be connected and / or fixed to the barrel cover portion, e.g., to a sidewall of a cover body of the barrel cover portion. For this, the barrel cover portion may comprise a complementary shaped flange connecting structure, e.g., a first flange connecting structure to form a mutual interconnect with the first flange part.

[0062] The second flange part may likewise comprise a second barrel cover connector to form or to constitute a mechanical interconnect with the barrel cover portion. Also here, the barrel cover portion, e.g., a sidewall of a cover body of the barrel cover portion comprises a second flange connecting structure to form or to provide a mechanical interconnect with the second barrel cover connector of the second flange part.

[0063] The first barrel cover connector may be exclusively provided with the first flange part. The second barrel cover connector may be exclusively provided with the second flange part. Upon a final assembly and by mutually attaching and connecting the first and the second flange parts the first barrel cover connector of the first flange part may engage with the first flange connecting structure of the barrel cover portion. Likewise, the second barrel cover connector of the second flange part may interconnect and may engage with the second flange connecting structure of the barrel cover connector. The first and the second flange connecting structures of the barrel cover portion may be provided on opposite sides, e.g., on transverse opposite or radially opposite sides of the sidewall of the cover body of the barrel cover portion.

[0064] By way of mutually corresponding and / or complementary shaped mechanical structures of the first barrel connector and the first flange connecting structure and by mutually corresponding and / or complementary shaped mechanical structures of the second barrel connector and the second flange connecting structure, there can be provided a positive fitting between the flange assembly and the barrel cover portion of the opaque housing of the blinding device. The flange assembly, hence, the first and the second flange parts and the barrel cover portion can be then mutually fixed and attached in a well-defined, easy and straightforward manner.

[0065] According to another example the first flange part comprises a first barrel cover connector and a second barrel cover connector. The first barrel cover connector is mechanically engageable with the first flange connecting structure of the barrel cover portion and the second barrel cover connector is configured to engage the second flange connecting structure. In this way, it may be provided that the first flange part can be attached and fixed to the barrel cover portion even without and / or independent of the second flange part. In this way, the fastening of the individual first and second flange parts to the barrel cover portion can be facilitated.

[0066] Also here, the first flange connecting structure and the second flange connecting structure of the barrel cover portion may be provided on opposite sides of the sidewall of the cover body of the barrel cover portion. The first and the second barrel cover connectors may be provided on respective sidewall sections of the first flange part. The respective first and second barrel cover connectors may be provided on an inside surface of a longitudinal protrusion of the first flange part, which protrusion may align with the recess of the first engaging section.

[0067] According to a further example the second flange part may comprise another first barrel cover connector and another second barrel cover connector. The first and the second barrel cover connectors may be configured to mechanically connect the barrel cover portion to the flange assembly.

[0068] The first barrel cover connector may likewise be configured to engage with the first flange connecting structure. The second barrel cover connector may be configured to engage with the second flange connecting structure. In this way, there can be also provided a mutual fastening of the first and second flange parts via the barrel cover portion.

[0069] Here, the first and second flange parts may be void of first and second engaging sections for a direct mutual engagement between the first and the second flange parts. Rather, and by way of the first and the second barrel cover connectors of the first flange part and by way of the another first barrel cover connector and the another second barrel cover connector of the second flange part, the first and the second flange parts can be each independently fastened and fixed to the barrel cover portion.

[0070] Here, the barrel cover portion, e.g., the sidewall of the cover body of the barrel cover portion may form a mount for the first flange part and for the second flange part. The first and the second flange parts may be fastened and fixed relative to each other via or through the barrel cover portion, e.g., through the sidewall of the cover body of the barrel cover portion.

[0071] According to a further example of the blinding device the barrel cover portion comprises an elongated hollow cover body comprising a sidewall confining a barrel receiving space. The sidewall comprises a flange connecting structure for connecting to the flange assembly. The flange connecting structure may comprise or include a first flange part connector and a second flange part connector. The first flange part connector may be configured to engage the first barrel cover connector. The second flange part connector may be configured and shaped to engage the second barrel cover connector.

[0072] According to some examples the first barrel cover connector comprises an inwardly extending protrusion, e.g. a protrusion with a beveled edge. The first flange part connector of the hollow cover body may comprise a complementary shaped recessed portion. It may comprise a recess or through recess in the sidewall of the hollow cover body. Likewise, the second barrel cover connector may comprise an inwardly extending protrusion of protection, e.g., with a beveled edge to engage with a complementary shaped recessed portion, which may likewise comprise a complementary -shaped recess.

[0073] By way of the beveled edge(s), there can be provided an elastic deformation of the respective first or second barrel cover connectors in the course of establishing a mutual assembly of the flange assembly to the barrel cover portion.

[0074] According to a further example the first flange part and the second flange part may be of symmetric shape. According to some examples the first flange part and the second flange part may comprise an identical shape. Hence, the first flange part and the second flange part may comprise a mirror symmetry with a symmetry axis extending along a longitudinal axis with respect to the elongation of the barrel cover portion. Specifically, the first and the second engaging sections comprise a mirror symmetry, such that oppositely oriented and identically shaped first and second flange parts can be either mutually assembled or can be assembled and attached to the barrel cover portion, which comprises respective oppositely located flange connecting structures of identical shape.

[0075] According to a further example of the blinding device the hollow cover body comprises a distal end provided with a through opening for an injection needle of the injection device. The distal end may comprise a distal end face with a through opening, which through opening is sized to receive a protective cap of the injection device there through. In a final assembly configuration and with the injection device assembled inside the opaque housing of the blinding device, the protective cap of the injection device may protrude through the distal through opening of the opaque housing thus allowing to detach the protective cap from the injection device so as to expose the injection needle. According to a further example the hollow cover body further comprises a proximal end, which is configured for fastening to the flange assembly of the opaque housing.

[0076] In a further example the flange connecting structure of the barrel cover portion comprises one of a recess or through opening in the sidewall at or near the proximal end of the hollow cover body. The recess or through opening of the sidewall of the barrel cover portion may be shaped and configured to mechanically engage with at least one of the first and the second barrel cover connectors and / or with at least one of the another first barrel cover connector and the another second barrel cover connector of first and second flange parts.

[0077] According to a further example of the blinding device the plunger cover portion comprises a telescopic assembly. The telescopic assembly comprises at least a first sleeve element and a second sleeve element coaxial to the first sleeve element. The first sleeve element and the second sleeve element are in a longitudinal sliding engagement. By way of the telescopic assembly there can be provided the plunger cover portion of variable longitudinal extent. The variable longitudinal extent of the plunger cover portion can be obtained by sliding the first sleeve element relative to the second sleeve element in longitudinal direction. Hence, a degree of mutual overlapping of the first sleeve element and the second sleeve element is directly correlated to the total longitudinal extent or total longitudinal size of the plunger cover portion.

[0078] Of course, the first sleeve element and the second sleeve element are made of an opaque material.

[0079] According to another example the first sleeve element comprises a first circumferential sidewall. The second sleeve element comprises a second circumferential sidewall. An outer surface of the second sleeve element matches with an inner circumference of the first sleeve element. In some examples, the outer circumference of the second sleeve element is enclosed or surrounded by the inner circumference of the first sleeve element. The cross-section of the sidewall of the first sleeve element and the cross-section of the sidewall of the second sleeve element is substantially constant as seen in longitudinal direction. This provides a rather smooth and easy longitudinal gliding or sliding of the first sleeve element relative to the second sleeve element.

[0080] According to some examples the first sleeve element is provided with the counter fastener of the plunger cover portion for fastening the plunger cover portion to the housing flange portion of the opaque housing. The second sleeve element may be mechanically engageable with a proximal end of the plunger of the injection device. Hence, the plunger of the injection device may be indirectly actuatable or movable by moving the second sleeve element relative to the first sleeve element or by moving the second sleeve element relative to the housing flange portion of the opaque housing.

[0081] The number of sleeve elements of the telescopic assembly of the plunger cover portion is in no way limited to only two sleeve elements. There may be provided numerous sleeve elements, which are arranged coaxial and which are in a longitudinal sliding engagement.

[0082] According to a further example the telescopic assembly comprises a terminating sleeve element comprising a terminating circumferential sidewall, which is in sliding engagement with one of the first circumferential sidewall and the second circumferential sidewall. With some examples, wherein the telescopic assembly comprises only a first and the second sleeve element the terminating sleeve element may form or constitute the second sleeve element.

[0083] With some examples, wherein the telescopic assembly comprises e.g., at least three sleeve elements the terminating sleeve element may be provided as a third sleeve element, which is in sliding engagement with the second sleeve element. Here, the second sleeve element may be in sliding engagement with the first sleeve element. With the example of a telescopic assembly comprising a first, a second and a third sleeve element it may be provided that an inside surface of the circumferential sidewall of the first sleeve element is in sliding engagement with an outside or outside surface of the circumferential sidewall of the second sleeve element. An inside surface of the circumferential sidewall of the second sleeve element may be in sliding engagement with an outside or outside surface of the circumferential sidewall of the third and hence of the terminating sleeve element.

[0084] The diameters or transverse cross-sections of the first and the second and of any further sleeve element of the telescopic assembly are complementary shaped so as to provide an entirely opaque telescopic assembly for each conceivable or available longitudinal extent of the plunger cover portion.

[0085] According to a further example the terminating sleeve element comprises a closed end face, e.g., a proximal end face. The closed end face of the terminating sleeve of the telescopic assembly is configured to engage with a plunger flange, which is provided at a proximal end of the movable plunger of the injection device. The closed end face of the terminating sleeve element may be in longitudinal abutment with the plunger flange of the movable plunger of the injection device. It may be fastened or fixed to the plunger flange, e.g. by way of a clip fastener or by way of a frictional fastening. In either way, there can be provided a bidirectional longitudinal fastening between the terminating sleeve element and the plunger flange of the movable plunger. In this way, the proximal end of the plunger cover portion can be fixed and fastener to the proximal end of the plunger of the injection device when assembled inside the opaque housing of the blinding device. Accordingly, the telescopic assembly of the plunger cover portion can be mechanically stabilized by the plunger of the injection device.

[0086] According to a further example the flange assembly of the housing of the blinding device may be further configured to engage with the plunger portion of the injection device when arranging or fixing the injection device inside the opaque housing. In this way, the injection device, e.g., the barrel of the injection device, can be fixed to the opaque housing of the blinding device. Here, the flange assembly of the housing of the blinding device provides a twofold or multiple function. It may provide a mutual fastening and connection between the barrel cover portion and the plunger cover portion of the opaque housing of the blinding device. In addition, the flange assembly and hence the first and the second flange parts may provide a fixing of the injection device, e.g., a fixing of a flange portion of the injection device inside the opaque housing of the blinding device.

[0087] According to another example the first sleeve element of the telescopic assembly comprises a distal end provided with the counter fastener, which is complementary shaped to the fastener of the housing flange portion or of the flange assembly. The first sleeve element may comprise a radially outwardly protruding projection forming or constituting the counter fastening profile, which is configured and shaped to engage with the fastening profile of the fastener of the housing flange portion. In this way, there can be provided a rather easy and straightforward mutual assembly and fastening between the housing flange portion or flange assembly and the plunger cover portion.

[0088] According to another aspect the present disclosure also relates to a blinding kit. The blinding kit comprises a blinding device as described above. The blinding kit further comprises an injection device arranged inside or to be arranged inside the opaque housing of the blinding device.

[0089] In further examples the blinding kit comprises a first blinding device and a second blinding device as well as a first injection device arranged or to be arranged in the first blinding device and a second injection device arranged or to be arranged in the second blinding device. Here, the first injection device as provided or arranged inside the housing of the first blinding device may be filled with a pharmaceutical product, e.g. a medicament and the second injection device arranged or to be arranged inside the second blinding device may be filled with a placebo. The blinding kit may be then used or prepared for a double-blind clinical trial. According to a further example the injection device(s) of the blinding kit comprise(s) a pre-filled syringe. The pre-filled syringes may be provided by different suppliers or manufacturers. They may distinguish from each other by a label as provided on an outside surface of the respective syringe barrel. They may also distinguish in the region of a barrel flange. Some of the barrels of the syringes may comprise a cutted edge portion, e.g. a planar-shaped edge portion at or in a surrounding or annularly shaped barrel flange. Such edge portions may allow to distinguish between barrels and hence between syringes of different manufacturers or suppliers.

[0090] According to further examples the injection devices of the blinding kit(s) distinguish by the size, geometric structure, constitution or color of a plunger.

[0091] By way of the presently proposed blinding device or blinding kit the entirety of the injection device can be covered and encased by the opaque housing of the blinding device such that a user of the injection device, when duly attached or arranged inside the opaque housing of the blinding device, cannot distinguish between injection devices of different suppliers or manufacturers. Accordingly, the user will be unable to distinguish between an injection device containing a pharmaceutical product and an injection device containing a placebo.

[0092] In another aspect the present disclosure also relates to a method of blinding an injection device for use in a clinical trial. The injection device comprises a plunger and a barrel filled with a medicament or filled with a placebo. The plunger is movable relative to the barrel for expelling of the medicament or placebo from the barrel. The injection device further comprises a housing flange portion at or near a proximal end of the barrel. The method of blinding the injection device comprises the steps of providing and / or using a blinding device as described above and arranging the plunger of the injection device at least partially in the plunger cover portion and a further step of arranging the barrel of the injection device inside the barrel cover portion. The method further comprises the step of mutually connecting the first flange part and the second flange part to form the flange assembly thereby connecting or interconnecting the plunger cover portion with the barrel cover portion.

[0093] Mutually connecting the first flange part and the second flange part may include a direct mutual fastening and fixing of the first and the second flange parts. It may further include to arrange and to fasten the first flange part to the barrel cover portion and / or to the plunger cover portion and / or to arrange and fix the second flange part to the barrel cover portion and / or to the plunger cover portion. In either way, the flange assembly comprising the first and the second flange parts in a final assembly configuration serve to provide a mutual interconnection between the barrel cover portion and the plunger cover portion. The variable longitudinal extent of the plunger cover portion allows and provides an unhindered and hence intuitive operation or actuation of the injection device while entirely located inside the opaque housing of the blinding device. The plunger of the injection device can be operated by applying a pressure to the proximal end of the plunger cover portion, which due to its variable longitudinal extent may become subject to a longitudinal compression, which may induce or come along with a distally directed displacement of the plunger relative to the barrel of the injection device.

[0094] Typically, the method of blinding as described herein is to be executed or conducted with a blinding device as described above. Insofar, all features, effects and benefits as described above in connection with the blinding device and with the blinding kit equally apply to the method of blinding the injection device for use in a clinical trial; and vice versa.

[0095] 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.

[0096] 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.

[0097] 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.

[0098] 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.

[0099] 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.

[0100] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0101] 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.

[0102] 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.

[0103] 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.

[0104] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1 Eligen, GRMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1 , CVX-096, ZYOG-1 , ZYD-1, GSK-2374697, DA-3091 , MAR-701 , MAR709, ZP- 2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA- 15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide- XTEN and Glucagon-Xten.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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). 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.

[0109] 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.

[0110] 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).

[0111] 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.

[0112] 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.

[0113] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needle- based injection systems 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.

[0114] 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).

[0115] 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).

[0116] Brief description of the drawings

[0117] In the following, numerous examples of a blinding device for use with an injection device, in particular for use with a pre-filled injection syringe or safety syringe are shown and described in greater detail by making reference to the drawings, in which:

[0118] Fig. 1 is a perspective illustration of a blinding device with an injection device arranged therein,

[0119] Fig. 2 is a schematic illustration of an injection device in an initial configuration,

[0120] Fig. 3 shows the injection device according to Fig. 2 during dose injection,

[0121] Fig. 4 shows the injection device of Figs. 2 and 3 after completion of dose injection,

[0122] Fig. 5 shows a longitudinal cross-section through the blinding kit of Fig. 1 in a initial configuration,

[0123] Fig. 6 shows the kit according to Fig. 5 after completion of dose injection,

[0124] Fig. 7 shows a perspective and exploded view of numerous parts of the blinding device, Fig. 8 shows a partially transparent view through a plunger cover portion of the blinding device,

[0125] Fig. 9 is a perspective illustration of a longitudinal cross-section of the blinding kit according to Figs. 7 and 8,

[0126] Fig. 10 shows details of the barrel cover portion and a flange part before mutual assembly, Fig. 11 shows the components of the blinding device of Fig. 10 when mutually assembled,

[0127] Fig. 12 shows first and second flange parts before mutual assembly,

[0128] Fig. 13 shows first and second flange parts in a final assembly configuration,

[0129] Fig. 14 shows a further example of a blinding kit,

[0130] Fig. 15 shows a further example of a blinding kit,

[0131] Fig. 16 shows a further example of a blinding kit and

[0132] Fig. 17 shows another example of a blinding kit, and

[0133] Fig. 18 is illustrative of a flowchart of conducting a method of blinding an injection device by making use of a blinding device as described herein.

[0134] Detailed description.

[0135] In Fig. 1 there is illustrated a blinding kit 100 comprising a blinding device 50 and an injection device 1. The blinding device 50 is configured to entirely cover or to entirely conceal the outer appearance of the injection device 1 as shown in Figs. 2-4. The blinding device 50 comprises an opaque housing 52 comprising numerous individual portions or parts. The opaque housing 52 is configured to cover the barrel 10 and a plunger 20 of the injection device 1. The opaque housing 52 comprises a barrel cover portion 54 to receive and to cover the barrel 10 of the injection device. The barrel cover portion 54 may be also configured and sized to accommodate or to receive a syringe housing 11 of an injection device 1 as described below with respect to Figs. 2-4.

[0136] The opaque housing 52 of the blinding device 50 further comprises a plunger cover portion 56 of variable longitudinal extent. The plunger cover portion 56 is configured and sized to receive and to cover a plunger 20 of the injection device 1. The opaque housing 52 further comprises a housing flange portion 55 protruding outwardly from the barrel cover portion 54 and / or protruding outwardly, e.g., radially outwardly from the plunger cover portion 56. The housing flange portion 55 may comprise a flange assembly 66.

[0137] The flange assembly 66 may comprise a first flange part 61 and a second flange part 62. The first flange part 61 and the second flange part 62 are mutually connectable to form the flange assembly 66. By way of the flange assembly 66 and hence by way of the first and the second flange parts 61, 62 the barrel cover portion 54 can be connected to the plunger cover portion 56; and vice versa.

[0138] The example of Figs. 2-4 relates to a so-called safety syringe 5 with a needle 15 retracting function, which needle retraction is triggered at the end of a dose dispensing procedure.

[0139] In the sequence of Figs. 2-4 an injection device 1 and its intended use is schematically illustrated. With the illustrated example the injection device 1 comprises a kind of a syringe, e.g. implemented as a safety syringe 5. The injection device 1 comprises a barrel 10 filled with a liquid injectable medicament 8. Towards a proximal longitudinal direction 3 the barrel 10 is sealed by a stopper 9, which is movable in distal direction 2 relative to the barrel 10. The barrel 10 may be of tubular shape. It may comprise an outlet 14 at its distal end. The outlet 14 may be provided with an injection needle 15, fastened to a distal end of the barrel 10. Towards the proximal end or proximal direction 3 the barrel 10 terminates with a radially outwardly extending or protruding flange portion 17, which could be used as a finger grip for an index finger and a middle finger of a user to suitably hold the syringe while the user may use a thumb of the same hand to press against a plunger 20 protruding proximally from the barrel 10. The barrel 10 may be made of a pharmaceutically inert material or chemically inert material, such as glass or some other vitreous material.

[0140] The stopper 9 may be integrally formed with a longitudinally extending plunger 20. The plunger 20 may comprise an elongated rod extending in longitudinal direction (z). With some examples the stopper 9 and the plunger 20 may be provided as separate pieces. Here, the plunger 20 may comprise a distal end 22 configured to detachably fasten to the stopper 9. The plunger 20 is further configured to exert a distally directed pressure onto the stopper 9 in order to move the stopper 9 in distal direction 2 relative to the barrel 10, thereby expelling a well-defined amount of the liquid medicament 8, i.e. a dose of predefined size, through the outlet 14 and into biological tissue when the injection needle 15 has penetrated or pierced the tissue. The stopper 9 may comprise an elastomeric material to hermetically seal the interior of the barrel 10.

[0141] The proximal end of the plunger 20 is typically provided with a radially widened plunger flange 21. The plunger flange 21 is typically configured to be depressed by a thumb of a user. With the example of Figs. 2-4 the injection device 1 is implemented as a safety syringe 5. It is provided with a syringe housing 11, which is of substantially elongated or tubular shape. The syringe housing 11 is sized to accommodate the barrel 10 as well as a spring element 27. The spring element 27 is operably engaged with the syringe housing 11 and with the barrel 10. It may be configured to induce a relative longitudinal motion between the barrel 10 and the syringe housing 11, particularly with a completion of a dose injection procedure.

[0142] The barrel 10 may be secured against a longitudinal motion relative to the housing 11 by an interlock 24. In the example as illustrated in Figs. 2 - 4, the interlock 24 is provided at or near a proximal end of the barrel 10 or syringe housing 11. The syringe housing 11, which may be also of sleeve-like shape, comprises a counter latch element 26 to releasably engage with a latch element 25 as provided on the barrel 10. The latch element 25 and the counter latch element 26 are initially in an engaged configuration by way of which a longitudinal displacement of the barrel 10 relative to the housing 11 is impeded or blocked.

[0143] It may be only upon the plunger 10 reaching a distal end configuration, in which the plunger flange 21 engages the counter latch element 26 in such a way that the counter latch element 26 is deformed of pivoted so as to give way for the latch element 25. Once the latch element 25 is released from the counter latch element 26, mechanical energy stored in the spring element 27 can be released thus leading to a longitudinal movement or longitudinal displacement of the barrel 10 relative to the syringe housing 11. Here, and as soon as the latch element 25 and the counter latch element 26 disengage, the barrel 10 is subject to a proximally directed movement under the effect of the relaxing spring element 26, which movement is apparent from a comparison of Figs. 3 and 4. Accordingly, the entire syringe or barrel 10 is retracted into the housing 10 in proximal direction 3 so as to retract the needle 15 into the syringe housing 11 and hence into the syringe carrier 13.

[0144] The outlet 14 or the needle 15 initially protruding from the distal end of the housing 11 and reaching through a through opening 28 as provided on a distal end face of the housing 11 is or are retracted into the interior of the syringe housing 11 as illustrated in Fig. 4. Here, the modified injection device T is in a shielded or protected configuration, in which the injection device 1 cannot be no longer used and wherein the distally protruding tip of the injection needle 15 is protected by the syringe housing 11.

[0145] The flange portion 18 may be complementary shaped to the flange portion 17. The proximal end of the flange portion 18 and / or the proximal end of the syringe housing 11 may be further provided with a beveled edge 23, which is configured to engage with the distally facing side or edge of the plunger flange 21 as the plunger 20 reaches a distal end position as shown in Fig.

[0146] 3. When the plunger flange 21 abuts against the beveled edge 23, the beveled edge 23 and hence the counter latch element 26 is urged radially outwardly, thereby disengaging from the latch elements 25, which may be simply provided by the radially outwardly extending flange portion 17 of the barrel 10. As further illustrated in Figs. 1 and 2, and in an initial configuration the outlet 14 and / or the injection needle 15 may be protected or covered by a separate protective cap 16. Before conducting an injection procedure, the protective cap 16 should be detached and removed from the outlet 14 or needle 15. In the presently illustrated example the counter latch element 26 may be located at or near a radially outwardly extending flange portion 18 of the syringe housing 11.

[0147] The barrel 10 of the syringe or injection device 1 may be encapsulated or mounted in a syringe carrier 13, which syringe carrier 13 is operably engaged with the spring element 27. The syringe carrier 13, which is only indicated in Figs. 2-4 may provide a dedicated sliding function inside the syringe housing 11 and may house the barrel 10 inside.

[0148] The blinding device 50 as further described herein may be particularly designed and configured for use with the injection device 1 as described above. However, it may be also usable with and it may be also configured for conventional syringe-type injection devices 1, which may only comprise a syringe barrel 10, an injection needle 15 and a plunger 20 longitudinally movable relative to the barrel 10.

[0149] In the following, reference is made to the numerous illustrations of the blinding device 50 as reflected by Figs. 5-13. The blinding device 50 comprises an opaque housing 52. The housing 52 comprises numerous parts or portions. The housing 52 comprises a barrel cover portion 54, a housing flange portion 55 and a plunger cover portion 56. The barrel cover portion 54 comprises a hollow cover body 90 comprising a sidewall 91, which is sized and shaped to receive the barrel 10 and / or the syringe housing 11 of the injection device 1.

[0150] The cover body 90 comprises a sidewall 91 of elongated shape. The sidewall 91 forms or encloses a barrel receiving space 92. The cover body 90 is of hollow shape and the sidewall 91 is a circumferentially closed sidewall to entirely cover and to entirely conceal the barrel 10 and / or the syringe housing 11 of the injection device 1. The sidewall 91 is of rectangular crosssection. However, it may be also of tubular or cylindrical and hence circular cross-section. The sidewall 91 may be complementary shaped to the sidewall of the syringe housing 11 or barrel 10.

[0151] The sidewall 91 and hence the hollow cover body 90 comprises a distal end 95 provided with a distal through opening 96. The hollow cover body 90 and hence the sidewall 91 also comprises a proximal end 97. The through opening 96 is sized to receive the protective cap 16 at least partially therethrough. In an initial configuration as e.g. shown in Fig. 5 the protective cap 16 porotrudes through the distally located through opening 96. This way, and immediately before use of a blinding kit 100, the protective cap 16 can be detached from the injection device 1 to expose the tipped end of the injection needle 15.

[0152] The proximal end 97 of the sidewall 91 is provided with a first flange connecting structure 93 and with a second flange connecting structure 94 for connecting and / or fixing the flange assembly 66 to the barrel cover portion 54. In the example as illustrated in Figs. 10 and 11 , both, the first and the second flange connecting structures 93, 94 comprise a through recess extending through the sidewall 91 of the hollow cover body 90.

[0153] The first and second flange connecting structures 93, 94 are complementary shaped to first and second barrel cover connectors 73, 73’, 74, 74’ as provided on or with the first flange part 61 and the second flange part 62, respectively. The first barrel cover connector 73 may be complementary shaped to the first flange connecting structure 93. The second barrel cover connector 74 is complementary shaped to the second flange connecting structure 94. The first flange connecting structure 93 may be provided or located on a portion of the sidewall 91 that is laterally or radially opposite to a portion of the sidewall 91 that is provided with the second flange connecting structure 94.

[0154] In this way and as becomes apparent from a comparison of Figs. 10 and 11 the first flange part 61 can be fastened individually to the proximal end 97 of the sidewall 91 of the hollow cover body 90, simply by engaging the first barrel cover connector 73 with the first flange connecting structure 93 and by engaging the second barrel cover connector 74 with the second flange connecting structure 94.

[0155] The barrel cover connectors 73, 74 and the flange connecting structures 93, 94 may comprise mutually corresponding and / or complementary-shaped fastening or fixing elements, such as protrusions and recesses by way of which there can be established a positive fit and positive fixing between the barrel cover connectors 73, 74 and the flange connecting structures 93, 94.

[0156] The plunger cover portion 56 is of variable longitudinal extent as becomes apparent from a comparison of Figs. 5 and 6. The plunger cover portion 56 comprises a telescopic assembly 40. The telescopic assembly 40 comprises a first sleeve element 41, a second sleeve element 42 and a third sleeve element 43. The third sleeve element 43 also forms or constitutes a terminating sleeve element. The third sleeve element 43 and hence the terminating sleeve element 43 forms or constitutes a proximal end of the plunger cover portion 56. The first sleeve element 41 forms or constitutes a distal end 48 of the plunger cover portion 56. The distal end 48 is provided with a counter fastener 49, which is complementary shaped to a fastener 65 provided at a proximally facing end face 60 of the housing flange portion 55 or of a flange assembly 66.

[0157] The first sleeve element 41 comprises a first circumferential sidewall 44. The second sleeve element 42 comprises a second circumferential sidewall 45 and the third sleeve element 43 comprises a third circumferential sidewall 46. The third sleeve element 43 comprises a cupshaped structure. The third circumferential sidewall 46 adjoins a closed proximal end face 47 thus forming a proximal end face of the telescopic assembly 40.

[0158] The end face 47 may comprise a distally extending depression 38, which may be further provided or equipped with a distance piece or spacer 39. In this way, the terminating sleeve element 43 may engage with the proximal plunger end and hence with a plunger flange 21 of the plunger 20 of the injection device 1 as indicated in Fig. 9. The first circumferential sidewall 44 is provided with a first stop element 34 at a proximal end to engage with a complementary shaped stop element 35 provided at the distal end of the second circumferential sidewall 45.

[0159] The second circumferential sidewall 45 is likewise provided with another stop element 36 at proximal end of the sidewall 45 to engage with a further stop element 37 as provided at the distal end of the third circumferential sidewall 46 of the third sleeve element 43.

[0160] In this way it can be provided that the individual sleeve elements 41, 42, 43 are movable relative to each other in longitudinal direction, e.g., in distal direction 2. The mutually engaging stop elements 34, 35, 36, 37 prevent a disassembly and hence a disconnection of the various sleeve elements 41 , 42, 43 when the plunger cover portion should be extended to a maximum longitudinal size.

[0161] The individual sleeve elements 41, 42, 43 are arranged coaxial with respect to the longitudinal direction 2, 3. They may be in longitudinal sliding or gliding engagement. As becomes apparent from Fig. 9, an inside surface of the first sidewall 44 is slightly larger compared to an outside surface of the second sidewall 45. Likewise, an inside surface of the second sidewall 45 is slightly larger than an outside surface of the third sidewall 46. The stop element 35 as provided at the distal end of the second sidewall 45 may be in sliding, e.g., in a longitudinal sliding engagement with the inside surface of the first sidewall 44.

[0162] Likewise, the inside facing end of the stop element 34, hence, an inside facing, e.g., a radially inside facing projection of the stop element 34 may be in sliding engagement with the outside surface of the second sidewall 45. In a similar manner, the outwardly, e.g., radially outwardly protruding stop element 37 as provided at the distal end of the third sidewall 46 may be in sliding engagement with the inside surface of the second sidewall 45 and an inside facing or inside protruding projection of the stop element 36 as provided at the proximal end of the second sidewall 45 may be in sliding engagement with an outside surface of the third sidewall 46.

[0163] In the extended configuration as shown in Fig. 9, the inwardly extending projection of the stop element 34 is in longitudinal abutment with the outside extending projection of the stop element 35. In this way, and when in longitudinal abutment any further proximally directed displacement of the second sidewall 45 relative to the first sidewall 44 can be blocked or prevented.

[0164] Likewise, the inside projecting part of the stop element 36 of the second sidewall 45 may be in longitudinal abutment or engagement with the outside facing protrusion or projection of the stop element 37. The stop element 35 is located at a distal offset from the stop element 34. Likewise, the stop element 37 is located at a distal offset from the stop element 36. Since the radial or transverse extent of the stop elements 36 and 37 and since the radial or transverse extent of the stop elements 34, 35 mutually overlaps the stop element 34 is configured to block a proximally directed movement of the stop element 35 beyond the proximal end of the first sleeve element 41. Likewise, the stop element 36 is configured to prevent or to block a proximally directed movement of the stop element 37 in proximal direction 3 beyond the stop element 36 and hence beyond the proximal end of the second sleeve element 42.

[0165] However, the numerous sleeve elements 41, 42, 43 can be moved in longitudinal direction relative to each other from the extended configuration as shown in Fig. 5 into a compressed configuration, as, e.g. shown in Fig. 6, wherein the sidewalls 44, 45, 46 of the individual sleeve elements 41 , 42, 43 are arranged in a staggered and hence in an at least partially longitudinally overlapping configuration.

[0166] The distal end 48 of the telescopic assembly 40 and hence the distal end of the plunger cover portion 56 is provided with the counter fastener 49. In the presently illustrated example the counter fastener 49 comprises a counter fastening profile 32 comprising a outwardly extending projection 33, e.g., in form of an outwardly extending circumferential rim or ring, which is configured to engage with a complementary shaped fastening profile 30 of the fastener 65 as provided at the proximally facing end face 60 of the first and second flange parts 61, 62.

[0167] The fastening profile 30 may comprise a circumferentially closed ring structure or a respective inwardly extending structure. It comprises a radially inwardly extending projection 31 , which is located at a pre-defined proximal distance from the end face 60. The proximal distance corresponds to the longitudinal extent of the counter fastening profile 32 and hence of the outwardly extending projection 33 at the distal end 48 of the telescopic assembly 40.

[0168] The housing flange portion 55 comprises a first flange part 61 and a second flange part 62 as illustrated in Figs. 12 and 13. The first and the second flange parts 61, 62 may be of identical shape. They may be made or formed symmetric with regards to a longitudinal axis, e.g. coinciding with the longitudinal symmetry axis of the barrel cover portion 54. The first flange part 61 comprises a first flange section 78 protruding outwardly, e.g., radially outwardly from the barrel cover portion 54 when the first flange part 61 is attached to the barrel cover portion 54. The first flange part 61 may further comprise a second flange section 79 protruding outwardly, e.g. radially outwardly in an opposite direction compared to the first flange section 78.

[0169] The first flange section 78 further comprises of forms a first receptacle 80. The second flange section 79 comprises a second receptacle 81. The first and the second receptacles 80, 81 as shown in Fig. 10 are sized and configured to receive the flange portion 17 of the barrel 10 or to receive the flange portion 18 of the syringe housing 11. The longitudinal size of the receptacles 80, 81 is particularly shaped to the respective longitudinal extent of the flange portion 17, 18 in order to provide a firm fixing of the injection device 1 to the respective flange part 61, 62, e.g. with respect to the longitudinal direction.

[0170] The flange part 61 comprises a proximal end face 60 extending in transverse or radial direction from the first flange section 78 to the second flange section 79. The end face 60 delimits and confines the receptacle 80, 81.

[0171] The first flange part 61 comprises a somewhat straight or evenly shaped abutment face 85 facing radially inwardly. The abutment face 85 is provided at the first flange section. A corresponding abutment face 86 is provided at the second flange section 79.

[0172] The receptacles 80, 81 are confined in longitudinal distal direction by a bottom 82. The bottom 82 confines the receptacle 80, 81 in distal direction 2. The end face 60 confines the receptacle 80, 81 in proximal direction 3. The receptacles 81, 82 are open towards a radial inside facing direction so as to receive the flange portion 17, 18 of the injection device 1. The insert opening of the receptacles 80, 81 and the adjoining abutment faces 85, 86 form part of a first engaging section 67 of the first flange part 61. The engaging section 67 is provided with a recess 69, e.g., located midway between the first and second flange sections 78, 79. The recess 69 may extend through the end face 60 as well as through the bottom 82.

[0173] The bottom 82 confines the recess 69. There are further provided first and second distally facing or distally extending projections 83, 84 extending from the inside facing end of the bottom

[0174] 82, which adjoins the recess 69. On an inside surface of the longitudinally extending projections

[0175] 83, 84 there are provided the first and second barrel cover connectors 73, 74. The first and second projections 83, 84 substantially extend parallel to the laterally opposite portions of the sidewall 91 of the cover body 90 of the barrel cover portion 54, which opposite portions are provides with the flange connecting structures 93, 94.

[0176] The radial or transverse distance between the longitudinally extending protections 83, 84 may match or may coincide with the transverse or radial distance between opposite portions of the sidewall 91. In this way, the proximal end 97 of the hollow cover body 90 can be squeezed, clamped or firmly held between the projections 83, 84 and the barrel cover connectors 73, 74 provided at the inside facing surface of the projections 83, 84.

[0177] The first flange part 61 is provided with a first fastening structure 63 protruding proximally from the end face 60. As illustrated in Fig. 10 the first fastening structure 63 forms part of a circumferentially closed fastener 65. The first fastening structure 63 is located radially or laterally outside the recess 69. The first engaging section 67 is configured to engage with a second engaging section 68 of the second flange part 62 as shown in Fig. 12 and 13. The first and the second flange parts 61, 62 may get in lateral or radial abutment with their mutually corresponding first and second engaging sections 67, 68.

[0178] The first engaging section 67 comprises a first connecting element 71 complementary shaped to a first counter connecting element 72 as provided on the second flange part 62. The connecting element 71 may be provided as a radially or tangentially protruding snap feature to mechanically engage with the complementary shaped counter snap feature of the counter connecting element 72 as provided on the second flange part 62.

[0179] The connecting element 71 may be provided on the second flange section 79. There may be provided another connecting element 7T, which is provided on the first flange section 78. The another connecting element 7T may be complementary shaped to another counter connecting element 72' of the second flange part 62. As becomes apparent from the illustration of Fig. 12 the connecting element 71 of the first flange part 61 may be identically shaped to the another counter connecting element 72' of the second flange part 62. Likewise, the counter connecting element 72 of the second flange part 62 may be identically shaped compare to the another connecting element 7T of the first flange part 61. In either way, the connecting elements 71, 7T and the complementary shaped counter connecting elements 72, 72' may provide a snap fit and hence a positive fitting between the first and the second flange parts 61 , 62, which may be identically shaped.

[0180] For ease of assembly, the flange parts 61 , 62 may each further comprise an inwardly protruding protrusion sized and configured as a guiding pin 77, 77' to be inserted in radial or transverse direction into the receptacle 80, 81 of the respective other flange part 62, 61. In this way the step of mutually assembling the first and second flange part 61, 62 can be facilitated. A guiding pin 77, 77' of one of the first flange part 61 and the second flange part 62 may start to slide into a receptacle 80, 81 of the other one of the first and the second flange part 61 , 62 in the course of mutual assembly of the first and the second flange parts 61 , 62 before the connecting element 71 , 7T engages the complementary shaped counter connecting element 72, 72'. By way of example, the guiding pin 77' of the second flange part 62 may be configured for insertion into the receptacle 81 of the first flange part 61. Vice versa, the guiding pin 77 of the first flange part 61 may be configured for insertion into a receptacle 8T of the second flange part 62.

[0181] In a final assembly as shown in Fig. 13 there is provided a longitudinally extending through opening or through recess in the flange assembly 66. The second flange part 62 may be identically shaped compared to the first flange part 61. The second flange part 62 comprises a second fastening structure 64 of identical or equal shape compared to the first fastening structure 63. In the final assembly configuration, the first and the second fastening structures 63, 64 mutually complement each other to form the fastener 65. It may be only by reaching the final assembly configuration and the mutual engagement of the first and the second engaging sections 67, 68 of the first and second flange parts 61 , 62 that the first and second fastening structures 63, 64 form a circumferentially closed structure of the fastener 65.

[0182] The fastener 65 comprises an annular or circumferentially closed fastening profile 30. In the final assembly configuration as shown in Fig. 13 the connecting elements 71 , 7T are in a snap fit engagement with the complementary shaped counter connecting elements 72, 72'. In this way, the first and the second flange parts 61 , 62 can be held together.

[0183] The second flange part 62 comprises a second recess 70, which is equally shaped compared to the first recess 69 of the first flange part 61. When in the final assembly configuration and when forming or constituting the flange assembly 66 the first and second recesses 69, 70 complement each other and form a through opening 89 through the flange assembly 66, which is sized to receive and / or to hold the barrel cover portion 54 therein. The projections 83, 84 of the first and the second flange parts 61, 62 adjoin each other and form a kind of a fastening flange or sidewall to engage with an outside surface of the sidewall 91 of the body 90 of the barrel cover portion 54. The barrel cover connectors 73, 74 may form a snap fit engagement with the first and second flange connecting structures 93, 94 as provided on the sidewall 91 of the cover body 90. The projections of the barrel cover connectors 73, 74 may comprise a beveled edge facing in distal direction 2. This may even provide and support a fastening of the barrel cover portion 54 to the flange assembly 66 after mutually interconnecting the first and the second flange parts 61 , 62.

[0184] Here, the proximal end 97 of the sidewall 91 of the cover body 90 may be simply urged in proximal direction into the through opening 89 formed by the first and second recesses 69, 70 until the barrel cover connectors 73, 74 engage the first and second flange connecting structures 93, 94 on the sidewall 91.

[0185] In this way there can be provided a mutual fastening and fixing of the flange assembly 66 to the barrel cover portion 54, and vice versa.

[0186] Since the projections 83, 84 of the first flange part 61 are located on opposite sides of the sidewall 91 of the cover body 90, each flange part 61 can be also assembled and fastened individuality to the barrel cover portion 54.

[0187] With other examples of the blinding device 50 there may not be required a direct mutual interconnection between the first and the second flange parts 61 , 62. Rather, the first and the second flange parts 61 , 62 may be held together or may be mutually fixed via the barrel cover portion 54.

[0188] The inner circumference of the fastener 65 as provided on the proximally facing end face 60 of the flange assembly 66 as shown in Fig. 13 is complementary shaped to the counter fastener 49 as provided at the distal end 48 of the telescopic assembly 40 and hence at the distal end 48 of the plunger cover portion 56. For fastening the plunger cover portion 56 to the flange portion 55 it may be required that a portion of the counter fastener 49 is engaged with e.g. one of the first and the second fastening structures 63, 64, e.g., by inserting the projection 33 into the gap formed between the projection 31 and the end face 60.

[0189] The further flange part 62 may be then brought into engagement with the first flange part 61 thereby bringing the second fastening structure 64 into engagement with the residual portion of the counter fastening profile 32. In this way, the outer circumference of the counter fastener 49 can be radially or transversely secured by the rim-like and inwardly extending projection 31 of the fastening profile 30 provided on the flange assembly 66.

[0190] In the example according to Fig. 7-9 there is provided a longitudinal fixing between the plunger and hence the plunger flange 21 and the terminating sleeve element 43. Here, the sleeve element 43 comprises recesses one 106, 107 in the third sidewall 46.

[0191] For fixing plunger 20 to the terminating sleeve element 43 there is further provided a fixing element 102 comprising a fixing ring 101. The fixing ring 101 comprises a kind of an annular structure with a slit 102. By way of the slit 102 the fixing element 110 can be urged or snapped onto the plunger 20, e.g. in radial direction onto the radially narrowed stem of the plunger 20. It may be then moved in proximal direction 3 relative to the plunger 20 and may frictionally engage with an inside surface 105 of the fixing ring 101 onto an outside surface of the radially widened plunger flange 21. On the outside of the fixing ring 101 there are provided numerous projections 103, 104, which are arranged and sized to engage the recesses 106, 107 in the third sidewall 46.

[0192] In this way there can be provided a longitudinal bidirectional mutual fastening and fixing between the plunger 20 and the telescopic assembly 40.

[0193] By way of the inwardly extending depression 38 at the proximal end face 47 of the telescopic assembly 40 that can be provided a well-defined receptacle for a thumb or any other finger of a user intending to apply a distally directed driving force or pressure onto the telescopic assembly 40 for inducing a distally directed displacement of the plunger 20 relative to the barrel 10. A distal section of the depression 38 may be further provided with a spacer 39. The spacer 39 may be made of a flexible material so as to compensate for any longitudinal tolerances between the longitudinal extent of the injection device 1 and the longitudinal extent of the housing 52 of the blinding device 50.

[0194] The bidirectional mutual connection between the proximal end of the telescopic assembly 40 and the plunger 20 is of particular benefit in that a distally directed movement of the telescopic assembly may transfer into a respective distally directed displacement or movement of the plunger relative to the barrel 10. Moreover, a proximally directed movement of the plunger 20, e.g. under the effect of the relaxing spring element 27 of the safety syringe 5 may induce a respective limited proximally directed expansion of the telescopic assembly 40 compared to the minimum longitudinal extent of the telescopic assembly 40. The further example of the blinding device 50 for a blinding kit 100 as shown in Fig. 14 varies from the example according to Fig. 5-13 in that the proximal end face 47 of the telescopic assembly 40 comprises a distally extending receptacle 57, which is configured to receive the plunger flange 21. Here, the receptacle 57 comprises one or numerous snap elements 58 provided at a distal end of a sidewall 59 confining the receptacle 57. The snap elements 58 are configured to grip or to snap under the distal end of the radially widened plunger flange 21. At the same time, a spacer 39 protruding distally from the inside of the distal end face 47 may get in longitudinal abutment with the proximal end face of the plunger flange 21. In this way, the plunger flange 21 may be securely and firmly held inside the receptacle 57. It may be likewise longitudinally fixed to the coupling assembly 40.

[0195] The further example as shown in Fig. 15 shows a further solution for providing at least unidirectional longitudinal fixing between the telescopic assembly 40 and the proximal end of the plunger 20. There, the plunger flange 21 is engaged with a distally projecting sidewall 59 provided on the inside of the end face 47. Here, the end face 47 may even comprise a through opening 87, which allows a user to directly apply a driving or actuation force onto the plunger

[0196] 20. This example may be used when injection devices 1 filled with a medicament and filled with a placebo in a double-blind clinical study are provided with in distinguishable plunger flanges

[0197] 21.

[0198] With the further example according to Fig. 16 the proximal end face 47 comprises a distally extending spacer 39 2 longitudinally abut with the proximal end face of the plunger flange 21. Here and for ease of applying a distally directed dispensing force onto the blinding device 50, an outside surface of the phase 47 is provided with a bowl 88, which may be configured to receive a finger, e.g., a thump of an operator.

[0199] Like the example according to Fig. 16 also the example as shown in Fig. 17 is void of a bidirectional fixing between the telescopic assembly 40 and the plunger 20. There, the proximal end face 47 of the telescopic assembly 40 is provided with distally extending depression 38, which is configured to receive a finger, e.g., a thump of a user. The inner most end of the depression 38 may be further provided with a spacer 39, e.g., for tolerance compensation.

[0200] The flowchart according to Fig. 18 shows numerous steps of a method of blinding an injection device 1 for use in a clinical trial. Here, and in a first step 200 an injection device 1 and a blinding device 50 may be provided. In step 202 the proximally protruding plunger 20 of the injection device 1 is inserted into the plunger cover portion 56. Optionally, the proximal end of the plunger 20, e.g., the plunger flange 21 may be fixed or connected to the terminating sleeve element 43 of the telescopic assembly 40.

[0201] In step 204, the barrel 10 and / or the syringe housing 11 of the injection device 1 can be introduced into the barrel cover portion 54. Thereafter, in step 206, the first flange part 61 may be attached to the proximal end 97 of the cover body 90 of the barrel cover portion 54 and to the distal end 48 of the telescopic assembly 40, hence to the distal end of the plunger cover portion 56.

[0202] In a further step 208 the second flange part 62 is attached to the proximal end 97 of the cover body 90 of the barrel cover portion 54 and to the distal end 48 of the telescopic assembly 40, hence to the distal end of the plunger cover portion 56. In this way, the barrel cover portion 54 and the plunger cover portion can be mutually attached and fixed and the injector device 1 can be entirely concealed by the opaque housing 52 of the blinding device 50.

[0203] Reference Numbers

[0204] 1 injection device

[0205] 2 distal direction

[0206] 3 proximal direction

[0207] 5 safety syringe

[0208] 8 medicament

[0209] 9 stopper

[0210] 10 barrel

[0211] 11 syringe housing

[0212] 12 shield

[0213] 13 syringe carrier

[0214] 14 outlet

[0215] 15 needle

[0216] 16 protective cap

[0217] 17 flange portion

[0218] 18 flange portion

[0219] 19 abutment face

[0220] 20 plunger

[0221] 21 plunger flange

[0222] 22 plunger end

[0223] 23 beveled edge

[0224] 24 interlock

[0225] 25 latch element

[0226] 26 counter latch element

[0227] 27 spring element

[0228] 28 through opening

[0229] 30 fastening profile

[0230] 31 projection

[0231] 32 counter fastening profile

[0232] 33 projection

[0233] 34 stop element

[0234] 35 stop element

[0235] 36 stop element

[0236] 37 stop element

[0237] 38 depression

[0238] 39 spacer 40 telescopic assembly

[0239] 41 sleeve element

[0240] 42 sleeve element

[0241] 43 sleeve element

[0242] 44 sidewall

[0243] 45 sidewall

[0244] 46 sidewall

[0245] 47 end face

[0246] 48 distal end

[0247] 49 counter fastener

[0248] 50 blinding device

[0249] 52 housing

[0250] 54 barrel cover portion

[0251] 55 housing flange portion

[0252] 56 plunger cover portion

[0253] 57 receptacle

[0254] 58 snap element

[0255] 59 sidewall

[0256] 60 end face

[0257] 61 flange part

[0258] 62 flange part

[0259] 63 fastening structure

[0260] 64 fastening structure

[0261] 65 fastener

[0262] 66 flange assembly

[0263] 67 engaging section

[0264] 68 engaging section

[0265] 69 recess

[0266] 70 recess

[0267] 71 connecting element

[0268] 72 counter connecting element

[0269] 73 barrel cover connector

[0270] 74 barrel cover connector

[0271] 77 guiding pin

[0272] 78 flange section

[0273] 79 flange section

[0274] 80 receptacle receptacle bottom projection projection abutment face abutment face through opening bowl through opening cover body sidewall barrel receiving space flange connecting structure flange connecting structure distal end through opening proximal end blinding kit fixing ring slit projection projection inside surface recess recess fixing element

Claims

42PAT24300-WO-PCTClaims1. A blinding device (50) for concealing an injection device (1) in clinical trials, wherein the injection device (1) comprises a movable plunger (20) and an elongated barrel (10) extending in a longitudinal direction (2, 3) and filled with a medicament (8) or with a placebo, wherein the plunger (20) is longitudinally movable relative to the barrel (10) for expelling the medicament (8) or the placebo from the barrel (10) and wherein the injection device (1) comprises a flange portion (17, 18) at or near a proximal end of the barrel (10), the blinding device (50) comprising: an opaque housing (52) to cover the barrel (10) and the plunger (20), the opaque housing (60) comprising: a barrel cover portion (54) to receive and to cover the barrel (10), a plunger cover portion (56) of variable longitudinal extent to receive and to cover the plunger (20), and a housing flange portion (55) protruding outwardly from the barrel cover portion (54), wherein the housing flange portion (55) comprises a first flange part (61) and a second flange part (62), which are mutually connectable to form a flange assembly (66) connecting the barrel cover portion (54) with the plunger cover portion (56).

2. The blinding device (50) according to claim 1, wherein the flange assembly (66) is connectable or fixable to at least one of a proximal longitudinal end of the barrel cover portion (54) and a distal end of the plunger cover portion (56).

3. The blinding device (50) according to any one of the preceding claims, wherein the first flange part (61) and the second flange part (62) are mutually fastenable along a transverse or radial fastening direction to form or to establish the flange assembly (66) thereby engaging with at least one of the proximal end of the barrel cover portion (54) and the distal end of the plunger cover portion (56).

4. The blinding device (50) according to any one of the preceding claims, wherein the first flange part (61) comprises a first flange section (78) protruding outwardly from the barrel cover portion (54) when the first flange part (61) is attached to the barrel cover portion (54) and wherein the first flange part (61) comprises or forms a first receptacle (80), which is sized and configured to receive a flange portion of the elongated barrel (10) of the injection device (1).

5. The blinding device (50) according to claim 1, wherein the housing flange portion (55)43 comprises a proximally facing end face (60) and a fastener (65) at the proximally facing end face (60) to mechanically engage with a complementary shaped counter fastener (49) of the plunger cover portion (56) for fastening the plunger cover portion (56) to the housing flange portion (55).

6. The blinding device (50) according to claim 5, wherein the first flange part (61) comprises a first fastening structure (63) and wherein the second flange part (62) comprises a second fastening structure (64), and wherein the first fastening structure (63) and the second fastening structure (64) complement each other to form the fastener (65).

7. The blinding device (50) according to any one of the preceding claims, wherein the first flange part (61) comprises a first engaging section (67), wherein the second flange part (62) comprises a second engaging section (68) and wherein the first flange part (61) and the second flange part (62) are mutually connectable by a mechanical engagement of the first engaging section (67) with the second engaging section (68).

8. The blinding device (50) according to claim 7, wherein the first engaging section (67) comprises a connecting element (71), wherein the second engaging section (68) comprises a counter connecting element (72) complementary shaped to the connecting element (71) and wherein the first engaging section (67) is mechanically engageable with the second engaging section (68) by a mechanical engagement of the connecting element (71) with the counter connecting element (72).

9. The blinding device (50) according to claim 7 or 8, wherein at least one of the first engaging section (67) and the second engaging section (68) comprises a recess (69, 70) configured to receive at least a portion of the barrel cover portion (54).

10. The blinding device (50) according to any one of the preceding claims, wherein the first flange part (61) comprises a first barrel cover connector (73) and a second barrel cover connector (74), wherein the second flange part (62) comprises another first barrel cover connector (73’) and another second barrel cover connector (74’) and wherein the first and the second barrel cover connectors (73, 74) are configured to mechanically connect the barrel cover portion (54) to the flange assembly (66).

11. The blinding device (50) according to any one of the preceding claims, wherein the barrel cover portion (54) comprises an elongated hollow cover body (90) comprising a sidewall44(91) confining a barrel receiving space (92), wherein the sidewall (91) comprises a flange connecting structure (93, 94) for connecting to the flange assembly (66).

12. The blinding device (50) according to any one of the preceding claims, wherein the plunger cover portion (56) comprises a telescopic assembly (40) comprising at least a first sleeve element (41) and a second sleeve element (42) coaxial to the first sleeve element (41) and in a longitudinal sliding engagement with the first sleeve element (41).

13. The blinding device (50) according to claim 12, wherein the first sleeve element (41) comprises a first circumferential sidewall (44), wherein the second sleeve element (42) comprises a second circumferential sidewall (45) and wherein an outer circumference of the second sleeve element (42) matches with an inner circumference of the first sleeve element (41).

14. The blinding device (50) according to claim 12 or 13, wherein the telescopic assembly (40) comprises a terminating sleeve element (43) comprising a terminating circumferential sidewall (46), which is in sliding engagement with one of the first circumferential sidewall (44) and the second circumferential sidewall (45).

15. The blinding device (50) according to claim 14, wherein the terminating sleeve element (43) comprises a closed end face (47) and wherein the terminating sleeve element (43) is configured to engage with a plunger flange (21) at a proximal end of the movable plunger (20) of the injection device (1).

16. The blinding device (50) according to claim 5 and according to any one of the preceding claims 12-15, wherein the first sleeve element (41) comprises a distal end (48) provided with the counter fastener (49), which is complementary shaped to the fastener of the housing flange portion (55).

17. A blinding kit (100) comprising a blinding device (50) according to any one of the preceding claims and further comprising an injection device (1) arranged inside the opaque housing (52) of the blinding device (20).

18. A method of blinding an injection device (1) for use in a clinical trial, wherein the injection device (1) comprises a movable plunger (20) and an elongated barrel (10) extending in a longitudinal direction (2, 3) and filled with a medicament (8) or with a placebo, wherein the plunger (20) is longitudinally movable relative to the barrel (10) for expelling the medicament (8)or the placebo from the barrel (10) and wherein the injection device (1) comprises a flange portion (17, 18) at or near a proximal end of the barrel (10), the method of blinding the injection device (1) comprising the steps of: using a blinding device (50) according to any one of the preceding claims 1-13 or using a blinding kit (14) according to claim 14, arranging the plunger (20) of the injection device (1) at least partially in the plunger cover portion (56), and mutually connecting the first flange part (61) and the second flange part (62) to form the flange assembly (66) interconnecting the plunger cover portion (56) with the barrel cover portion (54).

Images