Blinding device for injecting devices

Abstract

In one aspect the present disclosure relates to a blinding device (20) for concealing an injection device (1) for use in clinical trials, wherein the injection device (1) comprises plunger (11) and a barrel (4) filled with a medicament (12) or with a placebo, wherein the plunger (11) is movable relative to the barrel (4) for expelling of the medicament (12) of the placebo from the barrel (4), the blinding device (20) comprising: - an elongated opaque housing (23) extending in a longitudinal direction (z), the elongated opaque housing (23) comprising a first housing part (21) and a second housing part (22), which are movable relative to each other at least from an open configuration, in which the barrel (4) of the injection device (1) is insertable at least partially into at least one of the first housing part (21) and the second housing part (22), and a closed configuration, in which the first housing part (21) and the second housing part (22) cover up the barrel (4), - wherein at least one of the first housing part (21) and the second housing part (22) comprises a proximal end wall (54) with at least one of a recess (56) or a through opening (57) sized to receive at least a portion of the plunger (11) to extend through the recess (56) or through opening (57) in the longitudinal direction (z).

Description

[0001] Blinding Device for Injecting Devices

[0002] Description

[0003] Field

[0004] The present disclosure relates to the field of medical devices, particularly to injection devices, such as syringes and in particular to pre-filled syringes. Specifically, the present disclosure relates to a blinding device for concealing the outer appearance of an injection device or syringe for use in clinical trials.

[0005] Background

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

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

[0008] Some drug delivery or injection devices provide selecting of a dose of a medicament of variable size and subsequent injecting of the dose previously set. Other injection devices provide setting and dispensing of a fixed dose. Here, the amount of medicament that should be injected in accordance to a given prescription schedule is always the same and does not change or cannot be changed over time.

[0009] Some injection devices are implemented as reusable injection devices offering a user to replace a medicament container, such as a cartridge. Other injection devices are implemented as a disposable injection device. With disposable injection devices it is intended to discard the entirety of the injection device when the content, i.e. the medicament, has been used up. Disposable injection devices may be pre-filled with the injectable medicament.

[0010] 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 is removable attached to the syringe barrel and covers the needle when the syringe is not in use. At the time of injection, the rigid needle shield is simply pulled off of the syringe barrel to expose the needle.

[0011] As part of the protocols for the blinded study, 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.

[0012] Injection device or syringes are often filled at different facilities and / or in different batches.

[0013] 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.

[0014] It is therefore necessary to provide an improved blinding device for concealing the injection device, at least for concealing the barrel of the injection device during and / or for a clinical trial while at the same time providing a good and reliable handling thereof.

[0015] Summary

[0016] 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.

[0017] The blinding device comprises an elongated opaque housing extending in a longitudinal direction. The elongated opaque housing may adapt the shape or geometry of the injection device, e.g. implemented as a pre-filled syringe. The elongated opaque housing comprises a first housing part and a second housing part. The first and second housing parts are movable relative to each other at least from an open configuration, in which the barrel of the injection device is insertable at least partially into at least one of the first housing part and the second housing part. The first and second housing parts are movable from the open configuration towards and into a closed configuration, in which the first housing part and the second housing part cover up the barrel.

[0018] Typically, and when in the closed configuration, the barrel will be located between the first housing part and the second housing part. Typically, both, the first housing part and the second housing part are opaque and are hence a non-transparent.

[0019] At least one of the first housing part and the second housing part comprises a proximal end wall with at least one of a recess or a through opening, wherein the recess or through opening is sized to receive at least a portion of the plunger of the injection device to extend through the recess or through opening in the longitudinal direction.

[0020] The presently proposed blinding device is particularly configured for use of pre-filled syringes for a clinical trial. The first housing part and the second housing part may be transferable into the closed configuration, in which the first and the second housing parts confine a barrel receptacle, which is sized to receive the entirety of the barrel of the injection device. In this way, and when received in the blinding device the barrel of the injection device is no longer visible and can be used in the clinical trial.

[0021] At the same time and since the proximal end wall of at least one of the first housing part and the second housing part comprises at least one of a recess and a through opening at least a part of the plunger of the injection device may protrude through the proximal end wall and may be directly accessible for a user to operate the injection device. In this way, there can be provided a rather immediate and direct mechanical interaction between a user and the injection device for injecting the medicament or placebo into biological tissue during the clinical trial.

[0022] Moreover, assembling or arranging of the barrel of the injection device in at least one of the first housing part and the second housing part and transferring the two housing parts into the closed configuration may be rather straightforward and intuitive. The barrel may be fixed in the opaque housing. It may be fixable to at least one of the first housing part and the second housing part, especially when the barrel has been received in the barrel receptacle confined by the first and the second housing parts.

[0023] When the plunger of the injection device protrudes through the proximal end wall of the housing of the blinding device it is directly accessible for a user thereby allowing the user to immediately operate, e.g. to depress the plunger e.g. in a distal direction for injecting a dose of the medicament or placebo.

[0024] According to a further example the first housing part and the second housing part each comprise a longitudinal shell part to at least partially encase the barrel of the injection device. The longitudinal shell part may comprise a longitudinal extent that substantially corresponds to a longitudinal extent of the barrel of the injection device. This way, the entirety of the elongated barrel of the injection device may be encased by a mutual assembly of the first and the second housing parts of the elongated opaque housing of the blinding device. Separating the opaque housing of the blinding device into a first housing part and a second housing part allows for an easy assembly or engagement with the barrel of the injection device. The barrel can be rather easily inserted into the housing.

[0025] In some examples and when in the open configuration the first housing part may be separated from the second housing part. It in the closed configuration the first housing part may be attached or connected, e.g. fixed to the second housing part; and vice versa. In other examples the first housing part may be permanently connected to the second housing part in a movable manner. It may be e.g. pivotably attached to the second housing part. Here, the first housing part and the second housing part may be movable relative to each other in a pivotable or hinged manner to transfer the first and the second housing parts from the open configuration, in which an interior or a barrel receptacle for the barrel of the injection device is accessible from outside, into the closed configuration, in which the barrel of the injection device is entirely located and hence concealed by the elongated opaque housing of the blinding device.

[0026] According to a further example the longitudinal shell part comprises a semi-cylindrical shape. The barrel of the injection device may also comprise a cylindrical shape. The longitudinal shell part with a semicylindrical shape may cover or may encase half of a circumference of the barrel of the injection device. When both housing parts each comprise a longitudinal shell part of a semi-cylindrical shape, the first and the second housing parts, at least their respective longitudinal shell parts may conform or constitute a cylindrical housing portion configured to completely or to almost completely encase at least a cylindrical part of the barrel of the injection device.

[0027] According to a further example the first housing part and the second housing part are of identical shape. The first and the second housing parts may comprise a mirror symmetry with a symmetry axis extending along a longitudinal axis of the elongated housing. In this way, a first lateral side edge of a housing part may be complementary shaped to a second and oppositely located lateral side edge of the first housing part. Insofar, and in some examples, the first housing part and the second housing parts may be identical and may provide and enable a mutual fastening and / or a mutual connection and / or a mutual fixing when in the closed configuration so as to form or constitute a barrel receptacle for the injection device.

[0028] According to another example the first housing part and the second housing part each comprise a single-pieced component. Single pieced components are rather easy and cost efficient to manufacture. With the first housing part and the second housing part each comprising a single pieced component the mutual assembly as well as an arrangement or mounting of the injection device in at least one of the first and the second housing parts can be rather easily provided, e.g. in an intuitive and straightforward manner.

[0029] According to another example the elongated opaque housing consists of the first housing part and the second housing part connected to the first housing part. Hence, the housing may be void of any further components. It may be constituted by the first housing part and the second housing part. In this way, the entire housing of the blinding device may be rather simple and easy to manufacture as well as easy to assemble.

[0030] In some further examples the blinding device consists of the housing of the blinding device. Hence, the blinding device may be void of any further components except the housing with the first housing part and the second housing part. However, in other examples the blinding device may comprise additional components, such as one or several adapters as will be explained below.

[0031] According to another example at least one of the first housing part and the second housing part comprises an injection molded plastic material. This way, the first housing part and / or the second housing part may be made by injection molding, typically by way of injection molding of a plastic material. In this way, the first and the second housing parts can be produced and manufactured at moderate or low costs in high quantities or large numbers.

[0032] According to another example the injection molded plastic material comprises at least one of: Polyvinylchloride, Polyethylene, Polyether ether ketone (PEEK), Polycarbonate, Polyethylenimine (PEI), Polysulfone, Polypropylene and Polyurethane, Cyclic Olefin Copolymer (COC), Polylactide (PLA) and any combinations thereof.

[0033] At least some of these materials allow a rather cost efficient and straightforward injection molding of the first and second housing parts. Of course, first and second housing parts may be made from a non-transparent and hence optically opaque material so as to provide an effective blinding and concealing of the barrel of the injection device located inside the barrel receptacle of the housing. Some of the above-mentioned materials exhibit a particular biological compatibility. They may decompose when exposed to a decomposing environment, e.g. when exposed to thermal energy and / or humidity.

[0034] According to another example the first housing part and the second housing part each comprise a flange part comprising a first flange section and a second flange section. The first flange section and the second flange section protrude outwardly from opposite lateral sides of the first housing part and the second housing part, respectively. In some examples the first flange section protrudes radially outwardly from an outside surface of the first housing part and the second flange section protrudes radially outwardly along an opposite radial direction and hence from a radially oppositely located outside or lateral side of the respective housing part.

[0035] In some examples, the first housing part comprises first and second flange sections protruding diametrically opposite from opposite circumferential ends or sides of the first housing part. Likewise, the second housing part comprises first and second flange sections protruding or extending radially outwardly in opposite directions from an outside surface of the respective housing part, e.g. from a shell part of the respective housing part.

[0036] When in the closed configuration the flange part of the first housing part and the flange part of the second housing part may adjoin each other to complement or to form a flange part of the elongated opaque housing. The flange part of the elongated housing may be provided at or near a proximal end of the elongated opaque housing. Accordingly, the flange part of the first flange section may be provided at a longitudinal proximal end of the first housing part. The flange part of the second housing part may be located at a proximal end of the second housing part.

[0037] When in the closed configuration the flange part, and in particular the first and second flange sections of first and second housing parts may mutually adjoin or abut in radial direction so as to form a common flange of the housing of the blinding device. In some examples and particularly when the first and second housing parts are of substantially identical shape the first flange section of the first housing part may adjoin and / or may abut or complement the second flange section of the second housing part. Vice versa, the second flange section of the first housing part may complement, adjoin and / or abut with the first flange section of the second housing part when the first and the second housing parts reach or take their closed configuration.

[0038] The flange part of the elongated opaque housing provides an effective gripping of the housing and further provides a respective abutment, e.g. for an index finger and / or for a middle finger of a user intending to use the blinding device in the course of an injection procedure. Hence, the flange part as provided on at least one of the first housing part and the second housing part provides a bearing or abutment and may effectively substitute a respective barrel flange of the barrel of the injection device.

[0039] The flange part provides an effective gripping and handling of the blinding device when equipped with the injection device. In this way and when the injection device is securely held or fixed inside the barrel receptacle of the elongated opaque housing and when the plunger of the injection device protrudes proximally from the elongated opaque housing of the blinding device the flange part provides an intuitive and straightforward use and handling of the blinding device, similar to that of an ordinary syringe. Any injection forces applied by a thumb of a user onto the plunger of the injection device may be counteracted with at least one of an index finger and a middle finger of a user engaging the flange part of at least one of the first housing part and the second housing part.

[0040] According to a further example the flange part adjoins a proximal end of the longitudinal shell part. Hence, the flange part may form or constitute a proximal end of the longitudinal shell part. In some examples the flange protrudes radially outwardly from a proximal end of the longitudinal shell part and / or forms a longitudinal proximal end of the shell part.

[0041] According to a further example at least one of the first housing part and the second housing part comprises a flange receptacle extending in a direction transverse to the longitudinal direction. The flange receptacle is sized and configured to receive at least a portion of a barrel flange of the injection device. Typically, the barrel flange of the injection device protrudes radially outwardly from the barrel of the injection device. The barrel flange is typically provided at a proximal end of the barrel of the injection device. In some examples both, the first housing part and the second housing part each comprise a flange receptacle extending in the transverse direction and being each sized to receive at least a portion, e.g. half of a circumference of the barrel flange of the injection device.

[0042] In some examples the flange receptacle is provided in the flange part of at least one of the first housing part and the second housing part. When both housing parts each comprise a flange part, the flange part may comprise a flange receptacle as described above. This way, the first housing part may comprise a first flange receptacle in a flange part and the second housing part may comprise a second flange receptacle in the flange part. Both, the first and the second flange receptacles may be sized to receive a portion, e.g. half of a circumference of a barrel flange of the barrel of the injection device. In other words, the flange receptacles of first and second housing parts may complement each other to completely receive or to completely encase an annularly shaped and radially outwardly protruding barrel flange of the barrel of the injection device.

[0043] The longitudinal size of the flange receptacle may be adapted and / or may correspond to a longitudinal thickness or longitudinal size or extent of the barrel flange. In this way, the injection device, specifically the barrel of the injection device may be fixed in longitudinal direction relative to at least one of the first housing part and the second housing part, simply by introducing the barrel flange into the correspondingly or complementary shaped flange receptacle as provided in at least one of the first housing part and the second housing part.

[0044] In a further example the flange receptacle of the blinding device is located in the flange part and the flange receptacle is confined in a longitudinal proximal direction by the proximal end wall. This way, an inside surface of the proximal end wall may form a proximal abutment for the barrel flange of the barrel of the injection device when arranged inside the barrel receptacle as confined by the first and second housing parts. Moreover, and since the proximal end wall of at least one of the first housing part and the second housing part comprises at least one of a recess or through opening a plunger mechanically engaged with the barrel of the injection device may protrude through the proximal end wall and may be directly accessible from outside the blinding device for conducting or controlling an injection procedure.

[0045] The longitudinal or axial size of the flange receptacle may correspond to a longitudinal or axial thickness of the barrel flange. In other words, the barrel flange may be squeezed in the flange receptacle and may fictionally engage with the proximal and distal walls or confining structures of the flange receptacle. In this way, the barrel of the injection device can be fixed with regards to the longitudinal direction to the housing, in particular to first and / or second housing part of the housing of the blinding device.

[0046] According to another example the flange receptacle is confined in longitudinal distal direction by a proximal end face of the shell portion, which is provided by at least one of the first housing part and the second housing part, respectively. The shell part may comprise a semi-cylindrically shaped sidewall, which may terminate with a proximal end face in the flange receptacle. In other words, the distal confining structure or distal confinement of the flange receptacle may be formed or constituted by a proximal end face of the shell part of the first housing part and / or of the second housing part. In this way, the sidewall of the shell part may comprise or provide a two-fold function.

[0047] The sidewall may be of a geometric shape that corresponds to an outside surface of the barrel of the injection device. The longitudinal extent of the sidewall of the shell part may also correspond to a longitudinal extent of the barrel of the injection device. A proximal end of the shell part and hence a proximal end of the sidewall of the shell part may terminate or may abut with a distally facing edge or abutment face of the barrel flange of the barrel of the injection device. A distal end of the shell part or a distal end of the sidewall of the shell part may coincide or may correspond or may align with a distal end of a cylindrical part of the barrel.

[0048] In some examples the barrel of the injection device may comprise a radially narrowing shoulder portion at or near a distal outlet end. The shoulder portion may engage or may abut with a correspondingly-shaped shoulder portion or radially inwardly extending flange portion as provided at a distal end of the shell part or at a distal end of the sidewall of the shell part of the first and second housing parts. In this way, the barrel of the injection device may be fixed in longitudinal direction to at least one of the first housing part and the second housing part. In some examples, the barrel may be fixed to both, the distal housing part and the proximal housing part.

[0049] In a further example the shell part of at least one of the first housing part and the second housing part comprises a sidewall comprising an end face that coincides with or constitutes the proximal end face of the shell part.

[0050] In a further example the flange part of the first housing part comprises an inside facing front face to engage or to abut with a complementary or identically shaped inside facing front face of the flange part of the second housing part. The inside facing front faces of the first flange part and the second flange part may comprise a complementary shape so as to make a full-surface contact when the first housing part and the second housing part reach the closed configuration. In some examples the inside facing front face comprises a planar shape. In some examples both, the first housing part and the second housing part each comprise an inside facing front face in the flange part that is of planar shape. Such planar-shaped inwardly, i.e. radially inwardly facing front faces of the first housing part and the second housing part may facilitate establishment of a full-surface contact when the first and the second housing parts are assembled together.

[0051] In another example the second flange section comprises a fastener on or in the inside facing front face. The first flange section comprises a counter fastener on or in the inside facing front face. The counter fastener is complementary shaped to the fastener to mechanically engage with the fastener, particularly when the first and the second housing part reach the closed configuration.

[0052] Complementary shaped fasteners and counter fasteners on the inside facing front face of the first flange section and the second flange section enable a mutual fastening of first and second housing part when respective inside facing front faces of the first housing part and the second housing part get in mutual abutment. Typically, the position of the fastener is mirror symmetric to the position of the counter fastener with respect to a longitudinal axis of symmetry extending through the first or second housing parts in longitudinal direction.

[0053] According to a further example of the blinding device the first housing part comprises a first longitudinally extending side edge and a second longitudinally extending side edge at opposite circumferential ends of the first housing part. The second housing part comprises a first longitudinally extending side edge and a second longitudinally extending side edge at opposite circumferential ends of the second housing part. The first longitudinally extending side edge of the first housing part is engageable with the second longitudinally extending side edge of the second housing part and / or the second longitudinally extending side edge of the first housing part is engageable with the first longitudinally extending side edge of the second housing part. The oppositely located side edges of first and second housing parts may be configured to form a friction fit when the first housing part and the second housing part reach their closed configuration.

[0054] The side edges, i.e. the first side edge and the second side edge may be complementary shaped. Hence, the first side edge of the first housing part and the second side edge of the first housing part may be complementary shaped so as to allow and support a mutual fastening of first and second housing parts when the first housing is identically shaped to the second housing part.

[0055] For reaching a mutual assembly configuration the orientation of the second housing part, e.g. identically shaped to the first housing part, has to be rotated by 180° with regard to a longitudinal axis of symmetry. When the first longitudinally extending side edge is complementary shaped to the second longitudinally extending side edge, the first and second side edges of the first and the second housing parts can be mutually connected or mutually fixed.

[0056] According to another example the second longitudinally extending side edge of the second housing part comprises a fastener to mechanically engage with a complementary shaped counter fastener provided at or along the first longitudinally extending side edge of the first housing part. The fastener and the counter fastener may be located at a common longitudinal position as seen in longitudinal direction along the first and second longitudinally extending side edges. The fastener and the counter fastener may comprise at least one self-centering element or they may provide a self-centering of the first and the second housing parts in the course of a mutual assembly. In this way, the fastener and the counter fastener may also contribute to a proper and correct alignment of the first housing part and the second housing part during a mutual attachment and / or a mutual fixing in the closed configuration.

[0057] According to a further example the second longitudinally extending side edge of the first housing part comprises a fastener to mechanically engage with a complementary shaped counter fastener provided at the first longitudinally extending side edge of the second housing part. Hence, fasteners of equal or different type may be either provided on or at at least one of the first longitudinally extending side edge and a second longitudinally extending side edge. The opposite side edge may be then always provided with a complementary shaped counter fastener.

[0058] The fastener and the counter fastener may be shaped and configured to establish a non- releasable mutual fixing between the first housing part and the second housing part. In this way and once a closed configuration of the first housing part and the second housing part has been reached, the two-parts cannot be disassembled or disintegrated unless one of the housing parts is destroyed. According to a further example the fastener comprises a projection and the counter fastener comprises a recess or receptacle configured to receive the projection in a press-fitted configuration. In some examples a cross-section of the projection of the fastener is at least slightly larger than a cross-section of the recess or receptacle. In this way, the fastener and the counter fastener can only be assembled or transferred into a mutual fixing or fastening configuration when at least one of the fastener and the counter fastener is slightly deformed. Such a press-fit configuration is of particular use to form or to establish a non-releasable mutual fastening and fixing of the first housing part and the second housing part.

[0059] In some examples the projection of the fastener comprises a truncated cone. The recess of the counter fastener comprises a correspondingly or complementary shaped conical shape. By way of a truncated come and by way of a complementary shaped recess of the counter fastener there can be provided a press fitting arrangement between the fastener and the counter fastener. Moreover, by way of a truncated cone and / or by the respective conically-shaped recess there can be provided a self-centering of the first housing part relative to the second housing part upon inserting the fastener into the counter fastener; and vice versa.

[0060] By way of the conically-shaped fastener and / or by way of the conically shaped counter fastener the first housing part can be directly aligned to the second housing part during the assembly process; and vice versa.

[0061] According to another example the elongated opaque housing comprises a distal through opening at a distal end to receive at least one of a needle and a needle cap of the injection device to extend through the distal through opening in the longitudinal direction. The needle cap may be detachably fastened to the barrel and / or to an outlet of the barrel of the injection device. The needle cap may protrude from a distal end of the housing of the blinding device when the injection device, e.g. in form of a pre-filled syringe, is arranged inside the barrel receptacle of the housing of the blinding device.

[0062] Detachment of the needle cap is supported by the blinding device. Hence, the through opening at the distal end of the elongated opaque housing is large enough to allow a respective disassembling movement of the needle cap from the injection device.

[0063] According to another example the first housing part and the second housing part each comprise a through opening or recess at a distal end complementing each other to form or to constitute the distal through opening at the distal end of the elongated opaque housing. In other examples it is only one of the first housing part and the second housing part that comprises the through opening or recess at the distal end to form or to constitute the distally located through opening of the elongated opaque housing.

[0064] According to another example the barrel of the injection device comprises a radially narrowing shoulder portion at a longitudinal distal end. The elongated opaque housing comprises a complementary shaped or correspondingly shaped radially inwardly extending flange section at a distal end. The radially inwardly extending flange section may be complementary shaped to the radially narrowing shoulder portion of the barrel. In this way, the barrel can be tightly fixed inside the barrel receptacle of the elongated opaque housing of the blinding device. Moreover, also the distal end of the barrel of the injection device can be suitably covered and concealed by the opaque housing.

[0065] According to another example at least one of the first housing part and the second housing part comprises an inspection window for a visual inspection of the barrel of the injection device when located inside the elongated opaque housing. In some examples, the inspection window may be provided at or near the distal end of at least one of the first housing part and the second housing part. The inspection window may allow visual inspection of the content located inside the barrel of the injection device when the injection device is duly attached or arranged inside the barrel receptacle of the elongated opaque housing of the blinding device. The inspection window may be covered by at least one of an opaque cover, e.g. in form of a movable opaque flap or the like cover so as to provide a complete blinding of the interior of the elongated opaque housing in or during the clinical trial.

[0066] In a further example the blinding device comprises at least one of a first adapter part and a second adapter part configured to be arranged at or on an inside surface of a sidewall of at least one of the first housing part and the second housing part. At least one of the first adapter part and the second adapter part is configured to abut or to support an outside surface of the barrel of the injection device when arranged inside the elongated opaque housing of the blinding device. By way of at least one of a first adapter part and a second adapter part the blinding device can be configured for receiving differently-shaped barrels of different injection devices. In this way the overall design and configuration of the blinding device can be individually modified to conform or to adapt to different shapes of different injection devices.

[0067] In some examples the blinding device may be particularly configured to receive a barrel of an injection device comprising an interior volume of about 2 ml. In further examples the blinding device may be configured to receive a barrel of an injection device comprising an interior filling volume of about 1 ml. The 1 ml barrel and the 2 ml barrel may be of identical elongation and may both fit identically in longitudinal direction or with regards to the longitudinal direction into the elongated opaque housing. The differently sized barrels of different injection devices may distinguish only by their diameter. Here and by way of at least one of the first adapter part and the second adapter part, the inside structure of the barrel receptacle of the blinding device, as provided inside the elongated opaque housing, can be suitably adapted to the differently sized barrels of the injection devices featuring different diameters or different transverse crosssections.

[0068] The first adapter part and the second adapter part may comprise a kind of a lining. An outside surface of the first or second adapter part may abut in radial direction with an inside surface of a sidewall of at least one of the first housing part and the second housing part. An inside surface of at least one of the first adapter part and the second adapter part may be configured to engage or to abut with an outside surface of the barrel of the injection device. In this way and by making use of at least one of a first adapter part and a second adapter part, the barrel of the injection device can be tightly squeezed and fixed inside the barrel receptacle of the elongated opaque housing with regards to the radial direction.

[0069] In some examples at least one of the first adapter part and the second adapter part may comprise an elastic material. At least one of the first adapter part and the second adapter part may elastically deform when receiving the barrel of the injection device and when first and second housing parts are assembled or fixed together in the closed configuration.

[0070] In some examples there are provided first and second adapter parts. The first adapter part may be arranged or fixed to the second housing part. The second adapter part may be arranged and / or or fixed to the second housing part, typically to an inside of a sidewall of the second housing part. In some examples at least one of the first adapter part and the second adapter part may comprise a kind of a lining to be arranged radially between an outside surface of the barrel of the injection device and an inside surface of a sidewall of the elongated opaque housing. In this way, a radial gap, e g. provided between an outside surface of the barrel of the injection device and an inside surface of the sidewall of at least one of the first and the second housing parts can be effectively sealed or closed so as to provide a respective mutual abutment and fixing of the barrel inside the elongated opaque housing with respect to the radial direction.

[0071] According to a further example at least one of the first adapter part and the second adapter part comprises a longitudinal end face to engage or to abut with a stepped portion on the inside surface of the sidewall of at least one of the first housing part and the second housing part. In this way, there can be provided a fixing of e.g. a first adapter part to the first housing part and / or a fixing of the second adapter part to the second housing part. Here, a longitudinal end face of the respective adapter part may abut in longitudinal direction with the stepped portion on the inside surface of the sidewall of the respective first or second housing parts. In this way the first adapter part and / or the second adapter part may be squeezed in longitudinal direction between a distal stepped portion as provided at or near a distal end of at least one of the first and the second housing part and a proximal stepped portion at or near a proximal end of the first and the second housing part, e.g. near a proximal end of the shell part of at least one of the first housing part and the second housing part.

[0072] In another example of the blinding device at least one of the first adapter part and the second adapter part comprises a distal end face to engage with a distally located and proximally facing stepped portion on the inside surface of the sidewall. At least one of the first adapter part and the second adapter part comprises a proximal end face to engage with the proximally located and distally facing stepped portion on the inside surface of the sidewall. The longitudinal distance between the distally facing stepped portion and the proximally facing stepped portion on the inside surface of the sidewall of at least one of the first and the second housing parts may correspond to a longitudinal extent of the respective adapter part to be assembled inside the barrel receptacle as confined by the first housing part and the second housing part. In this way, the respective adapter part may be squeezed in longitudinal direction between the proximally facing stepped portion and the distally facing stepped portion as provided on the inside surface of the sidewall of the elongated opaque housing.

[0073] In other examples, and when an inside diameter of the elongated opaque housing matches with an outside diameter of the barrel, the inside surface of the sidewall of at least one of the first and the second housing part may be void of a stepped section or stepped portion. Here, the inside surface of the sidewall of at least one of the first housing part and the second housing part may be evenly shaped.

[0074] 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 elongated opaque housing of the blinding device.

[0075] 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.

[0076] 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.

[0077] By way of the presently proposed blinding device the entirety of the barrel flange will be covered and encased by the elongated opaque housing of the blinding device such that a user of the injection device, when duly attached or arranged inside the elongated 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.

[0078] 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 method of blinding the injection device comprises the steps of providing a blinding device as described above, wherein the blinding device comprises a first housing part and a second housing part in an open configuration.

[0079] When and as long as in the open configuration the inside of the first housing part and the second housing part is accessible from outside and is configured for receiving at least a barrel of an injection device partially. In a proceeding step the barrel of the injection device is at least partially arranged in one of the first housing part and the second housing part. Thereafter, the second housing part is moved relative to the first housing part to transfer the first housing part and the second housing part into the closed configuration, in which the first housing part and the second housing part cover-up the barrel and in which closed configuration at least a portion of the plunger longitudinally extends through the recess or through opening of the proximal end wall as provided by at least one of the first housing part and the second housing part.

[0080] 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.

[0081] 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.

[0082] 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.

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

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

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

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

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

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

[0089] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega- carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(co-carboxyheptadecanoyl) human insulin.

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

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

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

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

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

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

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

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

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

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

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

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

[0102] Brief description of the drawings

[0103] In the following, an example of a blinding device for use with an injection device, in particular for use with a pre-filled injection syringe is shown and described in greater detail by making reference to the drawings, in which:

[0104] Fig. 1 is a perspective illustration of the blinding device with a syringe body prior to an assembly of the syringe inside the blinding device,

[0105] Fig. 2 shows individual components of the blinding device,

[0106] Fig. 3 is a schematic illustration of an example of a syringe,

[0107] Fig. 4 is a side view of the blinding device,

[0108] Fig. 5 is a side view of the blinding device with a syringe assembled therein,

[0109] Fig. 6 is a further side view of the arrangement according to Fig. 5,

[0110] Fig. 7 is an enlarged perspective illustration of a portion of the blinding device, Fig. 8 schematically illustrates conically shaped and mutually corresponding protrusions and recesses of the blinding device,

[0111] Fig. 9 is a flowchart of a method of blinding the injection device,

[0112] Fig. 10 shows a housing part of the blinding device with an adapter part assembled therein, Fig. 11 shows a cross-section through the blinding device with an injection device assembled inside the elongated opaque housing, and

[0113] Fig. 12 is a perspective illustration of the blinding device. Detailed description

[0114] In Figs. 1 - 8 and in Figs. 9 - 12 there is illustrated one example of a blinding kit 100 comprising a blinding device 20 and an injection device 1. The injection device 1 is further illustrated in greater detail in Fig. 3. The injection device 1 may comprise a pre-field syringe. The injection device 1 comprises an elongated barrel 4 of e.g. cylindrical shape. The barrel 4 extends in a longitudinal direction z. Towards a distal direction 2 the elongated barrel 4 terminates in a needle mount 6, by way of which an injection needle 7 is attached to the barrel 4. A proximal end of the needle (not illustrated) is in flow communication with an inside or interior of the barrel 4. Towards a proximal direction 3 the barrel 4 is sealed by a movable stopper 8. The stopper 8 may comprise or may be made of an elastomeric material. In Fig. 11 the stopper 8 is shown in a proximal stop position as well as in a distal end position after expelling of the drug or medicament. In the distal end position the stopper is provided with reference number 8'.

[0115] The stopper 8 may seal the barrel 4 towards the proximal direction 3. The stopper 8 may be implemented as a part of a plunger 11. The plunger 11 may comprise the stopper 8 movably or slidably disposed in longitudinal direction (z) inside the barrel 4. The plunger 11 may further comprise a plunger rod 9 attachable or attached to the stopper 8. Towards a proximal end the plunger rod 9 may terminate with a radially widened plunger flange 10. The plunger flange 10 may provide a proximally facing abutment face, e.g. for engagement with a thumb of a user. This way, a user may apply a distally directed pressure onto the plunger 11 so as to urge the stopper 8 in distal direction 2. When the needle 7 pierces or punctures biological tissue a distally directed movement of the stopper 8 relative to the barrel 4 leads to the injection of a liquid medicament 12 or of a placebo initially provided inside the barrel 4 into the pierceable tissue.

[0116] Before use and when delivered to a patient or user injection device 1 is provided with a needle cap 13 covering the injection needle 7. The needle cap 13 is detachably connected to at least one of the barrel 4 and the needle mount 6. Before conducting an injection, the needle cap 13 has to be removed in order to expose the distal tipped end of the injection needle 7.

[0117] Towards or at a proximal end the barrel 4 comprises a radially outwardly protruding barrel flange 5. The barrel flange 5 may comprise an annular shape as e.g. indicated in Fig. 1. In some examples the barrel flange 5 comprises an annular shaped outside facing edge portion 15. The edge portion 15 may be interrupted by a straight or cutted edge portion 14 as shown in Fig. 1. The cutted edge portion 14 may extend along a tangential direction with regard to the cylindrical symmetry of the barrel 4. A cutted and / or a rather planar-shaped edge portion 14 may result from a particular production process of the barrel 4. The edge portion 14 may help to align, to handle and / or to grip the barrel 4 in an automated filling process with a pharmaceutical manufacturer.

[0118] In Fig. 1 the injection device 1 is illustrated without the plunger 11. However, in real conditions and when using the injection device 1 in a clinical trial the injection device 1 is equipped with the plunger 11 as shown in Fig. 3.

[0119] Towards a distal end the barrel 4 comprises a radially narrowing shoulder portion 17 as e.g. illustrated in Fig. 1. Hence, the needle mount 6 may protrude from a distal end of the shoulder portion 17. The shoulder portion 17 may define a longitudinal end position for the stopper 8 inside the barrel 4.

[0120] The blinding device 20 as shown in Figs. 1-8 comprises an elongated opaque housing 23. The housing 23 forms or constitutes a barrel receptacle 27, which is sized to receive the entirety of the barrel 4 of the injection device 1. The opaque housing 23 comprises a distally located through opening 72 at a distal end 24 through which at least one of the needle mount 6, the injection needle 7 and the needle 13 may protrude in longitudinal direction. The elongated opaque housing 23 further comprises a through opening 57 at or near its proximal end 24, through which through opening 57 at least a portion of the plunger 11 may extend in longitudinal direction. Here, at least a part of the plunger rod 9 and the plunger flange 10 may protrude from a proximal end 25 of the elongated opaque housing 23. In use, at least one of the needle cap 13, the needle 7 and the needle mount 6 may protrude from a distal end 24 of the elongated opaque housing 23.

[0121] The housing 23 comprises a first housing part 21 and a second housing part 22 as e.g. illustrated in Figs. 1 and 2. In the presently illustrated example the first housing part 21 and the second housing part 22 are identically shaped. Hence, the second housing part may be an identical copy of the first housing part. The first and the second housing parts 21, 22 each comprise an opaque and hence non-transparent structure so as to form or to constitute the elongated housing 23. The first housing part 21 and the second housing part 22 each comprise a longitudinally extending and semi-cylindrically shaped shell part 31. The shell part 31 comprises a semi-cylindrical sidewall 26 with an inside surface 44 facing towards and confining the barrel receptacle 27.

[0122] The barrel receptacle 27 may be complementary shaped to and / or is adapted to the shape of the outside structure or outside surface 18 of the barrel 4 of the injection device 1. The shell part 31 comprises a first side edge 32 and a second side edge 33. The first and the second housing parts 21 , 22 are transferable from an open configuration, as e.g. shown in Fig. 1, into a closed configuration, as e.g. shown in Figs. 4-6. In the closed configuration the first and the second housing part, e.g. comprising or made of an opaque material, are configured to cover up the barrel 4 located therebetween. In the closed configuration the first and the second housing parts 21 , 22 can be mutually fixed and connected. They may be mechanically connected with their first and second side edges 32, 33 and / or by way of flange parts 51.

[0123] The first and the second housing parts 21 , 22 further comprise a flange part 51 adjoining the shell part 31 towards the proximal direction 3. The flange part 51 comprises a first flange section 52 and a second flange section 53. The first flange section 52 protrudes along a first radial direction from an outside surface of the sidewall 26 of the longitudinally adjoining shell part 31. The second flange section 53 protrudes in an opposite radial direction from the shell part 31. First and second flange sections 52, 53 may protrude in or along diametrically oppositely facing radial directions.

[0124] The flange part 51 comprises a proximally facing end wall 54. In the radially outwardly protruding first and second flange sections 52, 53 the flange part 51 further comprises distally facing abutment faces 58, 59 as e.g. shown in Figs. 4 and 5. Here, the first flange section 52 comprises a first abutment face 58 and the second flange section 53 comprises a second abutment face 59 facing in distal direction 2. The first and second abutment faces 58, 59 enable and provide an abutment and / or a mechanical support for respective fingers of a user. E.g., one of the first and second abutment faces 58, 59 is configured for engagement with an index finger. The other one of the abutment faces 58, 59 is configured for abutment or engagement with a middle finger of a user while a user uses his thumb to apply a distally directed pressure onto the plunger flange 10 of the plunger 11 of the injection device 1 when duly arranged inside the elongated opaque housing 23.

[0125] The flange part 51 further comprises a flange receptacle 50, which is complementary shaped to the barrel flange 5 of the injection device 1. The flange receptacle 50 may be confined in proximal direction 3 by an inside face 55 of the end wall 54 of the flange part 51. Towards the distal direction 2 the flange receptacle 50 may be delimited or confined by a proximal end face 60 of the sidewall 26 of the shell part 31 of the respective first or second housing part 21 , 22.

[0126] A longitudinal distance between the proximal end face 60 and the inside surface 55 of the end wall 54 may correspond to or may be slightly larger than a longitudinal extent of the radially outwardly protruding barrel flange 5. In this way, the barrel flange 5 can be inserted in radial direction into the flange receptacle 50. It may be squeezed a press- fitted configuration between the proximal end face 60 and the inside surface 55 thereby providing a fixing of the barrel flange 5 and hence of the entire barrel 4 to the respective first and / or second housing parts 21, 22 with respect to the longitudinal direction (z).

[0127] As seen in radial direction and as seen from an inside or radial center of the first or second housing parts 21 , 22 the end wall 54 may comprise a semicircular recess 56, which may contribute or constitute the annular shaped through opening 57 when the first and the second housing parts 21 , 22 are attached and fixed in the closed configuration. Hence, an inside edge of the recess 56 or through opening 57 of the first housing part 21 may flush or align with a respective inside edge of the respective recess 56 or through opening 57 of the second housing part 22.

[0128] The flange part 51 further comprises a planar shaped an inwardly facing front face 30. Here, the front face 30 of the first flange section 51 adjoins or flushes with the inwardly facing front faces 30 of the first and second flange sections 52, 53. The front faces 30 of the flange part 51 of the first housing part 21 and the second housing part 22 may be complementary shaped so as to get in a surface contact when the first housing part 21 is attached and / or fixed to the second housing part 22.

[0129] In the closed configuration the entirety of the barrel flange 5 may be received in the flange receptacle 50 of the first and the second housing parts 21 , 22. The barrel flange 5 may be no longer visible from outside when the injection device 1 is duly arranged inside the opaque housing 23 of the blinding device 20. As particularly illustrated in Figs. 1 and 2 as well as in greater detail in Fig. 7, the first side edge 32 of the housing part 21, 22 is provided with one or several counter fasteners 42, e.g. implemented as a conical recess 43 or receptacle. The radially and / or circumferentially oppositely located second side edge 32 is provided with a complementary or correspondingly shaped fastener 40, e g. comprising a truncated cone shaped projection 41. The projection 41 and the complementary shaped recess 43 are arranged and provided at the same longitudinal position on the opposite side edges 32, 33 that allowing to mutually engage when the first housing part 21 is brought in radial abutment with the second housing part 22.

[0130] The first side edge 32 comprises a number of counter fasteners 42 distributed along the elongated first side edge 32. Correspondingly, the second side edge 33 is provided with complementary shaped fasteners 40 distributed along the longitudinal direction on the second side edge 33. The mutual engagement of the projection 41 and the recess 43 of respective fasteners 40 and counter fastener 42 is particularly illustrated in Fig. 8. The projection 41 of the fastener 40 comprises a truncated cone, of a length LP, which is at least equal in length or slightly shorter than a depth LR of a correspondingly shaped recess 43. Hence, LP < LR.

[0131] A width or transverse size of the projection WP, e.g. at foot of the projection 41 is slightly larger or equal to a respective cross-section WR of the recess 43 or receptacle. Hence, WR < WP. In either way there can be provided a press fitting and hence a non-releasable fixing between the outside surface of the projection 41 and an inside surface of the recess 43 when mutually fixing the first and the second housing parts 21, 22 in the closed configuration. Typically, the entirety of the projection 41 can be received in the recess 43 so that a respective front face 39 of the side edge 33 may get in at least partial or full surface-contact with the front face 29 as provided at or along the first side edge 32.

[0132] In the example as presently shown and as shown in greater detail in Figs. 7 the first side edge 32 comprises a longitudinal projection 43 extending all along the longitudinal extent of the first side edge 32. The projection 34 is complementary shaped to a longitudinal projection 35 provided all along the second side edge 33. As shown in Fig. 7 the projection 35 as provided all along the second side edge 33 is slightly recessed in radial direction with regards to the outside surface of the sidewall 26 of the shell part 31.

[0133] There is hence provided a recessed section at or along the second side edge 33 featuring a front face 28 to abut with a front face 38 of the elongated projection 34 of the first side edge 32. The elongated projection 34 further comprises an inside face 36 that is configured to engage or to align along an outside surface 37 of the projection 35.

[0134] The radial extent of the projection 35 is larger than a radial extent of the projection 34. The projection 34 protrudes in circumferential direction from a circumferentially facing front face 29 of the first side edge 32. The front face 29 is provided with the counter fastener 42 and is provided with numerous recesses 43. The front face 29 of the first housing part 21 is configured to abut the front face 39 of the second housing part 22; and vice versa. The front face 29 of the second housing part 22 is configured to align and / or to abut with the front face 39 of the second housing part 22. The front face 39 of the elongated projection 35 is provided with the fastener 40 and comprises the cone-shaped projection(s) 41 protruding in circumferential direction from this front face 39. In the mutual assembly configuration and hence when the first housing part 21 and the second housing part 22 reach the closed configuration, in which the fastener(s) 40 engage(s) the counter fastener(s) 42 the elongated and continuous projection 34 protruding in circumferential direction from the front face 29 of the first side edge 32 effectively covers the outside surface 37 of the complementary shaped longitudinal projection 35 as provided along the second side edge 33. In this way, there can be provided a kind of mutually engaging profiles along the first and the second side edges 32, 33, which prevents visual inspection or a visual look through an eventual gap between the first and second housing parts 21 , 22.

[0135] The distal end 24 of the elongated opaque housing 23 is formed or constituted by respective distal ends of the shell parts 31 of the first and the second housing parts 21., 22. Each housing part 21 , 22 comprises a recess or through opening 45 provided at the distal end 24 which mutually complement to form or constitute the through opening 72 as provided at the distal end 24 of the housing 23. The through opening 45 may be radially confined by a radially inwardly extending flange section 46 at the distal end 24 of the respective first and second housing parts 21, 22.

[0136] Here, the inside surface of the flange section 46 may form or may comprise a shoulder portion 47 complementary shaped to the outside surface or outside structure of the shoulder portion 17 as provided at the longitudinal end of the cylindrical portion of the barrel 4 of the injection device 1. In this way, also a distal end, namely the shoulder portion 17 of the barrel 4 can get in longitudinal abutment with the housing part 21 , 22, thus improving a longitudinal fixing or abutment of the barrel 4 inside the barrel receptacle 27 of the housing 23.

[0137] As particularly illustrated in Figs. 1 and 7, on the inside surface 44 of the sidewall 26 of the first and the second housing parts 21 , 22 there may be provided a distally located step 48 comprising a respective abutment face facing in proximal direction 3. There may be further provided a proximally located step 49 comprising a complementary shaped abutment surface facing in distal direction 2. The stepped portions or steps 48, 49 are provided at a longitudinal distance from each other that coincides or corresponds to a longitudinal extent of an optional adapter part 61, 62 as schematically illustrated in Fig. 2.

[0138] The first adapter part 61 may be configured for attachment or arrangement inside the shell part 31 of the first housing part 21 . The second adapter part 62 may be configured for a respective arrangement to an inside surface 44 of the sidewall 26 of the shell part 31 of the second housing part 22. The adapter parts 61 , 62 each comprise a shell section 63. They comprise an inside surface 64 configured to engage or to abut with an outside surface 18 of the barrel 4. The first and second adapter parts 61 , 62 also comprise an outside surface 65 configured to abut or to engage with the inside surface 44 of the sidewall 26 of respective first and second housing parts 21 , 22 in the region between the stepped portions 48, 49.

[0139] The steps 48, 49 provide a longitudinal squeezing or longitudinal attachment or clip fixing of the respective adapter parts 61 , 62 to the inside of the first and second housing parts 21 , 22, respectively. The shell section 63 of the adapter part 61 , 62 may comprise or form a lining 68 by way of which a difference in the outside diameter of the cross-section of the barrel 4 and an inside cross-section or inside diameter of the barrel receptacle 27 confined by the inside surfaces 44 of the sidewalls 26 of the first and second housing parts 21, 22 can be compensated. In this way, the blinding device 20 can be individually adapted to receive rather small sized injection devices 1 comprising a barrel 4 of reduced diameter. The adapter parts 61, 62 may be provided as separate pieces to be selectively mounted or arranged to the first and second housing parts in order to selectively provide a blinding device 20 that can be used with injection devices 1 , e.g. pre-filled syringes, of different transverse cross-section or diameter.

[0140] The adapter parts 61 , 62 may be identically shaped. They may comprise an elastic material so as to become slightly squeezed when the injection device 1 is inserted inside the barrel receptacle 27 and when the first and the second housing parts 21 , 22 are attached or fixed together.

[0141] In the example as further illustrated in Fig. 4, a portion of at least one of the first and the second housing parts 21 , 22 comprises a window 70, through which at least a portion of the barrel 4 is visually inspectable when arranged inside the barrel receptacle 27. The window 70 may comprise a material that distinguishes from the material of the housing part 21 , 22. It may comprise a transparent material whereas the residual housing part 21, 22 is made of a nontransparent and hence opaque material. In some examples, the entirety of the first and the second housing parts 21 , 22 may be made of a transparent material whereas, a major portion of the first and second housing parts 21 , 22 may be blinded, e.g. by a non-transparent coating or dye. Hence, the housing part 21, 22 may be blacked with the exception of the window 70. In some examples, the window 70 may be provided with a supplemental cover so as to cover the window 70 for and / or during a clinical trial. The window 70 may be only temporarily transparent or translucent so as to inspect the constitution of the medicament or placebo located inside the barrel 4 of the injection device 1.

[0142] In the flowchart of Fig. 9 there is illustrated a method of blinding an injection device 1 for use in a clinical trial. The injection device 1 comprises a plunger 9 and a barrel 4 filled with a medicament 12 or filled with a placebo. The plunger 9 is movable relative to the barrel 4 for expelling of the medicament or placebo from the barrel 4. The method of blinding the injection device 1 comprises a first step 100 of providing a blinding device 20 as described above, wherein the blinding device comprises a first housing part and a second housing part in an open configuration.

[0143] When and as long as in the open configuration the inside of the first housing part and the second housing part is accessible from outside and is configured for receiving at least a barrel of an injection device partially. In a proceeding step 102 the barrel of the injection device is at least partially arranged in one of the first housing part and the second housing part. Thereafter, and in step 104 the second housing part is moved relative to the first housing part to transfer the first housing part and the second housing part into the closed configuration, in which the first housing part and the second housing part cover-up the barrel and in which closed configuration at least a portion of the plunger longitudinally extends through the recess or through opening of the proximal end wall as provided by at least one of the first housing part and the second housing part. The blinding kit is then ready for use in a clinical trial.

[0144] Reference Numbers

[0145] 1 injection device

[0146] 2 distal direction

[0147] 3 proximal direction

[0148] 4 barrel

[0149] 5 barrel flange

[0150] 6 needle mount

[0151] 7 needle

[0152] 8 stopper

[0153] 9 plunger rod

[0154] 10 plunger flange

[0155] 11 plunger

[0156] 12 medicament

[0157] 13 needle cap

[0158] 1 edge portion

[0159] 15 edge portion

[0160] 17 shoulder portion

[0161] 18 outside surface

[0162] 20 blinding device

[0163] 21 housing part

[0164] 22 housing part

[0165] 23 housing

[0166] 24 distal end

[0167] 25 proximal end

[0168] 26 sidewall

[0169] 27 barrel receptacle

[0170] 28 front face

[0171] 29 front face

[0172] 30 front face

[0173] 31 shell part

[0174] 32 side edge

[0175] 33 side edge

[0176] 34 projection

[0177] 35 projection

[0178] 36 inside face

[0179] 37 outside face 38 front face

[0180] 39 front face

[0181] 40 fastener

[0182] 41 projection

[0183] 42 counter fastener

[0184] 43 recess

[0185] 44 inside surface

[0186] 45 through opening

[0187] 46 flange section

[0188] 47 shoulder portion

[0189] 48 step

[0190] 49 step

[0191] 50 flange receptacle

[0192] 51 flange part

[0193] 52 flange section

[0194] 53 flange section

[0195] 54 end wall

[0196] 55 inside face

[0197] 56 recess

[0198] 57 through opening

[0199] 58 abutment face

[0200] 59 abutment face

[0201] 60 proximal end face

[0202] 61 adapter part

[0203] 62 adapter part

[0204] 63 shell section

[0205] 64 inside surface

[0206] 65 outside surface

[0207] 66 end face

[0208] 67 end face

[0209] 68 lining

[0210] 70 window

[0211] 72 through opening

[0212] 100 blinding kit

Claims

PAT23259-WO-PCTClaims1. A blinding device (20) for concealing an injection device (1) for use in clinical trials, wherein the injection device (1) comprises plunger (11) and a barrel (4) filled with a medicament (12) or with a placebo, wherein the plunger (11) is movable relative to the barrel (4) for expelling of the medicament (12) or the placebo from the barrel (4), the blinding device (20) comprising: an elongated opaque housing (23) extending in a longitudinal direction (z), the elongated opaque housing (23) comprising a first housing part (21) and a second housing part (22), which are movable relative to each other at least from an open configuration, in which the barrel (4) of the injection device (1) is insertable at least partially into at least one of the first housing part (21) and the second housing part (22), and a closed configuration, in which the first housing part (21) and the second housing part (22) cover up the barrel (4), wherein at least one of the first housing part (21) and the second housing part (22) comprises a proximal end wall (54) with at least one of a recess (56) or a through opening (57) sized to receive at least a portion of the plunger (11) to extend through the recess (56) or through opening (57) in the longitudinal direction (z).

2. The blinding device (20) according to claim 1 , wherein the first housing part (21) and the second housing part (22) each comprise a longitudinal shell part (31) to at least partially encase the barrel (4) of the injection device (1).

3. The blinding device (20) according to any one of the preceding claims, wherein at least one of the first housing part (21) and the second housing part (22) comprises a flange part (51) comprising a first flange section (52) and a second flange section (53) protruding outwardly from opposite lateral sides of the first housing part (21) and the second housing part (22), respectively.

4. The blinding device (20) according to claims 2 and 3, wherein the flange part (51) adjoins a proximal end of the longitudinal shell part (31).

5. The blinding device (20) according to any one of the preceding claims, wherein at least one of the first housing part (21) and the second housing part (22) comprises a flange receptacle (50) extending in a direction transverse to the longitudinal direction (z) and being sized to receive at least a portion of a barrel flange (5) of the injection device (1).

6. The blinding device (20) according to any one of the preceding claims 3-5, wherein the flange receptacle (50) is located in the flange part (51) and wherein the flange receptacle (50) is confined in a longitudinal proximal direction (3) by the proximal end wall (54).

7. The blinding device (20) according to any one of the preceding claims 5 or 6, wherein the flange receptacle (50) is confined in longitudinal distal direction (2) by a proximal end face (60) of the shell part (31).

8. The blinding device according to any one of the preceding claims 3 or 4, wherein the flange part (51) of the first housing part (21) comprises an inside facing front face (30) to engage or to abut with a complementary or identically shaped inside facing front face (30') of the flange part (51) of the second housing part (22).

9. The blinding device according to claim 8, wherein the second flange section (53) comprises a fastener (40) on or in the inside facing front face (30), and wherein the first flange section (52) comprises a counter fastener (41) on or in the inside facing front face (30) and wherein the counter fastener (41) is complementary shaped to the fastener (40) to mechanically engage with the fastener (40).

10. The blinding device (20) according to any one of the preceding claims, wherein the first housing part (21) comprises a first longitudinally extending side edge (32) and a second longitudinally extending side edge (33) at opposite circumferential ends of the first housing part(21), wherein the second housing part (22) comprises a first longitudinally extending side edge (32) and a second longitudinally extending side edge (33) at opposite circumferential ends of the second housing part (22) and wherein the first longitudinally extending side edge (32) of the first housing part (21) is engageable with the second longitudinally extending side edge (33) of the second housing part(22) and / or wherein the second longitudinally extending side edge (33) of the first housing part (21) is engageable with the first longitudinally extending side edge (32) of the second housing part (22).

11. The blinding device (20) according to claim 10, wherein the second longitudinally extending side edge (33) of the second housing part (22) comprises a fastener (40) to mechanically engage with a complementary shaped counter fastener (42) provided at the first longitudinally extending side edge (32) of the first housing part (21).

12. The blinding device (20) according to claim 11 , wherein the fastener (40) comprises a projection (41) and wherein the counter fastener (42) comprises a recess (43) configured to receive the projection (41) in a press-fit configuration.

13. The blinding device (20) according to claim 12, wherein the projection (41) of the fastener (40) comprises a truncated cone and wherein the recess (43) of the counter fastener (42) comprises a conical shape.

14. The blinding device (20) according to any one of the preceding claims, wherein the elongated opaque housing (23) comprises a distal through opening (72) at a distal end (24) to receive at least one of a needle (7) and a needle cap (13) of the injection device (1) to extend through the distal through opening (72) in the longitudinal direction (z).

15. The blinding device (20) according to any one of the preceding claims, wherein at least one of the first housing part (21) and the second housing part (22) comprises an inspection window (70) for a visual inspection of the barrel (4) of the injection device (1) when located inside the elongated opaque housing (23).

16. The blinding device (20) according to any one of the preceding claims, further comprising at least one of a first adapter part (61) and a second adapter part (62) configured to be arranged at or on an inside surface (44) of a sidewall (26) of at least one of the first housing part (21) and the second housing part (22) and to abut or to support an outside surface (18) of the barrel (4) of the injection device (1).

17. The blinding device (20) according to any one of the preceding claims, wherein the first housing part (21) and the second housing part (22) are of identical shape.

18. A blinding kit (100) comprising a blinding device (20) according to any one of the preceding claims and further comprising an injection device (1) arranged inside the elongated opaque housing (23) of the blinding device (20).

19. A method of blinding an injection device (1) for use in a clinical trial, wherein the injection device (1) comprises plunger (11) and a barrel (4) filled with a medicament (12) or with a placebo, wherein the plunger (11) is movable relative to the barrel (4) for expelling of the medicament (12) or the placebo from the barrel (4), the method of blinding the injection device (1) comprising the steps of:providing a blinding device (20) according to any one of the preceding claims 1-13 with the first housing part (21) and the second housing part (22) in the open configuration, arranging the barrel (4) of the injection device (1) at least partially in one of the first housing part (21) and the second housing part (22), - moving the second housing part (22) relative to the first housing part (21) to transfer the first housing part (21) and the second housing part (22) into the closed configuration, in which the first housing part (21) and the second housing part (22) cover-up the barrel (4) and in which at least a portion of the plunger (11) extends through the recess (56) or through opening (57) of the proximal end wall (54) in the longitudinal direction (z).

Images