Needle shield removal assembly, method of assembling same, and drug delivery device

Abstract

A needle shield removal assembly for a drug delivery device is provided, comprising a needle shield gripper configured to operably engage a needle shield and interlock with the needle shield, and a gripper holder, wherein the needle shield gripper is fixed to the gripper holder via a connection interface established between the gripper holder and the needle shield gripper, wherein the connection interface is formed by engagement of at least one holder interface feature of the gripper holder with at least one gripper interface feature of the needle shield gripper, wherein the gripper holder has an opening configured and dimensioned for receiving the needle shield gripper and / or the needle shield, wherein the at least one holder interface feature is offset from the opening, wherein the gripper holder defines a receiving space for receiving the needle shield gripper therein, wherein the receiving space has an axial extension, in particular an axial extension pointing in a direction away from the opening, and wherein the needle shield gripper and the gripper holder are adjusted to each other to reduce or prevent a) mechanical contact of the gripper holder, in particular an inner surface thereof, with a kinked or twisted region of the needle shield gripper and / or b) mechanical contact of the gripper holder, in particular an inner surface thereof, with an edge or a corner of the needle shield gripper in the process of insertion of the needle shield gripper into the receiving space via an opening of the gripper holder that is angularly offset from the at least one holder interface feature. Additional embodiments of a needle shield removal assembly are disclosed. Furthermore, a drug delivery device and a method are provided.

Description

[0001] The present disclosure relates to a needle shield removal assembly, a method of assembling such an assembly and a drug delivery device.

[0002] In drug delivery devices, sometimes a needle shield covering a needle has to be removed from the needle before a drug delivery operation is performed with the device. This is sometimes done by means of a needle shield removal device or assembly. Such a removal device or removal assembly can facilitate the removal of the needle shield, for example because the removal of the needle shield can require a considerable force, or because the needle shield is not easily accessible from the outside of the device. SUMMARY

[0003] It is an object of the present disclosure to provide improvements relating to needle removal assemblies.

[0004] This object is achieved by the subject matter of the independent claims. Advantageous improvements and embodiments are subject to the dependent claims. However, the present disclosure can also contain advantageous features and embodiments which are different from the claimed ones. In particular, the present disclosure should not be seen as limited to the claimed embodiments.

[0005] One aspect of the present disclosure relates to a needle shield removal assembly for a drug delivery device. Another aspect of the present disclosure relates to a drug delivery device comprising a needle shield removal assembly. Yet another aspect of the present disclosure relates to a method of assembling a needle shield removal assembly.

[0006] The needle shield removal assembly manufactured or assembled in the method is preferably a needle shield removal assembly for a drug delivery device. The same applies to the needle shield removal assembly of the drug delivery device. Thus, features disclosed in relation to the needle shield removal assembly also apply to the method and / or the drug delivery device, and vice versa.

[0007] In one embodiment, the needle shield removal assembly comprises a needle shield holder. The needle shield holder can be configured to operably engage a needle shield, for example a needle shield of a drug delivery device. The needle shield can at least partially cover a needle of the drug delivery device. The needle shield holder can be configured to interlock with the needle shield. The needle shield holder can be configured to establish a form fit connection with the needle shield. For example, the needle shield holder can be configured to stretch into an outer surface of the needle shield to establish a secure connection with the needle shield, such that the needle shield can be removed together with the needle shield holder. The needle shield holder can be designed to receive the needle shield and / or the needle inside the needle shield holder.

[0008] In one embodiment, the needle shield removal assembly comprises a gripper holder. The needle shield gripper can be fixed to the gripper holder, for example by a connection interface established between the gripper holder and the needle shield gripper. The connection interface can fix the needle shield gripper against movement in at least one direction, preferably an axial direction, relative to the gripper holder. The needle shield gripper can be axially and / or rotationally locked to the gripper holder, preferably permanently. The needle shield gripper can be fixed against axial and / or rotational movement relative to the gripper holder in both directions. The connection interface can be formed by at least one holder interface feature of the gripper holder, preferably by a plurality of holder interface features of the gripper holder, engaging at least one gripper interface feature, preferably a plurality of gripper interface features of the needle shield gripper. If a plurality of interface features is provided, one holder interface feature can engage one associated gripper interface feature. The needle shield gripper can be received in a tubular section of the gripper holder. An outer surface of the needle shield gripper can face an inner surface of the gripper holder, for example an inner surface of the tubular section. Of course, different arrangements are possible. However, this arrangement has proven to be particularly advantageous.

[0009] In one embodiment, an outer surface of the needle shield gripper abuts an inner surface of the gripper holder. The respective surfaces can be radially facing surfaces.

[0010] In one embodiment, the gripper holder has an opening. In the following, this opening is sometimes also referred to as "holder opening". The opening can be designed in its configuration and dimensions for receiving the needle shield gripper and / or the needle shield. The (respective) holder interface feature can be offset from the opening, for example in a direction distal to the opening. A surface of the (respective) holder interface feature distal to the opening and a surface of the gripper interface feature facing the opening can be arranged to abut each other to form the connection interface. The holder interface feature can be axially offset from the opening of the gripper holder.

[0011] In one embodiment, the gripper holder has or defines a receiving space. In the receiving space, the needle shield gripper can be received and / or arranged. The needle shield gripper can be fixed within the receiving space. The receiving space can have an axial extension. The opening can be in communication with the receiving space. Thus, by the opening, the needle shield gripper can be inserted or introduced into the receiving space. During the insertion, the gripper interface feature can be moved towards the holder interface feature until the connection interface is established. The axial extension can be an extension distal to the opening, for example in a direction perpendicular to a plane defining the opening. The axial direction can extend along an axis running through a center of the opening and / or perpendicular to the plane defining the opening. On a side distal to the opening, the receiving space can be defined by an abutment surface, for example an abutment surface of a surface of the gripper holder.

[0012] In one embodiment, the drug delivery device, in addition to the needle shield removal assembly, preferably comprises a reservoir. The reservoir can comprise a drug or medicament, preferably in liquid form. The drug delivery device can comprise a needle. The needle can be at least partially covered by a needle shield. The needle shield holder can engage the needle shield, for example a radially facing surface and / or an outer surface of the needle shield. The needle shield can be removed from the needle by the needle shield removal assembly. That is, when the holder retainer is removed, the needle shield is also removed due to the connection or interlock between the needle shield holder and the needle shield. The needle shield can be of plastic. The reservoir can be a cartridge, preferably without a needle, or a syringe, preferably provided with a needle. In order to provide a fluid connection between the interior of the cartridge and the needle, the cartridge can be moved relative to the needle during an injection operation and vice versa. In case a pre-filled syringe is provided, such relative movement between the needle and the reservoir can be avoided. The reservoir can be static or moving during device operation. Typically, the needle and the needle shield mounted on the needle are typically stored together with the rest of the device, for example the reservoir, like the syringe barrel. Storage is typically performed at low temperature. Storage at low temperature tends to increase the adhesion of the needle shield on the reservoir and / or needle. This correspondingly increases the removal force required to remove the needle shield. Thus, for pre-filled syringes, high removal forces can occur in particular. However, the present disclosure is not limited to pre-filled syringes.

[0013] In one embodiment, the needle shield holder has an annular configuration or shape. Thus, the needle shield holder can resemble a sleeve. The needle shield holder can be a sleeve or can differ from a sleeve, as will be further explained below. A sleeve is a component which has no free corner end but only axial ends. The proposed needle shield holder can have a free corner end, as will become apparent from the further description below. However, the present disclosure also applies to needle shield holders having a sleeve shape, unless specifically stated otherwise.

[0014] During investigations of systems of a holder retainer and a needle shield holder which have been assembled to each other to form a needle shield removal assembly, it was found that many systems showed damage of one of the components, typically the holder retainer. In particular, the systems had for example scratches or flaking of the holder retainer material, for example within the receiving space. Of course, having loose particles in the system, like scratches or flaking or visible damage, can provoke user dissatisfaction and can reduce the user’s confidence that the device is configured correctly. Alternatively or additionally, the removal of material from a pre-manufactured component, for example from the holder retainer, due to scratches can reduce the structural stability of the component and thus is problematic, in particular when the forces involved in the removal of the needle shield can be rather high and should ensure that the needle shield is reliably removed. Thus, the generation of scratches or flaking should be avoided or at least reduced. The present disclosure contains various concepts which are suitable to solve this problem.

[0015] In one embodiment, the needle shield holder and the holder retainer are configured and / or adjusted to each other to reduce or prevent mechanical contact of the holder retainer and the needle shield holder, e.g. one or more segments of the needle shield holder, e.g. particularly segments which are likely to cause damage to the holder retainer, and / or one or more areas of the holder retainer. The areas of the holder retainer can be areas which have been identified to be particularly sensitive to damage by the needle shield holder. Accordingly, these areas of the holder retainer are also designated as sensitive areas herein. Damage has been found to be most likely to occur during assembly of the needle shield holder to the holder retainer, particularly when the needle shield holder is guided or inserted into the receiving space. Accordingly, the needle shield holder and the holder retainer can be configured and / or adjusted to each other to reduce or prevent mechanical contact of the holder retainer and the needle shield holder, preferably during insertion of the needle shield holder into the receiving space via the opening and / or before the connection interface is established.

[0016] In one embodiment, at least one sensitive area of the holder retainer is angularly offset from at least one retainer interface feature. Each sensitive area can be angularly offset from the associated retainer interface feature. The number of sensitive areas can be equal to the number of retainer interface features or different. Surprisingly, it has been found that areas which are angularly offset from the retainer interface features are particularly likely to be damaged, especially during assembly of the needle shield removal assembly. The angular position of the sensitive areas can be angularly located in the middle between two adjacent retainer interface features. Accordingly, it is particularly advantageous to prevent or reduce contact in these areas.

[0017] In one embodiment, the at least one sensitive area is angularly arranged between two angularly adjacent retainer interface features.

[0018] In one embodiment, the respective sensitive area is an area of an inner surface of the holder retainer.

[0019] In one embodiment, the segments of the needle shield holder which contact with the holder retainer can be reduced or prevented, e.g. in the sensitive areas, are kinked or twisted areas of the needle shield holder and / or edges or corners of the needle shield holder. It has been found that kinked or twisted areas of the needle shield holder are particularly likely to damage the holder retainer, e.g. in areas which are angularly offset from the retainer interface features, when engaging the holder retainer, e.g. by creating scratches or flaking debris. Alternatively or additionally, the same is true for edges or corners of the needle shield holder, particularly in areas which are angularly offset from the retainer interface features. In the context of the present disclosure, "angular" can refer to the azimuthal direction, i.e. a direction defined by an azimuthal or rotational angle with respect to an axis, e.g. with respect to a longitudinal axis through the opening.

[0020] An edge or a corner can be arranged at an end of the needle shield holder, for example at a front end. The end can face in axial direction. The front end can be the end that is first introduced into the opening and / or the end that is distanced from the opening in the needle shield removal assembly. The edge or the corner can refer to a surface area of the needle shield holder that faces away from the opening. The kink or twist region can extend along a side surface of the needle shield holder. The kink or twist region can define an edge or a corner, for example in an end region thereof, or not define an edge or a corner. The edge or the corner can be part of a sharp section of the needle shield holder. The edge or the corner can comprise an angled section, for example at the end of the kink or twist region. The angle defined by the angled section can be arranged in a plane perpendicular to the axis. The corner can be an angled section of the needle shield holder edge, for example at a front end of the needle shield holder.

[0021] It has been shown that edges or corners of the needle shield holder end are particularly prone to generate flaking or scraping debris during assembly, especially when the angled section contacts the holder retainer. The edges or corners can be defined by stamping or other methods that create sharp edges. Furthermore, the kink or twist region of the needle shield holder, for example on the side surface, particularly in the end region of the side surface close to the front end, can significantly contribute to or cause damage. Therefore, it is particularly advantageous to reduce or prevent contact of these parts of the needle shield holder with the holder retainer in sensitive areas. In non-sensitive areas, mechanical contact can exist during and / or after insertion of the needle shield holder into the receiving space.

[0022] In one embodiment, the needle shield holder has a plurality of twist or kink regions and / or corners or edges. One twist or kink region can separate two planes of the needle shield holder. Not all twist or kink regions and / or edges or corners can be angularly aligned with the sensitive area. The parts of the needle shield holder that are angularly aligned with the sensitive area are preferably adjusted or modified to reduce or prevent mechanical contact, in contrast to other parts that can have the same configuration as the parts that angularly overlap with the sensitive area before adjustment or modification. Alternatively or additionally, the section of the holder retainer that is adjacent to or within the sensitive area can be adjusted or modified to reduce or prevent mechanical contact of the holder retainer and the needle shield holder within the sensitive area. Surprisingly, it has been found that the area of the holder retainer that is angularly offset from the retainer interface feature is particularly prone to engage with the needle shield holder during insertion and generate scraping or flaking debris due to the mechanical cooperation with the needle shield holder. Therefore, by adjusting the needle shield holder and the holder retainer such that mechanical contact is prevented or reduced in this particular area, the generation of scraping or flaking debris can be reduced or even completely prevented. This, for example, increases the user's confidence in the proper functioning of the device.

[0023] In one embodiment, the holder holder comprises a plurality of holder interface features. The holder interface features are conveniently axially aligned, i.e. in the same axial position, and / or angularly separated from each other. Preferably, each holder interface feature has a corresponding gripper interface feature. The holder interface features can be evenly distributed in circumferential or angular direction. That is, the distance between two angularly adjacent holder interface features can be equal, preferably independent of which pair of angularly adjacent holder interface features is selected.

[0024] In one embodiment, the beginning of one or more sensitive areas of the holder holder can be defined by the axial position of the holder interface features. Alternatively or additionally, the sensitive areas can be offset distally or distally away from the opening relative to the holder interface features.

[0025] In one embodiment, the angular distance between one holder interface feature and a sensitive area of the holder holder is smaller than the distance between two adjacent holder interface features, preferably smaller than or equal to half of the distance. In other words, one sensitive area can be arranged between two angularly adjacent holder interface features, e.g. in the middle.

[0026] In one embodiment, the respective holder interface features preferably protrude inwardly into the receiving space. In particular, the holder interface features can define a free diameter in the area of the receiving space. In the area of the holder interface features, the inner diameter of the receiving space can be smaller than the outer diameter of the needle shield holder, in particular in the section of the needle shield holder which adjoins the holder interface features in the direction towards the opening and / or in the direction distally away from the opening.

[0027] In one embodiment, the needle shield holder is deformable, preferably elastically deformable. The needle shield holder can be deformable in radial direction. That is, when a radially directed force is applied to the needle shield holder, the needle shield holder can deform and, once the force is removed, the needle shield holder can recover its original shape due to an elastic restoring force. This can be advantageous in the assembly process, as an elastic deformation can be required to engage the holder interface features and the gripper interface features. However, if the needle shield holder elastically deforms, its shape, e.g. its cross-section, can change, thus the area of the holder holder which is engaged by the deformed needle shield holder can change and / or the force acting on the area engaged by the deformed needle shield holder can increase. The respective sensitive area can be an area into which or towards which the needle shield holder deforms during the assembly process, in particular when and / or until the needle shield holder engages the holder interface features and / or until the gripper interface features have engaged the holder interface features to establish the connection interface. The elastic deformation of the needle shield holder is less or even less rigid when subjected to an axial force, i.e. a force acting in axial direction, e.g. a force acting along the axial extension of the kink or bend region of the needle shield holder.

[0028] Accordingly, the elastic deformation capability in radial direction can be used to assemble the needle shield holder and the holder retainer to each other. The needle shield holder, when not deformed or relaxed, can have an outer diameter which is larger than an inner diameter defined in the area of the retainer interface feature, larger than an inner diameter defined in the area of the retainer interface feature which is offset towards the opening, and / or larger than an inner diameter defined in the area of the retainer interface feature which is offset away from the opening. That is, when the needle shield holder has been introduced into the opening, the elastic restoring force can act to maintain an abutment between the inner surface of the holder retainer and the outer surface of the needle shield holder.

[0029] In one embodiment, the respective retainer interface feature has a snap-in feature.

[0030] In one embodiment, the needle shield holder comprises a ramped surface area, which can be planar. Said surface area can be an outer surface area of the needle shield holder. The ramped surface area can extend radially away from the axis with increasing distance from an end of the needle shield holder closest to the ramped surface area. An angle between the ramped surface area and the axis, for example an angle defined by an axial extension of the receiving space, can be less than 90°, for example less than or equal to one of the following values: 60°, 55°, 50° or 45°. The ramped surface area can form a guide surface or an introduction surface of the needle shield holder which is arranged to interact with the retainer interface feature in order to elastically deform the needle shield holder during insertion of the needle shield holder into the receiving space. The ramped surface area can incorporate or introduce an axially extending surface area of the needle shield holder, as seen in a direction away from a front end of the needle shield holder. The ramped surface area can be angularly aligned or angularly overlap the holder interface feature.

[0031] In one embodiment, the ramped surface area angularly overlaps or is angularly aligned with the at least one retainer interface feature, in particular when the holder retainer and the needle shield holder have been assembled. If a plurality of retainer interface features is provided, preferably at least one or only one ramped surface area is provided which can interact with one of the retainer interface features during insertion. However, a plurality of ramped surface areas can also be provided. The ramped surface area can be arranged axially offset from the opening and the retainer interface feature when the needle shield holder has been inserted into the receiving space.

[0032] In one embodiment, the needle shield holder comprises a plurality of kinked or twisted regions and / or a plurality of edges or corners. One holder region of the needle shield holder, e.g. a planar region or a region less curved or kinked than the kinked or twisted regions, can be arranged between two adjacent kinked or twisted regions. The kinks or twists of the kinked or twisted regions can be oriented parallel to each other, e.g. parallel. The respective kinked or twisted regions can be axially oriented. The respective holder region can form a region of a lateral surface of the needle shield holder, e.g. a planar or curved surface region.

[0033] In one embodiment, at least one sensitive region can be arranged angularly between two adjacent kinked or twisted regions and / or between two angularly adjacent edges or corners. In other words, the kinked or twisted region or edge or corner closest to the sensitive region can be angularly offset from the sensitive region. In this way, it can be avoided that the kinked twisted regions and / or edges or corners contact the holder retainer at the sensitive region. Thus, the generation of flakes or scratches in the sensitive region can be avoided or at least significantly reduced. The region of the needle shield holder between two adjacent kinked or twisted regions can be planar, e.g. have a planar outer surface.

[0034] In one embodiment, the kinked or twisted regions are angularly arranged within the sensitive region.

[0035] In one embodiment, the holder retainer has a plurality of spatially separated sensitive regions or only one sensitive region.

[0036] In one embodiment, the sensitive regions are uniformly distributed in circumferential or angular direction.

[0037] In one embodiment, the holder interface feature is axially offset from the front end of the needle shield holder.

[0038] In one embodiment, at least a portion of the sensitive region is arranged axially offset from the retainer interface feature in a direction away from the opening. That is, the region between the retainer interface feature and the end of the receiving space facing away from the opening can be particularly prone to scratches or flakes.

[0039] In one embodiment, the needle shield holder has a cutout. The cutout can extend in axial direction, i.e. the cutout can be an axially extending or oriented cutout. The cutout can extend from an end of the needle shield holder, e.g. from the front end, e.g. towards the opening. The cutout can be provided in the front end region of the needle shield holder. The cutout can have a width. The width of the cutout can decrease along the axial extension of the cutout, e.g. when viewed in a direction away from the end of the needle shield holder. In other words, the cutout can taper, e.g. towards the opening. The end face of the cutout can extend perpendicularly with respect to the axis. The side face of the cutout can be inclined with respect to the axis, that is to say neither parallel nor perpendicular. The angle defined by the inclined surface with the axis can be less than 90°, preferably less than or equal to 60°, e.g. less than or equal to 45°.

[0040] In one embodiment, a kink or bend region and / or a corner or edge can angularly overlap with the cutout. The end of the kink or bend region and / or the corner or edge can be arranged in the cutout. The kink or bend region and / or the corner or edge can be angularly offset from the angular center point of the cutout. The angular center point can be arranged in a region of the cutout that extends perpendicularly with respect to the axis. The kink or bend region can define an angular border between a perpendicular section of the cutout surface and the inclined surface of the cutout. Offsetting the kink or bend region from the center point and / or from the perpendicular surface region can help to prevent the creation of flakes and / or scratches.

[0041] In one embodiment, the needle shield holder is elastically deformed when the connection interface has been established. In other words, the elastic deformation can still be present when the connection interface is established. This ensures that the inner surface of the holder retainer and the outer surface of the needle shield holder remain in contact and that the connection between the needle shield holder and the holder retainer is particularly reliable.

[0042] In one embodiment, the outer diameter of the needle shield holder is larger than the inner diameter of the opening in the non-deformed state, i.e. when the needle shield holder is not elastically deformed. Thus, in order to introduce the needle shield holder into the opening, the needle shield holder has to be elastically deformed. This elastic deformation can occur before the retainer interaction feature engages with the outer surface of the needle shield holder. The engagement can increase the elastic radial deformation, e.g. due to the diameter reduction in the region of the retainer interface feature. However, the initial elastic deformation can already hold the needle shield holder in a defined position with respect to the holder retainer. This is of course advantageous for the assembly process.

[0043] In one embodiment, the cross section of the needle shield holder in the relaxed state, i.e. when it is in its unelastically deformed or undeformed state, differs from the cross section of the opening and / or the receiving space when it is arranged in the receiving space in the elastically deformed state, e.g. the cross sections have different shapes. If applicable, the receiving space can have a circular shape or cross section, except for the region in which the retainer interface feature is provided.

[0044] In one embodiment, the diameter, e.g. the inner diameter and / or the outer diameter, of the needle shield holder in a region angularly offset from the holder interface feature can be smaller than the diameter in the region of the holder interface feature in a relaxed state, e.g. when the needle shield holder is not arranged in the receiving space and / or is not elastically deformed. The region with the smaller diameter can be the region which is configured to be angularly aligned with the sensitive region when the needle shield holder has been assembled to the holder retainer. This region can be angularly aligned with the sensitive region in the needle shield removal assembly. Thus, when the needle shield holder is deformed during assembly, the diameter difference has to be compensated for before the sensitive region is contacted, the sensitive region can likewise be angularly offset from the holder interface feature when the holder retainer and the needle shield holder have been assembled. The cross section of the needle shield holder in a relaxed state can be elliptical or polygonal.

[0045] In one embodiment, the needle shield holder has at least one needle shield interlock feature which is adapted to interlock with a needle shield. The needle shield holder can have a plurality of needle shield interlock features. The needle shield interlock features can be uniformly or non-uniformly distributed in an angular direction. The needle shield interlock features can be axially aligned. The respective retainer interface feature can be angularly aligned with the associated needle shield interlock feature. This has the advantage that the needle shield interlock features can be produced by forming openings in the needle shield holder. The openings in the needle shield holder can serve as holder interface features to engage the associated retainer interface features. Thus, it can be avoided that separate holder interface features are formed in the needle shield holder. Of course, separate holder interface features can also be formed. It can thus be advantageous to angularly align at least one retainer interface feature with the associated needle shield interlock feature. The respective needle shield interlock feature can be a barb. The respective needle shield interlock feature can project radially inwards.

[0046] In one embodiment, the needle shield holder has two free corner ends. In contrast to a closed ring configuration of a needle shield holder without free ends, such a configuration with two free corner ends can be advantageous from a manufacturing point of view. The needle shield holder can then be formed from a unitary sheet material by bending. The corner ends can overlap such that the needle shield holder defines a circumferentially closed interior space which is preferably adapted to receive a needle shield. In an alternative embodiment, the needle shield holder has a ring configuration.

[0047] In one embodiment, the respective bending or kinking region extends axially, preferably along the entire needle shield holder, that is to say from a first end towards and preferably up to a second end, wherein one of these ends can be a front end.

[0048] In an embodiment, the needle shield holder, preferably in the end section of the kink or twist region, comprises a notch. The notch can be radially directed, in particular radially inwardly directed. The notch can be arranged to face the at least one sensitive region when the needle shield holder has been introduced into the receiving space. By pressing the needle shield holder in a region which is to be arranged to face the sensitive region, an interaction between a potentially sharp edge or corner region of the needle shield holder and the (inner) surface of the holder retainer can be avoided or reduced. The notch can adjoin the kink or twist region and be performed by pressing into the kink or twist region after the kink or twist has been performed. Due to the notch, contact in the sensitive region can be avoided or at least reduced.

[0049] In an embodiment, the needle shield holder comprises a tab. The tab can be arranged between the kink or twist region and the (inner wall) of the holder retainer, in particular between the kink or twist region and the sensitive region. Thus, the tab can prevent contact of the holder retainer and the kink or twist region in the sensitive region of the holder retainer. In the end section of the needle shield holder, for example in a section close to the front end, the kink or twist region can be covered by the tab. The tab can be arranged between the needle shield holder and the holder retainer during insertion and / or when the connection interface has been established. The tab can be arranged in a radial position between the inner wall of the holder retainer and the kink or twist region. The tab can be moved into a position covering the kink or twist region after the kinking process defining the kink or twist region has been performed. An (outer) surface of the tab opposite to the (inner) wall of the holder retainer can be less kinked or twisted than the kink or twist region.

[0050] In an embodiment, the needle shield holder has a monolithic structure.

[0051] In an embodiment, one of the holder retainer and the needle shield holder has at least one or a plurality of protrusions. The respective protrusions can be arranged to adjoin or abut the other one of the holder retainer and the needle shield holder. The protrusions can be uniformly or non-uniformly, i.e. locally distributed in an angular direction. Optionally or additionally, the protrusions can be associated with or can be arranged close to, for example angularly close to, the (respective) sensitive region. Optionally or additionally, the respective protrusions can be associated with the kink or twist region and / or the edge or corner. Preferably, the plurality of protrusions can be associated with the kink or twist region and / or the edge or corner. The kink or twist region can be angularly arranged between the protrusions. By the protrusions, contact between the needle shield holder and the holder retainer in the sensitive region can be avoided, as contact can be prevented by abutment with the respective protrusions preventing mechanical contact of the needle shield holder and the holder retainer in the sensitive region. The respective protrusions can be angularly arranged outside of and / or angularly delimiting the sensitive region.

[0052] In one embodiment, the respective protrusion protrudes radially, for example inwardly or outwardly. The respective protrusion can have a radially free end.

[0053] In one embodiment, the needle shield holder comprises protrusion(s). The protrusion(s) can be arranged to engage or engage with the holder retainer, preferably with an inner surface of the holder retainer.

[0054] In one embodiment, the protrusion is associated with a kink or twist region of the needle shield holder and / or an edge or corner of the needle shield holder. For example, the protrusion can maintain a defined relative radial position, preferably with a radial spacing, between the kink or twist region of the needle shield holder and the holder retainer and / or between an edge or corner of the needle shield holder and the holder retainer during assembly and / or when the needle shield holder has been introduced into the receiving space. Preferably, at least two protrusions are associated with one kink or twist region. The protrusions can be axially aligned. The kink or twist region can be angularly arranged between the at least two protrusions. Alternatively or additionally, a corner or angular region of a front end or edge of the needle shield holder can be angularly arranged between the at least two protrusions. If there are multiple kink or twist regions, each of these kink or twist regions, or, as the case can be, the edge or corner, can have an associated protrusion if the kink or twist regions are arranged to face sensitive regions during assembly or in the assembled needle shield removal assembly.

[0055] In one embodiment, a free end of the protrusion can be radially and / or angularly offset from a radial end of the kink or twist region associated with the protrusion. The free end of the protrusion can protrude radially beyond the kink or twist region and / or the edge or corner of the needle shield holder. The needle shield holder can comprise at least two protrusions associated with a kink or twist region of the needle shield holder and / or an edge or corner of the needle shield holder. The free end of the protrusion can be radially offset from a radial end of the kink or twist region and / or the edge or corner of the needle shield holder associated with the protrusion. An envelope curve, for example a circle, extending through the free end of the protrusion and along an outer circumference of the needle shield holder can be radially offset from the radial end of the kink or twist region and / or the edge or corner.

[0056] In one embodiment, the protrusion can be formed as a bump of the needle shield holder. The bump can be formed by a recess of an opposite surface of the needle shield holder to the bump, for example by deep drawing or embossing. This facilitates the formation of the bump during production and does not require too many modifications in the production process of the needle shield holder. The bump can be radially oriented.

[0057] In one embodiment, the protrusion has a circumferentially closed boundary, for example a circular boundary, on a surface of the needle shield holder from which the protrusion protrudes.

[0058] In one embodiment, the protrusion is formed by an axially extending rib of the holder holder. The rib can have a radially free end. The length of the rib can be adjusted to the axial extension of the needle shield holder, for example at least 70% of the needle shield holder length. In this way, the protrusion can reliably prevent mechanical contact of the needle shield holder and the holder holder.

[0059] In one embodiment, the at least one protrusion is defined by molding, embossing or deep drawing. These processes can be easily integrated into the production of the holder holder and / or the needle shield holder, respectively, wherein embossing or deep drawing are particularly suitable for the needle shield holder, which can be metallic, and molding is particularly suitable for the holder holder, which can be plastic.

[0060] In one embodiment, the radial extension of the respective protrusion is greater than or equal to one of the following values: 0.1 mm, 0.2 mm, 0.3 mm. Alternatively or additionally, the radial extension of the protrusion can be less than or equal to one of the following values: 2 mm, 1.5 mm, 1 mm, 0.7 mm, 0.6 mm, 0.5 mm, 0.4 mm. Ranges can be formed by combining the above specified values as boundaries.

[0061] In one embodiment, the protrusion, for example at least a portion of the protrusion or the entire protrusion, is axially offset from the at least one holder interface feature in a direction away from the opening. In this area of the holder holder, the likelihood of scratches and flaking is high.

[0062] In one embodiment, the needle shield holder has at least one holder guiding feature, for example a cutout, for example a cutout discussed further above. The holder guiding feature can be arranged to cooperate with the holder guiding feature, for example by abutment. The holder guiding feature can be provided in the holder holder. The mechanical cooperation of the holder and the holder guiding feature can establish a guiding interface in order to achieve a desired angular relative orientation of the needle shield holder and the holder holder. In this way, it can be achieved that the holder interface feature and the associated holder interface feature can reliably engage during insertion of the needle shield holder into the receiving space. The mechanical cooperation, for example abutment, of the holder guiding feature and the holder guiding feature can be configured to guide the engagement of the holder interface feature and the holder interface feature.

[0063] In one embodiment, the holder holder comprises a radially extending recess or radial recess or radial opening, in particular a radially extending opening. The recess or opening can be arranged in a sensitive area, for example to prevent or reduce mechanical contact with the needle shield holder in the sensitive area. Thus, by removing material in the sensitive area from the holder holder, the generation of flaking or scratching debris can be avoided or reduced. The recess or radial opening or at least one section thereof can be offset from the holder interface feature in a direction away from the opening, e.g. the holder opening.

[0064] In one embodiment, the radial recess or radial opening is angularly offset from the at least one holder interface feature. Alternatively or additionally, the radial recess or radial opening is axially offset from the at least one holder interface feature. At least one portion of the radial recess or opening can be arranged in a section of the holder holder further away from the holder interface feature than from the holder opening, e.g. an end face thereof facing away from the holder opening. The radial recess or radial opening can be provided in a respective sensitive area, which will be further discussed above and below. Thus, features described with reference to a sensitive area should also be considered to refer to the radial recess or opening.

[0065] In one embodiment, the receiving space is preferably laterally and / or circumferentially defined by a portion of the holder holder. This portion of the holder holder can have a tubular or cylindrical configuration. In particular, this portion can comprise at least one section having a cylindrical surface, preferably being closed in an angular direction. This section can be provided between the holder opening and the at least one holder interface feature.

[0066] In one embodiment, the portion of the holder holder defining the receiving space is radially inwardly offset from an inner surface of the holder holder, in particular from an inner surface of an outer wall of the holder holder. In particular, a free space or hollow portion can be formed between an outer surface of the portion of the holder holder defining the receiving space and an inner surface of the holder holder, e.g. an inner surface of the outer wall. In this way, the receiving space can be formed inside the holder holder and is not easily affected by forces impacting on the outer wall. The outer wall of the holder holder can provide a user interaction surface, in particular an outer surface of the holder holder, which can be gripped by a user, e.g. in order to remove a needle shield. The outer surface of the portion defining the receiving space can face the inner surface of the outer wall, in particular without further surfaces between them.

[0067] In one embodiment, the radial recess or radial opening is connected to the receiving space. From the receiving space, the radial recess or radial opening can extend outwardly, in particular radially outwardly. The radial recess or radial opening can extend to or through the holder holder or a portion thereof. Advantageously, the portion through or into which the recess or opening extends is the portion delimiting or defining the receiving space.

[0068] The recess can be radially defined by the material of the holder holder, for example by the portion defining the receiving space. The opening can radially protrude through the entire portion and / or the entire holder holder, as appropriate. The opening can connect the receiving space with a free space or hollow portion defined between an outer surface of the portion of the holder holder defining the receiving space and an inner surface of the holder holder as described above.

[0069] In one embodiment, the radial recess or radial opening comprises a first axial end. The first axial end of the radial opening or radial recess can be formed by the portion of the holder holder defining the receiving space. The first axial end can axially define the opening or recess towards and / or at a side of the holder opening. The radial recess or radial opening can extend in axial direction away from the first axial end. The first axial end can be closed. In other words, an axially oriented surface, for example a distally oriented surface, can define the first axial end of the radial recess or radial opening. The first axial end can be axially offset from the holder opening, in particular distally from the holder opening, as indicated along the extension of the receiving space. The first axial end can be a proximal end of the radial recess or opening.

[0070] In one embodiment, the radial recess or radial opening comprises a second axial end. The second axial end can be axially offset from the first axial end and / or from the at least one holder interface feature, for example in a direction distally away from the holder opening. The second axial end can be an end distally away from the first axial end.

[0071] In one embodiment, the second axial end of the radial recess or radial opening is an open axial end. In other words, the holder holder can be free of an axially, for example proximally, oriented surface defining the second axial end of the recess or opening. The second axial end can be a distal end of the recess or opening. The open axial end facilitates determining the radial opening or radial recess by molding.

[0072] In one embodiment, the holder holder is a monolithic component. The holder holder can be moldable, for example in a single step molding process and / or using only one mold.

[0073] In one embodiment, a closure, for example a cap, is connected to the holder holder so as to close the holder holder. The closure can be arranged to close the holder holder at a side distally away from the holder opening. The closure can form a distal face of a cap assembly and / or needle shield removal assembly comprising the holder holder and the closure. The second axial end of the respective radial opening or recess can be closed by the closure connected to the holder holder.

[0074] In one embodiment, one or more side surfaces, for example angularly defining the radial opening or radial recess, for example the angular side surfaces are inclined. The respective side surfaces can be inclined with respect to an axis extending along the longitudinal direction, for example from the proximal end to the distal end of the holder holder. The side surfaces can face each other. Two angular side surfaces defining the radial recess or angular opening and facing each other in the angular direction can be inclined. The side surfaces can be connected by an end face arranged at a first axial end of the radial recess or radial opening.

[0075] In one embodiment, the width, in particular the angular width, of the radial recess or opening varies along the axial extension of the radial recess or radial opening.

[0076] In one embodiment, the angular width of the radial recess or radial opening increases, for example continuously, in a direction away from the first axial end. That is, the opening or recess can widen, for example continuously, in a direction away from the first axial end. This improves the moldability of the holder holder comprising the radial opening or recess.

[0077] In one embodiment, at least one holder interface feature, for example each holder interface feature, comprises an inclined region or inclined section. The inclined region can be arranged at an end of the holder interface feature facing the holder opening and / or the proximal end. This facilitates a (elastic) deformation of the needle shield holder when the holder is introduced into the receiving space due to the mechanical cooperation between the needle shield holder and the holder interface feature. The inclined region or section can form an introduction region for the cooperation between the needle shield holder and the holder holder during insertion of the holder into the receiving space. The inclined region can be inclined with respect to a longitudinal axis of the receiving space. The longitudinal axis can extend from the proximal end to the distal end of the receiving space. The angle of inclination with respect to the longitudinal axis can be an acute angle, for example an angle of less than 45°. The holder interface feature can comprise a (first) region which is less inclined with respect to the longitudinal axis than the inclined region, for example this region can extend parallel to the longitudinal axis. This region can be arranged distally of the inclined region. An end region or end face of the interface feature facing away from the holder opening can be inclined with respect to the longitudinal axis at an angle greater than the first region, for example the end region or surface can be oriented perpendicular with respect to the longitudinal axis. The end region or surface can be arranged to interact with the holder interface feature in order to form a connection interface. In other words, the holder interface feature can comprise a plurality of regions having different inclinations with respect to the longitudinal axis.

[0078] In one embodiment, the first axial end of the radial recess or radial opening is associated with the holder interface feature, in particular with an axial position of the holder interface feature. For example, the first axial end of the radial recess or radial opening can be arranged axially offset from the holder interface feature, e.g. close to the holder interface feature, and / or axially overlapping with the holder interface feature. For example, the axial offset between the holder interface feature, in particular an end thereof facing the holder opening, and the first axial end can be less than or equal to any of the following values:

[0079] - the distance and / or axial offset AO between the holder opening and the holder interface feature is preferably less than or equal to c*AO, wherein c is selected from: 0.5, 0.4, 0.3; and / or

[0080] - less than or equal to any of the following values: 5 mm, 4 mm, 3 mm, 2 mm; optionally or additionally, the axial offset between the holder interface feature, in particular an end thereof facing the holder opening, and the first axial end can be greater than or equal to any of the following values: 0.1 mm, 0.2 mm, 0.3 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm; for example, the axial offset can be between 0.1 mm and 5 mm; and / or

[0081] - an axial extension length of the holder interface feature.

[0082] In case of different distances of the holder interface features to the holder opening, the minimum distance, the maximum distance or the average distance over the number of holder interface features between the first axial end and the holder interface feature can be used to determine the axial offset AO between the holder opening and the holder interface feature.

[0083] As an alternative to a non-zero offset, the axial offset can be zero. If there is no axial offset, the axial end of the radial recess or opening coincides with the start of the holder interface feature. A non-zero offset can account for tolerances, e.g. in the manufacturing process, whereas the manufacturing of a holder of a gripper with zero axial offset can be more cost efficient.

[0084] In one embodiment, the first axial end of the radial recess or radial opening is arranged axially offset from the end of the at least one holder interface feature, e.g. the end of the at least one holder interface feature facing the holder opening. The first axial end can be axially offset from all holder interface features. The first axial end of the radial recess or radial opening can be arranged closer to the holder opening than the end of the (respective) holder interface feature. In other words, the axial offset between the first axial end and the holder opening can be smaller than the axial offset between the end of the holder interface feature facing the holder opening and the holder opening. In this way, it can be guaranteed that from the moment the needle shield gripper engages with the holder interface feature, the risk of scraping or creating flakes is reduced.

[0085] In one embodiment, the first axial end of the radial recess or radial opening is axially coinciding with the end of the at least one holder interface feature, e.g. the end of the at least one holder interface feature facing the holder opening. This configuration can have a zero axial offset between the first axial end and the end of the at least one holder interface feature.

[0086] In one embodiment, the first axial end of the radial recess or radial opening axially overlaps with the at least one holder interface feature. Preferably, the first axial end axially overlaps with a ramped region of the at least one holder interface feature, e.g. in a ramped region of the at least one holder interface feature facing the end of the holder opening. In other words, the axial position of the first axial end can be within the ramped region of the interface feature.

[0087] In one embodiment, the needle shield gripper comprises at least one kink or bend region overlapping with the radial opening or radial recess, in particular in angular direction and / or axial direction. The angular width of the radial recess or opening is suitably larger than the angular width of the kink or bend region of the needle shield gripper, e.g. of all kink or bend regions of the gripper. In this way, it can be ensured that the risk of the needle shield gripper scraping or creating flakes from the material of the gripper holder is significantly reduced. The axial extension of the radial recess or opening can be smaller than the axial extension length of the kink or bend region of the needle shield gripper, e.g. of all kink or bend regions of the gripper.

[0088] In one embodiment, the needle shield gripper radially protrudes into the radial recess or opening. Preferably, there is a radial gap between the needle shield gripper, in particular the kink or bend region of the gripper overlapping with the recess in angular direction, and the gripper holder located in the area of the radial opening or recess.

[0089] In one embodiment, at least a portion of the kink or bend region, e.g. only a portion thereof, axially extends along the radial opening. Thus, the kink or bend region can axially and angularly overlap with the radial recess or opening.

[0090] In one embodiment, the holder retainer is made of a softer material than the needle shield holder, for example plastic, the needle shield holder can be made of metal. Thus, the holder retainer can be more susceptible to being scratched than the needle shield holder.

[0091] In one embodiment, the needle shield holder is made of metal. The holder retainer can be plastic.

[0092] In one embodiment, the radial extension length of the respective protrusion, for example the protrusion on the holder retainer or the protrusion on the needle shield holder, is greater than or equal to one of the following values: 0.1 mm, 0.2 mm, 0.3 mm. Alternatively or additionally, the radial extension length of the respective protrusion can be less than or equal to one of the following values: 2 mm, 1.5 mm, 1 mm, 0.7 mm, 0.6 mm, 0.5 mm, 0.4 mm. Ranges can be formed by combining the above specified values as boundaries.

[0093] In one embodiment, the retainer interface feature is arranged to block movement of the needle shield holder towards the retainer opening, for example proximal movement of the holder, by the blocking portion of the needle shield holder abutting a surface of the retainer interface feature. The surface of the retainer interface feature is preferably facing away from the opening, for example towards the distal direction. The blocking portion of the needle shield holder can be facing towards the opening, for example towards the proximal direction. The blocking portion can be arranged close to or in association with an end face of the needle shield holder. The blocking portion of the needle shield holder can be arranged in a region of the needle shield holder between the end face of the needle shield holder and the axially oriented portion of the needle shield holder. The blocking portion can form or define a surface of the holder interface feature which is arranged to mechanically cooperate, for example abut, the retainer interface feature, for example a distal surface of the retainer interface feature.

[0094] Thus, as the blocking portion is provided for mechanical contact with the retainer interface feature, it can be avoided that the end face is used for interacting with the retainer interface feature. Thus, it can be avoided that the retainer interface feature and the end face with a potentially sharp edge or surface region mechanically interact. Thus, when the holder is guided into the holder, it can be avoided that the end face mechanically interacts with the surface, for example the inclined or beveled surface, of the retainer interface feature. This reduces the risk of creating flaps or scratches in the region of the retainer interface feature and the holder interface feature.

[0095] In one embodiment, the end face faces in a non-axial and / or non-proximal direction. In other words, the end face of the needle shield holder can face in a radial direction, e.g. radially inward, or in a distal direction, or away from the holder opening. In particular, the end face can be a radially oriented surface or a distally oriented surface. The end face can face in the same direction as the surface of the holder interface feature which is arranged to abut the blocking portion. Of course, this is particularly suitable for a distally facing end face.

[0096] In one embodiment, the end face is radially offset, e.g. inwardly offset, from the holder interface feature and / or from the blocking portion.

[0097] In one embodiment, the end face is axially, e.g. distally, offset from or axially aligned with the blocking portion.

[0098] In one embodiment, the blocking portion is arranged in the region of a tab or tongue of the holder. The tab or tongue can extend like a strip from the body of the holder. The free end of the tab or tongue can define the end face of the needle shield holder. The blocking portion can be arranged between the end face and the axially oriented portion of the needle shield holder. The tab or tongue can be bent or curved to define the blocking portion.

[0099] In one embodiment, the blocking portion is arranged in a curved or bent region of the needle shield holder. This region can be concavely curved as seen from the distal end of the needle shield holder.

[0100] In one embodiment, the blocking portion is arranged close to the end face, preferably less than one of the following distances offset from the end face, preferably as seen along the extension of the tab or tongue away from the end face: 2 mm, 1 mm, 0.5 mm.

[0101] In one embodiment, the blocking portion is a radially extending or oriented portion of the needle shield holder.

[0102] In one embodiment, the end face is defined by a cutting process, e.g. by cutting or stamping.

[0103] In one embodiment, the end face is defined by one or more sharp edges, or has a sharp surface structure. The edges of the surface structure can be defined by the production process, e.g. cutting or stamping.

[0104] In one embodiment, the needle shield holder is made of metal and / or the holder is made of plastic.

[0105] In one embodiment, the end face and / or the blocking portion is angularly aligned with the holder interface feature, and preferably distally offset from the holder interface feature or offset from the holder interface feature in a direction away from the opening.

[0106] In one embodiment, the blocking portion is arranged in a transition region of the needle shield holder. The transition region can be a curved region, for example a concavely curved region as seen from the end of the needle shield holder distal from the holder opening, for example from the distal end. In the transition region, the needle shield holder can change its orientation. In the transition region, the needle shield holder can change its orientation from a generally axial orientation to a generally radial orientation. In particular, in this way, a radially facing end face can be formed, for example during the course of the needle shield holder extending in proximal direction, as seen from the distal end of the needle shield holder or the end face end facing away from the holder opening.

[0107] In one embodiment, the end of the blocking portion is the end of the needle shield holder, for example the free end. In particular, the needle shield holder can be designed such that the blocking portion is immediately adjacent to the end face.

[0108] In one embodiment, the holder interface feature is an opening axially, for example distally, defined by the blocking portion. Thus, by providing the blocking portion as an axial end of the opening instead of a sharp or edged end face, the end face of the opening can become less sharp.

[0109] In one embodiment, the blocking portion is angularly aligned with one of the needle shield interlock features. Alternatively or additionally, at least one of the needle shield interlock features, for example the one angularly closest to the blocking portion, can protrude radially, for example inwardly, beyond the end face. The needle shield interlock feature can be axially, for example proximally, offset from the blocking portion.

[0110] In one embodiment, the blocking portion is provided in a curved or rounded region of the needle shield holder.

[0111] In one embodiment, the needle shield holder is concavely curved, preferably as seen from the end of the needle shield holder facing away from the holder opening. The needle shield holder can be concavely curved in the region of the blocking portion or adjacent thereto, preferably immediately adjacent to the blocking portion. By the concave curvature, a smooth transition between the axially extending portion and the end face can become easy with the formation of a suitable blocking portion.

[0112] In one embodiment, the drug delivery device comprises a housing. The housing can accommodate a drive mechanism of the drug delivery device. The drive mechanism can comprise a spring. The drive mechanism can comprise a plunger biased by the spring to drive a delivery operation, for example by moving the plunger relative to a reservoir by means of the spring driven plunger. The drug delivery device can be an auto-injector. The reservoir can be a pre-filled syringe. The needle of the pre-filled syringe can be covered by a needle shield. The needle shield can engage the pre-filled syringe, for example its syringe barrel. The needle shield can be a rigid needle shield or a soft needle shield. The needle shield holder can engage the needle shield. In contrast to a soft needle shield, a rigid needle shield can have a rigid outer shell. Within the rigid outer shell a softer material can be provided which engages the needle.

[0113] In one embodiment, the needle shield removal assembly is a cap assembly for covering an end, e.g. a dispensing end, of a drug delivery device. The contents of the reservoir can be expelled from the drug delivery device via the dispensing end. The cap assembly can be removably connected to the housing or body of the drug delivery device such that it can be removed prior to performing an injection or delivery operation. The needle shield can be removed with it when the cap assembly is removed. The cap assembly can cover the open end of the needle. The needle can be rigid.

[0114] In one embodiment, the needle is designed to pierce the skin of a patient using the drug delivery device.

[0115] In one embodiment, a method of assembling a needle shield removal assembly comprises the steps of:

[0116] - providing a clip holder holder comprising an opening and a receiving space in communication with said opening

[0117] - providing a needle shield clip comprising a clip interface feature,

[0118] - inserting said needle shield clip into said opening,

[0119] - guiding said needle shield clip into said receiving space,

[0120] - reducing or preventing mechanical contact of said clip holder and said needle shield clip during the insertion of said needle shield clip into said receiving space via the opening in at least one sensitive area of said clip holder, and / or

[0121] - securing the needle shield clip within the clip holder, e.g. by the connection interface further described above.

[0122] Prior to inserting the needle shield clip into the opening, one or more sensitive areas can have been identified. The sensitive areas can be sensitive to the generation of flaking, scratching or scuffing during the insertion of the needle shield clip into the receiving space. The insertion of the needle shield clip into the receiving space, the clip holder and / or the needle shield clip can be adjusted or configured to reduce or prevent mechanical contact of the needle shield clip and the clip holder in the sensitive areas, e.g. as described above. Said adjustment can comprise an investigation of the system with the needle shield clip and the clip holder, and the identification of one or more sensitive areas. Thereafter, the clip holder and / or the needle shield clip can be modified or adjusted to reduce or prevent mechanical contact of the needle shield clip and the clip holder in the identified sensitive areas.

[0123] In one advantageous embodiment, a needle shield removal assembly for a drug delivery device is provided, the assembly comprising:

[0124] - a needle shield holder configured to operably engage a needle shield and interlock with the needle shield, and

[0125] - a holder retainer, wherein the needle shield holder is fixed to the holder retainer via a connection interface established between the holder retainer and the needle shield holder, wherein the connection interface is formed by engagement of at least one retainer interface feature of the holder retainer with at least one holder interface feature of the needle shield holder,

[0126] - wherein the holder retainer has an opening configured and dimensioned for receiving the needle shield holder and / or the needle shield, wherein the at least one retainer interface feature is offset from the opening,

[0127] - wherein the holder retainer defines a receiving space for receiving the needle shield holder therein, wherein the receiving space has an axial extension, in particular an axial extension pointing away from the opening, and wherein the needle shield holder and the holder retainer are adjusted to each other to reduce or prevent

[0128] a) mechanical contact of the holder retainer, in particular an inner surface thereof, with a kinked or twisted region of the needle shield holder and / or

[0129] b) mechanical contact of the holder retainer, in particular an inner surface thereof, with an edge or a corner of the needle shield holder. As mentioned above, by considering sensitive regions, the generation of scratches or flaking debris can be reduced.

[0130] In another advantageous embodiment, a needle shield removal assembly for a drug delivery device is provided, the assembly comprising:

[0131] - a needle shield holder configured to operably engage a needle shield and interlock with the needle shield, and

[0132] - a holder retainer, wherein the needle shield holder is fixed to the holder retainer via a connection interface established between the holder retainer and the needle shield holder, wherein the connection interface is formed by engagement of at least one retainer interface feature of the holder retainer with at least one holder interface feature of the needle shield holder,

[0133] - wherein the holder holder has a holder opening which is configured and dimensioned for receiving the needle shield holder and / or the needle shield, wherein the at least one holder interface feature is offset from the holder opening, e.g. axially and / or distally,

[0134] - wherein the holder holder defines a receiving space for receiving the needle shield holder therein,

[0135] - wherein the receiving space has an axial extension directed away from the direction of the holder opening, e.g. distally, and wherein,

[0136] - the holder holder has a radial recess or a radial opening in a section of the holder holder which is axially and / or angularly offset from the at least one holder interface feature.

[0137] It has been found that a recess or an opening is particularly reliable to prevent the generation of scratch or flake-off debris.

[0138] In another advantageous embodiment, a needle shield removal assembly for a drug delivery device is provided, the needle shield removal assembly comprising:

[0139] - a needle shield holder configured to operably engage a needle shield and interlock with the needle shield, and

[0140] - a holder holder, wherein the needle shield holder is fixed to the holder holder via a connection interface established between the holder holder and the needle shield holder, wherein the connection interface is formed by engagement of at least one holder interface feature of the holder holder with at least one holder interface feature of the needle shield holder,

[0141] - wherein the holder holder has a holder opening which is configured and dimensioned for receiving the needle shield holder and / or the needle shield,

[0142] - wherein the holder interface feature is arranged to block movement of the needle shield holder towards the holder opening by a blocking portion of the needle shield holder, the blocking portion abutting a surface of the holder interface feature facing away from the opening, and

[0143] - wherein the blocking portion of the needle shield holder is arranged in an area between an end face of the needle shield holder and an axially oriented portion of the needle shield holder.

[0144] It has been found that a blocking portion is particularly reliable to prevent the generation of scratch or flake-off debris.

[0145] Further features, advantages and advantageous embodiments of the present disclosure will become apparent from the detailed description of exemplary embodiments given below with reference to the accompanying drawings. The exemplary embodiments are intended to illustrate the concepts explained further above, but are given by way of example only and are not intended to limit the disclosure - neither the description nor the claims - to the embodiments discussed below. In the drawings: BRIEF DESCRIPTION OF DRAWINGS

[0146] Fig. 1 is a schematic perspective partial cutaway view of an exemplary embodiment of an auto-injector.

[0147] Figs. 2A and 3 are perspective views of exemplary embodiments of a holder formed from a single piece of sheet material.

[0148] Fig. 2B is a cross-section of an exemplary embodiment of a holder.

[0149] Fig. 4 is a perspective view of an exemplary embodiment of a unitary sheet.

[0150] Fig. 5 is a cutaway view of an exemplary embodiment of a cap with an assembled holder.

[0151] Fig. 6 is a cutaway view of an exemplary embodiment of a cap with an assembled holder and an assembled protective needle shield.

[0152] Figs. 7A and 7B show another exemplary embodiment of a cap.

[0153] Fig. 8 schematically shows an embodiment of a holder.

[0154] Fig. 9 shows a cap that produces scratch or flake debris during assembly of the cap and holder.

[0155] Figs. 10A to 10D show embodiments of a holder.

[0156] Figs. 11A to 11C show embodiments of a cap.

[0157] Figs. 12A and 12B show embodiments of a cap.

[0158] Figs. 13A and 13B show embodiments of a holder.

[0159] Figs. 14A and 14B show embodiments of a holder.

[0160] Figs. 15A and 15B show embodiments of a holder.

[0161] Fig. 16 shows embodiments of a holder and cap assembled to one another.

[0162] Figs. 17A to 17G show embodiments of a cap and a holder assembled to the cap.

[0163] Figures 18A to 18D show another embodiment of a holder and cap. DETAILED DESCRIPTION

[0164] In the drawings, identical elements, similar classes of elements, and similar actions are provided with identical reference designations.

[0165] Figure 1 is a schematic perspective partial cross-sectional view of an exemplary embodiment of an assembled auto-injector 1.

[0166] The auto-injector 1 comprises a housing 2. The housing comprises a front portion 2.1, e.g. sleeve-shaped, and a rear portion 2.2. The front and rear portions are preferably fixed to each other, e.g. non-releasably. Alternatively, the housing 2 can be formed as a one-piece housing (not shown).

[0167] The housing 2 is adapted to accommodate a reservoir, in particular a syringe 3, e.g. a glass syringe. The syringe 3 can be a pre-filled syringe containing a liquid medicament M. The syringe can have a needle 4 arranged at a distal end. In another exemplary embodiment, the syringe 3 can be a cartridge comprising a medicament M and engaging a removable needle, e.g. by threads, snap fit, friction, etc. Alternatively, the cartridge can be engaged with the needle during an injection operation. In the exemplary embodiment shown, the syringe 3 is held in the housing 2. The syringe 3 is preferably supported in the housing at its proximal end by a syringe support 15. Preferably, the syringe and / or needle are stationary during operation of the auto-injector. Although the embodiments are directed to auto-injectors, the disclosed concepts regarding needle shield removal can also be applied to other types of delivery devices, i.e. non-auto-injectors.

[0168] The auto-injector 1 further comprises a protective needle shield 5 connected to the needle 4. For example, the protective needle shield 5 is detachably connected to the needle 4. The protective needle shield 5 can be a rubber needle shield (commonly referred to as: soft needle shield or SNS) or a rigid needle shield (short: RNS) consisting of rubber and / or a complete or partial plastic shell. The needle shield 5 can engage the syringe and / or needle. The needle shield can cover the needle tip.

[0169] A stopper 6 is provided or offered for sealing the syringe 3 in proximal direction P and for moving the medicament M contained in the syringe 3 through the needle 4. That is, if the stopper is displaced distally relative to the syringe, the medicament can be dispensed from the syringe. The stopper can seal the interior of the syringe in proximal direction.

[0170] 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. The drug or medicament can be used for a limited duration, or on a regular basis for chronic disorders.

[0171] As described below, the 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 APIs can 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. The nucleic acids can be incorporated into a molecular delivery system such as a vector, a plasmid, or a liposome. Mixtures of one or more drugs are also contemplated.

[0172] The drug or medicament can be contained in a primary package or“drug container” suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid 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 cases, the chamber can be designed to store a drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber can be designed to store a drug for about 1 month to about 2 years. Storage can be at room temperature (e.g., about 20°C) or refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container can be or can include a dual-chamber cartridge configured to separately store two or more components of a drug formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In these cases, the two chambers of the dual-chamber cartridge can 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 can be configured such that they are in fluid communication with one another (e.g., by way of a conduit between the two chambers) and allow the user to mix the two components if desired prior to dispensing. Alternatively, or additionally, the two chambers can be configured to allow mixing as the components are being dispensed into the human or animal body.

[0173] The drugs or medicaments contained in the drug delivery device 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, thromboembolic disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome, 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, e.g., the "Rote Liste", for example, in the 2014 version, main groups 12 (antidiabetika) or 86 (onkologische

[0174] 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 1 (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" refer to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example the structure 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 be a codable amino acid residue or other naturally occurring residue or a purely synthetic amino acid residue. 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 the structure of human insulin, wherein one or more organic substituent (e.g., a fatty acid) is bound to one or more amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide can have been deleted and / or replaced by other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, have been added to the naturally occurring peptide.

[0175] Examples of insulin analogues are Gly(A21 ), Arg(B25), Arg(B26) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0176] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detear, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl Lys B28Pro B29 human insulin; B28-N-palmitoyl-Lys B28Pro B29 human insulin; B30-N- myristoyl-Thr B29Lys B30 human insulin; B30-N-palmitoyl-Thr B29Lys B30 human insulin; B29-N- (N-palmitoyl-Y-glutamyl)-des(B30) human insulin, B29-N-ooxocarboxypentadecanoyl-Y-glutamyl-des(B30) human insulin (insulin degludec, ); B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(ooxocarboxyheptadecanoyl)-des(B30) and B29-N-(ooxocarboxyheptadecanoyl) human insulin.

[0177] Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixlirapid Exenatide (Exendin-4, Byetta, Amylin Limited, a 39 amino acid peptide produced by the salivary glands of the Gila monster), Liraplutide Semaglutide, Taspoglutide, Albiglutide Dulaglutide Examples of rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C, CM-3, GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR 709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Exenatide-XTEN and Glucagon-Xten.

[0178] Examples of oligonucleotides are e.g. mipomersin sodium It is a cholesterollowering antisense treatment for the treatment of familial hypercholesterolemia.

[0179] Examples of DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0180] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Turopin), Somatropine (Somatropin), Desmopressin, Teripressin, Goserelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Gonadorelin.

[0181] Examples of polysaccharides include glucosaminoglycane, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysacchar- ides (e.g. polysulfated forms of the above mentioned polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of a polysulfated low molecular weight heparin is Enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 It is a sodium hyaluronate.

[0182] The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen binding portion thereof. Examples of antigen binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a de-immunized antibody or a humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a 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 of an isotype or subtype that normally 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 dual variable region antibody-like binding proteins with cross-over binding region orientation (CODV).

[0183] The term "fragment" or "antibody fragment" refers to polypeptides derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that do not comprise a full-length antibody polypeptide, but that still comprise 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

[0184] The term "complementarity determining region" or "CDR" refers 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 that primarily serve to maintain 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.

[0185] 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).

[0186] Pharmaceutically acceptable salts of any of the APIs described herein are also contemplated for use in the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0187] Those skilled in the art will appreciate that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein can be made that will achieve like results (i.e., achieve the same or similar goals and / or end results). Such modifications are intended to fall within the scope of the full breadth of the invention.

[0188] The auto-injector 1 further comprises a sleeve-shaped needle guard 7. In an exemplary embodiment, the needle guard 7 is telescopically connected to the housing 2 and movable between an extended position relative to the housing 2 in which the needle 4 is covered and a retracted position relative to the housing 2 in which the needle 4 is exposed. Further, a guard spring 8 is arranged to bias the needle guard 7 in the distal direction D relative to the housing 2. Thus, the position in which the needle is covered can be the standard position of the needle guard as defined by the guard spring.

[0189] A drive spring 9, e.g. preferably in the shape of a helical compression spring, is arranged within the housing 2, e.g. in the proximal portion, in particular the back portion 2.2, of the housing. A plunger 10 is used to transfer the force of the drive spring 9 to the bung 6. In an exemplary embodiment, the plunger 10 is hollow and the drive spring 9 is arranged within the plunger 10 biasing the plunger 10 against the back portion 2.2 in the distal direction D. In another exemplary embodiment, the plunger 10 can be a solid piece without a hollow portion and the drive spring 9 can engage a proximal end of the plunger 10. Likewise, the drive spring 9 can be wrapped around the outer diameter of the plunger 10 and / or extend into the syringe 3.

[0190] The auto-injector 1 further comprises a plunger release mechanism 12. The plunger release mechanism 12 is arranged for preventing the release of the plunger 10 prior to the depression of the needle guard 7 and for releasing the plunger 10 once the needle guard 7 is sufficiently depressed. The plunger can be arranged to move the bung 6 during operation in order to eject or dispense the medicament from the syringe 3. Thus, the needle guard can act as a trigger member which is moved to trigger the injection operation.

[0191] In an exemplary embodiment, the auto-injector 1 further comprises at least one audible indicator 13 for generating an audible feedback for the user or patient indicating the completion of the medicament delivery. In other words: The audible indicator 13 is adapted to indicate to the user or patient that the full dose of the medicament M has been delivered. The audible indicator 13 is formed as e.g. a bistable spring and is held in the rear portion 2.2.

[0192] In order to allow for a precise support of the syringe 3 during and / or after assembly, the auto-injector 1 comprises a carrier 16 which is adapted to mount and hold the syringe 3 within the housing 2, e.g. in the forward or distal direction D. Due to manufacturing tolerances, the syringe 3 can have a variable length. Therefore, the flange 3.1 of the syringe 3 protrudes in the proximal direction P from the carrier 16. In order to support the axial position of the syringe 3 relative to the housing 2 after assembly, in particular during storage, transport and normal use, the syringe support 15 comprises one or more radially inwardly or longitudinally extending support beams 15.1 to accommodate the variable length of the syringe 3 in the assembled state. The support beams 15.1 are adapted to axially bias the syringe 3 within the housing 2 in the distal direction D and to compensate for the variable length of the syringe 3 in the distal direction D.

[0193] Furthermore, the auto-injector 1 comprises a cap 11 which can be removably provided at the distal end of the housing 2, in particular the distal end of the front portion 2.1. The cap 11 can be releasably connected to the housing, e.g. by a snap fit or a threaded connection. The cap 11 can comprise external gripping features 11.1 for facilitating the removal of the cap 11, e.g. by twisting and / or pulling the cap 11 off the housing 2. The cap 11 can further comprise a gripper 11.2 which is arranged to engage and grip the protective needle shield 5. The gripper 11.2 forms an internal gripping element and is fixed to the cap 11. The cap 11 can be plastic. The gripper 11.2 can be metal.

[0194] The cap 11 is adapted to form part of a needle shield remover or removal assembly. To this end, the cap 11 and the gripper 11.2 are connected in such a way that the cap 11, together with the fixed gripper 11.2, is removed from the auto-injector 1, removing the protective needle shield 5 from the needle 4. In other words, the gripper 11.2 is connected to the cap 11 in such a way that when the cap 11 is removed, the protective needle shield 5 is also removed from the needle 4. Thus, the cap assembly comprising the cap and the gripper fixed to the cap is a needle shield removal assembly. The cap 11 serves as a gripper holder.

[0195] Furthermore, a sheath pre-lock mechanism 14 is provided which is arranged and / or configured to prevent the recessing of the needle sheath 7 when the cap 11 is in place, thereby avoiding the unintentional activation of the auto-injector 1, e.g. if dropped during transport or packaging, etc.

[0196] Fig. 2A and Fig. 3 show exemplary embodiments of a holder 11.2 formed from a single piece, e.g. a sheet of a sheet metal or a sheet metal alloy. Fig. 2B shows an exemplary embodiment of a cross section of the holder 11.2.

[0197] The holder 11.2 comprises at least one holder carrier or body 11.3. The holder carrier 11.3 is multiply bent or kinked along a plurality of longitudinal folds, kinks or bends 11.4 to form a plurality of carrier portions 11.5. Each carrier portion can have or comprise a planar outer surface area. Furthermore, the holder carrier 11.3 is bent or angled in such a way that the outer carrier portions 11.5 partially overlap in overlapping regions 11.6. Thus, in the bent state, the holder carrier 11.3 has a pipe-like or tube-like shape with a polygonal cross section. The partial overlapping regions 11.6 in the bent state of the holder carrier 11.3 allow for compensation of manufacturing tolerances of the holder 11.2. The holder carrier has a free end which can be arranged close to the overlapping regions 11.6 for clamping the protective needle shield 5, more than one of the plurality of carrier portions 11.5 comprises a cut-out or opening 11.7 from which a respective barb 11.8 is bent and protrudes inwardly from an inner surface of the holder carrier 11.3, thus protruding inwardly from the inner surface of the carrier portion 11.5. In the assembled state, the inwardly inclined barbs 11.8 extend in the distal direction D of the auto-injector 1.

[0198] In the context of the present disclosure, "proximal" is used to designate a position or a direction pointing away from the dispensing end or application site of the device or component of the device under consideration. "Distal" is used to designate a position or a direction pointing towards the dispensing end or application site of the device or component of the device under consideration.

[0199] The barbs 11.8 are adapted to deflect and clamp the protective needle shield 5 during assembly of the needle shield 5 into the auto-injector 1 and to further clamp the needle shield 5 upon removal of the cap 11 from the auto-injector 1.

[0200] The barbs 11.8 are designed as hooks or have a form of a prong. In particular, the barbs 11.8 protrude inwardly from the inner surface of the carrier portion 11.5 and comprise a prong 11.9 on their free end. The prong 11.9 is adapted to press into or stretch into the outer surface of the protective needle shield 5 and to form an interference fit during assembly or at least a positive and / or non-positive connection during removal of the protective needle shield 5. According to another aspect, the prong 11.9 can be adapted to already stretch into the outer surface of the protective needle shield 5 upon assembly of the holder 11.2 onto the protective needle shield 5 as described above. That is, the form fit or positive fit can already be applied during assembly and not only after the beginning of the cap removal process.

[0201] According to the present embodiment, the prongs 11.9 are configured as two spikes arranged on each barb 11.8, respectively. This configuration is achieved by a concave shape between the two prongs 11.9 of each barb 11.8, respectively. Due to the concave shape and thus the controlled distance between the prongs 11.9, the penetration depth into the surface of the protective needle shield 5 can be limited. This is of particular importance when the needle shield 5 is a rubber needle shield, in which a penetration beyond a certain limit would affect the sterility by contacting the needle 4.

[0202] Furthermore, in order to correctly orient the holder 11.2 during assembly within the cap 11, the holder 11.2 comprises an orientation element 11.10 indicating the assembly orientation. The orientation element 11.10 is designed as a tactile indicator or a visual indicator or a combination thereof. In particular, one of the front surfaces of the holder carrier 11.3 is shaped, e.g. wavy or prong-shaped, while the other opposite front surface is flat. The orientation feature can be a cut-out.

[0203] Fig. 4 shows an exemplary embodiment of a single piece of sheet material 11.11 which can form the holder carrier 11.3. According to one aspect of the present disclosure, the holder 11.2 is manufactured by the following steps:

[0204] - providing a holder carrier 11.3 in the form of a sheet material 11.11, e.g. a metal sheet material such as a stamped or punched metal sheet;

[0205] - forming a plurality of barbs 11.8 in the holder carrier 11.3 by cutting, stamping, punching or die-punching;

[0206] - bending or kinking the holder carrier 11.3 multiple times along a plurality of longitudinal folds or lines 11.4 in such a way that a plurality of carrier portions 11.5 is formed, such that more than one of the plurality of carrier portions 11.5 comprises a respective barb 11.8;

[0207] - bending the barbs 11.8 such that the barbs 11.8 protrude from the inner surface of the associated carrier portion 11.5, e.g. as shown in Figs. 2 and 3.

[0208] The sheet material 11.11 can be a single piece of metal sheet material, e.g. stamped or punched cut to form the cut-outs or openings 11.7 and the barbs 11.8 in the cut-outs or openings 11.7.

[0209] To retain the holder 11.2 within the cap 11, the sheet 11.11 comprises at least one retention slot 11.12, which can be formed by cutting or stamping into the holder carrier 11.3. In the present embodiment, for example, two retention slots 11.12 are provided. The retention slots 11.12 serve to retain the holder 11.2 within the cap 11, for example by retaining the holding lugs 11.13 of the cap 11 shown in Fig. 5. It is particularly advantageous if the holding lugs 11.13 of the cap engage one of the openings 11.7, preferably the opening of the barb located in the middle of the respective barb group, to retain the holder 11.2 in the cap 11. In this case, a separate feature like the retention slots 11.12 on the holder to retain the holder in the cap can be avoided. Instead, the openings or cutouts 11.7 serve as holder interface features to engage the holding lugs. Since the cap serves as a holder retainer, the holding lugs can be the retainer interface features discussed in the introductory chapter.

[0210] In an alternative embodiment, to retain the holder 11.2 within the cap 11, the holder carrier 11.3 can comprise retention lugs 11.14 (dashed lines) and the cap 11 can comprise retention slots (not shown). In this case, the optional retention lugs 11.14 and the barbs 11.8 of the holder 11.2 are bent radially in the opposite direction to the holder carrier 11.3. In particular, the holder carrier 11.3 is formed as an anchoring or main portion comprising a plurality of barbs 11.8 or claws that are bent inwardly away from the holder carrier 11.3 and at an angle to the direction of the longitudinal axis A of the holder 11.2, abutting against the outer surface of the needle shield 5 to clamp the needle shield 5, wherein the retention lugs 11.14 are bent outwardly and oriented at an angle away from the axis A and abut against the inner cap surface of the cap 11 to clamp the cap 11.

[0211] Fig. 5 is a cross-sectional view of an exemplary embodiment of the cap 11 with the assembled holder 11.2 retained in the cap 11 by the holding lugs 11.13 engaging the retention slots 11.12. The holder 11.2 is fixed in the cap 11. The cap 11 comprises an external gripping feature 11.1 that a user can grip to remove the cap 11 from the auto-injector 1, wherein the cap 11 takes the holder 11.2 with it and the protective needle shield 5 with the holder 11.2 and thus together from the auto-injector 1, removing them from the needle 4. The barbs 11.8 are bent inwardly or angled and extend in the distal direction D to grasp the needle shield 5 in the assembled state or at the latest during removal of the protective needle shield 5 by removal of the cap 11.

[0212] Fig. 6 is a cross-sectional view of an exemplary embodiment of the cap 11 with the assembled holder 11.2 and the protective needle shield 5 assembled in the holder 11.2 by the interference fit of the barb 11.8 and the needle shield 5. The portion of the needle shield 5 held in the holder 11.2 is shown in a transparent manner to illustrate the interference fit of the barb 11.8 and the needle shield 5.

[0213] As an alternative to the interference fit of the barb 11.8 and the needle shield 5, the barb 11.8 can extend into the outer surface of the needle shield 5 to form a mechanical locking connection, for example a force locking connection, a form fit connection and / or a friction locking connection, at least during the removal of the protective needle shield 5, for example by interlocking structures, hooks and eyes or protrusions and undercuts, shaped surfaces, etc.

[0214] In one embodiment, the needle shield holder 11.2 has at least one outer edge and / or inner edge defined by stamping or cutting. Preferably, all outer edges and / or all inner edges of the needle shield holder are defined by stamping or cutting. This enables the formation of the needle shield holder in a defined manufacturing step without the need for significant subsequent modification steps to already manufactured parts, for example by stamping. As discussed above for the sheet metal, after stamping or cutting, the parts can be bent into the desired shape. However, the manufacturing method, for example stamping, can produce sharp edges of the holder as well as the subsequent bending, where this effect is particularly pronounced in the bending or kink areas produced by the bending, as the radius of curvature is particularly small and the associated forces are particularly high in these areas - the sides defined by these areas or the corners at the end of these areas - when these areas come into contact with the wall of the cap / holder holder.

[0215] Figures 7A and 7B show another exemplary embodiment of a cap 11. Figure 7A shows a cross-sectional view, while Figure 7B shows a top view as seen from the distal end D of the cap. The cap substantially corresponds to the cap discussed in connection with the previous embodiments. Thus, features already discussed above are not repeated here. Features not extensively discussed in the previous embodiments include a receiving space 11.15 configured and / or dimensioned to receive the holder 11.2 when the holder is introduced into the receiving space via the opening 11.16, e.g. the proximal opening or the holder opening. The holder can be received in the receiving space as a whole when the holder has been assembled to the cap. The receiving space 11.15 can be defined by a tubular or sleeve-like portion 11.17 of the cap, which is designed in its interior to receive the holder 11.2. In one embodiment, the portion 11.17 is offset inwardly from the inner surface of the outer wall 11.32 of the cap 11. The user can touch the outer wall to remove the cap at its outer surface, and a plurality of gripping features 11.33 can be provided at the outer surface thereof. At the end opposite to the opening 11.16, the receiving space 11.15 is defined by an abutment feature 11.30. In the shown embodiment, the abutment feature 11.30 comprises a plurality of slats 11.31. The slats 11.31 can be oriented radially. The slats can be evenly distributed in the circumferential direction. The slats can originate in a central region of the cap and extend radially outwardly when viewed from the opening in the distal direction. The slats 11.31 can extend towards the outer wall of the cap 11. The holder 11.2 can abut against the abutment feature 11.30 when the holder is received in the receiving space. The retention or holder lugs 11.13 are shown as holder interface features, and are also designated as holder interface features in the following. In the depicted embodiment, two holder interface features 11.13 are provided. They are oppositely arranged. If more than two holder interface features are provided, they can also be evenly distributed in the circumferential direction. Furthermore, a housing connector 11.18 is provided at the proximal end of the cap 11. The housing connector 11.18 can establish a releasable connection, e.g. a snap-fit connection, with the housing 2. A plurality of housing connectors (not explicitly shown) can be provided. The cap 11 further comprises at least one or a plurality of holder guiding features 11.19. The holder guiding features 11.19 can protrude into the receiving space 11.15. The holder guiding features are arranged to interact with the orientation element or feature 11.10 of the holder 11.2, in particular when the holder 11.2 is introduced into the receiving space 11.15. Due to the cooperation of the guiding features 11.19 and the orientation feature 11.10, a proper orientation of the holder interface features, e.g. the retention slots 11.12 or the cutouts or openings 11.7 defining the barbs 11.8, and the holder interface features 11.13 can be achieved. When correctly oriented in the angular direction, the interface features are engaged when the holder 11.2 is axially advanced within the receiving space 11.15.

[0216] The interface feature 11.13 has a sloped section on the side facing the opening 11.16 and a less sloped section on the side facing away from the opening, which is preferably more radially oriented than the sloped section. This facilitates the advancement of the holder 11.2 during assembly into the receiving space 11.15, accompanied by elastic deformation in the radial direction. When the holder 11.2 engages the section of the cap between the opening 11.16 and the interface feature 11.13, the holder can already be elastically deformed. When the holder interface feature has passed the holder interface feature 11.13, it is firmly held in the receiving space 11.15 since the radially oriented surface of the feature 11.13 prevents removal of the holder 11.2.

[0217] Fig. 8 schematically shows an embodiment of the holder 11.2. This embodiment essentially corresponds to the previously described embodiment, which is why the description focuses on the differences. The holder 11.2 has the same general shape as the previously described holder 11.2, with a folded longitudinal edge 11.13, which forms a kink or kink region. However, no separate retention slot 11.12 is provided. Instead, the lugs or interface features 11.13 of the cap 11 shown in Figs. 7A and 7B are designed to engage one of the openings 11.7, preferably the middle one of a group comprising three openings 11.7, of which only two are shown in Fig. 8.

[0218] The holder 11.2 has two opposite axial ends, a first or front end 11.20 and a second or rear end 11.21. The first end 11.20 is the end that is first introduced into the opening 11.15 during assembly. The holder 11.2 has an inclined surface area 11.22 provided at the front end 11.20. From the first end 11.20, the area 11.22 is inclined and directed away from the axis. The area 11.22 can be designed to interact with the holder interface feature 11.13 that should engage the associated holder interface feature 11.12. The inclined surface area 11.22 is aligned with the holder interface feature 11.12 and / or the holder interface feature 11.13, which should engage the holder interface feature and / or the holder interface feature when it is assembled at an angle to the cap 11. In axial direction, the inclined surface area 11.22 is offset from the holder interface feature 11.12, which in the embodiment shown in Fig. 8 can be formed by the opening 11.7. When the holder interface feature 11.13 contacts the surface area 11.22 during insertion of the holder 11.2 into the receiving space 11.16 and the holder 11.2 is further guided into the opening 11.16, the elastic deformation of the holder 11.2 in radial direction can increase, for example until the holder interface feature - opening 11.7 / retaining groove 11.12 - engages the holder interface feature 11.13. When the engagement is established, the elastic bias of the holder 11.2 can be reduced, for example until the holder abuts the cap 11.

[0219] In Fig. 8, a cut-out forming a holder orientation feature 11.10 is shown. The cut-out has an inclined side surface 11.23 that angularly defines the cut-out. In axial direction, the cut-out is defined by a surface 11.24 seen in axial direction away from the first end 11.20. The angular extension of the cut-out can decrease with increasing distance from the first end 11.20. In other words, the cut-out can taper towards the second end 11.21. When the cut-out is seen in plan view or top view, the surface 11.24 defining the cut-out in axial direction can extend perpendicular to the axis A over the cut-out. When seen in plan view or top view over the cut-out, the angle of the surface 11.23 relative to the axis can be less than 90°, for example 45 degrees or less. The kink or bend region 11.4 can extend along the longitudinal direction of the holder 11.2, preferably along the entire axial extension of the holder 11.2.

[0220] Thus, at the front end or leading edge, the kink or bend 11.4 can define a corner 11.25. The respective corner can be an angled region of the edge of the holder 11.2. The edge or corner 11.25 can be oriented in axial direction, i.e. facing away from the opening 11.16. When guiding the holder 11.2 of Fig. 8 into the cap 11, e.g. the holder of Figs. 7A and 7B, it has been found that the cap is scratched and / or tends to produce flakes of cap material. For example, when the cap and the holder have been assembled, flaking or scratching debris of cap material is found at the bottom of the receiving space facing away from the opening. The production of scratches or flaking can reduce the user's confidence that the device is correctly configured and / or reduce the structural stability of the needle shield removal assembly as material has been removed from the cap. Thus, it is considered advantageous to reduce or prevent the production of scratches or flaking.

[0221] When investigating the production of scratches or flaking, it has been found that some regions are particularly susceptible to the production of scratching debris. These regions are inner regions of the cap, in particular inner regions of portion 11.17. Surprisingly, it has been found that regions that are angularly offset from the interface feature 11.13, e.g. 90° offset in case two interface features 11.13 are provided, are particularly susceptible to the production of flaking or scratching debris. One particular susceptible region is a region that is angularly aligned with the holder guide feature 11.19, which region can be angularly offset from the holder interface feature, e.g. 90°. Alternatively or additionally, regions that are distally offset from the interface feature 11.13 are particularly susceptible to damage of the cap by the holder.

[0222] The presence of these regions can be due to elastic deformation of the holder 11.2 during assembly. Here, before the holder 11.2 engages the interface feature 11.13, the holder first elastically deforms slightly, e.g. due to the opening having a smaller diameter than the undeformed holder 11.2. Then, the radial elastic deformation increases. Thus, there can be rather large forces acting in radial direction and these forces can tend to enlarge the diameter of the holder in the region angularly offset from the holder interface feature 11.13. The production of scratches or flaking is particularly pronounced when the bend or kink region 11.4 and / or the associated corner 11.25 is arranged in a susceptible region.

[0223] Figure 9 shows the gripper guide feature 11.19 and the flaking or scraping 17 or another scraping material cap that is created during assembly. The scraping debris 17 occurs mainly in the area of the gripper guide feature 11.19, which is intended to cooperate with the orientation part 11.10. In the embodiment shown in Figure 8, it has been found that a kink or bend region 11.4 arranged at an angle in the area of the orientation feature 11.10 particularly contributes to scraping, since it is angularly offset from the gripper interface feature 11.12 / 11.7 and / or the holder interface feature 11.13. The same can also apply to the corner 11.25 and / or the kink or bend region arranged in the corner region of the further holder interface feature 11.13 shown in Figure 8. However, the main cause of the flaking is considered to be the elastic deformation that occurs when the holder interface feature engages the surface of the gripper 11.2 during assembly. Particularly sensitive regions can be regions in which the diameter is reduced if the gripper interface feature / retention groove 11.12 is included, regions in which the gripper 11.2 tends to deform, for example regions angularly offset from the gripper interface feature.

[0224] The creation of scraping or flaking can be due to sharp edges formed during the manufacture of the gripper 11.2, for example by stamping or another process described earlier, and / or due to small radii of curvature in the kink or bend region formed when the sheet is bent to form the gripper 11.2.

[0225] In the following, some concepts are proposed which are suitable for reducing or preventing the creation of scraping or flaking in the gripper holder / cap 11, in particular in sensitive regions thereof, when the gripper 11.2 is assembled onto the cap 11.

[0226] Figures 10A to 10D show one concept in which the gripper is modified, wherein Figures 10A to 10C show perspective views of a gripper 11.2 and Figure 10D shows a cross-sectional view, e.g. along the line S-S highlighted in Figure 10B. The gripper 11.2 corresponds to the gripper disclosed and discussed in connection with Figures 8 and the preceding embodiments. Accordingly, only the modifications are discussed here. In the shown embodiment, the gripper 11.2 is provided with a radially oriented protrusion 11.26. The protrusion is arranged close to the corner 11.25 and / or the angle and / or axial position of the kink or kink region 11.4 defining the corner 11.25 and / or the protrusion(s) arranged angularly between the two (opposite) gripper interface features / retention slots 11.12 and / or the protrusion arranged closest to the sensitive region. This corner 11.25 is particularly prone to generate scratches when contacting the (inner) wall of the cap 11, in particular the portion 11.17. The respective protrusion 11.26 can be axially offset in a direction away from the opening and away from the holder interface feature 11.13. The respective protrusion 11.26 can angularly overlap with the orientation feature or element 11.10. The respective protrusion 11.26 can at least partially, e.g. only partially, axially overlap with the opening 11.7 and / or the gripper interface features / retention slots 11.12.

[0227] The protrusion 11.26 can be formed by deep drawing or embossing, thus can be easily integrated into the manufacturing process of the gripper 11.2, as these methods are suitable methods for shaping metal parts or sheets.

[0228] In the region of the orientation feature 11.10, it is particularly advantageous when the gripper 11.2 contacts the cap 11, otherwise, a mechanical cooperation with the gripper guide feature 11.19 can not be achieved. A lack of cooperation would impede the guiding function and increase the likelihood of incorrectly assembled caps and grippers, i.e. such that a connection interface is established between the interface features 11.12 and 11.13. Thus, in the region of the guide feature 11.10, scratches or flaking debris can particularly occur. The protrusion can protrude about 0.45 mm from the surface of the gripper 11.2. The protrusion can have a closed circumferential edge, e.g. a rounded edge, on the outer surface of the gripper 11.2. The protrusion can have a generally hemispherical shape. The respective protrusion 11.26 can be confined to one surface of the gripper 11.2, e.g. a side surface. That is, the respective protrusion 11.26 can be confined to that surface, preferably to one of the portions 11.5, when viewed in plan on the surface of the gripper. The respective protrusion can have a circular or elliptical shape as shown in plan view of the free end of the protrusion.

[0229] Furthermore, as mentioned above, the orientation element or feature 11.10 is angularly offset from the holder interface feature 11.13 and / or the gripper interface feature 11.12 engaging the holder interface feature. This arrangement makes it possible for high contact forces between the gripper 11.2 and the gripper holder / cap 11 to occur in this region due to elastic deformation. The protrusions 11.26 can be produced by embossing using a ball punch, for example a ball punch with a diameter of 2.0 mm. The (maximum) diameter of the protrusions on the free end seen in the top view can be less than or equal to 2 mm. The protrusions can protrude less than 1 mm, preferably less than 0.8 mm or less than 0.7 mm, for example less than or equal to 0.5 mm, for example 0.45 mm + / - 0.05 mm, from the outer surface. Alternatively or additionally, the respective protrusions protrude 0.3 mm or more from the outer surface of the gripper 11.2. Protrusions of the respective height raised from the outer surface have proven to be particularly advantageous. With protrusions of a smaller height, for example 0.25 mm, an increased likelihood of generating scratches or flaking debris is observed. The protrusions 11.26 can be arranged such that they protrude radially beyond the kink or twist region 11.4 angularly arranged between the protrusions 11.26 and / or beyond the corner 11.25 angularly arranged between the protrusions 11.26. In particular, an envelope curve, for example a circle, running through the free ends of the protrusions 11.26 can have a radial distance to the corner 11.25 and / or the kink or twist region 11.4. In this way, the protrusions 11.26 can maintain the distance between the outer surface of the gripper 11.2 and the inner surface of the cap, in particular in the most important region, i.e. the sensitive region. In the depicted embodiment, only two protrusions are provided in association with one kink or twist region 11.4. However, it is understood that more protrusions can be provided. Furthermore, one or more protrusions can also be associated with a different kink or twist region or corner. Although an arrangement with an angularly arranged kink or twist region 11.4 between two protrusions 11.26 can be advantageous, the arrangement of the protrusions is not limited to this arrangement. Likewise, the protrusions do not have to be arranged symmetrically with respect to the twist or kink region 11.4 as shown. Rather, the two protrusions can be arranged on one side of the kink or twist region 11.4. It is also possible to provide only one protrusion. Furthermore, the number of protrusions on one side of the kink or twist region can be greater than or equal to the number of protrusions on the other side of the kink or twist region 11.4.

[0230] Figures 11A to 11C show another embodiment suitable for preventing scratches. Figures 11A and 11B are perspective cut-away views showing two variants of the embodiment, and Figure 11C shows a cut-away view perpendicular to the longitudinal axis, for example for Figure 11B.

[0231] In this embodiment, the protrusions 11.26 also serve to reduce or prevent mechanical contact. However, the protrusions 11.26 are not provided on the holder 11.2 as in the previous embodiments, but on the cap 11, for example on the inner surface of the portion 11.17. The protrusions 11.26 are directed radially inwards. The protrusions 11.26 are designed as longitudinally extending ribs. The protrusions can extend along the entire extension of the portion 11.17 of the cap. The axial extension length of the protrusions / ribs can be greater than or equal to 70% of the axial extension length of the holder 11.2. A plurality of protrusions 11.26, for example four or more, can be distributed, for example uniformly, in the circumferential or angular direction (see Fig. 11A). As shown in Figs. 11A and 11B, the protrusions 11.26 can be provided close to the sensitive area, for example the angular area of the holder guide feature 11.19. In Fig. 11B, the protrusions are provided only in the vicinity of the sensitive area, while in Fig. 11A the protrusions are provided circumferentially. Fig. 11C shows a schematic view of the assembled holder 11.2 for the variant in Fig. 11A. It is clear from this figure that the protrusions 11.26 contact the holder 11.2 in the area between two adjacent kink or kink areas 11.4. The contact area can be a planar outer surface area or a planar holder portion 11.5 of the holder 11.2. This concept has also proven to be suitable for preventing or reducing the generation of scratches or flaps. Here, the variant in Fig. 11B is evaluated as having a more decisive effect in preventing scratches than the variant in Fig. 11A, which also provides an improvement. The protrusions 11.26 can protrude less than or equal to 1 mm or less than or equal to 0.5 mm, for example less than or equal to 0.3 mm, from the inner surface of the cap. Alternatively or additionally, the protrusions 11.26 can protrude 0.3 mm or more from the inner surface of the cap 11.2. For example, the height of the protrusions relative to the inner surface from which they protrude can be 0.3 mm.

[0232] In one embodiment, the distance, preferably measured in the angular direction, between each protrusion 11.26 (protrusions provided on the holder holder / cap or on the holder) and the associated sensitive area, the associated kink or kink area, and / or the associated edge or corner of the needle shield holder, i.e. the angular distance, is less than or equal to one of the following values: 2 mm, 1.5 mm, 1 mm, 0.7 mm, 0.6 mm, 0.5 mm. In case of doubt, the distance can be measured from the border of the protrusion closest to the kink or kink area and / or the edge or corner along the surface of the element with the protrusion until the angular position of the border of the kink or kink area and / or the edge or corner is reached.

[0233] Figures 12A and 12B show another embodiment which is suitable to reduce or prevent scratch or peel-off generation. In this embodiment, in the sensitive area of the cap 11, in particular in the portion 11.17 defining the receiving space 11.15, an opening 11.27 is formed. The opening 11.27 can extend radially through one segment of the cap, e.g. the portion 11.17. The opening 11.27 can be defined during the molding process of the cap 11. The opening 11.27 can axially overlap with the interface feature 11.13. The opening 11.27 can extend axially in the distal area, or be offset from the interface feature 11.13 by the opening 11.16, preferably throughout the area up to the end of the receiving space 11.15. The opening can axially overlap with the interface feature 11.13. The use of the opening 11.27 has proven to be particularly advantageous also for avoiding scratch or peel-off debris. Figure 12B shows a view of the cap 11 as seen from the distal end, Figure 12A shows a schematic cross-section of the cap 11. Note that due to the provision of the opening in the sensitive area, there are no guiding features 11.19 in this area. As shown, the guiding features 11.19 can be angularly offset from the opening 11.27 or the sensitive area. Thus, despite the opening in the sensitive area, a guiding interface can still be established which guides the interface feature of the holder and the cap 11 / holder holder engagement during assembly.

[0234] Although in some figures the distal end of the cap 11 is open, it can be closed, e.g. by a suitable cover part assembled onto the cap 11 or by a closure integral with the rest of the cap 11. However, the open distal end facilitates the illustration of the embodiments.

[0235] Figures 13A and 13B show another embodiment. In Figure 13A, the gripper 11.2 is shown as in Figure 8. Thus, in the region of the orientation feature 11.10, the sharp corner 11.25 at the end of the bending or kinking region 11.4 is positioned, in particular within the surface 11.24 defining the cutout of the axially formed orientation feature. The surface 11.24 can extend perpendicularly or substantially perpendicularly with respect to the axis A. Figure 13B shows a possible solution to modify the embodiment of Figure 13A to reduce the risk of scratching of the gripper holder. To this end, the bending or kinking region 11.4 is moved away from the corner center of the cutout forming the orientation feature 11.10. For example, it can be repositioned within the corner between the surfaces 11.23 and 11.24 and / or within the boundary region between the inclined surface 11.23 and the end surface 11.24. This arrangement can require an additional folding operation. A carrier portion 11.5, which is preferably planar, can be positioned angularly in the region that has been identified as a sensitive region. In comparison to the gripper 11.2 shown in Figure 13A, this carrier portion can be defined by an additional folding operation. This concept also applies to reduce the risk of scratching, as it moves the sharp edges or corners of the sensitive region into an angularly adjacent region. The angular width of the cutout forming the orientation element or feature 11.10, for example the maximum or minimum angular width of the cutout, can be greater than or equal to the angular width of the sensitive region. As an alternative to the boundary region between the surfaces 11.23 and 11.24, the corner 11.25 can be positioned angularly overlapping or arranged in the inclined surface 11.23.

[0236] Figures 14A and 14B show another concept for reducing scratches. Here, in the relevant area of the holder 11.2, a tab 11.28 is arranged to be offset radially outward from the kink or twist area 11.4, in particular in the area of the sensitive area of the portion 11.17 of the cap 11. In the original state of the holder, i.e. when the tab has not yet been brought into the shown position, the tab can be oriented axially with the free end facing in the same direction as the front end 11.20 of the holder 11.2. The tab 11.28 can be folded or kinked until it covers the outer surface of the holder 11.2, in particular the kink or twist area 11.4. Then, the free end of the tab 11.28 can face in the same direction as the rear end 11.21 of the holder. Figure 14B shows a combination of the concepts of Figures 13B and 14A, wherein, in addition to angling the kink or twist area 11.4 away from the sensitive area, a tab 11.28 is provided. This can facilitate manufacturing, as the tab can be formed more easily with a planar or curved surface that is less curved than the kink or twist area. During assembly of the holder to the cap, the tab with the planar surface can be arranged between the cap and the rest of the holder 11.2, thereby preventing contact between the potentially scratching part of the holder and the cap. The outer surface of the tab 11.28 can be less twisted or curved than the kink or twist area 11.4 and / or the corner 11.25.

[0237] Figures 15A and 15B show another concept for reducing or preventing scratches. Figure 15A again shows schematically a holder 11.2, for example the holder shown in Figure 8. The holder has a sharp corner 11.25 that would be disposed in the sensitive area of the cap 11. By providing a notch 11.29, engagement between this corner 11.25 and the (inner) surface of the cap 11 is avoided. The notch 11.29 is disposed in the front end 11.20 of the cap 11, in particular in the area of the sharp edge 11.25 and / or the twisted or kinked area that defines the corner 11.25. The notch 11.29 is oriented in a radially inward direction, such that the edge 11.25 is offset inward from the inner surface of the cap 11, in particular the portion 11.17. Thus, surface and edge engagement is prevented. This will prevent the generation of scratches and flaps during assembly.

[0238] Figure 16 illustrates another concept. This embodiment is also suitable to prevent scratches or peeling during assembly of the holder 11.2 to the cap 11. In this embodiment, the holder 11.2 is modified compared to the holder shown in figure 8 to reduce or prevent scratches. In figure 16, the assembly state of the holder 11.2 in the receiving space 11.15 of the cap 11 is shown. The rest of the holder 11.2 and the cap can also be configured as shown in figures 7A, 7B and 8. As is apparent from figure 16, a gap G is formed between the holder 11.2 and the cap 11 in a potentially sensitive area. In this embodiment, the holder 11.2 is depicted with a generally elliptical cross-section, i.e. with a non-circular cross-section with different longitudinal directions. The opening 11.16 can have a circular shape. The cross-section of the holder 11.2 does not have to be formed as an ellipse. Rather, the holder 11.2 can also be formed with a polygonal cross-section. In this case, the envelope surface along the outer surface of the holder can be elliptical or at least not rotationally symmetrical. The holder 11.2 can have a distinct longitudinal main extension direction, in particular in the radial direction. In this embodiment, the main direction of the extension can be aligned along the radial direction defined by the two opposing interface features 11.13. The gap G can be provided on only one side of the holder 11.2 or on both, preferably opposite, sides, for example angularly separated by the contact area between the holder and the cap. The gap G can note that the force acting on the cap 11 in the region where the gap is arranged is reduced when the holder 11.2 is elastically deformed in the radial direction, as opposed to the case when the holder is arranged closer to the surface of the cap 11. The gap G has to close before the holder 11.2 is able to contact the cap 11. The radial dimension of the gap G can be determined by the distance by which the interface features 11.13 protrude into the receiving space 11.15. Preferably, the cap 11 and the holder 11.2 are adjusted such that the gap compensates for the entire elastic deformation when the interface features 11.13 cause a radial deformation of the holder 11.2.

[0239] When an irregularly or rotationally asymmetrically shaped (e.g. oval) holder 11.2 is inserted into the opening, it can still be elastically deformed by contact with the walls delimiting the opening or receiving space, even before the interface feature 11.13 engages with the outer surface of the holder 11.2. However, the shape of the deformed holder can still be such that the deformed holder 11.2 has a distinct longitudinal axis and / or an oval envelope curve, as shown in Fig. 16. Thus, when the interface feature 11.13, there is still a gap between the outer surface of the holder and the inner surface of the cap that has to be closed before the holder can contact the inner wall of the cap. The cross-section of the holder can be polygonal or continuously curved, e.g. oval. This cross-section can differ from the cross-section of the area of the opening and / or the part 11.17 between the opening 11.16 and the interface feature 11.13, which can be regular or rotationally symmetric. As in the previous embodiments, this concept can help to prevent or reduce the generation of scratches or flakes.

[0240] Figs. 17A to 17G show another embodiment of a cap 11 with an associated holder 11.2 that fits to the cap 11 based on different views. The cap 11 and the holder 11.2 substantially correspond to the components described further above, e.g. in connection with Figs. 2A to 8. Thus, the description associated with these figures also applies to this embodiment, unless specific differences are emphasized in the text below. Furthermore, the holder 11.2 can also have features discussed in connection with Figs. 10A to 10D. However, contrary to this embodiment, no protrusion 11.26 is provided to prevent or reduce contact of the cap and the holder 11.2 in sensitive areas, which has been discussed further above. Instead, this embodiment uses a solution similar to the one discussed in connection with the embodiment depicted in Figs. 12A and 12B. Thus, features disclosed in connection with this embodiment can also be used in this embodiment, unless specific differences are emphasized in the text below. Vice versa, features disclosed in this context can also be applied to other embodiments, unless there is incompatibility.

[0241] Figs. 17A to 17C show perspective views of the cap 11. Fig. 17A shows the cap 11 with a distal end closed by a closure or cap 11.34. In Fig. 17B, the distal end of the cap 11 is open. For example, the slats 11.31 are visible. An indicator 11.35, e.g. a symbol, e.g. an arrow, is provided on the outer surface of the outer wall 11.32. The indicator 11.35 can be defined by a plurality of gripping features 11.33. The indicator 11.35 can be recessed with respect to the plurality of gripping features 11.33. The indicator advantageously indicates the direction in which the cap has to be moved in order to be separated from the housing 2. Furthermore, also the housing connector 11.18, e.g. a resilient arm, is shown.

[0242] Fig. 17D shows a top view of the distal end of the cap 11. Here, the cover 11.34 is not connected to the cap 11. Fig. 17E shows a somewhat perspective cut view of the cap 11 taken essentially along the line B-B in Fig. 17D, wherein the cover 11.34 is connected to the cap 11. Fig. 17F shows a more inclined perspective cut view of the representation of Fig. 17E without the cover. The perspective cut view shown in Fig. 17G is taken from the section along the line C-C in Fig. 17D.

[0243] As shown in Fig. 17E, the clamp 11.2 is arranged within the receiving space 11.15 of the cap 11. The clamp 11.2 is arranged within a portion 11.17 of the cap 11. The portion 11.17 can generally be formed tubular or sleeve-like. As shown, the proximal end of the portion 11.17 is distally offset from the proximal end of the cap, e.g. as defined by the outer wall of the cap 11. At the distal end, e.g. close to the distal end of the cap 11, the portion 11.17 can be connected to the outer wall 11.32 via a slat 11.31. A portion of the clamp 11.2 can protrude proximally from the portion 11.17. However, the portion 11.17 is conveniently designed to accommodate at least a substantial portion of the clamp, e.g. 80% or more of its total length. As shown, the portion 11.17 is radially offset from the inner surface of the outer wall 11.32 of the cap 11. In this way, a free space is formed between the portion 11.17 and the outer wall 11.32. The clamp 11.2 can be in mechanical contact with one or more clamp guiding features 11.19 having a distal surface, e.g. a distal end surface. These features can interact with the clamp 11.2 to maintain or achieve a defined rotational orientation of the clamp 11.2 relative to the portion 11.17, e.g. when the clamp is introduced into the portion 11.17. As previously mentioned, the clamp 11.2 comprises a plurality of longitudinal folds, kinks or bends 11.4.

[0244] The holder interface feature or lug 11.13 of the cap 11 engages with the gripper interface feature (retaining groove 11.12 and / or cutout or opening 11.7). As shown, the gripper interface feature can be one of the cutouts or openings 11.7 defining the gripper feature 11.8, e.g. a barb, designed to interlock with the needle shield. As shown in Fig. 17E, but more clearly visible in Fig. 17F, the holder interface feature 11.13 comprises a beveled region or beveled section 11.36 at its end facing the holder opening 11.16 and / or the proximal end. The preferably planar surface of this section or region can form or define an acute angle with the longitudinal axis A, e.g. less than 45°. At its end facing away from the holder opening 11.16 and / or its distal end, the holder interface feature 11.13 can be arranged to interact with a surface of the gripper 11.2, e.g. a surface delimiting the retaining groove 11.12 and / or opening 11.7 distally. The end face 11.37 of the holder interface feature 11.13 disposed distally of the opening 11.16 or distal end preferably defines or forms an angle with the axis A which is larger than the angle defined by the region 11.36 with the axis. For example, the surface 11.37 can be oriented perpendicularly with respect to the axis A. The region 11.36 and the end face 11.37 can be connected by a connecting region 11.38 extending substantially parallel to the axis A.

[0245] As already discussed in connection with the embodiment shown in Figs. 12A and 12B, a radial opening 11.27 is provided. The opening 11.27 extends radially through the entire portion 11.17 and provides fluid communication between the receiving space and the free space arranged between the portion 11.17 and the inner surface of the outer wall 11.32 of the cap 11. At least one edge, kink or bend 11.4 is angularly arranged in a position overlapping with the respective opening (see Fig. 17D). The edge, kink or bend 11.4 can project radially into the opening 11.27. In the radial opening 11.27 shown in the upper half of Fig. 17D, a plurality of edges, kinks or bends 11.4 are angularly and / or radially arranged within the radial opening 11.27. There is a radial gap between the cap 11 and the respective edge, kink or bend 11.4.

[0246] The opening 11.27 has a first axial end 11.39. The first axial end 11.39 can axially delimit the respective opening on the side of the opening 11.27 facing the holder opening 11.16 and / or proximally. Preferably, the first axial end is offset from the end of the holder interface feature 11.13 facing the holder opening, e.g. the proximal end, e.g. the proximal end of the inclined region 11.36, or arranged axially overlapping the inclined region 11.36 of the holder interface feature. In other words, the axial beginning of the opening 11.27 can precede the axial beginning of the holder interface feature, as seen along the axis A from the holder opening 11.16 towards the holder interface feature 11.13. The opening 11.27 reduces the impact or mechanical load transmitted from the holder 11.2 to the cap 11, in particular in the section of the holder that axially deforms when the portion of the holder distal to the holding groove 11.12 interacts with the holder interface feature 11.13, as already described. The respective opening 11.27 can open at a second axial end 11.46 distal to the first axial end 11.39. That is, the opening 11.27 can be accessible from the distal end of the cap. This is easily identified in Fig. 17D, for example. The portion 11.17 defining the receiving space 11.15 has a section 11.40, e.g. on the side facing the holder opening 11.16. The section 11.40 is advantageously circumferentially closed and / or has a tubular configuration. The section 11.40 can improve the structural integrity and stability of the portion 11.17.

[0247] It should be noted that in addition to having a radial opening radially protruding through the entire portion 11.17, the recess defined radially outwardly by the portion 11.17 would also reduce the flake scraping in the cap 11 when assembling the cap 11 and the holder 11.2. However, this opening can have advantages in terms of manufacturing.

[0248] The axial offset between the proximal end of the holder interface feature 11.13 and the first axial end 11.39 can be smaller than the axial extension of the section 11.40. The axial offset between the first axial end and the holder interface feature can be smaller than or equal to 2 mm, e.g. 1.5 mm. The axial extension of the holder interface feature 11.13 can be 2 mm. As an alternative to the non-zero offset of the opening in the proximal direction relative to the holder interface feature, the first axial end 11.39 can be arranged at the same axial position as the proximal end of the holder interface feature or within the inclined region 11.36.

[0249] The angular width of the radial opening 11.27 can increase in the distal direction and / or away from the holder opening. If the size of the carrier portion 11.5 in the angular direction varies, the angular width, e.g. the minimum angular width of the respective radial opening or the maximum angular width of the respective radial opening, can be greater than or equal to the angular extension of one carrier portion 11.5 of the holder 11.2, e.g. the minimum or maximum angular extension of the carrier portion 11.5.

[0250] The surface delimiting the radial opening in the angular direction, e.g. the surface 11.45 shown in Fig. 17F, can be obliquely oriented with respect to the longitudinal axis A. The surface angularly delimiting the opening can be planar. The angular width of the radial opening 11.27 can continuously decrease as seen from the distal end D and along its axial extension, until it reaches its minimum at the first axial end 11.39.

[0251] As shown in Fig. 17E, the cover 11.34 is connected to the cap 11, e.g. by a snap-fit connection, which snap-fit connection cooperates with a snap feature 11.41 of the cover 11.34 and a corresponding snap feature 11.42. The snap feature 11.42 can be flexible in the radial direction and the snap feature 11.41 can be rigid, such that the cover 11.34 can be connected to the cap by axially moving the cap onto the cover. Alternatively, the snap feature 11.41 on the cover can be radially flexible and the snap feature 11.42 can be rigid.

[0252] As shown in Fig. 17G, a further radial opening 11.43 (or recess) is provided. The radial opening 11.43 is conveniently provided on the side of the holder interface feature 11.13 distal to the holder opening 11.16. A corresponding opening can be provided in the portion 11.17. The corresponding opening 11.43 can be arranged distal to the corresponding holder interface feature 11.13, e.g. angularly aligned with the feature. On the side towards the holder opening 11.16 and / or proximally, the opening 11.43 can be axially delimited by a surface 11.44. The surface 11.44 can at the same time form an end face 11.37, e.g. a distal end, of the holder interface feature 11.13. The radial opening 11.43 can provide advantages in the manufacturing process of the assembly comprising the cap 11 and the holder 11.2. For example, it can provide space to fix the cap 11 in a mounting or to apply a tool to handle the cap 11 while introducing the holder 11.2.

[0253] Figures 18A to 18D illustrate another embodiment of the needle shield removal assembly. When studying the solutions discussed in relation to Figures 17 and 12 and similar solutions, it has been found that the generation of flake scrapes has been significantly reduced. However, in very rare cases, the generation of residual scrapes or flakes can still be observed. The observed flake or scrape generation typically occurs in the area where the holder interface feature 11.13 (holder lugs) of the cap / holder holder 11 engages with the holder interface feature (retention slot 11.12 or opening 11.7). This area is illustrated in the schematic of Figure 18A. Figure 18A illustrates the holder interface feature 11.13 and the holder 11.2 with needle shield interlock feature or barb 11.8. The area where flake generation is observed is circled. This area is set distal to the distal surface 11.37 of the holder interface feature 11.13. Figure 18C illustrates an embodiment of the holder 11.2 where the area where flake generation is still observed is in the area of reference 11.47. Reference 11.47 represents a tab or tongue which is preferably flexible, defined angularly by an axially extending cut. Preferably, the tab or tongue is flexible relative to the rest of the holder 11.2. The axial extension length of the tab or tongue can be less than 20% of the axial extension length of the opening, for example less than 2mm. It is evident from Figure 18D that this area is identified as causing the residual scrape and flake generation, Figure 18D illustrates a photograph taken from the holder 11.2 where the flake debris 17 is shown in the circled area.

[0254] Fig. 18B shows a solution to avoid peeling or scratching in the area enclosed by Fig. 18A. Specifically, the tab or tongue 11.47 is bent or curved inwardly such that the free end 11.48 of the tab or tongue 11.47 faces in a radially inward direction, e.g. towards the axis. In this way, contact between the clip holder 11 and in particular the holder interface feature 11.13 and a sharp area or edge defined in the area of the (free) end 11.48 of the tab or tongue 11.47 can be avoided. Thus, as seen from the distal axial extension area or portion 11.49 of the clip 11.2, the clip 11.2, in particular in the area defining the opening engaged by the holder interface feature, can change its orientation to a radial orientation by a transition area 11.50. This change can end when the end face of the free end 11.48 faces radially. However, further bending is also possible such that the end portion is oriented e.g. distally, thereby forming an inverted U-shape of the clip 11.2 in the relevant portion (not shown in this embodiment). A blocking portion 11.51 interacting with the holder interface feature 11.13 to prevent removal of the clip 11.2 from the clip holder 11 is located between the axial portion 11.49 and the end portion 11.48 as seen along the extension of the clip 11.2. Preferably, the blocking portion 11.51 is located within the transition area 11.50 within the radial orientation area of the clip. The blocking portion can be directly adjacent to the end portion 11.48, e.g. within a range of 2 mm or less or 0.5 mm or less distance from the end portion 11.48 as seen along the surface of the needle shield clip 11.2.

[0255] It should be noted that each clip interface feature can be axially defined by a respective blocking portion.

[0256] Bending the tab or tongue can be relatively easy to achieve in the manufacturing process and does not require undue adjustments, e.g. establishing new cutting or stamping processes.

[0257] In an embodiment of the method of assembling a needle shield holder, the holder structure can be formed, for example, from a sheet of metal. The holder structure can be selectively deformed, for example, bent, or treated in one area to form a barrier portion, for example, a barrier portion as further specified above. Forming the barrier portion can comprise deforming an area of the holder structure such that a portion of the holder structure comprising an end face, for example, a surface of the end portion 11.48, is displaced out of a plane bounded by one, more or all remaining boundary surfaces of the holder structure opening in the holder structure, wherein, prior to the portion being displaced, the end face is disposed in the holder structure opening, for example, as in the sheet-like structure shown in Fig. 4. The displaced portion can define the barrier portion, for example, a curved or rounded portion. The needle shield holder can be shaped from the holder structure, for example, by bending the sheet-like holder structure into the desired shape of the needle shield holder. The finished needle shield holder comprises the barrier portion, which can be formed prior to or after the (re)shaping process performed with the holder structure. The needle shield holder can then be guided into the holder retainer or cap 11, as previously described, to form a needle shield holder assembly.

[0258] For the solution involving a barrier portion, the risk of creating flaking or scratching is further reduced, which is why the embodiments of the application are particularly suitable, preferably but not exclusively in combination with the solution discussed in connection with Figs. 12 and 17. In contrast to the solution discussed in connection with Figs. 12 and 17, which relies on a measurement occurring at an angular offset relative to the retainer interface feature, the solution discussed in connection with Fig. 18 relies on a measurement occurring in a region that is angularly overlapping with the retainer interface feature. We note that other features described herein in relation to the needle shield assembly also apply to this embodiment. In addition, features of this embodiment can also be used in other embodiments.

[0259] It should be noted that features disclosed above in connection with different aspects and embodiments can be combined with each other, whether they are contained in the description of the example embodiments or in the introductory or summary part of the present disclosure. Furthermore, features discussed only in the introductory part of the present disclosure should also be considered as disclosed in the part discussing the example embodiments, and vice versa.

[0260] The scope of protection is not limited to the examples given above. Any of the inventions disclosed herein are embodied in each new feature and each combination of features, in particular in every combination of any features mentioned in the claims, even if this feature or this combination of features is not explicitly mentioned in the claims or in the embodiments.

[0261] Reference signs

[0262] 1 Auto-injector

[0263] 2 Housing

[0264] 2.1 front portion

[0265] 2.2 rear portion

[0266] 2.4 proximal end

[0267] 3 syringe barrel

[0268] 3.1 flange

[0269] 4 needle

[0270] 5 needle shield

[0271] 6 plug

[0272] 7 needle guard

[0273] 8 guard spring

[0274] 9 drive spring

[0275] 10 plunger

[0276] 11 cap

[0277] 11.1 gripping feature

[0278] 11.2 gripper

[0279] 11.3 gripper carrier

[0280] 11.4 plurality of longitudinal folds

[0281] 11.5 carrier portion

[0282] 11.6 overlap region

[0283] 11.7 cut-out / opening

[0284] 11.8 barb

[0285] 11.9 pointed head

[0286] 11.10 orientation element

[0287] 11.11 sheet

[0288] 11.12 retention slot

[0289] 11.13 retaining lugs

[0290] 11.14 retaining lugs

[0291] 11.15 receiving space

[0292] 11.16 opening

[0293] 11.17 portion

[0294] 11.18 housing connector

[0295] 11.19 gripper guide feature

[0296] 11.20 first / leading end

[0297] 11.21 second / trailing end

[0298] 11.22 ramped surface region

[0299] 11.23 surface

[0300] 11.24 surface

[0301] 11.25 edge / corner

[0302] 11.26 protrusion

[0303] 11.27 opening

[0304] 11.28 tab

[0305] 11.29 notch

[0306] 11.30 abutment feature

[0307] 11.31 slat

[0308] 11.32 outer wall

[0309] 11.33 plurality of gripping features

[0310] 11.34 cover

[0311] 11.35 indicator

[0312] 11.36 ramped region

[0313] 11.37 surface

[0314] 11.38 region

[0315] 11.39 axial end

[0316] 11.40 section

[0317] 11.41 snap feature

[0318] 11.42 snap feature

[0319] 11.43 opening

[0320] 11.44 surface

[0321] 11.45 surface

[0322] 11.46 axial end

[0323] 11.47 tab or tongue

[0324] 11.48 free end

[0325] 11.49 axial portion

[0326] 11.50 transition region

[0327] 11.51 blocking portion

[0328] 12 plunger release mechanism

[0329] 13 sound indicator

[0330] 14 sheath pre-lock mechanism

[0331] 15 syringe support

[0332] 15.1 support beam

[0333] 16 carrier

[0334] 17 scraping / peeling

[0335] A longitudinal axis

[0336] D distal direction

[0337] G gap

[0338] M medicament

[0339] P proximal direction

Claims

1. Needle shield removal assembly for a drug delivery device (1), comprising: - a needle shield gripper (11.2) configured to operably engage a needle shield (5) and interlock with the needle shield, and - a gripper holder (11), wherein the needle shield gripper is fixed to the gripper holder via a connection interface established between the gripper holder and the needle shield gripper, wherein the connection interface is formed by engagement of at least one holder interface feature (11.13) of the gripper holder with at least one gripper interface feature (11.12, 11.7) of the needle shield gripper, - wherein the gripper holder has a holder opening (11.16) which is designed in its configuration and size for receiving the needle shield gripper and / or the needle shield, wherein the at least one holder interface feature is offset from the holder opening, - wherein the gripper holder defines a receiving space (11.15) for receiving the needle shield gripper therein, - wherein the receiving space has an axial extension directed in a direction away from the holder opening, and wherein, - the gripper holder has a radial recess or radial opening (11.27) in a section of the gripper holder which is angularly offset from the at least one holder interface feature, wherein a first axial end (11.39) of the radial recess or radial opening (11.27) facing the holder opening (11.16) is axially offset from the holder opening (11.16), and wherein the radial recess or radial opening (11.27) axially overlaps the at least one holder interface feature.

2. The needle shield removal assembly of claim 1, wherein, The receiving space (11.15) is defined by a portion (11.17) of the gripper holder (11), and wherein the portion comprises a section (11.40) having a cylindrical surface disposed between the holder opening and the holder interface feature.

3. The needle shield removal assembly of claim 2, wherein, The portion of the gripper holder is radially inwardly offset from an inner surface of the gripper holder.

4. The needle shield removal assembly of claim 2, wherein, The portion of the gripper holder is radially inwardly offset from an inner surface of an outer wall of the gripper holder.

5. The needle shield removal assembly of any of claims 1-4, wherein, The radial recess or radial opening (11.27) is connected to the receiving space (11.15), and seen from the receiving space, the radial recess or radial opening extends outwardly into or through the gripper holder (11) or a portion (11.17) thereof.

6. The needle shield removal assembly of any of claims 1-4, wherein, The at least one holder interface feature (11.13) protrudes into the receiving space (11.15), and / or wherein the gripper holder (11) is a monolithic component.

7. The needle shield removal assembly of any of claims 1-4, wherein, An angular width of the radial recess or radial opening (11.27) varies along an axial extension of the radial recess or radial opening.

8. The needle shield removal assembly of any of claims 1-4, wherein, A second axial end (11.46) of the radial recess or radial opening is axially offset from the at least one holder interface feature (11.13) in a direction away from the holder opening.

9. The needle shield removal assembly of claim 8, wherein, The second axial end (11.46) of the radial recess or radial opening (11.27) distal to the first axial end is an open axial end.

10. The needle shield removal assembly of any of claims 1-4, wherein, The first axial end (11.39) of the radial recess or radial opening (11.27) is arranged closer to the holder opening (11.16) than an end of the at least one holder interface feature facing the holder opening.

11. The needle shield removal assembly of any of claims 1-4, wherein, The first axial end (11.39) of the radial recess or radial opening (11.27) and the end of the at least one holder interface feature facing the holder opening are axially aligned.

12. The needle shield removal assembly of any of claims 1-4, wherein, The at least one holder interface feature (11.13) comprises a ramped region (11.36) at an end of the holder interface feature facing the holder opening (11.16).

13. The needle shield removal assembly of any of claims 1-4, wherein, The needle shield holder (11.2) comprises at least one kink or bend region (11.4) overlapping the radial recess or radial opening (11.27) as seen from the angular direction.

14. The needle shield removal assembly of claim 13, wherein, An angular width of the radial recess or radial opening (11.27) is greater than an angular width of the kink or bend region (11.4) of the needle shield holder (11.2).

15. The needle shield removal assembly of any of claims 1-4, wherein, The holder interface feature (11.13) is arranged to block movement of the needle shield holder (11.2) towards the holder opening (11.16) by a blocking portion (11.51) of the needle shield holder, the blocking portion abutting a surface (11.37) of the holder interface feature facing away from the opening.

16. The needle shield removal assembly of claim 15, wherein, The blocking portion (11.51) of the needle shield holder (11.2) is arranged in a region between an end face (11.48) of the needle shield holder and an axially oriented portion (11.49) of the needle shield holder.

17. The needle shield removal assembly of claim 15, wherein, The blocking portion (11.51) is arranged in a region of a tab or tongue (11.47) of the holder (11).

18. The needle shield removal assembly of claim 16, wherein, The end face (11.48) faces in a radially inward direction.

19. The needle shield removal assembly of claim 16, wherein, The end face (11.48) is a surface defined by cutting or stamping.

20. The needle shield removal assembly of claim 15, wherein, The blocking portion (11.51) is provided in a transition region (11.50) of the needle shield holder (11.2).

21. The needle shield removal assembly of claim 20, wherein, In the transition region (11.50), the needle shield holder (11.2) changes orientation from a generally axial orientation to a generally radial orientation.

22. The needle shield removal assembly of claim 15 wherein, The needle shield holder (11.2) is concavely curved in a region of or adjacent to the blocking portion (11.51).

23. The needle shield removal assembly of claim 15 wherein, The holder interface feature (11.12, 11.7) is an opening axially defined by the blocking portion (11.51).

24. The needle shield removal assembly of claim 16 wherein, The needle shield holder (11.2) has at least one needle shield interlock feature (11.8) adapted to interlock with the needle shield (5), wherein a) the blocking portion (11.51) is angularly aligned with one of the needle shield interlock features, and / or b) the needle shield interlock feature radially protrudes beyond the end face.

25. Needle shield removal assembly according to any of claims 1-4, wherein the needle shield holder (11.2) is elastically deformable in radial direction.

26. The needle shield removal assembly of any one of claims 1-4, wherein, The needle shield holder (11.2) comprises an inclined surface area (11.22) arranged at an axial position of the holder interface feature (11.13) offset in a direction away from the holder opening (11.16), and wherein the inclined surface area is angularly overlapping with the at least one holder interface feature.

27. The needle shield removal assembly of any of claims 1-4, wherein, The needle shield holder (11.2) has a plurality of needle shield interlock features (11.8) adapted to interlock with the needle shield (5), wherein the at least one holder interface feature (11.13) is angularly aligned with one of the needle shield interlock features.

28. The needle shield removal assembly of any of claims 1-4, wherein, The holder (11) comprises a radially extending recess or radial opening (11.27) in a sensitive area to prevent or reduce mechanical contact with the needle shield holder in the sensitive area.

29. The needle shield removal assembly of any of claims 1-4, wherein, The needle shield holder (11.2) comprises a plurality of kink or twist areas (11.4), wherein a planar area or a less kinked surface area of the needle shield holder is arranged between two adjacent kink or twist areas, and wherein at least one sensitive area is angularly arranged between two adjacent kink or twist areas.

30. Needle shield removal assembly according to claim 1, wherein, The needle shield holder and the holder holder are adjusted to each other to reduce or prevent, during insertion of the needle shield holder into the receiving space via an opening in the at least one sensitive area of the holder holder angularly offset from the at least one holder interface feature, a) mechanical contact of the holder holder with kink or twist areas (11.4) of the needle shield holder, and / or b) mechanical contact of the holder holder with edges or corners (11.20, 11.25) of the needle shield holder.

31. Needle shield removal assembly according to claim 1, wherein, The needle shield holder and the holder holder are adjusted to each other to reduce or prevent, during insertion of the needle shield holder into the receiving space via an opening in the at least one sensitive area of the holder holder angularly offset from the at least one holder interface feature, mechanical contact of an inner surface of the holder holder with kink or twist areas (11.4) of the needle shield holder.

32. Needle shield removal assembly according to claim 1, wherein, The needle shield holder and the holder holder are adjusted to each other to reduce or prevent, during insertion of the needle shield holder into the receiving space via an opening in the at least one sensitive area of the holder holder angularly offset from the at least one holder interface feature, mechanical contact of an inner surface of the holder holder with edges or corners (11.20, 11.25) of the needle shield holder.

33. A drug delivery device (1) comprising a needle shield removal assembly according to any one of claims 1-32 and a reservoir (3) comprising a drug (M), wherein the drug delivery device further comprises a needle (4) and a needle shield (5), the needle being at least partially covered by the needle shield, wherein the needle shield holder engages the needle shield such that the needle shield can be removed from the needle by means of the needle shield removal assembly, and wherein the needle shield removal assembly is a cap assembly of the drug delivery device.

34. The drug delivery device (1) according to claim 33, wherein the drug delivery device (1) is an auto-injector.

35. A method of assembling a needle shield removal assembly according to any one of claims 1-32, comprising the steps of: - inserting the needle shield holder into the opening, - guiding the needle shield holder into the receiving space, - reducing or preventing mechanical contact of the holder holder and a kink or twist region (11.4) of the needle shield holder during insertion of the needle shield holder into the receiving space via an opening in at least one sensitive region of the holder holder, - fixing the needle shield holder within the holder holder.

Images