Needle shroud unlock device for a medicament delivery device

Abstract

The present disclosure relates to a needle shroud unlock device for a medicament delivery device, e.g. an autoinjector. The needle shroud unlock device comprises an unlock element configured to unlock a needle shroud of the medicament delivery device when the needle shroud is in a locked out position, in which a needle shroud lock element of the needle shroud and a securing element of the medicament delivery device are engaged to prevent a proximal movement of the needle shroud relative to a housing of the medicament delivery device, e.g. into the housing. The unlock element is configured to disengage the needle shroud lock element and the securing element for unlocking the needle shroud. When unlocked, the needle shroud is proximally movable relative to the housing of the medicament delivery device, e.g. into the housing.

Description

[0001] Title

[0002] Needle shroud unlock device for a medicament delivery device

[0003] Background

[0004] Medicament delivery devices and / or medicament containers for said devices, e.g. syringes, are designed to be used for injecting a medicament / drug to a user / patient.

[0005] There are multiple-shot medicament delivery devices configured to discharge multiple doses of the medicament from a medicament container, e.g. a cartridge or barrel or syringe and therefore can be used for several injections. The International Organization for Standardization (ISO) requires that in multiple-shot devices a new needle is used for each injection. However, it is known that these users tend to use the same needle for more than one injection as a needle change for each injection is inconvenient. Further, the risk of harm caused by a contaminated needle for subcutaneous injections performed to the same user seems relatively low. From a technical point of view, the need for a needle (or syringe) change depends on the drug formulation and a potential risk of clogging of the needle. However, especially when injecting insulin, it does not seem necessary to change the needle for each injection.

[0006] On the other hand, there are disposable single-shot medicament delivery devices configured to enable the user to perform only one injection of the drug. The ISO requires the needle of the medicament delivery devices to be covered after the injection to prevent injuries of the user / patient. Usually, medicament delivery devices comprise a needle cover or shroud which is driven distally to protrude beyond the sharp tip of the needle, when medicament delivery device is removed from the injection site. For single-shot medicament delivery devices, the ISO requires that the needle shroud is locked out, i.e. the needle shroud is secured against a backward movement which would re-expose the needle. Hence, the single-shot medicament delivery device cannot be re-used and needs to be disposed entirely, thereby increasing the amount of waste.

[0007] Therefore, the current situation is unsatisfying and inefficient from an ecologic and economic perspective.

[0008] Summary In the following the term "distal" refers to directions, ends or surfaces which are arranged or are to be arranged to face or point towards a dispensing end of the medicament delivery device, of the system or of components thereof. In other words, the term "distal" refers to the direction towards an injection site and / or a tip of an injection needle of the device. On the other hand, the term “proximal” is used to specify directions, ends or surfaces which are arranged or are to be arranged to face away from or point away from the dispensing end and / or from the distal end of the medicament delivery device or components thereof. Accordingly, the term "proximal" refers to the direction pointing away from the injection site and / or a tip of an injection needle of the device. For example, the distal end may be the end closest to the dispensing end and / or furthest away from the proximal end and the proximal end may be the end furthest away from the dispensing end. A proximal surface may face away from the distal end and / or towards the proximal end. A distal surface may face towards the distal end and / or away from the proximal end. The dispensing end may be the needle end where a needle is arranged or a needle or needle unit is or is to be mounted to the device, for example.

[0009] In the following, if not explicitly indicated otherwise, the terms "axial" direction and / or "longitudinal” direction refer to an axis extending along the proximal-distal direction.

[0010] The present disclosure relates to a needle shroud unlock device for a medicament delivery device, e.g. an autoinjector, for unlocking and, optionally, resetting a needle shroud of the medicament delivery device from a locked out position. The present disclosure further relates to a needle shroud unlock device for a medicament delivery device for resetting the needle shroud of the medicament delivery device. The present disclosure further relates to a system comprising a medicament delivery device and a needle shroud unlock device for unlocking and, optionally, resetting a needle shroud of the medicament delivery device from its locked out position. The present disclosure further relates to a method for unlocking and, optionally, resetting a needle shroud of a medicament delivery device. The present disclosure further relates to the use of a needle shroud unlock device for unlocking and, optionally, resetting a needle shroud of a medicament delivery device from a locked out position. The present disclosure further relates to a medicament delivery device and a needle shroud unlock device for unlocking and, optionally, resetting a needle shroud of the medicament delivery device from its locked out position.

[0011] It is an object of the present disclosure to provide devices, a system and methods for unlocking and, optionally, resetting a needle shroud of a medicament delivery device, when it is in a locked out position. The object is solved by the needle shroud unlock device according to claim 1 , the system according to claim 14 and the method according to claim 15. Further aspects are described in the dependent claims.

[0012] In the locked out position, the needle shroud protrudes from the medicament delivery device, e.g. from a housing thereof, beyond a tip of a needle of the medicament delivery device, so that the needle cannot be touched by a user. For example, in the locked out position, the needle shroud may protrude beyond the tip of the needle as far as it protrudes beyond the tip of the needle in an initial or first position. The initial or first position is the position of the needle shroud relative to the needle and / or a housing of the medicament delivery device before the injection process is started or triggered. The injection process may be triggered by the needle shroud being moved from the first position in the proximal direction relative to the housing until reaching a second or trigger position. For example, the needle shroud may be moved proximally relatively to the housing by pressing the needle shroud against the injection site. In the first position, the needle shroud may be locked against a distal movement relative to the housing. For example, the needle shroud may interact with a plunger of the medicament delivery device such that the plunger limits the distal movement of the needle shroud relative to the housing in the first position. When the needle shroud is pressed against the injection site and thereby moved proximally relative to the housing, the needle shroud may rotate the plunger, which may unlock the distal movement of the needle shroud relative to the housing.

[0013] In one embodiment, in the locked out position, the needle shroud may protrude farther beyond the needle tip than in the first position. In one embodiment, in the first position, the needle shroud may protrude equally far or farther beyond the needle tip than in the locked out position.

[0014] The needle shroud may assume the locked out position when the medicament delivery device is removed from the injection site, e.g. after completion of an injection and / or when the injection is interrupted. The needle shroud may be driven to the locked out position by a needle shroud spring of the medicament delivery device, e.g. a compression spring. The needle shroud spring may be positioned to connect the needle shroud to the housing.

[0015] In the locked out position, the needle shroud is secured against any movement relative to the medicament delivery device which would expose the needle, e.g. a proximal movement of the needle shroud into the housing of the medicament delivery device. For that purpose, the needle shroud comprises a needle shroud lock element configured to engage a securing element of the medicament delivery device. The securing element may be provided by a surface of the housing, e.g. a distal end surface of the housing and / or a distally facing surface inside the housing.

[0016] The needle shroud lock element may be a flexible portion of the needle shroud, e.g. a snap arm formed at the needle shroud. Thus, the needle shroud lock element may be deflectable, e.g. in a predominantly radial direction, when the needle shroud is moved to the locked out position. For example, a proximally facing surface of the needle shroud lock element may engage a distally facing surface of the securing element, when the needle shroud lock element passes the securing element during the movement of the needle shroud to the locked out position, e.g. when the needle shroud is driven by the needles shroud spring.

[0017] Depending on the geometry of the needle shroud lock element and / or the securing element, there may be two types of locking out the needle shroud, i.e. an inside needle shroud lock out or an outside needle shroud lock out.

[0018] As regards the inside needle shroud lock out, the needle shroud lock element may comprise an inclined surface, which, for example, may be inclined in a radial inward direction when looked at from a distal end to a proximal end. Alternatively or additionally, the securing element may have an inclined surface, which, for example, may be inclined in a radial outward direction when looked at from a proximal end to a distal end.

[0019] As regards the outside needle shroud lock out, the needle shroud lock element may comprise an inclined surface, which, for example, may be inclined in a radial outward direction when looked at from a distal end to a proximal end. Alternatively or additionally, the securing element may have an inclined surface, which may be inclined in a radial inward direction when looked at from a proximal end to a distal end.

[0020] According to an aspect, the present disclosure relates to a needle shroud unlock device for a medicament delivery device. The needle shroud unlock device comprises an unlock element configured to unlock a needle shroud of the medicament delivery device when the needle shroud is in a locked out position. In specific, the unlock element is configured to disengage the needle shroud lock element and the securing element for unlocking the needle shroud from its locked out position. When the needle shroud is unlocked, the needle shroud is proximally movable relative to the housing of the medicament delivery device, e.g. into the housing.

[0021] According to an embodiment of the present disclosure, the needle shroud unlock device may comprise an interaction feature. The interaction feature may be configured to interact with the needle shroud lock element and / or the securing element when the needle shroud unlock device is connected to the medicament delivery device. Alternatively, the interaction feature may be configured to interact with the needle shroud lock element and / or the securing element when the unlock element is moved relatively to the needle shroud lock element and / or the securing element, after the needle shroud unlock device has been connected to the medicament delivery device.

[0022] According to an embodiment of the present disclosure, the interaction feature may be formed by a distal portion of the unlock element. The interaction feature may comprise one or more steps configured to abut on one or more surfaces of the medicament delivery device, e.g. the housing, to provide a stop for movements of the needle shroud unlock device, or parts thereof, relative to the medicament delivery device, e.g. the housing. The interaction feature may be configured to slide along a surface, e.g. the inclined surface, of the needle shroud lock element and / or the securing element when moved relatively thereto, thereby deflecting the needle shroud lock element and / or the securing element. The deflection may cause a disengagement of the needle shroud lock element and the securing element, thereby unlocking the needle shroud from its locked out position.

[0023] According to an embodiment of the present disclosure, the needle shroud unlock device may comprise a push element. The push element may be movable relative to the unlock element, after the needle shroud is unlocked. For example, the push element may be moved proximally relative to the unlock element, after the unlock element has reached a final proximal position in which it cannot move farther proximally relative to the needle shroud and / or the housing. In one embodiment, the push element may be movable relative to the unlock element before the unlock element has reached its final proximal position in which the needle shroud is unlocked. The push element may be configured to move the needle shroud relative to the housing of the medicament delivery device, e.g. in the proximal direction into the housing, when the needle shroud is unlocked. For example, the push element may be configured to move the needle shroud to its first position, in which it can be locked against a distal movement relative to the housing, e.g. by a locking means or mechanism of the medicament delivery device. In other words, the needle shroud may be reset to a state in which it was before the injection. This allows the user to re-use the medicament delivery device.

[0024] According to an embodiment of the present disclosure, the locking means may be configured to lock the needle shroud against a distal movement relative to the housing, as soon as the needle shroud reaches the first position.

[0025] The push element may be releasably coupled to the unlock element before the needle shroud is unlocked. Thus, the push element may follow a movement of the unlock element relative to the needle shroud, or vice versa, before the needle shroud is unlocked. When the needle shroud is unlocked, the coupling between the push element and the unlock element may be released such that the push element can move relatively to the unlock element, e.g. in the proximal direction.

[0026] The push element may comprise a push surface configured to interact with an engagement surface of the needle shroud to move the needle shroud in the proximal direction relative to the housing of the medicament delivery device, e.g. into the housing, after the needle shroud is unlocked. According to an embodiment of the present disclosure, the push element may move the needle shroud relative to the housing when the push element is moved in the proximal direction relative to the medicament delivery device, e.g. the housing. According to an embodiment of the present disclosure the engagement surface may be a distal end surface of the needle shroud.

[0027] According to an embodiment of the present disclosure, the unlock element and the push element may comprise an engagement surfaces. The engagement surface of the unlock element may be configured to interact with an engagement surface of the push element. In one embodiment, the push element may be carried by the unlock element when the unlock element is moved proximally relative to the housing and the engagement surfaces interact with each other, e.g. before the needle shroud is unlocked. Hence, the engagement surface of the unlock element may be a proximally facing surface and the engagement surface of the push element may be a distally facing surface.

[0028] In one embodiment, the unlock element may be carried by the push element when the push element is moved proximally relative to the housing and the engagement surfaces interact with each other, e.g. before the needle shroud is unlocked. Hence, the engagement surface of the unlock element may be a distally facing surface while the engagement surface of the push element may be a proximally facing surface

[0029] The push element may comprise a manipulation feature via which a relative movement between the push element and the unlock element can be controlled by the user. For example, the user may grip the manipulation feature. The manipulation feature may comprise a status indication feature, as described in detail below. The status indication feature may be configured to provide a feedback to the user regarding the position of the push element relative to the unlock element. Hence, the status indication feature may be configured to provide a feedback to the user regarding a position of the needle shroud relative to the housing. The status indication feature may be provided on an outer circumferential surface of the manipulation feature. The status indication feature may not be visible when the push element has reached a final proximal position relative to the unlock element and / or the medicament delivery device, e.g. the housing thereof.

[0030] In one embodiment, the user may control a relative movement between the push element and the unlock element, such that the user may push the push element proximally relative to the unlock element, when the needle shroud is unlocked, thereby moving the needle shroud to an initial or first position. In the first position, the needle shroud may be locked against a movement in the distal direction relative to the housing and may be movable in the proximal direction relative to housing, at least until reaching the trigger position. In the first position, a proximal movement of the needle shroud may be limited such than a proximal movement of the needle shroud relative to the housing is only possible to the extend which is required for unlocking the needle shroud and triggering the medicament delivery device. In other words, in the first position, the proximal movement of the needle shroud may be limited to a travelling distance of the needle shroud between the first position and the trigger position.

[0031] In the first position, the needle shroud may protrude beyond a tip of the needle to cover the tip of the needle. In the first position, the needle shroud may be farther proximal than in the locked out position. In other words, in the locked out position, the needle shroud may protrude farther beyond the tip of the needle than in the first position.

[0032] The manipulation feature may be integrally formed with the push element. The manipulation feature may be a distal protrusion of the push element protruding beyond a distal surface of the unlock element, e.g. the distal end surface of the unlock element. Moving the push element via the manipulation feature, e.g. by pushing the manipulation feature in the proximal direction, may cause the engagement surfaces of the push element and the unlock element to disengage. The push element may comprise means of improving the user’s grip, e.g. a rubber portion and / or steps and / or protrusions and / or grooves. In one embodiment, the manipulation feature may be formed by a radial surface of the push element, e.g. a radial outer surface.

[0033] According to an embodiment of the present disclosure, the needle shroud unlock device may comprise a purifying chamber configured to receive and / or purify the needle of the medicament delivery device, when needle shroud unlock device is connected to the medicament delivery device. The purifying chamber may contain a purifying agent configured to clean and / or sanitize the needle. The purifying agent may be in a liquid and / or gaseous and / or solid state. The purifying chamber may be sealed by a sealing element, e.g. a foil or a septum, which may be pierceable and / or removable from the purifying chamber. According to an embodiment of the present disclosure, the purifying chamber may be configured to receive a purifying container. The purifying container may comprise the purifying agent. The purifying container may be a blow-fill-seal container. At least a portion of the purifying chamber may be configured to be pierceable by the needle.

[0034] According to an embodiment of the present disclosure, the push element may comprise the purifying chamber. The purifying chamber may be configured to receive and / or purify the needle when the unlock element and / or the push element is moved, e.g. proximally, relative to one or more of the housing, the needle and the needle shroud, when the needle shroud unlock device is connected to the medicament delivery device.

[0035] According to an embodiment of the present disclosure, the purifying chamber may be configured to receive and / or purify the needle when the push element is moved, e.g. proximally, relative to one or more of the unlock element, the housing, the needle and the needle shroud, when the needle shroud unlock device is connected to the medicament delivery device.

[0036] According to an embodiment of the present disclosure, the unlock element may comprise the purifying chamber. The purifying chamber may be configured to receive and / or purify the needle when the unlock element is moved, e.g. proximally, relative to one or more of the push element, the housing, the needle and the needle shroud, when the needle shroud unlock device is connected to the medicament delivery device.

[0037] According to an embodiment of the present disclosure, the needle shroud unlock device may further comprise a purifying element comprising the purifying chamber. The purifying chamber may be configured to receive and / or purify the needle when the needle shroud unlock device is connected to the medicament delivery device, or when the purifying element is moved, e.g. proximally, relative to one or more of the needle, the needle shroud and the housing, while the needle shroud unlock device is connected to the medicament delivery device.

[0038] According to an embodiment of the present disclosure, the purifying element may be coupled to the unlock element such that a movement of the unlock element, e.g. an axial movement, relative to the medicament delivery device, e.g. the housing thereof, causes a corresponding movement of the purifying element relative to the medicament delivery device, e.g. the housing thereof. In other words, the purifying element may be carried be the unlock element.

[0039] According to an embodiment of the present disclosure, the purifying element may be coupled to the push element such that a movement of the push element, e.g. an axial movement, relative to the medicament delivery device, e.g. the housing thereof, causes a corresponding movement of the purifying element relative to the medicament delivery device, e.g. the housing thereof. In other words, the purifying element may be carried be the push element.

[0040] According to an embodiment of the present disclosure, the unlock element and the push element may be configured to be releasably coupled to each other to prevent a relative movement between the unlock element and the push element before the needle shroud is unlocked. Further, the unlock element and the push element may be configured to decouple and enable a relative movement between the unlock element and the push element after the needle shroud is unlocked.

[0041] According to an embodiment of the present disclosure, the unlock element may be carried by the push element when the push element is moved proximally relative to the medicament delivery device, e.g. the housing thereof, before the needle shroud is unlocked. For example, a coupling feature of the unlock element may interact with a corresponding recess feature of the push element. Alternatively or additionally, a coupling feature of the push element may interact with a corresponding recess feature of the unlock element.

[0042] According to an embodiment of the present disclosure the push element may comprise an interaction indication feature. The interaction indication feature may be configured to provide an indication to the user that the needle shroud unlock device shall be manipulated via a manipulation of the push element. In other words, the interaction indication feature may be configured to provide an indication to the user that the push element shall be a user interface and, preferably, that the unlock element does not need to be touched when operating the unlock device. This may be advantageous for several reasons, e.g. because the push element may have a larger distal surface and / or can be reached by the user more easily, which may increase usability. The interaction indication feature may be one or more of a print, engraving, or other visible marking on a surface of the push element. Depending on the geometry of the unlock device, the interaction indication feature may be provided on the unlock element, if the unlock element, at least partially, surrounds the push element, so that the push element is hard to reach. In general, the interaction indication feature may be provided on one or more of the components of the unlock device which are the most suitable for being touched and moved or manipulated by the user, when considering the direction in which a force of the user needs to be applied to the unlock device.

[0043] According to an embodiment of the present disclosure, the coupling feature of the unlock element may comprise a flexible portion, e.g. at least one snap arm. The recess feature may comprise a recess for forming a space for at least a part of the flexible portion, e.g. protrusion of the snap arm. The flexible portion may be configured to interact with a distal end of the needle shroud, e.g. the engagement surface thereof. This interaction may cause the flexible portion to deflect, thereby disengaging the coupling feature of the unlock element from the recess feature of the push element, when the needle shroud is unlocked. In other words, the unlock element and the push element may be decoupled, when the needle shroud is unlocked.

[0044] For example, the flexible portion may comprise an inclined surface configured to slide along the engagement surface of the needle shroud thereby deflecting the flexible portion and disengaging the push element and the unlock element, when a proximal force is applied to the push element and the unlock element has reached its final proximal position, in which the needle shroud is unlocked. In this position, a father proximal movement of the unlock element with respect to the security feature may be stopped, e.g. by the interaction feature abutting on the housing and / or the securing element.

[0045] According to an embodiment of the present disclosure, the recess feature of the unlock element may comprise a distal groove. The corresponding coupling feature of the push element may comprise a flexible portion, e.g. at least one snap arm. The flexible portion may be configured to interact with the distal groove of the unlock element before the needle shroud is unlocked.

[0046] When the needle shroud is unlocked, i.e. the unlock element is in its final proximal position an inclined surface of the coupling feature of the push element may interact with a proximal edge of the distal groove such that the flexible portion of the coupling feature is deflected, e.g. predominantly radially outwardly, thereby disengaging the coupling feature of the push element and the distal groove. In other words, the push element decouples from the unlock element, when the needle shroud is unlocked and the push element is moved proximally, e.g. due to a further proximal force of the user applied to the push element. When decoupled, the push element may move relatively to the unlock element, e.g. in the proximal direction, thereby moving the needle shroud proximally to its first position. When decoupled, the flexible portion may be deflected, which may tense the flexible portion.

[0047] In one embodiment, the recess feature of the unlock element may comprise a proximal groove. The coupling feature of the push element may be configured to engage the proximal groove when a part of the flexible portion, e.g. a radial inward protrusion of the snap-arm, is aligned with the proximal groove because the snap arm may relax, i.e. return to a non-deflected state. Due to the engagement between the coupling feature of the push element and the proximal groove of the unlock element, a final proximal position of the push element relative to the unlock element may be defined. The engagement of the coupling feature of the push element and the proximal groove of the unlock element may generate an acoustic and / or a haptic feedback indicating to the user that the push element has reached the final proximal position. In the final proximal position, the needle shroud may be in its first position. In the first position the needle shroud may be reset.

[0048] Alternatively, a proximal surface of the push element may abut on a distal surface of the unlock element, e.g. the distal end surface, to limit the relative proximal movement between the push element in the unlock element.

[0049] For compensating manufacturing tolerances and / or avoiding structural overdeterminations within the unlock device, there may be respective clearances between surfaces of the unlock element and surfaces of the push element. The clearances may be designed according to the structure of the unlock device, in particular according to the structure of the unlock element and the push element and parts thereof defining their relative spatial positions with respect to each other and / or the medicament delivery device.

[0050] According to an embodiment of the present disclosure, one or both of the unlock element and the push element may be circumferentially closed.

[0051] According to an embodiment of the present disclosure, a major part of the unlock element, i.e. more than 50 percent and preferably more than 80 percent of its axial length may be radially inside the push element. Alternatively, a major part of the push element, i.e. more than 50 percent and preferably more than 80 percent of its axial length may be radially inside the unlock element.

[0052] According to an embodiment of the present disclosure, the unlock element and / or the push element may be configured to be connectable to, e.g. attachable to, the medicament delivery device, e.g. to a distal end of the housing.

[0053] According to an embodiment of the present disclosure, the push element may form a space, e.g. an inner space, configured such that the push element at least partially surrounds the unlock element. Alternatively or additionally, the push element may comprise a first opening through which at least a portion of the unlock element, e.g. a distal end and / or a coupling feature of the unlock element may extend. The walls of the opening of the push element may be configured to guide a movement the unlock element or parts thereof which extend through the opening, during a relative movement between the unlock element and the push element.

[0054] According to an embodiment of the present disclosure, the unlock element may form a space configured such that the unlock element at least partially surrounds the push element. Alternatively or additionally, the unlock element may comprise a second opening through which at least a portion of the push element, e.g. a manipulation feature of the push element, may extend. The walls of the opening of the unlock element may be configured to guide a movement the push element or parts thereof which extend through the opening, during a relative movement between the unlock element and the push element.

[0055] According to an embodiment of the present disclosure, the interaction feature of the unlock element may be configured to interact with the needle shroud lock element and / or the securing element via a disengagement element of the medicament delivery device, when the needle shroud unlock device is attached to the medicament delivery device. Alternatively or additionally, the interaction feature of the unlock element may be configured to interact with the needle shroud lock element and / or the securing element via the disengagement element, during a movement, preferably an axial movement, more preferably a proximal movement, of the interaction feature relative to the needle shroud lock element and / or the securing element, respectively. The disengagement element may be a locking ring, which may be positioned radially inside the needle shroud.

[0056] According to an embodiment of the present disclosure, the interaction feature may be configured to move the disengagement element relative to the needle shroud lock element and / or the securing element such that the disengagement element slides along a surface of the needle shroud lock element and / or the securing element, respectively, thereby disengaging the needle shroud lock element and the securing element. Preferably, the interaction feature may be configured to move the disengagement element proximally relative to the needle shroud lock element and / or the securing element.

[0057] According to an embodiment of the present disclosure, the unlock element may comprise a status indication feature configured to provide a feedback to the user regarding the position of the needle shroud relative to the housing. The feedback may be a visual, acoustic and / or haptic feedback. For example, the status indication feature may be a visual status indication feature comprising one or more of a print, an engraving or the like. For the sake of facilitating the understanding, a visual status indication feature being a print will be exemplarily described in the following.

[0058] In one embodiment, the print may be positioned on the unlock element. Accordingly, the push element may comprise a viewing window enabling a user to see the print on the unlock element. This visual status indication feature may be visible at different times of the unlock and / or reset process of the needle shroud. For example, the status location feature may comprise prints in different colors being visible by the user at different times of the unlock and / or reset process. In one embodiment, the status indication feature may only be visible when the needle shroud is unlocked and / or reset.

[0059] Depending on the geometry of the needle shroud unlock device, especially the relative radial positioning between the unlock element and the push element, the above described features may be reversed or disposed differently to fulfill the desired function of informing the user about the status of the unlock and / or reset process. For example the push element may comprise the status indication feature while the unlock element may comprise the viewing window.

[0060] According to an aspect, the present disclosure relates to a system comprising a medicament delivery device and a needle shroud unlock device. The medicament delivery device comprises a needle shroud. After an injection has been triggered and / or completed and the medicament delivery device has been removed from the injection site, the needle shroud may be moved to and locked in a locked out position, as described in the foregoing. Hence, a needle of the medicament delivery device may be securely covered so that it cannot be touched by the user.

[0061] The needle shroud unlock device may be suitable to be connected, e.g. coupled or attached, to the medicament delivery device. The needle shroud unlock device is configured to unlock the needle shroud from the locked out position, thereby enabling a proximal movement of the needle shroud relative to the housing of the medicament delivery device. Further, the needle shroud unlock device may be configured to reset the needle shroud. For example, the needle shroud unlock device may be a needle shroud unlock device according to any one of the embodiments described in the foregoing.

[0062] According to an embodiment of the present disclosure, the needle shroud unlock device may be connected to or integrally formed with a part of the medicament delivery device. For example, the needle shroud unlock device may be connected, e.g. releasably connected, to an end cap of the medicament delivery device. The end cap may comprise means for removing a needle shield, e.g. a rigid needle shield or a soft needle shield, from a reservoir, e.g. a syringe, of the medicament delivery device. In one embodiment, an opening of the needle shroud unlock element, which is configured to receive the needle therein, may point in an opposite direction than an opening of the end cap, through which the needle or the needle shiel is received in the end cap before use of the medicament delivery device. In other words, the needle shroud unlock device and the end cap may be connected in such a way that turning the end cap by 180 degrees around a radial or a circumferential direction after removal of the needle shield from the medicament delivery device enables an attachment of the needle shroud unlock device to the medicament delivery device, e.g. a housing thereof, for unlocking and / or resetting the needle shroud thereof, as described in the foregoing. Alternatively, the opening of the needle shroud unlock device may point in the same direction as the opening of the end cap through which the needle is received before use of the medicament delivery device. In this configuration, the needle shroud unlock device may be configured to be separable from the end cap of the medicament delivery device, such that the separation makes the opening of the needle shroud unlock device accessible. In other words, after separation of the needle shroud unlock device from the end cap, the needle shroud unlock device may be connected to the medicament delivery device for unlocking and / or resetting the needle shroud, as described in the foregoing.

[0063] According to an embodiment of the present disclosure, the medicament delivery device may be an injection device, e.g. an autoinjector. Alternatively, the medicament delivery device may be an injection device in which the drug delivery process is manually driven by the user. In one embodiment, the medicament delivery device may be a variable dose injection device. In one embodiment, the medicament delivery device may be a fixed dose injection device. In one embodiment, the medicament delivery device may be a pen-device. In one embodiment, the medicament delivery device may be device with a flat form factor.

[0064] According to an embodiment of the present disclosure, the medicament delivery device may comprise a medicament container holder or carrier configured to retain a medicament container with a medicament. Alternatively, the medicament delivery device may comprise a medicament container with a medicament. For example, the medicament container may be a cartridge, a barrel, a reservoir or a syringe. The medicament container may be pre-filled.

[0065] According to an embodiment of the present disclosure, the medicament container may be a prefilled syringe. The syringe may comprise a needle shield, which may be a rigid needle shield or a soft needle shield. The needle shield has to be removed from the syringe before the injection.

[0066] According to an embodiment of the present disclosure, the medicament container may be a cartridge or barrel or reservoir, which may be configured to interact with a needle. The needle may be comprised in the medicament delivery device. Alternatively, the medicament delivery device may be configured to be connectable to the needle, e.g. via a needle carrier or needle hub. The needle may be configured to establish a fluid connection between the medicament container, containing the medicament to be delivered, and the injection site.

[0067] According to an aspect, the present disclosure relates to method for dispensing or delivering a medicament from a medicament delivery device or a system by using the medicament delivery device or the system. The medicament delivery device or the system may be a medicament delivery device or a system as described in the foregoing.

[0068] According to an aspect, the present disclosure relates to a method for unlocking a needle shroud of a medicament delivery device from a locked out position, in which a proximal movement of the needle shroud relative to a housing of the medicament delivery device, e.g. into the housing, is prevented. The method comprises the steps of connecting a needle shroud unlock device to the medicament delivery device, e.g. the housing thereof, and disengaging a needle shroud lock element and a securing element of the medicament delivery device for unlocking the needle shroud, such that the needle shroud is proximally movable relative to the housing of the medicament delivery device, e.g. into the housing. According to an embodiment of the present disclosure, the needle shroud unlock device may be a needle shroud unlock device as described in the foregoing.

[0069] According to an embodiment of the present disclosure, the method may further comprise the step of moving the needle shroud proximally relative to the medicament delivery device, e.g. inside a housing of the medicament delivery device, to its first position, as described in the foregoing.

[0070] According to an embodiment of the present disclosure, the method may further comprise the step of resetting the needle shroud, when the needle shroud is in the first position. Resetting the needle shroud may comprise locking the needle shroud in the first position against a distal movement relative to the housing. When moved proximally to the first position and locked against a distal movement relative to the housing, the needle shroud is reset.

[0071] According to an embodiment of the present disclosure, the method may further comprise the step of disconnecting the needle shroud unlock device and the medicament delivery device, after the needle shroud has been unlocked and / or reset. Hence, the medicament delivery device may be re-used.

[0072] According to an aspect, the present disclosure relates to a use of a needle shroud unlock device for unlocking a needle shroud of a medicament delivery device from a locked out position, in which a proximal movement of the needle shroud relative to a housing of the medicament delivery device, e.g. into the housing, is prevented. The needle shroud may be unlocked by disengaging a needle shroud lock element and a securing element of the medicament delivery device, such that the needle shroud is proximally movable relative to the housing of the medicament delivery device, e.g. into the housing. In one embodiment, the use of the needle shroud unlock device may comprise using the needle shroud unlock device for moving the needle shroud to its first position and resetting the needle shroud, as described in the foregoing.

[0073] In one embodiment, the needle shroud unlock device may be a needle shroud unlock device according to one of the foregoing embodiments.

[0074] The aspects and embodiments of the present disclosure provide the advantage that a needle shroud of a medicament delivery device may be unlocked and, optionally, reset after it has been in a locked out position. Hence, the medicament delivery device may be re-used after a needle shroud has been locked out. This allows for further doses to be administered with the same medicament delivery device and, optionally, from the same medicament container. This may be beneficial in terms of cost and waste. Hence, the aspects and embodiments of the present disclosure may be beneficial for economic and ecologic reasons.

[0075] Brief description of the drawings

[0076] Figures 1 A to 1 D illustrate an embodiment of a medicament delivery device according to the present disclosure.

[0077] Figures 1 E and 1 F illustrate an interaction between components of the medicament delivery device of Figures 1A to 1 D, when a needle shroud thereof is in a locked out position.

[0078] Figure 2A illustrates an embodiment of a needle shroud unlock device according to an aspect of the present disclosure.

[0079] Figure 2B illustrates the needle shroud unlock device of Figure 2A, when connected to a medicament delivery device.

[0080] Figures 3A to 3C illustrate a sequence of interactions between the needle shroud unlock device of Figure 2 and a medicament delivery device during unlocking and resetting of a needle shroud of the medicament delivery device.

[0081] Figure 3D to 3I illustrate detailed views of embodiments of portions of Figures 3A to 3C, according to an aspect of the present disclosure.

[0082] Figure 4 illustrates an embodiment of a needle shroud unlock device according to an aspect of the present disclosure. Figures 5A to 5C illustrate a sequence of interactions between the needle shroud unlock device of Figure 4 and a medicament delivery device during unlocking and resetting of a needle shroud of the medicament delivery device.

[0083] Figure 6A illustrates an embodiment of a needle shroud unlock device according to an aspect of the present disclosure.

[0084] Figure 6B illustrates the needle shroud unlock device of Figure 6A, when connected to a medicament delivery device.

[0085] Figures 7A to 7C illustrate a sequence of interactions between the needle shroud unlock device of Figure 6 and a medicament delivery device during unlocking and resetting of a needle shroud of the medicament delivery device.

[0086] Figure 8 illustrates a side view of an embodiment of a needle shroud unlock device according to an aspect of the present disclosure.

[0087] Figures 9A to 9C illustrate a sequence of interactions between a needle shroud unlock device according to an embodiment of the present disclosure and a medicament delivery device during unlocking and resetting of a needle shroud of the medicament delivery device.

[0088] Figure 10 illustrates an embodiment of a system according to an aspect of the present disclosure.

[0089] Figure 11 illustrates steps of a method for unlocking and resetting a needle shroud of a medicament delivery device according to an aspect of the present disclosure.

[0090] Figure 12 illustrates an expanded structural formula, molecular formula, and molecular weight of fitusiran, e.g. sodium form. embodiments

[0091] Identical elements, elements of the same kind and identically or similarly acting elements may be provided with the same reference numerals in the Figures.

[0092] Figures 1 A through 1 D illustrate an embodiment of a medicament delivery device 100 of the present disclosure in different stages of operation. The following general description of the medicament delivery device 100 applies to the medicament delivery devices 100a, and 100b of Figures 1E and 1F, if not indicated otherwise.

[0093] The medicament delivery device 100 may comprise a device body or housing 60. The housing 60 may comprise a viewing window through which an interior of the housing 60 may be seen, at least partially. The housing 60 may be provided to retain and / or may retain a medicament container, e.g. a pre-filled syringe 70, in its interior. The medicament, e.g. a liquid medicament or drug Dr, may be arranged in the pre-filled syringe 70. It should be noted that the following use of the term pre-filled syringe 70 does not limit the design of the container to a pre-filled syringe. Rather, containers other than a prefilled syringe may also be considered for implementation, e.g. cartridges. The housing 60 may be provided to retain and / or may retain a needle 71 , see Figure 1C. In other words, the needle 71 may be arranged or may be arranged in the housing 60. The needle 71 can be an integral part of the medicament container, e.g. the pre-filled syringe 70, such that it is permanently or releasably connected to a body of the medicament container. Alternatively, the needle 71 can be permanently or releasably connected to the medicament delivery device 100. In the first case, the medicament container may be a syringe. In the second case, the medicament container may be a cartridge. In case a cartridge is used as medicament container, initially, the medicament container and the needle can be fluidly disconnected and fluid communication between the medicament container interior and the needle 71 may only established during operation of the medicament delivery device 100. An optional medicament container carrier, such as a syringe holder 800, may be used to support and / or carry the medicament container within the housing 60.

[0094] The medicament delivery device may comprise a drive mechanism 101 configured to drive a drug delivery operation. The drive mechanism 101 may comprise a plunger 1000. The medicament delivery device 100, e.g. the drive mechanism 101, may further comprise a drive energy source, e.g. a drive spring (not shown), such as a compression spring or a torsion spring. The drive energy source may be arranged to drive the plunger 1000 in a distal direction D relative to the medicament container during the drug delivery operation. During this movement, a plunger stopper 1200 (see Figures 1 E and 1F, not shown in Figures 1A to 1D), which may be movably retained in the medicament container to seal the medicament container, may be displaced towards an outlet of the medicament container thereby dispensing the drug Dr through the outlet. The outlet may be formed or defined by the needle 71, see Figure 1C.

[0095] Other potential drive energy sources different from the drive spring comprise an electrical power cell or battery for driving the plunger 1000 by a motor or a reservoir suitable to provide gas pressure, where the gas pressure can be used to drive the drug delivery operation. The medicament delivery device 100 may be an autoinjector. The energy for driving the drug delivery operation in an autoinjector may be provided by components integral to drug delivery device 100 and does not have to be loaded into the device by the user during the operation of device 100 as is the case in many spring-driven pen-type variable dose injectors, where, usually, the energy is loaded into the spring by the user during a dose setting procedure. The device 100 may be a pen-type device.

[0096] The medicament delivery device 100 may expediently be a single shot device, i.e. it is provided to dispense only one dose. Alternatively, the medicament delivery device 100 may be a multishot device configured to dispense more than one dose from the same medicament container. The dose may correspond to a fraction of the amount of drug contained within the medicament container or to the entire amount. In the first case, the medicament container is not entirely emptied when the medicament delivery device 100 is operated or shot.

[0097] The pre-filled syringe 70 and / or the needle 71 may be axially secured within the medicament delivery device 100, e.g. within the housing 60, or may be movable relative to the housing 60, e.g. for piercing the skin. In the first case, the user may have to perform the movement for piercing the skin with needle 71. In the second case, piercing of the skin by the needle 71 may be driven by a needle insertion mechanism of the medicament delivery device 100. Automatic needle retraction may be used as well.

[0098] As depicted in Figure 1A, the medicament delivery device 100 may further comprise a cap 200. The cap 200 may be arranged at a distal end of the medicament delivery device 100. The cap 200 may be detachably connected to the remainder of device 100, e.g. the housing 60 and / or another component or member of the medicament delivery device 100. The cap 200 may cover the distal end of the remainder of the medicament delivery device 100 and / or a needle passage opening through which needle 71 , e.g. a distal needle tip, may protrude to pierce the skin for the drug delivery operation. The cap 200 may comprise a needle shield remover configured to engage a needle shield (e.g. a rigid needle shield, RNS, or a soft needle shield, SNS), which may cover the needle 71 , such that the needle shield is removed from the needle 71 together with the cap 200, e.g. when the cap 200 is detached or disconnected from device 100.

[0099] Figure 1B illustrates the medicament delivery device 100 with the cap 200 being removed. The device 100 may be in a state ready to be operated, e.g. ready to perform a drug delivery operation when the operation is triggered. As depicted, the medicament delivery device 100 may further comprise a needle shroud 50. The needle shroud 50 may protrude distally from the housing 60 and / or may have been covered by the cap 200 when the cap 200 was still attached to the housing 60. The needle shroud 50 may be movable relative to the housing 60, e.g. in a proximal direction P, from an initial position or first position X to a second position or trigger position Y. The needle shroud 50 may be provided to extend beyond the distal tip of needle 71 which may protrude from the housing 60 before the drug delivery operation is commenced. In the first position X, the needle shroud 50 may be locked against a movement in the distal direction D relative to the housing 60, e.g. by an interaction between the needle shroud 50 and the plunger 1000. From the first position X, the needle shroud 50 may be movable in the proximal direction P relative to housing 60, at least until reaching the trigger position Y. During this proximal movement, e.g. before the needle shroud 50 reaches the second position Y, the needle 71 may pierce the skin of the user. During the movement of the needle shroud 50 from the first position X to the second position Y, the needle shroud 50 may interact with the plunger 1000, e.g. rotate the plunger 1000, such that due to this interaction the needle shroud 50 is free to move in the distal direction D relative to the housing 60, when the needle shroud 50 has reached the second position Y.

[0100] The needle shroud 50 may serve as a trigger member of the medicament delivery device 100, which, when displaced proximally from the initial or first position X depicted in Figure 1 B to the second or trigger position Y (see Figure 1C) and may automatically initialize the drug delivery operation, preferably when it reaches the second position Y. For example, the drug delivery operation can be initialized by removing a mechanical lock which prevents movement of plunger 1000 in the distal direction D or by moving the plunger 1000 to disengage a mechanical lock via moving the needle shroud 50. Alternatively, the needle shroud 50 may enable triggering of the drug delivery operation via a trigger member, e.g. a trigger button which may be disposed on the proximal end of the housing 60, when moved from the first position X to the second position Y. In this case, the trigger member may be operated by the user to initiate the drug delivery operation. Alternatively, operating the trigger member to initiate the drug delivery operation may only be possible when the needle shroud 50 is in the second position Y.

[0101] In yet another alternative, the needle shroud 50 may only be provided to prevent needle stick injuries before and / or after use of medicament delivery device 100. In this case, the needle shroud 50 may be completely decoupled from the drive mechanism 101 and / or may not be involved in triggering or enabling triggering of the drug delivery operation at all.

[0102] The needle shroud 50 may be provided to bear against the skin of a user during injection. Hence, the distal surface of the needle shroud 50 may provide a bearing surface or a skin contact surface 501. The skin contact surface 501 may delimit and / or extend around a needle passage opening provided in needle shroud 50. The skin contact surface 501 may be ring-like, oval, elliptic, rectangular, quadratic, etc., circumferentially closed and / or be defined by an inward protrusion protruding radially from an inner wall of needle shroud 50, e.g. a distal cylindrical portion thereof. The skin contact surface 501 may be the distal end surface of needle cover 500, e.g. facing distally. The syringe 70 with the needle 71 may be axially fixed in the device 100. In this case, needle insertion into the skin may be done manually by the user instead of displacing the syringe 70 relative to the housing 60.

[0103] Figure 1C illustrates needle shroud 50 in the second position Y relative to device body. This is the position when the drug delivery operation has been initiated, can be initiated, and / or when the needle 71 pierces the skin, for example. The needle 71 may protrude axially from the skin contact surface 501 of the medicament delivery device 100 (particularly through the needle passage opening in needle shroud 50) and, by the distance with which it protrudes over the skin contact surface 501, penetrate the skin (the skin is not shown in this representation). This distance may be characteristic for or be equal to the injection depth. The device 100 may be maintained in contact with the skin until the drug delivery operation of drug Dr has been completed, which may be indicated by an optional audible, tactile, and / or visual indication or feedback provided by the medicament delivery device 100.

[0104] After the drug delivery operation has been completed, e.g. the plunger 1000 has moved distally, the device 100 may be removed from the skin. The needle shroud 50 may be biased relative to the housing 60 towards the first position by a needle shroud spring (not shown). Thus, when the device 100 is removed from the skin, the needle shroud 50 may be moved towards the first position X with respect to the housing 60 by the needle shroud spring. Specifically, the needle shroud 50 may be moved distally, e.g. beyond its first position X, into a final, third or locked out position Z relative to the housing 60 (see Figure 1D). In this position the needle shroud 50 may be axially locked relative to the housing 60 against movement in the proximal direction P, e.g. by a locking engagement between a needle shroud lock element 51 (not shown in Figure 1) of the needle shroud 50 and a corresponding securing element 61 (not shown in Figure 1) of the medicament delivery device 100. The securing element 61 may be part of the housing 60, e.g. it may be formed by a distally facing surface thereof.

[0105] The needle shroud lock element 51 may be flexible allowing a, predominantly, radial displacement thereof with respect to the longitudinal axis A when the needle shroud 50 transitions from one position to another position. For example, the needle shroud lock element 51 may comprise a snap arm with a radial protrusion and / or and inclined surface facilitating a radial deflection of the needle shroud lock element 51. The radial protrusion may protrude radially inwardly (see Figure 1 F) or outwardly (see Figure 1E) depending on the geometry and / or position of the securing element 61. In other words, the needle shroud lock element 51 in engagement with the securing element 61 may provide an inside (Figure 1 F) or outside (Figure 1 E) needle shroud lock. Alternatively or additionally, the securing element 61 may comprise a flexible portion allowing for a relative movement of the securing element 61 with respect to the needle shroud lock element 51 for engaging and / or disengaging the needle shroud lock element 51 and the securing element 61.

[0106] When the needle shroud lock element 51 and the securing element 61 are engaged, the needle shroud 50 is in its locked out position Z in which it cannot be displaced proximally relative to housing 60, e.g. into the second position Y and / or into the first position X. In the locked out position Z, a cover portion 502 of the needle shroud 50 protrudes farther distally from the device body 60 than a tip of the needle 71. This may protect the user from needle stick injuries after use.

[0107] In order to re-use the medicament delivery device 100, e.g. when medicament from the same medicament container shall be injected in more than one injection, the needle shroud 50 must be unlocked from its locked out position Z, which it assumed after the previous injection. Thus, the needle shroud lock element 51 and the securing element 61 must be disengaged to allow a proximal movement of the needle shroud 50 relative to the housing 60, thereby enabling the user to pierce the skin another time with the same needle 71.

[0108] For the sake of facilitating the understanding of the following Figures, certain features and / or elements of the described needle shroud unlock device 30 are depicted only once.

[0109] Nonetheless, these features and elements may exist several times, e.g. distributed around a circumference and / or with an axial offset along the longitudinal axis A, depending on the geometry of the medicament delivery device 100 and the features thereof, e.g. the needle shroud 50, the housing 60, the needle shroud lock element 51 and / or the securing element 61. For example, the features and elements of the needle shroud unlock device 30 may be distributed uniformly around the circumference, i.e. with similar angular offsets therebetween or between functionally linked groups of features. Alternatively, the distribution may be non- uniform.

[0110] The foregoing description applies to medicament delivery devices 100 in general. As regards the structures and mechanism of locking the needle shroud 50 in its locked out position Z, the interaction between the needle shroud lock out element 51 and the securing element 61 may be realized in different ways. For the sake of facilitating the understanding, the following explanations focus on medicament delivery devices 100 in which the needle shroud 50 comprises the needle shroud lock element 51 and the housing 60 comprises the securing element 61. The lock out may be an inside or outside needle shroud lock out, as described in the foregoing.

[0111] In particular, Figure 1 E illustrates a distal portion of a medicament delivery device 100 realized as a medicament delivery device 100a, in which the needle shroud lock element 51 comprises a radial outward protrusion. Accordingly, the securing element 61 is realized as a radial inward protrusion, e.g. protruding from an outer shell of the housing 60. This design is called an outside needle shroud lock out.

[0112] Figure 1 F illustrates a distal portion of medicament delivery device 100 realized as a medicament delivery device 100b, in which the needle shroud lock element 51 comprises a radial inward protrusion. Accordingly, the securing element 61 is realized differently, e.g. by a distally facing surface of the housing 60 which is positioned radially inside of the needle shroud 50. This design is called an inside needle shroud lock out.

[0113] Apart from the structures and mechanism of locking the needle shroud in its locked out position Z, other features of the medicament delivery devices 100a and 100b, e.g. the medicament container, may be identical.

[0114] Figure 2A illustrates schematically an embodiment of a needle shroud unlock device 30 of the present disclosure. Figure 2B schematically illustrates the needle shroud unlock device 30 of Figure 2A in a state in which it is connected to a medicament delivery device 100a.

[0115] The illustrated medicament delivery device 100a contains a syringe 70 comprising a medicament. The syringe 70 comprises a distal end 72 at which a needle 71 is attached. Alternatively, the medicament delivery device 100a may comprise a needle hub (not shown) with a needle so that different medicament containers, e.g. cartridges and barrels without an own needle may be used for medicament administration. The medicament delivery device further comprises a needle shroud 50 which comprises an engagement surface 53. The engagement surface 53 may be a distal end surface of the needle shroud 50. The distal end surface comprises a distal opening defined by a radial inner surface 54 of a radial inward protrusion of the needle shroud 50. Through this distal opening the needle 71 and, optionally, at least a portion of the distal end 72 of the syringe may protrude distally beyond the needle shroud 50 in order to enable piercing a user’s skin to a desired injection depth and administering the medicament.

[0116] In Figure 2B, the illustrated needle shroud 50 of the medicament delivery device 100a is in its locked out position, in which it cannot be moved proximally relatively to a housing 60 of the medicament delivery device 100a, e.g. after completion of an injection, when a user removes the medicament delivery device 100a from the injection site, to prevent needle stick injuries caused by the user touching the needle 71. In the locked out position the needle shroud lock element 51 and the securing element 61 are engaged.

[0117] In the illustrated embodiment, the needle shroud lock element 51 may be a deflectable protrusion, such as a snap arm, extending proximally from a distal portion of the needle shroud 50. The snap arm may comprise a radial outward protrusion. The securing element 61 may be a radial inward protrusion of the housing 60. The housing 60, e.g. a distally facing surface at a distal end of the housing 60, may comprise a needle shroud opening 64 allowing the needle shroud 50 an its lock element 51 to move distally past the securing element 61, when the needle shroud 50 is moved to its locked-out position. For example, the needle shroud 50 may be pushed distally with respect to the housing 60 due to a distal force of a needle shroud spring (not shown).

[0118] The needle shroud lock element 51 may comprise an inclined surface 52 which may slide along the securing element 61 , e.g. a proximal edge thereof, when the needle shroud 50 is moved distally relative to the housing 60. The sliding may cause a radial inward deflection of the needle shroud lock element 50. After the needle shroud lock element 51 has passed the securing element 61 , the needle shroud lock element 51 returns to its relaxed state, thereby engaging a distal surface of the securing element 61. This engagement locks the needle shroud 50 against proximal movement of the needle shroud 50 relative to the housing 60, i.e. the needle shroud 50 is in its locked out position Z.

[0119] The illustrated needle shroud unlock device 30 comprises an unlock element 1. At a proximal end, the unlock element 1 may comprise a first interaction feature 4a configured to interact with the needle shroud lock element 51 , e.g. the inclined surface 52, when the needle shroud unlock device 30 is connected to the medicament delivery device 100a. The interaction further continues when the needle shroud unlock device 30, in particular the unlock element 1 , is moved proximally relative to the needle shroud 50. As illustrated, the interaction feature 4a may be a proximal protrusion of the unlock element 1, which may fit into a space formed between the housing 60 and the needle shroud lock element 51, when the unlock element 1 is moved proximally relative to the needle shroud 50. There may already be such a space when the needle shroud lock element 51 is in its relaxed state. Alternatively, the interaction feature 4a may create said space by sliding along the inclined surface 52, which causes a deflection of the needle shroud lock element 51. An inner surface 65 of a distal protrusion at a distal end of the housing 60 may guide a proximal movement of the interaction feature 4a with respect to the housing 60 and the needle shroud lock element 51 by providing a radial limitation to the interaction feature 4a which prevents a radial outward deflection of the interaction feature 4a. Alternatively or additionally, the interaction feature 4a may be more rigid than the needle shroud lock element 51 , such that the needle shroud lock element 51 deflects radially inwardly when the interaction feature 4a slides along the inclined surface 52. The radial inward deflection causes a disengagement of the needle shroud lock element 51 and the securing element 61 , thereby unlocking the needle shroud 50.

[0120] The inner surface 65 of the distal protrusion at a distal end of the housing 60 may further comprise holding means (not shown) for limiting a distal movement of the unlock element 1 relative to the housing 60, when the needle shroud 50 is unlocked. For example, the holding means may secure the unlock element 1 against a distal movement relative to the housing 60. In one embodiment, the holding means may frictionally engage the unlock element 1, e.g. a radial outer surface of the interaction feature 4a, such that the unlock element 1 is held in position by frictional force. Alternatively, or additionally, the holding means and the unlock element 1 may be configured to form fit to each other thereby limiting a distal movement of the unlock element 1 relative to the housing 60.

[0121] At the proximal end, the unlock element 1 may comprise an axial stop feature 4c configured to interact with a distal end of the medicament delivery device 100a, e.g. a distal end surface 66 of the distal end of the housing 60, to provide a stop for the proximal movement of the unlock element 1 relative to the needle shroud 50 and the housing 60. Attentively or additionally, the proximal movement of the unlock element 1 relative to the needle shroud 50 and the housing 60 may be limited by the interaction feature 4a abutting on the securing element 61.

[0122] The illustrated unlock element 1 comprises an engagement surface 15 configured to interact with an engagement surface 16 of a push element 2 of the needle shroud unlock device 30, when the unlock element 1 is moved proximally, thereby carrying the push element 2 proximally with respect to the needle shroud 50 and the housing 60. As illustrated, the engagement surface 15 may be formed by a proximal surface of a radial inward protrusion of the unlock element 1. A corresponding distally facing surface of this radial inward protrusion may be a distal end surface 17 of the unlock element 1. The radial inward protrusion forms an opening 18 through which a portion of the push element 2, e.g. a manipulation feature 11 , may protrude distally beyond the distal end surface 17. Via one or both of the distal end surface 17 and a radial outer surface 21 of the unlock element 1 , a user may apply a force to the unlock element 1 for moving the unlock element 1 relatively to the needle shroud 50 and / or the housing 60.

[0123] In the illustrated embodiment, the push element 2 is positioned radially inside the unlock element 1. The push element 2 is configured to move the needle shroud 50 proximally relative to the securing element 61 after the needle shroud lock element 51 and the securing element 61 have been disengaged and the needle shroud 50 is unlocked. Thus, the push element 2 may be moved proximally with respect to the unlock element 1 and the housing 60, when the needle shroud 50 is unlocked.

[0124] The push element 2 may comprise a radial protrusion 23 configured to guide the proximal movement of the push element 2 relative to the unlock element 1. For example, an outer surface of the radial protrusion 23 may slide along a radial inner surface 22 of the unlock element 1 thereby supporting the push element 2 in a radial direction. Likewise, the radial inner surface 22 may provide a radial limitation to a radial outward movement of the needle shroud 50, thereby limiting a radial outward deflection of the distal end of the needle shroud 50. Alternatively, or additionally, a radial outer surface of the push element 2 may be guided by the radial inner surface 54 of the radial inward protrusion of the needle shroud 50, when the push element moves in the axial direction.

[0125] At a proximal end, the radial protrusion 23 comprises a push surface 5 configured to interact with the engagement surface 53 of the needle shroud 50 for transferring a movement of the push element 2 to the needle shroud 50 such that the needle shroud 50 may be moved proximally relative to the securing element 61, e.g. into the housing 60.

[0126] According to an embodiment of the present disclosure, the proximal movement of the needle shroud 50 relative to the housing 60 ends when the needle shroud 50 reaches its first position X (see Figures 1 B and 3C), in which the needle shroud 50 may be locked against a distal movement relative to the housing 60. In other words, the needle shroud 50 may be reset and the medicament delivery device 100a may be re-used, as explained in detail above.

[0127] The push element 2 comprises a reception space 20 configured to receive the needle 71 and the needle attachment element 72, during the proximal movement of the push element 2 relative to the housing 60 and / or the syringe 70. At its proximal end, the reception space 20 is open. At its distal end, the reception space 20 is separated from a purifying chamber 3 of the push element 2 by a sealing element 19, e.g. a membrane, septum, foil or the like, which is pierceable by the needle 71. The purifying chamber s contains a purifying substance, e.g. alcohol or ozone, for cleaning and / or sterilizing the needle 71.

[0128] In one embodiment, a cross section of the reception space 20 may be larger than a cross section of the purifying chamber 3. Alternatively (not shown), the cross section of the reception space 20 may be equal or smaller than the cross section of the purifying chamber 3. Figures 3A to 3C illustrate the sequence of unlocking and resetting the needle shroud 50 with the needle shroud unlock device 30 of Figure 2A.

[0129] Figures 3D to 3F illustrate a detailed view of embodiments of respective portions of Figures 3A to 3C marked with a dashed circle in the respective Figures. Specifically Figure 3D shows a detailed view of a portion of Figure 3A, Figure 3E shows a detailed view of a portion of Figure 3B and Figure 3F shows a detailed view of a portion Figure 3C.

[0130] Figures 3G to 31 illustrate a detailed view of embodiments of respective portions of Figures 3A to 3C marked with a dashed rectangle in the respective Figures. Specifically, Figure 3G shows a detailed view of a portion of Figure 3A, Figure 3H shows a detailed view of a portion of Figure 3B and Figure 31 shows a detailed view of a portion of Figure 30.

[0131] Some features visible in the Figures 3D to 31 may not be visible in the respective illustrations of Figure 2A and / or 3A to 30. The embodiments of Figure 2A and / or Figures 3A to 30 are however not limited to the embodiments shown in Figures 3D to 31.

[0132] In Figure 3A the needle shroud 50 is in its locked out position Z and the needle shroud unlock device 30 is connected to the medicament delivery device 100a. The unlock element 1 may be configured to be secured against distal movement through a transition fit interface between the unlock element 1 (e.g. a portion thereof) and the housing 60.

[0133] Alternatively, or additionally, as shown in the exemplary embodiments of Figures 3D to 3F, the first interaction feature 4a of the unlock element 1 may comprise a clip 4d. The clip 4d may be arranged at a proximal portion of the first interaction feature 4a. The clip 4d may be configured to protrude radially outwards. The clip 4d may be configured to interact with a recess 67 of the housing 60. At this stage (shown in Figure 3A) the clip 4d may not interact with the recess 67 of the housing 60 (see e.g. Figure 3D).

[0134] The user may grip the distal end surface 17 and / or the radial outer surface 21 of the unlock element 1 in order to move the unlock element in the proximal direction P relative to the housing 60 and the syringe 70. During this movement the first interaction feature 4a slides along the inclined surface 52 of the needle shroud lock element 51 , thereby deflecting the needle shroud lock element 51 radially inwardly. This deflection disengages the needle shroud lock element 51 and the securing element 61 (see Figure 3B), thereby unlocking the needle shroud 50. At this stage, the clip 4d may be configured to engage at this point the recess 67. The engagement of the clip 4d with the recess 67 of the housing may result in an engagement of the unlock element 1 with the housing 60. This engagement may prevent the unlock element 1 from disengaging (e.g. falling) distally (see e.g. Figure 3E).

[0135] As shown in Figure 3F, the clip 4d may remain engaged to recess 67 also during the sequence described in relation to Figure 3C.

[0136] The proximal movement of the unlock element 1 relative to the needle shroud 50 and the housing 60 is stopped by the axial stop feature 4c abutting on the distal end surface 66. Alternatively, or additionally, a proximal end surface of the interaction element 4a may abut on the securing element 61.

[0137] During the proximal movement of the unlock element 1 relative to the needle shroud 50 and the housing 60, the push element 2 may be carried by the unlock element 1 due to the interaction between the engagement surface 15 of the unlock element 1 and the engagement surface 16 of the push element 2. Thus, the user may not need to grip and / or move the push element 2 separately.

[0138] When the needle shroud 50 is unlocked, the user may move the push element 2 proximally relative to the unlock element 1 and the housing 60. For example, the user may push the push element 2 via the manipulation feature 11, e.g. by pushing a distal end surface 11a of the manipulation feature 11 , in the proximal direction P. During this movement, the push surface 5 interacts with an engagement surface 53 of the needle shroud 50 thereby moving the needle shroud 50 proximally relative to the securing element 61. This movement may continue until the needle shroud lock element 51 has passed the securing element 61 and the needle shroud 50 is moved to its first position X. In the first position X, the needle shroud 50 may be locked against a distal movement relative to the housing 60. For example, a locking mechanism (not illustrated) configured to lock the needle shroud 50 against distal movement, when the needle shroud is in the first position X, e.g. before the injection, may be reset. This resets the needle shroud 50, re-establishing a state of the needle shroud 50 prior to the injection.

[0139] The medicament delivery device 100a, e.g. the housing 60, may comprise a stop element 63. The stop element 63 may be configured to interact with a stop feature 11b of the push element 2, e.g. the proximal end surface 11 b of the push element 2, to provide a stop for the proximal movement of the push element 2 relative to the housing 60. This may prevent damage to the needle shroud 50 and / or to the needle shroud locking mechanism (not shown) caused by the user applying an excessive proximal force to the push element 2. During the proximal movement of the push element 2 relative to the syringe 70, the needle 71 and the needle attachment element 72 subsequently enter the reception space 20 through the proximal opening. When a proximal tip of the needle 71 reaches the sealing element 19, a farther proximal movement of the push element 2 relative to the syringe 70 causes the needle 71 to pierce the sealing element 19 so that the needle 71 enters the purifying chamber 3 (see Figures 3A and 3B). The reception space 20 may extend in the axial direction for the same length as the needle attachment element 72 protrudes distally beyond the housing 60. This may ensure that the whole free length of the needle 71 , i.e. the length of the needle 71 that distally extends from the needle attachment element 72, has entered the purifying chamber 3 when the proximal movement of the push element 2 stops (see Figure 3C). Alternatively, the reception space 20 may be designed such that only a part of the needle 71 enters the purifying chamber 3.

[0140] The manipulation feature 11 may further comprise status indication feature (not shown) configured to indicate to the user that the push element 2 is in its most proximal position, in other words, that the needle shroud 50 is moved to its first position X and / or reset. The status indication feature may provide a visual, audible and / or tactile feedback to the user. For example, the status indication feature may be an axial alignment of the distal end surface 17 of the unlock element with the distal end surface 11a of the manipulation feature 11 (see Figure 3C). Alternatively, or additionally, the status indication feature may comprise one or more visually perceivable elements, e.g. prints or engravings on the unlock element 1 , e.g. the distal end surface 17 thereof, and on the manipulation feature 11, e.g. the distal end surface 11a thereof. Alternatively, or additionally, the status indication feature may comprise one or more visually perceivable elements on a circumferential surface of the push element 2, e.g. the manipulation feature 11. The status indication feature may indicate to the user that the needle shroud 50 has been reset Consequently, the user may disconnect the needle shroud unlock device 30 from the medicament delivery device 100a and the medicament delivery device 100a may be re-used, e.g. to discharge another dose of medicament from the syringe 70.

[0141] Figures 3G to 3I show a detailed view of an embodiment of the distal part of the unlocking element 1 and the push element 2 of Figures 3A to 3C. The embodiments of Figures 3A to 3C are however not limited to the embodiments shown in Figures 3G to 3I.

[0142] The unlock element 1 may comprises a clip 1b configured to interact with the push element 2 and / or with the needle shroud 50. As can be seen in Figure 3G, during the first steps of the sequence of unlocking and resetting the needle shroud 50 with the needle shroud unlock device 30 of Figure 2A, (see. e.g. Figure 3A and the respective description), the clip 1b may protrude radially inwards. A distal surface 1c of the clip 1b may engage e.g. abut, with a surface of the push element 2. The push element 2 may be preventing from being moved proximally.

[0143] As described with respect to Figure 2A, the engagement surface 15 may be formed by a proximal surface of a radial inward protrusion of the unlock element 1. The radial inward protrusion may form an opening 18 through which a portion of the push element 2, e.g. a manipulation feature 11, may protrude distally beyond the distal end surface 17. The radial inward protrusion may further comprise a recess 18a.

[0144] In Figure 3H (corresponding to a detailed view of an embodiment of a portion of Figure 3B), the unlock element 1 may be pushed proximally. The clip 1b may interact with the distal end of the shroud 50 and thereby be deflected radially outwards. The clip 1b may comprise a ramped surface configured to interact with the distal end of the shroud 50. The interaction of the shroud 50 with the ramped surface may cause the clip 1b to deflect radially outwards.

[0145] The radial outward deflection of the clip 1 b may causes a disengagement of the unlock element 1 with the push element 2. The push element 2 may thereby be free to move, e.g. to be pushed, in a proximal direction (as shown in Figure 3I).

[0146] The push element 2 may comprise at a distal portion, a further clip 11c. The clip 11c may be configured to engage with the recess 18a of the radial inward protrusion of the unlock element 1 (see e.g. Figure 3I). When engaged with the recess 18a, the push element 2 may be axially locked in a distal direction with respect to the unlock element 1.

[0147] Through the movement of the push element 2 in a proximal direction (and thereby of the needle shroud 50), the clip 1b of the unlock element 1 may be disengaged from its engagement with the shroud 50. The clip 1b may therefore be free to return to its radially inwards protruding position (see Figure 3I).

[0148] In the following, further aspects and embodiments will be described with reference to Figures 4 to 12. In this context, identical elements, elements of the same kind and identically or similarly acting elements may be provided with the same reference numerals. A repetition of explanations regarding these elements may be omitted, where appropriate. If not explicitly indicated otherwise, reference is made to the explanations given in the context of the other aspects and embodiments of the present disclosure.

[0149] Figure 4 illustrates an embodiment of a needle shroud unlock device 30 according to the present disclosure. The needle shroud unlock device 30 comprises an unlock element 1, a push element 2 and a purifying element 6. The unlock element 1 comprises a recess feature, e.g. at least one notch or groove 7a, 7b disposed on the outer circumferential surface of the unlock element 1. The push element 2 comprises a corresponding coupling feature 8 configured to interact with the recess feature of the unlock element 1 such that the unlock element 1 is carried by the push element 2, when the push element 2 is moved with respect to one or more of the needle shroud 50, the housing 60 and the syringe 70. In the illustrated embodiment, the coupling feature 8 is a snap arm with a radial inward protrusion that engages the distal groove 7a of the unlock element 1, before the needle shroud 50 is unlocked (see Figure 5A).

[0150] The purifying element 6 may comprise at its distal end a block element 6a. The block element 6a may be configured as an integral part of the purifying element 6 or may be a separate component, e.g. a rip bayonet mounted on the distal end. The block element may be configured to extend radially outwards. The block element may be configured to interact with the distal surface of the push element 2. The push element 2 may act as an interface between the unlock element 1 and the purifying element 6.

[0151] As regards the geometry of a proximal end of the unlock element 1 and the interactions between the interaction feature 4a, the axial stop feature 4c, the inner surface 22, the needle shroud 50, the needle shroud lock element 51 , the housing 60, the securing element 61 and / or the distal surface 66, reference is made to the explanations given in the foregoing.

[0152] Figures 5A and 5B illustrate the sequence of unlocking of the needle shroud 50 with the needle shroud unlock device of Figure 4. In detail, the user may grip the push element 2 and move the push element 2 in the proximal direction P. Thereby, the unlock element 1 is carried by the push element 2 in the proximal direction P such that the interaction feature 4a slides along the inclined surface 52 of the needle shroud lock element 51 and thereby deflects the needle shroud lock element 51 radially inwardly, as described in the foregoing. When the axial stop feature 4c and / or a proximal surface of the interaction feature 4a abuts on the distal surface 66 and / or on the securing element 61 , respectively, the unlock element 1 has reached its proximal position in which the needle shroud lock element 51 and the securing element 61 are disengaged and the needle shroud 50 is unlocked (see Figure 5B).

[0153] Alternatively, or additionally, when the needle shroud unlock device 30 is connected to the medicament delivery device 100a, the user may grip the unlock element 1 directly and move the unlock element 1 in the proximal direction P relative to the needle shroud 50 for disengaging the needle shroud lock element 51 and the securing element 61. Hence, the push element 2 may be carried by the unlock element 1 , due to the interaction of the coupling feature 8 and the distal groove 7a. As illustrated in Figure 5B, when the needle shroud 50 is unlocked and the unlock element 1 is in its proximal position, a further proximal force applied to the push element 2 may cause the coupling feature 8 to disengage from the distal groove 7a. For example, when the coupling feature 8 is a snap arm with a radial inward protrusion, an inclined proximal surface of the radial inward protrusion may slide along an edge of the distal groove 7a, e.g. at a proximal portion of the distal groove 7a, such that the snap arm radially outwardly deflects and the radial inward protrusion of the snap arm disengages from the distal groove 7a. After this disengagement, the push element 2 may be moved proximally with respect to the unlock element 1 , thereby moving the needle shroud 50 proximally relative to the securing element 61 until the needle shroud 50 reaches its first position X (see Figure 5C), in which it may be reset, as described in the foregoing. When the needle shroud 50 is in the first position X, the push element 2 may be in its final proximal position relative to the unlock element 1 and / or the housing 60.

[0154] In one embodiment, the proximal movement of the push element 2 may be stopped by the coupling feature 8 engaging the proximal groove 7b (see Figure 5C). In this position, there may be a clearance (not shown) between the stop feature 11 b of the push element 2 and the distal end surface 17 of the unlock element 1.

[0155] In one embodiment (not shown), the proximal movement of the push element 2 may alternatively or additionally be stopped when a proximal end surface of the push element 2 contacts the distal end surface 66 of the distal end of the housing 60. In another embodiment (not shown) the purifying element 6 may be directly coupled to the unlock element 1 such that the purifying element 6 is e.g. carried by the unlock element 1 when the unlock element 1 is moved proximally relative to the needle shroud lock element 51, securing element 61 and / or the syringe 70.

[0156] In the illustrated embodiment, the purifying element 6 comprises the reception space 20, the sealing element 19 and the purifying chamber 3, the function of which is described in the foregoing. During the reset of the needle shroud 50, i.e. when the needle shroud 50 is moved from the locked out position Z (see Figure 5A) to the first position X (see Figure 5C), the needle 71 and the needle attachment element 72 may enter the reception space 20, the needle 71 may pierce the sealing element 19, the needle 71 may enter the purifying chamber 3 and the reception space 20 may seal the needle 71 and the needle attachment element 71, according to the sequence described in the foregoing. The proximal movement of the purifying element 6 may be limited by a contact between a proximal end surface of the purifying element 6 and the stop element 63 (see Figure 5B). The purifying element 6 may comprise a status indication feature 13 configured to indicate to the user that the needle shroud 50 is reset to its first position X. The status indication feature 13 may provide a visual, audible and / or tactile feedback to the user. In the embodiment illustrated in Figures 4 and 5, the status indication feature 13 comprises a visual feedback feature, e.g. a print, on the outer surface of a distal end of the purifying element 6. The print is designed such that it is at least partially hidden by the push element 2 before the needle shroud 50 is in its first position X (see Figures 5A and 5B). When the needle shroud 50 is in the first position X, the status indication feature 13 may be fully visible to the user (see Figure 5C). The purifying element 6 may also comprise at last one groove 13. The at least one axial groove may define the axial movement of the purifying element 6. The at least one groove 13 may be configured to act or to be as indication feature 13.

[0157] Figure 6A illustrates an embodiment of the unlock device 30 according to the present disclosure. The unlock device 30 comprises an unlock element 1 and a push element 2.

[0158] Figure 6B illustrates the needle shroud unlock device 30 of Figure 6A in a state in which it is connected to a medicament delivery device 100b. Apart from the needle shroud lock element 51 and the securing element 61 , the labelled features of the medicament delivery device 100b may be similar to the labelled features of the medicament delivery device 100a illustrated in Figures 1 E and 2 to 5.

[0159] As illustrated, the unlock element 1 may be disposed radially inside the push element 2. Additionally, the push element 2 may have a closed distal end. The closed distal end may limit a distal movement of the unlock element 1 relative to the push element 2. The unlock element 1 and the push element 2 may be engaged via a coupling feature 10 of the unlock element 1 interacting, e.g. engaging, with a recess feature 9 of the push element 2, before the needle shroud 50 is unlocked.

[0160] The coupling feature 10 may be flexible, e.g. a snap arm, such that it can deflect predominantly in a radial direction. The coupling feature 10 may comprise a first radial outward protrusion 24a forming an engagement surface 15 for interacting with the push element 2, e.g. engaging an engagement surface 16 of the push element 2. As illustrated in Figures 7A and 7B, the unlock element 1 may be carried by the push element 2 when the coupling feature 10 and the recess feature 9 are engaged via the engagement surfaces 15 and 16. Thus, a movement of the push element 2, e.g. when the user grips the push element 2 and moves it in the axial direction relative to one or more of the needle shroud 50, the housing 60 and the syringe 70, may cause a corresponding movement of the unlock element 1. At a proximal end, the coupling feature 10 may comprise a second radial outward protrusion 24b (see Figure 6A). The second radial outward protrusion 24b may comprise an inclined surface configured to facilitate a radial inward deflection of the coupling feature 10, e.g. when interacting with an engagement surface 53 of the needle shroud 50. Due to this deflection, the coupling feature 10 may disengage from the recess feature 9 of the push element 2 (see Figure 7B), thereby enabling a movement of the push element 2 relative to the unlock element 1 in the axial direction. According to an embodiment of the present disclosure (not shown), the first radial outward protrusion 24a may be shaped and positioned to form the engagement surface 15 and additionally provide an inclined surface configured to facilitate a radial inward deflection of the coupling feature 10, e.g. when interacting with an engagement surface 53 of the needle shroud 50. Hence, the coupling feature 10 may comprise only one radial outward protrusion.

[0161] The unlock element 1 may comprise the purifying chamber 3, the sealing element 19 and the reception space 20, the functions of which had been described in the foregoing.

[0162] The unlock element 1 further comprises a second interaction feature 4b configured to interact with the needle shroud lock element 51, e.g. slide along the inclined surface 52, when the needle shroud unlock device 30 is connected to the medicament delivery device 100b and the unlock element 1 is moved relative to the needle shroud 50, e.g. in the proximal direction P. This may unlock the needle shroud 50 by disengaging the needle shroud lock element 51 and the securing element 61, allowing the needle shroud 50 to be moved relative to the securing element 61 , as described in the foregoing.

[0163] Alternatively (not illustrated in Figures 6 and 7), the interaction feature 4b may interact with the needle shroud lock element 51 already when the needle shroud unlock device 30 connected to the medicament delivery device 100b.

[0164] As illustrated in Figures 6 and 7, the interaction feature 4b may be a proximal end of the unlock element 1. Referring to Figures 7B and 7C, when the needle shroud lock element 51 and the securing element 61 are disengaged, the second radial outward protrusion 24b, in specific its inclined surface, no longer interacts with the engagement surface 53 of the needle shroud 50. In other words, the coupling feature 10 of the unlock element 1 is deflected and disengaged from the recess feature 9 of the push element 2, such that the engagement surface 15 of the unlock element 1 no longer interacts with the engagement surface 16 of the push element 2 (see Figure 7B). Hence, the push element 2 may be moved proximally to a final proximal position with respect to the unlock element 1 and the housing, thereby moving the needle shroud 50 proximally to its first position X in which the needle shroud 50 may be reset (see Figure 7C). The proximal movement of the push element 2 may be limited by maximum proximal movement of the needle shroud 50, e.g. when the needle shroud reaches its first position X or its second position Y, in which a farther proximal movement of the needle shroud 50 may be limited. Alternatively, or additionally, the proximal movement of the push element 2 may be limited by a proximal surface of a proximal end of the push element 2 abutting on the distal end surface 66 of the distal end of the housing 60. Alternatively, or additionally, the proximal movement of the push element 2 may limited by a contact between the distal end surface 17 of the unlock element 1 and a proximally facing surface of a distal end of the push element 2.

[0165] In its final proximal position, a distal movement of the push element 2 relative to the housing 60 may be limited by holding means (not shown) of the inner surface 65 of the housing 60, as described before with respect to Figures 3A to 3C. In one embodiment, the holding means may frictionally engage the push element 2, e.g. a proximal protrusion thereof at a proximal end of the push element 2, such that the push element 2 is held in position by frictional force. Alternatively, or additionally, the holding means and the push element 2 may be configured to form fit to each other thereby limiting a distal movement of the push element 2 relative to the housing 60.

[0166] Figure 8 illustrates an embodiment of the needle shroud unlock device 30 in a perspective side view. The unlock element 1 comprises the status indication feature 13. According to the present disclosure, when the unlock element 1 is positioned radially inside the push element 13, the status indication feature 13 may be a print on the unlock element 1 that may be visible through a window 14 of the push element 2. The status indication feature 13 is configured to provide information to the user regarding the progress of the needle shroud unlock and / or reset process. For example, the status indication feature 13 may comprise prints of different colors distributed on a radial outer surface unlock element 1 in the axial direction. Thus, depending on the relative position between the push element 2 and the unlock element 1 , which, when the needle shroud unlock device 30 is connected to the medicament delivery device 100, 100a, 100b determines the position of the needle shroud 50 relative to the housing 60, different colors may be visible to the user at different times of the unlock and / or reset process. The different colors may be visible through the window 14. Alternatively, the status indication feature 13 may be a single print which is positioned such that it is only visible through the window 14 when the needle shroud 50 is reset.

[0167] Figures 9A to 9C illustrate the sequence of unlocking and resetting the needle shroud 50 with a needle shroud unlock device 30 according to an embodiment of the present disclosure. This needle shroud unlock device 30 mostly corresponds to the needle shroud unlock device illustrated in Figures 6 and 7. The only difference is that the unlock element 1, in specific the reception space 20 and the interaction feature 4b, are shorter in the axial direction.

[0168] The needle shroud unlock device 30 illustrated in Figures 9A to 9C is configured to unlock and, optionally, reset the needle shroud 50 of the medicament delivery device 100b. In this embodiment, the medicament delivery device 100b additionally comprises a disengagement element 62. The disengagement element 62 may be a locking ring which can be connected to the needle shroud 50. For example, the locking ring may be flexible so that it can be inserted into the needle shroud 50 from a distal end, e.g. when the needle shroud 50 is in its first position X. Alternatively, the locking ring may be inserted during manufacturing of the medicament delivery device 100b.

[0169] The disengagement element 62, e.g. the locking ring, may be particularly advantageous in medicament delivery devices 100b in which an opening defined by the radial inner surface 54 of the needle shroud 50 is smaller than the distance between the needle shroud lock element’s most inner surface 51a and the longitudinal axis A. In other words, the locking ring may be particularly advantageous if the distance between the radial inner surface 54 and the longitudinal axis A is smaller than the smallest distance between the needle shroud lock element 51 and the longitudinal axis A.

[0170] In detail, the interaction feature 4b of the unlock element 1 must be designed according to the diameter of the distal opening defined by the radial inner surface 54 as the interaction feature 4b needs to pass therethrough when the needle shroud unlock device 30 is connected to the medicament delivery device 100b. If the distance between the radial inner surface 54 and the longitudinal axis A is smaller than the smallest distance between the needle shroud lock element 51 and the longitudinal axis A, the interaction feature 4b may not be able to contact the needle shroud lock element 51, e.g. the inclined surface 52, when the unlock element 1 is moved proximally relative to the needle shroud 50. In other words, a radial outward extension of the interaction feature 4b might not be sufficient for disengaging the needle shroud lock element 51 and the securing element 61. Hence the needle shroud 50 might not be unlocked.

[0171] As the disengagement element 62 may be flexible or be inserted when the medicament delivery device 100b is assembled, the disengagement element 62 may have a wider radial extension than the interaction feature 4b because it can deform or does even not need to pass through the distal opening defined by the radial inner surface 54. Hence, the disengagement element 62 may extend far enough in a radial outward direction to interact with the needle shroud lock element 51 , e.g. slide along the inclined surface 52, when moved relatively to the needle shroud lock element 51, e.g. in the proximal direction P. Thus, as illustrated in Figures 9A to 9C, the interaction feature 4b may be configured to interact with the needle shroud lock element 51 via the disengagement element 62 for disengaging the needle shroud lock element 51 and the securing element 61, thereby unlocking the needle shroud 50 (see Figure 9B). When the needle shroud 50 is unlocked, the disengagement element 62 may abut on the securing element 61 , thereby limiting the proximal movement of the unlock element 1 relative to one or more of the needle shroud 50, the housing 60 and the syringe 70.

[0172] As described with respect to the needle shroud unlock device 30 of Figures 6 and 7, the coupling feature 10 of the unlock element 1 may disengage from the recess feature 9 of the push element 2, when the proximal movement of the unlock element 1 is blocked and a proximally directed force is applied to the push element 2. The details described in the context of Figures 6 and 7 regarding the interaction of features and elements for disengagement of the push element 2 and the unlock element 1 as well as the proximal movement and reset of the needle shroud 50 apply to the needle shroud unlock device illustrated in Figures 9A to 9C, likewise.

[0173] Figure 10 illustrates a system 300 according to an aspect of the present disclosure. The system 300 comprises a medicament delivery device 100, 100a, 100b and a needle shroud unlock device 30. The medicament delivery device 100, 100a, 100b may be a medicament delivery device as described in the foregoing. The medicament delivery device 100, 100a, 100b may be an autoinjector. The medicament delivery device 100, 100a, 100b, inter alia, comprises a housing 60, a drive mechanism 101 , a syringe 70 and a needle shroud 50. In the illustrated state, the needle shroud is in the locked out position Z, in which it is locked against a proximal movement relative to the housing 60. The needle shroud unlock device 30 is connected to a distal end of the medicament delivery device 100, 100a, 100b. The needle shroud unlock device 30 is configured to unlock the needle shroud 50 from the locked out position Z, thereby enabling a proximal movement of the needle shroud 50 relative to the housing 60 of the medicament delivery device 100, 100a, 100b. The illustrated needle shroud unlock device 30 comprises a push element 2 with a manipulation feature 11 via which a user may move the needle shroud to the first position X. In the first position, the needle shroud 50 may be reset, e.g. locked against a movement in a distal direction relative to the housing 60.

[0174] In Figure 10, the shroud unlock device 30 is a needle shroud unlock device 30 according to Figures 2 and 3 of the present disclosure. However, other needle shroud unlock devices, especially the needle shroud unlock devices 30 of other embodiments of the present disclosure, may be comprised in the system 300 instead of the exemplarily illustrated needle shroud unlock device 30 according to Figures 2 and 3. Figure 11 illustrates steps of a method for unlocking a needle shroud 50 of a medicament delivery device 100, 100a, 100b according to an aspect of the present disclosure. The method starts, when the needle shroud 50 is in a locked out position S100, Z, e.g. after completion of an injection and removal of the medicament delivery device from the injection site. In the locked out position, a needle shroud lock element 51 and a securing element 61 of the medicament delivery device 100, 100a, 100b are engaged, thereby locking the needle shroud 50 in the locked out position Z, as described in the foregoing.

[0175] A user may connect, S101 , a needle shroud unlock device to the medicament delivery device 100, 100a, 100b. For example, the user may attach the needle shroud unlock device to a housing 60 of the medicament delivery device 100, 100a, 100b, especially to a distal end thereof. The needle shroud unlock device may be a needle shroud unlock device 30 according to an embodiment of the present disclosure.

[0176] After connecting the needle shroud unlock device 30 to the medicament delivery device 100, 100a, 100b the needle shroud unlock device 30 may be operated by the user. For example, the user may push one or both of an unlock element 1 and a push element 1 of the needle shroud unlock device 30 proximally relatively to the needle shroud 50. Thereby, the needle shroud lock element 51 and the securing element 61 may be disengaged, S102, and the needle shroud 50 may be unlocked. When unlocked, the needle shroud 50 is proximally movable relative to the housing 60 of the medicament delivery device 100, 100a, 100b, e.g. into the housing 60.

[0177] In one embodiment, the method may further comprise the step of moving, S103, the needle shroud 50 to a first position X. In the first position X, the needle shroud 50 may be locked against a movement in a distal direction relative to the housing 60. Further, in the first position X, the needle shroud 50 may protrude less beyond a tip of the needle 71 than in the locked out position Z. In the first position, the needle shroud 50 may be reset S104, i.e. the needle shroud 50 may be secured against a distal movement relative to the housing 60 and / or the needle 71 , as described in the foregoing. In one embodiment moving, S103, and resetting, S104, may be realized as a single step.

[0178] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0179] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0180] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0181] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0182] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide. Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0183] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega- carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin. Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1 , GSK-2374697, DA-3091 , MAR-701 , MAR709, ZP- 2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA- 15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide- XTEN and Glucagon-Xten.

[0184] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

[0185] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0186] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0187] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0188] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0189] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0190] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0191] 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).

[0192] Further examples of APIs for the prophylaxis of hemophilia A or B, with or without inhibitors, include an siRNA targeting antithrombin. An example of an siRNA targeting antithrombin is fitusiran. The term “prophylaxis” and “prophylactic treatment” are used interchangeably herein. Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0193] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0194] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0195] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

[0196] As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1:2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0197] Fitusiran as the API for the medicament in the device

[0198] Fitusiran is a synthetic, chemically modified double-stranded small interfering RNA (siRNA) oligonucleotide covalently linked to a tri-antennary N-acetyl-galactosamine (GalNAc) ligand targeting AT3 mRNA in the liver, thereby suppressing the synthesis of antithrombin. See, e.g., Pasi et al., N Engl J Med. (2017) 377(9):819-28. The nucleosides in each strand of fitusiran are connected through either 3’-5’ phosphodiester or phosphorothioate linkages, thus forming the sugar-phosphate backbone of the oligonucleotide.

[0199] The sense strand and the antisense strand contain 21 and 23 nucleotides, respectively. The 3’ end of the sense strand is conjugated to the GalNAc containing moiety (referred to herein as L96) through a phosphodiester linkage. The sense strand contains two consecutive phosphorothioate linkages at its 5’ end. The antisense strand contains four phosphorothioate linkages, two at the 3’ end and two at the 5’ end. The 21 nucleotides of the sense strand hybridize with the complementary 21 nucleotides of the antisense strand, thus forming 21 nucleotide base pairs and a two-base overhang at the 3’-end of the antisense strand. See also U.S. Pat. 9,127,274, U.S. Pat. 11,091,759, US2020 / 0163987A1, and WO 2019 / 014187, the entire contents each of which are expressly incorporated herein by reference.

[0200] The two nucleotide strands of fitusiran are shown below: sense strand: 5’Gf-ps-Gm-ps-Uf-Um-Af-Am-Cf-Am-Cf-Cf-Af-Um-Uf-Um-Af-Cm-Uf-Um- Cf-Am-Af-L96 3’ (SEQ ID NO:1), and antisense strand: 5’ Um-ps-Uf-ps-Gm-Af-Am-Gf-Um-Af-Am-Af-Um-Gm-Gm-Uf-Gm-Uf- Um-Af-Am-Cf-Cm-ps-Am-ps-Gm 3’ (SEQ ID NO:2), wherein

[0201] Af = 2’ -deoxy- 2’-fluoroadenosine Cf = 2’ -deoxy- 2’-fluorocytidine Gf = 2’ -deoxy- 2’-fluoroguanosine Uf = 2’ -deoxy- 2’-fluorouridine Am = 2’-O-methyladenosine Cm = 2’-O-methylcytidine Gm = 2’-O-methylguanosine Um = 2’-O-methyluridine (hyphen) = 3’-5’ phosphodiester linkage sodium salt “-ps-” = 3’-5’ phosphorothioate linkage sodium salt and wherein L96 has the following formula:

[0202] (I).

[0203] As used herein, the terms 2’ -deoxy- 2’-fluoroadenosine and 2’-fluoroadenosine may be used interchangeably.

[0204] As used herein, the terms 2’ -deoxy- 2’-fluorocytidine and 2’-fluorocytidine may be used interchangeably.

[0205] As used herein, the terms 2’ -deoxy- 2’-fluoroguanosine and 2’-fluoroguanosine may be used interchangeably.

[0206] As used herein, the terms 2’ -deoxy- 2’-fluorouridine and 2’-fluorouridine may be used interchangeably.

[0207] The expanded structural formula, molecular formula, and molecular weight of fitusiran, e.g. in sodium form, are shown in Figure 12.

[0208] The structure of fitusiran can also be described using the following diagram, wherein the X is O:

[0209] Fitusiran is shown in Figure 12 in sodium salt form.

[0210] In some embodiments, the device delivers fitusiran in an aqueous solution, wherein fitusiran is at a concentration of about 40 to about 200 mg / mL (e.g., about 50 to about 150 mg / mL, about 80 to about 110 mg / mL, or about 90 to about 110 mg / mL). As used herein, values intermediate to recited ranges and values are also intended to be part of this disclosure. In addition, ranges of values using a combination of any of recited values as upper and / or lower limits are intended to be included. In further embodiments, the pharmaceutical formulation comprises fitusiran in an aqueous solution at a concentration of about 40, about 50, about 75, about 100, about 125, about 150, or about 200 mg / mL. In certain embodiments, fitusiran is provided in an aqueous solution at a concentration of about 100 mg / mL.

[0211] The term “deliver,” “delivers,” or “delivering” is intended to mean “administer,” “administers,” or “administering.”

[0212] Unless specifically stated or otherwise evident from the context, as used herein, the term “approximately” or "about" refers to a value that is within an acceptable error range for a particular value determined by a person of ordinary skill, a portion of which will depend on how the measurement or determination is made. For example, “approximately” or "about" may mean a range of up to 10% (ie, ±10%). Therefore, “approximately” or "about" can be understood as greater than or less than 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1 %, 0.05%, 0.01%, or 0.001%. When a specific value is provided in this disclosure, unless otherwise stated, the meaning of “approximately” or "about" should be assumed to be within an acceptable error range for that specific value.

[0213] While the fitusiran dosage weight described herein refers to the weight of fitusiran free acid (active moiety), administration of fitusiran to patients herein refers to administration of fitusiran sodium (drug substance) provided in a pharmaceutically suitable aqueous solution (e.g., a phosphate-buffered saline at a physiological pH). For example, about 100 mg / mL fitusiran means about 100 mg of fitusiran free acid (equivalent to about 106 mg fitusiran sodium, the drug substance) per mL. Unless otherwise indicated, a fitusiran weight recited in the present disclosure is the weight of fitusiran free acid (the active moiety).

[0214] In some embodiments, a pharmaceutical formulation in the device comprises fitusiran in a phosphate-buffered saline. The phosphate concentration in the solution may be about 1 to about 10 mM (e.g., about 2, about 3, about 4, about 5, about 6, about 7, about 8, or about 9 mM), with a pH of about 6.0-8.0. The pharmaceutical formulations herein may include a stabilizing agent such as EDTA. The pharmaceutical formulations may be preservative-free. In some embodiments, the fitusiran pharmaceutical formulation in the device is preservative-free and comprises, consists of, or consists essentially of about 100 mg of fitusiran per mL of an approximately 5 mM phosphate buffered saline (PBS) solution. In some embodiments, the fitusiran pharmaceutical formulation in the device is preservative-free and comprises, consists of, or consists essentially of fitusiran in an approximately 5 mM phosphate buffered saline (PBS) solution. The PBS solution is composed of sodium chloride, dibasic sodium phosphate (heptahydrate), and monobasic sodium phosphate (monohydrate). Sodium hydroxide solution and diluted phosphoric acid may be used to adjust the pH of the formulation to about 7.0 or about 7.1. In some embodiments, the fitusiran formulation in the device for subcutaneous delivery contains fitusiran in a 5 mM phosphate buffered saline having 0.64 mM NaH2PO4, 4.36 mM Na2HPC>4, and 84 mM NaCI at pH 7.0. In certain embodiments, the formulation of fitusiran solution for subcutaneous delivery is shown in Table 1 below: Table 1. Exemplary Fitusiran Formulation

[0215] *q.s.: quantum satis

[0216] In some embodiments, the formulation of fitusiran solution for subcutaneous delivery with the device can be described as shown in Table 2 below.

[0217] Table 2. Exemplary Fitusiran Formulation

[0218] In some embodiments, the device may be used to deliver a single dose of fitusiran wherein the single dose comprises about 20 to about 80 mg of fitusiran (e.g., about 20 mg, about 25 mg, about 30 mg, about 40 mg, about 50 mg, or about 80 mg). In some embodiments, the device may be used to deliver single dose of fitusiran, wherein the single dose comprises about 1 to about 30 mg of fitusiran (e.g., about 1.25 mg, about 2.5 mg, about 5 mg, about 10 mg, about 20 mg, or about 30 mg).

[0219] In one embodiment, the device may be used to deliver a single dose of about 80 mg of fitusiran.

[0220] In one embodiment, the device may be used to deliver a single dose of about 50 mg of fitusiran.

[0221] In one embodiment, the device may be used to deliver a single dose of about 20 mg of fitusiran.

[0222] In one embodiment, the device may be used to deliver a single dose of about 30 mg of fitusiran.

[0223] In one embodiment, the device may be used to deliver a single dose of about 10 mg of fitusiran.

[0224] In one embodiment, the device may be used to deliver a single dose of about 5 mg of fitusiran. In one embodiment, the device may be used to deliver a single dose of about 2.5 mg of fitusiran. In one embodiment, the device may be used to deliver a single dose of about 1.25 mg of fitusiran.

[0225] In some embodiments, the single dose of fitusiran may be delivered in about 0.5 mL to about 1 mL delivery volumes (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL). Other delivery volumes described herein may also be used.

[0226] In one embodiment, the device may be used to deliver a single dose of about 80 mg of fitusiran in about 0.8 mL (about 100 mg fitusiran / mL). In one embodiment, the device may be used to deliver a single dose of about 50 mg of fitusiran in about 0.5 mL (about 100 mg fitusiran / mL). In one embodiment, the device may be used to deliver a single dose of about 20 mg of fitusiran in about 0.5 mL (about 40 mg fitusiran / mL). In one embodiment, the device may be used to deliver a single dose of about 30 mg of fitusiran in about 0.5 mL (about 60 mg fitusiran / mL). In one embodiment, the device may be used to deliver a single dose of about 10 mg of fitusiran in about 0.5 mL (about 20 mg fitusiran / mL). In one embodiment, the device may be used to deliver a single dose of about 5 mg of fitusiran in about 0.5 mL (about 10 mg fitusiran / mL). In one embodiment, the device may be used to deliver a single dose of about 2.5 mg of fitusiran in about 0.5 mL (about 5 mg fitusiran / mL). In one embodiment, the device may be used to deliver a single dose of about 1.25 mg of fitusiran in about 0.5 mL (about 2.5 mg fitusiran / mL).

[0227] In one embodiment, the device delivers fitusiran at a prophylactically effective amount to prophylactically treat hemophilia (e.g., hemophilia A or B, in a patient with or without inhibitors) in a patient in need thereof (e.g., a hemophilia A or B patient, with or without inhibitors). “Prophylactically effective amount” refers to the amount of fitusiran that helps the patient with hemophilia A or B, with or without inhibitors to achieve a desired clinical endpoint such as reducing the Annualized Bleeding Rate (ABR), Annualized Joint Bleeding Rate (AjBR), Annualized Spontaneous Bleeding Rate (AsBR), or the frequency of bleeding episodes. As used herein in the context of fitusiran, the term “treat” “treating,” or “treatment” includes prophylactic treatment of the disease and refers to achievement of a desired clinical endpoint.

[0228] A hemophilia A or B patient with inhibitors refers to a patient who has developed alloantibodies to the factor he / she has previously received (e.g., factor VIII for hemophilia A patients or factor IX for hemophilia B patients). A hemophilia A or B patient with inhibitors may become refractory to replacement coagulation factor therapies. A patient without inhibitors refers to a patient who does not have such alloantibodies. The present treatment methods may be beneficial for hemophilia A patients with inhibitors, as well as for hemophilia B patients with inhibitors.

[0229] As used herein, a patient with “hemophilia A or B, with or without inhibitors,” or refers to 1) a hemophilia A patient with inhibitors, or 2) a hemophilia B patient with inhibitors, 3) a hemophilia A patient without inhibitors, or 4) a hemophilia B patient without inhibitors. As used herein, a patient refers to a human patient. A patient can also refer to a human subject.

[0230] In some embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of about 50 mg of fitusiran once every two months (or every eight weeks). In other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of about 50 mg of fitusiran every month (or every four weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of about 80 mg of fitusiran every two months (or every eight weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of about 80 mg of fitusiran every month (or every four weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of about 20 mg of fitusiran every two months (or every eight weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of about 20 mg of fitusiran every month (or every four weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of about 10 mg of fitusiran every month (or every four weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of fitusiran at about 30 mg every month (or every four weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of fitusiran at about 5 mg every month (or every four weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of fitusiran at about 2.5 mg every month (or every four weeks). In yet other embodiments, the device may be used to prophylactically treat a patient with hemophilia A or B, with or without inhibitors, with a subcutaneous dose of fitusiran at about 1.25 mg every month (or every four weeks).

[0231] Accordingly, provided herein is a method of prophylactic treatment of a patient with hemophilia A or hemophilia B, with or without inhibitors, comprising subcutaneously delivering with the device a prophylactically effective amount of fitusiran to the patient in need thereof. The prophylactically effective amount of fitusiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactically effective amount of fitusiran may be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The prophylactically effective amount of fitusiran may be delivered every month (or every four weeks) or once every two months (or every eight weeks). Fitusiran may be delivered in about 0.5 mL to about 1 mL delivery volumes (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0232] As an example, a method of prophylactic treatment of a patient with hemophilia A or hemophilia B, with or without inhibitors, may comprise subcutaneously delivering with the device about 50 mg of fitusiran to the patient in need thereof every month (or every four weeks) or once every two months (or every eight weeks). The about 50 mg of fitusiran may be delivered in about 0.5 mL PBS (at a concentration of about 100 mg fitusiran / mL).

[0233] Further provided herein is a method of reducing the frequency of bleeding episodes in a patient with hemophilia A or B, with or without inhibitors, comprising subcutaneously delivering with the device a prophylactically effective amount of fitusiran to the patient in need thereof. The prophylactically effective amount of fitusiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactically effective amount of fitusiran may be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The prophylactically effective amount of fitusiran may be delivered every month (or every four weeks) or once every two months (or every eight weeks). Fitusiran may be delivered in about 0.5 mL to about 1 mL delivery volumes (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL). As an example, a method of reducing the frequency of bleeding episodes in a patient with hemophilia A or B, with or without inhibitors, may comprise subcutaneously delivering with the device about 50 mg of fitusiran to the patient in need thereof every month (or every four weeks) or once every two months (or every eight weeks). The about 50 mg of fitusiran may be delivered in about 0.5 mL PBS (at a concentration of about 100 mg fitusiran / mL).

[0234] Also, provided herein is a method of reducing the ABR in a patient with hemophilia A or B, with or without inhibitors, comprising subcutaneously delivering with the device a prophylactically effective amount of fitusiran to the patient in need thereof. The prophylactically effective amount of fitusiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactically effective amount of fitusiran may be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The prophylactically effective amount of fitusiran may be delivered every month (or every four weeks) or once every two months (or every eight weeks). Fitusiran may be delivered in about 0.5 mL to about 1 mL delivery volumes (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0235] As an example, a method of reducing the ABR in a patient with hemophilia A or B, with or without inhibitors, may comprise subcutaneously delivering with the device about 50 mg of fitusiran to the patient in need thereof every month (or every four weeks) or once every two months (or every eight weeks). The about 50 mg of fitusiran may be delivered in about 0.5 mL PBS (at a concentration of about 100 mg fitusiran / mL).

[0236] Also, provided herein is a method of reducing the AjBR in a patient with hemophilia A or B, with or without inhibitors, comprising subcutaneously delivering with the device a prophylactically effective amount of fitusiran to the patient in need thereof. The prophylactically effective amount of fitusiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactically effective amount of fitusiran may be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The prophylactically effective amount of fitusiran may be delivered every month (or every four weeks) or once every two months (or every eight weeks). The fitusiran may be delivered in about 0.5 mL to about 1 mL delivery volumes (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0237] As an example, a method of reducing the AjBR in a patient with hemophilia A or B, with or without inhibitors, may comprise subcutaneously delivering with the device about 50 mg of fitusiran to the patient in need thereof every month (or every four weeks) or once every two months (or every eight weeks). The about 50 mg of fitusiran may be delivered in about 0.5 mL PBS (at a concentration of about 100 mg fitusiran / mL).

[0238] Also, provided herein is a method of reducing the AsBR in a patient with hemophilia A or B, with or without inhibitors, comprising subcutaneously delivering with the device a prophylactically effective amount of fitusiran to the patient in need thereof. The prophylactically effective amount of fitusiran may be any dose provided herein, such as about 1 to about 80 mg, about 1 to about 30 mg, or about 20 to about 80 mg. The prophylactically effective amount of fitusiran may be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The prophylactically effective amount of fitusiran may be delivered every month (or every four weeks) or once every two months (or every eight weeks). Fitusiran may be delivered in about 0.5 mL to about 1 mL delivery volumes (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0239] As an example, a method of reducing the AsBR in a patient with hemophilia A or B, with or without inhibitors, may comprise subcutaneously delivering with the device about 50 mg of fitusiran to the patient in need thereof every month (or every four weeks) or once every two months (or every eight weeks). The about 50 mg of fitusiran may be delivered in about 0.5 mL PBS (at a concentration of about 100 mg fitusiran / mL).

[0240] Similar drug delivery devices as the ones discussed above are described in WO2015 / 004049 A1 , WO 2015 / 004052 A1, WO2015 / 144870 A1 , WO2016 / 193374 A1, WO2016 / 193343 A1, WO2016 / 193375 A1, WO2016 / 193346 A1 , WO2016 / 193348 A1 , WO2016 / 193352 A1, WO2016 / 193353 A1, WO2016 / 193355 A1, WO2019 / 086561 A1, WO2019 / 086562 A1, WO2019 / 086575 A1, WO2019 / 086563 A1 , WO2019 / 086564 A1 , WO2019 / 086576 A1, W02019 / 101613 A1, W02020 / 069994 A1 , W02020 / 200995 A1 , W02020 / 245206 A1, W02020 / 074570 A1 , W02022 / 003093 A1 , WO2022 / 106504 A1 , WO2017 / 089263 A1 , WO2016 / 193344 A1, WO2016 / 193356 A1, W02019 / 101689 A1 , WO2020 / 239844 A1 , EP1743666B1 , US20050101919, US7955304, US7442185, US8308695, and US8529510, the entire disclosure content of each of which is included by reference for all purposes into the present disclosure.

[0241] Although embodiments of the present disclosure and their advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made therein without departing from the spirit and scope of the disclosure as defined by the appended claims. For example, it will be readily understood by those skilled in the art that many of the features, functions, processes and methods described herein may be varied while remaining within the scope of the present disclosure. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the system, process, manufacture, method or steps described in the present disclosure. As one of ordinary skill in the art will readily appreciate from the disclosure of the present disclosure, systems, processes, manufacture, methods or steps presently existing or to be developed later that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present disclosure. Accordingly, the appended claims are intended to include within their scope such systems, processes, methods or steps. The embodiments mentioned in the first part of the description may be combined with each other. The embodiments of the description of Figures may also be combined with each other. Further, it is possible to combine embodiments mentioned in the first part of the description with examples of the second part of the description which relates to Figures 1 to 12.

[0242] Reference numerals

[0243] A longitudinal axis

[0244] D distal direction

[0245] P proximal direction

[0246] X first needle shroud position

[0247] Y second needle shroud position

[0248] Z, S100 locked out needle shroud position

[0249] 1 unlock element

[0250] 1b clip

[0251] 2 push element

[0252] 3 purifying chamber

[0253] 4a interaction feature

[0254] 4b interaction feature

[0255] 4c axial stop feature

[0256] 4d clip

[0257] 5 push surface of push element

[0258] 6 purifying element

[0259] 6a block element

[0260] 7a distal groove of unlock element

[0261] 7b proximal groove unlock element

[0262] 8 coupling feature of push element

[0263] 9 recess feature of push element

[0264] 10 coupling feature of unlock element

[0265] 11 manipulation feature of push element

[0266] 11a distal end surface of push element

[0267] 11b stop feature of push element

[0268] 11c clip

[0269] 12 opening of push element

[0270] 13 status indication feature

[0271] 14 viewing window

[0272] 15 engagement surface of unlock element

[0273] 16 engagement surface of push element

[0274] 17 distal end surface of unlock element 18 opening of unlock element

[0275] 18a recess

[0276] 19 sealing element

[0277] 20 reception space

[0278] 21 radial outer surface of unlock element

[0279] 22 radial inner surface of unlock element

[0280] 23 radial protrusion of push element

[0281] 24a first radial outward protrusion of coupling feature of unlock element

[0282] 24b second radial outward protrusion of coupling feature of unlock element

[0283] 30 needle shroud unlock device

[0284] 50 needle shroud

[0285] 51 needle shroud lock element

[0286] 51a most inner surface of needle shroud lock element

[0287] 52 inclined surface of needle shroud lock element

[0288] 53 engagement surface of needle shroud

[0289] 54 radial inner surface of radial inward protrusion of needle shroud

[0290] 60 housing

[0291] 61 securing element

[0292] 62 disengagement element

[0293] 63 stop element

[0294] 64 needle shroud opening

[0295] 65 inner surface of distal end

[0296] 66 distal surface of distal end

[0297] 67 recess

[0298] 70 syringe

[0299] 71 needle

[0300] 72 needle attachment element

[0301] 100 medicament delivery device

[0302] 100a medicament delivery device with outside needle shroud lock

[0303] 100b medicament delivery device with inside needle shroud lock

[0304] 101 drive mechanism

[0305] 200 cap

[0306] 300 system

[0307] 501 skin contact surface 502 cover portion

[0308] 800 syringe holder

[0309] 1000 plunger

[0310] 1200 stopper S101 connecting needle shroud unlock device to medicament delivery device

[0311] 5102 disengaging needle shroud lock element and securing element

[0312] 5103 moving needle shroud to first position

[0313] 5104 resetting needle shroud

Claims

Claims1. A needle shroud unlock device (30) for a medicament delivery device (100, 100a, 100b), e.g. an autoinjector, the needle shroud unlock device (30) comprising: an unlock element (1) configured to unlock a needle shroud (50) of the medicament delivery device (100, 100a, 100b) when the needle shroud (50) is in a locked out position, in which a needle shroud lock element (51) of the needle shroud (50) and a securing element (61) of the medicament delivery device (100, 100a, 100b) are engaged to prevent a proximal movement of the needle shroud (50) relative to a housing (60) of the medicament delivery device (100, 100a, 100b), e.g. into the housing (60), wherein the unlock element (1) is configured to disengage the needle shroud lock element (51) and the securing element (61) for unlocking the needle shroud (50), and wherein, when the needle shroud (50) is unlocked, the needle shroud (50) is proximally movable relative to the housing (60) of the medicament delivery device (100, 100a, 100b), e.g. into the housing (60).

2. The needle shroud unlock device (30) of claim 1, wherein the unlock element (1) comprises an interaction feature (4a, 4b) configured to interact with the needle shroud lock element (51) and / or the securing element (61) when: i) the needle shroud unlock device (30) is connected to the medicament delivery device (100, 100a, 100b) or ii) when the unlock element (1) is moved relatively to the needle shroud lock element (51) and / or the securing element (61) after the needle shroud unlock device (30) has been connected to the medicament delivery device (100, 100a, 100b) an.

3. The needle shroud unlock device (30) of claim 2, wherein the interaction feature (4a, 4b) is configured to slide along a surface of the needle shroud lock element (51) and / or the securing element (61) when moved relatively thereto, thereby disengaging the needle shroud lock element (51) and the securing element (61).

4. The needle shroud unlock device (30) of any one of the preceding claims, further comprising: a push element (2) movable relative to the unlock element (1) and configured to move the needle shroud (50) in the proximal direction relative to the housing (60) of the medicament delivery device (100, 100a, 100b), e.g. into the housing (60), when the needle shroud (50) is unlocked.

5. The needle shroud unlock device (30) of claim 4, wherein the push element (2) is releasably coupled to the unlock element (1) such that the push element (2) follows a movement of the unlock element (1) relative to the needle shroud (50), or vice versa, before the needle shroud (50) is unlocked.

6. The needle shroud unlock device (30) of claim 4 or 5, wherein the push element (2) comprises a push surface (5) configured to interact with an engagement surface (53) of the needle shroud (50) to move the needle shroud (50) in the proximal direction relative to the housing (60) of the medicament delivery device (100, 100a, 100b), e.g. into the housing (60), when the push element (2) is moved in the proximal direction relative to the medicament delivery device (100, 100a, 100b).

7. The needle shroud unlock device (30) of any one of claims 4 to 6, wherein an engagement surface (15) of the unlock element (1) is configured to interact with an engagement surface (16) of the push element (2), such that the push element (2) is carried by the unlock element (1) when the unlock element (1) is moved proximally relative to the housing (60) of the medicament delivery device (100, 100a, 100b), before the needle shroud (50) is unlocked.

8. The needle shroud unlock device (30) of any one of claims 4 to 7, wherein the push element (2) comprises a manipulation feature (11) via which a relative movement between the push element (2) and the unlock element (1) can be controlled by a user.

9. The needle shroud unlock device (30) of any one of claims 1 to 8, wherein i) the push element (2) comprises a purifying chamber (3) configured to receive and / or purify a needle (71) of the medicament delivery device (100, 100a, 100b), or ii) the unlock element (1) comprises a purifying chamber (3) configured to receive and / or purify a needle (71) of the medicament delivery device (100, 100a, 100b), or iii) the needle shroud unlock device (30) comprises a purifying element (6) comprising a purifying chamber (3) configured to receive and / or purify a needle (71) of the medicament delivery device (100, 100a, 100b).

10. The needle shroud unlock device (30) of any one of claims 4 to 9, wherein the unlock element (1) and the push element (2) are configured to be releasably coupled to each other to prevent a relative movement between the unlock element (1) and the push element (2) before the needle shroud (50) is unlocked, andwherein the unlock element (1) and the push element (2) are configured to decouple and enable a relative movement between the unlock element (1) and the push element (2) after the needle shroud (50) is unlocked.

11. The needle shroud unlock device (30) of claim 10, wherein the unlock element (1) is carried by the push element (2) when the push element (2) is moved proximally relative to the medicament delivery device (100, 100a, 100b), e.g. the housing (60) thereof, before the needle shroud (50) is unlocked, due to: i) an interaction between a coupling feature (10) of the unlock element (1) and a corresponding recess feature (9) of the push element (2), or ii) an interaction between a coupling feature (8) of the push element (2) and a corresponding recess feature (7a, 7b) of the unlock element (1).

12. The needle shroud unlock device (30) of claim 11 , wherein the coupling feature (10) of the unlock element (1) comprises a flexible portion, e.g. a snap arm, which is configured to interact with a distal end of the needle shroud (50) thereby disengaging the coupling feature (10) from the recess feature (9) to decouple the unlock element (1) and the push element (2), when the needle shroud (50) is unlocked.

13. The needle shroud unlock device (30) of claim 11 , wherein the recess feature (7a, 7b) of the unlock element (1) comprises a distal groove (7a) and, optionally, a proximal groove (7b), and wherein the coupling feature (8) of the push element (2) comprises a flexible portion, e.g. a snap arm, which is configured to: i) interact with the distal groove (7a) of the unlock element (1) before the needle shroud (50) is unlocked, ii) disengage from the distal groove (7a) to decouple the unlock element (1) and the push element (2) after the needle shroud (50) is unlocked, and, optionally, iii) re-engage with the proximal groove (7b) of the unlock element (1) to define a final relative proximal position between the push element (2) and the unlock element (1).

14. A system (300) comprising a medicament delivery device (100, 100a, 100b) and a needle shroud unlock device (30), wherein the medicament delivery device (100, 100a, 100b) comprises a needle shroud (50) locked against a proximal movement relative to a housing (60) of the medicament delivery device (100, 100a, 100b) in a locked out position, and wherein the needle shroud unlock device (30) is configured to unlock the needle shroud (50) from the locked out position, thereby enabling a proximal movement of the needle shroud (50) relative to the housing (60) of the medicament delivery device(100, 100a, 100b), wherein, optionally, the needle shroud unlock device (30) is a needle shroud unlock device (30) of any one of claims 1 to 13.

15. Method for unlocking a needle shroud (50) of a medicament delivery device (100, 100a, 100b) from a locked out position, in which a proximal movement of the needle shroud(50) relative to a housing (60) of the medicament delivery device (100, 100a, 100b), e.g. into the housing (60), is prevented, the method comprising the steps of: connecting (S101) a needle shroud unlock device to the medicament delivery device (100, 100a, 100b), e.g. a housing (60) thereof, and disengaging (S102) a needle shroud lock element (51) and a securing element (61) of the medicament delivery device (100, 100a, 100b) for unlocking the needle shroud (50), such that the needle shroud (50) is proximally movable relative to the housing (60) of the medicament delivery device (100, 100a, 100b), e.g. into the housing (60), wherein, optionally, the needle shroud unlock device is a needle shroud unlock device (30) according to any one of claims 1 to 14.

Images