Medicament delivery device and medicament delivery assembly

Abstract

The medicament delivery device (2) comprises a base assembly to which a medicament container (3) is mountable and a plunger rod device (7) axially movable for acting, in an expelling movement towards proximally, on a plunger (31) of the medicament container (3) for expelling the medicament. It also comprises a driver biasing member (9) and a driver assembly biased by the driver biasing member (9) and coupled to the plunger rod device (7), configured carry a driver movement causing the expelling movement. In addition, a dose setting mechanism for setting and correcting a dosing amount is provided which comprises - a first dosing member (61) and a second dosing member (62) which are rotationally coupled and axially movable relative to one another, wherein an angle of rotation assumed by the first dosing member (61) determines the dosing amount - a ratchet mechanism with a first ratchet structure rotationally locked to, the driver assembly and a second ratchet structure rotationally locked to the second dosing member (62), which, in a setting state, are engaged with one another and which, in a correcting state, are disengaged from one another, and which, in the setting state, o enable a rotation of the second ratchet structure (R2) relative to the first ratchet structure in a first sense of rotation; and o inhibit a rotation of the second ratchet structure (R2) relative to the first ratchet structure (R1) in a second sense of rotation opposite the first sense of rotation.

Description

[0001] Medicament Delivery Device and Medicament Delivery Assembly

[0002] TECHNICAL FIELD

[0003] The invention is in the field of medicament delivery devices. In particular, it relates to automatic medicament delivery devices. The invention more particularly relates to medicament delivery devices for delivering multiple doses of a medicament from one medicament container, more specifically, wherein a user can set the dosing amount to be delivered (variable dose medicament delivery device).

[0004] BACKGROUND

[0005] Medicament delivery devices for automatic delivery of a medicament by selfadministration are well-known. Especially, they may be equipped to accommodate a medicament container, for example a medicament container with a septum (or another seal) to be perforated immediately prior to use, or a syringe. Often, the medicament delivery device and the medicament container are pre-assembled to constitute a medicament delivery assembly for self-administration.

[0006] Automatic medicament delivery devices are known which have a pretensioned spring which stores and provides, when a dose release mechanism is activated, the energy required for expelling the medicament from the medicament container.

[0007] Furthermore, medicament delivery device are known which can expel multiple doses of a medicament from one medicament container, wherein for each dose, the user can set a desired dosing amount by means of a dose setting mechanism.

[0008] However, it can happen that the user sets a false dosing amount. If the false amount is too low, the user can, in case of various known medicament delivery devices, simply continue the setting process until the desired dosing amount is reached. However, it may happen that the user accidentally sets a too high dose. If the dose setting mechanism does not provide the possibility to correct the dosing amount to a lower value, the dose has to be discarded, and the user has to set the dosing amount anew afterwards.

[0009] From WO 2016 / 135237, a drug delivery device with reset mechanism is known. In that case, the user can set (and increase) a dosing amount by turning a dose setting member in a clockwise (cw) direction, and turn the dose setting member in a counter clockwise (ccw) direction to decrease the dosing amount. The dose setting mechanism involves two ratchet mechanisms.

[0010] SUMMARY

[0011] It is an object of the present invention to provide a medicament delivery device overcoming disadvantages of prior art medicament delivery devices. Especially, it is an object to provide a medicament delivery device suitable for delivering multiple doses of a medicament wherein the user can set the dosing amount for each dose and, more particularly, can correct a set dosing amount before delivery of the dose. The device should have a high usability and should be safe.

[0012] Another object of the invention is to provide a medicament delivery device which does not increase its length more and more with increasing dosing amounts set by the user.

[0013] Another object of the invention is to provide a medicament delivery device which can display an indication of a set dosing amount in a simple way.

[0014] Another object of the invention is to provide a medicament delivery device which can be manufactured relatively simply.

[0015] Another object of the invention is to provide a medicament delivery device which comprises a relatively low number of parts to be assembled.

[0016] Another object of the invention is to provide a medicament delivery device which enables a user to set dosing amount in a simple and / or intuitive way. Another object of the invention is to provide a medicament delivery device which enables a user to correct a set dosing amount in a simple and / or intuitive way, in particular to decrease an initially set dosing amount.

[0017] Another object of the invention is to provide a medicament delivery device which enables a user to correct a set dosing amount towards higher as well as towards lower dosing amounts in a simple and / or intuitive way.

[0018] Further objects and various advantages emerge from the description and embodiments below.

[0019] At least one of these objects is achieved by the device and assembly as defined in the claims.

[0020] The medicament delivery device is a medicament delivery device for accommodating a medicament container containing a medicament and for expelling multiple doses of the medicament from the medicament container. The medicament delivery device defines a device axis and comprises

[0021] - a base assembly to which the medicament container is mountable;

[0022] - a plunger rod device axially movable for acting, in an expelling movement in which the plunger rod device moves towards proximally, on a plunger of the medicament container for expelling the medicament therefrom;

[0023] - a driver biasing member, e.g., a torsion spring, such as a helical torsion spring; and

[0024] - a driver assembly biased by the driver biasing member and coupled to the plunger rod device, which is configured to carry out, biased by the driver biasing member, a driver movement, wherein the driver movement causes the expelling movement.

[0025] More specifically, the driver movement causes the expelling movement because of the coupling to the plunger rod device. The medicament delivery device further comprises a dose setting mechanism for setting and correcting a dosing amount for a dose of the medicament to be expelled.

[0026] Therein, the dose setting mechanism comprises

[0027] - a first dosing member and a second dosing member;

[0028] - a ratchet mechanism, in particular a releasable one-way ratchet mechanism;

[0029] - a set-control biasing member; and

[0030] - a control mechanism.

[0031] The first dosing member and the second dosing member are rotationally coupled to one another and axially movable relative to one another. This is more particularly the case in both, in the setting state and in the correcting state (cf. below). An angle of rotation assumed by the first dosing member determines (defines) the dosing amount. Thus, the user can set a dosing amount by setting a said angle or rotation. More particularly, it is an angle of rotation assumed by the first dosing member at the time of starting the expelling of a dose (in particular: at the time of releasing the dose release mechanism, cf. below) which determines the dosing amount. Said angle of rotation can be an angle relative to an initial rotational position of the first dosing member.

[0032] More particularly: Said angle of rotation assumed by the first dosing member is an angle of rotation assumed by the second ratchet structure relative to an initial rotational position of the the second ratchet structure - because the first and second dosing members are rotationally locked to one another, and the second ratchet structure is comprised in the second dosing member. Said angle of rotation assumed by the first dosing member can also be identified with an angle of rotation by which the second dosing member (and thus the second ratchet structure) is rotated relative to the first ratchet structure (and thus relative to the driver assembly) during setting / correcting a dosing amount (using the dose setting mechanism). The ratchet mechanism comprises a first ratchet structure which is rotationally locked to, in particular comprised in, the driver assembly, and a second ratchet structure rotationally locked to, in particular comprised in, the second dosing member. In a setting state, the first and second ratchet structures are engaged with one another, and, in a correcting state, they are disengaged from one another. Furthermore, in the setting state, they

[0033] - enable a rotation of the second ratchet structure relative to the first ratchet structure in a first sense of rotation, e.g., cw; and

[0034] - inhibit a rotation of the second ratchet structure relative to the first ratchet structure in a second sense of rotation opposite the first sense of rotation, e.g., ccw.

[0035] The ratchet structures and their interaction can be implemented in a way are known in the art.

[0036] A rotation of the second dosing member and thus of the second ratchet structure relative to the first ratchet structure in the first sense of rotation can be considered a setting movement.

[0037] When two parts are rotationally locked, this means that rotational movements of the two parts are locked to one another - e.g., rotational movements of the driver assembly are locked to (and thus identical to) rotational movements of the first ratchet structure; and rotational movements of the second ratchet structure are locked to (and thus identical to) rotational movements of the second dosing member.

[0038] The second dosing member, more specifically, is operable, in particular rotatable, by the user to set and to correct (if desired) a dosing amount.

[0039] In embodiments, in the correcting state, a rotation of the second ratchet structure relative to the first ratchet structure is, by the ratchet mechanism, inhibited neither in a first sense of rotation nor in the second sense of rotation. The set-control biasing member is configured to bias the second dosing member in a second axial direction, e.g., in a proximal direction, to bias the second ratchet structure to engage with the first ratchet structure. Thus, the biasing can bias the second dosing member towards the setting state. The biasing can more specifically be a biasing relative to the base assembly.

[0040] The control mechanism is operable by a user to selectably switch between the setting state and the correcting state by the user causing a first movement of the second dosing member into the first axial direction, e.g., towards distally, to switch from the setting state into the correcting state, and by the user causing a second movement of the second dosing member into a second axial direction opposite the first axial direction, e.g., towards proximally, to switch from the correcting state into the setting state.

[0041] In other words, in a purely axial movement, the user can switch between the setting state and the correcting state and thus engage and disengage the first and second ratchet structures.

[0042] Accordingly, in embodiments, the first movement is a movement into the first axial direction. In said WO 2016 / 135237, in contrast, a change from setting to correcting involves a rotating movement caused by the user.

[0043] The dosing amount setting and correcting can this way be implemented in a user-friendly and intuitively operable way. In addition, the medicament delivery device is relatively simple to manufacture, involving a not very high number of parts which are not particularly difficult to manufacture.

[0044] Furthermore, due to the provision of the first and second dosing members, the medicament delivery device does not increase its length more and more with increasing dosing amounts set by the user. This will be come clearer from the description below.

[0045] In addition, the provision of the first and second dosing members makes possible that the medicament delivery device can display an indication of a set dosing amount in a simple way. This will be come clearer from the description below.

[0046] And it can be implemented that the corrections applied to a set dosing amount are possible towards decreasing and towards increasing the set dosing amount.

[0047] The user can cause the first movement, e.g., by pulling the second dosing member, in particular away from the base assembly. And the user can cause the second movement, e.g., by releasing the second dosing member, wherein the set-control biasing member then moves the second dosing member back, e.g., towards proximally and, e.g., towards the base assembly.

[0048] The user has to counteract the set-control biasing member during the first movement and thus when switching from the setting state to the correcting state. On the other hand, to cause the second movement, the user merely has to release the second dosing member, as the set-control biasing member will move the second dosing member back, i.e. the set-control biasing member moves the second ratchet structure (with the second dosing member) back into engagement with the first ratchet member, thus changing from the correcting state into the setting state.

[0049] Accordingly, in the setting state, a dosing amount is settable by the user by rotating the second dosing member in the first sense of rotation, and, in the correcting state, a set dosing amount is correctable by a user by rotating the second dosing member. The latter may in particular take place in any of the first sense of rotation and of the second sense of rotation.

[0050] Thus, when the user merely rotates the second dosing member (in the first sense of rotation, as rotation in the second sense of rotation being blocked by the ratchet mechanism), the user can set a dosing amount. This corresponds to the normal case of using the medicament delivery device. However, in case a correction of a set dose is required, the user causes the first movement to disengage the first and second ratchet structures, enabling him / her to apply corrections to the dosing amount set so far. In particular, in the correcting state, the second ratchet structure is rotatable in both senses of rotation, i.e., cw as well as ccw, in the correcting state. Note that in the unusual case that the user would not initially set a dosing amount but initially already cause the first movement, a rotation of the second dosing member (and of the second ratchet structure) would initially be possible only in the first sense of rotation.

[0051] The first and second movements are, more specifically, movements relative to the base assembly and relative to the first ratchet structure.

[0052] In embodiments, the device axis is the axis about which the second dosing member is rotatable.

[0053] In embodiments where the driver movement is a rotational movement, the device axis is the axis about which the driver assembly rotates in the driver movement.

[0054] In embodiments, a first end of the driver biasing member is rotationally locked (in particular is affixed) to the base assembly, and a second end of the driver biasing member is rotationally locked (in particular is affixed) to the second dosing member. And thus, more specifically, because of the rotational coupling between the first and the second dosing member, the second end of the driver biasing member is rotationally locked also to the first dosing member. And furthermore, the driver biasing member is pre-tensioned such that a rotation of the second end relative to the first end in the first sense of rotation increases a bias of the driver biasing member.

[0055] Thus, the rotation of the second dosing member in the first sense of rotation increases the tension of the pre-tensioned driver biasing member.

[0056] Accordingly, the energy deposited in the driver biasing member by the user setting a dosing amount can be used for driving the plunger rod device distally (via the driver assembly), so that the time required for expelling doses of identical dosing amounts, is at least approximately identical, regardless of whether the dose is expelled when the medicament container is still full or already nearly empty. In embodiments, one of the base assembly and of the first dosing member comprises a rotation-guiding feature, the other one comprising at least one cooperating feature cooperating with the rotation-guiding feature to guide rotational movements of the first dosing member relative to the base assembly. And in addition, the rotation-guiding feature comprises a first stop cooperating with the at least one cooperating feature to inhibit a rotation of the first dosing member in the second sense of rotation when the at least one cooperating feature abuts the first stop. Therein, the rotational position of the first dosing member in which the at least one cooperating feature abuts the first stop is the initial rotational position.

[0057] This is a way how the angle of rotation assumed by the first dosing member can determine the dosing amount.

[0058] In embodiments, the rotation-guiding feature comprises a second stop cooperating with the at least one cooperating feature to inhibit a rotation of the first dosing member in the first sense of rotation when the at least one cooperating feature abuts the second stop. This way, a maximum angle of rotation of the first dosing member and thus a maximum settable dosing amount can be implemented.

[0059] In embodiments, the rotation-guiding feature is a helical feature. This way, a rotation of the first dosing member causes an additional translational movement of the first dosing member.

[0060] In embodiments, the helical feature comprises a thread.

[0061] Also, non-helical features as rotation-guiding features are possible. E.g., if rotations only smaller than 360° are enabled (and sufficient), the rotationguiding feature can be, .e.g., a circular groove in the base assembly, e.g., in a device body of the base assembly, which provides two stops, e.g., a groove of 350°, the io° being not grooved, thus providing, at one end, the first stop and, at its other end, the second stop.

[0062] The cooperating feature can be, e.g., a protrusion, e.g., a helical protrusion. In embodiments, the medicament delivery device comprises a dose release mechanism operable by a user to release a dose. As mentioned before, the dosing amount of an expelled dose can be determined by the dosing amount set (and optionally corrected) when operating (releasing) the dose release mechanism.

[0063] In embodiments, the medicament delivery device comprises a dose release mechanism comprising a trigger element, wherein the trigger element is operable by a user to release a dose by bringing dose release mechanism from an inhibiting state into a releasing state, wherein the dose release mechanism is couplable to the driver assembly to block the driver movement in the inhibiting state and to enable the driver movement in the releasing state. Operating the dose release mechanism, accordingly, can suspend the rotational locking of the driver assembly. When the dose release mechanism is in the inhibiting state (not operated), it rotationally locks the driver assembly or, in other words, rotationally couples the driver assembly to the base assembly and to the device body, respectively. Thus, thus, during expelling, the driver assembly can rotate, driven by the driver biasing member.

[0064] E.g., the dose release mechanism can for this purpose comprise a releasable (and re-engageable) splined connection between the trigger element and the driver assembly.

[0065] In embodiments, the trigger element is operable by a user to be movable from an inhibiting position in which the trigger element is coupled to the driver assembly to block the driver movement, to a releasing position in which the trigger element is decoupled from the driver assembly not to block the driver movement, the dose release mechanism further comprising a trigger biasing member biasing the activation element towards the inhibiting position. Thus, without user action, the trigger biasing member keeps the trigger element in the inhibiting position (and the release mechanism in the inhibiting state), and for moving the trigger element into the releasing position (and bringing the release mechanism in the releasing state), the user has to counteract the bias of the trigger biasing member.

[0066] In embodiments, operating the trigger element is sliding the trigger element, in particular sliding the trigger element in a longitudinal direction.

[0067] Operating the trigger element can comprise sliding the trigger element.

[0068] In embodiments, the driver biasing member is a torsion spring, in particular a helical torsion spring, and the driver assembly comprises a plunger nut device cooperating with the plunger rod device. Furthermore, one of the plunger nut device and of the plunger rod device comprises a helical guidance feature, and the other one comprises a guidance cooperation feature cooperating with the helical guidance feature to obtain the expelling movement from the driver movement, wherein the driver movement is a rotational movement. This is a way of implementing that the driver assembly causes the expelling movement of the plunger rod device, driven by the driver biasing member. By the cooperation of the helical guidance feature and the guidance cooperation feature, a rotation of the driver assembly, as caused by the driver biasing member, causes a proximal movement of the plunger rod device.

[0069] In embodiments, one of the first dosing member and of the second dosing member comprises first longitudinal splines, the other one comprising second features cooperating with the first longitudinal splines to rotationally couple the first dosing member and the second dosing member to one another while enabling axial relative movements of the first dosing member and the second dosing member. The second features can be, e.g., protrusions or longitudinal splines or longitudinal grooves.

[0070] In embodiments, the base assembly comprises a generally tubular shaped part, e.g., a device body, the second dosing member comprising a generally tubular shaped section located, at least in part, inside the generally tubular shaped part, at least one of the generally tubular shaped part and of the generally tubular shaped section comprising a guiding structure, the other one comprising a cooperating surface cooperating with the guiding structure to provide guidance for axial and rotational movements of the second dosing member (62) relative to the base assembly. This is a way to enable guided axial movements of the second dosing member which in addition enable rotations of the second dosing member. For example, the second dosing member can comprise, in the tubular shaped section, outwardly protruding protrusions or an outwardly protruding circumferential ridge cooperating with an interior cylindrical surface of the base assembly, e.g., of a device body.

[0071] In embodiments, one of the base assembly and of the second dosing member comprises a first limiting feature, the other one comprising a second limiting feature, the first limiting feature and the second limiting feature cooperating to provide a stop limiting a distal movement of the second dosing member towards distally. This way, a stop is provided for the first movement or for the second movement (whichever is a distal movement).

[0072] In embodiments, the first axial direction is a distal direction. In this case, for example, the user pulls the second dosing member towards distally to enter the correcting state, and, releasing the second dosing member, the set-control biasing member moves the second dosing member back towards proximally into the setting state. And the first ratchet surface (cf. below) faces towards distally.

[0073] However vice versa is possible, too:

[0074] In embodiments, the first axial direction is a proximal direction. In this case, for example, the user presses the second dosing member towards proximally to enter the correcting state, and, releasing the second dosing member, the set-control biasing member moves the second dosing member back towards distally into the setting state. And the first ratchet surface (cf. below) faces towards proximally.

[0075] In embodiments, the set-control biasing member comprises a flexible portion of the second dosing member. In particular, the second dosing member and the set-control biasing member can form a unitary part. This is a way of implementing the set-control biasing member which does not increase the number of parts to be manufactured and assembled.

[0076] However, implementing the set-control biasing member in form of a separate spring, e.g., as a compression spring or an extension spring, is also possible.

[0077] In embodiments, the base assembly comprises a window, and the second dosing member comprises a plurality of signs which are distributed over a circumference on an outside face of the second dosing member and arranged to be visible through the window in the setting state to indicate a set dosing amount. This way, a user can better determine a dosing amount. E.g., the window can be an opening, or a region made of a transparent material.

[0078] Due to the provision of the first and second dosing members, the second dosing member can be located axially at one and the same position when a dosing amount is set, independent of the value of the dosing amount, even when the rotation-guiding feature of the first dosing member is a helical feature causing a change of axial position of the first dosing member in reaction setting different dosing amounts.

[0079] The signs can be provided, e.g., on an outer surface of a generally tubular shaped section of the second dosing member.

[0080] In embodiments, the signs are arranged to be visible through the window to indicate a set dosing amount also in the correcting state.

[0081] In embodiments, the ratchet mechanism comprises a first ratchet surface which is aligned perpendicularly to the device axis, the first ratchet structure comprising a plurality of first ratchet teeth which protrude from the first ratchet surface and are radially extended and circumferentially distributed. The ratchet mechanism further comprises a second ratchet surface facing the first ratchet surface, wherein the second ratchet surface which is aligned perpendicularly to the device axis, the second ratchet structure comprising a plurality of second ratchet teeth which protrude from the second ratchet surface and are radially extended and circumferentially distributed. This is a robust and space-saving way of implementing the ratchet mechanism.

[0082] In embodiments, the first ratchet surface faces distally and the second ratchet surface faces proximally. Accordingly, the first ratchet teeth (8sd) protrude distally, whereas the second ratchet teeth (62d) protrude proximally.

[0083] However, differently shaped first and second ratchet are possible, too, e.g., conical first and second ratchet surfaces are possible.

[0084] In embodiments, first ratchet surface is comprised in the driver assembly.

[0085] In embodiments, the second ratchet structure is distal relative to the first ratchet structure.

[0086] However, it is alternatively also possible that the first axial direction is proximal, and that for switching from the setting state to the correcting state, the user pushes the second dosing member proximally (i.e., the user moves the second dosing member proximally); and the first ratchet structure is distal of the second ratchet structure.

[0087] In embodiments, the second ratchet structure forms a unitary part with the second dosing member. This simplifies the manufacture, reducing the number of parts to be manufactured and assembled.

[0088] In embodiments, the medicament delivery device is a disposable medicament delivery device.

[0089] In other embodiments, the medicament delivery device is a re-usable medicament delivery device.

[0090] The medicament delivery device in particular is a variable dose (settable dose) medicament delivery device.

[0091] The medicament delivery device in particular is ab automatic medicament delivery device. The medicament delivery assembly comprises the medicament delivery device as herein described and further comprises the medicament container assembled with the medicament delivery device.

[0092] In the present disclosure, when the term “distal direction” is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term “distal part / end” is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which during use of the medicament delivery device is / are located furthest away from the dose delivery site. Correspondingly, when the term “proximal direction” is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device. When the term “proximal part / end” is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which during use of the medicament delivery device is / are located closest to the dose delivery site.

[0093] Further, the terms “longitudinal”, “longitudinally”, “axially” and “axial” refer to a direction extending from the proximal end to the distal end and along the device or components thereof, typically in the direction of the longest extension of the device and / or component.

[0094] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0095] Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to a / an / the element, apparatus, member, component, means, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, member component, means, etc., unless explicitly stated otherwise. BRIEF DESCRIPTION OF THE DRAWINGS

[0096] Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings.

[0097] Figure 1A a perspective view of a medicament delivery assembly with a needle assembly;

[0098] Figure 1B a perspective view of the medicament delivery device of the medicament delivery assembly of Fig. 1A;

[0099] Figure 2 the container housing of the medicament delivery assembly of Fig. 1A;

[0100] Figure 3 the medicament container of the medicament delivery assembly of Fig. 1A;

[0101] Figures 4 to 19 show various parts of the medicament delivery device of Figs. 1A, 1B;

[0102] Figure 4 the device body;

[0103] Figure 5A a view onto a cross-section through the medicament delivery device of Figs. 1A, 1B;

[0104] Figure 5B a view onto a cross-section of the front dosing part assembled with the device body;

[0105] Figure 6 the plunger rod;

[0106] Figure 7 the plunger nut;

[0107] Figure 8 the drive spring;

[0108] Figure 9 the driver holder;

[0109] Figure 10 the driver coupling;

[0110] Figure 11 the activation slider (trigger element);

[0111] Figure 12A the driver cap;

[0112] Figure 12B the driver cap in a different view; Figure 13A the front dosing part (first dosing member);

[0113] Figure 13B the rear dosing part (second dosing member);

[0114] Figure 14 the dose setting assembly comprising the first and second dosing members;

[0115] Figure 15A the locking device;

[0116] Figure 15B a detail of the distal end of the locking device;

[0117] Figure 16A a view onto a cross-section through the locking device assembled with the plunger rod;

[0118] Figure 16B a cross-sectional view of the plunger rod assembled with several further parts of the medicament delivery device;

[0119] Figure 17 a partial assembly of the medicament delivery device;

[0120] Figure 18 a perspective view onto a cross-section through rear dosing part;

[0121] Figure 18A shows a perspective view onto a detail of a cross-section through the medicament delivery device perpendicular to the device axis;

[0122] Figure 19 shows a perspective view onto a cross-section through a partial assembly of the medicament delivery device comprising the rear dosing part.

[0123] The described embodiments are meant as examples or for clarifying the invention and shall not limit the invention.

[0124] DETAILED DESCRIPTION

[0125] Fig. 1A shows a medicament delivery assembly 1 with a needle assembly 15 mounted which is shown partially transparent. The medicament delivery assembly 1 comprises a container housing 4 in which a medicament container 3 is accommodated and a medicament delivery device 2 to which the container housing 4 can be mounted, as illustrated. Fig. 1B shows the medicament delivery device 2. When the container housing 4 is mounted to the medicament delivery device 2, more particularly to a device body 5 thereof (cf. Fig. 4), container housing 4 and medicament container 3 are essentially immovable relative to the device body 5. The medicament delivery device 2 and, more particularly, its plunger rod 7 (Fig. 6) or its plunger nut 8 (Fig. 7) defines a device axis A.

[0126] Fig. 2 shows the container housing 4 in more detail, and Fig. 3 shows the medicament container 3, e.g., as known in the field, which comprises a vessel 35 containing a medicament 33, and a proximal closure comprising a septum 32 closing off the medicament container towards proximally which is to be pierced by a needle of the needle assembly 15 to expel portions of the medicament 33 therethrough. Medicament container 3 also comprises a plunger 31 initially seated near its distal end, which closes off the medicament container 4 towards distally and which can be moved towards proximally in order to dispense the medicament 33 when a needle assembly 15 is mounted.

[0127] Container housing 4 (Fig. 2) has a seat for the medicament container 3 which is open towards distally and into which the medicament container 3 is insertable. The proximal end of the container housing 4 has an outer thread 42 for mounting the needle assembly 15. Through housing windows 41, a user may see the medicament container 3 and can estimate how much of the medicament33 is left in it, with the assistance of dose indicators 43.

[0128] Figs. 4-19 illustrate the elements of the medicament delivery device 2.

[0129] Fig. 4 shows device body 5 which forms a portion of the housing of the medicament delivery device 2. Fig. 5A shows a view onto a cross-section through the medicament delivery device 2. Fig. 5B shows a view onto a cross-section of a front dosing part 61 assembled with the device body 5. Fig. 6 shows the plunger rod 7 which is to be proximally moved to move the plunger 31 proximally to expel doses of the medicament 33. Fig. 7 shows a plunger nut 8 to cooperate with plunger rod 7 to achieve the proximal movement. Fig. 8 shows a drive spring 9 which is a pre-tensioned helical torsion spring to force plunger nut 8 to rotate for the expelling of a dose. At its proximal end, drive spring 9 is affixed to a driver holder 91 (Fig. 9) which is affixed to device body 5, and at its distal end, it is affixed to a driver coupling 92 (Fig. 10). Fig. 11 shows an activation slider 13 or trigger element, which is an activation element to enable a user to initiate the expelling of a dose.

[0130] Figs. 12A, 12B show a driver cap 85 which is affixed to plunger nut 8, the two forming a driver assembly. The driver assembly is rotatable but cannot move towards proximally, because its proximal end abuts the device body 5 (cf. the thick arrow in Fig. 5A). Driver cap 85 cooperates with a dose setting assembly 6 (Fig. 14) comprising a front dosing part 61 (Fig. 13A) and a rear dosing part 62 (Fig. 13B). The front dosing part 61 can also be referred to as first dosing member; and the rear dosing part can also be referred to as second dosing member or as dosing element. Fig. 15A shows a locking device 10, and Fig. 15B shows its distal portion. Locking device 10 cooperates with plunger rod 7 to prevent the setting of another dose when an amount of the medicament 33 remaining in medicament container 3 is below a threshold amount (and thus is assumed to be too small for continuing to use the medicament container 3), as inferred from an axial position (and from a length of a proximal travel so far) of the plunger rod 7. Fig. 16A shows a view onto a cross-section through the locking device 10 assembled with the plunger rod 7, prior to reaching said threshold amount. Fig. 16B shows a cross-sectional view of the plunger rod 7 assembled with the locking device 10, the rear dosing part 62, the driver cap 85, the driver coupling 92 and a locking spring 11 (also referred to as locking biasing member) after reaching the threshold amount. Other elements are not shown in Fig. 16B.

[0131] Fig. 17 shows a partial assembly of the medicament delivery device 2 comprising the plunger rod 7, the plunger nut 8, a trigger spring 14 cooperating with the activation slider 13 to force the latter towards distally relative to the container housing 4 and to the device body 5, the driver cap 85, the locking device io and the locking spring n to force the latter towards distally relative to the driver cap 85 and to the device body 5. Other elements are not shown in Fig. 17.

[0132] Fig. 18 shows a perspective view onto a cross-section through rear dosing part 62. Fig. 19 shows a perspective view onto a cross-section through a partial assembly of the medicament delivery device 2 comprising rear dosing part 62, driver cap 85, locking device 10 and locking spring 11 when the device termination mechanism of the medicament delivery device 2 is activated.

[0133] To set a dosing amount for a dose to be expelled (also more briefly referred to as dose setting or setting a dose), the user turns the rear dosing part 62 in a clockwise direction (cw). Rear dosing part 62 (Figs. 13B, 14) has a generally barrel-like configuration. It has a knob-part 62a at its distal end, and towards its proximal end, it has a generally tubular shape. Knob-part 62a is knurled, having a plurality of ridges distributed over its circumference, which are aligned generally parallel to the device axis A, i.e. they are longitudinally aligned. A distal travel of rear dosing part 62 (relative to device body 5) is limited by cooperation of a flange-like circumferential ridge 62b and a corresponding abutting surface (not shown in the figures) in the interior of device body 5, e.g., a surface of a groove or of a ridge at the interior surface of device body 5. And it is rotatably mounted in device body 5 by ridge 62b, too. When distally pulling the rear dosing part 62 for correcting a set dosing amount, the axial distance by which rear dose drum 62 can travel is limited by flange-like circumferential ridge 62b abutting said corresponding abutting surface of, e.g., said groove. The circumferential ridge 62b can provide guidance for movements (axial and rotational) of the rear dosing part 62 relative to the device body 5. Ridge 62b’ can also have one or both of the functions of flange-like circumferential ridge 62b, i.e. provide guidance for movements (especially a rotational mounting) and provide a limitation for movements of the rear dosing part 62 towards distally. Furthermore, rear dosing part 62 is rotationally locked to front dosing part 61 and, at the same time, these two are axially moveable relative to one another. This is the case because rear dosing part 62 is in splined connection with front dosing part 62, as by cooperation of longitudinal splines 62c in the interior of rear dosing part 62 with longitudinal grooves 61c in the exterior of front dosing part 61. Thus, rotating rear dosing part 62 causes a corresponding rotation of front dosing part 61. The two parts are rotationally locked.

[0134] Front dosing part 61 (Figs. 13A, 14) has a generally tubular configuration, with helical features 61a close to its proximal end, to cooperate with interior threads 51 of device body 5 (Fig. 4). Fig. 5B shows a view onto a crosssection of front dosing part 61 assembled with device body 5.

[0135] Thus, cw turning rear dosing part 62 results in cw turning of front dosing part 61 combined with a distal movement of front dosing part 61.

[0136] On the exterior of rear dosing part 62, markings, such as signs S (symbolically illustrated in Fig. 14), can be provided along a circumference of rear dosing part 62 which can be visible through a body window 52 of device body 5. E.g., an indication of a set dosing amount can be provided by the markings. However, if rear dosing part 62 can be rotated and is rotated by more than 360°, the markings will repeat. Accordingly, they cannot correctly represent the set dosing amount in such cases. But if only rotations smaller than 360° are enabled, e.g., by implementation of a suitable stop structure in interior threads 51, the signs S can correctly correspond to (and indicate) set dosing amounts.

[0137] However, providing signs on the front dosing part 61 can reflect dosing amounts also beyond 360° (possibly beyond multiples of 360°) because of the distal movement of front dosing part 61 which is linked to the rotational (cw) movement of front dosing part 61. Providing another window in device body 5 and, e.g., using other signs, distributed along a helical path on the exterior of front dosing part 61, a user can be informed about the set dosing amount also beyond 360° even without further signs such as the signs S on the rear dosing part 62; or, in another implementation, signs distributed along a longitudinal path on the exterior of front dosing part 61 can be used in a combined fashion together with signs S on the exterior of rear dosing part 62 to inform the user about the set dosing amount also beyond 360°. In the latter case, e.g., the signs on the exterior of the front dosing part 61 can indicate the number of completed 360° turns (or, rather, the corresponding dosing amount), and the signs S on the exterior of the rear dosing part 62 can indicate the number of fractions of a 360° turn that have taken place before reaching the next 360° turn, thus indicating the number of smaller units that add up to the completed 360° turns.

[0138] Furthermore, since the front dosing part 61 and the rear dosing part 62 are axially moveable relative to one another, the rear dosing part 62 can (and does) maintain its axial position, even if front dosing part 61 moves distally during dosing amount setting. Accordingly, it does not move distally further and further out of the device body 5 when increasing the set dosing amount. The medicament delivery device 2 thus does not increase its length during dose setting.

[0139] In an initial state, the helical features 61a can be in an end position of the threads 51, in which no further ccw (counterclockwise) rotation is possible, but only cw rotation. Accordingly, after having set a dose (by cw rotation) and expelling that dose (ccw rotation), the threads 51 can provide a stop for the helical movement (rotation, combined with axial movement) of the front dosing part 61, thus providing a stop and a reference for the setting of the dosing amount. And it defines also the rotational (initial) position of the rear dosing part 62 in the initial state.

[0140] Furthermore, the cw turning of rear dosing part 62 results in a cw rotation of driver coupling 92, because the two are rotationally locked to one another. This is because they are in splined connection with one another. Driver coupling 92 has spline grooves 92d cooperating with the longitudinal splines 62c. Drive spring 9 is, at its proximal end, affixed to drive holder 91 and thus also to device body 5, as snap fit arms 9ie of drive holder 91 cooperate with snap fit openings 59 of device body 5. And at its distal end, drive spring 9 is affixed to driver coupling 92. Already in the initial state, drive spring 9 is pretensioned to force the dose setting assembly 6 to rotate in a ccw direction.

[0141] Thus, when cw rotating the dose setting assembly 6, additional tension of drive spring 9 is produced. However, a ratchet mechanism inhibits an immediate ccw returning of the dose setting assembly 6 to the initial state.

[0142] For this purpose, rear dosing part 62 forms a first ratchet structure Ri cooperating with a second ratchet structure R2 of the driver cap 85. Driver cap 85 is affixed to plunger nut 8 by a snap fit connection, as snap fit arms 85c of driver cap 85 cooperate with snap fit openings 8e of plunger nut 8.

[0143] Instead of forming a unitary part with rear dosing part 62, first ratchet structure Ri could also be a separate part which however is affixed to rear dosing part 62.

[0144] The first ratchet structure Ri comprises a plurality of ratchet teeth 8sr, e.g., an array of ratchet teeth 8sd, each having a stop surface Ris and an inclined surface Rii.

[0145] The second ratchet structure R2 comprises a plurality of ratchet teeth 62d, e.g., an array of ratchet teeth 62d, each having a stop surface and an inclined surface.

[0146] The teeth 62d, 8sd are generally radially aligned. And they axially protrude from respective surfaces which are aligned perpendicularly to the device axis A. However, the teeth 62d, 8sd could also protrude from conical surfaces, a convex conical surface facing a corresponding concave conical surface.

[0147] As generally known for ratchets, the teeth 62d and 82d cooperate to facilitate a cw rotation of the rear dosing part 62 relative to the driver cap 85, namely by the respective inclined surfaces sliding along one another and thus causing a slight distal movement of the rear dosing part 62 and letting the teeth 62d pass over the teeth 8sd; and a ccw rotation of the rear dosing part 62 relative to the driver cap 85 is inhibited by an abutting of the stop surfaces - unless further measures are taken, as described below. Thus, a user can set a dosing amount by cw turning the read dosing part 62, whereas - unless said further measures are made use of - he / she cannot turn the read dosing part 62 in a ccw direction for achieving a reduction of the set dosing amount.

[0148] Of course, in other embodiments, the cw and ccw rotations can be interchanged.

[0149] Fig. 18A shows a perspective view onto a detail of a cross-section through the medicament delivery device 2 perpendicular to the device axis A, approximately at the position indicated by the thick dashed lines in Fig. 18.

[0150] The first and second ratchet structures Ri, R2 are present on surfaces aligned perpendicularly to the device axis A. The teeth 62d protrude towards proximally from a proximally facing surface of rear dosing part 62, and the teeth 82d protrude towards distally from a distally facing surface of driver cap 85. In alternative embodiments, teeth 62d could protrude towards distally from a distally facing surface of rear dosing part 62, and the teeth 82d could protrude towards proximally from a proximally facing surface of driver cap 85. However, in still other embodiments, the surfaces could be conical surfaces, as mentioned above already.

[0151] Rear dosing part 62 is proximally biased. A force exerted by user is required to cause a moving of rear dosing part 62 towards distally. The proximal bias is caused by means of a setting spring 69 which can be integrally formed with rear dosing part 62, cooperating with a stop-forming feature affixed to the device body 7, such as with a flange-like circumferential ridge protruding inwardly from an interior surface of device body 5 (not shown in the figures). Setting spring 69 can be an elastic bar affixed at its ends and describing an arc having an apex towards distally, as illustrated (Fig. 14). Of course, other ways of producing the proximal bias on rear dosing part 62 are possible, e.g., based on a flexible bar at the device body 5 or based on a separate spring.

[0152] The setting spring 69 not only enables the setting of a dose by enabling the slight distal movement of the rear dosing part 62 required for operating the ratchet mechanism (letting the teeth 62d pass over the teeth 8sd) when cw turning the rear dosing part 62. But further enables a user to disengage the ratchet mechanism (and thus to override the ratchet mechanism) by pulling the rear dosing part 62 towards distally, counteracting the bias of setting spring 69.

[0153] When the ratchet mechanism is disengaged this way, the user can correct a setting made just before (former setting); the medicament delivery device 2 and the dose setting mechanism, respectively, can be considered in a correction state then. In the correction state, the user can selectively turn the rear dose part 62 ccw to reduce the former setting or turn the rear dose part 62 cw to further increase the former setting. Thus, the user can correct a setting he / she made.

[0154] In said alternative embodiments, the user would press the rear dosing part 62 towards proximally in order to disengage the ratchet mechanism for changing (correcting) a setting. In case of said still other embodiments, the user would either pull or press the rear dosing part 62 to disengage the ratchet mechanism for changing a setting, depending on whether the conical surface of the first ratchet part faces partially towards proximally or partially towards distally.

[0155] When disengaging the ratchet mechanism, the driver coupling 92 continues to be rotationally locked to rear dosing part 62, as does the front dosing part 61, and thus, the user can freely select, by rotating the rear dosing part 62 whether to increase the dose setting (and to which extent) or to reduce the dose setting (and to which extent), wherein the reduction to zero is possible, but not below zero, because when a reduction to zero is selected (by the ccw rotation), the helical features 61a are in an end position of the threads 51, in which no further ccw rotation is possible; the helical features 61a abut a stop at the end of the threads 51. While in the correction state, the user not only counteracts (in axial direction) the setting spring 69, but the rear dosing part 62 also is biased towards ccw rotation by drive spring 9. Thus, for further increasing the dosing amount (by cw rotation), the user has to counteract the torsion force of drive spring 9, whereas when decreasing a dose setting, the corresponding ccw rotation is facilitated by drive spring 9.

[0156] When the user decides to have reached a desired dose setting, he / she causes the ratchet mechanism to engage again (back into the setting state), by discontinuing the pulling of the read dosing part 62. Then, expelling of the set (corrected) dose can take place. Even if the user, after discontinuing the pulling of the rear dosing part 62 and thus engaging the ratchet mechanism, is not content with the set corrected dosing amount, he / she can further increase the dosing amount in the setting state (by cw rotation of the rear dosing part) and / or carry out a further correction step (by pulling, rotating, discontinuing pulling); and this can be done one or more times - before finally causing the expelling of the multiply corrected dose setting.

[0157] Expelling of a set dose (irrespective of whether corrected or not corrected) is caused by the user by moving (sliding) the activation slider 13 towards proximally. Activation slider 13 is mounted to device body 5 in a longitudinally slidable way: A protrusion 13a cooperates with a guiding slit in device body 5 (not shown); and guiding features 13b cooperating (i) with cooperating slit rims 46 of container housing 4 and (ii) with features 56 of device body 5. Activation slider 13 is mounted to device body 5 in a rotationally locked way.

[0158] The trigger spring 14 (or trigger biasing member; Fig. 17), e.g., a helical compression spring, forces activation slider 13 towards distally. In the activated (proximal) position, a rotation lock structure 13c of activation slider 13 disengages a cooperating rotation lock structure 83 of plunger nut 8, whereas these are engaged with one another in the initial (distal; not activated) position, so as to rotationally lock the plunger nut 8 to activation slider 13 and thus to device body 5. Both rotation lock structures 13c, 83 can comprise longitudinally aligned splines which are distributed over a circumference, as illustrated in Figs. 7, 11.

[0159] Plunger nut 8 has an interior thread 82 (plunger nut thread) cooperating with an exterior thread 72 (plunger rod thread) of plunger rod 7. The two threads 72, 82 are engaged with one another, so that a ccw rotation of plunger nut 8 causes a proximal movement of plunger rod 7. Towards its proximal end, plunger nut 8 is rotatably supported by an interior bore 91a of driver holder 91, and towards its distal end, plunger nut 8 is rotatably supported by an interior bore 92a of driver coupling 91. Device body 5 has a plunger rod guiding portion 54 comprising an opening through which plunger rod 7 extends. The plunger rod guiding portion 54 comprises two guiding protrusions 57 which rotationally lock plunger rod 7 by cooperating with two longitudinal guiding faces 75 of plunger rod 7.

[0160] In reaction to an activation (sliding the activation slider 13 towards proximally, as described) - of course, with a non-zero dose set - plunger nut 8 is free to rotate (guiding protrusions 54 and 57 disengaged) and will rotate in a ccw sense of rotation, because drive spring 9 is biased by cw rotation (cw-pre-tensioned, and in addition, by the setting of a dosing amount by cw rotation), and the distal end of drive spring 9 is affixed to driver coupling 92 which again is rotationally locked to rear dosing part 62, and rear dosing part 62 is, via the ratchet mechanism, rotationally locked to driver cap 85 which again is affixed to plunger nut 8.

[0161] Accordingly, when expelling a dose, plunger rod 7 is moved towards proximally, as driven by the ccw rotation of plunger nut 8 which is driven by drive spring 9. And this ccw rotation is carried out, too, by the distal end of drive spring 9, by driver coupling 92, by driver cap 5, by rear dosing part 62 and by front dosing part 61, wherein the latter also stops the ccw rotation (as described above, in the end position) and thus determines the end of the expelling. The medicament delivery device 2 not only has the described dose setting mechanism but has furthermore a device termination mechanism which can also be referred to as end lock mechanism.

[0162] The described dose setting mechanism can also be implemented without the device termination mechanism. And the device termination mechanism can also be implemented with a different dose setting mechanism, e.g., with a dose setting mechanism which does not allow corrections of a set dosing amount, at least for corrections which shall decrease the set dosing amount. E.g., the device termination mechanism can be implemented with a dose setting mechanism corresponding with the described one, but without the correction possibility and / or with merely a single dose setting part (e.g., as if the front and rear dosing parts were one and the same or completely locked to one another).

[0163] The device termination mechanism ensures that the medicament delivery device 2 is locked after the plunger rod 7 has proximally moved a predetermined maximum length. In other words, the device termination mechanism shall ensure that the device 2 is locked when a predetermined maximum amount of the medicament 33 has been expelled from the medicament container 3 and, accordingly, when only a predetermined minimum amount (threshold amount) of the medicament 33 still remains in the medicament container 3, respectively.

[0164] For locking the medicament delivery device 2, the ratchet mechanism is locked in the engaged position. This is accomplished by means of locking device 10 interacting on the one hand with plunger rod 7 and on the other hand, with both, the driver cap 85 and the rear dosing part 62. Furthermore, medicament delivery device 2 is locked in that a further movement towards proximally of plunger rod 7 is inhibited.

[0165] To activate the device termination mechanism, a coupling structure 107 at the proximal end 10a of locking device 10 engages with, more particularly abuts, a coupling structure 71 at the distal end 7b of plunger rod 7. This takes place, e.g., when the plunger rod 7 moves proximally. The locking device 10 is still in a non-linking position, but plunger rod device 7, while moving proximally has reached an axial threshold position. When the coupling structure 107 and the coupling structure 71 are engaged, and plunger rod 7 moves further proximally, plunger rod 7 pulls the locking device 10 towards proximally, until plunger rod device 7 reaches an end position and the locking device 10 reaches a linking position.

[0166] The plunger rod 7 moves proximally in particular during an expelling of a last dose or of a partial dose.

[0167] Fig. 16A shows the locking device 10 assembled with the plunger device 7 in a perspective view onto a cross-section, before the threshold amount is reached. The proximal end 10a of locking device 10 is far more proximal than the distal end 7b of plunger rod 7.

[0168] In Fig. 16B, the threshold amount is reached, and the two coupling structures 71, 107 are engaged by abutting one another. Fig. 19 also shows this state, when the device terminating mechanism is activated, but in a perspective view onto a cross-section of a partial assembly of the medicament delivery device 2.

[0169] Locking device 10 is biased towards distally by locking spring 11, e.g., a helical compression spring, abutting driver cap 85 at its proximal end and abutting an abutting structure 109 of locking device 10 near its distal end 10b (e.g., comprised in a spline structure 106’, cf. below).

[0170] Near its distal end 10b, locking device 10 has a blocking structure 108’ cooperating with a blocking structure 81’ of driver cap 85 when the two blocking structures 81’, 108’ are engaged, which is the case when the device termination mechanism is activated, as then, locking device 10 is moved towards proximally. The blocking structure 81’ as well as the blocking structure 108’ comprise blocking features 81 and 108, respectively, which can be, as illustrated, generally longitudinally aligned wedge-shaped splines, tapered towards distally in case of blocking features 81 and tapered towards proximally in case of blocking features 108. When engaged, the two blocking structures 81’, 108’ are rotationally fixed to one another, as their respective blocking features 8, 108 abut, coupling rotational movements of driver cap 85 and rotational movements of locking device 10. In addition, plunger rod 7 cannot move further towards proximally because of its coupling to the locking device 10, while locking device 10 cannot move further towards proximally because of the wedge-shape of the blocking features 108 of the locking device 10 and of the blocking features 81 of the driver cap 85, and driver cap 85 cannot move further towards proximally because it is part of the driver assembly, and plunger nut 8 abuts the device body 5 inhibiting proximal movements (cf. the arrow in Fig. 5A).

[0171] Also, near its distal end 10b, locking device 10 furthermore has a spline structure 106’ with splines 106 embodied as longitudinal, outwardly protruding splines distributed over a circumference. These cooperate with a spline structure 68’ with splines 68 of rear dosing part 62, embodied as longitudinal, inwardly protruding splines distributed over a circumference. These two spline structures 68’, 108’ are engaged with one another at any time during normal operation of the medicament delivery device 2, for rotationally locking the locking device 10 to the rear dosing part 62, while they are axially movable relative to one another. Fig. 18 shows rear dosing part 62 in a perspective view onto a cross-section.

[0172] Before activation of the device termination mechanism, locking spring 11 is in an expanded state, and the blocking structure 108’ is distant and disengaged from the blocking structure 81’, and blocking structure 106’ is distant and disengaged from the blocking structure 68’. But by activation of the device termination mechanism, it is brought into a compressed state, as locking device 10 is moved towards proximally, and the two blocking structures 81’, 108’ as well as the two blocking structures 68’, 106’ engage.

[0173] The blocking structure 108’ and the spline structure 106’ together form a linkage structure 110. The linkage structure can link to one another, at least rotation-wise, the rear dosing member 62 and the driver cap 85. When the device termination mechanism is activated, locking device io is rotationally locked (or even affixed) to driver cap 85 and rotationally locked to rear dosing part 62. Accordingly, it is not possible anymore in that state (the locking device 10 in the linking position) to rotate rear dosing part 62 relative to driver cap 85, and thus, it is not possible then to set a dosing amount. And it is not possible to expel another dose. If no dosing amount can be set (because rear dosing part 62 cannot be rotated relative to driver cap 85), no dose of the medicament 33 can be expelled. This can be useful in particular when the medicament delivery device 2 is a disposable device, i.e. a device to be used with only one medicament container 3, thus with no provision to replace the medicament container 3, at least not once that a first dose has been expelled from the medicament container 3.

[0174] Accordingly, a user cannot set another dosing amount and cannot expel another dose when the threshold amount is reached, i.e. when it can be assumed that the amount of the medicament 33 in the container is too small for another dose.

[0175] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0176] Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia and / or dyslipidemia, cardiovascular disease, diabetes (e.g. type 1 or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behget’s disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycaemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, Factor V Leiden), and cancer.

[0177] Exemplary types of drugs that could be included in the delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapies, radioisotopes and / or nuclear medicines, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogues, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies.

[0178] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro- apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.

[0179] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-i (GLP-i) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Ci esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor- associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-1 / PD-L1) inhibitors / modulators, B-lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, B-lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulators, lymphocyte-activation gene 3 (LAG3; also known as cluster of differentiation 223 or CD223) antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation W137 (CDW137) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD159 or NKG2) modulators, glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig- like receptor (KIR) modulators, growth arrest-specific protein 6 (GAS6) / AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation W123 (CDwi23) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumorinfiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.

[0180] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-ia, interferon beta-ib, peginterferon beta-ia, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins.

[0181] Exemplary drugs that could be included in the delivery devices described herein may also include, but are not limited to, oncology treatments such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab.

[0182] Exemplary drugs that could be included in the delivery devices described herein include “generic” or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the “innovator” or “branded” version of each, as in the non-limiting example of innovator medicament adalimumab and biosimilars such as adalimumab- afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

[0183] Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.

[0184] Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer’s solution, Heparin Lock Flush solution, loo U / mL Heparin Lock Flush Solution, or 5000 U / mL Heparin Lock Flush Solution.

[0185] Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also include separately administered or co-formulated dispersion enhancers (e.g. an animal-derived, human-derived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.

[0186] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mF0LF0X6, mFOLFOXy, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini- CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC- EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C- MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

[0187] Various modifications to the embodiments described are possible and will occur to those skilled in the art without departing from the invention which is defined by the following claims.

Claims

CLAIMS1. A medicament delivery device (2) for accommodating a medicament container (3) containing a medicament and for expelling multiple doses of the medicament (33) from the medicament container (3), the medicament delivery device defining a device axis (A) and comprising- a base assembly to which the medicament container (3) is mountable;- a plunger rod device (7) axially movable for acting, in an expelling movement in which the plunger rod device (7) moves towards proximally, on a plunger (31) of the medicament container (3) for expelling the medicament therefrom;- a driver biasing member (9);- a driver assembly biased by the driver biasing member (9) and coupled to the plunger rod device (7), configured to carry out, biased by the driver biasing member (9), a driver movement, the driver movement causing the expelling movement; and- a dose setting mechanism for setting and correcting a dosing amount for a dose of the medicament (33) to be expelled, the dose setting mechanism comprising o a first dosing member (61) and a second dosing member (62) which are rotationally coupled to one another and axially movable relative to one another, wherein an angle of rotation assumed by the first dosing member (61) determines the dosing amount; o a ratchet mechanism with a first ratchet structure (Ri) rotationally locked to, in particular comprised in, the driver assembly and a second ratchet structure (R2) rotationally locked to, in particular comprised in, the second dosing member (62), which, in a setting state, are engaged with one another and which, in a correcting state, are disengaged from one another, and which, in the setting state,■ enable a rotation of the second ratchet structure (R2) relative to the first ratchet structure in a first sense of rotation; and■ inhibit a rotation of the second ratchet structure (R2) relative to the first ratchet structure (Ri) in a second sense of rotation opposite the first sense of rotation;- a set-control biasing member (69) configured to bias the second dosing member (62) in a second axial direction to bias the second ratchet structure (R2) to engage with the first ratchet structure (Ri); and- a control mechanism operable by a user to selectably switch between the setting state and the correcting state, by the user causing a first movement of the second dosing member (62) into the first axial direction to switch from the setting state into the correcting state, and by the user causing a second movement of the second dosing member (62) into a second axial direction opposite the first axial direction to switch from the correcting state into the setting state.

2. The medicament delivery device (2) according to claim 1, wherein a first end of the driver biasing member (9) is rotationally locked to the base assembly, and a second end of the driver biasing member (9) is rotationally locked to the second dosing member (62); wherein the driver biasing member (9) is pre-tensioned such that a rotation of the second end relative to the first end in the first sense of rotation increases a bias of the driver biasing member (9).

3. The medicament delivery device (2) according to claim 1 or claim 2, one of the base assembly and of the first dosing member (61) comprising a rotation-guiding feature (51), the other one comprising at least one cooperating feature (61a) cooperating with the rotation-guiding feature (51) to guide rotational movements of the first dosing member relative to the base assembly, wherein the rotation-guiding feature (51) comprises a first stop cooperating with the at least one cooperating feature (61a) to inhibit a rotation of the first dosing member (61) in the second sense of rotation whenthe at least one cooperating feature (6ia) abuts the first stop, wherein the rotational position of the first dosing member (61) in which the at least one cooperating feature (6ia) abuts the first stop is the initial rotational position.

4. The medicament delivery device (2) according to one of claims 1 to 3, comprising a dose release mechanism comprising a trigger element (13), wherein the trigger element (13) is operable by a user to release a dose by bringing dose release mechanism from an inhibiting state into a releasing state, wherein the dose release mechanism is couplable to the driver assembly to block the driver movement in the inhibiting state and to enable the driver movement in the releasing state.

5. The medicament delivery device (2) according to claim 4, wherein the trigger element (13) is operable by a user to be movable from an inhibiting position in which the trigger element (13) is coupled to the driver assembly to block the driver movement, to a releasing position in which the trigger element (13) is decoupled from the driver assembly not to block the driver movement, the dose release mechanism further comprising a trigger biasing member (14) biasing the activation element (13) towards the inhibiting position.

6. The medicament delivery device (2) according to one of claims 1 to 5, wherein the driver biasing member (9) is a torsion spring, in particular a helical torsion spring, the driver assembly comprising a plunger nut device (8) cooperating with the plunger rod device (7), one of the plunger nut device (8) and of the plunger rod device (7) comprising a helical guidance feature (72), the other one comprising a guidance cooperation feature (82) cooperating with the helical guidance feature (72) to obtain the expelling movement from the driver movement, wherein the driver movement is a rotational movement.

7. The medicament delivery device (2) according to one of claims 1 to 6, wherein one of the first dosing member (61) and of the a second dosing member (62) comprises first longitudinal splines (62c), the other onecomprising second features (6ic) cooperating with the first longitudinal splines (62c) to rotationally couple the first dosing member (61) and the second dosing member (62) to one another while enabling axial relative movements of the first dosing member (61) and the second dosing member (62).

8. The medicament delivery device (2) according to one of claims 1 to 7, the base assembly comprising a generally tubular shaped part (5), the second dosing member (62) comprising a generally tubular shaped section located, at least in part, inside the generally tubular shaped part (5), at least one of the generally tubular shaped part (5) and of the generally tubular shaped section comprising a guiding structure (62b; 62b’), the other one comprising a cooperating surface cooperating with the guiding structure (62b, 62b’) to provide guidance for axial and rotational movements of the second dosing member (62) relative to the base assembly.

9. The medicament delivery device (2) according to one of claims 1 to 8, one of the base assembly and of the second dosing member (62) comprising a first limiting feature (62b; 62b’), the other one comprising a second limiting feature, the first limiting feature (62b; 62b’) and the second limiting feature cooperating to provide a stop limiting a distal movement of the second dosing member (62) towards distally.

10. The medicament delivery device (2) according to one of claims 1 to 9, wherein the first axial direction is a distal direction.

11. The medicament delivery device (2) according to one of claims 1 to 10, wherein the set-control biasing member (69) comprises a flexible portion of the second dosing member (62).

12. The medicament delivery device (2) according to one of claims 1 to 11, the base assembly comprising a window (52), the second dosing member (62) comprising a plurality of signs (S) distributed over a circumference on an outside face of the second dosing member (62) and arranged to be visible through the window (52) in the setting state to indicate a set dosing amount.13- The medicament delivery device (2) according to one of claims 1 to 12, the ratchet mechanism comprising a first ratchet surface which is aligned perpendicularly to the device axis (A), the first ratchet structure (Ri) comprising a plurality of first ratchet teeth (8sd) which protrude from the first ratchet surface and are radially extended and circumferentially distributed; the ratchet mechanism further comprising a second ratchet surface facing the first ratchet surface, wherein the second ratchet surface which is aligned perpendicularly to the device axis (A), the second ratchet structure (R2) comprising a plurality of second ratchet teeth (62d) which protrude from the second ratchet surface and are radially extended and circumferentially distributed.

14. The medicament delivery device (2) according to one of claims 1 to 13, wherein the second ratchet structure (R2) forms a unitary part with the second dosing member (62).

15. A medicament delivery assembly (1), comprising the medicament delivery device (2) according to one of claims 1 to 15, further comprising the medicament container (3) assembled with the medicament delivery device (2).

Images