Medicament delivery device

Abstract

Medicament delivery device having a proximal end pointing towards a dose delivery site and a distal end opposite the proximal end, the device comprising: a housing (3), a plunger rod (4) comprising a blocking protrusion, a medicament delivery member cover (1) coupled to the housing (3) and axially movable between an extended position and a retracted position with respect to the housing (3), wherein the housing (3) comprises a stop configured to engage with the blocking protrusion, wherein the plunger rod (4) is axially blocked in a proximal direction with respect to the housing (3) in a first position of the blocking protrusion and axially moveable with respect to the housing (3) in a second position of the blocking protrusion, wherein the member cover (1) comprises an engagement surface configured to interact with the blocking protrusion, and wherein, when the medicament delivery member cover (1) is pushed in a distal direction into the retracted position, the engagement surface is configured to translate the blocking protrusion from the first position to the second position.

Description

[0001] Medicament delivery device

[0002] TECHNICAL FIELD

[0003] The present disclosure relates to a medicament delivery device and in particular to an activation mechanism of a medicament delivery device.

[0004] BACKGROUND

[0005] A medicament delivery device, in particular an autoinjector, according to the prior art comprises a housing comprising a front housing and a rear housing. The housing is adapted to hold a medicament container, such as a syringe. The syringe may be a pre-filled syringe and have a needle as a medicament delivery member arranged at a proximal end. When the autoinjector and / or the syringe are assembled, a protective needle sheath may be removably coupled to the needle. The protective needle sheath may be made of a flexible shell (for instance composed of rubber) and / or a rigid shell (for instance composed of plastic). A stopper, also called plunger, maybe arranged for sealing the syringe distally and for expelling a medicament contained in the syringe through the needle. In other exemplary embodiments, the medicament container may be a cartridge which includes the medicament and engages a removable needle (e.g., by threads, snaps, friction, etc.).

[0006] A cap may be removably disposed at a proximal end of the housing. The cap may include an element (e.g., a barb, a hook, a narrowed section, etc.) arranged to engage the protective needle sheath, the housing and / or a medicament delivery member cover, also referred to as needle cover, telescoped within the housing. The cap may comprise grip features for facilitating removal of the cap (e.g., by twisting and / or pulling the cap relative to the housing).

[0007] A medicament delivery member cover biasing member (for instance a coil spring) may be arranged to bias the medicament delivery member cover in a proximal direction relative to the housing, before injection, for safety reasons. The medicament delivery member cover biasing member needs to be compressed at the beginning of injection in order to retract the medicament delivery member cover inside the housing and uncover the medicament delivery member, thereby activating the device.

[0008] A pre-loaded drive biasing member, for instance a pre-compressed drive coil spring, may be arranged within the housing. A plunger rod may be used to forward force from the drive biasing member to the stopper. In an exemplary embodiment, the plunger rod is hollow and the drive biasing member is arranged within the plunger rod. In another exemplary embodiment, the plunger rod is solid and the drive biasing member engages a distal end of the plunger rod. When the pre-loaded drive biasing member is released, the drive biasing member biases the plunger rod in the proximal direction relative to the housing, releasing the plunger rod. Besides that, the plunger rod may itself comprise means for sealing the medicament container such that no stopper needs to be provided.

[0009] A plunger rod release mechanism may be arranged for preventing release of the plunger rod prior to retraction of the medicament delivery member cover relative to the housing and for releasing the plunger rod only once the medicament delivery member cover is sufficiently retracted.

[0010] A medicament delivery member cover lock mechanism (needle cover lock mechanism) may be arranged to prevent retraction of the medicament delivery member cover relative to the housing when the cap is in place, thereby avoiding unintentional activation of the autoinjector (e.g., if dropped, during shipping or packaging, etc.). Such mechanisms are known in the art and will not be described in detail.

[0011] However, there is a need to further improve the triggering mechanism of medicament delivery devices while effectively preventing inadvertent activation of the device.

[0012] This need is met by a device according to the present disclosure. SUMMARY

[0013] Reference should now be made to the appended claims.

[0014] The invention relates to a medicament delivery device, the medicament delivery device having a proximal end pointing towards a dose delivery site during use of the medicament delivery device, and a distal end opposite the proximal end, the medicament delivery device comprising: a housing comprising a longitudinal axis, a plunger rod comprising a blocking protrusion, a pre-loaded drive biasing member exerting a force on the plunger rod in the proximal direction, a medicament delivery member cover coupled to the housing and axially movable between an extended position and a retracted position with respect to the housing, wherein the housing comprises a stop configured to engage with the blocking protrusion of the plunger rod, wherein the plunger rod is axially blocked in a proximal direction with respect to the housing in a first position of the blocking protrusion and axially moveable with respect to the housing in a second position of the blocking protrusion, wherein the medicament delivery member cover comprises an engagement surface configured to interact with the blocking protrusion, and wherein, when the medicament delivery member cover is pushed in a distal direction into the retracted position, the engagement surface is configured to translate the blocking protrusion from the first position to the second position, wherein the medicament delivery member cover comprises two medicament delivery member cover arms extending in the distal direction, wherein the medicament delivery member cover arms each comprise an axial slot extending in the axial direction and configured to receive the stop, wherein the axial slot is configured to guide the medicament delivery member cover in the axial direction. In a non-limiting embodiment, the plunger rod is rotationally fixed with respect to the housing and the blocking protrusion comprises at least one flexible arm extending in the distal direction and a radial outward direction with respect to the longitudinal axis, and a plunger rod block is provided at each distal end of the at least one flexible arm, wherein a proximal surface of the plunger rod block abuts the stop of the housing in the first position.

[0015] In a non-limiting embodiment, the engagement surface of the medicament delivery member cover comprises at least one protrusion extending from an inner circumferential surface of each of the medicament delivery member cover arms in a radial direction towards the longitudinal axis, and preferably, the at least one protrusion is sloped towards a distal end of the arms.

[0016] In a non-limiting embodiment, the protrusion, when the medicament delivery member cover is distally pushed in the retracted position, is configured to engage with the plunger rod block such that the flexible arms are forced in the radial direction towards the longitudinal axis, wherein said engagement translates the plunger rod block from the first position to the second position, and in the second position, the flexible arm is in a radial position in which the abutment of the plunger rod block on the stop is released and the plunger rod is axially moveable in the proximal direction.

[0017] In a non-limiting embodiment, the medicament delivery member cover is rotationally fixed with respect to the housing.

[0018] The invention is specified by the independent claim. Preferred embodiments are defined in the dependent claims. In the following description, although numerous features may be designated as optional, it is nevertheless acknowledged that all features comprised in the independent claims are not to be read as optional.

[0019] 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.

[0020] 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.

[0021] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0022] Further, the terms “circumference”, “circumferential”, or “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a longitudinal axis extending in the direction of the longest extension of the device and / or component. Similarly, “radial” or “radially” refer to a direction extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis.

[0023] When a component is said to move proximally, distally, axially in a proximal direction, axially in a distal direction or equivalent terms, the movement is relative to the housing of the injection device, unless mentioned otherwise.

[0024] 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

[0025] Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings.

[0026] Figure 1A shows a distal end of a plunger rod according to an example of the present disclosure.

[0027] Figures 1B and 1C show a distal end of a medicament delivery member cover according to examples of the present disclosure.

[0028] Figure 1D shows a distal end of a housing according to an example of the present disclosure.

[0029] Figure 2 shows a partial view of a medicament delivery device comprising the elements of Figures 1A to 1D in an assembled state.

[0030] Figures 3A to 3C are depictions of an activation sequence of the device according to Figure 2.

[0031] Figures 4A to 4C are depictions of an activation sequence of the device according to Figures 2 or 3A to 3C.

[0032] Figure 5 is an exploded view of the device according to Figures 1A to 4C.

[0033] Figure 6A shows a distal end of a plunger rod according to an example of the present disclosure.

[0034] Figure 6B shows a distal end of a medicament delivery member cover according to an example of the present disclosure.

[0035] Figure 6C shows a distal end of a housing according to an example of the present disclosure.

[0036] Figures 7A and 7B show partial views of an activation sequence of a medicament delivery device comprising the elements of Figures 6A to 6C. Figures 7C and 7D show the partial views of Figures 7A and 7B from a different perspective.

[0037] Figures 8A to 8C are depictions of an activation sequence of the device according to Figures 7A to 7D.

[0038] Figure 9 is an exploded view of the device according to Figures 6A to 8C.

[0039] DETAILED DESCRIPTION

[0040] The activation mechanism according to the present invention can be employed for various medicament delivery devices. Thus, only the parts relevant for carrying out the disclosure will be described in detail.

[0041] In the figures, elements not essential for carrying out the invention have been omitted. In particular, not all figures show a complete outer housing, biasing members, a medicament container, cap, etc. in order not to render the depictions overly complicated and not to blur the scope of the disclosure.

[0042] In the following, the assembled state refers to a state in which the device is delivered to the patient, i.e., before activation and medicament delivery. In the assembled state, the plunger rod is in a locked position and not able to move in the proximal direction. In the activation state, the medicament delivery member cover is moved in the distal direction along the longitudinal axis from an extended position to a retracted position. In the activated state, the plunger rod is free to move in the proximal direction for medicament delivery. The plunger rod may thus be displaceable along the axial direction.

[0043] The medicament delivery member cover can be moved from the extended to the retracted position. Therefore, the medicament delivery member cover can be displaced in the axial direction. In the extended position, the medicament delivery member cover extends in a proximal direction from the housing. Thereby, a medicament delivery member, e.g., a needle, may be covered by the medicament delivery member cover. By pushing the medicament delivery member cover in the distal direction, e.g., by pushing the device onto a medicament delivery site, the medicament delivery member cover is moved to the retracted position for activating medicament delivery. After delivery, the medicament delivery member cover may be moved back to the extended position to cover the medicament delivery member. The medicament delivery member cover may also be locked in the extended position after medicament delivery to and prevent injuries of the patient.

[0044] In the following, the term engagement encompasses any kind of interaction between the named features such as abutment, clamping, locking, biasing, flexing, etc.

[0045] The present disclosure is directed towards a medicament delivery device, comprising a housing 2, 3 having a longitudinal axis, a plunger rod 4 comprising a blocking protrusion 41, 42, 43, 44 and a medicament delivery member cover 1 coupled to the housing 2, 3 and being axially movable between an extended position and a retracted position with respect to the housing 2, 3.

[0046] The housing 2, 3 comprises a stop 21, 31 configured to engage with the blocking protrusion 41, 42, 43, 44 of the plunger rod 4. The plunger rod 4 is axially fixed in a proximal direction towards a medicament delivery site with respect to the housing 2, 3 in a first position of the blocking protrusion 41, 42, 43, 44 and axially moveable with respect to the housing 2, 3 in a second position of the blocking protrusion 41, 42, 43, 44. The medicament delivery member cover 1 comprises an engagement surface 12, 13, 15 configured to interact with the blocking protrusion 41, 42, 43, 44. When the medicament delivery member cover 1 is pushed in a distal direction away from the medicament delivery site into the retracted position, the engagement surface 12, 13, 15 is configured to translate the blocking protrusion 41, 42, 43, 44 from the first position to the second position.

[0047] Fig. 1A shows a distal end of a plunger rod 4 according to an embodiment of the present disclosure. The plunger rod 4 may comprise a longitudinally extending portion which is provided with a stopper at its proximal end to expel a medicament as described above. At a distal portion of the plunger rod 4, at least one flexible arm 41, in the present embodiment two flexible arms 41, may be provided which may extend in the distal direction and a radial outward direction with respect to the longitudinal axis. The flexible arms 41 may be positioned at opposing outer circumferential surfaces of the longitudinally extending portion of the plunger rod. In case there are more than two flexible arms 41, the positioning might have to be adapted accordingly.

[0048] At the distal ends of each of the flexible arms 41, plunger rod blocks 42 may be provided forming the blocking protrusions. In the depicted embodiment, the plunger rod blocks 42 comprise a central portion which is substantially rectangular in a cross section. On at least one side portion of the plunger rod blocks 42 in the circumferential direction, in Fig. 1A on both side portions, slanted or phased surfaces may be provided. An outer circumferential surface of the plunger rod blocks 42 may be phased in the proximal and radial inward direction as shown in Fig. 1A. Other shapes providing the same functionality may also be encompassed by the present disclosure.

[0049] In this embodiment, the plunger rod blocks 42 do not extend beyond the distal end of the plunger rod 4 but this is not to be viewed as limiting the present disclosure.

[0050] The central portion of the plunger rod block 42 may extend further than an end of the respective flexible arm 41 in a radial direction for forming the abutment surface resting on the stop 31.

[0051] As described above, a drive biasing member, for instance a coil spring or other energy accumulating member (not shown) may be provided exerting a force on the plunger rod 4 in the proximal direction for expelling a medicament when the plunger rod 4 is free to move in the proximal direction. The drive biasing member may be provided between the distal end of the plunger rod 4 and a distal end of the housing 3, a rear cap or the like.

[0052] Figs. 1B and 1C show the distal ends of a medicament delivery member cover

[0053] 1 or needle cover according to embodiments of the present disclosure. The medicament delivery member cover 1 may comprise at least one protrusion 12 extending in the radial inward direction. In particular, the medicament delivery member cover 1 may comprise at least one medicament delivery member cover arm n extending in the distal direction, wherein the at least one protrusion 12 is located on an inner circumferential surface of the medicament delivery member cover arm n. Moreover, the medicament delivery member cover arm n may comprise an axial slot 14. The axial slot 14 may be provided at the distal end of each of the arms 11 (so that the arm 11 is divided into two sub-arms) and may be open towards the distal end of each of the arms 11. A pair of protrusions 12 may be provided for each axial slot 14, that is, one protrusion 12 may be provided on each lateral side of the axial slots 14, i.e., on each sub-arm. Each protrusion 12 may thus interact with the one side portion of the plunger rod block 42 if the device is designed as in Figs. 1A to 1C.

[0054] The protrusion 12 may form the engagement surface engaging with the plunger rod block 42 during activation of the device. The engagement surface may particularly be formed by a distally directed end surface of the protrusion 12. As shown in Fig. 1B, the distally directed end surface of the protrusion 12 may be sloped, e.g., having a constant slope or a varying slope as shown in Fig. 1C. The protrusion 12 may be sloped towards the distal end of the medicament delivery member cover 1, in particular of the medicament delivery member cover arm 11.

[0055] A varying slope may minimise the initial activation force and thus facilitate handling of the device.

[0056] Fig. 1D shows a partial view of a distal end of a housing 3 according to an embodiment. The housing 3 comprises a stop 31 configured to engage the plunger rod block 42. The housing 3 maybe formed as a substantially (hollow) cylindrical body. The stop 31 maybe provided on an inner circumferential surface of the housing 3 and may extend in an axial / longitudinal direction. The stop 31 may also be formed as a slim abutment protrusion. The medicament delivery member cover 1 may be provided inside the housing 3 in the radial direction and the plunger rod 4 may be provided inside the medicament delivery member cover 1 in the radial direction.

[0057] Generally, the number of blocking protrusions 41, 42, 43, 44 may correspond to the number of stops 21, 31 and the number of blocking protrusions 41, 42, 43, 44 may correspond to the number of engagement surfaces 13, 15 or the number of pairs of engagement surfaces 12.

[0058] Fig. 2 shows a partial view of an assembled medicament delivery device comprising the medicament delivery member cover 1, the housing 3 (transparently displayed) and the plunger rod 4 according to Figs. 1A to 1D. In the assembled state depicted in Fig. 2, the plunger rod block 42 abuts the stop 31 in axial direction. This is referred to as the first position of the plunger rod block 42. Thus, the plunger rod 4 is not able to be moved in the proximal direction.

[0059] The protrusion 12 forming the engagement surface and the stop 31 maybe spatially separated. The housing 3, the medicament delivery member cover 1 and the plunger rod 4 may be rotationally fixed with respect to each other. For example, the stop 31 maybe placed in the axial slot 14, i.e., the axial slot 14 may receive the stop 31 and thus the medicament delivery member cover 1 may be guided in the axial direction. The medicament delivery member cover 1 may be axially displaceable with respect to the housing 3 and the plunger rod 4 from the extended to the retracted position (and back) and the plunger rod 4 may be axially displaceable with respect to the housing 3 and the medicament delivery member cover 1 from the assembled to the activated position (i.e., before and after medicament delivery).

[0060] That is, the plunger rod 4 may be in a non-rotational configuration. Due to the flexible arms 41, this embodiment may be referred to as a radial activation embodiment.

[0061] Figs. 3A to 3C show an activation sequence of the above-describe device. In

[0062] Fig. 3A, the device is in the assembled state and the plunger rod block 42 (blocking protrusion) is in the first position abutting the stop 31 of the housing 3 (not shown). The plunger rod 4 is blocked in the proximal direction via the abutment of the plunger rod block 42 on the stop 31.

[0063] The plunger rod arm 41 and the plunger rod block 42 may form the blocking protrusion.

[0064] When the medicament delivery member cover 1 is distally pushed in the retracted position as indicated by the arrow in Fig. 3A, the protrusion 12 (engagement surface) is configured to engage with the plunger rod block 42 (blocking protrusion) such that the flexible arms 41 are forced in the radial direction towards the longitudinal axis (see activation state in Fig. 3B). Said engagement translates the plunger rod block 42 from the first position to the second position via the inwardly protruding protrusion 12. Due to the flexible arms 41, the plunger rod block 42 is configured to be moved inwardly towards the longitudinal axis via the flexible arms 42.

[0065] Fig. 3C shows the same activation state as Fig. 3B, wherein the medicament delivery member cover 1 has been omitted. The flexible arms 11 and thus the plunger rod block 42 have been moved or biased towards the longitudinal axis. The plunger rod block 42 is just touching the stop 31 and the plunger rod 4 is thus not yet fully released.

[0066] In the second position, the flexible arm 41 is in a radial position in which the abutment of the plunger rod block 42 on the stop 31 is released (i.e., further inwards than in Fig. 3C) and the plunger rod 4 is axially moveable in the proximal direction to expel the medicament from the medicament container.

[0067] Figs. 4A to 4C show an activation sequence of the above-described device. In the figures, the housing 3 is transparently displayed and the cap and rear cap closing the housing at the distal end are not shown.

[0068] In Fig. 4A, the device is in the assembled state, wherein cap (not shown) and needle sheath (extending beyond the medicament delivery member cover / needle cover 1 in the proximal direction) are still placed on the device. The medicament delivery member cover 1 is in its extended position covering the needle.

[0069] After removal of the cap and the needle sheath, when the medicament delivery member cover i is pushed in the distal direction, e.g. by pushing the device onto the medicament delivery site, the medicament delivery member cover i is displaced from the extended to the retracted position, thereby releasing the abutment of the plunger rod block 42 on the stop 31 as described above.

[0070] Fig. 4B shows an activation state of the device corresponding to Figs. 3B and 3C, just before release of the plunger rod 4.

[0071] In Fig. 4C, the device is in the activated state and the plunger rod 4 has been moved in the proximal direction by the drive biasing member (not shown). The plunger rod block 42 may slide along the inner circumferential surface of the medicament delivery member cover arms 11 during medicament expulsion. Fig. 4C shows the plunger rod 4 in its final position.

[0072] Thereafter, the medicament delivery member cover 1 may be pushed back to the extended position by a medicament delivery member cover biasing member (not shown), for instance a coil spring, and locked in that position in order to prevent injuries.

[0073] Fig. 5 shows an exploded view of the above-described medicament delivery device with a cap, a needle sheath, a syringe 5, a medicament delivery member cover 1, a housing 3 and a plunger rod 4.

[0074] In the following, an embodiment related to the above embodiment will be described. Unless explicitly indicated otherwise, the above descriptions equally apply to the embodiment of Figs. 6 to 9. In this embodiment, the plunger rod is in a rotational configuration (rotational activation).

[0075] The plunger rod 4 according to Fig. 6A comprises a longitudinally extending portion which is configured to contact and push a stopper at its proximal end to expel a medicament as described above. At a distal portion of the plunger rod 4, at least one arm 41, in the present embodiment two arms 41, may be provided which may extend in the distal direction and a radial outward direction with respect to the longitudinal axis. The arms 41 may be positioned at opposing outer circumferential surfaces of the longitudinally extending portion of the plunger rod. In case there are more than two arms 41, the positioning might have to be adapted accordingly.

[0076] In this embodiment, the arms 41 are formed as triangular sections protruding from an outer circumferential surface of the longitudinally extending portion. The arms 41 are rigidly designed. The arms 41 may also be provided in a shape as shown in Fig. 1A but as a more rigid construction. Although it may be advantageous if no flexing towards the longitudinal axis occurs, a certain amount of flexing may also be tolerated.

[0077] At the distal ends of each of the arms 41, sloped plunger rod blocks 42 may be provided forming the blocking protrusions. Alternatively, the plunger rod arm 41 and the sloped plunger rod block 42 may form the blocking protrusion.

[0078] In the depicted embodiment, the sloped plunger rod blocks 42 comprise a central portion which is substantially rectangular in a cross section. On at least one side portion of the sloped plunger rod blocks 42, a slanted or phased surface may be provided in the circumferential direction of the longitudinal axis.

[0079] The sloped plunger rod blocks 42 may be phased in the proximal and circumferential direction as shown in Fig. 6A. Other shapes providing the same functionality may also be encompassed by the present disclosure.

[0080] In this embodiment, the sloped plunger rod blocks 42 extend beyond the distal end of the plunger rod 4 but this is not to be viewed as limiting the present disclosure. The sloped plunger rod block 42 may extend further than an end of the respective flexible arm 41 in a radial direction for forming the abutment surface resting on the stop 31.

[0081] As described above, a drive biasing member, for instance a coil spring or other energy accumulating member (not shown) may be provided exerting a force on the plunger rod 4 in the proximal direction for expelling a medicament when the plunger rod 4 is free to move in the proximal direction. The drive biasing member may be provided between the distal end of the plunger rod and a distal end of the housing 3, a rear cap or the like.

[0082] Fig. 6B shows a distal end of a medicament delivery member cover 1 according to an embodiment. The medicament delivery member cover 1 comprises at least one sloped surface 13 acting as an engagement surface. The medicament delivery member cover 1 may comprise at least one medicament delivery member cover arm 11, wherein the sloped surface 13 is provided on respective distal ends of the arms 11. The sloped surface 13 may be sloped in a circumferential direction and proximal direction. A reinforcement rib may be provided as shown in Fig. 6B to broaden the sloped surface 13 and provide a higher rigidity.

[0083] Fig. 6C shows a distal end of the housing 3 as a transparent view. As described in the above embodiment, the housing 3 comprises a stop 31 for abutment with the sloped plunger rod block 42. The stop 31 may be formed as a longitudinally extending member (i.e., in the axial direction) on an inner circumferential surface of the housing 3. Further, a guide protrusion 32 formed as a longitudinally extending member may be provided on the inner circumferential surface of the housing 3 offset to the stop 31 in the circumferential direction. In particular, the distance between the stop 31 and the guide protrusion 32 may correspond to the width of the medicament delivery member cover arm 11 such that the medicament delivery member cover 11 may be guided in the axial direction. As indicated above the number of stops 31 and guide protrusions 32 may correspond to the number of medicament delivery member cover arms 11 and the number of sloped plunger rod blocks 42 may correspond to the number of stops 31, and sloped surfaces 13, respectively.

[0084] In the embodiment of Figs. 6A to 9, the plunger rod 4 is rotationally provided and thus moveable in the circumferential direction and the axial direction with respect to the housing 3 and the medicament delivery member cover 1. The medicament delivery member cover 1 is displaceable in the axial direction with respect to the housing 3 and the plunger rod 4 but rotationally fixed with respect to the housing 3.

[0085] The sloped surface 13 and the sloped plunger rod block 42 may be provided at an angle of 30 to 60 degrees, particularly 45 degrees, with respect to the longitudinal axis. The slopes of the sloped surface 13 and the sloped plunger rod block 42 may be complementary.

[0086] Figs. 7A and 7B show an activation sequence of a device according to an embodiment comprising the plunger rod 4, the medicament delivery member cover 1 and the housing 3 according to Figs. 6A to 6C, wherein the housing 3 is transparently displayed.

[0087] Fig. 7A shows a partial view of the device in an assembled state. In the assembled state, the sloped plunger rod block 42 abuts the stop 31. The sloped plunger rod block 42 is in its first position, wherein a movement of the plunger rod 4 in the proximal direction is prevented by the abutment.

[0088] In particular, a proximal end surface of the sloped plunger rod block 42 (e.g., of the central portion of the sloped plunger rod block 42 as shown in Fig. 7A) is in contact with a distal end surface of the stop 31.

[0089] The medicament delivery member cover 1 is in its extended position. As can be seen from Figs. 7A and 7B, the medicament delivery member cover arms 11 may be guided in the axial direction between the stop 31 and the guide protrusion 32. When the medicament delivery member cover 1 is distally pushed in the retracted position as indicated by the arrow in Fig. 7A, e.g., by pushing the device onto a medicament delivery site, the sloped surface 13 is configured to engage with the sloped side surface of the sloped plunger rod block 42 such that the sloped plunger rod block 42 is rotationally translated from the first position towards the second position as shown in Fig. 7B. The plunger rod 4 is rotated together with the sloped plunger rod block 42.

[0090] In Fig. 7B, the device is in the activation position in which the sloped plunger rod block 42 still abuts the stop 31 and the plunger rod 4 is thus not yet free to be moved in the proximal direction for medicament expulsion.

[0091] This can also be clearly seen from Figs. 7C and 7D showing the same sequence as Figs. 7A and 7B, respectively, from a different perspective.

[0092] When the sloped plunger rod block 42 is turned further than shown in Figs. 7B and 7D and reaches the second position, the abutment of the proximal surface of the sloped plunger rod block 42 on the stop 31 is released and the plunger rod 4 is axially moveable in a proximal direction towards the medicament delivery site.

[0093] Figs. 8A to 8C show an activation sequence of a device as described above in conjunction with Figs. 6 and 7, wherein housing 3 is transparently displayed and the cap as well as a rear cap closing the device at its distal end are not shown.

[0094] In Fig. 8A, the device is in the assembled state, wherein cap (not shown) and needle sheath (not shown) are still placed on the device. The medicament delivery member cover 1 is in its extended position covering the needle.

[0095] After removal of the cap and the needle sheath, when the medicament delivery member cover 1 is pushed in the distal direction, e.g., by pushing the device onto the medicament delivery site, the medicament delivery member cover 1 is displaced from the extended to the retracted position, thereby releasing the abutment of the sloped plunger rod block 42 on the stop 31 as described above via the interaction of the sloped surface 13 with the sloped plunger rod block 42.

[0096] Fig. 8B shows an activation state of the device corresponding to Figs. 7B and 7D, just before release of the plunger rod 4.

[0097] In Fig. 8C, the device is in the activated state and the plunger rod 4 has been moved in the proximal direction by the drive biasing member (not shown). Fig. 8C shows the final position of the plunger rod 4.

[0098] Thereafter, the medicament delivery member cover 1 may be pushed back to the extended position by a medicament delivery member cover biasing member (not shown), for instance a coil spring, and locked in that position in order to prevent injuries.

[0099] Fig. 9 shows an exploded view of the device described with reference to Figs. 6A to 8C having a cap, a needle sheath, a syringe 5, a medicament delivery member cover 1, a housing 3 and a plunger rod 4.

[0100] In the present disclosure, an improved mechanism for activation of a medicament delivery device and in particular for release of a plunger rod has been presented.

[0101] According to the present disclosure, handling of the medicament delivery device may be facilitated while preventing inadvertent activation of the device and injuries of a user.

[0102] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0103] 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, hi dradenitis 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, Behqet'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.

[0104] 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.

[0105] 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. 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 (CDW123) 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.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] 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.

[0110] 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, 100 U / mL Heparin Lock Flush Solution, or 5000 U / mL Heparin Lock Flush Solution.

[0111] 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.

[0112] 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, mFOLFOX6, 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. 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. Medicament delivery device, the medicament delivery device having a proximal end pointing towards a dose delivery site during use of the medicament delivery device, and a distal end opposite the proximal end, the medicament delivery device comprising: a housing (2, 3) comprising a longitudinal axis, a plunger rod (4) comprising a blocking protrusion (41, 42, 43, 44), a pre-loaded drive biasing member (6) exerting a force on the plunger rod (4) in the proximal direction, a medicament delivery member cover (1) coupled to the housing (2, 3) and axially movable between an extended position and a retracted position with respect to the housing (2, 3), wherein the housing (2, 3) comprises a stop (21, 31) configured to engage with the blocking protrusion (41, 42, 43, 44) of the plunger rod (4), wherein the plunger rod (4) is axially blocked in a proximal direction with respect to the housing (2, 3) in a first position of the blocking protrusion (41, 42, 43, 44) and axially moveable with respect to the housing (2, 3) in a second position of the blocking protrusion (41, 42, 43, 44), wherein the medicament delivery member cover (1) comprises an engagement surface (12, 13, 15) configured to interact with the blocking protrusion (41, 42, 43, 44), and wherein, when the medicament delivery member cover (1) is pushed in a distal direction into the retracted position, the engagement surface (12, 13, 15) is configured to translate the blocking protrusion (41, 42, 43, 44) from the first position to the second position. wherein the medicament delivery member cover (1) comprises two medicament delivery member cover arms (11) extending in the distal direction wherein the medicament delivery member cover arms (11) each comprise an axial slot (14) extending in the axial direction and configured to receive the stop (31), wherein the axial slot (14) is configured to guide the medicament delivery member cover (1) in the axial direction.

2. Medicament delivery device according to claim 1, wherein the plunger rod (4) is rotationally fixed with respect to the housing and the blocking protrusion comprises at least one flexible arm (41) extending in the distal direction and a radial outward direction with respect to the longitudinal axis, wherein a plunger rod block (42) is provided at each distal end of the at least one flexible arm (41), wherein a proximal surface of the plunger rod block (42) abuts the stop (31) of the housing (3) in the first position.

3. Medicament delivery device according to any of the previous claims, wherein the engagement surface of the medicament delivery member cover (1) comprises at least one protrusion (12) extending from an inner circumferential surface of each of the medicament delivery member cover arms (11) in a radial direction towards the longitudinal axis, wherein preferably, the at least one protrusion (12) is sloped towards a distal end of the arms (11).

4. Medicament delivery device according to claim 3, wherein the protrusion (12), when the medicament delivery member cover (1) is distally pushed in the retracted position, is configured to engage with the plunger rod block (42) such that the flexible arms (41) are forced in the radial direction towards the longitudinal axis, wherein said engagement translates the plunger rod block (42) from the first position to the second position, wherein in the second position, the flexible arm (41) is in a radial position in which the abutment of the plunger rod block (42) on the stop (31) is released and the plunger rod (4) is axially moveable in the proximal direction.

5. Medicament delivery device according to any one of the preceding claims, wherein the medicament delivery member cover (1) is rotationally fixed with respect to the housing (3).

6. Medicament delivery device according to claim 1, wherein the plunger rod (4) is rotationally provided with respect to the housing and the blocking protrusion comprises at least one arm (41) extending in the distal direction and a radial outward direction with respect to the longitudinal axis, wherein a sloped plunger rod block (42) is provided at each distal end of the at least one flexible arm (41), wherein a proximal surface of the sloped plunger rod block (42) abuts the stop (31) of the housing (3) in the first position.

7. Medicament delivery device according to claim 1 or 6, wherein the medicament delivery member cover (1) comprises two medicament delivery member cover arms (11) extending in the distal direction, wherein the engagement surface of the medicament delivery member cover (1) comprises at least one sloped surface (13) provided at a distal end of each of the arms (11).

8. Medicament delivery device according to claim 7, wherein the sloped surface (13), when the medicament delivery member cover (1) is distally pushed in the retracted position, is configured to engage with a sloped side surface of the sloped plunger rod block (42) such that the sloped plunger rod block (42) together with the plunger rod (4) are rotationally translated from the first position to the second position, wherein in the second position, the abutment of the proximal surface of the sloped plunger rod block (42) on the stop (31) is released and the plunger rod (4) is axially moveable in a proximal direction towards the medicament delivery site.

9. Medicament delivery device according to any one of claims 6 to 8, wherein the medicament delivery member cover (1) is rotationally fixed with respect to the housing (3), wherein preferably, the housing (3) comprises a guide protrusion (32) on an inner circumferential surface of the housing (3) configured to guide the medicament delivery member cover arms (11) in the axial direction.

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