A sub-assembly of a medicament delivery device

Abstract

A sub-assembly of a medicament delivery device, the sub-assembly comprising: a biased plunger rod extending along a longitudinal axis between a proximal end and a distal end; a rotator having a fastener having a first circumferentially directed surface and a second circumferentially directed surface facing in the opposite circumferential direction of the first circumferentially directed surface; a plunger rod holder positioned between the rotator and the plunger rod in a direction transverse to the longitudinal axis; wherein the plunger rod holder comprises a counter fastener having a first circumferentially directed surface and a second circumferentially directed surface facing in the opposite circumferential direction of the first circumferentially directed surface; and wherein before the rotator is rotated to a second position, the first circumferentially directed surface of the fastener of the rotator is adjacent to the first circumferentially directed surface of the counter fastener of the plunger rod holder; and the second circumferentially directed surface of the fastener of the rotator is adjacent to the second circumferentially directed surface of the counter fastener of the plunger rod holder.

Description

[0001] TITLE

[0002] A sub-assembly of a medicament delivery device

[0003] TECHNICAL FIELD

[0004] The present disclosure generally relates to a sub-assembly of a medicament delivery device, and particularly to a sub-assembly of a medicament delivery device that comprises a rotator.

[0005] BACKGROUND

[0006] Medicament delivery devices such as pen-type manual injectors or auto-injectors are generally known for the self-administration of a medicament by patients without formal medical training. For example, patients suffering from diabetes may require repeated injections of insulin, or patients may require regular injections of other types of medicaments, such as growth hormones.

[0007] It is an advantage when the medicament delivery devices for self-administration comprise automatic functions so that even if users are without professional training or are in an emergency situation, the users can easily and properly use the medicament delivery devices.

[0008] Even though many of the devices on the market, as well as the ones described above, have their respective advantages, there is still room for improvement.

[0009] SUMMARY

[0010] The invention is defined by the appended claims, to which reference should now be made.

[0011] 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 under 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 under use of the medicament delivery device is / are located closest to the dose delivery site.

[0012] Further, the term “longitudinal”, “longitudinally”, “axially” or “axial” refer to a direction extending from the proximal end to the distal end, typically along the device or components thereof in the direction of the longest extension of the device and / or component.

[0013] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0014] Further, the terms “circumference”, “circumferential”, or “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a central 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.

[0015] There is hence provided a sub-assembly of a medicament delivery device, the sub-assembly comprising: a biased plunger rod extending along a longitudinal axis between a proximal end and a distal end; a rotator having a fastener having a first circumferentially directed surface and a second circumferentially directed surface facing in the opposite circumferential direction of the first circumferentially directed surface; a plunger rod holder positioned between the rotator and the plunger rod in a direction transverse to the longitudinal axis; wherein the plunger rod holder comprises a counter fastener having a first circumferentially directed surface and a second circumferentially directed surface facing in the opposite circumferential direction of the first circumferentially directed surface; wherein the rotator is configured to rotate, relative to the plunger rod holder between a first position where the biased plunger rod is blocked from being moved relative to the plunger rod holder in the direction of the longitudinal axis to a second position where the biased plunger rod is allowed to be moved relative to the plunger rod holder in the direction of the longitudinal axis; wherein before the rotator is rotated to the second position, the first circumferentially directed surface of the fastener of the rotator is adjacent to the first circumferentially directed surface of the counter fastener of the plunger rod holder; and the second circumferentially directed surface of the fastener of the rotator is adjacent to the second circumferentially directed surface of the counter fastener of the plunger rod holder.

[0016] As the rotation of the rotator is configured to enable the plunger rod to move in the direction of the longitudinal axis, any unintentional rotation of the rotator is unwanted. When the sub-assembly is assembled into other components and forms a medicament delivery device, the unintentional rotation of the rotator can be prevented by connection between multiple components of the medicament delivery device. Thus, the engagement between the fastener of the rotator and the counter fastener of the plunger rod holder is configured to provide a transportation lock before the sub-assembly is assembled into other components and forms a medicament delivery device. Before the medicament delivery device is formed, the rotator is exposed; thus, if the sub-assembly is shaken or the rotator is touched during transportation, unintentional rotation of the rotator might occur. The transportation lock provided by the fastener of the rotator and the counter fastener of the plunger rod holder can mitigate this issue.

[0017] Preferably, according to one embodiment, the plunger rod holder comprises a flexible portion having a distally directed surface.

[0018] Preferably, according to one embodiment, the biased plunger rod comprises a proximally directed surface engaged with the distally directed surface of the plunger rod holder.

[0019] Preferably, according to one embodiment, the rotator comprises a support wall adjacent to the flexible portion of the plunger rod holder when the rotator is in the first position such that the flexible portion of the plunger rod holder is blocked from moving in the direction transverse to the longitudinal axis. Preferably, according to one embodiment, the support wall of the rotator is offset from the flexible portion of the plunger rod holder when the rotator is in the second position such that the flexible portion of the plunger rod holder can be moved in the direction transverse to the longitudinal axis.

[0020] Preferably, according to one embodiment, the flexible portion of the plunger rod holder is moved in the direction transverse to the longitudinal axis by the biased plunger rod.

[0021] Preferably, according to one embodiment, the rotator comprises a distally directed surface engaged with a proximally directed surface of the plunger rod when the rotator is in the first position; and wherein the distally directed surface of the rotator is offset from the proximally directed surface of the plunger rod when the rotator is in the second position.

[0022] Preferably, according to one embodiment, the sub-assembly comprises a spring extending between a first end attached to the biased plunger rod and a second end attached to the plunger rod holder.

[0023] Preferably, according to one embodiment, the fastener is a groove or a cut-out; and wherein the counter fastener is a protrusion extending towards the groove or the cut-out.

[0024] Preferably, according to one embodiment, the fastener is a protrusion; and wherein the counter fastener is a groove or the cut-out open towards the protrusion.

[0025] Preferably, according to one embodiment, the protrusion is arranged on a flexible portion such that the protrusion is movable in the direction transverse to the longitudinal axis.

[0026] Preferably, according to one embodiment, the groove or the cut-out is open in the direction of the longitudinal axis.

[0027] Preferably, according to one embodiment, the groove or the cut-out is open in the direction transverse to the longitudinal axis.

[0028] Preferably, according to one embodiment, the plunger rod holder comprises a flexible arm extending in the direction of the longitudinal axis.

[0029] Preferably, according to one embodiment, the flexible arm is engaged with a distally directed surface of the rotator.

[0030] Preferably, according to one embodiment, at least one of the first circumferentially directed surface of the fastener and the first circumferentially directed surface of the counter fastener is a chamfered surface.

[0031] Preferably, according to one embodiment, the sub-assembly comprises an actuator enclosing the rotator.

[0032] Preferably, according to one embodiment, the rotator is configured to be moved relative to the plunger rod holder from a preassembled position to the first position before the rotator is rotated to the second position. Preferably, according to one embodiment, when the rotator is in the preassembled position, the first circumferentially directed surface of the fastener of the rotator is adjacent to the first circumferentially directed surface of the counter fastener of the plunger rod holder; and the second circumferentially directed surface of the fastener of the rotator is adjacent to the second circumferentially directed surface of the counter fastener of the plunger rod holder.

[0033] Preferably, according to one embodiment, the actuator is rotatably immovable relative to the plunger rod holder.

[0034] Preferably, according to one embodiment, the actuator comprises a guide surface; wherein the rotator comprises a counter guide surface configured to be moved along the guide surface when the rotator is moved relative to the actuator from a proximal position where the rotator is in the preassembled position to a distal position where the rotator is in the first position.

[0035] Preferably, according to one embodiment, a slot is arranged in a wall of the actuator and extending in the direction of the longitudinal axis; wherein the rotator comprises a rib extending in the direction transverse to the longitudinal axis; wherein side edges of the slot comprise the guide surface; and wherein the rib of the rotator comprises the counter guide surface.

[0036] Preferably, according to one embodiment, the guide surface is curved such that the rotator is guided to rotate by the guide surface when the rotator is moved from the proximal position to the distal position

[0037] Preferably, according to one embodiment, the plunger rod holder comprises a first distally directed surface and a second distally directed surface proximally arranged relative to the first distally directed surface.

[0038] Preferably, according to one embodiment, the first distally directed surface is positioned between the first circumferentially directed surface of the plunger rod holder and the second circumferentially directed surface of the plunger rod holder.

[0039] Preferably, according to one embodiment, the rotator comprises a proximally directed surface extending from the first circumferentially directed surface of the rotator to the second circumferentially directed surface of the rotator.

[0040] Preferably, according to one embodiment, the rotator is configured to be moved from the preassembled position where the first distally directed surface of the plunger rod holder is engaged with the proximally directed surface of the rotator to the first position where the second distally directed surface of the plunger rod holder is engaged with the proximally directed surface of the rotator.

[0041] Preferably, according to one embodiment, the sub-assembly comprises a resilient member positioned between the actuator and the rotator in the direction of the longitudinal axis. Preferably, according to one embodiment, the resilient member is configured to move the rotator from the preassembled position to the first position when the rotator is assembled to the actuator.

[0042] Preferably, according to one embodiment, the plunger rod holder comprises a flange.

[0043] Preferably, according to one embodiment, the rotator comprises a distal portion having a distally directed surface.

[0044] Preferably, according to one embodiment, when the rotator is in the preassembled position, the distally directed surface of the rotator is positioned distally beyond the flange such that the resilient member can be in contact with the distally directed surface of the distal portion of the rotator.

[0045] Preferably, according to one embodiment, when the rotator is in the first position, the distal portion of the rotator is biased proximally beyond the flange or is lined up with the flange by the resilient member.

[0046] Another aspect of the invention provides a medicament delivery device comprising the cap assembly as mentioned above.

[0047] Preferably, according to one embodiment, the medicament delivery device comprises a medicament container.

[0048] Preferably, according to one embodiment, the medicament container is made of glass or plastic.

[0049] Preferably, according to one embodiment, the medicament container is a syringe, a cartridge or a collapsible bag.

[0050] Preferably, according to one embodiment, the medicament container is integral to a medicament delivery member.

[0051] Preferably, according to one embodiment, the medicament container is configured to be connected to a medicament delivery member before a medicament delivery operation takes place.

[0052] Preferably, according to one embodiment, the medicament container comprises multiple chambers to container different substances respectively.

[0053] Preferably, according to one embodiment, the medicament delivery device is an autoinjector, a manual injector, a safety syringe, an inhaler, a sprayer, or an infusion pump.

[0054] Furthermore, 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, component, means, etc.” are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, etc., unless explicitly stated otherwise.

[0055] BRIEF DESCRIPTION OF THE DRAWINGS The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:

[0056] Figs 1A and 1 B are perspective views of a medicament delivery device;

[0057] Fig. 2 is a perspective view of an example of an administration mechanism of the medicament delivery device in Figs 1A and 1B;

[0058] Fig. 3 shows the administration mechanism in Fig. 2 with the medicament delivery member cover removed exposing a medicament container holder;

[0059] Figs 4 and 5 show perspective views of certain components of the administration mechanism in Fig. 2;

[0060] Figs 6 and 7 show additional components of the administration mechanism in Fig. 2;

[0061] Fig. 8 is a longitudinal section of a plunger holder and plunger rod of the administration mechanism, the section being at a right angle to the longitudinal section in Fig. 8; and

[0062] Figs 9A-B show longitudinal sections of the medicament delivery device in Fig. 1A-B in different stages of operation.

[0063] Figs 10-15 show perspective views of certain components of the medicament delivery device in Fig. 2;

[0064] Fig. 16 shows a perspective view of a sub-assembly that can be used in the medicament delivery device of Fig. 1A.

[0065] Figs 17-18 show perspective views of the sub-assembly of Fig. 16 in another example.

[0066] Fig. 19 shows a plunger rod of the sub-assembly of Fig. 16 in another example.

[0067] Fig. 20 and Fig. 22 show cross-section views of a rotator of the sub-assembly of Fig 17 in different positions relative to a plunger rod holder of the sub-assembly of Fig 17.

[0068] Fig. 21 shows perspective views of the sub-assembly of Fig. 16 in another example.

[0069] Fig. 23 shows a perspective view of the sub-assembly of Fig. 17 in another example.

[0070] Fig. 24-26B show perspective views of the sub-assembly of Fig. 16 in another example.

[0071] DETAILED DESCRIPTION

[0072] Figs 1-26B illustrate a sub-assembly of a medicament delivery device. The sub-assembly comprises a biased plunger rod 23 extending along a longitudinal axis L between a proximal end and a distal end. In one example, the plunger rod 23 is elongated. The sub-assembly comprises a rotator 25’; 25”; 25”’ having a fastener 250’; 250”; 250’” having a first circumferentially directed surface 250a”; 250a’”and a second circumferentially directed surface 250b”; 250b’” facing in the opposite circumferential direction of the first circumferentially directed surface 250a”; 250a’”. The sub-assembly comprises a plunger rod holder 2T; 21”; 2T” positioned between the rotator 25’; 25”; 25’” and the plunger rod 23 in a direction transverse to the longitudinal axis L. The plunger rod holder 2T; 21”; 2T” comprises a counter fastener 210’; 210”; 210’” having a first circumferentially directed surface 210a”; 210a’” and a second circumferentially directed surface 210b”; 210b’” facing in the opposite circumferential direction of the first circumferentially directed surface 210a”; 210a’”. The rotator 25’; 25”; 25’” is configured to rotate, relative to the plunger rod holder 2T; 21”; 2T”, between a first position where the biased plunger rod 23 is blocked from being moved relative to the plunger rod holder 2T; 21”; 2T” in the direction of the longitudinal axis L to a second position where the biased plunger rod 23 is allowed to be moved relative to the plunger rod holder 2T; 21”; 2T” in the direction of the longitudinal axis L. Before the rotator 25’; 25”; 25’” is rotated to the second position, the first circumferentially directed surface 250a”; 250a” of the fastener 250’; 250”; 250’” of the rotator 25’; 25”; 25’” is adjacent to the first circumferentially directed surface 210’; 210”; 210’” of the counter fastener 210’; 210a”; 210a’” of the plunger rod holder 2T; 21”; 2T”; and the second circumferentially directed surface 250b”; 250b’” of the fastener 250’; 250”; 250’” of the rotator 25’; 25”; 25’” is adjacent to the second circumferentially directed surface 210b”; 210b’” of the counter fastener 210’; 210”; 210’” of the plunger rod holder 2T; 21”; 2T”.

[0073] In a preferred example, the plunger rod holder 2T; 21”; 2T” is configured to engage the plunger rod 23 when the rotator 25’; 25”; 25’” in the first position and disengage from the plunger rod 23 when the rotator 25’; 25”; 25’” is in the second position such that the plunger rod 23 is axially immovable in the proximal direction relative to the plunger rod holder 2T; 21”; 2T” when the rotator is in the first position and can be moved in the proximal direction relative to the plunger rod holder 2T; 21”; 2T” when the rotator is in the second position. Alternatively, the rotator is configured to engage with the plunger rod when the rotator is in the first position and disengage from the plunger rod when the rotator is in the second position.

[0074] The first circumferentially directed surface of the fastener 250’; 250”; 250”’of the rotator 25’; 25”; 25’” and the first circumferentially directed surface of the counter fastener 210’; 210”; 210’” of the plunger rod holder 2T; 21”; 2T”; and the second circumferentially directed surface of the fastener 250’; 250”; 250”’of the rotator 25'; 25"; 25"' and the second circumferentially directed surface of the counter fastener 210; 210”; 210’” of the plunger rod holder 2T; 21”; 2T” are configured to prevent unintentional rotation of the rotator 25’; 25”; 25’” before the medicament delivery device comprising the sub-assembly as mentioned above is fully assembled and ready to be used by an end user. In other words, a transportation lock of the sub-assembly is provided by the engagement of the first circumferentially directed surface of the fastener 250’; 250”; 250’” of the rotator 25’; 25”; 25’” and the first circumferentially directed surface of the counter fastener 210; 210”; 210’” of the plunger rod holder 2T; 21”; 2T”; as well as the engagement of the second circumferentially directed surface of the fastener 250’; 250”; 250’” of the rotator 25'; 25"; 25'" and the second circumferentially directed surface of the counter fastener 210; 210”; 210’” of the plunger rod holder 2T; 21”; 2T” before the sub-assembly is assembled to other components and thereby formed a medicament delivery device. In one example, the fastener 250” of the rotator 25”is a groove or a cut-out 250”. In this example, the counter fastener 210” of the plunger rod holder 21” is a protrusion 210” extending towards the groove or the cut-out 250”. Alternatively, or additionally, the fastener 250’; 250”’ of the rotator 25’ is a protrusion 250’; 250’”. In this example, the counter fastener 210’; 210’” of the plunger rod holder 21’ is a groove or the cut-out 210’; 210’” open towards the protrusion 250’; 250’”. In the mentioned two examples, preferably, the protrusion 210”; 250’” is arranged on a flexible portion, as shown in Fig. 18 or Fig. 25, such that the protrusion 210”; 250’” is movable in the direction transverse to the longitudinal axis L. In a preferred example, the plunger rod holder 21” comprises a flexible arm 211” extending in the direction of the longitudinal axis L. In this example, the flexible arm 211f is engaged with a distally directed surface 251’ of the rotator 25”. In one example, the groove or the cut-out 210’ is open in the direction of the longitudinal axis L, as shown in Fig. 16. Alternatively, or additionally, the groove or the cut-out 250”; 210’” is open in the direction transverse to the longitudinal axis L, as shown in Fig. 17 and Fig. 24.

[0075] In a preferred example, at least one of the first circumferentially directed surface 250a” of the fastener 250’; 250” and the first circumferentially directed surface 210a” of the counter fastener 210’; 210” is a chamfered surface, as shown in Figs 16-17.

[0076] In another example, the sub-assembly comprises an actuator 13 enclosing the rotator 25’; 25”; 25’”, as shown in Fig. 23. The actuator 13 is configured to control the rotation of the rotator from the first position to the second position. The interaction between the actuator 13 and the rotator 25’; 25”; 25’” will be explained in detail later.

[0077] In another example, the rotator 25”; 25’” is configured to be moved relative to the plunger rod holder 2T; 21”; 2T” from a preassembled position to the first position before the rotator 25”; 25’” is rotated to the second position. In this example, the rotator 25"; 25"' is configured to be moved from the preassembled position to the first position in an assembling stage, e.g., the stage where components of the subassembly are being assembled to form the sub-assembly or the stage that the sub-assembly is being assembled to other components to form the medicament delivery device. Alternatively, the transportation lock provided by the fastener 250’ and the counter fastener 210’ can be released when the rotator 25’ is rotated from the first position to the second position.

[0078] In this example, when the rotator 25”; 25’” is in the preassembled position, the first circumferentially directed surface of the fastener 250”; 250’” of the rotator 25”; 25’” is adjacent to the first circumferentially directed surface of the counter fastener 210”; 210’” of the plunger rod holder 21”; 2T”; and the second circumferentially directed surface of the fastener 250”; 250’” of the rotator 25”; 25’” is adjacent to the second circumferentially directed surface of the counter fastener 210”; 210’” of the plunger rod holder 21”; 2T”.

[0079] In one example as shown in Figs 17-22, the fastener 250” of the rotator 25” is a groove 250”. In this example, the counter fastener 210” of the plunger rod holder 21” is a protrusion 210”. In a preferred example, the plunger rod holder 21” comprises a distally extending arm 211” comprising the fastener 210”. In a preferred example, a window 230 is arranged in a wall of the plunger rod 23 configured to enable the distally extending arm 211” of the plunger rod holder 21” to radially flex. In this example, the fastener 250” of the rotator 25” is engaged with the counter fastener 211” of the plunger rod holder 21” when the rotator 25” is in the preassembled position, as shown in Fig. 20. As a result, the unintentional rotation of the rotator relative to the plunger rod holder can be avoided. In this example, the rotator 25” can be rotated to the first position (as shown in Fig. 22) by an assembling tool or the actuator 13 (will be explained in detail later). Alternatively, the rotator can be rotated directly to the second position during use of a medicament delivery device by an end user; in this case, the first position of the rotator is shown in Fig. 20 and the second position of the rotator is shown in Fig. 22.

[0080] In one example where the sub-assembly comprises the actuator 13, as shown in Fig .23, the actuator 13 is rotatably immovable relative to the plunger rod holder 21 ;’ 21”; 21”’. The actuator 13 comprises a guide surface 132. The rotator 25” comprises a counter guide surface 251a” configured to be moved along the guide surface 132 when the rotator 25” is moved relative to the actuator 13 from a proximal position where the rotator 25” is in the preassembled position to a distal position where the rotator25” is in the first position. In a preferred example, a slot 133 is arranged in a wall 130 of the actuator 13 and extends in the direction of the longitudinal axis L. The rotator 25” comprises a rib 251” extending in the direction transverse to the longitudinal axis L. In this example, the side edges of the slot 133 comprise the guide surface and the rib of the rotator 25” comprises the counter guide surface. In a preferred example, as shown in Fig. 23, the guide surface 132 is curved such that the rotator 25” is guided to rotate by the guide surface 132 when the rotator 25” is moved from the proximal position to the distal position.

[0081] In another example, as shown in Figs 24, 26A-26B, the plunger rod holder 2T” comprises a first distally directed surface 210c’” and a second distally directed surface 212a’” proximally arranged relative to the first distally directed surface 210c’”. The first distally directed surface 210c’” is positioned between the first circumferentially directed surface 210a’” of the plunger rod holder 2T” and the second circumferentially directed surface 210b’” of the plunger rod holder 2T”. In this example, the rotator 25’” comprises a proximally directed surface 250c’” extending from the first circumferentially directed surface 250a’”of the rotator 25’” to the second circumferentially directed surface 250b’” of the rotator 25’”, as shown in Fig. 25. The rotator 25’” is configured to be moved from the preassembled position where the first distally directed surface 210c’” of the plunger rod holder 2T” is engaged with the proximally directed surfaced 250c’” of the rotator 25’”, as shown in Fig. 26A, to the first position where the second distally directed surface 212a’” of the plunger rod holder 2T” is engaged with the proximally directed surface 250c’” of the rotator 25’”, as shown in Fig. 26B. In this example, when the rotator 25’” is in the preassembled position, as shown in Fig. 26A, the fastener 250’” and the counter fastener 210’” is engaged; thus, the unintentional rotation of the rotator 25’” can be avoided. In one example, a circumferential groove 212’” is arranged in a wall of the plunger rod holder 2T”. An edge of the circumferential groove 212’” comprises the second distally directed surface 212a’”. Thus, the rotator 25’” can be rotated when the rotator 25’” is in the first position.

[0082] In a preferred example, the rotator 25’” comprises a flexible arm 252’” comprising the fastener 250’”. In one example, the rotator is configured to be axially moved from the preassembled position to the first position by an assembling tool. Alternatively, the rotator can be axially moved from the preassembled position to the first position by assembling another component of the sub-assembly. For example, as shown in Fig. 26B, the sub-assembly comprises a resilient member 27. In one example where the subassembly comprises the actuator 13, the resilient member 27 is positioned between the actuator 13 and the rotator 25”’ in the direction of the longitudinal axis L. The resilient member 27 is configured to move the rotator 25”’ from the preassembled position to the first position when the rotator 25’” is assembled to the actuator 13. In a preferred example, as shown in Fig. 26B, the plunger rod holder 2T” comprises a flange 21 f. The rotator 25’” comprises a distal portion 253’” having a distally directed surface 253c’”. When the rotator 25’” is in the preassembled position, the distally directed surface 253c’” of the rotator 25’” is positioned distally beyond the flange 21 f such that the resilient member 27 can be in contact with the distally directed surface 253c’” of the distal portion of the rotator 25’”. When the rotator 25’” is in the first position, the distal portion of the rotator 25’” is biased proximally beyond the flange 21 f or is lined up with the flange 21 f by the resilient member 27. In a preferred example, as shown in Figs 26A-26B, the distal position 253’” of the rotator 25’” comprises an extending wall 253a’”and a cut-out 235b’” in the extending wall 253a’”. When the rotator 25’” is in the preassembled position, as shown in Fig. 26A, the flange 21f of the plunger rod holder 2T” is received within the cut-out 253b’” and the extending wall 253a’” distally extends beyond the flange 21 f of the plunger rod holder 2T”. In this example, the extending wall 253a’” comprises the distally directed surface 253c’”. When the resilient member 27 is assembled, the resilient member 27 moves the rotator 25’” proximally relative to the plunger rod holder 2T” until the resilient member 27 is engaged with the flange 21 f of the plunger rod holder 2T” as shown in Fig. 26B.

[0083] Fig. 1 A shows a perspective view of an example of the medicament delivery device comprising the subassembly where the plunger rod holder 2T; 21”; 2T” of the sub-assembly is configured to engage the plunger rod 23 of the sub-assembly. It should be noted that all examples of sub-assemblies as mentioned above, except the embodiments that the rotator is configured to engage the plunger rod, can all be used in the medicament delivery device mentioned below. The plunger rod holder 21 and the rotator 25 in the medicament delivery device as explained below can be the plunger rod holder 2T; 21”; 2T” and the rotator 25’; 25”; 25’” in any examples of sub-assemblies as mentioned above.

[0084] The medicament delivery device comprises an administration mechanism. The term ‘administration mechanism’ in this context is a mechanism or device which when the medicament delivery device is activated, shifts the medicament container and / or the medicament delivery member in the proximal direction.

[0085] The medicament delivery device 1 comprises a housing 3 having a proximal end 3a and a distal end 3b, and a cap assembly 5. Fig. 1B shows the medicament delivery device 1 with the cap assembly 5 removed.

[0086] The medicament delivery device 1 also has an elongated medicament delivery member cover 7 which is linearly displaceable inside the housing 3, relative to the housing 3. The medicament delivery member cover 7 is biased in the proximal direction and movable from an initial extended position relative to the housing 3, in which position a proximal portion of the medicament delivery member cover 7 extends from the proximal end 3a of the housing 3, shown in Fig. 1B, to a retracted position. The direction of movement towards the retracted position is indicated by the arrow. Due to it being proximally biased, the medicament delivery member cover 7 is shifted proximally when the distal force is removed, thereby again obtaining an extended position relative to the housing 3. In one example, the medicament delivery member cover 7 is configured to operably engage with the housing 3 when reaching a final extended position after having been released from the retracted position. The medicament delivery member cover 7 is thus retained in the final extended position. In one example, the housing comprises a body 30. An opening 31 is arranged in the body 30 of the housing. Furthermore, in one example, the housing comprises a counter fixture 32 configured to be releasably engaged with a fixture 50a of the cap assembly 5.

[0087] The medicament delivery device 1 also includes an administration mechanism. In Fig. 2 the housing 3 has been removed to expose an example of an administration mechanism. In one example, the administration mechanism of the medicament delivery device 1 comprises the medicament delivery member cover 7, an actuator sleeve 11 , and the actuator 13 received by the actuator sleeve 11. In a preferred example, the medicament delivery member cover 7 comprises a tubular proximal portion 70 configured to surround a medicament delivery member, as shown in Fig. 10. The distal end of the medicament delivery member cover 7 is aligned with the actuator sleeve 11 and arranged proximally with respect to the actuator sleeve 11 . Distal displacement of the medicament delivery member cover 7 therefore displaces the actuator sleeve 11 in the distal direction. In one example, the actuator sleeve is initially spaced apart from the medicament delivery member cover; thus, the medicament delivery member cover needs to be moved in the distal direction with a predetermined distance before encounters the actuator sleeve. As a result, an unintentional movement of the medicament delivery member cover will not accidentally trigger the administration mechanism. Alternatively, a distal end 71 of the medicament delivery member cover 7 is initially next to the actuator sleeve 11 , as shown in Fig. 15.

[0088] The actuator sleeve 11 and the medicament delivery member cover 7 are biased in the proximal direction. The administration mechanism may thus include a biasing member 15, for example, a spring, arranged distally with respect to the actuator sleeve 11 . The actuator 13 may according to one variation include a distal flange 14 supporting the biasing member 15. Distal displacement of the medicament delivery member cover 7 hence moves the actuator sleeve 11 distally thereby compressing the biasing member 15. The medicament delivery member cover 7 is thus urged by the biasing member 15 towards its extended position relative to the housing 3. In one example, the actuator 13 comprises a proximal portion 130 positioned within the housing 3, and a distal portion 131 positioned outside the distal end of the housing 3, as shown in Fig. 13. In a preferred example, the actuator 13 is snap fitted to the housing 3.

[0089] The medicament delivery member cover 7 is configured to be rotationally locked relative to the housing 3.

[0090] This can for example be achieved by a structure provided on the outer surface of the medicament delivery member cover 7, configured to engage with a corresponding structure provided on the inner surface of the housing 3. Alternatively, or additionally, a cross-section of the medicament delivery member cover 7 (observing along the longitudinal axis) and a cross-section of the housing 3 (observing along the longitudinal axis) can be non-circular. For example, both medicament delivery member cover and the housing may comprise bodies respectively having rectangular cross-sections.

[0091] Similarly, the actuator sleeve 11 is configured to be rotationally locked relative to the housing 3. The actuator sleeve 11 may for this purpose for example have a guide structure arranged on its outer surface and configured to engage with a corresponding guide structure provided on the inner surface of the housing 3.

[0092] The medicament delivery member cover 7 may according to one variation include a radial protrusion configured to engage with the housing 3 when the medicament delivery member cover 7 returns towards the extended position from the retracted position, thereby becoming axially locked relative to the housing in a final extended position. The radial protrusion may extend radially outwards and be radially flexible, allowing it to slide into a recess or opening of the inner surface of the housing 3 thereby interlocking these two components. Alternatively, or additionally, the actuator sleeve 11 comprises the radial protrusion 7b, as shown in Fig. 2. As the medicament delivery member cover 7 is configured to be in contact with the actuator sleeve 11 when the medicament delivery member cover 7 is moved in the distal direction, once the actuator sleeve 11 is locked to the housing 3, the medicament delivery member cover 7 is also locked to the housing 3.

[0093] Fig. 3 shows the arrangement in Fig. 2 with the medicament delivery member cover 7 removed to expose a proximally displaceable medicament container holder 17 configured to accommodate a medicament container provided with a medicament delivery member, such as the needle 19 shown in the present example. In a preferred example, the medicament container holder 17 comprises a damper 18. Preferably, the damper 18 is made of resilient material, e.g., TPE. In a preferred example, the damper 18 comprises a protrusion 18a snap that fits into an opening 17b of the medicament container holder 17. The damper 18 is configured to support a flange of the medicament container to avoid damage.

[0094] The administration mechanism furthermore includes the plunger holder 21 configured to be received by the actuator 13. The plunger holder 21 may be provided with a proximal flange 21a configured to bear against the medicament container arranged inside the medicament container. Proximal displacement of the plunger holder 21 hence urges the medicament container and the medicament container holder 17 in the proximal direction, providing an auto-penetration functionality.

[0095] The plunger holder 21 may also be provided with a container holder fastener 21 b configured to engage with a counter container holder fastener 17a of the medicament container holder 17. In one example, the container holder fastener 21 b is an opening, and the counter container holder fastener 17a is a flexible arm configured to be snap-fitted into the opening 21 b. The plunger holder 21 and the medicament container holder 17 are hence axially interlocked with each other so that axial displacement in the distal direction of the plunger holder 21 also results in a corresponding distal displacement of the medicament container holder 17. In one example, the housing 3 comprises an inspection window 30e, as shown in Fig. 15, aligned with the engagement between the container holder fastener 21 b and the counter container holder fastener 17a such that in the production line, the assembling defect can be checked via the inspection window 30e.

[0096] Fig. 4 shows the administration mechanism with the medicament container holder 17 removed. The exemplified administration mechanism further comprises the plunger rod 23 arranged within the plunger holder 21 , and a rotator not shown in Fig. 4. The actuator sleeve 11 , the actuator 13, the rotator 25, the plunger holder 21 and the plunger rod 23 are generally concentric to one another.

[0097] Fig. 5 shows the administration mechanism without the actuator sleeve 11 , exposing the actuator 13. The actuator sleeve 11 and the actuator 13 are rotationally locked relative to each other. Since the actuator sleeve 11 is configured to be rotationally locked relative to the housing 3, the actuator 13 is also rotationally locked relative to the housing 3. The actuator sleeve 11 and the actuator 13 are however configured to be axially displaceable relative to each other. The actuator 13 may thus for example comprise one or more axial ribs configured to engage with corresponding grooves of the actuator sleeve 11 . Relative axial displacement may thereby be provided while preventing relative rotation between these components.

[0098] The actuator 13 has a flexible radially inwards extending arm 13b. This flexible radially inwards extending arm 13b is prevented from flexing radially outwards by the inner surface of the actuator sleeve 11 when the actuator sleeve 11 is in its initial position. In particular, the inner surface of the actuator sleeve 11 bears against the flexible radially inwards extending arm 13b such that the arm 13b bears against a radial surface of the plunger holder 21 in the initial extended position of the medicament delivery member cover 7, as will be explained in more detail in the following.

[0099] In Fig. 6, the actuator 13 has been removed to expose the rotator 25 which is arranged around the plunger holder 21 and to show a proximal portion of the plunger holder 21 . The plunger holder 21 has a radially extending ledge 21c having a proximally directed surface 21 d. The flexible radially inwards extending arm 13b bears against this proximally directed surface 21 d in the initial extended position of the medicament delivery member cover 7. Moreover, the plunger holder 21 is proximally biased by the resilient member 27, arranged inside the actuator. The engagement between the flexible radially inwards extending arm 13b and the proximally directed surface 21 d prevents the plunger holder 21 from proximal displacement due to the biasing as long as the actuator sleeve 11 prevents the flexible radially inwards extending portion 13b from flexing radially outwards. In a preferred example, the plunger holder 21 comprises a distally directed surface adjacent to the resilient member 27. In a preferred example, the plunger holder 21 comprises a flange 21 f having the distally directed surface adjacent to the resilient member 27, as shown in Fig. 14. In a preferred example, the flange 21 f is flexible. In this example, the rotator 25 can be assembled to the plunger holder 21 by passing through the distal end of the plunger holder 21. The flange 21 f is deformed inwardly by the rotator 25 when the rotator passes by, then flexes back to its initial configuration. Thus, the rotator 25 is positioned between the ledge 21 c and the flange 21 f, as shown in Fig. 6. The rotator 25 bears against a distally directed surface of the plunger holder 21 , which prevents the rotator 25 from independently moving proximally relative to the plunger holder 21 when the medicament delivery device is fully assembled and ready to be used by an end user. In one example, the ledge 21c comprises the distally directed surface of the plunger holder 21 . The rotator 25 is also proximally biased. In particular, the rotator 25 is proximally biased by the resilient member 27.

[0100] The rotator 25 has a guide structure 25a. In one example, the guide structure 25a is formed by a recess / cut-out in a wall of the rotator 25 facing in a direction away from the longitudinal axis L, e.g., facing outwards. The guide structure 25a includes a proximal portion 25d defined by an axial groove portion and a contiguous proximal portion 25b defined by an inclined groove portion. The inclined groove portion is inclined with respect to a plane extending through the centre of the rotator 25 and parallel with the axial groove portion. The guide structure 25a is dimensioned to receive a protrusion 13c of the actuator 13. In one example, the protrusion of the actuator 13 is the flexible radially inwards extending arm. Alternatively, the protrusion 13c of the actuator 13 extends from a second flexible arm, as shown in Fig. 9a. As a result, when the plunger holder 21 is released and thus, axially moves relative to the actuator 13, the rotator 25 is moved in the distal direction by the resilient member 27 together with the plunger holder 21 , the protrusion 13c will reach the inclined groove portion, forcing the rotator 25 to rotate.

[0101] In Fig. 7, the rotator 25 has been moved away from the plunger holder 21 to expose the plunger holder 21. The plunger rod 23 is configured to be proximally biased by a power source 29. In one example, the power source 29 is another biasing member 29 as shown in Fig. 8. In one example, the spring 29 extends between a first end attached to the biased plunger rod 23 and a second end attached to the plunger rod holder 21 . In one example, this biasing member 29 is arranged inside the hollow plunger rod 23. Alternatively, the resilient member can be positioned between a distal end of the plunger rod and a proximally directed surface of the plunger holder; thus, the plunger rod doesn’t need to be hollow. The plunger holder 21 is configured to initially engage with the plunger rod 23 to prevent the plunger rod 23 from axial displacement in the proximal direction. In one example where the plunger rod holder 21 is configured to engage with the plunger rod 21 , the plunger rod holder 21 comprises a flexible portion having a distally directed surface. The biased plunger rod comprises a proximally directed surface engaged with the distally directed surface of the plunger rod holder. In this example, the rotator 25 comprises a support wall adjacent to the flexible portion of the plunger rod holder 21 when the rotator 25 is in the first position such that the flexible portion of the plunger rod holder 21 is blocked from moving in the direction transverse to the longitudinal axis. The support wall of the rotator 25 is offset from the flexible portion of the plunger rod holder 21 when the rotator 25 is in the second position such that the flexible portion of the plunger rod holder 21 can moved in the direction transverse to the longitudinal axis L. In a preferred example, the flexible portion of the plunger rod holder 21 is moved in the direction transverse to the longitudinal axis L by the biased plunger rod 23. For example, the plunger holder 21 has one or more flexible radially inwards extending tab(s) 21 e configured to engage with a corresponding radial opening(s) 23a of the plunger rod 23, as shown in Fig. 8. In this example, the rotator 25 comprises the support wall extending from an inner surface of the rotator 25 towards the longitudinal axis L. The support wall is configured to prevent the flexible radially inwards extending tab 21 e from flexing radially outwards so that it engages with the radial opening 23a of the plunger rod 23. When the rotator 25 is rotated, the support wall is no longer radially aligned with the flexible radially inwards extending tab(s) 21 . The plunger rod 23 is thereby released from its engagement with the plunger holder 21 allowing it to move proximally so that medicament expulsion may be commenced. Thus, the plunger rod 23 can be biased towards the proximal end of the housing 3 by the biasing member 29. Alternatively, the rotator may be provided with a window, i.e. an opening configured to align with the flexible radially inwards extending tab 21 e when the rotator is rotated.

[0102] Alternatively, in one example where the rotator is configured to engage with the plunger rod, the rotator comprises a distally directed surface engaged with a proximally directed surface of the plunger rod when the rotator is in the first position; and wherein the distally directed surface of the rotator is offset from the proximally directed surface of the plunger rod when the rotator is in the second position.

[0103] Fig. 9A shows a longitudinal section of the medicament delivery device 1 in an initial state in which the cap assembly 5 is positioned proximally relative to the housing 3 to protect the internal components of the medicament delivery device 1. In this position, a number of components are biased in the proximal direction. In particular, the resilient member 27, termed a first resilient member, is configured to bias the plunger holder 21 and the rotator 25 proximally, biasing member 29, termed a second resilient member, is configured to bias the plunger rod 23 proximally, and biasing member 15, termed a third resilient member, is configured to bias the medicament delivery member cover 7 proximally. According to the present example, each biasing member 15, 27, 29 is a spring. It should be noted that the biasing member 29 is configured to bias the plunger rod to expel the contained medicament; thus, all suitable energy sources, e.g., gas canister or motor, can be used as the power source 29 to bias the plunger rod 23.

[0104] The exemplified medicament delivery device 1 accommodates a medicament container 37, a medicament delivery member in the form of a needle 19, and a delivery member shield 33, i.e. a needle shield. The cap assembly 5 is provided with a delivery member shield remover 35 for removing the delivery member shield 33 when the cap assembly 5 is removed, as mentioned above. It should be noted that the medicament delivery member might be a spray nozzle, e.g., when the medicament delivery device is a jet injector, that needs to be sealed before use. Thus, the delivery member shield and therefore the delivery member shield remover might be needed for those medicament delivery devices without needles.

[0105] Turning now to Fig. 9B, the medicament delivery device 1 is again in the initial position, however with the cap assembly 5 removed. The delivery member shield 33 has thus been removed by the delivery member shield remover 35. The medicament delivery member cover 7 extends from the proximal end 3a of the housing 3 and is arranged in the extended position. Moreover, the actuator sleeve 11 is arranged in its initial position. In this state, the medicament delivery device 1 is ready for injection, activation being initiated by fully pushing the medicament delivery member cover 7 distally into the housing 3, the direction being indicated by the arrow.

[0106] Once the medicament delivery member cover 7 has been pushed distally into the housing 3, the medicament delivery member cover 7 has hence been moved linearly inside the housing 3. The distal end 71 of the medicament delivery member cover 7 is thereby brought towards and into contact with the proximal end of the 11 b of the actuator sleeve 11 , thereby displacing the actuator sleeve 11 in the distal direction.

[0107] In a preferred example, the actuator sleeve 11 has an inner dimension, namely the distance between two opposite inner surfaces which prevents the flexible radially inwards extending arm 13b of the actuator 13 from flexing radially outwards, which is smaller than the corresponding inner dimension of the medicament delivery member cover 7. Hereto, when the actuator sleeve 11 has been displaced sufficiently far distally by the medicament delivery member cover 7, the medicament delivery member cover 7 will be axially aligned with, the flexible radially inwards extending arm 13b. Because of the larger inner dimension of the medicament delivery member cover 7, the flexible radially inwards extending arm 13b is allowed to flex radially outwards as it is being urged by the proximally biased plunger holder 21. In this manner, the radial ledge 21c is allowed to pass underneath the flexible radially inwards extending arm 13b. The plunger holder 21 is thus released from being axially interlocked with the actuator 13 and moved proximally due to the proximal force exerted by the first resilient member 27.

[0108] When the rotator 25 moves together with the plunger holder 21 in the proximal direction relative to the actuator 13, the protrusion 13c is hence moved into the guide structure 25a. The protrusion 13c is hence moved in the guide structure 25a, from the proximal portion into a distal portion 25c. As previously mentioned, the plunger holder 21 is configured to displace the medicament container 37 proximally since the proximal flange 21 a of the plunger holder 21 bears against a distal flange 37a of the medicament container 37.

[0109] The axial length of the proximal portion 25b of the guide structure 25a determines the amount that the plunger holder 21 is moved proximally and thus the amount that the medicament container 37 is moved proximally before medicament expulsion can commence. The axial length may in particular be dependent on a particular application of the medicament delivery device 1 . According to the present example, the medicament container 37 is moved proximally to such an extent that the needle 19 is shifted proximally to extend fully beyond the proximal end 3a of the housing 3.

[0110] When the protrusion 13c moves into the distal portion 25c, the rotator 25 is rotated, since the actuator 13 is rotationally locked relative to the housing 3. When the rotator is rotated, the support surface of the rotator is no longer aligned with the flexible radially inwards extending tab 21 e. The flexible radially inwards extending tab 21 e will thereby be allowed to flex radially as a result of the proximally directed force provided by the biasing member 29.

[0111] The plunger rod 23 is thereby released from its engagement with the plunger holder 21 , allowing it to move proximally as a result of it being biased proximally by the biasing member 29. Upon being released from engagement with the plunger holder 21 , the plunger rod 23 is configured to proximally displace a plunger 38 arranged in the medicament container 37, and to move it proximally until the entire dose of medicament has been expelled through the needle 19. Once the medicament delivery operation is completed, the user of the medicament delivery device is instructed to lift the medicament delivery member cover 7 from a medicament delivery site. Thus, the medicament delivery member cover 7 is moved proximally until the radial protrusion 7b engages with the opening 3c of the housing 3. The medicament delivery member cover 7 will thereby interlock with the housing 3 (via the engagement between the protrusion 7b of the actuator sleeve 11 ) and is thus prevented from being subsequently moved distally towards the retracted position. The used needle 19 will thus be covered by the medicament delivery member cover 7 ensuring anyone handling the used medicament delivery device 1 from being pierced by it.

[0112] Furthermore, according to another aspect of the invention, a safety mechanism for the medicament delivery device can be provided. The safety mechanism is configured to prevent the administration mechanism being accidentally triggered before the user plans to use the medicament delivery device, e.g., when the medicament delivery device falls.

[0113] As mentioned above, the initial distal displacement of the medicament delivery member cover 7 is configured to trigger the administration mechanism of the medicament delivery device, thus, the safety mechanism is provided by limiting the distal displacement of the medicament delivery member cover 7. In this example, the medicament delivery member cover comprises a flexible arm 72 comprising a radially outwards extending protrusion 72a, as shown in Figs 1 B, 9A-9B, and 10. When cap assembly 5 is attached to the housing 3, as shown in Fig. 9A, the flexible arm 72 of the medicament delivery member cover 7 is blocked from flexing radially inwards by the inner body of the cap assembly 5. As a result, the radially outwards extending protrusion 72a is blocked from moving towards the distal end of the housing 3 by a proximally directed surface 30a of the housing 3. Thus, before the cap assembly 5 is removed from the housing 3, the medicament delivery member cover 7 is prevented from moving in the distal direction relative to the housing 3 such that the accidental trigger of the administration mechanism can be prevented. Once the user plans to use the medicament delivery device, the user removes the cap assembly 5. As the flexible arm 72 of the medicament delivery member cover 7 is no longer blocked from flexing radially inwards, the distal displacement of the medicament delivery member cover 7 deforms the flexible arm 72 when the radially outwards extending protrusion 72a is in contact with the proximally directed surface 30a of the housing 3.

[0114] Furthermore, in a preferred example, the medicament delivery member cover 7 comprises a distal block 73a, preferably, is a protrusion extending from the proximal portion 70 of the medicament delivery member cover, as shown in Fig. 10. The distal block 73a is configured to be positioned in a recess 30c in a wall of the housing 3. A distal end 30d of the recess 30c is configured to define a maximum movable distance of the medicament delivery member cover 7 in the distal direction relative to the housing 3. In a preferred example, the distal block 73a extends from a second flexible arm 73. Furthermore, a proximal end 73b of the distal block 73a is a chamfer surface facing towards the proximal end of the housing 3. As a result, the medicament delivery member cover 7 can be assembled, in the production line, into the housing 3 by being inserted from the distal end of the housing 3 until the distal block 73a is positioned within the recess 30c. Furthermore, the housing of the medicament delivery device, as mentioned in any example, may be provided with (i.e. , molded in, molded with) a compound featuring persistently antimicrobial, antifungal, and / or antiviral properties. Alternatively, a compound featuring persistently antimicrobial, antifungal, and / or antiviral properties may be applied to the molded (i.e., finished) components through secondary processes (e.g., chemical vapor deposition), spraying, or dipping processes.

[0115] The medicament delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders. Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia, diabetes (e.g. type 2 diabetes), psoriasis, migraines, multiple sclerosis, anaemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycaemia, obesity, anaphylaxis and allergies. Exemplary types of medicaments that could be included in the medicament delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, antibodies, antibody-drug conjugates, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogues, protein variants, protein precursors, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies and / or protein derivatives. Exemplary medicaments that could be included in the medicament delivery devices described herein include, but are not limited to (with non-limiting examples of relevant disorders in brackets): etanercept (rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis)), evolocumab (hypercholesterolaemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraines), alirocumab (rheumatoid arthritis), methotrexate (amethopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-1 a (multiple sclerosis), sumatriptan (migraines), adalimumab (rheumatoid arthritis), darbepoetin alfa (anaemia), belimumab (lupus), peginterferon beta-1 a' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatitis, asthma, nasal polyps, allergies), glucagon (acute hypoglycaemia), epinephrine (anaphylaxis), insulin (diabetes), atropine and vedolizumab (inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis)) , 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. Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the medicament 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. Pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) may include one or more other active ingredients, or may be the only active ingredient present.

[0116] Exemplary medicaments that could be included in the medicament delivery devices described herein include, but are not limited to, an immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, EB-cell receptors, or costimulatory proteins.

[0117] Exemplary medicaments that could be included in the medicament delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as HER-2 receptor modulators, interleukin modulators, interferon modulators, CD38 modulators, CD22 modulators, CCR4 modulators, VEGF modulators, EGFR modulators, CD79b modulators, Trop-2 modulators, CD52 modulators, BCMA modulators, PDGFRA modulators, SLAMF7 modulators, PD-1 / PD-L1 inhibitors / modulators, B-lymphocyte antigen CD19 inhibitors, B-lymphocyte antigen CD20 modulators, CD3 modulators, CTLA-4 inhibitors, TIM-3 modulators, VISTA modulators, INDO inhibitors, LAG3 (CD223) antagonists, CD276 antigen modulators, CD47 antagonists, CD30 modulators, CD73 modulators, CD66 modulators, CDw137 agonists, CD158 modulators, CD27 modulators, CD58 modulators, CD80 modulators, CD33 modulators, APRIL receptor modulators, HLA antigen modulators, EGFR modulators, B-lymphocyte cell adhesion molecule modulators, CDw123 modulators, Erbb2 tyrosine kinase receptor modulators, mesothelin modulators, HAVCR2 antagonists, NY-ESO-1 0X40 receptor agonist modulators, adenosine A2 receptors, ICOS modulators, CD40 modulators, TIL therapies, or TOR therapies.

[0118] Exemplary medicaments that could be included in the medicament delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAG, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, 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, DTPACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

[0119] Exemplary medicaments that could be included in the medicament delivery devices described herein include, but are not limited to, those used for chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy medicaments 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. The inventive concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.

[0120] Some other aspects of the invention are defined by the following clauses.

[0121] 1. A sub-assembly of a medicament delivery device, the sub-assembly comprising: a biased plunger rod (23) extending along a longitudinal axis between a proximal end and a distal end; a rotator (25’; 25”; 25”’) having a fastener having a first circumferentially directed surface and a second circumferentially directed surface facing in the opposite circumferential direction of the first circumferentially directed surface; a plunger rod holder (2T; 21”; 2T”) positioned between the rotator (25’; 25”; 25’”) and the plunger rod (23) in a direction transverse to the longitudinal axis; wherein the plunger rod holder (2T; 21”; 2T”) comprises a counter fastener having a first circumferentially directed surface and a second circumferentially directed surface facing in the opposite circumferential direction of the first circumferentially directed surface; wherein the rotator (25’; 25”; 25’”) is configured to rotate, relative to the plunger rod holder (2T; 21”; 2T”) between a first position where the biased plunger rod (23) is blocked from being moved relative to the plunger rod holder (2T; 21”; 2T”) in the direction of the longitudinal axis to a second position where the biased plunger rod (23) is allowed to be moved relative to the plunger rod holder (2T; 21”; 2T”) in the direction of the longitudinal axis; wherein before the rotator (25’; 25”; 25’”) is rotated to the second position, the first circumferentially directed surface of the fastener of the rotator (25’; 25”; 25’”) is adjacent to the first circumferentially directed surface of the counter fastener of the plunger rod holder (2T; 21”; 21’”); and the second circumferentially directed surface of the fastener of the rotator (25’; 25”; 25’”) is adjacent to the second circumferentially directed surface of the counter fastener of the plunger rod holder (2T; 21”; 21"').

[0122] 2. The sub-assembly according to clause 1 , wherein the plunger rod holder (2T; 21”; 21’”) comprises a flexible portion having a distally directed surface; wherein the biased plunger rod (23) comprises proximally directed surface engaged with the distally directed surface of the plunger rod holder (21’ 21”; 21’”); wherein the rotator (25’; 25”; 25’”) comprises a support wall adjacent to the flexible portion of the plunger rod holder (21’; 21”; 21’”) when the rotator (25’; 25”; 25’”) is in the first position such that the flexible portion of the plunger rod holder (21’; 21”; 21’”) is blocked from moving in the direction transverse to the longitudinal axis; wherein the support wall of the rotator (25’; 25”; 25’”) is offset from the flexible portion of the plunger rod holder (21’; 21”; 21’”) when the rotator (25’; 25”; 25’”) is in the second position such that the flexible portion of the plunger rod holder (21’; 21”; 21’”) can moved in the direction transverse to the longitudinal axis. 3. The sub-assembly according to clause 2, wherein the flexible portion of the plunger rod holder (2T; 21”; 2T”) is moved in the direction transverse to the longitudinal axis by the biased plunger rod (23).

[0123] 4. The sub-assembly according to clause 1 , wherein the rotator (25’; 25”; 25”’) comprises a distally directed surface engaged with a proximally directed surface of the plunger rod (23) when the rotator (25’; 25”; 25’”) is in the first position; and wherein the distally directed surface of the rotator (25’; 25”; 25’”) is offset from the proximally directed surface of the plunger rod (23) when the rotator (25’; 25”; 25’”) is in the second position.

[0124] 5. The sub-assembly according to any one of the preceding clauses, wherein the sub-assembly comprises a spring (29) extending between a first end attached to the biased plunger rod (23) and a second end attached to the plunger rod holder (2T; 21”; 21”’).

[0125] 6. The sub-assembly according to any one of the preceding clauses, wherein the fastener is a groove or a cut-out; and wherein the counter fastener is a protrusion extending towards the groove or the cut-out.

[0126] 7. The sub-assembly according to any one of clauses 1-5, wherein the fastener is a protrusion; and wherein the counter fastener is a groove or the cut-out open towards the protrusion.

[0127] 8. The sub-assembly according to clause 6 or clause 7, wherein the protrusion is arranged on a flexible portion such that the protrusion is movable in the direction transverse to the longitudinal axis.

[0128] 9. The sub-assembly according to any one of clauses 6-8, wherein the groove or the cut-out is open in the direction of the longitudinal axis.

[0129] 10. The sub-assembly according to any one of clauses 6-8, wherein the groove or the cut-out is open in the direction transverse to the longitudinal axis.

[0130] 11. The sub-assembly according to clause 9, wherein the plunger rod holder comprises a flexible arm extending in the direction of the longitudinal axis; wherein the flexible arm is engaged with a distally directed surface of the rotator.

[0131] 12. The sub-assembly according to any one of the preceding clauses, wherein at least one of the first circumferentially directed surface of the fastener and the first circumferentially directed surface of the counter fastener is a chamfered surface.

[0132] 13. The sub-assembly according to any one of the preceding clauses, wherein the sub-assembly comprises an actuator enclosing the rotator. 14. The sub-assembly according to any one of the preceding clauses, wherein the rotator is configured to be moved relative to the plunger rod holder from a preassembled position to the first position before the rotator is rotated to the second position; wherein when the rotator is in the preassembled position, the first circumferentially directed surface of the fastener of the rotator is adjacent to the first circumferentially directed surface of the counter fastener of the plunger rod holder; and the second circumferentially directed surface of the fastener of the rotator is adjacent to the second circumferentially directed surface of the counter fastener of the plunger rod holder.

[0133] 15. The sub-assembly according to a combination of clause 13 and clause 14, wherein the actuator is rotatably immovable relative to the plunger rod holder; wherein the actuator comprises a guide surface; wherein the rotator comprises a counter guide surface configured to be moved along the guide surface when the rotator is moved relative to the actuator from a proximal position where the rotator is in the preassembled position to a distal position where the rotator is in the first position.

[0134] 16. The sub-assembly according to clause 15, wherein a slot is arranged in a wall of the actuator and extending in the direction of the longitudinal axis; wherein the rotator comprises a rib extending in the direction transverse to the longitudinal axis; wherein side edges of the slot comprise the guide surface; and wherein the rib of the rotator comprises the counter guide surface.

[0135] 17. The sub-assembly according to clause 16, wherein the guide surface is curved such that the rotator is guided to rotate by the guide surface when the rotator is moved from the proximal position to the distal position.

[0136] 18. The sub-assembly according to clause 14, wherein the plunger rod holder comprises a first distally directed surface and a second distally directed surface proximally arranged relative to the first distally directed surface; wherein the first distally directed surface is positioned between the first circumferentially directed surface of the plunger rod holder and the second circumferentially directed surface of the plunger rod holder; wherein the rotator comprises a proximally directed surface extending from the first circumferentially directed surface of the rotator to the second circumferentially directed surface of the rotator; wherein the rotator is configured to be moved from the preassembled position where the first distally directed surface of the plunger rod holder is engaged with the proximally directed surfaced of the rotator to the first position where the second distally directed surface of the plunger rod holder is engaged with the proximally directed surface of the rotator.

[0137] 19. The sub-assembly according to clause 18 when dependent on clause 13, wherein the subassembly comprises a resilient member positioned between the actuator and the rotator in the direction of the longitudinal axis; wherein the resilient member is configured to move the rotator from the preassembled position to the first position when the rotator is assembled to the actuator. The sub-assembly according to clause 19, wherein the plunger rod holder comprises a flange; wherein the rotator comprises a distal portion having a distally directed surface; wherein when the rotator is in the preassembled position, the distally directed surface of the rotator is positioned distally beyond the flange such that the resilient member can be in contact with the distally directed surface of the distal portion of the rotator; and wherein when the rotator is in the first position, the distal portion of the rotator is biased proximally beyond the flange or is lined up with the flange by the resilient member. A medicament delivery device comprises the sub-assembly according to any one of the preceding clauses.

Claims

CLAIMS1. A sub-assembly of a medicament delivery device, the sub-assembly comprising: a biased plunger rod (23) extending along a longitudinal axis between a proximal end and a distal end; a rotator (25’; 25”; 25”’) having a fastener having a first circumferentially directed surface and a second circumferentially directed surface facing in the opposite circumferential direction of the first circumferentially directed surface; a plunger rod holder (21’; 21”; 21’”) positioned between the rotator (25’; 25”; 25’”) and the plunger rod (23) in a direction transverse to the longitudinal axis; wherein the plunger rod holder (21’; 21”; 21’”) comprises a counter fastener having a first circumferentially directed surface and a second circumferentially directed surface facing in the opposite circumferential direction of the first circumferentially directed surface; wherein the rotator (25’; 25”; 25’”) is configured to rotate, relative to the plunger rod holder (21’; 21”; 21’”) between a first position where the biased plunger rod (23) is blocked from being moved relative to the plunger rod holder (21’; 21”; 21’”) in the direction of the longitudinal axis to a second position where the biased plunger rod (23) is allowed to be moved relative to the plunger rod holder (21’; 21”; 21’”) in the direction of the longitudinal axis; wherein before the rotator (25’; 25”; 25’”) is rotated to the second position, the first circumferentially directed surface of the fastener of the rotator (25’; 25”; 25’”) is adjacent to the first circumferentially directed surface of the counter fastener of the plunger rod holder (21’; 21”; 21’”); and the second circumferentially directed surface of the fastener of the rotator (25’; 25”; 25’”) is adjacent to the second circumferentially directed surface of the counter fastener of the plunger rod holder (21’; 21”; 21’”).

2. The sub-assembly according to claim 1, wherein the plunger rod holder (2T; 21”; 2T”) comprises a flexible portion having a distally directed surface; wherein the biased plunger rod (23) comprises proximally directed surface engaged with the distally directed surface of the plunger rod holder (2T; 21”; 21’”); wherein the rotator (25’; 25”; 25’”) comprises a support wall adjacent to the flexible portion of the plunger rod holder (2T; 21”; 2T”) when the rotator (25’; 25”; 25’”) is in the first position such that the flexible portion of the plunger rod holder (2T; 21”; 2T”) is blocked from moving in the direction transverse to the longitudinal axis; wherein the support wall of the rotator (25’; 25”; 25’”) is offset from the flexible portion of the plunger rod holder (2T; 21”; 2T”) when the rotator (25’; 25”; 25’”) is in the second position such that the flexible portion of the plunger rod holder (2T; 21”; 2T”) can moved in the direction transverse to the longitudinal axis.

3. The sub-assembly according to claim 2, wherein the flexible portion of the plunger rod holder (2T; 21”; 2T”) is moved in the direction transverse to the longitudinal axis by the biased plunger rod (23).

4. The sub-assembly according to claim 1 , wherein the rotator (25’; 25”; 25”’) comprises a distally directed surface engaged with a proximally directed surface of the plunger rod (23) when the rotator (25’; 25”; 25’”) is in the first position; and wherein the distally directed surface of the rotator (25’; 25”; 25’”) is offset from the proximally directed surface of the plunger rod (23) when the rotator (25’; 25”; 25’”) is in the second position.

5. The sub-assembly according to any one of the preceding claims, wherein the sub-assembly comprises a spring (29) extending between a first end attached to the biased plunger rod (23) and a second end attached to the plunger rod holder (2T; 21”; 21”’).

6. The sub-assembly according to any one of the preceding claims, wherein the fastener is a groove or a cut-out; and wherein the counter fastener is a protrusion extending towards the groove or the cut-out.

7. The sub-assembly according to any one of claims 1-5, wherein the fastener is a protrusion; and wherein the counter fastener is a groove or the cut-out open towards the protrusion.

8. The sub-assembly according to claim 6 or claim 7, wherein the protrusion is arranged on a flexible portion such that the protrusion is movable in the direction transverse to the longitudinal axis.

9. The sub-assembly according to any one of the preceding claims, wherein at least one of the first circumferentially directed surface of the fastener and the first circumferentially directed surface of the counter fastener is a chamfered surface.

10. The sub-assembly according to any one of the preceding claims, wherein the sub-assembly comprises an actuator enclosing the rotator.

11. The sub-assembly according to any one of the preceding claims, wherein the rotator is configured to be moved relative to the plunger rod holder from a preassembled position to the first position before the rotator is rotated to the second position; wherein when the rotator is in the preassembled position, the first circumferentially directed surface of the fastener of the rotator is adjacent to the first circumferentially directed surface of the counter fastener of the plunger rod holder; and the second circumferentially directed surface of the fastener of the rotator is adjacent to the second circumferentially directed surface of the counter fastener of the plunger rod holder.

12. The sub-assembly according to a combination of claim 10 and claim 11 , wherein the actuator is rotatably immovable relative to the plunger rod holder; wherein the actuator comprises a guide surface; wherein the rotator comprises a counter guide surface configured to be moved along the guide surface when the rotator is moved relative to the actuator from a proximal position wherethe rotator is in the preassembled position to a distal position where the rotator is in the first position.

13. The sub-assembly according to claim 12, wherein a slot is arranged in a wall of the actuator and extending in the direction of the longitudinal axis; wherein the rotator comprises a rib extending in the direction transverse to the longitudinal axis; wherein side edges of the slot comprise the guide surface; and wherein the rib of the rotator comprises the counter guide surface.

14. The sub-assembly according to claim 11 , wherein the plunger rod holder comprises a first distally directed surface and a second distally directed surface proximally arranged relative to the first distally directed surface; wherein the first distally directed surface is positioned between the first circumferentially directed surface of the plunger rod holder and the second circumferentially directed surface of the plunger rod holder; wherein the rotator comprises a proximally directed surface extending from the first circumferentially directed surface of the rotator to the second circumferentially directed surface of the rotator; wherein the rotator is configured to be moved from the preassembled position where the first distally directed surface of the plunger rod holder is engaged with the proximally directed surfaced of the rotator to the first position where the second distally directed surface of the plunger rod holder is engaged with the proximally directed surface of the rotator.

15. The sub-assembly according to claim 14 when dependent on claim 10, wherein the sub-assembly comprises a resilient member positioned between the actuator and the rotator in the direction of the longitudinal axis; wherein the resilient member is configured to move the rotator from the preassembled position to the first position when the rotator is assembled to the actuator.

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