A sub-assembly of a medicament delivery device

Abstract

A sub-assembly of a medicament delivery device, the sub-assembly comprising a drive unit comprising: a plunger rod extending along a longitudinal axis from a proximal end and a distal end; wherein the plunger rod comprises a proximally directed surface; wherein the proximally directed surface is a chamfered surface; a power source operably connected to the plunger rod for applying a force on to the plunger rod along the longitudinal axis; a rotator rotatable around the longitudinal axis; wherein the rotator comprises a first distally directed surface engaged with the proximally directed surface of the plunger rod such that the force from the power source is capable of rotating the rotator around the longitudinal axis via the chamfered interface; and an activator operably connected to the rotator; wherein the activator is movable in the direction of the longitudinal axis from a holding position where the activator is circumferentially engaged with the rotator such that the rotator is blocked by the activator from being rotated around the longitudinal axis to a released position where the activator is circumferentially disengaged from the rotator such that the rotator is allowed to be rotated around the longitudinal axis.

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 comprises a rotator.

[0005] BACKGROUND

[0006] Medicament delivery devices such as auto-injectors, inhalers and on-body devices are generally known for the self-administration of a medicament by patients without formal medical training. Therefore, those medicament delivery devices usually comprise multiple automatic functions and are usually delivered to end-users with prefilled medicament containers. Using a rotator in a medicament delivery device to hold a plunger rod is a well- proved design in the market. With this design, a user usually requires to manually move the rotator to rotate by an axial movement of another component. Although this desgin has multiple advantages, it is difficult to handle a more powerful power source as the rotator usually bears the force from the power source and might be difficult to be rotated.

[0007] It has been appreciated that improved solutions for providing a reliable trigger mechanism of the medicament delivery operation that can be used with a more powerful power source.

[0008] SUMMARY

[0009] The invention is defined by the appended claims, to which reference should now be made.

[0010] 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.

[0011] 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. Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0012] 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.

[0013] There is hence provided a sub-assembly of a medicament delivery device, the sub-assembly comprises a drive unit comprising: a plunger rod extending along a longitudinal axis from a proximal end and a distal end. The plunger rod comprises a proximally directed surface; and the proximally directed surface is a chamfered surface. The drive unit comprises a power source operably connected to the plunger rod for applying a force on to the plunger rod along the longitudinal axis; and a rotator rotatable around the longitudinal axis. The rotator comprises a first distally directed surface engaged with the proximally directed surface of the plunger rod such that the force from the power source is capable of rotating the rotator around the longitudinal axis via the chamfered interface. The drive unit comprises an activator operably connected to the rotator. The activator is movable in the direction of the longitudinal axis from a holding position where the activator is circumferentially engaged with the rotator such that the rotator is blocked by the activator from being rotated around the longitudinal axis to a released position where the activator is circumferentially disengaged from the rotator such that the rotator is allowed to be rotated around the longitudinal axis.

[0014] Preferably, according to another embodiment, the activator is configured to be distally moved from the holding position to the released position.

[0015] Preferably, according to another embodiment, the activator is configured to be proximally moved from the holding position to the released position.

[0016] Preferably, according to another embodiment, the activator comprises a user-accessible section such that a user of the medicament delivery device can manually move the activator from the holding position to the released position via the user-accessible section.

[0017] Preferably, according to another embodiment, the rotator comprises a second distally directed surface next to the first distally directed surface.

[0018] Preferably, according to another embodiment, the second distally directed surface is longitudinally and circumferentially offset to the first distally directed surface such that the first and the second distally directed surfaces are configured to be sequentially engaged with the proximally directed surface of the plunger rod. Preferably, according to another embodiment, the second distally directed surface is configured to be engaged with the proximally directed surface of the plunger rod such that the force from the power source is capable of rotating the rotator around the longitudinal axis via the chamfered interface between the rotator and the plunger rod.

[0019] Preferably, according to another embodiment, the activator is movable in the direction of the longitudinal axis from an initial released position where the activator is circumferentially disengaged from the rotator such that the rotator is allowed to be rotated around the longitudinal axis to the holding position.

[0020] Preferably, according to another embodiment, the activator is movable in the direction of the longitudinal axis from an initial holding position where the activator is circumferentially engaged with the rotator such that the rotator is allowed to be rotated around the longitudinal axis to a initial released position.

[0021] Preferably, according to another embodiment, the activator is movable in a first direction from the holding position to the released position.

[0022] Preferably, according to another embodiment, the activator is movable in a second direction opposite to the first direction from the initial holding position to the initial released position.

[0023] Preferably, according to another embodiment, the activator comprises a protrusion.

[0024] Preferably, according to another embodiment, a slot / groove is arranged in a wall of the rotator.

[0025] Preferably, according to another embodiment, the protrusion of the activator is positioned within the slot / groove of the rotator when the activator is in the holding position.

[0026] Preferably, according to another embodiment, the sub-assembly comprises a housing extending along the longitudinal axis between a proximal end and a distal end.

[0027] Preferably, according to another embodiment, the drive unit is accommodated within the housing.

[0028] Preferably, according to another embodiment, the activator comprises a tubular proximal section being telescopic relative to the proximal end of the housing.

[0029] Preferably, according to another embodiment, the tubular proximal section comprises the user-accessible section.

[0030] Preferably, according to another embodiment, the sub-assembly comprises a button. Preferably, according to another embodiment, the button comprises the user-accessible section.

[0031] Preferably, according to another embodiment, the button is protruding from the distal end of the housing.

[0032] Preferably, according to another embodiment, the button is protruding from the housing in a direction transverse to the longitudinal axis.

[0033] Preferably, according to another embodiment, the housing comprises a distally directed surface engaged with a proximally directed surface of the rotator.

[0034] Preferably, according to another embodiment, the sub-assembly comprises a biasing member configured to bias the proximal tubular section of the activator out of the proximal end of the housing.

[0035] Preferably, according to another embodiment, the protrusion of the activator is moved along the helical surface of the protrusion of the rotator when the proximal tubular section of the activator is biased out of the proximal end of the housing.

[0036] Preferably, according to another embodiment, the medicament delivery device is an injection device, an inhalation device, or a medical sprayer.

[0037] 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, 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.

[0038] BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Embodiments of the inventive concept will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0040] Fig. 1 A schematically shows a perspective view of a medicament delivery device;

[0041] Fig. 1 B schematically shows a perspective view of components of a delivery member unit of the medicament delivery device of Fig. 1 A;

[0042] Fig. 1 C schematically shows a perspective view the delivery member unit of Fig. 1 B without a cover;

[0043] Fig. 1 D schematically shows a cross-section view of the delivery member unit of Fig. 1 B; Fig. 2A schematically shows a perspective view of a rotator of the medicament delivery device of Fig. 1 ;

[0044] Fig. 2B schematically shows a perspective view of a plunger rod of the medicament delivery device of Fig. 1 ;

[0045] Fig. 3A schematically shows a perspective view of a rotator of the medicament delivery device of Fig. 1 in another embodiment;

[0046] Fig. 3B schematically shows a perspective view of a plunger rod of the medicament delivery device of Fig. 1 in another embodiment;

[0047] Fig. 4 schematically shows a perspective view of the rotator of the medicament delivery device of Fig. 1 ;

[0048] Fig. 5 schematically shows a perspective view of an activator of the medicament delivery device of Fig. 1 ;

[0049] Figs 6A-6B schematically show perspective views of an activator and a rotator in another embodiment;

[0050] Fig. 7A schematically shows a cross-section view of the medicament delivery device of Fig. 1A.

[0051] Fig. 7B schematically shows a cross-section view of the medicament delivery device of Fig. 1 A when a cover is removed.

[0052] DETAILED DESCRIPTION

[0053] Figs 1 A-7B illustrate a sub-assembly of medicament delivery device. The medicament delivery device comprises a drive unit configured to expel a medicament contained within the medicament container 8 of the medicament delivery device when the medicament delivery device is in use. In one preferred example, the medicament delivery device is an autoinjector comprising an automatic function of priming and / or mixing substances from multiple chambers within a single medicament container. Alternatively, the medicament delivery device can be an inhalation device or a medical sprayer.

[0054] The sub-assembly comprises a plunger rod 5 extending along a longitudinal axis L from a proximal end and a distal end. The plunger rod 5 comprises a proximally directed surface 52; 52’. The sub-assembly comprises a power source 12 operably connected to the plunger rod 5 for applying a force on to the plunger rod 5 along the longitudinal axis L. A rotator 4 rotatable around the longitudinal axis L. The rotator 4 comprises a first distally directed surface 42; 42’ engaged with the proximally directed surface 52; 52’ of the plunger rod 5 to form a chamfered interface such that the force from the power source 12 is capable of rotating the rotator 4 around the longitudinal axis L via the chamfered interface. The subassembly comprises an activator 3; 3’ operably connected to the rotator 4. The activator 3; 3’ is movable in the direction of the longitudinal axis L from a holding position where the activator 3; 3’ is circumferentially engaged with the rotator 4 such that the rotator 4 is blocked by the activator 3; 3’ from being rotated around the longitudinal axis L to a released position where the activator 3; 3’ is circumferentially disengaged from the rotator 4 such that the rotator 4 is allowed to be rotated around the longitudinal axis L.

[0055] The power source is configured to provide force onto the plunger rod and thereby move the plunger rod in the proximal direction along the longitudinal axis L to expel contained medicament when the medicament delivery operation is started. In one example, the power source 12 is a compression spring. Alternatively, or additionally, the power source can be a torsion spring, a tension spring, a gas canister, a pneumatic pump, an electro-chemical pump, or an electro-mechanical motor.

[0056] In one embodiment, the proximally directed surface 52 of the plunger rod 5 is a chamfered surface 52. The chamfered interface is therefore formed when the proximally directed surface 52 of the plunger rod 5 is engaged with the first distally directed surface 42 of the rotator 4. In this example, the first distally directed surface 42 of the rotator 4 can be a chamfered surface or a flat surface (a surface being generally perpendicular to the longitudinal axis L), as shown in Figs 2A-2B. Alternatively, the first distally directed surface 42’ of the rotator 4 is a chamfered surface. Similarly, the chamfered interface is therefore formed when the proximally directed surface 52’ of the plunger rod 5 is engaged with the first distally directed surface 42’ of the rotator 4. In this example, the proximally directed surface 52’ of the plunger rod 5 can be a chamfered surface or a flat surface (a surface being generally perpendicular to the longitudinal axis L), as shown in Figs 3A-3B.

[0057] Before an operation of the medicament delivery device, e.g., expelling contained medicament by a proximal movement of the plunger rod, and / or expelling contained air in a medicament container by a proximal movement of the plunger rod, the plunger rod is blocked from moving by the engagement between the proximally directed surface of the plunger rod and the first distally directed surface of the rotator. Once the rotator is allowed to rotate, the force from the power source can rotate the rotator via the chamfered interface between the proximally directed surface of the plunger rod and the first distally directed surface of the rotator until the first distally directed surface of the rotator is no longer blocking the proximally directed surface of the plunger rod in the proximal direction. As a result, the plunger rod is moved in the proximal direction by the power source to expel the contained medicament. In a preferred example, the activator 3; 3’ comprises a user-accessible section 3a; 3a’ such that a user of the medicament delivery device can manually move the activator 3; 3’ from the holding position to the released position via the user-accessible section 3a; 3a’. In this example, the medicament delivery operation can be triggered by a user’s action directly, thus the device can be more compact as there is no need to position multiple components between the user and the activator to transfer the user’s action to a trigger movement of the medicament delivery operation. Furthermore, as the rotator is configured to be rotated by the power source, the user only needs to move the activator 3; 3’ linearly away from the rotator instead of manually rotating the rotator, the device therefore easier to be handled by the user. Furthermore, the rotator is configured to be rotated around the longitudinal axis to release the plunger rod instead of transversely moving away from the plunger rod can also make the medicament delivery device comprises the drive unit being more compact.

[0058] In one example, the activator is configured to be distally moved from the holding position to the released position. For example, as shown in Figs 4-6B, the activator 3; 3’ comprises a protrusion 30; 30’. In one example, the rotator 4 is configured to be rotated around the longitudinal axis L in a counterclockwise direction R (when observes from the distal end of the rotator). In this example, the protrusion 30 of the activator 3 is configured to be moved distally along a longitudinal rib 43a of the rotator 4, as shown in Figs 4-5. Alternatively, the rotator 4’ is blocked the engagement between the protrusion 30’ of the activator 3’ and two circumferentially extending ledges 43a’, 43b’ of the rotator 3’ from being rotated, as shown in Figs 6A-6B. Thus, only when the protrusion 30; 30’ of the activator 3; 3’ is moved away from the engagement with the rotator 4; 4’, the rotator 4; 4’ is allowed to be rotated. For example, the activator 3’ can be a removable pin configured to be removed by the user. Alternatively, the activator 3 can be operably connected to a medicament delivery member guard and is configured to be moved manually by the user in the distal direction for triggering a medicament delivery operation.

[0059] In one example, a slot / groove 43; 43’ is arranged in a wall 40; 40’ of the rotator 4; 4’. In one example, the groove 43 is formed by a pair of parallel arranged ribs 47b, 43a extending in the direction of the longitudinal axis L on a surface of the wall 40 of the rotator 4. Alternatively, the groove 43’ is formed by the two circumferentially extending ledges 43a’, 43b’ of the rotator 4’. The protrusion 30; 30’ of the activator 3; 3’ is positioned within the slot / groove 43; 43’ of the rotator 4; 4’ when the activator 3; 3’ is in the holding position. In this example, when the activator 3; 3’ is moved distally away from the slot / groove 43; 43’, the rotator 4; 4’ is allowed to be rotated. The rotational direction of the rotator 4; 4’ is designed by the direction of the chamfered interface.

[0060] Alternatively, the activator is configured to be proximally moved from the holding position to the released position. For example, the rotation of the rotator can be used to release the plunger rod to perform a priming and / or mixing operation, e.g., expelling contained air before expelling medicament or reconstituting the medicament within two chambers. In this example, the activator is configured to be proximally moved from the holding position to the released position. For example, the activator 3 is connected to a biasing member 31 , as shown in Figs 7A-7B. In this example, the plunger rod is configured to move a distance D upon released. In this example, the activator 3 is retained in a pretensioned state against the biasing member 31 by a cover 20 of the medicament delivery device. When the cover 20 is removed from the activator 3, the activator 3 is moved from a proximal position to a distal position by the biasing member 31 . In one example, the proximal movement of the activator 3 can move the activator 3 from the holding position where the protrusion 30 of the activator 3 is positioned in a groove 47 of the rotator 4 to the release position where the protrusion30 of the activator 3 is moved out from the groove 47 of the rotator 4, as shown in Fig. 4. In one example, the groove 47 of the rotator is formed by a pair of longitudinal ledges 47a, 47b on the body 40 of the rotator 4.

[0061] In one example, the rotator 4 comprises a second distally directed surface 41 ; 41 ’ next to the first distally directed surface 42. The second distally directed surface 41 ; 41 ’ is longitudinally and circumferentially offset to the first distally directed surface 42; 42’ such that the first and the second distally directed surfaces 41 ; 41 ’, 42; 42’ are configured to be sequentially engaged with the proximally directed surface 52; 52’ of the plunger rod 5.

[0062] In one example, the second distally directed surface 41 ; 41 ’ is configured to be engaged with the proximally directed surface 52; 52’ of the plunger rod 5 such that the force from the power source is capable of rotating the rotator 4 around the longitudinal axis via the chamfered interface between the rotator 4 and the plunger rod 5. Similarly, in one example, the proximally directed surface 52 of the plunger rod 5 is a chamfered surface 52. The chamfered interface is therefore formed when the proximally directed surface 52 of the plunger rod 5 is engaged with the second distally directed surface 41 of the rotator 4. In this example, the first distally directed surface 42 of the rotator 4 can be a chamfered surface or a flat surface (a surface being generally perpendicular to the longitudinal axis L), as shown in Figs 2A-2B. Alternatively, the second distally directed surface 41 ’ of the rotator 4 is a chamfered surface. Similarly, the chamfered interface is therefore formed when the proximally directed surface 52’ of the plunger rod 5 is engaged with the second distally directed surface 41 ’ of the rotator 4. In this example, the proximally directed surface 52’ of the plunger rod 5 can be a chamfered surface or a flat surface (a surface being generally perpendicular to the longitudinal axis L), as shown in Figs 3A-3B. In one example, the first and the second distally directed surfaces 41 , 42 are flat surfaces, as shown in Figs 2A-2B. In this example, the proximally directed surface 52 of the plunger rod 5 is the chamfered surface 52. In another example, the first and the second distally directed surfaces 41 ’, 42’ are chamfered surfaces, as shown in Figs 3A-3B. In this example, the proximally directed surface 52’ of the plunger rod 5 is the flat surface 52’.

[0063] In one example, the activator 3 is movable in the direction of the longitudinal axis L from an initial released position where the activator 3 is circumferentially disengaged from the rotator

[0064] 4 such that the rotator 4 is allowed to be rotated around the longitudinal axis to the holding position. Furthermore, in a preferred example, the activator 3 is movable in the direction of the longitudinal axis L from an initial holding position where the activator 3 is circumferentially engaged with the rotator 4 such that the rotator 4 is allowed to be rotated around the longitudinal axis L to the initial released position. Preferably, the activator 3 is movable in a first direction from the holding position to the released position. In this example, the activator 3 is movable in a second direction opposite to the first direction from the initial holding position to the initial released position. For example, as shown in Fig. 4, when the protrusion 30 of the activator 3 is positioned in the groove 47 of the rotator 4 when the activator 3 is in the initial holding position. As a result, the rotator 4 is prevented from being rotated as the protrusion 30 of the activator 3 is circumferentially engaged with the pair of longitudinal ledges 47a, 47b on the body 40 of the rotator 4. The activator 3 is configured to be proximally moved relative to the rotator 4 until the protrusion 30 of the activator 3 being out from the groove 47 of the rotator 4. As a result, the activator 3 is moved into the initial released position where the activator 3 is circumferentially disengaged from the rotator 4. Thus, the chamfered interface between the rotator 4 and the plunger rod 5 as mentioned above enables the power source to rotate the rotator 4 via the plunger rod 5. The plunger rod

[0065] 5 is therefore released from the second distally directed surface 41 ; 41 ’ of the rotator 4. The rotation of the rotator 4 can be stopped when the protrusion 30 of the activator 3 encounter the longitudinal rib 43a of the rotator 4, as shown in Fig. 4, thus, the activator 3 is moved into the holding position. As the second distally directed surface 41 is next to the first distally directed surface 42, the movement of the plunger rod in the direction of the longitudinal axis L is blocked by the first distally directed surface 42 when the rotator 4 is blocked from being rotated. When the activator 3 is distally moved relative to the rotator 4 from the holding position to the released position, as mentioned above, the chamfered interface causes the rotator 4 to further rotate. As a result, the plunger rod 5 is released from the rotator 4. It should be noted that, the movement of the activator from the initial released position to holding position is optional.

[0066] In one example, the sub-assembly comprises a housing 10 extending along the longitudinal axis L between a proximal end and a distal end, as shown in Fig. 1 . The drive unit, as mentioned in any one of above examples, is accommodated within the housing 10. In a preferred example, the activator 3 comprises a tubular proximal section 3a. The tubular proximal section 3a is telescopic relative to the proximal end of the housing 10. In this example, the tubular proximal section 3a of the activator 3 is configured to enclose a medicament delivery member 21 , e.g., a needle or a nozzle. Therefore, the user can be prevented from accidentally accessing to the medicament delivery member 21 before and / or after use of the medicament delivery device. In this example, the tubular proximal section 3a comprises the user-accessible section. In this example, when the user moves the tubular proximal section 3a of the activator 3, e.g., by pressing a proximal surface of the tubular proximal section 3a against a medicament delivery site, to expose the medicament delivery member, the activator 3 is moved in the distal direction relative to the rotator 4. As the result, the activator 3 is moved from the holding position to the released position. Additionally, in another example, the activator 3 is connected to the biasing member 31 . In this example, the biasing member 31 is configured to bias the proximal tubular section 3a of the activator 3 in the proximal direction relative to the proximal end of the housing 10. In one example where the sub-assembly comprises the cover 20, the cover 20 is configured to b operably attached to the housing 10. As mentioned above, the cover 20 is configured to retain the activator 3 in a pretensioned state against the biasing member 31 . As a result, when the user removes the cover 20 from the housing 10, the plunger rod 5 is released from the second proximally directed surface 41 of the rotator 4. As shown in Fis 7A-7B, the plunger rod 5 is thereby moved in the proximal direction for a distance D. Therefore, air contained within the medicament container can be expelled. When the user further pushes the proximal tubular section 3a of the activator 3 against the medicament delivery site, the activator 3 is moved in the distal direction from the holding position to the released position. Thus, the plunger rod 5 can be further released from the first proximally directed surface 42 of the rotator 4 to expel medicament. Preferably, in this example, the protrusion 30 of the activator 3 is positioned on a distal section 3b of the activator 3. The distal section 3b of the activator 3 is accommodated within the housing 10.

[0067] In one example, the rotator 4 is immovable relative to the housing 10 in the direction of the longitudinal axis L. For example, the housing 10 comprises a distally directed surface engaged with a proximally directed surface 45 of the rotator 4. Alternatively, the rotator is configured to be moved together with the plunger rod in the proximal direction. In this example, the proximal movement of the rotator and the plunger rod is configured to expose the medicament delivery member. For example, when the medicament delivery member is a needle, an automatic penetration function can be provided, e.g., the needle is pushed through a skin of the user by the proximal movement of the rotator and the plunger rod.

[0068] In another example, the second distally directed surface of the rotator can be a flat surface, and the first surface of the rotator can be a chamfered surface. In this example, the proximally directed surface of the plunger rod can be a flat surface. For example, the rotator can be rotated by the activator to release the plunger rod from the second distally directed surface. In this example, the activator 3 is rotationally immovable relative to the housing. The rotator 4 comprises a protrusion 46 having a helical surface 46a directed to the protrusion 30 of the activator 3 such that when the protrusion 30 of the activator 3 moves along the helical surface of the 46 protrusion of the rotator 4 is rotated by the activator 3. Alternatively, or additionally, the protrusion 46 with the helical surface 46a of the rotator 4 can be used together with the chamfered interface between the second distally directed surface 42 of the rotator 4 and the proximally directed surface 52 of the plunger rod 5. In this example, both the chamfered interface between the plunger rod 5 and the rotator 4, and the interaction between the protrusion 30 of the activator 3 and the helical surface 46a of the rotator 4 contribute to the rotation of the rotator 4. In one example where the sub-assembly comprises the biasing member 31 , the protrusion 30 of the activator 3 is moved along the helical surface 46a of the protrusion 46 of the rotator 4 when the proximal tubular section 3a of the activator 3 is biased out of the proximal end of the housing 10.

[0069] In another example, the sub-assembly comprises a button. In this example, the button comprises the user-accessible section. In one example, the button is protruding from the distal end of the housing. Alternatively, the button is protruding from the housing in a direction transverse to the longitudinal axis.

[0070] Another aspect of the invention provides a medicament delivery device comprises the subassembly according to any one of the preceding examples. The medicament delivery device comprises a medicament container. The medicament container can be a syringe, a cartridge, or a collapsible bag. The medicament container can be mainly made of plastic or glass. In one example where the medicament container is a syringe, the medicament delivery member is integral at a proximal end of the syringe. In one example where the medicament delivery device is a needle, the medicament delivery device further comprises a needle shield configured to seal the needle; and a needle shield remover attached to the needle shield and the cap such that when the user removes the cap, the needle shield can be removed from the needle. In another example where the medicament container is a cartridge or a collapsible bag, the medicament delivery member can be packed as a delivery member unit. For example, as shown in Figs 1 B-1 D, the delivery member unit comprises the cover 20 extending along the longitudinal axis L between a proximal end (closed end) and a distal end (open end). The cover 20 is configured to cover the medicament delivery member, e.g., a needle of the medicament delivery device when the medicament delivery device is an injector, before a medicament delivery operation, namely, before use of the medicament delivery device. As the medicament delivery member is arranged at the proximal end of the medicament delivery device, the cover 20 is configured to be at least partially attached to the medicament delivery device. In a preferred example, the cover is configured to cover a needle. In a preferred example, the cover 20 comprises a sleeve-shaped body extending between the proximal end and the distal end. Alternatively, the cover comprises a flat, button-shaped body, in this example, the medicament delivery member is mainly received within the housing of the medicament delivery device, thus, the cover is configured to cover the proximal end tip of the medicament delivery device. In one example, the cap assembly comprises a delivery member shield remover arranged within the cover. In an example where the medicament delivery device is an autoinjector with a medicament container comprising a rigid needle shield and / or flexible needle shield, the delivery member shield remover of the cap assembly is configured to fixedly engage with at least one of a rigid needle shield and a flexible needle shield of the medicament container. In this example, the medicament container is a syringe (a medicament container with an integral needle or nozzle on the medicament container). In another example, as shown in Figs 2B-D, the delivery member unit comprises the cover and a base 23, and optionally a delivery member 21 and a delivery member holder 22. The delivery member 21 , the delivery member holder 22, and the base 23 are all arranged at least partially within the cover 20 and are all movable relative to the cover 20. The delivery member 21 is fixed to the delivery member holder 22. The delivery member 21 comprises a distal sharp end and a proximal delivery end. In this example, the medicament container 3 is a cartridge (a medicament container without an integral needle or nozzle on the medicament container). The distal shape end of the delivery member 21 is configured to penetrate a proximal seal of the medicament container 3 upon being activated so as to establish fluid communication between the medicament container and the proximal delivery end of the delivery member 21 . The proximal delivery end of the delivery member 21 is configured to deliver the contained medicament to an end-user. For example, the proximal delivery end of the delivery member 21 can be a needle or a spray nozzle. The base 23 comprises a proximal portion 23a, a distal portion 23b and a counter fastener 23c. The delivery member holder 22 and the delivery member 22 are received within the proximal portion of the base 23. The counter fastener 23c is configured to engage with the fastener 16 of the housing 10 during the assembling process of the medicament delivery device. In a preferred example, the fastener 16a and the counter fastener 23c form a snap-fit engagement. In a preferred example, when the cap assembly 2 comprises the delivery member 21 and delivery member holder 22, the establishment of fluid communication between the medicament container and the proximal delivery end of the delivery member 21 is activated by the removal of the cover 20. On the other hand, in an example where the cap assembly 2 doesn’t comprise the delivery member 21 and delivery member holder 22, then the end-user can establish fluid communication between the medicament container and a delivery member by attaching a delivery member, e.g. attaching a pen needle.

[0071] It should be noted that the description of this invention will not explain how to activate the fluid communication between the medicament container and the proximal delivery end of the delivery member by the removal of the cover in detail, because there are many different ways of activating the fluid communication between the medicament container and the proximal delivery end of the delivery member (see e.g. the disclosure of W02009150078), and the how to activate the fluid communication between the medicament container and the proximal delivery end of the delivery member is not a part of the invention.

[0072] 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 (a metho pterin) (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.

[0073] 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, B-cell receptors, or costimulatory proteins.

[0074] 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 TCR therapies.

[0075] 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, TAC, 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, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

[0076] 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.

[0077] 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.

[0078] Some other aspects of the invention are defined by the following clauses.

[0079] 1 . A sub-assembly of a medicament delivery device, the sub-assembly comprising a drive unit comprising: a plunger rod extending along a longitudinal axis from a proximal end and a distal end; wherein the plunger rod comprises a proximally directed surface; wherein the proximally directed surface is a chamfered surface; a power source operably connected to the plunger rod for applying a force on to the plunger rod along the longitudinal axis; a rotator rotatable around the longitudinal axis; wherein the rotator comprises a first distally directed surface engaged with the proximally directed surface of the plunger rod such that the force from the power source is capable of rotating the rotator around the longitudinal axis via the chamfered interface; and an activator operably connected to the rotator; wherein the activator is movable in the direction of the longitudinal axis from a holding position where the activator is circumferentially engaged with the rotator such that the rotator is blocked by the activator from being rotated around the longitudinal axis to a released position where the activator is circumferentially disengaged from the rotator such that the rotator is allowed to be rotated around the longitudinal axis. 2. The sub-assembly according to clause 1 , wherein the activator is configured to be distally moved from the holding position to the released position.

[0080] 3. The sub-assembly according to clause 1 , wherein the activator is configured to be proximally moved from the holding position to the released position.

[0081] 4. The sub-assembly according to clause 1 or 2, wherein the activator comprises a user-accessible section such that a user of the medicament delivery device can manually move the activator from the holding position to the released position via the user-accessible section.

[0082] 5. The sub-assembly according to any one of the preceding clauses, wherein the rotator comprises a second distally directed surface next to the first distally directed surface; wherein the second distally directed surface is longitudinally and circumferentially offset to the first distally directed surface such that the first and the second distally directed surfaces are configured to be sequentially engaged with the proximally directed surface of the plunger rod.

[0083] 6. The sub-assembly according to clause 5, wherein the second distally directed surface is configured to be engaged with the proximally directed surface of the plunger rod such that the force from the power source is capable of rotating the rotator around the longitudinal axis via the chamfered interface between the rotator and the plunger rod.

[0084] 7. The sub-assembly according to clause 5 or 6, wherein the activator is movable in the direction of the longitudinal axis from an initial released position where the activator is circumferentially disengaged from the rotator such that the rotator is allowed to be rotated around the longitudinal axis to the holding position.

[0085] 8. The sub-assembly according to clause 7, wherein the activator is movable in the direction of the longitudinal axis from an initial holding position where the activator is circumferentially engaged with the rotator such that the rotator is allowed to be rotated around the longitudinal axis to an initial released position.

[0086] 9. The sub-assembly according to clause 7 or 8, wherein the activator is movable in a first direction from the holding position to the released position; and wherein the activator is movable in a second direction opposite to the first direction from the initial holding position to the initial released position. The sub-assembly according to any one of the preceding clauses, wherein the activator comprises a protrusion; wherein a slot / groove is arranged in a wall of the rotator; and wherein the protrusion of the activator is positioned within the slot / groove of the rotator when the activator is in the holding position. The sub-assembly according to any one of the preceding clauses, wherein the subassembly comprises a housing extending along the longitudinal axis between a proximal end and a distal end; wherein the drive unit is accommodated within the housing. The sub-assembly according to clause 11 , wherein the activator comprises a tubular proximal section being telescopic relative to the proximal end of the housing. The sub-assembly according to clause 12 when dependent on clause 4, wherein the tubular proximal section comprises the user-accessible section. The sub-assembly according to clause 11 or 12 when dependent on clause 4, wherein the sub-assembly comprises a button; wherein the button comprises the user-accessible section. The sub-assembly according to clause 14, wherein the button is protruding from the distal end of the housing. The sub-assembly according to clause 14, wherein the button is protruding from the housing in a direction transverse to the longitudinal axis. The sub-assembly according to any one of clause 12-17, wherein the housing comprises a distally directed surface engaged with a proximally directed surface of the rotator. The sub-assembly according to clause 17 when dependent on clause 10, wherein the activator is rotationally immovable relative to the housing; and wherein the rotator comprises a protrusion having a helical surface directed to the protrusion of the activator such that when the protrusion of the activator moves along the helical surface of the protrusion of the rotator is rotated by the activator. The sub-assembly according to clause 18, wherein the sub-assembly comprises a biasing member configured to bias the proximal tubular section of the activator out of the proximal end of the housing; and wherein the protrusion of the activator is moved along the helical surface of the protrusion of the rotator when the proximal tubular section of the activator is biased out of the proximal end of the housing.

[0087] 20. A sub-assembly of a medicament delivery device, the sub-assembly comprising: a housing extending along a longitudinal axis from a proximal end and a distal end; a drive unit accommodated within the housing; wherein the drive unit comprises: a plunger rod comprising a proximally directed surface; a power source operably connected to the plunger rod for applying a force on to the plunger rod along the longitudinal axis; a rotator rotatable around the longitudinal axis; wherein the rotator comprises a first distally directed surface engaged with the proximally directed surface of the plunger rod to form a chamfered interface such that the force from the power source is capable of rotating the rotator around the longitudinal axis via the chamfered interface; and an activator operably connected to the rotator; wherein the activator is rotationally immovable relative to the housing; wherein the activator is movable in the direction of the longitudinal axis from a holding position where the activator is circumferentially engaged with the rotator such that the rotator is blocked by the activator from being rotated around the longitudinal axis to a released position where the activator is circumferentially disengaged from the rotator such that the rotator is allowed to be rotated around the longitudinal axis; and wherein the activator comprises a tubular proximal section being telescopic relative to the proximal end of the housing.

[0088] 21 . The sub-assembly according to clause 20, wherein the activator is configured to be distally moved from the holding position to the released position.

[0089] 22. The sub-assembly according to clause 20, wherein the activator is configured to be proximally moved from the holding position to the released position.

[0090] 23. The sub-assembly according to clause 20 or 21 , wherein the activator comprises a user-accessible section such that a user of the medicament delivery device can manually move the activator from the holding position to the released position via the user-accessible section.

[0091] 24. The sub-assembly according to any one of the preceding clauses, wherein the rotator comprises a protrusion having a helical surface directed to the protrusion of the activator such that when the protrusion of the activator moves along the helical surface of the protrusion of the rotator is rotated by the activator. The sub-assembly according to any one of the preceding clauses, wherein the rotator comprises a second distally directed surface next to the first distally directed surface; wherein the second distally directed surface is longitudinally and circumferentially offset to the first distally directed surface such that the first and the second distally directed surfaces are configured to be sequentially engaged with the proximally directed surface of the plunger rod. The sub-assembly according to clause 25, wherein the second distally directed surface is configured to form a chamfered interface with the proximally directed surface of the plunger rod such that the force from the power source is capable of rotating the rotator around the longitudinal axis via the chamfered interface between the rotator and the plunger rod. The sub-assembly according to clause 25 or 26, wherein the activator is movable in the direction of the longitudinal axis from the released position to a second holding position where the activator is circumferentially engaged with the rotator such that the rotator is blocked by the activator again from being rotated around the longitudinal axis. The sub-assembly according to clause 27, wherein the activator is movable in the direction of the longitudinal axis from the second holding position to a second released position where the activator is circumferentially disengaged from the rotator such that the rotator is allowed to be rotated around the longitudinal axis. The sub-assembly according to clause 27 or 28, wherein the activator is movable in a first direction from the holding position to the released position; and wherein the activator is movable in a second direction opposite to the first direction from the released position to the second holding position. The sub-assembly according to any one of the preceding clauses, wherein the activator comprises a protrusion; wherein a slot / groove is arranged in a wall of the rotator; and wherein the protrusion of the activator is positioned within the slot / groove of the rotator when the activator is in the holding position.

Claims

CLAIMS1 . A sub-assembly of a medicament delivery device, the sub-assembly comprising a drive unit comprising: a plunger rod extending along a longitudinal axis from a proximal end and a distal end; wherein the plunger rod comprises a proximally directed surface; wherein the proximally directed surface is a chamfered surface; a power source operably connected to the plunger rod for applying a force on to the plunger rod along the longitudinal axis; a rotator rotatable around the longitudinal axis; wherein the rotator comprises a first distally directed surface engaged with the proximally directed surface of the plunger rod such that the force from the power source is capable of rotating the rotator around the longitudinal axis via the chamfered interface; and an activator operably connected to the rotator; wherein the activator is movable in the direction of the longitudinal axis from a holding position where the activator is circumferentially engaged with the rotator such that the rotator is blocked by the activator from being rotated around the longitudinal axis to a released position where the activator is circumferentially disengaged from the rotator such that the rotator is allowed to be rotated around the longitudinal axis.

2. The sub-assembly according to claim 1 , wherein the activator is configured to be distally moved from the holding position to the released position.

3. The sub-assembly according to claim 1 or 2, wherein the activator comprises a user- accessible section such that a user of the medicament delivery device can manually move the activator from the holding position to the released position via the user- accessible section.

4. The sub-assembly according to any one of the preceding claims, wherein the rotator comprises a second distally directed surface next to the first distally directed surface; wherein the second distally directed surface is longitudinally and circumferentially offset to the first distally directed surface such that the first and the second distally directed surfaces are configured to be sequentially engaged with the proximally directed surface of the plunger rod.

5. The sub-assembly according to claim 4, wherein the second distally directed surface is configured to be engaged with the proximally directed surface of the plunger rod such that the force from the power source is capable of rotating the rotator around the longitudinal axis via the chamfered interface between the rotator and the plunger rod.

6. The sub-assembly according to claim 4 or 5, wherein the activator is movable in the direction of the longitudinal axis from an initial released position where the activator is circumferentially disengaged from the rotator such that the rotator is allowed to be rotated around the longitudinal axis to the holding position.

7. The sub-assembly according to claim 6, wherein the activator is movable in the direction of the longitudinal axis from an initial holding position where the activator is circumferentially engaged with the rotator such that the rotator is allowed to be rotated around the longitudinal axis to an initial released position.

8. The sub-assembly according to claim 6 or 7, wherein the activator is movable in a first direction from the holding position to the released position; and wherein the activator is movable in a second direction opposite to the first direction from the initial holding position to the initial released position.

9. The sub-assembly according to any one of the preceding claims, wherein the activator comprises a protrusion; wherein a slot / groove is arranged in a wall of the rotator; and wherein the protrusion of the activator is positioned within the slot / groove of the rotator when the activator is in the holding position.

10. The sub-assembly according to any one of the preceding claims, wherein the subassembly comprises a housing extending along the longitudinal axis between a proximal end and a distal end; wherein the drive unit is accommodated within the housing.11 . The sub-assembly according to claim 10, wherein the activator comprises a tubular proximal section being telescopic relative to the proximal end of the housing.

12. The sub-assembly according to claim 1 1 when dependent on claim 3, wherein the tubular proximal section comprises the user-accessible section.

13. The sub-assembly according to any one of claim 10-12, wherein the housing comprises a distally directed surface engaged with a proximally directed surface of the rotator.

14. The sub-assembly according to claim 13 when dependent on claim 9, wherein the activator is rotationally immovable relative to the housing; and wherein the rotator comprises a protrusion having a helical surface directed to the protrusion of theactivator such that when the protrusion of the activator moves along the helical surface of the protrusion of the rotator is rotated by the activator.

15. The sub-assembly according to claim 14, wherein the sub-assembly comprises a biasing member configured to bias the proximal tubular section of the activator out of the proximal end of the housing; and wherein the protrusion of the activator is moved along the helical surface of the protrusion of the rotator when the proximal tubular section of the activator is biased out of the proximal end of the housing.

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