A sub-assembly for a medicament delivery device
The sub-assembly for medicament delivery devices locks the activation sleeve using a clutch and spring mechanism, addressing unintentional activation issues during transport, ensuring safe handling and preventing accidental medicament expulsion.
Patent Information
- Application Number
- PCT/EP2024/088402
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-01-24
- Filing Date
- 2024-12-23
- Publication Date
- 2025-07-31
AI Technical Summary
Current medicament delivery devices face issues with unintentional activation due to relative movement between components during transport or handling, which can be triggered by vibrations or accidental forces, leading to undesired medicament expulsion.
A sub-assembly for a medicament delivery device featuring a housing, activation sleeve, clutch, and spring configuration that locks the activation sleeve in a first position, preventing axial movement and ensuring safe transport, with a clutch and spring mechanism to securely maintain the activation sleeve in place until intentional activation.
The solution enhances transportation safety by preventing unintended axial movement of the activation sleeve, ensuring secure locking until deliberate activation, thereby reducing accidental medicament delivery.
Smart Images

Figure EP2024088402_31072025_PF_FP_ABST
Abstract
Description
[0001] A SUB-ASSEMBLY FOR A MEDICAMENT DELIVERY DEVICE
[0002] TECHNICAL FIELD
[0003] The present disclosure generally relates to medical devices for medicament administration.
[0004] BACKGROUND
[0005] A number of medical conditions require injections. These days, a number of different injection devices exist, including various types of pen injectors, autoinjectors and on-body devices. Although many of these devices have enabled major improvements in the management of a number of medical conditions, various limitations do still exist in the current technology.
[0006] The medicament is typically comprised in a medicament container within the medicament delivery device, the medicament container being configured to expel the medicament via some type of delivery member, such as a needle or a nozzle. A medicament delivery action may be activated by releasing a pretensioned plunger rod configured to act on the medicament container, whereafter medicament is continuously expelled from the medicament container until the end of the medicament delivery action. Many medicament delivery devices comprises components which are movable relative each other. The relative movement between two specific components may activate the medicament delivery device, e.g. by exposing the delivery member or initiating expel of medicament from the medicament container. During transport or when handling the medicament delivery device prior to use, such relative movement between the components is undesired as it may unintentionally activate the medicament delivery device. Thus, to avoid such unintentional relative movement, the two components can be secured relative each other, e.g. by axially or radially fixating one component to the other, or by means of a locking element, wherein a release of the locking element allows a relative movement of the two components. However, vibrations or accidentally applied forces may result in an unintentional release of the locking between the two components which may result in an unintentional activation of the medicament delivery device. In considering these problems, the applicant has appreciated that various developments could be made to help improve the medicament delivery devices on the market today, which are set out in more detail below.
[0007] SUMMARY
[0008] An object of the present disclosure is to provide a sub-assembly for a medicament delivery device, and a medicament delivery device, which solves, or at least mitigates problems of the prior art.
[0009] There is hence provided a sub-assembly for a medicament delivery device configured to expel medicament from a medicament container. The subassembly comprises: a housing having a proximal end and a distal end, the housing having a proximally facing surface; an activation sleeve arranged inside the housing, the activation sleeve having a distally facing surface and a proximally facing surface; a clutch arranged radially inside of the activation sleeve, the clutch comprising a blocking surface arranged to abut the proximally facing surface of the activation sleeve in a first locking position to prevent axial movement of the activation sleeve in the proximal direction; and a spring arranged distally of the activation sleeve between the proximally facing surface of the housing and the distally facing surface of the activation sleeve, wherein the spring is arranged to pre-tension the activation sleeve in the first locking position.
[0010] The activation sleeve can thus be arranged in an axially locked position in an improved manner. Thereby, the transportation of the sub-assembly can be achieved with increased safety. The arrangement providing the activation sleeve in the first locking position may be referred to as a transportation lock. That is, by the above configuration, unintended axial movement of the activation sleeve is prevented, enhancing transportation safety by ensuring that the activation sleeve remains securely arranged in the first locking position. The spring maybe referred to as a compression spring.
[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.
[0012] 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.
[0013] 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.
[0014] 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.
[0015] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.
[0016] 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.
[0017] 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.
[0018] According to one embodiment, the clutch further comprises a radially protruding arm comprising the blocking surface. Hereby, a robust and reliable structure for the blocking surface is provided. For example, the protruding arm may extend radially towards the housing. According to one embodiment, the radially protruding arm extends into an opening of the activation sleeve.
[0019] According to one embodiment, the radially protruding arm positioned within the opening of the activation sleeve and thereby rotationally lock the clutch to the activation sleeve.
[0020] According to one embodiment, the protruding arm may serve dual purposes, one being to comprise the blocking surface to prevent the activation sleeve from moving axially in the proximal direction, and the other being to rotationally lock the clutch to the activation sleeve. For example, the radially protruding arm may comprise a rotationally locking surface abutting an inner contacting surface of the opening of the activation sleeve. Thus, for embodiments in which the activation sleeve is rotationally locked relative to the housing, the clutch is rotationally locked relative to the housing.
[0021] Alternatively, or additionally, according to one embodiment, the subassembly comprises a support structure being enclosed by the clutch. The support structure is engaged with the clutch and form an interface having a non-circular cross-section when observes along the centre axis. As a result, the clutch cannot rotate relative to the activation sleeve. The non-circular cross-section can be a triangle, square, rectangular cross-section when observes along the centre axis. The support structure can be an inner housing or as a part of a locking component that will be explained later.
[0022] Hereby, unintentional activation and / or undesired movement of internal components of the sub-assembly is prevented.
[0023] According to one embodiment, the housing comprises a radially protruding ledge including the proximally facing surface, wherein the activation sleeve comprises a tubular sleeve portion including the distally facing surface, wherein the proximally facing surface and the distally facing surface are axially aligned. Hereby, the arrangement of the spring to pre-tension the activation sleeve is facilitated. That is, the internal arrangement of the spring inside the housing may be improved. According to one embodiment, the spring is arranged to pre-tension the activation sleeve in the proximal direction such that the proximally facing surface of the activation sleeve is pushed against the blocking surface of the clutch. Thus, the activation sleeve is pre-tensioned to move in the proximal direction, but is prevented from moving axially in the proximal direction by the clutch and the interaction with the blocking surface. Thus, the activation sleeve is advantageously axially fixated in the first locking position.
[0024] According to one embodiment, the sub-assembly further comprises: a plunger rod arranged inside the housing; a pre-tensioned rotatable driver for the plunger rod, the rotatable driver being operably arranged to, upon activation, rotate and thereby move the plunger rod proximally to act on the medicament container for expelling the medicament, the rotatable driver having a contacting surface; wherein the clutch is arranged proximally of the rotatable driver, the clutch comprising a locking surface arranged to interact with the contacting surface to rotationally lock the rotatable driver in its pretensioned state. Thus, the clutch prevents the rotatable driver to rotate, and thereby also prevents the activation leading to the plunger rod to move proximally to act on the medicament container. The rotational lock formed by the locking surface and contacting surface may e.g. comprise a male-female structure, e.g. in the form of a protrusion of the rotatable driver arrangement connecting with an indentation of the clutch. The rotatable driver may be pre-tensioned by a torsion spring. For example, the torsion spring may be pre-stressed in between a distal part of the housing and a distally facing surface of the rotatable driver. Thus, the rotatable driver may be pre-stressed to rotate, but being arrangeable in a pre-tensioned state in which the rotatable driver is rotationally fixed relative to the housing.
[0025] According to one embodiment, the contacting surface of the rotatable driver is facing at least partly in the proximal direction and the locking surface of the clutch is facing at least partly in the distal direction. The specific orientation of the contacting surface and the locking surface enables a secure lock, enhancing the safety and reliability of the sub-assembly by preventing accidental activation of the rotatable driver. The contacting surface and the locking surface may e.g. be inclined surfaces, typically matching inclined surfaces.
[0026] According to one embodiment, the rotatable driver comprises an inner facing threaded surface and the plunger rod comprises an outer facing threaded surface, wherein the inner and outer facing threaded surfaces are arranged to directly interact to transform a rotational movement of the rotatable driver to a rotational movement of the plunger rod. Hereby, an advantageous feeding of the plunger rod in the proximal direction is provided. Thus, upon activation of the rotatable driver, typically by releasing the rotational lock to the clutch as will be described later, the rotatable driver is free to rotate. Upon rotation of the rotatable driver, the plunger rod will rotate owing to the interaction between the inner and outer facing threaded surfaces. That is, as the rotatable driver is typically axially fixed relative to the housing, the rotation of the rotatable driver and the rotation of the plunger rod will result in a feeding of the plunger rod in the proximal direction. For example, the inner and outer facing threaded surfaces may be configured to cooperate in a screw-nut connection. Thus, as the inner facing threaded surface of the rotatable driver mate with the outer facing threaded surface of the plunger rod, a rotational movement of the plunger rod will result in that the plunger rod is moved axially relative to the rotatable driver.
[0027] According to one embodiment, the rotatable driver comprises a tubular main driver portion holding the plunger rod, the tubular main driver portion having the inner facing threaded surface. That is, the tubular main driver portion is hollow, and may comprise a cylindrically shaped inner bore, wherein surface(s) of the inner bore facing towards a centre axis of the tubular main driver portion comprises, or forms, the inner facing threaded surface. Correspondingly, the plunger rod being configured to be move within the cylindrically shaped inner bore of the tubular main driver portion, comprises surface(s) facing away from a centre axis of the plunger rod, wherein such surface(s) comprises, or forms, the outer facing threaded surface. According to one embodiment, the sub-assembly further comprises a locking component having a holding arm arranged to abut a holding surface of the clutch to axially lock the clutch, and to thereby axially lock the rotatable driver in its pre-tensioned state. Hereby, the safety and reliability of the subassembly is further improved and accidental activation of the rotatable driver prevented. The rotatable driver may thus be locked in between the clutch and the torsion spring. As the clutch is axially locked by the locking component, the rotational lock formed by the locking surface and contacting surface of the clutch and the rotatable driver is active, preventing the rotatable driver from being activated and to rotate by means of the force from the torsion spring.
[0028] According to one embodiment, the locking component comprises a radial protrusion configured to rotationally lock the locking component to the housing. Hereby, the locking component maybe axially fixed to the housing in an advantageous manner. For example, the radial protrusion of the locking component may extend radially beyond the activation sleeve and into an indentation of the housing, or onto a brim or ledge of the housing. The indentation, or brim or ledge, is typically arranged in an inner facing surface of the housing.
[0029] According to one embodiment, the activation sleeve is arranged radially outside of, and enclosing, at least a portion of the locking component. Hereby, a compact and efficient structure of the activation sleeve and locking component is provided.
[0030] According to one embodiment, the activation sleeve comprises a holding portion arranged to, in the first locking position of the activation sleeve, abut the holding arm for preventing the holding arm to flex radially outwards and become distant from to the holding surface of the clutch. The holding portion is typically arranged radially outside of the holding arm.
[0031] According to one embodiment, the activation sleeve is arranged to, upon being subject an external force in the distal direction, move from its first locking position to an activation position by moving in the distal direction. Thus, by providing an external force in the distal direction overcoming the force of the spring pre-tensioning the activation sleeve in the proximal direction, the activation sleeve may move in the distal direction to its activation position. Hereby, activation of the sub-assembly maybe initiated as will be described in the following.
[0032] According to one embodiment, the holding portion is arranged to move distally pass the holding arm upon movement of the activation sleeve from its first locking position into its activation position, to thereby enable the holding arm to flex radially outwards and release the holding surface of the clutch from the holding arm, and to thereby release the clutch to move in the proximal direction. Thus, as the holding portion is moved axially in the distal direction, the holding arm is released. Hereby, the clutch is released from its axial fixed position.
[0033] According to one embodiment, the contacting surface and the locking surface are chamfered, wherein the rotatable driver is arranged push the clutch in the proximal direction when the clutch is released, and to thereby distant the locking surface from the contacting surface, whereby the rotatable driver is free to rotate. The torsion spring is typically arranged to pre-tension the rotatable driver in the proximal direction, in addition to being pre-stressed to rotate, whereby the axial release of the clutch result in that the rotatable driver may push the clutch proximally to thereby release the rotational lock formed by the locking surface and contacting surface, and to thereby activate the sub-assembly or medicament delivery device. Thus, after activation of the rotatable driver, the torsion spring is configured to rotate the rotatable driver until the torsion spring becomes unbiased, or un-tensioned. Hereby, the plunger rod may move in the proximal direction and act on the medicament container to expel medicament therefrom.
[0034] According to one embodiment, the sub-assembly further comprises a needle cover axially fixed to the activation sleeve and operatively configured to distally push the activation sleeve into its activation position for initiating expel of medicament from the medicament container. Thus, the previously mentioned external force in the distal direction may be provided to the activation sleeve by the needle cover, and the spring may be referred to as a needle cover spring. For example, the needle cover is subject to an external force in the distal direction by that the needle cover is pressed against the dose delivery site. The needle cover is typically arranged to move axially relative the housing, and may protrude proximally of the housing to cover a needle of the medicament container.
[0035] According to one embodiment, the needle cover comprises a first locking structure, and the activation sleeve comprises a second locking structure arranged to lock to the first locking structure to thereby axially lock the needle cover to the activation sleeve. Hereby, the needle cover and the activation sleeve maybe axially locked to each other and may move in unison.
[0036] According to one embodiment, the activation sleeve comprises a tubular proximal portion configured to surround a needle of the medicament container, wherein the activation sleeve is operatively configured to move into its activation position for initiating expel of medicament from the medicament container. Thus, the activation sleeve may have a needle cover portion. In other words, the activation sleeve and the needle cover may form an integral component.
[0037] According to one embodiment, the sub-assembly further comprises a lockout surface axially fixated relative to the housing, and an interacting surface axially fixated relative to the activation sleeve, the interacting surface being arranged to lock to the lockout surface, wherein the spring is operatively arranged to push the activation sleeve proximally from its activation position to a lockout position in which the lockout surface locks to the interacting surface. Hereby, the activation sleeve can be brought into a second locking position being a lockout position, subsequent to being in its activation positions (and corresponding medicament delivery). An effect obtainable thereby is an improved lockout of the activation sleeve. That is, after use, the activation sleeve is arranged in a final state in which it is axially locked. Thus, the activation sleeve cannot move axially subsequent to the lockout operation. As the activation sleeve is axially locked, it obstructs movement of other components which are directly linked to the axial movement of the activation sleeve.
[0038] According to one embodiment, the lockout surface is comprised in one of a lockout protrusion and lockout indentation, and the interacting surface is comprised in the other of the lockout protrusion and lockout indentation, such that the lockout protrusion and lockout indentation lockingly interact with each other. Hereby, the lockout surface and the interacting surface can lockingly interact in an advantageous manner.
[0039] According to one embodiment, the sub-assembly further comprises a syringe carrier arranged to hold the medicament container inside the housing, wherein the syringe carrier comprising the lockout surface. Hereby, the lockout surface and the interacting surface may be brought into engagement with each other to axially lock the activation sleeve in a reliant manner.
[0040] According to one embodiment, the interacting surface is comprised in the activation sleeve. Thus, for example, the activation sleeve and the syringe carrier are arranged to axially lock to each other in the lockout position of the activation sleeve. For example, the interacting surface is comprised in a resilient tongue arranged to face the syringe carrier. As the activation sleeve is brought into the lockout position, the resilient tongue may locking interact with an indentation, or a ledge, of the syringe carrier, wherein the indentation or ledge comprises the lockout surface.
[0041] According to one embodiment, the lockout surface is comprised in the housing. Hereby, the lockout surface and the interacting surface maybe brought into engagement with each other to axially lock the activation sleeve in a reliant manner.
[0042] According to one embodiment, the interacting surface is comprised in the needle cover. For example, the needle cover and the housing are arranged to axially lock to each outer in the lockout position of the activation sleeve. For example, the interacting surface is comprised in a resilient tongue arranged to face the housing. As the activation sleeve is brought into the lockout position, the resilient tongue of the needle cover may locking interact with an indentation, or a ledge, of the housing, wherein the indentation or ledge comprises the lockout surface.
[0043] According to one embodiment, the previously mentioned lockout surface of the syringe carrier is a first lockout surface and the previously mentioned interacting surface of the activation sleeve is a first interacting surface. Correspondingly, the previously mentioned lockout surface of the housing is a second lockout surface and the previously mentioned interacting surface of the needle cover is a second interacting surface. Thus, the sub-assembly may comprise both the first lockout surface and first interacting surface as well as the second lockout surface and the second interacting surface. Hereby, a more reliable lockout function is achieved.
[0044] According to one embodiment, the activation sleeve is arranged further proximally in the lockout position as compared to in the first locking position. Hereby, the needle of the medicament container may be fully protected by the needle cover or by the tubular proximal portion of the activation sleeve, as the needle cover or tubular proximal portion will be arranged further proximal in the lockout position of the activation sleeve as compared to in the first locking position of the activation sleeve.
[0045] According to a second aspect of the present disclosure, there is provided a medicament delivery device for expelling medicament from a medicament container, the medicament delivery device comprising the sub-assembly according to the first aspect.
[0046] Effects and features of the second aspect are largely analogous to those described above in connection with the first aspect. Embodiments mentioned in relation to the first aspect are largely compatible with the second aspect.
[0047] According to one embodiment, applicable to any one of the first and second aspects of the disclosure, the medicament container is a syringe. The medicament container typically comprises a medicament delivery member in the form of a needle.
[0048] 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.
[0049] BRIEF DESCRIPTION OF THE DRAWINGS
[0050] The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:
[0051] Fig. 1 is a perspective view of a medicament delivery device according to embodiments of the present disclosure;
[0052] Fig. 2 is an exploded view of the medicament delivery device and a subassembly thereof according to embodiments of the present disclosure;
[0053] Fig. 3 is a perspective, partly cross-sectional view of at least a part of the subassembly according to embodiments of the present disclosure;
[0054] Fig. 4 is a perspective view of components of the sub-assembly according to embodiments of the present disclosure;
[0055] Fig. 5 is a perspective view of components of the sub-assembly according to embodiments of the present disclosure;
[0056] Figs. 6A and 6B are perspective views of components of the sub-assembly according to embodiments of the present disclosure;
[0057] Fig. 7 is a perspective view of an example component of the sub-assembly according to embodiments of the present disclosure. DETAILED DESCRIPTION
[0058] The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like numbers refer to like members throughout the description.
[0059] Fig. i shows an example of a medicament delivery device i such as an autoinjector of an injection device according to embodiments of the present disclosure. The medicament delivery device i is configured to expel medicament from a medicament container 15 via a medicament delivery member 2, here embodied as needle, to a user at a dose delivery site. The medicament delivery device 1 extends from a proximal end la to a distal end ib relative to the axis 112. A needle cover 5 is arranged at the proximal end la and is configured to cover, and exposing, the needle 2 by moving axially relative a housing 3.
[0060] The axis 112 is in Fig. 1 a centre axis, from which a circumferential direction 131 relative to the centre axis 112 and a radial direction 132 extending radially relative to the centre axis 112, can be defined.
[0061] The medicament delivery device 1 comprises a sub-assembly 11, the subassembly comprising the housing 3 having a proximal end 3a and a distal end 3b.
[0062] Fig. 2 is an exploded view of the medicament delivery device 1 and subassembly 11 of the medicament delivery device 1. The sub-assembly 11 comprises the housing 3 shown in Fig. 1. The housing 3 is here divided into a first housing part 4a and a second housing part 4b in the form of a rear cap.
[0063] The sub-assembly 11 further comprises an activation sleeve 7 arranged inside the housing 3. The activation sleeve 7 maybe rotationally fixed relative to the housing 3, e.g. relative to the first housing part 4a, but is typically movable in the axial direction inside the housing 3. The activation sleeve 7 comprises a distally facing surface 7c and a proximally facing surface yd (better shown in Fig. 3)-
[0064] The sub-assembly 11 further comprises a clutch 9 arranged radially inside of the activation sleeve 7. The clutch 9 comprises a blocking surface 9d arranged to abut the proximally facing surface yd of the activation sleeve 7 in a first locking position to prevent axial movement of the activation sleeve 7 in the proximal direction. The clutch 9 may further comprise a locking surface 9b arranged at the distal end portion of the clutch 9.
[0065] The sub-assembly 11 further comprises a spring 90 arranged distally of the activation sleeve 7 between a proximally facing surface 3c (shown in Fig. 3) of the housing 3 and the distally facing surface 7c of the activation sleeve 7. The spring 90 is arranged to pre-tension the activation sleeve 7 in the first locking position. The spring 90 maybe referred to as a compression spring 90.
[0066] Moreover, the sub-assembly 11 may comprises a plunger rod 13 arranged inside the housing 3, or at least inside the first housing part 4a.
[0067] The sub-assembly 11 may further comprise a pre-tensioned rotatable driver 20 for the plunger rod 13. The rotatable driver 20 is operably arranged to, upon activation, rotate and thereby move the plunger rod 13 proximally to act on the medicament container 15 for expelling a medicament. The rotatable driver 20 comprises a contacting surface 20a arranged to interact with the locking surface 9b of the clutch 9 to rotationally lock the rotatable driver 20 in a pre-tensioned state. The rotatable driver 20 is pre-tensioned by a torsion spring 80. The torsion spring 80 is tensioned between the rotatable driver 20 and a distal housing part 4c. The distal housing part 4c may be a separate component to the housing 3 but fixedly attached to the housing 3, e.g. to the first housing part 4a. As an alternative, the distal housing part 4c is integrated into the housing 3. The sub-assembly n may further comprise a locking component 8 having a holding arm 8c arranged to abut a holding surface 9c of the clutch 9 to axially lock the clutch 9, and to thereby axially lock the rotatable driver 20 in its pretensioned state.
[0068] The sub-assembly 11 may further comprise a spinner 23 arranged in the distal portion of the sub-assembly 11. The spinner 23 may be rotationally locked to the rotatable driver 20 via a rotational lock 22. As the housing 3 may comprise a sight window arranged in a distal portion of the housing 3, e.g. in the second housing part 4b, the rotatable spinner 23, and its speed of rotation, may be visible in a proximal direction through the sight window. Hereby, feedback of the rotatable spinner 23 may be provided to a user.
[0069] The sub-assembly 11 may further comprise the needle cover 5 shown in Fig. 1. The needle cover 5 is arranged to move axially relative the housing 3, and is operatively configured to distally push the activation sleeve 7 into an activation position in which the holding arm 8c is distant from the holding surface 9 c of the clutch 9 to thereby release the rotatable driver 20 from its pre-tensioned state. That is, as the holding arm 8c is distant from the holding surface 9c of the clutch 9, the clutch 9 may move axially and the contacting surface 20a of the rotatable driver 20 maybe released from the locking surface 9b of the clutch, and thus no longer prevent the rotatable driver 20 from rotating by the action of the torsion spring 80.
[0070] The sub-assembly 11 may further comprise a syringe carrier 6 arranged to hold the medicament container 15 inside the housing 3.
[0071] The sub-assembly 11 may further comprise an outer cap (not shown) being removably arranged relative to the housing 3, and / or the needle cover 5. Thus, by removing the outer cap, the needle 2 of the medicament container 15 may be exposed.
[0072] Fig. 3 is a perspective, cross sectional view of at least a part of the subassembly 11. In Fig. 3, the first housing part 4a of the housing 3 is shown, as well as the activation sleeve 7, the locking component 8, the clutch 9, the spring 90 and the rotatable driver 20. The activation sleeve 7 is arranged radially outside of, and enclosing, at least a part of the clutch 9, and the clutch 9 is arranged radially outside of, and enclosing, at least a part of the locking component 8. Thus, the activation sleeve 7 is arranged radially outside of, and enclosing, at least a portion of the locking component 8.
[0073] The spring 90 is compressed between the proximally facing surface 3c of the housing 3 and the distally facing surface 7c of the activation sleeve 7, as described with reference to Fig. 2, to pre-tension, or push, the activation sleeve 7 in the proximal direction. In more detail, the housing 3 comprises a radially protruding ledge 3d including the proximally facing surface 3c. Moreover, the activation sleeve 7 comprises a tubular sleeve portion 7b including the distally facing surface 7c. Hereby, the proximally facing surface 3c and the distally facing surface 7c are axially aligned, improving the arrangement of the spring 90. Thus, the spring 90 is arranged to pre-tension the activation sleeve 7 in the proximal direction such that the proximally facing surface yd of the activation sleeve 7 is pushed against the blocking surface 9d of the clutch 9.
[0074] As seen in Fig. 3, the activation sleeve 7 is tubular, or comprises an inner cylindrical space, in which the clutch 9 is at least partly arranged. Moreover, the clutch 9 comprises a radially protruding arm 9a comprising the blocking surface 9d. The radially protruding arm 9a extends into an opening yf of the activation sleeve 7. The opening yf is at least partly defined by the proximally facing surface yd. Thus, as the radially protruding arm 9 a extends in the opening yf, and as the blocking surface 9d is a distally facing surface, the blocking surface 9d of the radially protruding arm 9a abut the proximally facing surface yd inside the opening yf to prevent axial movement of the activation sleeve 7 in the proximal direction (the movement in the proximal direction of the activation sleeve 7 being biased by the spring 90). Thus, the activation sleeve 7 is locked in the first locking position by the spring 90 and the clutch 9. Moreover, as the radially protruding arm 9a extends into the opening yf of the activation sleeve 7, the clutch 9 may be rotationally locked to the activation sleeve 7 by internal walls of the opening yf arranged perpendicular to the proximal facing surface yd. Alternatively or additionally, the locking component 8 comprises an central protrusion extending into a central opening of the clutch 9. In this example, the central protrusion engages with the clutch 9 and thereby forms a interface having a non-circular cross-section when observes along the centre axis 112. As a result, the radially protruding arm 9a can be used only as an axial stop between the activation sleeve 7 and the clutch 9 to hold the activation sleeve in the first locking position.
[0075] As also shown in Fig. 3, the plunger rod 13 is arranged inside the housing 3 and through the rotatable driver 20. In more detail, the rotatable driver 20 is operably arranged to, upon activation, rotate and thereby move the plunger rod 13 proximally to act on the medicament container 15 for expelling the medicament. The rotatable driver 20 is pre-tensioned by torsion spring 90 as described with reference to Fig. 2.
[0076] Turning to Fig. 4 showing a perspective view of the clutch 9 and rotatable driver 20. The clutch 9 is arranged distally of the rotatable driver 20, and locks the rotatable driver 20 in the axial direction and prevents the rotatable driver 20 from rotating. The locking surface 9b of the clutch 9 and the contacting surface 20a of the rotatable driver 20 is shown in Fig. 4. The locking surface 9a faces at least partly in the distal direction and the contacting surface 20a faces at least partly in the proximal direction. Moreover, the locking surface 9b and the contacting surface 20a are chamfered and interacts in a rotationally locking manner whereby the rotatable driver 20 is rotationally locked. Thus, the locking surface 9b of the clutch 9 rotationally lock the rotatable driver 20 in the pre-tensioned state. Moreover, in Fig. 4, the radially protruding arm 9 a and the blocking surface 9d described with reference to Fig. 3 are shown.
[0077] Turning to Fig. 5 showing a perspective view of the locking component 8 and the clutch 9. The locking component 8 is shown as being arranged radially outside of the clutch 9. The holding arm 8c is as shown in Fig. 5 arranged to abut the holding surface 9c of the clutch 9 to axially lock the clutch 9. Thus, the clutch 9 is axially locked to the locking component 8, and the rotatable driver 20 is axially locked in its pre-tensioned state by the clutch 9. Moreover, the locking component 8 comprises a radial protrusion 8d configured to rotationally lock the locking component 8 to the housing 3. Thus, the radial protrusion 8d extends radially into the housing 3, typically into an indentation in the inner facing surface of the first housing part 4a, to axially lock the locking component 8 to the housing 3.
[0078] Fig. 6A and 6B show perspective views of the activation sleeve 7 and the locking component 8 in the first locking position (Fig. 6A) and an activation position (Fig. 6B) of the activation sleeve 7. As shown in Fig. 6A, the activation sleeve 7 comprises a holding portion ye arranged to, in the first locking position of the activation sleeve 7, abut the holding arm 8c for preventing the holding arm 8c to flex radially outwards and become distant from to the holding surface 9 c of the clutch 9. The activation sleeve 7 is arranged to, upon being subject an external force in the distal direction, move from its first locking position in Fig. 6A to the activation position shown in Fig. 6b by moving in the distal direction. Moreover, in Fig. 6A, the opening yf of the activation sleeve 7, described with reference to Fig. 3, through which the radially protruding arm 9a of the clutch 9 comprising the blocking surface 9d, is arranged to extend into, is shown.
[0079] Upon movement of the activation sleeve 7 from its first locking position to the activation position shown in Fig. 6B, the holding portion ye is moved distally pass the holding arm 8c to thereby enable the holding arm 8c to flex radially outwards and release the holding surface 9c of the clutch 9 from the holding arm 8c, described with reference to Fig. 5. Hereby the clutch 9 is released to move in the proximal direction. In a preferred example, the holding arm 8c comprises a proximally directed surface. In this example, once the clutch 9 move past the holding arm 8c, the holding arm 8c is configured to snap back to the clutch 9. As a result, the proximally directed surface of the holding arm 8c is configured to block the clutch 9 from moving in the distal direction. For example, the activation sleeve 7 maybe moved distally by that the needle cover 5, e.g. due to an external force being exerted on a proximal part 5b of the needle cover 5. Moreover, as the contacting surface 20a of the rotatable driver 20 and the locking surface 9b of the clutch 9 are chamfered, as described with reference to Fig. 4, the rotatable driver 20 is arranged push the clutch 9 in the proximal direction when the clutch 9 is released. Hereby, the locking surface 9b is moved distant to the contacting surface 20a, releasing the rotational lock, whereby the rotatable driver 20 is free to rotate. That is, the rotatable driver 20 is activated.
[0080] Upon activation of the rotatable driver 20, the rotatable driver 20 rotates owing to its pre-tensioned state of the torsion spring 80. Upon rotation of the rotatable driver 20, the plunger rod 13 will rotate. In more detail, the rotatable driver 20 comprises an inner facing threaded surface 20b (shown in Fig. 4), and the plunger rod 13 comprises an outer facing threaded surface 13b (shown in Fig. 3), wherein the inner and outer facing threaded surfaces 20b, 13b are arranged to directly interact to transform a rotational movement of the rotatable driver 20 to a rotational movement of the plunger rod 13. That is, as the rotatable driver 20 is typically axially fixed relative to the housing 3, the rotation of the rotatable driver 20 and the rotation of the plunger rod 13 will result in a feeding of the plunger rod 13 in the proximal direction. That is, plunger rod 13 is activated.
[0081] Moreover, as the rotatable driver 20 is rotationally fixed to the rotational lock 22 and the rotatable spinner 23, the rotational lock 22 and spinner 23 will rotate together with the rotatable driver 20.
[0082] Turning back to Fig. 3. As mentioned previously, the sub-assembly 11 may comprise a needle cover 5. The needle cover 5 is axially fixed to the activation sleeve 7, typically by that a distal portion of the needle cover 5 is attached to a proximal portion of the activation sleeve 7. Hereby, the needle cover 5 may distally push the activation sleeve 7 into its activation position for initiating expel of medicament from the medicament container 15, as previously described. In more detail, the needle cover 5 may comprises a first locking structure 5a, and the activation sleeve 7 may comprise a second locking structure 7a arranged to lock to the first locking structure 5a of the needle cover 5 to thereby axially lock the needle cover 5 to the activation sleeve 7.
[0083] The first and second locking structures 5a, 7a may e.g. be a snap-lock.
[0084] However, according to one embodiment, as shown in Fig. 7, the activation sleeve 7’ comprises a tubular proximal portion 7’a configured to surround a needle of the medicament container 15. Thus, the activation sleeve 7’ may have a needle cover portion 7’a. In other words, the activation sleeve 7 and the needle cover 5 as previously described may be integrated and formed as a single component 7’. Thus, the activation sleeve 7’ of Fig. 7 may comprise all of the corresponding features of the activation sleeve 7 as previously described.
[0085] Subsequent to activation, or subsequent to the proximal movement of the plunger rod 13 and the expel of medicament of the medicament container 15, the sub-assembly 11 maybe lockout, or brought into a locked-out state. For example, the sub-assembly 11 may comprise a first lockout surface 6c and a first interacting surface 7g configured to lockingly interact with the first lockout surface 6c. The first lockout surface 6c is typically axially fixated relative to the housing 3, and the first interacting surface 7g is typically axially fixated relative to the activation sleeve 7. For example, the syringe carrier 6 may comprise the first lockout surface 6c, and the activation sleeve 7 may comprise the first interacting surface 7g. Hereby, the first lockout surface 6c and the first interacting surface 7g may be brought into engagement with each other such that the activation sleeve 7 is brought into a lockout position by axially locking to the syringe carrier 6.
[0086] For example, the first lockout surface 6c of the syringe carrier maybe comprised in a first lockout indentation 31a, and the first interacting surface 7g comprised in a first lockout protrusion 30a, such that the first lockout protrusion 30a and first lockout indentation 31a lockingly interact with each other. As shown in Fig. 3, the second locking structure 7a may also comprise the first interacting surface 7g, and form part of the first lockout protrusion 30a. Additionally, or alternatively, the sub-assembly n may comprise a second lockout surface 3e and a second interacting surface 5d configured to lockingly interact with the second lockout surface 3e. The second lockout surface 3e is typically axially fixated relative to the housing 3, and the second interacting surface 5d is typically axially fixated relative to the activation sleeve 7. For example, the housing 3, such as the first housing part 4a, may comprise the second lockout surface 3e, and the needle cover 5 may comprise the second interacting surface 5d. Hereby, the second lockout surface 3e and the second interacting surface 5d may be brought into engagement with each other such that the needle cover 5, and the activation sleeve 7, are brought into a corresponding lockout position by axially locking to the housing 3.
[0087] For example, the second lockout surface 3e of the housing 3 maybe comprised in a second lockout indentation 31b, and the second interacting surface 5d comprised in a second lockout protrusion 30b, such that the second lockout protrusion 30b and second lockout indentation 31b lockingly interact with each other.
[0088] The activation sleeve 7 is typically brought into its lockout position by the force of the spring 90 which is operatively arranged to push the activation sleeve 7 proximally from its activation position to its lockout position in which the first and / or second lockout surface(s) 6c, 3e locks to the corresponding first and / or second interacting surface(s) 5d, 7g.
[0089] 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.
[0090] Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia and / or dyslipidemia, cardiovascular disease, diabetes (e.g. type 1 or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behqet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycaemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, Factor V Leiden), and cancer.
[0091] Exemplary types of drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapies, radioisotopes and / or nuclear medicines, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogues, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies.
[0092] Exemplary drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.
[0093] Exemplary drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-i (GLP-i) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Ci esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor-associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-i / PD- Li) inhibitors / modulators, B-lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, B-lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T- lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domaincontaining protein (PVRIG) modulators, lymphocyte-activation gene 3 (LAG3; also known as cluster of differentiation 223 or CD223) antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation W137 (CDW137) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD 80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD159 or NKG2) modulators, glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig-like receptor (KIR) modulators, growth arrest-specific protein 6 (GAS6) / AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation W123 (CDW123) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumor-infiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.
[0094] Exemplary drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-ia, interferon beta-ib, peginterferon beta-ia, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins.
[0095] Exemplary drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein may also include, but are not limited to, oncology treatments such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, famtrastuzumab 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.
[0096] Exemplary drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein include “generic” or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the “innovator” or “branded” version of each, as in the non-limiting example of innovator medicament adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.
[0097] Exemplary drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.
[0098] Exemplary drugs that could be included in the medicament containers, and administrated by the medicament delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer’s solution, Heparin Lock Flush solution, 100 U / mL Heparin Lock Flush Solution, or 5000 U / mL Heparin Lock Flush Solution.
[0099] Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the medicament containers, and administrated by 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. Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also include separately administered or co-formulated dispersion enhancers (e.g. an animal-derived, human-derived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.
[0100] Exemplary drugs that could be included in the medicament containers, and administrated by 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, mF0LF0X6, mFOLFOXy, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.
[0101] 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.
[0102] Some other aspects of the invention are defined by the following clauses.
[0103] 1. A sub-assembly (11) for a medicament delivery device (1) configured to expel medicament from a medicament container (15), the sub-assembly (11) comprising: a housing (3) having a proximal end (3a) and a distal end (3b), the housing (3) having a proximally facing surface (3c); an activation sleeve (7, 7’) arranged inside the housing (3), the activation sleeve (7, 7’) having a distally facing surface (7c) and a proximally facing surface (yd); a clutch (9) arranged radially inside of the activation sleeve (7, 7’), the clutch (9) comprising a blocking surface (9d) arranged to abut the proximally facing surface (yd) of the activation sleeve (7, 7’) in a first locking position to prevent axial movement of the activation sleeve (7, 7’) in the proximal direction; and a spring (90) arranged distally of the activation sleeve (7, 7’) between the proximally facing surface (3c) of the housing (3) and the distally facing surface (7c) of the activation sleeve (7, 7’), wherein the spring (90) is arranged to pre-tension the activation sleeve (7, 7’) in the first locking position.
[0104] 2. The sub-assembly (11) according to clause 1, wherein the clutch (9) further comprises a radially protruding arm (9a) comprising the blocking surface (9d).
[0105] 3. The sub-assembly (11) according to clause 2, wherein the radially protruding arm (9a) extends into an opening (yf) of the activation sleeve (7, 7’)-
[0106] 4. The sub-assembly (11) according to any one of the preceding clauses, wherein the housing (3) comprises a radially protruding ledge (3d) including the proximally facing surface (3c), and wherein the activation sleeve (7, 7’) comprises a tubular sleeve portion (7b) including the distally facing surface (7c), wherein the proximally facing surface (3c) and the distally facing surface (7c) are axially aligned.
[0107] 5. The sub-assembly (11) according to any one of the preceding clauses, wherein the spring (90) is arranged to pre-tension the activation sleeve (7, 7’) in the proximal direction such that the proximally facing surface (yd) of the activation sleeve (7, 7’) is pushed against the blocking surface (9d) of the clutch (9).
[0108] 6. The sub-assembly (11) according to any one of the preceding clauses, further comprising: a plunger rod (13) arranged inside the housing (3); a pre-tensioned rotatable driver (20) for the plunger rod (13), the rotatable driver (20) being operably arranged to, upon activation, rotate and thereby move the plunger rod (13) proximally to act on the medicament container (15) for expelling the medicament, the rotatable driver (20) having a contacting surface (20a); wherein the clutch (9) is arranged distally of the rotatable driver (20), the clutch (9) comprising a locking surface (9b) arranged to interact with the contacting surface (20a) to rotationally lock the rotatable driver (20) in its pre-tensioned state.
[0109] 7. The sub-assembly (11) according to clause 6, wherein the contacting surface (20a) of the rotatable driver (20) is facing at least partly in the proximal direction and the locking surface (9b) of the clutch (9) is facing at least partly in the distal direction.
[0110] 8. The sub-assembly (11) according to any one of clauses 6-7, further comprising a locking component (8) having a holding arm (8c) arranged to abut a holding surface (9c) of the clutch (9) to axially lock the clutch (9), and to thereby axially lock the rotatable driver (20) in its pre-tensioned state.
[0111] 9. The sub-assembly (11) according to clause 8, wherein the locking component (8) comprises a radial protrusion (8d) configured to rotationally lock the locking component (8) to the housing (3).
[0112] 10. The sub-assembly (11) according to any one of clauses 8-9, wherein the activation sleeve (7, 7’) is arranged radially outside of, and enclosing, at least a portion of the locking component (8).
[0113] 11. The sub-assembly (11) according to clause 10, wherein the activation sleeve (7, 7’) comprises a holding portion (7e) arranged to, in the first locking position of the activation sleeve (7, 7’), abut the holding arm (8c) for preventing the holding arm (8c) to flex radially outwards and become distant from to the holding surface (9c) of the clutch (9).
[0114] 12. The sub-assembly (11) according to any one of the preceding clauses, wherein the activation sleeve (7, 7’) is arranged to, upon being subject an external force in the distal direction, move from its first locking position to an activation position by moving in the distal direction. 13- The sub-assembly (n) according to clauses n and 12, wherein the holding portion (ye) is arranged to move distally pass the holding arm (8c) upon movement of the activation sleeve (7, 7’) from its first locking position into its activation position, to thereby enable the holding arm (8c) to flex radially outwards and release the holding surface (9c) of the clutch (9) from the holding arm (8c), and to thereby release the clutch (9) to move in the proximal direction.
[0115] 14. The sub-assembly (11) according to clause 11, wherein the contacting surface (20a) and the locking surface (9b) are chamfered, and wherein the rotatable driver (20) is arranged push the clutch (9) in the proximal direction when the clutch (9) is released, and to thereby distant the locking surface (9b) from the contacting surface (11), whereby the rotatable driver (20) is free to rotate.
[0116] 15. The sub-assembly (11) according to any one of clauses 12-14, further comprising a needle cover (5) axially fixed to the activation sleeve (7) and operatively configured to distally push the activation sleeve (7) into its activation position for initiating expel of medicament from the medicament container (15).
[0117] 16. The sub-assembly (11) according to clause 15, wherein the needle cover (5) comprises a first locking structure (5a), and the activation sleeve (7) comprises a second locking structure (7a) arranged to lock to the first locking structure (5a) to thereby axially lock the needle cover (5) to the activation sleeve (7).
[0118] 17. The sub-assembly (11) according to any one of clauses 12-14, wherein the activation sleeve (7’) comprises a tubular proximal portion (7’a) configured to surround a needle of the medicament container (15), and wherein the activation sleeve (7’) is operatively configured to move into its activation position for initiating expel of medicament from the medicament container (15). 18. The sub-assembly (n) according to any one of clauses 12-17, further comprising a lockout surface (6c, 3e) axially fixated relative to the housing (3), and an interacting surface (sd, 7g) axially fixated relative to the activation sleeve (7, 7’), the interacting surface (sd ,7g) being arranged to lock to the lockout surface (6c, 3e), and wherein the spring (90) is operatively arranged to push the activation sleeve (7, 7’) proximally from its activation position to a lockout position in which the lockout surface (6c, 3e) locks to the interacting surface (sd, 7g).
[0119] 19. The sub-assembly (11) according to clause 18, wherein the lockout surface (6c, 3e) is comprised in one of a lockout protrusion (30a, 30b) and lockout indentation (31a, 31b), and the interacting surface (sd, 5f) is comprised in the other of the lockout protrusion and lockout indentation, such that the lockout protrusion (30a, 30b) and lockout indentation (31a, 31b) lockingly interact with each other.
[0120] 20. The sub-assembly (11) according to clause 18, further comprising a syringe carrier (6) arranged to hold the medicament container (15) inside the housing, wherein the syringe carrier (6) comprising the lockout surface (3e).
[0121] 21. The sub-assembly (11) according to clause 18, wherein the lockout surface (3e) is comprised in the housing (3).
[0122] 22. A medicament delivery device (1) for expelling medicament from a medicament container (15), the medicament delivery device (1) comprising the sub-assembly (11) according to any one of clauses 1-21.
Claims
CLAIMS1. A sub-assembly (n) for a medicament delivery device (i) configured to expel medicament from a medicament container (15), the sub-assembly (11) comprising: a housing (3) having a proximal end (3a) and a distal end (3b), the housing (3) having a proximally facing surface (3c); an activation sleeve (7, 7’) arranged inside the housing (3), the activation sleeve (7, 7’) having a distally facing surface (7c) and a proximally facing surface (yd); a clutch (9) arranged radially inside of the activation sleeve (7, 7’), the clutch (9) comprising a blocking surface (9d) arranged to abut the proximally facing surface (yd) of the activation sleeve (7, 7’) in a first locking position to prevent axial movement of the activation sleeve (7, 7’) in the proximal direction; and a spring (90) arranged distally of the activation sleeve (7, 7’) between the proximally facing surface (3c) of the housing (3) and the distally facing surface (7c) of the activation sleeve (7, 7’), wherein the spring (90) is arranged to pre-tension the activation sleeve (7, 7’) in the first locking position.
2. The sub-assembly (11) according to claim 1, wherein the clutch (9) further comprises a radially protruding arm (9a) comprising the blocking surface (9d).
3. The sub-assembly (11) according to claim 2, wherein the radially protruding arm (9 a) extends into an opening (yf) of the activation sleeve (7, 7’)-4. The sub-assembly (11) according to any one of the preceding claims, wherein the housing (3) comprises a radially protruding ledge (3d) including the proximally facing surface (3c), and wherein the activation sleeve (7, 7’)comprises a tubular sleeve portion (7b) including the distally facing surface (7c), wherein the proximally facing surface (3c) and the distally facing surface (7c) are axially aligned.
5. The sub-assembly (11) according to any one of the preceding claims, wherein the spring (90) is arranged to pre-tension the activation sleeve (7, 7’) in the proximal direction such that the proximally facing surface (yd) of the activation sleeve (7, 7’) is pushed against the blocking surface (9d) of the clutch (9).
6. The sub-assembly (11) according to any one of the preceding claims, further comprising: a plunger rod (13) arranged inside the housing (3); a pre-tensioned rotatable driver (20) for the plunger rod (13), the rotatable driver (20) being operably arranged to, upon activation, rotate and thereby move the plunger rod (13) proximally to act on the medicament container (15) for expelling the medicament, the rotatable driver (20) having a contacting surface (20a); wherein the clutch (9) is arranged distally of the rotatable driver (20), the clutch (9) comprising a locking surface (9b) arranged to interact with the contacting surface (20a) to rotationally lock the rotatable driver (20) in its pre-tensioned state.
7. The sub-assembly (11) according to claim 6, wherein the contacting surface (20a) of the rotatable driver (20) is facing at least partly in the proximal direction and the locking surface (9b) of the clutch (9) is facing at least partly in the distal direction.
8. The sub-assembly (11) according to any one of claims 6-7, further comprising a locking component (8) having a holding arm (8c) arranged to abut a holding surface (9c) of the clutch (9) to axially lock the clutch (9), and to thereby axially lock the rotatable driver (20) in its pre-tensioned state.
9. The sub-assembly (n) according to claim 8, wherein the locking component (8) comprises a radial protrusion (8d) configured to rotationally lock the locking component (8) to the housing (3).
10. The sub-assembly (11) according to any one of claims 8-9, wherein the activation sleeve (7, 7’) is arranged radially outside of, and enclosing, at least a portion of the locking component (8).
11. The sub-assembly (11) according to claim 10, wherein the activation sleeve (7, 7’) comprises a holding portion (ye) arranged to, in the first locking position of the activation sleeve (7, 7’), abut the holding arm (8c) for preventing the holding arm (8c) to flex radially outwards and become distant from to the holding surface (9c) of the clutch (9).
12. The sub-assembly (11) according to any one of the preceding claims, wherein the activation sleeve (7, 7’) is arranged to, upon being subject an external force in the distal direction, move from its first locking position to an activation position by moving in the distal direction.
13. The sub-assembly (11) according to claims 11 and 12, wherein the holding portion (ye) is arranged to move distally pass the holding arm (8c) upon movement of the activation sleeve (7, 7’) from its first locking position into its activation position, to thereby enable the holding arm (8c) to flex radially outwards and release the holding surface (9c) of the clutch (9) from the holding arm (8c), and to thereby release the clutch (9) to move in the proximal direction.
14. The sub-assembly (11) according to claim 11, wherein the contacting surface (20a) and the locking surface (9b) are chamfered, and wherein the rotatable driver (20) is arranged push the clutch (9) in the proximal direction when the clutch (9) is released, and to thereby distant the locking surface (9b) from the contacting surface (11), whereby the rotatable driver (20) is free to rotate.15- The sub-assembly (11) according to any one of claims 12-14, further comprising a needle cover (5) axially fixed to the activation sleeve (7) and operatively configured to distally push the activation sleeve (7) into its activation position for initiating expel of medicament from the medicament container (15).
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