A subassembly of a medicament delivery device for activation release

Abstract

The present disclosure generally relates to medicament delivery devices (1), and particularly concerns a subassembly (33) for releasing device activation.

Description

[0001] A SUBASSEMBLY OF A MEDICAMENT DELIVERY DEVICE FOR

[0002] ACTIVATION RELEASE

[0003] TECHNICAL FIELD

[0004] The present disclosure generally relates to medicament delivery devices, and particularly concerns a subassembly for releasing device activation.

[0005] BACKGROUND

[0006] A number of medical conditions require injections. These days, a number of different injection devices exist, including various types of pen injectors, autoinjectors and infusion devices for large volume injections. 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. 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, for example concerning mechanisms for activating the medicament delivery device for an injection event.

[0007] SUMMARY

[0008] An object of the present disclosure is to provide a subassembly for a medicament delivery device, which solves, or at least mitigates problems of the prior art.

[0009] According to a first aspect of the present disclosure, there is provided a subassembly of a medicament delivery device, which medicament delivery device extends from a proximal end adapted to face an injection site, to a distal end, along a longitudinal axis, comprising: a driver that is spring loaded to rotate about the longitudinal axis to cause injection activation for the medicament delivery device, the driver comprises a set of chamfered structures on a proximally facing surface of the driver, a clutch comprising a set of chamfered structures on a distally facing surface of the clutch that form an interlock with the set of proximally facing chamfered structures of the driver, the clutch further comprises a least one proximally facing surface on at least one radially outwards extending protrusion, a lock member comprising at least one radially flexible arm arranged radially outside the clutch and comprising a protrusion engaged with the proximally facing surface of the clutch to prevent axial motion in the proximal direction for the clutch, the lock member further comprising an anti -rotation connection to the clutch, and an activation sleeve arranged coaxial with and outside the lock member so that a radially inwards facing surface of the activation sleeve is aligned with and prevent the radially flexible arm from flexing radially outwards with respect to the longitudinal axis, the activation sleeve being axially movable in the distal direction by engagement with a needle cover of the medicament delivery device, wherein the axial motion of the activation sleeve causes its radially inwards facing surface to move distally and away from the radially flexible arm of the lock member to release the radially flexible arm to allow it to flex radially outwards by interaction with the proximally facing surface of the clutch to release the clutch for axial motion in the proximal direction.

[0010] Injection activation is herein that a plunger rod is released so that it can move longitudinally to cause compression of a medicament container inside the medicament delivery device.

[0011] The lock member is preferably rationally and axially locked to a housing of the medicament delivery device.

[0012] Embodiments of the present disclosure advantageously provides for a locking mechanism that prevents device activation until the activation sleeve has moved sufficiently in the distal direction cause by the motion of the needle cover. That, is, a timely release of the activation of the device is provided. Furthermore, chamfered structures on the proximally facing surface of the driver that interact with chamfered structures on the distally facing surface of the clutch provides an efficient lock and release mechanism.

[0013] 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 components 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.

[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”, “circumferentially” refer to a circumference or a circumferential direction 301 relative to an axis 102, 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 302 extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis.

[0017] According to one embodiment, the anti-rotation connection of the lock member may comprise a protruding guide shaped to match a shape of a receiving connection of the clutch. Hereby, a simple yet robust and reliable anti-rotation connection is provided.

[0018] According to one embodiment, the anti-rotation connection may allow axial motion of the clutch. Advantageously, this allows for the clutch to move axially due to interaction between chamfered surfaces of the clutch the chamfered structures of the driver. According to one embodiment, the interlock between the chamfered surfaces of the driver and the chamfered surfaces of the clutch are configured to transfer a rotational motion of the spring-loaded driver to an axial motion of the clutch guided by the anti-rotational connection.

[0019] According to one embodiment, prior to the axial motion of the activation sleeve that release the at least one radially flexible arm, the proximally facing surface of the clutch maybe biased against the protrusion of the flexible arm by the force transfer of the interlock. That is, as soon as the flexible arm is released, the flexible arm is pushed radially outwards by the interaction with the proximally facing surface of the clutch providing activation of the device with little delay.

[0020] According to one embodiment, the proximally facing surface of the clutch maybe inclined with respect to the longitudinal axis. The inclination facilitates moving the radially flexible arm of the lock member radially outwards.

[0021] According to one embodiment, the protrusion of the flexible arm may comprise an inclined distally facing surface that engages with the proximally facing surface of the clutch. Also this inclination facilitates moving the radially flexible arm of the lock member radially outwards.

[0022] According to one embodiment, once the flexible arm of the lock member is released to flex radially outwards, the clutch is moved proximally by a force transfer from the driver via the interlock so that the protrusion of the clutch reach to a position proximally with respect to the protrusion of the lock member.

[0023] Furthermore, the flexible arm may snap back in position once the protrusion of the clutch reach to a position proximal with respect to the protrusion. This advantageously prevents the lock member from moving back to its origination position and thus prevents the clutch from re-engaging with the driver. According to one embodiment, the clutch may comprise at least one radially outwards facing surface located distally relative to the protrusion of the clutch, the at least one radially outwards facing surface is arranged to receive the at least one protrusion of the at least one radially flexible arm and maintain the at least one radially flexible arm in a radially outwards flexed position once the protrusion of the clutch reach to proximally with respect to the protrusion. The at least one radially outwards facing surface of the clutch is somewhat elevated relative to the surface of the clutch proximal to the protrusion of the clutch. When the at least one radially flexible arm is flexed outwards to a position where it can intercept a proximal motion of the activation sleeve, such motion of the activation sleeve is prevented. This advantageously ensures that the device is maintained in a lockout state.

[0024] That is, the at least one radially flexible arm may be configured to prevent the activation sleeve from moving back to its initial proximal position.

[0025] According to one embodiment, the at least one radially flexible arm maybe maintained flexed outwards to a position directly proximal to at least one proximal facing surface of the activation sleeve wherein a proximal movement of the activation sleeve cause engagement between the at least one radially flexible arm and the at least one proximal facing surface of the activation sleeve.

[0026] According to one embodiment, once the flexible arm of the lock member is released to flex radially outwards, the clutch is moved proximally by a force transfer from the driver via the interlock so that the interlock between the chamfered surfaces of the driver and the chamfered surfaces of the clutch is disengaged and the driver is free to rotate. Thus, improved device activation is provided.

[0027] According to one embodiment, the driver, the clutch, and the lock member comprise an axial through holes aligned with each other along the longitudinal axis. The through-holes provide a convenient location for a plunger rod. According to one embodiment, the protrusion of the clutch may reach circumferentially at least partly around the clutch. Thus, interaction between the protrusion of the clutch and the flexible arm is provided even if the clutch is rotated axially.

[0028] According to one embodiment, the lock member comprising two flexible arms arranged on opposite sides of the lock member with respect to the longitudinal axis. In this way, a distribution of forces during interaction with the protrusion of the clutch is more symmetric facilitating axial motion of the clutch.

[0029] According to one embodiment, the activation sleeve may comprise oppositely oriented surfaces that are aligned with corresponding surfaces of the lock member, wherein an engagement between surfaces of the activation sleeve and the surfaces of the lock member prevents rotational motion of the lock member with respect to the activation sleeve. The oppositely oriented surfaces are preferably planar.

[0030] According to one embodiment, the at least one radially outwards extending protrusion of the clutch maybe a first at least one radially outwards extending protrusion, wherein the clutch may comprise a second at least one radially outwards extending protrusion proximally arranged relative to the first at least one radially outwards extending protrusion. This second at least one radially outwards extending protrusion ensures that the activation sleeve is maintained in place during handling and assembly of the device.

[0031] According to one embodiment, the radial height of the second at least one radially outwards extending protrusion may be lower than the radial height of the first at least one radially outwards extending protrusion. The radial height is lower than the original rib just to make it easy for the at least one flexible arm to snap over during assembly but still hold it in place. There is further provided a medicament delivery device comprising the subassembly according to any one of the herein disclosed embodiments.

[0032] 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 member, apparatus, component, means, etc.” are to be interpreted openly as referring to at least one instance of the member, apparatus, component, means, etc., unless explicitly stated otherwise.

[0033] BRIEF DESCRIPTION OF THE DRAWINGS

[0034] The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:

[0035] Fig. 1 is a perspective view of a medicament delivery device according to embodiments of the present disclosure;

[0036] Fig. 2 is a perspective view of the medicament delivery device without the housing according to embodiments of the present disclosure;

[0037] Fig. 3 is an exploded view of a subassembly according to embodiments of the present disclosure;

[0038] Fig. 4A is a perspective view of an activation shield according to embodiments of the present disclosure;

[0039] Fig. 4B is a perspective view of an activation shield according to embodiments of the present disclosure;

[0040] Fig. 5A is a perspective view of a lock member according to embodiments of the present disclosure;

[0041] Fig. 5B is a perspective view of a lock member according to embodiments of the present disclosure;

[0042] Fig. 5C is a cross-section of a lock member in a housing according to embodiments of the present disclosure; Fig. 6A is a perspective view of a clutch according to embodiments of the present disclosure;

[0043] Fig. 6B is a perspective view of a clutch according to embodiments of the present disclosure;

[0044] Fig. 7A is a perspective view of a driver according to embodiments of the present disclosure;

[0045] Fig. 7B is a perspective view of a driver according to embodiments of the present disclosure;

[0046] Fig. 8 is a cross-section of a subassembly according to embodiments of the present disclosure;

[0047] Fig. 9 is a cross-section of a subassembly according to embodiments of the present disclosure;

[0048] Fig. 10 is a cross-section of a subassembly according to embodiments of the present disclosure;

[0049] Fig. 11 is a perspective view of a subassembly and a plunger rod according to embodiments of the present disclosure;

[0050] Fig 12 is a perspective view of a clutch according to embodiments of the present disclosure;

[0051] Fig. 13 is a cross-section of a subassembly according to embodiments of the present disclosure;

[0052] Fig. 14 is a cross-section of a subassembly according to embodiments of the present disclosure. DETAILED DESCRIPTION

[0053] 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.

[0054] Fig. i shows an example of a medicament delivery device i such as an autoinjector according to embodiments of the present disclosure. The medicament delivery device i is configured to expel medicament from a medicament container via a medicament delivery member such as a needle, to a user at a dose delivery site. The medicament delivery device i extends from a proximal end la to a distal end ib relative to the axis 102.

[0055] The medicament delivery device 1 comprises a housing 3 with a window 4 and a lock arm 6 that prevents axial motion of a lock member of the herein described subassembly with respect to the housing 3. The housing 3 has a proximal end 3a and a distal end 3b. A needle cover 8 is configured to cover a needle and extends out from the proximal end 3 a of the housing 3.

[0056] A medicament container is placed inside the housing 3 from which medicament is expelled under the action of a plunger rod.

[0057] At the distal end ib is a rear cap 10 arranged to close the distal end of the housing 3.

[0058] Fig. 2 illustrates the medicament delivery device 1 with the housing 3 and the rear cap 10 removed.

[0059] The needle cover 8 includes arms 12 that extends distally and that reaches towards and may abut against proximally facing surfaces 13 of an activation sleeve 14. The arms 12 further comprises an opening 16 in which snap-arms 18 of the activation sleeve 14 may engage.

[0060] When the needle cover 8 moves distally the arms 12 cause the activation sleeve 14 to move distally. For example, for an injection event, the needle cover moves distally by being pushed against a user’s skin towards a retracted position whereby the arms 12 push the activation sleeve distally.

[0061] The medicament delivery device 1 further comprises a needle cover spring 20 that exerts a proximal force that biases the needle cover 8 towards an extended position.

[0062] Furthermore, the medicament delivery device 1 comprises a torsional spring 22. A driver 24 is spring loaded by the torsional spring 22 to rotate about the longitudinal axis 102.

[0063] The medicament delivery device 1 further comprises a syringe carrier 26 locked to a lock member 28 at an opening 30 engaging with a hook 32 of the syringe carrier 26.

[0064] Fig. 3 is an exploded view of a subassembly 33 according to the present disclosure.

[0065] The subassembly 33 comprises a driver 24 comprising a set of chamfered structures 36 on a proximally facing surface. A clutch 38 comprising a set of chamfered structures 40 on a distally facing surface 42 of the clutch 38. The chamfered structures 40 of the clutch 38 are configured to interlock with the of chamfered structures 36 of the driver 24.

[0066] The subassembly 33 further comprises a lock member 28 comprising at least one radially flexible arm 44 arranged radially outside the clutch 38. The at least one radially flexible arm 44 comprises a protrusion 46 that extends radially inwards towards the clutch 38. The anti-rotation connection 48 can guide the clutch 38 to move axially but does not allow rotation of the clutch 38 with respect to the lock member 28 about the longitudinal axis 102. The subassembly 33 further comprises the activation sleeve 14 arranged coaxial with and outside the lock member 28. The activation sleeve 14 is axially movable in the distal direction by engagement with the needle cover 8 of the medicament delivery device 1. The needle cover 8 acts on the proximally facing surface 13 of the activation sleeve 14 to move it distally.

[0067] Figs. 4A-B are perspective views of the activation sleeve 14. The activation sleeve 14 comprises radially inwards facing surfaces 50 that initially is aligned with and prevent the radially flexible arm 44 of the lock member 28 to flex radially outwards with respect to the longitudinal axis 102.

[0068] The distally facing surfaces 52 on the protrusion 54, opposite the proximally facing surface 16, provides support against the needle cover spring 20.

[0069] The activation sleeve 14 comprises oppositely oriented surfaces 51 and 53 that are aligned with corresponding surfaces 45 and 47 of the lock member 28. An engagement between surfaces 51 and 53 of the activation sleeve 14 and the surfaces of the lock member 28 prevents rotational motion of the lock member 28 with respect to the activation sleeve 14.

[0070] Figs. 5A-B are perspective views of the lock member 28. The lock member 28 comprises the at least one radially flexible arm 44 arranged radially outside the clutch 38 and comprising a protrusion 46. The protrusion 46 comprises an inclined distally facing surface 56 and an inclined proximally facing surface 58. The protrusion 46 may include a generally pointy end between the inclined surfaces.

[0071] The radially flexible arm 44 comprises a free end 44a where the protrusion 46 is located and a fixed end 44b. The free end 44a can move, by flexing, relative the fixed end 44b.

[0072] The anti-rotation structure 48 of the lock member 28 is a protruding guide shaped to match a shape of a receiving connection of the clutch 38. The guide 48 protrudes in the distal direction. The shape of the cross-section of the guide 48 is matched with the shape of the cross-section of the receiving connection of the clutch 38 such that it only allows axial motion of the clutch 38. In this example embodiment, the guide 48 has a substantially rectangular shape.

[0073] Further the lock member 28 comprises a longitudinal through-hole 60 where a plunger rod can move longitudinally. In the through-hole, radially inwards reaching curved threads 62 are arranged to interact with threads on the plunger rod to cause a longitudinal motion of the plunger rod when it is rotated by the driver 24.

[0074] Fig. 5C is a cross-section of the lock member 28 in the housing 3. The lock member 28 comprises a curved bar 39, also shown in figs. 5A-B which is arranged between two parallel inner rails 41 to prevents the lock member 28 from rotating with respect to the housing 3. The lock arm 6 of the housing 3 engage with the proximally facing surface 43 of the bar 39 to prevent the lock member 28 from moving proximally with respect to the housing, as limited by the engagement.

[0075] Figs. 6A-B are perspective views of the clutch 38 comprising a set of chamfered structures 40 on a distally facing surface 42 of the clutch 38. The chamfered structures 40 form an interlock with the set of proximally facing matching chamfered structures 34 of the driver 24. The chamfered structures include surfaces 40 that are inclined or bevelled or sloped at an angle relative the longitudinal axis. Neighbouring chamfered surfaces 40 maybe interleaved by surfaces 62 angled differently such as having a normal axis parallel with the longitudinal axis 102.

[0076] The clutch 38 further comprises a least one proximally facing surface 64 on at least one radially outwards extending protrusion 66. In this example embodiment, the clutch comprises two oppositely arranged protrusions 66. The protrusions 66 of the clutch 38 reach circumferentially at least partly around the clutch 38. The proximally facing surfaces 64 of the clutch 38 are inclined with respect to the longitudinal axis 102. Furthermore, on an opposite side of the protrusions 66, there is an inclined distally facing surface 68.

[0077] The clutch 38 further comprises a longitudinal through hole 70 forming the receiving connection 70 of the clutch 38. The anti-rotation structure 48 of the lock member 28 is fitted in the matching receiving connection 70 of the clutch 38. The outline of the through hole 70 matches that of the antirotation structure 48 such that the clutch can move linearly along the antirotation structure 48 but cannot rotate with respect to the lock member 28.

[0078] Figs. 7A-B are perspective views of the driver 24 comprising the set of chamfered structures 34 on the proximally facing surface 36 of the driver 24. The chamfered structures 34 substantially matches those of the clutch 34 such that an interlock is formed between the driver 24 and the clutch 38.

[0079] The torsional spring 22 (see fig. 2) is placed to surround the distal tubular structure 72 of the driver 24 and to lay against the flange 76.

[0080] The driver 74 comprises a longitudinal through-hole 74 in which protrusions 76 reach radially inwards such that the through-hole 74 is non-circular. The protrusions may extend longitudinally along the entire, or at least a portion of the length of the through-hole 74. The protrusions 76 are configured to engage with outer structures of the plunger rod such that when the driver 74 is rotated under the spring force of the torsional spring 22, the plunger rod also rotates. The plunger rod interacts with the threads 62 of the lock member 28 so that the rotation of the plunger rod causes it to move longitudinally.

[0081] Fig. 8 is a cross-section of the subassembly 33 in a state before the activation sleeve 14 has been moved distally by the needle cover. The activation sleeve 14 arranged coaxial with and outside the lock member 28. In this position, the radially inwards facing surface 50 of the activation sleeve 14 is aligned with and prevent the radially flexible arm 44 from flexing radially outwards with respect to the longitudinal axis. The driver 24 that is spring loaded to rotate about the longitudinal axis comprises the set of chamfered structures 34 that are interlocked with the chamfered structures 40 of the clutch 38. Since the driver 24 is rotationally spring loaded and the chamfered structures 34 that are interlocked with the chamfered structures 40 of the clutch 38, the driver is constantly attempting to move the clutch 38 linearly in the proximal direction. That is, rotating the driver 24 will cause a linear motion of the clutch 38. Furthermore, the clutch 38 is fitted on the anti-rotation connection 48 of the lock member 28 such that the clutch can only move linearly.

[0082] The clutch 38 further comprises the a least one proximally facing surface 64 on the radially outwards extending protrusions. Prior to an axial motion of the activation sleeve that release the at least one radially flexible arm 44, the proximally facing surface 64 of the clutch 38 is biased against the protrusion 46 of the flexible arm 44 by the force transfer of the interlock. That is, the driver is attempting to rotate and thus cause the clutch to move proximally, whereby the proximally facing inclined surface 64 of the clutch 38 abuts against the distally facing surface 56 of the protrusion 46 pf the lock member 28.

[0083] Fig. 9 is a cross-section of the subassembly 33 in a state when the activation sleeve 14 has been moved, indicated by arrow 304 distally by the needle cover. The radially inwards facing surface 50 thereby moves distally and away from the radially flexible arm 44 of the lock member 28 to release the radially flexible arm 44 to allow it to flex radially outwards, arrow 308, by interaction with the proximally facing inclined surface 64 of the clutch 38 to release the clutch 38 for axial motion in the proximal direction, indicated by arrow 306. The flexing of the flexible arm 44 is facilitated by that the protrusion 46 comprises the inclined distally facing surface 56 that engages with the proximally facing surface 64 of the clutch 38.

[0084] When the arms 44 are released to flex radially outwards, the clutch 38 can move proximally whereby the driver can initiate its rotation indicated by arrow 308. The interlock between the chamfered surfaces 34 of the driver 24 and the chamfered surfaces 40 of the clutch 38 is configured to transfer a rotational motion of the spring-loaded driver 24 to an axial motion of the clutch 38 guided by the anti-rotational connection 48.

[0085] Fig. 10 is a cross-section of the subassembly 33 when the activation sleeve 14 has move further proximally and the clutch 38 has moved so that the flexible arm 44 has snapped back in a position distal of the protrusion 66 of the clutch 38. That is, once the flexible arm 44 of the lock member 28 is released to flex radially outwards, the clutch 38 is moved proximally by a force transfer from the driver 24 via the interlock by the chamfered structures 40, 34, so that the protrusion 66 of the clutch 38 reach to a position proximally with respect to the protrusion 46 of the lock member 28. The interlock between the chamfered surfaces 34 of the driver 24 and the chamfered surfaces 40 of the clutch 38 is disengaged and the driver 24 is free to rotate. That the flexible arm 44 snaps back in position once the protrusion 66 of the clutch reach to proximally with respect to the protrusion 46 of the lock member 28 prevents the clutch 38 from re-engaging with the driver 24.

[0086] In the aligned through-holes along the longitudinal axis 102 is a plunger rod arranged which is better seen in fig. 11.

[0087] Fig 11 is a perspective view of the subassembly 33 without the activation sleeve and after the clutch 38 is moved away, proximally from the driver 24 being free to rotate. As discussed in relation to fig 7B, the driver 24 comprises protrusions in the through-hole such that the rotation of the driver 24 cause rotation of the plunger rod 78. When the plunger rod 78 is rotated, outer threads 80 of the plunger rod 78 interact with the threads 62 (see e.g., fig. 10) of the lock member 28 thereby moving the plunger rod 78 in the proximal direction indicated by arrow 310.

[0088] Fig 12 is a perspective view of a clutch 88 comprising a set of chamfered structures 40 on a distally facing surface 86 of the clutch 88 in an analogous way to the clutch 38 described above. The function of the chamfered structures 40 are the same as for the clutch 38. The clutch 88 further comprises at least one radially outwards facing surface 82 located distally relative to the protrusion 66 of the clutch 88. In this embodiment, the surface 82 is part of a protrusion 62 extending in the distal direction from a distally facing surface 86 of the clutch 88. The surface 82 is here shown somewhat curved but may also be e.g., planar.

[0089] The surface 82 is located distally directly next to or distally adjacent to the protrusion 66. That is, the surface 82 is located adjacent to the protrusion 66 along an axis parallel to the longitudinal axis 102 of the device 1. The surface maybe connected with the inclined distally facing surface 68 of the protrusion 66.

[0090] Furthermore, the clutch 88 further comprises in addition to the first 66 at least one radially outwards extending protrusion, also a second 84 at least one radially outwards extending protrusion. The second protrusions 84 are proximally arranged relative to the first protrusion 66. A valley 90 is formed between adjacent first and second protrusions 66, 84. Furthermore, the radial height of the second 84 at least one radially outwards extending protrusion is lower than the radial height of the first 66 at least one radially outwards extending protrusion. The second protrusions 84 ensures that the activation sleeve 14 is maintained in place during handling and assembly of the device.

[0091] Fig. 13 is a cross-section of the subassembly 33 in a state before the activation sleeve 14 has been moved distally by the needle cover as discussed in relation to fig. 8. In this position, the activation sleeve 14 is aligned with and prevent the radially flexible arm 44 from flexing radially outwards with respect to the longitudinal axis 102. The protrusion 46 of the flexible arm 44 is engaged in the valley 90 between the first and second protrusions 66 and 84.

[0092] Fig. 14 is a cross-section of the subassembly 33 when the activation sleeve 14 has move proximally and the clutch 88 has moved so that the flexible arm 44 of the lock member 28 has snapped back in a position distal of the protrusion 66 of the clutch 88. The protrusions 46 of the flexible arms 44 are received on the radially outwards facing surfaces 82 of the clutch 88. The surface 82 is somewhat elevated with respect to the valley 90 such that the radially flexible arms 44 are maintained in a radially outwards flexed position as indicated by arrow 312 (only shown on one flexible arm 44). In this flexed position, the radially flexible arms 44 prevents the activation sleeve 14 from moving back to its initial proximal position. In other words, the radially flexible arms have flexed outwards to a maintained position directly proximal to at least one proximal facing surface 92 of the activation sleeve 14. If the activation sleeve moves proximally, an engagement between the distal most part of the radially flexible arms 44 and the proximal facing surfaces of the activation sleeve would occur that prevents further proximal motion of the activation sleeve 14. This advantageously ensures that the device is maintained in a lockout state.

[0093] Embodiments of the present disclosure may be applied to various medicament delivery devices. In one possible implementation, the medicament delivery device maybe an autoinjector.

[0094] A medicament delivery device (such as an autoinjector) may generally include various other components. For example, a sensor unit which may recognize medicament delivery events, such as the needle inserted into an attachment portion of e.g., a pad, injection started, and medicament delivery operation ends, a memory unit which is configured to store the recorded data during the medicament delivery operation, a connectivity unit configured to transmit the stored data to a smart device or the network directly, a processing unit configured to control the entire system and processes the data before transmitting it, and / or user interface units that are configured to provide feedback to the patient, such as status LEDs, haptic, and / or audio feedback.

[0095] When the medicament delivery device is placed into the attachment portion, the sensors inside of the pad are configured to recognize the event and give feedback to the patient via haptic / visual or audio elements. When the medicament delivery finishes, the sensors are configured to recognize the event and give feedback to the patient again. Further, the collected data is stored in the memory unit and may be transmitted to the smart device / network via the connectivity unit after the medicament delivery event finishes.

[0096] The sensor can be one of or the combination of the following: a mechanical switch, a Hall-effect sensor, an accelerometer.

[0097] The mechanical switch, hall-effect sensor, or accelerometer can be used for detection of the insertion of a needle into an injection port.

[0098] The accelerometer can be used for detecting medicament delivery events.

[0099] Possible wireless communication methods include Bluetooth and Cellular Networks.

[0100] Bluetooth connectivity requires a smart device to transmit the stored data to the network and it requires a pairing action between the pad and the smart device before being able to use the supporting pad in case of 2-way connection. But it’s a cheaper alternative and it requires less space on PCB. A i-way connection does not require pairing.

[0101] The cellular network does not require any pairing process, it can be used as a plug-n-play device, no prior setup is needed, but it’s more expensive and it requires more space on PCB.

[0102] Depending on the requirements of the product any of those two technologies can be used.

[0103] Such processing units or processing circuitry may comprise a logic circuit or control unit including a microprocessor, microcontroller, programmable digital signal processor or another programmable device. The processing circuitry may also, or instead, each include an application specific integrated circuit, a programmable gate array or programmable array logic, a programmable logic device, or a digital signal processor. Where the processing circuitry includes a programmable device such as the microprocessor, microcontroller or programmable digital signal processor mentioned above, the processor may further include computer executable code that controls operation of the programmable device.

[0104] 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 drugs that could be included in the medicament delivery devices described herein include, but are not limited to, antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogues, protein variants, protein precursors, and / or protein derivatives. Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to (with non-limiting examples of relevant disorders in brackets): etanercept (rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis)), evolocumab (hypercholesterolaemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraines), alirocumab (rheumatoid arthritis), methotrexate (amethopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-ia (multiple sclerosis), sumatriptan (migraines), adalimumab (rheumatoid arthritis), darbepoetin alfa (anaemia), belimumab (lupus), peginterferon beta-ia' (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)). 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.

[0105] 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. In particular, whilst various distinct embodiments have been described with reference to the drawings, it will be appreciated that components of these distinct embodiments maybe interchanged to provide further embodiments.

Claims

CLAIMS i. A subassembly (33) of a medicament delivery device, which medicament delivery device extends from a proximal end adapted to face an injection site, to a distal end, along a longitudinal axis (102), comprising: a driver (24) that is spring loaded to rotate about the longitudinal axis to cause injection activation for the medicament delivery device, the driver comprises a set of chamfered structures (34) on a proximally facing surface (36) of the driver, a clutch (38) comprising a set of chamfered structures (40) on a distally facing surface (42) of the clutch that form an interlock with the set of proximally facing chamfered structures (34) of the driver (24), the clutch further comprises a least one proximally facing surface (64) on at least one radially outwards extending protrusion (66), a lock member (28) comprising at least one radially flexible arm (44) arranged radially outside the clutch and comprising a protrusion (48) engaged with the proximally facing surface (64) of the clutch (38) to prevent axial motion in the proximal direction for the clutch (38), the lock member (28) further comprising an anti-rotation connection (48) to the clutch (38), and an activation sleeve (14) arranged coaxial with and outside the lock member (28) so that a radially inwards facing surface (50) of the activation sleeve (14) is aligned with and prevent the radially flexible arm (44) from flexing radially outwards with respect to the longitudinal axis, the activation sleeve being axially movable in the distal direction by engagement with a needle cover of the medicament delivery device, wherein the axial motion of the activation sleeve causes its radially inwards facing surface (50) to move distally and away from the radially flexible arm (44) of the lock member (28) to release the radially flexible arm to allow it to flex radially outwards by interaction with the proximally facingsurface (64) of the clutch (38) to release the clutch for axial motion in the proximal direction, wherein the interlock between the chamfered surfaces (40) of the driver (24) and the chamfered surfaces (34) of the clutch (38) is configured to transfer a rotational motion of the spring-loaded driver (24) to an axial motion of the clutch (38) guided by the anti -rotational connection (48).

2. The subassembly (33) of claim 1, wherein the anti-rotation connection (48) of the lock member (28) comprises a protruding guide shaped to match a shape of a receiving connection (70) of the clutch (38).

3. The subassembly (33) of any of claims 1-2, wherein the anti-rotation connection (48) allows axial motion of the clutch (38).

4. The subassembly (33) of any of claims 1-3, wherein prior to the axial motion of the activation sleeve that release the at least one radially flexible arm (44), the proximally facing surface (64) of the clutch (38) is biased against the protrusion (48) of the flexible arm (44) by the force transfer of the interlock.

5. The subassembly (33) of any of the preceding claims, wherein the proximally facing surface (64) of the clutch (38) is inclined with respect to the longitudinal axis.

6. The subassembly (33) of any of the preceding claims, wherein the protrusion (46) comprises an inclined distally facing surface (58) that engages with the proximally facing surface (64) of the clutch.

7. The subassembly (33) of any of the preceding claims, wherein once the flexible arm (44) of the lock member (28) is released to flex radially outwards, the clutch (38) is moved proximally by a force transfer from the driver via the interlock so that the protrusion (66) of the clutch reach to aposition proximally with respect to the protrusion (46) of the lock member (28).

8. The subassembly (33) of claim 7, where the flexible arm (44) snaps back in position once the protrusion (66) of the clutch reach to proximally with respect to the protrusion (46).

9. The subassembly (33) of claim 7, wherein the clutch (38) comprises at least one radially outwards facing surface (82) located distally relative to the protrusion (66) of the clutch, the at least one radially outwards facing surface (82) is arranged to receive the at least one protrusion (46) of the at least one radially flexible arm (44) and maintain the at least one radially flexible arm (44) in a radially outwards flexed position once the protrusion (66) of the clutch reach to proximally with respect to the protrusion (46).

10. The subassembly (33) of claims 9, wherein the at least one radially flexible arm (44) is configured to prevent the activation sleeve from moving back to its initial proximal position.

11. The subassembly (33) of any of claims 9-10, wherein the at least one radially flexible arm (44) is maintained flexed outwards to a position directly proximal to at least one proximal facing surface of the activation sleeve wherein a proximal movement of the activation sleeve cause engagement between the at least one radially flexible arm (44) and the at least one proximal facing surface of the activation sleeve.

12. The subassembly (33) of any of the preceding claims, wherein once the flexible arm (44) of the lock member (28) is released to flex radially outwards, the clutch (38) is moved proximally by a force transfer from the driver (24) via the interlock so that the interlock between the chamfered surfaces (34) of the driver (24) and the chamfered surfaces (40) of the clutch (38) is disengaged and the driver (24) is free to rotate.13- The subassembly (33) of any of the preceding claims, wherein the driver (38), the clutch (38), and the lock member (28) comprise an axial through holes (60, 70, 74) aligned with each other along the longitudinal axis (102).

14. The subassembly (33) of any of the preceding claims, the protrusion (66) of the clutch reach circumferentially at least partly around the clutch.

15. The subassembly (33) of any of the preceding claims, the lock member (28) comprising two flexible arms (44) arranged on opposite sides of the lock member with respect to the longitudinal axis.

16. The subassembly (33) of any of the preceding claims, wherein the activation sleeve comprises oppositely oriented surfaces (51, 53) that are radially outside and aligned with corresponding surfaces (45, 47) of the lock member (28), wherein an engagement between surfaces of the activation sleeve and the surfaces of the lock member prevents rotational motion of the lock member with respect to the activation sleeve.

17. The subassembly (33) of any of the preceding claims, the at least one radially outwards extending protrusion of the clutch being a first (66) at least one radially outwards extending protrusion, wherein the clutch comprises a second (84) at least one radially outwards extending protrusion proximally arranged relative to the first at least one radially outwards extending protrusion.

18. The subassembly (33) of claim 17, wherein the radial height of the second at least one radially outwards extending protrusion is lower than the radial height of the first at least one radially outwards extending protrusion.

19. A medicament delivery device (1) comprising the subassembly (33) according to any one of the preceding claims.

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