Medicament delivery device

Abstract

A medicament delivery device has a signal element (25, 180, 198, 294) and a feedback mechanism (110, 295, 315) that is released on completion of medicament delivery to move a distance before interacting with the signal element (25, 180, 198, 294) to produce an end of medicament delivery signal. A delay mechanism (150, 170, 190, 914, 195, 300) exerts a force on the feedback mechanism (110, 295, 315) during the movement to slow the feedback mechanism (110, 295, 315) and thereby introduce a delay between the completion of medicament delivery and the production of the signal.

Description

[0001] MEDICAMENT DELIVERY DEVICE

[0002] TECHNICAL FIELD

[0003] The present disclosure relates to a medicament delivery device and in particular to an improved, more user-friendly, automatic medicament delivery device providing confirmation to a user when an injection has been made.

[0004] BACKGROUND

[0005] Many medicament delivery devices are developed for self-administration, i.e., a user performs the medicament delivery themselves. This requires a medicament delivery device which is as safe to use and as easy to handle as possible. In order to meet these requirements, it is desirable to minimise the risk of human errors, reduce the number of actions need to be performed in order to receive a dose and to make the device intuitive and ergonomic to use. Further, in order to minimize the risk of human errors, it is desirable to have the device as pre-assembled as possible.

[0006] WO 2011 / 123024 Al discloses a medicament delivery device that is reliable and easy to use when handling and activating. This is achieved by a medicament delivery device comprising a drive means configured to act on a medicament container for expelling a medicament, a holding means configured to hold said drive means in a pre-tensioned state, an activation means configured to interact with said holding means for releasing said drive means from the pretensioned state, wherein the device further comprises feedback means configured to interact both with said holding means and with said drive means for generating an audible and / or tactile and / or visual signal indicating that the medicament has been completely expelled.

[0007] With some autoinjector designs that provide one or more clicks indicative of stages of the injection process, the user may lift the injector from the injection site immediately after hearing a click intended to signal the end of the injection. In some circumstances this can lead to premature lifting of the autoinjector, which in turn may result in the needle being removed before the end of the intended medicament delivery and the delivery of less volume of the medicament than in the prefilled syringe. SUMMARY

[0008] An object underlying the present disclosure is to provide a medicament delivery device that prevents or at least reduces a premature lift risk. This object is achieved with the features of the claims.

[0009] A medicament delivery device according to an aspect of the disclosure has a signal element and a feedback mechanism that is released on completion of medicament delivery to move a distance before interacting with the signal element to produce an end of medicament delivery signal, and a delay mechanism that exerts a force on the feedback mechanism during the movement to slow the feedback mechanism and thereby introduce a delay between the completion of medicament delivery and the production of the signal.

[0010] The medicament delivery device may further comprise a drive mechanism configured to act on a medicament container for expelling a medicament; a holding mechanism configured to hold said drive mechanism in a pre-tensioned state; and an activation mechanism configured to interact with said holding mechanism for releasing said drive mechanism from the pretensioned state. When the feedback mechanism is released from its initial state it is displaced by a force of a resilient member to a feedback state for generating the end of medicament delivery signal; and the delay mechanism configured to influence the displacement of the feedback mechanism before reaching its feedback state.

[0011] The feedback mechanism may be configured to interact both with said holding mechanism and with said drive mechanism for generating the end of medicament delivery signal.

[0012] The resilient member may be a first resilient member and part of the drive mechanism, wherein the feedback mechanism is displaced by a remaining force of the first resilient member to the feedback state.

[0013] The delay mechanism may be configured to influence the speed profile of the feedback mechanism. The delay mechanism may be configured to influence the displacement of the feedback mechanism by applying a force on the feedback mechanism acting against the driving force of the feedback mechanism.

[0014] The delay mechanism may be configured to decelerate the displacement of the feedback mechanism.

[0015] The feedback mechanism may be a longitudinally extending member.

[0016] Preferably, said longitudinally extending member is an elongated U-shaped bracket comprising a transversal wall and two longitudinally extending flexible arms provided with angled support members extending radially outward.

[0017] The transversal wall of the U-shaped bracket may be arranged at a predetermined distance D from the signal element of the medicament delivery device when the drive mechanism is in the pre-tensioned state, which signal element is preferably an inner distal surface of the medicament delivery device.

[0018] The delay mechanism may be functionally located between the feedback mechanism and the signal element.

[0019] The delay mechanism may comprise a deformable element.

[0020] The delay mechanism may comprise delay element. The delay element may have a first end facing the feedback mechanism when being in its initial position, and along the longitudinal axis of the medicament delivery device an opposite second end contacting a distal element of the medicament delivery device.

[0021] The first end of the delay element is spaced from the feedback mechanism along the longitudinal axis of the medicament delivery device.

[0022] The delay element may have a U-shape when viewed in transversal direction of the medicament delivery device. The U-shape may be provided by a cylindrical wall having two opposing recesses corresponding to the two longitudinally extending flexible arms of the feedback mechanism.

[0023] At least one of the recesses may have at least one of the longitudinally extending recess walls a protrusion in circumferential direction. The protrusion may have the form of a first ramp ramping up towards the distal end, the first ramp being provided adjacent the first end of the delay mechanism. The protrusion may further comprise a second ramp ramping down from the first ramp towards the distal end.

[0024] The feedback mechanism may comprise at least one groove at the edge of the two longitudinally extending flexible arms, the at least one groove being formed and arranged for each groove accommodating one of the at least one protrusion when the feedback mechanism has reached its feedback position.

[0025] The delay mechanism may be is made from a deformable material.

[0026] The drive mechanism may comprise a plunger rod and a first resilient member which is pretensioned arranged within the plunger rod.

[0027] The delay mechanism may comprise one or more magnets providing a repulsive force. Preferably, an inner rear wall of the medicament delivery device comprises magnets corresponding in number and location to the magnets of the delay mechanism.

[0028] The drive mechanism may comprise a plunger rod, a first resilient member which is pretensioned arranged within the plunger rod, and a guide rod arranged within the first resilient member. Preferably, a proximally facing surface of the transversal wall of the feedback mechanism is in contact with a distally facing wall of the guide rod. The guide rod (96) may be T-shaped at its distal end in longitudinal cross section.

[0029] The delay mechanism may have a first, proximal end, and along the longitudinal axis of the medicament delivery device an opposite second, distal end being axially spaced from an inner rear wall of the medicament delivery device. The delay mechanism may be connected to the guide rod at its T-shaped end. The delay mechanism may have at least two longitudinally extending circumferential leg portions holding the guide rod in releasable manner. Each of the leg portions may comprise the magnet being arranged such that their magnetic repulsive force acts in longitudinal direction. The medicament delivery device may be configured to allow the leg portions to deflect radially after being displaced axially for a first predetermined distance to release the guide rod. The deflection may be caused by the repulsive force of the magnets.

[0030] Preferably, a signal, preferably an audible signal, is generated for confirming that a medicament delivery has been performed when the distal end of the plunger rod has passed the supporting members, such that the longitudinally extending flexible arms, with the support members, are released and allowed to move, enabling the signal generating member to move in the distal direction by a remaining force exerted by said first resilient member, whereby the transversal wall of the signal generating member hits the signal element, preferably the inner rear wall.

[0031] The delay mechanism may comprise two or more elements.

[0032] The delay mechanism may comprise a disk structure located at the distally facing side of the feedback mechanism. The disk structure may comprise two radial guide pins at its circumferential surface, preferably being spaced 180° from each other.

[0033] The delay mechanism may further comprise a third resilient element between the distally facing side of the disk structure and the rear inner wall of the medicament delivery device.

[0034] The delay mechanism may comprise a sleeve element abutting against the inner rear wall. The third resilient element may be at least partially accommodated in the sleeve element.

[0035] The sleeve element may comprise two cut-outs at its proximal side, preferably 180° offset from each other.

[0036] Each cut out may comprise a helical guiding track for guiding a guide pin of the disk structure from a proximal side of the cut-out towards and to a distal end of the helical guiding track, thus urging the disk structure to rotate, wherein the distal end of the helical guiding track provided the signal generating element in the form of a rotation stop point. The guiding pins and the rotation stop points may form part of the signal element.

[0037] Each cut-out may be essentially triangular in shape when viewed in transversal direction with the helical guiding track forming one side of the triangle, preferably the hypothenuse.

[0038] The disk structure may consist of a single piece, or the disk structure may comprise an outer circumferential annular element and at least one inner circular element stacked in longitudinal direction.

[0039] The drive mechanism may comprise a plunger rod, and wherein the plunger rod comprises a proximal part and a separate distal part being connected to each other by the resilient member.

[0040] The delay mechanism may be formed by the proximal end wall of the proximal plunger part frictionally contacting a syringe of the medicament delivery device.

[0041] The distal part of the plunger rod may be of generally cylindrical configuration and comprises at least one circumferentially extending slot in its cylindrical wall. The plunger rod may comprise two circumferentially extending slots being offset from each other by 180°. The slot or slots may extend over an angular range of about 45 to 90°.

[0042] The proximal part of the plunger rod may comprise one or more radial protrusions protruding radially outwards and being located in a corresponding slot. The slot(s) may form part of the signal element and the corresponding protrusion(s) may form part of the feedback mechanism.

[0043] In the initial state of the feedback mechanism the protrusions may be located at one circumferential end of the corresponding slot, and the signal being caused by displacing the protrusions within its respective slot and hitting the opposing end of the slot in the feedback position.

[0044] The resilient member may be a torsion spring causing a rotation of the proximal part of the plunger rod relative to the distal part of the plunger rod. The plunger rod parts may comprise at its outer circumferential surface longitudinally extending grooves corresponding with protrusions or ribs in a distal part of the medicament delivery device.

[0045] The delay mechanism may comprise two or more elements.

[0046] The drive mechanism may comprise a plunger rod.

[0047] The delay mechanism may be of generally annular configuration and surrounds a proximal portion of the plunger rod.

[0048] The delay mechanism may comprise a first annular element, a second annular element, and the resilient member being a torsion spring connecting the first annular element and the second annular element with each other.

[0049] The first annular element may comprise at least one protrusion projecting radially inwards.

[0050] The first annular element may comprise two protrusions projecting radially inwards, preferably being offset by 180°.

[0051] The plunger rod may comprise at least one longitudinally extending groove for receiving the corresponding protrusion(s) of the first annular element.

[0052] The plunger rod may have a distal neck portion having an outer diameter corresponding the outer diameter at the bottom of the groove(s) such that the first annular element is adapted to be rotationally displaced when the protrusion(s) leave the groove(s) at their distal end.

[0053] The protrusion(s) of the first annular element may form the feedback mechanism which is released from its initial state when being located in the groove(s) and displaced by a force of the resilient member to the feedback state.

[0054] The protrusions in the feedback state hit onto the signal element of the medicament delivery device, preferably the wings of the tubular extension part. The second annular element and the first annular element may form a closed annular space being filled with a dampening liquid, preferably dampening oil.

[0055] The first annular element may have an internal rib provided in the closed annular space acting against the dampening liquid when the first annular element rotates relative to the second annular element.

[0056] The device may further comprise a tubular housing having a proximal end and an opposite distal end.

[0057] The activation mechanism may be a tubular activation member slidably and coaxially arranged in relation to the tubular housing.

[0058] The medicament delivery device may further comprise a container holder coaxially arranged within the tubular activation member and fixedly attached to the tubular housing.

[0059] The medicament container may be arranged within said container holder and the medicament container may comprise a pre-determined volume of medicament, a slidable stopper and a delivery member.

[0060] The drive mechanism may comprise a plunger rod and a first resilient member which is pretensioned arranged within the plunger rod and the plunger rod may be arranged to be in contact with the slidable stopper within the medicament container.

[0061] The holding mechanism may be a tubular extension part fixedly connected to the distal end of the tubular housing and a tubular operation member which is interactively connected both to the tubular extension part and to the tubular activation member, such that when said tubular activation member is pressed against a delivery site said tubular operation member is rotated in relation to said tubular extension part whereby said drive mechanism are released from the pre-tensioned state for exerting a pressure on the slidable stopper and thereby expelling the medicament. The longitudinally extending signal generating member of the feedback mechanism may be interactively connected to said tubular extension part and to said drive mechanism, such that when the plunger rod is completely released from the tubular extension part and the longitudinally extending signal generating member, the longitudinally extending signal generating member is released from said tubular extension part and displaced distally by a remaining force of the first resilient member for generating the signal indicating that the medicament has been completely expelled.

[0062] The tubular operation member may comprise a first co-acting mechanism interactively connected to a corresponding first co-acting mechanism of the tubular activation member and a second co-acting mechanism interactively connected to a corresponding second co-acting mechanism of the tubular extension part. The plunger rod may comprise a releasable engaging element interactively connected to the corresponding second co-acting element of the tubular extension part and a proximal end wall being in contact with the slidable stopper. The longitudinally extending signal generating member may be releasable arranged on an inner surface of the tubular extension part. The first resilient member may have a first end abutting the proximal end wall of the plunger rod and a second end abutting a transversal wall of the signal generating member.

[0063] The second co-acting element may comprise a groove on an inner surface of the tubular operation member and the corresponding second co-acting element of the tubular extension part may comprise a resilient tongue having a radial inward protrusion.

[0064] The releasable engaging element may comprise a groove on an outer surface of the plunger rod releasable engaged to the radial inward protrusion of the resilient tongue adapted to hold the drive mechanism in the pre-tensioned state.

[0065] The first co-acting mechanism may comprise a groove on an outer surface of the tubular operation member and the first corresponding co-acting element may comprise a radial inward extending protrusion on the distal end of the inner surface of the tubular activation member, such that the radial inward extending protrusion is adapted to be guided within the groove on an outer surface of the tubular operation member forcing the tubular operation member to rotate when the tubular activation member is distally moved, whereby the resilient tongue is flexed radial outward into a groove on the inner surface of the tubular operation member and the radial inward extended protrusion is disengaged from the groove on the outer surface of the plunger rod such that the drive mechanism are released from the pre-tensioned state.

[0066] The support members may be adapted to rest on an annular proximal end of the tubular extension part when the drive mechanism is in the pre-tensioned state.

[0067] BRIEF DESCRIPTION OF THE DRAWINGS

[0068] In the following detailed description of embodiments of the disclosure, reference will be made to the accompanying drawings, of which

[0069] Fig.l shows an exploded view of elements of a first aspect of a first embodiment of the present disclosure.

[0070] Fig. 2 shows the feedback mechanism and the delay element of the first aspect of a first embodiment of the present disclosure in the initial state.

[0071] Fig. 3 shows the feedback mechanism and the delay element of the first aspect of a first embodiment of the present disclosure in the feedback state.

[0072] Fig. 4 shows a perspective view of the feedback mechanism and the delay element of the first aspect of a first embodiment of the present disclosure in the initial state.

[0073] Fig. 5 shows an enlarged perspective view of the feedback mechanism and the delay element of the first aspect of a first embodiment of the present disclosure in the initial state.

[0074] Fig. 6 shows an enlarged perspective view of the delay element of the first aspect of a first embodiment of the present disclosure.

[0075] Fig. 7 shows an exploded view of elements of a second aspect of the first embodiment of the present disclosure.

[0076] Fig. 8 shows a perspective view of the feedback mechanism and the delay mechanism of the second aspect of the first embodiment of the disclosure in the initial state. Fig. 9 shows a perspective enlarged view of part of the feedback mechanism and the delay mechanism of the second aspect of the first embodiment of the disclosure in the initial state.

[0077] Fig. 10 shows a perspective view from above.

[0078] Fig. 11 shows a perspective view form below.

[0079] Fig. 12 shows an exploded view of elements of a third aspect of the first embodiment of the present disclosure.

[0080] Fig. 13 shows a perspective view of the feedback mechanism and the delay mechanism of the third aspect of the first embodiment of the disclosure in the initial state.

[0081] Fig. 14 shows an exploded view of the feedback mechanism and the delay mechanism of the third aspect of the first embodiment of the disclosure.

[0082] Fig. 15 shows an exploded perspective view of the delay mechanism of the third aspect of the first embodiment of the disclosure.

[0083] Fig. 16 shows a perspective bottom view of the disk structure of the third aspect of the first embodiment of the disclosure.

[0084] Fig. 17 shows a perspective cross-sectional view of the disk structure of the third aspect of the first embodiment of the disclosure.

[0085] Fig. 18 shows an exploded view of elements of a first aspect of a second embodiment of the present disclosure.

[0086] Fig. 19 shows the feedback mechanism and the delay mechanism of the first aspect of the second embodiment of the disclosure in the initial state.

[0087] Fig. 20 shows the elements of Fig. 19 in slightly exploded state.

[0088] Fig. 21 shows the elements of Fig. 19 in further exploded state.

[0089] Fig. 22 shows a different perspective view of Fig. 21.

[0090] Fig. 23 shows further details of the first aspect of the second embodiment of the disclosure.

[0091] Fig. 24 shows an exploded view of elements of a second aspect of the second embodiment of the present disclosure.

[0092] Fig. 25 shows a perspective cross-sectional view of the medicament delivery device of the second aspect of the second embodiment of the disclosure.

[0093] Fig. 26 shows a perspective view of the delay mechanism of the second aspect of the second embodiment of the disclosure. Fig. 27 shows an exploded view from above of the delay mechanism of the second aspect of the second embodiment of the disclosure.

[0094] Fig. 28 shows an exploded view from below of the delay mechanism of the second aspect of the second embodiment of the disclosure.

[0095] Fig. 29 shows the delay mechanism and the plunger rod of the second aspect of the second embodiment of the disclosure.

[0096] Fig. 30A - Fig.30C shows perspective views of different components of the medicament delivery device according to an aspect of the disclosure.

[0097] Figs. 31A - Fig. 31D shows perspective views of different states of the medicament delivery device according to an aspect of the disclosure.

[0098] Fig. 32 illustrates a plunger rod and audio-tacit-visual signal generating member assembly according to an aspect of the disclosure.

[0099] Fig. 33A - Fig. 33C illustrates the components of the audio-tacit-visual signal generating member, and plunger rod assembly according to an aspect of the disclosure.

[0100] Fig. 34 shows a perspective view of a driving mechanism comprised in the present disclosure.

[0101] Fig. 35A - Fig. 35C shows a side view of the tubular housing and the audio-tacit-visual signal generating member in operation.

[0102] DETAILED DESCRIPTION

[0103] In the present disclosure, when the term "distal direction" is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term "distal part / end" is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which under use of the medicament delivery device is / are located furthest away from the dose delivery site. Correspondingly, when the term "proximal direction" is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device. When the term "proximal part / end" is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which under use of the medicament delivery device is / are located closest to the dose delivery site. 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.

[0104] Similarly, the terms "transverse", "transversal" and "transversally" refer to a direction generally across or perpendicular to the longitudinal direction.

[0105] Further, the terms "circumference", "circumferential", or "circumferentially" refer to a circumference or a circumferential direction relative to an axis, typically a central axis extending in the direction of the longest extension of the device and / or component. Similarly, "radial" or "radially" refer to a direction extending radially relative to the axis, and "rotation", "rotational" and "rotationally" refer to rotation relative to the axis.

[0106] The term "delay element" refers to a single element or component of the medicament delivery device that provides a delay function. "Delay function" refers to a configuration of the delay element to influence the displacement of the feedback mechanism before reaching its feedback state.

[0107] The term delay mechanism refers to an assembly of two or more elements or components that together provide a delay function. "Delay function" refers to a configuration of the delay mechanism to influence the displacement of the feedback mechanism before reaching its feedback state.

[0108] The term "before reaching its feedback state" is intended to distinguish a delay during movement of the feedback mechanism from an influence on the feedback mechanism that stops movement or displacement of the feedback mechanism.

[0109] The term "feedback state" refers to a state where movement of the feedback mechanism has ended or stopped.

[0110] The general structure of a medicament delivery device according to a first embodiment according to an aspect of the disclosure will be described with reference to Figs. 30A to 35C. Fig. 30A illustrates, in perspective, a tubular housing 20 of an exemplary medicament delivery device according to an aspect of the disclosure. The tubular housing 20 has a proximal end 11 and an opposite distal end 12. The tubular housing 20 further comprises a protrusion (not illustrated) on its inner wall. The protrusion is adapted for receiving a structure 36 of an activation mechanism, such as a tubular activation member 30 (see Fig. 30B). The structure 36 of the tubular activation member 30 is used for locking the tubular activation member 30, inside the tubular housing 20, when the tubular activation member 30 is in its most proximal position, after an injection has been made. The tubular housing 20 further accommodates a medicament container 80 (see Fig. 30C). The medicament injection device 1 further comprises a tubular extension part 22, being coaxially arranged and fixedly attached to the distal end 12 of the tubular housing 20, preferably by a flexible tongue 15 engaging with a corresponding ledge 23 (see Fig. 34) of the tubular extension part 22.

[0111] Fig. 30B illustrates the tubular activation member 30 of the medicament injection device 1. The tubular activation member 30 have a contact member 31 and a first co-acting element 35, which in an exemplary embodiment is a protrusion. In an exemplary embodiment of the disclosure there are two first co-acting elements 35 which are used for activating the medicament delivery device 1 as will be described in detail below.

[0112] A guiding element 34 is adapted to cooperate with a corresponding guiding rod (not shown) at the interior of the tubular housing 20, with the purpose to prevent the tubular activation member 30 rotating in relation to the tubular housing 20 and to allow the tubular activation member 30 to move in the axial direction in relation to the tubular housing 20. In a preferred embodiment of the disclosure there are two guiding elements 34 for engaging the guiding rod (not shown). According to an embodiment of the disclosure, a second resilient member 24 (see Fig. 30C), such as a biasing element, which in an exemplary embodiment is a compression spring, is arranged at the proximal end of the tubular activation member 30 for moving it in a proximal direction.

[0113] Fig. 30C illustrates the interior of the medicament delivery device 1 further comprising the second resilient member 24 arranged in relation to the tubular activation member 30 for moving it in a proximal direction from a non-activated position to an activated position. The medicament container 80 is arranged within the container holder 50 and has a predetermined volume of medicament, a slidable stopper and a delivery member. In an exemplary embodiment of the disclosure the medicament container 80 is a syringe provided with a needle 61 as the delivery member, however the disclosure should not be limited to this, other embodiments could include a medicament cartridge having a membrane, or the like where a delivery member can be adapted

[0114] In the medicament delivery device 1 is also included a tubular operation member 100 (see Fig. 34) comprising a first corresponding co-acting mechanism 101, 102, 103 interactively connected to the first co-acting element 35 of the tubular activation member 30 (see Fig. 30B), and a drive mechanism comprising a plunger rod 90 and a first resilient member 91 arranged within the plunger rod 90. The plunger rod 90 comprises a releasable engaging element 94 as a cut- out / recess (see Fig. 33C) interactively connected to a corresponding second co-acting element 121 (see Fig. 34) of the tubular extension part 22. The first resilient member 91 is in an exemplary embodiment of the disclosure a compression spring. The proximal end 92 of the plunger rod 90 is in contact with the slidable stopper 83. The tubular operation member 100 (see Fig. 34) is rotatably and coaxially arranged on a proximal part of the tubular extension part 22 between the container holder 50 and an annular ledge of the tubular extension part 22 at the distal end of the tubular housing 20.

[0115] Together, the tubular extension part 22 and the tubular operation member 100 form a holding mechanism, for holding the drive mechanism in a pre-tensioned state prior to penetration of the patient's skin. Upon actuation of the activation mechanism, a feedback mechanism interacts with the holding mechanism and the drive mechanism to signal that a medicament has been completely expelled.

[0116] Fig. 31A - Fig. 31D show simplified perspective views of the medicament delivery device 1 according to an aspect of the disclosure, where Fig. 31A illustrates an initial, non-activated, state of the medicament delivery device 1 having a cap 10. Fig. 31B shows an activated state of the medicament delivery device 1, where the cap 10 is removed. Fig. 31C shows the penetration and injection state of the medicament delivery device 1 and finally Fig. 31D shows the medicament delivery device 1 in a final locked state. With references to Fig. 31A, the medicament delivery device 1 comprises the tubular housing 20, having a proximal end 11 and an opposite distal end 12. The medicament injection device 1 further comprises the tubular activation member 30 which is slidably and coaxially arranged inside the tubular housing 20. The cap 10 comprises a distal end surface, abutting with the proximal end surface of the tubular activation member 30 such that when the cap 10 is manually operated and detached, it allows the tubular activation member 30 to resist the force from the second resilient member 24 (Fig. 30C) from its nonactivated position to its activated position.

[0117] Fig. 31B shows the medicament delivery device 1 when it is ready for use. When a user is about to perform a medicament delivery, e.g. an injection he / she presses the proximal end, i.e. the annular contact member 31, against the delivery site e.g. an injection site. The tubular activation member 30 is then moved in the distal direction, in relation to the tubular housing 20, and during the relative movement when having a medicament delivery device as an injection device, then a needle 61 manually penetrates the skin. When the tubular activation member 30 is about to reach its most distal position in relation to the tubular housing 20 the medicament delivery is performed. A medicament delivery is automatically performed when the tubular activation member 30, being in an activated position, is moved in a distal direction in relation to the tubular housing 20, to a delivery state position, where the annular contact member 31 is close to the proximal end 11 of the tubular housing 20.

[0118] Fig. 31C illustrates when the delivery is made, then the user removes the medicament delivery device 1 from the delivery site, thereby allowing the tubular activation member 30 to move in the proximal direction in relation to the tubular housing 20, by the force exerted by the second resilient member 24 and finally reaches a final state; the locked state.

[0119] Fig. 31D illustrates the medicament delivery device 1 in its final and locked state, wherein the tubular activation member 30 once more is in its most proximal position, as illustrated. In this state the proximal part of the tubular activation member 30 fully protects the delivery member 61 and the tubular activation member 30 is also locked, by the first co-acting element 35 in the distal end of the tubular activation member 30, engaging with a flexible tongue 104 (see Fig. 34) of member 100 in the final position in order to prevent unintentional availability of the delivery member 61.

[0120] Fig. 32 illustrates various aspects of the feedback mechanism, such as a signal generating member 110 and its implementations (see also Fig. 33A - Fig. 33C) according to an aspect of the disclosure. Fig. 32 illustrates an embodiment of the disclosure comprising the signal generating member 110 adapted to generate an audible and / or tactile and / or visible injection confirmation signal upon a performed medicament delivery. The medicament delivery confirmation signal is generated when the drive mechanism changes from a pre-tensioned state in which the first resilient member 91 is pretensioned within the plunger rod 90 and the plunger rod 90 is engaged to the tubular extension part 100, to a released state in which the plunger rod 90 is completely released from the tubular extension part 22 and is no longer in contact with the signal generating member 110.

[0121] Fig. 33A to Fig. 33C illustrate a side view and perspective views, respectively, of the signal generating member 110 according to an embodiment of the disclosure. In the illustrated embodiment, the signal generating member 110 is an elongated U-shaped bracket, provided with at least two elongated arms 111, directed in the proximal direction, and a lower part, a distal transversal end wall, 112 directed in the distal direction of the medicament delivery device 1, when arranged within the tubular extension part 22. The signal generating member 110 may be made from metal, plastic, or any combination of these materials.

[0122] Fig. 33C is a perspective, and partly exploded, view of the signal generating member 110 in relation to the plunger rod 90 and the first resilient member 91. The upper parts of the arms 111 are provided with angled support members 113 extending in essentially radial outward directions with regard to a longitudinal axis of the U-shaped bracket 110. The U-shaped bracket 110 is adapted to enclose at least a part of the plunger rod 90 and the first resilient member 91, and the support members 113 are adapted to rest on an annular surface on the proximal end of the tubular extension part 22 when the drive mechanism are in a pre-tensioned state, i.e. the opening 94 of the plunger rod 90 is engaged with a flexible tongue 121 of the tubular extension part 22.

[0123] When the drive mechanism is in the pre-tensioned state, the distal end of the U-shaped bracket 110 is arranged at a predetermined distance "D" (see Fig. 35A) from an inner distal surface of said tubular extension part 22 and when the drive mechanism is in the released state, the distal end of the U-bracket 110 is in contact with the inner distal surface of said tubular extension part 22. The audible and / or tactile and / or visible confirmation signal is generated when the distal end of the U-shaped bracket 110 hits and contacts the inner distal surface of the tubular extension part 22 by a remaining force exerted by said first resilient member 91. Thus, during the delivery procedure, when the distal end of the plunger rod 90 passes by the supporting members 113, the arms 111 with the support members 113 are released and allowed to move in a radial inward direction, e.g. due to a pre-tension of the arms 111, enabling the U-shaped bracket 110 to move in the distal direction and the signal, typically an audible sound and / or a visual signal and / or a tactile signal, is generated almost immediately as the U-shaped bracket 110 hits the distal end of the tubular extension part 22.

[0124] In the pre-injection state, the U-shaped bracket 110 is arranged such that the arms 111 are positioned in a space along the plunger rod 90 between the plunger rod 90 and the tubular extension part 22 enclosing the plunger rod 90. The support members 113 have an extension in the radial outward direction that exceeds the radial extension of the space between the plunger rod 90 and the inner wall of the tubular extension part 22 to ensure that the signal generating member 110 is not released prior the plunger rod 90 moving away from between the arms 111.

[0125] The outer distal surface of the distal transversal end wall 112 may further have a protrusion (not illustrated), adapted to be guided through an opening, typically a through hole (also not illustrated) of the distal end wall of the tubular extension part 22 and extends distally a predetermined distance overthe outer surface of said tubular extension part 22. In an exemplary embodiment of the disclosure, the distally extending protrusion has a bright and / or different colour than the rest of the device for generating a visual signal. Thus, said protrusion will enable both a tactile and a visual signal when the U-shaped bracket 110 hits the distal end of the tubular extension part 22.

[0126] Fig. 34 illustrates the drive mechanism and the holding mechanism. The holding mechanism comprises the tubular operation member 100 and the tubular extension part 22. The above- mentioned first co-acting elements 35 are at least one inwardly extending protrusion (see Fig. 30B) on the distal end of the inner surface of the tubular activation member 30 and the first corresponding co-acting mechanism is at least one groove 101, 102, 103 on an outer surface of the tubular operation member 100, such that said radial inwards extending protrusion 35 is adapted to be guided within the at least one groove 101, 102, 103. This arrangement forces the tubular operation member 100 to rotate when the tubular activation member 30 is moved axially relative to the tubular operation member 100. A second co-acting mechanism for releasing the plunger rod 90 and the first resilient member 91 from the pre-tensioned state comprises at least one groove 105 of the tubular operation member 100 that engages with a flexible tongue 121 on the tubular extension part 22, which locks the plunger rod 90 by a radially inwards extending protrusion of the flexible tongue 121 and engaging with the opening 94 of the plunger rod 90. When the tubular operation member 100 is rotated, at least one groove 105 of the tubular operation member 100 allows the radial inwards extending protrusion of the flexible tongue 121 to radial extension, thereby releasing the engagement between the protrusion on the flexible tongue 121 of the tubular extension part 22 and the opening 94 of the plunger rod 90, thus releasing the plunger rod 90, exerted by the force of the first resilient member 91, in a proximal direction.

[0127] The medicament delivery device 1 further comprises a locking mechanism between the tubular extension part 22 and the tubular operation member 100. The locking mechanism is preferably at least one ledge 106 on an annular surface of the tubular operation member 100 and a corresponding second co-acting mechanism is at least one protrusion 95 on an outer surface of the tubular extension part 22. The at least one protrusion 95 abuts the at least one ledge 106 to hold the tubular operation member 100 axially fixed with respect to the tubular extension part 22. The ledge 106 also incorporates a circumferentially facing surface arranged to abut the protrusion during assembly to assist correct rotational orientation of the tubular operation member 100. The ledge may prevent rotation of the tubular operation member in one circumferential location, e.g. counter-clockwise when viewed from the proximal end. In the illustrated embodiment two protrusions 95 and two circumferentially facing surfaces are provided, spaced apart around the ledge 106 by 180 degrees, such that the tubular operation member 100 is free to rotation only 180 degrees.

[0128] The medicament delivery device 1 further comprises a locking mechanism interactively connected to the tubular activation member 30. The locking mechanism is the flexible tongue 104 on the at least one groove 103 of the tubular operation member 100 which locks the radially inwards extending protrusion 35 when said protrusion 35 is moved axially over the tongue 104.

[0129] Fig. 35A to Fig. 35C illustrate simplified side views of the distal part of the medicament delivery device 1 according to an exemplary embodiment of the present disclosure. The drawings show the tubular extension part 22 that partly encloses the drive mechanism, e.g. the plunger rod 90 and the first resilient member 91, and the signal generating member 110.

[0130] In Fig. 35A the medicament delivery device 1 is ready for use, wherein the signal generating member 110 is at a predetermined distance "D" from the inner distal surface of the tubular extension part 22.

[0131] In Fig. 35B the delivery procedure is initiated and the plunger rod 90 moves in the proximal direction forcing the slidable stopper 83 (not shown) to expel the medicament via the delivery member 61. When the distal end of the plunger rod 90 has passed the proximal part of the signal generating member 110 the arms 111 of the signal generating member 110 flex inwards allowing the signal generating member 110 to move in the distal direction, resulting in a sound, and / or a tactile signal and / or a visual signal being generated when the signal generating member 110 contacts the inner distal surface of the tubular extension part 22. This is illustrated by Fig. 35C.

[0132] Operation of the medicament delivery device 1 will now be described in more detail. In the pretensioned state, the at least one protrusion 95 is abutting the ledge 106. When the cap 10 is removed the medicament delivery device 1 is ready for use. The tubular activation member 30 is initially in its most proximal position. It is then forced in the distal direction by the user pressing it against an injection site. This causes the protrusion 35 to move along the groove of the tubular operation member 100 from position 101 to position 102. This causes rotation of the tubular operation member 100, in an anticlockwise direction as seen from the distal end. During the rotation of the tubular operation member 100, the protrusion 95 is moved along the ledge 106, and groove 105 is rotated to align with the flexible tongue 121. This allows the flexible tongue to be displaced radially outwards to release the pre-tensioned plunger rod 90 to move in the proximal direction, by the force exerted by the first resilient member 91. The plunger rod 90 exerts force on the slidable stopper 83 in the medicament container 80 to cause the medicament to be delivered.

[0133] When the medicament has been delivered and the medicament delivery device 1 is removed from the injection site, the tubular activation member 30 is forced in the proximal direction, by means of the second resilient member 34. The locking mechanism, e.g. a flexible tongue 104 (see Fig. 34), associated with the at least one groove of the tubular operation member 100 then locks the radially inwards extending protrusion 35 as the radially inwards extending protrusion 35 is axially moved over the tongue 104 to prevent the tubular operation member 100 moving axially in the distal direction again.

[0134] The generation of the signal functions as follows. When the drive mechanism is in the pretensioned state, the distal end of the U-bracket 110 is arranged at a predetermined distance "D" (see Fig. 35A) from an inner distal surface of said tubular extension part 22 and when the drive mechanism is in the released state, the distal end of the U-bracket 110 is in contact with the inner distal surface of said tubular extension part 22. The audible and / or tactile and / or visible confirmation signal is generated when the distal end of the U-bracket 110 hits and contacts the inner distal surface of the tubular extension part 22 by a remaining force exerted by said first resilient member 91. Thus, during the delivery procedure, when the distal end of the plunger rod 90 passes by the supporting members 113, the arms 111 with the support members 113 are released and allowed to move in a radial inward direction, due to a pre-tension of the arms 111, enabling the U-bracket 110 to move in the distal direction and the signal, typically an audible sound and / or a visual signal and / or a tactile signal is generated, when the U-bracket 110 hits the distal end of the tubular extension part 22. In the pre-injection state, the U-bracket 110 is arranged such that the arms 111 are positioned in a space along the plunger rod 90 between the plunger rod 90 and the tubular extension part 22 enclosing the plunger rod 90. The support members 113 must have an extension in the radial outward direction that exceeds the radial extension of the space between the plunger rod 90 and the inner wall of the tubular extension part 22 to secure that the signal generating member 110 is not released before the plunger rod 90 has moved away from between the arms 111.

[0135] A medicament delivery device according to a first aspect of the first embodiment is illustrated in Fig. 1. Fig. 1 shows the tubular activator member 30, the second resilient member 24, the medicament container 80 with the slidable stopper 83. Furthermore, Fig. 1 shows the plunger rod 90 with the first resilient member 91 and the guide rod 96. Fig. 1 also shows the tubular extension part 22, the tubular operation member 100 and the signal generating member 110. As part of this aspect of the first embodiment, Fig. 1 shows a delay mechanism comprising a delay element 150. The general concept of the delay element 150 in cooperation with the signal generating member 110 is shown in Fig.2 and Fig. 3. In an initial position, the signal generating member 110 is axially offset from the delay element 150 (Fig. 2). Thus, the delay element 150 is located between the signal generating member 110 and the tubular extension part 22. Fig. 3 shows the signal generating member 110 having reached its final position. In Fig. 2, it can be seen that the signal generating member 110 has one or more recesses 115 that will be described in more detail below. The delay element 150 has one or more protrusions 156 that will also be described in more detail below. In the preferred embodiment illustrated, see for example Fig. 4, the delay element 150 has four protrusions 156, and the signal generating member has four corresponding recesses 115.

[0136] The delay element 150 has a first end 151 facing the feedback mechanism, e.g. the signal generating member 110 when in its initial position (see Fig. 5). The delay element 150 has a second end 152 that is located at an opposite end along the longitudinal axis of the medicament delivery device 1. The second end 152 contacts a distal element of the medicament delivery device, for example the tubular extension part 22.

[0137] The first end 151 of the delay element 150 is spaced from the feedback mechanism 110 along the longitudinal axis of the medicament delivery device 1, as shown in Fig. 5. The delay element

[0138] 150 has a U-shape when viewed in transversal direction of the medicament delivery device. This U-shape is provided by a cylindrical wall 153 that has two opposing cut outs 154. The cut outs 154 correspond to the two longitudinally extending flexible arms 111 of the feedback mechanism 110. At least one of the cut outs 154 has a protrusion 156. The protrusion 156 extends in circumferential direction. The protrusion 156 is located at at least one of the longitudinally extending cut out walls 155 of the cut out 154. In the embodiment shown in Fig. 5, each cut out 154 has two opposite longitudinally extending walls 155, and at each of these walls a protrusion 156 is formed.

[0139] In the preferred embodiment, see Fig. 6, the protrusion 156 has the form of a first ramp 157 ramping up towards the distal end. In other words, the circumferential gap between two opposing longitudinal walls 155 of the cut out 154 is getting smaller from the first (proximal) end

[0140] 151 of the delay element 150 towards a second (distal) end. The first ramp 157 is provided adjacent the first end 151 of the delay element 150. It is preferred that the protrusion 156 further comprises a second ramp 158 ramping down from the first ramp 157 towards the distal end. In other words, towards the distal end of the cut out 154, the width of the gap between two opposing longitudinal walls 155 of the cut out 154 is getting wider. The transition between the fist ramp 155 and the second ramp 156 is preferably stepless but can include a step from a narrower width of the gap in circumferential direction to a greater width.

[0141] The feedback mechanism, e.g. the signal generating member 110, comprises at least one recess 115 at the edge of the two longitudinally extending flexible arms 111. This can be seen in Fig. 5, for example. The at least one recess 115 is formed and arranged such that each recess 115 accommodates one of the at least one protrusion 156 of the delay element when the feedback mechanism has reached its feedback position.

[0142] When the U-shaped signal generating member 110 is pushed towards the distal end by the first resilient member 91, e.g. a plunger rod spring, the distal part thereof enters the delay element 150. The protrusions 156 give resistance to the signal generating member 110 to slow down it. The displacement of the feedback mechanism before reaching its feedback state is influenced, i.e., delayed. The U-shaped signal generating member 110 keeps slowing down until its recesses 115 pass through the protrusions 156 of delay element 150. The, when the recesses 115 have passed the protrusions, the U-shaped signal generating member 110 is released and accelerates until it hits the bottom of the delay element 150 or of the tubular extension part 22, and this creates a delayed feedback signal.

[0143] Preferably, the delay element 150 is made from a deformable material, such as rubber, TPE (Thermoplastic Elastomer), or Silicon rubber.

[0144] A second aspect of the first embodiment is shown in Figs. 7 to 11. This aspect is similar to the previous aspect. However, it has a delay mechanism 170. Fig. 7 also visualizes with reference numeral 180 an inner rear wall of the medicament delivery device 1. The inner rear wall of the medicament delivery device may form the signal element.

[0145] In this aspect the delay mechanism 170 comprises one or more magnets 171. These magnets 171 provide a repulsive force, and this causes a delay of the movement of the feedback mechanism. In other words, the delay mechanism 170 is configured to influence the displacement of the feedback mechanism before reaching its feedback state.

[0146] The inner rear wall 180 of the medicament delivery device 1 consists of a magnetic material or (also) comprises corresponding magnets 181. These magnets 181 correspond in number and location to the magnets 171 of the delay mechanism 170, and may be considered forming part of the delay mechanism 170.

[0147] The drive mechanism comprises a plunger rod 90, a first resilient member 91 which is pretensioned arranged within the plunger rod 90, and a guide rod 96 arranged within the first resilient member 91. In Fig. 8, the plunger rod 90 can be seen between the two legs 111 of the signal generating member 110. Furthermore, the distal end of the guide rod 96 is shown in Fig. 8. A proximally facing surface of the transversal wall 112 of the feedback mechanism is in contact with a distally facing wall of the guide rod 96. The guide rod 96 is T-shaped at its distal end in longitudinal cross section.

[0148] The delay mechanism 170 has a first, proximal end 172, and along the longitudinal axis of the medicament delivery device an opposite second, distal end 173. The distal end 172 is axially spaced from an inner rear wall 180 of the medicament delivery device (see Fig. 8 and Fig. 9).

[0149] The delay mechanism 170 is connected to the guide rod 96 at its T-shaped end. In the shown embodiment, the delay mechanism 170 has at least two longitudinally extending circumferential leg portions 174 holding the guide rod 96 in releasable manner. It can also have three such legs, offset from each other by 120°. Each leg 174 has a protrusion 175 being directed radially inwards. The protrusion is formed with a groove 176 that accommodates and holds part of the guide rod 96 (see Fig. 8).

[0150] Each of the leg portions 174 comprises the magnet 171, and the magnet 171 is arranged such that the magnetic repulsive force between magnets 171 and magnets 181 (or the magnetic inner rear wall 180) acts in the longitudinal direction. This allows the leg portions 174 to deflect radially outwards after being displaced axially for a first predetermined distance to release the guide rod 96. The axial displacement is caused by the first resilient member 91, i.e., the plunger spring, and because this causes the distance between the opposing magnets 171, 181 of the delay mechanism 170 and the wall 180 to be reduced, the deflection is caused by the repulsive force of the magnets 171, 181.

[0151] When the plunger rod 90 leaves the tubular extension part 22 in proximal direction, the plunger spring pushes distally the U-shaped signal generating member 110, the guide rod 96, and the delay mechanism 170. Magnetic repulsion between the magnets 171 and 181 being moved towards each other gives resistance to the guide rod 96 and thus slows it down. Displacement of the delay mechanism 170 with its leg portions 174 distally will result in the leg portions 174 protruding from the distal end of the tubular extension part 22. When leg portions 174 of the delay mechanism 170 leave the hollow tube of the tubular extension part 22, the delay mechanism 170 will be opened due to the magnetic repulsion. The leg portions 174 are free to deflect radially outwards- caused by the repulsive magnetic force - and this increases the diameter between the two opposing grooves 176. The guide rod 96 is no longer held by the opposing grooves 176. The guide rod 96 and thus the U-shaped signal generating member 110 will be released and hit the inner rear wall 180 to create the delayed feedback signal.

[0152] A third aspect of the first embodiment is shown in Figs. 12 to 17. This aspect is similar to the previous aspect with regard the basic mechanism of the medicament delivery device. However, it has a delay mechanism. In fact, in this aspect a delay mechanism consisting of two or more elements is provided. This delay mechanism converts an axial movement of the feedback mechanism to a rotational movement of the delay mechanism.

[0153] The delay mechanism of this aspect comprises a disk structure 190 located at the distally facing side of the feedback mechanism, i.e., of the signal generating member 110 (see, e.g., Fig. 14). The disk structure 190 comprises two radial guide pins 191 at its circumferential surface, preferably being spaced 180° from each other. It is also envisaged that there are, for example, three or four such guide pins, or even only one guide pin.

[0154] The disk structure 190 may consist of a single piece, i.e., a disk with the unitary formed guide pins 191. In an alternative embodiment, the disk structure 191 consists of more than one element. For example, it may comprise an outer circumferential annular element 192 and at least one inner circular element 193. In Fig. 17, the annular element 192 is shown, enclosing an inner circular element 193. At the right-hand side also a guide pin 191 can be seen. An inner circular ledge of the annular element is received in an annular groove of the inner circular element 192. If more than one inner circular elements are provided, they may be stacked in longitudinal direction. At the bottom of the disk structure 190, a spring groove 199 is present. This receives an end of a third resilient element 194, which is in this example a spring, being another component of the delay mechanism of this embodiment.

[0155] The third resilient element 194 is arranged between the distally facing side of the disk structure 190 and the rear inner wall of the medicament delivery device.

[0156] The delay mechanism further comprises a sleeve element 195 abutting against the inner rear wall of the medicament delivery device. The third resilient element 194 is at least partially accommodated in the sleeve element 195.

[0157] In the embodiment shown, for example in Fig. 15, the sleeve element 195 comprises two cutouts 196 at its proximal side, preferably 180° offset from each other. The number and location of cut-outs corresponds to the number of guide pins at the disk structure 190. Each cut out 196 comprises a helical guiding track 197 for guiding a corresponding guide pin 191 of the disk structure 190 from a proximal side of the cut-out 196 towards and to a distal end of the helical guiding track 197. This urges the disk structure 190 to rotate, wherein the distal end of the helical guiding track 197 provides the signal element in the form of a rotation stop point 198.

[0158] Thus, the guiding pins 191 form part of the delay mechanism, and the rotation stop points 198 in this embodiment provide the signal to the user.

[0159] Each cut-out 196 may be essentially triangular in shape when viewed in transversal direction. The helical guiding track 197 forms one side of the triangle, preferably the hypothenuse. As shown in Fig. 16, for example, the guide pin 191 has a correspondingly slanted shape. The angle of the helical guide track with regard to a transversal plane is the same or essentially the same as the angle of the wall of the protrusion 191 contacting the helical guide track 197.

[0160] In this aspect of the first embodiment, when the plunger rod leaves the tubular extension part 22, the U-shaped signal generating member 110 is released and moves distally. This causes compression on the disk structure 190 and the spring 194. The spring 194 gives resistance to the signal generating member 110 and the disk structure 190 to slow them down. The guiding pins 1

[0161] 191 slowly spin down through the helical guide track 197 of the sleeve element 195. At the end of the helical guide track 197, the guiding pins 191 hit rotation stop point 198 and create the delayed feedback signal.

[0162] Figs. 18 to 23 show a first aspect of a second embodiment of the present disclosure. In contrast to the first embodiment with its various aspects, the second embodiment does not require a signal generating member in the form of a U-shaped bracket.

[0163] In this aspect, the drive mechanism comprises a plunger rod 290, and this plunger rod 290 has a proximal part and a distal part. The proximal part 291 and the distal part 292 are coupled to each other by a resilient member 293. In this aspect of the second embodiment, the delay mechanism is formed by the proximal end of the proximal part 291, which interacts with the medicament container, such as syringe 80 of the medicament delivery device 1.

[0164] As can be seen in, for example, Figs 19, 20 and 21, the distal part 292 of the plunger rod 290 is of generally cylindrical configuration and has at least one circumferentially extending slot 294 in its cylindrical wall. In a preferred embodiment, the plunger rod 290 comprises two circumferentially extending slots 294 being offset from each other by 180°. The one slot or the more slots 294 extend over an angular range of about 45 to 90°.

[0165] The proximal part 291 of the plunger rod 290 comprises one or more radial protrusions 295. For example, Fig. 21 shows two opposing protrusions 295. Each of these protrusions protrudes radially outwards and is located in a corresponding slot 294. The slot(s) 294 form part of the signal element and the corresponding protrusion(s) 295 form part of the feedback mechanism. In the initial state of the feedback mechanism the protrusions 295 are located at one circumferential end of the corresponding slot 294. The signal to the user is caused by displacing the protrusions 295 within its respective slot 294 so that they hit the opposing end of the slot 294 in the feedback position. The displacement is caused by the resilient member 293 which is in the embodiment shown a torsion spring. This torsion spring causes a rotation of the proximal part 291 of the plunger rod 290 relative to the distal part 292 of the plunger rod 290. As shown in Fig. 23, both plunger rod parts 291, 292 comprise at its outer circumferential surface longitudinally extending grooves 296 corresponding to protrusions or ribs 297 in a distal part of the medicament delivery device, for example in the tubular extension part 22. This aspect of the second embodiment separates the plunger rod 290 into two pieces, and the two pieces are connected by the torsion spring. Due to the grooves or chutes on the two plunger rod parts that match with the protrusions or ribs, during the injection, the plunger rod parts are initially fixed against rotation by the tubular extension part 22. As soon as the proximal part of the plunger rod 291 leaves the tubular extension part 22, the torsion spring 294 starts to release its stored energy and this causes rotation of the proximal plunger rod part 291. The distal plunger rod part is still held against rotation by the engagement of its grooves 296 with the ribs 297. Once the proximal plunger rod part 291 rotates, the friction force between the medicament container 80, e.g. syringe, and the plunger rod 290 provides rotation resistance to slow down the rotation velocity of plunger rod proximal part 291. For example, in the case of the illustrated syringe the plunger 83 rotates with the proximal plunger rod part 291 and friction between the plunger 83 and the inner surface of the syringe slows the rotation. In another example, the proximal plunger rod part 291 rotates relative to the plunger 83, but since the plunger rod 291 is still being urged against the plunger 83 by the first resilient member 91 friction between the proximal plunger rod part 291 and the plunger 83 may be high and act to slow the rotation. This contrasts with the situation in which a feedback member in the form of a U-shaped bracket is free to move substantially unhindered. At the end, the protrusions 295 of the proximal part 291 hit the rotation stop end of the distal part 292 and create the delayed feedback signal.

[0166] Figs. 24 to 29 show a second aspect of a second embodiment of the present disclosure. In contrast to the first embodiment with its various aspects, the second embodiment does not require a signal generating member in the form of a U-shaped bracket.

[0167] The drive mechanism comprises a plunger rod 90 which is shown in Fig. 29, for example. The delay mechanism 300 is of generally annular configuration and surrounds a proximal portion of the plunger rod 96. The perspective cross-sectional view of Fig. 25 illustrates the location of the delay mechanism 300 in this embodiment.

[0168] The delay mechanism 300 comprises a first annular element 310, a second annular element 320, and a resilient member 330. The resilient member 330 can be a torsion spring that connects the first annular element 310 and the second annular element 320 with each other.

[0169] As shown in Figs. 27 and 28, the first annular element 310 can consist of two semi-circular parts that together form an annular shape, and also the second annular element can consist of two semi-circular parts that together form an annular shape. The torsion spring 330 is located in the space formed by the two annular elements.

[0170] As can be seen in these drawings, the first annular element 310 comprises at least one protrusion 315 that projects radially inwards. Preferably, as shown, for example, in Fig. 29, the first annular element 310 comprises two protrusions 315 projecting radially inwards, preferably being offset by 180°. On the other hand, the plunger rod 90 comprises at least one longitudinally extending groove 340 for receiving the corresponding protrusions 315 of the first annular element 310. Fig. 29 shows two such opposing grooves 340.

[0171] The plunger rod 90 has a distal neck portion 341 that can also be seen in Fig. 29. The distal neck portion 341 has an outer diameter that corresponds to the outer diameter at the bottom of the grooves 340. This allows for the first annular element 310 to be rotationally displaced when the protrusions 315 leave the grooves 340 at their distal end.

[0172] In this aspect of the second embodiment, the protrusions 315 of the first annular element 310 form the feedback mechanism. In the initial state, this feedback mechanism is located in the grooves 340. When it is released from this initial state, i.e., when the protrusions 315 reach the distal neck portion 341, the first annular element 310 is displaced by the force of the resilient member 330 towards the feedback state. The first annular element 310 rotates. Prior to the rotation, the plunger rod 90 moves in proximal direction and the protrusions 315 slide along grooves 340. That is, the plunger rod 90 first moves relative to the delay mechanism 300 in axial direction. In the feedback state, the protrusions 315 hit the signal element of the medicament delivery device 1. In the embodiment shown, the protrusions 315 hit the wings 25 (see Fig. 24) of the tubular extension part 22.

[0173] Preferably, the second annular element 320 and the first annular element 310 form a closed annular space 325 being filled with a damping liquid, preferably damping oil. The first annular element 310 has an internal rib or rib ring 350 (see Figs. 27 and 28) provided in the closed annular space 325. The rib or rib ring acts against the damping liquid when the first annular element 310 rotates relative to the second annular element 320. This provides a further damping and delay of the rotation of the first annular element 310 Initially, in this aspect of the second embodiment, the protrusions 315 are locked against rotation by the grooves or fixing tracks of the plunger rod. The torsion spring stores energy. When the plunger rod leaves the tubular extension member, the protrusions 315 are released from the grooves or fixing tracks and the first annular element 310 starts to rotate due to the torsion spring releasing force. The damper oil surrounding the torsion spring will increase viscosity coefficient and provide further rotation residence to further slow down the rotation velocity of the first annular element. At the end of the rotational displacement, the protrusions 315 hit the wings of the tubular extension part 22 and create the delayed feedback signal.

[0174] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0175] 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, Behcet'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.

[0176] Exemplary types of drugs that could be included in the delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapies, radioisotopes and / or nuclear medicines, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogues, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies.

[0177] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro- apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.

[0178] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-1 (GLP-1) modulators, glucosedependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Cl esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor-associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet- derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD- 1 / PD-L1) inhibitors / modulators, B-lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, B-lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulators, lymphocyte-activation gene 3 (LAG3; also known as cluster of differentiation 223 or CD223) antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation wl37 (CDwl37) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD159 or NKG2) modulators, glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig-like receptor (KIR) modulators, growth arrest-specific protein 6 (GAS6) / AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation wl23 (CDwl23) 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.

[0179] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-la, interferon beta-lb, peginterferon beta-la, 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.

[0180] Exemplary drugs that could be included in the delivery devices described herein may also include, but are not limited to, oncology treatments such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab.

[0181] Exemplary drugs that could be included in the delivery devices described herein include "generic" or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the "innovator" or "branded" version of each, as in the non-limiting example of innovator medicament adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

[0182] Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.

[0183] Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer's solution, Heparin Lock Flush solution, 100 U / mL Heparin Lock Flush Solution, or 5000 U / mL Heparin Lock Flush Solution.

[0184] Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also include separately administered or co-formulated dispersion enhancers (e.g. an animal-derived, human-derived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.

[0185] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R- HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

Claims

CLAIMS1. A medicament delivery device (1) having a signal element (25, 180, 198, 294) and a feedback mechanism (110, 295, 315) that is released on completion of medicament delivery to move a distance before interacting with the signal element (25, 180, 198, 294) to produce an end of medicament delivery signal, and a delay mechanism (150, 170, 190, 914, 195, 300) that exerts a force on the feedback mechanism (110, 295, 315) during the movement to slow the feedback mechanism (110, 295, 315) and thereby introduce a delay between the completion of medicament delivery and the production of the signal.

2. A medicament delivery device (1) of claim 1, further comprising:- drive mechanism (90, 91) configured to act on a medicament container (80) for expelling a medicament; holding mechanism (22, 100) configured to hold said drive mechanism (90, 91) in a pre-tensioned state;- activation mechanism (30, 35, 101, 102, 103) configured to interact with said holding mechanism (22, 100) for releasing said drive mechanism (90, 91) from the pretensioned state; and- wherein when the feedback mechanism (110) is released from its initial state it is displaced by a force of a resilient member to a feedback state for generating the end of medicament delivery signal; and the delay mechanism configured to influence the displacement of the feedback mechanism (110) before reaching its feedback state.

3. A medicament delivery device (1) according to claim 2, wherein the feedback mechanism (110) is configured to interact both with said holding mechanism (22, 100) and with said drive mechanism (90, 91) for generating the end of medicament delivery signal.

4. A medicament delivery device (1) according to claim 3, wherein the resilient member is a first resilient member (91) and part of the drive mechanism (90, 91), wherein the feedback mechanism (110) is displaced by a remaining force of the first resilient member (91) to the feedback state.

5. A medicament delivery device (1) according to claim 2, 3, or 4, wherein the delay mechanism is configured to influence the speed profile of the feedback mechanism (110).

6. A medicament delivery device (1) according to any one of claims 1 to 5, wherein the delay mechanism is configured to influence the displacement of the feedback mechanism (110) by applying a force on the feedback mechanism (110) acting against the driving force of the feedback mechanism (110).

7. A medicament delivery device (1) according to any one of claims 1 to 6, wherein the delay mechanism is configured to decelerate the displacement of the feedback mechanism.

8. A medicament delivery device (1) according to any one of the preceding claims, wherein said feedback mechanism (110) is a longitudinally extending member (110).

9. A medicament delivery device (1) according to claim 8, wherein said longitudinally extending member (110) is an elongated U-shaped bracket comprising a transversal wall (112) and two longitudinally extending flexible arms (111) provided with angled support members (113) extending radially outward.

10. A medicament delivery device (1) according to claim 9 wherein the transversal wall (112) of the U-shaped bracket is arranged at a predetermined distance D from the signal element (180) of the medicament delivery device (1) when the drive mechanism (90, 91) is in the pre-tensioned state, which signal element (180) is preferably an inner distal surface of the medicament delivery device (1).

11. A medicament delivery device according to any one of the preceding claims, wherein the delay mechanism (150) is functionally located between the feedback mechanism (110) and the signal element (180).

12. A medicament delivery device (1) according to any one of the preceding claims, wherein the delay mechanism (150) comprises a deformable element.

13. A medicament delivery device (1) according to any one of the preceding claims, wherein the delay mechanism comprises a delay element (150), wherein the delay element (150) has a first end (151) facing the feedback mechanism (110) when being in its initial position, and along the longitudinal axis of the medicament delivery device (1) an opposite second end (152) contacting a distal element of the medicament delivery device (1).

14. A medicament delivery device (1) according to claim 13, wherein the first end (151) of the delay element (150) is spaced from the feedback mechanism (110) along the longitudinal axis of the medicament delivery device (1).

15. A medicament delivery device (1) according to claim 13 or 14, wherein the delay element (150) has a U-shape when viewed in transversal direction of the medicament delivery device (1).

16. A medicament delivery device (1) according to claim 15, wherein the U-shape is provided by a cylindrical wall (153) having two opposing cut outs (154) corresponding to the two longitudinally extending flexible arms (111) of the feedback mechanism (110).

17. A medicament delivery device (1) according to claim 16, wherein at least one of the cut outs (154) has at at least one of the longitudinally extending cut out walls (155) a protrusion (156) in circumferential direction.

18. A medicament delivery device (1) according to claim 17, wherein the protrusion (156) has the form of a first ramp (157) ramping up towards the distal end, the first ramp (157) being provided adjacent the first end (151) of the delay mechanism (150).

19. A medicament delivery device (1) according to claim 18, wherein the protrusion (156) further comprises a second ramp (158) ramping down from the first ramp (157) towards the distal end.

20. A medicament delivery device (1) according to claim 17, 18, or 19, wherein the feedback mechanism (110) comprises at least one recess (115) at the edge of the two longitudinally extending flexible arms (111), the at least one recess (115) being formed and arranged foreach recess (115) accommodating one of the at least one protrusion (156) when the feedback mechanism (110) has reached its feedback position.

21. A medicament delivery device (1) according to any one of claims 11 to 20, wherein the delay element (150) is made from a deformable material.

22. A medicament delivery device (1) according to any one of claims 11 to 21, wherein the drive mechanism (90, 91) comprises a plunger rod (90) and a first resilient member (91) which is pre-tensioned arranged within the plunger rod (90).

23. A medicament delivery device (1) according to any one of claims 1 to 9, wherein the delay mechanism (170) comprises one or more magnets (171) providing a repulsive force.

24. A medicament delivery device (1) according to claim 23, wherein an inner rear wall (180) of the medicament delivery device comprises magnets (181) corresponding in number and location to the magnets (171) of the delay mechanism (170).

25. A medicament delivery device (1) according to claim 23 or 24, wherein the drive mechanism comprises a plunger rod (90), a first resilient member (91) which is pretensioned arranged within the plunger rod (90), and a guide rod (96) arranged within the first resilient member (91).

26. A medicament delivery device (1) according to claim 25, wherein a proximally facing surface of the transversal wall (112) of the feedback mechanism (110) is in contact with a distally facing wall of the guide rod (96).

27. A medicament delivery device (1) according to claim 26, wherein the guide rod (96) is T- shaped at its distal end in longitudinal cross section.

28. A medicament delivery device (1) according to claim 27, wherein the delay mechanism (170) has a first, proximal end (172), and along the longitudinal axis of the medicament delivery device (1) an opposite second, distal end (173) being axially spaced from an inner rear wall (180) of the medicament delivery device (1).

29. A medicament delivery device (1) according to claim 28, wherein the delay mechanism(170) is connected to the guide rod (96) at its T-shaped end.

30. A medicament delivery device (1) according to claim 29, wherein the delay mechanism (170) has at least two longitudinally extending circumferential leg portions (174) holding the guide rod (96) in releasable manner.

31. A medicament delivery device (1) according to claim 30, wherein each of the leg portions (174) comprises the magnet (171) being arranged such that their magnetic repulsive force acts in longitudinal direction.

32. A medicament delivery device (1) according to claim 31, wherein the medicament delivery device (1) is configured to allow the leg portions (174) to deflect radially after being displaced axially for a first predetermined distance to release the guide rod (96).

33. A medicament delivery device (1) according to claim 32, wherein the deflection is caused by the repulsive force of the magnets (171, 181).

34. A medicament delivery device (1) according to any one of claims 22 to 33, wherein a signal, preferably an audible signal, is generated for confirming that a medicament delivery has been performed when the distal end of the plunger rod (90) has passed the supporting members (113), such that the longitudinally extending flexible arms (111), with the support members (113), are released and allowed to move, enabling the signal generating member (110) to move in the distal direction by a remaining force exerted by said first resilient member (91), whereby the transversal wall (112) of the signal generating member (110) hits the signal element, preferably the inner rear wall.

35. A medicament delivery device (1) according to any one of claims 1 to 10, wherein the delay mechanism comprises two or more elements.

36. A medicament delivery device (1) according to claim 35, wherein the delay mechanism comprises a disk structure (190) located at the distally facing side of the feedback mechanism.

37. A medicament delivery device (1) according to claim 36, wherein the disk structure (190) comprises two radial guide pins (191) at its circumferential surface, preferably being spaced 180° from each other.

38. A medicament delivery device (1) according to claim 36, or 37, wherein the delay mechanism further comprises a third resilient element (194) between the distally facing side of the disk structure (190) and the rear inner wall of the medicament delivery device (1).

39. A medicament delivery device (1) according to claim 38, wherein the delay mechanism comprises a sleeve element (195) abutting against the inner rear wall, the third resilient element (194) being at least partially accommodated in the sleeve element (195).

40. A medicament delivery device (1) according to claim 39, wherein the sleeve element (195) comprises two cut-outs (196) at its proximal side, preferably 180° offset from each other.

41. A medicament delivery device (1) according to claim 40, wherein each cut out (196) comprises a helical guiding track (197) for guiding a guide pin (191) of the disk structure (190) from a proximal side of the cut-out (196) towards and to a distal end of the helical guiding track (197), thus urging the disk structure (190) to rotate, wherein the distal end of the helical guiding track (197) provided the signal generating element in the form of a rotation stop point (198).

42. A medicament delivery device (1) according to claim 41, wherein the guiding pins (191) and the rotation stop points (198) form part of the signal element.

43. A medicament delivery device (1) according to claim 41 or 42, wherein each cut-out (196) is essentially triangular in shape when viewed in transversal direction with the helical guiding track (197) forming one side of the triangle, preferably the hypothenuse.

44. A medicament delivery device (1) according to any one of claims 36 to 44, wherein the disk structure (190) consists of a single piece, or wherein the disk structure (191) comprises an outer circumferential annular element (192) and at least one inner circular element (193) stacked in longitudinal direction.

45. A medicament delivery device (1) according to any one of claims 2 to 7, wherein the drive mechanism comprises a plunger rod (290), and wherein the plunger rod (290) comprises a proximal part (291) and a separate distal part (292) being connected to each other by the resilient member (293).

46. A medicament delivery device (1) according to claim 45, wherein the delay mechanism is formed by the proximal end wall of the proximal plunger part (291) frictionally contacting a syringe (80) of the medicament delivery device (1).

47. A medicament delivery device (1) according to claim 45, or 46, wherein the distal part (292) of the plunger rod (290) is of generally cylindrical configuration and comprises at least one circumferentially extending slot (294) in its cylindrical wall.

48. A medicament delivery device (1) according to claim 47, wherein the plunger rod (290) comprises two circumferentially extending slots (294) being offset from each other by 180°.

49. A medicament delivery device (1) according to claim 47 or 48, wherein the slot (294) or slots (294) extend over an angular range of about 45 to 90°.

50. A medicament delivery device (1) according to any one of claims 47 to 49, wherein the proximal part (291) of the plunger rod (290) comprises one or more radial protrusions (295) protruding radially outwards and being located in a corresponding slot (294).

51. A medicament delivery device (1) according to claim 50, wherein the slot(s) (294) form part of the signal element and the corresponding protrusion(s) (295) form part of the feedback mechanism.

52. A medicament delivery device (1) according to claim 51, wherein in the initial state of the feedback mechanism the protrusions (295) are located at one circumferential end of the corresponding slot (294), and the signal being caused by displacing the protrusions (295) within its respective slot (294) and hitting the opposing end of the slot (294) in the feedback position.

53. A medicament delivery device (1) according to claim 52, wherein the resilient member (293) is a torsion spring causing a rotation of the proximal part (291) of the plunger rod (290) relative to the distal part (292) of the plunger rod (290).

54. A medicament delivery device (1) according to any one of claims 45 to 53, wherein the plunger rod parts (291, 292) comprise at its outer circumferential surface longitudinally extending grooves (296) corresponding with protrusions or ribs (297) in a distal part of the medicament delivery device (1).

55. A medicament delivery device (1) according to any one of claims 1 to 10, wherein the delay mechanism (300) comprises two or more elements.

56. A medicament delivery device (1) according to claim 55, wherein the drive mechanism comprises a plunger rod (90).

57. A medicament delivery device (1) according to claim 56, wherein the delay mechanism (300) is of generally annular configuration and surrounds a proximal portion of the plunger rod (96).

58. A medicament delivery device (1) according to claim 57, wherein the delay mechanism (300) comprises a first annular element (310), a second annular element (320), and the resilient member (330) being a torsion spring connecting the first annular element (310) and the second annular element (320) with each other.

59. A medicament delivery device (1) according to claim 57 or 58, wherein the first annular element (310) comprises at least one protrusion (315) projecting radially inwards.

60. A medicament delivery device (1) according to claim 59, wherein the first annular element (310) comprises two protrusions (315) projecting radially inwards, preferably being offset by 180°.

61. A medicament delivery device (1) according to claim 60, wherein the plunger rod (90) comprises at least one longitudinally extending groove (340) for receiving the corresponding protrusion(s) (315) of the first annular element (310).

62. A medicament delivery device (1) according to claim 61, wherein the plunger rod (90) has a distal neck portion (341) having an outer diameter corresponding the outer diameter at the bottom of the groove(s) (340) such that the first annular element (310) is adapted to be rotationally displaced when the protrusion(s) (315) leave the groove(s) (340) at their distal end.

63. A medicament delivery device (1) according to claim 62, wherein the protrusion(s) (315) of the first annular element (310) form the feedback mechanism which is released from its initial state when being located in the groove(s) (340) and displaced by a force of the resilient member (330) to the feedback state.

64. A medicament delivery device (1) according to claim 63, wherein the protrusions (315) in the feedback state hit onto the signal element of the medicament delivery device, preferably the wings (25) of the tubular extension part (22).

65. A medicament delivery device (1) according to any one of claims 58 to 64, wherein the second annular element (320) and the first annular element (310) form a closed annular space (325) being filled with a dampening liquid, preferably dampening oil.

66. A medicament delivery device (1) according to claim 65, wherein the first annular element (310) has an internal rib (350) provided in the closed annular space (325) acting against the dampening liquid when the first annular element (310) rotates relative to the second annular element (320).

67. A medicament delivery device (1) according to any one of the preceding claims, wherein the device further comprises a tubular housing (20) having a proximal end (11) and an opposite distal end (12).

68. A medicament delivery device (1) according to claim 67 wherein the activation mechanism is a tubular activation member (30) slidably and coaxially arranged in relation to the tubular housing (20).

69. A medicament delivery device (1) according to claim 68 wherein the device further comprises a container holder (50) coaxially arranged within the tubular activation member (30) and fixedly attached to the tubular housing (20).

70. A medicament delivery device (1) according to claim 69 wherein the medicament container (80) is arranged within said container holder (50) and wherein said medicament container (80) comprises a pre-determined volume of medicament, a slidable stopper (83) and a delivery member (61).

71. A medicament delivery device (1) according to claim 70 wherein the drive mechanism comprises a plunger rod (90) and a first resilient member (91) which is pre-tensioned arranged within the plunger rod (90) and wherein said plunger rod (90) is arranged to be in contact with the slidable stopper (83) within the medicament container (80).

72. A medicament delivery device (1) according to claim 71 wherein the holding mechanism are a tubular extension part (22) fixedly connected to the distal end of the tubular housing (20) and a tubular operation member (100) which is interactively connected both to the tubular extension part (22) and to the tubular activation member (30), such that when said tubular activation member (30) is pressed against a delivery site said tubular operation member (100) is rotated in relation to said tubular extension part (22) whereby said drive mechanism are released from the pre-tensioned state for exerting a pressure on the slidable stopper (83) and thereby expelling the medicament.

73. A medicament delivery device (1) according to claim 72 wherein the longitudinally extending signal generating member (110) of the feedback mechanism is interactively connected to said tubular extension part (22) and to said drive mechanism, such that when the plunger rod is completely released from the tubular extension part and the longitudinally extending signal generating member, the longitudinally extending signal generating member (110) is released from said tubular extension part (22) and displaced distally by a remaining force of the first resilient member (91) for generating the signal indicating that the medicament has been completely expelled.

74. A medicament delivery device (1) according to claim 73, wherein the tubular operation member (100) comprises a first corresponding co-acting mechanism (101, 102, 103) interactively connected to a first co-acting mechanism (35) of the tubular activation member (30) and a second co-acting mechanism (105) interactively connected to a corresponding second co-acting element (121) of the tubular extension part (22); wherein the plunger rod (90) comprises a releasable engaging element (94) interactively connected to the corresponding second co-acting element (121) of the tubular extension part (22) and a proximal end wall (122) being in contact with the slidable stopper (83); wherein the longitudinally extending signal generating member (110) is releasable arranged on an inner surface of the tubular extension part (22); and wherein the first resilient member (91) has a first end (92) abutting the proximal end wall of the plunger rod (90) and a second end (93) abutting a transversal wall (112) of the signal generating member (110).

75. A medicament delivery device (1) according to claim 74, wherein the second co-acting element (105) comprises a groove on an inner surface of the tubular operation member (100) and the corresponding second co-acting element (121) of the tubular extension part (22) comprises a resilient tongue having a radial inward protrusion.

76. A medicament delivery device (1) according to claim 75, wherein the releasable engaging element (94) comprises a groove on an outer surface of the plunger rod (90) releasableengaged to the radial inward protrusion of the resilient tongue (121) adapted to hold the drive mechanism in the pre-tensioned state.

77. A medicament delivery device (1) according to claim 76, wherein the first corresponding co-acting mechanism (101, 102, 103) comprise a groove on an outer surface of the tubular operation member (100) and the first co-acting element (35) comprise a radial inward extending protrusion on the distal end of the inner surface of the tubular activation member (30), such that the radial inward extending protrusion (35) is adapted to be guided within the groove (101, 102, 103) on an outer surface of the tubular operation member (100) forcing the tubular operation member (100) to rotate when the tubular activation member (30) is distally moved, whereby the resilient tongue (121) is flexed radial outward into a groove (105) on the inner surface of the tubular operation member (100) and the radial inward extended protrusion is disengaged from the groove (94) on the outer surface of the plunger rod (90) such that the drive mechanism are released from the pre-tensioned state.

78. A medicament delivery device (1) according to anyone of the preceding claims 74 to 77, wherein said support members (113) are adapted to rest on an annular proximal end of the tubular extension part (22) when the drive mechanism is in the pre-tensioned state.

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