Medicament delivery device

Abstract

This text concerns a medicament delivery device for expelling multiple doses a medicament from a medicament container. The medicament delivery device comprises a plunger rod assembly comprising a main plunger rod device and an auxiliary plunger rod device which are rotationally coupled, and a biasing member for forcing the plunger rod assembly in the proximal direction. It also comprises a loading mechanism for a user to cause, by twisting a twisting element, a loading step to bias the biasing member. It further comprises an activation mechanism for the user to activate medicament delivery, which comprises an activation button (13) rotationally coupled to the twisting element (12); a cam feature (112); and a cam-cooperating feature (132). The cam feature (112) or the cam-cooperating feature (132) is comprised in the activation button (13), and the other one is couplable to the base assembly. The activation mechanism is operable by the user to activate medicament delivery by pushing the activation button (13) towards proximally from a first position into a second position. And the twisting of the twisting element (12) causes the activation button (13) to be moved towards distally from the second position into the first position by cooperation of the cam feature (112) and the cam-cooperating feature (132).

Description

[0001] MEDICAMENT DELIVERY DEVICE

[0002] TECHNICAL FIELD

[0003] The invention is in the field of medicament delivery devices. In particular, it relates to automatic medicament delivery devices for delivering multiple doses of a medicament from one medicament container, in particular wherein the dosing amounts are pre-defined, set by the medicament delivery device.

[0004] BACKGROUND

[0005] Medicament delivery devices for automatic delivery of a medicament by self-administration are well-known. Especially, they may be equipped to accommodate a medicament container, for example a syringe or a medicament container with a septum (or another seal) to be perforated immediately prior to use. When the medicament delivery device and the medicament container are assembled, they constitute a medicament delivery assembly for self-administration.

[0006] For large doses, single use autoinjectors with a tensioned spring dominate the market, whereas for small doses, pen injectors containing multiple doses have been the main route. Such pen injectors are mainly operated manually, in that the user presses a button to inject the medicament with manual force. This is not a viable option for larger doses. To increase sustainability and minimize the generated waste, an autoinjector suitable for large doses and, at the same time, containing multiple doses would be desirable, even though this requires the patient to change needle before each dose.

[0007] For such a multi dose device, the dosing amount is set by the device, in contrast to a single dose device where the dosing amount is defined by the medicament container, and the device merely has to ensure that all of the medicament is expelled from the medicament container. A patient may start with a specific dosing amount, and depending on tolerability and effectiveness, the dosing amount may have to be increased or decreased. Some devices let the patient set the dose by means of a variable dose mechanism. This however bears a risk for human errors where the patient injects wrong dosing amounts.

[0008] Fixed dose devices are safer in use in this regard, as they make it impossible for the user to set a wrong dosing amount. SUMMARY

[0009] It is an object of the present invention to provide a medicament delivery device overcoming disadvantages of prior art medicament delivery devices. Especially, it is an object to provide a medicament delivery device suitable for delivering multiple doses, in particular multiple predefined doses, of a medicament in a reliable and reproducible manner. The device should have a high usability and should be safe.

[0010] Another possible object of the invention is to provide a medicament delivery device which is particularly simple to operate.

[0011] Another possible object of the invention is to provide a medicament delivery device which is particularly safe to operate.

[0012] Another possible object of the invention is to provide a medicament delivery device which is has an activation mechanism to release medicament delivery, wherein the activation mechanism is easy to use and / or safe to use.

[0013] Another possible object of the invention is to provide a medicament delivery device which is easy to assemble.

[0014] Another possible object of the invention is to provide a medicament delivery device which is particularly ecological.

[0015] Further objects and various advantages emerge from the description and embodiments below.

[0016] The medicament delivery device is a medicament delivery device for accommodating a medicament container which comprises a plunger and contains a medicament. It is configured for expelling multiple doses, in particular pre-defined doses set by the medicament delivery device, of the medicament from the medicament container. The medicament delivery device extends axially between a proximal end and a distal end and defines a proximodistal device axis, wherein the proximal end is the one pointing towards a dose delivery site during use of the medicament delivery device.

[0017] The medicament delivery device comprises: a base assembly to which the medicament container is mountable in a stationary manner; a plunger rod assembly which is axially movable relative to the base assembly for interacting with the medicament container for expelling the medicament therefrom; and a biasing member configured to force the plunger rod assembly in the proximal direction.

[0018] The plunger rod assembly comprises a main plunger rod device and an auxiliary plunger rod device, wherein the main plunger rod device is configured to act on the plunger to expel the medicament from the medicament container by moving in the proximal direction.

[0019] The medicament delivery device further comprises a loading mechanism configured for a user to cause a loading step comprising causing a loading movement of the auxiliary plunger rod device moving the auxiliary plunger rod device from an unloaded position into a loaded position and thereby biasing the biasing member.

[0020] The loading mechanism comprises a twisting element which is rotationally couplable to, more particularly coupled to, the auxiliary plunger rod device and which is configured to be twisted by the user relative to the base assembly in a first sense of rotation to cause the loading movement.

[0021] The medicament delivery device further comprises an activation mechanism for the user to activate medicament delivery. It comprises: an activation button rotationally coupled to the twisting element; a cam feature; and a cam-cooperating feature.

[0022] One of the cam feature and of the cam-cooperating feature is comprised in the activation button, and the other one is couplable to, in particular fixable to, the base assembly.

[0023] The activation mechanism is operable by the user to activate medicament delivery by pushing the activation button towards proximally from a first position into a second position. The first position can also be referred to as pressable position or as loaded position. The second position can also be referred to as pressed position or unloaded position.

[0024] The twisting of the twisting element by the user to cause the loading movement furthermore causes the activation button to be moved towards distally from the second position into the first position by cooperation of the cam feature and the cam-cooperating feature. In particular, the cam feature and the cam-cooperating feature can cooperate by abutting one another, more particularly by sliding on one another.

[0025] This way, the activation button can be reset from its second position to its first position, in particular by the user causing the loading step, more particularly by twisting the twisting element in the first sense of rotation.

[0026] The biasing member is a compression spring, more particularly a helical compression spring.

[0027] The loading movement comprises a movement of the auxiliaiy plunger rod device in the distal direction relative to the base assembly and to the main plunger rod device.

[0028] The loading movement in addition comprises a rotational movement of the auxiliary plunger rod device relative to the base assembly and to the main plunger rod device.

[0029] In embodiments, the twisting element is rotatable relative to the base assembly. In particular, the twisting element can comprise a sleeve with a radially outer skirt face, and the base assembly can have, at its distal end, a rear bore having a radially inner bore surface, and the skirt face and the bore surface cooperate to form a bearing for rotations of the twisting element relative to the base assembly. The rear bore can be comprised, more particularly, in a device body comprised in the base assembly.

[0030] In embodiments, an axial position of the twisting element is limited to-wards proximally by the base assembly. In particular, the twisting element can have a generally proximally facing shoulder face which cooperates with a generally distally facing rear face of the base assembly, more particularly of a device body comprised in the base assembly.

[0031] In embodiments, the twisting element is axially coupled to the spring stop.

[0032] In embodiments, the twisting element comprises one or more radially inwardly protruding retention ledges, and the spring stop comprises a retention rim cooperating with the one or more retention ledges to form a snap fit connection impeding movements towards distally of the twisting element relative to the spring stop.

[0033] In embodiments, the cam feature comprises a cam curve.

[0034] In embodiments, the cam-cooperating feature comprises a protrusion configured to abut the cam curve. In embodiments, the cam feature is couplable to, in particular fixable to, the base assembly.

[0035] In embodiments, the cam feature is comprised in a spring stop of the medicament delivery device which is couplable to, in particular fixable to, the base assembly.

[0036] In embodiments, the cam-cooperating feature is comprised in the activation button.

[0037] In embodiments, the cam-cooperating feature comprises a protrusion, in particular a protrusion of the activation button. That protrusion can also be referred to as sliding protrusion.

[0038] In embodiments, the cam feature is couplable to, in particular fixable to, the base assembly, and the cam-cooperating feature is comprised in the activation button.

[0039] In embodiments, the cam feature comprises a cam curve for resetting activation button from its second to its first position. Said cam curve can also be referred to as a reset slope.

[0040] In embodiments, the cam feature comprises a strongly sloped section and one or more nonsloped or slightly sloped sections: And the cooperation of the cam feature and the camcooperating feature in the non-sloped or slightly sloped sections blocks a movement of the activation button towards proximally. And the cooperation of the cam feature and the camcooperating feature in the strongly sloped section causes the activation button to be moved towards distally for at least 6o%, in particular for at least 75%, more particularly for at least 80% of a travel toward distally of the activation button from the second position to the first position. Therein, the cooperation of the cam-cooperating feature with the strongly sloped section takes place merely in a final phase of the loading movement, in particular wherein the final phase makes up for at most 35%, in particular for at most 25%, more particularly for at most 20%, of the loading movement.

[0041] In embodiments, the cam feature comprises one or more sloped sections and one or more nonsloped sections.

[0042] In embodiments, the cooperation of the cam feature and the cam-cooperating feature in the sloped sections causes the activation button to be moved towards distally.

[0043] In embodiments, the cooperation of the cam feature and the cam-cooperating feature in the non-sloped sections blocks a movement of the activation button towards proximally. More particularly, this way, a rotational load on the twisting element when trying to press (towards proximally) the activation button can be largely avoided when the cam-cooperating feature cooperates with the cam feature in the non-sloped sections. Pressing the activation button can be prevented very efficiently when the cam-cooperating feature cooperates with the cam feature in the non-sloped sections.

[0044] In embodiments, each sloped section is adjacent one of the non-sloped sections.

[0045] The implementation of the sloped sections and the non- sloped sections can make possible resetting of the activation button from the second to the first position in a step-wise fashion.

[0046] In embodiments, the loading mechanism is configured to cause the loading movement by the user twisting the twisting element in two or more successive twisting actions, wherein in between the twisting actions, the auxiliary plunger rod device is in a resting position in which a movement towards proximally of the auxiliary plunger rod device is blocked; and the camcooperating feature abuts the cam feature in one of the non-sloped sections when the auxiliary plunger rod device is in a resting position.

[0047] In embodiments, during each of the twisting actions, the cam-cooperating feature abuts one of the sloped sections briefly before the auxiliary plunger rod device reaches one of the resting positions. This way, a movement towards distally of the activation button during loading takes place only briefly before the auxiliary plunger rod device reaches one of the resting positions. This can provide a particularly good visual and / or haptic indication to the user regarding the progress of the loading step.

[0048] In embodiments, the cam feature comprises a recessed section adjacent that one of the nonsloped sections which is arranged most distally, thus enabling the activation button to move towards proximally from the first position into the second position. This way, pressing of the activation button by the user is made possible when the auxiliary plunger rod device is in the loaded position and at the end of the loading step, respectively.

[0049] In embodiments, the medicament delivery device further comprises one or more snap fit connections between the activation button and the twisting element for hampering a movement towards distally of the activation button relative to the twisting element.

[0050] In embodiments, the medicament delivery device further comprises for at least one of the nonsloped sections a snap fit connection between the activation button and the twisting element for hampering a movement towards distally of the activation button relative to the twisting element when the cam-cooperating feature cooperates with, e.g., abuts, said at least one of the non-sloped sections. In embodiments, the pushing of the activation button towards proximally from the first position into the second position causes a release of a movement towards proximally of the plunger rod assembly. Said release is, more particularly, driven by the biasing member.

[0051] In embodiments, the activation button comprises one or more interacting elements, in particular two interacting elements, cooperating with the plunger rod assembly, more particularly with the auxiliary plunger rod device, to cause the release of the movement towards proximally of the plunger rod assembly.

[0052] In embodiments, the interacting elements are activation wings.

[0053] In embodiments, one of the auxiliary plunger rod device and of the base assembly comprises a pair of locking arms, each locking arm having a locking protrusion, and the other one comprises one or more locking structures capable of engaging with one or more of the locking protrusions, wherein the medicament delivery device is configured for the locking arms to flex in a resilient manner in response to the user causing the loading movement and to flex back for the locking protrusions to engage the locking structures immediately before the loaded position has been reached by the auxiliary plunger rod device. And the activation structure comprises one or more interacting elements configured to cooperate with the locking arms, in particular with the locking protrusions, when the user pushes the activation button towards proximally from the first position into the second position, to flex the locking arms until the locking protrusions get out of engagement with the locking structures, so that the biasing member displaces the plunger rod assembly towards proximally.

[0054] In embodiments, the locking structures comprise shelves, each shelve having a ridge running in a circumferential direction and a support surface capable of engaging with at least one of the locking protrusions.

[0055] In embodiments, the activation button is rotationally coupled to the twisting element by a ledge of the twisting element which cooperates with an activation slit of the activation button, in particular wherein the activation slit is formed in a sleeve-like proximal part of the activation button, more particularly wherein the activation slit is formed between the interacting elements.

[0056] In embodiments, one of the activation button and of the twisting element comprises a first retaining feature, and the other one comprises a second retaining feature cooperating with the first retaining feature to limit a movability of the activation button towards distally relative to the twisting element, in particular to limit said movability by abutting one another when a distal-most position of the activation button relative to the twisting element is reached, more particularly when the first position is reached.

[0057] In embodiments, one or both of the first and of the second retaining features is a protrusion.

[0058] In embodiments, the first retaining feature is formed at an axial end of a longitudinal opening. The longitudinal opening is comprised in that one of the activation button and of the twisting element which also comprises the first retaining feature.

[0059] In embodiments, the first retaining feature is formed at a proximal end of a longitudinal opening of the activation button.

[0060] In embodiments, the second retaining feature moves inside the longitudinal opening during the loading step.

[0061] In embodiments, the activation button comprises a distal end part having a generally radially outwardly facing outer face, the outer face bearing markings indicative of a progress of the loading step, in particular visual markings at different axial positions.

[0062] In embodiments, said markings are markings for indicating to a user the progress of the loading step.

[0063] In embodiments, each of the markings is associated to one of the non-sloped sections.

[0064] In embodiments, each of the markings is associated to one of the resting positions.

[0065] In embodiments, each of the markings is positioned to become visual, more particularly visual to the user, during the loading step, when the cam-cooperating feature cooperates with, e.g., abuts, its respective associated non-sloped section. In particular, the markings become visual by the distal end part extending distally out of the twisting element sufficiently far to expose the respective marking.

[0066] In embodiments, the loading mechanism furthermore comprises: a helical feature; and a cooperating feature cooperating with the helical feature to cause a translational movement of the auxiliary plunger rod device relative to the base assembly in reaction to a rotation of the auxiliary plunger rod device about the device axis. And one of the auxiliary plunger rod device and of the base assembly comprises the helical feature, and the other one comprises the cooperating feature. In particular, the helical feature is comprised in the auxiliary plunger rod device, and the cooperating feature is comprised in the base assembly.

[0067] In embodiments, the helical feature has one or more first sections in which it has a first lead, and one or more second sections in which it has a second lead which is different from the first lead. And the cooperating feature has a first support face having a lead corresponding to the first lead and has a second support face having a lead corresponding to the second lead. And during a portion of the loading step, the first support face abuts the helical feature in one of the first sections, and during another portion of the loading step, the second support face abuts the helical feature in one of the second sections.

[0068] In embodiments, the first lead and the second lead have identical orientations.

[0069] In embodiments, the helical feature has (in addition to the first sections; or in addition to the first sections and the second sections) one or more third sections in which it has a third lead having an orientation which is different from an orientation of the first lead, and the cooperating feature has a third support face having a lead corresponding to the third lead.

[0070] In embodiments, the helical feature comprises two helical slopes, and the medicament delivery device comprises two cooperating features to cooperate with a respective one of the helical slopes each, wherein the two helical slope are offset by i8o° with respect to one another and are arranged at different radial positions; and, in particular, wherein the cooperating features are offset by i8o° with respect to one another.

[0071] In embodiments, the biasing member is a drive spring of the medicament delivery device.

[0072] In embodiments, the medicament delivery device comprises a coupling mechanism coupling rotations of the auxiliary plunger rod device relative to the main plunger rod device to axial movements of the auxiliary plunger rod device relative to the main plunger rod device by cooperation of a first coupling structure comprised in the main plunger rod device and a second coupling structure comprised in the auxiliary plunger rod device.

[0073] In embodiments, the first coupling structure comprises a thread, and the second coupling structure comprises an internal thread.

[0074] In embodiments, the loading movement comprises a movement of the auxiliary plunger rod device in the distal direction relative to the base assembly and to the main plunger rod device. In embodiments, the loading movement in addition comprises a rotational movement of the auxiliary plunger rod device relative to the base assembly and to the main plunger rod device, in particular in the first sense of rotation.

[0075] In embodiments, the medicament delivery device is configured for the loading mechanism to be activated a plurality of times, by the loading mechanism being equipped for the user to cause one or more additional loading movements in respective reloading actions. And in particular, the unloaded position of the auxiliary plunger rod device is the same for each of the multiple doses, and the loaded position of the auxiliary plunger rod device is the same for each of the multiple doses.

[0076] In embodiments, the base assembly defines a dosage stop for a movement of the plunger rod assembly in the proximal direction, when the auxiliary plunger rod device has reached the unloaded position; and the loading mechanism is equipped for the user to cause the one or more additional loading movements in respective reloading actions after the plunger rod assembly has reached the dosage stop.

[0077] In embodiments, the helical feature comprises a helical slope. In particular the helical slope is comprised in the auxiliary plunger rod device, and the cooperating feature is comprised in the base assembly.

[0078] In embodiments, the cooperating feature comprises a protrusion, in particular a ledge.

[0079] 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 during 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 during use of the medicament delivery device is / are located closest to the dose delivery site.

[0080] Further, the terms “longitudinal”, “longitudinally”, “axially” and “axial” refer to a direction extending from the proximal end to the distal end and along the device or components thereof, typically in the direction of the longest extension of the device and / or component.

[0081] Similarly, the terms “radial”, “radially”, “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction. Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to a / an / the element, apparatus, member, component, means, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, member component, means, etc., unless explicitly stated otherwise.

[0082] BRIEF DESCRIPTION OF THE DRAWINGS

[0083] Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings. The drawings show:

[0084] Figure i a medicament delivery partial device, in a perspective view;

[0085] Figure 2 a container housing mountable to the medicament delivery partial device of

[0086] Fig. 1, in a perspective view;

[0087] Figure 3 a medicament container;

[0088] Figure 4 a detail of the container housing of Fig. 2;

[0089] Figure 5A the device body of the medicament delivery partial device of Fig. 1, in a perspective view;

[0090] Figure 5B a detail of the device body of Fig. 5A;

[0091] Figures 6A-6D the medicament delivery device in different stages regarding the mounting step;

[0092] Figure 7 a detail of the medicament delivery assembly, with the container housing approximately in the intermediate position, the container housing is shown in a transparent fashion;

[0093] Figure 8 the plunger rod assembly of the medicament delivery partial device of Fig. 1, in a perspective view;

[0094] Figure 9 the medicament delivery assembly comprising the medicament delivery partial device of Fig. 1 and the container housing of Fig. 2, with attached needle assembly;

[0095] Figures 10A, 10B, 10C the plunger rod guiding member of the device of Fig. 1, in different perspective views;

[0096] Figures 11A, 11B, 11C the device body of the device of Fig. 1, in different perspective views; Figures 12A-12D a view onto a cross-section of a detail of the medicament delivery device, to illustrate different stages of the mounting step;

[0097] Figure 13 a perspective view onto a cross-section through the device body of the medicament delivery device, showing the second securing structure;

[0098] Figure 14 the plunger nut of the plunger rod assembly of the medicament delivery partial device of Fig. 1, in a transparent fashion, in perspective view;

[0099] Figure 15 a perspective view onto a cross-section through parts of the medicament delivery device;

[0100] Figure 16 a spring stop of the medicament delivery device, in a perspective view;

[0101] Figure 17 the spring stop as shown in Fig. 16, from a different perspective;

[0102] Figure 18 a loading sleeve of the medicament delivery device, in a perspective view;

[0103] Figure 19 an activation button of the medicament delivery device, in a perspective view;

[0104] Figure 20 a plunger nut of the 360° embodiment of the medicament delivery device, in a perspective view;

[0105] Figure 21A a perspective view of the device body of the medicament delivery device;

[0106] Figure 21B a perspective view onto a cross-section through the device body of the medicament delivery device;

[0107] Figure 22 the device body of the medicament delivery device in a transparent fashion;

[0108] Figure 23A a detail of the device body of the medicament delivery device, in a perspective view;

[0109] Figure 23B a detail of the device body of the medicament delivery device, in a perspective view;

[0110] Figure 24A a cross-section through a detail of the plunger nut of the medicament delivery device;

[0111] Figure 24B a detail of Figure 24A;

[0112] Figures 25A to 25D a detail of the medicament delivery device in different states during the loading step, in a perspective view, the device body shown in a transparent fashion;

[0113] Figures 26A-26D alternative securing mechanisms, in a top view, strongly schematized; Figure 27 a detail of a plunger rod with spinner, strongly schematized, in a cross- sectional view;

[0114] Figures 28A a perspective view onto cross-section through the medicament delivery device, briefly before engagement of the ratchet mechanism;

[0115] Figures 28B a perspective view onto cross-section through the medicament delivery device, with engaged ratchet mechanism;

[0116] Figures 29A, 298 a detail of Fig. 28A and 28B, respectively;

[0117] Figure 30 a detail of the plunger rod at the distal end of the plunger rod, in a perspective view;

[0118] Figure 31A a perspective view onto a cross-section through the plunger rod assembly of the device of Fig. 1, after expelling of the last dose has taken place;

[0119] Figure 31B a perspective view onto a cross-section through the plunger rod assembly of the device of Fig. 1, with the auxiliary plunger rod device in the terminal position;

[0120] Figures 32A, 32B a perspective view of the activation button assembled with the spring stop, before loading and after loading, respectively;

[0121] Figures 33A, 33B the bearing member (and the signalling member) in two different perspective views;

[0122] Figures 34A, 34Bthe spring stop (and the bearing seat and the cooperation member) in two different perspective views;

[0123] Figures 35A-35E a subassembly of the medicament delivery device in a perspective view, in different stages regarding loading / expelling;

[0124] Figure 36 the bearing member assembled with the spring stop, with the signalling member in the start position;

[0125] Figure 37 a perspective view of a cross-section through the bearing member assembled with the spring stop, at 250° locking rotation, like in Fig. 35C;

[0126] Figure 38A a view onto a cross-section of a detail of the medicament delivery device in a loaded state;

[0127] Figure 38B a detailed view of image section B in Figure 38A; Figure 38C a view onto a cross-section of a detail of the medicament delivery device in a loaded state just as the medicament delivery device is activated;

[0128] Figures 39A to 39D illustrations of different stages during assembly of a subassembly of the medicament delivery device, in a perspective view;

[0129] Figures 40 to 42 illustrations of the stages of Figs. 39B to 39D, respectively, showing a detail of the subassembly, in a different perspective view;

[0130] Figure 43 the subassembly assembled with the spring stop, in a perspective view, where the spring stop is shown in a transparent fashion;

[0131] Figure 44 a perspective view of the spring stop assembled with the plunger nut in the loaded position, wherein the spring stop is shown in a transparent fashion;

[0132] Figure 45 a cross-section through the spring stop assembled with the plunger nut in the loaded position, but with a small gap shown between their contact faces;

[0133] Figure 46 a detail of a cross-section through the spring stop assembled with the plunger nut in the loaded position, strongly schematized;

[0134] Figures 47A, 47B the loading sleeve assembled with the plunger nut in the unloaded state and in the loaded state, respectively, in perspective views, wherein the loading sleeve is illustrated in a transparent fashion;

[0135] Figure 48 a view towards distally onto a cross-section through the loading sleeve assembled with the plunger nut in the loaded state;

[0136] Figure 49 a diagram showing the toque to be applied during loading in dependence of the twisting angle;

[0137] Figure 50 a view onto a cross-section through the medicament delivery device after 180° loading;

[0138] Figure 51 a side view of the activation button, to illustrate markings;

[0139] Figure 52 a perspective view of a cross-section through the activation button assembled with the loading sleeve, where the second retaining protrusion is about to abut first retaining protrusion;

[0140] Figure 53 a detail of the activation button cooperating with the loading sleeve, where the activation button is in its second position, strongly schematized;

[0141] Figure 54A the cap in a perspective view; Figure 54B a detail of the distal end of the cap of Fig. 54A, in a perspective view;

[0142] Figure 55A the container housing for the other priming mechanism, in a perspective view;

[0143] Figures 55B, 55C details of the distal end of the container housing of Fig. 55A, in a perspective view:

[0144] Figure 56 a detail of the proximal end of the container housing for the other priming mechanism, in a perspective view;

[0145] Figure 57 the medicament delivery device for the other priming mechanism, in the intermediate state, in a perspective view;

[0146] Figures 58A, 58B, 58C a detail of the medicament delivery device of Fig. 57, in the initial state, in the intermediate state, and in the mounted state, respectively, in a perspective view;

[0147] Figures 59A, 59B, 59C a detail of the medicament delivery device of Fig. 57, in the initial state, in the intermediate state, and in the mounted state, respectively, in a perspective view, wherein the container housing is not shown;

[0148] Figures 60A, 60B, 60C a detail of the medicament delivery device of Fig. 57, in the initial state, in the intermediate state, and in the mounted state, respectively, in a perspective view, wherein the cap is not shown;

[0149] Figures 61A, 61B, 61C, 61D a perspective view onto a cross-section through the medicament delivery device of Fig. 57 in the initial state, in the intermediate state, in the mounted state, and in the ready state, respectively;

[0150] Figures 62A-62Dthe revised device body, in different perspective views;

[0151] Figures 63A-63B the revised container housing, in different perspective views;

[0152] Figures 64A-64C the revised plunger rod guiding member (“plug”), in different perspective views;

[0153] Figure 65 a perspective view onto a detail of a cross-section through the revised medicament delivery device (plug 54’ in the locked position; revised container housing and revised device body in the final positioning);

[0154] Figures 66A, 66Ba perspective view at a cross-section through a revised medicament delivery device (locked position; final positioning), but with differently engaged first and second toothings; Figure 67 a revised plunger nut, in a perspective view;

[0155] Figure 68 a cross-section through a revised device body, in a perspective view;

[0156] Figures 69A-69D a revised plunger rod, in different perspective views, wherein Figures 69B to 69D show only the distal end of the revised plunger rod;

[0157] Figures 70A, 70B different cross-sections through a medicament delivery device with the revised plunger rod of Figures 70A-70D, after expelling of the last dose has taken place;

[0158] Figure 71 a detail of the revised plunger rod of Figs. 69A-69D engaged with the revised plunger nut of Fig. 67, after expelling of the last dose has taken place, wherein the revised plunger rod and the revised plunger nut are shown in a transparent fashion;

[0159] Figures 72A-72C a revised spring stop in different perspective views, wherein Figure 72C shows only the proximal end of the revised spring stop;

[0160] Figures 73A-73B a revised activation button in different perspective views;

[0161] Figure 74 the proximal end of a further revised plunger nut, in a perspective view;

[0162] Figures 75A-75C a revised signalling member in different perspective views, wherein Figure 75C shows only the distal end of the revised signalling member;

[0163] Figures 76A to 76F a further revised device body or details thereof in different perspective views, wherein Fig. 76F shows a cross-section;

[0164] Figures 77A, 77B a further revised container housing in different perspective views;

[0165] Figures 78A, 78B a further revised plunger rod guiding member in different perspective views;

[0166] Figure 79A a perspective view onto a cross-section perpendicular to the device axis through a further revised medicament delivery device implementing the further revised mounting mechanism and the further revised plunger rod fixing mechanism, in the unlocked state;

[0167] Figure 79B a perspective view onto a cross-section perpendicular to the device axis through a further revised medicament delivery device implementing the further revised mounting mechanism and the further revised plunger rod fixing mechanism, in the locked state; Figure 8o a perspective view onto a detail of a cross-section through a further revised medicament delivery device, with the further revised plunger rod guiding member in the locked position;

[0168] Figures 81A-81D an illustration of the principle of the improved plunger rod positioning process and of the locking of the further revised locking plug;

[0169] Figures 82A, 82B a detail each of the medicament delivery device in the final state, in perspective view in which the further revised container housing is illustrated partially in a transparent fashion (82A) and in a partial cross-section (82B), illustrating the axial travel distance td;

[0170] Figure 83 a partly cross-sectional perspective view of the proximal end of the rear part of the medicament delivery device;

[0171] Figure 84 a perspective view of the proximal end of the rear part of the medicament delivery device illustrating the hampering mechanism;

[0172] Figures 85A, 85B a detail of a cross-section perpendicular to the device axis through the medicament delivery device illustrating the clearance between the revised first and second toothings;

[0173] Figure 86 a detail of a cross-section through a medicament delivery device in the unlocked state, highlighting rotational orientations of the teeth of the resilient arm, of the revised second toothing and of the revised first toothing.

[0174] DETAILED DESCRIPTION

[0175] Fig. 1 shows, in a perspective view, a medicament delivery partial device 2’ (also sometimes referred to as power pack) comprising a device body 5 and a plunger rod 7 (as a main plunger rod device). It has a device axis A which is a proximodistal axis, and comprises a plunger rod thread 72.

[0176] Fig. 2 shows a container housing 4 for accommodating a medicament container. It is mountable to the medicament delivery partial device 2’, more particularly to the device body 5, to form a medicament delivery device. It comprises, at its proximal end, a needle assembly thread 42 for mounting thereto a needle assembly comprising a needle device (also sometimes referred to as delivery member) such as a cannula. And it comprises, as an option, a housing windows 41 through which the user may see the medicament container to determine how many doses are left in the container. Fig. 3 shows the medicament container 3 containing a medicament. It can be accommodated in medicament container 4 and comprises a seal 32 such as a septum, to be pierced by the needle device, and a plunger 31 to be forced proximally in order to expel portions of the medicament through a needle device piercing the seal 32.

[0177] The container housing 4 accommodates medicament container 3. The container housing 4 together with the container 3 is also referred to as container assembly or cassette. Mounting the container assembly, i.e., the container housing 4 including the medicament container 3, to the medicament delivery partial device 2’ forms a medicament delivery assembly.

[0178] Mounting Mechanism

[0179] The medicament delivery device implements a mounting mechanism for mounting the container housing to the device body.

[0180] Fig. 4 shows a detail of the container housing of Fig. 2.

[0181] Fig. 5A shows the device body 5 of the medicament delivery partial device 2’ in a perspective view, and Fig. 5B shows a detail thereof.

[0182] Device body 5 has the general shape of a hollow circular cylinder, comprising an outer housing part 58 having the general shape of a hollow circular cylinder. Inside outer housing part 58, device body 5 has an inner tube part 59 (Figs. 21A, 21B). A plunger rod guiding member 54 (cf. Figs. 10A, 10B, 10C) is axially fixed relative to device body 5 and rotationally fixed to plunger rod 7 for axially guiding plunger rod 7. Plunger rod guiding member 54 is part of a securing mechanism and of a plunger rod fixing mechanism, as will be described below. These two functions could also be implemented in two separate plunger rod guiding members, but implementing them in a single part may simplify manufacture and assembly of the medicament delivery device.

[0183] The medicament deliveiy partial device 2’, more particularly the device body 5, comprises a first guiding structure 18 comprising an outwardly (radially) protruding protrusion. The container housing 4 comprises a second guiding structure 19 to cooperate with the first guiding structure 18. Second guiding structure 19 comprises a first portion 191 and a second portion 192.

[0184] During a first partial movement of the mounting step, container housing 4 is guided relative to device body 5 by cooperation of the protrusion and the first portion 191, and during a subsequent second partial movement of the mounting step, container housing 4 is guided relative to device body 5 by cooperation of the protrusion and the second portion 192.

[0185] Figs. 6Ato 6D show the medicament delivery assembly 1 in different stages regarding mounting the container housing 4 to the medicament delivery partial device 2’ or more precisely to device body 5.

[0186] Initially, the medicament delivery partial device 2’ and the container housing 4 (and the container assembly, respectively) are separate from one another, cf. Fig. 6A. In the mounting step for mounting the container housing 4 to the device body 5, container housing 4 is moved in a guided fashion, by cooperation of the first guiding structure 18 and the second guiding structure 19. It is in addition guided by a first guiding surface 5a of a tube-shaped portion 50 of device body 5 cooperating with guiding ridges 4a of a sleeve-shaped distal portion 46 of container housing 4, to provide axial and rotational guiding during mounting.

[0187] In a first partial movement, container housing 4 is moved distally to reach an intermediate position. In a second partial movement, container housing 4 is moved rotationally to reach a mounted position (from the intermediate position).

[0188] Fig. 6A illustrates the situation before the mounting step, when container housing 4 is in an unmounted position, separate from device body 5. Then, container housing 4 is moved distally during the first partial movement. Fig. 6B illustrates the situation at the end of the first partial movement, where container housing 4 is in the intermediate position.

[0189] Fig. 7 shows a detail of the medicament delivery assembly with container housing 4 approximately in the intermediate position. Therein, container housing 4 is shown in a transparent fashion. In this situation, the protrusion of first guiding structure 18, more particular its sliding surface 18a abuts the second guiding structure 19, more particularly its sliding face 19a. During the first partial movement, first guiding structure 18 had been axially guided by first portion 191 of second guiding structure 19, embodied as a groove, minimizing rotational movements of container housing 4 relative to device body 5.

[0190] For accomplishing the mounting step, a second partial movement of the container housing 4 takes place, subsequently to the first (distal) partial movement. This second partial movement is substantially a rotation, guided by cooperation of the protrusion of the first guiding structure 18 and the second guiding structure 19, more particularly the second portion 192 thereof. More specifically, sliding side face 18a (cf. Fig. 5B, Fig. 7) is guided by sliding face 19a (cf. Figs 4, Fig. 7). The sliding face 19a is aligned generally circumferentially, but it is optionally slanted, best visible in Figs. 6B to 6D. Accordingly, the second partial movement comprises, in addition to the rotation, a (slight) distal movement. In other embodiments, sliding face 19a is aligned generally circumferentially, but it is slanted in the other direction. Accordingly, the second partial movement in that case comprises, in addition to the rotation, a (slight) proximal movement. And in still other embodiments, sliding face 19a is aligned generally circumferentially, not slanted. Accordingly, the second partial movement in that case is essentially a rotation (no axial movement). Below, the further effects of these different alignments will be explained.

[0191] Fig. 6C shows the situation between the intermediate position and the mounted position.

[0192] At the end of the second partial movement (cf. Fig. 6D), the protrusion of first guiding structure 18 is locked in an opening of the second guiding structure 19, more particularly of the second portion 192 thereof. A snap fit connection between a chamfered protrusion 55 (cf. Figs. 5A, 11C) of device body 5 and one of the guiding ridges 4a (cf. Fig. 4) blocks a rotation back towards the intermediate position. This way, attempts to remove the container housing from the medicament deliveiy partial device can be inhibited.

[0193] In other embodiments, the first guiding structures 18 and the second guiding structures 19 are embodied in a different fashion. For example, second guiding structures 19 could comprise a protrusion cooperating with a groove or slit of the first guiding structure 18.

[0194] As pointed out, the second partial movement, leading from the intermediate position (Fig. 6B) to the mounted position (Fig. 6D), is a generally rotational movement, but in the illustrated embodiment it also comprises a (small) distal movement portion by virtue of the slope of the sliding face 19a, which forces the container housing 4 more and more distally during rotationally moving the container housing 4 during the second partial movement. Fig. 6D illustrates the mounted position, whereas Fig. 6C illustrates a situation approximately half-way between the intermediate position and the mounted position.

[0195] Fig. 9 shows the medicament delivery assembly 1 with the container housing in the mounted position (like in Fig. 6D), but with an attached needle assembly 15, a cannula 15a thereof piercing the septum 32 of the container 3. A needle case of the needle assembly 15 is not shown in Fig. 9, and an inner needle shield of the needle assembly 15 is shown in a transparent fashion. The distal movement portion of the second partial movement effects, in the illustrated embodiment, a pre-bias of a drive spring which forces the plunger rod 7 distally, as will be explained below.

[0196] Securing Mechanism

[0197] The medicament delivery device 2 also comprises a securing mechanism for rotationally securing the plunger rod 7 in an initial rotational position relative to the device body 5. The described medicament delivery device 2 comprises a plunger rod assembly 101 (cf. Fig. 8) comprising the plunger rod 7 (also referred to as main plunger rod device) and a plunger nut 8 (also referred to as auxiliary plunger rod device). Fig. 8 shows the plunger rod assembly 101 in a perspective view, in a state in which one or more doses have been expelled already.

[0198] The securing mechanism is operated by operating the mounting mechanism.

[0199] Axial and rotational movements of the plunger rod 7 relative to the plunger nut 8 are coupled by a coupling mechanism. For this, plunger rod 7 comprises the plunger rod thread 72 as a first coupling structure (cf. Figs. 1, 8), and plunger nut 8 comprises an internal thread 82 as a second coupling structure (cf. Figs. 14, 20).

[0200] Thus, securing plunger rod 7 in the initial rotational position not only provides a defined rotational position, but generally also a defined axial position of plunger rod 7.

[0201] Further below, the securing mechanism is described in detail.

[0202] Plunger Rod Fixing Mechanism

[0203] The medicament deliveiy device 2 also comprises a plunger rod fixing mechanism for inhibiting a rotatability of the plunger rod 7. The plunger rod fixing mechanism is operated by operating the mounting mechanism.

[0204] The plunger rod assembly 101 and further parts and functions of the medicament delivery device 2 such as a loading mechanism for repeatedly biasing the drive spring 9 (as a biasing member) forcing the plunger rod 7 proximally, can be embodied, e.g., as described in the following.

[0205] The medicament deliveiy partial device 2’ comprises the plunger rod assembly 101 for dispensing the medicament by being moved towards proximally and thereby acting on the plunger 31. The plunger rod assembly (Fig. 8) comprises the plunger rod 7 and the plunger nut 8 (Figs. 14, 20). The plunger rod 7 has the plunger rod thread 72 which is an exterior thread running along a substantial portion of its axial extension. It is seated, at least partially (depending on the state of the medicament delivery device) in an interior of plunger nut 8. Internal thread 82 (cf. Fig. 14) of plunger nut 8 engages with plunger rod thread 72 of the plunger rod 7.

[0206] Plunger nut 8 further comprises an outwardly protruding circumferential feature, such as a shoulder, having a distally facing face 81.

[0207] A distal portion of plunger nut 8 runs inside a sleeve-like spring stop 11 (Fig. 16 and Fig. 17). The spring stop 11 has spring stop coupling features 111 engaging with second coupling holes 56 (as base assembly coupling structures) of the device body 5 and to connect the spring stop 11 to the device body 5 in the assembled state, wherein a movement towards proximally of spring stop 11 can be possible, e.g., caused by a user during activation. The device body 5 and the medicament container 4, are fixed to one another. On a circumference facing towards distally, spring stop 11 comprises a spring stop slope 112. Furthermore, spring stop 11 forms, at its proximal end, a bearing seat 180 which cooperates with a bearing member 160 (Figs. 33A, 33B, 34A, 34B, 37) so as to function as a bearing for a drive spring 9.

[0208] Drive spring 9 - serving as biasing member - is arranged between the distally facing face 81 of plunger nut 8 and a bearing surface i6of of bearing member 160 which faces towards proximally. The medicament delivery device further comprises a loading sleeve 12 (Fig. 18) as a twisting element, that is arranged distally of the device body 5 and surrounds a proximal portion of the spring stop 11, while a distal portion thereof and the bearing seat 180 are surrounded by the device body 5, as is the bearing member 160.

[0209] Inside of the loading sleeve 12 and extending into an interior of spring stop 11, the medicament delivery device further has an activation button 13 (Fig. 19). Activation button 13 comprises two activation wings 133 forming activation slits 134 and, on one of the activation wings 133 a sliding protrusion 132.

[0210] Medicament Delivery

[0211] For medicament delivery, the following steps are carried out (after mounting the container assembly):

[0212] • A. Needle assembly affixing: The needle assembly 15 is mounted to the medicament delivery device (container assembly 4 already mounted to the medicament delivery partial device 2’). This will cause the septum 32 of the medicament container to be penetrated by the needle 15a, whereupon the medicament is capable of being expelled through needle 15a. As will be explained below, the medicament delivery device is already primed at this point.

[0213] • B. Loading: The drive spring 9 is increasingly compressed between the distally facing face 81 of plunger nut 8 and the bearing surface i6of of bearing member 160, and bearing member 160 abuts bearing seat 180 (formed as a unitary part with spring stop 11) by causing the plunger nut 8 to move towards distally. This loading step is caused by a loading action by the user, namely by a twisting of the loading sleeve 12 relative to the device body 5 by 360° (or, cf. below, by 180°). At this point, the container assembly, the plunger rod guiding member 54 and the spring stop 11 (and thus also bearing seat 180) are fixedly connected to the device body 5. The plunger rod 7 is prevented from rotating by the shape of the outer geometry of the plunger rod 7 (flat sides 7f as outer coupling surfaces) cooperating with the plunger rod guiding member 54, more particularly with flat sides 54f of plunger rod guiding member 54 as inner coupling surfaces (Figs. 10A-10C). The rotation of the loading sleeve 12, however, is transferred to the plunger nut 8 and to the activation button 13 by an inwardly protruding structure, namely by inwardly protruding ledges 121 (Fig. 18) cooperating with ledges 88 (Fig. 20) and with activation slits 134, respectively. The rotation of plunger nut 8 causes plunger nut 8 to move backward, i.e., towards distal, against the spring force of drive spring 9. This brings plunger nut 8 from an unloaded position to a loaded position, in a movement towards distally referred to as loading movement.

[0214] • C. Expelling. When the medicament delivery device is in the loaded state, the medicament delivery step maybe initiated by pressing the activation button 13. Upon activation, the plunger rod assembly 101 comprising the plunger nut 8 and the plunger rod 7 is allowed to travel towards proximally, driven by the drive spring 9 that expands from the compressed state to a relaxed state and thereby acts on the distally facing face 81 of plunger nut 8. This causes a dose of the medicament to be expelled through the needle, the dose being defined by the axial distance the plunger rod assembly 101 travels from the loaded state back to the unloaded state. The travel towards distally terminates when plunger nut 8 reaches a dosage stop 57 (stop shoulder of device body 5, cf. Fig. 12A). Plunger nut 8 at this point is in an unloaded position.

[0215] • Steps A., B., and C. are repeated for each one of the further doses.

[0216] In case of a discardable device as shown in the figures, the medicament delivery device is discarded after the last dose has been expelled. In case of a re-usable device, the following steps D. and E. are carried out, and steps A., B., C. and D., optionally also step E. (typically only in case of the last dose) are repeated for each one of the further doses.

[0217] • D. Needle assembly removal. After delivery of a full dose, the user removes the needle assembly 15. In this state, the medicament delivery device (with the container assembly mounted) can be stored away awaiting further use. If no dose is left, as an alternative, the container assembly may be unmounted and disposed directly, cf. step E.

[0218] • E. Unmounting. Typically after the last dose has been expelled, but alternatively also already after expelling an earlier dose, the container assembly is unmounted (from the medicament delivery partial device 2’) and can be discarded. The medicament delivery partial device 2’ (with the container assembly unmounted) can be stored away awaiting further use, typically with a new container assembly (with a full medicament container) or with a container assembly from which one or more doses have been expelled while still containing medicament for one or more doses.

[0219] Locking After Last Dose

[0220] It can be undesirable to cause the expelling of further medicament after the last dose has been expelled, in particular since in that case, the amount of medicament expelled maybe undefined and / or less than a prescribed dose. In order to prevent the expelling of medicament after the last dose has been expelled, the loading mechanism can be blocked, such that the loading cannot be completed. Accordingly, plunger nut 8 is not moved back to the loaded position, and activation (by pressing activation button 13) is thus disabled.

[0221] For accomplishing this, towards its distal end, plunger rod 7 has an outwardly protruding protrusion 79 (cf. Fig. 30) as a first blocking member, which cooperates with a second blocking member 89 (cf. Fig. 31a) in form of the internal thread 82 (of plunger nut 8). When the two blocking members 79, 89 abut, they can prevent that plunger nut 8 is returned to the loaded position.

[0222] Fig. 30 shows, in a perspective view, a detail of plunger rod 7, at the distal end of plunger rod 7. In axial direction(s), protrusion 79 can optionally be chamfered, as shown in Fig. 30, where the chamfer towards proximally is referenced 79a. This way, undesired catching of plunger rod 7 with plunger nut 8 can be avoided. Optionally and not shown in the Figures, protrusion 79 can be chamfered in an approximately circumferential direction. This way, protrusion 79 can seize with internal thread 82 (second blocking member 89) when plunger nut 8 is moved towards distally starting from the unloaded position. There is a gap axial travel of plunger nut 8 (along which plunger nut 8 still can move towards distally) and a corresponding gap angle by which loading sleeve 12 still can be turned by the user after the expelling of the last dose (plunger nut 8 being in the unloaded position after said expelling), until the described reload-blocking mechanism is actuated and blocks plunger nut 8 from moving further towards distally (relative to plunger rod 7 and device body 5) by the cooperation of protrusion 79 and internal thread 82. The two abut (and optionally seize), so that plunger nut 8 is in a terminal position which is axially located between the loaded position and the unloaded position and from which it cannot move further. In the described embodiment, the gap angle is about 8o°. Positioning protrusion 79 (more particularly its proximal end) further proximally or further distally, one can decrease and increase, respectively, the gap axial travel (and the corresponding gap angle).

[0223] Fig. 31A shows a perspective view onto a cross-section through the plunger rod assembly 101, in the state after the expelling of the last dose has taken place. Plunger nut 8 is in the unloaded position, and as can be seen, protrusion 79 is axially distant from and not abutting internal thread 82. If the user now turns loading sleeve 12, this will be possible for only about 8o° (the gap angle), not for the full 360°, and plunger nut 8 travels distally only for the gap axial travel (and not up to the loaded position) until further turning is blocked by the reloadblocking mechanism.

[0224] Fig. 31B shows a perspective view onto a cross-section through plunger rod assembly 101, with plunger nut 8 in the terminal position. Protrusion 79 (as the first blocking member) abuts internal thread 82 of plunger nut 8 (as second blocking member 89), blocking further loading.

[0225] Thus, the user, if trying to prepare expelling of a further dose by trying to carry out a loading step, perceives a feedback (interrupted turning of loading sleeve 12) indicating that no further dose can be expelled and, accordingly, that the device is used up and can be discarded.

[0226] The embodiment described so far and below is configured for a rotation by 360° for the loading step. Alternatively, e.g., a rotation of 180° for the loading step could be implemented. The advantage of a greater rotation is that more energy can be stored in the biasing member (drive spring 9) for a given torque, or less torque is required for a given energy. This may especially be an issue if the user wants to use a comparably thin needle to minimize pain during injections. A thin needle comes about with the need for a higher plunger force and hence a higher energy stored in biasing member 9 for a given dosage. Fig. 20 shows a view of the plunger nut 8 highlighting features close to its proximal end used during the loading step. Plunger nut 8 has an inner slope 143 and an outer slope 142 as helical features, which belong to a slope extension 141 of plunger nut 8. Slopes 142, 143 are generally helical slopes. They cooperate with support ledges 240 as cooperating features which are comprised in device body 5.

[0227] One support ledge 240 protrudes towards inwardly from outer housing part 58, another support ledge 240 protrudes towards outwardly from inner tube part 59 of device body 5. Fig. 21A shows device body 5 in a perspective view generally towards proximally, Fig. 21B shows a perspective view generally towards proximally onto a cross-section through device body 5. Fig. 22 shows device body 5 in a transparent fashion. Figs. 23A and 23B each show a detail of device body 5.

[0228] Close to their distal end, support ledges 240 have support faces 241 to slide on inner slope 143 and on outer slope 142, respectively, during loading. The support faces 241 are aligned to form a two-dimensional contact with the respective slope 142, 143, for minimizing deformation and wear. They can have a lead corresponding to the lead of the inner slope 143 and of the outer slope 142, respectively. As illustrated, support ledges 240 can have more than one support face each, such as first support faces 241 and second support faces 242, which have different leads so that the device body can be used with plunger nuts having different leads of their slopes 142, 143, such as to adjust a torque required for carrying out the loading step.

[0229] More particularly, partially with reference to Fig. 20 and Figs. 21A, 21B, 23A, 23B, outer slope 142 has first sections 142a having a first lead, e.g., 14 mm, and second sections 142b having a second lead, e.g., 12 mm. And the inwardly protruding support ledge 240 has a first support face 241 and a second support surface 242, wherein the first support face 241 cooperates with the first sections 142a and has a corresponding lead, and the second support face 242 cooperates with the second sections 142b and has a corresponding lead.

[0230] And similarly for the inner slope 143:

[0231] With partial reference to Fig. 20 and Figs. 21A, 21B, 23A, 23B, inner slope 143 has first sections 143a having the first lead, e.g., 14 mm, and second sections 143b having the second lead, e.g., 12 mm. And the outwardly protruding support ledge 240 has a first support face 241 and a second support surface 242, wherein the first support face 241 cooperates with the first sections 143a and has a corresponding lead, and the second support face 242 cooperates with the second sections 143b and has a corresponding lead. By means of the two different leads, e.g., 14 mm and 12 mm, it is possible to vary the lead and thus the torque required for the loading during the loading step. Using a helical compression spring as the drive spring 9, the force required for compressing drive spring 9 increases the more compressed drive spring 9 is. Thus, a maximum torque required is lower when, in a more compressed state of drive spring 9, plunger nut 8 slides on device body 5 with the lower lead (e.g., 12 mm of second sections 142b, 143b and second support faces 242). And, vice versa, more compression of drive spring 9 per twisting angle during loading can be gained at a not too high torque when plunger nut 8 slides on device body 5 with the higher lead (e.g., 14 mm of first sections 142a, 143a and first support faces 241) in a less compressed state of drive spring 9.

[0232] And furthermore, a signalling mechanism of the medicament delivery device, which will be described further below, is loaded (energized) during the loading step, wherein the loading of the signalling mechanism takes place at the beginning of the loading step in order to keep the maximum torque required during loading low. Furthermore, since the torque for loading the signalling mechanism adds up to the torque which would be required without loading the signalling mechanism, torques to be applied during the beginning of the loading step can be kept low by letting plunger nut 8 slide on device body 5 with the lower lead (e.g., 12 mm of second sections 142b, 143b and second support faces 242).

[0233] Furthermore, support ledges 240 can have an additional support face 243 each, for simplifying resetting of a dose and for simplifying changing grip during the loading step. Outer slope 142 and inner slope 143 both have ramps 144 (as step features) matching with additional support faces 243, so as to define resting positions.

[0234] In the described embodiment, outer slope 142 and inner slope 143 each have three such ramps 144 cooperating with the respective additional support face 243. They are positioned at 90°, 180° and 270°, respectively, to provide three resting positions during the loading step, which are evenly distributed (with respect to the twisting angle). Thus, the user can load the medicament delivery device in four separate (and consecutive) twisting actions.

[0235] The ramps 144 and additional support faces 243 have matching leads, thus ensuring a two- dimensional contact between them. By selecting the lead of ramps 144 and additional support faces 243, the torque required for resetting a dose (during loading) can be tailored. For example, the lead of ramps 144 and additional support faces 243 can be selected to amount to the negative of a lead of outer slope 142 and inner slope 143, e.g., of the first lead or of the second lead or of a lead in between these, in which case the torque required for resetting a dose is comparable to the torque for setting a dose. Forces During Loading

[0236] Fig. 49 shows a diagram showing the torque to be applied during loading (y-axis; in Nmm) in dependence of the twisting angle (x-axis) for an exemplary embodiment, wherein the loading comprises the loading of the signalling mechanism, which takes place right at the beginning of the loading, from o° to about 330twisting angle. The letter “L” designates ranges where the lead is lower (e.g., 12 mm), the letter “H” designates ranges where the lead is higher (e.g., 14 mm), and the letter “N” designates ranges where the lead is negative (e.g., -13 mm),

[0237] Up to about 330, the torque is relatively high (due to loading the signalling mechanism) and at the same time is lowered by having the lower lead, so that the maximum torque during the first twisting action is not excessively high. When the signalling mechanism is loaded, the higher lead is used. And for each of the four twisting actions, in a range of about 150to 30° before the resting position (or the loaded position) is reached, a change takes place from the higher pitch to the lower pitch. This way, the maximum torque during each of the twisting actions can be reduced. And, accordingly, reaching the resting position (and the loaded position, respectively) is facilitated for the user. And, wear is reduced this way, too, as linelike contacts between support ledges 240 on the one hand and slopes 142, 142 on the other hand are largely avoided, in favor of two-dimensional contacts. More specifically, if one would not change to the lower pitch before reaching a resting position, an edge which would then be present where the high pitch section 142a, 143a would adjoin the negative pitch ramp 144, would slide (or rather scratch) over the low-pitch second support surfaces 242, resulting in wear from this line contact.

[0238] Having two (or more) support faces of different leads at the cooperating features (support ledges 240), as in case of the described device body 5, it is, moreover, possible to use that device body 5 for expelling medicament doses of a dosing amount which lies in a range of dosing amounts (and plunger travels per dosage, respectively). This can be accomplished by using it together with one of a number of plunger nuts which have the two different leads distributed over the respective slopes (142 and 143) so that the proportion of the overall range with first lead and of the overall range with the second lead is different for different ones of the plunger nuts. E.g., if the dosing amount shall be minimized, only the lower lead is implemented in the slopes 142, 143; if the dosing amount shall be maximized, only the higher lead is implemented in the slopes 142, 143; and if the dosing amount shall be between these two dosing amounts, one or more sections of the slopes 142, 143 have the lower lead, and one or more other sections of the slopes 142, 143 have the higher lead - like shown in the described embodiment. Furthermore, the support faces 241, 242 are inclined to provide radial support. They are inclined by some degrees, e.g., between 30and io°, with respect to a plane perpendicular to device axis A. The slopes 142, 143 are correspondingly inclined, ensuring the two- dimensional contact. Figs.24A, 24B illustrate the inclination of outer slope 142, Fig. 24A shows a cross-section through a detail of plunger nut 8, and Fig. 24B shows a detail of Fig. 24A. This also increases the surface area in which support ledges 240 abut slopes 142 and 143, respectively. And this can decrease the strain to which support ledges 240 and slopes 142 and 143 are subjected. Towards the end of the loading process, this can be particularly useful, as contact surface areas at that point are particularly small. The described inclination can also reduce the risk of a derailing of support ledges 240 from slopes 142 and 143-

[0239] Fig. 50 shows a view onto a cross-section through the medicament delivery device after 180° loading / twisting. The described inclination is illustrated in Fig. 50 by dotted lines.

[0240] Another way of reducing the risk of a derailing of support ledges 240 from slopes 142 and 143 is illustrated in Figs. 23A, 23B and 50.

[0241] Distally from the support ledges 240, device body 5 has respective protrusions 245 as radial support structures. They are facing generally radially and, as shown in Fig. 50, abut a generally radially facing surface of a respective one of the slopes 142, 143. More precisely, one of the protrusions 245 faces radially outwardly and abuts a radially inwardly facing surface of inner slope 143; and the other one faces radially inwardly and abuts a radially outwardly facing surface of outer slope 142.

[0242] A distally facing shoulder of plunger nut 8 comprises the distally facing face 81 against which drive spring 9 presses.

[0243] Figs. 25A to 25D show a detail of the medicament delivery device in different stages during the loading step, namely in an initial loading state (Fig. 25A), after a 450rotation (Fig. 25B), after a 180° rotation (Fig. 25C), and at after a 3550rotation (Fig. 25D), i.e. close a final loading state after a 360° rotation. Device body 5 is shown in a transparent fashion in Figs. 25A to 25D.

[0244] As can be seen in Figs. 25A to 25D, plunger nut 8 travels more and more towards distally with increasing rotation angle. Accordingly, drive spring 9 is compressed more and more with increasing rotation angle. In contrast to an embodiment with 180° rotation, such as with two (helical) slopes of 180° offset with respect to one another by a rotation of 180° around device axis A, the (generally helical) slopes 142, 143 in the illustrated embodiment extend by 360° around device axis A, instead of only 180°. To this end, the following measures are taken in the illustrated 360° embodiment, in particular compared to an 180° embodiment:

[0245] • In order to avoid any bending force on plunger rod 7 and plunger nut 8 when the latter is subject to the rotation during the loading step, the two slopes offset by 180° with respect to one another are provided. In the 180° embodiment, this is readily possible by arranging the two slopes at the same axial position, offset by 180° with respect to one another. This solution, however, does not work for slopes that extend by more than 180° around device axis A. In the illustrated 360° embodiment, the two slopes 142, 143 are at different radial positions (i.e., inner slope 143 is further inside than outer slope 142), but they otherwise have a 180° axial symmetry with respect to one another. A rotation by 180° thus transfers one slope to the other slope, except for the different radial positions.

[0246] • The slopes 142, 143 of the 360° embodiment have ramps 144 that prevent unwinding. The user usually cannot twist a full turn (360°) at once but has to change grip between partial rotations. The ramps 144 define stops for any unwinding movement, cooperating with the additional support faces 243. In the depicted 360° embodiment, ramps 144 are arranged at 90°, 180°, and 270°. However, it would be sufficient if one ramp per slope, arranged at 180°, was present. Alternatives include ramps at 120° and 240°, or more ramps arranged with regular or also irregular spacings. In 180° rotation embodiments, ramps may be dispensed with, but alternatively, they could be used in that case, too.

[0247] Furthermore, the signalling mechanism and the support mechanism have to be adjusted when implementing full loading at 180° instead of at 360°.

[0248] The axial position of activation button 13 changes during loading from a second position (pressed position or unloaded position) to a first position (pressable position or loaded position). No additional spring or the like is required therefor. For this, activation button 13 is coupled to spring stop 11. Sliding protrusion 132 cooperates with spring stop slope 112, so as to push activation button 13 towards distally during loading, by activation button 13 rotating together with plunger nut 8, and sliding protrusion 132 abutting spring stop slope 112. Accordingly, spring stop slope 112 can be considered a cam feature and acts as a reset slope for activation button 13, and sliding protrusion 132 acts as a cam-cooperating feature. The user’s twisting of loading sleeve 12 causes a rotation of activation button 13 effecting that activation button 13 is pushed out towards distally by sliding protrusion 132 sliding up spring stop slope 112.

[0249] Fig. 32A shows a perspective view of activation button 13 assembled with spring stop 11 before loading (with plunger nut 8 in the unloaded position and activation button 13 in the second position) or at the end of an expelling of medicament. The curved arrow in Fig. 32A symbolizes the direction of rotation of activation button 13 (and plunger nut 8) during loading - which shall be referred to as first sense of rotation. Similarly, Fig. 32B shows the situation after loading (with plunger nut 8 in the loaded position and activation button 13 in the first position) and thus before another activation. As can be seen in Fig. 32B, sliding protrusion 132 is not prevented by spring stop slope 112 from being moved towards proximally, because spring stop slope 112 has a recessed section 112c (cf. also Fig. 34B).

[0250] The cooperation of sliding protrusion 132 with spring stop slope 112 also effects that activation button 13 cannot be moved towards proximally, e.g., by a user trying to initiate another expelling of medicament, before the loaded state is reached, i.e. before plunger nut 8 is in the loaded position. Thus, the reload-blocking mechanism makes impossible that a further expelling of medicament can be effected after the pre-defined N doses have been expelled, because it prevents that a further loading movement can be carried out, as plunger nut 8 cannot reach the loaded position, and the cooperation (abutting) of sliding protrusion 132 and spring stop slope 112 prevents a movement towards proximally of activation button 13 before the loaded position is reached.

[0251] Spring stop slope 112 has sloped sections 112a and non-sloped sections 112b. Sliding protrusion 132 abuts and slides on a sloped sections 112a each time briefly before a resting position is reached. This way, activation button 13 moves further out (towards distally) briefly before a resting position is reached, so that this movement is well perceivable by the user, visually and / or haptically. Activation button 13 accordingly is moved towards distally in a step-wise manner. The non-sloped sections 112b in between provide a high resistance against possible attempts by the user to press activation button 13 (towards distally) before the loaded position (and recessed section 112c) is reached, as sliding protrusion 132 then acts perpendicularly against spring stop slope 112.

[0252] Spring stop slope 112 and the corresponding cam feature, respectively, exhibits the following sections in the following order (in the first sense of rotation), cf. also Figs 32A, 32B, 34B: recessed section 112c, a first non-sloped section 112b, a first sloped section 112a, a second non-sloped section 112b, a second sloped section 112a, a third non-sloped section 112b, a third sloped section 112a, a fourth non-sloped section 112b, a fourth sloped section 112a, and a fifth non-sloped section 112b.

[0253] Details of Activation

[0254] Activation button optionally can bear markings 13m, such as visual markings 13m illustrated in Fig. 51. Fig. 51 shows a side view of activation button 13. Activation button has a distal end part 13d to be accessed by the user to push activation button 13 towards proximally for activation, and distal end part 13d has an outer face i3f on which the markings 13m are present, e.g., in form of circumferential lines.

[0255] For example: At the beginning of a loading step, no marking is visible, as they are all hidden inside loading sleeve 12. In the first resting position (after 90° loading rotation), a first marking 13m is visible; in the second resting position (after 180° loading rotation), a second marking 13m is visible; in the third resting position (after 270° loading rotation), a third marking 13m is visible, and at the end of loading (after 360° loading rotation), a fourth marking 13m is visible.

[0256] The extent by which activation button 13 can be pressed (moved) towards proximally is controlled by the cooperation of sliding protrusion 132 and spring stop slope 112, as described. However, also possible movements of activation button 13 relative to device body 5 or to loading sleeve 12 towards distally can be controlled, e.g., limited, such as by cooperation of a first retaining protrusion 123 of loading sleeve 12 (cf. Fig. 18) with a second retaining protrusion 135 of activation button 13.

[0257] Fig. 52 shows a perspective view of a cross-section through activation button 13 assembled with loading sleeve 12, where second retaining protrusion 135 is about to abut first retaining protrusion 123, impeding a removal of activation button 13 from the rest of the medicament delivery device. First retaining protrusion 123 protrudes radially inwardly from an inner face of loading sleeve 12. Second retaining protrusion 135 is formed by the proximal end of a longitudinal opening 136 (in the illustrated embodiment: a longitudinal slit) in one of the activation wings 133. It is arranged just distally from sliding protrusion 132. First retaining protrusion 123 protrudes into longitudinal opening 136.

[0258] As an option, a movement of activation button 13 towards distally into the first position during loading before the end of the loading step is reached can be impeded. This can be accomplished by implementing a snap fit connection between activation button 13 and twisting element 12 which hampers a movement towards distally of activation button 13 relative to twisting element 12 at 0° loading rotation and in the resting positions at 90°, 180° and 270° loading rotation. E.g., as illustrated in a strongly schematized way in Fig. 53, longitudinal opening 136 can comprise snap fit features 136s cooperating with first retaining protrusion 123 for that purpose.

[0259] Fig- 53 shows, in a strongly schematized way, a detail of activation button 13 (more particularly: longitudinal opening 136) cooperating with loading sleeve 12 (more particularly: first retaining protrusion 123), where activation button 13 is in its second position.

[0260] In an alternative embodiment (not shown in the figures), spring stop slope 112 (and, accordingly, the corresponding cam feature) has a single non-sloped section 112b only and a single sloped section 112a only which interconnects recessed section 112c and the (single) non-sloped section 112b. Activation button 13 is not moved out (towards distally) before the last twisting action is carried out. Throughout the previous twisting actions, sliding protrusion 132 abuts recessed section 112c only. Sliding protrusion 132 abuts and slides on sloped section 112a only briefly before the loaded position is reached and more particularly after the last resting position was reached. This way, activation button 13 is moved out (towards distally) only briefly before the loaded position is reached and not before the last resting position was reached. Activation button 13, accordingly, is moved towards distally from the second position to the first position in a single step briefly before reaching the loaded position and, more particularly during the last twisting action.

[0261] During a loading step for biasing drive spring 9 and during expelling the doses of the medicament, rotation of plunger rod 7 has to be blocked. On the other hand, as will be explained below, during mounting the container housing 4 to device body 5, plunger rod 7 has to move axially and thus has to be rotatable, because the coupling mechanism couples rotational and axial movements of plunger rod 7 by cooperation with plunger nut 8.

[0262] Plunger rod 7 is axially guided by and rotationally locked to plunger rod guiding member 54 (also referred to as plunger rod guiding portion) which is accommodated in device body 5. Figs. 10A, 10B, 10C show plunger rod guiding member 54 in different perspective views. Plunger rod 7 is prevented from rotating relative to plunger rod guiding member 54 by the shape of the outer geometry of the plunger rod 7 cooperating with shape of the inner geometry of the plunger rod guiding member 54. The flat sides 7f of plunger rod 7 (cf. Fig. 1) slide along the flat sides 54f of plunger rod guiding member 54 (Figs. 10A, 10C) during distal movements of plunger rod 7. In order to selectively enable and disable rotation of plunger rod 7, plunger rod guiding member 54 is selectively rotatable. The described medicament delivery device implements two mechanisms for accomplishing this, the plunger rod fixing mechanism and the securing mechanism.

[0263] The securing mechanism secures plunger rod 7 in an initial rotational position from before the start of a mounting of container housing 4 to device body 5, i.e. before the mounting step starts, until the securing is released during the first partial movement. Because of the coupling mechanism, securing plunger rod 7 in a rotational position (the initial rotational position) at the same time means to secure plunger rod 7 in an axial position (the initial axial position).

[0264] Priming

[0265] By carrying out the mounting step, also a priming is accomplished. For ensuring a suitable priming which closes mechanical gaps for ensuring that the first dose to be expelled has the correct dosing amount with a desired precision, plunger rod 7 is secured by the securing mechanism, effecting that in the initial axial position, plunger rod 7 will abut the plunger 31 during the first partial movement of the container housing 4 - which is a distal movement of container housing 4 (relative to device body 5).

[0266] Figs. i2Ato 12D illustrate, in a cross-section, different stages of the mounting step. In Fig. 12A, only the partial medicament delivery device 2’ is shown, which at that point is separate from the container housing. Plunger rod 7 is in its initial axial position and in its initial rotational position. As can be seen in Fig. 12A, an axial clearance exists between the plunger rod thread 72 and the inner thread 82 of plunger nut 8. At this stage, plunger rod thread 72 and inner thread 82 can in instances abut, however, as shown in Fig. 12A, there can be an axial gap as indicated by the dashed lines and the arrows.

[0267] In Fig. 12B, the first partial movement has continued until plunger rod 7 abuts plunger 31. The securing mechanism ensures that this abutting takes place during the mounting step. The axial gap still persists.

[0268] During the further distal movement of container housing 4 (during the first partial movement), plunger 31 (which is abutting plunger rod 7) moves plunger rod 7 towards distally. A priming movement of plunger rod 7 begins. And in a first phase of the priming movement, this is a non-rotational distal movement, because the coupling between plunger rod 7 and plunger nut 8 is not yet effective due to the axial clearance and the axial gap, respectively. However, at the end of the first phase, plunger rod thread 72 and the inner thread 82 abut (the axial gap has vanished; the coupling mechanism becomes effective), as shown in Fig. 12C. The arrow in Fig. 12C points at the abutting; no axial gap anymore.

[0269] During the further distal movement of plunger rod 7 effected by the first partial movement, the movement of plunger rod 7 is a combined rotational and distal movement (due to the coupling mechanism). This second phase of the priming movement ends when the first partial movement ends. Thus, it ends when first guiding structure 18 abuts second guiding structure 19 (cf. Fig. 7).

[0270] Fig. 12D shows the situation at the end of the first partial movement. Container housing 4 is in the intermediate position.

[0271] In order to secure plunger rod 7 in the initial rotational position, plunger rod guiding member 54 comprises two radially flexing arms as first securing structures 61 of the securing mechanism which cooperate with a second securing structure 62 comprised in device body 5, such as a securing indentation. The securing mechanism forms a pawl structure. Alternatively, a single radially flexing arm could be implemented, or three radially flexing arms, or even more.

[0272] Figs. 10A to 10C show plunger rod guiding member 54 in different perspective views. Fig. 13 shows a view onto a cross-section through device body 5 exhibiting second securing structure 62 in form of an axially aligned profiling comprising multiple identical notches, e.g., notches distributed over the circumference. Fig. 15 shows a view onto a cross-section through parts of the medicament delivery device, namely plunger rod 7, plunger rod guiding member 54 and device body 5, with plunger rod 7 in the initial rotational position.

[0273] The radially flexing arms have contact portions 61a, e.g., bulge-shaped protrusions, which cooperate with the notches. In order to move plunger rod 7 out of the initial rotational position, plunger rod 7 has to carry out a rotation (“releasing rotation”) which has a torque exceeding a threshold torque. If the torque is not high enough, plunger rod guiding member 54 will continue being rotationally locked to the device body 5. The radially flexing arms need to be forced radially inwardly (near contact portions 61a) far enough to move out of one of the notches and into a neighboring notch. The threshold torque can be selected such that any torques (about device axis A) expected to be exerted on the plunger rod before mounting the container housing to the device body are lower than the threshold torque. For example, the partial medicament delivery device may undergo some transportation before the mounting, and the threshold torque can be large enough (e.g., the bows deep enough and the radially flexing arms stiff enough) to secure the plunger rod in the initial rotational position during the transportation.

[0274] The securing mechanism can be implemented in various ways, not only as described above. E.g., as schematically illustrated in Fig. 26A in a top view, it is not necessary to provide a plurality of notches or, more precisely it is not necessary to provide more notches than contact portions. But it is sufficient to have a single one per contact portion 61a, even when implementing radially flexing arms for second securing structures 62. In this case, carrying out the mounting step can be accomplished in a smoother fashion than with the multiple notches as shown in Fig. 13, where the second securing structure 62 effects a bumpy feedback to a user carrying out the mounting step.

[0275] And the assignment of protrusions and indentations can be vice versa. E.g., as shown schematically in Fig. 26B in a top view, the second securing structure 62 can comprise a protrusion 62a, whereas the first securing structure 61 can comprise one or more notches, e.g., one notch per radially flexing arm, as contact portion 61a.

[0276] And instead of having flexing arms comprised in the first securing structures 61, they could be comprised in the second securing structures 62, having a contact portion 62a’, whereas the first securing structures 61 could comprise a securing protrusion or indentation 61a’. This is schematically illustrated in Fig. 26C.

[0277] And further variants are possible, such as a breakable connection formed by the first and second securing structures 61, 62, which locks the rotation of plunger rod guiding member 54 relative to device body 5 and breaks if a torque exceeding the threshold torque is applied, to enable the rotation. E.g., the first securing structure 61 comprises a breakable pin which in the initial rotational position (of plunger rod 7 - and thus also of plunger rod guiding member 54) protrudes into an opening of second securing structure 62. This is schematically illustrated in Fig. 26D.

[0278] As explained above, plunger rod 7 has to be able to rotate during the mounting, as it must move towards distally to close mechanical gaps. However, it may not rotate during loading and dose expelling. Accordingly, plunger rod 7 has to be fixed later. This is accomplished by the plunger rod fixing mechanism and takes place during the second partial movement of the mounting step.

[0279] For this, device body 5 comprises resilient arms 25 which are circumferentially extended and are bendable towards inwardly. Figs. 11A, 11B, 11C show device body 5 in different perspective views.

[0280] Resilient arms 25 comprise, at their free end, a protrusion 25a protruding outwardly, and a first ratchet member 25b facing inwardly, i.e., towards device axis A.

[0281] During mounting the container housing 4, more particularly, during the second partial movement, the free ends of the resilient arms 25 are pushed inwardly (towards device axis A) by the sleeve-shaped distal portion 46 of the container housing 4 (because of the rotation of the second partial movement), so as to enter a state referred to as inhibiting state shown in Fig. 11C. More particularly, portions 45 of the sleeve-shaped distal portion 46, as second coupling features, protrude towards inwardly and cooperate with the protrusions 25a, as first coupling features, so that the arms 25 enter the inhibiting state, as their free ends are pushed inwardly. It is noted that the “coupling features” are to be distinguished from the “coupling structures”. This way, the first ratchet members 25b engage with a second ratchet member 54b present on the outside of plunger rod guiding member 54. This engagement of the ratchet mechanism results in a rotational locking of plunger rod guiding member 54, i.e., plunger rod guiding member 54 is rotationally blocked relative to device body 5 in this state; the resilient arms 25 (first coupling features) are in the inhibiting state and the plunger rod fixing mechanism is activated.

[0282] The ratchet mechanism, when engaged, blocks a rotatability of plunger rod guiding member 54 completely and thus also in the first sense of rotation which is equal to the sense of rotation of the rotational portion of the combined rotational and distal movement of plunger rod 7. The first sense of rotation is also equal to the sense of rotation of a rotation caused by the coupling mechanism when moving plunger rod 7 towards distally (relative to plunger nut 8). In the illustrated example, the first sense of rotation is counter clockwise (ccw) when referring to an axis pointing towards distally along device axis A, cf. Figs. 10A, 11B; the curved arrow in Fig. 10A illustrates the ccw sense of rotation. A rotation of plunger rod guiding member 54 in the opposite sense of rotation (cw) is also blocked by the ratchet mechanism. The teeth of ratchet structures 24b, 54b are shaped accordingly.

[0283] Plunger rod guiding member 54 is axially fixed relative to device body 5 by a flange 54k of plunger rod guiding member 54 cooperating with distally facing side faces 25s of the resilient arms 25 and an abutting face 25! of a shoulder of device body 5.

[0284] Fig. 6B shows the medicament delivery device 2, with the container housing 4 in the intermediate position. The plunger rod rotation is not yet fixed at this point. Then, the second partial movement is carried out, and during that, protrusion 25a is pressed down by portion 45 of sleeve-shaped distal portion 46. Fig. 6C shows the situation during the second partial movement, with activated plunger rod fixing mechanism; plunger rod rotation is fixed, the resilient arms 25 are in the inhibiting state, first ratchet members 25b and second ratchet member 54b are engaged.

[0285] The plunger rod fixing mechanism stays activated up to and also in the mounted position which is shown in Fig. 6D.

[0286] Implementing the plunger rod fixing mechanism with the ratchet mechanism as described also has another effect, namely an effect which contributes to reducing mechanical gaps that could lead to an incorrect dosing amount of the first dose, i.e. it contributes to priming. This is explained with reference to Figs. 28A, 28B and 29A, 29B.

[0287] Figs. 28A, 28B show, in a perspective view, a cross-section through the medicament delivery device. In Fig. 28A, the ratchet mechanism is about to engage, in Fig. 28B, it is engaged.

[0288] Figs. 29A, 29B each show an enlarged detail of Fig. 28A and 28B, respectively.

[0289] Fig. 28A shows the situation briefly before the end of the second partial movement, resilient arms 25 are not yet in the inhibiting state. Prior thereto, plunger rod 7 had carried out the second phase of the priming movement, which means that plunger rod 7 had rotated ccw and thus had driven plunger rod guiding member 54 to rotate ccw as well, cf. the curved open arrows in Figs. 28A, 29A.

[0290] In practice, some amount of play has to exist between plunger rod 7 and plunger rod guiding member 54, so that an amount of rotational play exists between the two. Because of the ccw- directed driving of plunger rod guiding member 54 by plunger rod 7, some gaps originating from the play between plunger rod 7 and plunger rod guiding member 54 are closed (”ccw- gaps”; cf. the solid black arrows in Figs. 28A, 29A), whereas other gaps are (wide) open (”cw- gaps”; cf. the dashed arrows in Figs. 28A, 29A). In the situation shown in Figs. 28A, 29A, the second phase of the priming movement is terminated; the abutting with closed ccw-gaps takes place as shown in Figs. 28A, 29A.

[0291] Subsequently, when, near the end of the second partial movement, the ratchet members 25b and 54b engage, the teeth of first ratchet member 25b and the teeth of second ratchet member 54b cooperate to produce a cw rotation of plunger nut guiding member 54, as indicated by the curved open arrows in Figs. 28B, 29B. Accordingly, the ccw-gaps open up (cf. the solid black arrows in Figs. 28B, 29B), whereas the cw-gaps reduce (cf. the dashed arrows in Figs. 28B, 29B). Depending on circumstances, the cw-gaps may even close (not illustrated). For example, the teeth could be designed to be wider in order to achieve a larger cw rotation angle in reaction to the engagement.

[0292] Since plunger rod 7 is forced cw during expelling of a dose of the medicament, the described reduction of the cw-gap effects a more precise dosing amount of the first dose, as the cw-gap is smaller after the engagement of the ratchet mechanism.

[0293] As described above, plunger rod 7 is part of plunger rod assembly 101 which in addition comprises a plunger nut 8 (as an auxiliary plunger rod device) shown in Fig. 14 in a transparent fashion to make better visible internal thread 82 which engages with the plunger rod thread 72 of plunger rod 7. At the end of an expelling movement during which both, plunger rod 7 and plunger nut 8 move proximally, forced by drive spring 9, the plunger rod assembly (and thus plunger rod 7 and plunger nut 8) are still proximally forced by drive spring 9.

[0294] However, before mounting the container housing 4, plunger rod 7 can rotate relative to plunger nut 8, which is made use of during mounting of container housing 4, more particularly during the first partial movement. But when, during the second partial movement, the plunger rod fixing mechanism is activated as described above, it blocks a rotatability of plunger rod 7 (relative to the device body 5). In this situation, with the rotation of plunger rod 7 locked, the above-explained (small) distal movement portion of the second partial movement takes place (by virtue of the slope of the second guiding feature, more particularly of sliding face 19a). Accordingly, said distal movement portion causes the medicament container 3 and thus also the plunger 31 to move distally (medicament container 3 is stationary in container housing 4), and thus, plunger 31, abutting the proximal end of plunger rod 7, forces plunger rod 7 and therewith also plunger nut 8 to move distally - against the force exerted by drive spring 9. And, as a consequence, the pre-bias of drive spring 9, which has been mentioned above already, is caused.

[0295] Therefore, as soon as the septum 32 is perforated by a needle device (cf. step A above), such as a cannula of the needle assembly 15, drive spring 9 moves the plunger rod assembly 101 proximally, causing plunger rod 7 to move plunger 31 proximally. Thus, clearances are removed, and a small portion of the medicament is likely expelled.

[0296] However, in instances it can be undesirable to apply pressure to the medicament, at least for long time periods. In such cases, the slope of the second guiding structure 19 can be zero or can even run along the opposite direction, so that the container housing 4 moves towards proximally during the second partial movement.

[0297] The embodiments described herein have the generally optional property that the coupling of the plunger rod thread 72 on the one hand and the internal thread 82 on the other hand is subject to a clearance, as explained above. This can avoid subjecting the medicament to pressure after expelling of a dose.

[0298] In view of the fact that plunger rod 7 rotates while abutting plunger 31, namely during the second phase of the priming movement, providing a spinner can reduce friction. Fig. 27 shows, in a strongly schematized way, a cross-section through a detail of plunger rod 7 with a spinner 73 mounted to its proximal end. Spinner 73 is snapped onto plunger rod 7 and is rotatably mounted by forming a rotational bearing between plunger rod 7 and spinner 73. An abutting of plunger rod 7 and plunger 31 in such an embodiment with a spinner is an indirect abutting (via spinner 73).

[0299] Other Priming Mechanism

[0300] It is also possible to implement a different priming mechanism. This other priming mechanism will be explained below with reference to Figs. 54A to 61D. In this priming mechanism, the priming is accomplished by the user turning a cap 6 of the medicament delivery device 2 (cf. Figs 54A. 54B), wherein it can be provided that this turning (and priming) is necessarily carried out by the user, namely in order to be able to expel a first dose of the medicament. And on the other hand, it can be provided that the medicament is not exerted to pressure effected by the plunger rod during its shelflife, more particularly in the time between sealing the medicament container 3 and briefly before the first use.

[0301] Figs. 54A, 54B show, in perspective views, the cap 6, in full and a detail of its distal end, respectively.

[0302] Figs. 55A, 55B, 55C show, in perspective views, container housing 4, in full and details of its distal end, respectively. Container housing 4 has, in this embodiment, some further features (compared to the embodiment described herein otherwise), as does device body 5, which is shown, in part, in a perspective view in Fig. 56. Most of these features are present two times, as shown in the figures, arranged with 180° rotational symmetry, for increased stability. It would be possible to provide some or all of the features merely once or even three times, e.g., with 120° rotational symmetry. Fig. 57 shows, in a side view, medicament delivery device 2 in an intermediate state in which it is handed to a user.

[0303] The bent arrows in Figs 54A, 55A, 56 symbolize the first sense of rotation.

[0304] With reference to Figs. 54A, 54B, cap 6 is generally tube shaped, with a closed proximal end and comprises a slit 670 and distally adjacent slit 670 a cam curve member 650, also referred to as cap control cam member. Cam curve member 650 comprises, along a section of a circumference, three sections which adjoin one another in the first sense of rotation, namely, an attachment section 651, an intermediate section 652 and a removal section 653. Intermediate section 652 protrudes radially inwardly relative to attachment section 651 and removal section 653.

[0305] At its distal end, cap 6 has a planar distally facing contact surface 660 extending over the full circumference, also referred to as generally distally facing first structure.

[0306] At its inner surface, cap 6 has a coupling ledge 690 running along a longitudinal direction.

[0307] With reference to Figs. 55A, 55B, 55C, container housing 4 has at its outer surface a coupling groove 490 running along a longitudinal direction, to cooperate with coupling ledge 690, so as to rotationally couple cap 6 and container housing 4 while allowing relative axial movements of the two parts.

[0308] Container housing 4 comprises a cam curve member 450, also referred to as mounting cam member, which comprises, along a section of a circumference, three sections which adjoin one another in the first sense of rotation, namely, an attachment section 451, an intermediate section 452 and a final section 453, wherein between intermediate section 452 and final section 453, there is slanted section 455. Attachment section 451 forms an opening, whereas intermediate section 452 and removal section 453 form proximally facing abutment rims, wherein final section 453 protrudes, with reference to a longitudinal coordinate, further towards proximally than intermediate section 452 by a pre-defined axial distance. Slanted section 455 forms a slanted rim interconnecting the two sections 452, 453.

[0309] Container housing 4 comprises a planar proximally facing contact surface 460 extending over the full circumference, also referred to as generally proximally facing first structure 460, which cooperates with contact surface 660 by abutting one another when cap 6 is attached to container housing 4. Furthermore, regarding the cooperation of container housing 4 with device body 5, container housing 4 comprises a distally facing first structure 410 which comprises bumps 410b as spacers, and it comprises recessed sections 415 and a distally facing second structure 420. And it comprises a second blocking structure 480 which comprises three blocking structures which follow one another on a section of a circumference in the first sense of rotation, namely an initial blocking structure 481, an intermediate blocking structure 482 and a final blocking structure 483. Each of the blocking structures 481, 482, 483 comprises a longitudinally running groove at an inner side of container housing 4.

[0310] With reference to Fig. 56, device body 5 comprises, at its proximal end, a mounting protrusion 550, also referred to as mounting abutment member or as cap control abutment member, which cooperates with cam curve member 450 and with cam curve member 650.

[0311] Furthermore, regarding the cooperation of device body 5 with container housing 4, device body 5 comprises a proximally facing first structure 510 which comprises bumps 510b as spacers, and it comprises recessed sections 515 and a proximally facing second structure 520. And it comprises a first blocking structure which comprises a ledge 580 to cooperate with the three blocking structures 481, 482, 483 to allow, when engaged, a rotation of container housing 4 relative to device body 5 in the first sense of rotation (ccw), while blocking a rotation of container housing 4 relative to device body 5 in the opposite sense of rotation (cw).

[0312] Now, final steps of assembling the medicament delivery device 2 are described, as well as the steps to be carried out by the user before a first dose of medicament can be expelled.

[0313] In an unmounted state, container housing 4 and cap 6 are separate from medicament partial device 2’ (cf. Fig 1) and, accordingly, from device body 5.

[0314] To change from the unmounted state to an intermediate state, container housing 4 and cap 6 are firstly, together or one after the other, moved coaxially relative to device body 5 to reach an initial state, and are subsequently jointly rotated by a pre-defined angle, e.g., by 250, in the first sense of rotation, which, in the described example, is ccw.

[0315] In this intermediate state, the medicament delivery device 2 is handed to the user who jointly rotates container housing 4 and cap 6 by another pre-defined angle, e.g., also by 250, in the first sense of rotation (ccw) to change to a mounted state. In contrast to the intermediate state, it is possible in the mounted state to remove cap 6 from the rest of medicament delivery device 2, namely by moving it towards proximally. This way, a ready state is reached in which medicament delivery device 2 is ready for expelling a first dose (cap 6 removed).

[0316] The priming takes place when changing from the intermediate state to the mounted state.

[0317] Figs. 58A, 58B, 58C show a detail of the medicament delivery device 2 in a perspective view.

[0318] Figs. 59A, 59B, 59C show a similar detail of the medicament delivery device 2 in a perspective view, wherein container housing 4 is not shown.

[0319] Figs. 60A, 60B, 60C show again a similar detail of the medicament delivery device 2 in a perspective view, wherein cap 6 is not shown.

[0320] In Figs. 58A, 59A, 60A, medicament delivery device 2 is in the initial state.

[0321] In Figs. 58B, 59B, 60B, medicament delivery device 2 is in the intermediate state.

[0322] In Figs. 58C, 59C, 60C, medicament delivery device 2 is in the mounted state.

[0323] When cap 6 is assembled with container housing 4, cap 6 encloses a proximal portion of container housing 4 and contact surface 460 abuts contact surface 660. This is the case in the initial state, in the intermediate state and in the mounted state. Cap 6 can be assembled with container housing 4 after assembling container housing 4 with device body 5 or already before that, i.e. already in the unmounted state and thus before changing from the unmounted state to the initial state.

[0324] In order to change from the unmounted state to the initial state (Figs. 58A, 59A, 60A), the distal end of device body 5 is inserted into the proximal ends of cap 6 and of container housing 4, which is enabled by attachment section 651 and attachment section 451 letting mounting protrusion 550 pass, attachment section 651 being recessed accordingly and attachment section 451 forming a suitable opening. Cap 6 and container housing 4 are moved towards distally coaxially with and relative to device body 5.

[0325] To change to the intermediate state, cap 6 and container housing 4 are jointly rotated ccw. This way, mounting protrusion 550 abuts intermediate section 652 of cam curve member 650 of cap 6 and intermediate section 452 of cam curve member 450 of container housing 4, so that a movement towards proximally of cap 6 and container housing 4 is impeded.

[0326] Furthermore, in the initial state and in the intermediate state, a movement towards distally of container housing 4 (relative to device body 5) is impeded by bumps 510b abutting distally facing second structure 420 and by bumps 410b abutting proximally facing second structure 520. Accordingly, there is a well-defined gap present between container housing 4 and device body 5 which is indicated in Figs. 58A, 58B by a pair or arrows. The axial extension of this gap can correspond to the pre-defined axial distance present between intermediate section 452 and a final section 453.

[0327] Just like in the way described further above, plunger rod 7 is rotatable and thus also axially movable in the unmounted state and in the initial state, because resilient arms 25 are not yet pushed inwardly, cf. Fig. 59A. Therefore, plunger 31 abuts the proximal end of plunger rod 7, and plunger rod 7 is pushed towards distally during the change from the unmounted state to the initial state. And the abutting continues also during the change from the initial state to the intermediate state (Figs. 58B, 59B, 60B). In the intermediate state (Fig. 59B) and in the mounted state (Fig. 59C), resilient arms 25 are bent inwardly, thus rotationally locking plunger rod 7. Due to the coupling between plunger rod 7 and plunger nut 8, the rotational locking also causes an axial locking of plunger rod 7. Accordingly, plunger rod 7 cannot move towards distally in the intermediate state and thus cannot move towards distally during transport to the user.

[0328] In the intermediate state, cap 6 and container housing 4 are mounted to the medicament partial device 2’, and plunger rod 7 abuts plunger 31 but does not pressurize it. Accordingly, the medicament is not pressurized during its shelflife.

[0329] The change from the intermediate state to the mounted state is accomplished by the user turning cap 6 and container housing 4 ccw another time, resulting in mounting protrusion 550 sliding along slanted section 455 and changing from abutting intermediate section 452 to abutting final section 453, thus forcing cap 6 and container housing 4 towards distally. This distal movement (priming-enabling movement of container housing 4) is furthermore enabled by the bumps 410b, 510b being received in the recesses 515 and 415, respectively, in the mounted state.

[0330] The bumps 410b, 510b effect that the axial travel towards distally of container housing 4 (and cap 6) effected by the two different axial positions of intermediate section 452 and final section 453, respectively, is well-defined. And, accordingly, also the corresponding axial travel towards distally of plunger 31 relative to device body and thus relative to plunger rod 7 (which is rotationally and axially blocked at this point) is well-defined, such that a very controlled priming can take place in the described way. Furthermore, in the initial state, in the intermediate state and in the mounted state, the ccw rotation of container housing 4 (relative to device body 5) is enabled, whereas a corresponding cw rotation is blocked, namely by ledge 580 being engaged with initial blocking structure 481, intermediate blocking structure 482 and final blocking structure 483, respectively, to form corresponding snap connections, cf. Figs. 61A to 61D.

[0331] Figs. 61A, 61B, 61C, 61D each show a perspective view onto a cross-section through the medicament delivery device 2 and through the medicament delivery assembly 1, respectively, in different states, namely in the initial state (Fig. 61A), in the intermediate state (Fig. 61B), in the mounted state (Fig. 61C) and in the ready state (Fig. 61D), mainly to illustrate the first blocking structure (580) and the second blocking structures (480).

[0332] Thus, the medicament delivery device 2 ensures that a user receiving the medicament delivery device 2 in the intermediate state necessarily carries out the change from the intermediate state to the mounted state - which on the one hand is necessary to remove cap 6 and on the other hand effects the priming.

[0333] Signalling Mechanism

[0334] The described medicament delivery device 2 furthermore generates a signal at the end of each dose delivery (“end click”). This is accomplished by a signalling mechanism, more particularly by the bearing formed by bearing member 160 (as a signalling member) cooperating with bearing seat 180 (of spring stop 11; as a cooperation member). The signal - which can be perceived by the user as a click (audibly) and in a tactile manner - is caused by a movement (signalling movement) of the bearing member 160, which is a movement towards distally. The signalling member (bearing member 160) hits the cooperation member (bearing seat 180), which causes the signal. The energy required for producing the movement of the bearing member 160 is provided by drive spring 9, and the user can repeatedly produce a corresponding bias on the bearing member 160 just by the same user action he / she carries out when loading drive spring 9 to provide the energy for the expelling of the doses, i.e., by the twisting of loading sleeve 12. As has been explained above, the loading (or energizing) of the signalling mechanism is accomplished at the beginning of the loading step, so as to keep the maximum torque required during the loading step low.

[0335] In this regard, bearing member 160 has, at its distal end, a circumferential ridge 170 forming a cam curve 170s and acting as a distance varying feature. And bearing seat 180 has, as a cooperation feature cooperating with circumferential ridge 170, a circumferential ridge 190 forming an approximately identically shaped cam curve 190s as a cam-cooperating structure cooperating with cam curve 170s. Rotation of the ridges 170 and 190 relative to one another causes a change in axial distance of bearing member 160 relative to bearing seat 180.

[0336] Having approximately identically shaped cam curves 170s, 190s can provide improved stability of the bearing in a respective rotational relative position of bearing member 160 and bearing seat 180, namely when the axial distance between bearing member 160 and bearing seat 180 is smallest.

[0337] Prevention of end-click during loading

[0338] Figs. 33A, 33B show bearing member 160 and thus the signalling member, comprising circumferential ridge 170 in two different perspective views.

[0339] Figs. 34A, 34B show spring stop 11 comprising bearing seat 180 and circumferential ridge 190 in two different perspective views.

[0340] Ridge 170 of bearing member 160 and cam curve 170s have a threefold rotational symmetry. Along a circumference of bearing member 160, cam curve 170s has three identical partial cam curves, ranging 120° each, appended one after the other. Each partial cam curve has, extending 120° along a circumference of bearing member 160, a bottom section Si adjacent a sloped section S2 adjacent a top section S3 adjacent a step feature S4.

[0341] Ridge 190 of bearing seat 180 of spring stop 11 has a cam curve 190s which corresponds to the one of ridge 170. It also has threefold rotational symmetry and comprises three partial cam curves with similar constituents (bottom section Si’, sloped section S2’, top section S3’, step feature S4’) corresponding to those of cam curve 170s. However, whereas at cam curve 170s, the top section S3 is protruding (towards distally) from bearing member 160, top section S3 of cam curve 190’ is recessed (towards distally) in bearing seat 180 and so on.

[0342] Drive spring 9 forces bearing member 160 towards distally against bearing seat 180 so that they abut one another. Bearing seat 180, being a part of spring stop 11, is rotationally fix (affixed to the base assembly).

[0343] Depending on the rotational relative position of bearing member 160 and bearing seat 180, the axial distance between bearing member 160 and bearing seat 180 changes. Due to the threefold rotational symmetiy of both cam curves 170s, 190s, also their contact points or contact surfaces have a threefold rotational symmetry. This way, tilts and wobbles between bearing member 160 and bearing seat 180 (and thus between the signalling member and the cooperation member) can be avoided. Irrespective of their rotational relative position, bearing member 160 and bearing seat 180 have identical axial orientations, as drive spring 9 forces bearing member 160 towards distally to abut bearing seat 180 (and thus spring stop 11), the abutting always taking place with threefold rotational symmetry.

[0344] Bearing member 160 is rotationally coupled to plunger nut 8 by a control mechanism which comprises, as a first control member, an edge 165c (also referred to as control edge) present in a sleeve part 161 of bearing member 160 and delimiting an opening 165; and a protrusion 87 (also referred to as control protrusion) comprised in plunger nut 8 as a second control member which cooperates with edge 165c, cf. Figs. 31, 33A, 33B. More particularly, edge 165c of bearing member 160 cooperates with protrusion 87 by abutting one another while protrusion 87 slides along edge 165c. Edge 165c runs generally longitudinally, but has a bend 165b.

[0345] Figs. 35A to 35E show, in perspective views, a subassembly of the medicament delivery device in different stages regarding loading / expelling. Fig. 35A shows the initial loading state (o° loaded); Fig. 35B shows the situation after a 180° loading rotation; Fig. 35C shows the situation after a 250° loading rotation; Fig. 35D shows the situation after a complete 360° loading rotation, i.e. in a final loading state; and Fig. 35E shows the situation after an expelling of a dose has taken place.

[0346] Fig. 36 shows, in a perspective view, bearing member 160 assembled with spring stop 11 (and more particularly with bearing seat 180), wherein bearing member 160 (as the signalling member) is in a start position, as will be explained below.

[0347] Before loading starts, e.g., after a dose has been expelled, bearing member 160 and bearing seat 180 are positioned close to one another as shown in Fig. 35A (minimum axial distance of bearing member 160 and bearing seat 180). During loading (step B.), the rotation of plunger nut 8 (caused by a user twisting loading sleeve 12 in a first sense of rotation) causes a rotation in the first sense of rotation of bearing member 160, as symbolized by the arrow in Fig. 35A, because protrusion 87 of plunger nut 8, acting as a second control member, cooperates accordingly with edge 165c, respectively, acting as a first control member. At this stage, protrusion 87 abuts a proximal longitudinal portion of edge 165c.

[0348] Fig. 35B shows the situation after 180° of loading rotation. Because of the coupling between rotations and translation of plunger nut 8 relative to device body 5, plunger nut 8 is at this stage located further towards distally, now abutting a distal longitudinal portion of edge 165c. Protrusion 87 has rotated bearing member 160, but since it has passed bend 165b in the meantime, the angle by which bearing member 160 has rotated is smaller than the angle by which plunger nut 8 has rotated. In other words: The control mechanism (and in particular the bend 165b) has effected that the loading rotation (in the first sense of rotation) of bearing member 160 during the loading movement is reduced relative to the rotation (in the first sense of rotation) of plunger nut 8.

[0349] It is reduced by an angle referred to as difference angle of rotation. Furthermore, the axial distance between bearing member 160 and bearing seat 180 is increased; top sections S3 of bearing member 160 abut the bottom sections Si’ of bearing seat 180.

[0350] It is obvious (from the threefold rotational symmetry) that, if the axial distance between bearing member 160 and bearing seat 180 were determined by the cam curves 170s, 190s only, the minimal axial distance would be reached three times during a full (360°) loading; namely at 0° (as shown in Fig. 35A) and at 120° and at 240° rotational relative position of bearing member 160 and bearing seat 180. And of course, during a 360° rotational relative movement of bearing member 160 and bearing seat 180, the axial distance between bearing member 160 and bearing seat 180 would in that case describe three times the same variation.

[0351] However, this can be undesirable and can be avoided by a support mechanism, as described below.

[0352] In Fig. 35C, the state at a 250° loading rotation is illustrated, where there is no abutting of bearing member 160 and bearing seat 180 - because of said support mechanism. Bearing member 160 and bearing seat 180 are at a maximum axial distance.

[0353] In Fig. 35D, a full 360° loading has been accomplished. Because of bend 165b of edge 165c, the rotational relative position of bearing member 160 and bearing seat 180 in this stage is not 360° (relative to the situation at o° loading, cf. Fig. 35A), but is lower than 360° by said difference angle of rotation - which is determined by bend 165b, more particularly by the difference in azimuthal position (regarding device axis A) of the proximal longitudinal portion of edge 165c and the distal longitudinal portion of edge 165c. In other words, the loading step ends already before bearing member 160 has rotated full 360°.

[0354] In the stage (cf. Fig. 35D), bearing member 160 and bearing seat 180 are abutting one another at the maximum axial distance; their axial distance is maximum. In this situation, the top sections S3 (close to step features S4) abut base sections Si’ at their ends close to the respective step features S4’. The arrow in Fig. 35D points at this abutting.

[0355] A further rotation (of plunger nut 8, in the first sense of rotation; and of bearing member 160, respectively) would cause an abutting of bearing member 160 and bearing seat 180 in the position with minimal axial distance. But this does not happen at this stage, because this is, at this stage, prevented, as explained below.

[0356] Fig. 35D at the same time shows the initial situation for the expelling of a dose (cf. step C.). The medicament delivery device 2 is in the loaded state, and bearing member 160 (as the signalling member) is in a charged position, at maximum distance between bearing member 160 and bearing seat 180.

[0357] To stabilize the rotational position of bushing member 160 relative to bearing member 180 (and spring stop 11, respectively), opening 165 has, towards its distal end, a narrowing i6sn (cf. Fig. 33B).

[0358] Fig. 35E illustrates the stage after a dose has been expelled. During expelling, plunger nut 8 (along with plunger rod 7) moves solely axially (towards proximally) - due to plunger rod 7 being rotationally coupled to device body 5 (via plunger rod guiding member 54). Protrusion 87 initially slides along the distal longitudinal portion of edge 165c; the rotational relative position of bearing member 160 and bearing seat 180 remains constant. But sliding along bend 165b, however, the cooperation of protrusion 87 and edge 165c effects a rotation of bearing member 160 - in the first sense of rotation, by the same difference angle of rotation as has been mentioned before (which was “stolen” during loading by the offset effected by bend 165b as explained above). This happens towards the end of the expelling.

[0359] This rotational movement (also referred to as initiating movement) of bearing member 160 takes bearing member 160 from the charged position (cf. Fig. 35D) to a start position which is symbolized in Fig. 36. This is a start position for the signalling movement of bearing member 160 (as the signalling member). Signalling movement is a (rapid) movement of bearing member 160 towards distally to hit onto bearing seat 180 (as the cooperation member) - causing the signal (end click) at the end of dose delivery.

[0360] After the initiating movement, bearing member 160 and bearing seat 180 do not block anymore a distal movement (the signalling movement) of bearing member 160; the mutual support of the cam structures 170s and 190s in the charged position is lost. Instead, in a short time, and forced by drive spring 9, bearing member 160 moves towards distally and hits bearing seat 180. More particularly, first abutting surfaces 160a, e.g., the distally facing surfaces of the bottom sections Si of bearing member 160, hit second abutting surface 180a, e.g., the proximally facing surfaces of the bottom sections Si’ of bearing seat 180. The abutting of the first and second abutting surfaces 160a, 180a generates a click sound and can also be perceived in a tactile manner. Bearing member 160 ends up in a discharged positions - where the force exerted to it by drive spring 9 is smaller than in the charged position and in the start position. The energy that was stored in drive spring 9 due to the maximum axial distance of bearing member 160 and bearing seat 180 achieved by the rotation of the bearing member 160, has been used for accelerating bearing member 160 against bearing seat 180.

[0361] Thus, the control mechanism, more particularly edge 165c as the first control member and protrusion 87 as the second control member cooperate to unblock the signalling movement at the end of the expelling of each dose by causing the initiating movement. And this is accomplished by deriving from the respective expelling movement (which is a movement towards proximally of plunger rod arrangement 101), at the end of the respective expelling movement, an extra rotation of bearing member 160 as the signalling member in the first sense of rotation about the difference angle of rotation mentioned above.

[0362] The signalling movement takes the signalling mechanism back to the initial situation for the loading, which is illustrated in Fig. 35E.

[0363] As mentioned before, there would be two signals generated during loading, because of the threefold symmetry of the cam curves 170s, 190s. In order to avoid these, another mechanism, referred to as support mechanism, is implemented in the medicament delivery device. It is explained with reference to Figs. 33A, 33B, 34A, 34B, 37.

[0364] Fig. 37 shows a perspective view of a cross-section through bearing member 160 assembled with spring stop 11, at 250° locking rotation (like in Fig. 35C).

[0365] The support mechanism comprises a circumferential support ridge 166 as a first support structure and two support protrusions 188 present, too, at a circumference, as a second support structure. Support ridge 166 is comprised in bearing member 160, whereas support protrusions 188 are comprised in bearing seat 180. However, in other implementations, this is vice versa. And the support protrusions 188 can alternatively be implemented as a more ridge-like structure rather than as separate protrusions having a circumferentially short extension as illustrated. Support ridge 166 can form a cam curve. And also the second support structure can form a cam curve. The radius of the circumference at which support ridge 166 and support protrusions 188 are arranged, is smaller than the radius of the circumference at which circumferential ridge 170 and circumferential ridge 190 of the signalling mechanism are arranged. In other implementations this is vice versa.

[0366] Support ridge 166 comprises two identical portions having a recessed section Ti followed by a sloped section T2 followed by a top section T3. Support protrusions 188 have a proximally facing support face 189 each, to abut a respective top section T3 each.

[0367] Support ridge 166 and support protrusions 188 cooperate to not block the signalling movement at the end of the expelling movement and thus to not block the signalling movement in one of three 120° sections of rotational relative orientation of bearing member 160 and bearing seat 180, so that the generation of the end click is not hampered by the support mechanism. In that 120° range, the protrusions 188 face the recessed sections Ti. However, support ridge 166 and support protrusions 188 furthermore cooperate to block the signalling movement (and thus the end click) in the remaining two 120° sections of rotational relative orientation of bearing member 160 and bearing seat 180, i.e. in the remaining 240° of rotational relative orientation of bearing member 160 and bearing seat 180. This is accomplished by support ridge 166 abutting support protrusions 188 in that range, to keep bearing member 160 (as the signalling member) in the charged position, as shown in Figs. 35C, 37. More particularly, support faces 189 abut top sections T3 for that purpose.

[0368] Activation

[0369] Fig. 38A shows a view onto a cross-section of a detail of the medicament delivery device 2, wherein the auxiliary plunger rod device 8 is in a loaded position, i.e. after a user has caused a movement of the auxiliary plunger rod device 8 in the distal direction relative to the base assembly and to the main plunger rod device. In the loaded position, the medicament delivery device 2 is ready for the user to initiate expelling of the medicament from the medicament container (not shown). In the embodiment shown in Fig. 38A, the auxiliary plunger rod device 8 comprises two locking arms, i.e. first locking arm 85a and second locking arm 85b. Each locking arm 85a, 85b has a locking protrusion 86a, 86b on a proximal end of the respective locking arm 85a, 85b. The base assembly has a spring stop 11 comprising a first shelf 51a and a second shelf 51b. Each shelf 51a, 51b comprises a support surface configured to engage with one of the locking protrusions and a ridge running in a circumferential direction of the device 2, as will be described in more detail for Fig. 38B showing a detailed view of image section B in Fig. 38A. The activation mechanism of the medicament delivery device 2 comprises an activation button 13 with two activation wings 133 radially inside of loading sleeve 12. Each activation wing 133 serves as an interacting element configured to cooperate with one of the locking protrusions 86a, 86b to flex the locking arms 85a, 85b in the flexing direction until the locking protrusions 86a, 86b get out of engagement with the shelves 51a, 51b which, accordingly, function as locking structures.

[0370] Fig. 38B shows a detailed view of image section B in Fig. 38A. Each of the two shelves comprises a support surface and a ridge, as illustrated in Fig. 38B for the second shelf 51b, i.e. the second shelf 51b comprises a second support surface 53b for engaging with the second locking protrusion 86b of the second locking arm 85b and a second ridge 52b running in a circumferential direction of the medicament delivery device. Each of the two locking protrusions comprises a contact surface 85c for being contacted by one of the interacting elements, as illustrated in Fig. 38B for the second locking protrusion 86b of the second locking arm 85b. The contact surface 85c of the second locking protrusion 86b runs at an angle relative to the proximal end of the activation wing 133, as illustrated by the dashed line in Fig. 38B. The contact surface 85c forms an angle P of approximately 25 degrees with the device axis A, as illustrated in Fig. 38B with the aid of the dotted line which is aligned parallel to device axis 5 and which is coplanar with the dotted line and with device axis 5. The second support surface 53b has a radial dimension W of approximately 3 mm and the activation wing 133 has a radial dimension T of approximately 4 mm. Thus, the radial dimension T of the activation wing 133 exceeds the radial dimension W of the corresponding second support surface 53b. In other words, the radial dimension of the second support surface 53b is smaller than the radial dimension of the activation wing 133. The same applies to the first support surface 53a.

[0371] Fig. 38C shows a cross-section of a detail of the medicament delivery device 2 in a loaded state just after a user has pressed activation button 13 with activation wings 133 towards proximally so that the proximal ends of each of the two activation wings 133 abut one of the support surfaces 53a, 53b of the shelves 51a, 51b. Movement of the activation wings 133 towards proximally, the flexing direction of the locking arms 85a, 85b, which is radially inward, as well as displacement of the plunger assembly by the biasing member (not shown) towards proximally after the locking protrusions 86a, 86b have been pushed off their respective shelves 51a, 51b is illustrated in Fig. 38C by black arrows. As can be seen from Fig. 38C, the activation wings 133 protrude the ridges 52a, 52b of the respective shelves 51a, 41b in the flexing direction when the activation wings 133 abut the respective support surfaces 53a? 53b. This ensures that the locking protrusions 86a, 86b are pushed off, i.e. get out of engagement with, their respective support surfaces 53a, 53b so that the plunger rod assembly is released and the biasing member displaces the plunger rod assembly towards proximally.

[0372] As can be seen in Figs. 38A, 38C, loading sleeve 12 is limited regarding its movement towards proximally by device body 5. More particularly, loading sleeve 12 has a proximally facing circumferential shoulder face 12a which cooperates with a distally facing circumferential rear face 5r of device body 5. Furthermore, loading sleeve 12 has at its proximal end a sleeve 12s with a skirt face i2f (cf. Figs. 18, 52) which, as a bearing surface, provides radial position control for loading sleeve 12 with respect to device body 5, in particular by cooperating with an inside surface of device body 5. Sleeve 12s is located inside a rear bore 5b of device body 5 (cf. Fig. 5A).

[0373] Regarding movement of loading sleeve 12 towards distally, but also towards proximally, loading sleeve 12 cooperates with spring stop 11. More particularly, retention ledges I2r of loading sleeve 12 (cf. Fig. 18) cooperate with a retention rim nr of spring stop 11 (cf.

[0374] Figs. 32A, 34B) which form a snap fit connection between loading sleeve 12 and spring stop 11.

[0375] Accordingly, detachment of loading sleeve 12 from the medicament delivery device is prevented, and axial movements of loading sleeve 12 (relative to device body 5) are limited.

[0376] Assembly

[0377] During assembly of medicament delivery device 2, the locking arms 85a, 85b (also referenced as “85” only) can be of assistance. This is explained with reference to Figs. 39Ato 39D and Figs. 40 to 42. As will become clear below, locking arms 85a, 85b can also be referred to as snap members.

[0378] Figs. 39A to 39D show illustrations of different stages during assembly of a subassembly 2a of medicament delivery device 2, in a perspective view.

[0379] Figs. 40 to 42 show illustrations of the stages shown in Figs. 39B to 39D, respectively, wherein each time, a detail of the subassembly 2a is illustrated.

[0380] In Fig. 39A, drive spring 9 (as a biasing member) is shown mounted to plunger nut 8. In Figs. 39B and 40, bearing member 160 is shown during an assembling movement, sliding on respective contact surfaces 85c of locking arms 85. In Figs. 39C and 41, bearing member 160 is in a position where it is pushed beyond locking arms 85, and in Figs. 39D and 42, bearing member 160 is forced by drive spring 9 to abut locking arms 85. The subassembly 2a comprises plunger nut 8, drive spring 9 and bearing member 160.

[0381] The assembly of subassembly 2a is a part of the assembly of medicament delivery device 2. For example, firstly, subassembly 2a can be assembled, and thereafter, subassembly 2a (in its assembled state) is assembled with further parts of the medicament delivery device 2.

[0382] We now describe the assembly of subassembly 2a.

[0383] In a first step, drive spring 9 is mounted to plunger nut 8 by sliding it onto and along a shaft part 8s of plunger nut 8, towards proximally (Fig. 39A). Drive spring 9, with its proximal end, can then abut a first abutting structure 80 of plunger nut 8, e.g., a distally facing circumferential surface adjoining and radially protruding shaft part 8s. Sleeve part 161 is thus slid into drive spring 9.

[0384] For increased clarity, in Figs. 39A to 39D, the proximal end of drive spring 9 is illustrated as having a distance to the first abutting structure 80 instead of abutting it.

[0385] In a second step, bearing member 160 is slid onto and along shaft part 8s in an assembling movement towards proximally, during which it abuts a distal end 9d of drive spring 9 and thus compresses drive spring 9. More precisely, bearing surface i6of (as a second abutting structure) abuts distal end 9d.

[0386] Bearing member 160 is generally tube-shaped, and sleeve part 161 forms a proximal portion of bearing member 160 and serves as a radial support for drive spring 9 (close to its distal end 9d).

[0387] In Figs. 39B and 40, an inside surface or edge of bearing member 160 slides on contact surface 85c of locking arm 85 and flexes it radially inwardly. Contact surface 85c is, more particularly, comprised in locking protrusion 86. Contact surface 85c is tapered towards distally, cf. also Fig. 38B (angle therein).

[0388] Moving bearing member 160 further towards proximally (during the assembling movement) and thus compressing drive spring 9 further, bearing member 160 passes locking arms 85 so that they are not anymore forced by bearing member 160 to be flexed inwardly. This is shown in Figs. 39 and 41, where an axial distance between bearing member 160 and locking arms 85 exists. More particularly, there is an axial distance between a first blocking face 160s of bearing member 160 and a second blocking face 8sf of locking arm 85, more particularly of locking protrusion 86.

[0389] At that point, locking arms 85 are thus back in an unflexed (relaxed) state. First blocking face 160s is, in the illustrated case, embodied by circumferential support ridge 166 (cf. above), and second blocking face 85! is, in the illustrated case, embodied by a proximally facing end surface of locking protrusion 86.

[0390] When pushing bearing member 160 towards proximally is terminated at this point and bearing member 160 is thus released, the force of (compressed) drive spring 9 forces bearing member 160 towards distally - until bearing member 160 (more particularly: first blocking face 160s) abuts locking arms 85 (more particularly: second blocking faces 8sf).

[0391] Thus, bearing member 160 and locking arms 85 cooperate in a snap fit fashion, and - in the assembled state of subassembly 2a - they secure drive spring 9 in a compressed state (drive spring 9 abutting, at its proximal end, first abutting structure 80 of plunger nut 8 and, at its distal end, second abutting structure i6of of bearing member 160). This assembled state of subassembly 2a in which first blocking face 160s abuts second blocking face 85! is shown in Figs. 39D and 42.

[0392] In this assembled state, bearing member 160 is forced towards distally by drive spring 9, while a (further) movement towards distally is blocked by locking arms 85.

[0393] Accordingly, drive spring 9 is secured in subassembly 2a in this assembled state, thus constituting an intermediate securement of drive spring 9 regarding the assembly of the medicament delivery device 2.

[0394] At some point during the further assembly of the medicament delivery device 2, spring stop 11 will be brought into contact with bearing member 160 and will move bearing member 160 towards proximally (thus compressing drive spring 9 further). In the assembled medicament delivery device 2, the two form a glide bearing. More particularly, for constituting a bearing, bearing seat 180 of spring stop 11 (cf. Figs. 34A, 34B) cooperates with bearing member 160.

[0395] In the assembled medicament delivery device 2, bearing member 160, accordingly, is positioned further towards proximally than in the assembled state of subassembly 2a. The situation may then, e.g., look like illustrated in Figs. 39C and 41, or the axial distance between locking arms 85 and bearing member 160 is different from what is shown in Figs. 39C and 41.

[0396] Fig. 43 shows a detail of subassembly 2a assembled with spring stop 11, which is shown in a transparent fashion, wherein the medicament delivery device 2 is in the loaded state. In this state, the axial distance between locking arms 85 and bearing member 160 is particularly large. Termination of Loading

[0397] Further above, various aspects of the loading mechanism have already been described. However, in the following, another aspect of the loading mechanism will be described, with reference to Figs. 44 to 46 and with further reference to Figs. 35A, 35B, 35C, 35E.

[0398] It can be desirable to have an automatism which ensures that the user cannot overrotate the loading sleeve 12 when loading (or reloading), i.e. an automatism which inhibits the loading action to exceed a rotation of 360° (or, in other embodiments, 180°) of loading sleeve 12. On the other hand, it shall be possible for the user to turn loading sleeve 12 again (for another 360° - or 180°) after a dose has been delivered (except in case the last dose has been delivered, cf. above).

[0399] In the described embodiment, this is accomplished making use of the loading movement carried out by plunger nut 8, more particularly of the fact that plunger nut 8 carries out a combined axial and rotational movement during loading, axial towards distally and rotational in the first sense of rotation.

[0400] Fig. 44 shows a perspective view of spring stop 11 assembled with plunger nut 8 in the loaded position, wherein spring stop 11 is shown in a transparent fashion. The first sense of rotation is illustrated by the bent arrow in Fig. 44. In this loaded state, protrusion 87 (acting as a first blocking feature) abuts support protrusion 188 (acting a second blocking feature). Since spring stop 11 is rotationally fixed to device body 5, the user cannot twist loading sleeve 12 any further (which would more particularly be a turning beyond 360°), as loading sleeve 12 is rotationally fixed to plunger nut 8 by cooperation of ledge 88 and ledges 121.

[0401] Of course, the first blocking feature could alternatively also be embodied separately from protrusion 87. In other words, two separate items could be used for contributing to the control of the movement of bearing member 160 and for preventing overrotation of loading sleeve 12, respectively. And similarly, the second blocking feature could alternatively also be embodied separately from support protrusion 188. In other words, two separate items could be used for contributing to the support mechanism (suppressing undesired signal generation during loading) and for preventing overrotation of loading sleeve 12, respectively.

[0402] A contact face 87c of protrusion 87 abuts a contact face 188c of support protrusion 188, as emerges from Fig. 45 which shows, in a cross-section and viewing towards distally, spring stop 11 assembled with plunger nut 8 in the loaded position, but where a small gap is shown between the contact faces 87c and 188c for increased clarity (or, in an alternative view, as if the loaded state had just not yet have been reached in Fig. 45).

[0403] During loading before the loaded position is reached (cf., e.g., Figs. 35A to 35C) or during expelling (cf., e.g., Fig. 35E), there is no inhibition of a rotation in the first sense of rotation of plunger nut 8 (relative to device body 5) by cooperation (abutting) of the first and second blocking features (protrusion 87 and support protrusion 188). Accordingly, twisting loading sleeve 12 (in the first sense of rotation) is not impeded by cooperation (in particular: abutting) of the first and second blocking features outside the loading position and, more particularly, in the unloaded position. The latter enables a reloading after a dose delivery.

[0404] In the illustrated embodiment, protrusion 87 is a radially outwardly protruding protrusion of plunger nut 8, and protrusion 188 is a radially inwardly protruding protrusion of spring stop 11. The contact faces 87c, 188c are transversely facing, and contact face 87c faces generally towards the first sense of rotation (in Fig. 45 illustrated by the thick bent arrow), whereas contact faces 188c faces generally away from the first sense of rotation.

[0405] Since considerable forces, exerted by the user, may act on the protrusions 87, 188 at the end of a loading step, e.g., in case the user has not recognized that the loading is already terminated and that the loaded position has already been reached, the contact surfaces 87c, 188c maybe shaped and aligned, respectively, to better withstand such forces. It is possible to achieve that the material involved is then strained less, and that larger forces (or rather torques) can be withstood. This is schematically illustrated in Fig. 46 showing a detail of a cross-section (viewing towards distally) through spring stop 11 assembled with plunger nut 8 in the loaded position. The first sense of rotation is illustrated by the thick bent arrow in Fig. 46. Protrusions 87 and 188 abut at their contact surfaces 87c and 188c, respectively, forming a contact interface 875. Contact interface 875 is aligned to face transversely, and a transversal direction lying in contact interface 875 is symbolized by the dotted line in Fig. 46 which extends beyond contact interface 875 in two directions.

[0406] Both protrusions 87 and 188 are undercut at their respective contact faces 87c and 188c, respectively.

[0407] A radial direction passing centrally through contact interface 875 is illustrated by the dashed line in Fig. 46. As indicated by the thin bend arrow in Fig. 46, contact interface 875 is inclined with respect to said radial direction. Under these circumstances, when a user tries to twist loading sleeve beyond 360° and thus to force plunger nut 8 beyond the loaded position, protrusion 87 will be forced to move radially outwardly, and protrusion 188 will be forced to move radially inwardly, and thus forced to increase the surface area of contact interface 875. This can be readily understood by decomposing the involved forces: The respective forces acting on the respective protrusion (87 and 188, respectively) are perpendicular to the respective contact surface (87c and 188c, respectively), and can be decomposed into a tangential force component and a radial force component - and because of the inclination of contact interface 875 (and of the contact surfaces 87c and 188c), the radial force component is non-zero. And the radial force component is directed radially outwardly for the outwardly protruding protrusion, i.e. for protrusion 87, and is directed radially inwardly for the inwardly protruding protrusion, i.e. for protrusion 188.

[0408] This way of shaping or aligning of contact interface 875 can counteract tendencies of the protrusions 87, 188 to slip one over the other, thus making it more difficult for a user to overrotate loading sleeve 12.

[0409] As has been explained further above, plunger nut 8 and loading sleeve 12 are rotationally coupled (and axially moveable one relative to the other) by ledge 88 cooperating with ledge 121. Therefore, it can alternatively or in addition, be made more difficult for a user to overrotate loading sleeve 12 by structuring the herein involved protrusions (ledge 88 and ledge 121) similarly to the ones just discussed (protrusions 87, 188), resulting the already described effects.

[0410] Figs. 47A and 47B show loading sleeve 12 assembled with plunger nut 8 in the unloaded state (47A) and in the loaded state (47B), respectively, wherein loading sleeve 12 is illustrated in a transparent fashion.

[0411] Fig. 48 shows a view towards distally onto a cross-section through loading sleeve 12 assembled with plunger nut 8 in the loaded state. Protrusion 88 (acting as a first feature) abuts ledge 121 (acting a second feature).

[0412] The abutting contact faces (also referred to as contacting faces) are referenced 88c and 121c, the contact interface (also referred to as contacting interface) is referenced 875’. The angle by which contacting interface 875’ is inclined with respect to a radial direction (dashed in Fig. 48) passing centrally through contacting interface 875’ is symbolized at the two small arrows in Fig. 48. REVISED EMBODIMENTS

[0413] In the following, several parts and features will be described which can replace corresponding parts and features described above. For simplicity and conciseness, those parts and features shall be referred to as “revised”. And an embodiment implementing one or more of the revised parts and features shall be referred to as a revised embodiment. The remaining parts and features can be implemented in an above-described way or differently.

[0414] Revised Mounting Mechanism and Plunger Rod Fixing Mechanism

[0415] Figs. 62A to 62D show a revised device body 5’ in different perspective views, Figs. 63A and 63B show a revised container housing 4’ in different perspective views, and Figs. 64Ato 64C show a revised plunger rod guiding member 54’ (also sometimes referred to as locking plug) in different perspective views. These revised parts enable the implementation of a revised mounting mechanism and of a revised plunger rod fixing mechanism.

[0416] In the mounting process, a mounting movement is carried out which is a relative movement of revised container housing 4’ (and attached parts) and revised device body 5’ (and attached parts). Initially, revised container housing 4’ and revised device body 5’ are in a first positioning in which they are separate from one another. Then, in a first relative movement, the two parts are moved towards one another in an axial direction, e.g., holding revised container housing 4’ stationary and moving revised device body 5’ towards proximally. A sleeve-shaped proximal portion 560 of revised device body 5’ is moved into revised sleeveshaped distal portion 46’ of revised container housing 4’. The first relative movement ends in an intermediate positioning of revised container housing 4’ and revised device body 5’, terminated by a rear stop arrangement, more particularly by three proximally facing first rear stop faces 561 of revised device body 5’ abutting a corresponding one of three distally facing second rear stop faces 461 of revised container housing 4’.

[0417] First rear stop faces 561 are comprised in proximal protrusions on the outside of sleeveshaped proximal portion 560. Second rear stop faces 461 are comprised in recesses at the distal end of revised sleeve-shaped distal portion 46’.

[0418] Then, in a second relative movement, which, too, is an axial relative movement, the two parts are moved into a final positioning. In the final positioning, revised container housing 4’ is positioned further proximally relative to revised device body 5’ than in the intermediate positioning. The second relative movement is terminated by a front stop arrangement, more particularly by four distally facing first front stop faces 562 of revised device body 5’ abutting a corresponding one of four proximally facing second front stop faces 462 of revised container housing 4’.

[0419] First front stop faces 562 are comprised in radially outwardly protruding protrusions 566 on the outside of sleeve-shaped proximal portion 560 which, towards proximally, comprise inclined faces 563 facilitating carrying out the second relative movement by cooperating with inclined faces 463 present on the inside of revised sleeve-shaped distal portion 46’. Inclined faces 563 slide on inclined faces 463 when sliding revised sleeve-shaped distal portion 46’ along sleeve-shaped distal portion 560 during the second relative movement. Second front stop faces 462 are comprised in openings 466 in revised sleeve-shaped distal portion 46’.

[0420] Protrusions 566 which sometimes can also be referred to as snap fit protrusions, cooperate with openings 466 which sometimes can also be referred to as snap fit openings, to form snap fit connections which inhibit a removal of revised container housing 4’ from revised device body 5’ when the final positioning is reached, actually already when the intermediate positioning is reached, and more particularly already briefly before the intermediate position is reached, i.e. towards the end of the first relative movement. The snap fit connections can be considered to form a snap fit arrangement.

[0421] For ensuring a suitable relative rotational orientation of revised device body 5’ and revised container housing 4’, one or both of the two parts can be suitably rotated manually or in an automated fashion (not illustrated) before the first relative movement starts or at least at some point during the first relative movement and before the intermediate positioning is reached. And / or mechanical guiding structures can be provided at the two parts which cooperate to provide guidance for the two parts during the first relative movement in order to suitably adjust the relative rotational orientation of the two parts during the first relative movement (not illustrated).

[0422] The revised mounting mechanism furthermore comprises a relaxation mechanism which causes the change from the intermediate positioning to the final positioning. The relaxation mechanism comprises a biasing device which, in the illustrated embodiment, is embodied as a part of revised device body 5’, more particularly of sleeve-shaped distal portion 560, namely as two beams 590. The two beams 590 are extended along a portion of a circumference and can be bent in a longitudinal direction towards distally. More particularly, beams 590 can be resiliently deformed in this way.

[0423] During the first relative movement, more particularly in a final phase of the first relative movement, first abutment faces 591 of beams 590 come into contact with and abut second abutment faces 469 of longitudinal protrusions on the inside of revised sleeve-shaped distal portion 46’. First abutment faces 591 are facing generally towards proximally, and second abutment faces 469, which also can be referred to as cooperating elements, are facing generally towards distally and are aligned generally parallel to first abutment faces 591.

[0424] During said final phase of the first relative movement, resilient forces of the beams 590 have to be counteracted when moving revised container housing 4’ further towards the intermediate positioning. This way, the relaxation mechanism changes from a relaxed state to a tensioned state. Concurrently, also beams 590 change from a relaxed (equilibrium) state to a tensioned state.

[0425] A force needs to be applied in order to maintain the intermediate positioning, because the relaxation mechanism, more particularly beams 590 (cooperating with the longitudinal protrusions and with second abutment faces 469, more particularly), force revised container housing 4’ towards proximally with respect to revised device body 5’. Such a force can be supplied manually or, rather, by an apparatus for automated assembly (mounting apparatus), more particularly by an apparatus for automated mounting of revised container housing 4’ to revised device body 5’.

[0426] When application of such force is terminated, beams 590 seek to undo their deformation and thus make use of the energy of deformation stored therein by the first relative movement for moving revised container housing 4’ back towards proximally (first abutment faces 591 cooperating with second abutment faces 469).

[0427] When the final positioning is reached, i.e. at the end of the second relative movement, and because of the front stop arrangement, the relaxation mechanism remains (and beams 590 remain) in a released state which is different from the relaxed state and in which the beams are still, to some extent, resiliently deformed. Thus, in the released state (of beams 590 and of the relaxation mechanism) and thus in the final positioning (of revised container housing 4’ and revised device body 5’), beams 590 still force revised container housing 4’ towards proximally. The front stop arrangement defines the final positioning, as described above. And the relaxation mechanism secures the final positioning, namely by beams 590 (more particularly their first abutment faces 591) cooperating with second abutment faces 469 to force the front stop arrangement (and the corresponding snap fit arrangement) to remain engaged, i.e. first front stop faces 562 abutting second front stop faces 462, because of the remaining deformation of beams 590 in the released state. In other embodiments (not shown), one or more beams are comprised in or affixed to revised container housing 4’, whereas items abutting and deforming the beams (analogous to the longitudinal protrusions) are comprised in or affixed to revised device body 4’.

[0428] In yet other embodiments (not shown), the relaxation mechanism comprises a spring, such as a helical compression spring instead of beams which is compressed (or extended) in the intermediate state and is partially relaxed in the final state.

[0429] Generally, also other resilient structures can be used instead of the beams 590.

[0430] The effect achieved by the described revised mounting process and more particularly by the relaxation mechanism is that it can be avoided that pressure is applied to the medicament in medicament container 3 during its shelflife. After the revised mounting process has been carried out, plunger rod assembly 101, more particularly plunger rod 7 or, if present, spinner 73 mounted at a proximal end of plunger rod 7, is either not in contact with plunger 31 or applies so little pressure to plunger 31 that no pressure is applied to the medicament in medicament container 3 by plunger rod assembly 101. Carrying out the revised mounting process, the axial position of plunger rod 7 is automatically aligned (in axial direction). In other words, we have described an auto-aligning plunger rod positioning process. Despite unavoidable variations in the axial position of the distal end of the plunger 31 relative to the container housing 4, plunger rod assembly 101 will apply, in the final positioning, no pressure to the medicament in medicament container 3.

[0431] At the beginning of the revised mounting process (i.e. in the first positioning), plunger rod 7 protrudes from revised device body 5’ (towards proximally), and as soon as plunger rod assembly 101 (more particularly plunger rod 7 or spinner 73) abuts plunger 31 (during the first relative movement), plunger rod 7 will be moved towards distally, until the second positioning is reached (defined by the rear stop arrangement). At that time, plunger rod 7 is still rotatable relative to revised device body 5’, as plunger rod guiding member 54 and the revised plunger rod guiding member 54’ described below, respectively, is still rotatable relative to revised device body 5’, plunger rod 7 being furthermore rotationally coupled to plunger nut 8. When reaching the intermediate positioning, plunger rod assembly 101 (or rather plunger rod 7 or spinner 73) still abuts plunger 31.

[0432] The second relative movement (caused by the relaxation mechanism) moves revised container housing 4’ (and thus also plunger 31) towards proximally, while the position of plunger rod assembly 101 (including plunger rod 7) remains unchanged. Accordingly, in the final positioning, plunger rod assembly 101 (or rather plunger rod 7 or spinner 73) will be either not in contact with plunger 31 anymore or will still be in contact with plunger 31 but apply less pressure to plunger 31, depending on a deformability (elasticity and / or plasticity) of plunger 31. Thus, it can be achieved by the mounting process that no pressure is applied to the medicament by plunger rod assembly 101.

[0433] As illustrated and described, both, first rear stop faces 561 and first front stop faces 562, are embodied in one and the same part, namely in revised device body 5’; they are both comprised in one and the same unitary part, which can be an injection molded part. This way, it is possible to achieve a very high precision of their relative position in the manufacture of the medicament delivery device.

[0434] And also, as illustrated and described, both, second rear stop faces 461 and second front stop faces 462, are embodied in one and the same part, namely in revised container housing 4’; they are both comprised in one and the same unitary part, which can be an injection molded part. This way, it is possible to achieve a very high precision of their relative position in the manufacture of the medicament delivery device.

[0435] And due to the combination of these ways of embodying the rear stop arrangement and the front stop arrangement, it is possible to achieve a very high precision regarding the difference in axial position of revised container housing 4’ relative to revised device body 5’ in the first positioning and in the second positioning. In other words, it is made possible this way to manufacture medicament delivery devices in which an axial travel distance of revised container housing 4’ (relative to revised device body 5’) from the intermediate positioning to the final positioning is very precise, i.e. said axial travel distance can be implemented with very high reproducibility in the manufacture.

[0436] This facilitates ensuring not only that no pressure is applied to the medicament (in the final positioning), but that at the same time plunger rod 7 is retracted from plunger 31 so little only (in the second relative movement) that the first dose expelled will have the correct amount of the medicament, i.e. that plunger rod 7 is not retracted so far (by the second relative movement) that an amount of the medicament expelled as the first dose is outside specifications for the dosing amount (or that a separate priming process would be required for ensuring a correctly dimensioned first dose).

[0437] As will be described below in detail in conjunction with the revised plunger rod fixing mechanism, revised plunger rod guiding member 54’ can introduce, depending on circumstances, an axial shift towards proximally or towards distally of plunger rod 7 while revised container housing 4’ and revised device body 5’ are in the intermediate positioning. And an axial shift distance of this axial shift of plunger rod 7 (relative to revised container housing 4’) is expected to remain up to and in the final positioning.

[0438] This axial shift emphasizes the positive effect of the revised mounting mechanism and, more particularly, of the relaxation mechanism, and also of the above-explained precision of the axial travel distance of revised container housing 4’ (relative to revised device body 5’) caused by the second relative movement. Namely, the relaxation mechanism can be (and in the illustrated case is) designed such that in the final positioning, plunger rod assembly 101 (or rather plunger rod 7 or spinner 73) is (axially) positioned such that no pressure is applied to the medicament, even under consideration of the axial shift distance; and, moreover, such that the first dose will have the correct amount of the medicament (within specifications for the dosing amount), even under consideration of the axial shift distance.

[0439] As will be explained below, at least for some plunger rod fixing mechanisms (such as for the above described one and for the revised one, cf. below), the axial shift distance can be zero or can be positive (i.e. towards proximally) or can be negative (i.e. towards distally), depending on circumstances. This will be explained in detail for the revised plunger rod fixing mechanism, which involves a rotation locking mechanism which is different from the rotation locking mechanism involved in the above-described plunger rod fixing mechanisms. In contrast to the above-described rotation locking mechanism which is a ratchet mechanism, the rotation locking mechanism of the revised plunger rod fixing mechanisms described below involves splines which are engaged in an axial relative movement.

[0440] In the revised plunger rod fixing mechanism, revised plunger rod guiding member 54’ is used. Revised plunger rod guiding member 54’ can be considered a plug (e.g., locking plug), and for conciseness, it will also be simply referred to as plug 54’ in the following.

[0441] Plug 54' is of generally tube-like shape. It is a hull body encircling an axially extended central opening 54c. At the distal end of the central opening, plug 54’ provides axial guidance for and rotational coupling to plunger rod 7, in the way described above for plunger rod guiding member 54. For this, it comprises flat sides 54f cooperating with flat sides 7f of plunger rod 7 (cf. Figs. 1, 30) extending through the central opening.

[0442] Plug 54’ is insertable (from proximally, towards distally) into sleeve-shaped proximal portion 560 of revised device body 5’. Before carrying out the first relative movement, plug 54’ is inserted into sleeve-shaped proximal portion 560 of revised device body 5’ and moved into an unlocked position in which plug 54’ is free to rotate relative to revised device body 5’, but its axial movability relative to revised device body 5’ is limited. With plug 54’ being free to rotate, also plunger rod 7 is free to rotate (relative to revised device body 5’).

[0443] Plug 54’ has three circumferential ribs, namely a first circumferential rib 541 and, proximally thereof, second circumferential rib 542, and distally of first circumferential rib 541, an assembly rib 543 as an assembly facilitating structure. First circumferential rib 541 and second circumferential rib 542 and assembly rib 543 have proximally facing transversal faces 54ip and 542p and 543p, respectively, and generally distally facing inclined faces 54id and 542d and 543d, respectively. A first circumferential retention groove 546 is formed by and between assembly rib 543 and first circumferential rib 541; and a second circumferential retention groove 547 is formed by and between first circumferential rib 541 and second circumferential 542.

[0444] Revised device body 5’ has retention protrusions 500 which cooperate with the three circumferential ribs 541, 542,543. Retention protrusions 500 are protruding radially inwardly from respective bendable arms 502 which can be resiliently bent radially outwardly, so that respective retention protrusion 500 is moved radially outwardly in a resiliently way. Retention protrusions 500 have distally facing transversal faces 5ood and generally proximally facing inclined faces 5OOp.

[0445] In order to reach the unlocked position, plug 54’ is moved axially towards distally (relative to revised device body 54’), until retention protrusion 500 is axially located in first retention groove 546 (and thus between assembly rib 543 and first circumferential rib 541. For this, inclined faces 5OOp slide over inclined face 543d, so that retention protrusions 500 are moved outwardly and then back inwardly again. A first snap fit connection is established which inhibits a moving back of plug 54’ towards proximally by transversal faces 500d abutting transversal faces 543p. Movements towards distally of plug 54’ are hampered by inclined faces 5OOp cooperating with inclined face 54id.

[0446] With plug 54’ in the unlocked position, the first relative movement is carried out; the intermediate positioning of revised device body 5’ and revised container housing 4’ is reached.

[0447] As will become clear below, it can have detrimental effects if plug 54’ can rotate with very low friction when in the unlocked position. A controlled amount of friction in the rotation can hamper or even completely avoid any rotation of plug 54’ taking place in absence of purposeful forces, more particularly in absence of forces caused by the first relative movement. For introducing such a controlled amount of friction (voluntary friction) pips 544 of plug 54’ can be provided as friction increasing features, e.g., close to the proximal end of plug 54’, namely for sliding, in the unlocked position, on an inner surface 564 of revised device body 5’ (more particularly of sleeve-shaped distal portion 560) as further friction increasing features.

[0448] For an increased control of the amount of friction achieved by the cooperation of pips 544 and inner surface 564, axial cuts 548 are provided near the proximal end of plug 54’, extending up to the proximal end of plug 54’.

[0449] Other ways of introducing friction are possible, too.

[0450] Remaining in the intermediate position by counteracting the force of beams 590 in their tensioned state, plug 54’ is moved further towards distally to reach its locked position. In the locked position, plug 54’ is rotationally coupled to revised device body 5’, and its axial movability relative to revised device body 5’ is limited.

[0451] Fig. 65 is a perspective view onto a detail of a cross-section through revised medicament delivery device 2’, with plug 54’ in the locked position, revised container housing 4’ and revised device body 5’ are in the final positioning.

[0452] Moving plug 54’ into the locked position is accomplished using external tools (not shown) which can be rod-shaped and which are moved radially inwardly into first retention groove 546 in order to cooperate with transversal face 543p as assembly facilitating face, namely by abutting transversal face 543p, and moving towards distally, thus shifting plug 54’ towards distally (relative to revised device body 54’), from the unlocked position into the locked position.

[0453] In order to enable access for the external tool to plug 54’ and more particularly to transversal faces 543p, revised device body 54’ has access openings 505, and revised container housing has further access openings 405 through which the external tools can extend during moving plug 54’ from the unlocked into the locked position. The external tools can be, e.g., rods which are generally radially aligned during the mounting process, more particularly during the plunger rod fixing and rotation locking.

[0454] In the locked position (cf. Fig. 65), retention protrusion 500 is axially located in second retention groove 547 (and thus between first circumferential rib 541 and second circumferential rib 542). For reaching the locked position, inclined faces 5OOp slide over inclined faces 542d, so that retention protrusions 500 are moved outwardly and then back inwardly again. A second snap fit connection is established which inhibits moving plug 54’ back towards proximally by transversal faces 5ood abutting transversal faces 54ip. Movements towards distally of plug 54’ are hampered by inclined faces 5oop cooperating with inclined face 542d.

[0455] The rotational locking of plug 54’ relative to revised device body 5’ is accomplished by means of a first toothing 545 of plug 54’ as a first locking feature engaging with a second toothing 599 of revised device body 5’ as a second locking feature (cf. Fig. 62D). Engagement of the first toothing 545 and the second toothing 599 takes place by a generally axial relative movement, namely by moving plug 54’ towards distally from the unlocked position to the locked position.

[0456] The first toothing 545 comprises first locking splines 549 of plug 54’ which engage with second locking splines 509 of the second toothing 599 when the rotation locking takes place, i.e. when moving plug 54’ towards distally from the unlocked position to the locked position.

[0457] First locking splines 549 protrude radially outwardly and are distributed over a circumference of plug 54’. Second locking splines 509 protrude radially inwardly and are distributed over a circumference of revised device body 5’, more particularly over a circumference of sleeve-shaped proximal portion 560. First and second locking splines 549, 509 are longitudinally extended splines.

[0458] In the unlocked position, first locking splines 549 and second locking splines 509 are not engaged, as first locking splines 549 are proximally distanced from second locking splines 509. In the locked position, however, they are engaged, because their axial positions have an overlap.

[0459] The relative rotational orientation of first locking splines 549 and second locking splines 509 at the time of engaging them, i.e. at the time of changing from the unlocked to the locked position, is undetermined. It is basically random, how the first and the second toothing are rotationally oriented relative to one another when the engagement starts.

[0460] There are three extreme cases: In the first case, the relative rotational orientation is maintained, i.e. no rotational shift of plug 54’ relative to revised device body 5’ is induced. The change from the unlocked position to the locked position in that case can take place without introducing a rotational shift. The relative rotational position of plug 54’ and revised device body 5’ can be identical in the locked position and in the unlocked position. This can be the case, e.g., when each first locking spline 549 is located rotationally in the middle between two neighboring second locking splines 509.

[0461] In the second and third extreme cases, there are first locking splines 549 which are in line with respective second locking splines 509, i.e. they have identical rotational positions. In this case, plug 54’ will have to rotate by a maximum rotational shift, either cw or ccw, relative to revised device body 5’. In case there are, e.g., N first locking splines 549 and N second locking splines 509, evenly distributed over a circumference (N designating an integer), the rotational shift is either 36o° / 2N or is -36o° / 2N.

[0462] Thus, the engagement of the first toothing 545 and the second toothing 599 results in a rotational shift somewhere in an uncertainty range which, in said case with N first locking splines 549 and N second locking splines 509, ranges from 36o° / 2N to -36o° / 2N.

[0463] In order to facilitate the change from the unlocked to the locked position, the distal ends of the first locking splines 549 and the proximal ends of the second locking splines 509 are rounded.

[0464] Due to the above-described coupling mechanism which couples rotational and axial movements of plunger rod 7 by cooperation with plunger nut 8, the rotational shift results in the above-announced axial shift. Thus, the axial shift is generally proportional to the rotational shift. Accordingly: the larger the uncertainty of the rotational shift, the larger the uncertainty of the axial shift.

[0465] Therefore, in order to ensure that no pressure is applied to the medicament (in the final positioning and thus during shelflife), the axial travel distance (defined by the second relative movement) has to be chosen the larger the higher the uncertainty of the rotational shift. This, however effects that, depending on circumstances (random relative rotational position of plug 54’ and revised device body 5’ when reaching the intermediate state), the axial distance between plunger rod arrangement 101 (more particularly plunger rod 7 or spinner 73, if applicable) and plunger 31 is rather large - which bears the risk of expelling a too small first dose.

[0466] Thus, a rotational distance between two neighboring engagement positions should be small, which in case of N first locking splines 549 and N second locking splines 509 evenly distributed over a circumference corresponds to selecting a high number N of splines. However, this also means that splines need to be thin (in particular at the bottom), which limits the applicable torque and results in a difficult manufacture of the splines, in particular when manufacturing plug 54’ and / or revised device body 5’ in an injection molding process. Size constraints in the radial direction strongly limit in practice the possibility of choosing a larger circumference for the toothings 545, 599 to remedy the torque problems and the manufacturing problems.

[0467] Another way of simplifying the manufacture of the toothings 545, 599 has been developed. The number of splines (even of both, of first locking splines 549 and of second locking splines 509) has been reduced, while maintaining the rotational distance between two neighboring engagement positions. Instead of having N first locking splines (549) which are evenly distributed over a circumference and N second locking splines (509) which are evenly distributed over a circumference, there are only N / 2 first locking splines 549 and N / 2 second locking splines 509, but still, the engagement of the toothings 545 and 599 provides N engagement positions which are rotationally distanced by 36o° / N.

[0468] Figs. 66A, 66B show a perspective view each at a cross-section through a revised medicament delivery device 2’, with differently engaged first and second toothings 545, 599.

[0469] As shown in Figs. 66A, 66B:

[0470] Each of the first locking splines 549 is rotationally distanced by 36o° / N to its directly neighboring first locking spline 549 in a first rotational direction (for half or the splines: cw, for the other half: ccw) and is rotationally distanced by io8o° / N to its directly neighboring first locking spline 549 in a second rotational direction (for half or the splines: cw, for the other half: ccw). This is symbolized in Fig. 66Aby the two double-sided bend solid arrows.

[0471] And each of the second locking splines 509 is rotationally distanced by 720° / N to its directly neighboring second locking spline 509 in a first rotational direction (for half or the splines: cw, for the other half: ccw) and is rotationally distanced by 720° / N to its directly neighboring second locking spline 509 in a second rotational direction (for half or the splines: cw, for the other half: ccw). This is symbolized in Fig. 66Aby the two double-sided bend dashed arrows.

[0472] Alternatively, the distribution of splines depicted for the first locking splines 549 can be provided for the second locking splines 509 and vice versa (not illustrated).

[0473] In Figs.66A, 66B, plug 54’ is in the locked position. And revised container housing 4’ and revised device body are in the final positioning. Compared to having N evenly distributed splines over a circumference, only half as many (i.e. N / 2) first locking splines 549 and only half as many (i.e. N / 2) second locking splines 509 are provided here. Accordingly, only half the number of splines is manufactured while maintaining the rotational distance between two neighboring engagement positions. Relative to the case of N evenly distributed splines, every third and fourth first locking spline 549 is left out and every second second locking spline 509 is left out.

[0474] In Fig. 66A, alternatingly, no first locking spline 549 or two first locking splines 549 are arranged between two neighboring second locking splines 509, whereas in Fig. 66B, one first locking spline 549 is arranged between every pair of second locking splines 509.

[0475] Figs. 66A and 66B can also be understood as an illustration of those two neighboring engagement positions which are the two possible resulting relative rotational positions of the two toothings 545, 599 in the intermediate positioning for the case that the first locking splines 549 are in line with respective second locking splines 509 when approaching the intermediate positioning (cf. the second and third extreme cases mentioned above).

[0476] The described revised mounting mechanism furthermore effects that the mechanical plays involved (in the coupling mechanism between plunger rod 7 and plunger nut 8; in the rotational coupling between plunger rod 7 and plug 54’; between spinner 73 and plunger rod 7, if applicable) are in a defined state because of the first relative movement. This makes possible to very precisely dimension the axial travel distance (of the second relative movement) under consideration of the uncertainty range originating from the engagement of the toothings 545, 599 of the rotation locking mechanism, in order to avoid application of pressure to the medicament in every case while minimizing the axial distance by which plunger rod 7 has to travel in case of the largest distal axial shift distance (originating from the respective rotational shift of plug 54’).

[0477] As will be understood now, it can be advantageous to ensure that plunger rod 7 does not continue rotating and, accordingly, does not continue moving further towards distally after the first relative movement has terminated. This could be the case if friction involved in such rotating is very low. However, the above-described pips 544 can be designed to introduce enough friction so that such effects are acceptably small and / or reproducible.

[0478] For avoiding the detrimental effect of the randomness of the relative rotational orientation of the first toothing 545 and the second toothing 599 when the engagement starts, other measures could be taken. For example, one could determine the relative rotational position of the two parts to be engaged and then apply an appropriate adjusting rotation of the one part relative to the other part, so as to avoid a rotational shift upon engagement and thus avoid a corresponding axial shift. However, this is difficult, as the determining or rotational position sensing is difficult, and having to apply the adjusting rotation is difficult, too, and it also requires the application of a rotation in the mounting process.

[0479] The before-described revised mounting process - and the related plunger rod fixing mechanism and rotation locking mechanism - however can be carried out without having to apply a rotational movement to one of the parts. It is sufficient to merely move the parts of the medicament deliveiy device in axial directions. This facilitates the mounting process. And also tools involved in the mounting process do not need to be moved in a rotational movement, linear movements are sufficient for these, too.

[0480] The revised mounting process furthermore can render superfluous a separate priming process. When ensuring that the amount of gas in medicament container 3 is rather low - to an extent which is practicable in industrial processes - then neither during the mounting process nor later, e.g., when applying the medicament, a priming needs to be carried out. The precision achievable in the described revised processes is sufficient to accomplish this.

[0481] Further Revised Mounting Mechanism and Plunger Rod Fixing Mechanism

[0482] In the following, a further revised mounting mechanism and a further revised plunger rod fixing mechanism shall be described as well as an improved plunger rod positioning process.

[0483] Figs. 76A to 76F show a further revised device body 5” or details thereof in different perspective views (Fig. 76F showing a cross-section), Figs. 77A and 77B show a further revised container housing 4” in different perspective views, and Figs. 78A and 78B show a further revised plunger rod guiding member 54” in different perspective views. Further revised plunger rod guiding member 54” can be considered a plug (e.g., locking plug), and for conciseness, it will also be simply referred to as plug 54” in the following.

[0484] These further revised parts enable the implementation of the further revised mounting mechanism and of the further revised plunger rod fixing mechanism as well as of the improved plunger rod positioning process.

[0485] In the mounting process, a mounting movement is carried out which is a relative movement of further revised container housing 4” (and attached parts) and further revised device body 5” (and attached parts). Initially, further revised container housing 4” and further revised device body 5” are in a first positioning in which they are separate from one another. Then, in a first relative movement, the two parts are moved towards one another in an axial direction, e.g., holding further revised container housing 4” stationary and moving further revised device body 5” towards proximally. A sleeve-shaped proximal portion 560’ of further revised device body 5” is moved into a sleeve-shaped distal portion 46” of further revised container housing 4”. The first relative movement ends in an intermediate positioning of further revised container housing 4” and further revised device body 5”, terminated by a rear stop arrangement, more particularly by a proximally facing first rear stop face 561’ (Fig. 76D) of further revised device body 5” abutting a distally facing second rear stop face 461’ of further revised container housing 4”. In an alternative embodiment which is not illustrated, the distal reference surface 477 and a proximally facing surface 588 (cf. Figs. 76C, 76D, 81C) for the rear stop arrangement form the rear stop arrangement.

[0486] First rear stop face 561’ is comprised in proximal protrusion on the outside of sleeve-shaped proximal portion 560’. Second rear stop face 461’ is comprised in a recess at the distal end of sleeve-shaped distal portion 46”. In case of said alternative embodiment, said proximal protrusion and said recess can be used to ensure a correct rotational relative positioning of the device body and the container housing.

[0487] Then, in a second relative movement, which, too, is an axial relative movement, the two parts are moved into a final positioning. In the final positioning, further revised container housing 4” is positioned further towards proximally relative to further revised device body 5” than in the intermediate positioning. The second relative movement is terminated by a front stop arrangement, more particularly by four distally facing first front stop faces 562’ (Fig. 76B) of further revised device body 5” abutting a corresponding one of four proximally facing second front stop faces 462’ of further revised container housing 4”.

[0488] First front stop faces 562’ are comprised in radially outwardly protruding protrusions 566’ on the outside of sleeve-shaped proximal portion 560’ which, towards proximally, comprise inclined faces 563’ (Fig. 76B) facilitating carrying out the second relative movement. Inclined faces 563’ slide on an inside edge of the distal end of sleeve-shaped distal portion 46”.

[0489] Second front stop faces 462’ are comprised in openings 466’ in sleeve-shaped distal portion 46”.

[0490] Protrusions 566’ which sometimes can also be referred to as snap fit protrusions, cooperate with openings 466’ which sometimes can also be referred to as snap fit openings, to form snap fit connections which inhibit a removal of further revised container housing 4” from further revised device body 5” when the final positioning is reached, actually already when the intermediate positioning is reached, and more particularly already briefly before the intermediate position is reached, i.e. towards the end of the first relative movement. The snap fit connections can be considered to form a snap fit arrangement. For ensuring a suitable relative rotational orientation of further revised device body 5” and further revised container housing 4”, one or both of the two parts can be suitably rotated manually or in an automated fashion (not illustrated) before the first relative movement starts or at least at some point during the first relative movement and before the intermediate positioning is reached. And / or mechanical guiding structures can be provided at the two parts which cooperate to provide guidance for the two parts during the first relative movement in order to suitably adjust the relative rotational orientation of the two parts during the first relative movement (not illustrated).

[0491] The further revised mounting mechanism furthermore comprises a revised relaxation mechanism which causes the change from the intermediate positioning to the final positioning. The revised relaxation mechanism comprises a biasing device which, in the illustrated embodiment, is embodied as a part of further revised device body 5”, more particularly of sleeve-shaped distal portion 560’, namely as two beams 590’ (Fig. 76C). The two beams 590’ are extended along a portion of a circumference and can be bent in a longitudinal direction towards distally. More particularly, beams 590’ can be resiliently deformed in this way.

[0492] During the first relative movement, more particularly in a final phase of the first relative movement, first abutment protrusions 591’ of beams 590’ come into contact with and abut an abutment face 469’ (Fig. 77B) present on the inside of sleeve-shaped distal portion 46”. First abutment protrusions 591’ are facing generally towards proximally, and abutment face 469’, which also can be referred to as a cooperating element, is facing generally towards distally and is aligned generally perpendicular to the device axis.

[0493] During said final phase of the first relative movement, resilient forces of the beams 590’ have to be counteracted when moving further revised container housing 4” further towards the intermediate positioning. This way, the revised relaxation mechanism changes from a relaxed state to a tensioned state. Concurrently, also beams 590’ change from a relaxed (equilibrium) state to a tensioned state.

[0494] A force needs to be applied in order to maintain the intermediate positioning, because the revised relaxation mechanism, more particularly beams 590’ (first abutment protrusions 591’ cooperating with abutment face 469’), force further revised container housing 4” towards proximally with respect to further revised device body 5”. Such a force can be supplied manually or, rather, by an apparatus for automated assembly (mounting apparatus), more particularly by an apparatus for automated mounting of further revised container housing 4” to further revised device body 5”. When application of such force is terminated, beams 590’ seek to undo their deformation and thus make use of the energy of deformation stored therein by the first relative movement for moving further revised container housing 4” back towards proximally (first abutment protrusions 591’ cooperating with abutment face 469’).

[0495] When the final positioning is reached, i.e. at the end of the second relative movement, and because of the front stop arrangement, the revised relaxation mechanism remains (and beams 590’ remain) in a released state which is different from the relaxed state and in which the beams are still, to some extent, resiliently deformed. Thus, in the released state (of beams 590’ and of the relaxation mechanism) and thus in the final positioning (of further revised container housing 4” and further revised device body 5”), beams 590’ still force further revised container housing 4” towards proximally. The front stop arrangement defines the final positioning, as described above. And the revised relaxation mechanism secures the final positioning, namely by beams 590’ (more particularly their first abutment protrusions 591’) cooperating with abutment face 469’ to force the front stop arrangement (and the corresponding snap fit arrangement) to remain engaged, i.e. first front stop faces 562’ abutting second front stop faces 462’, because of the remaining deformation of beams 590’ in the released state.

[0496] In other embodiments (not shown), one or more beams are comprised in or affixed to further revised container housing 4”, whereas one or more items abutting and deforming the beams (analogous to the abutment face 469’) are comprised in or affixed to further revised device body 4”.

[0497] In yet other embodiments (not shown), the revised relaxation mechanism comprises, as a biasing device, a spring, such as a helical compression spring instead of beams which is compressed (or extended) in the intermediate state and is partially relaxed in the final state.

[0498] Generally, also other resilient structures, instead of the beams 590’, can be used as biasing devices.

[0499] The effect achieved by the described further revised mounting process and more particularly by the revised relaxation mechanism is that it can be avoided that pressure is applied to the medicament in medicament container 3 during its shelflife. After the further revised mounting process has been carried out, plunger rod assembly 101, more particularly plunger rod 7 (or, if present, spinner 73 mounted at a proximal end of plunger rod 7) is either not in contact with plunger 31 or applies so little pressure to plunger 31 that no pressure is applied to the medicament in medicament container 3 by plunger rod assembly 101. This will be explained in detail below.

[0500] Above, in conjunction with the revised mounting process, we have described an autoaligning plunger rod positioning process. In that auto-aligning plunger rod positioning process, plunger rod 7 initially (in the first positioning) protrudes from further revised device body 5” (towards proximally) and is moved towards distally during the first relative movement by the plunger 31 abutting the proximal end of plunger rod 7 (or, if present, of spinner 73).

[0501] This auto-aligning plunger rod positioning process can also be applied in case of the further revised plunger rod fixing mechanism (and further revised mounting mechanism). The details can be inferred from the description above.

[0502] However, alternatively, another, improved plunger rod positioning process can be applied which shall be described with reference to Figs. 81A to 81D. In the improved plunger rod positioning process, a long travel of plunger rod 7 driven by plunger 31 during the first relative movement is avoided. Instead, already before the first relative movement begins, namely in a first phase of the improved plunger rod positioning process, an assembly jig 700 is used to move plunger rod 7 towards distally to a start position.

[0503] Figs. 81A to 81D illustrate the principle of how the movement of the plunger rod 7 towards distally to the start position can be accomplished. Assembly jig 700 is shown in a strongly schematized way in a cross-section. The respective parts of the medicament delivery device are shown in a cross-section (except for plunger rod 7 in Fig. 81B).

[0504] Assembly jig 700 comprises a spacer rod 710 and a spacer sleeve 720 having a proximal end 711 and 721, respectively, and a distal end 712 and 722, respectively. Spacer rod 710 is arranged radially within spacer sleeve 720 and is axially movable relative to spacer sleeve 720. The axial length (axial extension along the device axis) of spacer rod 710 from proximal end 711 to distal end 712 is, in the illustrations of Figs. 81A to 81D, identical to the axial length (axial extension along the device axis) of spacer sleeve 720 from proximal end 721 to distal end 722. As will become clear further below, spacer rod 710 should be longer than that in order to accomplish the desired positioning of plunger rod 7, i.e. to move plunger rod 7 to the start position. Assembly jig 700 also comprises a locking sleeve 750 which is axially movable relative to spacer rod 710 and spacer sleeve 720. Radially, locking sleeve 750 is arranged between spacer rod 710 and spacer sleeve 720.

[0505] In a first step (Fig. 81A), an axial protrusion length is determined, and spacer rod 710 is set to protrude towards proximally with respect to spacer sleeve 720 by said axial protrusion length. The axial protrusion length is the axial distance between the distal end of plunger 31 and a distal reference surface 477 of further revised container housing 4”. In Figs. 81A to 81D, the axial protrusion length is symbolized by the double-headed arrow. This can be accomplished e.g., by measuring the axial protrusion length and then axially move spacer rod 710 relative to spacer sleeve 720 until proximal end 711 of spacer rod 710 protrudes (towards proximally) proximal end 721 of spacer sleeve 720 by the measured axial protrusion length. Or, as shown in Fig. 81A, assembly jig 700 is, more particularly spacer rod 710 and spacer sleeve 720 are, moved towards proximally with respect to medicament container 3 assembled with further revised container housing 4” (which form a front assembly of the medicament delivery device) until both, proximal end 711 abuts the distal end of plunger 31, and proximal end 721 abuts the distal reference surface 477 (cf. also Figs 77A, 77B).

[0506] The axial position of spacer rod 710, in particular relative to spacer sleeve 720, can be locked, which can be done at this point.

[0507] Prepared this way, assembly jig 700 can be used to position plunger rod 7 in the start position, cf. Figs. 81B, 81C.

[0508] If spacer rod 710 and spacer sleeve 720 have the same axial length, a in the illustrated case, the axial protrusion length exists also at the distal end of assembly jig 700, only that there, spacer sleeve 720 axially protrudes spacer rod towards distally by the axial protrusion length (left hand side of Fig. 81B). Now, moving the rear assembly (comprising further revised device body 5” and plunger rod 7 and attached parts) towards proximally against the distal end of assembly jig 700 (with spacer rod 710 positioned axially at the axial protrusion length), as symbolized by the open arrow in Fig. 81B, distal end 712 will abut the proximal end of plunger rod 7, and plunger rod 7 will be moved towards distally, until distal end 722 abuts a proximal reference surface 577 of further revised device body 5” (cf. Figs 76A, 76C). Alternatively, proximally facing surface 588 (cf. Figs. 76C, 76D, 81C) can function as the proximal reference surface. Initially, plunger rod 7 typically protrudes much further towards distally than shown in Fig. 81B. Plunger rod 7 can be moved towards distally (being pressed by spacer rod 700), because plug 54” - to which it is rotationally coupled - is still rotatable relative to further revised device body 5”.

[0509] Fig. 81C illustrates the situation, when plunger rod 7 has reached the start position, wherein in fact, this is not the correct start position, as Figs. 81A to 81D merely illustrate the principle of the improved plunger rod positioning process. As has been mentioned above already, spacer rod 710 needs to be longer than spacer sleeve 720 in order to position plunger rod 7 in the actual start position. Namely, spacer rod 710 should be longer by the sum of the differences in axial position of the involved datum surfaces. Figs. 81C, 81D however, illustrate the start position for the (unrealistic) case that in the assembled state, i.e. in the final positioning, the distal reference surface 477 is axially at the same position as is the proximal reference surface 577. Yet, in fact, the final positioning is defined by the front stop arrangement and thus by distally facing first front stop faces 562’ (Fig. 76B, 81C) of further revised device body 5” abutting proximally facing second front stop faces 462’ (Fig. 81A) of further revised container housing 4”.

[0510] Thus, in order to reach the correct start position based on the illustrated principle, spacer rod 710 needs to be longer by the axial distance between distal reference surface 477 and second front stop faces 462’ plus the axial distance between proximal reference surface 577 and first front stop faces 562’.

[0511] Instead of selecting the axial length of spacer rod 710 as described and using assembly jig 700 in the described way for setting the correct start position, it would alternatively also be possible to measure (with respect to a suitable datum face, such as to second front stop faces 462’) the axial position of plunger 31 (more particularly the axial position of the distal end of plunger 31), and to afterwards set plunger rod 7 to the correct start position, based on the measured plunger position, again with respect to a suitable datum face, such as to first front stop faces 562’. A jig like assembly jig 700 can be used for this. An actuator can be used for axially moving plunger rod 7 (and / or spacer rod 710), not illustrated.

[0512] Due to the described process, in particular using assembly jig 700, the start position is individually adjusted for a matching pair of front assembly and rear assembly, taking into account unavoidable variations in the axial position of the distal end of the plunger 31 relative to the further revised container housing 4”. Remarkably, this process allows to directly inspect the (axial) position of plunger rod 7, and this before the front assembly and the rear assembly are assembled with one another. It is noted that up to here, no pressure (or at no appreciable pressure) has been applied to plunger 31 or to the medicament.

[0513] At this point, plug 54” can be moved towards distally to its locked position by means of locking sleeve 750, as will be explained in more detail below, with reference to Fig. 81D. After plug 54” has reached its locked position, the mounting can begin, with the first relative movement.

[0514] Plunger rod 7 abuts plunger 31 not before the intermediate position is reached (defined by the rear stop arrangement), which is a consequence of the described improved plunger rod positioning process, e.g., with assembly jig 700, and of the start position. But in the intermediate position, plunger rod 7 and plunger 31 abut or are nearly abutting.

[0515] Subsequently, the second relative movement (caused by the revised relaxation mechanism) moves further revised container housing 4” (and thus also plunger 31) towards proximally (relative to further revised device body 5”), while the position of plunger rod assembly 101 (including plunger rod 7) remains unchanged (except for effects caused by the plug 54” which will be discussed below). Accordingly, in the final positioning, plunger rod assembly 101 (or rather plunger rod 7 or, if present, spinner 73) will not be in contact with plunger 31, but will be distanced, namely by an axial travel distance, cf. below. Thus, it can be achieved by the mounting process that no pressure is applied to the medicament by plunger rod assembly 101.

[0516] As illustrated and described, both, first rear stop face 561’ and first front stop faces 562’, are embodied in one and the same part, namely in further revised device body 5”; they are both comprised in one and the same unitary part, which can be an injection molded part. This way, it is possible to achieve a very high precision of their relative position in the manufacture of the medicament delivery device.

[0517] And also, as illustrated and described, both, second rear stop face 461’ and second front stop faces 462’, are embodied in one and the same part, namely in further revised container housing 4”; they are both comprised in one and the same unitary part, which can be an injection molded part. This way, it is possible to achieve a very high precision of their relative position in the manufacture of the medicament delivery device.

[0518] And due to the combination of these ways of embodying the rear stop arrangement and the front stop arrangement, it is possible to achieve a very high precision regarding the difference in axial position of further revised container housing 4” relative to further revised device body 5” in the first positioning and in the second positioning. In other words, it is made possible this way to manufacture medicament delivery devices in which an axial travel distance of further revised container housing 4” (relative to further revised device body 5”) from the intermediate positioning to the final positioning is very precise, i.e. said axial travel distance can be implemented with very high reproducibility in the manufacture. Such an axial travel distance can also sometimes be referred to as overtravel and can be in the range of, e.g., between 0.05 mm and 0.5 mm. Figs. 82A, 82B show a detail of the medicament delivery device in the final state and illustrate the axial travel distance (designated as “td”) . Fig. 82A shows a perspective view in which the further revised container housing 4” is illustrated partially in a transparent fashion. Fig. 82B shows a partial cross-section.

[0519] This facilitates ensuring not only that no pressure is applied to the medicament (in the final positioning), but that at the same time plunger rod 7 is retracted from plunger 31 so little only (in the second relative movement) that the first dose expelled will have the correct amount of the medicament, i.e. that plunger rod 7 is not retracted so far (by the second relative movement) that an amount of the medicament expelled as the first dose would be outside specifications for the dosing amount (or that a separate priming process would be required for ensuring a correctly dimensioned first dose).

[0520] As will be described below in conjunction with the further revised plunger rod fixing mechanism, plug 54” can introduce, depending on circumstances, an axial shift towards proximally or towards distally of plunger rod 7 after plug 54” has been moved from the unlocked into the locked position. An axial shift distance of such an axial shift of plunger rod 7 (relative to further revised container housing 4”) can amount to, e.g., in the range of between 0.1 mm and 0.3 mm. The axial travel distance explained above is chosen so that it is at least as large as, in particular larger than, the maximally possible axial shift of plunger rod 7 towards proximally. This way, it is ensured that in the final position, no pressure is applied by plunger rod assembly 101 (more particularly by plunger rod 7) to plunger 31 and thus to the medicament. There will typically be a gap located distally from plunger 31 which avoids such pressure. The axial shift distance is expected to remain up to and in the final positioning.

[0521] Fig. 80 is a perspective view onto a detail of a cross-section through further revised medicament delivery device 2”, with plug 54” in the locked position. Further revised container housing 4” and further revised device body 5” are in the final positioning.

[0522] In the locked position (cf. Fig. 80), circumferential protrusion 540 is located axially distally from first mechanical stop 510b (not visible in Fig. 80). In the unlocked position, however, circumferential protrusion 540 is axially located between first mechanical stop 510a and first mechanical stop 510b, as can be seen in Fig. 83.

[0523] The axial shift emphasizes the positive effect of the further revised mounting mechanism and, more particularly, of the relaxation mechanism, and also of the above-explained precision of the axial travel distance of further revised container housing 4” (relative to further revised device body 5”) caused by the second relative movement. Namely, the revised relaxation mechanism can be (and in the illustrated case is) designed such that in the final positioning, plunger rod assembly 101 (or rather plunger rod 7) is (axially) positioned such that no pressure is applied to the medicament, even under consideration of the axial shift distance; and, moreover, such that the first dose will have the correct amount of the medicament (within specifications for the dosing amount), even under consideration of the axial shift distance.

[0524] The axial travel distance can be suitably selected to accomplish this.

[0525] For the further revised plunger rod fixing mechanism, the axial shift distance can be zero or can be positive (i.e. towards proximally) or can be negative (i.e. towards distally), depending on circumstances. This will be explained in detail for the further revised plunger rod fixing mechanism, which involves a revised rotation locking mechanism which only partially is similar to the rotation locking mechanism described above for the revised plunger rod fixing mechanism. Also the further revised rotation locking mechanism involves two sets of splines which are engaged in an axial relative movement.

[0526] In the further revised plunger rod fixing mechanism, plug 54” is used.

[0527] Plug 54” (Figs. 78A, 78B) is of generally tube-like or ring -like shape. It is a hull body encircling an axially extended central opening 54c’. Central opening 54c’ provides axial guidance for and rotational coupling to plunger rod 7, in fact in the way described above for plunger rod guiding members 54 and 54’. For this, it comprises flat sides 54f cooperating with flat sides 7f of plunger rod 7 (cf. Figs. 1, 30) extending through central opening 54c’.

[0528] Plug 54” is insertable (from proximally, towards distally) into sleeve-shaped proximal portion 560’ of further revised device body 5”. Before carrying out the first relative movement, plug 54” is inserted into sleeve-shaped proximal portion 560’ of further revised device body 5” and moved into an unlocked position in which plug 54” is free to rotate relative to further revised device body 5”, but its axial movability relative to further revised device body 5” is limited. With plug 54” being free to rotate, also plunger rod 7 is free to rotate (relative to further revised device body 5”).

[0529] Plug 54” has, at its proximal end, a circumferential protrusion 540 which has a circumferential stop face 540s and can also function as an assembly facilitating structure 543’, as will be described below. Stop face 540s is sometimes also referred to as assembly facilitating face.

[0530] Further revised device body 5” has two identical resilient arms 571 having a free end 571a and a fix end 571b each (Fig. 76E). (Resilient arms 571 are not to be confused with resilient arms 25.) At free end 571a, resilient arm 571 forms two mechanical stops 501a, 501b, mechanical stop 501a being positioned further towards proximally than mechanical stop 501b. Mechanical stops 501a, 501b cooperate with circumferential protrusion 540 (by abutting), more particularly with stop face 540s; and together, they form a retention mechanism. The retention mechanism impedes a moving back towards proximally of plug 54 •

[0531] Mechanical stops 501a, 501b are protruding radially inwardly from resilient arm 571. Resilient arm 571 can be resiliently bent radially outwardly, so that mechanical stops 501a, 501b are moved radially outwardly in a resiliently way.

[0532] In order to reach the unlocked position (during assembly, before starting the improved plunger rod positioning process), plug 54” is moved axially towards distally (relative to further revised device body 54”), until circumferential protrusion 540 is axially located between mechanical stop 501a and mechanical stop 501b. For this, circumferential protrusion 540 slides across mechanical stop 501a, so that mechanical stop 501a (and free end 571 of resilient arm 571) is moved radially outwardly and then back inwardly again. A first snap fit connection is thus established which inhibits a moving back of plug 54” towards proximally by mechanical stop 501a (more particularly its distally facing face) abutting circumferential protrusion 540, more particularly stop face 540s. Movements towards distally of plug 54” are inhibited this way. Fig. 83 illustrates this in a partly cross-sectional perspective view of the proximal end of the rear part of the medicament delivery device.

[0533] With plug 54” in the unlocked position, the improved plunger rod positioning process is carried out (cf. above), and subsequently, the further revised mounting process is carried out (cf. above). As will become clear below, it can have detrimental effects if plug 54” can rotate freely and with very low friction, respectively, when in the unlocked position. Accordingly, hampering a rotation of plug 54” in the unlocked position can be desirable. For accomplishing this, a rotation hampering mechanism is provided. The rotation hampering mechanism comprises resilient arm 571 as a first hampering feature and a revised first toothing 545’ of plug 54” as a second hampering feature 572, which cooperate with one another to hamper relative rotational movements of plug 54” and further revised device body 5” in the unlocked state, in particular by abutting one another in the unlocked state, more particularly by engaging one another in the unlocked state.

[0534] More particularly, the first hampering feature is formed by teeth 574 present at free end 571b of resilient arm 571 (Figs. 76E, 76F), which function as a contact feature and which, in the unlocked state, are in mechanical contact with the second hampering feature, i.e. with revised first toothing 545'.

[0535] The first hampering feature (resilient arm 571) is a resilient feature which applies a resilient force to the second hampering feature 572 in the unlocked state to force the two parts into mechanical contact in order to hamper relative rotational movements of plug 54” and further revised device body 5” in the unlocked state.

[0536] More particularly, teeth 574, as a contact feature, apply, in the unlocked state, a resilient force to revised first toothing 545’ forming second hampering feature 572, in order to force the contact feature (teeth 574) into mechanical contact with second hampering feature 572 (revised first toothing 545') in order to hamper relative rotational movements of plug 54” and further revised device body 5” in the unlocked state.

[0537] Accordingly, the first and second hampering features are shaped to be in an engagement with one another in the unlocked state to hold plug 54” rotationally in position (relative to further revised device body 5”). The teeth 574 are shaped to position into spaces between neighboring teeth 549 (also referred to as splines 549) of revised first toothing 545’ of plug 54”. This can be seen in Fig. 79A showing a perspective view onto a cross-section perpendicular to the device axis through a further revised medicament delivery device 2” in the unlocked state, implementing the further revised mounting mechanism and the further revised plunger rod fixing mechanism. Fig. 84 illustrates this in a perspective view of the proximal end of the rear part of the medicament delivery device.

[0538] Thus, in the unlocked state, plug 54” is in a rotational relative position (relative to further revised device body 5”) which is defined by said engagement. More particularly, the engagement holds plug 54” and further revised device 5” in a rotational relative position which is defined by the engagement, unless a torque exceeding a threshold torque is applied. That torque would have to be large enough to bend resilient arm 571 radially outwardly until a tooth of contact feature 574 initially sitting in a interstice between two neighboring teeth of revised first toothing 545’ sits on one of said two neighboring teeth, and beyond, where the resilience of resilient arm 571 would lead to further rotation so as to let said tooth of contact feature 574 engage into a neighboring interstice.

[0539] The teeth 574, accordingly, effect that plug 54” can be in a number of discrete rotational relative positions of plug 54” and device body 5” only.

[0540] And the teeth 574 also enhance shelflife of rear parts of the medicament delivery device (which may be transported and / or stored before the assembly with a front part and the further revised mounting process, respectively, takes place), because a resilient force (exerted by arm 571) and the corresponding threshold torque, respectively, has to be overcome for rotating plug 54” from one of the discrete rotational relative positions to a neighboring one, even if material creep has weakened arm 571.

[0541] The design of arm 571 and of teeth 574 can be suitably selected to avoid undesired rotations of plug 54” on the one hand and to minimize the force required to moving plunger rod 7 towards distally to the start position. For example, if arm 571 would be too strong, moving plunger rod 7 towards distally to the start position in the improved plunger rod positioning process could require forces which could compress drive spring 9 (via plunger nut 8). In another example, if arm 571 would be too weak, it might happen, e.g., during transport, that plunger rod 7 could move out of the engagement with plunger nut 8 and thus would be lost.

[0542] The rotation hampering mechanism is a way to hamper or even completely avoid any rotation of plug 54” taking place in absence of purposeful forces, more particularly in absence of forces caused by the improved plunger rod positioning process.

[0543] The engagement and the rotation hampering mechanism, respectively, ensure the presence of resistance against rotation of plug 54” between the end of the improved plunger rod positioning process and the locking of plug 54”, so that undesired rotation of plunger rod 7 is avoided (due to the rotational coupling between plug 54” and plunger rod 7), so that also undesired axial movements of plunger rod 7 are avoided (due to the coupling between plunger rod 7 and plunger nut 8). After the plunger rod positioning and before the mounting, i.e. when plunger rod 7 has been moved into the start position (cf. Fig. 81C), and before the first relative movement is carried out, plug 54” is moved further towards distally to reach its locked position. In the locked position, plug 54” is rotationally coupled to further revised device body 5”, and its axial movability relative to further revised device body 5” is limited.

[0544] Fig. 81D illustrates how locking sleeve 750 of assembly jig 700 moves plug 54” from the unlocked position (Fig. 81C) to the locked position by moving towards distally while abutting circumferential stop face 540s. Moving distally, distal end 752 of locking sleeve 750 enters sleeve-shaped proximal portion 560’ of further revised device body 5", abuts plug 54”, and plug 54” is shifted towards distally (relative to further revised device body 54”), from the unlocked position into the locked position. Locking sleeve 750 cooperates with circumferential protrusion 540 which thus functions as an assembly facilitating structure 543’, namely by abutting stop face 540s.

[0545] For reaching the locked position, circumferential protrusion 540 slides over first mechanical stop 510b, so that the free ends 571a of resilient arms 571 are moved outwardly and then back inwardly again. A second snap fit connection is established which inhibits moving plug 54” back towards proximally by circumferential stop face 540s abutting first mechanical stop 510b.

[0546] The rotational locking of plug 54” relative to further revised device body 5” is accomplished by means of the already mentioned revised first toothing 545’ of plug 54” and its teeth 549 (also referred to as first locking splines), respectively, as a first locking feature, engaging with a revised second toothing 599’ (Fig. 76A) of further revised device body 5” and with its revised second locking splines 509’, respectively, as a second locking feature (cf. Fig. 79B). Fig. 79B shows a perspective view onto a cross-section perpendicular to the device axis through a further revised medicament delivery device implementing the further revised mounting mechanism and the further revised plunger rod fixing mechanism, in the locked state. Engagement of the revised first toothing 545’ and the revised second toothing 599’ takes place by a generally axial relative movement, namely by moving plug 54” towards distally from the unlocked position to the locked position.

[0547] Revised first toothing 545’ comprises first locking splines 549 of plug 54” which engage with revised second locking splines 509’ of revised second toothing 599’ when the rotation locking takes place, i.e. when moving plug 54” towards distally from the unlocked position to the locked position. First locking splines 549 protrude radially outwardly and are distributed over a circumference of plug 54”. Revised second locking splines 509’ protrude radially inwardly and are distributed over a circumference of further revised device body 5”, more particularly over a circumference of sleeve-shaped proximal portion 560’. Said splines 549, 509’ are longitudinally extended splines.

[0548] As has been explained above, the revised first toothing 545’ and its revised first locking splines 549, respectively, also function as second hampering feature 572.

[0549] First locking splines 549 of plug 54” and revised second locking splines 509’ of revised second toothing 599’ both have chamfered lead-in faces which in instances can facilitate their engagement, i.e. their meshing.

[0550] In the unlocked position, first locking splines 549 and revised second locking splines 509’ are not engaged, as first locking splines 549 are proximally distanced from revised second locking splines 509’. In the locked position, however, they are engaged, because their axial positions have an overlap.

[0551] Unlike in the case of the revised plunger rod fixing mechanism described further above, the relative rotational orientation of first locking splines 549 and revised second locking splines 509’ at the time of engaging, i.e. at the time of changing from the unlocked to the locked position in case of the further revised plunger rod fixing mechanism, is not undetermined. It is not basically random, but rather well-defined, how the first and the second toothing are rotationally oriented relative to one another when the engagement starts.

[0552] This is achieved by the rotation hampering mechanism, more particularly by the teeth 574 of resilient arm 571 (Figs. 76E, 76F, 84), which, in the unlocked state, are in mechanical contact with revised first toothing 545'. The teeth 574 are, for this purpose, aligned (rotationally aligned) with respect to revised second toothing 599' (Fig. 76A) and thus to revised second locking splines 509'. More particularly, the teeth 574 are rotationally aligned so as to hold plug 54” in a rotational position which is identical to a rotational position plug 54” in its locked position, i.e. to a rotational position plug 54” has when its revised first toothing 545' is engaged with revised second toothing 599' of further revised device body 5”. Accordingly, moving plug 54” from the unlocked to the locked position does not introduce a rotational shift from an undetermined, random initial rotational position of plug 54” and of its first toothing 545', respectively, which is in contrast to the case of the revised plunger rod fixing mechanism described further above. In the present further revised plunger rod fixing mechanism, first locking splines 549 are aligned (by teeth 574, relative to revised second locking splines 509’) to effect that no rotation of plug 54” is caused when moving plug 54” towards distally from the unlocked to the locked position. Plug 54” thus can be moved from the unlocked to the locked position in a purely axial movement. This way, it is possible to move plug 54” from the unlocked to the locked position by application of relatively low and relatively constant forces (for different medicament delivery devices. For example, it can be safely avoided that teeth 549 (revised first locking splines) centrally abut teeth 509’ (revised second locking splines) when locking plug 54”, which would result in having to apply relatively high forces, which is undesirable.

[0553] The described rotation hampering mechanism with teeth 574 thus makes possible that revised first toothing 545' is engages with revised second toothing 599' without causing a rotation of plug 54”.

[0554] This can be inferred from Fig. 86.

[0555] Fig. 86 shows a detail of a cross-section (perpendicular to the device axis) through a medicament delivery device in the unlocked state, highlighting rotational orientations of teeth 574 of the resilient arm 571, of the revised second toothing 599’ and of revised first toothing 545’.

[0556] It is remarked that the provision of teeth 574 effects that plug 54” can have discrete rotational positions only, relative to further revised device body 5”, already in the unlocked state. This is in contrast to, e.g., revised plug 54’ (cf. Fig. 64A) where plug 54’ can be in any of a continuous range of rotational positions (relative to the device body) in the unlocked position, as pips 544 and inner surface 564 of revised device body 54’ (cf. Fig. 64A) do not force an engagement in discrete rotational positions.

[0557] Both, teeth 574 and revised second locking splines 509’ are comprised in one and the same part, namely in further revised device body 5”, so that the rotational alignment can be implemented with very high precision.

[0558] Yet, the discrete rotational positions in the start position cause an uncertainty. This is the case, because the start position can be reached (axially) only within the precision enabled by the discrete rotational positions of plug 54”. Thus, the start position is reachable only within an uncertainty range.

[0559] And there is another undetermined (random) effect, namely the rotational clearance which necessarily exists between the two toothings 545’, 599’. This clearance is illustrated in Figs. 85A and 85B which show a detail of a cross-section (perpendicular to the device axis) through the medicament delivery device each. The arrows at the dashed lines indicate the angular clearance between teeth 549 of the revised first toothing 545’ and teeth of revised second toothing 599’, namely revised second locking splines 509’. However, this rotational clearance does not contribute to uncertainty with respect to the achieved axial position of plunger rod 7 and to application of pressure to the plunger 31 and to the accuracy of the first dose, respectively. This, because always only a compressive load acts on plunger rod 7 which biases all rotational clearances to one extreme. Yet, said clearance allows for a small axial move of plunger rod 7, but practically, the only force to possibly cause such an axial move is the mass of plunger rod device 7 itself, and that force is practically negligible and will thus be neglected in the following.

[0560] Due to the above-described coupling mechanism which couples rotational and axial movements of plunger rod 7 by cooperation with plunger nut 8, the effect of the uncertainty range from the discrete rotational positions results in the above-announced axial shift. The axial shift is generally proportional to the rotational shift. Accordingly: The larger the rotational distance between neighboring discrete rotational positions, the larger the uncertainty of the axial shift.

[0561] Therefore, in order to ensure that no pressure is applied to the medicament (in the final positioning and thus during shelflife), the axial travel distance (defined by the second relative movement) has to be chosen the e higher the distance between neighboring discrete rotational positions. This, however effects that, depending on circumstances, the axial distance between plunger rod arrangement 101 (more particularly plunger rod 7) and plunger 31 is rather large - which bears the risk of expelling a too small first dose. A small distance between neighboring discrete rotational positions can thus be desirable.

[0562] Other sources of uncertainty regarding the axial position of plunger rod 7 are (i) the measurement error when determining the position of stopper 31, (ii) the actuator positioning error when setting the axial position of plunger rod 7, and (iii) the uncertainty from the second relative movement, i.e. the uncertainty in the axial positional shift from the intermediate positioning to the final positioning.

[0563] By the dashed lines with the open arrows, Fig. 82B illustrates the axial distance in the final state between plunger 31 and plunger rod 7, which results from axial travel distance td (caused by the second relative movement) and the axial shift carried out by plunger rod 7 (caused by the rotational distance between neighboring discrete rotational positions). In the illustrated case, the axial shift effectively adds up to axial travel distance td, as plunger rod 7 is moved towards distally when plug 54” moves from the unlocked to the locked position, so that the axial distance in the final state between plunger 31 and plunger rod 7 is larger than axial travel distance td.

[0564] The bent arrow in Fig. 82B points at the abutting of first front stop faces 562’ and second front stop faces 462’ of protrusion 566’ and of opening 466’, respectively (cf. also Figs. 76B, 76E and 77A), where there is no gap, i.e. no axial distance, because of the abutting forced by beams 590’ (cf. Fig. 76E).

[0565] As will be understood now, it can be advantageous to ensure that plunger rod 7 does not carry out undesired rotations between the end of the improved plunger rod positioning process and the locking of plug 54", e.g., it should be avoided that plunger rod 7 (and plug 54”) continues rotating at the end of the improved plunger rod positioning process and, accordingly, that plunger rod 7 continues moving further towards distally after spacer rod 710 has discontinued moving towards distally at the end of the improved plunger rod positioning process. Undesired rotations (and corresponding axial movements) could take place if no measures were taken to hamper rotation of plug 54” in the unlocked state. However, the described rotation hampering mechanism in which a resilient force presses teeth 574 onto revised first toothing 545’ to hold plug 54” in a rotational position (cf. Figs. 84, 86) can ensure that - in the unlocked state - unintentional axial movements of plunger rod 7 are avoided, while still enabling to carry out the improved plunger rod positioning process during which plug 54” has to rotate in order to enable that plunger rod 7 is moved towards distally.

[0566] The described further revised mounting process - and the related further revised plunger rod fixing mechanism and rotation locking mechanism and improved plunger rod positioning process -can be carried out without having to apply a rotational movement to one of the parts. It is sufficient to merely move the parts of the medicament delivery device in axial directions. Also, assembly jig 700 can be used as described without having to apply a rotational movement to it. Linear movements are sufficient also for assembly jig 700. This facilitates the mounting process.

[0567] The further revised mounting process can render superfluous a separate priming process. When ensuring that the amount of gas in medicament container 3 is rather low - to an extent which is practicable in industrial processes - then neither during the mounting process nor later, e.g., when applying the medicament, a priming needs to be carried out. The precision achievable in the described processes is sufficient to accomplish this. Revised Loading Mechanism

[0568] In the following, a revised loading mechanism is described. One aspect thereof concerns the helical feature and slopes extension, respectively, and the cooperating feature and the support ledge, respectively. In embodiments described above, slope extension 141 has two slopes 142, 143 (offset by 180°) which cooperate with one of two support ledges 240 (cf., e.g., Figs. 20, 21A, 21B). This can reduce tilting and bending problems of plunger nut 8.

[0569] However, it turns out that it is possible to realize the reloading in a fully functional way also by using merely a single slope and a single support ledge. This strongly simplifies manufacture. And problems regarding tilting or bending of the plunger nut can be avoided by providing a stabilizing bearing for the plunger nut in the device body.

[0570] Fig. 67 shows, in a perspective view, a revised plunger nut 8’ having a revised slope extension 141’ which has merely a single revised slope 142’.

[0571] Fig. 68 shows a perspective view onto a cross-section through a revised device body 5’ which is different from the revised device body 5’ of Figs. 62A-62D, but could be identical thereto, provided it also comprises a single revised support ledge 240’ as shown in Fig. 68.

[0572] Revised slope 142’ and revised support ledge 240’ cooperate in the same way as described above for (outer) slope 142 and one of the support ledges 240.

[0573] Refraining from a second slope and a second support ledge, there is more space available (in the radial direction) for revised slope 142’ and for revised support ledge 240’, so that these can be designed to be thicker (in the radial direction) which provides a larger contact area between the parts, which again reduces the risk of damage and / or reduces the requirements for the materials, e.g., regarding hardness.

[0574] The stabilizing bearing is embodied by an outer surface i4if of revised slope extension 141’ cooperating with an inner surface 5f of revised device body 5’. During relative rotations of revised plunger nut 8’ and revised device body 5’, outer surface i4if and inner surface 5f rotationally slide upon one another which avoids or at least strongly limits tilting of revised plunger nut 8’ with respect to device axis A and revised device body 5’.

[0575] Another effect of the stabilizing bearing is that it strongly reduces the risk of derailing. Accordingly, as visible in Fig. 68, a radial support structure such as protrusions 245 (cf. Fig. 23B) can be dispensed with. Revised Reload Blocking Mechanism

[0576] Above, a reload blocking mechanism has been described, cf., e.g., Figs.30, 31A, 31B. In the following, we describe a revised reload blocking mechanism. This revised reload blocking mechanism simplifies assembling the plunger rod (i.e. a revised plunger rod) with the plunger rod guiding member 54 or with the revised plunger rod guiding member 54’. The revised plunger rod 7’ can be moved into and completely through the plunger rod guiding member 54 (or the revised plunger rod guiding member 54’).

[0577] Figs. 69A-69D show a revised plunger rod 7’ in different perspective views, wherein Figs. 69B to 69D show only the distal end of revised plunger rod 7’. Like the plunger rod 7 described further above (cf., e.g., Fig. 30), plunger rod thread 72 is a double-start thread, i.e. plunger rod thread 72 comprises two interlacing partial threads. In cooperation with the already described second coupling structure 82, this provides an increased stability against tilting of plunger rod 7 or of revised plunger rod 7’ relative to plunger nut 8 or to revised plunger nut 8’.

[0578] Revised plunger rod 7’ comprises two revised first blocking members 79’ which are embodied as a blocking ridge each. The blocking ridges are longitudinally extended and connect to a distal end of plunger rod thread 72. From the distal ends of plunger rod thread 72, the blocking ridges extend towards distally.

[0579] In contrast to the first blocking members 79 described further above, the revised first blocking members 79’ do not protrude outwardly from flat sides 7f, but are located between the two planes which are defined by the two flat sides 7f. Accordingly, revised plunger rod 7’ can be moved into and through central opening 54c of plunger rod guiding member 54 or of revised plunger rod guiding member 54’, while revised plunger rod 7’ is rotationally locked to plunger rod guiding member 54 or of revised plunger rod guiding member 54’.

[0580] Figures 70A, 70B show different cross-sections through a medicament delivery device with revised plunger rod 7’ of Figures 70A-70D, after expelling of the last dose has taken place. And Figure 71 shows a detail of revised plunger rod 7’ engaged with revised plunger nut 8’ after expelling of the last dose has taken place. In Figure 71, revised plunger rod 7’ and the revised plunger nut 8’ are illustrated in a transparent fashion.

[0581] In Figs. 70A, 70B, 71 the gap angle - which in the embodiment described further above amounts to about 8o° - is small. It amounts to between o° and io°. Distal ends 82 of internal thread 82 nearly abut the blocking ridges. Accordingly, the illustrated position of revised plunger rod 7’, in which the expelling of the last dose has just taken place, is close to the terminal position. Thus, a user trying to reload the medicament delivery device another time after the last dose has been expelled, will very quickly notice that the medicament delivery device will not expel another dose.

[0582] Revised Spring Stop

[0583] The spring stop 11 described further above and more particularly its spring stop slope 112 effect that activation button 13 moves further out (towards distally) each time briefly before a resting position is reached. Figs. 72A to 72C show a revised spring stop 11’ which has a differently shaped revised spring stop slope 112’ as a cam feature. Fig. 72C shows only the proximal end of revised spring stop 11’. Revised spring stop slope 112’ has a first flat section H2d (also referred to as recessed section) extending over about 30°, followed by a first sloped section H2e (also referred to as slightly sloped section) extending over about 270°, which is followed by a second sloped section H2f (also referred to as strongly sloped section) extending over about 550, which again is followed by a second flat section 112g extending over about 8° only.

[0584] Figures 73A, 73B show a revised activation button 13’ having a revised sliding protrusion 132’ for cooperating with revised spring stop slope 112’ by sliding thereupon when revised activation button 13' and revised spring stop 11' are rotated relative to one another. Revised sliding protrusion 132’ is chamfered and has an inclined section 132!.

[0585] During loading (twisting of loading sleeve 12), revised activation button 13’ rotates together with loading sleeve 12, and while revised sliding protrusion 132' slides on first flat section H2d, the axial position of revised activation button 13’ remains unchanged in its second position. Sliding on first sloped section H2e, revised activation button 13’ moves only slightly towards distally, as the slope of revised spring stop slope 112' is very small in first sloped section H2e. First flat section H2d and first sloped section H2e provide great resistance against any movement of revised activation button 13’ towards proximally. Towards the end of the loading, revised sliding protrusion 132' slides on second sloped section H2f which has a steep slope so that revised activation button 13’ is moved to its first position in which revised sliding protrusion 132' abuts second flat section 112g. Inclined section 132! facilitates the movement of revised activation button 13’ over step feature H2h between second flat section 112g and recessed first flat section H2d.

[0586] Accordingly, revised spring stop slope 112’ notably out moves revised activation button 13’ towards distally only towards the end of the loading process, thus providing a user-perceivable signal that the loading process is about to be finished. Furthermore, revised activation button 13’ has a notch I3n which provides rotational orientation for revised activation button 13’ during assembly of the medicament delivery device. Notch i3n is located between first flat section H2d and first sloped section H2e.

[0587] Further Revised Plunger Nut

[0588] As described further above, plunger nut 8 has, at its slope extension 141, more particularly at its slopes 142, 143, three ramps 144 (as step features) which match with additional support faces 243 of support ledges 240 of device body 5, so as to define resting positions making it easy for a user to cariy out the loading process in a number of subsequent turnings. Resting positions are this way defined at 90°, 180° and 270° loading rotation. The same applies for revised plunger nut 8’ (Fig. 67) and its revised slope extension 141’ and more particularly its revised (single) slope 142' cooperating with revised support ledge 240’ of revised device body 5’ (Fig. 68).

[0589] However, the design of the plunger nut and its manufacture can be simplified by defining the resting positions in another part of the medicament delivery device. Fig. 74 shows the proximal end of a further revised plunger nut 8” with its further revised slope extension 141” which, like revised slope extension 141’, has only a single slope 142”.

[0590] The further revised slope 142”, however, does not exhibit any ramps (as step features) for defining resting positions. Of course, similar to plunger nut 8, there could also be two (further revised) slopes which do not exhibit any ramps (as step features).

[0591] Defining the resting positions, in this embodiment (further revised embodiment), is accomplished by revised spring stop 11’ (cf. Figs. 72A-72C) cooperating with a revised signalling member 160’ (corresponding to a revised bearing member), cf. Figs. 75A to 75C. More specifically, the resting positions are defined by a revised bearing seat 180’ embodied in revised spring stop 11’, more particularly by a revised cooperation feature 190’ and camcooperating structure 190s’ thereof, respectively, cooperating with a revised distance varying feature 170’ and, more particularly with a revised cam curve 170s’ thereof.

[0592] Figs. 75A to 75C show the revised signalling member 160’ in different perspective views, wherein Fig. 75C shows only the distal end of revised signalling member 160’.

[0593] Revised Signalling Mechanism

[0594] Revised distance vaiying feature 170’ and revised cam curve 170s’ have a fourfold rotational symmetry (in contrast to the threefold rotational symmetry of the non-revised features). Along a circumference of revised signalling member 160’, revised cam curve 170s’ has four identical partial cam curves, ranging 90° each, appended one after the other. Each partial cam curve has, extending 90° along a circumference of revised signalling member 160’, a bottom section Ri adjacent a sloped section R2 adjacent a top section R3 adjacent a step feature R4.

[0595] Revised cooperation feature 190’ and cam-cooperating structure 190s’, respectively, of revised spring stop 11’ also have a fourfold symmetry (in contrast to the threefold rotational symmetry of the non-revised features). It comprises along a circumference of revised bearing seat 180’, four identical partial cam curves, ranging 90° each, appended one after the other. Each partial cam curve has, extending 90° along a circumference of revised bearing seat 180’, a sloped section Q2 adjacent a top section Q3 adjacent a step feature Q4.

[0596] At the end of expelling a dose, the signal (“end click”) is generated by top sections Q3 hitting bottom sections Ri (close to respective step features R4). Accordingly, the abutting of first abutting surfaces 160a (of top sections Q3) and second abutting surfaces 180a (of portions of bottom sections Ri) (cf. Figs. 72C and 75C, respectively) generates a click sound and can also be perceived in a tactile manner.

[0597] Revised Dose Resetting

[0598] Resting positions are established (during loading) by step features Q4 abutting respective step features R4. This way, loading sleeve 12 and revised spring stop 11’ can rotate back (driven by drive spring 9) not further than the last resting position.

[0599] However, step features Q4 and also step features R4 are inclined with respect to longitudinal directions, which facilitates a resetting of a dose. A user can apply a torque to undo the loading at this point.

[0600] Step features Q4 and step features R4 have matching leads, thus ensuring a two-dimensional contact between them. By suitably selecting the lead of features Q4 and step features R4, the torque required for resetting a dose (during loading) can be tailored. For example, they can be selected so that the torque required for resetting a dose is comparable to the torque required for setting a dose.

[0601] Revised Support Mechanism

[0602] In Fig. 75C, also a revised first support structure 166’ of revised bearing member (or signalling member) 160’ is shown. Similarly to what has been described above (support mechanism), the generation of the end click during loading is avoided by revised first support structure 166’ cooperating with a revised second support structure 188’ of revised spring stop 11’ (cf. Fig. 72B). For this, a revised support face 189’ of revised second support structure 188’ slides on revised support structure 166’ (support ridge), so as to ensure that a distance exists between step features Q4 and step features R4 during loading.

[0603] In contrast to support structure 166, revised first support structure 166’ does not comprise a sloped section (such as T3 in Figs. 33A, 33B), but is comprises two flat sections which are chamfered, so as to facilitate revised second support structures 188’ sliding onto and off the flat sections. Sliding onto the flat sections is further facilitated by revised second support structures 188’ having an inclined section 189! (cf. Fig. 72B).

[0604] Furthermore, revised signalling member 160’ has an outer coating, namely a hard coating. Revised signalling member 160’ is an injection molded part. After the injection molding process with an injection molding material, the hard coating is applied in a coating process. The material of the coating has a hardness, in particular a scratch hardness, exceeding the hardness of the injection molding material. Revised signalling member 160’ can be more robust because of the coating. This can also find application for signalling member 160.

[0605] Applications

[0606] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0607] 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, Behgef 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.

[0608] 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.

[0609] 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.

[0610] 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-i) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Ci esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor-associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B- cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-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 W137 (CDwi37) 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 arrestspecific protein 6 (GAS6) / AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation W123 (CDwi23) 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.

[0611] 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-ia, interferon beta-ib, peginterferon beta-ia, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins. 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.

[0612] 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.

[0613] 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.

[0614] 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, too U / mL Heparin Lock Flush Solution, or 5000 U / mL Heparin Lock Flush Solution. 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 maybe 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.

[0615] 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, mF0LF0X6, mFOLFOX , FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R- EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA- Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DTPACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

[0616] Various modifications to the embodiments described are possible and will occur to those skilled in the art without departing from the invention which is defined by the following claims.

Claims

99CLAIMS1. A medicament delivery device (2) for accommodating a medicament container (3) comprising a plunger (31) and containing a medicament, and for expelling multiple predefined doses of the medicament from the medicament container (3), wherein dosing amounts of the doses are pre-defined, set by the medicament delivery device (2), the device (2) extending axially between a proximal end and a distal end and defining a proximodistal device axis (A), the proximal end being the one pointing towards a dose delivery site during use of the medicament delivery device (2), the device (2) comprising: a base assembly to which the medicament container (3) is mountable in a stationary manner, a plunger rod assembly (101) being axially movable relative to the base assembly for interacting with the medicament container (3) for expelling the medicament therefrom, and a biasing member (9) configured to force the plunger rod assembly (101) in the proximal direction, wherein the biasing member (9) is a compression spring, in particular a helical compression spring; wherein the plunger rod assembly (101) comprises a main plunger rod device (7; 7’) and an auxiliary plunger rod device (8; 8’), wherein the main plunger rod device (7; 7’) is configured to act on the plunger (31) to expel the medicament from the medicament container (3) by moving in the proximal direction; the medicament delivery device (2) further comprising a loading mechanism configured for a user to cause a loading step comprising a loading movement of the auxiliary plunger rod device (8) from an unloaded position to a loaded position and thereby biases the biasing member (9), wherein the loading movement comprises a movement of the auxiliary plunger rod device (8; 8’) in the distal direction relative to the base assembly and to the main plunger rod device (7; 7’) and in addition comprises a rotational movement of the auxiliary plunger rod device (8; 8’) relative to the base assembly and to the main plunger rod device (7; 7’), and wherein the loading mechanism comprises a twisting element (12) rotationally coupled to the auxiliary plunger rod device (8; 8’) and configured to be twisted by the user relative to the base assembly in a first sense of rotation to cause the loading movement; the device (2) further comprising an activation mechanism for the user to activate medicament delivery, the activation mechanism comprising an activation button (13; 13’) rotationally coupled to the twisting element (12), a cam feature (112; 112’), and a cam-cooperating feature (132; 132’);wherein one of the cam feature (112; 112’) and of the cam-cooperating feature (132; 132’) is comprised in the activation button (13; 13’), and the other one is couplable to the base assembly; wherein the activation mechanism is operable by the user to activate medicament delivery by pushing the activation button (13; 13) towards proximally from a first position into a second position; and wherein the twisting of the twisting element (12) by the user to cause the loading movement furthermore causes the activation button (13; 13) to be moved towards distally from the second position into the first position by cooperation of the cam feature (112; 112’) and the camcooperating feature (132; 132’).

2. The medicament delivery device (2) according to claim 1, wherein the cam feature (112; 112’) comprises a cam curve, and the cam-cooperating feature (132; 132’) comprises a protrusion configured to abut the cam curve.

3. The medicament delivery device (2) according to claim 1 or claim 2, wherein the cam feature (112; 112’) is couplable to the base assembly, and the cam-cooperating feature (132; 132’) is comprised in the activation button (13; 13’).

4. The medicament delivery device (2) according to one of the preceding claims, the cam feature (112’) comprising a strongly sloped section (ii2f) and one or more non-sloped or slightly sloped sections (ii2d, H2e, 112g), the cooperation of the cam feature (112’) and the cam-cooperating feature (132; 132’) in the non-sloped or slightly sloped sections (ii2d, H2e, 112g) blocking a movement of the activation button (13, 13’) towards proximally, and the cooperation of the cam feature (112’) and the cam-cooperating feature (132, 132’) in the strongly sloped section (ii2f) causing the activation button (13; 13’) to be moved towards distally for at least 60%, in particular for at least 75%, more particularly for at least 80% of a travel toward distally of the activation button (13; 13’) from the second position to the first position, wherein the cooperation of the cam-cooperating feature (132; 132’) with the strongly sloped section (ii2f) takes place merely in a final phase of the loading movement, in particular wherein the final phase makes up for at most 35%, in particular for at most 25%, more particularly for at most 20%, of the loading movement.

5. The medicament delivery device (2) according to one of the preceding claims, the cam feature (112; 112’) comprising one or more sloped sections (112a; H2e, H2f) and one or more non-sloped sections (112b; H2d, 112g), the cooperation of the cam feature (112; 112’) and the101 cam-cooperating feature (132; 132’) in the sloped sections (112a; H2e, H2f) causing the activation button (13; 13’) to be moved towards distally, and the cooperation of the cam feature (112; 112’) and the cam-cooperating feature (132; 132’) in the non-sloped sections (112b; H2d, 112g) blocking a movement of the activation button (13; 13’) towards proximally.

6. The medicament delivery device (2) according to claim 5, wherein the loading mechanism is configured to cause the loading movement by the user twisting the twisting element in two or more successive twisting actions, wherein in between the twisting actions, the auxiliary plunger rod device (8; 8’) is in a resting position in which a movement towards proximally of the auxiliary plunger rod device (8; 8’) is blocked, and wherein the camcooperating feature (132; 132’) abuts the cam feature (112; 112’) in one of the non-sloped sections (112b; H2d, 112g) when the auxiliary plunger rod device (8; 8’) is in a resting position.

7. The medicament delivery device (2) according to claim 6, wherein, during each of the twisting actions, the cam-cooperating feature (132; 132’) abuts one of the sloped sections (112a) briefly before the auxiliary plunger rod device (8) reaches one of the resting positions.

8. The medicament delivery device (2) according to one of claims 5 to 7, the cam feature (112; 112’) comprising a recessed section (112c; H2d) adjacent that one of the non-sloped sections (112b; 112g) which is arranged most distally, thus enabling the activation button (13; 13’) to move towards proximally from the first position into the second position.

9. The medicament delivery device (2) according to one of claims 4 to 8, further comprising one or more snap fit connections between the activation button (13: 13’) and the twisting element (12) for hampering a movement towards distally of the activation button (13; 13’) relative to the twisting element (12).

10. The medicament delivery device (2) according to one of the preceding claims, wherein the pushing of the activation button (13; 13’) towards proximally from the first position into the second position causes a release of a movement towards proximally of the plunger rod assembly (101).

11. The medicament delivery device (2) according to claim 10, the activation button (13; 13’) comprising one or more interacting elements (133), in particular two interacting elements (133)? cooperating with the plunger rod assembly (101), more particularly with the auxiliary plunger rod device (8), to cause the release of the movement towards proximally of the plunger rod assembly (101).10212. The medicament delivery device (2) according to one of the preceding claims, wherein one of the auxiliary plunger rod device (8; 8’) and of the base assembly comprises a pair of locking arms (85), each locking arm (85) having a locking protrusion (86), and the other one comprises one or more locking structures (51a, 51b) capable of engaging with one or more of the locking protrusions (86), wherein the medicament delivery device (2) is configured for the locking arms (85) to flex in a resilient manner in response to the user causing the loading movement and to flex back for the locking protrusions (86) to engage the locking structures (51a, 51b) immediately before the loaded position has been reached by the auxiliary plunger rod device (8), and wherein the activation button (13; 13’) comprises one or more interacting elements (133) configured to cooperate with the locking arms (85), in particular with the locking protrusions (86), when the user pushes the activation button (13; 13’) towards proximally from the first position into the second position, to flex the locking arms (85) until the locking protrusions (86) get out of engagement with the locking structures (51a, 51b), so that the biasing member (9) displaces the plunger rod assembly (101) towards proximally.

13. The medicament delivery device (2) according to one of the preceding claims, wherein the activation button (13; 13’) is rotationally coupled to the twisting element (12) by a ledge (121) of the twisting element (12) which cooperates with an activation slit (134) of the activation button (13; 13’), in particular wherein the activation slit (134) is formed in a sleevelike proximal part of the activation button (13; 13’), more particularly wherein the activation slit (134) is formed between the interacting elements (133).

14. The medicament delivery device (2) according to one of the preceding claims, wherein one of the activation button (13; 13) and of the twisting element (12) comprises a first retaining feature (135), and the other one comprises a second retaining feature (123) cooperating with the first retaining feature (123) to limit a movability of the activation button (13; 13) towards distally relative to the twisting element (12), in particular to limit said movability by abutting one another when a distal-most position of the activation button (13) relative to the twisting element (12) is reached, in particular when the first position is reached.

15. The medicament delivery device (2) according to one of the preceding claims, wherein the activation button (13; 13) comprises a distal end part (13d) having a generally radially outwardly facing outer face (i3f), the outer face (i3f) bearing markings (13m) indicative of a progress of the loading step, in particular visual markings (13m) at different axial positions.

16. The medicament delivery device (2) according to one of the preceding claims, wherein the loading mechanism furthermore comprises:103 a helical feature (142; 143; 142’); and a cooperating feature (240; 240’) cooperating with the helical feature (142; 143; 142’) to cause a translational movement of the auxiliary plunger rod device (8; 8’) relative to the base assembly in reaction to a rotation of the auxiliary plunger rod device (8; 8’) about the device axis (A); wherein one of the auxiliary plunger rod device (8; 8’) and of the base assembly comprises the helical feature (142; 143; 142’), and the other one comprises the cooperating feature (240; 240').

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