Dose delivery mechanism

Abstract

A dose delivery mechanism includes a piston rod and a nut, where the piston rod forms an external thread that meshes with an internal thread of the nut, where, during dose setting, the nut is configured to rotate relative to the piston rod to advance the nut in a distal direction relative to the piston rod by a first distance; an actuation member movable by a user to effect delivery of a set dose; and a housing wherein a second threaded connection is provided wherein the second threaded connection is configured to cause the actuation member to travel a second distance in a distal direction during dose setting wherein the actuation member is coupled to the piston rod via a nut during dose delivery, the piston rod is coupled to the actuating member to advance the piston rod in a proximal direction by a first distance when the actuating member is moved proximally by a second distance, where the second distance is less than 1.5 times the first distance.

Description

Technical Field

[0001] The present invention relates to a dose delivery mechanism, such as an injection pen. Background Art

[0002] An injection pen can be used to self-inject a certain amount of medication, i.e. a certain dose. To self-inject a medication, the patient usually has to set the desired dose and then push an actuation member at the distal end of the injection pen in a proximal direction. Most pens use a gear transmission mechanism with a gear ratio between 2 and 4 to reduce the force required to push the actuation member. Such pens are limited in the amount of medication that can be self-injected during one actuation of the pen, because there is a maximum distance that the actuation member can be comfortably pushed with the thumb when holding the pen in one hand.

[0003] There is a need for a dose delivery mechanism that allows for self-injection of larger amounts of medication in a comfortable manner. Summary of the invention

[0004] This object is met by a dose delivery mechanism comprising: a piston rod and a nut, wherein the piston rod forms an external thread that meshes with an internal thread of the nut, wherein during dose setting, the nut is configured to rotate relative to the piston rod to advance the nut in a distal direction relative to the piston rod by a first distance; an actuation member that is movable by a user to achieve delivery of a set dose; and a housing, wherein a second threaded connection is provided, wherein the second threaded connection is configured to cause the actuation member to travel a second distance in a distal direction during dose setting, wherein the actuation member is coupled to the piston rod via the nut during dose delivery to advance the piston rod in a proximal direction by the first distance when the actuation member moves proximally by the second distance, wherein the second distance is less than 1.5 times the first distance.

[0005] The general idea behind the present invention is a dose delivery mechanism having a relatively small gear ratio to allow for delivery of a relatively high amount of drug with a relatively small axial movement of the actuation member.

[0006] The second threaded connection may have a constant pitch. The second threaded connection may act between the housing and the actuation member. The actuation member may be configured to follow a path defined by the second threaded connection during dose setting. Alternatively, the actuation member may also be configured to travel a second distance linearly during dose setting while a separate component of the dose delivery mechanism follows a path defined by the second threaded connection.

[0007] For example, the second threaded connector may act between the dosing member and the housing of the dose setting mechanism. Thus, the dosing member may be configured to follow the path defined by the second threaded connector during dose setting. For example, the dosing member may directly engage with the housing via the second threaded connector so that the dosing member and the housing form the second threaded connector. The dosing member and / or the housing may also be connected to the second threaded connector via one or more corresponding intermediate members, such as via an intermediate member axially and / or rotationally fixed relative to the dosing member and / or via an intermediate member axially and / or rotationally fixed relative to the housing.

[0008] The actuation member may be configured to travel both rotationally and linearly in the distal direction with the dosing member during dose setting.Alternatively, the actuation member may also be configured to travel only linearly and non-rotationally in the distal direction with the dosing member during dose setting.

[0009] The dose delivery mechanism may include a dose setting member configured to be held and actuated (e.g., rotated) by a user to set a dose to be injected. For example, rotation of the dose setting member may cause two members (such as a housing and a dosing member) that are engaged with each other via a second threaded connector to rotate relative to each other during dose setting. The dose setting member may be configured to be integral with the actuation member or rigidly connected to the actuation member, for example as a member that is rotated for setting a dose to be injected and is pushed in a proximal direction to achieve delivery of the set dose. The dose setting member may also be configured to be separate from the actuation member, for example as a dose setting ring provided around the housing of the dose delivery mechanism.

[0010] The first distance is defined by the pitch of the first threaded connection between the piston rod and the nut, and the second distance is defined by the pitch of the second threaded connection. The first distance must match the required discharge dose. When a typical commercial cartridge with a nominal filling capacity of 3 ml is used, the distance will be about 14 mm to discharge 1.0 ml. The limit of the second distance is given by a usability assessment and may be, for example, 20 mm. Therefore, if the maximum dose to be discharged from the pen-type injector will be 1 ml, the pitch of the second threaded connection will be less than 1.4 times the pitch of the first connection. Additionally or alternatively, the minimum allowable value of the second pitch may be greater than the maximum allowable value of the first pitch, and the minimum allowable value of the second pitch is the minimum value that the second pitch can adopt within its manufacturing tolerance, and the maximum allowable value of the first pitch is the maximum value that the first pitch can adopt within its manufacturing tolerance.

[0011] During dose setting and / or delivery, the piston rod may be rotationally fixed relative to the housing.

[0012] Embodiments of the dose delivery mechanism are defined by the dependent claims and described in the following disclosure.

[0013] According to an embodiment, the first distance is substantially equal to the second distance.This allows self-injection of even larger amounts of drug while ensuring that the distance the actuation member needs to be pushed in order to inject this amount of drug is small enough that the actuation member can be pushed in a comfortable manner.

[0014] The first distance and the second distance may be substantially equal if the second distance and / or the pitch of the second threaded connection is at most 1.01 times, in particular at most 1.005 times, the first distance and / or the pitch of the first threaded connection.

[0015] The actuating member can be configured to push the piston rod in a proximal direction directly or via one or more intermediate members during dose delivery. For example, the actuating member can be configured to push a threaded member (such as a dosing member) connected to the housing via a second threaded connector in a proximal direction during dose delivery, and thus achieve the rotation of the threaded member along the second threaded connector. Then, the threaded member can be configured to push the piston rod in a proximal direction, for example via an intermediate member (such as a nut). During dose delivery, the nut can be rotationally fixed relative to the piston rod, so that due to the mutual threaded connection of the nut and the piston rod, the proximal movement of the nut causes the piston rod to move proximally.

[0016] The dose delivery mechanism may be configured to advance the piston rod in the proximal direction during dose delivery at the same speed as the actuation member is moved in the distal direction during dose delivery.

[0017] During dose delivery, only a single threaded connection, such as the second threaded connection, may enable guided axial and rotational relative movement between components of the dose delivery device.

[0018] According to a further embodiment, all parts configured to rotate relative to the housing during dose delivery are connected to the housing via exactly one thread. "Connected to the housing via exactly one thread" means that all parts configured to rotate relative to the housing during dose delivery form a subassembly, and wherein the subassembly is connected to the housing via a single threaded connector. That means, there is no second threaded connector acting between the housing and the subassembly (i.e., connecting the housing and the subassembly). The pitch of the single threaded connector defines the axial distance traveled by all rotating parts rotating during dose delivery for a given angle of rotation. All parts configured to rotate relative to the housing during dose delivery can be axially and rotationally fixed relative to each other during dose delivery. During dose setting, one or more of these parts can be rotationally and / or axially movable relative to one or more other parts of these parts. For other embodiments, the parts rotating relative to the housing during dose delivery can also be rotationally and axially fixed relative to each other during dose setting.

[0019] The part configured to rotate relative to the housing during dose delivery may include a driver, a dose sleeve, a dosing member and / or a snap element.

[0020] Exactly one thread may be, for example, a second threaded connection.

[0021] The dose delivery mechanism may have a dose setting unit including a dosing member, and the dosing member may be rotationally fixed to the dose setting member and / or the actuating member during dose setting. The dosing member, the dose setting member and the actuating member may be rotatable (e.g., in unison) to set the desired dose. The dosing member may be connected to the housing via a second threaded connection.

[0022] During dose delivery, the dosing member may be rotationally disengaged from the dose setting member and / or the actuating member. The dosing member may be configured to rotate relative to the housing during dose delivery. Additionally or alternatively, the dose setting member and / or the actuating member may be configured to be rotationally fixed relative to the housing during dose delivery.

[0023] The dosing member may be configured to rotate relative to the housing during dose delivery. The dosing member may be connected to the housing of the device via the second threaded connector during dose delivery. The proximal movement of the actuating member during dose delivery may cause the dosing member to follow a path defined by the second threaded connector in a proximal direction.

[0024] The dosing member can be configured to apply a force on the piston rod during dose delivery, such as a linear force in the proximal direction. For example, the dosing member can apply a force to the piston rod via the nut. The dosing member can be configured to advance in the proximal direction during dose delivery and thereby abut the nut. Then, the nut and the piston rod can be pulled toward the proximal direction together with the dosing member.

[0025] According to an embodiment, the dose delivery mechanism further comprises a dose setting unit having a dose sleeve indicating the set dose, the dose sleeve being rotationally coupled to the actuation member during dose setting. The actuation member and the dose sleeve may be rotatable to set the desired dose. Preferably, the actuation member and the dose sleeve may be rotated in unison to set the desired dose. The dose sleeve may be connected to the housing via a second threaded connection.

[0026] The dose sleeve may constitute the dosing member or it may be a part of the dosing member which is axially and / or rotationally fixed to other parts of the dosing member.

[0027] According to an embodiment, the dose sleeve and the actuation member are rotationally decoupled during dose delivery, so that the actuation member does not rotate during dose delivery. This allows to comfortably push the actuation member without causing friction between the thumb and the actuation member.

[0028] According to an embodiment, the dose delivery mechanism further comprises a driver, wherein the driver applies a force to the nut to drive the piston rod during dose delivery. The dose sleeve and the driver may be formed as one piece or may be rotationally and axially rigidly connected to each other. The dose sleeve and the driver may be part of a dosing member.

[0029] According to a further embodiment, the driver directly abuts the nut to drive the piston rod during dose delivery. This allows the force applied to the driver to be transmitted directly to the nut.

[0030] According to an embodiment, the driver is forced to rotate relative to the housing during dose delivery. This rotational movement is preferably caused by the second threaded connection.

[0031] According to a further embodiment, the dose delivery mechanism comprises a spring, which acts between the housing and the actuation member during dose setting.The spring may be arranged between the housing and the dose sleeve or between the housing and the driver.

[0032] Additionally or alternatively, a spring may act between the housing and the dosing member.

[0033] Preferably, the spring is configured to support the user in moving the actuation member to achieve delivery of the set dose. This ensures that the patient requires less force to inject the set dose. In order to ensure that the spring supports moving the actuation member until the end of the injection, the spring can be preloaded in the delivery state (i.e. the state in which the pen is delivered to the user).

[0034] The spring may be a torsion spring. If the torsion spring is a helical torsion spring, a large support force may be achieved. Preferably, the spring is configured to be tensioned during dose setting. In other words, the spring is preferably arranged in the dose delivery mechanism such that a rotational movement of the dose setting knob (e.g., an actuating member) causes the spring to be tensioned or further tensioned.

[0035] According to an embodiment, the spring is coupled to a piston rod guide which guides the linear movement of the piston rod and the driver.The piston rod guide may be part of the housing or fixedly coupled to the housing.

[0036] Preferably, the spring is arranged in the proximal part of the dose delivery mechanism, in particular in the proximal end section. The dose delivery mechanism (e.g., a unit for setting a dose and delivering the set dose) can be coupled to a drug preparation unit, such as a unit intended to mix a lyophilized drug with a solvent before use (i.e., a reconstitution unit). It can also be coupled to a unit comprising a cartridge that already contains a ready-to-use drug.

[0037] According to an embodiment, the actuation member is rotationally fixed to the nut during dose setting and dose delivery.The actuation member may comprise longitudinally extending torque transmission means (such as longitudinally extending ribs) which engage with longitudinally extending torque transmission means (e.g. longitudinally extending grooves) of the nut.

[0038] According to another embodiment, the driver and a part of the housing, in particular the piston rod guide, form the second threaded connection. Preferably, the driver and an inner housing part, in particular an inner housing part arranged radially inside the dose sleeve, form the second threaded connection. In general, a part that is rotatable during dose delivery, in particular a part that is rotatable during dose setting and dose delivery, such as the dose sleeve or the driver, and any part that is not rotatable relative to the housing during dose delivery may form the second threaded connection.

[0039] According to an embodiment, the piston rod is linearly guided in the housing. Alternatively or additionally, the piston rod can be non-rotatably mounted to the housing, i.e. non-rotatably supported by the housing. In order to support the piston rod in such a way that the piston rod is linearly but non-rotatably guided in the housing, the housing, in particular the piston rod guide, can have a longitudinal through-opening, the non-circular inner circumference of which corresponds to the non-circular outer circumference of the piston rod.

[0040] A ball bearing may be provided to reduce friction during dose delivery. A bearing may be arranged between the driver and the nut to reduce friction between the driver and the nut. Alternatively or additionally, a washer may be arranged between the driver and the nut, the washer being made of a low friction material, such as, for example, PTFE. Prior to the development of the dose delivery mechanism, it was believed that a gear ratio greater than 2 was required to allow the user to comfortably inject a set dose. However, the improvements described above and below make it possible to provide a dose delivery mechanism having a gear ratio lower than 2 and even lower than 1.5, but still allowing the user to comfortably inject a set dose.

[0041] According to an embodiment, the speed v of the actuation member during dose delivery am and the piston rod velocity v pr In other words, preferably the actuation member and the piston rod are moved simultaneously in the proximal direction at the same speed during dose delivery.

[0042] According to an embodiment, the nut is configured not to rotate relative to the housing and / or the piston rod during dose delivery. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] These and other features, aspects and advantages are described below with reference to the accompanying drawings. Throughout the accompanying drawings, similar reference numerals consistently represent corresponding features. The embodiments shown in the drawings may be modified in many ways without departing from the invention.

[0044] Figure 1 An exploded view of an injection pen according to the present invention is shown.

[0045] Figure 2A Shows Figure 1 A perspective view of the knob cover of an injection pen.

[0046] Figure 2B Shows Figure 2A Side view of the knob cover.

[0047] Figure 2C Shows Figure 2B The knob cover is along Figure 2B Sectional view along line AA.

[0048] Figure 3A Shows Figure 1 Perspective view of the injection button of an injection pen.

[0049] Figure 3B Shows Figure 3A Side view of the injection button.

[0050] Figure 3C Shows Figure 3B The injection button is along Figure 3B Sectional view along line AA.

[0051] Figure 3D Shows Figure 3B The injection button is along Figure 3B A cross-sectional view along line BB.

[0052] Figure 3E Shows Figure 3B The injection button is along Figure 3B Cross-sectional view along line CC.

[0053] Figure 4A Shows Figure 1 Perspective view of the snap ring of an injection pen.

[0054] Figure 4B Shows Figure 4A A top view of the snap ring.

[0055] Figure 4C Shows Figure 4A Side view of the snap ring.

[0056] Figure 4D Shows Figure 4A Bottom view of the snap ring.

[0057] Figure 5A Shows Figure 1 First perspective view of the dose setting knob of an injection pen.

[0058] Figure 5B Shows Figure 5A Second perspective view of the dose setting knob.

[0059] Figure 5C Shows Figure 5A Side view of the dose setting knob.

[0060] Figure 5D Shows Figure 5A The dose setting knob is along Figure 5C A cross-sectional view of line AA.

[0061] Fig. 6A Shows Figure 1 A perspective view of the snap-fit ​​element of an injection pen.

[0062] Figure 6B Shows Fig. 6A Side view of the snap-fit ​​element.

[0063] Figure 6C Shows Fig. 6A The snap-on elements are along Figure 6B A cross-sectional view of line AA.

[0064] Fig. 7A Shows Figure 1A perspective view of the connector of an injection pen.

[0065] Figure 7B Shows Fig. 7A Bottom view of the connector.

[0066] Figure 7C Shows Fig. 7A Side view of the connector.

[0067] Fig.7D Shows Fig. 7A A top view of the connector.

[0068] Fig. 8A Shows Figure 1 First perspective view of the dose selector of an injection pen.

[0069] Figure 8B Shows Fig. 8A Bottom view of the dose selector.

[0070] Figure 8C Shows Fig. 8A Side view of the dose selector.

[0071] Fig.8D Shows Fig. 8A The dose selector is along the Figure 8C Sectional view along line AA.

[0072] Fig. 8E Shows Fig. 8A The dose selector is along the Figure 8C A cross-sectional view along line BB.

[0073] Fig. 9 Shows Fig. 8A Second perspective view of the dose selector of .

[0074] Fig. 10A Shows Figure 1 A perspective view of the knob key of an injection pen.

[0075] Fig. 10B Shows Fig. 10A Side view of the knob key.

[0076] Fig.11A Shows Figure 1 A perspective view of the housing of an injection pen.

[0077] Fig. 11B Shows Fig.11A A side view of the housing.

[0078] Fig. 11C Shows Fig.11A The shell along Fig. 11B Sectional view along line AA.

[0079] Fig. 12A Shows Figure 1 A first side view of a dose setting sleeve of an injection pen.

[0080] Fig. 12B Shows Fig. 12A A second side view of the dose setting sleeve.

[0081] Fig. 12C Shows Fig. 12A A third side view of the dose setting sleeve.

[0082] Fig.12D Shows Fig. 12A A fourth side view of the dose setting sleeve.

[0083] Fig.12E Shows Fig. 12A Front view of the dose setting sleeve.

[0084] Fig.12F Shows Fig. 12A A first perspective view of a dose setting sleeve.

[0085] Figure 12G Shows Fig. 12A A second perspective view of the dose setting sleeve of FIG.

[0086] Fig.13A Shows Figure 1 Perspective view of the driver of the injection pen.

[0087] Fig. 13B Shows Fig.13A First side view of the drive.

[0088] Fig. 13C Shows Fig.13A Second side view of the drive.

[0089] Fig.13D Shows Fig.13A The drive along Fig. 13C A cross-sectional view of line AA.

[0090] Fig.14A Shows Figure 1 First perspective view of the nut of the injection pen.

[0091] Fig. 14B Shows Fig.14A A second perspective view of the nut.

[0092] Fig. 14C Shows Fig.14A Side view of the nut.

[0093] Fig.14DShows Fig.14A The nut along Fig. 14C A first cross-sectional view of line AA.

[0094] Fig.14E Shows Fig.14A The nut along Fig. 14C A second cross-sectional view along line BB.

[0095] Fig.15A Shows Figure 1 A first side view of the piston rod guide of an injection pen.

[0096] Fig. 15B Shows Fig.15A A second side view of the piston rod guide.

[0097] Fig. 15C Shows Fig.15A The piston rod guides along Fig.15A Sectional view along line AA.

[0098] Fig.15D Shows Fig.15A A perspective view of the piston rod guide.

[0099] Fig.16A Shows Fig.15A A first longitudinal cross-sectional view of a piston rod guide.

[0100] Fig. 16B Shows Fig.15A A second longitudinal cross-sectional view of the piston rod guide.

[0101] Fig. 16C Shows Fig.15A A perspective view of the piston rod guide.

[0102] Fig.17A Shows Figure 1 Side view of the piston rod of the injection pen.

[0103] Fig. 17B Shows Fig.17A The piston rod moves along Fig.17A Sectional view along line AA.

[0104] Fig. 17C Shows Fig.17A A first perspective view of the piston rod.

[0105] Fig.17D Shows Fig.17A A second perspective view of the piston rod.

[0106] Fig.18A Shows Figure 1 Perspective view of the piston disk of an injection pen.

[0107] Fig.18B Shows Fig.18A Top view of the piston disc.

[0108] Fig.18C Shows Fig.18A The piston disc along Fig.18B Sectional view along line AA.

[0109] Fig.19A Shows Figure 1 A perspective view of the dual-chamber cartridge of the injection pen.

[0110] Fig.19B Shows Fig.19A Side view of a dual chamber cartridge.

[0111] Fig.19C Shows Fig.19A The dual chamber cartridge follows Fig.19B Sectional view along line AA.

[0112] Fig. 20A Shows Figure 1 A perspective view of a cartridge container for an injection pen.

[0113] Fig. 20B Shows Fig. 20A A first side view of a cartridge container.

[0114] Fig. 20C Shows Fig. 20A A second side view of the cartridge container.

[0115] Fig.20D Shows Fig. 20A The cartridge container is along Fig. 20C Sectional view along line AA.

[0116] Fig.21A Shows Figure 1 First perspective view of the cartridge key of an injection pen.

[0117] Fig. 21B Shows Fig.21A A second perspective view of the cartridge key.

[0118] Fig. 21C Shows Fig.21A A first side view of a cartridge key.

[0119] Fig.21D Shows Fig.21A A second side view of the cartridge key.

[0120] Fig.22A Shows Fig.21A A third side view of a cartridge key.

[0121] Fig. 22B Shows Fig.21A The cartridge key is along Fig.22A Sectional view along line AA.

[0122] Fig.23A Shows Figure 1 Side view of the injection pen in the delivery state.

[0123] Fig. 23B Shows Fig.23A The injection pen is along Fig.23A Sectional view along line AA.

[0124] Fig.24 Shows Fig.23A A perspective view of an injection pen without a knob cover and with some parts shown transparently.

[0125] Fig.25A Shows Fig.23A Second side view of the injection pen.

[0126] Fig.25B Shows Fig.23A The injection pen is along Fig.25A Sectional view along line AA.

[0127] Fig.26A Shows Figure 1 Side view of the injection pen in the reconstituted state.

[0128] Fig.26B Shows Fig.26A The injection pen is along Fig.26A Sectional view along line AA.

[0129] Fig.27A Shows Fig.26A Second side view of the injection pen.

[0130] Fig.27B Shows Fig.26A A third side view of the injection pen.

[0131] Fig.27C Shows Fig.26A The injection pen is along Fig.27B Sectional view along line AA.

[0132] Fig.28A Shows Figure 1 Side view of the injection pen with the knob cover loosened.

[0133] Fig.28B Shows Fig.28A The injection pen is along Fig.28A Sectional view along line AA.

[0134] Fig.29A Shows Figure 1 Side view of the injection pen in the end-of-reconstitution state.

[0135] Fig.29B Shows Fig.29A The injection pen is along Fig.29A Sectional view along line AA.

[0136] Fig. 30A Shows Figure 1 Side view of the injection pen in the dose setting state.

[0137] Fig. 30B Shows Fig. 30A The injection pen is along Fig. 30A Sectional view along line AA.

[0138] Fig.31A Shows Figure 1 Side view of the injection pen at the start of injection.

[0139] Fig.31B Shows Fig.31A The injection pen is along Fig.31A Sectional view along line AA.

[0140] Fig.32A Shows Figure 1 Another side view of the injection pen at the start of injection.

[0141] Fig.32B Shows Fig.32A The injection pen is along Fig.32A An enlarged cross-sectional view of line AA.

[0142] Fig.33A Shows Figure 1 Side view of the injection pen at the end of injection.

[0143] Fig.33B Shows Fig.33A The injection pen is along Fig.33A Sectional view along line AA.

[0144] Fig.34 A second injection pen according to the present disclosure is shown in a pre-assembled state.

[0145] Fig.35 Another view of the second injection pen is shown in a pre-assembled state.

[0146] Fig.36 An exploded view of a second injection pen is shown.

[0147] Fig.37 A longitudinal cut through the second injection pen in a pre-assembled state is shown.

[0148] Fig.38 A detailed view of the distal part of the second injection pen is shown in a pre-assembled state.

[0149] Fig.39 A detailed view of the distal end of a second injection pen is shown in an assembled state during dose setting.

[0150] Fig.40 Another view of the distal end of the second injection pen is shown in the assembled state during dose setting.

[0151] Fig.41 A detailed view of the distal end of the second injection pen is shown in an assembled state during dose delivery.

[0152] Fig.42 Another view of the distal end of the second injection pen is shown in an assembled state during dose delivery.

[0153] Fig.43 A longitudinal section through the dose setting elements of a first injection pen and a second injection pen is shown.

[0154] Fig.44 A perspective view of a longitudinal section through the dose setting member is shown.

[0155] Fig.45 A perspective distal view of the dose setting element is shown.

[0156] Fig.46 A perspective proximal view of the dose setting element is shown.

[0157] Fig.47 A perspective view of a third injection pen according to the present disclosure is shown.

[0158] Fig.48 An exploded view of a third injection pen is shown.

[0159] Fig.49 A longitudinal section through the dose delivery mechanism of a third injection pen is shown.

[0160] Fig.50 A perspective distal view of a dosing member of a third injection pen is shown.

[0161] Fig.51 A perspective longitudinal section through a dosing member of a third injection pen is shown.

[0162] Fig.52 A perspective view of the piston rod of a third injection pen is shown.

[0163] Fig.53 A perspective distal view of an extension of a third injection pen is shown.

[0164] Fig.54 Shows Fig.53 Distal view of the extension shown in .

[0165] Fig.55 Shows Fig.53 Proximal view of the extension shown in .

[0166] Fig.56 A perspective view of a coupling element of a third injection pen is shown.

[0167] Fig.57 A perspective view of the bearing, piston rod, extension, coupling element and adjustment element of a third injection pen is shown.

[0168] Fig.58 A proximal perspective view of an adjustment element of a third injection pen is shown.

[0169] Fig.59 A side view of the adjustment element of a third injection pen is shown.

[0170] Fig.60 Shown along Fig.59 Line AA in passes through a radial section of the adjustment element of the third injection pen.

[0171] Fig.61 Shown along Fig.59 The line BB in passes through the radial section of the adjustment element of the third injection pen.

[0172] Fig.62 A perspective view of a coupling member of a third injection pen is shown. Fig.63 A perspective distal view of the cartridge of a third injection pen is shown.

[0173] Fig.64 A longitudinal section through the barrel of a third injection pen is shown.

[0174] Fig.65 A perspective view of a housing insert of a third injection pen is shown.

[0175] Fig.66 A perspective view of the connector of a third injection pen is shown.

[0176] Fig.67 A perspective view of a longitudinal section through the connector of a third injection pen is shown.

[0177] Fig.68 A side view of the third injection pen is shown in an assembled state during dose setting.

[0178] Fig.69 A side view of a third injection pen is shown in a pre-assembled state.

[0179] Fig.70 A detailed view of a longitudinal section through the distal end of a third injection pen in an assembled state during dose setting is shown.

[0180] Fig.71 A detailed view of a further longitudinal section through the distal end of the third injection pen in the assembled state during dose setting is shown.

[0181] Fig.72 Shown is a detailed view of a longitudinal section through the distal end of a third injection pen in an assembled state during dose delivery.

[0182] Fig.73 A detailed view of a further longitudinal section through the distal end of the third injection pen in an assembled state during dose delivery is shown.

[0183] Fig.74 A detailed view of a longitudinal section through the distal end of a third injection pen in a pre-assembled state is shown.

[0184] Fig.75 A detailed view of a further longitudinal section through the distal end of a third injection pen in a pre-assembled state is shown.

[0185] Fig.76 A perspective view of a fourth injection pen according to the present disclosure is shown.

[0186] Fig.77 A side view of a fourth injection pen is shown in an assembled state during dose setting.

[0187] Fig.78 A side view of a fourth injection pen is shown in a pre-assembled state, wherein the adjustment element is in a pre-assembled position.

[0188] Fig.79 A side view of a fourth injection pen is shown in a pre-assembled state, wherein the adjustment element is in an adjustment position.

[0189] Fig.80 An exploded view of a fourth injection pen is shown.

[0190] Fig.81 A longitudinal section through the dose delivery mechanism of a fourth injection pen is shown in an assembled state during dose setting.

[0191] Fig.82 A perspective view of a coupling element of a fourth injection pen is shown.

[0192] Fig.83 Shown along line AA through Fig.82 A radial section of the coupling element is shown in FIG.

[0193] Fig.84 A perspective view of the piston rod of a fourth injection pen is shown.

[0194] Fig.85 A perspective proximal view of an adjustment element of a fourth injection pen is shown.

[0195] Fig.86 A side view of the adjustment element of a fourth injection pen is shown.

[0196] Fig.87 Shown along Fig.86 The line AA in passes through a first longitudinal section of the adjusting element.

[0197] Fig.88 The adjustment element of the fourth injection pen is shown along a direction perpendicular to Fig.86 Additional side view of the direction of the direction.

[0198] Fig.89 Shown along Fig.88 The line AA in passes through the second longitudinal section of the adjusting element.

[0199] Fig.90 A perspective distal view of the cartridge of a fourth injection pen is shown.

[0200] Fig.91 A perspective distal view of the insert of the sleeve is shown.

[0201] Fig.92 A perspective proximal view of the insert of the sleeve is shown.

[0202] Fig.93 A perspective distal view of the outer portion of the sleeve is shown.

[0203] Fig.94 A side view of a coupling member of a fourth injection pen is shown.

[0204] Fig.95 It is along Fig.90 The line AA in passes through the longitudinal section of the connecting member.

[0205] Fig.96 Shown along Fig.90 The line BB in passes through the radial section of the connecting member.

[0206] Fig.97 A perspective distal view of a dosing member of a fourth injection pen is shown.

[0207] Fig.98 A perspective view of a longitudinal section through the dosing member is shown.

[0208] Fig.99A longitudinal section through the distal end of the dose delivery mechanism of a fourth injection pen in an assembled state during dose setting is shown.

[0209] Fig.100 A further longitudinal section through the distal end of the dose delivery mechanism of a fourth injection pen in an assembled state during dose setting is shown.

[0210] Fig.101 A longitudinal section through the distal end of the dose delivery mechanism of a fourth injection pen in an assembled state during dose delivery is shown.

[0211] Fig.102 A further longitudinal section through the distal end of the dose delivery mechanism of a fourth injection pen in an assembled state during dose delivery is shown.

[0212] Fig.103 A longitudinal section through the distal end of the dose delivery mechanism of a fourth injection pen in a pre-assembled state is shown, wherein the adjustment element is in the pre-assembled position.

[0213] Fig.104 A further longitudinal section through the distal end of the dose delivery mechanism of a fourth injection pen in a pre-assembled state is shown, wherein the adjustment element is in a pre-assembled position.

[0214] Fig.105 A longitudinal section through the distal end of the dose delivery mechanism of a fourth injection pen in a pre-assembled state is shown, wherein the adjustment element is in an adjustment position.

[0215] Fig.106 A further longitudinal section through the distal end of the dose delivery mechanism of a fourth injection pen in a pre-assembled state is shown, wherein the adjustment element is in an adjustment position. DETAILED DESCRIPTION

[0216] refer to Figures 1 to 22B , describes the various parts of the injection pen 10 according to the present invention. FIG. 23A to FIG. 33B , describing how the pen is intended to be used.

[0217] Figure 1An exploded view of a medicament delivery device in the form of an injection pen 10 is shown. The injection pen 10 comprises, in order from the distal end 12 to the proximal end 14: a knob cover 16, which may also be referred to as a knob lock, a cover or a retaining element; an injection button 18, which may be part of an actuating member; a snap ring 20; a dose setting knob 22, which may also be referred to as a dose setting element, a dose adjustment member or a knob and may be part of an actuating member; a snap element 24, which may also be referred to as a dose setting device; a connector 26; a dose selector 28; a knob key 30, which may also be referred to as a clip; a housing 32, which may also be referred to as a body; a dose setting sleeve 34, which may also be referred to as a dose sleeve or a dose indicating member; a driver 36; a nut 38; a spring 40; a piston rod guide 42, which may also be referred to as a piston guide; a piston rod 44; a piston disc 46, which may also be referred to as a bearing; a dual chamber cartridge 48, which may also be referred to as a medicament container, a fluid compartment or a cartridge; a cartridge container 50; and a cartridge holder or cartridge key 52. The assembly of the cartridge container 50 and the cartridge holder 52 may also be referred to as a medicament container holder. Thus, the cartridge container 50 provides an outer container holder of the container holder and the cartridge key 52 provides an inner container holder.

[0218] Although the above-mentioned parts of the injection pen 10 may each be formed as a separate part to simplify the production of the separate parts, it will generally be possible to have one or more of the parts formed integrally with each other. For example, the injection button 18, the snap ring 20 and / or the dose setting knob 22 may be formed integrally with each other. Furthermore, the dose setting sleeve 34 and the driver 36 may be formed integrally with each other. Typically, even the housing 32 and the piston rod guide 42 may be formed integrally with each other.

[0219] Different parts can be grouped together to define different functional units. For example, the section between the injection button 18 and the piston rod guide 42 can be referred to as a dose setting mechanism 54, a dose setting unit, a dose delivery mechanism and / or a dose delivery activation mechanism. On the other hand, the section between the piston rod guide 42 and the cartridge key 52 can be referred to as a drug reconstitution unit 56 or a reconstitution device. The cartridge container 50 and the cartridge holder 52 can be referred to as a cartridge holding unit. The cartridge container 50, the cartridge holder 52 and the cartridge 48 can be referred to as a cartridge unit. For example, the cartridge unit can be sold separately from the rest of the injection pen 10 in a pre-assembled state or as a separate part.

[0220] Next, the above-mentioned parts of the injection pen 10 are described in order starting from the distal end portion 12 and ending at the proximal end portion 14 , which are opposite ends of the injection pen 10 and the proximal end portion 14 includes a dispensing outlet:

[0221] FIG. 2A to FIG. 2CThe knob cover 16 is depicted. During delivery (i.e. shipping) of the injection pen 10 to a customer (e.g. a patient), the knob cover 16 covers the dose setting knob 22. The knob cover 16 is completely detachable from the rest of the injection pen 10. The knob cover 16 is attachable to and / or detachable from the housing 32 via two deformable wings 58, which can be deflected outwardly (i.e. in a radial direction) to detach the knob cover 16 from the housing 32. The wings 58 form a proximal end section of the knob cover 16. On an inner surface of each of the wings 58, form-fitting engagement means in the form of lugs 60 are provided, which are configured to engage with the housing 32, in particular with a radially extending coupling surface 228 (cf. Fig. 15C ) engages to axially fix the knob cover 16 relative to the housing 32 in the distal direction. Beside each of the lugs 60, a window 62 (i.e., a radially extending opening) is formed in the wing portion 58. When the knob cover 16 is attached to the housing 32, the window 62 is positioned where the housing 32 forms a circumferentially extending protrusion 64 (refer to Fig.25A ). On the distal side of each window 62 (i.e., away from the lug 60), a seat 66 is formed on the inner side surface of the corresponding wing 58. The width of the seat 66 is adapted to the recess or cutout 68 (refer to Fig.11A ) width. In addition, the support 66 forms a front surface 66a that axially abuts the radially extending surface 32a (refer to Fig. 11B The radially extending surface 32a defines a stop surface that prevents the knob cover 16 from moving proximally relative to the housing 32, for example, in the event that the injection pen 10 falls to the floor with the distal end 12 first. To further ensure that the knob cover 16 does not move in the proximal direction 1 beyond its attachment position, the axial abutment projection 70 (refer to Fig.11A ) may be formed on the outer surface of the housing 32. The protrusion 70 is configured to be aligned with the gap 72 (refer to Figure 2C ) are engaged so that the proximal front surface of the knob cover 16 abuts the distal front surface of the axial support protrusion 70.

[0222] The form-fitting engagement between the abutment 66 and the cutout 68 and / or the form-fitting engagement between the protrusion 70 and the gap 72 ensures that the knob cover 16 is rotationally constrained relative to the housing 32 when the knob cover 16 is attached to the housing 32 .

[0223] As from Figure 2AIt can be seen that the knob cover 16 can only be detached from the rest of the injection pen 10 by linearly moving the knob cover 16 in the distal direction. To do so, a linear recess 74 is formed on the inner circumferential surface of the knob cover 16, which corresponds to the anti-rolling means 76 in the form of an axially extending rib of the dose setting knob 22 (see FIG. Figure 5B ). Therefore, the dose setting knob 22 is blocked from rotating inside the knob cover 16 by the form-fitting engagement of the linear recess 74 and the anti-roll feature 76. Figure 2A As can be seen in the figure, the knob cover 16 also forms an anti-roll feature 78 in the form of an axially extending rib on the outer surface of the knob cover 16. The anti-roll features 76 and 78 ensure that the injection pen 10 and the knob cover 16 will not roll away when placed on a flat surface. Figure 2A It can also be seen that the knob cover 16 has a closed circumference 16a and a closed face 16b at its distal end. Thus, the knob cover 16 forms a closed sleeve around the distal section of the injection pen 10.

[0224] FIG. 3A to FIG. 3E The injection button 18 is depicted. The injection button 18 forms a distal front surface 80 to apply a force to the injection button 18 to inject a set dose. The injection button 18 includes an axial fixing means 82 to axially attach the injection button 18 to the snap ring 20 (refer to Figures 4A-4D ), which is axially connected to the dose setting knob 22 (refer to FIG. 5A to FIG. 5D ). The axial fixing means 82 comprises two elastically deformable hooks 82 which engage with circumferentially extending ribs 84 on the snap ring 20. The snap ring 20 further comprises axial fixing means 86 in the form of elastically deformable bendable hooks which engage with undercuts 88 formed in the dose setting knob 22. The injection button 18, the snap ring 20 and the dose setting knob 22 are permanently axially fixed to each other in the assembled state of the dose delivery mechanism 54.

[0225] The injection button 18 also forms a rotational securing means 90 in the form of a radially extending rib. The rib 90 is in contact with a rotational securing means 92 in the form of teeth arranged in the inner circumferential surface of the snap ring 20 (see Figure 4A ) form-fittingly engage to rotationally connect the injection button 18 to the snap ring 20. The rotational securing means 92 forms a toothed portion 93 of the snap ring 20, and the ribs 90 form an engagement portion of the injection button 18. The snap ring 20 comprises rotational securing means 94 in the form of axially extending recesses which define the side surfaces of the elastically deformable bendable hooks 86 and engage with rotational securing means 96 in the form of axially extending ribs on the inner circumferential surface of the dose setting knob 22 (refer to Figure 5A ) join.

[0226] After assembly and in the assembled state of the dose delivery mechanism 54 , the injection button 18 , the snap ring 20 and the dose setting knob 22 are rigidly connected to each other and form both a dose setting member and an actuation member of the dose delivery mechanism 54 .

[0227] The injection button 18 forms a cylindrical portion 18a. On the cylindrical portion 18a, an assembly means 98 in the form of a projection is formed to axially pre-assemble the injection button 18 with the snap element 24. More precisely, the lower (ie, proximal) assembly means 98b (refer to Figure 3C ) restricts the distal movement of the injection button 18 relative to the snap element 24 by interfering with the coupling means 102 on the snap element 24. The upper (i.e., distal) assembly means 98a restricts the proximal movement of the injection button 18 relative to the snap element 24 by interfering with the coupling means 102 on the snap element 24 after pre-assembly, and restricts the distal movement of the injection button 18 after final assembly. When the snap element 24 and the injection button 18 are pre-assembled (i.e., in a pre-assembled state), the coupling means 102 is arranged between the proximal assembly means 98b and the distal assembly means 98a. In the pre-assembled state, the injection button 18 is not yet rigidly connected to the snap ring 20 and the dose setting knob 22. However, when the coupling means 102 is arranged distally of the distal assembly means 98a (i.e., in an assembled state), the injection button 18 is rigidly connected to the snap ring 20 and the dose setting knob 22. The injection button 18 also forms coupling means 100 in the form of projections arranged on elastically inwardly bendable portions on the outer circumferential surface of the injection button 18. These inwardly bendable portions extend in the axial direction and are sectionally surrounded by cutouts 101.

[0228] The coupling device 100 is configured to permanently axially lock the injection button 18 after an injection has been completed and thus also lock the snap ring 20 and the dose setting knob 22 to the snap element 24, so that the injection pen 10 cannot be operated. That is, when the injection button 18 is axially moved to initiate dose delivery, the coupling device 100 passes through a circumferentially extending ledge 102 (refer to FIG. 1 ) on the snap element 24. Fig. 6A ) in the form of a radially inwardly extending coupling device. The radially inwardly extending ledge 102 causes the protrusions arranged on the elastically inwardly bendable portion 100 to bend inwardly until the protrusions have passed the ledge 102. In order to reduce the force required to push the protrusions 100 over the ledge 102, the protrusions 100 form a chamfered outer surface 100a. Alternatively or additionally, the ledge 102 may form a chamfered inner surface. When the protrusions 100 have passed the ledge 102, they quickly return to their neutral position, which causes the injection button 18 to be permanently axially locked relative to the snap element 24. This feature ensures that the injection pen 10 can only be used once to inject exactly one dose.

[0229] like Figure 3C and Figure 3E As can be best seen in FIG. 1 , the injection button 18 includes an axially extending rib 104 on its inner circumferential surface. The axially extending rib 104 engages in an axially extending groove 106 (see FIG. 1 ) of the nut 38. Fig. 14C ) to form a rotational fixing device. Due to the axially extending ribs 104 and the corresponding axially extending grooves 106, the injection button 18 and the nut 38 can be axially moved relative to each other but are rotationally fixed to each other.

[0230] like Figure 5B and Figure 5D As can be best seen from the top, a set of teeth 108 is formed in an axial section on the inner circumferential side of the dose setting knob 22. These teeth 108 are configured to engage with the snap element 24 (refer to FIG. 2 ) arranged on the dose setting knob 22 during the dose setting. Figures 6A-6C ) in a distal section on the outer circumferential surface of the ). Thus, when the dose setting knob 22 is rotated during dose setting, the catch element 24 is also rotated. Fig. 6A As can be seen in the figure, the teeth 110 are only arranged in two opposite sections of the snap element 24, while the section between the two opposite sections does not form any teeth. This is advantageous for the production of the injection pen 10. Alternatively, the teeth 110 can be formed along the entire circumference of the snap element 24.

[0231] The snap-fit ​​element 24 forms an axial section of reduced cross-section, thereby forming a coupling surface 112 for the connector 26. The connector 26 shown in the figure is formed as a one-piece part. However, the connector 26 can also be formed by a plurality of (e.g. two) parts connected to each other, for example via a form-fitting connection. The connector 26 has an open cross-section (cf. Fig.7D ), so it can be clamped onto the snap element 24 at a reduced cross section. Since the length L1 of the connector 26 in the axial direction corresponds to the length L2 of the axial section of reduced cross section in the axial direction, the connector 26 is axially fixedly connected to the snap element 24 in both directions. However, the connector 26 is rotatable relative to the snap element 24. When the dose setting knob 22 is pushed in the proximal direction 1 to initiate dose delivery, the teeth 108 of the dose setting knob 22 engage with a set of teeth 114 formed on the outer circumferential surface of the connector 26 instead of the teeth 110 of the snap element 24, so that the snap element 24 can rotate relative to the dose setting knob 22 during dose delivery. Since the connector 26 is rotationally fixed to the housing 32 via the dose selector 28, the engagement between the teeth 108 of the dose setting knob 22 and the teeth 114 of the connector 26 ensures that the dose setting knob 22 does not rotate relative to the housing 32 during dose delivery.

[0232] The snap element 24 further comprises an engagement feature 116 in the form of an axially extending radial protrusion. The engagement feature 116 is an axially extending rib. The engagement feature 116 may have a symmetrical cross-section in a radial plane perpendicular to the longitudinal axis of the injection pen 10 or an asymmetrical cross-section. The engagement feature 116 is configured to engage with dose stops 118a, 118b, 118c and 118d (see FIG. 1 ) formed on the inner circumferential surface of the dose selector 28. Figure 8B ) to set the desired dose. Therefore, the engagement feature 116 is used as a dose limiting element and the engagement feature 116 together with the dose stops 118a, 118b, 118c, 118d form the dose limiting mechanism 115 of the injection pen 10. The dose limiting element 116 is located on the elastically deformable section 120 (i.e. the axially extending arm partially surrounded by the cutout 121). When the dose limiting element 116 passes one of the dose stops 118a, 118b, 118c and 118d, the elastically deformable section 120 bends inwardly. In order to reduce the force required to rotate the dose setting knob 22 and the snap element 24 relative to the dose selector 28 to increase or decrease the set dose, the dose stop 118 has chamfered side surfaces 122a-d and 123a-d. According to Figure 8B In the embodiment shown in , the dose stoppers 118a-d have a cross section that is symmetrical in a radial plane perpendicular to the longitudinal axis of the injection pen 10. In other words, the pitches of the chamfered side surfaces 122 and 123 are equal to each other for their magnitude. Fig. 9 In another embodiment shown in , the chamfered side surfaces 122a'-d' that contact the protrusion 116 to deform the elastically deformable section 120 when the dose is set to a higher dose have a smaller pitch than the chamfered side surfaces 123a'-d' that contact the protrusion 116 when the dose is set to a lower dose. The side surfaces 123a-d define a rotational position corresponding to the settable dose. The spring 40 is configured to rotate the snap element 24 relative to the dose selector 28 so that the dose limiting element 116 abuts one of the side surfaces 123a-d.

[0233] The snap element 24 further comprises a hard stop 124 in the form of an axially extending rib, which abuts a hard stop 126 formed on the dose selector 28 when the injection pen 10 is delivered to the customer. Contrary to known pens, the hard stop 126 does not correspond to a zero dose stop, but rather to a preset dose stop. Further discussion of this feature follows. The hard stop 124 is axially away from the dose limiting element 116, but axially aligned with the dose limiting element 116. The hard stop 124 is configured to abut an end-of-dose setting hard stop 128.

[0234] The snap element 24 further comprises axial and rotational securing means in the form of radially extending openings 130 and axially extending slots 132 to axially and rotationally secure the snap element 24 to the driver 36. Fig.13A As can be seen in the figure, the driver 36 has an axially extending rib 134 configured to engage with the groove 132 of the snap element 24. In addition, the driver 36 has a protrusion 136, which has a chamfered surface 136a that engages with the opening 130 of the snap element 24. While the opening 130 and the protrusion 136 form an axial fixing device, the groove 132 and the rib 134 form a rotational fixing device. Due to the axial and rotational fixing device, the snap element 24 and the driver 36 can be connected to each other in a defined relative rotational position. In order to strengthen the rotational fixation between the snap element 24 and the driver 36, on the snap element 24 (refer to Figure 6C ) is formed on the inner circumferential surface of the drive 36, and the axially extending rib 138 is aligned with the axially extending groove 140 (reference Fig.13D ) join.

[0235] FIG. 8A to FIG. 8E The dose selector 28 is depicted. The dose selector 28 comprises an axial fixing means 142 in the form of a circumferentially extending protrusion on the inner circumferential surface of the distal section of the dose selector 28. The dose selector 28 is inserted into the circumferentially extending inlet 144 (refer to Figure 5B ) and is axially fixed to the dose setting knob 22. In the inlet 144, the dose setting knob 22 forms an axial fixing means 146 in the form of a circumferentially extending protrusion on an outer circumferential surface engaging with the axial fixing means 142 of the dose selector 28 to form an axial connection allowing relative rotational movement between the dose selector 28 and the dose setting knob 22.

[0236] like Fig. 8E As can be best seen, a rotational securing feature 148 in the form of an axially extending groove is formed on the inner circumferential surface of the dose selector 28. The rotational securing feature 148 is formed in conjunction with a groove formed on the connector 26 (refer to Figure 7B ) is engaged with a rotational securing means 150 in the form of an axially extending rib on the outer circumferential surface of the housing 32 (reference numeral 26). The rotational securing means 148, 150 allow axial movement between the dosage selector 28 and the connector 26. The dosage selector 28 further includes a rotational securing means 152 in the form of an axially extending rib formed on the outer circumferential surface of the dosage selector 26. The rotational securing means 152 engages with a rotational securing means 152 formed on the outer circumferential surface of the housing 32 (reference numeral 26). Fig. 11C) is engaged with a rotational securing feature 154 in the form of an axially extending groove on the inner circumferential surface of the housing 32. The rotational securing features 152, 154 are configured to define a single possible rotational alignment that allows the dosage selector 28 to be inserted into the housing 32. The rotational securing features 150, 152 allow axial movement between the dosage selector 28 and the housing 32.

[0237] To limit the deliverable dose, the dose selector 28 (see Figure 8B ) is formed with a circumferentially extending rib 156 having cut-out openings 158a, 158b, 158c and 158d. The cut-out openings 158a, 158b, 158c and 158d are assigned to the respective dose stops 118a, 118b, 118c and 118d. The rib 156 with its cut-out openings 158a, 158b, 158c and 158d ensures that an injection is only possible if the dose limiting element 116 of the snap element 24 is in an angular position associated with one of the cut-out openings 158a, 158b, 158c and 158d (i.e. associated with one of the settable doses). If the dose limiting element 116 is not in an angular position associated with one of the cut-out openings 158a-d, an axial movement of the dose limiting element 116 and therefore of the snap element 24 relative to the dose selector 28 is blocked by the circumferentially extending rib 156. As shown from Figure 8B As can be seen, there is no cut-out assigned to the preset dose hard stop 126. Thus, when the injection pen 10 is set to the preset dose, starting an injection is prohibited.

[0238] According to an alternative embodiment, the circumferentially extending rib 156 may be arranged to interact with the hard stop 124 instead of the dose limiting element 116. Thus, an injection will only be possible if the hard stop 124 of the snap element 24 will be in an angular position associated with one of the cutouts 158a, 158b, 158c and 158d (i.e. associated with one of the settable doses).

[0239] Fig. 10A and Fig. 10B The knob key 30 is depicted. The knob key 30 is configured to be attached to the outer circumferential surface of the dose selector 28 to prevent the dose setting knob 24 from being accidentally moved in the proximal direction 1 relative to the housing 32 in the event that the injection pen 10 in the delivery state falls onto its proximal end. The width W1 of the clamping element 30 corresponds to the width W2 between the proximal edge 160 of the dose setting knob 22 and the distal edge 162 of the housing 32 (refer to Fig.29A). The knob key 30 is C-shaped and has retaining protrusions 164, which interact with the rotation fixing means 152 on the outer circumferential surface of the dosage selector 28 to attach the knob key 30 to the dosage selector 28. The knob key 30 can be removed from the dosage selector 28 by slightly bending the C-shaped knob key 30. In the delivery state, the knob cover 16 extends around the knob key 30 to hold the knob key 30 in place. The knob key 30 can only be removed from the dosage selector 28 after the knob cover 16 has been removed.

[0240] FIG. 11A to FIG. 11C The housing 32 is shown in FIG. The housing 32 forms a viewing window 166 for displaying the state of the injection pen 10 indicated by the dose sleeve 34, in particular the set dose, through the window 166. The dose sleeve 34 rotates relative to the housing during dose setting and dose delivery, which causes the content displayed through the window 166 to change. Labels 168a-168d for different settable doses (see FIG. Fig. 12C and Fig.12D ) are located in different circumferential positions along the outer circumferential surface of the dose sleeve 34. In addition, the preset dose label 168e (reference Fig. 12B ) is located on the dose sleeve 34, the preset dose label corresponding to the preset dose (ie, the amount of medicine to be injected if the injection can be started from the preset dose). Fig. 12A and Fig. 12B As can be seen in the figure, the preset dose label 168e is different from the zero dose label 168f (i.e., a label indicating that no medicament will be injected if an injection is to be started from this state). When the injection has been completed, the zero dose label 168f is shown through the window 166. The labels 168a, 168b, 168c and 168d correspond to the settable doses defined by the dose stops 118a, 118b, 118c and 118d.

[0241] The dose sleeve 34 is rotationally and axially rigidly coupled to a driver 36 (refer to Figures 13A-13D ). In order to rotationally couple the dose sleeve 34 to the driver 36, corresponding non-circular outer circumferential surfaces 169a and inner circumferential surfaces 169b are formed on the driver 36 and the dose sleeve 34, respectively. In addition, the dose sleeve 34 forms a fixing section 171 which is pinched between the proximal end of the snap element 24 and the face surface 173 of the driver 36 (refer to Fig.13A ) between the dose sleeve 34 to axially fix the driver 36 and the snap element 24. The driver 36 forms an external thread 170 which mates with an internal thread 172 of the piston guide 42 (refer to Figures 16A-16B) are engaged. The threaded connections 170, 172 cause the driver 36 to rotate when the driver 36 moves axially relative to the piston guide 42, and cause the driver 36 to move axially relative to the piston guide 42 when the driver 36 rotates relative to the piston guide 42. In addition, the driver 36 defines end stops 174, which abut the end stops 176 of the piston guide 42 at the end of dose delivery. The surfaces defining the end stops 174, 176 are arranged parallel to the center axis of the injection pen and face in the radial direction. The driver 36 also forms an attachment means 177 in the form of a radially extending hook for attaching one end section of the spring 40 to the driver 36. The other end section of the spring 40 is attached to an attachment means 179 (reference 179) at the outer circumferential surface of the piston rod guide 42. Fig. 16C ).

[0242] According to an alternative version, the dose sleeve and the driver may be formed as separate parts which are axially movable relative to each other but rotationally fixed to each other, and both the dose sleeve and the driver may have threads threadedly coupled to the housing. The threads of the dose sleeve and the threads of the driver may have different pitches.

[0243] The piston guide 42 is axially and radially fixed to the housing 32 and can therefore be considered as part of the housing. In order to axially fix the piston guide 42 to the housing 32, axial fixing means 178 in the form of circumferentially extending grooves are formed on the piston guide 42, which are connected to axial fixing means 180 in the form of circumferentially extending ribs formed on the inner circumferential surface of the housing 32 (see FIG. Fig.11A ) In order to rotationally fix the piston guide 42 to the housing 32, rotation fixing means 182 in the form of axially extending grooves are formed on the outer circumferential surface 262 of the piston guide 42, and these rotation fixing means are engaged with rotation fixing means 184 in the form of axially extending ribs formed on the inner circumferential surface of the housing 32 (refer to Fig.11A The axial securing means 178, 180 and the rotational securing means 182, 184 allow the piston rod guide 42 to be attached to the housing 32 in exactly one relative rotational position.

[0244] The piston guide 42 has an out-of-round axial opening 186 (see Fig. 15C ), the non-circular axial opening corresponds to the non-circular cross-section 188 of the piston rod 44 (reference Fig. 17B ). Therefore, the piston rod 44 is axially movable relative to the piston rod guide 42, but cannot rotate relative to the piston rod guide 42. The piston rod 44 forms an external thread 190, which mates with the internal thread 192 of the nut 38 (refer to Fig.14D) engagement. The external thread 190 and the internal thread 192 form a threaded connection 189 between the piston rod 44 as a first threaded element and the nut 38 as a second threaded element. The piston rod 44 and the nut 38 can move relative to each other in a combined axial and rotational movement guided by force. In the proximal end section of the nut 38, an annular pressing surface 194 extending in the distal direction is formed on the nut 38. During dose delivery, the pressing surface 194 abuts against the front surface 196 of the driver 36. During dose delivery, the driver 36 moves relative to the piston rod guide 42 with a combined axial and rotational movement, while the nut 38 is rotationally fixed to the housing 32. In order to reduce friction during dose delivery, a ball bearing and / or a sliding disc made of a low-friction material can be arranged between the pressing surface 194 and the front surface 196 of the driver 36. In both cases, during dose delivery, the driver 36 pushes the piston rod 44 in the proximal direction 1 via the nut 38.

[0245] The piston rod 44 forms at its proximal end coupling means 198 in the form of undercuts which are connected to the piston plate 46 (see Figures 18A-18C ) is engaged with a coupling device 200 in the form of radially inwardly extending ribs on the inner circumferential surface of the .

[0246] FIG. 15A to FIG. 22B Depicted are portions of a drug mixing or reconstitution unit 56 that is configured to mix the various components (typically a lyophilized drug and a liquid solvent) to form an injectable liquid drug. FIG. 19A to FIG. 19C In FIG. 4 , a dual chamber cartridge 48 is shown. The dual chamber cartridge 48 is made of a transparent material such as glass. Fig.19C It can be seen that the cartridge 48 forms a first chamber 202 and a second chamber 204. Fig.19C In the delivery state shown in FIG, the first chamber 202 arranged proximally of the second chamber 204 includes a bypass 206. The first chamber 202 and the second chamber 204 are separated by a first sealing element (e.g., made of a rubber material) 208, which is axially slidably arranged inside the dual-chamber cartridge 48. In other words, the first sealing element 208 forms the distal end of the first chamber 202 and the proximal end of the second chamber 204.

[0247] The second sealing element 210 (eg, made of a rubber material) forms the distal end of the second chamber 204. The second sealing element 210 may also be referred to as a plunger. During mixing of the two components, the piston disc 46 abuts against the distal end surface of the second sealing element 210.

[0248] In the delivery state, the lyophilized drug is in the first chamber 202 and the solvent is in the second chamber 204 .

[0249] The dual chamber cartridge 48 is stored in the cartridge key 52 (reference Fig.21A-22b). The cartridge key 52 is axially and rotationally fixed to the cartridge container 50. To achieve this, the cartridge key 52 forms axial fixing means 212 in the form of circumferentially extending grooves, which axial fixing means 214 in the form of circumferentially extending ribs on the inner circumferential surface of the cartridge container 50 (refer to Fig. 20A ) engagement. In addition, the cartridge key 52 forms rotational securing features 216 in the form of radially extending ribs that engage rotational securing features 218 in the form of radially extending grooves on the inner circumferential surface of the cartridge container 50. When the cartridge key 52 is attached to the cartridge container 50, the annular end surface 266 ( Fig. 22B ) and the corresponding annular end surface 268 ( Fig. 20A ) are in mid-air adjoining. Both annular end faces 266 and 268 can be arranged perpendicular to the longitudinal axis of the pen 10. In addition, when the cartridge key 52 is attached to the cartridge container 50, the window 220 formed in the cartridge key 52 is aligned with the window 222 in the cartridge container 50, so that the patient can see the drug inside the transparent double-chamber cartridge 48 during reconstitution. At the proximal end of the cartridge key 52 (which also defines the proximal end of the injection pen 10), a thread 224 is formed for attaching a needle (not shown). The thread 224 surrounds an opening 252 at the proximal end of the cartridge holder 52. The opening 252 is configured to receive a needle connected to the internal fluid of the cartridge 48 inserted into the cartridge holder 52.

[0250] The cartridge key 52 forms an inner surface 254 ( Fig. 22B ), the inner surface of which defines a cylindrical seat for receiving the cartridge 48 and preventing the cartridge 48 from tilting relative to the longitudinal axis. Tilting of the cartridge 48 is prevented by regional contact between the cylindrical outer surface 256 of the cartridge and the inner surface 254 in the retaining section 249 of the cartridge holder 52. In addition, the cartridge holder 52 forms a cut-out port 221 to receive the bypass 206 of the dual-chamber cartridge 48. The bypass 206 engages the cut-out port 221 in a shape-fitting manner so that the dual-chamber cartridge 48 is axially and rotationally fixed to the cartridge key 52. ​​On opposite sides of the cut-out port 221, a groove 223 extending in the axial direction is formed. The groove 223 allows the cartridge key 52 to be reversibly widened to axially insert the dual-chamber cartridge 48 with the bypass 206.

[0251] To mix the different components in the dual chamber cartridge 48 and activate the injection pen 10, the cartridge container 50 is screwed onto the piston rod guide 42 until the distal end surface 226 of the cartridge container 50 abuts the proximal surface 228 of the piston guide 42 (see Fig. 15BTo do this, the cartridge container 50 forms an outer surface 246 that can be grasped with one hand to screw the cartridge container 50 onto the piston rod guide 42. When the cartridge container 50 is screwed onto the piston rod guide 42, the proximal portion of the piston rod guide 42 enters the annular space 258 (between the outer circumferential surface 264 of the cartridge holder 52 and the inner circumferential surface 260 of the cartridge container 50) Fig. 23B ), thereby defining the inner space 248 of the cartridge container 260. In order to screw the cartridge container 50 onto the piston rod guide 42, a first thread 230 is formed on the inner circumferential surface 260 of the cartridge container 50, and the first thread is engaged with a second thread 232 formed on the outer circumferential surface 262 of the piston rod guide 42. Fig.15A As can be seen in FIG. 1 , the piston rod guide 42 forms a snap element 234. If the snap element 234 engages with one of the openings 236, 238 and 240, the snap element 234 allows the cartridge container 50 to be screwed relative to the piston rod guide 42 in the distal direction (i.e., a combined axial and rotational movement of forced guidance), but blocks the cartridge container 50 from being screwed relative to the piston rod guide 42 in the proximal direction 1. The first opening 236 (refer to FIG. 1 ) is a first opening 236 (refer to FIG. 1 ). Fig. 20B ) is configured to define the starting position of the cartridge container 50 and ensure that the cartridge container 50 cannot be removed from the piston rod guide 42. Fig.25A and Fig.25B This starting position or delivery state is shown in .

[0252] The second opening 238 defines a reconstitution state of the cartridge container 50. In this state, the second chamber 202 still contains air, allowing the injection pen 10 to move back and forth to ensure that the drugs are evenly mixed together. The second opening 238 can be omitted. Therefore, the present disclosure is also directed to embodiments of the injection pen 10 that feature the first opening 236 and the third opening 240 but not the second opening 238. The third opening 240 defines a knob cap release state of the cartridge container 50, in which most of the air is expelled from the second chamber 202, which now contains the reconstituted medicament ready for use.

[0253] In About FIG. 23A to FIG. 33B In the following, different states of the injection pen 10 during use of the pen 10 are described.

[0254] FIG. 23A to FIG. 25B The injection pen 10 is depicted in the delivery state. Fig.23A As can be seen in FIG, the knob cover 16 covers the distal end section of the injection pen 10 up to the joint between the housing 32 and the piston guide 42. Therefore, the dose setting knob 22 is completely covered by the knob cover 16, making it impossible for the user to set the dose prematurely in this state. Fig. 23BIt can be seen that, in the delivery state, the drug reconstitution unit 56 forms two separate chambers 202, 204 divided by the first sealing element 208. That means that the two components of the drug (each stored in one of the two chambers 202, 204) have not yet been mixed together. Fig.24 As can be seen in the figure, the knob cover 16 is deleted to show the contents below the knob cover 16, and the dose setting sleeve 34 indicates that the injection pen 10 is in a preset state different from the zero dose state. Therefore, the dose setting knob 22 is also in a preset position different from the zero dose position. Fig.25A and Fig.25B It can be seen in FIG. 4 that the snap element 234 of the piston rod guide 42 snaps into the first opening 236 of the cartridge container 50. Fig.24 In the figure, the cartridge container 50 is depicted as translucent so as to show the first thread 230 formed on the inner circumferential surface of the cartridge container 50. Secondly, the piston rod guide 42 is also depicted as translucent to show the position of the piston rod 44 in a preset state.

[0255] To begin preparation of the drug, such as from comparison 25A and Fig.26A As can be seen in FIG. 1 , the user rotates the cartridge container 50, which causes the cartridge container 50 including the cartridge key 52 and the dual chamber cartridge 48 to move in the distal direction relative to the piston rod guide 42. The piston rod guide 42 thereby moves into the annular space 258 ( 258 ) between the cartridge container 50 and the cartridge holder 52. Fig. 23B ). The piston disc 46 is stuck to the piston rod 44, which is rotationally fixed by the piston rod guide 42 and axially fixed by the nut 38. Therefore, the piston disc 46 blocks the movement of the second sealing element 210 arranged in the dual-chamber cartridge 48, so that when the cartridge container 50 is further screwed onto the piston rod guide 42, the second sealing element 210 slides along the inner circumferential surface of the dual-chamber cartridge 48. The solvent stored in the second chamber 204 pushes against the first sealing element 208, which also causes the first sealing element 208 to slide along the inner circumferential surface of the dual-chamber cartridge 48. This will cause excessive pressure in the cartridge, but the air can escape through the double-ended needle attached to the thread 224 by the user. When the first sealing element 208 reaches the bypass 206 (reference Fig. 23B ), the first chamber 202 and the second chamber 204 are connected by the bypass 206, and thus the lyophilized drug stored in the first chamber 202 and the solvent stored in the second chamber 204 are mixed.

[0256] exist FIG. 26A to FIG. 27C In the reconstituted state shown in FIG, the mixed drug is stored in the first chamber 202 between the first sealing element 208 and the proximal end 14 of the dual chamber cartridge 48. Fig.26BAs can be seen in FIG, the proximal end surface of the second sealing element 210 abuts against the distal end surface of the first sealing element 208, so that the second chamber 204 no longer exists in the reconstructed state. Fig.27C It can be seen that the snap element 234 of the piston rod guide 42 snaps into the second opening 238 of the cartridge container 50. In this state, the front chamber 202 still contains a large amount of air, which helps to create turbulence when moving the pen, making the mixing of the lyophilized drug easier. As mentioned above, the second opening 238 can be omitted. In that case, the mixing is carried out with a lower amount of residual air.

[0257] After the drug reconstitution is completed, the user further rotates the cartridge container 50, thereby causing the cartridge container 50 to further move axially in the distal direction relative to the piston rod guide 42. This causes the displacement section 242 located at the distal end of the cartridge container 50 to engage with the wings 58 of the knob cover 16 and expand these wings radially outward (refer to Fig.28B ). Expanding the wings 58 radially outward causes the form-fitting engagement means 60 of the knob cover 16 to disengage from the coupling surface 228, so that the knob cover 16 is axially movable relative to the housing 32. It is now possible to pull the knob cover 16 away from the housing 32 in the distal direction, thereby producing Fig.29A and Fig.29B . When the cartridge container 50 is completely screwed onto the piston rod guide 42, the radial end stop 244 formed on the outer circumferential surface 262 of the piston rod guide 42 abuts against the radial end stop (not shown) on the inner circumferential surface of the cartridge container 50. In addition, the snap element 234 of the piston rod guide 42 snaps into the third opening 240. Thus, the cartridge container 50 is rotationally locked to the piston rod guide 42 and the housing 32 of the device. Thus, the movement of the cartridge container 50 and the cartridge 48 relative to the housing 32 and the piston rod guide 42 is prohibited.

[0258] like Fig.29A and Fig.29B 2, the knob key 30 is still clamped to the outer circumferential surface of the dose selector 28, between the proximal edge 160 of the dose setting knob 22 and the distal edge 162 of the housing 32. The knob key 30 can only be removed from the dose selector 28 after the knob cover 16 has been removed by slightly bending the knob key 30.

[0259] Afterwards, if you compare Fig.29A and Fig. 30AIt can be seen that the user rotates the dose setting knob 22 to set a desired dose from a plurality of possible settable doses. In this example, the dose setting knob 22 is rotated 180° to set the desired dose. When the dose setting knob 22 is rotated, the dose setting knob 22 performs a combined axial and rotational movement (i.e., a helical movement) in a distal direction that is forcibly guided.

[0260] Rotating the dose setting knob 22 causes rotation of: the injection button 18, which is axially and rotationally connected to the dose setting knob 22 via the snap ring 20; the snap element 24, which is rotationally connected to the dose setting knob 22 via the teeth 108 intermeshing with the teeth 110; the driver 36, which is rotationally and axially coupled to the snap element 24; and the dose setting sleeve 34, which is rotationally and axially coupled to the driver 36. Due to the engagement of the outer thread 170 of the driver 36 and the inner thread 172 of the piston rod guide 42, the rotation of the driver 36 causes the driver 36 to move axially in the distal direction. The axial movement of the driver 36 causes the snap element 24 to move in the distal direction, which pushes the injection button 18 and the dose setting knob 22 in the distal direction via the coupling means 102 of the snap element 24 interacting with the assembly means 98 of the injection button 18. This causes the dose setting knob 22 to perform a positively guided combined axial and rotational movement during dose setting.

[0261] Furthermore, rotating the dose setting knob 22 causes the injection button 18, which is rotationally coupled to the nut 38, to rotate. Since the piston rod 44 is rotationally fixedly coupled to the piston rod guide 42 (due to their corresponding non-circular cross-sections 186, 188), the nut 38 moves in the distal direction when the dose setting knob 22 and thus the nut 38 rotates.

[0262] The amount of axial movement of the nut 38 relative to the piston rod 44 and the driver 36 relative to the piston guide 42 depends on the pitch of the respective threads. The external threads 170 of the driver 36 have a larger pitch than the external threads 190 of the piston rod 44, so that the driver 36 moves more in the distal direction than the nut 38. For example, the external threads 170 of the driver 36 may have a pitch of 10.71 mm, and the external threads 190 of the piston rod 44 may have a pitch of 10.21 mm.

[0263] When a desired dose is set, the helical torsion spring 40 applies a torque to the snap element 24 via the driver 36 to bring the dose defining element 116 into abutment with the respective dose stop 118a to 118d, i.e. with its side surface 122b. Due to the spring 40, the injection pen 10 is configured to rotationally self-align the snap element 24 and the dose selector 28 in different predefined rotational positions defining a predefined dose.

[0264] If the user then pushes the injection button 18 on the distal end 12 of the injection pen 10, the dose setting knob 22 moves relative to the snap element 24 in the proximal direction 1. This causes the coupling means 100 to bend when passing the circumferential crosspiece 102 causing a reaction force in the distal direction, which the user must overcome in order to start the injection process. The movement of the dose setting knob 22 relative to the snap element 24 in the proximal direction 1 also causes the teeth 108 of the dose setting knob 22 to disengage from the teeth 110 of the snap element 24 and instead the teeth 108 of the dose setting knob 22 engage with the teeth 114 of the connector 26. Since the connector 26 is rotationally coupled to the housing 32 via the dose selector 28, the dose setting knob 22 is rotationally fixed to the housing 32. Therefore, during dose delivery, the dose setting knob 22, the injection button 18, the dose selector 28 and the nut 38 do not rotate relative to the housing 32.

[0265] If the user pushes the injection button 18 further, the injection button 18 and the dose selector 28 move relative to the snap element 24 in the proximal direction 1. Thereby, the dose limiting element 116 of the snap element 24 passes through the circumferentially extending rib 156 on the dose selector 28 through the respective cutouts 158a-158d corresponding to the set dose. At the same time, the hard stop 126 of the dose selector 28 moves relative to the hard stop 124 on the snap element 24 in the axial direction, which allows the dose selector 28 and the snap element 24 to rotate relative to each other beyond the preset dose position towards the zero dose position.

[0266] When the injection button 18 is pushed during dose delivery, the injection button 18 pushes the driver 36 in the proximal direction 1 via the snap element 24. The spring 40 supports the axial movement of the driver 36 by applying a torque to the driver 36, thereby causing the driver 36 to move axially in the proximal direction 1 due to the external thread 170 of the driver 36. The driver pushes the nut 38 in the proximal direction 1, which causes the piston rod 44 to move in the proximal direction 1. The movement of the piston rod 44 and the piston disc 46 in the proximal direction 1 causes the drug to be injected into the patient. Since the injection pen 10 is made to inject a relatively large amount of drug, the pen 10 does not have a so-called gear transmission. In other words, the parts that are configured to rotate relative to the housing during dose delivery are connected to the housing 32. This means that the distance that the piston disc 46 is advanced is substantially equal to the distance that the injection button 18 is pushed relative to the housing 32 in the proximal direction 1.

[0267] Since the driver rotates relative to the housing (due to the external thread 170 of the driver), the dose setting sleeve 34 rotates during dose delivery. At the end of dose delivery (refer to Fig.33A and Fig.33B), the dose setting sleeve 34 is in a rotated position in which the zero dose label is visible through the window 166 of the housing 32. The dose stop 174 of the driver 36 (refer to Fig. 13B ) and the dose stop 176 of the piston rod guide 42 (reference Fig. 16C ) defines the end of the movement of the injection button 18 in the proximal direction 1 during dose delivery.

[0268] At the end of dose delivery, the coupling means 100 on the injection button 18 passes the coupling means 102 of the snap element 24 when the injection is initiated, which permanently rotationally couples the dose setting knob 22 and the injection button 18 to the housing 32. Thus, the injection pen 10 is rendered inoperable as the user cannot rotate the dose setting knob 22 to set a new dose.

[0269] The injection pen 10 allows the axial position of the piston rod 44 to be adjusted relative to the housing 32 in the pre-assembled state of the dose delivery mechanism 54. In the pre-assembled state, the injection button 18, which forms the adjustment element 18 of the dose delivery mechanism 54, engages with its distal assembly means 98a with the coupling means 102 of the snap element 24. This allows the injection button 18 to be positioned in a pre-assembly position which is more distal than its assembly position in the assembled state of the dose delivery mechanism 54, in which the adjustment element 18 engages with its proximal assembly means 98b with the coupling means 102.

[0270] In the pre-assembly position, the adjusting element 18 protrudes from the dose setting element 22 and is free to rotate relative to the dose setting element 22. Rotation of the adjusting element 18 then rotates the nut 38 relative to the piston rod 44 and thereby causes an axial movement of the piston rod 44 due to the threaded connection 189 between the piston rod 44 and the nut 38.

[0271] The adjustment of the piston rod 44 in the pre-assembled state is further detailed below in connection with a second injection pen 330 according to the present disclosure, which is a variation of the injection pen 10 shown in the previous figures.

[0272] Fig.34 and Fig.35 The second injection pen 300 is shown in a pre-assembled state. Fig.36 An exploded view of a second injection pen is shown, and Fig.37 A longitudinal section through the second injection pen 300 in a pre-assembled state is shown.The second injection pen 300 is constructed as disclosed for the injection pen 10 of the previous figures, and vice versa, as long as differences are not disclosed in the description or the figures.

[0273] The second injection pen 300 comprises a dose delivery mechanism 354. The dose delivery mechanism 354 of the second injection pen 300 is constructed as disclosed for the dose delivery mechanism 54 of the injection pen 10, and vice versa, as long as differences are not disclosed in the description or drawings.

[0274] The dose delivery mechanism 354 comprises a housing 332 having an upper housing portion 333 and a piston rod guide 342 forming a lower housing portion. The upper housing portion 333 and the piston rod guide 342 are rigidly connected to each other via a form-fitting connection. In particular, the upper housing portion 333 and the piston rod guide 342 are axially and rotationally fixed to each other. The lower housing portion formed by the piston rod guide 342 is configured to be connected to a medicament container holder 305 receiving a medicament container 348. The medicament container holder 305 comprises a connector 307 at a distal end of the medicament container holder 305. The connector 307 is configured to be connected to a corresponding connector 343 of the piston rod guide 342, which is accessible at the proximal side of the piston rod guide 342. After the medicament container holder 305 is attached to the housing 332, the connectors 307, 343 provide a non-releasable form-fitting connection between the medicament container holder 305 and the housing 332.

[0275] The medication container 348 has a single medication chamber that is sealed by a single plunger 210 at its distal end (see Fig.35 ). The medicament chamber contains a fluid medicament. At its proximal needle end 349, the medicament container 348 includes a septum that is configured to be pierced when the double-sided cannula is attached to the needle connector 306 located at the proximal end of the medicament container holder 305. During storage of the injection pen 300, the cap 301 can be releasably attached to the medicament container holder 305.

[0276] The dose delivery mechanism 354 comprises an injection button constituting the adjustment member 318, a snap element 24, a dosing element 334 and a driver 336. In the pre-assembled state and in the assembled state of the injection pen 300, the snap element 24 and the dosing element 334 are rigidly connected to each other and form a dosing member 323 of the dose delivery mechanism 354. The dosing element 334 is coupled to the housing 332 of the dose delivery mechanism 354 via a threaded connection 335. The threaded connection 335 comprises an external thread on the outer surface of the dosing member 323 and an internal thread on the inner surface of the housing 332 ( Fig.36 For other embodiments, the dosing member 323 may also be constructed as a single component.

[0277] The dosing member 323 constitutes a dose indicating member of the dose delivery mechanism 354. Thus, the dosing element 334 comprises indicia which are visible through a window in the upper housing part 333 of the housing 332 when the dosing member 323 is rotated relative to the housing 332 during dose setting.

[0278] The driver 336 is connected to the housing 332 via an additional threaded connection 337, which acts between the driver 336 and the piston rod guide 342, as described for the driver 36 and the piston rod guide 42 of the injection pen 10. In addition, the driver 336 is rotationally fixed and axially movable relative to the dosing member 323 via a spline connection. Thus, the driver 336 is received in the dosing element 334 of the dosing member 323. The spline connection includes first spline elements on the outer circumference of the driver 336, which engage with corresponding second spline elements on the inner circumference of the dosing element 334. The simultaneous rotation of the driver 336 and the dosing member 323 requires an axial movement of the driver 336 (due to the additional threaded connection 337 to the housing 332) and a simultaneous axial movement of the dosing member 323 (due to the threaded connection 335 to the housing 332).

[0279] The pitch of the threaded connection 335 between the dosing member 334 and the housing 332 deviates from the pitch of the further threaded connection 337 between the driver 336 and the housing 332. The ratio of these pitches defines the mechanical advantage of the dose delivery mechanism 354 during dose delivery, and the dosing member 334 is forced to move proximally a first axial distance causing the driver 336 to move proximally a second axial distance that deviates from the first axial distance.

[0280] Fig.38 A detailed view of the distal portion of the second injection pen 300 in a pre-assembled state is shown. The adjustment element 318 deviates from the adjustment element 18 of the injection pen 10 in that it does not feature a coupling device 100 for axially locking the adjustment element 18 to the snap element 24 when a dose is delivered. Therefore, the second injection pen 300 allows a user-definable dose to be set and injected repeatedly. Apart from this modification, the adjustment element 318 is constructed as disclosed for the adjustment element 18, and vice versa. In particular, the adjustment element 18 of the injection pen 10 is configured to adjust the position of the piston rod 46 in the pre-assembled state in the same manner as disclosed below for the adjustment element 318 of the second injection pen 300. Furthermore, the adjustment element 318 forms an actuation member of the second injection pen 300. The actuation member is configured to be activated by a user to deliver a set dose. Exemplarily, the actuation member is configured to be pushed by a user in a proximal direction to deliver a set dose.

[0281] exist Fig.37 and Fig.38 In the pre-assembled state shown in , the proximal assembly means 98b of the adjustment element 318 engages with the coupling means 102 of the snap element 24 to allow the adjustment element 318 to be positioned in the pre-assembly position relative to the housing 332. The pre-assembly position is the most distal axial position of the adjustment element 318, which is reached when the assembly means 98b engages with the coupling means 102 of the snap element 24 when the adjustment element 318 moves distally. A biasing element 250 in the form of a spring, which acts between the snap element 24 and the adjustment element 318, biases the adjustment element 318 in the distal direction into the pre-assembly position. Since the injection pen 10 does not feature a biasing element 250, the adjustment element 18 of the injection pen 10 is not held in the pre-assembly position. For the injection pen 10, the assembler of the device manually positions the adjustment element 18 in the pre-assembly position.

[0282] The assembly means 98b forms a latching part of a latching mechanism 99, and the coupling means 102 of the snap element 24 forms a latching counterpart of the latching mechanism 99. Furthermore, the dosing member 323 together with the snap element 24 forms a counter-member of the latching mechanism 99. The latching mechanism 99 prevents the adjustment element 318 from being removed from the housing 332 in the pre-assembled state.

[0283] In the pre-assembled position, the adjusting element 318 protrudes distally from the dose setting element formed by the dose knob 22. Then, the rotation securing means 90 of the adjusting element 318 does not engage the rotation securing means 94 of the snap ring 20, so that the adjusting element 318 is rotatably movable relative to the housing 332 and the dose setting element 22.

[0284] In the pre-assembly position, the assembler of the injection pen 300 has access to the outer edge 19 of the adjustment element 318. When the adjustment element 318 is rotated relative to the housing 332 and the dose setting element 22, the adjustment element 318 rotates the nut 38. Thereby, the nut 38 does not move axially relative to the housing 332, because it is limited by the stationary driver 336 pushing the pressing surface 194 at the proximal end of the nut 38. Then, the threaded connection 189 between the piston rod 44 forming the first threaded element and the rotating nut 38 forming the second threaded element causes the piston rod 44 to move axially relative to the housing 332. Therefore, the second injection pen 300 allows the axial position of the piston rod 44 to be adjusted by rotating the adjustment element 318 relative to the housing 332 and the dose setting element 22. The same applies to the injection pen 10, the injection button 18 of which also forms the adjustment element.

[0285] The dose delivery mechanism 54, 354 of the injection pen 10, 300 each comprises a rotation lock 89, which is formed by a rotation fixing means 90 of the respective adjusting element 18, 318 and a toothed portion 93 of the respective snap ring 20. Thereby, the snap ring 20 forms a connector between the respective adjusting element 18, 318 and the respective dose setting element 22, and the adjusting element 18, 318 is rotationally and / or axially fixed to the dose setting element 22 in the assembled state via the connector 20. Furthermore, the dose setting element 22 forms a counter element to which the adjusting element 18, 318 is attached in the assembled state of the respective dose delivery mechanism 54, 354.

[0286] Furthermore, the axial fixing means 82 of the adjusting element 18, 318 and the rib 84 of the snap ring 20 each form an axial lock 81 which allows an axial movement between the adjusting element 18, 318 and the dose setting element 22 in the pre-assembled state of the dose delivery mechanism 54, 354 and prevents an axial movement between the adjusting element 18, 318 and the dose setting element 22 in the assembled state.

[0287] The axial fixing means 82 of the adjusting element 18, 318 and the ribs 84 of the snap ring 20 also form a blocking mechanism, which acts between the adjusting element 18, 318 and the counter-element formed by the dose setting element 22. In the assembled state of the dose delivery mechanism 54, 354, the blocking mechanism blocks the adjustment element 18, 318 from moving from the second position relative to the counter-element into the first position relative to the counter-element. Thereby, the second position is a proximal position in which the adjusting element 18, 318 is rotationally and axially fixed to the counter-element, and the first position is a distal position occupied by the adjusting element 18, 318 in the pre-assembled state and in which the adjusting element 18, 318 can rotate relative to the counter-element.

[0288] Fig.39 shows a detailed view of a longitudinal section through the distal end of the second injection pen 300 in an assembled state during dose setting, and Fig.40 A detailed view of a further longitudinal section through the distal end of the second injection pen 300 in the assembled state during dose setting is shown. Fig.39 and Fig.40 The section planes of the longitudinal sections shown in FIG. 5 are oriented perpendicular to one another.

[0289] The injection pen 300 is transformed from the pre-assembled state to the assembled state by moving the adjustment element 318 proximally from the pre-assembly position into the assembled position relative to the dose setting element 22 and the housing 332. This rotationally and axially locks the adjustment element 318 to the dose setting element 22 via the connector 20, the rotation lock 89 and the axial lock 81. In the assembled state, the distal assembly means 98a of the adjustment element 318 engage with the coupling means 102 of the snap element 24, thus irreversibly blocking the adjustment element 318 from moving from the assembled position into the pre-assembly position.

[0290] The distal assembly means 98a of the adjustment element 318 forms a latching portion of the locking mechanism 97, which is configured to prevent the adjustment element 318 from moving from the assembly position to the pre-assembly position relative to the housing 332. The coupling means 102 of the snap element 24 forms a latching counterpart of the locking mechanism 97, and the dosing member 323 and the snap element 24 together form a counter member of the locking mechanism 97.

[0291] Fig.41 shows a detailed view of a longitudinal section through the distal end of the second injection pen 300 in an assembled state during dose delivery, and Fig.42 A detailed view of a further longitudinal section through the distal end of the second injection pen 300 in an assembled state during dose delivery is shown. Fig.41 and Fig.42 The section planes of the longitudinal sections shown in FIG. are oriented perpendicular to each other. Thus, Fig.41 and Fig.42 The injection pen 300 is shown at the end of dose delivery when the set dose has been completely expelled and the user of the injection pen 300 is still pressing the adjustment element 318 in the proximal direction 1 .

[0292] During dose setting in the assembled state, the adjustment element 318 is rotationally coupled to the dosing member 323 via the clutch mechanism 107 formed by teeth 108 on the inner surface of the dose setting element 22 (see FIG. 5 ) and teeth 110 on the outer surface of the snap element 24 (see FIG. 6 ). The dose setting element 22 forms a first clutch member of the clutch mechanism 107 and the snap element 24 forms a second clutch member of the clutch mechanism 107. The dosing members 23, 323 of the dose delivery mechanism 54, 354 each form a respective further member of the dose delivery mechanism 54, 354.

[0293] For each dose delivery mechanism 54, 354, the corresponding clutch mechanism 107 rotationally couples the corresponding adjustment element 18, 318 to the corresponding further component in the closed state of the corresponding clutch mechanism 107 during dose setting in the assembled state, and rotationally decouples the corresponding adjustment element 18, 318 from the corresponding further component in the open state of the corresponding clutch mechanism 107 during dose delivery in the assembled state.

[0294] For other embodiments of the clutch mechanism 107 that couples the adjustment element 18, 318 to another component, the second clutch component can also be formed integrally with the other component. For example, when the snap element 24 and the dosing element 334 are integrally formed as a one-piece dosing component 323, the dosing component 323 constitutes the other component and at the same time constitutes the second clutch component.

[0295] During dose delivery, the clutch mechanism 107 is opened, thereby rotationally decoupling the adjusting element 318 and the dosing member 323. In the pre-assembled state, the clutch mechanism 107 is closed but the adjusting element 318 is rotationally decoupled from the clutch mechanism 107, so that the clutch mechanism 107 does not transfer the rotation of the adjusting element 318 to the dosing member 323. In particular, in the pre-assembled state, the adjusting element 318 is rotationally decoupled from both the dose setting element 22 and the dosing member 323.

[0296] During dose delivery in the assembled state, the adjusting element 318 is rotationally coupled to the housing 332 via the further clutch mechanism 113, whereby the further clutch mechanism 113 is formed by the teeth 108 on the inner surface of the dose setting element 22 and the teeth 114 on the outer surface of the connector 26. Thereby, the dose setting element 22 forms a first clutch member of the further clutch mechanism 113 and the connector 26 forms a second clutch member of the further clutch mechanism 113. If the further clutch mechanism 113 is in the closed state and the first clutch member is engaged with the second clutch member, the adjusting element 318 is rotationally fixed to the additional member, which is formed by the housing 332.

[0297] During dose setting, the further clutch mechanism 113 is opened so that the adjusting element 318 is allowed to rotate relative to the housing 332. During dose delivery, the further clutch mechanism 118 is closed so that the adjusting element is rotationally fixed relative to the housing. In the pre-assembled state, the adjusting element 318 is rotationally disengaged from the further clutch mechanism 113 because it is allowed to rotate relative to both the first clutch member formed by the dose setting element 22 and the second clutch member formed by the connector 26.

[0298] Fig.43shows a longitudinal section through the dose setting element 22 of the injection pen 10 and the second injection pen 300, Fig.44 shows a perspective view of a longitudinal section through the dose setting element 22, Fig.45 A perspective distal view of the dose setting element 22 is shown, and Fig.46 A perspective proximal view of the dose setting member 22 with the teeth 108 of the clutch mechanism 107 , 113 is shown.

[0299] For both the clutch mechanism 107 and the further clutch mechanism 113, the clutch mechanisms 107, 113 are in a closed state during one of dose setting and dose delivery, and the clutch mechanisms 107, 113 are in an open state during the other of dose setting and dose delivery. Thus, the clutch mechanism 107 is closed when the further clutch mechanism 113 is open, and the clutch mechanism 107 is open when the further clutch mechanism 113 is closed.

[0300] Furthermore, for each clutch mechanism 107, 113, the adjusting element 318 occupies a dose setting position relative to the respective second clutch member 24, 26 during dose setting, and occupies a dose delivery position relative to the respective second clutch member 24, 26 during dose delivery. Thereby, the dose delivery position is axially displaced relative to the dose setting position. Exemplarily, the dose delivery position is axially displaced in the proximal direction 1.

[0301] For the dose delivery mechanism 54 , 354 , the further clutch mechanism 113 also forms a locking mechanism which is configured to rotationally lock the adjustment element 18 , 318 to the housing 32 , 332 during dose delivery in the assembled state.

[0302] The dose selectors 28 of the dose delivery mechanisms 54, 354 each form a holding member of the respective dose delivery mechanism 54, 354. Each adjusting element 18, 318 is located in a first axial position relative to the holding member in the pre-assembled state, and each adjusting element 18, 318 is transferred from the first axial position to a second axial position relative to the holding member, thereby transforming the respective dose delivery mechanism 54, 354 from the pre-assembled state to the assembled state. Each adjusting element 18, 318 is rotatable relative to the holding member in the pre-assembled state.

[0303] During dose setting in the assembled state, each adjustment element 18, 318 is rotatable relative to the respective retaining member, and during dose delivery in the assembled state, each adjustment element 18, 318 is rotationally fixed relative to the respective retaining member. For the dose delivery mechanism 54, 354, each adjustment element 18, 318 is axially fixed relative to the respective retaining member in the assembled state.

[0304] For the dose delivery mechanism 54, 354, during dose setting in the assembled state, the first threaded element formed by the piston rod 44 is axially stationary relative to the third element of the dose delivery mechanism 54, 354. Thereby, the third element is the housing 32, 332. Furthermore, during dose setting in the assembled state, the second threaded element formed by the nut 38 is axially moved relative to the third element. During adjustment of the piston rod 44 in the pre-assembled state, the first threaded element formed by the piston rod 44 is axially moved relative to the third element formed by the housing 32, 332, and the second threaded element formed by the nut 38 is axially stationary relative to the third element formed by the housing 302, 332.

[0305] The dose limiting mechanism 115 acting between the snap element 24 and the dose selector 28 of the dose delivery mechanism 54 , 354 is inactive in the pre-assembled state because the adjustment element 318 is rotationally disengaged from the snap element 24 so that the snap element 24 does not rotate when the adjustment element 318 rotates.

[0306] For both dose delivery mechanisms 54, 354, the adjustment element 18, 318 is configured to rotate in a pre-assembled state after the medicament container 48, 348 has been attached until the bearing 46 contacts the distal surface of the plunger 210. A method for adjusting the position of the piston rod 44 in a pre-assembled state of the dose delivery mechanism 54, 354 may include the steps of attaching the medicament container 48, 348 to the housing 32, 332 and rotating the adjustment element 18, 318 until the bearing 46 contacts the distal surface of the plunger 210. Then, the adjustment element 18, 318 may be further rotated until a predetermined torque is required for rotation. Then, the dose delivery mechanism 54, 354 may be transformed from the pre-assembled state to the assembled state.

[0307] The adjustment element 18, 380 can also be rotated until the bearing 46 is located at a distance greater than zero from the distal surface of the plunger 210, thereby forming a gap between the distal surface of the plunger 210 and the proximal surface of the bearing 46. This distance can be measured, for example, by measuring the position of the bearing 46 relative to the plunger 210 passing through the medication container 305, which can be made of a transparent material.

[0308] Alternatively, the method may further comprise the step of adjusting the position of the piston rod 44 by rotating the adjustment element 18, 318 when the medicament container 48, 348 is not attached to the housing 32, 332. The method may then comprise the step of placing the dose delivery mechanism 54, 354 in an assembly jig in a pre-assembled state and rotating the adjustment element 18, 318 until the proximal surface of the bearing 46 contacts a reference surface provided by the assembly jig. Thereby, the reference surface may be located within the proximal cylindrical portion of the connector 43 of the injection pen 10.

[0309] For example, for the injection pen 300, the medicament container 348 may be attached to the housing 332, and then the adjustment element 318 may be rotated until the bearing 46 contacts the distal surface of the plunger 210. The adjustment element 318 may then be further rotated until a predetermined torque is required for rotation.

[0310] For the dose delivery mechanism 54 of the injection pen 10, the proximal portion of the piston rod guide 42 forms a connector 43, which is configured to connect the medicament container 48 to the housing 32 in an axially movable manner, so that the medicament container 48 can perform an axial movement from the receiving position into the operating position after being connected to the housing 32. Thereby, the receiving position is defined by the engagement of the snap element 234 of the connector 43 with the distal opening 236 of the medicament container holder 50, 52. The operating position is defined by the engagement of the snap element 234 with the proximal opening 240 of the medicament container holder 50, 52 after the medicament container holder 50, 52 has been screwed onto the connector 43.

[0311] For the injection pen 10, the dose delivery mechanism 54 can be provided without the drug container holder 50, 52 being attached to the housing 32, and before the drug container holder 50, 52 is attached to the housing 32, the position of the piston rod 44 can be adjusted by rotating the adjustment element 18. For example, the dose delivery mechanism 54 can be placed in an assembly jig. Then, the adjustment element 18 can be rotated until the bearing 46 contacts the reference surface of the assembly jig and the bearing 46 and the piston rod 44 have reached a predetermined position relative to the housing 32.

[0312] Thus, the piston rod 44 is adjusted relative to the housing 32 to a position that ensures that the bearing 46 is in contact with the plunger 210 during the movement of the medicament container 48 from the receiving position to the operating position. In addition, the position of the piston rod 44 is adjusted to ensure that a certain amount of liquid medicament is discharged from the medicament container 48 at the end of the movement to the operating position. For example, the position can be adjusted so that the amount of medicament is discharged only during the last quarter-turn screwing movement of the medicament container holder 50, 52 onto the proximal part of the piston rod guide 42.

[0313] For both the first injection pen 10 and the second injection pen 300, when the actuation member 18 moves proximally a second distance, the piston rod 44 may be advanced in the proximal direction 1 by a first distance, wherein the second distance is less than 1.5 times the first distance. For the first injection pen 10, the first distance is equal to the second distance. Furthermore, the actuation member 18 travels the second distance, while the piston rod 44 travels the first distance. For the second injection pen 300, the ratio between the second distance and the first distance is given by the ratio of the pitch of the threaded connection 335 between the dosing member 323 and the housing 332 and the pitch of the further threaded connection 337 between the driver 336 and the housing 332.

[0314] An alternative embodiment of the second injection pen 300 may also include a single threaded connection between all components of the second injection pen 300 that rotate during dose delivery and the housing 332. Such an alternative embodiment may include the dosing component 23 of the first injection pen 10. Similar to the first injection pen 10, the dosing component 23 may include Figure 1 The driver 36, the dosing element 34 and the snap element 24 are shown in FIG.

[0315] Additionally or alternatively, the second injection pen 300 may also include the drug reconstitution unit 56 of the first injection pen 10. Such a second injection pen 300 may then be configured to receive the dual chamber cartridge 48 and perform reconstitution of the lyophilized drug prior to drug delivery.

[0316] Additionally or alternatively, the second injection pen 300 may also be configured to permanently axially lock the actuation member (e.g., the actuation member formed by the adjustment element 318) and / or the dose setting element 22 to the dosing member 323 upon dose delivery. The second injection pen 300 may then include the coupling device 100 described in conjunction with the first injection pen 10.

[0317] In general, the first injection pen 10 and the second injection pen 300 may each comprise a blocking mechanism configured to prevent setting and / or delivery of a second dose after a first dose has been delivered with the respective injection pen 10, 300. The blocking mechanism may be configured to permanently at least rotationally fix the dose setting element 22 to the housing 32, 332 when a dose is delivered, such as when a first set dose is delivered. Additionally or alternatively, the blocking mechanism may be configured to permanently axially fix the actuation member 18 to the counter-member, whereby the actuation member 18 moves relative to the counter-member to initiate delivery of the set dose. For the injection pen 10, 300, the respective counter-member is exemplarily formed by a dosing member 23, 323.

[0318] The blocking mechanism may include a first blocking portion that engages a second blocking portion to prevent setting and / or delivering the second dose. For the first injection pen 10 and the second injection pen 300 , the first blocking portion is exemplarily formed by the coupling device 100 and the second blocking portion is exemplarily formed by the coupling device 102 .

[0319] The injection pen 10, 300 may include a clutch mechanism that rotationally locks the dose setting element 22 to the housing in a closed state of the clutch mechanism during dose delivery. By locking the clutch mechanism in a closed state, the blocking mechanism may permanently fix the dose setting element 22 at least rotationally to the housing 32, 332. The clutch mechanism may, for example, be the clutch mechanism 107.

[0320] The clutch mechanism may comprise, for example, a first clutch part (such as teeth 114 of the connector 26) which engages with a second clutch part (such as teeth 108 of the dose setting element 22) in a closed state of the clutch mechanism and disengages from the second clutch part in an open state of the clutch mechanism. For example, the first clutch part and the second clutch part may engage and disengage with each other when axially moving relative to each other. For example, the clutch mechanism may be locked in a closed state, for example by axially locking the first clutch part to the second clutch part.

[0321] Similar to the first injection pen 10, embodiments of the second injection pen 300 can be configured to restrict a user from prematurely activating the second injection pen 300. Similar to the first injection pen 10, embodiments of the second injection pen 300 can be configured to axially lock the actuation member 318 relative to the housing 332 before setting and delivering the first dose. Similar to the first injection pen 10, the second injection pen 300 can include a knob cover 16 and / or a knob key 30.

[0322] Similar to the first injection pen 10, the second injection pen 300 can also be preset to an injectable dose higher than zero in the delivery condition. For example, the dosing member 323 can be preset to a position corresponding to a set dose higher than zero. Similar to the first injection pen 10, the second injection pen 300 can be configured to prevent the preset injectable dose from being reduced to zero.

[0323] For both the first injection pen 10 and the second injection pen 300, the dosing member 23, 323 is blocked from rotating in a rotational direction at a first angular position during dose setting, and is blocked from rotating in a rotational direction at a second angular position during dose delivery, whereby the second angular position is spaced apart from the first angular position in the rotational direction by a distance corresponding to a preset dose above zero. The second angular position may be occupied by the dosing member 23, 323, for example, at the end of dose delivery.

[0324] The first injection pen 10 and the second injection pen 300 may include: a first stopper that limits rotation in a rotational direction at a first angular position during dose setting; and / or a second stopper that limits rotation in a rotational direction at a second angular position during dose delivery (e.g., at the end of dose delivery). The first stopper may be, for example, Fig. 9 The stopper 126 shown in FIG. 1 and / or the second stopper may be, for example, Fig. 13B and Fig.15D The end stops 174, 176 shown in FIG.

[0325] For alternative embodiments, a stopper that prevents the dosing member 23, 323 from rotating at the end of dose delivery may also be provided at the corresponding dose selector 28. The stopper may, for example, interact with a corresponding stopper (such as a hard stopper 124) provided at the dosing member 23, 323. Such a stopper is disclosed in document WO 2020015980 A1, the disclosure of which is incorporated by reference in its entirety into the present disclosure, including the configuration of the stopper, which is referred to as a zero dose hard stopper in document WO 2020015980 A1.

[0326] Fig.47 shows a perspective view of a third injection pen 500 according to the present disclosure, Fig.48 An exploded view of a third injection pen 500 is shown, and Fig.49 A longitudinal section through the dose delivery mechanism 554 of the third injection pen 500 in an assembled state during dose setting is shown. The third injection pen 500 is constructed as disclosed for the second injection pen 300 and vice versa, as long as differences are not disclosed in the description or drawings.

[0327] The dose delivery mechanism 554 comprises a housing 532 configured to be connected to the medication container holder 505 via a non-releasable form-fitting connection. The connection comprises a connector 506 at the distal end of the medication container holder 505. The connector 506 is configured to engage with a corresponding connector 543 at the proximal end of the housing 532, see Fig.49 The connection is configured as a non-releasable snap-fit ​​connection.

[0328] The medication container holder 505 is configured to receive the medication container 348 that has been described in conjunction with the second injection pen 300. At the proximal end, the medication container holder 505 includes a needle connector 306 that is configured to receive a double-ended needle assembly 501 having a double-ended cannula 502. The needle connector 300 is connected to the needle assembly 501 via a threaded connector. Alternatively, the connector may also be configured as a Luer lock, a snap-fit ​​connector, or the like. When the needle assembly 501 is mounted on the medication container holder 505, the distal end of the cannula 502 pierces the septum at the proximal needle end 349 of the medication container 348. The proximal end of the cannula 502 is covered by a needle cap 503 that is removed before using the injection pen 500. During storage of the injection pen 500, a cap 504 covers the medication container holder 505.

[0329] The dose delivery mechanism 554 comprises a dosing member 523 which is axially fixed and rotationally movable relative to the housing 532 by a rotatable fixing device 560 . Fig.50 depicts a perspective distal view of the dosing member 523, and Fig.51A longitudinal section through the dosing member 523 is depicted. The rotatable fixing means 560 comprises an annular rim 561 at the proximal end of the dosing member 523 and a corresponding retaining lug 533 at the proximal end of the housing 532. The retaining lug 533 snaps behind the annular rim 561 and thus axially fixes the dosing member 523 to the housing 532.

[0330] The dose delivery mechanism 554 further comprises a piston rod 44 which is Fig.52 567 at the proximal end of the dosing member 523. Thus, the piston rod 44 is connected to the dosing member 523 via a threaded connection 189. The threaded connection 189 comprises an internal thread in the opening 567 of the dosing member 523 and an external thread arranged at the outer circumference of the piston rod 44. The piston rod 44 forms a first threaded element of the threaded connection 189, and the dosing member 523 forms a second threaded element of the threaded connection 189. At its proximal end, the piston rod 44 comprises coupling means 198, which connect the bearing 46 to the piston rod 44 in an axially fixed and rotationally movable manner.

[0331] Fig.53 A perspective distal view of the extension 525 of the dose delivery mechanism 554 is depicted, Fig.54 A distal view of extension 525 is depicted, and Fig.55 A proximal view of the extension 525 is depicted. The extension 525 is received in the dosing member 523. It is held in the dosing member 523 in an axially fixed and rotatably movable manner by a rotatable fixing device 570. The rotatable fixing device 570 illustratively includes an annular ridge 571 at the proximal end of the extension 525 and a corresponding lug 566 provided at the proximal end of the dosing member 523. The lug 566 is caught behind the annular ridge 571 from the proximal side of the extension 525 and thereby axially fixes the extension 525 to the dosing member 523.

[0332] The piston rod 44 is axially movable and rotationally fixed relative to the extension 525. At its proximal end, the extension comprises a non-circular opening 573 adapted to the corresponding non-circular outer shape of the piston rod 44. The piston rod 44 is received in the opening 573, thereby rotationally locking the piston rod 44 to the extension 525 while allowing relative axial movement between the piston rod 44 and the extension 525.

[0333] Fig.56 Depicted is a perspective view of a coupling element 520 of a dose delivery mechanism 554. The coupling element 520 comprises an end plate 580 at its distal end and two rods 582 extending axially and parallel to each other in a proximal direction.

[0334] The coupling element 520 is rotationally fixed relative to the piston rod 44 and axially movable. Thus, it is coupled to the piston rod 44 via the extension 525. Fig.57 It can be seen that the rod 582 of the coupling element 520 is received between two ridges 575 of the extension 525, which extend radially from the inner surface of the extension 525. Thus, the ridges 575 extend parallel to each other in the axial direction. The rod 582 and the ridges 575 provide an axially movable connection between the coupling element 520 and the extension 525, which rotationally fixes the coupling element 520 to the extension 525.

[0335] As from Fig.57 It can be further seen that the adjustment element 518 is axially and rotationally fixed to the distal end of the coupling element 520. Fig.58 depicts a proximal perspective view of the adjustment element 518, Fig.59 depicts a side view of the adjustment element 518, Fig.60 Depicts the Fig.59 The line AA in passes through the radial section of the adjustment element 518, and Fig.61 Depicts the Fig.59 The line BB in FIG. 5 passes through a radial section of the adjustment element 518 .

[0336] The adjustment element 518 is axially and rotationally fixed to the coupling element 520. Thus, the adjustment element 518 and the coupling element 520 form a single component of the dose delivery mechanism 554. Fig.56 It can be seen that the coupling element 520 includes an axial fixing element 584, which is part of the axial fixing device acting between the adjustment element 518 and the coupling element 520 and engages with a corresponding axial fixing element provided at the adjustment element 518. Thus, the axial fixing element 584 of the coupling element 520 is configured as a snap hook, and the corresponding axial fixing element of the adjustment element 518 is configured as a circumferential edge that engages with the snap hook. The coupling element 520 further includes at least one rotational fixing element 585, for example several rotational fixing elements 585. The rotational fixing element 585 engages with a corresponding rotational fixing element provided at the adjustment element 518, and thereby rotationally locks the adjustment element 518 to the coupling element 520. The rotational fixing element 585 of the coupling element 520 is configured as a longitudinal ridge extending parallel to the axial direction. These ridges are received between corresponding longitudinal recesses 586 provided in the adjustment element 518. For other embodiments of the dose delivery mechanism 554, the adjustment element 518 and the coupling element 520 can also be configured as a one-piece single component.

[0337] Fig.62A perspective view of the coupling member 524 of the dose delivery mechanism 554 is depicted. The coupling member 524 is configured as a hollow member. Fig.49 It can be seen that the coupling member 524 is located between the dosing member 523 and the extension 525. Thus, the coupling member 524 is placed within the dosing member 523 and receives the extension 525 in the inner cavity. The coupling member 524 is rotationally fixed to the dosing member 523 via an axially movable rotational fixing device 563. The rotational fixing device 563 includes a longitudinal recess 590 provided on the outer surface of the coupling member 524, which engages a corresponding longitudinal ridge 564 provided on the inner surface of the dosing member 523, see Fig.50 and Fig.51 .

[0338] Fig.63 A perspective distal view of the sleeve 528 of the dose delivery mechanism 554 is depicted, and Fig.64 A longitudinal section through the sleeve 528 is depicted. The sleeve 528 is constructed as a hollow member. Fig.49 It can be seen that the sleeve 528 is located between the housing 532 and the dosing member 523.

[0339] The sleeve 528 is threadably connected to and threadably engages with the dosing member 523. The threaded connection between the sleeve 528 and the dosing member 523 includes internal threads 612 disposed on the inner surface of the sleeve 528 engaging external threads 562 disposed on the outer surface of the dosing member 523.

[0340] In addition, the sleeve 528 is connected to the housing 532 in a rotationally fixed and axially movable manner. The connection between the sleeve 528 and the housing 532 thus includes a connector 620. The connector 620 is located at the distal end of the housing 532. It is axially and rotationally fixed relative to the housing 532. For other embodiments, the connector 620 can also be formed integrally with the housing 532. The connector 620 includes a pair of radial lugs 622 arranged at the outer surface of the connector 620. The radial lugs 622 engage with the corresponding openings 535 accessible at the inner surface of the housing 532. The connector 620 further includes an outer annular rim 626 arranged at the distal end of the connector 620. The annular rim 626 rests against the distal surface of the housing 532, thereby preventing the connector 620 from moving in the proximal direction.

[0341] On the inner surface of the connector 620, longitudinal recesses 624 are provided which engage with corresponding longitudinal ridges 616 on the outer surface of the sleeve 528. This provides a rotationally fixed and axially movable connection between the housing 532 and the sleeve 528.

[0342] The dose sleeve 523 is configured as a dose indicating member and includes markings on its outer surface for indicating a set dose. A window 610 is formed in the sleeve 528 through which the dose sleeve 523 is visible. The window 610 of the sleeve 528 is aligned with a housing window 534 provided in the housing 532 so that the dose sleeve 523 is visible from the outside of the housing 532. The set dose is then indicated by the markings visible through the windows 534, 610.

[0343] The coupling member 524 is axially fixed and rotationally movable relative to the sleeve 528. The connection between the coupling member 524 and the sleeve 528 includes a connector 527.

[0344] Fig.66 depicts a perspective view of connector 527, and Fig.67 A perspective view of a longitudinal section through the connector 527 is depicted. The connector 527 is axially and rotationally fixed relative to the sleeve 528. It includes longitudinal ridges 632 on its outer surface which align with corresponding recesses 618 provided on the inner surface of the sleeve 528 (see Fig.64 ) engagement. In addition, the connector 527 includes radially extending lugs 630 that engage with accessible openings 614 on the inner surface of the sleeve 528. This engagement prevents the connector 527 from being removed from the sleeve 528.

[0345] On the inner surface of the connector 527, a distal blocking element 635 and a proximal blocking element 654 are formed. The blocking elements 635, 654 provide an axially fixed and rotatably movable connection to the coupling member 524. Thus, an annular rim 592 (refer to Fig.62 ) is received between blocking elements 635, 654.

[0346] In addition, a radial stopper 568 is formed between the sleeve 528 and the dosing member 523. The radial stopper 568 is configured to stop the relative rotation between the dosing member 523 and the sleeve 528 at the end of the dose delivery, and thus also stop the relative rotation between the dosing member 523 and the housing 532. The radial stopper 568 includes at least one stopper surface 569 disposed at the dosing member 523 and a corresponding stopper surface 636 disposed at the connector 527. The stopper surfaces 569, 636 are oriented parallel to each other and are configured to engage with each other at the end of the dose delivery. The stopper surfaces 569, 636 form a certain angle with a radial plane oriented perpendicular to the longitudinal axis of the dose delivery mechanism 554. For the third injection pen 500, the stopper surfaces 569, 636 are oriented parallel to the longitudinal axis. Although the stopper surface 636 is disposed at the connector 527, for other embodiments, the stopper surface 636 may also be disposed directly at the sleeve 528.

[0347] For the third injection pen 500, the adjustment element 518 forms a dose setting member of the dose delivery mechanism 554. To set the dose to be delivered, the user rotates the adjustment element 518 relative to the housing 532 in the assembled state.

[0348] Fig.68 A side view of the third injection pen 500 is depicted in an assembled state during dose setting when no dose is set. Fig.69 A side view of the third injection pen 500 in a pre-assembled state is depicted. In the pre-assembled state, the adjustment element 518 is located in a pre-assembly position relative to the housing 532, and in the assembled state during dose setting and without setting a dose, the adjustment element 518 is located in an assembled position relative to the housing 532. Thereby, the assembled position is located more distally than the pre-assembly position.

[0349] Fig.70 shows a detailed view of a longitudinal section through the distal end of the third injection pen 500 in an assembled state during dose setting, and Fig.71 A detailed view of a further longitudinal section through the distal end of the third injection pen 500 in an assembled state during dose setting is shown. Fig.71 The longitudinal section plane of the view shown in FIG. Fig.70 The longitudinal section plane orientation shown in .

[0350] During dose setting, the adjusting element 518 is rotationally fixed relative to the coupling member 524 by the clutch mechanism 507. Rotation of the adjusting element 518 then causes rotation of the piston rod 44 (due to the rotational fixation achieved via the extension 525 and the coupling element 520) and simultaneous rotation of the dosing member 523 (due to the rotational fixation achieved via the coupling element 520, the clutch mechanism 507 and the coupling member 524). Since both the piston rod 44 and the dosing member 523 rotate at the same speed relative to the housing 532 during dose setting, the piston rod 44 does not change its axial position relative to the housing 532 despite the presence of the threaded connection 189 between the piston rod 44 and the dosing member 523.

[0351] The rotation of the dosing member 523 relative to the sleeve 528 during dose setting causes the sleeve 528 to move axially relative to the housing 532 in the distal direction due to the threaded connection 562, 612. This also causes the adjustment element 518 and the coupling element 520 to move distally. In addition, the coupling member 524 also moves distally due to the axially fixed and rotationally movable connection to the sleeve 528 via the connector 527.

[0352] As from Fig.70 and Fig.71 It can be seen that the adjustment element 518 is coupled to the sleeve 528 via a locking mechanism 597, which prevents the adjustment element 518 and the coupling element 520 from moving distally relative to the sleeve 528. Figure 58 to Figure 61 , Fig.63 and Fig.64 It can be seen that the latching mechanism 597 includes a latching portion 600 located at the proximal end of the adjustment element 518, which engages with a latching counterpart 529 of the sleeve 528. The latching counterpart 529 of the sleeve 528 is configured as an annular edge located at the outer surface of the sleeve 528. The latching portion 600 of the adjustment element 518 is configured as a corresponding radial lug provided on the inner surface of the adjustment element 518. In the assembled position of the adjustment element 518, the radial lug 600 engages with the annular edge 529, thereby preventing the adjustment element 518 from moving further distally into the pre-assembled position.

[0353] The adjustment element 518 and the coupling element 520 are biased in the distal direction relative to the sleeve 528 by the biasing member 250, which is configured as a compression spring and is Fig.48 but in Fig.70 and Fig.71 Not visible in.

[0354] During dose setting, the window 610 of the sleeve 528 moves axially along the dosing member 523 during rotation of the dosing member 523 and axial movement of the sleeve 528 relative to the housing 532. Thereby, the corresponding marking on the dose sleeve 523 visible through the window 610 indicates the currently set dose.

[0355] To deliver a set dose, a user of the third injection pen 500 pushes the adjustment element 518 and the coupling element 520 in the proximal direction 1 against the force of the biasing member 250 .

[0356] Fig.72 shows a detailed view of a longitudinal section through the distal end of the third injection pen 500 in an assembled state during dose delivery, and Fig.73 A detailed view of a further longitudinal section through the distal end of the third injection pen 500 in an assembled state during dose delivery is shown, whereby the longitudinal section plane is perpendicular to Fig.73 The longitudinal cutting plane of the view in is oriented. Thus, Fig.72 , Fig.73 The dose delivery mechanism 554 of the third injection pen 500 is shown at the end of dose delivery when the set dose has been completely expelled and the user is still pressing the adjustment element 518 and the coupling element 520 in the proximal direction.

[0357] During dose delivery, the adjusting element 518 and the coupling element 520 are rotationally locked to the housing 532 via the sleeve 528. This is because the proximal movement of the coupling element 520 and the adjusting element 518 relative to the sleeve 528 at the beginning of dose delivery closes the clutch mechanism 513 between the adjusting element 518 and the sleeve 528. The clutch mechanism 513 includes teeth 515 formed at the adjusting element 518 and corresponding teeth 514 formed at the distal end of the sleeve 528. The clutch mechanism 513 also rotationally locks the piston rod 44 to the housing 532 via the extension 525, the coupling element 520, the adjusting element 518 and the sleeve 528 during dose delivery.

[0358] The proximal movement of the coupling element 520 relative to the coupling member 524 at the start of dose delivery causes the clutch mechanism 507 between the coupling element 520 and the coupling member 524 to open, so that the coupling member 524 becomes rotatable relative to the coupling element 520. After the clutch mechanism 507 is disengaged, further proximal movement of the coupling element 520 pushes the sleeve 528 in the proximal direction 1. The proximal movement of the sleeve 528 rotates the dosing member 523 via the threaded connection 612 between the sleeve 528 and the dosing member 523. Since the piston rod 44 is rotationally locked to the housing 332 during dose delivery, the rotation of the dosing member 523 causes the piston rod 44 to move proximally, which is driven via the threaded connection 189.

[0359] Fig.74 shows a detailed view of a longitudinal section through the distal end of the third injection pen 500 in a pre-assembled state of the dose delivery mechanism 554, and Fig.75 A detailed view of a further longitudinal section through the distal end of the third injection pen 500 in a pre-assembled state is shown, whereby the longitudinal section plane is perpendicular to Fig.74 Orients the longitudinal cutting plane of the view in .

[0360] In the pre-assembled state, the adjustment element 518 and the coupling element 520 are located in an adjustment position relative to the housing 532 and the sleeve 528. In the adjustment position, the adjustment element 518 and the coupling element 520 are displaced in the distal direction relative to their respective assembly positions in the assembled state.

[0361] The dose delivery mechanism 554 comprises a further locking mechanism 599 which prevents disassembly of the adjustment element 518 and the coupling element 520 in the pre-assembled state. The further locking mechanism 599 comprises a latching portion 600 of the adjustment element 518 and a further latching counterpart 530 located at the distal end of the sleeve 528. Thus, the further latching counterpart 530 is located distally of the latching counterpart 529.

[0362] The additional latch counterpart 530 is configured to receive an angled recess of a radial lug of the latch portion 600 of the adjustment element 518. Thus, the latch portion 600 formed by the radial lug releasably engages the additional latch counterpart 530 and allows the adjustment element 518 to move proximally while blocking distal movement.

[0363] In the pre-assembled state, the clutch mechanism 507 between the coupling element 520 and the coupling member 524 is open, so that the adjustment element 518 is rotationally disengaged from the dosing member 523. At the same time, the adjustment element 518 is rotationally coupled and rotationally fixed relative to the piston rod 44 by the coupling element 520 and the extension 525. The rotation of the adjustment element 518 relative to the housing 532 thereby causes the piston rod 44 to rotate relative to the housing 532 and the dosing member 523. Due to the threaded connection 189 between the dosing member 523 and the piston rod 44, the piston rod 44 moves axially relative to the housing 332 when the adjustment element 518 rotates.

[0364] For the clutch mechanism 507, the coupling element 520 forms a first clutch member of the clutch mechanism 507 and the coupling member 524 forms a second clutch member of the clutch mechanism 507. The dosing member 523 of the dose delivery mechanism 554 forms a further member of the dose delivery mechanism 54, 354, to which the adjusting element 518 is rotationally coupled during dose setting in the assembled state and from which the adjusting element 518 is rotationally decoupled during dose delivery in the assembled state.

[0365] The coupling element 520 includes a first clutch portion 508 of the clutch mechanism 507. The first clutch portion 508 is configured as radial teeth disposed on the outer surface of the coupling element 520. The coupling member 524 includes a second clutch portion 509 of the clutch mechanism 507. The second clutch portion 509 is configured as radial teeth disposed on the inner surface of the coupling member 524. In the closed state of the clutch mechanism 507, the first clutch portion 508 is engaged with the second clutch portion 509, as shown in FIG. Fig.71 as shown in .

[0366] During adjustment of the piston rod in the pre-assembled state, the clutch mechanism 507 is in the open state. As a result, the first clutch part 508 and the second clutch part 509 are disengaged by positioning them at a certain axial distance from each other. As a result, the first clutch part 508 is displaced from the second clutch part 509 in the distal direction, which is opposite to the proximal direction 1, see Fig.74 During dose delivery in the assembled state, the clutch mechanism 507 is also in the open state. Thereby, the first clutch part 508 and the second clutch part 509 are also disengaged by positioning them at a certain axial distance from each other, whereby the second clutch part 509 is displaced from the first clutch part 508 in the proximal direction 1, see Fig.72 .

[0367] Furthermore, the adjusting element 518 forms a first clutch member of the clutch mechanism 513 and the sleeve 528 forms a second clutch member of the clutch mechanism 513. A housing 532 of the dose delivery mechanism 554 forms an additional member of the dose delivery mechanism 554, to which the adjusting element 518 is rotationally coupled during dose setting in the assembled state and from which the adjusting element 518 is rotationally decoupled during dose delivery in the assembled state.

[0368] The sleeve 528 forms a retaining member for the adjustment element 518 .

[0369] The dose delivery mechanism 554 includes a dose limiting mechanism 115 that defines a dose that can be set by a user. The engagement feature 116 of the dose limiting mechanism 115 is disposed at the adjustment element 518, see Fig.58 The engagement feature 116 is configured as a radially extending lug that is flexible in the radial direction. The engagement feature 116 engages with a corresponding dose stop 118 disposed at the distal end of the sleeve 528, see Fig.63 , Fig.64 The dose stop 118 is configured as a longitudinal recess formed at the inner surface of the sleeve 528. During dose setting, the adjustment element 518 and the coupling element 520 are configured to perform more than one full revolution around the longitudinal axis of the dose delivery mechanism 554.

[0370] During adjustment of the piston rod 44 in the pre-assembled state, the dose limiting mechanism 115 of the dose delivery mechanism 554 does not function. This is because the engagement feature 116 is axially displaced relative to the dose stop 118 so that the engagement feature 116 and the dose stop 118 are disengaged from each other, see Fig.75 .

[0371] For the dose delivery mechanism 554, the housing 532 forms a third element, and during adjustment of the piston rod in the pre-assembled state, the first threaded element formed by the piston rod 44 rotates relative to the third element, while the second threaded element formed by the dosing member 523 is rotationally fixed relative to the third element. During dose delivery in the assembled state, the first threaded element formed by the piston rod 44 is rotationally fixed relative to the third element formed by the housing 532, and the second threaded element formed by the dosing member 523 rotates relative to the third element.

[0372] For the third injection pen 500, the piston rod 44 may be configured to advance a first distance in the proximal direction 1 when the actuation member 520 moves proximally a second distance, wherein the second distance is less than 1.5 times the first distance. For the third injection pen 500, the ratio between the second distance and the first distance is given by the ratio of the pitch of the threaded connection 189 between the piston rod 44 and the dosing member 523 and the pitch of the further threaded connection 562 between the sleeve 528 and the dosing member 523.

[0373] Additionally or alternatively, the third injection pen 500 may also include the drug reconstitution unit 56 of the first injection pen 10. Such a third injection pen 500 may then be configured to receive the dual chamber cartridge 48 and perform reconstitution of the lyophilized drug prior to drug delivery.

[0374] Similar to the first injection pen 10, embodiments of the third injection pen 500 may be configured to restrict a user from prematurely activating the third injection pen 500. Similar to the first injection pen 10, embodiments of the third injection pen 500 may be configured to axially lock the actuation member 520 relative to the housing 532 before setting and delivering the first dose. Similar to the first injection pen 10, the third injection pen 500 may include a knob cover 16 and / or a knob key 30.

[0375] Fig.76 A perspective view of a fourth injection pen 700 according to the present disclosure is shown. The fourth injection pen 700 is a modification of the third injection pen 500. The fourth injection pen 700 is constructed as disclosed for the third injection pen 500 as long as the difference is not disclosed in the specification or the drawings. Hereinafter, components of the fourth injection pen 700 that perform the same functions as corresponding components of the third injection pen 500 are labeled with the same reference numerals. However, these components may be distinguished in shape and / or appearance between the third injection pen 500 and the fourth injection pen 700.

[0376] Fig.77 A side view of the fourth injection pen 700 is shown in an assembled state during dose setting. Thereby, no dose is set and the adjustment element 518 of the dose delivery mechanism 754 of the fourth injection pen 700 is positioned in an assembled position relative to the housing 532 of the dose delivery mechanism 754 .

[0377] Fig.78 A side view of the fourth injection pen 700 is shown in a preassembled state, wherein the adjustment element 518 is in a preassembled position relative to the housing 532. In the preassembled position, the adjustment element 518 is displaced from its assembly position in a distal direction, whereby the distal direction is oriented perpendicular to the proximal direction 1.

[0378] Fig.79 A side view of a fourth injection pen in a pre-assembled state is shown, wherein the adjustment element 518 is in an adjustment position. In the adjustment position, the adjustment element 518 is displaced in the proximal direction compared to the pre-assembled position.

[0379] Fig.80 An exploded view of a fourth injection pen 700 is shown, and Fig.81 A longitudinal section through the dose delivery mechanism 754 of the fourth injection pen 700 is shown in an assembled state during dose setting and without a dose being set.

[0380] Similar to the dose delivery mechanism 554 of the third injection pen 500, the dose delivery mechanism 754 of the fourth injection pen 700 includes a coupling element 720 that is rotationally fixed and axially movable relative to the piston rod 44. Unlike the dose delivery mechanism 554, the dose delivery mechanism 754 does not feature an extension 525. Instead, the coupling element 720 directly engages the piston rod 44 to rotationally fix the coupling element 720 to the piston rod 44 and allow axial movement between the coupling element 720 and the piston rod 44.

[0381] In addition, the dose delivery mechanism 754 includes a biasing element in the form of a spring that is not in the Fig.80 and Fig.81 In both the pre-assembled state and the assembled state of the dose delivery mechanism 754, the biasing element biases the adjustment element 518 in the distal direction.

[0382] Fig.82 A perspective view of the coupling element 720 of the dose delivery mechanism 754 is shown, and Fig.83 Shown along Fig.82 The line AA shown in FIG. 7 passes through a radial section of the coupling element 720 . The coupling element 720 is configured as a tubular member extending in the longitudinal direction. It has a non-circular inner cross-section configured to receive the piston rod 44 . Fig.84 The piston rod 44 shown in FIG. 4 has a distal section 45 whose outer shape is configured to engage with a non-circular inner cross-section of a coupling element 720 to rotationally lock the piston rod 44 and the coupling element 720 and allow axial movement between the coupling element 720 and the piston rod 44 .

[0383] Figure 85 to Figure 89 An adjustment element 518 of a dose delivery mechanism 754 is depicted. The adjustment element 518 engages with a distal portion of a coupling element 720. Thus, the adjustment element 518 is rotationally fixed relative to the coupling element 720 in both the pre-assembled state and the assembled state of the dose delivery mechanism 704. The rotation lock between the coupling element 720 and the adjustment element 518 includes a non-circular outer cross-section of the coupling element 720 that matches and engages with a corresponding inner shape of the central opening 519 of the adjustment element 518.

[0384] The locking mechanism 597 acts between the coupling element 720 and the adjusting element 518. In the assembled state of the dose delivery mechanism 754, the locking mechanism 597 prevents the adjusting element 518 from moving distally from the assembled position to the pre-assembled position relative to the housing 532. The locking mechanism 597 includes a latch portion 600 formed at the adjusting element 518 and a latch counterpart 529 formed at the coupling element 720. The latch portion 600 is configured as a flexible hook protruding radially inwardly from the inner surface of the adjusting element 518 at the opening 519. The latch counterpart 529 is configured as a recessed portion at the outer surface in the distal portion of the coupling element 720.

[0385] The coupling element 720 may form a retaining member of the dose delivery mechanism 754 .

[0386] In the pre-assembled state of the dose delivery mechanism 754, the adjustment element 518 is located in a more distal position relative to the coupling element 720 than in the assembled state. In this position, the adjustment element 518 is prevented from being detached from the dose delivery mechanism 754 and the coupling element 720 by the further latching mechanism 599. The further latching portion of the further latching mechanism 599 is formed by the latching portion 600, and the further latching counterpart 530 of the further latching mechanism 599 is formed by an additional recess at the outer surface of the coupling element 720. Thereby, the further latching counterpart 530 is located at the distal side of the latching counterpart 529.

[0387] Figure 90 to Figure 93 The sleeve 528 of the dose delivery mechanism 754 is shown rotationally fixed and axially movable relative to the housing 532. The sleeve 528 includes longitudinal recesses on its outer surface that engage corresponding longitudinal ridges on the inner surface of the housing 532 to rotationally fix the sleeve 528 to the housing 532. The sleeve 528 includes an outer portion 528a and an insert 528b that is rotationally and axially fixed within the outer portion 528a at a distal end of the outer portion 528a.

[0388] The dose limiting mechanism 115 of the dose delivery mechanism 754 acts between the adjustment element 518 and the sleeve 528. The dose limiting mechanism 115 includes engagement features 116, which are configured as flexible hooks and are provided at the proximal end of the adjustment element 518. The engagement features 116 interact with a dose stop 118 provided in a proximal portion of the inner surface of the insert 528b of the sleeve 528.

[0389] In addition, the dose delivery mechanism 754 includes a clutch mechanism 513 acting between the adjustment element 518 and the sleeve 528. The clutch mechanism 513 includes teeth 515 located at the proximal outer surface of the adjustment element 518. When the clutch mechanism 513 is closed, the teeth 515 engage with corresponding teeth 514 provided in the distal portion of the inner surface of the insert 528b. Thus, the inner surface is the side surface of the cavity formed at the distal end of the insert 528b and the sleeve 528.

[0390] The adjusting element 518 forms a first clutch member of the clutch mechanism 513, and the sleeve 528 forms a second clutch member of the clutch mechanism 513. The housing 532 of the dose delivery mechanism 754 forms an additional component of the dose delivery mechanism 754, to which the adjusting element 518 is rotationally coupled during dose setting in the assembled state, and from which the adjusting element 518 is rotationally decoupled during dose delivery in the assembled state. Furthermore, the clutch mechanism 513 forms a locking mechanism, which rotationally locks the adjusting element 718 to the housing 532 during dose delivery in the assembled state of the dose delivery mechanism 754.

[0391] Figures 94 to 96 The coupling member 524 of the dose delivery mechanism 754 is shown. The coupling member 524 is axially fixed to the sleeve 528 by a rim 592 provided at the distal end of the coupling member 524. The rim 592 is retained between a proximal blocking element 634 and a distal blocking element 635 provided at the proximal end of the insert 528b. The proximal blocking element 634 is configured as a flexible hook, and the distal blocking element 635 is formed by a radial surface of the insert 528b.

[0392] The clutch mechanism 507 acts between the coupling member 524 and the coupling element 720 received in the coupling member 524. The clutch mechanism 507 comprises a first clutch part 508, which is located on the outer surface of the coupling element 720 and comprises longitudinal teeth. The clutch mechanism 507 further comprises a second clutch part 509, which is located on the inner surface of the coupling member 524. The second clutch part 509 is configured as longitudinal teeth, which mesh with the longitudinal teeth of the first clutch part 508 in the closed state of the clutch.

[0393] The coupling element 520 forms a first clutch member of the clutch mechanism 507 and the coupling member 524 forms a second clutch member of the clutch mechanism 507. The dosing member 523 of the dose delivery mechanism 754 forms a further member of the dose delivery mechanism 754, to which the adjusting element 518 is rotationally coupled during dose setting in the assembled state and from which the adjusting element 518 is rotationally decoupled during dose delivery in the assembled state.

[0394] Fig.97 and Fig.98 The dosing member 523 of the dose delivery mechanism 754 is shown. A radial stop 568 is provided between the dosing member 523 and the insert 528b of the sleeve 528. The radial stop 568 comprises a stop surface 636 at the proximal extension of the insert 528b and a corresponding stop surface 569 at the distal end of the dosing member 523.

[0395] As from Fig.99 and Fig.100 (These two figures show the dose delivery mechanism 754 in an assembled state during dose setting and without setting a dose) It can be seen that during dose setting, the clutch mechanism 507 between the coupling element 720 and the coupling member 524 is closed, and the clutch mechanism 513 between the adjustment element 518 and the sleeve 528 is opened. Dose setting is then achieved by rotating the adjustment element 720 in the same manner as described for the third injection pen 500.

[0396] Fig.101 and Fig.102 The dose delivery mechanism 754 is depicted in an assembled state during dose delivery, when the set dose has been fully expelled and the user still pushes the adjustment element 518 in the proximal direction 1. During dose delivery, the clutch mechanism 507 is opened, thereby allowing rotation between the piston rod 44 and the dosing member 523, and the clutch mechanism 513 is closed, thereby rotationally locking the piston rod 44 to the housing 532.

[0397] Fig.103 and Fig.104 The dose delivery mechanism 754 is depicted in a pre-assembled state. Compared to the assembled state, the adjustment element 518 is displaced in the distal direction relative to the coupling element 720 and the housing 532. The latch portion 600 of the adjustment element 518 then engages with a further latch counterpart 530 disposed distally of the latch counterpart 529 at the coupling element 720. Fig.103 and Fig.104 In the state depicted in , the adjustment element 518 is positioned in a pre-assembly position relative to the housing 532 .

[0398] In order to adjust the position of the piston rod 44 in the pre-assembled state, the adjusting element 518 is pushed from the pre-assembled position into the adjusting position in the proximal direction 1 against the biasing force of the spring acting between the adjusting element 518 and the sleeve 528, as shown in FIG. Fig.105 and Fig.106. The proximal movement of the adjusting element 518 causes the coupling element 720 to move proximally and causes the clutch mechanism 507 to open. At the same time, the clutch mechanism 513 remains open and prevents the teeth 515 of the adjusting element 518 from engaging with the teeth 514 of the sleeve 528. This is due to the axial offset between the teeth 513 and 514.

[0399] When the assembler of the fourth injection pen 700 rotates the adjustment element 518 to Fig.105 and Fig.106 , the piston rod 44 rotates with the adjusting element 518, and the dosing member 523 does not rotate due to the clutch mechanism 507 being open. The rotation of the piston rod 44 relative to the dosing member 523 then moves the piston rod 44 axially relative to the housing 532 via the threaded connection 189.

[0400] For the fourth injection pen 700, the piston rod 44 can be configured to advance a first distance in the proximal direction 1 when the actuation member 518 moves proximally a second distance, wherein the second distance is less than 1.5 times the first distance. For the fourth injection pen 700, the ratio between the second distance and the first distance is given by the ratio of the pitch of the threaded connection 189 between the piston rod 44 and the dosing member 523 and the pitch of the further threaded connection 562 between the sleeve 528 and the dosing member 523.

[0401] Additionally or alternatively, the fourth injection pen 700 may also include the drug reconstitution unit 56 of the first injection pen 10. Such a fourth injection pen 700 may then be configured to receive the dual chamber cartridge 48 and perform reconstitution of the lyophilized drug prior to drug delivery.

[0402] Similar to the first injection pen 10, embodiments of the fourth injection pen 700 may be configured to restrict a user from prematurely activating the fourth injection pen 700. Similar to the first injection pen 10, embodiments of the fourth injection pen 700 may be configured to axially lock the actuation member 520 relative to the housing 532 before setting and delivering the first dose. Similar to the first injection pen 10, the fourth injection pen 700 may include a knob cover 16 and / or a knob key 30.

[0403] The mechanism may include a dose limiting mechanism that allows a user of the device to set at least one dose of the medicament for delivery. For example, the dose limiting mechanism may be configured to allow only a single predetermined dose to be set. Alternatively, the dose limiting mechanism may also be configured to allow a user to set a plurality of different predetermined doses, such as two or more different doses.

[0404] For the injection pen 10, 300, 500, 700, the dose delivery mechanism 54, 354, 554, 754 each comprises a dose limiting mechanism 115, wherein the respective dose limiting mechanism 115 acts between the respective dose setting element 18, 318, 518 and the housing 32, 332, 532 during dose setting. Thereby, the dose limiting mechanism 115 has at least one dose stop 118 and a counter element 116, wherein the counter element 116 is configured to rotate relative to the dose stop 118 when the dose setting element 38, 318, 518 is rotated during dose setting, and wherein the counter element 116 is configured to engage the dose stop 118 when a dose has been set. The counter element 116 is formed by the respective engagement feature 116 of the dose delivery mechanism 54, 354, 554, 754.

[0405] The dose limiting mechanism 115 may define rotational positions of the dose setting element 22, 518 relative to the housing 32, 332, 532, which rotational positions correspond to settable doses. For each settable dose, the dose limiting mechanism 115 may include a separate dose stop 118. The dose setting element 22, 518 may then be configured to perform only less than one full rotation during dose setting. For the third injection pen 500 and the fourth injection pen 700, the dose limiting mechanism 115 may also include individual dose stops 118 defining more than a single dose, for example, individual dose stops 118 may be configured to engage with the counter element 116 once per full rotation of the counter element 116 relative to the dose stop 118.

[0406] The counter element 116 may be configured as a flexible element that snaps onto the dose stop 118 when setting a dose. For example, the counter element 116 may be configured as a flexible protrusion at a component of the respective dose delivery mechanism 54, 354, 554, 754. The counter element 116 may, for example, be integrally formed with the component of the respective dose delivery mechanism 54, 354, 554, 754 to which it is fixed. For the first injection pen 10 and the second injection pen 300, the component is formed by the dosing member 23, 323, and for the third injection pen 500 and the fourth injection pen 700, the component is formed by the dose setting element 518.

[0407] For the first injection pen 10 and the second injection pen 300, the engagement of the counter element 116 with the dose stop 118 prevents the spring 40 from releasing energy stored when the dose setting element 22 is rotated during dose setting. Thereby, the dose limiting mechanism 115 may provide a lockout function that holds the spring 40 in a tensioned state until a dose is delivered by transitioning the respective dose delivery mechanism 54, 354 from a dose setting state to a dose delivery state.

[0408] For the first injection pen 10 and the second injection pen 300, the counter element 116 is configured to disengage from the dose stop 118 when the respective dose delivery mechanism 54, 354 transitions from the dose setting state to the dose delivery state. This prevents the dose limiting mechanism 115 from interfering with the delivery of the set dose. In addition, it may allow the spring 40 to release energy stored when rotating during dose setting. For embodiments with more than a single dose stop 118, the counter element 116 may be configured to disengage from all dose stops 118 when the respective dose delivery mechanism 54, 354 transitions to the dose delivery state. This may allow the counter element 116 to rotate back to its initial position during dose delivery without interfering with the dose stop 118. The initial position may correspond to a zero dose position in which no dose is set.

[0409] For example, the counter element 116 may be configured to disengage from the dose stop 118 by being moved axially relative to the dose stop 118 .

[0410] For the injection pen 10, 300, 500, 700, one of the dose stop 118 and the counter element 116, such as the dose stop 118, is rotationally fixed relative to the housing 32, 332, 532. The one of the dose stop 118 and the counter element 116 may then be axially movable relative to the dose setting element 22, 518.

[0411] For the first injection pen 10 and the second injection pen 300, the one of the dose stop 118 and the counter element 116, such as the dose stop 118, is axially fixed relative to the button 18, 318. This allows the one of the dose stop 118 and the counter element 116 to move together with the button 18, 318 when the corresponding dose delivery mechanism 54, 354 is transferred from the dose setting state to the dose delivery state. Then, the one of the dose stop 118 and the counter element 116 can be disengaged from the other of the dose stop 118 and the counter element 116 by this movement. For example, the one of the dose stop 118 and the counter element 116 can be linearly guided at the housing 32, 332.

[0412] For some embodiments, the dose stop 118 and the counter element 116 are fixed to the outer housing part of the corresponding dose delivery mechanism 54, 354, 554, 754. The outer housing part can be fixed to a connector for connecting the medicament container 48, 348 to the corresponding dose delivery mechanism 54, 354, 554, 754. Alternatively, the outer housing part can also be movable relative to the connector, such as axially movable. Additionally, the outer housing part can be rotationally fixed relative to the connector. For example, the outer housing part can be a housing connector, such as a housing connector that is engaged with the housing 32, 332, 532 via a connector that is axially movable and rotationally fixed. For the first injection pen 10 and the second injection pen 300, the outer housing part is formed by the dose selector 28, and for the third injection pen 500 and the fourth injection pen 700, the outer housing part is formed by the sleeve 528.

[0413] For the first injection pen 10 and the second injection pen 300, the dose limiting mechanism 115 acts between the dosing member 23, 323 and the housing 32, 332, 532. It then defines the rotational positions of the dosing member 23, 323 relative to the housing 32, 332, which correspond to the settable doses.

[0414] For the first injection pen 10 and the second injection pen 300, the dose stop 118 and the other of the counter element 116, such as the counter element 116, are rotationally fixed relative to the dosing member 23, 323. Exemplarily, the dose stop 118 and the other of the counter element 116 are rotationally fixed relative to the dosing member 23, 323. Exemplarily, the dose stop 118 and the other of the counter element 116 are permanently rotationally fixed relative to the dosing member 23, 323. The dose stop 118 and the other of the counter element 116 are exemplarily additionally fixed to the dosing member 23, 323, such as fixed to a first part of the dosing member 23, 323 that is movable relative to the housing 32, 332, 532.

[0415] For the first injection pen 10, the second injection pen 300, the third injection pen 500 and the fourth injection pen 700, the other of the dose stop 118 and the counter element 116 (such as the counter element 116) is axially movable relative to the button 18, 318, 518. The one of the dose stop 118 and the counter element 116 (such as the dose stop 118) is axially fixed relative to the button 18, 318, 518. This allows the dose stop 118 to be disengaged from the counter element 116 by moving the button relative to the housing 32, 332, 532, just as in the case of the first injection pen 10 and the second injection pen 300.

[0416] For the second injection pen 300, the dose delivery mechanism 354 includes a blocking mechanism having a first element and a second element, wherein when the button 318 is released during dose delivery, the first element engages the second element to prevent the corresponding dose delivery mechanism 354 from transitioning from the dose delivery state to the dose setting state. This keeps the corresponding dose delivery mechanism 354 in the dose delivery state and prevents the dose setting from changing when the dose delivery is interrupted due to the torque provided by the spring 40. The blocking mechanism can block the button 318 from moving distally against the biasing force that biases the button 318 in the distal direction. The biasing force can be provided by the biasing element 250.

[0417] The blocking mechanism is configured to disengage the first element from the second element at the zero dose position, where the set dose has been fully delivered. This allows the dose delivery mechanism 354 to return to the dose setting state so that a subsequent dose can be set after the previous dose delivery has been completed.

[0418] Illustratively, the first element rotates relative to the second element in a first direction during dose setting and rotates in a second direction opposite to the first direction during dose delivery. The relative movement between the first element and the second element may bring the first element and the second element into relative positions that prevent mutual engagement at the end of dose delivery and / or when a dose has been set.

[0419] For the second injection pen 300 , the first element is configured as a circumferential rib 156 extending longitudinally around the axis of the housing 332 , and the second element is configured as a stopper or counter element formed by the engagement feature 116 of the snap element 24 , which travels along the circumferential rib 124 during dose delivery.

[0420] Exemplarily, when the button 318 is released at the end of dose delivery, the second element passes the first element. For example, the second element may pass through an opening in the first element. At the end of dose delivery, the second element may rotate to align with the opening.

[0421] Additionally or alternatively, a blocking mechanism may be configured to prevent the dose delivery mechanism 354 from transitioning from the dose setting state to the dose delivery state unless a dose has been set. Such a blocking mechanism is exemplarily also implemented in the dose delivery mechanism 54 of the first injection pen 10. Exemplarily, when the dose delivery mechanism 54, 354 transitions from the dose setting state to the dose delivery state, the second element passes through the first element. Exemplarily, the second element passes through one of the openings or cutouts 158 in the first element. When the dose has been set, the second element is exemplarily rotated to align with the opening 158.

[0422] Illustratively, when the mechanism transitions from a dose setting state to a dose delivery state, the second element passes through one of the openings or cutouts 158 in the first element. Such openings 158 prevent obstruction and thus allow the button 18, 318 to move axially to initiate dose delivery.

[0423] Exemplarily, the first element of the blocking mechanism and one of the dose stop 118 and the counter element 116 (such as the dose stop 118) are fixed to the same component of the dose delivery mechanism 54, 354. In addition, the second element of the blocking mechanism and the other of the dose stop 118 and the counter element 116 (such as the counter element 116) are fixed to the same other component of the dose delivery mechanism 54, 354. This allows precise alignment of the respective elements of the blocking mechanism and the respective elements of the dose limiting mechanism 115 and improves the reliability of the dose delivery mechanism 54, 354.

[0424] The component of the mechanism comprising the first element of the blocking mechanism and the one of the dose stop 118 and the counter element 116 is exemplarily a dose selector 28 of the dose delivery mechanism 54, 354. The further component of the dose delivery mechanism 54, 354 comprising the second element of the blocking mechanism and the other of the dose stop 118 and the counter element 116 is exemplarily a carrier that is rotatably movable relative to the dose selector 28. The carrier is exemplarily a part of the dosing member 23, 323, i.e. constituted by the snap element 24 of the dosing member 23, 323.

[0425] The dose selector 28 is illustratively located at least partially within the outer housing (ie, the housing 32, 332) of the dose delivery mechanism 54, 354. The dose selector 28 is illustratively configured to protrude from the outer housing.

[0426] Exemplarily, one of the first and second elements of the blocking mechanism and one of the dose stop 118 and the counter element 118 are formed from a single element. As an example, the second element of the blocking mechanism and the counter element 116 of the dose limiting mechanism 115 are formed from a single element. This facilitates alignment of the components of the blocking mechanism relative to the components of the dose limiting mechanism 115.

[0427] The single element is illustratively a flexible element which is configured to snap onto the dose stop 118 when rotated relative to the dose stop 118 .

[0428] For the first injection pen 10 and the second injection pen 300, the dose delivery mechanism 54, 354 comprises a maximum dose mechanism which limits further rotation of the dose setting element 22 when dialing beyond the maximum dose setting, wherein the maximum dose mechanism comprises a maximum dose stop 126, exemplarily formed by a hard stop 128, and a blocking portion 124, exemplarily formed by a hard stop 124, and wherein the blocking portion 124 is configured to engage the maximum dose stop 126-128 when dialing beyond the maximum dose setting. This provides a well-defined end position of rotation of the dose setting element 22. The maximum dose stop 126-128 can also absorb torque provided by the user and direct the torque to the housing 32, 332 of the dose delivery mechanism 54, 354.

[0429] The blocking portion 124 illustratively engages the maximum dose stop 126128 just at the maximum dose setting. For other embodiments, the blocking portion 124 may engage the maximum dose stop 126128 only after a predefined amount has been dialed beyond the maximum dose setting.

[0430] The blocking portion 124 is exemplarily configured as a hard stop that is rigidly connected (such as, integrally formed) with a component of the mechanism. Likewise, the maximum dose stop 126126 is exemplarily configured as such a hard stop.

[0431] Illustratively, the maximum dose stop 126126 and the blocking portion 124 are configured to rotate relative to each other during dose setting. As an example, one of the maximum dose stop 126126 and the blocking portion 124 (i.e., the maximum dose stop 126126) may be rotationally fixed relative to the housing 32, 332 during dose setting, and the other of the maximum dose stop 126126 and the blocking portion 124 (such as the blocking portion 124) may be rotationally fixed relative to the dose setting element 22 during dose setting. The other of the maximum dose stop 126126 and the blocking portion 124 may be rotationally movable relative to the dose setting element 22 during dose delivery.

[0432] Exemplarily, the maximum dose stop 126 is configured as a radial stop, and the blocking portion 124 is configured to rotate against the maximum dose stop 126 when dialing over the maximum dose. Such a radial stop provides a well-defined rotational position in which the blocking portion 124 and the maximum dose stop 126 engage.

[0433] The maximum dose stopper 126 and the blocking portion 124 exemplarily include engagement surfaces that engage with each other. These engagement surfaces are exemplarily oriented substantially perpendicular (ie, perpendicular) to the circumferential direction around the longitudinal axis of the dose delivery mechanism 54, 354.

[0434] Illustratively, one of the maximum dose stop 126 and the blocking portion 124, such as the maximum dose stop 126, is rotationally fixed relative to the housing 32, 332. The one of the maximum dose stop 126 and the blocking portion 124 is illustratively permanently rotationally fixed relative to the housing 32, 332 during both dose setting and dose delivery.

[0435] Illustratively, one of the maximum dose stopper 126 and the blocking portion 124 is fixed to an outer housing portion of the dose delivery mechanism 54, 354. The outer housing portion is exemplarily configured as a housing connector between the dose setting element 22 and the housing 32, 332 of the injection pen 10, 300. The outer housing portion is configured as a dose selector 28.

[0436] Exemplarily, the other of the maximum dose stopper 126 and the blocking portion 124 (such as the blocking portion 124) is rotationally fixed relative to the dosing member 23, 323. The other of the maximum dose stopper 126 and the blocking portion 124 is then rotated relative to the housing 332, 32 during both dose setting and dose delivery. This allows the maximum dose mechanism to be reset during dose delivery. For embodiments in which the rotational position of the dosing member 23, 323 defines the set dose, the maximum dose stopper 126 and the blocking portion 124 are rotationally fixed to the dosing member 23, 323 to precisely define the maximum dose position in which the maximum dose stopper 126 and the blocking portion 124 engage with each other.

[0437] Illustratively, the other of the maximum dose stopper 126 and the blocking portion 124 is fixed to a coupling member which rotationally couples the dosing member 23 , 323 to the dose setting element during dose setting. The coupling member is formed by the snap element 24 .

[0438] Exemplarily, one of the dose stop 118 and the counter element 116 (such as the dose stop 118) and one of the maximum dose stop 126 and the blocking portion 124 (such as the maximum dose stop 126) are fixed to the same component of the dose delivery mechanism 54, 354. This allows the relative positions of the components of the dose limiting mechanism 115 relative to the components of the maximum dose mechanism to be accurately defined. The component of the dose delivery mechanism 54, 354 is exemplarily the dose selector 28.

[0439] Exemplarily, the dose stop 118 and the other of the counter element 116 (such as the counter element 116) and the maximum dose stop 126 and the other of the blocking portion 124 (such as the blocking portion 124) are fixed to the same further component of the dose delivery mechanism 54, 354. This also allows the relative positions of the components of the dose limiting mechanism 115 relative to the components of the maximum dose mechanism to be accurately defined. The further component can be, for example, a carrier that is rotatably movable relative to the dose selector 28 and is formed by the snap element 24.

[0440] Exemplarily, the dose delivery mechanism 54, 354 of the first injection pen 10 and the second injection pen 300 comprises a zero dose mechanism that prevents further axial movement of the nut 38 at the end of dose delivery, wherein the zero dose mechanism comprises a zero dose stop and a further blocking portion, and wherein the further blocking portion is configured to engage the zero dose stop at the end of dose delivery. This provides a clearly defined end position for the piston rod 44 at the end of dose delivery, and thus facilitates accurately defining the amount of medicine delivered.

[0441] For the first injection pen 10, the zero dose stop is formed by the end stop 176 at the guide 42 of the piston rod 44, and a further blocking portion is formed by the end stop 174 at the driver 36. For the second injection pen 300, the zero dose stop is formed as a protrusion on the inner surface of the dose selector 28, and a further blocking portion is formed by the hard stop 124 at the snap element 24.

[0442] The further blocking portion 124, 174 is illustratively configured as a hard stop that is rigidly connected (such as integrally formed) with a component of the dose delivery mechanism 54, 354. Likewise, the zero dose stop 176 is illustratively configured as such a hard stop.

[0443] Exemplarily, the zero dose stop 176 and the further blocking portion 124, 174 are configured to rotate relative to each other during dose delivery. For example, one of the zero dose stop 176 and the further blocking portion 124, 174 (such as the zero dose stop 176) is rotationally fixed relative to the housing 32, 332 during dose setting, and the zero dose stop 176 and the other of the further blocking portion 124, 174 (such as the further blocking portion 124, 174) is rotationally fixed relative to the dose setting element 22 during dose setting. The other of the zero dose stop 176 and the further blocking portion 124, 174 is exemplarily rotatably movable relative to the dose setting element 22 during dose delivery.

[0444] Exemplarily, the zero dose stop 176 is configured as a radial stop and the further blocking part 124, 174 is configured to rotate against the zero dose stop 176 at the end of dose delivery. Such a radial stop provides a well-defined rotational position in which the further blocking part 124, 174 and the zero dose stop 176 become engaged with each other.

[0445] The zero dose stopper 176 and the further blocking portion 124, 174 illustratively include engagement surfaces that engage with each other. These engagement surfaces may be oriented substantially perpendicularly (such as perpendicularly) to the circumferential direction around the longitudinal axis of the dose delivery mechanism 54, 354.

[0446] Illustratively, one of the zero dose stop 176 and the further blocking portion 124, 174, such as the zero dose stop 176, is rotationally fixed relative to the housing 32, 332. The zero dose stop 176 and the further blocking portion 124, 174 are illustratively permanently rotationally fixed relative to the housing 32, 332 during both dose setting and dose delivery.

[0447] Illustratively, the zero-dose stopper 176 and one of the further blocking portions 124, 174 are fixed to an outer housing portion of the dose delivery mechanism 54, 354. For the second injection pen 300, the outer housing portion is exemplarily configured as a housing connector between the dose setting element 22 and the housing 332 of the second injection pen 300. Likewise, the first injection pen 10 may alternatively include such a zero-dose stopper 176.

[0448] Exemplarily, the other of the zero dose stop 176 and the further blocking portion 124, 174 is rotationally fixed relative to the dosing member 23, 323. Then, the other of the zero dose stop 176 and the further blocking portion 124 is rotated relative to the housing 32, 332 during both dose setting and dose delivery. This allows the zero dose mechanism to be reset during dose delivery. For embodiments in which the rotational position of the dosing member 23, 323 defines the set dose, the zero dose stop 176 and the further blocking portion 124, 174 being rotationally fixed to the dosing member 23, 323 accurately defines the zero dose position in which the zero dose stop and the further blocking portion 124 engage each other.

[0449] For the second injection pen 200, the zero dose stopper 176 and the other of the further blocking portions 124, 174 are fixed to a coupling member which rotationally couples the dosing member 23, 323 to the dose setting member 22 during dose setting. The coupling member is formed by the snap element 24 of the dosing member 323. Likewise, the first injection pen 10 may include such a configuration.

[0450] Exemplarily, one of the dose stopper 118 and the counter element 116 of the second injection pen 300 (such as the dose stopper 118) and one of the zero dose stopper and the further blocking portion 124 of the second injection pen 300 (such as the zero dose stopper) are fixed to the same component of the dose delivery mechanism 354. This allows the relative positions of the components of the dose limiting mechanism 115 relative to the components of the zero dose mechanism to be accurately defined. The component of the dose delivery mechanism 354 is exemplarily the dose selector 28. Likewise, the first injection pen 10 may have such a configuration.

[0451] Exemplarily, the dose stop 118 and the other of the counter element 116 (such as the counter element 116) of the second injection pen 300 and the other of the zero dose stop and the further blocking portion 124 (such as the further blocking portion 124) of the second injection pen 300 are fixed to the same further component of the dose delivery mechanism 354. This also allows the relative positions of the components of the dose limiting mechanism 115 relative to the components of the zero dose mechanism to be accurately defined. The further component may be, for example, a carrier that is rotatably movable relative to the dose selector 28. Likewise, the first injection pen 10 may have such a configuration.

[0452] Exemplarily, the second injection pen 300, the maximum dose stopper 126 of the maximum dose mechanism and one of the blocking portion 124, and the zero dose stopper and one of the further blocking portion 124 of the zero dose mechanism (such as the maximum dose stopper 126 and the zero dose stopper) are fixed to the same component of the mechanism. In addition, the maximum dose stopper 126 of the maximum dose mechanism and the other of the blocking portion 124, and the zero dose stopper and the further blocking portion 124 of the zero dose mechanism (such as the blocking portion 124 and the further blocking portion 124) are fixed to the same further component of the mechanism. This provides precise alignment between the components of the maximum dose mechanism and the components of the zero dose mechanism. Likewise, the first injection pen 10 may have such a configuration.

[0453] Regardless of whether they are fixed to the same component of the mechanism, the maximum dose stopper 126 and / or the minimum dose stopper may be integrally formed with the component to which they are fixed. Similarly, the blocking portion 124 and / or the further blocking portion 124 may be integrally formed with the component to which they are fixed.

[0454] Exemplarily, for the second injection pen 300, the blocking portion 124 of the maximum dose mechanism forms a further blocking portion 124 of the minimum dose mechanism. This allows the distance between the maximum dose position and the zero dose position to be precisely defined. Likewise, the first injection pen 10 may have such a configuration.

[0455] In general, the dose delivery mechanism 54, 354, 554, 754 may include a clutch mechanism 113 having a first engagement portion and a second engagement portion, wherein the clutch mechanism 113 is closed during one of dose setting and dose delivery and is opened during the other of dose setting and dose delivery. When the first engagement portion and the second engagement portion are not engaged with each other, the clutch mechanism 113 is in an open state, and when the first engagement portion and the second engagement portion are engaged with each other, the clutch mechanism 113 is in a closed state.

[0456] Illustratively, the dose delivery mechanism 54, 354 of the first injection pen and the second injection pen includes a clutch mechanism 113, wherein the clutch mechanism 113 rotationally locks the nut 38 to the piston rod 44 during dose delivery and rotationally releases the nut 38 from the piston rod 44 during dose setting. By rotationally locking the nut 38 to the piston rod 44, the clutch mechanism 113 forces the nut 38 to move proximally together with the piston rod 44. Illustratively, the clutch mechanism 113 rotationally locks a threaded connection 189 coupling the nut 38 to the piston rod 44. The clutch mechanism 113 locks the nut 38 to the piston rod 44 in a closed state and rotationally releases the nut 38 from the piston rod 44 in an open state.

[0457] The clutch mechanism 113 exemplarily includes a first engagement portion and a second engagement portion, and the first engagement portion and the second engagement portion are configured to engage with each other to rotationally lock the nut 38 to the piston rod 44. The first engagement portion and the second engagement portion are exemplarily configured to become disengaged from each other by relative axial movement relative to each other. The first engagement portion is exemplarily formed by the teeth 114 of the connector 26, and the second engagement portion is exemplarily formed by the teeth 108 of the dose setting element 22.

[0458] The clutch mechanism 113 is illustratively configured to transition from an open state to a closed state when the button 18, 318 moves and the dose delivery mechanism 54, 354 transitions from a dose setting state to a dose delivery state. One of the first engagement portion and the second engagement portion (such as the second engagement portion) is axially fixed relative to the button 18, 318, and the other of the first engagement portion and the second engagement portion (such as the first engagement portion) is axially fixed relative to the housing 32, 332. Additionally or alternatively, the first engagement portion is axially fixed relative to the dosing member 23, 323.

[0459] Illustratively, the first engagement portion is rotationally fixed to the housing 32 , 332 , and the second engagement portion is rotationally fixed to the nut 38 .

[0460] The second engagement portion is exemplarily rotationally fixed to the button 18 , 318 and / or the dose setting member 22 .

[0461] Illustratively, the clutch mechanism 113 rotationally secures the nut 38 to the piston rod 44 via the housing 32 , 332 and, for example, via the dose setting element 22 and / or the button 18 , 318 during dose delivery.

[0462] Illustratively, the clutch mechanism 113 acts between the button 18 , 318 and the housing 32 , 332 and / or between the dose setting member 22 and the housing 32 , 332 .

[0463] Exemplarily, the button 18, 318 is rotationally coupled (such as permanently rotationally coupled) to one of the first engagement portion and the second engagement portion. As an example, the button 18, 318 constitutes the one of the first engagement portion and the second engagement portion.

[0464] Exemplarily, the dose delivery mechanism 54, 354 comprises a further clutch mechanism 107, wherein the further clutch mechanism 107 rotationally locks the dose setting element 22 to one end of the spring 40 during dose setting and disengages the dose setting element 22 from the one end of the spring 40 during dose delivery. Furthermore, the further clutch mechanism 107 has a further first engagement portion and a further second engagement portion, wherein the further first engagement portion is configured to move into engagement with the further second engagement portion to rotationally lock the dose setting element 22 to the one end of the spring 40. The further clutch mechanism 107 allows tensioning the spring 40 during dose setting and at the same time prevents the dose setting element 22 from rotating when the spring 40 is relaxed again during dose delivery. The further first engagement portion is exemplarily formed by teeth 110 at the snap element 23, and the further second engagement portion is exemplarily formed by teeth 108 at the button 22.

[0465] The further clutch mechanism 107 is exemplarily transferred from a closed state (in which the further first engagement portion is engaged with the further second engagement portion) to an open state (in which the further first engagement portion is disengaged from the further second engagement portion) by movement of the button 18, 318. The movement of the button 18, 318 is exemplarily a movement that transfers the dose delivery mechanism 54, 354 from the dose setting state to the dose delivery state.

[0466] Illustratively, one of the further first engagement portion and the further second engagement portion, such as the further second engagement portion, is rotationally and axially fixed to the dose setting member 22. This allows the further clutch mechanism 107 to be opened and closed by a relative movement of the dose setting member 22 relative to the other of the further first engagement portion and the further second engagement portion.

[0467] Illustratively, one of the further first engagement portion and the further second engagement portion is rotationally and axially fixed to the button 18, 318. Thereby, the dose setting member 22 is at least rotationally fixed to the button 18, 318.

[0468] Exemplarily, the further clutch mechanism 107 acts between the dosing member 23, 323 and the dose setting element 22. The dosing member 23, 323 may then rotationally couple the dose setting element 22 to the one end of the spring 40.

[0469] Exemplarily, one of the further first engagement portion and the further second engagement portion (such as the further first engagement portion) is rotationally fixed to the dosing member 23, 323. Exemplarily, the one of the further first engagement portion and the further second engagement portion may be axially fixed to the dosing member 23, 323.

[0470] Exemplarily, the clutch mechanism 113 comprises a first engagement portion which engages a second engagement portion during dose delivery to rotationally secure the nut 38 to the piston rod 44, wherein the further second engagement portion of the further clutch mechanism 107 forms the first engagement portion of the clutch mechanism 113. This provides a compact construction of the clutch mechanisms 107, 113.

[0471] The nut 38 is exemplarily rotationally fixed relative to the button 18, 318 and / or the dose setting element 22. As an example, the nut 38 is rotationally fixed and axially movable relative to the button 18, 318 and / or the dose setting element 22. It is coupled to the button 18, 318 and / or the dose setting element 22 by a rotation lock. The rotation lock is formed by the nut 38 and one of the button 18, 318 and the dose setting element 22 (such as the button 18, 318).

[0472] When the dose delivery mechanism 54, 354 is in the dose setting state, the nut 38 is rotationally movable relative to the piston rod 44, and when the dose delivery mechanism 54, 354 is in the dose delivery state, the nut 38 is rotationally fixed relative to the piston rod 44. Due to the threaded connection between the nut 38 and the piston rod 44, rotation of the nut 38 relative to the piston rod 44 during dose setting results in axial movement. By rotationally locking the nut 38 to the piston rod 44 during dose delivery, the threaded connection between the nut 38 and the piston rod 44 is blocked and the nut 38 and the piston rod 44 become axially fixed relative to each other.

[0473] The nut 38 is rotated by the dose setting member 22 during dose setting and performs an axial movement due to the threaded connection to the piston rod 44. The rotation of the nut 38 causes the nut 38 to translate axially in the distal direction along the thread on the piston rod 44 during dose setting and in the proximal direction during dose cancellation. The axial movement of the nut 38 relative to the piston rod 44 defines the axial movement of the piston rod 44 during dose delivery and thus defines the amount of medicament expelled during dose delivery.

[0474] Some general comments about this disclosure:

[0475] The second threaded connection 170, 172 may be provided between the driver 36 and the piston rod guide 42. However, there are a number of other options in which the second threaded connection 170, 172 may be provided. For example, the second threaded connection may be provided between the dosing element 34 and the housing 32. The second threaded connection 170, 172 preferably acts between any part rigidly connected to the driver 36 and any part rigidly connected to the housing 32.

[0476] Preferably, the actuation member 18, 20, 22 is coupled to the piston rod 44 via the nut 38 in such a way that an axial movement of the actuation member 18, 20, 22 during dose delivery causes an axial movement of the nut 38 and the piston rod 44. In order to apply an axial force from the nut 38 to the piston rod 44 to axially move the piston rod 44 via the nut 38 during dose delivery, the nut 38 engages with the piston rod 44 via the outer thread 190 and the inner thread 192 to form a first threaded connection with the piston rod 44. During dose delivery, the nut 38 and the piston rod 44 are blocked from relative rotational movement, so that an axial movement of the nut 38 causes an axial movement of the piston rod 44.

[0477] With regard to the optional feature that "all parts configured to rotate relative to the housing 32 during dose delivery are connected to the housing 32 via exactly one threaded connection 170, 172", it should be noted that the dose delivery mechanism 54 may include a driver 36, a dose sleeve 34 and / or a snap element 24. One or more of these parts may be configured to rotate relative to the housing 32 during dose delivery. In addition, the delivery mechanism 54 may have one or more additional parts that are configured to rotate relative to the housing 32 during dose delivery. All parts of the delivery mechanism 54 that are configured to rotate relative to the housing 32 during dose delivery may form a subassembly. The subassembly may form exactly one threaded connection 170, 172 with the housing 32 or any part that is rigidly connected to the housing 32.

[0478] The coupling means 100, 102 may be formed on the injection button and the snap element 24. However, the coupling means 100 may alternatively be formed on the snap ring 20 or the dose setting knob 22. The coupling means 102 may generally be formed on any part that is not axially movable relative to the housing. A person skilled in the art will appreciate that there are multiple options for where to place the coupling means 100, 102. If the coupling means 100, 102 is configured to permanently axially lock the dose setting knob 22 to the dose setting device or housing 50, this may be accomplished in a variety of ways, such as by a permanent form-fit connection or by a permanent friction-fit connection.

[0479] Typically, the dose setting mechanism may comprise a clutch connecting the nut 38 to the piston rod 44, wherein the nut 38 is rotationally fixed to the piston rod 44 during dispensing and rotates relative to the piston rod 44 during dose setting. Preferably, during dose setting, rotating the dose setting knob effects a rotation of the nut 38 relative to the piston rod 44. There are various ways how to design the connection between the dose setting knob and the nut 38.

[0480] Typically, the piston rod 44 may be rotationally fixed relative to the housing during dose delivery / dispensing.

[0481] The proximal portion 14 includes a dispensing outlet. The distal portion 12 is disposed at an opposite end of the proximal portion 14. The dispensing outlet may include one of a needle, a cannula, and a connection point of the needle or the cannula.

[0482] The cover 16 may cover a portion of the dose delivery activation mechanism that is configured to activate dose delivery. The dose delivery activation mechanism is a portion that is configured to permit dispensing of a dose from the delivery device. The activation mechanism may include an injection button 18 that forms the distal end face of the injection pen. The cover 16 may also cover a dose setting knob 22. Thus, the cover 16 prevents setting a dose and / or activating an injection before mixing of the two components is complete.

[0483] The delivery condition is a condition in which all parts of the dose delivery mechanism 54 are arranged relative to each other in the same position as they were after manufacturing the dose delivery mechanism 54. In other words, the delivery condition is a condition in which the user has not rotated or otherwise changed the position of the dose setting member 34 relative to the housing. Thus, when the user has set a dose, the dose delivery mechanism 54 is no longer in the "delivery condition" but is instead in a "set state". According to an embodiment, in the "delivery condition", the dose setting knob 22 is not rotatable towards the zero dose position. According to an embodiment, actuation is blocked in the "delivery condition" to prevent accidental activation.

[0484] The dose delivery mechanism may include an activation member 18, a dose setting knob 22, a snap element 24, a dose selector 28 and / or a clip 30. The activation member 18 may be configured to be pushed by a user to start an injection process. The snap element 24 is preferably configured to engage with the dose selector 28 (preferably in different rotational positions) to define a settable dose. The clip 30 may be used in conjunction with the knob cover 16 to prevent the activation member 18 from moving relative to the housing 32 when the pen falls onto its proximal end 14.

[0485] Reference numerals list

[0486] 1 Proximal direction

[0487] 10 Injection Pen

[0488] 12 Distal end

[0489] 14 Proximal end

[0490] 16 Knob Cover

[0491] 16a Closed circle

[0492] 16b Closed surface

[0493] 18 Injection button / adjustment element

[0494] 18a Cylindrical part

[0495] 19 Outer edge

[0496] 20 snap rings / connectors

[0497] 22Dose setting knob / dose setting element

[0498] 23. Dosing components

[0499] 24 snap-on components

[0500] 26 Connectors

[0501] 28 sleeves / dose selector

[0502] 30 knob keys

[0503] 32 Shell

[0504] 32a surface

[0505] 34 Dose setting sleeve / dosing element

[0506] 36Drive

[0507] 38 Nut

[0508] 40 Spring

[0509] 42 Piston rod guide

[0510] 43 Connectors

[0511] 44 piston rod

[0512] 45 distal segment

[0513] 46 piston disc / bearing

[0514] 48 Cartridges

[0515] 50 Cartridge Containers / Medicine Containers

[0516] 52 Cartridge key / cartridge holder

[0517] 54Dose delivery mechanism

[0518] 56 Drug Reconstitution Unit

[0519] 58 Wing

[0520] 60 lugs

[0521] 62 windows

[0522] 64 bulge

[0523] 66 supports

[0524] 66a front surface

[0525] 68 resection port

[0526] 69 chamfered part

[0527] 70 Axial support protrusion

[0528] 72 Gap

[0529] 74 linear recess

[0530] 76 Anti-roll device

[0531] 78 Anti-roll device

[0532] 80 front surface

[0533] 81 Axial lock

[0534] 82 axial fixing device

[0535] 84 ribs

[0536] 86 axial fixing device

[0537] 88 Undercut

[0538] 89 Rotation Lock

[0539] 90° rotation fixture

[0540] 92 Rotating Fixing Device

[0541] 93 toothed part

[0542] 94 Rotating Fixing Device

[0543] 96 Rotating Fixing Device

[0544] 97 locking mechanism

[0545] 98 Assembled Devices

[0546] 98a Latch part

[0547] 98b Additional latch part

[0548] 100 Connectors

[0549] 100a chamfered surface

[0550] 101 resection port

[0551] 102 Connector / Latch Counterpart

[0552] 104 ribs

[0553] 106 grooves

[0554] 107 Clutch Mechanism

[0555] 108 teeth

[0556] 110 teeth

[0557] 112 connection surface

[0558] 114 teeth

[0559] 115 Dosage Limitation Agency

[0560] 116 Joint Features

[0561] 118 Dose Stop

[0562] 118a Dose stop

[0563] 118b Dose stop

[0564] 118c Dose stop

[0565] 118d Dose stop

[0566] 120 elastically deformable section

[0567] 121 resection port

[0568] 122a-d side surface

[0569] 123a-d side surface

[0570] 124 hard stop

[0571] 126 hard stop

[0572] 128 hard stop

[0573] 130 openings

[0574] 132 slots

[0575] 134 ribs

[0576] 136 protrusion

[0577] 136a Chamfered surface

[0578] 138 ribs

[0579] 140 grooves

[0580] 142 axial fixing device

[0581] 144 Entrance

[0582] 146 axial fixing device

[0583] 148 Rotating Fixing Device

[0584] 150 Rotating Fixing Device

[0585] 152 Rotating Fixing Device

[0586] 154 Rotating Fixing Device

[0587] 156 ribs

[0588] 158a Resection

[0589] 158b Resection

[0590] 158c Resection

[0591] 158d resection

[0592] 160 Near side edge

[0593] 162 Distal edge

[0594] 164 Keep protrusion

[0595] 166 windows

[0596] 168a Tags

[0597] 168b tag

[0598] 168c Tags

[0599] 168d Tags

[0600] 168e Tags

[0601] 169a Out-of-round outer peripheral surface

[0602] 169b Out-of-round inner circumferential surface

[0603] 170 external thread

[0604] 171 Fixed section

[0605] 172 internal thread

[0606] 173 surfaces

[0607] 174 End Stops

[0608] 176 End Stops

[0609] 177 Attachment Devices

[0610] 178 axial fixing device

[0611] 179 Attachment Devices

[0612] 180 axial fixing device

[0613] 182 Rotating Fixing Device

[0614] 184 Rotating Fixing Device

[0615] 186 Opening

[0616] 188 Section

[0617] 189 threaded connector

[0618] 190 external thread

[0619] 192 internal thread

[0620] 194 Pressing surface

[0621] 196 front surface

[0622] 198 Connectors

[0623] 200 Connectors

[0624] Room 202, Room 1

[0625] Room 204

[0626] 206 Bypass

[0627] 208 first sealing element

[0628] 210 Sealing element / plunger

[0629] 212 axial fixing device

[0630] 214 axial fixing device

[0631] 216 Rotating Fixing Device

[0632] 218 Rotating Fixing Device

[0633] 220 Window

[0634] 221 resection port

[0635] 222 Window

[0636] 223 slots

[0637] 224 thread

[0638] 226 end surface

[0639] 228 Surface

[0640] 230 first thread

[0641] 232 second thread

[0642] 234 snap-on components

[0643] 236 openings

[0644] 238 Opening

[0645] 240 openings

[0646] 242 shift section

[0647] 244 Radial end stop

[0648] 246 External surface

[0649] 248 Inner Space

[0650] 249 Keep Section

[0651] 250 Bias element

[0652] 252 Opening

[0653] 254 Inner surface

[0654] 256 external surface

[0655] 258 Ring Space

[0656] 260 inner circumferential surface

[0657] 262 Outer circumferential surface

[0658] 264 Outer circumferential surface

[0659] 266 end face

[0660] 268 end face

[0661] 300 Drug Delivery Device

[0662] 301 cap

[0663] 305 container holder

[0664] 306-pin connector

[0665] 307 Connector

[0666] 318 regulating element

[0667] 323 quantitative drug delivery component

[0668] 332 Shell

[0669] 333 Upper shell part

[0670] 334 Dosing Components

[0671] 335 threaded connector

[0672] 336 Drive

[0673] 337 Other threaded connections

[0674] 342 piston rod guide

[0675] 343 Connector

[0676] 348 medicine container

[0677] 349 pin terminal

[0678] 354 Dose delivery mechanism

[0679] 500 Drug Delivery Device

[0680] 501 pin assembly

[0681] 502 casing

[0682] 503 needle cap

[0683] 504 cap

[0684] 505 container holder

[0685] 506 Connector

[0686] 507 Clutch

[0687] 508 first clutch part

[0688] 509 Second Clutch Part

[0689] 513 Clutch Mechanism

[0690] 514 teeth

[0691] 515 teeth

[0692] 518 regulating element

[0693] 520 connection element

[0694] 523 quantitative drug delivery component

[0695] 524 connection components

[0696] 525 extension

[0697] 527 Connector

[0698] 528 sleeve

[0699] 528a External part

[0700] 529 Latch Counterpart

[0701] 530 Additional latch counterparts

[0702] 532 Shell

[0703] 533 Retaining lugs

[0704] 534 Shell Window

[0705] 535 Opening

[0706] 543 Connector

[0707] 554 Dose delivery mechanism

[0708] 560 degree rotatable fixture

[0709] 561 Circular Edge

[0710] 562 thread

[0711] 563 Rotating Fixture

[0712] 564 longitudinal ridges

[0713] 566 lugs

[0714] 567 Opening

[0715] 568 Radial Stop

[0716] 569 stop surface

[0717] 570 Rotatable Fixing Device

[0718] 571 Circular Edge

[0719] 573 Opening

[0720] 575 Ridge

[0721] 580 end plate

[0722] 582 strokes

[0723] 584 axial fixing device

[0724] 585 Rotating Fixture

[0725] 586 concavity

[0726] 587 Clicker

[0727] 590 recess

[0728] 592 Edge

[0729] 597 locking mechanism

[0730] 599 Additional locking mechanisms

[0731] 600 Latch Part

[0732] 610 Window

[0733] 612 thread

[0734] 614 opening

[0735] 616 Ridge

[0736] 618 concave part

[0737] 620 Connector

[0738] 622 lugs

[0739] 624 concavity

[0740] 626 Circular Edge

[0741] 630 lugs

[0742] 632 Ridge

[0743] 634 Proximal blocking element

[0744] 635 Distal blocking element

[0745] 636 stop surface

[0746] 700 Drug Delivery Device

[0747] 720 connection element

[0748] 754 Dose delivery mechanism

[0749] L1 length

[0750] L2 length

[0751] W1 Width

[0752] W2 width

[0753] The present disclosure also relates to the following first group of enumerated embodiments:

[0754] 1. A dose setting mechanism (54) configured to set a desired dose of an injection device (10), the dose setting mechanism (54) comprising a housing (32), a dose setting knob (18, 22) and a dose setting device (24),

[0755] wherein the dose setting knob (22) is configured to set a desired dose by a positively guided combined axial and rotational movement of the dose setting knob (22) relative to the housing (32),

[0756] Wherein, the dose setting mechanism (54) comprises one or more coupling devices (100),

[0757] And wherein, upon drug delivery, the dose setting knob (18, 22) moves axially relative to the dose setting device (24) and / or the housing (32), and the one or more coupling means (100) are configured to engage at least one of the dose setting device (24) and the housing (32) to thereby permanently axially lock the dose setting knob (18, 22) to the respective one of the dose setting device (24) and the housing (32).

[0758] 2. The dose setting mechanism according to embodiment 1,

[0759] Wherein the dose setting mechanism is configured to set a desired dose of a single-use injection device, the single-use injection device being rendered inoperable when the dose setting knob is axially locked to the respective ones of the dose setting mechanism and the housing.

[0760] 3. The dose setting mechanism (54) according to embodiment 1 or 2,

[0761] Wherein, when the dose setting knob (18, 22) is axially locked to the respective one of the dose setting device (24) and the housing (32), the dose setting knob (18, 22) is non-rotatable relative to the dose setting device (24) and / or the housing (32).

[0762] 4. A dose setting mechanism according to any one of the preceding embodiments,

[0763] Therein, the one or more coupling means (100) are configured to cooperate between the dose setting device (24) and the dose setting knob (18, 22).

[0764] 5. A dose setting mechanism (54) according to any one of the preceding embodiments,

[0765] Wherein the dose setting knob (18, 22) comprises the one or more coupling means (100) configured to cooperate with the respective ones of the dose setting device (24) and the housing (32).

[0766] 6. A dose setting mechanism (54) according to any one of the preceding embodiments,

[0767] Therein, the one or more coupling means (100) are arranged on the outer circumferential surface of the dose setting knob (18, 22), and corresponding coupling means (102), such as circumferentially extending ledges, are arranged on the inner circumferential surface of the dose setting device (24).

[0768] 7. A dose setting mechanism (54) according to any one of the preceding embodiments,

[0769] Therein, the one or more coupling devices (100) include one or more snap elements, in particular one or more elastically deformable tongue-shaped parts.

[0770] 8. The dose setting mechanism according to embodiment 7,

[0771] Therein, the one or more snap elements have a chamfered surface configured to engage with a protrusion (102), in particular a circumferentially extending crosspiece, to elastically deform the snap element.

[0772] 9. A dose setting mechanism (54) according to any one of the preceding embodiments,

[0773] Wherein, the cutout (101) is arranged beside at least one of the one or more connecting devices (100).

[0774] 10. The dose setting mechanism according to embodiment 9,

[0775] Wherein, the cutout (101) is provided sectionally around at least one of the one or more coupling devices (100).

[0776] 11. A dose setting mechanism (54) according to any one of the preceding embodiments,

[0777] Therein, the dose setting device (24) comprises one or more protrusions (116) for setting the desired dose and cooperating with the dose selector (28).

[0778] 12. The dose setting mechanism according to any one of the preceding embodiments,

[0779] wherein the dose setting knob (18, 22) is coupled to the dose selector (28) in a rotationally fixed manner during drug delivery, and / or wherein, during dose setting, the dose setting knob (18, 22) rotates relative to the housing (32) while the dose selector (28) does not rotate relative to the housing (32).

[0780] 13. A dose setting mechanism (54) according to any one of the preceding embodiments,

[0781] The dose setting knob (18, 22) forms an end surface for manually pushing the dose setting knob (18, 22) in an axial direction relative to the dose setting device (24) and / or the housing (32) during drug delivery.

[0782] 14. The dose setting mechanism according to any one of the preceding embodiments,

[0783] The dose setting knob (18, 22) and the dose setting device (24) are axially movable relative to each other when setting a dose by rotating the dose setting knob (18, 22) relative to the housing (32).

[0784] 15. The dose setting mechanism according to any one of the preceding embodiments,

[0785] wherein the dose setting means (24) and the dose setting knob (18, 22) are rotationally fixed to each other during dose setting, and / or wherein the dose setting means (24) and the dose setting knob (18, 22) rotate relative to each other upon drug delivery.

[0786] 16. The dose setting mechanism (54) according to any one of the preceding embodiments,

[0787] The dose setting device (24) rotates relative to the housing (32) during drug delivery, and / or the dose setting knob (18, 22) does not rotate relative to the housing (32) during drug delivery.

[0788] 17. The dose setting mechanism according to any one of the preceding embodiments,

[0789] The dose setting knob (18, 22) and the dose setting device (24) are axially movable relative to the housing (32) during dose setting.

[0790] 18. The dose setting mechanism according to any one of the preceding embodiments,

[0791] The dose setting knob (18, 22) and the dose setting device (24) are configured not to move relative to each other during dose setting.

[0792] 19. The dose setting mechanism (54) according to any one of the preceding embodiments,

[0793] The dose setting knob (18, 22) comprises an injection button (18), and the one or more coupling means (100) are configured to permanently axially lock the injection button (18) to the respective one of the dose setting device (24) and the housing (32).

[0794] 20. The dose setting mechanism according to any one of the preceding embodiments,

[0795] Therein, at least a portion of the dose setting knob (18, 22) moves axially when a dose is dispensed.

[0796] 21. The dose setting mechanism according to any one of the preceding embodiments,

[0797] Therein, the dose setting knob (18, 22) comprises an injection button (18), and the injection button (18) moves axially when a dose is dispensed.

[0798] 22. The dose setting mechanism according to any one of the preceding embodiments,

[0799] wherein upon drug delivery, the dose setting knob (18, 22) moves axially relative to the dose setting device (24), and the one or more coupling means (100) are configured to engage the dose setting device (24) to thereby permanently axially lock the dose setting knob (18, 22) to the dose setting device (24) due to the relative movement of the dose setting knob (18, 22) and the dose setting device (24).

[0800] 23. A medicament delivery device (10), in particular an injection device, comprising a dose setting mechanism (54) according to any of the preceding embodiments.

[0801] 24. A single use and single dosage pen having one or more doses selectable for a single use using a dose setting mechanism (54) according to any one of the preceding embodiments.

[0802] 25. A method for locking a medication delivery device (10), in particular an injection pen (10), after the first use of the injection pen (10), the method comprising the following steps:

[0803] The dose is set by positively guided combined axial and rotational movement of the dose setting knob (18, 22) relative to the housing (32), and

[0804] A dose setting knob (18, 22) of a dose setting mechanism (54) is axially moved relative to a dose setting device (24) and / or a housing (32), thereby activating one or more coupling means (100) to permanently axially lock the dose setting knob (18, 22).

[0805] 26. The method for locking a drug delivery device (10), in particular an injection pen (10), according to embodiment 25,

[0806] The method comprises the following steps:

[0807] The dose setting knob (18, 22) of the dose setting mechanism (54) is axially moved relative to the dose setting device (24) and / or the housing (32), thereby moving one or more coupling means (100) of the dose setting knob (18, 22) into engagement with the dose setting device (24) or the housing (32) and axially locking the dose setting knob (18, 22) to the dose setting device (24) and / or the housing (32).

[0808] 27. The method for locking an injection pen according to embodiment 25 or 26,

[0809] Therein, at least a portion of the dose setting knob (18, 22) moves axially when a dose is dispensed.

[0810] 28. A method for locking an injection pen according to any one of the method embodiments,

[0811] wherein the dose setting knob (18, 22) comprises an injection button (18), and wherein the injection button (18) moves axially upon dose dispensing.

[0812] 29. A method for locking an injection pen according to any one of the method embodiments,

[0813] The dose setting knob (18, 22) of the dose setting mechanism (54) is axially moved relative to the dose setting device (24) and / or the housing (32) by manually pushing the dose setting knob (18, 22) in the axial direction.

[0814] 30. The method for locking an injection pen according to any one of the method embodiments,

[0815] The dose setting knob (18, 22) of the dose setting mechanism (54) is moved axially backward relative to the housing (32) before the dose setting knob (18, 22) is moved axially forward relative to the dose setting device (24) and / or the housing (32) to set a desired dose of the drug delivery device, in particular the injection device (10).

[0816] 31. A method for locking an injection pen according to any one of the method embodiments,

[0817] Therein, by rotating the dose setting knob (18, 22) relative to the housing, the dose setting knob (18, 22) is moved axially rearward relative to the housing (32).

[0818] The present disclosure also relates to the following second group of enumerated embodiments:

[0819] 1. A kit comprising a drug delivery device (10), the drug delivery device comprising a dose delivery activation mechanism (54), the dose delivery activation mechanism being configured to adjust the drug delivery device (10) from an inactive state to an active state in which a dose can be delivered,

[0820] and a cover (16) mechanically attached to the drug delivery device (10) prior to use of the drug delivery device (10), the cover (16) being configured to cover at least a portion of the dose delivery activation mechanism (54) such that a user is restricted from prematurely activating the drug delivery device (10),

[0821] And the cover (16) is configured to be movable in a distal direction to uncover the portion of the dose delivery activation mechanism (54) to activate the drug delivery device (10) during use of the drug delivery device (10).

[0822] 2. The kit according to embodiment 1,

[0823] The cover (16) is detachable from the drug delivery device (10).

[0824] 3. The kit according to embodiment 1 or 2,

[0825] Therein, the drug delivery device (10) and the cover (16) include form-fitting engagement means (58, 228) for releasably attaching the cover (16) to the drug delivery device (10) prior to use of the drug delivery device (10).

[0826] 4. The kit according to embodiment 3,

[0827] Therein, the form-fitting engagement means (58, 228) comprise one, two or more snap-fit ​​connections.

[0828] 5. A set according to embodiment 3 or 4, wherein the form-fitting engagement devices (58, 228) include one, two or more wings (58), which can be deflected outwardly relative to a longitudinal axis extending through the drug delivery device (10), in particular deflected in a radial direction.

[0829] 6. The set according to any one of embodiments 3 to 5, wherein the form-fitting engagement means comprise one, two or more lugs, in particular lugs having a triangular outer cross-section in at least one plane thereof.

[0830] 7. The set according to embodiment 6, wherein the one, two or more lugs are arranged directly adjacent to the window of the cover.

[0831] 8. The set of embodiment 7, wherein the standoffs are arranged at opposite sides of the window relative to the lugs.

[0832] 9. The kit of embodiment 8, wherein the support is configured to contact a housing of the drug delivery device.

[0833] 10. The kit of embodiment 8 or 9, wherein the support is configured to contact a resection opening in the drug delivery device.

[0834] 11. The set according to embodiments 6 to 10, wherein the lugs are arranged at the proximal ends of the wings, in particular wherein one lug is provided per wing.

[0835] 12. A set according to any one of the preceding embodiments,

[0836] Wherein, removal means (242) are provided to remove the cover (16) from the drug delivery device (10), preferably wherein these removal means (242) engage the wings (58), in particular the lugs, to deflect the wings (58) outwardly to facilitate removal of the cover (16).

[0837] 13. The kit according to embodiment 12,

[0838] wherein the kit comprises a detachable element (50) attachable or pre-attached to a drug delivery device (10), and

[0839] Wherein, the disassembly element (50) includes a disassembly device (242).

[0840] 14. The kit according to embodiment 13,

[0841] Therein, the disassembly element (50) is a cartridge container.

[0842] 15. The kit according to embodiment 14,

[0843] In which, the cartridge container (50) is configured to be attached to, in particular screwed to, a drug delivery device (10), in particular a housing (32, 42) of the drug delivery device (10), and the disassembly device (242) is configured to remove the cover (16) from the drug delivery device (10) at the same time or after the cartridge container (50) is attached to, in particular screwed to, the drug delivery device (10).

[0844] 16. A kit according to any one of the preceding embodiments,

[0845] Therein, the dose delivery activation mechanism (54) includes a dose setting assembly for manually setting a dose.

[0846] 17. A kit according to any one of the preceding embodiments,

[0847] wherein the dose setting assembly comprises a knob (22), and wherein the knob (22) is rotated to set the dose, preferably

[0848] Therein, the knob (22) can be rotated in one direction to increase the dose and can be rotated in the opposite direction to decrease the dose.

[0849] 18. A kit according to any one of the preceding embodiments,

[0850] Therein, in the assembled state of the kit, the cap (16) is rotationally and / or axially constrained relative to the drug delivery device (10).

[0851] 19. A kit according to any one of the preceding embodiments,

[0852] Wherein the housing of the drug delivery device has a chamfered portion, in particular wherein the cut-out is provided in the chamfered portion, and the cover comprises a collar of complementary shape adjoining the chamfered portion.

[0853] 20. The set according to any one of the preceding embodiments, wherein a distal end of the cover, in particular a distal end away from the wing, is one of open or closed.

[0854] 21. The set according to any of the preceding embodiments, wherein an inner shape of the cover (16) is shaped to complement an outer shape of at least a portion of the medication delivery device (10) housing the dose delivery activation mechanism (54).

[0855] 22. A set according to any one of the preceding embodiments,

[0856] Therein, the drug delivery device (10) is part of a pen-type injector (10).

[0857] 23. A set according to any one of the preceding embodiments,

[0858] Therein, the drug delivery device comprises a snap element and a dose selector, which snap element and the dose selector are rotated relative to each other to set a dose.

[0859] 24. A kit according to any one of the preceding embodiments,

[0860] The drug delivery device comprises a nut with an internal thread and a piston rod with an external thread, wherein the external thread is engaged with the internal thread of the nut.

[0861] 25. A kit according to any one of the preceding embodiments,

[0862] Therein, the cover has the form of a sleeve which is placed on the medication delivery device in an axial direction.

[0863] 26. A kit according to any one of the preceding embodiments,

[0864] Therein, the cover is placed on the drug delivery device from a distal end of the drug delivery device.

[0865] 27. A set according to any one of the preceding embodiments,

[0866] The cover (16) is configured to cover at least a portion of the dose delivery activation mechanism (54) so ​​that a user is restricted from activating the medicament delivery device (10), in particular setting a dose, before preparing a medicament in a container cartridge (48), in particular before mixing two or more components of the medicament in the container cartridge (48).

[0867] 28. The kit according to embodiment 27,

[0868] Therein, the container cartridge is configured for preparing a medicament when the container cartridge is attached to, in particular screwed onto, a medicament delivery device.

[0869] 29. A cap for a medication delivery device, the cap being configured to be mechanically attached to the medication delivery device to cover at least a portion of a dose setting assembly of the medication delivery device such that a user is restricted from prematurely setting a dose of the medication delivery device.

[0870] 30. A method for avoiding premature dose setting on a drug delivery device (10), the method comprising:

[0871] A cover (16) is attached to a drug delivery device (10) for covering a dose delivery activation mechanism (54) of the drug delivery device (10) such that a user is restricted from prematurely setting a dose before using the drug delivery device (10), and such that the cover (16) can be moved in a distal direction to uncover the dose delivery activation mechanism (54) to activate the drug delivery device (10) during use of the drug delivery device (10).

[0872] 31. The method according to embodiment 30,

[0873] Therein, the cap is detached from the drug delivery device before use of the drug delivery device, preferably after the drug preparation steps have been performed.

[0874] 32. The method according to embodiment 31,

[0875] Therein, the cover is detached by a detachment device provided on the cartridge container, which is attached to the drug delivery device.

[0876] 33. The method according to embodiment 31 or 32,

[0877] Therein, the cover is detached from the drug delivery device by disengaging a snap-fit ​​connection between the cover and the drug delivery device.

[0878] 34. The method according to any one of the method embodiments,

[0879] The drug delivery device is used by the following steps:

[0880] A) setting a dose using a dose setting assembly, and

[0881] B) Injection of set dose.

[0882] The present disclosure further relates to the following third group of enumerated embodiments:

[0883] 1. A dose delivery mechanism (54), comprising:

[0884] a housing (32),

[0885] a piston rod (44) configured to act on a plunger (46) sealing a fluid compartment (48) and to move in an axial direction relative to the housing (32) to deliver a set dose, and

[0886] a dose setting member (34) movable relative to the piston rod (44),

[0887] wherein the position of the dose setting member (34) relative to the housing (32) defines the set dose, and

[0888] Therein, in the delivery condition, the dose setting member (34) is preset to a position corresponding to a set dose above zero.

[0889] 2. The dose delivery mechanism (54) according to embodiment 1,

[0890] Therein, in the delivery condition, the position of the dose setting member (34) corresponds to a dose between zero dose and a minimum dose deliverable by the dose delivery mechanism (54), e.g. a minimum dose according to the treatment for which the dose delivery mechanism is intended.

[0891] 3. A dose delivery mechanism (54) according to any one of the preceding embodiments,

[0892] It further comprises a dose indicating member (34) which indicates a set dose depending on the rotational position of the dose indicating member (34) relative to the housing (32).

[0893] 4. The dose delivery mechanism (54) according to embodiment 3,

[0894] Therein, the dose setting member (34) is configured as a dose indicating member (34).

[0895] 5. The dose delivery mechanism (54) according to embodiment 3 or 4,

[0896] Therein, in the delivery condition, the dose indicating member (34) indicates a set dose different from a zero dose.

[0897] 6. The dose delivery mechanism according to embodiment 5,

[0898] Therein, in the delivery condition the dose indicating member indicates the set dose as a dose between a zero dose and a minimum dose deliverable by the dose delivery mechanism, eg a minimum dose according to the treatment the dose delivery mechanism is intended for.

[0899] 7. The dose delivery mechanism (54) according to any one of the preceding embodiments,

[0900] The dose setting member (34) is configured to move, such as rotate, relative to the housing (32) to set a dose different from a preset dose, such as a dose given by the treatment or one of a plurality of doses given by the treatment.

[0901] 8. The dose delivery mechanism (54) according to embodiment 7,

[0902] The dose setting member (34) is not directly movable from the preset position to the zero dose position, for example, is not directly rotatable from the preset position to the zero dose position.

[0903] 9. The dose delivery mechanism according to embodiment 8,

[0904] Therein, two parts arranged inside the housing of the dose delivery mechanism are configured to cooperate with each other to prevent a first one of the two parts from moving, e.g. rotating, relative to a second one of the two parts, thereby blocking the dose setting member from moving directly from a preset position to a zero dose position.

[0905] 10. The dose delivery mechanism according to embodiment 9,

[0906] wherein the two parts each form a hard stop, and

[0907] Therein, the two hard stops are configured to cooperate with each other to prevent a first of the two parts from moving, eg rotating, relative to a second of the two parts, thereby blocking the dose setting member from moving from the preset position to the zero dose position.

[0908] 11. The dose delivery mechanism according to embodiment 10,

[0909] Therein, the two hard stops are configured to be misaligned during delivery of a set dose, such as a therapeutic dose, such that the two hard stops are movable beyond each other, such as rotatable beyond each other, during delivery of said dose.

[0910] 12. The dose delivery mechanism (54) according to any one of the preceding embodiments,

[0911] further comprising an activation member (18) configured to move, for example in a proximal direction, to initiate delivery of a set dose,

[0912] Therein, when the dose setting member (34) is in the preset position, the activation member (18) is blocked from initiating delivery of the set dose.

[0913] 13. The dose delivery mechanism (54) according to embodiment 12,

[0914] Therein, a separate element (30), such as a clip, is provided to prevent premature movement of the activation member (18) relative to the housing (32) before the separate element (32) is removed, for example due to the dose delivery mechanism (54) falling onto the proximal end (14) of the dose delivery mechanism (54).

[0915] 14. The dose delivery mechanism (54) according to embodiment 12 or 13,

[0916] Two parts (24, 28) disposed inside a housing (32) of a dose delivery mechanism (54) are configured to cooperate with each other to prevent an activation member (18) from inadvertently moving relative to the housing (32), e.g. in a proximal direction, from a preset position.

[0917] 15. The dose delivery mechanism (54) according to embodiment 14,

[0918] The first of the two parts forms a blocking structure (156), in particular a circumferentially extending rib (156), and the second of the two parts forms an engagement feature (116) which is configured to engage with the blocking structure (156) when the two parts are moved relative to each other so as to block the activation member (18) from initiating delivery of a set dose when the dose setting member (34) is in the preset position.

[0919] 16. The dose delivery mechanism according to embodiment 15,

[0920] Therein, the resection opening is arranged in the blocking structure, in an angular position in which the engagement feature is arranged, for example when setting a therapeutic dose, for example different from the preset dose, so that the engagement feature can move beyond the blocking structure through the corresponding resection opening during dose delivery of the set dose.

[0921] 17. The dose delivery mechanism according to embodiment 16,

[0922] Therein, the cutout opening is arranged next to the corresponding dose limiting element.

[0923] 18. The dose delivery mechanism according to embodiments 15 to 17,

[0924] Wherein, the engagement feature is arranged on the snap element.

[0925] 19. The dose delivery mechanism (54) according to any one of the preceding embodiments,

[0926] Two parts arranged inside a housing (32) of a dose delivery mechanism (54) include respective dose defining elements (116, 118a-118d) configured to cooperate with each other to define a plurality of relative positions corresponding to settable doses.

[0927] 20. The dose delivery mechanism according to embodiments 14 and 19,

[0928] Therein, the two parts arranged inside the housing of the dose delivery mechanism are configured to cooperate with each other to prevent the activation member from being accidentally moved relative to the housing from a preset position, for example in the proximal direction. The two parts are two parts including corresponding dose limiting elements, which are configured to cooperate with each other to define a plurality of positions relative to each other corresponding to settable doses.

[0929] 21. The dose delivery mechanism (54) according to embodiment 19 or 20,

[0930] Therein, the positions are defined by dose stops (118a-118d) formed on a first of the two parts, which dose stops are configured to contact snap elements (116) on a second of the two parts.

[0931] 22. The dose delivery mechanism according to embodiment 21,

[0932] Therein, the snap-in element (116) is preloaded against the respective dose stop (118a-118d) by a spring (40), in particular a torsion spring.

[0933] 23. The dose delivery mechanism of any of embodiments 21 or 22, wherein at least one of the dose stops has a chamfered surface to guide the snap element past the dose stop during setting of a higher dose, and / or

[0934] Therein, at least one of the dose stops has a surface opposite the chamfered surface, which surface is configured to allow movement of the catch element during setting of a lower dose.

[0935] 24. The dose delivery mechanism according to embodiments 19 to 23,

[0936] Therein, the two parts are configured to cooperate with each other to prevent one of the parts from inadvertently moving relative to the other of the parts, so that the activation member is blocked from moving relative to the housing starting from a preset position.

[0937] 25. The dose delivery mechanism according to any one of the preceding embodiments,

[0938] Therein, at the end of the dose delivery procedure, the dose delivery mechanism is configured to reach a zero dose state.

[0939] 26. The dose delivery mechanism according to any one of the preceding embodiments,

[0940] Therein, at the end of the dose delivery procedure, the dose indicating member indicates that the dose delivery mechanism is in the zero dose position.

[0941] 27. The dose delivery mechanism according to any one of the preceding embodiments,

[0942] wherein the dose delivery mechanism comprises a nut meshingly engaged with the piston rod, and

[0943] Therein, the axial movement of the nut relative to the piston rod corresponds to the amount of the dose set by the dose delivery mechanism.

[0944] 28. The dose delivery mechanism of embodiment 27,

[0945] Therein, the piston rod is non-rotatably mounted to the housing.

[0946] 29. The dose delivery mechanism according to embodiment 27 or 28,

[0947] In this case, the piston rod is guided linearly in the housing.

[0948] 30. The dose delivery mechanism according to any one of embodiments 27 to 29,

[0949] Therein, the nut is configured not to rotate relative to the housing and the piston rod during dose delivery.

[0950] 31. The dose delivery mechanism according to any one of the preceding embodiments,

[0951] Therein, the driver is forced to rotate relative to the housing during dose delivery, the driver being configured to exert a force on the nut to move the piston rod via the nut in a proximal direction.

[0952] 32. The dose delivery mechanism according to any one of the preceding embodiments,

[0953] Therein, the dose delivery mechanism is configured to be disposable after a single use.

[0954] 33. A medicament delivery device (10), in particular an injection device, having a dose delivery mechanism (54) according to any of the preceding embodiments.

[0955] 34. An assembly of a dose delivery mechanism and a removable element, such as a clip, the dose delivery mechanism comprising:

[0956] case,

[0957] a piston rod configured to act on the plunger sealing the fluid compartment and to move in an axial direction relative to the housing to deliver a set dose,

[0958] a dose setting member, which is movable relative to the piston rod,

[0959] wherein the position of the dose setting member relative to the housing defines the set dose, and

[0960] an activation member movable relative to the housing, in particular in a proximal direction, for delivering a set dose,

[0961] Therein, the removable element is arranged between the housing and the activation member to prevent a premature movement of the activation member relative to the housing, in particular in said proximal direction, before the removable element is removed.

[0962] 35. The assembly according to embodiment 34,

[0963] further comprising a cover mechanically attached to the dose delivery mechanism prior to use of the dose delivery mechanism,

[0964] The cover is configured to cover at least a portion of the dose delivery mechanism and / or at least a portion of the removable element such that the removable element is blocked from being removed from the dose delivery mechanism,

[0965] And wherein the cover is configured to be movable to uncover said portion of the dose delivery mechanism and / or said portion of the removable element such that the removable element can be removed from the dose delivery mechanism.

[0966] 36. A dose delivery mechanism comprising:

[0967] case,

[0968] a dose adjustment member movable relative to the housing to adjust the dose and / or an activation member to deliver the set dose,

[0969] and a dose indicating member which indicates a set dose depending on the rotational position of the dose indicating member relative to the housing,

[0970] Therein, in the delivery condition, the dose delivery mechanism is preset to a dose above zero.

[0971] 37. The dose delivery mechanism according to embodiment 36,

[0972] Therein, in the delivery condition the dose adjustment member and / or the activation member is preset to a position corresponding to a dose above zero.

[0973] 38. The dose delivery mechanism of embodiment 35 or 36,

[0974] Therein, in the delivery condition, the dose delivery mechanism is preset to a dose between zero dose and a minimum dose, eg a minimum dose according to the treatment for which the dose delivery mechanism is intended.

[0975] 39. The dose delivery mechanism according to any of the preceding embodiments 36 to 38, wherein, in the delivery condition, the dose indicating member indicates a set dose different from a zero dose.

[0976] 40. The dose delivery mechanism of embodiment 39, wherein, in the delivery condition, the dose indicating member indicates the set dose as a dose between zero dose and a minimum dose, the minimum dose being a minimum dose according to the treatment the dose delivery mechanism is intended for.

[0977] 41. The dose delivery mechanism according to any one of the preceding embodiments 36 to 40,

[0978] Therein, the dose adjustment member and the activation member are fixedly connected to each other or are formed integrally with each other.

[0979] 42. A method for providing a dose delivery mechanism having: a housing,

[0980] a dose adjustment member movable relative to the housing to set a dose and / or an activation member to deliver the set dose,

[0981] and a dose indicating member which indicates a set dose depending on the rotational position of the dose indicating member relative to the housing,

[0982] The method comprises the following steps:

[0983] The dose delivery mechanism is delivered to the customer in a state preset to a dose above zero.

[0984] 43. An assembly of a dose delivery mechanism and a removable element, such as a clip, the dose delivery mechanism comprising:

[0985] case,

[0986] a dose indicating member which indicates a set dose depending on the rotational position of the dose indicating member relative to the housing, and

[0987] an activation member movable relative to the housing, in particular in a proximal direction, for delivering a set dose,

[0988] Therein, the removable element is arranged between the housing and the activation member to prevent a premature movement of the activation member relative to the housing, in particular in said proximal direction, before the removable element is removed.

[0989] 44. The assembly according to embodiment 43,

[0990] further comprising a cover mechanically attached to the dose delivery mechanism prior to use of the dose delivery mechanism,

[0991] The cover is configured to cover at least a portion of the dose delivery mechanism and / or at least a portion of the removable element such that the removable element is blocked from being removed from the dose delivery mechanism,

[0992] And wherein the cover is configured to be movable to uncover said portion of the dose delivery mechanism and / or said portion of the removable element such that the removable element can be removed from the dose delivery mechanism.

[0993] 45. A method for providing a dose delivery mechanism (54) having: a housing (32),

[0994] a piston rod (44) configured to act on a plunger (46) sealing a fluid compartment (48) and to move in an axial direction relative to the housing (32) to deliver a set dose, and

[0995] a dose setting member (34) movable relative to the piston rod (44),

[0996] wherein the position of the dose setting member (34) relative to the housing (32) defines the set dose,

[0997] The method comprises the following steps:

[0998] A dose delivery mechanism (54), in particular a medicament delivery device (10) having a dose delivery mechanism (54), is delivered to a customer in a state where the dose is preset to a dose higher than zero.

Claims

1. A dose delivery mechanism (54), comprising: A piston rod (44) and a nut (38), wherein the piston rod (44) forms an outer thread (190) that engages with an inner thread (192) of the nut (38), wherein during dose setting, the nut (38) is configured to rotate relative to the piston rod (44) to advance the nut (38) in a distal direction relative to the piston rod (44) by a first distance, an actuation member (18, 20, 22) movable by a user to effect delivery of a set dose, and a housing (32), Therein, a second threaded connection (170, 172) is provided, wherein the second threaded connection (170, 172) is configured to cause the actuation member (18, 20, 22) to travel a second distance in the distal direction during dose setting, wherein the actuating member (18, 20, 22) is coupled to the piston rod (44) via the nut (38) during dose delivery to advance the piston rod (44) in a proximal direction by the first distance when the actuating member (18, 20, 22) moves proximally by the second distance, The second distance is less than 1.5 times of the first distance.

2. The dose delivery mechanism (54) according to claim 1, in, The first distance is substantially equal to the second distance.

3. A dose delivery mechanism (54) according to claim 1 or 2, in, All parts configured to rotate relative to the housing (32) during dose delivery, such as the driver (36), the dose sleeve (34) and the snap element (24), are connected to the housing (32) via exactly one threaded connection (170, 172).

4. A dose delivery mechanism (54) according to any one of the preceding claims, Further comprising a dose setting unit having a dose sleeve (34) indicating a set dose, the dose sleeve being rotationally coupled to the actuation member (18, 20, 22) during dose setting, wherein The actuation member (18, 20, 22) and the dose sleeve (34) are rotatable to set a desired dose, In particular, wherein the dose sleeve (34) and the actuation member (18, 20, 22) are rotationally decoupled during dose delivery, such that the actuation member (18, 20, 22) does not rotate during dose delivery.

5. The dose delivery mechanism (54) according to claim 4, in, The dose delivery mechanism (54) further comprises a driver (36), wherein the driver (36) applies a force to the nut (38) to drive the piston rod (44) during dose delivery, and wherein the dose sleeve (34) and the driver (36) are formed in one piece or are rotationally and axially rigidly connected to one another, In particular, wherein the driver (36) directly abuts against the nut (38) during dose delivery to drive the piston rod (44), and / or Therein, the driver (36) is forced to rotate relative to the housing (32) during dose delivery.

6. A dose delivery mechanism (54) according to any one of the preceding claims, comprising a spring (40) acting between the housing (32) and the actuation member (18, 20, 22) during dose setting, In particular, The spring (40) is arranged between the housing (32, 42) and the dose sleeve (34) or between the housing (32, 42) and the driver (36).

7. The dose delivery mechanism (54) according to claim 6, in, The spring (40) is configured to support a user in moving the actuation member (18, 20, 22) to effect delivery of a set dose.

8. A dose delivery mechanism (54) according to any one of claims 6 or 7, in, The spring (40) is a torsion spring, in particular a helical torsion spring, and / or Therein, the spring (40) is configured to be tensioned during dose setting.

9. A dose delivery mechanism (54) according to any one of claims 6 to 8, in, The spring (40) is coupled to a piston rod guide (42) which guides the linear movement of the piston rod (44) and the driver (36), and / or Therein, the spring (40) is arranged in a proximal part of the mechanism, in particular in a proximal end section.

10. The dose delivery mechanism (54) according to any one of the preceding claims, in, The actuation member (18, 20, 22) is rotationally fixed to the nut (38) during dose setting and dose delivery.

11. A dose delivery mechanism (54) according to any one of the preceding claims, in, The driver (36) and the housing (32, 42) form the second threaded connection (170, 172), preferably wherein: The driver (36) and an inner housing part, in particular an inner housing part arranged radially inside the dose sleeve (34), form the second threaded connection (170, 172).

12. A dose delivery mechanism (54) according to any one of the preceding claims, in, The housing (32, 42) has a longitudinal through-opening (186), the non-circular inner circumference of the longitudinal through-opening corresponds to the non-circular outer circumference (188) of the piston rod (44), and / or Therein, ball bearings and / or gliding elements made of low friction material are provided to reduce friction during dose delivery.

13. A dose delivery mechanism (54) according to any one of the preceding claims, in, The speed v of the actuation member (18, 20, 22) during dose delivery am and the speed v of the piston rod (44) pr same.

14. A dose delivery mechanism (54) according to any one of the preceding claims, in, The piston rod (44) is linearly guided in the housing (32, 42) and / or wherein the piston rod (44) is non-rotatably mounted to the housing (32, 42).

15. A dose delivery mechanism (54) according to any one of the preceding claims, in, The nut (38) is configured not to rotate relative to the housing (32, 42) and / or the piston rod (44) during dose delivery.

16. A dose delivery mechanism (54) according to any one of the preceding claims, in, The actuating member (18, 20, 22) is configured to apply an axial force to the driver (36) during dose delivery, the driver (36) is configured to apply the axial force to the nut (38), and the nut (38) is configured to apply the axial force to the piston rod (44) via the external thread (190) and the internal thread (192) to advance the piston rod (44) in the proximal direction by the first distance when the actuating member (18, 20, 22) moves proximally by the second distance.

Images