Dose delivery mechanism and method for providing dose delivery mechanism

Abstract

A dose delivery mechanism is disclosed, comprising: a housing; a piston rod configured to act on a plunger sealing the fluid compartment and move in an axial direction relative to the housing to deliver a set dose; and a dose setting member movable relative to the housing during dose setting, where a position of the dose setting member relative to the housing defines a set dose, and where, in a delivery state, the dose setting member is preset to a position corresponding to the set dose greater than zero.

Description

Technical Field

[0001] The present invention relates to a dose delivery mechanism having: a housing; a piston rod configured to act on a plunger sealing a fluid compartment and to move in an axial direction relative to the housing to deliver a set dose; and a dose setting member, which is movable relative to the housing during dose setting, wherein the position of the dose setting member relative to the housing defines the set dose. Background Art

[0002] Such a dose delivery mechanism can be provided in the form of a pen and can be used for insulin therapy or growth hormone therapy. Known pens are delivered in a zero dose state to the person delivering the dose, usually the patient, but the person can also be a doctor, for example in a clinical trial, or when the patient is unable to deliver the drug himself. This means that the pen is delivered in a state in which the position of the dose setting member corresponds to a position in which, if the pen would be activated in this state, the dose delivery mechanism would substantially not deliver the drug. In order to set the dose, a knob must usually be turned. In order to set a large dose, the knob must usually be turned over a large angle range, for example over 180°. This is inconvenient for the user. Summary of the invention

[0003] The object of the present invention is to provide a dose delivery mechanism with improved dose setting and a method allowing improved dose setting. In particular, the object of the present invention is to make dose setting more convenient for the user, especially when intending to set a large dose, and to provide a method allowing convenient dose setting.

[0004] This object is met by a dose delivery mechanism according to claim 1. The dose delivery mechanism comprises: a housing; a piston rod configured to act on a plunger of a sealed fluid compartment and to move in an axial direction relative to the housing to deliver a set dose; and a dose setting member, which is movable relative to the housing during dose setting. The position of the dose setting member relative to the housing defines the set dose. In a delivery state, the dose setting member is preset to a position corresponding to a set dose greater than zero.

[0005] The present invention is based on the idea that the dose delivery mechanism is provided to the person using the dose delivery mechanism in a state in which the dose delivery mechanism is not provided in a zero dose state but in a state requiring less effort to set the desired dose. In other words, the delivery state of the dose delivery mechanism is a state in which the dose delivery mechanism is preset to a dose greater than zero.

[0006] Embodiments of the dose delivery mechanism are defined by the dependent claims and described in the following disclosure.

[0007] According to an embodiment, in the delivery state, the position of the dose setting member corresponds to a dose between zero dose and a minimum dose deliverable by the dose delivery mechanism, i.e. the minimum dose is, for example, the minimum dose that the dose delivery mechanism is intended to use for each treatment. Thus, a person using the dose delivery mechanism has to set a dose, regardless of the desired dose. This ensures that the person does not forget to set the correct dose before dose delivery.

[0008] In order to show the status of the dose delivery mechanism to a person using the dose delivery mechanism, the dose delivery mechanism may comprise a dose indication member which indicates the set dose depending on the position of the dose indication member relative to the housing. In particular, the dose delivery mechanism may comprise a dose indication member which indicates the set dose depending on the rotational position and / or axial position of the dose indication member relative to the housing. If the dose setting member can be rotated by more than 360°, the dose indication member should indicate the set dose depending on the axial position of the dose indication member relative to the housing, since the set dose is not clearly defined by the rotational position. On the other hand, if the dose setting member cannot be rotated by more than 360°, the dose indication member may indicate the set dose depending on the rotational position of the dose indication member relative to the housing, since the set dose is clearly defined by the rotational position.

[0009] According to an embodiment, the dose setting member is configured as a dose indicating member. In other words, the dose setting member and the dose indicating member may be one functional unit, in particular formed integrally with each other.

[0010] In order to show a person using the dose delivery mechanism that the dose delivery mechanism is in a preset state, in the delivery state the dose indicating member may indicate that the set dose is different from the zero dose. In particular, in the delivery state the dose indicating member may indicate that the set dose is a dose between the zero dose and the minimum dose deliverable by the dose delivery mechanism, e.g. the minimum dose that the dose delivery mechanism is intended for each treatment.

[0011] According to an embodiment, the dose setting member is configured to move, e.g. rotate, relative to the housing to set a dose different from the preset dose, e.g. a dose given by the treatment or one of several doses given by the treatment. In order to easily show the set dose to the user, the housing may have a viewing window, e.g. an opening, through which the dose setting member can show the set dose.

[0012] Preferably, the dose setting member cannot move, for example rotate, directly from the preset position to the zero dose position. Conversely, the dose setting member may be prevented from moving, for example rotating, directly from the preset position to the zero dose position.

[0013] In order to prevent the dose setting member from moving directly from the preset position to the zero dose position, two parts arranged inside the housing of the dose delivery mechanism may be configured to cooperate with each other to prevent a first part of the two parts from moving, e.g., rotating, relative to a second part of the two parts, thereby preventing the dose setting member from moving directly from the preset position to the zero dose position. The two parts may each form a hard stop. The two hard stops may be configured to cooperate with each other to prevent a first part of the two parts from moving, e.g., rotating, relative to a second part of the two parts, thereby preventing the dose setting member from moving from the preset position to the zero dose position.

[0014] The two hard stops may be configured to be misaligned during delivery of a dose (eg, a therapeutic dose) such that the two hard stops are movable, eg, rotatable, past each other during delivery of the dose.

[0015] The dose delivery mechanism may further comprise an activation member configured to move, for example, in a proximal direction, to initiate delivery of a set dose. When the dose setting member is in a preset position, the activation member is prevented from initiating delivery of the set dose. The activation member (which may also be referred to as a dose activation member) may be configured to also be used for dose adjustment. In other words, the activation member may be a dose adjustment and activation member. The dose adjustment member may be a dose setting knob.

[0016] According to an embodiment, a separate element, such as a clamp, is provided to prevent premature movement of the activation member relative to the housing, for example due to the dose delivery mechanism falling onto the proximal end of the dose delivery mechanism, before the separate element is removed. According to an embodiment, a retaining element, such as a knob cover, is provided, which retaining element has to be removed before the separate element can be removed.

[0017] According to an embodiment, two parts arranged inside the housing of the dose delivery mechanism are configured to cooperate with each other to prevent an unintended movement of the activation member relative to the housing, for example in the proximal direction, starting from a preset position. For example, a first part of the two parts may form a blocking structure, in particular a rib extending in the circumferential direction, and a second part of the two parts may form an engagement feature, which is configured to engage with the blocking structure when the two parts move relative to each other, so as to prevent the activation member from initiating delivery of the set dose when the dose setting member is in the preset position.

[0018] Preferably, a cutout is provided in the blocking structure, e.g. at an angular position in which the engagement feature is arranged when, e.g., a therapeutic dose different from the preset dose is set, such that during dose delivery of the set dose, the engagement feature can move through the respective cutout past the blocking structure. The cutout may be provided next to the corresponding dose limiting element. The engagement feature may be provided on the snap element.

[0019] According to an embodiment, the two parts arranged inside the housing of the dose delivery mechanism comprise respective dose limiting elements which are configured to cooperate with each other to define a plurality of relative positions to each other corresponding to the settable doses. Preferably, the two parts arranged inside the housing of the dose delivery mechanism which are configured to cooperate with each other to prevent an unintended movement of the activation member relative to the housing, e.g. in the proximal direction, from a preset position are two parts comprising respective dose limiting elements which are configured to cooperate with each other to define a plurality of relative positions to each other corresponding to the settable doses.

[0020] The relative position corresponding to the settable dose may be defined by dose stops formed on a first of the two parts, which are configured to contact a snap element, in particular an engagement feature provided on the snap element, on a second of the two parts. Preferably, the snap element, in particular the engagement feature provided on the snap element, is preloaded onto the respective dose stop by a spring, in particular a torsion spring. At least one of the dose stops may have a chamfered surface to guide the snap element, in particular the engagement feature provided on the snap element, over the dose stop during setting of a larger dose. At least one of the dose stops may have a surface opposite to the chamfered surface, which surface is configured to allow the snap element to move during setting of a smaller dose.

[0021] The two parts may be configured to cooperate with each other to prevent unintended movement of one of the parts relative to the other of the parts, such that the activation member is prevented from moving relative to the housing from the preset position. This helps the user avoid premature activation of the dose delivery mechanism before setting the correct dose.

[0022] At the end of a dose delivery procedure, the dose delivery mechanism may be configured to reach a zero dose state. This lets the user know that the dose has been fully delivered to the patient. Similarly, at the end of a dose delivery procedure, the dose indication member may indicate that the dose delivery mechanism is in a zero dose position. This allows the user to easily check whether the dose has been fully delivered to the patient.

[0023] According to an embodiment, the dose delivery mechanism comprises a nut meshingly engaged with the piston rod. The axial movement of the nut relative to the piston rod may correspond to the amount of the dose set by the dose delivery mechanism. The piston rod may be non-rotatably mounted to the housing. Furthermore, the piston rod may be linearly guided in the housing. The nut may be configured not to rotate relative to the housing and the piston rod during dose delivery.

[0024] According to an embodiment, a driver configured to apply a force to the nut to move the piston rod via the nut in the proximal direction is forced to rotate relative to the housing during dose delivery.

[0025] According to another embodiment, the dosage delivery mechanism is configured to be disposable after a single use. In other words, the dosage delivery mechanism cannot be used more than once.

[0026] The present invention further relates to a method for providing a dose delivery mechanism having: a housing; a piston rod configured to act on a plunger of a sealed fluid compartment and to move in an axial direction relative to the housing to deliver a set dose; and a dose setting member movable relative to the housing during dose setting,

[0027] Wherein the position of the dose setting member relative to the housing defines the set dose, the method comprises the step of delivering the dose delivery mechanism to a customer, such as a patient, in a state preset to a dose greater than zero.

[0028] The present invention also relates to a dose delivery mechanism, in particular an assembly of a dose delivery mechanism having at least one feature disclosed in the present application and a removable element, such as a clamp, the dose delivery mechanism comprising:

[0029] A housing; a piston rod configured to act as a plunger of the sealed fluid compartment and to move relative to the housing in an axial direction to deliver a set dose; a dose setting member, which is movable relative to the housing during dose setting, wherein the position of the dose setting member relative to the housing defines the set dose; and an activation member, which is movable relative to the housing, in particular in a proximal direction, to deliver the set dose, wherein the removable element is arranged between the housing and the activation member to prevent premature movement of the activation member relative to the housing, in particular in said proximal direction, before the removable element is removed. The removable element may be C-shaped and may be attached to the dose delivery mechanism from a radial direction between the housing and the activation member.

[0030] According to an embodiment, the assembly further comprises a cover. The cover may be mechanically attached to the dose delivery mechanism prior to use of the dose delivery mechanism. 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 removal of the removable element from the dose delivery mechanism is prevented. The cover may be configured to be removable to expose said portion of the dose delivery mechanism and / or a portion of the removable element such that the removable element may be removed from the dose delivery mechanism.

[0031] The object of the present invention is achieved by a dose delivery mechanism comprising a housing, a dose adjustment member movable relative to the housing for adjusting a dose and / or an activation member for delivering a set dose, and a dose indication member, in particular for indicating the set dose depending on a rotational position of the dose indication member relative to the housing, wherein in a delivery state the dose delivery mechanism is preset to a dose greater than zero.

[0032] According to an embodiment, in the delivery state the dose adjustment member and / or the activation member is preset to a position corresponding to a dose greater than zero.

[0033] Preferably, in the delivery state, the dose delivery mechanism can be preset to a dose between zero dose and a minimum dose, for example a minimum dose that the dose delivery mechanism is intended to use for each treatment.

[0034] According to an embodiment, in the delivery state, the dose indicating member indicates that the set dose is different from the zero dose. In particular, in the delivery state, the dose indicating member may indicate that the set dose is a dose between the zero dose and a minimum dose, the minimum dose being the minimum dose that the dose delivery mechanism is intended to use for each treatment. In order to simplify the use of the dose delivery mechanism, the dose adjustment member and the activation member may be fixedly connected to each other, or formed integrally with each other.

[0035] The object of the present invention is also achieved by a method for providing a dose delivery mechanism having a housing, a dose adjustment member movable relative to the housing for setting a dose and / or an activation member for delivering the set dose, and a dose indication member indicating the set dose, in particular depending on a rotational position of the dose indication member relative to the housing,

[0036] The method comprises the steps of delivering the dose delivery mechanism to a customer in a state where the dose is preset to be greater than zero.

[0037] Also disclosed is an assembly of a dose delivery mechanism and a removable element such as a clamp, the dose delivery mechanism comprising a housing,

[0038] A dose indication member, in particular indicating a set dose depending on the rotational position of the dose indication member relative to the housing, and an activation member, which can be moved relative to the housing, in particular in a proximal direction, to deliver the set dose, wherein the removable element is arranged between the housing and the activation member to prevent premature movement of the activation member relative to the housing, in particular in the proximal direction, before the removable element is removed.

[0039] The assembly may include a cover that is mechanically attached to the dose delivery mechanism prior to use of the dose delivery mechanism. The cover may be configured to cover at least a portion of the dose delivery mechanism and / or at least a portion of the removable element such that removal of the removable element from the dose delivery mechanism is prevented. The cover may be configured to be removable to expose the portion of the dose delivery mechanism and / or a portion of the removable element such that the removable element may be removed from the dose delivery mechanism. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] These and other features, aspects and advantages are described below with reference to the accompanying drawings. In all drawings, like reference numerals consistently denote corresponding features.

[0041] Figure 1 An exploded view of an injection pen according to the invention is shown.

[0042] Figure 2A Show Figure 1 A perspective view of the knob cover of an injection pen.

[0043] Figure 2B Show Figure 2A Side view of the knob cover.

[0044] Figure 2C Show Figure 2B The knob cover is along Figure 2B Section view of line AA.

[0045] Figure 3A Show Figure 1 Perspective view of the injection button of an injection pen.

[0046] Figure 3B Show Figure 3A Side view of the injection button.

[0047] Figure 3C Show Figure 3B The injection button is along Figure 3B Section view of line AA.

[0048] Figure 3D Show Figure 3B The injection button is along Figure 3B A cross-sectional view along line BB.

[0049] Figure 3E Show Figure 3B The injection button is along Figure 3B Cross-sectional view along line CC.

[0050] Figure 4A Show Figure 1 A perspective view of the retaining ring of an injection pen.

[0051] Figure 4BShow Figure 4A Top view of the clasp.

[0052] Figure 4C Show Figure 4A Side view of the retaining ring.

[0053] Figure 4D Show Figure 4A Bottom view of the retaining ring.

[0054] Figure 5A Show Figure 1 First perspective view of the dose setting knob of an injection pen.

[0055] Figure 5B Show Figure 5A Second perspective view of the dose setting knob.

[0056] Figure 5C Show Figure 5A Side view of the dose setting knob.

[0057] Figure 5D Show Figure 5A The dose setting knob is along Figure 5C Section view of line AA.

[0058] Fig. 6A Show Figure 1 A perspective view of the snap-fit ​​element of an injection pen.

[0059] Figure 6B Show Fig. 6A Side view of the snap-fit ​​element.

[0060] Figure 6C Show Fig. 6A The snap-on elements are along Figure 6B Section view of line AA.

[0061] Fig. 7A Show Figure 1 A perspective view of the connector of an injection pen.

[0062] Figure 7B Show Fig. 7A Bottom view of the connector.

[0063] Figure 7C Show Fig. 7A Side view of the connector.

[0064] Fig.7D Show Fig. 7A Top view of the connector.

[0065] Fig. 8A Show Figure 1 First perspective view of the dose selector of an injection pen.

[0066] Figure 8B Show Fig. 8A Bottom view of the dose selector.

[0067] Figure 8C Show Fig. 8A Side view of the dose selector.

[0068] Fig.8D Show Fig. 8A The dose selector is along the Figure 8C Section view of line AA.

[0069] Fig. 8E Show Fig. 8A The dose selector is along the Figure 8C A cross-sectional view along line BB.

[0070] Fig. 9 Show Fig. 8A Second perspective view of the dose selector of .

[0071] Fig. 10A Show Figure 1 A perspective view of the knob key of an injection pen.

[0072] Fig. 10B Show Fig. 10A Side view of the knob key.

[0073] Fig.11A Show Figure 1 A perspective view of the housing of an injection pen.

[0074] Fig. 11B Show Fig.11A A side view of the housing.

[0075] Fig. 11C Show Fig.11A The shell along Fig. 11B Section view of line AA.

[0076] Fig. 12A Show Figure 1 A first side view of a dose setting sleeve of an injection pen.

[0077] Fig. 12B Show Fig. 12A A second side view of the dose setting sleeve.

[0078] Fig. 12C Show Fig. 12A A third side view of the dose setting sleeve.

[0079] Fig.12D Show Fig. 12A A fourth side view of the dose setting sleeve.

[0080] Fig.12E Show Fig. 12A Front view of the dose setting sleeve.

[0081] Fig.12F Show Fig. 12A A first perspective view of a dose setting sleeve.

[0082] Figure 12G Show Fig. 12A A second perspective view of the dose setting sleeve of FIG.

[0083] Fig.13A Show Figure 1 Perspective view of the driver of the injection pen.

[0084] Fig. 13B Show Fig.13A First side view of the drive.

[0085] Fig. 13C Show Fig.13A Second side view of the drive.

[0086] Fig.13D Show Fig.13A The drive along Fig. 13C Section view of line AA.

[0087] Fig.14A Show Figure 1 First perspective view of the nut of the injection pen.

[0088] Fig. 14B Show Fig.14A A second perspective view of the nut.

[0089] Fig. 14C Show Fig.14A Side view of the nut.

[0090] Fig.14D Show Fig.14A The nut along Fig. 14C First cross-sectional view of line AA.

[0091] Fig.14E Show Fig.14A The nut along Fig. 14C A second cross-sectional view of line BB.

[0092] Fig.15A Show Figure 1 A first side view of the piston rod guide of an injection pen.

[0093] Fig. 15B Show Fig.15A A second side view of the piston rod guide.

[0094] Fig. 15C Show Fig.15A The piston rod guides along Fig.15A Section view of line AA.

[0095] Fig.15D Show Fig.15A A perspective view of the piston rod guide.

[0096] Fig.16A Show Fig.15A A first longitudinal cross-sectional view of a piston rod guide.

[0097] Fig. 16B Show Fig.15A A second longitudinal cross-sectional view of the piston rod guide.

[0098] Fig. 16C Show Fig.15A A perspective view of the piston rod guide.

[0099] Fig.17A Show Figure 1 Side view of the piston rod of the injection pen.

[0100] Fig. 17B Show Fig.17A The piston rod moves along Fig.17A Section view of line AA.

[0101] Fig. 17C Show Fig.17A A first perspective view of the piston rod.

[0102] Fig.17D Show Fig.17A A second perspective view of the piston rod.

[0103] Fig.18A Show Figure 1 Perspective view of the piston disk of an injection pen.

[0104] Fig.18B Show Fig.18A top view of a piston disk.

[0105] Fig. 18C Show Fig.18A The piston disc along Fig.18B Section view of line AA.

[0106] Fig.19A Show Figure 1 A perspective view of the dual-chamber cartridge of an injection pen.

[0107] Fig.19B Show Fig.19A Side view of a dual chamber cartridge.

[0108] Fig.19C Show Fig.19AThe dual chamber cartridge follows Fig.19B Section view of line AA.

[0109] Fig. 20A Show Figure 1 A perspective view of a cartridge container for an injection pen.

[0110] Fig. 20B Show Fig. 20A A first side view of a cartridge container.

[0111] Fig. 20C Show Fig. 20A A second side view of the cartridge container.

[0112] Fig.20D Show Fig. 20A The cartridge container is along Fig. 20C Section view of line AA.

[0113] Fig.21A Show Figure 1 First perspective view of the cartridge key of an injection pen.

[0114] Fig. 21B Show Fig.21A A second perspective view of the cartridge key.

[0115] Fig. 21C Show Fig.21A A first side view of a cartridge key.

[0116] Fig.21D Show Fig.21A A second side view of the cartridge key.

[0117] Fig.22A Show Fig.21A A third side view of a cartridge key.

[0118] Fig. 22B Show Fig.21A The cartridge key is along Fig.22A Section view of line AA.

[0119] Fig.23A Show Figure 1 Side view of the injection pen in the delivery state.

[0120] Fig. 23B Show Fig.23A The injection pen is along Fig.23A Section view of line AA.

[0121] Fig.24 Show Fig.23A A perspective view of the injection pen of without the knob cover and with some parts shown transparently.

[0122] Fig.25A Show Fig.23A Second side view of the injection pen.

[0123] Fig.25B Show Fig.23A The injection pen is along Fig.25A Section view of line AA.

[0124] Fig.26A Show Figure 1 Side view of the injection pen in the reconstituted state.

[0125] Fig.26B Show Fig.26A The injection pen is along Fig.26A Section view of line AA.

[0126] Fig.27A Show Fig.26A Second side view of the injection pen.

[0127] Fig.27B Show Fig.26A A third side view of the injection pen.

[0128] Fig.27C Show Fig.26A The injection pen is along Fig.27B Section view of line AA.

[0129] Fig.28A Show Figure 1 Side view of the injection pen with the knob cover not tightened.

[0130] Fig.28B Show Fig.28A The injection pen is along Fig.28A Section view of line AA.

[0131] Fig.29A Show Figure 1 Side view of the injection pen in the end-reconstitution state.

[0132] Fig.29B Show Fig.29A The injection pen is along Fig.29A Section view of line AA.

[0133] Fig. 30A Show Figure 1 Side view of the injection pen in the set dosage state.

[0134] Fig. 30B Show Fig. 30A The injection pen is along Fig. 30A Section view of line AA.

[0135] Fig.31A Show Figure 1 Side view of the injection pen at the start of injection.

[0136] Fig.31B Show Fig.31A The injection pen is along Fig.31A Section view of line AA.

[0137] Fig.32A Show Figure 1 Another side view of the injection pen at the start of injection.

[0138] Fig.32B Show Fig.32A The injection pen is along Fig.32A An enlarged cross-sectional view of line AA.

[0139] Fig.33A Show Figure 1 Side view of the injection pen at the end of injection.

[0140] Fig.33B Show Fig.33A The injection pen is along Fig.33A Section view of line AA.

[0141] Fig.34 A second injection pen according to the present disclosure is shown in a pre-assembled state.

[0142] Fig.35 Another view showing the second injection pen in a pre-assembled state.

[0143] Fig.36 An exploded view of a second injection pen is shown.

[0144] Fig.37 A longitudinal section through a second injection pen in a pre-assembled state is shown.

[0145] Fig.38 A detailed view of the distal part of the second injection pen is shown in a pre-assembled state.

[0146] Fig.39 A detailed view of the distal end of the second injection pen is shown in the assembled state during dose setting.

[0147] Fig.40 Another view showing the distal end of the second injection pen in an assembled state during dose setting.

[0148] Fig.41 A detailed view of the distal end of the second injection pen is shown in the assembled state during dose delivery.

[0149] Fig.42Another view showing the distal end of the second injection pen and the assembled state during dose delivery.

[0150] Fig.43 A longitudinal section through the dose setting elements of a first injection pen and a second injection pen is shown.

[0151] Fig.44 A perspective view showing a longitudinal section through the dose setting member.

[0152] Fig.45 A perspective distal view of the dose setting element is shown.

[0153] Fig.46 A perspective proximal view of the dose setting element is shown.

[0154] Fig.47 A perspective view of a third injection pen according to the present disclosure is shown.

[0155] Fig.48 An exploded view of a third injection pen is shown.

[0156] Fig.49 A longitudinal section through the dose delivery mechanism of a third injection pen is shown.

[0157] Fig.50 A perspective distal view of a dosing member of a third injection pen is shown.

[0158] Fig.51 A perspective longitudinal section through a dosing member of a third injection pen is shown.

[0159] Fig.52 A perspective view showing the piston rod of a third injection pen.

[0160] Fig.53 A perspective distal view of an extension of a third injection pen is shown.

[0161] Fig.54 Show Fig.53 Distal view of the extension shown in .

[0162] Fig.55 Show Fig.53 A proximal view of the extension shown in FIG.

[0163] Fig.56 A perspective view of a coupling element of a third injection pen is shown.

[0164] Fig.57 A perspective view showing the bearing, piston rod, extension, coupling element and adjustment element of a third injection pen.

[0165] Fig.58 A proximal perspective view of an adjustment element of a third injection pen is shown.

[0166] Fig.59 A side view of the adjustment element of a third injection pen is shown.

[0167] Fig.60 Shown along Fig.59 The line AA in FIG. 5 passes through the radial section of the adjustment element of the third injection device.

[0168] Fig.61 Shown along Fig.59 The line BB in FIG. 1 passes through the radial section of the adjustment element of the third injection device.

[0169] Fig.62 A perspective view showing a coupling member of a third injection pen.

[0170] Fig.63 A perspective distal view of the cartridge of a third injection pen is shown.

[0171] Fig.64 A longitudinal section through the barrel of a third injection pen is shown.

[0172] Fig.65 A perspective view of a housing insert of a third injection pen is shown.

[0173] Fig.66 A perspective view showing the connector of a third injection pen.

[0174] Fig.67 A perspective view showing a longitudinal section through the connector of a third injection pen.

[0175] Fig.68 A side view of the third injection pen is shown in an assembled state during dose setting.

[0176] Fig.69 A side view of the third injection pen is shown in a pre-assembled state.

[0177] 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.

[0178] 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.

[0179] Fig.72 A detailed view of a longitudinal section through the distal end of a third injection pen in an assembled state during dose delivery is shown.

[0180] Fig.73A detailed view of a further longitudinal section through the distal end of a third injection pen in an assembled state during dose delivery is shown.

[0181] 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.

[0182] 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.

[0183] Fig.76 A perspective view of a fourth injection pen according to the present disclosure is shown.

[0184] Fig.77 A side view of the fourth injection pen is shown in an assembled state during dose setting.

[0185] Fig.78 A side view of a fourth injection pen is shown in a pre-assembled state with an adjustment element in a pre-assembly position.

[0186] Fig.79 A side view of a fourth injection pen is shown in a pre-assembled state with an adjustment element in an adjustment position.

[0187] Fig.80 An exploded view of a fourth injection pen is shown.

[0188] Fig.81 A longitudinal section through the dose delivery mechanism of a fourth injection pen is shown in an assembled state during dose setting.

[0189] Fig.82 A perspective view of a coupling element of a fourth injection pen is shown.

[0190] Fig.83 Shown along line AA through Fig.82 A radial cross section of a coupling element is shown in FIG.

[0191] Fig.84 A perspective view of the piston rod of a fourth injection pen is shown.

[0192] Fig.85 A perspective proximal view of an adjustment element of a fourth injection pen is shown.

[0193] Fig.86 A side view of the adjustment element of a fourth injection pen is shown.

[0194] Fig.87 Shown along Fig.86 The line AA in passes through a first longitudinal section of the adjustment element.

[0195] Fig.88 The adjustment element of the fourth injection pen is shown in a vertical direction. Fig.86 Additional side view in the direction of .

[0196] Fig.89 Shown along Fig.88 The line BB in passes through the second longitudinal section of the adjusting element.

[0197] Fig.90 A perspective distal view of the cartridge of a fourth injection pen is shown.

[0198] Fig.91 A perspective distal view of the insert showing the sleeve.

[0199] Fig.92 A perspective proximal view of the insert showing the sleeve.

[0200] Fig.93 A perspective distal view of the outer portion of the sleeve is shown.

[0201] Fig.94 A side view of a coupling member of a fourth injection pen is shown.

[0202] Fig.95 Along Fig.90 The line AA in passes through the longitudinal section of the connecting member.

[0203] Fig.96 Shown along Fig.90 The line BB in passes through the radial section of the coupling member.

[0204] Fig.97 A perspective distal view of a dosing member of a fourth injection pen is shown.

[0205] Fig.98 A perspective view showing a longitudinal section through the dosing member.

[0206] Fig.99 A longitudinal section through the distal end of the dose delivery mechanism of a fourth injection pen is shown in an assembled state during dose setting.

[0207] Fig.100 A further longitudinal section through the distal end of the dose delivery mechanism of a fourth injection pen is shown in an assembled state during dose setting.

[0208] Fig.101 A longitudinal section through the distal end of the dose delivery mechanism of a fourth injection pen is shown in an assembled state during dose delivery.

[0209] Fig.102A further longitudinal section through the distal end of the dose delivery mechanism of a fourth injection pen is shown in an assembled state during dose delivery.

[0210] Fig.103 A longitudinal section through the distal end of the dose delivery mechanism of a fourth injection pen in a preassembled state is shown with the adjustment element in the preassembled position.

[0211] Fig.104 A further longitudinal section through the distal end of the dose delivery mechanism of a fourth injection pen in a preassembled state is shown with the adjustment element in the preassembled position.

[0212] Fig.105 A longitudinal section through the distal end of a dose delivery mechanism of a fourth injection pen in a pre-assembled state is shown with the adjustment element in the adjustment position.

[0213] 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 with the adjustment element in the adjustment position. DETAILED DESCRIPTION

[0214] refer to Figures 1 to 22B , describing the components of the injection pen 10 according to the present invention. Then, referring to FIG. 23A to FIG. 33B , describing how you intend to use the pen.

[0215] Figure 1 An 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 actuation 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 actuation 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, while the cartridge key 52 provides an inner container holder of the container holder.

[0216] Although the above-mentioned parts of the injection pen 10 can each be formed as a separate part to simplify the production of these separate parts, it will generally be possible to form one or more of these parts integrally with each other. For example, the injection button 18, the snap ring 20 and / or the dose setting knob 22 can be integrally formed with each other. In addition, the dose setting sleeve 34 and the driver 36 can be integrally formed with each other. Typically, even the housing 32 and the piston rod guide 42 can be integrally formed with each other.

[0217] Different parts can be combined 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.

[0218] Next, the above-mentioned parts of the injection pen 10 are described in order starting from the distal end 12 and ending at the proximal end 14 , which are opposite ends of the injection pen 10 , and the proximal end 14 includes a dispensing outlet:

[0219] FIG. 2A to FIG. 2C The 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 can be attached to and / or detached 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 the inner surface of each wing 58, a form-fitting engagement means in the form of a lug 60 is provided, which is configured to engage with the housing 32, in particular with a radially extending coupling surface 228 (see FIG. 2 ) formed on the piston guide 42. Fig. 15C ) engage to axially fix the knob cover 16 in the distal direction relative to the housing 32. Immediately adjacent each lug 60, a window 62, i.e., a radially extending opening, is formed in the wing 58. When the knob cover 16 is attached to the housing 32, the window 62 is located at an axial position where the housing 32 forms a circumferentially extending protrusion 64 (see Fig.25A). On the distal side of each window 62 (i.e., away from the lug 60), an abutment 66 is formed on the inner side surface of the corresponding wing 58. The width of the abutment 66 accommodates the width of the notch or cutout 68 on the outer surface of the housing 32 (see Fig.11A ), more specifically, to accommodate the width of the notch or cutout 68 formed in the chamfered portion 69 on the outer surface of the housing 32. In addition, the abutment 66 forms a front surface 66a that axially abuts the radially extending surface 32a defining the proximal end of the cutout 68 when the knob cover 16 is attached to the housing 32 (see Fig. 11B ). The radially extending surface 32a defines a stop surface that stops the knob cover 16 from moving proximally relative to the housing 32, for example if 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 beyond its attachment position in the proximal direction 1, an axial abutment ridge 70 may be formed on the outer surface of the housing 32 (see Fig.11A The raised portion 70 is arranged to be aligned with the gap 72 formed between the wings 58 (see Figure 2C ) are engaged so that the proximal front surface of the knob cover 16 abuts the distal front surface of the axially adjacent protrusion 70.

[0220] When the knob cover 16 is attached to the housing 32 , the form-fitting engagement between the abutment 66 and the cutout 68 and / or the form-fitting engagement between the protrusion 70 and the void 72 ensures that the knob cover 16 is limited in rotation relative to the housing 32 .

[0221] As from Figure 2A It 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 Figure 5B ). Thus, the dose setting knob 22 is prevented from rotating inside the knob cover 16 by the form-fitting engagement of the linear recess 74 and the anti-rolling device 76. Figure 2A As can be seen in FIG. 1 , the knob cover 16 also forms an anti-roll device 78 in the form of an axially extending rib on the outer surface of the knob cover 16. The anti-roll devices 76 and 78 ensure that the injection pen 10 and the knob cover 16 do not roll when placed on a flat surface. Figure 2A It can also be seen that the knob cover 16 has a closed circumferential portion 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.

[0222] FIG. 3A to FIG. 3EThe injection button 18 is shown. The injection button 18 forms a distal front surface 80 to apply a force to the injection button 18 to inject the set dose. The injection button 18 includes an axial fixation means 82 to axially attach the injection button 18 to the snap ring 20 (see Figures 4A-4D ), the collar 20 is axially connected to the dose setting knob 22 (see 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 an axial fixing means 86 in the form of an elastically deformable bent hook, which engages with an undercut 88 formed in the dose setting knob 22. 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 permanently axially fixed to each other.

[0223] The injection button 18 also forms a rotational securing means 90 in the form of radially extending ribs. The ribs 90 are in contact with the rotational securing means 92 in the form of teeth arranged in the inner circumferential surface of the collar 20 (see Figure 4A ) is engaged in a form-fitting manner to rotationally connect the injection button 18 to the collar 20. The rotation fixing means 92 forms a toothed portion 93 of the collar 20, and the rib 90 forms an engagement portion of the injection button 18. The collar 20 includes a rotation fixing means 94 in the form of an axially extending recess, which defines a side surface of the elastically deformable bent hook 86 and engages with a rotation fixing means 96 in the form of an axially extending rib on the inner circumferential surface of the dose setting knob 22 (see Figure 5A ) join.

[0224] After assembly of the dose delivery mechanism 54 and in its assembled state, the injection button 18 , the snap ring 20 and the dose setting knob 22 are rigidly connected to each other and form both the dose setting member and the actuation member of the dose delivery mechanism 54 .

[0225] The injection button 18 is formed into a cylindrical portion 18a. On the cylindrical portion 18a, an assembly means 98 in the form of a ridge is formed to axially pre-assemble the injection button 18 with the snap element 24. More precisely, the lower (ie, proximal) assembly means 98b (see Figure 3C) restricts the distal movement of the injection button 18 relative to the snap element 24 by obstructing the coupling device 102 on the snap element 24. The upper (i.e., distal) assembly device 98a restricts the proximal movement of the injection button 18 relative to the snap element 24 by obstructing the coupling device 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 device 102 is arranged between the proximal assembly device 98b and the distal assembly device 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 device 102 is arranged on the distal side of the distal assembly device 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 protrusions, which are 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 (partially) surrounded by cutouts 101.

[0226] The coupling device 100 is configured to permanently axially lock the injection button 18, and therefore the snap ring 20 and the dose setting knob 22, to the snap element 24 after an injection has been completed, so as to render the injection pen 10 inoperable. That is, when the injection button 18 is axially moved to initiate dose delivery, the coupling device 100 passes through a radially inwardly extending coupling device in the form of a circumferentially extending ledge 102 on the snap element 24 (see Fig. 6A ). The radially inwardly extending rim 102 causes the projections arranged on the elastically inwardly bendable portion 100 to bend inwardly until these projections have passed the rim 102. In order to reduce the force required to push the projection 100 over the rim 102, the projection 100 forms a chamfered outer surface 100a. Alternatively or in addition, the rim 102 may form a chamfered inner surface. When the projection 100 has passed the rim 102, it moves back to its 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.

[0227] like Figure 3C and Figure 3E As 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 of the nut 38 (see FIG. 1 ). Fig. 14C 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.

[0228] like Figure 5B and Figure 5D As best seen above, a set of teeth 108 are formed in an axial section on the inner circumferential side of the dose setting knob 22. These teeth 108 are configured to engage with a set of teeth 110 (see FIG. 1 ) arranged in a distal section on the outer circumferential surface of the snap element 24 during dose setting. Figures 6A-6C ) engages. Therefore, when the dose setting knob 22 is rotated during dose setting, the snap element 24 also rotates. Fig. 6A As can be seen in FIG, 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 has advantages with regard to the production of the injection pen 10. Alternatively, the teeth 110 can be formed along the entire circumferential portion of the snap element 24.

[0229] The snap element 24 forms an axial section with a reduced cross section, thereby forming a coupling surface 112 of 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 (for example two) parts connected to each other, for example via a form-fitting connection. The connector 26 has an open cross section (see Fig.7D ), so that it can be snapped onto the snap element 24 at a reduced cross section. Since the connector 26 has a length L1 in the axial direction, which corresponds to the length L2 in the axial direction of the axial section with the reduced cross section, the connector 26 is axially fixedly connected to the snap element 24 in both directions. However, the connector 26 can rotate 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, rather than the teeth 110 of the snap element 24, so that during dose delivery, the snap element 24 can rotate relative to the dose setting knob 22. 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, because the connector 26 is rotationally fixed to the housing 32 via the dose selector 28.

[0230] The snap element 24 further comprises an engagement feature 116 in the form of an axially extending radial projection. The engagement feature 116 is an axially extending rib. The engagement feature 116 may have a symmetrical cross-section or an asymmetrical cross-section in a radial plane perpendicular to the longitudinal axis of the injection pen 10. The engagement feature 116 is configured to engage with dose stops 118a, 118b, 118c and 118d formed on the inner circumferential surface of the dose selector 28 (see Figure 8B) to set the desired dose. Therefore, the engagement feature 116 acts 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 an elastically deformable section 120 (i.e. an 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 stop 118a-d has a symmetrical cross-section in a radial plane perpendicular to the longitudinal axis of the injection pen 10. In other words, the amount of the slope of the chamfered side surfaces 122 and 123 is equal to each other. Fig. 9 In another embodiment shown in , the pitch of 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 larger dose is smaller than the pitch of the chamfered side surfaces 123a'-d' that contact the protrusion 116 when the dose is set to a smaller 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.

[0231] 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 is as 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 a dose setting end hard stop 128.

[0232] The snap element 24 also includes 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.13AAs can be seen in the drawing, the driver 36 has an axially extending rib 134, which is configured to engage with the groove 132 of the snap element 24. In addition, the driver 36 has a protrusion 136 with a chamfered surface 136a, which engages with the opening 130 of the snap element 24. Although 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, an axially extending rib 138 is formed on the inner circumferential surface of the snap element 24 (see Figure 6C ), the rib 138 and the axially extending groove 140 on the outer circumferential surface of the driver 36 (see Fig.13D ) join.

[0233] FIG. 8A to FIG. 8E The dose selector 28 is shown. The dose selector 28 comprises an axial fixing device 142 in the form of a circumferentially extending protrusion on the inner circumferential surface of the distal section of the dose selector 28. By inserting the distal section with the axial fixing device 142 into the circumferentially extending access opening 144 (see Figure 5B ), the dose selector 28 is axially fixed to the dose setting knob 22. In the access port 144, the dose setting knob 22 forms an axial fixing device 146 in the form of a circumferentially extending protrusion on the outer circumferential surface, and the axial fixing device 146 engages with the axial fixing device 142 of the dose selector 28 to form an axial connection that allows relative rotational movement between the dose selector 28 and the dose setting knob 22.

[0234] like Fig. 8E As best seen in the figure, a rotation fixing device 148 in the form of an axially extending groove is formed on the inner circumferential surface of the dosage selector 28. The rotation fixing device 148 is formed on the outer circumferential surface of the connector 26 and is in the form of an axially extending rib. Rotation fixing device 150 (see Figure 7B ) are engaged. The rotational fixing means 148, 150 allow axial movement between the dosage selector 28 and the connector 26. The dosage selector 28 also includes a rotational fixing means 152 in the form of an axially extending rib formed on the outer circumferential surface of the dosage selector 26. The rotational fixing means 152 is engaged with a rotational fixing means 154 in the form of an axially extending groove formed on the inner circumferential surface of the housing 32 (see Fig. 11C The rotational fixation means 152, 154 are configured to define one possible rotational alignment allowing the dosage selector 28 to be inserted into the housing 32. The rotational fixation means 150, 152 allow axial movement between the dosage selector 28 and the housing 32.

[0235] In order to limit the deliverable dose, the dose selector 28 (see Figure 8B ) is formed with a circumferentially extending rib 156 having cutouts 158a, 158b, 158c and 158d. The cutouts 158a, 158b, 158c and 158d are assigned to the respective dose stops 118a, 118b, 118c and 118d. The rib 156 and its cutouts 158a, 158b, 158c and 158d ensure that an injection can only be performed when the dose limiting element 116 of the snap element 24 is in an angular position associated with one of the cutouts 158a, 158b, 158c and 158d (i.e. associated with one settable dose). If the dose limiting element 116 is not in an angular position associated with one of the cutouts 158a-d, the circumferentially extending rib 156 prevents an axial movement of the dose limiting element 116 and therefore the snap element 24 relative to the dose selector 28. As shown from Figure 8B It can be seen that no cutout is allocated to the preset dose hard stop 126. Thus, when the injection pen 10 is set to a preset dose, starting an injection is inhibited.

[0236] 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 initiated when the hard stop 124 of the snap element 24 is in an angular position associated with one of the cutouts 158a, 158b, 158c and 158d (i.e. associated with one settable dose).

[0237] Fig. 10A and Fig. 10B The knob key 30 is shown. 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 when the injection pen 10 in the delivery state falls on its proximal end. The width W1 of the clamp 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 (see Fig.29A ). The knob key 30 is C-shaped and has a retaining projection 164 that interacts with the rotation fixing device 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.

[0238] exist FIG. 11A to FIG. 11CThe housing 32 is shown in FIG. The housing 32 forms a viewing window 166 for displaying the state of the injection pen 10, in particular the set dose indicated by the dose sleeve 34, through the window 166. During dose setting and dose delivery, the dose sleeve 34 rotates relative to the housing, which causes the things displayed through the window 166 to change. At different circumferential positions along the outer circumferential surface of the dose sleeve 34, labels 168a-168d for different settable doses are positioned (see Fig. 12C and Fig.12D In addition, a preset dose label 168e is positioned on the dose sleeve 34 (see Fig. 12B ), which corresponds to the preset dose, i.e., the amount of drug that would be injected if the injection could start from the preset dose. Fig. 12A and Fig. 12B It can be seen that the preset dose label 168e is different from the zero dose label 168f, which is a label indicating that if the injection is to be started in this state, no medicament will be injected. When the injection has been completed, this zero dose label 168f is displayed 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.

[0239] The dose sleeve 34 is rotationally and axially rigidly coupled to a driver 36 (see Figures 13A-13D ). In order to rotationally couple the dose sleeve 34 to the driver 36, corresponding out-of-round outer circumferential surfaces 169a and out-of-round 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 clamped between the proximal end of the snap element 24 and the facing surface 173 of the driver 36 (see 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 the internal thread 172 of the piston guide 42 (see 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 an end stop 174, which abuts against an end stop 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 middle axis of the injection pen and face in a radial direction. The driver 36 also forms an attachment device 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 device 179 at the outer circumferential surface of the piston rod guide 42 (see Fig. 16C ).

[0240] According to an alternative variant, the dose sleeve and the driver may be formed as separate parts axially movable relative to each other but rotationally fixed to each other, and both may have threads threadedly coupled to the housing.The threads of the dose sleeve and the threads of the driver may have different pitches.

[0241] The piston guide 42 is axially and radially fixed to the housing 32 and can therefore be considered as a part of the housing. In order to axially fix the piston guide 42 to the housing 32, an axial fixing device 178 in the form of a circumferentially extending groove is formed on the piston guide 42, and the axial fixing device 178 is in the form of a circumferentially extending rib formed on the inner circumferential surface of the housing 32. 180 (see Fig.11A ) is engaged. In order to rotationally fix the piston guide 42 to the housing 32, a rotation fixing device 182 in the form of an axially extending groove is formed on the outer circumferential surface 262 of the piston guide 42, and the rotation fixing device 182 is engaged with the rotation fixing device 184 in the form of an axially extending rib formed on the inner circumferential surface of the housing 32 (see Fig.11A The axial and rotational securing means 178, 180, 182 and 184 allow the piston rod guide 42 to be attached to the housing 32 in exactly one relative rotational position.

[0242] The piston guide 42 has an out-of-round axial opening 186 (see Fig. 15C ), which corresponds to the non-round cross section 188 of the piston rod 44 (see Fig. 17B ). Therefore, the piston rod 44 can move axially 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 (see Fig.14D) are engaged. The outer thread 190 and the inner thread 192 form a threaded connection 189 between the piston rod 44 as a first threaded element and the nut 38 at the 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, this pressing surface 194 abuts against a front surface 196 of the driver 36. During dose delivery, the driver 36 moves with a combined axial and rotational movement relative to the piston rod guide 42, 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 disk 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.

[0243] The piston rod 44 forms at its proximal end a coupling device 198 in the form of an undercut which mates with a coupling device 200 in the form of a radially inwardly extending rib on the inner circumferential surface of the piston disk 46 (see Figures 18A-18C ) join.

[0244] FIG. 15A to FIG. 22B Components of a drug mixing or reconstitution unit 56 configured to mix different components (typically a lyophilized drug and a liquid solvent) to form an injectable liquid drug are shown. 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 , 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 208, for example made of a rubber material, which is axially slidably arranged inside the double-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. The second sealing element 210, for example made of a rubber material, forms the distal end of the second chamber 204. The second sealing element 210 can also be called a plunger. During the mixing of the two components, the piston disc 46 abuts the distal end face of the second sealing element 210.

[0245] In the delivery state, the lyophilized drug is in the first chamber 202 and the solvent is in the second chamber 204 .

[0246] The dual chamber cartridge 48 is stored in the cartridge key 52 (see Fig.21A- Figure 22b). The cartridge key 52 is axially and rotationally fixed to the cartridge container 50. To achieve this, the cartridge key 52 forms an axial fixing device 212 in the form of a circumferentially extending groove, which is in contact with the axial fixing device 214 in the form of a circumferentially extending rib on the inner circumferential surface of the cartridge container 50 (see Fig. 20A ) engagement. In addition, the cartridge key 52 forms a rotational securing device 216 in the form of a radially extending rib, which engages a rotational securing device 218 in the form of a radially extending groove 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 adjacent in the air. Both the 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 during reconstitution, the patient can see the drug inside the transparent double-chamber cartridge 48. 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 the opening 252 at the proximal end of the cartridge holder 52. The opening 252 is configured to receive a needle that is connected to the interior fluid of the cartridge 48 inserted into the cartridge holder 52.

[0247] The cartridge key 52 forms an inner surface 254 ( Fig. 22B ), the inner surface 254 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 the surface contact between the cylindrical outer surface 256 of the cartridge and the inner surface 254 in the holding section 249 of the cartridge holder 52. In addition, the cartridge holder 52 forms a cutout 221 to receive the bypass 206 of the dual-chamber cartridge 48. The bypass 206 engages the cutout 221 in a form-fitting manner so that the dual-chamber cartridge 48 is axially and rotationally fixed to the cartridge key 52. ​​On the opposite side of the cutout 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.

[0248] To mix the different components in the dual chamber cartridge 48 and prime 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. 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 ), the inner circumferential surface defines 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 230 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 in the distal direction (i.e., a combined axial and rotational movement of forced guidance) relative to the piston rod guide 42, but prevents the cartridge container 50 from being screwed in the proximal direction 1 relative to the piston rod guide 42. The first opening 236 (see 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. This starting position or delivery state is shown in Fig.25A and Fig.25B middle.

[0249] The second opening 238 defines a reconstituted state of the cartridge container 50. In this state, the second chamber 202 still contains air, allowing the injection pen 10 to be moved back and forth to ensure that the medication is evenly mixed together. The second opening 238 can be omitted. Therefore, the present disclosure also relates to embodiments of the injection pen 10 that feature a first opening 236 and a third opening 240 instead of the second opening 238. The third opening 240 defines a knob cap unfastened state of the cartridge container 50, in which most of the air is exhausted from the second chamber 202, which now contains the reconstituted medication ready for use.

[0250] In the following, reference FIG. 23A to FIG. 33B , describing different states of the injection pen 10 during use of the pen 10 .

[0251] FIG. 23A to FIG. 25B The injection pen 10 is shown 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 junction between the housing 32 and the piston guide 42. Thus, the dose setting knob 22 is completely covered by the knob cover 16, so that in this state, the user cannot set the dose prematurely. Fig. 23BIt can be seen that, in the delivery state, the drug reconstitution unit 56 forms two separate chambers 202, 204 separated by the first sealing element 208. This 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 FIG. 1 , where the knob cover 16 is erased to show what is underneath the knob cover 16 , 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 As can be seen in FIG. 4 , 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 in order 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 in order to show the position of the piston rod 44 in a preset state.

[0252] To start the preparation of the drug, such as by comparing Fig.25A and Fig.26A It can be seen that 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. As a result, the piston rod guide 42 moves into the annular space 258 ( 258 ) between the cartridge container 50 and the cartridge holder 52. Fig. 23B ). The piston disc 46 is clamped onto 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 prevents the second sealing element 210 arranged in the dual-chamber cartridge 48 from moving, so that the second sealing element 210 slides along the inner circumferential surface of the dual-chamber cartridge 48, and the cartridge container 50 is further screwed onto the piston rod guide 42. The solvent stored in the second chamber 204 pushes 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 create an overpressure in the cartridge, but 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 (see 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 is mixed with the solvent stored in the second chamber 204.

[0253] 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. 2 , the proximal end surface of the second sealing element 210 abuts against the distal end surface of the first sealing element 208, so that in the reconstructed state, the second chamber 204 no longer exists. Fig.27C As can be seen in the figure, 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 lot of air, which helps to create turbulence when moving the pen, making mixing of the lyophilized drug easier. As mentioned previously, the second opening 238 can be omitted. In this case, mixing occurs with a low amount of residual air.

[0254] After the reconstitution of the drug is completed, the user further rotates the cartridge container 500, 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 wing 58 of the knob cover 16 and spread the wing 58 radially outward (see Fig.28B ). The radially outwardly spreading wings 58 cause the form-fitting engagement means 60 of the knob cover 16 to disengage from the coupling surface 228, so that the knob cover 16 can be moved axially relative to the housing 32. The knob cover 16 can now be pulled off the housing 32 in the distal direction, thereby producing Fig.29A and Fig.29B The state shown above. 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. Therefore, the cartridge container 50 is rotationally locked to the piston rod guide 42 and the housing 32 of the device. Therefore, the movement of the cartridge container 50 and the cartridge 48 relative to the housing 32 and the piston rod guide 42 is suppressed.

[0255] like Fig.29A and Fig.29B As can be seen in the figure, at this stage, the knob key 30 is still stuck 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 removing the knob cover 16 by slightly bending the knob key 30.

[0256] Then, as in comparison Fig.29A and Fig. 30A As can be seen, 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.

[0257] Rotating the dose setting knob 22 causes rotation of the following components: the injection button 18 axially and rotationally connected to the dose setting knob 22 via the snap ring 20; the snap element 24 rotationally connected to the dose setting knob 22 via the teeth 108 meshing with the teeth 110; the driver 36 rotationally and axially coupled to the snap element 24; and the dose setting sleeve 34 rotationally and axially coupled to the driver 36. Due to the engagement of the outer thread 170 of the driver 36 with 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 combined axial and rotational movement of forced guidance during dose setting.

[0258] Furthermore, rotating the dose setting knob 22 causes rotation of the injection button 18 which is rotationally coupled to the nut 38. Since the piston rod 44 is rotationally fixedly coupled to the piston rod guide 42 (due to their corresponding non-round cross-sections 186, 188), when the dose setting knob 22, and thus the nut 38, is rotated, the nut 38 moves in the distal direction.

[0259] 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 pitch of the external threads 170 of the driver 36 is greater than the pitch of 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 pitch of the external threads 170 of the driver 36 may be 10.71 mm, while the pitch of the external threads 190 of the piston rod 44 may be 10.21 mm.

[0260] When setting a desired dose, 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.

[0261] 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 in the proximal direction 1 relative to the catch element 24. This causes the coupling device 100 to bend when passing the circumferential ledge 102, thereby generating 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 in the proximal direction 1 relative to the catch element 24 also causes the teeth 108 of the dose setting knob 22 to disengage from the teeth 110 of the catch 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.

[0262] If the user pushes the injection button 18 further, the injection button 18 and the dose selector 28 are moved in the proximal direction 1 relative to the snap element 24. 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 is moved in the axial direction relative to the hard stop 124 on the snap element 24, which allows the dose selector 28 and the snap element 24 to rotate relative to each other through the preset dose position towards the zero dose position.

[0263] 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 relatively large amounts of drug, the pen 10 does not have a so-called transmission device. In other words, the part that is configured to rotate relative to the housing during dose delivery is connected to the housing 32. This means that the distance that the piston disc 46 advances is substantially equal to the distance that the injection button 18 is pushed in the proximal direction 1 relative to the housing 32.

[0264] Since the driver rotates relative to the housing due to its external thread 170, the dose setting sleeve 34 rotates during dose delivery. Fig.33A and Fig.33B), the dose setting sleeve 34 is in a rotational position in which the zero dose label can be seen through the window 166 of the housing 32. The end-of-dose stop 174 of the driver 36 (see Fig. 13B ) and the end-of-dose stop 176 of the piston rod guide 42 (see Fig. 16C ) defines the end of movement of the injection button 18 in the proximal direction 1 during dose delivery.

[0265] 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.

[0266] In the pre-assembled state of the dose delivery mechanism 54, the injection pen 10 allows adjustment of the axial position of the piston rod 44 relative to the housing 32. In the pre-assembled state, the injection button 18 forming 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 positioning the injection button 18 in a pre-assembled position that is more distal than its assembled 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.

[0267] In the pre-assembled 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.

[0268] The adjustment of the piston rod 44 in the pre-assembled state is described in further detail below in conjunction 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.

[0269] Fig.34 and Fig.35 The second injection pen 300 is shown in a pre-assembled state. Fig.36 An exploded view of the 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 configured 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 drawings.

[0270] The second injection pen 300 comprises a dose delivery mechanism 354. The dose delivery mechanism 354 of the second injection pen 300 is configured 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.

[0271] The dose delivery mechanism 354 comprises a housing 332 having an upper housing part 333 and a piston rod guide 342 forming a lower housing part. The upper housing part 333 and the piston rod guide 342 are rigidly connected to each other via a form-fit connection. In particular, the upper housing part 333 and the piston rod guide 342 are axially and rotationally fixed to each other. The lower housing part formed by the piston rod guide 342 is configured to be connected to a medicament container holder 305 that receives a medicament container 348. The medicament container holder 305 comprises a connector 307, which is located at the 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, and the corresponding connector 343 can be accessed at the proximal side of the piston rod guide 342. After the medicament container holder 305 has been attached to the housing 332 , the connectors 307 , 343 provide a non-releasable form-fit connection between the medicament container holder 305 and the housing 332 .

[0272] The medication container 348 has a single medication chamber that is sealed at its distal end by a single plunger 210 (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 is releasably attached to the medicament container holder 305.

[0273] 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 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 outer thread on the outer surface of the dosing member 323 and an inner thread on the inner surface of the housing 332 (in the embodiment of FIG. 336). Fig.36 For other embodiments, the dosing member 323 may also be configured as a single component.

[0274] The dosing member 323 constitutes a dose indicating member of the dose delivery mechanism 354. Thus, the dosing element 334 comprises several markings which are visible through a window in the upper housing part 333 of the housing 332 when the dosing member 323 rotates relative to the housing 332 during dose setting.

[0275] The driver 336 is connected to the housing 332 via a further threaded connection 337 acting 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. Furthermore, 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 comprises first spline elements on the outer circumferential portion of the driver 336, which engage with corresponding second spline elements on the inner circumferential portion 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 further 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).

[0276] The pitch of the threaded connection 335 between the dosing member 334 and the housing 332 is different 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 different from the first axial distance.

[0277] Fig.38 A detailed view of the distal part of the second injection pen 300 in a pre-assembled state is shown. The adjustment element 318 differs from the adjustment element 18 of the injection pen 10 in that it does not feature a coupling device 100 that axially locks the adjustment element 18 to the snap element 24 when a dose is delivered. Therefore, the second injection pen 300 allows repeated setting and injection of user-definable doses. Apart from this modification, the adjustment element 318 is configured 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.

[0278] 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 (the biasing element 250 acts between the snap element 24 and the adjustment element 318) biases the adjustment element 318 in the distal direction to the pre-assembly position. Since the injection pen 10 does not feature the biasing element 250, the adjustment element 18 of the injection pen 10 is not maintained 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.

[0279] The assembly means 98b forms a latching part of the latching mechanism 99, while the coupling means 102 of the snap element 24 forms a latching counterpart of the latching mechanism 99. Furthermore, the dosing member 323 with the snap element 24 forms a counterpart of the latching mechanism 99. The latching mechanism 99 prevents the adjustment element 318 from being disassembled from the housing 332 in the pre-assembled state.

[0280] In the pre-assembled position, the adjustment element 318 protrudes distally from the dose setting element formed by the dose knob 22. The rotational fixation 90 of the adjustment element 318 then does not engage the rotational fixation 94 of the collar 20, so that the adjustment element 318 is rotationally movable relative to the housing 332 and the dose setting element 22.

[0281] In the pre-assembled position, the outer edge 19 of the adjustment element 318 is accessible to an assembler of the injection pen 300. 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 constrained by the driver 336 that pushes the pressing surface 194 at the proximal end of the nut 38 immobile. The threaded connection 189 between the piston rod 44, which forms the first threaded element, and the rotating nut 38, which forms the second threaded element, then 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.

[0282] The dose delivery mechanisms 54, 354 of the injection pens 10, 300 each comprise a rotation lock 89 formed by a rotation fixation 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 counterpart element to which the adjusting element 18, 318 is attached in the assembled state of the respective dose delivery mechanism 54, 354.

[0283] Furthermore, the axial securing 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 a 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 an assembled state.

[0284] The axial fixing means 82 of the adjusting element 18, 318 and the ribs 84 of the snap ring 20 also form a latching 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 latching mechanism prevents the adjusting element 18, 318 from moving from the second position relative to the counter-element to the first position relative to the counter-element. Thus, the second position is a proximal position in which the adjusting element 18, 318 is rotationally and axially fixed to the counter-element, while the first position is a distal position, which the adjusting element 18, 318 occupies in the pre-assembled state and in which the adjusting element 18, 318 can rotate relative to the counter-element.

[0285] 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 is shown in the assembled state during dose setting. Fig.39 and Fig.40 The section planes of the longitudinal sections shown in FIG. 5 are oriented perpendicular to one another.

[0286] The injection pen 300 is transformed from the pre-assembled state into the assembled state by moving the adjusting element 318 proximally from the pre-assembled position to the assembled position relative to the dose setting element 22 and the housing 332. This rotationally and axially locks the adjusting element 318 to the dose setting element 22 via the connector 20, the rotational lock 89 and the axial lock 81. In the assembled state, the distal assembly means 98a of the adjusting element 318 engage with the coupling means 102 of the snap element 24, thus irreversibly preventing the adjusting element 318 from moving from the assembled position to the pre-assembled position.

[0287] The distal assembly means 98a of the adjustment element 318 forms a latching portion of the latching mechanism 97, which is configured to prevent the adjustment element 318 from moving from the assembled position to the pre-assembled position relative to the housing 332. The coupling means 102 of the snap element 24 forms a latching counterpart of the latching mechanism 97, and the dosing member 323 with the snap element 24 forms a counterpart of the latching mechanism 97.

[0288] 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 is shown in the assembled state during dose delivery. Fig.41 and Fig.42 The section planes of the longitudinal sections shown in are oriented perpendicular to each other. 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 .

[0289] In the assembled state, during dose setting, the adjustment element 318 is rotationally coupled to the dosing member 323 via a clutch mechanism 107 (clutch), which is formed by teeth 108 (see FIG. 5 ) on the inner side surface of the dose setting element 22 and teeth 110 (see FIG. 6 ) on the outer side surface of the catch element 24. The dose setting element 22 forms a first coupling member of the clutch mechanism 107, while the catch element 24 forms a second coupling 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.

[0290] For each dose delivery mechanism 54, 354, in the assembled state, during dose setting, in the closed state of the corresponding coupling mechanism 107, the corresponding coupling mechanism 107 rotationally couples the corresponding adjustment element 18, 318 to the corresponding other component; in the assembled state, during dose delivery, in the open state of the corresponding coupling mechanism 107, the corresponding coupling mechanism 107 rotationally decouples the corresponding adjustment element 18, 318 from the corresponding other component.

[0291] For other embodiments of the coupling mechanism 107 that couples the adjustment element 18, 318 to other components, the second coupling component can also be formed integrally with these other components. For example, when the snap element 24 and the dosing element 334 are integrally formed as a one-piece dosing component 323, this dosing component 323 constitutes the other component and at the same time constitutes the second coupling component.

[0292] During dose delivery, the coupling mechanism 107 is opened, thereby rotationally decoupling the adjusting element 318 from the dosing member 323. In the pre-assembled state, the coupling mechanism 107 is closed, but the adjusting element 318 is rotationally decoupled from the coupling mechanism 107, so that the coupling 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.

[0293] In the assembled state, during dose delivery, the adjustment element 318 is rotationally coupled to the housing 332 via the further coupling mechanism 113, wherein the further coupling mechanism 113 is formed by the teeth 108 on the inner side surface of the dose setting element 22 and the teeth 114 on the outer side surface of the connector 26. Thereby, the dose setting element 22 forms a first coupling member of the further coupling mechanism 113 and the connector 26 forms a second coupling member of the further coupling mechanism 113. If the further coupling mechanism 113 is in the closed state and the first coupling member is engaged with the second coupling member, the adjustment element 318 is rotationally fixed to the additional member, which is formed by the housing 332.

[0294] During dose setting, the further coupling mechanism 113 is opened so that the adjusting element 318 is allowed to rotate relative to the housing 332. During dose delivery, the further coupling 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 decoupled from the further coupling mechanism 113, since it is allowed to rotate relative to both the first coupling member formed by the dose setting element 22 and the second coupling member formed by the connector 26.

[0295] Fig.43 shows a longitudinal section through the dose setting element 22 of the injection pen 10 and the second injection pen 300, Fig.44 A perspective view showing 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 element 22 with the teeth 108 of the coupling mechanism 107 , 113 is shown.

[0296] For both the coupling mechanism 107 and the further coupling mechanism 113, the coupling mechanism 107, 113 is in a closed state during one phase of dose setting and dose delivery, while the coupling mechanism 107, 113 is in an open state during the other phase of dose setting and dose delivery. Thus, when the further coupling mechanism 113 is open, the coupling mechanism 107 is closed; and when the further coupling mechanism 113 is closed, the coupling mechanism 107 is open.

[0297] Furthermore, for each coupling mechanism 107, 113, the adjustment element 318 occupies a dose setting position relative to the respective second coupling member 24, 26 during dose setting, and occupies a dose delivery position relative to the respective second coupling member 24, 26 during dose delivery. Thus, 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.

[0298] For the dose delivery mechanism 54 , 354 , the further coupling mechanism 113 also forms a locking mechanism which is configured to rotationally lock the adjustment element 18 , 318 to the housing 32 , 332 in the assembled state during dose delivery.

[0299] The dose selectors 28 of the dose delivery mechanisms 54, 354 each form a retaining member of the respective dose delivery mechanism 54, 354. In the pre-assembled state, each adjustment element 18, 318 is located in a first axial position relative to the retaining member, and each adjustment element 18, 318 is transferred from the first axial position to the second axial position relative to the retaining member, thereby transforming the respective dose delivery mechanism 54, 354 from the pre-assembled state to the assembled state. In the pre-assembled state, each adjustment element 18, 318 can rotate relative to the retaining member.

[0300] In the assembled state, each adjustment element 18, 318 is rotatable relative to the respective retaining member during dose setting, and in the assembled state, each adjustment element 18, 318 is rotationally fixed relative to the respective retaining member during dose delivery. For the dose delivery mechanism 54, 354, in the assembled state, each adjustment element 18, 318 is axially fixed relative to the respective retaining member.

[0301] For the dose delivery mechanism 54, 354, in the assembled state, during dose setting, the first threaded element formed by the piston rod 44 is axially immobile relative to a third element of the dose delivery mechanism 54, 354. The third element is thereby the housing 32, 332. Furthermore, in the assembled state, during dose setting, 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, while the second threaded element formed by the nut 38 is axially immobile relative to the third element formed by the housing 302, 332.

[0302] 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 decoupled from the snap element 24 , so that the snap element 24 does not rotate when the adjustment element 318 rotates.

[0303] For both dose delivery mechanisms 54, 354, the adjustment element 18, 318 is configured to be rotated in a pre-assembled state until the bearing 46 touches the distal surface of the plunger 210 after the medicament container 48, 348 has been attached. The method for adjusting the position of the piston rod 44 in the 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 touches 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.

[0304] The adjustment element 18, 380 can also be rotated until the bearing 46 is positioned 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. The distance can be measured, for example, by measuring the position of the bearing 46 relative to the plunger 210 through the medication container 305, which can be made of a transparent material.

[0305] Alternatively, the method may further comprise the step of adjusting the position of the piston rod 44 by rotating the adjusting 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 a pre-assembled state in an assembly jig and rotating the adjusting element 18, 318 until the proximal surface of the bearing 46 touches 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.

[0306] For example, for the injection pen 300, the medication container 348 may be attached to the housing 332, and then the adjustment element 318 may be rotated until the bearing 46 touches the distal surface of the plunger 210. The adjustment element 318 may then be further rotated until a predetermined torque is required for rotation.

[0307] 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 axially movably to the housing 32, so that the medicament container 48 can perform an axial movement from the receiving position to the operating position after being connected to the housing 32. Thereby, the receiving position is defined by the snap element 234 of the connector 43 engaging with the distal opening 236 of the medicament container holder 50, 52. The operating position is defined by the snap element 234 engaging 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.

[0308] 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 the position of the piston rod 44 can be adjusted by rotating the adjustment element 18 before attaching the drug container holder 50, 52 to the housing 32. 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 touches 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.

[0309] 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, at the end of the movement to the operating position, a certain amount of liquid medicament is discharged from the medicament container 48. For example, the position can be adjusted so that the amount of medicament is discharged only during the last quarter turn of the screwing movement of the medicament container holder 50, 52 onto the proximal part of the piston rod guide 42.

[0310] 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 advance a first distance in the proximal direction 1, 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 members 323 and the pitch of the further threaded connection 337 between the driver 336 and the housing 332.

[0311] Alternative embodiments 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 alternative embodiments may include the dosing component 23 of the first injection pen 10. As with 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.

[0312] 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 be configured to receive the dual-chamber cartridge 48 and perform reconstitution of the lyophilized drug before drug delivery.

[0313] Additionally or alternatively, the second injection pen 300 may also be configured to permanently axially lock the actuation member (such as 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.

[0314] 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 by means of the respective injection pen 10, 300. The blocking mechanism may be configured to permanently fix the dose setting element 22 to the housing 32, 332 at least rotationally 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 fix the actuation member 18 axially to a 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.

[0315] 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 , while the second blocking portion is exemplarily formed by the coupling device 102 .

[0316] The injection pen 10, 300 may comprise a coupling mechanism which, in a closed state of the coupling mechanism, rotationally locks the dose setting member 22 to the housing during dose delivery. The blocking mechanism may at least rotationally permanently fix the dose setting member 22 to the housing 32, 332 by locking the coupling mechanism in a closed state. The coupling mechanism may be, for example, the coupling mechanism 107.

[0317] The coupling mechanism may comprise, for example, a first coupling part (such as teeth 114 of the connector 26) which engages with a second coupling part (such as teeth 108 of the dose setting element 22) in a closed state of the coupling mechanism and disengages from the second coupling part in an open state of the coupling mechanism. For example, the first coupling part and the second coupling part may engage and disengage with each other when axially moving relative to each other. The coupling mechanism may be locked in a closed state, for example, by axially locking the first coupling part to the second coupling part.

[0318] Embodiments of the second injection pen 300 may be configured, like the first injection pen 10, to prevent a user from prematurely activating the second injection pen 300. Embodiments of the second injection pen 300 may be configured, like the first injection pen 10, to axially lock the actuation member 318 relative to the housing 332 before setting and delivering the first dose. Like the first injection pen 10, the second injection pen 300 may include a knob cover 16 and / or a knob key 30.

[0319] Like the first injection pen 10, the second injection pen 300 can also be preset to an injectable dose greater than zero in the delivery state. For example, the dosing member 323 can be preset to a position corresponding to a set dose greater than zero. Like the first injection pen 10, the second injection pen 300 can be configured to prevent the preset injectable dose from decreasing to zero.

[0320] 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 greater than zero. For example, at the end of dose delivery, the dosing member 23, 323 may occupy the second angular position.

[0321] 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.

[0322] 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, and in document WO 2020015980 A1, the stopper is referred to as a zero dose hard stopper.

[0323] 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 is shown in an assembled state during dose setting. The third injection pen 500 is configured as disclosed for the second injection pen 300 and vice versa, as long as differences are not disclosed in the description or the drawings.

[0324] The dose delivery mechanism 554 comprises a housing 532 configured to be connected to the medication container holder 505 via a non-releasable form-fit 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.

[0325] The medicine container holder 505 is configured to receive the medicine container 348 described in conjunction with the second injection pen 300. At the proximal end, the medicine container holder 505 includes a needle connector 306, which 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 connection. Alternatively, the connection can also be configured as a Luer lock, a snap-fit ​​connection or the like. When the needle assembly 501 is mounted on the medicine container holder 505, the distal end of the cannula 502 pierces the septum at the proximal needle end 349 of the medicine container 348. The proximal end of the cannula 502 is covered by a needle cap 503, which is removed before using the injection pen 500. During the storage of the injection pen 500, the cap 504 covers the medicine container holder 505.

[0326] 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 fixture 560 . Fig.50 A perspective distal view of the dosing member 523 is shown, and Fig.51 A longitudinal section through the dosing member 523 is depicted. The rotatable fixture 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 secures the dosing member 523 to the housing 532.

[0327] The dosage delivery mechanism 554 also includes a piston rod 44, which is Fig.52 523. The piston rod 44 is received in an opening 567 at the proximal end of the dosing member 523. Thereby, 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 provided at an outer circumferential portion of the piston rod 44. The piston rod 44 forms a first threaded element of the threaded connection 189, while the dosing member 523 forms a second threaded element of the threaded connection 189. At its proximal end, the piston rod 44 comprises a coupling device 198, which connects the bearing 46 axially fixedly and rotationally movable to the piston rod 44.

[0328] Fig.53 A perspective distal view of the extension 525 of the dose delivery mechanism 554 is shown, Fig.54 A distal view of the extension 525 is shown, and Fig.55A proximal view of the extension 525 is depicted. The extension 525 is received in the dosing member 523. It is held axially fixed and rotatably movable in the dosing member 523 by a rotatable fixing 570. The rotatable fixing 570 illustratively comprises 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.

[0329] 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.

[0330] Fig.56 Shown 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 bars 582 extending axially and parallel to each other in a proximal direction.

[0331] The coupling element 520 is rotationally fixed relative to the piston rod 44 and is axially movable. Thus, it is coupled to the piston rod 44 via the extension 525. Fig.57 It can be seen that the bar 582 of the coupling element 520 is received between two ridges 575 of the extension 525 that extend radially from the inner surface of the extension 525. Thus, the ridges 575 extend parallel to each other in the axial direction. The bar 582 and the ridges 575 provide an axially movable connection between the coupling element 520 and the extension 525, thereby rotationally fixing the coupling element 520 to the extension 525.

[0332] As from Fig.57 It can further be seen that the adjustment element 518 is axially and rotationally fixed to the distal end of the coupling element 520. Fig.58 A proximal perspective view of the adjustment element 518 is shown. Fig.59 A side view of the adjustment element 518 is shown. Fig.60 Draw along Fig.59 The line AA in FIG. 5 passes through the radial section of the adjustment element 518, and Fig.61 Draw along Fig.59 The line BB in FIG. 5 passes through a radial section of the adjustment element 518 .

[0333] 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 a part of the axial fixing member acting between the adjusting element 518 and the coupling element 520, and is engaged with the corresponding axial fixing element provided at the adjusting 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 adjusting element 518 is configured as a circumferential edge engaged with the snap hook. The coupling element 520 also includes at least one rotation fixing element 585, such as several rotation fixing elements 585. The rotation fixing element 585 is engaged with the corresponding rotation fixing element provided at the adjusting element 518, and thereby the adjusting element 518 is rotationally locked to the coupling element 520. The rotation 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 the corresponding longitudinal recesses 586 provided in the adjusting element 518. For other embodiments of the dose delivery mechanism 554, the adjustment element 518 and the coupling element 520 may also be configured as a one-piece, single component.

[0334] Fig.62 A perspective view of the coupling member 524 of the dose delivery mechanism 554 is shown. 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 fixture 563. The rotational fixture 563 includes a longitudinal notch 590 provided on the outer surface of the coupling member 524, which engages a corresponding longitudinal ridge 564 provided on the inner side surface of the dosing member 523, see Fig.50 and Fig.51 .

[0335] Fig.63 A perspective distal view of the sleeve 528 of the dose delivery mechanism 554 is shown, and Fig.64 A longitudinal section through the sleeve 528 is shown. The sleeve 528 is configured 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 .

[0336] The sleeve 528 is threadedly connected to and threadedly engaged with the dosing member 523. The threaded connection between the sleeve 528 and the dosing member 523 includes an internal thread 612 provided on the inner side surface of the sleeve 528, which engages an external thread 562 provided on the outer surface of the dosing member 523.

[0337] In addition, sleeve 528 is rotationally fixed and axially movable connected to housing 532. Thus, the connection between sleeve 528 and housing 532 includes connector 620. Connector 620 is located at the distal end of housing 532. It is axially and rotationally fixed relative to housing 532. For other embodiments, connector 620 can also be formed integrally with housing 532. Connector 620 includes a pair of radial lugs 622 provided at the outer surface of connector 620. The radial lugs 622 engage with corresponding openings 535 accessible at the inner surface of housing 532. Connector 620 also includes an outer annular rim 626 provided at the distal end of connector 620. The annular rim 626 rests on the distal surface of housing 532, thereby preventing connector 620 from moving in the proximal direction.

[0338] Longitudinal notches 624 are provided on the inside surface of the connector 620 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.

[0339] The dose sleeve 523 is configured as a dose indicating member and includes markings on its outer surface for indicating the set dose. A window 610 is formed in the sleeve 528, through which the dose sleeve 523 can be seen. 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 can be seen from outside the housing 532. The markings visible through the windows 534, 610 indicate the set dose.

[0340] 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.

[0341] Fig.66 A perspective view of connector 527 is shown, and Fig.67 A perspective view of a longitudinal section through the connector 527 is shown. The connector 527 is axially and rotationally fixed relative to the sleeve 528. The connector comprises a longitudinal ridge 632 on its outer surface which aligns with a corresponding notch 618 provided on the inner side surface of the sleeve 528 (see Fig.64) engagement. In addition, the connector 527 includes radially extending lugs 630 that engage with openings 614 accessible on the inside surface of the sleeve 528. This engagement prevents the connector 527 from being removed from the sleeve 528.

[0342] On the inner side 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 rotationally movable connection to the coupling member 524. Thus, a distal blocking element 635 and a proximal blocking element 654 are provided on the outer surface of the coupling member 524 and extend in the radial direction (see Fig.62 )'s annular edge 592 is received between blocking elements 635 , 654 .

[0343] In addition, a radial stopper 568 is formed between the sleeve 528 and the dosing member 523. This radial stopper 568 is configured to stop the relative rotation between the dosing member 523 and the sleeve 528, and thus between the dosing member 523 and the housing 532 at the end of the dose delivery. The radial stopper 568 includes at least one stopper surface 569 provided at the dosing member 523 and a corresponding stopper surface 636 provided 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 an 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 provided at the connector 527, for other embodiments, the stopper surface 636 may also be provided directly at the sleeve 528.

[0344] 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.

[0345] Fig.68 A side view of the third injection pen 500 is shown in an assembled state during dose setting, where no dose has been set. Fig.69 A side view of the third injection pen 500 is shown in a pre-assembled state. In the pre-assembled state, the adjustment element 518 is located in a pre-assembled position relative to the housing 532, and in the assembled state, during dose setting, and when no dose is set, the adjustment element 518 is located in an assembled position relative to the housing 532. Thus, the assembled position is located more proximally than the pre-assembled position.

[0346] 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 views shown in FIG. 1 are oriented in the longitudinal cutting plane.

[0347] During dose setting, the adjustment element 518 is rotationally fixed relative to the coupling member 524 by the coupling mechanism 507. The rotation of the adjustment element 518 then causes a rotation of the piston rod 44 (due to the rotational fixation via the extension 525 and the coupling element 520) and a simultaneous rotation of the dosing member 523 (due to the rotational fixation via the coupling element 520, the coupling 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.

[0348] Due to the threaded connection 562, 612, the rotation of the dosing member 523 relative to the sleeve 528 during dose setting causes the sleeve 528 to move axially in the distal direction relative to the housing 532. 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.

[0349] As from Fig.70 and Fig.71 It can be seen that the adjustment element 518 is coupled to the sleeve 528 via a latch 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 latch mechanism 597 includes a latch portion 600 located at the proximal end of the adjustment element 518, which engages with a latch counterpart portion 529 of the sleeve 528. The latch counterpart portion 529 of the sleeve 528 is configured as an annular edge located at the outer side surface of the sleeve 528. The latch 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 to the pre-assembled position.

[0350] 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 shown in FIG. Fig.48 in and Fig.70 and Fig.71 Not visible in.

[0351] During dose setting, during rotation of the dosing member 523 and axial movement of the sleeve 528 relative to the housing 532, the window 610 of the sleeve 528 moves axially along the dosing member 523. Thereby, the corresponding marking on the dose sleeve 523 visible through the window 610 indicates the currently set dose.

[0352] 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 .

[0353] 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.

[0354] 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 start of dose delivery closes the coupling mechanism 513 between the adjusting element 518 and the sleeve 528. The coupling 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 coupling 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.

[0355] The proximal movement of the coupling element 520 relative to the coupling member 524 at the start of dose delivery causes the coupling 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 coupling 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 proximal movement of the piston rod 44, which is driven via the threaded connection 189.

[0356] 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 preassembled state is shown, whereby the longitudinal section plane is perpendicular to Fig.74 The longitudinal cutting plane orientation of the view in .

[0357] 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 assembled positions in the assembled state.

[0358] The dose delivery mechanism 554 comprises a further latching mechanism 599 which prevents disassembly of the adjustment element 518 and the coupling element 520 in the pre-assembled state. The further latching 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. Thereby, the further latching counterpart 530 is positioned distally from the latching counterpart 529.

[0359] The further latch counterpart 530 is configured as an angular recess that receives the radial lug of the latch portion 600 of the adjustment element 518. Thus, the latch portion 600 formed by the radial lug releasably engages with the further latch counterpart 530 and allows proximal movement of the adjustment element 518 while blocking distal movement.

[0360] In the pre-assembled state, the coupling mechanism 507 between the coupling element 520 and the coupling member 524 is open, so that the adjustment element 518 is rotationally decoupled 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. Thus, the rotation of the adjustment element 518 relative to the housing 532 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.

[0361] For the coupling mechanism 507, the coupling element 520 forms a first coupling member of the coupling mechanism 507 and the coupling member 524 forms a second coupling member of the coupling 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 adjustment element 518 is rotationally coupled during dose setting in the assembled state and from which the adjustment element 518 is rotationally decoupled during dose delivery in the assembled state.

[0362] The coupling element 520 includes a first coupling part 508 of the coupling mechanism 507. The first coupling part 508 is configured as radial teeth provided on the outer surface of the coupling element 520. The coupling member 524 includes a second coupling part 509 of the coupling mechanism 507. The second coupling part 509 is configured as radial teeth located on the inner side surface of the coupling member 524. In the closed state of the coupling mechanism 507, the first coupling part 508 is engaged with the second coupling part 509, as shown in FIG. Fig.71 as shown in .

[0363] During adjustment of the piston rod in the pre-assembled state, the coupling mechanism 507 is in the open state. Thereby, the first coupling part 508 and the second coupling part 509 are disengaged by positioning the first coupling part 508 and the second coupling part 509 at a certain axial distance from each other. Thereby, the first coupling part 508 is displaced from the second coupling part 509 in the distal direction, which is opposite to the proximal direction 1, see Fig.74 In the assembled state, during dose delivery, the coupling mechanism 507 is also in the open state. Thereby, the first coupling part 508 and the second coupling part 509 are also disengaged by positioning the first coupling part 508 and the second coupling part 509 at a certain axial distance from each other, whereby the second coupling part 509 is displaced from the first coupling part 508 in the proximal direction 1, see Fig.72 .

[0364] Furthermore, the adjustment element 518 forms a first coupling member of the coupling mechanism 513 and the sleeve 528 forms a second coupling member of the coupling mechanism 513. The housing 532 of the dose delivery mechanism 554 forms an additional member of the dose delivery mechanism 554 to which, in the assembled state, the adjustment element 518 is rotationally coupled during dose setting and from which, in the assembled state, the adjustment element 518 is rotationally decoupled during dose delivery.

[0365] The sleeve 528 forms a retaining member for the adjustment element 518 .

[0366] The dose delivery mechanism 554 includes a dose limiting mechanism 115 that limits a dose that can be set by a user. The engagement feature 116 of the dose limiting mechanism 115 is provided at the adjustment element 518, see Fig.58 The engagement feature 116 is configured as a radially extending lug which is flexible in the radial direction. The engagement feature 116 engages with a corresponding dose stop 118 provided at the distal end of the sleeve 528, see Fig.63 , 64 The dose stop 118 is configured as a longitudinal notch 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 rotation around the longitudinal axis of the dose delivery mechanism 554.

[0367] During adjustment of the piston rod 44 in the pre-assembled state, the dose limiting mechanism 115 of the dose delivery mechanism 554 is inactive. 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 out of mutual engagement, see Fig.75 .

[0368] 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. In the assembled state, during dose delivery, 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.

[0369] For the third injection pen 500, the piston rod 44 can 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 to the pitch of the further threaded connection 562 between the sleeve 528 and the dosing member 523.

[0370] 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 be configured to receive the dual-chamber cartridge 48 and perform reconstitution of the lyophilized drug before drug delivery.

[0371] Embodiments of the third injection pen 500 may be configured, like the first injection pen 10, to prevent a user from prematurely activating the third injection pen 500. Embodiments of the third injection pen 500 may be configured, like the first injection pen 10, to axially lock the actuation member 520 relative to the housing 532 before setting and delivering the first dose. Like the first injection pen 10, the third injection pen 500 may include a knob cover 16 and / or a knob key 30.

[0372] 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 configured 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 marked with the same reference numerals. However, these components differ in shape and / or appearance between the third injection pen 500 and the fourth injection pen 700.

[0373] 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 .

[0374] Fig.78 A side view of the fourth injection pen 700 is shown in a preassembled state with the adjustment element 518 in a preassembled position relative to the housing 532. In the preassembled position, the adjustment element 518 is displaced in a distal direction from its assembled position, whereby the distal direction is oriented perpendicular to the proximal direction 1.

[0375] Fig.79A side view of the fourth injection pen in a pre-assembled state is shown with the adjustment element 518 in the adjustment position. In the adjustment position the adjustment element 518 is displaced in the proximal direction compared to the pre-assembled position.

[0376] 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, without a dose being set.

[0377] Like 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 (does not have) 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 to allow axial movement between the coupling element 720 and the piston rod 44.

[0378] The dose delivery mechanism 754 also includes a biasing element in the form of a spring that Fig.80 and Fig.81 The biasing element biases the adjustment element 518 in the distal direction both in the pre-assembled state and in the assembled state of the dose delivery mechanism 754 .

[0379] 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 a 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 the non-circular inner cross-section of the 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 .

[0380] Figure 85 to Figure 89An 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. Thereby, the adjustment element 518 is rotationally fixed relative to the coupling element 720 in both a pre-assembled state and an assembled state of the dose delivery mechanism 704. The rotation lock between the coupling element 720 and the adjustment element 518 comprises a non-circular outer cross-section of the coupling element 720 that matches and engages with a corresponding inner shape of a central opening 519 of the adjustment element 518.

[0381] The latch mechanism 597 acts between the coupling element 720 and the adjusting element 518. In the assembled state of the dose delivery mechanism 754, the latch 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 latch mechanism 597 includes a latch portion 600 formed at the adjusting element 518 and a latch mating portion 529 formed at the coupling element 720. The latch portion 600 is configured as a flexible hook that protrudes radially inwardly from the inner surface of the adjusting element 518 at the opening 519. The latch mating portion 529 is configured as a recess at the outer surface in the distal portion of the coupling element 720.

[0382] The coupling element 720 may form a retaining member of the dose delivery mechanism 754 .

[0383] In the pre-assembled state of the dose delivery mechanism 754, the adjustment element 518 is positioned 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 disassembled 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.

[0384] Figure 90 to Figure 93 The sleeve 528 of the dose delivery mechanism 754 is shown, the sleeve 528 being rotationally fixed and axially movable relative to the housing 532. The sleeve 528 includes longitudinal notches on its outer surface that engage corresponding longitudinal ridges on the inside 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.

[0385] 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 comprises an engagement feature 116 which is configured as a flexible hook and is provided at the proximal end of the adjustment element 518. The engagement feature 116 interacts with a dose stop 118 provided in a proximal portion of the inner side surface of the insert 528b of the sleeve 528.

[0386] Furthermore, the dose delivery mechanism 754 comprises a coupling mechanism 513 acting between the adjustment element 518 and the sleeve 528. The coupling mechanism 513 comprises teeth 515 located at the proximal outer surface of the adjustment element 518. When the coupling 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.

[0387] The adjusting element 518 forms a first coupling member of the coupling mechanism 513, and the sleeve 528 forms a second coupling member of the coupling mechanism 513. The housing 532 of the dose delivery mechanism 754 forms an additional member of the dose delivery mechanism 754, to which the adjusting element 518 is rotationally coupled in the assembled state during dose setting, and from which the adjusting element 518 is rotationally decoupled in the assembled state during dose delivery. Furthermore, the coupling mechanism 513 forms a locking mechanism, which, in the assembled state of the dose delivery mechanism 754, rotationally locks the adjusting element 718 to the housing 53 during dose delivery.

[0388] 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 held 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.

[0389] The coupling mechanism 507 acts between the coupling member 524 and the coupling element 720, which is received in the coupling member 524. The coupling mechanism 507 comprises a first coupling part 508, which is located at the outer side surface of the coupling element 720 and comprises longitudinal teeth. The coupling mechanism 507 also comprises a second coupling part 509, which is located on the inner side surface of the coupling member 524. The second coupling part 509 is configured as longitudinal teeth, which mesh with the longitudinal teeth of the first coupling part 508 in the closed state of the coupling.

[0390] The coupling element 520 forms a first coupling member of the coupling mechanism 507, and the coupling member 524 forms a second coupling member of the coupling 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 adjustment element 518 is rotationally coupled during dose setting in the assembled state, and from which the adjustment element 518 is rotationally decoupled during dose delivery in the assembled state.

[0391] 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.

[0392] As from Fig.99 and Fig.100 ( Fig.99 and Fig.100 The dose delivery mechanism 754 is shown in an assembled state during dose setting without setting a dose. It can be seen that during dose setting, the coupling mechanism 507 between the coupling element 720 and the coupling member 524 is closed, while the coupling 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.

[0393] 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 completely expelled and the user still pushes the adjustment element 518 in the proximal direction 1. During dose delivery, the coupling mechanism 507 opens, thus allowing a rotation between the piston rod 44 and the dosing member 523, and the coupling mechanism 513 closes, thus rotationally locking the piston rod 44 to the housing 532.

[0394] Fig.103 and Fig.104 The dose delivery mechanism 754 is shown 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 provided at the coupling element 720 distally from the latch counterpart 529. Fig.103 and Fig.104 In the state shown in FIG. 5 , the adjustment element 518 is positioned in a pre-assembly position relative to the housing 532 .

[0395] 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 to the adjustment 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 adjustment element 518 results in the proximal movement of the coupling element 720 and the opening of the coupling mechanism 507. At the same time, the coupling mechanism 513 remains open and prevents the teeth 515 of the adjustment 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.

[0396] When the assembler of the fourth injection pen 700 Fig.105 and Fig.106 When the adjusting element 518 is rotated to the adjustment position shown in FIG. 1 , the piston rod 44 rotates together with the adjusting element 518, and the dosing member 523 does not rotate due to the open coupling mechanism 507. The rotation of the piston rod 44 relative to the dosing member 523 causes the piston rod 44 to move axially relative to the housing 532 via the threaded connection 189.

[0397] 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 to the pitch of the further threaded connection 562 between the sleeve 528 and the dosing member 523.

[0398] 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 be configured to receive the dual-chamber cartridge 48 and perform reconstitution of the lyophilized drug before drug delivery.

[0399] Embodiments of the fourth injection pen 700 may be configured, like the first injection pen 10, to prevent a user from prematurely activating the fourth injection pen 700. Embodiments of the fourth injection pen 700 may be configured, like the first injection pen 10, to axially lock the actuation member 520 relative to the housing 532 before setting and delivering the first dose. Like the first injection pen 10, the fourth injection pen 700 may include a knob cover 16 and / or a knob key 30.

[0400] 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.

[0401] For the injection pen 10, 300, 500, 700, the dose delivery mechanism 54, 354, 554, 754 each comprises a dose limiting mechanism 115, wherein during dose setting, the respective dose limiting mechanism 115 acts between the respective dose setting element 18, 318, 518 and the housing 32, 332, 532. 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 a respective engagement feature 116 of the dose delivery mechanism 54, 354, 554, 754.

[0402] 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 complete rotation during dose setting. For the third injection pen 500 and the fourth injection pen 700, the dose limiting mechanism 115 may also include a separate dose stop 118 that defines more than a single dose, for example, the separate dose stop 118 may be configured to engage with the counterpart element 116 once for each complete rotation of the counterpart element 116 relative to the dose stop 118.

[0403] The counterpart element 116 may be configured as a flexible element that snaps onto the dose stop 118 when setting the dose. For example, the counterpart element 116 may be configured as a flexible protrusion at a component of the respective dose delivery mechanism 54, 354, 554, 754. The counterpart element 116 may, for example, be formed integrally with a component to which the counterpart element of the respective dose delivery mechanism 54, 354, 554, 754 is fixed. For the first injection pen 10 and the second injection pen 300, the component is formed by the dosing member 23, 323; for the third injection pen 500 and the fourth injection pen 700, the component is formed by the dose setting element 518.

[0404] 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 during dose setting when the dose setting element 22 is rotated. Thereby, the dose limiting mechanism 115 may provide a latching 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.

[0405] 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 is transformed 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 is transformed into 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.

[0406] For example, the counter element 116 may be configured to be disengaged from the dose stop 118 by being axially moved relative to the dose stop 118 .

[0407] 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 can then be axially moved relative to the dose setting element 22, 518.

[0408] For the first injection pen 10 and the second injection pen 300, 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 dose stop 118 and the counter element 116 to be moved 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. The one of the dose stop 118 and the counter element 116 can then be disengaged from the other of the dose stop 118 and the counter element 116 by this movement. For example, the dose stop 118 and the counter element 116 can be linearly guided at the housing 32, 332.

[0409] For some embodiments, the dose stop 118 and the one of the mating elements 116 are fixed to an outer housing portion of the respective dose delivery mechanism 54, 354, 554, 754. The outer housing portion may be fixed to a connection for coupling the medicament container 48, 348 to the respective dose delivery mechanism 54, 354, 554, 754. Alternatively, the outer housing portion may also be movable relative to the connection, such as axially movable. In addition, the outer housing portion may be rotationally fixed relative to the connection. For example, the outer housing portion may be a housing connector, such as a housing connector engaged with the housing 32, 332, 532 via an axially movable and rotationally fixed connection. For the first injection pen 10 and the second injection pen 300, the outer housing portion is formed by the dose selector 28; for the third injection pen 500 and the fourth injection pen 700, the outer housing portion is formed by the sleeve 528.

[0410] For the first injection pen 10 and the second injection pen 300, the dose limiting mechanism 115 acts between the dosing member 23, 332 and the housing 32, 332, 532. It then defines the rotational positions of the dosing member 23, 332 relative to the housing 32, 332, which correspond to the settable doses.

[0411] 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, 332. Exemplarily, the dose stop 118 and the other of the counter element 116 are rotationally fixed relative to the dosing member 23, 332. The dose stop 118 and the other of the counter element 116 are exemplarily additionally fixed to the dosing member 23, 332, such as to a first part of the dosing member 23, 332 that is movable relative to the housing 32, 332, 532.

[0412] For the first injection pen 10, the second injection pen 300, the third injection pen 500 and the fourth injection pen 700, the dose stop 118 and the other of the counter element 116, such as the counter element 116, are axially movable relative to the button 18, 318, 518. 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, as is the case with the first injection pen 10 and the second injection pen 300.

[0413] For the second injection pen 300, the dose delivery mechanism 354 includes a blocking mechanism having a first element and a second element, wherein during dose delivery, when the button 318 is released, the first element engages the second element to prevent the corresponding dose delivery mechanism 354 from changing from the dose delivery state to the dose setting state. This maintains the corresponding dose delivery mechanism 354 in the dose delivery state and prevents a change in the dose setting when the dose delivery is interrupted by the torque provided by the spring 40. The blocking mechanism can block the distal movement of the button 318 against the biasing force biasing the button 318 in the distal direction. The biasing force can be provided by the biasing element 250.

[0414] The blocking mechanism is configured to disengage the first element from the second element in 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.

[0415] Exemplarily, the first element rotates in a first direction relative to the second element 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 can bring the first element and the second element into a relative position that prevents mutual engagement at the end of dose delivery and / or when a dose has been set.

[0416] 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.

[0417] Exemplarily, when the button 318 is released at the end of the dose delivery, the second element passes the first element. For example, the second element can pass through an opening in the first element. At the end of the dose delivery, the second element can be rotated to align with the opening.

[0418] Additionally or alternatively, the 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 the dose has been set. Such a blocking mechanism is also exemplarily 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.

[0419] Illustratively, when the mechanism is transitioned 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 an opening 158 prevents obstruction and thus allows axial movement of the button 18, 318 to initiate dose delivery.

[0420] Exemplarily, one of the dose stop 118 and the counter element 116 (such as the dose stop 118) and the first element of the blocking mechanism are fixed to the same component of the dose delivery mechanism 54, 354. In addition, the other of the dose stop 118 and the counter element 116 (such as the counter element 116) and the second element of the blocking mechanism are fixed to the same further component of the dose delivery mechanism 54, 354. This allows to precisely align the elements of the blocking mechanism with the elements of the dose limiting mechanism 115 and enhance the reliability of the dose delivery mechanism 54, 354.

[0421] The component of the mechanism comprising the first element of the blocking mechanism and 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 rotationally movable relative to the dose selector 28. The carrier is exemplarily a part of the dosing member 23, 332, i.e. the snap element 24 of the dosing member 23, 323.

[0422] 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.

[0423] 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 by 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 by a single element. This facilitates alignment of the components of the blocking mechanism relative to the components of the dose limiting mechanism 115.

[0424] The single element is exemplarily a flexible element which is configured to snap onto the dose stop 118 when rotated relative to the dose stop 118 .

[0425] 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 exceeds a 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 exceeds 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.

[0426] 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 the maximum dose setting has been dialed past by a predefined amount.

[0427] The blocking portion 124 is exemplarily configured as a hard stop that is rigidly connected to a component of the mechanism, such as being integrally formed. Likewise, the maximum dose stop 126126 is exemplarily configured as such a hard stop.

[0428] 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, while 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.

[0429] Illustratively, 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 past the maximum dose. Such a radial stop provides a well-defined rotational position where the blocking portion 124 and the maximum dose stop 126 engage.

[0430] The maximum dose stop 126 and the blocking portion 124 exemplarily comprise mutually engaging engagement surfaces. These engagement surfaces exemplarily are oriented substantially vertically (ie perpendicular to the circumferential direction around the longitudinal axis of the dose delivery mechanism 54, 354).

[0431] Illustratively, the maximum dose stop 126 and one of the blocking portion 124, such as the maximum dose stop 126, is rotationally fixed relative to the housing 32, 332. The maximum dose stop 126 and the one of the blocking portion 124 are illustratively permanently rotationally fixed relative to the housing 32, 332 both during dose setting and dose delivery.

[0432] Exemplarily, 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.

[0433] Exemplarily, the maximum dose stop 126 and another element of the blocking portion 124 (such as the blocking portion 124) are rotationally fixed relative to the dosing member 23, 332. The maximum dose stop 126 and this other element of the blocking portion 124 are 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, 332 defines the dose that has been set, the maximum dose stop 126 and one of the blocking portion 124 are rotationally fixed to the dosing member 23, 332 to precisely define the maximum dose position in which the maximum dose stop 126 and the blocking portion 124 engage with each other.

[0434] Exemplarily, the maximum dose stop 126 and the further element of the blocking portion 124 are fixed to a coupling member which rotationally couples the dosing member 23 , 332 to the dose setting member during dose setting. The coupling member is formed by the snap element 24 .

[0435] 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 position of the components of the dose limiting mechanism 115 relative to the components of the maximum dose mechanism to be precisely defined. The component of the dose delivery mechanism 54, 354 is exemplarily the dose selector 28.

[0436] 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 position 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 which is rotatably movable relative to the dose selector 28 and is formed by the snap element 24.

[0437] Exemplarily, the dose delivery mechanism 54, 354 of the first injection pen 10 and the second injection pen 300 comprises a zero dose mechanism which 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 well-defined end position for the piston rod 44 at the end of dose delivery and thus helps to accurately define the amount of medicament delivered.

[0438] 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, while the 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 inside surface of the dose selector 28, while the further blocking portion is formed by the hard stop 124 at the snap element 24.

[0439] The further blocking portion 124, 174 is exemplarily configured as a hard stop, which is rigidly connected, such as integrally formed, with a component of the dose delivery mechanism 54, 354. Likewise, the zero dose stop 176 is exemplarily configured as such a hard stop.

[0440] 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, while the other of the zero dose stop 176 and 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 rotationally movable relative to the dose setting element 22 during dose delivery.

[0441] 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 come into mutual engagement.

[0442] The zero dose stop 176 and the further blocking portion 124, 174 exemplarily comprise mutually engaging engagement surfaces. These engagement surfaces may be oriented substantially vertically (such as perpendicular to a circumferential direction around a longitudinal axis of the dose delivery mechanism 54, 354).

[0443] Illustratively, the zero dose stop 176 and one of the further blocking parts 124, 174, such as the zero dose stop 176, are rotationally fixed relative to the housing 32, 332. The zero dose stop 176 and one of the further blocking parts 124, 174 are illustratively permanently rotationally fixed relative to the housing 32, 332 both during dose setting and dose delivery.

[0444] Exemplarily, 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. Alternatively, the first injection pen 10 may also comprise such a zero-dose stopper 176.

[0445] Exemplarily, the zero dose stop 176 and the other element of the further blocking portion 124, 174 are rotationally fixed relative to the dosing member 23, 332. The zero dose stop 176 and the other element of the further blocking portion 124 rotate relative to the housing 32, 332 during both dose setting and dose delivery. This allows the zero dose mechanism to be reset during dose setting. For embodiments in which the rotational position of the dosing member 23, 332 defines the dose that has been set, the zero dose stop 176 and one of the further blocking portions 124, 174 are rotationally fixed to the dosing member 23, 332 to precisely define the zero dose position in which the zero dose stop and the further blocking portion 124 engage with each other.

[0446] For the second injection pen 200, the zero dose stop 176 and the further element of the further blocking portion 124, 174 are fixed to a coupling member which rotationally couples the dosing member 23, 332 to the dose setting member 22 during dose setting. The coupling member is formed by the snap element 24 of the dosing member 323. The first injection pen 10 may also comprise such a configuration.

[0447] Exemplarily, the dose stop 118 of the second injection pen 300 and one of the counter element 116 (such as the dose stop 118) and the zero dose stop of the second injection pen 300 and one of the further blocking portion 124 (such as the zero dose stop) are fixed to the same component of the dose delivery mechanism 354. This allows the relative position of the components of the dose limiting mechanism 115 relative to the components of the zero dose mechanism to be precisely defined. This component of the dose delivery mechanism 354 is exemplarily the dose selector 28. The first injection pen 10 may also have such a configuration.

[0448] 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 zero dose stop and the other of 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 position of the components of the dose limiting mechanism 115 with respect to the components of the zero dose mechanism to be precisely defined. The further component may, for example, be a carrier that is rotatably movable relative to the dose selector 28. The first injection pen 10 may also have such a configuration.

[0449] Exemplarily, for the second injection pen 300, the maximum dose stopper 126 of the maximum dose mechanism and one element in the blocking portion 124 and the zero dose stopper of the zero dose mechanism and one element in the further blocking portion 124 (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 another element in the blocking portion 124 and the zero dose stopper of the zero dose mechanism and another element in the further blocking portion 124 (such as the blocking portion 124 and the further blocking portion 124) are fixed to the same further component of the mechanism. This achieves precise alignment between the components of the maximum dose mechanism and the components of the zero dose mechanism. The first injection pen 10 may also have such a configuration.

[0450] 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.

[0451] 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. The first injection pen 10 may also have such a configuration.

[0452] In general, the dose delivery mechanism 54, 354, 554, 754 may include a coupling mechanism 113 having a first engagement portion and a second engagement portion, wherein the coupling mechanism 113 is closed during one stage of dose setting and dose delivery, and is open during the other stage of dose setting and dose delivery. When the first engagement portion and the second engagement portion are not engaged with each other, the coupling mechanism 113 is in an open state; and when the first engagement portion and the second engagement portion are engaged with each other, the coupling mechanism 113 is in a closed state.

[0453] Illustratively, the dose delivery mechanism 54, 354 of the first injection pen and the second injection pen comprises a coupling mechanism 113, wherein the coupling 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 coupling mechanism 113 forces the nut 38 to move proximally together with the piston rod 44. Illustratively, the coupling mechanism 113 rotationally locks a threaded connection 189 coupling the nut 38 to the piston rod 44. The coupling 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.

[0454] The coupling mechanism 113 exemplarily comprises 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.

[0455] The coupling 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 and second engagement portions (such as the second engagement portion) is axially fixed relative to the button 18, 318, while the other of the first and second engagement portions (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, 332.

[0456] 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 .

[0457] The second engagement portion is exemplarily rotationally fixed to the button 18 , 318 and / or the dose setting member 22 .

[0458] Illustratively, the coupling 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.

[0459] Illustratively, the coupling mechanism 113 acts between the button 1 , 318 and the housing 32 , 332 and / or between the dose setting member 22 and the housing 32 , 332 .

[0460] Exemplarily, the button 18, 318 is rotationally coupled (such as permanently rotationally coupled) to one of the first and second engagement portions. As an example, the button 18, 318 constitutes the one of the first and second engagement portions.

[0461] Exemplarily, the dose delivery mechanism 54, 354 comprises a further coupling mechanism 107, wherein the further coupling mechanism 107 rotationally locks the dose setting element 22 to one end of the spring 40 during dose setting and decouples the dose setting element 22 from the one end of the spring 40 during dose delivery. Furthermore, the further coupling 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 end of the spring 40. The further coupling mechanism 107 allows tensioning the spring 40 during dose setting and at the same time prevents the dose setting element 22 from rotating during dose delivery when the spring 40 is relaxed again. The further first engagement portion is exemplarily formed by teeth 110 at the snap element 23, while the further second engagement portion is exemplarily formed by teeth 108 at the button 22.

[0462] The further coupling 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.

[0463] Illustratively, one of the further first and second engagement portions, such as the further second engagement portion, is rotationally and axially fixed to the dose setting member 22. This allows the further coupling 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 and second engagement portions.

[0464] Illustratively, the 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.

[0465] Exemplarily, the further coupling mechanism 107 acts between the dosing member 23, 332 and the dose setting element 22. The dosing member 23, 332 may then rotationally couple the dose setting element 22 to this end of the spring 40.

[0466] Exemplarily, one of the further first and second engagement portions, such as the further first engagement portion, is rotationally fixed to the dosing member 23, 332. Exemplarily, the one of the further first and second engagement portions may be axially fixed to the dosing member 23, 332.

[0467] Exemplarily, the coupling 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 coupling mechanism 107 forms the first engagement portion of the coupling mechanism 113. This provides a compact construction of the coupling mechanisms 107, 113.

[0468] 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 one of the button 18, 318 and the dose setting element 22 (such as the button 18, 318) and the nut 38.

[0469] 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, while 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, the rotation of the nut 38 relative to the piston rod 44 during dose setting causes 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.

[0470] During dose setting, the nut 38 is rotated by the dose setting member 22 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.

[0471] Some general notes about this disclosure:

[0472] The second threaded connection 170, 172 may be provided between the driver 36 and the piston rod guide 42. However, there are various 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.

[0473] Preferably, the actuation member 18, 20, 22 is coupled to the piston rod 44 via the nut 38, such that axial movement of the actuation member 18, 20, 22 during dose delivery causes axial movement of the nut 38 and the piston rod 44. To apply an axial force from the nut 38 to the piston rod 44 during dose delivery to move the piston rod 44 in an axial direction via the nut 38, the nut 38 forms a first threaded connection with the piston rod 44 via an outer thread 190 that meshes with an inner thread 192. The nut 38 and the piston rod 44 are blocked from relative rotational movement during dose delivery, such that axial movement of the nut 38 causes axial movement of the piston rod 44.

[0474] 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 is 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 configured to rotate relative to the housing 32 during dose delivery. All parts of the delivery mechanism 54 configured to rotate relative to the housing 32 during dose delivery may form a subassembly. This subassembly may form exactly one threaded connection 170, 172 with the housing 32 or any part rigidly connected to the housing 32.

[0475] The coupling means 100, 102 may be formed on the injection button and the snap element 24. However, alternatively, the coupling means 100 may 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 various options for placing 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.

[0476] Typically, the dose setting mechanism may include a coupling 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, rotating the dose setting knob causes the nut 38 to rotate relative to the piston rod 44 during dose setting. There are a variety of ways to design the connection between the dose setting knob and the nut 38.

[0477] Typically, the piston rod 44 may be rotationally fixed relative to the housing during dose delivery / dispensing.

[0478] The proximal end 14 includes a dispensing outlet. The distal end 12 is arranged at an opposite end of the proximal end 14. The dispensing outlet may include one of a needle, a cannula, and a connection point for the needle or the cannula.

[0479] The cap 16 may cover a portion of a dose delivery activation mechanism configured to activate dose delivery. The dose delivery activation mechanism is a part configured to permit dispensing of a dose from a delivery device. The activation mechanism may include an injection button 18, which forms the distal end face of the injection pen. The cap 16 may also cover a dose setting knob 22. Thereby, the cap 16 prevents setting the dose and / or activating the injection before mixing of the two components is complete.

[0480] The delivery state is a state in which all parts of the dose delivery mechanism 54 are arranged in the same relative position relative to each other as they were after manufacturing the dose delivery mechanism 54. In other words, the delivery state is a state in which the user has not yet 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 state", but in the "setting state". According to an embodiment, in the "delivery state", the dose setting knob 22 is not rotatable towards the zero dose position. According to an embodiment, in the "delivery state", actuation is blocked to prevent accidental activation.

[0481] 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 is dropped on its proximal end 14.

[0482] Reference numerals list

[0483] 1 Proximal direction

[0484] 10 Injection Pen

[0485] 12 Distal end

[0486] 14 Proximal end

[0487] 16 Knob cover

[0488] 16a Closed circumferential portion

[0489] 16b Closed surface

[0490] 18 Injection button / adjusting element

[0491] 18a Cylindrical part

[0492] 19 Outer edge

[0493] 20 Clamp / Connector

[0494] 22 Dose setting knob / dose setting element

[0495] 23 Dosing components

[0496] 24 snap-on components

[0497] 26 Connectors

[0498] 28 Sleeve / dose selector

[0499] 30 Knob key

[0500] 32 Shell

[0501] 32a Surface

[0502] 34 Dose setting sleeve / dosing element

[0503] 36 Driver

[0504] 38 Nut

[0505] 40 Spring

[0506] 42 Piston rod guide

[0507] 43 Connectors

[0508] 44 Piston rod

[0509] 45 Distal segment

[0510] 46 Piston disc / bearing

[0511] 48 Cartridge

[0512] 50 Cartridge containers / medicine containers

[0513] 52 Cartridge key / cartridge holder

[0514] 54 Dose delivery mechanism

[0515] 56 Drug Reconstitution Unit

[0516] 58 Wing

[0517] 60 Lugs

[0518] 62 Window

[0519] 64 ridge

[0520] 66 Adjacent part

[0521] 66a Front surface

[0522] 68 incision

[0523] 69 Beveled section

[0524] 70 Axial adjacent ridge

[0525] 72 Gap

[0526] 74 Linear notch

[0527] 76 Anti-roll device

[0528] 78 Anti-roll device

[0529] 80 front surface

[0530] 81 Axial lock

[0531] 82 Axial fixing device

[0532] 84 Ribs

[0533] 86 Axial fixing device

[0534] 88 Undercut

[0535] 89 Rotation Lock

[0536] 90 Rotating Fixture

[0537] 92 Rotating Fixing Device

[0538] 93 Toothed part

[0539] 94 Rotating Fixing Device

[0540] 96 Rotating Fixing Device

[0541] 97 Latch mechanism

[0542] 98 Assembly device

[0543] 98a Latch section

[0544] 98b Additional latch section

[0545] 100 Connecting device

[0546] 100a Beveled surface

[0547] 101 Incision

[0548] 102 Coupling device / latch mating part

[0549] 104 Ribs

[0550] 106 grooves

[0551] 107 Coupling mechanism

[0552] 108 teeth

[0553] 110 teeth

[0554] 112 Joint surface

[0555] 114 teeth

[0556] 115 Dose Limitation Agency

[0557] 116 Joint feature

[0558] 118 Dose stop

[0559] 118a Dose stop

[0560] 118b Dose stop

[0561] 118c Dose stop

[0562] 118d Dose stop

[0563] 120 elastically deformable section

[0564] 121 Incision

[0565] 122a-d Side surface

[0566] 123a-d Side surface

[0567] 124 Hard Stop

[0568] 126 Hard stop

[0569] 128 Hard Stop

[0570] 130 Opening

[0571] 132 slots

[0572] 134 Ribs

[0573] 136 protrusion

[0574] 136a Beveled surface

[0575] 138 Ribs

[0576] 140 Grooves

[0577] 142 Axial fixing device

[0578] 144 Entrance

[0579] 146 Axial fixing device

[0580] 148 Rotating Fixing Device

[0581] 150 Rotating Fixing Device

[0582] 152 Rotating Fixing Device

[0583] 154 Rotating Fixing Device

[0584] 156 Ribs

[0585] 158a Incision

[0586] 158b Incision

[0587] 158c incision

[0588] 158d incision

[0589] 160 Nearside edge

[0590] 162 Distal edge

[0591] 164 retaining projection

[0592] 166 Window

[0593] 168a Tags

[0594] 168b Tags

[0595] 168c Tags

[0596] 168d Tags

[0597] 168e Tags

[0598] 169a Out-of-round outer peripheral surface

[0599] 169b Out-of-round inner circumferential surface

[0600] 170 External thread

[0601] 171 Fixed segments

[0602] 172 Internal thread

[0603] 173 Surface facing

[0604] 174 End stop

[0605] 176 End stop

[0606] 177 Attachment

[0607] 178 Axial fixing device

[0608] 179 Attachment

[0609] 180 Axial fixing device

[0610] 182 Rotating Fixing Device

[0611] 184 Rotating Fixing Device

[0612] 186 Opening

[0613] 188 Cross section

[0614] 189 Threaded connection

[0615] 190 External thread

[0616] 192 Internal thread

[0617] 194 Pressing surface

[0618] 196 front surface

[0619] 198 Connecting device

[0620] 200 Connection device

[0621] Room 202

[0622] Room 204

[0623] 206 Bypass

[0624] 208 first sealing element

[0625] 210 Second sealing element / plunger

[0626] 212 Axial fixing device

[0627] 214 Axial fixing device

[0628] 216 Rotating Fixing Device

[0629] 218 Rotating Fixing Device

[0630] 220 Window

[0631] 221 Incision

[0632] 222 Window

[0633] 223 slots

[0634] 224 Thread

[0635] 226 End surface

[0636] 228 Surface

[0637] 230 First thread

[0638] 232 Second thread

[0639] 234 snap-on components

[0640] 236 Opening

[0641] 238 Opening

[0642] 240 Opening

[0643] 242 Displacement section

[0644] 244 Radial end stop

[0645] 246 External surface

[0646] 248 Interior Space

[0647] 249 Keep Section

[0648] 250 Bias element

[0649] 252 Opening

[0650] 254 Inner surface

[0651] 256 External surface

[0652] 258 Ring Space

[0653] 260 Inner circumferential surface

[0654] 262 Outer circumferential surface

[0655] 264 Outer circumferential surface

[0656] 266 End face

[0657] 268 End face

[0658] 300 Drug delivery equipment

[0659] 301 Cap

[0660] 305 Container Holder

[0661] 306-pin connector

[0662] 307 Connector

[0663] 318 Adjustment element

[0664] 323 Dosing components

[0665] 332 Shell

[0666] 333 Upper shell part

[0667] 334 Dosing Components

[0668] 335 threaded connection

[0669] 336 Driver

[0670] 337 Additional threaded connections

[0671] 342 Piston rod guide

[0672] 343 Connector

[0673] 348 Medicine Container

[0674] 349 Needle end

[0675] 354 Dose delivery mechanism

[0676] 500 Drug delivery equipment

[0677] 501 Needle Assembly

[0678] 502 Intubation

[0679] 503 Needle Cap

[0680] 504 Cap

[0681] 505 Container Holder

[0682] 506 Connector

[0683] 507 Coupling

[0684] 508 First coupling part

[0685] 509 Second coupling part

[0686] 513 Coupling mechanism

[0687] 514 teeth

[0688] 515 teeth

[0689] 518 Adjustment element

[0690] 520 Connecting element

[0691] 523 Dosing components

[0692] 524 Connecting components

[0693] 525 Extension

[0694] 527 Connector

[0695] 528 Sleeve

[0696] 528a External part

[0697] 529 Latch Mating Section

[0698] 530 Additional latch mating part

[0699] 532 Housing

[0700] 533 Retaining lug

[0701] 534 Shell Window

[0702] 535 Opening

[0703] 543 Connector

[0704] 554 Dose delivery mechanism

[0705] 560 Rotatable Fixing

[0706] 561 Circular Edge

[0707] 562 Thread

[0708] 563 Rotating Fixture

[0709] 564 longitudinal ridge

[0710] 566 Lug

[0711] 567 Opening

[0712] 568 Radial stop

[0713] 569 Stop surface

[0714] 570 Rotatable Fixing

[0715] 571 Circular Edge

[0716] 573 Opening

[0717] 575 Ridge

[0718] 580 End Plate

[0719] 582 bars

[0720] 584 Axial fixing

[0721] 585 Rotating Fixture

[0722] 586 Notch

[0723] 587 Buttoning Device

[0724] 590 Notch

[0725] 592 Edge

[0726] 597 Latch mechanism

[0727] 599 Additional latching mechanism

[0728] 600 Latch Section

[0729] 610 Window

[0730] 612 Thread

[0731] 614 Opening

[0732] 616 Ridge

[0733] 618 Notch

[0734] 620 Connector

[0735] 622 Lug

[0736] 624 Notch

[0737] 626 Circular Edge

[0738] 630 Lug

[0739] 632 Ridge

[0740] 634 Proximal blocking element

[0741] 635 Distal blocking element

[0742] 636 Stop surface

[0743] 700 Drug Delivery Equipment

[0744] 720 Connecting element

[0745] 754 Dose delivery mechanism

[0746] L1 Length

[0747] L2 Length

[0748] W1 Width

[0749] W2 Width

Claims

1. A dosage delivery mechanism (54), comprising: a housing (32), a piston rod (44) configured to act on a plunger (46) of a sealed fluid compartment (48) and to move in an axial direction relative to the housing (32) to deliver a set dose, and a dose setting member (34) movable relative to the housing (32) during dose setting, wherein the position of the dose setting member (34) relative to the housing (32) defines the set dose, and Wherein in the delivery state, the dose setting member (34) is preset to a position corresponding to a set dose greater than zero.

2. The dosage delivery mechanism (54) according to claim 1, wherein in the delivery state 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), such as a minimum dose intended for each treatment by the dose delivery mechanism.

3. A dose delivery mechanism (54) according to any one of the preceding claims, It further comprises a dose indicating member (34) which indicates a set dose depending on a position, in particular a rotational position or an axial position, of the dose indicating member (34) relative to the housing (32).

4. The dosage delivery mechanism (54) according to claim 3, Wherein the dose setting member (34) is configured as the dose indicating member (34).

5. A dosage delivery mechanism (54) according to claim 3 or 4, Wherein in the delivery state, the dose indicating member (34) indicates that the set dose is different from zero dose.

6. A dose delivery mechanism (54) according to any one of the preceding claims, The dose setting member (34) is configured to move, such as rotate, relative to the housing (32) to set a dose different from the preset dose, such as a dose given by the treatment or one of several doses given by the treatment.

7. The dosage delivery mechanism (54) according to claim 6, The dose setting member (34) cannot be moved, for example rotated, directly from a preset position to a zero dose position.

8. A dose delivery mechanism (54) according to any one of the preceding claims, It further comprises an activation member (18) configured to move, for example in a proximal direction, to initiate delivery of the set dose, Wherein when the dose setting member (34) is in the preset position, the activation member (18) is prevented from initiating delivery of the set dose.

9. The dosage delivery mechanism (54) according to claim 8, A separate element (30), such as a clamp, is provided to prevent premature movement of the activation member (18) relative to the housing (32), such as by the dose delivery mechanism (54) falling onto the proximal end (14) of the dose delivery mechanism (54), before the separate element (32) is removed.

10. The dosage delivery mechanism (54) according to claim 8 or 9, Two parts (24, 28) arranged inside the housing (32) of the dose delivery mechanism (54) are configured to cooperate with each other to prevent unintended movement of the activation member (18) relative to the housing (32) from the preset position, for example in the proximal direction.

11. The dosage delivery mechanism (54) according to claim 10, 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 prevent the activation member (18) from initiating delivery of the set dose when the dose setting member (34) is in the preset position.

12. The dose delivery mechanism (54) according to any one of the preceding claims, Two parts arranged inside the housing (32) of the dose delivery mechanism (54) include corresponding dose limiting elements (116, 118a-118d), which are configured to cooperate with each other to define a plurality of relative positions corresponding to settable doses.

13. The dosage delivery mechanism (54) according to claim 12, wherein the position is defined by a dose stop (118a-118d) formed on a first of the two parts, the dose stop (118a-118d) being configured to contact a snap element (116) on a second of the two parts, preferably The snap-in element (116) is preloaded onto the corresponding dose stop (118a-118d) by a spring (40), in particular a torsion spring.

14. A medicament delivery device (10), in particular an injection device, having a dose delivery mechanism (54) according to any of the preceding claims.

15. A method for providing a dose delivery mechanism (54), the dose delivery mechanism (54) having: a housing (32), a piston rod (44) configured to act on a plunger (46) of a sealed fluid compartment (48) and to move in an axial direction relative to the housing (32) to deliver a set dose, and a dose setting member (34) movable relative to the housing (32) during dose setting, wherein the position of the dose setting member (34) relative to the housing (32) defines the set dose, The method comprises the following steps: The dosage delivery mechanism (54), in particular a medicament delivery device (10) having the dosage delivery mechanism (54), is delivered to a customer in a state where a dosage greater than zero is preset.

Images