Dose delivery mechanism

Abstract

A dose delivery mechanism for a drug delivery device comprises: a housing; a piston rod; and an adjusting element. The housing is configured to be connected to a medicament container sealed by a plunger. Further, the dose delivery mechanism has a pre-assembled state and an assembled state in which the dose delivery mechanism is configured to axially move the piston rod in the proximal direction relative to the housing during dose delivery such that the piston rod exerts an axial force in the proximal direction on the plunger of the medicament container to expel medicament from the medicament container. In the pre-assembled state, the adjustment element is configured to perform rotation relative to the housing, where rotation of the adjustment element causes axial movement of the piston rod for adjusting an axial position of the piston rod relative to the housing prior to transition of the dose delivery mechanism from the pre-assembled state to the assembled state. In the pre-assembled state, the outer edge of the adjustment element is accessible to an assembler of the device to effect rotation of the adjustment element and axial movement of the piston rod. The adjustment element is configured to perform rotation at least when in a pre-assembled position relative to the housing, where the pre-assembled position is a distal-most position of the adjustment element relative to the housing in a pre-assembled state. Further, the dose delivery mechanism is configured to convert rotation of the adjustment element into axial movement of the piston rod through a single threaded connection in a pre-assembled state, where the threaded connection includes a first threaded element in threaded engagement with a second threaded element.

Description

Technical Field

[0001] The present disclosure relates to a dose delivery mechanism for a drug delivery device, a drug delivery device having a dose delivery mechanism and a method for adjusting a dose delivery mechanism. Background Art

[0002] A drug delivery device (e.g., an injection device) for delivering a liquid drug to a patient generally comprises a drug container containing the drug and a dose delivery mechanism configured to discharge a predetermined dose of the drug from the container. The drug container generally comprises a movable plunger at a distal side away from the delivery site, which seals the drug container and moves in a proximal direction toward the injection site to discharge the drug from the container. In order to move the plunger, the dose delivery mechanism generally comprises a piston rod, which acts on the plunger by moving the plunger in a proximal direction. The dose to be delivered is then defined by the axial movement of the plunger in the drug container.

[0003] The position of the plunger within the drug container is usually specified with a manufacturing tolerance of ±0.4 mm or ±0.5 mm. After the drug container is assembled to the dose delivery mechanism, such tolerances may cause the bearing located at the piston rod and configured to push the plunger to contact and pressurize the plunger after final assembly, or to be positioned at a distance from the plunger, leaving a gap between the bearing and the plunger.

[0004] When contacting the plunger, the piston rod should not significantly compress the plunger, because permanent pressure applied to the plunger between final assembly of the device and first use is undesirable. For example, when attaching the needle to the drug container for the first time, the user will experience a loss of drug. In addition, expansion of the drug during transportation, for example due to temperature and / or pressure changes, may damage the device.

[0005] When the bearing of the piston rod is positioned at a certain distance from the plunger, the gap between the plunger and the bearing varies from pen to pen due to manufacturing tolerances. Thus, the drug delivery device is usually primed by the user at least before delivering the first dose. The user attaches the needle to the drug container, sets the dose, and expels the set dose into the air. Depending on the size of the gap and the size of the dose used for preparation, the user may have to repeat the process until at least some of the drug is expelled. For a device prepared by the user, the position of the plunger after the drug container is attached to the dose delivery mechanism should be large enough to be compatible with all possible manufacturing tolerances of the plunger position. At the same time, it should be small enough to avoid too many preparation steps and / or to avoid expelling an excessive amount of drug during priming.

[0006] Furthermore, the user may forget to prime the device before use. This will result in an incorrect amount of drug being expelled, as the distance the piston rod moves to close the gap does not contribute to drug delivery, and the larger the gap, the greater the inaccuracy in the first dose delivery.

[0007] Therefore, there is a need to adjust the piston rod of the dose delivery mechanism to a well-defined position during assembly of the drug delivery device.

[0008] It is therefore an object of the present disclosure to provide a dose delivery mechanism for a drug delivery device, a drug delivery device having a dose delivery mechanism and a method which allows reliable and simple adjustment of the position of a piston rod. Summary of the invention

[0009] According to the independent claims, the present disclosure provides a dose delivery mechanism for a drug delivery device, a drug delivery device having a dose delivery mechanism and a method for adjusting a dose delivery mechanism. Embodiments are given in the dependent claims, the description and the drawings.

[0010] In one aspect, the present disclosure relates to a dose delivery mechanism for a drug delivery device, the dose delivery mechanism comprising: a housing; a piston rod; and an adjustment element. The housing is configured to be connected to a drug container sealed by a plunger. In addition, the dose delivery mechanism has a pre-assembled state and an assembled state, wherein, in the assembled state, the dose delivery mechanism is configured to cause the piston rod to move axially in a proximal direction relative to the housing during dose delivery, so that the piston rod exerts an axial force in a proximal direction on the plunger of the drug container to discharge the drug from the drug container. In the pre-assembled state, the adjustment element is configured to perform a rotation relative to the housing, wherein the rotation of the adjustment element causes the axial movement of the piston rod for adjusting the axial position of the piston rod relative to the housing before the dose delivery mechanism is transformed from the pre-assembled state to the assembled state. In the pre-assembled state, the outer edge of the adjustment element is accessible to an assembler of the device to achieve the rotation of the adjustment element and the axial movement of the piston rod. The adjustment element is configured to perform a rotation at least when it is in a pre-assembled position relative to the housing, wherein the pre-assembled position is the most distal position of the adjustment element relative to the housing in the pre-assembled state. Furthermore, the dose delivery mechanism is configured to convert a rotation of the adjustment element into an axial movement of the piston rod in a pre-assembled state by means of a single threaded connection, wherein the threaded connection comprises a first threaded element threadably engaged with a second threaded element.

[0011] The dose delivery mechanism according to the present disclosure allows the position of the piston rod to be adjusted in a simple and user-friendly manner prior to assembly. By providing an adjustment element with an outer edge accessible to an assembler of the device, rotation of the adjustment element can be easily achieved by directly grasping the outer edge by hand or by using an assembly tool that engages with the outer edge. In general, adjustment of the position of the piston rod can be performed manually or in an automated assembly line.

[0012] By allowing the adjustment element to rotate in a preassembly position, which is its most distal position relative to the housing, adjustment of the position of the piston rod is further simplified since the adjustment process does not need to be accommodated for example axial proximal movement of the adjustment element before or during rotation.

[0013] Finally, a single threaded connection for converting the rotation of the adjustment element into the axial movement of the piston rod provides a simple mechanical construction of the adjustment mechanism. This results in low forces required for adjustment, but still allows precise adjustment of the position of the piston rod.

[0014] With this dose delivery mechanism, the position of the piston rod can be adjusted after final assembly to provide a gap between the plunger and the bearing of the piston rod, or the position of the piston rod can be adjusted after final assembly to position the bearing at the plunger. Thus, the adjustment of the position of the piston rod can be performed with the drug container already attached to the dose delivery mechanism, or can be performed before the drug container is attached to the dose delivery mechanism.

[0015] The adjustment element can be configured not to move axially relative to the housing during adjustment of the axial position of the piston rod. This provides a mechanically simple adjustment of the piston rod.

[0016] The dose delivery mechanism may be configured to hold the adjustment element in the pre-assembly position. For example, the dose delivery mechanism may be configured to hold the adjustment element in the pre-assembly position in such a way that the adjustment element autonomously occupies the pre-assembly position in the pre-assembly state. For example, the dose delivery mechanism may include a lock that holds the adjustment element in the pre-assembly position. The lock may be configured as a releasable lock, such as a latching connection. When the dose delivery mechanism is transformed from the pre-assembly state to the assembled state, the lock may be opened to allow the adjustment element to leave the pre-assembly position.

[0017] The dose delivery mechanism may additionally or alternatively hold the adjustment element in the pre-assembled position by biasing the adjustment element to the pre-assembled position. The adjustment element may then be configured to move against the biasing force and out of the pre-assembled position when the dose delivery mechanism is converted from the pre-assembled state to the assembled state.

[0018] For other embodiments, the dose delivery mechanism may not be configured to retain the adjustment element in the pre-assembly position, and the adjustment element may be configured to move axially away from the pre-assembly position when the dose setting mechanism is in the pre-assembly state. The adjustment element may be configured to move from the pre-assembly position to an axial position where it can no longer rotate relative to the housing. For these embodiments, the assembler first places the adjustment element distally relative to the housing in the pre-assembly position and retains the adjustment element in the pre-assembly position during adjustment of the piston rod.

[0019] The drug delivery device may be configured as an injection device, such as a pen-type injection device. The drug container may be configured to receive a cannula at its proximal end to deliver the drug through the cannula.

[0020] The dose delivery mechanism may include a dose limiting mechanism that allows a user of the device to set at least one dose of the drug 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.

[0021] The dose delivery mechanism may be configured as a one-time mechanism, which only allows a dose to be set once and subsequently prevents the user from setting and delivering further doses. The dose delivery mechanism may also be configured as a multi-use mechanism, which allows a dose to be repeatedly set for delivery.

[0022] The drug delivery device may be configured as a disposable device, which is discarded after the last dose has been expelled from the drug container.

[0023] For the dose delivery mechanism, the delivery of the drug may require the user to apply an axial force, for example on an actuation member of the dose delivery mechanism. For example, the user may have to apply an axial force relative to the housing. For example, the actuation member may be an adjustment member or a member rigidly connected to the adjustment member.

[0024] For other embodiments, the dose delivery mechanism may be configured as an automatic mechanism.Such a dose delivery mechanism may provide a force sufficient to automatically deliver a set dose from an energy storage such as a spring.

[0025] In the assembled state, the dose delivery mechanism may be configured to prevent the piston rod from moving axially when the adjustment element is rotated, unless the rotation occurs during delivery of a set dose. For example, the adjustment element may be configured to rotate relative to the housing in the assembled state during dose setting. Thus, the dose delivery mechanism may be configured to prevent the piston rod from moving axially when the adjustment element is rotated during dose setting.

[0026] The first threaded element and the second threaded element may be configured to rotate relative to each other during dose setting in the assembled state. Additionally or alternatively, the first threaded element and the second threaded element may be configured to rotate relative to each other during dose delivery in the assembled state.

[0027] The dose delivery mechanism may include a bearing configured to directly contact the plunger of the attached drug container. The bearing may be located at the piston rod. Thus, it may be formed integrally with the piston rod. Alternatively, it may be configured as a separate component, such as a disc, which is located between the piston rod and the plunger. For example, the bearing may be attached to the piston rod.

[0028] The housing may be configured to be connected to the medicament container by having a connection device that allows a separate container holder comprising the medicament container to be attached to the housing. For example, the connection device may be configured as a form fit, such as a snap connector or a threaded connector, or as an adhesive bond, such as a welded or glued connection. Alternatively, the housing may also be connected to the medicament container by comprising a container holder that is integrally formed with a housing section comprising components of the dose delivery mechanism.

[0029] According to one embodiment, the adjustment element is configured to rotate until the bearing at the piston rod contacts the plunger of the drug container. This allows the bearing to be positioned in direct contact with the plunger. Alternatively, the bearing can also be positioned at any distance from the piston rod, for example by stopping the rotation of the adjustment element and the axial movement of the piston rod in the proximal direction before the bearing contacts the plunger.

[0030] According to one embodiment, the adjustment element is configured to cause proximal movement of the piston rod when rotated by the assembler. In addition, the adjustment element can also be configured to cause distal movement of the piston rod when rotated in a direction opposite to the direction causing proximal movement. This allows precise positioning of the piston rod independent of its initial position.

[0031] According to one embodiment, the adjustment element protrudes in the distal direction from the remaining components of the dose delivery mechanism in the pre-assembled state. The adjustment element, e.g. its outer edge, is then easily accessible for adjusting the piston rod. In addition, the remaining parts of the dose delivery mechanism, e.g. the housing, can be easily held during adjustment. For example, the adjustment element may protrude in the distal direction from a dose setting element of the dose delivery mechanism, wherein the dose setting element is configured to be gripped by a user of the device during dose setting in the assembled state.

[0032] According to one embodiment, the adjustment element is configured to be transferred from a pre-assembly position to an assembly position relative to the housing when the dose delivery mechanism is transferred from the pre-assembly state to the assembly state. For example, the adjustment element can be axially moved from the pre-assembly position to the assembly position. Thereby, the adjustment element can be moved in the proximal direction.

[0033] The assembly position may be a position that the adjustment element occupies in a passive state of the dose delivery mechanism, the passive state being a state in which the dose delivery mechanism is not operated by a user. For example, the assembly position may be a position that the adjustment element occupies in the assembled state before setting and delivering a dose of medicament. In the assembled state, the dose delivery mechanism may be configured to bias the adjustment element into the assembly position. The passive state may be a state of the dose delivery mechanism in which no dose to be delivered is set.

[0034] The transition of the adjustment element from the pre-assembly position to the assembly position may result in the dose delivery mechanism being transitioned from the pre-assembly state to the assembly state. For example, the adjustment element may be used as a switching device to switch the dose delivery mechanism from the pre-assembly state to the assembly state. This allows for a simple final assembly of the dose delivery mechanism, as a single element is first rotated to adjust the position of the piston rod and subsequently moved to transform the dose delivery mechanism into its assembly state.

[0035] For alternative embodiments, the adjustment element may also be configured to perform a rotation for adjusting the position of the piston rod when the adjustment element is in an adjustment position deviating from the pre-assembly position. Also for these embodiments, the dose delivery mechanism may be configured to hold the adjustment element in the pre-assembly position. Then, before adjusting the position of the piston rod, the adjustment element is transferred from the pre-assembly position to the adjustment position, for example by axially moving the adjustment element, for example by moving the adjustment element in the proximal or distal direction. By requiring a separate movement to initiate adjustment of the piston rod, this prevents accidental movement of the piston rod during final assembly. The adjustment element may be configured to achieve rotation when simultaneously pushed into the adjustment position by the assembler of the device.

[0036] For these alternative embodiments, the adjustment element can be configured to be pushed into the adjustment position from the pre-assembly position in the proximal direction.This allows an ergonomic adjustment of the position of the piston rod by performing a combined push and turn operation on the adjustment element.

[0037] According to one embodiment, the dose delivery mechanism comprises a biasing element which, in the pre-assembled state, biases the adjustment element relative to the housing to a pre-assembled position.The adjustment element is then releasably held in the pre-assembled position by the biasing force.

[0038] According to one embodiment, the adjustment element is configured to move axially from the pre-assembled position to the assembled position when the dose delivery mechanism is transformed from the pre-assembled state to the assembled state. For example, the adjustment element can be configured to move axially in the proximal direction. This allows the dose delivery mechanism to be easily transformed from the pre-assembled state to the assembled state.

[0039] According to one embodiment, the adjustment element is blocked, e.g. irreversibly blocked, from returning to the pre-assembly position relative to the housing in the assembly position. By preventing the adjustment element from returning to the pre-assembly position, any loss of adjustment of the position of the piston rod after final assembly is prevented. Although blocked from returning to the pre-assembly position, the adjustment element is still movable, e.g. axially movable in the assembly position. For example, the adjustment element is still movable in the same axial direction as the adjustment element is moved when transferring from the pre-assembly position to the assembly position.

[0040] According to one embodiment, the dose delivery mechanism comprises a locking mechanism, which is configured to prevent the adjustment element from moving from the assembly position to the pre-assembly position.Such a locking mechanism provides a mechanically simple locking mechanism.

[0041] According to one embodiment, the dose delivery mechanism comprises a corresponding component, and the locking mechanism comprises a locking portion of the adjustment element and a locking corresponding portion of the corresponding component, wherein the locking portion and the locking corresponding portion are configured to directly engage with each other in an assembled state to prevent the adjustment element from moving relative to the housing in at least one direction. By arranging the locking portion directly at the adjustment element, the adjustment element is reliably held in the assembled state. The locking portion can be formed integrally with the adjustment element, for example, it can be formed integrally with the outer edge of the adjustment element.

[0042] For other embodiments, the locking portion can also be a part of an intermediate member, which is fixedly connected to the adjustment element at least in one of the axial direction and the radial direction. For example, the intermediate member can be fixed to the adjustment element only in the axial direction or in both the axial and radial directions.

[0043] According to one embodiment, the dose delivery mechanism comprises a further locking mechanism, which is configured to prevent the adjustment element from being separated from the housing in the pre-assembled state. Such a locking mechanism provides a well-defined configuration of the dose delivery mechanism in the pre-assembled state and thus facilitates adjustment of the piston rod. The locking mechanism can also be configured to hold the adjustment element in the pre-assembled position.

[0044] According to one embodiment, the other locking mechanism comprises another locking portion of the adjustment element and another locking corresponding portion of another corresponding member, wherein the other locking portion and the other locking corresponding portion are configured to directly engage with each other in a pre-assembled state to prevent the adjustment element from moving relative to the housing in at least one direction. By directly arranging the other locking portion at the adjustment element, the adjustment element is reliably prevented from being separated from the housing in the pre-assembled state. The other locking portion can be formed integrally with the adjustment element, for example, it can be formed integrally with the outer edge of the adjustment element.

[0045] For other embodiments, the other locking portion can also be a part of another intermediate member, which is fixedly connected to the adjustment element at least in one of the axial direction and the radial direction. For example, the other intermediate member can be fixed to the adjustment element only in the axial direction or in both the axial and radial directions.

[0046] The corresponding component of the locking mechanism and the other corresponding component of the other locking mechanism can be a single component of the dose delivery mechanism. Likewise, the intermediate component of the locking mechanism and the other intermediate component of the other locking mechanism can be a single component of the dose delivery mechanism. This provides a simple construction of the dose delivery mechanism.

[0047] According to one embodiment, the locking mechanism and the further locking mechanism share a single locking part or a single locking counterpart. The single locking part can then be configured to engage with the first locking counterpart in the assembled state and to engage with the second locking counterpart in the pre-assembled state. Likewise, the single locking counterpart can be configured to engage with the first locking part in the assembled state and to engage with the second locking part in the pre-assembled state. Such a common locking part or locking counterpart allows a simple construction of the dose delivery mechanism.

[0048] According to one embodiment, the pitch of the single threaded connection defines a ratio of an axial distance to a circumferential distance, and in the pre-assembled state, when the adjustment element is rotated by the circumferential distance, the piston rod travels the axial distance relative to the housing. Thus, the pitch of the threaded connection defines a transmission ratio for adjusting the axial position of the piston rod.

[0049] According to one embodiment, during one of dose setting and dose delivery in the assembled state, the first and second threaded elements rotate relative to each other, wherein during the other of dose setting and dose delivery in the assembled state, the first and second threaded elements do not rotate relative to each other. Such a construction allows the use of a threaded connection that also functions during dose delivery or dose setting for adjusting the position of the piston rod. This provides a simple construction of the dose delivery mechanism.

[0050] For example, the second threaded element may be configured to rotate relative to the first threaded element during dose setting and not rotate relative to the first threaded element during dose delivery. The second threaded element may also be configured not to rotate relative to the first threaded element during dose setting and rotate relative to the first threaded element during dose delivery.

[0051] According to one embodiment, during dose delivery or dose setting in the assembled state, the first threaded element is rotationally stationary relative to a third element of the dose delivery mechanism and the second threaded element rotates relative to the third element. Furthermore, during adjustment of the piston rod in the pre-assembled state, the first threaded element rotates relative to the third element of the dose delivery mechanism and the second threaded element is rotationally stationary relative to the third element. For such a dose delivery mechanism, adjustment of the piston rod in the pre-assembled state is based on a kinematic inversion of the relative rotation between the first threaded element and the second threaded element during dose delivery or dose setting. Thus, the first and second threaded elements can also be used to axially move the piston rod during dose delivery. This provides a simple construction of the dose delivery mechanism.

[0052] According to one embodiment, during dose setting or dose delivery in the assembled state, the first threaded element is axially stationary relative to a third element of the dose delivery mechanism and the second threaded element is axially moved relative to the third element. During adjustment of the piston rod in the pre-assembled state, the first threaded element is axially moved relative to the third element of the dose delivery mechanism and the second threaded element is axially stationary relative to the third element. For such a dose delivery mechanism, adjustment of the piston rod in the pre-assembled state is based on a kinematic inversion of the relative axial movement between the first threaded element and the second threaded element during dose setting or dose delivery. Thus, the first and second threaded elements can also be used to axially move the piston rod during dose delivery. This provides a simple construction of the dose delivery mechanism.

[0053] According to one embodiment, the third element is the housing.Thus, during dose setting, only one of the first and second threaded elements rotates relative to the housing, and during dose delivery, only the other of the first and second threaded elements rotates relative to the housing.

[0054] According to one embodiment, the first threaded element is a piston rod. By providing the threaded connection directly at the piston rod, the piston rod can be precisely adjusted in the pre-assembled state. For example, the dose delivery mechanism does not include any intermediate components between the piston rod and the threaded connection, which intermediate components could introduce additional play during adjustment of the piston rod.

[0055] The second threaded element may be a nut which rotates relative to the housing during dose setting and which is rotationally fixed relative to the housing during dose delivery. The first threaded element may then be rotationally fixed relative to the housing both during dose setting and dose delivery. Additionally or alternatively, the first threaded element may be rotationally fixed relative to the housing during adjustment of the piston rod in the pre-assembled state, and the second threaded element may be configured to rotate relative to the housing during adjustment of the piston rod in the pre-assembled state.

[0056] The second threaded element may also be a dose sleeve, which rotates relative to the housing both during dose setting and dose delivery. Then, the first threaded element may be rotationally fixed relative to the housing during dose delivery, and it may rotate relative to the housing during dose setting. For example, during dose setting, the first threaded element may be rotationally fixed relative to the second threaded element. In addition, the second threaded element may be configured not to rotate relative to the housing in a pre-assembled state, and the first threaded element may rotate relative to the housing in a pre-assembled state when the adjustment element is rotated.

[0057] According to one embodiment, during the axial movement of the piston rod in the pre-assembled state, one of the first threaded element and the second threaded element maintains its axial position relative to the housing. This element then defines an anchor point for the axial movement of the piston rod in the pre-assembled state. This allows a precise adjustment of the piston rod, since any play between the axial anchor point and the threaded connection is avoided.

[0058] According to one embodiment, in the pre-assembled state, one of the first and second threaded elements is configured not to rotate during rotation of the adjustment element. This element then defines an anchor point for the rotational movement of the piston rod in the pre-assembled state and allows precise adjustment of the piston rod.

[0059] According to one embodiment, the threaded connection acts between the adjustment element and the piston rod. For example, the piston rod may be rotationally fixed relative to the first threaded element and the adjustment element may be rotationally fixed relative to the second threaded element. Thereby, the piston rod may be configured as the first threaded element and / or the adjustment element may be configured as the second threaded element. This provides a simple construction of the dose delivery mechanism.

[0060] For alternative embodiments, the threaded connection may act between the piston rod and the housing in the pre-assembled state. For example, in the pre-assembled state, the threaded connection may act between the piston rod and an intermediate member that is rotationally and / or axially fixed relative to the housing.

[0061] According to one embodiment, the dose delivery mechanism comprises a nut threadedly connected, e.g. threadedly engaged, with the piston rod, wherein, in a pre-assembled state, a rotation of the adjustment element causes a rotation of the nut to axially move the piston rod relative to the housing. The piston rod can then be the first threaded element and / or the nut can be the second threaded element.

[0062] According to one embodiment, the adjustment element is rotationally fixed to the nut and axially slidable relative to the nut. This allows an axial movement of the piston rod without requiring a corresponding axial movement of the adjustment element.

[0063] According to one embodiment, in the assembled state, the nut is rotated by the adjustment element during dose setting and performs an axial movement due to the threaded connection with the piston rod. According to one embodiment, in the assembled state, the rotation of the nut causes the nut to translate axially in the distal direction along the thread located on the piston rod during dose setting and in the proximal direction during dose cancellation. Thus, the axial movement of the nut relative to the piston rod may define the axial movement of the piston rod during dose delivery and thus the amount of drug expelled during dose delivery.

[0064] According to one embodiment, in the assembled state the nut does not rotate during dose delivery but is only axially moved with the piston rod in the proximal direction by a distance, wherein the distance is proportional to the set dose.

[0065] According to one embodiment, the dose delivery mechanism comprises a further component, wherein during adjustment of the piston rod in the pre-assembled state, the adjustment element is rotationally decoupled from the further component and during dose setting in the assembled state, the adjustment element is rotationally coupled to the further component. Furthermore, the adjustment element is rotationally decoupled from the further component during dose delivery in the assembled state. Rotationally coupling the adjustment element to the further component during dose setting may prevent an axial movement of the piston rod during dose setting. By allowing the adjustment element to be rotationally movable relative to the further component, the adjustment element may be rotationally decoupled from the further component. By rotationally fixing the adjustment element to the further component, the adjustment element may be rotationally coupled to the further component.

[0066] When the dose delivery mechanism is in the pre-assembled state, the adjustment element may be permanently rotationally decoupled from the further component. Alternatively, the adjustment element may also be rotationally decoupled from the further component only during adjustment of the position of the piston rod in the pre-assembled state. For example, if the adjustment element has to be brought into the adjustment position to adjust the position of the piston rod, the adjustment element may be rotationally decoupled from the further component only when in the adjustment position. With such an embodiment, the adjustment element may be rotationally coupled to the further component when in the pre-assembled position.

[0067] According to one embodiment, the further member is threadedly connected to the housing. This may result in an axial movement of both the further member and the adjustment element during dose setting. The dose delivery mechanism may then be configured to deliver a set dose in case this axial movement is reversed during dose delivery, e.g. by a user of the device pushing the further member proximally in an axial direction.

[0068] According to one embodiment, the further member is a dose indicating member indicating the set dose.The dose indicating member may comprise markings visible from outside the housing at least during dose setting.

[0069] According to one embodiment, the further component rotates relative to the piston rod during dose setting and / or the further component does not rotate relative to the piston rod during position adjustment of the piston rod in the pre-assembled state.

[0070] According to one embodiment, the further component maintains its axial position relative to the housing of the dose delivery mechanism when the setting element is rotated in the pre-assembled state.

[0071] According to one embodiment, the dose delivery mechanism comprises a clutch mechanism having a first clutch member and a second clutch member. During dose setting in the assembled state, the first clutch member and the second clutch member engage with each other to rotationally couple the adjustment element to the other member in the closed state of the clutch mechanism, and during dose delivery in the assembled state, the first clutch member and the second clutch member disengage from each other to rotationally decouple the adjustment element from the other member in the open state of the clutch mechanism. Such a clutch mechanism provides a mechanically simple means for rotationally coupling and decoupling the adjustment element and the other member in the assembled state.

[0072] Generally speaking, when the first clutch member and the second clutch member are not engaged with each other, the clutch mechanism is in an open state, and when the first clutch member and the second clutch member are engaged with each other, the clutch is in a closed state.

[0073] The clutch mechanism may connect the adjustment element to the further component via a coupling member. The coupling member may be rotationally fixed relative to the further component. If the clutch mechanism is disconnected in the pre-assembled state, it allows the adjustment element to rotate relative to the coupling member, and if the clutch mechanism is disconnected in the assembled state during dose delivery, it allows the adjustment element to rotate relative to the coupling member.

[0074] According to one embodiment, the adjustment element is rotationally decoupled from both the first clutch member and the second clutch member in the pre-assembled state. Thus, in the pre-assembled state, the clutch mechanism is not rotationally connected to the adjustment member. This then also rotationally decouples the adjustment element from the other member. During adjustment of the piston rod in the pre-assembled state, the clutch mechanism may be in a closed state. For example, the clutch mechanism may be permanently in a closed state when the dose delivery mechanism is in the pre-assembled state.

[0075] According to one embodiment, the adjustment element is rotationally fixed relative to one of the first clutch member and the second clutch member in the pre-assembled state. During the adjustment of the position of the piston rod in the pre-assembled state, the clutch mechanism is in a disconnected state and the first clutch member and the second clutch member are disengaged from each other, thereby allowing the adjustment element to rotate relative to the other member. For this embodiment, the action of the clutch mechanism is also used to rotationally decouple the adjustment element from the other member during the adjustment of the position of the piston rod.

[0076] The clutch mechanism may be permanently in the open state when the dose delivery mechanism is in the pre-assembled state. The clutch mechanism may also be in the open state only during adjustment of the piston rod in the pre-assembled state. For example, if the adjustment element has to be brought into the adjustment position in order to adjust the position of the piston rod, the clutch mechanism may be in the open state only when the adjustment element is in the adjustment position and may be in the closed state if the adjustment element is in the pre-assembled position.

[0077] According to one embodiment, the clutch mechanism comprises a first clutch part and a second clutch part, wherein the first clutch part and the second clutch part engage with each other in a closed state of the clutch mechanism and disengage from each other in a disconnected state of the clutch. Thereby, in a pre-assembled state of the dose delivery mechanism, the first clutch part is located at a first axial side of the second clutch part in the disconnected state of the clutch mechanism, and in an assembled state of the dose delivery mechanism, the first clutch part is located at a second axial side of the second clutch part in the disconnected state. The second axial side is opposite to the first axial side.

[0078] Such a configuration provides a simple mechanism for disconnecting the clutch mechanism in the pre-assembled state. For example, when the dose delivery mechanism is converted from the pre-assembled state to the assembled state, the adjustment element and the first clutch part can be axially moved, and this axial movement can engage the first clutch part with the second clutch part and thus close the clutch.

[0079] Generally speaking, the dose delivery mechanism may comprise a clutch mechanism having a first clutch member and a second clutch member, wherein, in the assembled state, the clutch mechanism is closed during one of dose setting and dose delivery, and is open during the other of dose setting and dose delivery. Thus, the adjustment element may be rotationally decoupled from both the first clutch member and the second clutch member in the pre-assembled state.

[0080] According to one embodiment, the adjustment element is rotationally coupled, e.g. permanently rotationally coupled, to one of the first clutch member and the second clutch member in the assembled state. In addition, the adjustment element can be rotationally coupled, e.g. permanently rotationally coupled, to the one of the first clutch member and the second clutch member in the pre-assembled state. For example, the adjustment element can constitute the one of the first clutch member and the second clutch member.

[0081] Generally speaking, the clutch mechanism may be opened in the pre-assembled state, thereby allowing the adjustment element to rotate relative to the other component, and the clutch mechanism may be opened in the assembled state during dose delivery, thereby allowing the adjustment element to rotate relative to the other component. The clutch mechanism may then be closed in the assembled state during dose setting.

[0082] According to one embodiment, the dose delivery mechanism is configured to hold the clutch mechanism in the disconnected state in the pre-assembled state. For example, the dose delivery mechanism may bias the clutch mechanism to the disconnected state. The dose delivery mechanism may also hold the clutch mechanism in the disconnected state by locking the clutch mechanism in the disconnected state, for example, the dose delivery mechanism may reversibly lock the clutch mechanism in the disconnected state.

[0083] According to one embodiment, in the pre-assembled state, the clutch mechanism is allowed to close from the disconnected state only when the dose delivery mechanism is transferred from the pre-assembled state to the assembled state. This safely keeps the clutch mechanism disconnected in the pre-assembled state.

[0084] For alternative embodiments, the dose delivery mechanism may be configured to maintain the clutch mechanism in a closed state in the pre-assembled state. For example, the dose delivery mechanism may bias the clutch mechanism to the closed state. Then, the clutch mechanism may be configured to be opened by moving the adjustment element, for example, by moving the adjustment element from the pre-assembled position to the adjustment position.

[0085] According to one embodiment, the dose delivery mechanism comprises an actuating element, and when the actuating element moves proximally from the dose setting position to the dose delivery position, the clutch mechanism is changed from a closed state to an open state to enable the proximal movement of the piston rod when the actuating element moves proximally. The actuating element may be a button configured to be pressed by a user to deliver a set amount of drug. For example, the actuating element may be formed by an adjustment element.

[0086] According to one embodiment, during adjustment of the piston rod in the pre-assembled state and during dose setting in the assembled state, the adjustment element is rotationally decoupled from the additional component of the dose delivery mechanism. Furthermore, during dose delivery in the assembled state, the adjustment element is rotationally fixed to the additional component. Thus, rotation of the adjustment element during dose setting may contribute to setting a dose to be delivered by the dose delivery mechanism without moving the piston rod during dose setting.

[0087] According to one embodiment, the additional component is a housing.

[0088] According to one embodiment, the adjustment element is rotatable relative to the counter element in the pre-assembled state and is rotationally fixed, e.g. irreversibly rotationally fixed, to the counter element in the assembled state. The rotational fixing of the adjustment element to the counter element may then allow the dose delivery mechanism to be transferred from the pre-assembled state to the assembled state. For example, the adjustment element may be additionally axially fixed, e.g. irreversibly axially fixed, to the counter element in the assembled state.

[0089] According to one embodiment, in the pre-assembled state, the adjustment element is in a first axial position relative to a corresponding element of the dose delivery mechanism, and the adjustment element is configured to be axially moved from the first axial position to a second axial position relative to the corresponding element when the dose delivery mechanism is transferred from the pre-assembled state to the assembled state, wherein in the assembled state, the adjustment element is axially fixed, e.g., irreversibly axially fixed to the corresponding element. Thus, in the assembled state, the adjustment element and the corresponding element can act as a single component of the dose delivery mechanism.

[0090] According to one embodiment, the dose delivery mechanism comprises a locking mechanism acting between the adjustment element and the counter element, wherein the locking mechanism is configured to prevent the adjustment element from moving from the second position to the first position in the assembled state. This prevents the dose delivery mechanism from returning to a pre-assembled state of final assembly.

[0091] The dose delivery mechanism may comprise an intermediate element acting between the adjustment element and the corresponding element. The locking mechanism may then act between the intermediate element and one of the adjustment element and the corresponding element. The other of the adjustment element and the corresponding element may then be axially and / or rotationally fixed to the intermediate element. For example, the locking mechanism may act between the adjustment element and the intermediate element, and the intermediate element may be rotationally and / or axially fixed to the corresponding element.

[0092] The locking part of the locking mechanism can be formed at the adjustment element. Additionally or alternatively, another locking part of the locking mechanism can be formed at the corresponding element.

[0093] According to one embodiment, the counter element is a dose setting element of the dose delivery mechanism, wherein the dose setting element is configured to be gripped by a user of the dose delivery mechanism in the assembled state to set the dose to be delivered. The adjustment element and the counter element may then provide a dose setting member of the dose delivery mechanism, which is configured to be rotated by a user to set the dose to be delivered in the assembled state. This allows to integrate the fixing of the adjustment element with the counter element into the dose setting element in a mechanically simple manner.

[0094] According to one embodiment, the adjustment element protrudes distally from the counter element in the pre-assembled state.Such a configuration facilitates manipulation of the adjustment element in the pre-assembled state.

[0095] According to one embodiment, in the assembled state, the adjustment element does not protrude distally from the counterpart element. This prevents the adjustment element from being easily accessible to a user of the device and thus prevents the user from forcibly pushing the adjustment element into the pre-assembly position again.

[0096] According to one embodiment, the dose delivery mechanism comprises a rotation lock, wherein the rotation lock allows a rotational movement between the adjustment element and the counter element in a pre-assembled state of the dose delivery mechanism. The adjustment element is rotationally fixed relative to the counter element by the rotation lock in the assembled state, and the rotation lock allows fixing the adjustment element to the counter element in a plurality of mutual relative rotational positions. Such a rotation lock provides a reliable rotational fixation of the adjustment element to the counter element, regardless of the amount of rotation required to position the piston rod in the pre-assembled state.

[0097] The rotary lock may act between the intermediate element and one of the adjustment element and the corresponding element. Then, the other of the adjustment element and the corresponding element may be rotationally fixed to the intermediate element, for example in both the pre-assembled state and the assembled state. A portion of the rotary lock may be formed at the adjustment element, for example integrally with the adjustment element. Additionally or alternatively, another portion of the rotary lock may be formed at the corresponding element, for example integrally with the corresponding element.

[0098] According to one embodiment, the rotation lock comprises a toothed portion defining a plurality of rotational positions and an engagement portion configured to engage with the toothed portion to rotationally lock the adjustment element to the counterpart element when the dose delivery mechanism is transformed from the pre-assembled state to the assembled state.

[0099] The toothed portion may comprise a plurality of teeth arranged circumferentially around the longitudinal axis of the dose delivery mechanism. For example, the teeth may be located at the intermediate element. The engagement portion may comprise at least one engagement tooth, which engages with a tooth of the toothed portion, so that the adjustment element may be rotationally locked to the counter element. For example, the engagement portion may comprise a plurality of engagement teeth. This provides a reliable rotational fixation.

[0100] According to one embodiment, the dose delivery mechanism comprises an axial lock, wherein the axial lock allows an axial movement between the setting element and the counter element in a pre-assembled state of the dose delivery mechanism and prevents an axial movement between the setting element and the counter element in an assembled state.

[0101] The axial lock may act between the intermediate element and one of the adjustment element and the corresponding element. Then, the other of the adjustment element and the corresponding element may be rotationally fixed to the intermediate element, for example in both the pre-assembled state and the assembled state. A part of the axial lock may be formed at the adjustment element, for example integrally with the adjustment element. Additionally or alternatively, another part of the axial lock may be formed at the corresponding element, for example integrally with the corresponding element.

[0102] According to one embodiment, the axial lock allows the adjustment element to be axially fixed to the counterpart element in a plurality of mutual relative rotational positions. For example, the axial lock may include a circumferential portion, such as a circumferential rib, which is positioned circumferentially around the longitudinal axis of the dose delivery mechanism. Furthermore, the axial lock may include at least one engagement portion, which is configured to engage with the circumferential portion when axially locking the adjustment element to the counterpart element.

[0103] The axial lock may be configured as a snap-fit ​​connection. For example, the engagement portion may be configured as a flexible hook that snaps onto the circumferential portion when the axial lock is closed.

[0104] According to one embodiment, the dose delivery mechanism comprises a connector, wherein the adjustment element is rotationally and / or axially fixed to the counter element by the connector in the assembled state. Such a connector facilitates achieving a rotational lock and / or an axial lock. The connector may constitute an intermediate element.

[0105] According to one embodiment, the connector is axially locked to the counter element both in the pre-assembled state and in the assembled state.The axial lock between the adjustment element and the counter element can then act between the adjustment element and the connector.

[0106] According to one embodiment, the connector is rotationally locked to the counter element both in the pre-assembled state and in the assembled state. This provides a secure rotational locking of the adjustment element with the counter element via the connector.

[0107] According to one embodiment, the rotation lock is located between the adjustment element and the connector. For example, a first part of the rotation lock may be formed at the adjustment element, and a second part of the rotation lock may be formed at the connector.

[0108] According to one embodiment, the connector includes one of a toothed portion and an engagement portion, and the adjustment element includes the other of the toothed portion and the engagement portion. For example, the engagement portion may be formed at the adjustment element, and the toothed portion may be formed at the connector.

[0109] According to one embodiment, the axial lock is located between the adjustment element and the connector. For example, a first part of the axial lock, such as an engagement part, may be formed at the adjustment element, and a second part of the axial lock, such as a circumferential part, may be formed at the connector.

[0110] According to one embodiment, the adjustment element is configured to rotate relative to the piston rod when rotating relative to the housing in the pre-assembled state. This allows providing a threaded connection that converts a rotation of the adjustment element into an axial movement of the piston rod between the adjustment element and the piston rod.

[0111] According to one embodiment, the piston rod is rotationally fixed relative to the housing in the pre-assembled state.

[0112] According to one embodiment, the adjustment element is rotationally fixed relative to the piston rod in the pre-assembled state. This allows the piston rod to be rotated during adjustment of the axial position of the piston rod. The threaded connection can then act between the piston rod and the housing.

[0113] According to one embodiment, in the assembled state, during dose setting and / or during dose delivery, the piston rod is rotationally fixed relative to the housing.For example, the piston rod may be permanently fixed relative to the housing.

[0114] According to one embodiment, in a preassembled state, the adjustment element is in a first axial position relative to a retaining member of the dose delivery mechanism, wherein the adjustment element is configured to be axially moved from the first axial position to a second axial position relative to the retaining member when the dose delivery mechanism is transferred from the preassembled state to the assembled state, wherein the adjustment element is rotatable relative to the retaining member in the preassembled state.

[0115] The adjusting element may be in a first axial position relative to the retaining member when the adjusting element is in a pre-assembled position relative to the housing, and it may be in a second axial position relative to the retaining member when the adjusting element is in an assembled position relative to the housing. The retaining member may be an extension connecting the adjusting element to the housing. The retaining member may protrude distally from the housing. The retaining member may be rotationally fixed and axially movable relative to the housing. The retaining member may be configured as a housing extension, and at least a portion of the retaining member may form a housing for the dose delivery mechanism.

[0116] The retaining member may be configured as a dose selector or a sleeve or a coupling element of the dose delivery mechanism.

[0117] According to one embodiment, during dose setting in the assembled state, the adjustment element is rotatable relative to the retaining member. Rotation of the adjustment element relative to the retaining member can then be used both for adjusting the piston rod in the pre-assembled state and for setting a dose in the assembled state.

[0118] According to one embodiment, during dose delivery in the assembled state, the adjustment element is rotationally fixed to the retaining member. This may also rotationally fix the adjustment element to the housing via the retaining member. Rotationally fixing the adjustment element to the retaining member may prevent a change in the set dose during dose delivery.

[0119] According to one embodiment, the adjustment element is axially movable relative to the retaining member in the assembled state.For example, in the assembled state, the adjustment element is axially movable to transform the dose delivery mechanism from a dose setting state to a dose delivery state.

[0120] For alternative embodiments, the adjustment element may also be axially fixed relative to the retaining member in the assembled state.For these embodiments, the adjustment element may be configured to move axially with the retaining member to switch the dose delivery mechanism from the dose setting state to the dose delivery state.

[0121] According to one embodiment, the adjustment element is biased in the distal direction when the dose delivery mechanism is in the pre-assembled state. This may provide a simple mechanism for holding the adjustment element in the pre-assembled position.

[0122] According to one embodiment, the adjustment element is configured to occupy a dose setting position in the assembled state, and the adjustment element is movable, for example axially movable, in the assembled state. The adjustment element may occupy the dose setting position relative to the second clutch member of the clutch mechanism of the dose delivery mechanism. If the adjustment element occupies the dose setting position, the clutch mechanism may be in one of an open state or a closed state.

[0123] The adjustment element may also occupy a dose setting position relative to the housing and may be movable relative to the housing. Alternatively, the adjustment element may occupy a dose setting position relative to the retaining member and may be movable relative to the retaining member.

[0124] According to one embodiment, the adjustment element is configured to be moved proximally from the dose setting position to the dose delivery position in the assembled state. This axial movement can then change the dose delivery mechanism from a dose setting state in which the user can set the dose to be delivered to a dose delivery state in which the user can deliver the set dose. The adjustment element can be moved relative to the second clutch member to the dose delivery position. If the adjustment element is in the dose delivery position, the clutch mechanism can be in the other of the open state or the closed state.

[0125] According to one embodiment, the adjustment element is biased into the dose setting position in the assembled state. This allows for easy dose setting without first having to manually position the adjustment element in the dose setting position.

[0126] According to one embodiment, the adjustment element is configured as a dose setting element of the dose delivery mechanism, wherein the dose setting element is configured to be grasped by a user of the dose delivery mechanism in an assembled state in order to set a dose to be delivered.

[0127] According to one embodiment, the adjustment element is configured to be rotated in the assembled state to set the dose of drug to be delivered by the dose delivery mechanism. Thus, rotation of the adjustment element can be used to adjust the position of the piston rod in the pre-assembled state and to set the dose in the assembled state without moving the piston rod. This provides a mechanically simple construction of the dose delivery mechanism.

[0128] According to one embodiment, the dose delivery mechanism comprises a locking mechanism, wherein, in the assembled state, the locking mechanism rotationally locks the adjustment element to the housing during dose delivery.

[0129] According to one embodiment, the dose delivery mechanism comprises a dose limiting mechanism which defines a rotational position of the adjustment element relative to the housing, the rotational position corresponding to a dose settable by a user in the assembled state, wherein the dose limiting mechanism is inactive during rotation of the adjustment element in the pre-assembled state. This allows precise positioning of the piston rod by rotating the adjustment element without interfering with the dose limiting mechanism.

[0130] According to one embodiment, the dose limiting mechanism comprises at least one engagement feature and at least one dose stop which rotate relative to each other when the setting element is rotated in the assembled state and which engage with each other when setting a dose in the assembled state.

[0131] According to one embodiment, during rotation of the setting element in the pre-assembled state, the engagement feature and the at least one dose stop do not rotate relative to each other. This prevents the dose limiting mechanism from functioning during rotation of the setting element in the pre-assembled state.

[0132] According to one embodiment, during rotation of the adjustment element in the pre-assembled state, the engagement feature and the at least one dose stop rotate relative to each other and in the pre-assembled state the engagement feature and the at least one dose stop do not engage with each other. For example, in the pre-assembled state and / or during position adjustment of the piston rod, the engagement feature and the at least one dose stop may be positioned axially offset from each other. This also prevents the dose limiting mechanism from functioning during rotation of the adjustment element in the pre-assembled state.

[0133] According to one embodiment, the housing comprises a connector for connecting the medicament container to the housing, and the connector is configured to axially movably connect the medicament container to the housing, such that the medicament container is configured to perform an axial movement from the receiving position to the operating position after being connected to the housing.

[0134] Thereby, the bearing of the piston rod may be located at a distance from the plunger in the medicament container when the medicament container is in the receiving position, and the bearing may be in contact with the plunger when the medicament container is in the operating position.

[0135] The connector may be configured as a threaded connector, and the medicament container may be configured to be moved from the receiving position to the operating position by rotating a container holder including the medicament container along the threaded connector.

[0136] According to one embodiment, the connector is configured to bring the plunger into contact with a bearing located at the piston rod when the drug container is axially moved from the receiving position to the operating position. For example, the connector can be configured to bring the plunger into contact with the bearing before the drug container reaches the operating position. This allows the bearing to push the plunger during movement of the drug container, for example, to expel a certain amount of drug and / or reconstitute a lyophilized drug.

[0137] Thus, the movement of the drug container from the receiving position to the operating position may result in an axial movement of the plunger in the drug container due to the bearing pushing the plunger. This may then also involve the expulsion of a certain amount of drug. The movement of the drug container from the receiving position to the operating position may be performed by the user before the first dose of drug is expelled.

[0138] Additionally or alternatively, axial movement of the plunger within the drug container may cause the drug within the drug container to be reconstituted from a lyophilized state into a solution.

[0139] For embodiments in which the drug container is moved from a receiving position to an operating position, the position of the piston rod can be adjusted in a pre-assembled state in such a way that the bearing contacts the piston rod during the movement of the drug container. In addition, the piston rod can be adjusted to a position in which the amount of drug is expelled at the end of the movement of the drug container. The adjusted position of the piston rod can cause contact between the bearing and the plunger and / or the expulsion of the drug regardless of the initial position of the plunger relative to the housing of the cartridge, as long as the initial position is within a predetermined manufacturing tolerance.

[0140] For other embodiments, the position of the piston rod may also be adjusted in such a way that the bearing of the piston rod contacts the plunger in the assembled state.

[0141] The present disclosure also relates to a drug delivery device having a dose delivery mechanism according to the present disclosure and a drug container attached to the dose delivery mechanism. The drug container comprises a plunger and a bearing at a piston rod, the bearing being positioned at a predetermined distance relative to the plunger.

[0142] All embodiments and technical effects disclosed in connection with the dose delivery mechanism or method according to the present disclosure are also applicable to the drug delivery device, and vice versa.

[0143] According to one embodiment, the predetermined distance is zero, so that the bearing contacts the plunger.This allows a user of the drug delivery device to expel a first dose of drug just as accurately, without having to prime the device prior to use.

[0144] According to one embodiment, the predetermined distance is greater than zero. This prevents the piston rod from pressurizing the plunger before the device is used, for example during transport.

[0145] According to one embodiment, the predetermined distance is less than an axial distance travelled by the medicament container from the receiving position to the operating position.Therefore, the plunger may come into contact with the bearing when the medicament container is moved from the receiving position to the operating position.

[0146] The present disclosure also relates to a method for adjusting the position of a piston rod of a dose delivery mechanism of a drug delivery device, the dose delivery mechanism comprising: a housing; a piston rod; and an adjustment element. Thereby, the housing is configured to be connected to a drug container sealed by a plunger. In addition, the method further comprises:

[0147] - providing the dose delivery mechanism in a pre-assembled state, wherein, in the pre-assembled state, the outer edge of the adjustment element is accessible to an assembler of the device to enable rotation of the adjustment element and axial movement of the piston rod;

[0148] - in a pre-assembled state, adjusting the axial position of the piston rod relative to the housing by rotating the adjustment element and thereby causing an axial movement of the piston rod relative to the housing, wherein the rotation of the adjustment element is converted into an axial movement of the piston rod via a single threaded connection of the dose delivery mechanism; and

[0149] - converting the dose delivery mechanism from a pre-assembled state into an assembled state, wherein, in the assembled state, the dose delivery mechanism is configured to axially move the piston rod in a proximal direction relative to the housing during dose delivery, so that the piston rod exerts an axial force in a proximal direction on a plunger of the drug container to expel the drug from the drug container.

[0150] The dosage delivery mechanism may be a dosage delivery mechanism according to the present disclosure. All embodiments and technical effects disclosed in conjunction with the dosage delivery mechanism are also applicable to the method, and vice versa. Additionally or alternatively, the drug delivery device may be a drug delivery device according to the present disclosure. All embodiments and technical effects disclosed in conjunction with the drug delivery device are also applicable to the method, and vice versa.

[0151] According to one embodiment, the dose delivery mechanism is provided with an attached drug container in a pre-assembled state. The method may then comprise the step of placing a bearing at the piston rod at a predetermined distance from a plunger of the drug container. For example, the predetermined distance may be zero, such that the bearing contacts the plunger. The predetermined distance may also be greater than zero, such that the bearing is positioned away from the plunger.

[0152] The method may further comprise the step of determining the distance between the bearing and the plunger, such as the step of monitoring the distance between the bearing and the plunger. For example, these steps may be performed by visually inspecting the position of the bearing, such as through a transparent component of the drug delivery device. The distance may also be determined by sensing contact between the bearing and the plunger, such as by sensing an increase in torque required to rotate the adjustment element after the bearing contacts the plunger.

[0153] According to one embodiment, the medicament container does not move relative to the housing when the axial position of the piston rod is adjusted.For example, the medicament container may be fixedly connected to the housing of the dose delivery mechanism in a pre-assembled state.

[0154] According to one embodiment, the axial position of the piston rod is adjusted to place the bearing at the piston rod in contact with a reference surface.Such a reference surface provides a simple way to adjust the position of the piston rod to a predetermined axial position.

[0155] According to one embodiment, the reference surface is provided by a surface of a plunger of the medicament container.This provides for an accurate positioning of the piston rod relative to the plunger of the medicament container actually used with the drug delivery device.

[0156] According to one embodiment, the dose delivery mechanism is provided in a pre-assembled state without an attached medicament container, and the method further comprises placing the dose delivery mechanism in an assembly fixture.

[0157] Such an assembly jig helps to position the piston rod at a well-defined position relative to the housing.For example, after placing the dose delivery mechanism in the assembly jig, at least a part of the assembly jig or the assembly jig may be axially fixed relative to the housing.

[0158] According to one embodiment, the reference surface is provided by a surface of an assembly fixture.This allows adjusting the piston rod to a well-defined position relative to the housing without attaching a medicament container and / or without the bearing contacting the plunger of the medicament container.

[0159] According to one embodiment, during adjustment of the axial position the piston rod is axially moved until a predetermined torque is required for rotation of the adjustment element. During adjustment of the position of the piston rod, this torque may be monitored by a measuring device. The increase in torque may be caused by a bearing of the piston rod contacting a reference surface, such as a surface of a plunger of a drug container attached to the housing or a reference surface of an assembly fixture to which the dose delivery mechanism has been attached.

[0160] According to one embodiment, the method further comprises measuring the position of the piston rod with a measuring device in order to determine the adjusted position of the piston rod. The measuring device may be one of an optical measuring device or a mechanical measuring device, such as an assembly fixture having a reference surface. The optical measuring device may be a camera or the like. With the optical measuring device, the position of the piston rod may be measured through a transparent part of the drug delivery device, such as through a transparent drug container holder and / or a transparent drug container. BRIEF DESCRIPTION OF THE DRAWINGS

[0161] Exemplary embodiments and functionality of the present disclosure are described herein in conjunction with the following figures.

[0162] Figure 1 An exploded view of an injection pen according to the invention is shown.

[0163] Figure 2A Shows Figure 1 A perspective view of the knob cover of an injection pen.

[0164] Figure 2B Shows Figure 2A Side view of the knob cover.

[0165] Figure 2C Shown along Figure 2B Line AA Figure 2B Cross-section view of the knob cover.

[0166] Figure 3A Shows Figure 1 Perspective view of the injection button of an injection pen.

[0167] Figure 3B Shows Figure 3A Side view of the injection button.

[0168] Figure 3C Shown along Figure 3B Line AA Figure 3B Cross-section view of the injection button.

[0169] Figure 3D Shown along Figure 3B Line BB Figure 3B Cross-section view of the injection button.

[0170] Figure 3E Shown along Figure 3B Line CC Figure 3B Cross-section view of the injection button.

[0171] Figure 4A Shows Figure 1 A perspective view of the retaining ring of an injection pen.

[0172] Figure 4B Shows Figure 4A Top view of the clasp.

[0173] Figure 4C Shows Figure 4A Side view of the retaining ring.

[0174] Figure 4D Shows Figure 4A Bottom view of the retaining ring.

[0175] Figure 5A Shows Figure 1 First perspective view of the dose setting knob of an injection pen.

[0176] Figure 5BShows Figure 5A Second perspective view of the dose setting knob.

[0177] Figure 5C Shows Figure 5A Side view of the dose setting knob.

[0178] Figure 5D Shown along Figure 5C Line AA Figure 5A Cross-section of the dose setting knob.

[0179] Fig. 6A Shows Figure 1 A perspective view of the snap-fit ​​element of an injection pen.

[0180] Figure 6B Shows Fig. 6A Side view of the snap-fit ​​element.

[0181] Figure 6C Shown along Figure 6B Line AA Fig. 6A A cross-sectional view of a snap-fit ​​element.

[0182] Fig. 7A Shows Figure 1 A perspective view of the connector of an injection pen.

[0183] Figure 7B Shows Fig. 7A Bottom view of the connector.

[0184] Figure 7C Shows Fig. 7A Side view of the connector.

[0185] Fig.7D Shows Fig. 7A Top view of the connector.

[0186] Fig. 8A Shows Figure 1 First perspective view of the dose selector of an injection pen.

[0187] Figure 8B Shows Fig. 8A Bottom view of the dose selector.

[0188] Figure 8C Shows Fig. 8A Side view of the dose selector.

[0189] Fig.8D Shown along Figure 8C Line AA Fig. 8A Cross-sectional view of the dose selector.

[0190] Fig. 8E Shown along Figure 8C Line BB Fig. 8A Cross-sectional view of the dose selector.

[0191] Fig. 9 Shows Fig. 8A Second perspective view of the dose selector of .

[0192] Fig. 10A Shows Figure 1 A perspective view of the knob key of an injection pen.

[0193] Fig. 10B Shows Fig. 10A Side view of the knob key.

[0194] Fig.11A Shows Figure 1 A perspective view of the housing of an injection pen.

[0195] Fig. 11B Shows Fig.11A A side view of the housing.

[0196] Fig. 11C Shown along Fig. 11B Line AA Fig.11A A cross-sectional view of the shell.

[0197] Fig. 12A Shows Figure 1 A first side view of a dose setting sleeve of an injection pen.

[0198] Fig. 12B Shows Fig. 12A A second side view of the dose setting sleeve.

[0199] Fig. 12C Shows Fig. 12A A third side view of the dose setting sleeve.

[0200] Fig.12D Shows Fig. 12A A fourth side view of the dose setting sleeve.

[0201] Fig.12E Shows Fig. 12A Front view of the dose setting sleeve.

[0202] Fig.12F Shows Fig. 12A A first perspective view of a dose setting sleeve.

[0203] Figure 12G Shows Fig. 12A A second perspective view of the dose setting sleeve of FIG.

[0204] Fig.13A Shows Figure 1Perspective view of the driver of the injection pen.

[0205] Fig. 13B Shows Fig.13A First side view of the drive.

[0206] Fig. 13C Shows Fig.13A Second side view of the drive.

[0207] Fig.13D Shown along Fig. 13C Line AA Fig.13A A cross-sectional view of the drive.

[0208] Fig.14A Shows Figure 1 First perspective view of the nut of the injection pen.

[0209] Fig. 14B Shows Fig.14A A second perspective view of the nut.

[0210] Fig. 14C Shows Fig.14A Side view of the nut.

[0211] Fig.14D Shown along Fig. 14C Line AA Fig.14A First cross-sectional view of a nut.

[0212] Fig.14E Shown along Fig. 14C Line BB Fig.14A A second cross-sectional view of the nut.

[0213] Fig.15A Shows Figure 1 A first side view of the piston rod guide of an injection pen.

[0214] Fig. 15B Shows Fig.15A A second side view of the piston rod guide.

[0215] Fig. 15C Shown along Fig.15A Line AA Fig.15A sectional view of the piston rod guide.

[0216] Fig.15D Shows Fig.15A A perspective view of the piston rod guide.

[0217] Fig.16A Shows Fig.15A A first longitudinal cross-sectional view of a piston rod guide.

[0218] Fig. 16BShows Fig.15A A second longitudinal cross-sectional view of the piston rod guide.

[0219] Fig. 16C Shows Fig.15A A perspective view of the piston rod guide.

[0220] Fig.17A Shows Figure 1 Side view of the piston rod of the injection pen.

[0221] Fig. 17B Shown along Fig.17A Line AA Fig.17A Cross-section of the piston rod.

[0222] Fig. 17C Shows Fig.17A A first perspective view of the piston rod.

[0223] Fig.17D Shows Fig.17A A second perspective view of the piston rod.

[0224] Fig.18A Shows Figure 1 Perspective view of the piston disk of an injection pen.

[0225] Fig.18B Shows Fig.18A top view of a piston disk.

[0226] Fig.18C Shown along Fig.18B Line AA Fig.18A Cross-section of the piston disc.

[0227] Fig.19A Shows Figure 1 A perspective view of the dual-chamber cartridge of an injection pen.

[0228] Fig.19B Shows Fig.19A Side view of a dual chamber cartridge.

[0229] Fig.19C Shown along Fig.19B Line AA Fig.19A Cross-sectional view of a dual-chamber cylinder.

[0230] Fig. 20A Shows Figure 1 A perspective view of the cartridge container of an injection pen.

[0231] Fig. 20B Shows Fig. 20A A first side view of a cartridge container.

[0232] Fig. 20C Shows Fig. 20A A second side view of a cartridge container.

[0233] Fig.20D Shown along Fig. 20C Line AA Fig. 20A A cross-sectional view of a cartridge container.

[0234] Fig.21A Shows Figure 1 A first perspective view of the barrel key of an injection pen.

[0235] Fig.21B Shows Fig.21A A second perspective view of the barrel key.

[0236] Fig. 21C Shows Fig.21A A first side view of a barrel key.

[0237] Fig.21D Shows Fig.21A A second side view of the barrel key.

[0238] Fig.22A Shows Fig.21A A third side view of the barrel key.

[0239] Fig. 22B Shown along Fig.22A Line AA Fig.21A Cross-sectional view of the barrel key.

[0240] Fig.23A Shows the as-delivered state Figure 1 Side view of the injection pen.

[0241] Fig. 23B Shown along Fig.23A Line AA Fig.23A Cross-sectional view of an injection pen.

[0242] Fig.24 Shown without knob cover and with some parts transparent Fig.23A Perspective view of an injection pen.

[0243] Fig.25A Shows Fig.23A Second side view of the injection pen.

[0244] Fig.25B Shown along Fig.25A Line AA Fig.23A Cross-sectional view of an injection pen.

[0245] Fig.26A Shows the reorganization state Figure 1 Side view of the injection pen.

[0246] Fig.26B Shown along Fig.26A Line AA Fig.26A Cross-sectional view of an injection pen.

[0247] Fig.27A Shows Fig.26A Second side view of the injection pen.

[0248] Fig.27B Shows Fig.26A A third side view of the injection pen.

[0249] Fig.27C Shown along Fig.27B Line AA Fig.26A Cross-sectional view of an injection pen.

[0250] Fig.28A Shown with the knob cover unfastened Figure 1 Side view of the injection pen.

[0251] Fig.28B Shown along Fig.28A Line AA Fig.28A Cross-sectional view of an injection pen.

[0252] Fig.29A shows the state at the end of the reorganization Figure 1 Side view of the injection pen.

[0253] Fig.29B Shown along Fig.29A Line AA Fig.29A Cross-sectional view of an injection pen.

[0254] Fig. 30A Shows the dose setting state Figure 1 Side view of the injection pen.

[0255] Fig. 30B Shown along Fig. 30A Line AA Fig. 30A Cross-sectional view of an injection pen.

[0256] Fig.31A Shows the injection start state Figure 1 Side view of the injection pen.

[0257] Fig.31B Shown along Fig.31A Line AA Fig.31A Cross-sectional view of an injection pen.

[0258] Fig.32A Shows the injection start state Figure 1Another side view of the injection pen.

[0259] Fig.32B Shown along Fig.32A Line AA Fig.32A An enlarged cross-sectional view of the injection pen.

[0260] Fig.33A Shows the injection end state Figure 1 Side view of the injection pen.

[0261] Fig.33B Shown along Fig.33A Line AA Fig.33A Cross-sectional view of an injection pen.

[0262] Fig.34 A second injection pen according to the present disclosure is shown in a pre-assembled state.

[0263] Fig.35 Another view of the second injection pen is shown in a pre-assembled state.

[0264] Fig.36 An exploded view of a second injection pen is shown.

[0265] Fig.37 A longitudinal section through a second injection pen is shown in a pre-assembled state.

[0266] Fig.38 A detailed view of the distal part of the second injection pen is shown in a pre-assembled state.

[0267] Fig.39 A detailed view of the distal end of a second injection pen is shown in an assembled state during dose setting.

[0268] Fig.40 Another view of the distal end of the second injection pen is shown in the assembled state during dose setting.

[0269] Fig.41 A detailed view of the distal end of the second injection pen is shown in an assembled state during dose delivery.

[0270] Fig.42 Another view of the distal end of the second injection pen is shown in the assembled state during dose delivery.

[0271] Fig.43 A longitudinal cross-section of the dose setting elements of a first and a second injection pen is shown.

[0272] Fig.44 A perspective view of a longitudinal section of the dose setting member is shown.

[0273] Fig.45A distal perspective view of the dose setting element is shown.

[0274] Fig.46 A proximal perspective view of the dose setting element is shown.

[0275] Fig.47 A perspective view of a third injection pen according to the present disclosure is shown.

[0276] Fig.48 An exploded view of a third injection pen is shown.

[0277] Fig.49 A longitudinal cross-section of the dose delivery mechanism of a third injection pen is shown.

[0278] Fig.50 A distal perspective view of a dosing member of a third injection pen is shown.

[0279] Fig.51 A longitudinal cutaway perspective view of a dosing member of a third injection pen is shown.

[0280] Fig.52 A perspective view of the piston rod of a third injection pen is shown.

[0281] Fig.53 A distal perspective view of an extension of a third injection pen is shown.

[0282] Fig.54 Shows Fig.53 Distal view of the extension shown in .

[0283] Fig.55 Shows Fig.53 A proximal view of the extension shown in FIG.

[0284] Fig.56 A perspective view of a coupling element of a third injection pen is shown.

[0285] Fig.57 A perspective view of the bearing, piston rod, extension, coupling element and adjustment element of a third injection pen is shown.

[0286] Fig.58 A proximal perspective view of an adjustment element of a third injection pen is shown.

[0287] Fig.59 A side view of an adjustment element of a third injection pen is shown.

[0288] Fig.60 Shown along Fig.59 Radial section through the third injected adjustment element along line AA.

[0289] Fig.61 Shown along Fig.59Radial section through the adjustment element of the third injection along line BB.

[0290] Fig.62 A perspective view of a coupling member of a third injection pen is shown.

[0291] Fig.63 A distal perspective view of the barrel of a third injection pen is shown.

[0292] Fig.64 A longitudinal cross-section of the cartridge of a third injection pen is shown.

[0293] Fig.65 A perspective view of a housing insert of a third injection pen is shown.

[0294] Fig.66 A perspective view of the connector of a third injection pen is shown.

[0295] Fig.67 A perspective view of a longitudinal section of a connector of a third injection pen is shown.

[0296] Fig.68 A side view of the third injection pen is shown in an assembled state during dose setting.

[0297] Fig.69 A side view of a third injection pen is shown in a pre-assembled state.

[0298] Fig.70 A detailed view in longitudinal section of the distal end of a third injection pen is shown in an assembled state during dose setting.

[0299] Fig.71 Another longitudinally cut detailed view of the distal end of the third injection pen is shown in an assembled state during dose setting.

[0300] Fig.72 A detailed view in longitudinal section of the distal end of a third injection pen is shown in an assembled state during dose delivery.

[0301] Fig.73 Another longitudinally cut detailed view of the distal end of a third injection pen is shown in an assembled state during dose delivery.

[0302] Fig.74 A detailed view in longitudinal section of the distal end of a third injection pen is shown in a pre-assembled state.

[0303] Fig.75 Another longitudinally cut detailed view of the distal end of a third injection pen is shown in a pre-assembled state.

[0304] Fig.76 A perspective view of a fourth injection pen according to the present disclosure is shown.

[0305] Fig.77 A side view of a fourth injection pen is shown in an assembled state during dose setting.

[0306] Fig.78 A side view of a fourth injection pen in a pre-assembled state is shown, wherein the adjustment element is in a pre-assembled position.

[0307] Fig.79 A side view of a fourth injection pen is shown in a pre-assembled state, wherein the adjustment element is in an adjustment position.

[0308] Fig.80 An exploded view of a fourth injection pen is shown.

[0309] Fig.81 A longitudinal section through the dose delivery mechanism of a fourth injection pen is shown in an assembled state during dose setting.

[0310] Fig.82 A perspective view of a coupling element of a fourth injection pen is shown.

[0311] Fig.83 Shows the line AA Fig.82 A radial cross-section of the coupling element shown in FIG.

[0312] Fig.84 A perspective view of the piston rod of a fourth injection pen is shown.

[0313] Fig.85 A proximal perspective view of an adjustment element of a fourth injection pen is shown.

[0314] Fig.86 A side view of an adjustment element of a fourth injection pen is shown.

[0315] Fig.87 Shown along Fig.86 First longitudinal section of the adjustment element along line AA in FIG.

[0316] Fig.88 Shown in perpendicular to Fig.86 Another side view of the adjustment element of the fourth injection pen in the direction of .

[0317] Fig.89 Shown along Fig.88 Second longitudinal section of the adjustment element along line BB in FIG.

[0318] Fig.90 A distal perspective view of the barrel of a fourth injection pen is shown.

[0319] Fig.91 A distal perspective view of the insert of the sleeve is shown.

[0320] Fig.92 A proximal perspective view of the insert of the sleeve is shown.

[0321] Fig.93 A distal perspective view of the outer portion of the sleeve is shown.

[0322] Fig.94 A side view of a coupling member of a fourth injection pen is shown.

[0323] Fig.95 Shown along Fig.90 A longitudinal cross-sectional view of the coupling member along line AA in FIG.

[0324] Fig.96 Shown along Fig.90 A radial cross-sectional view of the coupling member along line BB in FIG.

[0325] Fig.97 A distal perspective view of a dosing member of a fourth injection pen is shown.

[0326] Fig.98 A perspective view in longitudinal section of the dosing member is shown.

[0327] Fig.99 A longitudinal cross-section of the distal end of the dose delivery mechanism of a fourth injection pen is shown in an assembled state during dose setting.

[0328] Fig.100 Another longitudinal section view of the distal end of the dose delivery mechanism of a fourth injection pen is shown in an assembled state during dose setting.

[0329] Fig.101 A longitudinal section view of the distal end of the dose delivery mechanism of a fourth injection pen is shown in an assembled state during dose delivery.

[0330] Fig.102 Another longitudinal section view of the distal end of the dose delivery mechanism of a fourth injection pen is shown in an assembled state during dose delivery.

[0331] Fig.103 A longitudinal section through the distal end of a dose delivery mechanism of a fourth injection pen is shown in a pre-assembled state, wherein the adjustment element is in a pre-assembled position.

[0332] Fig.104 Another longitudinal section through the distal end of the dose delivery mechanism of a fourth injection pen is shown in a pre-assembled state, with the adjustment element in the pre-assembled position.

[0333] Fig.105A longitudinal section through the distal end of a dose delivery mechanism of a fourth injection pen is shown in a pre-assembled state with an adjustment element in an adjustment position.

[0334] Fig.106 Another longitudinal section through the distal end of the dose delivery mechanism of a fourth injection pen is shown in a pre-assembled state with the adjustment element in an adjustment position. DETAILED DESCRIPTION

[0335] refer to Figures 1 to 22B , describes the various parts of the injection pen 10 according to the present invention. Figures 23A to 33B Describes how the pen is intended to be used.

[0336] Figure 1 An exploded view of a drug delivery device in the form of an injection pen 10 is shown. The injection pen 10 comprises, in order from the distal end 12 to the proximal end 14: a knob cover 16, which may also be referred to as a knob lock, a cover or a retaining element; an injection button 18, which may be part of an actuating member; a snap ring 20; a dose setting knob 22, which may also be referred to as a dose setting element, a dose adjustment member or a knob, and may be part of an actuating member; a snap element 24, which may also be referred to as a dose setting device; a connector 26; a dose selector 28; a knob key 30, which may also be referred to as a clip; a housing 32, which may also be referred to as a body; a dose setting sleeve 34, which may also be referred to as a dose sleeve or a dose indicating member; a driver 36; a nut 38; a spring 40; a piston rod guide 42, which may also be referred to as a piston guide; a piston rod 44; a piston disc 46, which may also be referred to as a bearing; a dual chamber cartridge 48, which may also be referred to as a drug 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 drug container holder. Thus, the cartridge container 50 provides an outer container holder, and the cartridge key 52 provides an inner container holder of the container holder.

[0337] Although the above-mentioned parts of the injection pen 10 may each be formed as a separate part to simplify the production of the separate parts, it will generally be possible to form one or more parts integrally with each other. For example, the injection button 18, the snap ring 20 and / or the dose setting knob 22 may be integrally formed with each other. Furthermore, the dose setting sleeve 34 and the driver 36 may be integrally formed with each other. In general, even the housing 32 and the piston rod guide 42 may be integrally formed with each other.

[0338] Different parts can be grouped together to define different functional units. For example, the section between the injection button 18 and the piston rod guide 42 can be referred to as a dose setting mechanism 54, a dose setting unit, a dose delivery mechanism and / or a dose delivery activation mechanism. On the other hand, the section between the piston rod guide 42 and the barrel key 52 can be referred to as a drug reconstitution unit 56 or a reconstitution device. The barrel container 50 and the barrel holder 52 can be referred to as a barrel holding unit. The barrel container 50, the barrel holder 52 and the barrel 48 can be referred to as a barrel unit. For example, the barrel unit can be sold separately from the rest of the injection pen 10 in a pre-assembled state or as a separate part.

[0339] 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:

[0340] Figures 2A to 2C The knob cover 16 is depicted. During delivery, i.e. shipment, 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 can be completely separated from the rest of the injection pen 10. The knob cover 16 can be attached to and / or separated from the housing 32 by means of two deformable wings 58, which can be deflected outwardly, i.e. in a radial direction, to separate 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 formed on the piston guide 42 (see Fig. 15C ) engage to axially fix the knob cover 16 in the distal direction relative to the housing 32. Immediately adjacent to 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 the housing 32 to form a circumferentially extending protrusion 64 (see Fig.25A ) at an axial position. On the far side of each window 62, i.e., on the side away from the lug 60, an abutment 66 is formed on the inner side surface of the corresponding wing 58. The abutment 66 has a width that is the same as the recess or cutout 68 (see FIG. 1 ) on the outer surface of the housing 32. Fig.11A ), more specifically, the width of the recess or cutout 68 in the chamfered portion 69 formed on the outer surface of the housing 32. In addition, when the knob cover 16 is attached to the housing 32, the abutment 66 forms a front surface 66a that axially abuts the radially extending surface 32a (see Fig. 11B), the radially extending surface 32a defines the proximal end of the cutout 68. The radially extending surface 32a defines a stop surface that prevents the knob cover 16 from moving proximally relative to the housing 32, for example, in the event that the injection pen 10 falls to the floor with the distal end 12 first. To further ensure that the knob cover 16 does not move beyond its attachment position in the proximal direction 1, an axial abutment protrusion 70 (see Fig.11A The projection 70 is configured to form a gap 72 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.

[0341] 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 rotationally restrained relative to the housing 32 when the knob cover 16 is attached to the housing 32 .

[0342] As from Figure 2A As can be seen, the knob cover 16 can only be separated 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 device 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 within the knob cover 16 by the form-fitting engagement of the linear recess 74 and the anti-roll feature 76. Figure 2A As can be seen in the figure, the knob cover 16 also forms an anti-roll 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 will not roll away when placed on a flat surface. Figure 2A It can also be seen that the knob cover 16 has a closed perimeter 16a and a closed face 16b at its distal end. Thus, the knob cover 16 forms a closed sleeve surrounding the distal section of the injection pen 10.

[0343] Figures 3A to 3E The injection button 18 is depicted. The injection button 18 forms a distal front surface 80 to apply a force to the injection button 18 to inject a set dose. The injection button 18 includes an axial fixing device 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 Figures 5A to 5D). The axial fixing means 82 comprises two elastically deformable hooks 82 which engage with circumferentially extending ribs 84 on the snap ring 20. The snap ring 20 further comprises axial fixing means 86 in the form of elastically deformable bendable hooks which engage with undercuts 88 formed in the dose setting knob 22. The injection button 18, the snap ring 20 and the dose setting knob 22 are permanently axially fixed to each other in the assembled state of the dose delivery mechanism 54.

[0344] The injection button 18 also forms a rotational securing means 90 in the form of radially extending ribs. The ribs 90 are connected to the rotational securing means 92 in the form of teeth arranged in the inner peripheral surface of the collar 20 (see Figure 4A ) engages in a form-fitting manner to rotationally connect the injection button 18 to the collar 20. The rotational securing 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 comprises a rotational securing means 94 in the form of an axially extending recess which defines a side surface of the elastically deformable bendable hook 86 and engages with a rotational securing 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.

[0345] After assembly and in the assembled state of the dose delivery mechanism 54 , the injection button 18 , the snap ring 20 and the dose setting knob 22 are rigidly connected to each other and form both a dose setting member and an actuation member of the dose delivery mechanism 54 .

[0346] 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 projection is formed to axially pre-assemble the injection button 18 with the snap element 24. More precisely, the lower, i.e. proximal assembly means 98b (see Figure 3C) by interfering with the coupling means 102 on the snap element 24 to limit the distal movement of the injection button 18 relative to the snap element 24. The upper, i.e. distal, assembly means 98a limits the proximal movement of the injection button 18 relative to the snap element 24 by interfering with the coupling means 102 on the snap element 24 after pre-assembly, and limits the distal movement of the injection button 18 after final assembly. When the snap element 24 and the injection button 18 are pre-assembled, i.e. in a pre-assembled state, the coupling means 102 is arranged between the proximal assembly means 98b and the distal assembly means 98a. In the pre-assembled state, the injection button 18 is not yet rigidly connected to the snap ring 20 and the dose setting knob 22. However, when the coupling means 102 is arranged distally of the distal assembly means 98a, i.e. in an assembled state, the injection button 18 is rigidly connected to the snap ring 20 and the dose setting knob 22. The injection button 18 also forms a coupling means 100 in the form of a protrusion, which is arranged on an elastically inwardly bendable portion on the outer peripheral surface of the injection button 18. The inwardly bendable portion extends in the axial direction and is partially surrounded by the cutout 101.

[0347] The coupling device 100 is configured to permanently axially lock the injection button 18 after the injection is completed, and thus also lock the snap ring 20 and the dose setting knob 22 to the snap element 24, so that the injection pen 10 cannot be operated. That is, when the injection button 18 is axially moved to initiate dose delivery, the coupling device 100 is locked by the circumferentially extending flange 102 on the snap element 24 (see Fig. 6A ) in the form of a radially inwardly extending coupling device. The radially inwardly extending flange 102 causes the protrusions arranged on the elastically inwardly bendable portion 100 to bend inwardly until the protrusions pass the flange 102. In order to reduce the force required to push the protrusions 100 through the flange 102, the protrusions 100 form a chamfered outer surface 100a. Alternatively or additionally, the flange 102 may form a chamfered inner surface. When the protrusions 100 have passed the flange 102, they will spring back to their neutral position, which allows 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 a precise dose.

[0348] As in Figure 3C and 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 the nut 38 (see FIG. 1 ). Fig. 14C ) in an axially extending groove 106 to form a rotational fixing device. Due to the axially extending ribs 104 and the corresponding axially extending grooves 106, the injection button 18 and the nut 38 can move axially relative to each other, but are fixed to each other in rotation.

[0349] As in Figure 5B and5D As can be best seen in FIG. 1 , a set of teeth 108 is formed in an axial section on the inner circumferential side of the dose setting knob 22. These teeth 108 are configured to engage with 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 ) engagement. Therefore, when the dose setting knob 22 is rotated during dose setting, the snap element 24 will also rotate. Fig. 6A As can be seen in the figure, the teeth 110 are only arranged in two opposite sections of the snap element 24, while the section between the two opposite sections does not form any teeth. This has advantages for the production of the injection pen 10. Alternatively, the teeth 110 can be formed along the entire circumference of the snap element 24.

[0350] The snap element 24 forms an axial section with a reduced cross section, thereby forming a coupling surface 112 for the connector 26. The connector 26 shown in the figure is formed as an integral part. However, the connector 26 can also be formed by a plurality of, for example, two parts connected to each other, for example by a form-fit connection. The connector 26 has an open cross section (see Fig.7D ), so it can be clipped 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 a 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 start dose delivery, the teeth 108 of the dose setting knob 22 engage with a set of teeth 114 formed on the outer circumferential surface of the connector 26 instead of the teeth 110 of the snap element 24, so that the snap element 24 can rotate relative to the dose setting knob 22 during dose delivery. 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 by the dose selector 28.

[0351] The snap element 24 further comprises an engagement feature 116 in the form of an axially extending radial protrusion. The engagement feature 116 is an axially extending rib. The engagement feature 116 may have a symmetrical cross-section 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 serves as a dose limiting element and the engagement feature 116 together with the dose stops 118a, 118b, 118c, 118d form a dose limiting mechanism 115 of the injection pen 10. The dose limiting element 116 is located on an elastically deformable section 120, i.e. on an axially extending arm that is partially surrounded by the cutout 121. When the dose limiting element 116 passes one of the dose stops 118a, 118b, 118c and 118d, the elastically deformable section 120 bends inwardly. In order to reduce the force required to rotate the dose setting knob 22 and the snap element 24 relative to the dose selector 28 to increase or decrease the set dose, the dose stop 118 has chamfered side surfaces 122a-d and 123a-d. According to Figure 8B In the embodiment shown in , the dose stoppers 118a-d have a symmetrical cross-section in a radial plane perpendicular to the longitudinal axis of the injection pen 10. In other words, the chamfered side surfaces 122 and 123 have spacings that are equal in magnitude to each other. Fig. 9 In another embodiment shown in , the chamfered side surfaces 122a'-d' that contact the protrusion 116 to deform the elastically deformable section 120 when the dose is set to a higher dose have a smaller spacing than the chamfered side surfaces 123a'-d' that contact the protrusion 116 when the dose is set to a lower dose. The side surfaces 123a-d define a rotational position corresponding to the settable dose. The spring 40 is configured to rotate the snap element 24 relative to the dose selector 28 so that the dose limiting element 116 abuts one of the side surfaces 123a-d.

[0352] The snap element 24 further comprises a hard stop 124 in the form of an axially extending rib, which abuts a hard stop 126 formed on the dose selector 28 when the injection pen 10 is delivered to the customer. Contrary to known pens, the hard stop 126 does not correspond to a zero dose stop, but rather to a preset dose stop. Further discussion of this feature follows. The hard stop 124 is axially spaced from the dose limiting element 116, but axially aligned with the dose limiting element 116. The hard stop 124 is configured to abut an end-of-dose setting hard stop 128.

[0353] 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 drawings, the driver 36 has an axially extending rib 134, which is configured to engage with the notch 132 of the snap element 24. In addition, the driver 36 has a protrusion 136, which has a chamfered surface 136a, which engages with the opening 130 of the snap element 24. While the opening 130 and the protrusion 136 form an axial fixing device, the notch 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 peripheral surface of the driver 36 (see Fig.13D ) join.

[0354] Figures 8A to 8E The dose selector 28 is depicted. 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. The dose selector 28 is inserted into the circumferentially extending inlet 144 (see Figure 5B ) and is axially fixed to the dose setting knob 22. In the inlet 144, the dose setting knob 22 forms an axial fixing device 146 in the form of a circumferentially extending protrusion on the outer circumferential surface, which 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.

[0355] As in Fig. 8E As best seen in FIG. 1 , a rotational securing device 148 in the form of an axially extending groove is formed on the inner circumferential surface of the dosage selector 28. The rotational securing device 148 is in the form of an axially extending rib formed on the outer circumferential surface of the connector 26 (see FIG. 1 ). Figure 7B ) are engaged. The rotational securing means 148, 150 allow axial movement between the dosage selector 28 and the connector 26. The dosage selector 28 further includes a rotational securing means 152 in the form of an axially extending rib formed on the outer peripheral surface of the dosage selector 26. The rotational securing means 152 engages with a rotational securing means 154 in the form of an axially extending groove formed on the inner peripheral surface of the housing 32 (see Fig. 11C The rotational fixation means 152, 154 are configured to define a single possible rotational alignment that allows the dosage selector 28 to be inserted into the housing 32. The rotational fixation means 150, 152 allow axial movement between the dosage selector 28 and the housing 32.

[0356] In order to limit the deliverable dose, a 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 with its cutouts 158a, 158b, 158c and 158d ensures that an injection is only possible 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 of the settable doses. If the dose limiting element 116 is not in an angular position associated with one of the cutouts 158a-d, an axial movement of the dose limiting element 116 and therefore of the snap element 24 relative to the dose selector 28 is blocked by the circumferentially extending rib 156. As shown from Figure 8B As can be seen, no cutout is allocated for the preset dose hard stop 126. Thus, when the injection pen 10 is set to a preset dose, starting an injection is prohibited.

[0357] 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 is only possible 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 of the settable doses.

[0358] Fig. 10A and 10B The knob key 30 is depicted. The knob key 30 is configured to be attached to the outer peripheral surface of the dose selector 28 to prevent the dose setting knob 24 from accidentally moving in the proximal direction 1 relative to the housing 32 when the injection pen 10 in the delivery state falls onto its proximal end. The clip element 30 has a width W1, which 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 protrusion 164, which interacts with the rotation fixing device 152 on the outer peripheral 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 is removed.

[0359] The housing 32 is Figures 11A to 11CThe housing 32 forms a viewing window 166 for displaying the status of the injection pen 10, in particular the set dose indicated by the dose sleeve 34 through the window 166. The dose sleeve 34 rotates relative to the housing during dose setting and dose delivery, which causes the content displayed through the window 166 to change. At different circumferential positions along the outer circumferential surface of the dose sleeve 34, labels 168a-168d for different settable doses are located (see Fig. 12C and 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 12B As can be seen, the preset dose label 168e is different from the zero dose label 168f, which is a label indicating that no drug will be injected if the injection is started in this state. When the injection is completed, the zero dose label 168f will be displayed through the window 166. Labels 168a, 168b, 168c and 168d correspond to the settable doses defined by the dose stoppers 118a, 118b, 118c and 118d.

[0360] 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 non-circular outer circumferential surfaces 169a and inner circumferential surfaces 169b are formed on the driver 36 and the dose sleeve 34, respectively. In addition, the dose sleeve 34 forms a fixing section 171, which is clamped between the proximal end of the snap element 24 and the face 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 rotate the driver 36 when the driver 36 moves axially relative to the piston guide 42, and move the driver 36 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 center 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 (see Fig. 16C ).

[0361] According to an alternative version, the dose sleeve and the driver may be formed as separate parts which are axially movable relative to each other but rotationally fixed to each other, and both the dose sleeve and the driver may have threads threadedly coupled to the housing. The threads of the dose sleeve and the threads of the driver may have different pitches.

[0362] The piston guide 42 is axially and radially fixed to the housing 32 and can therefore be regarded 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 formed on the inner peripheral surface of the housing 32. The axial fixing device 180 in the form of a circumferentially extending rib (see Fig.11A ) 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 peripheral surface 262 of the piston guide 42, and the rotation fixing device 182 is engaged with a rotation fixing device 184 in the form of an axially extending rib formed on the inner peripheral 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.

[0363] The piston guide 42 has a non-circular axial opening 186 (see Fig. 15C ), which is in contrast to the non-circular cross-section 188 of the piston rod 44 (see Fig. 17B ) corresponds to the piston rod 44. 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 aligns 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 as a second threaded element. The piston rod 44 and the nut 38 can move relative to each other in a combined axial and rotational movement of forced guidance. 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 relative to the piston rod guide 42 in a combined axial and rotational movement, while the nut 38 is rotationally fixed to the housing 32. In order to reduce friction during dose delivery, a ball bearing and / or a sliding 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.

[0364] The piston rod 44 forms a coupling device 198 in the form of an undercut at its proximal end, which couples with a coupling device 200 in the form of a radially inwardly extending rib on the inner peripheral surface of the piston plate 46 (see Figures 18A-18C ) join.

[0365] Figures 15A to 22B Portions of a drug mixing or reconstitution unit 56 are depicted, which is configured to mix different components, typically a lyophilized drug and a liquid solvent, to form an injectable liquid drug. Figures 19A to 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 As can be seen, the barrel 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, which is made of a rubber material, for example, and is axially slidably arranged in the double chamber barrel 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.

[0366] In the delivery state, the lyophilized drug is in the first chamber 202 and the solvent is in the second chamber 204 .

[0367] The dual chamber cartridge 48 is stored in the cartridge key 52 (see Fig.21A -22b). The barrel key 52 is axially and rotationally fixed to the barrel container 50. To achieve this, the barrel 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 peripheral surface of the barrel container 50 (see Fig. 20A ) engagement. In addition, the barrel key 52 forms a rotational securing device 216 in the form of a radially extending rib, which engages with a rotational securing device 218 in the form of a radially extending groove on the inner peripheral surface of the barrel container 50. When the barrel key 52 is attached to the barrel container 50, the annular end surface 266 ( Fig. 22B ) and the corresponding annular end surface 268 ( Fig. 20A) axial abutment (aerial abutment). Both annular end faces 266 and 268 can be arranged perpendicular to the longitudinal axis of the pen 10. In addition, when the barrel key 52 is attached to the barrel container 50, the window 220 formed in the barrel key 52 is aligned with the window 222 in the barrel container 50, so that the patient can see the medicine in the transparent dual-chamber barrel 48 during reconstitution. At the proximal end of the barrel key 52, which also defines the proximal end of the injection pen 10, a thread 224 is formed for attaching a needle (not shown). The thread 224 surrounds an opening 252 at the proximal end of the barrel holder 52. The opening 252 is configured to receive a needle connected to the interior fluid of the barrel 48 inserted into the barrel holder 52.

[0368] The barrel key 52 forms an inner surface 254 ( Fig. 22B ), the inner surface 254 defines a cylindrical socket that receives the barrel 48 and prevents the barrel 48 from tilting relative to the longitudinal axis. Tilting of the barrel 48 is prevented by the area contact between the cylindrical outer surface 256 of the barrel and the inner surface 254 in the retaining section 249 of the barrel holder 52. In addition, the barrel holder 52 forms a cutout 221 to receive the bypass 206 of the dual-chamber barrel 48. The bypass 206 engages the cutout 221 in a form-fitting manner so that the dual-chamber barrel 48 is axially and rotationally fixed to the barrel key 52. ​​On the opposite side of the cutout 221, a notch 223 extending in the axial direction is formed. The notch 223 allows the barrel key 52 to be reversibly widened to axially insert the dual-chamber barrel 48 with the bypass 206.

[0369] To mix the different components in the dual chamber cartridge 48 and prepare the injection pen 10, the cartridge container 50 is screwed onto the piston rod guide 42 until the distal surface 226 of the cartridge container 50 abuts the proximal surface 228 of the piston guide 42 (see Fig. 15B To do this, the cartridge container 50 forms an outer surface 246 that can be grasped with one hand to rotate the cartridge container 50 onto the piston rod guide 42. When the cartridge container 50 is rotated onto the piston rod guide 42, the proximal portion of the piston rod guide 42 enters the annular space 258 (between the outer peripheral surface 264 of the cartridge holder 52 and the inner peripheral surface 260 of the cartridge container 50) Fig. 23B ), thereby defining the inner space 248 of the cartridge container 260. In order to screw the cartridge container 50 onto the piston rod guide 42, a first thread 230 is formed on the inner circumferential surface 260 of the cartridge container 50, and the first thread 230 is engaged with a second thread 232 formed on the outer circumferential surface 262 of the piston rod guide 42. Fig.15AAs can be seen in the figure, the piston rod guide 42 forms a snap element 234. If the snap element 234 is engaged with one of the openings 236, 238 and 240, the snap element 234 allows the cartridge container 50 to rotate relative to the piston rod guide 42 in the distal direction, i.e., a combined axial and rotational movement of the forced guide, but prevents the cartridge container 50 from rotating relative to the piston rod guide 42 in the proximal direction 1. The first opening 236 (see Fig. 20B ) is configured to define the starting position of the cartridge container 50 and ensure that the cartridge container 50 cannot be separated from the piston rod guide 42. Fig.25A and 25B This starting position or delivery state is shown in .

[0370] 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 move forward and backward to ensure that the drugs are evenly mixed together. The second opening 238 can be omitted. Therefore, the present disclosure also relates to an embodiment of the injection pen 10, which has the first opening 236 and the third opening 240, but does not have the second opening 238. The third opening 240 defines a knob cover unfastened state of the cartridge container 50, wherein most of the air is exhausted from the second chamber 202, which now contains the reconstituted drug ready for use.

[0371] In the following about Figures 23A to 33B , which describes different states of the injection pen 10 during use of the pen 10 .

[0372] FIG. 23A to FIG. 25B The injection pen 10 is depicted in a 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, making it impossible for the user to set a dose prematurely in this state. Fig. 23B As can be seen, 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 the figure, the knob cover 16 is eliminated to show the portion below the knob cover 16, and the dose setting sleeve 34 indicates that the injection pen 10 is in a preset state different from the zero dose state. Therefore, the dose setting knob 22 is also in a preset position different from the zero dose position. As shown in Fig.25A and 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, the cartridge container 50 is depicted as translucent in order to show the first threads 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.

[0373] To begin preparation of a drug product, such as by comparing Fig.25A and 26A As can be seen, 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 snapped 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 movement of the second sealing element 210 arranged in the dual-chamber barrel 48, so that when the barrel container 50 is further rotated onto the piston rod guide 42, the second sealing element 210 slides along the inner circumferential surface of the dual-chamber barrel 48. 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 barrel 48. This will cause an overpressure in the barrel, but the air can escape through the double-ended needle attached to the thread 224 by the user. When the first sealing element 208 reaches the bypass 206 (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 and the solvent stored in the second chamber 204 are mixed.

[0374] exist Figures 26A to 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.26B As can be seen in FIG. 2 , the proximal surface of the second sealing element 210 abuts against the distal surface of the first sealing element 208, so that the second chamber 204 no longer exists in the reconstituted state. Fig.27C As can be seen in the figure, the snap element 234 of the piston rod guide 42 is snapped 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 the mixing of the lyophilized drug easier. As mentioned above, the second opening 238 can be omitted. In this case, mixing is performed with a small amount of air remaining.

[0375] After the drug reconstitution is completed, the user further rotates the cartridge container 50, thereby further moving the cartridge container 50 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 extend the wing 58 radially outward (see Fig.28B ). Extending the wings 58 radially outward disengages the form-fitting engagement means 60 of the knob cover 16 from the coupling surface 228, so that the knob cover 16 can move axially relative to the housing 32. The knob cover 16 can now be pulled away from the housing 32 in the distal direction, thereby obtaining Fig.29A and 29B When the cartridge container 50 is completely rotated onto the piston rod guide 42, the radial end stopper 244 formed on the outer peripheral surface 262 of the piston rod guide 42 abuts against the radial end stopper (not shown) on the inner peripheral 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 prohibited.

[0376] As in Fig.29A and 29B As can be seen in the figure, the knob key 30 is still clamped to the outer peripheral 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.

[0377] Afterwards, if we compare Fig.29A and 30A As can be seen, the user rotates the dose setting knob 22 to set a desired dose among 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 forced-guided manner in the distal direction.

[0378] Rotating the dose setting knob 22 causes rotation of the injection button 18, which is axially and rotationally connected to the dose setting knob 22 by the snap ring 20; the snap element 24, which is rotationally connected to the dose setting knob 22 by the teeth 108 intermeshing with the teeth 110; the driver 36, which is rotationally and axially coupled to the snap element 24; and the dose setting sleeve 34, which is rotationally and axially coupled to the driver 36. Due to the engagement of the outer thread 170 of the driver 36 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 through 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.

[0379] Furthermore, rotating the dose setting knob 22 causes a 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 its corresponding non-circular cross-sections 186, 188, the nut 38 moves in the distal direction when the dose setting knob 22 is rotated and thus the nut 38 is rotated.

[0380] The amount of axial movement of the nut 38 relative to the piston rod 44 and the driver 36 relative to the piston guide 42 depends on the pitch of the respective threads. The external thread 170 of the driver 36 has a larger pitch than the external thread 190 of the piston rod 44, so that the driver 36 moves more in the distal direction than the nut 38. For example, the external thread 170 of the driver 36 may have a pitch of 10.71 mm, and the external thread 190 of the piston rod 44 may have a pitch of 10.21 mm.

[0381] When a desired dose is set, the helical torsion spring 40 applies a torque to the snap element 24 via the driver 36 to bring the dose defining element 116 into abutment with the respective dose stop 118a to 118d, i.e., into abutment with the side surface 122b thereof. 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 predetermined rotational positions defining a predetermined dose.

[0382] If the user subsequently presses 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, which bends when passing the circumferential flange 102, to cause a reaction force in the distal direction, which the user needs to 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, causes the teeth 108 of the dose setting knob 22 to 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.

[0383] If the user further presses the injection button 18, the injection button 18 and the dose selector 28 move in the proximal direction 1 relative to the snap element 24. Thereby, the dose limiting element 116 of the snap element 24 passes the circumferentially extending rib 156 on the dose selector 28 through the respective cutouts 158a-158d corresponding to the set dose. At the same time, the hard stop 126 of the dose selector 28 moves 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.

[0384] When the injection button 18 is pressed 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 relative to the housing 32 in the proximal direction 1.

[0385] 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 33B), the dose setting sleeve 34 is in a rotated position in which the zero dose label is visible through the window 166 of the housing 32. The 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 point of the movement of the injection button 18 in the proximal direction 1 during dose delivery.

[0386] At the end of dose delivery, the coupling means 100 on the injection button 18 passes over 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. As a result, the injection pen 10 becomes inoperable as the user cannot rotate the dose setting knob 22 to set a new dose.

[0387] The injection pen 10 allows the axial position of the piston rod 44 to be adjusted relative to the housing 32 in the pre-assembled state of the dose delivery mechanism 54. In the pre-assembled state, the injection button 18 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 the injection button 18 to be positioned in a more distal pre-assembly position than its assembly position in the assembled state of the dose delivery mechanism 54, in which the adjustment element 18 engages with its proximal assembly means 98b with the coupling means 102.

[0388] In the pre-assembled position, the adjustment element 18 protrudes from the dose setting element 22 and is free to rotate relative to the dose setting element 22. Rotation of the adjustment 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.

[0389] 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.

[0390] Fig.34 and Fig.35 The second injection pen 300 is shown in a pre-assembled state. Fig.36 shows an exploded view of a second injection pen, and Fig.37 A longitudinal section of the second injection pen 300 is shown in a pre-assembled state. The second injection pen 300 is constructed as disclosed for the injection pen 10 of the previous figures, and vice versa, as long as differences are not disclosed in the description or the figures.

[0391] The second injection pen 300 comprises a dose delivery mechanism 354. The dose delivery mechanism 354 of the second injection pen 300 is constructed as disclosed for the dose delivery mechanism 54 of the injection pen 10, and vice versa, as long as differences are not disclosed in the description or drawings.

[0392] 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 by 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 receiving a medicament container 348. The medicament container holder 305 comprises a connector 307 at a distal end of the medicament container holder 305. The connector 307 is configured to be connected to a corresponding connector 343 of the piston rod guide 342, which is accessible at the proximal side of the piston rod guide 342. After the medicament container holder 305 is attached to the housing 332, the connectors 307, 343 provide a non-releasable form-fit connection between the medicament container holder 305 and the housing 332.

[0393] The drug container 348 has a single drug chamber which is sealed at its distal end by a single plunger 210 (see Fig.35 ). The drug chamber contains a fluid drug. At its proximal needle end 349, the drug 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 drug container holder 305. During storage of the injection pen 300, the cap 301 can be releasably attached to the drug container holder 305.

[0394] 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 external thread on the outer surface of the dosing member 323 and an internal thread on the inner surface of the housing 332 ( Fig.36 For other embodiments, the quantitative supply member 323 may also be constructed as a single component.

[0395] The dosing member 323 constitutes a dose indicating member of the dose delivery mechanism 354. Thus, the dosing element 334 comprises markings which are visible through a window in the upper housing part 333 of the housing 332 when the dosing element 323 rotates relative to the housing 332 during dose setting.

[0396] The driver 336 is connected to the housing 332 by another threaded connection 337, which acts between the driver 336 and the piston rod guide 342, as described for the driver 36 and the piston rod guide 42 of the injection pen 10. In addition, the driver 336 is rotationally fixed and axially movable relative to the dosing member 323 by a spline connection. Thus, the driver 336 is received in the dosing element 334 of the dosing member 323. The spline connection includes a first spline element on the outer periphery of the driver 336, which engages with a corresponding second spline element on the inner periphery 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 other threaded connection 337 with the housing 332, and requires a simultaneous axial movement of the dosing member 323 due to the threaded connection 335 with the housing 332.

[0397] The pitch of the threaded connection 335 between the dosing member 334 and the housing 332 is different from the pitch of another 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 forced proximal movement of the dosing member 334 by a first axial distance causes the driver 336 to move proximally by a second axial distance that deviates from the first axial distance.

[0398] 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 have a coupling device 100 to axially lock 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 constructed as disclosed for the adjustment element 18, and vice versa. In particular, the adjustment element 18 of the injection pen 10 is configured to adjust the position of the piston rod 46 in the pre-assembled state in the same manner as disclosed below for the adjustment element 318 of the second injection pen 300. Furthermore, the adjustment element 318 forms an actuation member of the second injection pen 300. The actuation member is configured to be activated by a user to deliver a set dose. Exemplarily, the actuation member is configured to be pushed by a user in the proximal direction to deliver a set dose.

[0399] exist Fig.37 and38 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 a pre-assembly position relative to the housing 332. The pre-assembly position is the most distal axial position of the adjustment element 318 reached when the assembly means 98b engages with the coupling means 102 of the snap element 24 upon distal movement of the adjustment element 318. The biasing element 250 is in the form of a spring, which acts between the snap element 24 and the adjustment element 318, which biases the adjustment element 318 in the distal direction to the pre-assembly position. Since the injection pen 10 does not have 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.

[0400] The assembly device 98b forms the locking part of the locking mechanism 99, and the coupling device 102 of the snap element 24 forms the locking counterpart of the locking mechanism 99. In addition, the dosing member 323 with the snap element 24 forms the counterpart of the locking mechanism 99. The locking mechanism 99 prevents the adjustment element 318 from being disengaged from the housing 332 in the preassembled state.

[0401] In the pre-assembled position, the adjustment element 318 protrudes distally from the dose setting element formed by the dose knob 22. The rotational securing means 90 of the adjustment element 318 then does not engage the rotational securing means 94 of the snap ring 20, so that the adjustment element 318 is rotationally movable relative to the housing 332 and the dose setting element 22.

[0402] In the pre-assembly position, the assembler of the injection pen 300 has access to the outer edge 19 of the adjustment element 318. When the adjustment element 318 is rotated relative to the housing 332 and the dose setting element 22, the adjustment element 318 rotates the nut 38. The nut 38 thus cannot move axially relative to the housing 332, because it is limited by the fixed driver 336 pushing against the pressing surface 194 at the proximal end of the nut 38. Then, 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, enables the piston rod 44 to move axially relative to the housing 332. Thus, 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, whose injection button 18 also forms an adjustment element.

[0403] The dose delivery mechanisms 54, 354 of the injection pens 10, 300 each comprise a rotation lock 89, which is formed by a rotational fixation 90 of the respective adjustment 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 adjustment element 18, 318 and the respective dose setting element 22, and the adjustment element 18, 318 is rotationally and / or axially fixed to the dose setting element 22 in the assembled state by means of the connector 20. Furthermore, the dose setting element 22 forms a counter element to which the adjustment element 18, 318 is attached in the assembled state of the respective dose delivery mechanism 54, 354.

[0404] Furthermore, the axial fixing means 82 of the setting 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 setting 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 setting element 18, 318 and the dose setting element 22 in an assembled state.

[0405] The axial fixing means 82 of the setting element 18, 318 and the ribs 84 of the snap ring 20 also form a locking mechanism, which acts between the setting 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 locking mechanism prevents the setting element 18, 318 from moving from a second position relative to the counter-element to a first position relative to the counter-element. Thereby, the second position is a proximal position, in which the setting element 18, 318 is rotationally and axially fixed to the counter-element, and the first position is a distal position, which the setting element 18, 318 occupies in the pre-assembled state and in which the setting element 18, 318 can rotate relative to the counter-element.

[0406] Fig.39 shows a detailed view in longitudinal section of the distal end of the second injection pen 300 in an assembled state during dose setting, and Fig.40 Another longitudinally cut detailed view of the distal end of the second injection pen 300 is shown in an assembled state during dose setting. Fig.39 and 40 The section planes of the longitudinal sections shown in FIG. 5 are oriented perpendicular to one another.

[0407] The injection pen 300 is transformed from the pre-assembled state into the assembled state by moving the adjustment element 318 proximally from the pre-assembly position to the assembled position relative to the dose setting element 22 and the housing 332. This rotationally and axially locks the adjustment element 318 to the dose setting element 22 via the connector 20, the rotation lock 89 and the axial lock 81. In the assembled state, the distal assembly means 98a of the adjustment element 318 engage with the coupling means 102 of the snap element 24, thereby irreversibly preventing the adjustment element 318 from moving from the assembled position to the pre-assembly position.

[0408] The distal assembly means 98a of the adjustment element 318 forms a locking portion of the locking mechanism 97, which is configured to prevent the adjustment element 318 from moving from the assembly position to the pre-assembly position relative to the housing 332. The coupling means 102 of the snap element 24 forms a locking counterpart of the locking mechanism 97, and the dosing member 323 with the snap element 24 forms a counterpart of the locking mechanism 97.

[0409] Fig.41 shows a detailed view in longitudinal section of the distal end of the second injection pen 300 in an assembled state during dose delivery, and Fig.42 Another longitudinally cut detailed view of the distal end of the second injection pen 300 is shown in an assembled state during dose delivery. Fig.41 and 42 The section planes of the longitudinal sections shown in FIG. 5 are oriented perpendicular to one another. Fig.41 and 42 The injection pen 300 is thereby shown at the end of dose delivery, when the set dose has been completely expelled and the adjustment element 318 is still pressed in the proximal direction 1 by the user of the injection pen 300 .

[0410] During dose setting in the assembled state, the adjustment element 318 is rotationally coupled to the dosing member 323 via a clutch mechanism 107 formed by teeth 108 on the inner surface of the dose setting element 22 (see FIG. 5 ) and teeth 110 on the outer surface of the snap element 24 (see FIG. 6 ). The dose setting element 22 forms a first clutch member of the clutch mechanism 107 and the snap element 24 forms a second clutch member of the clutch mechanism 107. The dosing members 23, 323 of the dose delivery mechanism 54, 354 each form a respective further member of the dose delivery mechanism 54, 354.

[0411] With each dose delivery mechanism 54, 354, during dose setting in the assembled state, the corresponding clutch mechanism 107 rotationally couples the corresponding adjustment element 18, 318 to the corresponding other component in the closed state of the corresponding clutch mechanism 107, and during dose delivery in the assembled state, the corresponding adjustment element 18, 318 is rotationally separated from the corresponding other component in the open state of the corresponding clutch mechanism 107.

[0412] For other embodiments of the clutch mechanism 107 that couples the adjustment element 18, 318 to another component, the second clutch component can also be formed integrally with the other component. For example, when the snap element 24 and the dosing element 334 are integrally formed into a one-piece dosing component 323, the dosing component 323 constitutes the other component and simultaneously constitutes the second clutch component.

[0413] During dose delivery, the clutch mechanism 107 is disconnected, thereby rotationally decoupling the adjustment element 318 and the dosing member 323. In the pre-assembled state, the clutch mechanism 107 is closed, but the adjustment element 318 is rotationally decoupled from the clutch mechanism 107, so that the clutch mechanism 107 does not transfer the rotation of the adjustment element 318 to the dosing member 323. In particular, the adjustment element 318 is rotationally decoupled from both the dose setting element 22 and the dosing member 323 in the pre-assembled state.

[0414] During dose delivery in the assembled state, the adjustment element 318 is rotationally coupled to the housing 332 via a further clutch mechanism 113, whereby the further clutch mechanism 113 is formed by teeth 108 on the inner surface of the dose setting element 22 and teeth 114 on the outer surface of the connector 26. Thereby, the dose setting element 22 forms a first clutch member of the further clutch mechanism 113 and the connector 26 forms a second clutch member of the further clutch mechanism 113. If the further clutch mechanism 113 is in the closed state and the first clutch member is engaged with the second clutch member, the adjustment element 318 is rotationally fixed to the additional member, which is formed by the housing 332.

[0415] During dose setting, the further clutch mechanism 113 is opened so that the adjustment element 318 is allowed to rotate relative to the housing 332. During dose delivery, the further clutch mechanism 118 is closed so that the adjustment element is rotationally fixed relative to the housing. In the pre-assembled state, the adjustment element 318 is rotationally decoupled from the further clutch mechanism 113, as it is allowed to rotate relative to both the first clutch member formed by the dose setting element 22 and the second clutch member formed by the connector 26.

[0416] Fig.43A longitudinal section through the dose setting element 22 of the injection pen 10 and the second injection pen 300 is shown, Fig.44 shows a perspective view of a longitudinal section of the dose setting element 22, Fig.45 A distal perspective view of the dose setting element 22 is shown, and Fig.46 A proximal perspective view of the dose setting member 22 with the teeth 108 of the clutch mechanism 107 , 113 is shown.

[0417] For both the clutch mechanism 107 and the further clutch mechanism 113, the clutch mechanisms 107, 113 are in a closed state during one of dose setting and dose delivery, and the clutch mechanisms 107, 113 are in an open state during the other of dose setting and dose delivery. Thus, the clutch mechanism 107 is closed when the further clutch mechanism 113 is open, and the clutch mechanism 107 is open when the further clutch mechanism 113 is closed.

[0418] Furthermore, for each clutch mechanism 107, 113, the adjustment element 318 occupies a dose setting position relative to the respective second clutch member 24, 26 during dose setting, and it occupies a dose delivery position relative to the respective second clutch member 24, 26 during dose delivery. Thereby, the dose delivery position is axially moved relative to the dose setting position. Exemplarily, the dose delivery position is axially moved in the proximal direction 1.

[0419] For the dose delivery mechanism 54 , 354 , the further clutch mechanism 113 also forms a locking mechanism which is configured to rotationally lock the adjustment element 18 , 318 to the housing 32 , 332 during dose delivery in the assembled state.

[0420] The dose selectors 28 of the dose delivery mechanisms 54, 354 each form a retaining member of the respective dose delivery mechanism 54, 354. Each adjustment element 18, 318 is located in a first axial position relative to the retaining member in the pre-assembled state, and each adjustment element 18, 318 is transferred from the first axial position to a 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. Each adjustment element 18, 318 is rotatable relative to the retaining member in the pre-assembled state.

[0421] During dose setting in the assembled state, each adjustment element 18, 318 is rotatable relative to the respective retaining member, and during dose delivery in the assembled state, each adjustment element 18, 318 is rotationally fixed relative to the respective retaining member. For the dose delivery mechanism 54, 354, each adjustment element 18, 318 is axially fixed relative to the respective retaining member in the assembled state.

[0422] For the dose delivery mechanism 54, 354, during dose setting in the assembled state, the first threaded element formed by the piston rod 44 is axially stationary relative to a third element of the dose delivery mechanism 54, 354. The third element is thereby the housing 32, 332. Furthermore, during dose setting in the assembled state, the second threaded element formed by the nut 38 is axially moved relative to the third element. Upon adjustment of the piston rod 44 in the pre-assembled state, the first threaded element formed by the piston rod 44 is axially moved relative to the third element formed by the housing 32, 332, and the second threaded element formed by the nut 38 is axially stationary relative to the third element formed by the housing 302, 332.

[0423] 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 setting element 318 is rotationally decoupled from the snap element 24 , so that the snap element 24 does not rotate when the setting element 318 rotates.

[0424] For both dose delivery mechanisms 54, 354, the adjustment element 18, 318 is configured to rotate in a pre-assembled state until the bearing 46 contacts the distal surface of the plunger 210 after the drug container 48, 348 is 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 following steps: attaching the drug container 48, 348 to the housing 32, 332; and rotating the adjustment element 18, 318 until the bearing 46 contacts the distal surface of the plunger 210. Then, the adjustment element 18, 318 may be further rotated until a predetermined torque is required for rotation. Then, the dose delivery mechanism 54, 354 may be transformed from the pre-assembled state to the assembled state.

[0425] The adjustment element 18, 380 may also be rotated until the bearing 46 is located at a distance greater than zero from the distal surface of the plunger 210, thereby forming a gap between the distal surface of the plunger 210 and the proximal surface of the bearing 46. For example, the distance may be measured by measuring the position of the bearing 46 relative to the plunger 210 through the drug container 305, which may be made of a transparent material.

[0426] Alternatively, the method may further comprise the step of adjusting the position of the piston rod 44 by rotating the adjustment element 18, 318 without the drug container 48, 348 being 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 fixture and rotating the adjustment element 18, 318 until the proximal surface of the bearing 46 contacts a reference surface provided by the assembly fixture. Thereby, the reference surface may be located within the proximal cylindrical portion of the connector 43 of the injection pen 10.

[0427] For example, for the injection pen 300, the drug container 348 may be attached to the housing 332, and then the adjustment element 318 may be rotated until the bearing 46 contacts the distal surface of the plunger 210. The adjustment element 318 may then be further rotated until a predetermined torque is required for rotation.

[0428] 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 an axially movable drug container 48 to the housing 32, so that the drug container 48 can perform an axial movement from a receiving position to an operating position after being connected to the housing 32. Thereby, the receiving position is defined by a snap element 234 of the connector 43 engaging with a distal opening 236 of the drug container holder 50, 52. The operating position is defined by the snap element 234 engaging with a proximal opening 240 of the drug container holder 50, 52 after the drug container holder 50, 52 is screwed onto the connector 43.

[0429] For the injection pen 10, the dose delivery mechanism 54 can be provided without attaching the drug container holder 50, 52 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 contacts the reference surface of the assembly jig and the bearing 46 and the piston rod 44 have reached a predetermined position relative to the housing 32.

[0430] Thus, the piston rod 44 is adjusted to a position relative to the housing 32 that ensures that the bearing 46 is in contact with the plunger 210 during the movement of the drug container 48 from the receiving position to the operating position. In addition, the position of the piston rod 44 is adjusted to ensure that a certain amount of liquid drug is discharged from the drug container 48 at the end of the movement to the operating position. For example, the position can be adjusted so that the amount of drug is discharged only during the last quarter of a rotation of the drug container holder 50, 52 onto the proximal portion of the piston rod guide 42.

[0431] For both the first injection pen 10 and the second injection pen 300, the piston rod 44 may advance a first distance in the proximal direction 1 when the actuation member 18 moves proximally a second distance, wherein the second distance is less than 1.5 times the first distance. For the first injection pen 10, the first distance is equal to the second distance. Furthermore, when the piston rod 44 travels the first distance, the actuation member 18 travels the second distance. For the second injection pen 300, the ratio between the second distance and the first distance is given by the ratio of the pitch of the threaded connection 335 between the dosing member 323 and the pitch of another threaded connection 337 between the driver 336 and the housing 332.

[0432] 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 member 23 of the first injection pen 10. As with the first injection pen 10, the dosing member 23 may include Figure 1 The drive 36 , the dosing element 34 and the snap-in element 24 are shown in FIG.

[0433] Additionally or alternatively, the second injection pen 300 may further include the drug reconstitution unit 56 of the first injection pen 10. Thus, such a second injection pen 300 may be configured to receive the dual-chamber cartridge 48 and perform reconstitution of the lyophilized drug prior to drug delivery.

[0434] Additionally or alternatively, the second injection pen 300 may also be configured to permanently axially lock an actuation member, such as an 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 comprise the coupling device 100 described in conjunction with the first injection pen 10.

[0435] 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 delivering a second dose after a first dose has been delivered with the respective injection pen 10, 300. The blocking mechanism may be configured to permanently fix the dose setting element 22 at least rotationally to the housing 32, 332 when a dose is delivered, e.g. 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 the counterpart member, whereby the actuation member 18 moves relative to the counterpart member to initiate delivery of the set dose. For the injection pen 10, 300, the respective counterpart member is exemplarily formed by the dosing member 23, 323.

[0436] 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 and second injection pens 10 , 300 , the first blocking portion is exemplarily formed by the coupling device 100 and the second blocking portion is exemplarily formed by the coupling device 102 .

[0437] The injection pen 10, 300 may comprise a clutch mechanism which rotationally locks the dose setting member 22 to the housing in a closed state of the clutch mechanism during dose delivery. By locking the clutch mechanism in a closed state, the blocking mechanism may permanently fix the dose setting member 22 at least rotationally to the housing 32, 332. The clutch mechanism may, for example, be the clutch mechanism 107.

[0438] For example, the clutch mechanism may include a first clutch part (e.g., teeth 114 of the connector 26) that engages with a second clutch part (e.g., teeth 108 of the dose setting element 22) in a closed state of the clutch mechanism and disengages from the second clutch part in an open state of the clutch mechanism. For example, the first and second clutch parts may engage and disengage with each other upon axial relative movement relative to each other. For example, the clutch mechanism may be locked in a closed state by axially locking the first clutch part to the second clutch part.

[0439] Similar to the first injection pen 10, embodiments of the second injection pen 300 can be configured to prevent a user from prematurely activating the second injection pen 300. Similar to the first injection pen 10, embodiments of the second injection pen 300 can be configured to axially lock the actuation member 318 relative to the housing 332 before setting and delivering the first dose. Similar to the first injection pen 10, the second injection pen 300 can include a knob cover 16 and / or a knob key 30.

[0440] Similar to the first injection pen 10, the second injection pen 300 can also be preset to an injectable dose higher than zero in the delivery state. For example, the dosing member 323 can be preset to a position corresponding to a set dose higher than zero. Similar to the first injection pen 10, the second injection pen 300 can be configured to prevent the preset injectable dose from being reduced to zero.

[0441] For both the first and second injection pens 10, 300, the dosing member 23, 323 stops rotating in the rotational direction at a first angular position during dose setting, and stops rotating in the 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 higher than zero. For example, the dosing member 23, 323 may be in the second angular position at the end of dose delivery.

[0442] The first and second injection pens 10, 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, for example at the end of dose delivery. For example, the first stopper may be Fig. 9 The stopper 126 shown in FIG. 1 and / or the second stopper may be, for example, Fig. 13B and 15D The end stops 174, 176 shown in FIG.

[0443] 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. For example, the stopper may interact with a corresponding stopper (e.g., 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 construction of the stopper, which is referred to as a zero dose hard stopper in document WO 2020015980 A1.

[0444] 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 cutaway view of 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 constructed as disclosed for the second injection pen 300 and vice versa, as long as differences are not disclosed in the description or drawings.

[0445] The dose delivery mechanism 554 comprises a housing 532 which is configured to be connected to the medicament container holder 505 via a non-releasable form-fit connection. The connection comprises a connector 506 at the distal end of the medicament 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 designed as a non-releasable snap-on connection.

[0446] The drug container holder 505 is configured to receive the drug container 348 already described in conjunction with the second injection pen 300. At the proximal end, the drug 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 by a threaded connection. Alternatively, the connection may also be configured as a Luer lock, a snap connection, etc. When the needle assembly 501 is mounted on the drug container holder 505, the distal end of the cannula 502 pierces the septum at the proximal needle end 349 of the drug container 348. The proximal end of the cannula 502 is covered by a needle cap 503, which is removed before use of the injection pen 500. During storage of the injection pen 500, the cap 504 covers the drug container holder 505.

[0447] 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 distal perspective view of the dosing member 523 is depicted, and Fig.51A longitudinal cutaway view of 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.

[0448] The dose delivery mechanism 554 also includes a piston rod 44, which is Fig.52 567 at the proximal end of the dosing member 523. Thus, the piston rod 44 is connected to the dosing member 523 via a threaded connection 189. The threaded connection 189 comprises an internal thread in the opening 567 of the dosing member 523 and an external thread arranged at the outer periphery of the piston rod 44. The piston rod 44 forms a first threaded element of the threaded connection 189, and the dosing member 523 forms a second threaded element of the threaded connection 189. At its proximal end, the piston rod 44 comprises a coupling device 198, which connects an axially fixed and rotationally movable bearing 46 to the piston rod 44.

[0449] Fig.53 depicts a distal perspective view of the extension 525 of the dose delivery mechanism 554, Fig.54 A distal view of extension 525 is depicted, and Fig.55 A proximal view of the extension 525 is depicted. The extension 525 is received in the dosing member 523. It is held axially fixed and rotatably movable in the dosing member 523 by a rotatable fixture 570. The rotatable fixture 570 illustratively comprises an annular ridge 571 at the proximal end of the extension 525 and a corresponding lug 566 disposed at the proximal end of the dosing member 523. The lug 566 snaps into place 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.

[0450] The piston rod 44 is axially movable but rotationally fixed relative to the extension 525. At its proximal end, the extension comprises a non-circular opening 573, which is 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.

[0451] Fig.56 Depicted is a perspective view of a coupling element 520 of a dose delivery mechanism 554. The coupling element 520 comprises an end plate 580 at its distal end and two rods 582 extending axially in a proximal direction and parallel to each other.

[0452] The coupling element 520 is rotationally fixed and axially movable relative to the piston rod 44. Thus, it is coupled to the piston rod 44 via the extension 525. Fig.57 As can be seen, the rod 582 of the coupling element 520 is received between two ridges 575 of the extension 525, which extend radially from the inner surface of the extension 525. Thus, the ridges 575 extend parallel to each other in the axial direction. The rod 582 and the ridges 575 provide an axially movable connection between the coupling element 520 and the extension 525, which fixes the coupling element 520 to the extension 525 in rotation.

[0453] 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 depicts a proximal perspective view of the adjustment element 518, Fig.59 depicts a side view of the tuning element 518, Fig.60 Depicted along Fig.59 A radial cross-section of the adjustment element 518 along line AA in FIG. 1 , and Fig.61 Depicted along Fig.59 0048 is a radial cross-section of the adjustment element 518 along line BB in FIG.

[0454] 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 As can be seen, the coupling element 520 comprises an axial fixing element 584, which is part of an axial fixing member acting between the adjustment element 518 and the coupling element 520 and engages with a corresponding axial fixing element provided at the adjustment element 518. Thus, the axial fixing element 584 of the coupling element 520 is configured as a snap hook, and the corresponding axial fixing element of the adjustment element 518 is configured as a circumferential edge engaging with the snap hook. The coupling element 520 also comprises at least one rotation fixing element 585, for example a plurality of rotation fixing elements 585. The rotation fixing element 585 engages with a corresponding rotation fixing element provided at the adjustment element 518 and thereby rotationally locks the adjustment element 518 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 corresponding longitudinal recesses 586 provided in the adjustment element 518. For other embodiments of the dose delivery mechanism 554, the adjustment element 518 and the coupling element 520 can also be configured as a single component of a single piece.

[0455] Fig.62 A perspective view of the coupling member 524 of the dose delivery mechanism 554 is depicted. The coupling member 524 is configured as a hollow member. Fig.49As can be seen, 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 by an axially movable rotational fixture 563. The rotational fixture 563 includes a longitudinal recess 590 provided on the outer surface of the coupling member 524, which engages a corresponding longitudinal ridge 564 provided on the inner surface of the dosing member 523, see Fig.50 and 51 .

[0456] Fig.63 A distal perspective view of the sleeve 528 of the dose delivery mechanism 554 is depicted, and Fig.64 A longitudinal cross-sectional view of the sleeve 528 is depicted. The sleeve 528 is constructed as a hollow member. Fig.49 As can be seen, the sleeve 528 is located between the housing 532 and the dosing member 523 .

[0457] The sleeve 528 is threadedly connected 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 surface of the sleeve 528, which engages an external thread 562 provided on the outer surface of the dosing member 523.

[0458] In addition, sleeve 528 is connected to housing 532 in a rotationally fixed and axially movably manner. The connection between sleeve 528 and housing 532 thus includes a 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 may also be formed integrally with housing 532. Connector 620 includes a pair of radial lugs 622, which are arranged at the outer surface of connector 620. The radial lugs 622 engage with corresponding openings 535 that are accessible at the inner surface of housing 532. Connector 620 also includes an outer annular rim 626 arranged at the distal end of connector 620. The annular rim 626 rests against the distal surface of housing 532, thereby preventing connector 620 from moving in the proximal direction.

[0459] On the inner surface of the connector 620, longitudinal recesses 624 are provided which engage with corresponding longitudinal ridges 616 on the outer surface of the sleeve 528. This provides a rotationally fixed and axially movable connection between the housing 532 and the sleeve 528.

[0460] The dose sleeve 523 is configured as a dose indicating member and includes markings on its outer surface for indicating a set dose. A window 610 is formed in the sleeve 528 through which the dose sleeve 523 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 is visible from the outside of the housing 532. The set dose is then indicated by means of the markings visible through the windows 534, 610.

[0461] 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.

[0462] Fig.66 depicts a perspective view of connector 527, and Fig.67 A perspective view of a longitudinal section of the connector 527 is depicted. The connector 527 is axially and rotationally fixed relative to the sleeve 528. It includes longitudinal ridges 632 on its outer surface that align with corresponding recesses 618 provided on the inner surface of the sleeve 528 (see Fig.64 ) engagement. In addition, the connector 527 includes radially extending lugs 630 that engage with openings 614 accessible on the inner surface of the sleeve 528. This engagement prevents the connector 527 from being removed from the sleeve 528.

[0463] A distal blocking element 635 and a proximal blocking element 654 are formed on the inner surface of the connector 527. The blocking elements 635 and 654 provide an axially fixed and rotationally movable connection for the coupling member 524. Thus, an annular edge 592 (see FIG. 5A ) disposed on the outer surface of the coupling member 524 and extending in the radial direction is Fig.62 ) is received between blocking elements 635, 654.

[0464] In addition, a radial stopper 568 is formed between the sleeve 528 and the dosing member 523. The radial stopper 568 is configured to stop the relative rotation between the dosing member 523 and the sleeve 528 at the end of the dose delivery, and thus also stop the relative rotation between the dosing member 523 and the housing 532. The radial stopper 568 includes at least one stopper surface 569 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 a certain angle with a radial plane oriented perpendicular to the longitudinal axis of the dose delivery mechanism 554. For the third injection pen 500, the stopper surfaces 569, 636 are oriented parallel to the longitudinal axis. Although the stopper surface 636 is provided at the connector 527, for other embodiments, the stopper surface 636 may also be provided directly at the sleeve 528.

[0465] 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.

[0466] Fig.68 A side view of the third injection pen 500 is depicted in an assembled state during dose setting when no dose is set. Fig.69 A side view of the third injection pen 500 in a pre-assembled state is depicted. In the pre-assembled state, the adjustment element 518 is located in a pre-assembly position relative to the housing 532, and in the assembled state during dose setting and without setting a dose, the adjustment element 518 is in an assembled position relative to the housing 532. Thus, the assembled position is located more proximally than the pre-assembly position.

[0467] Fig.70 shows a detailed view of a longitudinal section of the distal end of the third injection pen 500 in an assembled state during dose setting, and Fig.71 Another longitudinally cut detailed view of the distal end of the third injection pen 500 is shown in an assembled state during dose setting. Fig.71 The longitudinal section plane of the view shown in FIG. Fig.70 The longitudinal cutting plane orientation of the views shown in .

[0468] During dose setting, the setting element 518 is rotationally fixed relative to the coupling member 524 by the clutch mechanism 507. Thus, a rotation of the setting element 518 results in a rotation of the piston rod 44 due to the rotational fixation by the extension 525 and the coupling element 520, and a simultaneous rotation of the dosing member 523 due to the rotational fixation by the coupling element 520, the clutch mechanism 507 and the coupling member 524. Since both the piston rod 44 and the dosing member 523 rotate at the same speed relative to the housing 532 during dose setting, the piston rod 44 does not change its axial position relative to the housing 532 despite the threaded connection 189 between the piston rod 44 and the dosing member 523.

[0469] 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 due to the threaded connection 562, 612. This also results in a distal movement of the adjustment element 518 and the coupling element 520. Furthermore, due to the axially fixed and rotationally movable connection to the sleeve 528 via the connector 527, the coupling member 524 is also moved distally.

[0470] As from Fig.70 and 71As can be seen, the adjustment element 518 is coupled to the sleeve 528 via a locking mechanism 597 that prevents the adjustment element 518 and the coupling element 520 from moving distally relative to the sleeve 528. Figures 58 to 61 , 63 and 64, the locking mechanism 597 includes a locking portion 600 located at the proximal end of the adjustment element 518, which engages with a locking counterpart 529 of the sleeve 528. The locking counterpart 529 of the sleeve 528 is configured as an annular edge located at the outer surface of the sleeve 528. The locking 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 state.

[0471] 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 Fig.48 is shown in Fig.70 and 71 Not visible in.

[0472] 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.

[0473] 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 .

[0474] Fig.72 shows a detailed view of a longitudinal section of the distal end of the third injection pen 500 in an assembled state during dose delivery, and Fig.73 Another detailed view of a longitudinal section of the distal end of the third injection pen 500 is shown in an assembled state during dose delivery, whereby the longitudinal section plane is perpendicular to Fig.73 The longitudinal cutting plane of the view in is oriented. Thus, Fig.72 , 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.

[0475] During dose delivery, the adjustment 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 adjustment element 518 relative to the sleeve 528 at the start of dose delivery closes the clutch mechanism 513 between the adjustment element 518 and the sleeve 528. The clutch mechanism 513 includes teeth 515 formed at the adjustment element 518 and corresponding teeth 514 formed at the distal end of the sleeve 528. The clutch mechanism 513 also rotationally locks the piston rod 44 to the housing 532 via the extension 525, the coupling element 520, the adjustment element 518 and the sleeve 528 during dose delivery.

[0476] The proximal movement of the coupling element 520 relative to the coupling member 524 at the start of dose delivery causes the clutch mechanism 507 between the coupling element 520 and the coupling member 524 to be disconnected, so that the coupling member 524 becomes rotatable relative to the coupling element 520. After the clutch mechanism 507 is disengaged, the further proximal movement of the coupling element 520 pushes the sleeve 528 in the proximal direction 1. The proximal movement of the sleeve 528 causes the dosing member 523 to rotate 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 by the threaded connection 189.

[0477] Fig.74 A detailed view of a longitudinal section of the distal end of the third injection pen 500 is shown in a pre-assembled state of the dose delivery mechanism 554, and Fig.75 Another detailed view of a longitudinal section of the distal end of the third injection pen 500 in a pre-assembled state is shown, whereby the longitudinal section plane is perpendicular to Fig.74 Orients the longitudinal cutting plane of the view in .

[0478] 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 this adjustment position, the adjustment element 518 and the coupling element 520 are displaced in the distal direction relative to their respective assembly positions in the assembled state.

[0479] The dose delivery mechanism 554 comprises another locking mechanism 599, which prevents the adjustment element 518 and the coupling element 520 from being separated in the pre-assembled state. The other locking mechanism 599 comprises a locking portion 600 of the adjustment element 518 and another locking counterpart 530 located at the distal end of the sleeve 528. Thus, the other locking counterpart 530 is located distally of the locking counterpart 529.

[0480] The other locking counterpart 530 is configured as an angular recess that receives the radial lug of the locking portion 600 of the adjustment element 518. Thus, the locking portion 600 formed by the radial lug is releasably engaged with the other locking counterpart 530 and allows proximal movement of the adjustment element 518 while preventing distal movement.

[0481] In the pre-assembled state, the clutch mechanism 507 between the coupling element 520 and the coupling member 524 is disconnected, so that the adjustment element 518 is rotationally separated from the dosing member 523. At the same time, the adjustment element 518 is rotationally coupled and rotationally fixed relative to the piston rod 44 by the coupling element 520 and the extension 525. The rotation of the adjustment element 518 relative to the housing 532 thus 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.

[0482] For the clutch mechanism 507, the coupling element 520 forms a first clutch member of the clutch mechanism 507 and the coupling member 524 forms a second clutch member of the clutch mechanism 507. The dosing member 523 of the dose delivery mechanism 554 forms a further member of the dose delivery mechanism 54, 354 to which the 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.

[0483] The coupling element 520 includes a first clutch portion 508 of the clutch mechanism 507. The first clutch portion 508 is configured as radial teeth disposed on an outer surface of the coupling element 520. The coupling member 524 includes a second clutch portion 509 of the clutch mechanism 507. The second clutch portion 509 is configured as radial teeth disposed on an inner surface of the coupling member 524. In the closed state of the clutch mechanism 507, the first clutch portion 508 is engaged with the second clutch portion 509, as shown in FIG. Fig.71 as shown in .

[0484] During adjustment of the piston rod in the pre-assembled state, the clutch mechanism 507 is in a disengaged state. Thereby, the first clutch part 508 and the second clutch part 509 are disengaged by positioning them axially spaced apart from each other. Thereby, the first clutch part 508 is displaced from the second clutch part 509 in a distal direction, which is opposite to the proximal direction 1, see Fig.74During dose delivery in the assembled state, the clutch mechanism 507 is also in the disengaged state. Thereby, the first clutch part 508 and the second clutch part 509 are also disengaged by positioning them axially spaced apart from each other, whereby the second clutch part 509 is displaced from the first clutch part 508 in the proximal direction 1, see Fig.72 .

[0485] Furthermore, the adjustment element 518 forms a first clutch member of the clutch mechanism 513 and the sleeve 528 forms a second clutch member of the clutch mechanism 513. The housing 532 of the dose delivery mechanism 554 forms an additional member of the dose delivery mechanism 554, 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.

[0486] The sleeve 528 forms a retaining member for the adjustment element 518 .

[0487] 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 recess formed at the inner surface of the sleeve 528. During dose setting, the adjustment element 518 and the coupling element 520 are configured to perform more than one full rotation around the longitudinal axis of the dose delivery mechanism 554.

[0488] During adjustment of the piston rod 44 in the pre-assembled state, the dose limiting mechanism 115 of the dose delivery mechanism 554 is not functional. This is because the engagement feature 116 moves axially relative to the dose stop 118 to disengage the engagement feature 116 and the dose stop 118 from mutual engagement, see Fig.75 .

[0489] 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 this third element, while the second threaded element formed by the dosing member 523 is rotationally fixed relative to this third element. During dose delivery in the assembled state, the first threaded element formed by the piston rod 44 is rotationally fixed relative to the third element formed by the housing 532, and the second threaded element formed by the dosing member 523 rotates relative to this third element.

[0490] For the third injection pen 500, the piston rod 44 may be configured to advance a first distance in the proximal direction 1 when the actuation member 520 moves proximally a second distance, wherein the second distance is less than 1.5 times the first distance. For the third injection pen 500, the ratio between the second distance and the first distance is given by the ratio of the pitch of the threaded connection 189 between the piston rod 44 and the dosing member 523 to the pitch of another threaded connection 562 between the sleeve 528 and the dosing member 523.

[0491] Additionally or alternatively, the third injection pen 500 may further include the drug reconstitution unit 56 of the first injection pen 10. Thus, such a third injection pen 500 may be configured to receive the dual-chamber cartridge 48 and perform reconstitution of the lyophilized drug prior to drug delivery.

[0492] Similar to the first injection pen 10, embodiments of the third injection pen 500 may be configured to prevent a user from prematurely activating the third injection pen 500. Similar to the first injection pen 10, embodiments of the third injection pen 500 may be configured to axially lock the actuation member 520 relative to the housing 532 before setting and delivering the first dose. Similar to the first injection pen 10, the third injection pen 500 may include a knob cover 16 and / or a knob key 30.

[0493] 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 variant of the third injection pen 500. The fourth injection pen 700 is constructed as disclosed for the third injection pen 500 as long as the difference is not disclosed in the specification or the drawings. Hereinafter, components of the fourth injection pen 700 that perform the same functions as corresponding components of the third injection pen 500 are labeled with the same reference numerals. However, these components may be distinguished in shape and / or appearance between the third injection pen 500 and the fourth injection pen 700.

[0494] 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 in an assembled position relative to the housing 532 of the dose delivery mechanism 754 .

[0495] Fig.78 A side view of the fourth injection pen 700 in a preassembled state is shown, wherein the adjustment element 518 is in a preassembled position relative to the housing 532. In the preassembled position, the adjustment element 518 is moved from its assembly position in a distal direction, whereby the distal direction is oriented perpendicular to the proximal direction 1.

[0496] Fig.79A side view of a fourth injection pen in a pre-assembled state is shown, wherein the adjustment element 518 is in an adjustment position. In this adjustment position, the adjustment element 518 is moved in the proximal direction compared to the pre-assembled position.

[0497] Fig.80 An exploded view of a fourth injection pen 700 is shown, and Fig.81 A longitudinal cross-section of the dose delivery mechanism 754 of the fourth injection pen 700 is shown in an assembled state during dose setting without setting a dose.

[0498] Similar to the dose delivery mechanism 554 of the third injection pen 500, the dose delivery mechanism 754 of the fourth injection pen 700 includes a coupling element 720 that is rotationally fixed and axially movable relative to the piston rod 44. Unlike the dose delivery mechanism 554, the dose delivery mechanism 754 does not have an extension 525. Instead, the coupling element 720 directly engages with 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.

[0499] In addition, the dose delivery mechanism 754 also includes a biasing element in the form of a spring, which is not Fig.80 and 81 The biasing element biases the adjustment element 518 in the distal direction in both the pre-assembled state and the assembled state of the dose delivery mechanism 754.

[0500] 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 4. A radial cross-section of the coupling element 720 along line AA is shown in FIG. The coupling element 720 is configured as a tubular member extending in the longitudinal direction. It has a non-circular inner cross-section configured to receive the piston rod 44. Fig.84 The piston rod 44 shown in FIG. 4 has a distal section 45 having a profile configured to engage with a non-circular inner cross-section of a coupling element 720 to rotationally lock the piston rod 44 and the coupling element 720 and allow axial movement between the coupling element 720 and the piston rod 44 .

[0501] Figures 85 to 89The adjustment element 518 of the dose delivery mechanism 754 is depicted. The adjustment element 518 engages with a distal portion of the coupling element 720. Thus, the adjustment element 518 is rotationally fixed relative to the coupling element 720 in both the pre-assembled state and the assembled state of the dose delivery mechanism 704. The rotation lock between the coupling element 720 and the adjustment element 518 includes a non-circular outer cross-section of the coupling element 720 that matches and engages with a corresponding inner shape of the central opening 519 of the adjustment element 518.

[0502] The locking mechanism 597 acts between the coupling element 720 and the adjustment element 518. In the assembled state of the dose delivery mechanism 754, the locking mechanism 597 prevents the adjustment element 518 from moving distally from the assembly position to the pre-assembly position relative to the housing 532. The locking mechanism 597 includes a locking portion 600 formed at the adjustment element 518 and a locking corresponding portion 529 formed at the coupling element 720. The locking portion 600 is configured as a flexible hook, which protrudes radially inward from the inner surface of the adjustment element 518 at the opening 519. The locking corresponding portion 529 is configured as a recessed portion at the outer surface in the distal portion of the coupling element 720.

[0503] The coupling element 720 may form a retaining member of the dose delivery mechanism 754 .

[0504] In the pre-assembled state of the dose delivery mechanism 754, the adjustment element 518 is located at 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 separated from the dose delivery mechanism 754 and the coupling element 720 by the further locking mechanism 599. The further locking portion of the further locking mechanism 599 is formed by the locking portion 600, and the further locking counterpart 530 of the further locking mechanism 599 is formed by an additional recess at the outer surface of the coupling element 720. Thus, the further locking counterpart 530 is located at the distal side of the locking counterpart 529.

[0505] Figure 90 to Figure 93 A sleeve 528 of a dose delivery mechanism 754 is shown that is rotationally fixed and axially movable relative to a housing 532. The sleeve 528 includes longitudinal recesses on its outer surface that engage corresponding longitudinal ridges on the inner surface of the housing 532 to rotationally fix the sleeve 528 to the housing 532. The sleeve 528 includes an outer portion 528a and an insert 528b that is rotationally and axially fixed within the outer portion 528a at a distal end of the outer portion 528a.

[0506] The dose limiting mechanism 115 of the dose delivery mechanism 754 acts between the adjustment element 518 and the sleeve 528. The dose limiting mechanism 115 includes an engagement feature 116 configured as a flexible hook and disposed at the proximal end of the adjustment element 518. The engagement feature 116 interacts with a dose stop 118 disposed in a proximal portion of the inner surface of the insert 528b of the sleeve 528.

[0507] Furthermore, the dose delivery mechanism 754 comprises a clutch mechanism 513 acting between the adjustment element 518 and the sleeve 528. The clutch mechanism 513 comprises teeth 515 located at the proximal outer surface of the adjustment element 518. When the clutch mechanism 513 is closed, the teeth 515 engage with corresponding teeth 514 provided in the distal portion of the inner surface of the insert 528b. Thus, the inner surface is the side surface of the cavity formed at the distal end of the insert 528b and the sleeve 528.

[0508] The adjustment element 518 forms a first clutch member of the clutch mechanism 513, and the sleeve 528 forms a second clutch member of the clutch mechanism 513. The housing 532 of the dose delivery mechanism 754 forms an additional component of the dose delivery mechanism 754, to which the 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. Furthermore, the clutch mechanism 513 forms a locking mechanism, which rotationally locks the adjustment element 718 to the housing 532 during dose delivery in the assembled state of the dose delivery mechanism 754.

[0509] 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.

[0510] The clutch mechanism 507 acts between the coupling member 524 and the coupling element 720 received in the coupling member 524. The clutch mechanism 507 comprises a first clutch portion 508, which is located on the outer surface of the coupling element 720 and comprises longitudinal teeth. The clutch mechanism 507 further comprises a second clutch portion 509, which is located on the inner surface of the coupling member 524. The second clutch portion 509 is configured as longitudinal teeth, which mesh with the longitudinal teeth of the first clutch portion 508 in the closed state of the clutch.

[0511] The coupling element 520 forms a first clutch member of the clutch mechanism 507 and the coupling member 524 forms a second clutch member of the clutch mechanism 507. The dosing member 523 of the dose delivery mechanism 754 forms a further member of the dose delivery mechanism 754 to which the 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.

[0512] Fig.97 and 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.

[0513] As from Fig.99 and Fig.100 As can be seen, the Fig.99 and Fig.100 The dose delivery mechanism 754 is shown in an assembled state during dose setting without setting a dose, during which the clutch mechanism 507 between the coupling element 720 and the coupling member 524 is closed, and the clutch mechanism 513 between the adjustment element 518 and the sleeve 528 is opened. Dose setting is then achieved by rotating the adjustment element 720 in the same manner as described for the third injection pen 500.

[0514] Fig.101 and 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 clutch mechanism 507 is opened, thereby allowing rotation between the piston rod 44 and the dosing member 523, and the clutch mechanism 513 is closed, thereby rotationally locking the piston rod 44 to the housing 532.

[0515] Fig.103 and 104 The dose delivery mechanism 754 is depicted in a pre-assembled state. Compared to the assembled state, the adjustment element 518 is moved in the distal direction relative to the coupling element 720 and the housing 532. As a result, the locking portion 600 of the adjustment element 518 engages with another locking counterpart 530 disposed distally of the locking counterpart 529 at the coupling element 720. Fig.103 and 104 In the state depicted in , the adjustment element 518 is located in a pre-assembly position relative to the housing 532 .

[0516] In order to adjust the position of the piston rod 44 in the pre-assembled state, the adjustment 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 adjustment element 518 and the sleeve 528, as shown in FIG. Fig.105 and 106 . The proximal movement of the adjustment element 518 causes the proximal movement of the coupling element 720 and causes the disconnection of the clutch mechanism 507. At the same time, the clutch mechanism 513 remains disconnected 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 the teeth 514.

[0517] When the assembler of the fourth injection pen 700 rotates the adjustment element 518 to Fig.105 and 106 In the adjustment position depicted in FIG, the piston rod 44 rotates with the adjustment element 518, and the dosing member 523 does not rotate due to the disconnected clutch mechanism 507. Thus, 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.

[0518] For the fourth injection pen 700, the piston rod 44 may 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 another threaded connection 562 between the sleeve 528 and the dosing member 523.

[0519] Additionally or alternatively, the fourth injection pen 700 may further include the drug reconstitution unit 56 of the first injection pen 10. Thus, such a fourth injection pen 700 may be configured to receive the dual-chamber cartridge 48 and perform reconstitution of the lyophilized drug prior to drug delivery.

[0520] Similar to the first injection pen 10, embodiments of the fourth injection pen 700 may be configured to prevent a user from prematurely activating the fourth injection pen 700. Similar to the first injection pen 10, embodiments of the fourth injection pen 700 may be configured to axially lock the actuation member 520 relative to the housing 532 before setting and delivering the first dose. Similar to the first injection pen 10, the fourth injection pen 700 may include a knob cover 16 and / or a knob key 30.

[0521] The mechanism may include a dose limiting mechanism that allows a user of the device to set at least one dose of the drug 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.

[0522] For the injection pen 10, 300, 500, 700, the dose delivery mechanism 54, 354, 554, 754 each comprises a dose limiting mechanism 115, wherein the respective dose limiting mechanism 115 acts between the respective dose setting element 18, 318, 518 and the housing 32, 332, 532 during dose setting. Thereby, the dose limiting mechanism 115 has at least one dose stop 118 and a corresponding element 116, wherein the corresponding 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 corresponding element 116 is configured to engage the dose stop 118 when the dose has been set. The corresponding element 116 is formed by a respective engagement feature 116 of the dose delivery mechanism 54, 354, 554, 754.

[0523] The dose limiting mechanism 115 may define a rotational position of the dose setting element 22, 518 relative to the housing 32, 332, 532 corresponding to a settable dose. For each settable dose, the dose limiting mechanism 115 may include a separate dose stop 118. Thus, the dose setting element 22, 518 may be configured to perform less than one full rotation during dose setting. For the third and fourth injection pens 500, 700, the dose limiting mechanism 115 may also include a discrete dose stop 118 defining more than a single dose, for example, the discrete dose stop 118 may be configured to engage with the corresponding element 116 once for each full rotation of the corresponding element 116 relative to the dose stop 118.

[0524] The corresponding element 116 may be configured as a flexible element that snaps onto the dose stop 118 when setting a dose. For example, the corresponding element 116 may be configured as a flexible protrusion at a component of the corresponding dose delivery mechanism 54, 354, 554, 754. For example, the corresponding element 116 may be formed integrally with the component of the corresponding dose delivery mechanism 54, 354, 554, 754 to which it is fixed. For the first and second injection pens 10, 300, the component is formed by the dosing member 23, 323, while for the third and fourth injection pens 500, 700, it is formed by the dose setting element 518.

[0525] For the first and second injection pens 10, 300, the engagement of the corresponding 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 lock function, which holds the spring 40 in a tensioned state until a dose is delivered by switching the corresponding dose delivery mechanism 54, 354 from a dose setting state to a dose delivery state.

[0526] For the first and second injection pens 10, 300, the corresponding element 116 is configured to disengage from the dose stop 118 when the corresponding dose delivery mechanism 54, 354 is switched 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 corresponding element 116 may be configured to disengage from all dose stops 118 when the corresponding dose delivery mechanism 54, 354 is switched to the dose delivery state. This may allow the corresponding 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 where no dose is set.

[0527] For example, the corresponding element 116 may be configured to disengage from the dose stop 118 by being axially moved relative to the dose stop 118 .

[0528] For the injection pen 10, 300, 500, 700, one of the dose stop 118 and the corresponding element 116, for example the dose stop 118, is rotationally fixed relative to the housing 32, 332, 532. One of the dose stop 118 and the corresponding element 116 is then axially movable relative to the dose setting element 22, 518.

[0529] For the first and second injection pens 10, 300, the one of the dose stop 118 and the corresponding element 116, e.g. the dose stop 118, is axially fixed relative to the button 18, 318. This allows the one of the dose stop 118 and the corresponding element 116 to be moved together with the button 18, 318 when the corresponding dose delivery mechanism 54, 354 is switched from a dose setting state to a dose delivery state. The one of the dose stop 118 and the corresponding element 116 may then be disengaged from the other of the dose stop 118 and the corresponding element 116 by this movement. For example, the one of the dose stop 118 and the corresponding element 116 may be linearly guided at the housing 32, 332.

[0530] For some embodiments, the one of the dose stop 118 and the corresponding element 116 is fixed to an outer housing part of the respective dose delivery mechanism 54, 354, 554, 754. The outer housing part may be fixed to a connection for coupling the drug container 48, 348 to the respective dose delivery mechanism 54, 354, 554, 754. Alternatively, the outer housing part may also be movable relative to the connection, for example axially movable. In addition, the outer housing part may be rotationally fixed relative to the connection. For example, the outer housing part may be a housing connector, for example a housing connector engaged with the housing 32, 332, 532 by an axially movable and rotationally fixed connection. For the first and second injection pens 10, 300, the outer housing part is formed by the dose selector 28, and for the third and fourth injection pens 500, 700, it is formed by the sleeve 528.

[0531] For the first and second injection pens 10, 300, the dose limiting mechanism 115 acts between the dosing member 23, 332 and the housing 32, 332, 532. It then defines a rotational position of the dosing member 23, 332 relative to the housing 32, 332 corresponding to a settable dose.

[0532] For the first and second injection pens 10, 300, the other of the dose stop 118 and the corresponding element 116, e.g. the corresponding element 116, is rotationally fixed relative to the dosing member 23, 332. Exemplarily, the other of the dose stop 118 and the corresponding element 116 is permanently rotationally fixed relative to the dosing member 23, 332. The other of the dose stop 118 and the corresponding element 116 is exemplarily additionally fixed to the dosing member 23, 332, e.g. fixed to a first part of the dosing member 23, 332 that is movable relative to the housing 32, 332, 532.

[0533] For the first, second, third and fourth injection pens 10, 300, 500, 700, the other of the dose stop 118 and the corresponding element 116, e.g. the corresponding element 116, is axially movable relative to the button 18, 318, 518. The one of the dose stop 118 and the corresponding element 116, e.g. 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 corresponding element 116 by moving the button relative to the housing 32, 332, 532, just as in the case of the first and second injection pens 10, 300.

[0534] For the second injection pen 300, the dose delivery mechanism 354 includes a blocking mechanism having a first element and a second element, wherein when the button 318 is released during dose delivery, the first element engages the second element to prevent the corresponding dose delivery mechanism 354 from changing from the dose delivery state to the dose setting state. This keeps the corresponding dose delivery mechanism 354 in the dose delivery state and prevents the dose setting from changing when the dose delivery is interrupted due to the torque provided by the spring 40. The blocking mechanism can resist the distal movement of the button 318 against the biasing force that biases the button 318 in the distal direction. The biasing force can be provided by the biasing element 250.

[0535] The blocking mechanism is configured to disengage the first element from the second element at the zero dose position where the set dose has been fully delivered. This allows the dose delivery mechanism 354 to return to the dose setting state so that a subsequent dose can be set after the previous drug delivery is completed.

[0536] 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 and second elements may bring the first and second elements into a relative position which prevents mutual engagement at the end of dose delivery and / or when a dose has been set.

[0537] 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 corresponding element formed by the engagement feature 116 of the snap element 24 , which travels along the circumferential rib 124 during dose delivery.

[0538] 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.

[0539] 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.

[0540] Illustratively, when the mechanism is switched 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.

[0541] Exemplarily, the first element of the blocking mechanism and one of the dose stop 118 and the corresponding element 116, e.g. the dose stop 118, are fixed to the same component of the dose delivery mechanism 54, 354. Furthermore, the second element of the blocking mechanism and the other of the dose stop 118 and the corresponding element 116, e.g. the corresponding element 116, are fixed to the same other component of the dose delivery mechanism 54, 354. This allows precise alignment of the elements of the blocking mechanism and the elements of the dose limiting mechanism 115, and enhances the reliability of the dose delivery mechanism 54, 354.

[0542] The mechanism component including the first element of the blocking mechanism and the one of the dose stop 118 and the corresponding element 116 is exemplarily a dose selector 28 of the dose delivery mechanism 54, 354. The other component of the dose delivery mechanism 54, 354 including the second element of the blocking mechanism and the other of the dose stop 118 and the corresponding element 116 is exemplarily a carrier that is rotatably movable relative to the dose selector 28. The carrier is exemplarily a part of the metering supply component 23, 332, that is, it is constituted by the snap element 24 of the metering supply component 23, 323.

[0543] The dose selector 28 is illustratively located at least partially within the outer housing of the dose delivery mechanism 54, 354, ie, the housing 32, 332. The dose selector 28 is illustratively configured to protrude from the outer housing.

[0544] Exemplarily, one of the first and second elements of the blocking mechanism and one of the dose stop 118 and the corresponding element 118 are formed by a single element. As an example, the second element of the blocking mechanism and the corresponding 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.

[0545] The single element is exemplarily a flexible element which is configured to snap onto the dose stopper 118 when rotated relative to the dose stopper 118 .

[0546] For the first and second injection pens 10, 300, the dose delivery mechanism 54, 354 comprises a maximum dose mechanism which limits further rotation of the dose setting element 22 when the maximum dose setting is dialed, 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 the maximum dose setting is dialed. This provides a well-defined rotation end position 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.

[0547] The blocking portion 124 illustratively engages the maximum dose stop 126, 128 just at the maximum dose setting. For other embodiments, the blocking portion 124 may engage the maximum dose stop 126, 128 only after the maximum dose setting is dialed a predetermined amount.

[0548] 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 stops 126, 126 are exemplarily configured as such a hard stop.

[0549] Illustratively, the maximum dose stop 126 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 126, 126 and the blocking portion 124, i.e., the maximum dose stop 126, 126, may be rotationally fixed relative to the housing 32, 332 during dose setting, and the other of the maximum dose stop 126, 126 and the blocking portion 124, e.g., the blocking portion 124, may be rotationally fixed relative to the dose setting member 22 during dose setting. The other of the maximum dose stop 126, 126 and the blocking portion 124 may be rotationally movable relative to the dose setting member 22 during dose delivery.

[0550] Exemplarily, the maximum dose stop 126 is configured as a radial stop and the blocking portion 124 is configured to rotate against the maximum dose stop 126 when the maximum dose is dialed. Such a radial stop provides a well-defined rotational position in which the blocking portion 124 and the maximum dose stop 126 engage.

[0551] The maximum dose stopper 126 and the blocking portion 124 exemplarily comprise engagement surfaces that engage with each other. The engagement surfaces are exemplarily oriented substantially perpendicularly, ie perpendicularly, to a circumferential direction around the longitudinal axis of the dose delivery mechanism 54,354.

[0552] Illustratively, one of the maximum dose stop 126 and the blocking portion 124, e.g. the maximum dose stop 126, is rotationally fixed relative to the housing 32, 332. The one of the maximum dose stop 126 and the blocking portion 124 is illustratively permanently rotationally fixed relative to the housing 32, 332 both during dose setting and dose delivery.

[0553] Exemplarily, the 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.

[0554] Exemplarily, the other of the maximum dose stop 126 and the blocking portion 124, for example the blocking portion 124, is rotationally fixed relative to the dosing member 23, 332. Then, the other of the maximum dose stop 126 and the blocking portion 124 rotates 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 set dose, rotationally fixing the one of the maximum dose stop 126 and the blocking portion 124 to the dosing member 23, 332 precisely defines the maximum dose position in which the maximum dose stop 126 and the blocking portion 124 engage with each other.

[0555] Exemplarily, the other of the maximum dose stop 126 and the blocking portion 124 is fixed to a coupling member which rotationally couples the dosing member 23 , 332 to the dose setting element during dose setting. The coupling member is formed by the snap element 24 .

[0556] Exemplarily, one of the dose stop 118 and the corresponding element 116, e.g. the dose stop 118, and one of the maximum dose stop 126 and the blocking portion 124, e.g. 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.

[0557] Exemplarily, the other of the dose stop 118 and the corresponding element 116, such as the corresponding element 116, and the other of the maximum dose stop 126 and the blocking portion 124, such as the blocking portion 124, are fixed to the same other 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. For example, the other component can be a carrier that is rotatably movable relative to the dose selector 28 and is formed by the snap element 24.

[0558] Exemplarily, the dose delivery mechanism 54, 354 of the first and second injection pens 10, 300 comprises a zero dose mechanism that prevents further axial movement of the nut 38 at the end of dose delivery, wherein the zero dose mechanism comprises a zero dose stop and a further blocking portion, and wherein the further blocking portion is configured to engage the zero dose stop at the end of dose delivery. This provides a clearly defined end position for the piston rod 44 at the end of dose delivery and thus helps to accurately define the amount of drug delivered.

[0559] For the first injection pen 10, the zero dose stop is formed by the end stop 176 at the guide 42 of the piston rod 44, and 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 inner surface of the dose selector 28, and the further blocking portion is formed by the hard stop 124 at the snap element 24.

[0560] The further blocking portion 124, 174 is exemplarily configured as a hard stop, which is rigidly connected, for example integrally formed, to a component of the dose delivery mechanism 54, 354. Likewise, the zero dose stop 176 is exemplarily configured as such a hard stop.

[0561] 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, the zero dose stop 176 and one of the further blocking portions 124, 174, e.g. the zero dose stop 176, are rotationally fixed relative to the housing 32, 332 during dose setting, and the zero dose stop 176 and the other of the further blocking portions 124, 174, e.g. the other blocking portion 124, 174, are rotationally fixed relative to the dose setting element 22 during dose setting. The zero dose stop 176 and the other of the further blocking portions 124, 174 are exemplarily rotationally movable relative to the dose setting element 22 during dose delivery.

[0562] 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 engagement with each other.

[0563] The zero dose stopper 176 and the further blocking portion 124, 174 exemplarily comprise engagement surfaces engaging each other. These engagement surfaces may be oriented substantially perpendicularly, for example perpendicularly, to a circumferential direction around the longitudinal axis of the dose delivery mechanism 54, 354.

[0564] Exemplarily, the zero dose stop 176 and one of the further blocking parts 124, 174, e.g. the zero dose stop 176, are rotationally fixed relative to the housing 32, 332. The zero dose stop 176 and the one of the further blocking parts 124, 174 are exemplarily permanently rotationally fixed relative to the housing 32, 332 both during dose setting and dose delivery.

[0565] Exemplarily, the zero-dose stopper 176 and the 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. Furthermore, the first injection pen 10 may alternatively include such a zero-dose stopper 176.

[0566] Exemplarily, the zero dose stop 176 and the other of the further blocking parts 124, 174 are rotationally fixed relative to the dosing member 23, 332. The zero dose stop 176 and the other of the further blocking parts 124 are then rotated relative to the housing 32, 332 during both dose setting and dose delivery. This allows the zero dose mechanism to be reset during dose setting. For embodiments in which the rotational position of the dosing member 23, 332 defines the set dose, the zero dose stop 176 and the one of the further blocking parts 124, 174 being rotationally fixed to the dosing member 23, 332 precisely defines the zero dose position in which the zero dose stop and the further blocking part 124 engage with each other.

[0567] For the second injection pen 200, the zero dose stopper 176 and the other of the further blocking portions 124, 174 are fixed to a coupling member which rotationally couples the dosing member 23, 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 include such a configuration.

[0568] Exemplarily, one of the dose stopper 118 and the corresponding element 116 of the second injection pen 300, for example the dose stopper 118, and one of the zero dose stopper and the further blocking portion 124 of the second injection pen 300, for example the zero dose stopper, 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. The component of the dose delivery mechanism 354 is exemplarily the dose selector 28. The first injection pen 10 may also have such a configuration.

[0569] Exemplarily, the other of the dose stop 118 and the corresponding element 116 of the second injection pen 300, such as the corresponding element 116, and the other of the zero dose stop and the further blocking portion 124 of the second injection pen 300, such as the further blocking portion 124, 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 relative to the components of the zero dose mechanism to be accurately defined. For example, the further component may be a carrier that is rotatably movable relative to the dose selector 28. The first injection pen 10 may also have such a configuration.

[0570] Exemplarily, the second injection pen 300, the maximum dose stopper 126 of the maximum dose mechanism and one of the blocking portions 124, and the zero dose stopper and the other blocking portion 124 of the zero dose mechanism, such as the maximum dose stopper 126 and the zero dose stopper, are fixed to the same component of the mechanism. In addition, the maximum dose stopper 126 of the maximum dose mechanism and the other of the blocking portions 124, and the zero dose stopper and the other of the blocking portions 124 of the zero dose mechanism, such as the blocking portion 124 and the other blocking portion 124, are fixed to the same other component of the mechanism. This provides 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.

[0571] 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.

[0572] Exemplarily, for the second injection pen 300, the blocking portion 124 of the maximum dose mechanism forms the 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.

[0573] In general, the dose delivery mechanism 54, 354, 554, 754 may include a clutch mechanism 113 having a first engagement portion and a second engagement portion, wherein the clutch mechanism 113 is closed during one of dose setting and dose delivery, and is open during the other of dose setting and dose delivery. When the first engagement portion and the second engagement portion are not engaged with each other, the clutch mechanism 113 is in an open state, and when the first engagement portion and the second engagement portion are engaged with each other, the clutch mechanism 113 is in a closed state.

[0574] Illustratively, the dose delivery mechanism 54, 354 of the first and second injection pens comprises a clutch mechanism 113, wherein the clutch mechanism 113 rotationally locks the nut 38 to the piston rod 44 during dose delivery and rotationally releases the nut 38 from the piston rod 44 during dose setting. By rotationally locking the nut 38 to the piston rod 44, the clutch mechanism 113 forces the nut 38 to move proximally together with the piston rod 44. Illustratively, the clutch mechanism 113 rotationally locks the threaded connection 189 coupling the nut 38 to the piston rod 44. The clutch mechanism 113 locks the nut 38 to the piston rod 44 in a closed state and rotationally releases the nut 38 from the piston rod 44 in an open state.

[0575] The clutch 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 disengage 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.

[0576] The clutch mechanism 113 is illustratively configured to switch from the open state to the closed state when the button 18, 318 moves and the dose delivery mechanism 54, 354 switches from the dose setting state to the dose delivery state. One of the first engagement portion and the second engagement portion, such as the second engagement portion, is axially fixed relative to the button 18, 318, and the other of the first engagement portion and the second engagement portion, such as the first engagement portion, is axially fixed relative to the housing 32, 332. Additionally or alternatively, the first engagement portion is axially fixed relative to the metering member 23, 332.

[0577] Exemplarily, the first engagement portion is rotationally fixed to the housing 32 , 332 , and the second engagement portion is rotationally fixed to the nut 38 .

[0578] The second engagement portion is exemplarily rotationally fixed to the button 18 , 318 and / or the dose setting element 22 .

[0579] Illustratively, the clutch mechanism 113 rotationally secures the nut 38 to the piston rod 44 via the housing 32 , 332 and, for example, via the dose setting element 22 and / or the button 18 , 318 during dose delivery.

[0580] Illustratively, the clutch 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 .

[0581] Exemplarily, the button 18, 318 is rotationally coupled, for example permanently rotationally coupled, to one of the first engagement portion and the second engagement portion. As an example, the button 18, 318 constitutes the one of the first engagement portion and the second engagement portion.

[0582] Exemplarily, the dose delivery mechanism 54, 354 comprises a further clutch mechanism 107, wherein the further clutch mechanism 107 rotationally locks the dose setting element 22 to one end of the spring 40 during dose setting and decouples the dose setting element 22 from the one end of the spring 40 during dose delivery. Furthermore, the further clutch mechanism 107 has a further first engagement portion and a further second engagement portion, wherein the further first engagement portion is configured to move into engagement with the further second engagement portion to rotationally lock the dose setting element 22 to the one end of the spring 40. The further clutch mechanism 107 allows the spring 40 to be tightened 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 catch element 23, and the further second engagement portion is exemplarily formed by teeth 108 at the button 22.

[0583] By the movement of the button 18, 318, the other clutch mechanism 107 is exemplarily transformed from a closed state, in which the other first engagement portion is engaged with the other second engagement portion, to an open state, in which the other first engagement portion is disengaged from the other second engagement portion. The movement of the button 18, 318 is exemplarily a movement that transforms the dose delivery mechanism 54, 354 from a dose setting state to a dose delivery state.

[0584] Exemplarily, one of the further first engagement portion and the further second engagement portion, for example the further second engagement portion, is rotationally and axially fixed to the dose setting member 22. This allows opening and closing of the further clutch mechanism 107 by relative movement of the dose setting member 22 relative to the other of the further first engagement portion and the further second engagement portion.

[0585] Exemplarily, said 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.

[0586] Exemplarily, the further clutch mechanism 107 acts between the dosing member 23, 332 and the dose setting element 22. The dosing member 23, 332 can then rotationally couple the dose setting element 22 onto one end of the spring 40.

[0587] Exemplarily, one of the further first engagement portion and the further second engagement portion, for example the further first engagement portion, is rotationally fixed to the dosing member 23, 332. Exemplarily, the one of the further first engagement portion and the further second engagement portion may be axially fixed to the dosing member 23, 332.

[0588] Exemplarily, the clutch mechanism 113 comprises a first engagement portion which engages a second engagement portion to rotationally secure the nut 38 to the piston rod 44 during dose delivery, wherein the further second engagement portion of the further clutch mechanism 107 forms the first engagement portion of the clutch mechanism 113. This provides a compact construction of the clutch mechanisms 107, 113.

[0589] The nut 38 is exemplarily rotationally fixed relative to the button 18, 318 and / or the dose setting element 22. As an example, the nut 38 is rotationally fixed and axially movable relative to the button 18, 318 and / or the dose setting element 22. It is coupled to the button 18, 318 and / or the dose setting element 22 by a rotation lock. The rotation lock is formed by the nut 38 and one of the button 18, 318 and the dose setting element 22, for example the button 18, 318.

[0590] When the dose delivery mechanism 54, 354 is in the dose setting state, the nut 38 is rotationally movable relative to the piston rod 44, and when the dose delivery mechanism 54, 354 is in the dose delivery state, the nut 38 is rotationally fixed relative to the piston rod 44. Rotation of the nut 38 relative to the piston rod 44 during dose setting results in axial movement due to the threaded connection between the nut 38 and the piston rod 44. 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.

[0591] The nut 38 is rotated by the dose setting member 22 during dose setting and performs an axial movement due to the threaded connection with 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 to translate 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 drug expelled during dose delivery.

[0592] Some general comments about this disclosure:

[0593] 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 for providing the second threaded connection 170, 172. For example, a 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.

[0594] Preferably, the actuation members 18, 20, 22 are coupled to the piston rod 44 via the nut 38 in such a way that during dose delivery, axial movement of the actuation members 18, 20, 22 causes axial movement of the nut 38 and the piston rod 44. In order to apply an axial force from the nut 38 to the piston rod 44 during dose delivery to move the piston rod 44 in the 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. During dose delivery, the nut 38 and the piston rod 44 are prevented from relative rotational movement, so that axial movement of the nut 38 causes axial movement of the piston rod 44.

[0595] 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 by exactly one threaded connection 170, 172", it is pointed out that the dose delivery mechanism 54 may include the driver 36, the dose sleeve 34 and / or the 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 components that are 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. The subassembly may form exactly one threaded connection 170, 172 with the housing 32 or any part rigidly connected to the housing 32.

[0596] The coupling means 100, 102 may be formed on the injection button and the snap element 24. However, the coupling means 100 may alternatively be formed on the snap ring 20 or the dose setting knob 22. The coupling means 102 may generally be formed on any part that cannot move axially relative to the housing. A person skilled in the art will appreciate that there are various options for where to place the coupling means 100, 102. If the coupling means 100, 102 is configured to permanently axially lock the dose setting knob 22 to the dose setting device or housing 50, this may be accomplished in a variety of ways, such as by a permanent form-fit connection or by a permanent friction-fit connection.

[0597] Generally speaking, the dose setting mechanism may comprise a clutch connecting the nut 38 to the piston rod 44, wherein the nut 38 is rotationally fixed to the piston rod 44 during dispensing and rotates relative to the piston rod 44 during dose setting. Preferably, during dose setting, rotating the dose setting knob causes rotation of the nut 38 relative to the piston rod 44. There are various ways how to design the connection between the dose setting knob and the nut 38.

[0598] Generally speaking, the piston rod 44 may be rotationally fixed relative to the housing during dose delivery / dispensing.

[0599] The proximal end 14 includes a dispensing outlet. The distal end 12 is disposed 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 a needle or a cannula.

[0600] The cover 16 may cover a portion of the dose delivery activation mechanism that is configured to activate dose delivery. The dose delivery activation mechanism is a portion that is configured to allow a dose to be dispensed from the delivery device. The activation mechanism may include an injection button 18 that forms the distal face of the injection pen. The cover 16 may also cover a dose setting knob 22. Thereby, the cover 16 prevents setting a dose and / or activating an injection before mixing of the two components is complete.

[0601] The delivery condition is a condition 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 manufacture of the dose delivery mechanism 54. In other words, the delivery condition is a condition in which the user has not rotated or otherwise changed the position of the dose setting member 34 relative to the housing. Thus, when the user sets a dose, the dose delivery mechanism 54 is no longer in the "delivery condition" but is instead in the "set state". According to one embodiment, in the "delivery condition", the dose setting knob 22 cannot be rotated towards the zero dose position. According to one embodiment, actuation is blocked in the "delivery condition" to prevent accidental activation.

[0602] 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 initiate an injection process. The snap element 24 is preferably configured to engage with the dose selector 28, preferably at different rotational positions, to define a settable dose. The clip 30 may be used in conjunction with the knob cover 16 to prevent movement of the activation member 18 relative to the housing 32 when the pen falls onto its proximal end 14.

[0603] The present disclosure also relates to the following embodiments:

[0604] 1. A dose delivery mechanism (54, 354, 554) for a drug delivery device (10, 300, 500, 700), comprising:

[0605] Housing (32, 332, 532);

[0606] a piston rod (44); and

[0607] Adjustment element (18, 318, 518),

[0608] wherein the housing (32, 332, 532) is configured to be connected to a drug container (48, 348) sealed by a plunger (210),

[0609] The dosage delivery mechanism (54, 354, 554) has a pre-assembled state and an assembled state.

[0610] wherein, in an assembled state, the dose delivery mechanism (54, 354, 554) is configured to cause the piston rod (44) to move axially in a proximal direction (1) relative to the housing (32, 332, 532) during dose delivery, so that the piston rod (44) exerts an axial force in the proximal direction (1) on the plunger (210) of the drug container (48, 348) to discharge the drug from the drug container (48, 348), and

[0611] wherein, in a pre-assembled state, the adjustment element (18, 318, 518) is configured to rotate relative to the housing (32, 332, 532),

[0612] wherein rotation of the adjustment element (18, 318, 518) causes axial movement of the piston rod (44) for adjusting the axial position of the piston rod (44) relative to the housing (32, 332, 532) before the dose delivery mechanism (54, 354, 554) is transformed from a pre-assembled state to an assembled state.

[0613] 2. The dosage delivery mechanism (54, 354, 554) as described in Example 1,

[0614] Therein, the adjustment element (18, 318, 518) is configured to rotate until a bearing (46) located at the piston rod (44) contacts a plunger (210) of a drug container (48, 348).

[0615] 3. A dose delivery mechanism (54, 354, 554) as described in at least one of the preceding embodiments,

[0616] The outer edge (19) of the adjustment element (18, 318, 518) is accessible to an assembler of the device in a pre-assembled state to achieve rotation of the adjustment element (18, 318, 518) and axial movement of the piston rod (44).

[0617] Wherein, for example, the adjustment element (18, 318, 518) is configured to cause proximal movement of the piston rod (44) when rotated by an assembler.

[0618] 4. A dose delivery mechanism (54, 354, 554) as described in at least one of the preceding embodiments,

[0619] Therein, the adjustment element (18, 318, 518) protrudes in the distal direction from the remaining components of the dose delivery mechanism (54, 354, 554) in a pre-assembled state.

[0620] 5. A dose delivery mechanism (54, 354, 554) as described in at least one of the preceding embodiments,

[0621] Wherein, in the pre-assembled state, the adjustment element (18, 318, 518) is in a pre-assembled position relative to the housing (32, 332, 532),

[0622] wherein the adjustment element (18, 318, 518) is configured to be transferred from a pre-assembly position to an assembly position relative to the housing (32, 332, 532) when the dose delivery mechanism (54, 354, 554) is transferred from a pre-assembly state to an assembly state,

[0623] Wherein, for example, the displacement of the adjustment element (18, 318, 518) causes the dose delivery mechanism (54, 354, 554) to be transformed from a pre-assembled state to an assembled state.

[0624] 6. The dosage delivery mechanism (54, 354, 554) as described in Example 5,

[0625] Therein, the adjustment element (18, 318, 518) is configured to perform rotation when located in the pre-assembly position.

[0626] 7. The dosage delivery mechanism (554) as described in Example 5,

[0627] wherein the adjustment element (518) is configured to rotate when in an adjustment position deviating from the pre-assembly position,

[0628] Therein, for example, the adjustment element (518) is configured to be pushed in the proximal direction (1) from a pre-assembly position into an adjustment position.

[0629] 8. The dose delivery mechanism (54, 354, 554) of at least one of embodiments 5 to 7,

[0630] The dose delivery mechanism (54, 354, 554) is configured to hold the adjustment element (18, 318, 518) in a pre-assembled position relative to the housing (32, 332, 532) in a pre-assembled state.

[0631] 9. The dose delivery mechanism (354, 554) of at least one of embodiments 5 to 8,

[0632] The dosage delivery mechanism (354, 554) includes a biasing element (250) which biases the adjustment element (318, 518) to a pre-assembled position relative to the housing (332, 532) in a pre-assembled state.

[0633] 10. The dose delivery mechanism (54, 354, 554) of at least one of embodiments 5 to 9,

[0634] Wherein the adjustment element (18, 318, 518) is configured to move axially from a pre-assembled position to an assembled position when the dose delivery mechanism (54, 354, 554) is transformed from a pre-assembled state to an assembled state.

[0635] 11. The dose delivery mechanism (54, 354, 554) of at least one of embodiments 5 to 10,

[0636] In the assembly position, the adjustment element (18, 318, 518) is blocked, for example irreversibly blocked, from returning to the pre-assembly position relative to the housing (32, 332, 532).

[0637] 12. The dosage delivery mechanism (54, 354, 554) of embodiment 11,

[0638] The dose delivery mechanism (54, 354, 554) includes a locking mechanism (97, 597) configured to prevent the adjustment element (18, 318, 518) from moving from an assembly position to a pre-assembly position.

[0639] 13. The dosage delivery mechanism (54, 354, 554) of embodiment 12,

[0640] wherein the dosage delivery mechanism (54, 354, 554) comprises corresponding components (23, 323, 528, 720),

[0641] The locking mechanism (97, 597) includes a locking portion (98a, 600) of an adjustment element (18, 318, 518) and a locking corresponding portion (102, 529) of a corresponding component (23, 323, 528, 720).

[0642] The locking portion (98a, 600) and the locking counterpart (102, 529) are configured to directly engage with each other in an assembled state to prevent the adjustment element (18, 318, 518) from moving relative to the housing (32, 332, 532).

[0643] 14. The dose delivery mechanism (54, 354, 554) of at least one of the preceding embodiments,

[0644] The dosage delivery mechanism (54, 354, 554) includes another locking mechanism (99, 599) which is configured to prevent the adjustment element (18, 318, 518) from being separated from the housing (32, 332, 532) in a pre-assembled state.

[0645] 15. The dosage delivery mechanism (54, 354, 554) of embodiment 14,

[0646] The other locking mechanism (99, 599) comprises another locking portion (98b, 600) of the adjustment element (18, 318, 518) and another locking corresponding portion (102, 530) of another corresponding component (23, 323, 528, 720).

[0647] The other locking portion (98b, 600) and the other locking counterpart (102, 530) are configured to directly engage with each other in a pre-assembled state to prevent the adjustment element (18, 318, 518) from moving relative to the housing (32, 332, 532).

[0648] 16. The dose delivery mechanism (54, 354, 554) of at least one of embodiments 12 and 13 and at least one of embodiments 14 and 15,

[0649] The locking mechanism (97, 597) and the other locking mechanism (99, 599) share a single locking portion (98a, 98b, 600) or a single locking corresponding portion (102, 529, 530).

[0650] 17. The dose delivery mechanism (54, 354, 554) according to at least one of the preceding embodiments,

[0651] The dosage delivery mechanism (54, 354, 554) is configured to convert the rotation of the adjustment element (18, 318, 518) into the axial movement of the piston rod (44) via a single threaded connection (189) in a pre-assembled state.

[0652] wherein the threaded connection (189) includes a first threaded element (44) threadably engaged with a second threaded element (38, 523),

[0653] Wherein, for example, the pitch of the single threaded connection (189) defines a ratio of an axial distance to a circumferential distance, and the piston rod (44) travels the axial distance relative to the housing (32, 332, 532) when the adjustment element (18, 318, 518) rotates the circumferential distance.

[0654] 18. The dose delivery mechanism (54, 354, 554) of embodiment 17,

[0655] wherein, in an assembled state, the first and second threaded elements (38, 44, 523) rotate relative to each other during one of dose setting and dose delivery,

[0656] Wherein, in the assembled state, the first and second threaded elements (38, 44, 523) do not rotate relative to each other during the other of dose setting and dose delivery.

[0657] 19. The dose delivery mechanism (54, 354, 554) of at least one of embodiments 17 and 18,

[0658] wherein during dose delivery in the assembled state, the first threaded element (44) is rotationally stationary relative to a third element (32, 332, 532) of the dose delivery mechanism (54, 354, 554), and the second threaded element (38, 523) is rotated relative to the third element (32, 332, 532),

[0659] During adjustment of the piston rod (44) in the pre-assembled state, the first threaded element (44) rotates relative to the third element (32, 332, 532) of the dose delivery mechanism (54, 354, 554), and the second threaded element (38, 523) is rotationally stationary relative to the third element (32, 332, 532).

[0660] 20. The dose delivery mechanism (54, 354, 554) of embodiment 19,

[0661] Among them, the third element (32, 332, 532) is a shell (32, 332, 532).

[0662] 21. The dose delivery mechanism (54, 354, 554) of at least one of embodiments 17 to 20,

[0663] Wherein, the first threaded element (44) is a piston rod (44).

[0664] 22. The dose delivery mechanism (54, 354, 554) of at least one of embodiments 17 to 21,

[0665] Therein, in a pre-assembled state, during axial movement of the piston rod (44), one of the first threaded element (44) and the second threaded element (38, 523) maintains its axial position relative to the housing (32, 332, 532).

[0666] 23. The dose delivery mechanism (54, 354, 554) of at least one of embodiments 17 to 22,

[0667] One of the first threaded element (44) and the second threaded element (38, 523) is configured not to rotate during rotation of the adjustment element (18, 318, 518) in a pre-assembled state.

[0668] 24. The dose delivery mechanism (54, 354) of at least one of embodiments 17 to 23,

[0669] In this case, a threaded connection (189) acts between the adjustment element (18, 318) and the piston rod (44).

[0670] 25. The dose delivery mechanism (54, 354) according to at least one of the preceding embodiments,

[0671] The dosage delivery mechanism (54, 354) includes a nut (38) which is threadedly connected to, for example, threadedly engaged with, the piston rod (44).

[0672] In the pre-assembled state, the rotation of the adjustment element (18, 318) causes the rotation of the nut (38) to move the piston rod (44) axially relative to the housing (32, 332).

[0673] 26. The dose delivery mechanism (54, 354) of embodiment 25,

[0674] Therein, the adjustment element (18, 318) is rotationally fixed to the nut (38) and is axially slidable relative to the nut (38).

[0675] 27. The dose delivery mechanism (54, 354) of at least one of embodiments 25 and 26,

[0676] Therein, in the assembled state, the nut (38) is rotated by the adjustment element (18, 318) during dose setting and performs an axial movement due to the threaded connection (189) with the piston rod (44).

[0677] 28. The dose delivery mechanism (54, 354) of at least one of embodiments 25 to 27,

[0678] Therein, in the assembled state, rotation of the nut (38) causes the nut (38) to translate axially in the distal direction along a thread (190) on the piston rod (44) during dose setting, and to translate in the proximal direction (1) during dose cancellation.

[0679] 29. The dose delivery mechanism (54, 354) of at least one of embodiments 25 to 28,

[0680] In the assembled state, the nut (38) does not rotate during dose delivery, but only moves axially along the proximal direction with the piston rod (44) for a distance, wherein the distance is proportional to the set dose.

[0681] 30. The dose delivery mechanism (54, 354, 554) according to at least one of the preceding embodiments,

[0682] Wherein, the dosage delivery mechanism (54, 354, 554) comprises another component (23, 323, 523),

[0683] wherein during adjustment of the piston rod (44) in the pre-assembled state, the adjustment element (18, 318, 518) is rotationally decoupled from the further component (23, 323, 523),

[0684] wherein during dose setting in the assembled state, the adjustment element (18, 318, 518) is rotationally coupled to the further component (23, 323, 523),

[0685] Therein, during dose delivery in the assembled state, the adjustment element (18, 318, 518) is rotationally decoupled from the further component (23, 323, 523).

[0686] 31. The dose delivery mechanism (54, 354, 554) of embodiment 30,

[0687] The other component (23, 323, 523) is threadedly connected to the housing (32, 332, 532).

[0688] 32. The dose delivery mechanism (54, 354, 554) of at least one of embodiments 30 and 31,

[0689] The other component (23, 323, 523) is a dose indicating component for indicating a set dose.

[0690] 33. The dose delivery mechanism (54, 354) of at least one of embodiments 30 to 32,

[0691] wherein during dose setting, the further member (23, 323) rotates relative to the piston rod (44), and / or

[0692] Therein, during adjustment of the position of the piston rod (44) in the pre-assembled state, the further component (23, 323) does not rotate relative to the piston rod (44).

[0693] 34. The dose delivery mechanism (54, 354, 554) of at least one of embodiments 30 to 33,

[0694] Therein, in the pre-assembled state, the further component (23, 323, 523) maintains its axial position relative to the housing (32, 332, 532) of the dose delivery mechanism (54, 354, 554) when the adjustment element (18, 318, 518) is rotated.

[0695] 35. The dose delivery mechanism (54, 354, 554) of at least one of the preceding embodiments,

[0696] wherein during adjustment of the piston rod (44) in the pre-assembled state, the adjustment element (18, 318, 518) is rotationally decoupled from the additional component (32, 332, 532) of the dose delivery mechanism (54, 354, 554),

[0697] wherein during dose setting in the assembled state, the adjustment element (18, 318, 518) is rotationally separated from the additional component (32, 332, 532),

[0698] Therein, during dose delivery in the assembled state, the adjustment element (18, 318, 518) is rotationally fixed to the additional component (32, 332, 532).

[0699] 36. The dose delivery mechanism (54, 354, 554) of embodiment 35,

[0700] The additional component (32, 332, 532) is a shell (32, 332, 532).

[0701] 37. The dose delivery mechanism (54, 354) according to at least one of the preceding embodiments,

[0702] The adjustment element (18, 318) is rotatable relative to the counter element (22) in a preassembled state and is rotationally fixed, for example irreversibly rotationally fixed, to the counter element (22) in an assembled state.

[0703] 38. The dosage delivery mechanism (54, 354) of embodiment 37,

[0704] wherein, in a pre-assembled state, the adjustment element (18, 318) is in a first axial position relative to a corresponding element (22) of the dose delivery mechanism (54, 354),

[0705] wherein the adjustment element (18, 318) is configured to move axially from a first axial position to a second axial position relative to the corresponding element (22) when the dose delivery mechanism (54, 354) is transformed from a pre-assembled state to an assembled state,

[0706] Therein, the adjustment element (18, 318) is axially fixed, for example irreversibly axially fixed, to the counter element (22) in the assembled state.

[0707] 39. The dosage delivery mechanism (54, 354) of embodiment 38,

[0708] The dosage delivery mechanism (54, 354) comprises a locking mechanism acting between the adjustment element (18, 318) and the corresponding element (22),

[0709] The locking mechanism is configured to prevent the adjustment element (18, 318) from moving from the second position to the first position in an assembled state.

[0710] 40. The dose delivery mechanism (54, 354) of at least one of embodiments 37 to 39,

[0711] wherein the corresponding element (22) is a dose setting element (22) of a dose delivery mechanism (54, 354),

[0712] Therein, the dose setting element (22) is configured to be grasped by a user of the dose delivery mechanism (54, 354) in an assembled state to set a dose to be delivered.

[0713] 41. The dose delivery mechanism (54, 354) of at least one of embodiments 37 to 40,

[0714] Therein, the adjustment element (18, 318) protrudes distally from the counterpart element (22) in the pre-assembled state.

[0715] 42. The dose delivery mechanism (54, 354) of at least one of embodiments 37 to 41,

[0716] Therein, the adjustment element (18, 318) does not protrude distally from the counterpart element (22) in the assembled state.

[0717] 43. The dose delivery mechanism (54, 354) as described in embodiments 37 to 42,

[0718] Wherein, the dose delivery mechanism (54, 354) comprises a rotary lock (89),

[0719] wherein the rotary lock (89) allows a rotational movement between the adjustment element (18, 318) and the corresponding element (22) in a pre-assembled state of the dose delivery mechanism (54, 354),

[0720] The adjustment element (18, 318) is rotationally fixed relative to the counter element (22) in the assembled state by a rotary lock (89).

[0721] Therein, the rotation lock (89) allows the adjustment element (18, 318) to be fixed to the corresponding element (22) in a plurality of relative rotational positions.

[0722] 44. The dosage delivery mechanism (54, 354) of embodiment 43,

[0723] The rotation lock (89) includes a toothed portion (93) defining a plurality of rotational positions and an engagement portion (90), wherein the engagement portion (90) is configured to engage with the toothed portion (93) when the dose delivery mechanism (54, 354) is transformed from a pre-assembled state to an assembled state to rotationally lock the adjustment element (18, 318) to the corresponding element (22).

[0724] 45. The dose delivery mechanism (54, 354) of at least one of embodiments 37 to 44,

[0725] Wherein, the dose delivery mechanism (54, 354) comprises an axial lock (81),

[0726] wherein the axial lock (81) allows an axial movement between the adjustment element (18) and the counter element (22) in a pre-assembled state of the dose delivery mechanism (54, 354),

[0727] Therein, the axial lock (81) prevents an axial displacement between the adjustment element (18, 318) and the counter element (22) in the assembled state.

[0728] 46. ​​The dose delivery mechanism (54, 354) of embodiment 45,

[0729] Therein, the axial lock (81) allows the adjustment element (18, 318) to be axially fixed to the corresponding element (22) in a plurality of relative rotational positions to each other.

[0730] 47. The dose delivery mechanism (54, 354) of at least one of embodiments 37 to 46,

[0731] Wherein, the dosage delivery mechanism (54, 354) includes a connector (20),

[0732] Therein, the adjustment element (18) is rotationally and / or axially fixed to the counter element (22) via the connector (20) in the assembled state.

[0733] 48. The dose delivery mechanism (54, 354) of embodiment 47,

[0734] Therein, the connector (20) is axially locked to the corresponding element (22) both in the pre-assembled state and in the assembled state.

[0735] 49. The dose delivery mechanism (54, 354) of at least one of embodiments 47 and 48,

[0736] Therein, the connector (20) is rotationally locked to the corresponding element (22) both in the pre-assembled state and in the assembled state.

[0737] 50. The dose delivery mechanism (54, 354) of at least one of embodiments 43 and 44 and at least one of embodiments 47 to 49,

[0738] The rotary lock (89) is located between the adjustment element (18, 318) and the connector (20).

[0739] 51. The dose delivery mechanism (54, 354) of embodiments 44 and 50,

[0740] wherein the connector (20) includes one of a toothed portion (93) and an engagement portion (90), and

[0741] Therein, the adjustment element (18, 318) includes the other of the toothed portion (93) and the engagement portion (90).

[0742] 52. The dose delivery mechanism (54, 354) of at least one of embodiments 45 and 46 and at least one of embodiments 47 to 51,

[0743] The axial lock (81) is located between the adjustment element (18) and the connector (20).

[0744] 53. The dose delivery mechanism (54, 354) of at least one of the preceding embodiments,

[0745] The adjustment element (18, 318) is configured to rotate relative to the piston rod (44) when the adjustment element (18, 318) is rotated relative to the housing (32) in a pre-assembled state.

[0746] 54. The dose delivery mechanism (54, 354) of at least one of the preceding embodiments,

[0747] In this case, the piston rod (44) is rotationally fixed relative to the housing (32, 332) in the preassembled state.

[0748] 55. The dose delivery mechanism (554) of at least one of embodiments 1 to 52,

[0749] In this case, the adjustment element (518) is rotationally fixed relative to the piston rod (44) in the preassembled state.

[0750] 56. The dose delivery mechanism (54, 354, 554) of at least one of the preceding embodiments,

[0751] Therein, during dose setting and / or during dose delivery, the piston rod (44) is rotationally fixed relative to the housing (32, 332, 532) in the assembled state.

[0752] 57. The dose delivery mechanism (54) according to at least one of the preceding embodiments,

[0753] The dosage delivery mechanism (54) comprises a clutch mechanism (107, 113) comprising a first clutch member (22) and a second clutch member (23, 26),

[0754] wherein, in an assembled state, the clutch mechanism (107, 113) is closed during one of dose setting and dose delivery, and is open during the other of dose setting and dose delivery,

[0755] Therein, the adjustment element (18) is rotationally decoupled from both the first clutch component (22) and the second clutch component (23, 26) in a pre-assembled state.

[0756] 58. The dosage delivery mechanism (54) of embodiment 57,

[0757] Therein, the adjustment element (18) is rotationally coupled, for example permanently rotationally coupled, to the first clutch component (22) and one of the second clutch components (23, 26) in an assembled state.

[0758] 59. The dose delivery mechanism (54, 354, 554, 754) of at least one of the preceding embodiments,

[0759] wherein, in a pre-assembled state, the adjustment element (18, 318, 518) is in a first axial position relative to a retaining member (28, 528) of a dose delivery mechanism (54, 354, 554, 754),

[0760] wherein the adjustment element (18, 318, 518) is configured to move axially from a first axial position to a second axial position relative to the retaining member (28, 528) when the dose delivery mechanism (54, 354, 554, 754) is transformed from a pre-assembled state to an assembled state,

[0761] The adjustment element (18, 318, 518) is rotatable relative to the retaining component (28, 528) in a pre-assembled state.

[0762] 60. The dose delivery mechanism (54, 354, 554, 754) of embodiment 59,

[0763] Therein, during dose setting in the assembled state, the adjustment element (18, 318, 518) is rotatable relative to the retaining member (28, 528).

[0764] 61. The dose delivery mechanism (54, 354, 554, 754) of at least one of embodiments 59 and 60,

[0765] Therein, the adjustment element (18, 318, 518) is rotationally fixed to the retaining member (28, 528) during dose delivery in the assembled state.

[0766] 62. The dose delivery mechanism (554, 754) of at least one of embodiments 59 to 61,

[0767] In this case, the adjustment element (518) is axially movable relative to the retaining component (528) in the assembled state.

[0768] 63. The dose delivery mechanism (554, 754) of at least one of the preceding embodiments,

[0769] wherein the dosage delivery mechanism (554, 754) comprises a clutch mechanism (507) having a first clutch member (520) and a second clutch member (524),

[0770] wherein a clutch mechanism (507) connects the adjustment element (518) to another component (523),

[0771] wherein the clutch mechanism (507) is disconnected in a pre-assembled state, thereby allowing the adjustment element (18, 318, 518) to rotate relative to the other component (523),

[0772] Therein, the clutch mechanism (507) is disengaged in the assembled state during dose delivery, thereby allowing the adjustment element (18, 318, 518) to rotate relative to the further component (523).

[0773] 64. The dose delivery mechanism (554, 754) of embodiment 63,

[0774] Therein, the clutch mechanism (507) is closed in the assembled state during dose setting.

[0775] 65. The dose delivery mechanism (554, 754) of at least one of embodiments 63 and 64,

[0776] Therein, the dosage delivery mechanism (554) is configured to maintain the clutch mechanism (507) in a disconnected state in a pre-assembled state.

[0777] 66. The dose delivery mechanism (554, 754) of at least one of embodiments 63 to 65,

[0778] Only when the dosage delivery mechanism (554, 754) is transformed from the pre-assembled state to the assembled state, the clutch mechanism (507) is allowed to close from the disconnected state in the pre-assembled state.

[0779] 67. The dose delivery mechanism (554, 754) of at least one of embodiments 63 to 66,

[0780] The clutch mechanism (507) includes a first clutch part (508) and a second clutch part (509).

[0781] wherein the first clutch part (508) and the second clutch part (509) engage with each other in a closed state of the clutch mechanism (507) and disengage from each other in a disconnected state of the clutch mechanism (507),

[0782] wherein, in a pre-assembled state of the dosage delivery mechanism (554), the first clutch part (508) is located on a first axial side of the second clutch part (509) in a disconnected state,

[0783] wherein, in the assembled state of the dosage delivery mechanism (54), the first clutch part (508) is located on the second axial side of the second clutch part (509) in the disconnected state,

[0784] The second axial side is opposite to the first axial side.

[0785] 68. The dose delivery mechanism (354, 554) of at least one of the preceding embodiments,

[0786] Wherein, when the dose delivery mechanism (354, 554) is in a pre-assembled state, the adjustment element (318, 518) is biased in a distal direction.

[0787] 69. The dose delivery mechanism (54, 354, 554) of at least one of the preceding embodiments,

[0788] wherein the adjustment element (18, 318, 518) is configured to occupy a dose setting position in an assembled state,

[0789] The adjustment element (18, 318, 518) is movable in the assembled state, for example, axially movable.

[0790] 70. The dose delivery mechanism (54, 354, 554) of embodiment 69,

[0791] Therein, the adjustment element (18, 318, 518) is biased to a dose setting position in an assembled state.

[0792] 71. The dose delivery mechanism (54, 354, 554) of at least one of embodiments 69 and 70,

[0793] Therein, the adjustment element (18, 318, 518) is configured to be moved proximally from a dose setting position to a dose delivery position in an assembled state.

[0794] 72. The dose delivery mechanism (54, 354, 554) of embodiment 71,

[0795] Wherein, the dosage delivery mechanism (54, 354, 554) comprises a clutch mechanism (107, 507) and an actuating element (18, 318, 520),

[0796] When the adjustment element (18, 318, 518) moves proximally from the dose setting position to the dose delivery position, the clutch mechanism (107, 507) changes from a closed state to an open state, so as to achieve proximal movement of the piston rod (44) when the actuating element (18, 318, 520) moves proximally.

[0797] 73. The dose delivery mechanism (554) of at least one of the preceding embodiments,

[0798] wherein the adjustment element (518) is configured as a dose setting element of a dose delivery mechanism (554),

[0799] Therein, the dose setting element is configured to be grasped by a user of the dose delivery mechanism (554) in an assembled state to set a dose to be delivered.

[0800] 74. The dose delivery mechanism (54, 354, 554) of at least one of the preceding embodiments,

[0801] Therein, the adjustment element (18, 318, 518) is configured to be rotated in an assembled state to set a dose of a drug to be delivered by a dose delivery mechanism (54, 354, 554).

[0802] 75. The dose delivery mechanism (54, 354, 554) of at least one of the preceding embodiments,

[0803] Wherein, the dosage delivery mechanism (54, 354, 554) comprises a locking mechanism (113, 513),

[0804] Therein, a locking mechanism (113, 513) rotationally locks the adjustment element (18, 318, 518) to the housing (32, 332, 532) during dose delivery in the assembled state.

[0805] 76. The dose delivery mechanism (54, 354, 554) of at least one of the preceding embodiments,

[0806] The dose delivery mechanism (54, 354, 554) comprises a dose limiting mechanism (115) which limits the dose that can be set by the user in the assembled state.

[0807] wherein the dose limiting mechanism (115) limits a rotational position of the adjustment element (18, 318, 518) relative to the housing (32, 332, 532), the rotational position corresponding to a dose that can be set by a user,

[0808] Therein, the dose limiting mechanism (115) is inactive during rotation of the adjustment element (18, 318, 518) in the pre-assembled state.

[0809] 77. The dose delivery mechanism (54, 354, 554) of embodiment 76,

[0810] The dose limiting mechanism (115) comprises at least one engagement feature (116) and at least one dose stop (118), which in an assembled state rotate relative to each other when the adjustment element (18, 318, 518) rotates and engage with each other when setting a dose in the assembled state.

[0811] 78. The dose delivery mechanism (54, 354) of embodiment 77,

[0812] Wherein, during rotation of the adjustment element (18, 318, 518) in a pre-assembled state, the engagement feature (116) and the at least one dose stop (118) do not rotate relative to each other.

[0813] 79. The dose delivery mechanism (554) of embodiment 77,

[0814] wherein during rotation of the adjustment element (18, 318, 518) in the pre-assembled state, the engagement feature (116) and the at least one dose stop (118) are rotated relative to each other,

[0815] wherein the engagement feature (116) and the at least one dose stop (118) do not engage with each other in a pre-assembled state,

[0816] Therein, for example, the engagement feature (116) and the at least one dose stop (118) are positioned axially offset from each other in a pre-assembled state.

[0817] 80. The dose delivery mechanism (54) according to at least one of the preceding embodiments,

[0818] wherein the housing (32) comprises a connector (43) for connecting the drug container (48) to the housing (32),

[0819] The connector (43) is configured to axially movably connect the drug container (48) to the housing (32), so that the drug container (48) is configured to perform an axial movement from a receiving position to an operating position after being connected to the housing (32).

[0820] 81. The dose delivery mechanism (54) of embodiment 80,

[0821] The connector (43) is configured to cause the plunger (210) to contact the bearing (46) located at the piston rod (44) when the drug container (48) is axially moved from the receiving position to the operating position.

[0822] Therein, for example, the connector (43) is configured to bring the plunger (210) into contact with the bearing (46) before the drug container (48) reaches the operating position.

[0823] 82. A drug delivery device (10, 300, 500, 700) having a dose delivery mechanism (54, 354, 554) according to one of the preceding embodiments, and

[0824] a medicament container (48, 348) attached to a dose delivery mechanism (54, 354, 554), the medicament container (48, 348) comprising a plunger (210),

[0825] The bearing (46) located at the piston rod (44) is located at a predetermined distance relative to the plunger (210).

[0826] 83. The drug delivery device (10, 300, 500, 700) of embodiment 82, wherein the predetermined distance is zero such that the bearing (46) contacts the plunger (210).

[0827] 84. The drug delivery device (10, 300, 500, 700) of embodiment 82, wherein the predetermined distance is greater than zero.

[0828] 85. The drug delivery device (10, 300, 500, 700) of at least embodiments 81 and 84,

[0829] Wherein the predetermined distance is less than an axial distance traveled by the drug container (48, 348) from the receiving position to the operating position.

[0830] 86. A method for adjusting the position of a piston rod (44) of a dose delivery mechanism (54, 354, 554) of a drug delivery device (10, 300, 500, 700),

[0831] The dose delivery mechanism (54, 354, 554) comprises:

[0832] Housing (32, 332, 532);

[0833] a piston rod (44); and

[0834] Adjustment element (18, 318, 518),

[0835] wherein the housing (32, 332, 532) is configured to be connected to a drug container (48, 348) sealed by a plunger (210),

[0836] The method comprises:

[0837] - providing a dose delivery mechanism (54, 354, 554) in a pre-assembled state;

[0838] - adjusting the axial position of the piston rod (44) relative to the housing (32, 332, 532) by rotating the adjustment element (18, 318, 518) in the pre-assembled state and thereby causing an axial movement of the piston rod (44) relative to the housing (32, 332, 532); and

[0839] - transforming the dose delivery mechanism (54, 354, 554) from a pre-assembled state into an assembled state,

[0840] In which, in the assembled state, the dose delivery mechanism (54, 354, 554) is configured to cause the piston rod (44) to move axially in the proximal direction (1) relative to the housing (32, 332, 532) during dose delivery, so that the piston rod (44) exerts an axial force in the proximal direction (1) on the plunger (210) of the drug container (48, 348) to discharge the drug from the drug container (48, 348).

[0841] 87. The method of embodiment 86,

[0842] Therein, a dose delivery mechanism (54, 354, 554) is provided in a pre-assembled state with an attached medicament container (48, 348).

[0843] 88. The method of embodiment 87,

[0844] When the axial position of the piston rod (44) is adjusted, the drug container (48, 348) does not move relative to the housing (32, 332, 532).

[0845] 89. The method of at least one of embodiments 86 to 88,

[0846] Therein, the axial position of the piston rod (44) is adjusted to place a bearing (46) located at the piston rod (44) in contact with a reference surface.

[0847] 90. The method of embodiment 89,

[0848] Therein, the reference surface is provided by the surface of the plunger (210) of the drug container (48, 348).

[0849] 91. The method of embodiment 89,

[0850] wherein the dose delivery mechanism (54, 354, 554) is arranged in a pre-assembled state without the drug container (48, 348) attached,

[0851] Wherein, the method further comprises:

[0852] - placing the dose delivery mechanism (54, 354, 554) in an assembly fixture;

[0853] The reference surface is provided by the surface of the assembly fixture.

[0854] 92. The method of at least one of embodiments 86 to 91,

[0855] Therein, during adjustment of the axial position the piston rod (44) is moved axially until a predetermined torque is required for rotation of the adjustment element (18, 318, 518).

[0856] 93. The method of at least one of embodiments 86 to 92,

[0857] Wherein, the method further comprises:

[0858] - measuring the position of the piston rod (44) by means of a measuring device in order to determine the adjusted position of the piston rod (44),

[0859] Wherein, for example, the measuring device is one of an optical measuring device and a mechanical measuring device, such as an assembly fixture having a reference surface.

[0860] Reference numerals:

[0861] 1 Proximal direction

[0862] 10 Injection Pen

[0863] 12 Remote

[0864] 14 Proximal

[0865] 16 Knob cover

[0866] 16a Closed perimeter

[0867] 16b Closed surface

[0868] 18 Injection button / adjustment element

[0869] 18a Cylindrical part

[0870] 19 Outer edge

[0871] 20 Clamp / Connector

[0872] 22Dose setting knob / dose setting element

[0873] 23. Quantitative supply component

[0874] 24 snap-on components

[0875] 26 Connectors

[0876] 28 sleeves / dose selector

[0877] 30 Knob key

[0878] 32 Shell

[0879] 32a Surface

[0880] 34 Dose setting sleeve / dosing element

[0881] 36 Driver

[0882] 38 Nut

[0883] 40 Spring

[0884] 42 Piston rod guide

[0885] 43 Connectors

[0886] 44 Piston rod

[0887] 45 Distal segment

[0888] 46 piston disc / bearing

[0889] 48 barrels

[0890] 50 cartridge container / drug container

[0891] 52 Barrel Key / Barrel Retainer

[0892] 54 Dose delivery mechanism

[0893] 56 Pharmaceutical Reconstitution Unit

[0894] 58 Wing

[0895] 60 Lugs

[0896] 62 Window

[0897] 64 bulge

[0898] 66 Adjacent part

[0899] 66a Front surface

[0900] 68 incision

[0901] 69 Chamfered part

[0902] 70 Axial abutment protrusion

[0903] 72 Gap

[0904] 74 Linear recess

[0905] 76 Anti-roll device

[0906] 78 Anti-roll device

[0907] 80 front surface

[0908] 81 Axial lock

[0909] 82 Axial fixing device

[0910] 84 Ribs

[0911] 86 Axial fixing device

[0912] 88 Undercut

[0913] 89 Rotation Lock

[0914] 90 Rotation Fixture

[0915] 92 Rotating fixture

[0916] 93 Toothed part

[0917] 94 Rotating Fixture

[0918] 96 Rotating Fixture

[0919] 97 Locking mechanism

[0920] 98 Assembly device

[0921] 98a Locking part

[0922] 98b Another locking part

[0923] 100 Coupling device

[0924] 100a Chamfered surface

[0925] 101 Incision

[0926] 102 Coupling device / locking corresponding part

[0927] 104 Ribs

[0928] 106 slots

[0929] 107 Clutch mechanism

[0930] 108 teeth

[0931] 110 teeth

[0932] 112 Coupling surface

[0933] 114 teeth

[0934] 115 Dose Limitation Agency

[0935] 116 Engagement feature

[0936] 118 Dose stop

[0937] 118a Dose stop

[0938] 118b Dose stop

[0939] 118c Dose stop

[0940] 118d Dose stop

[0941] 120 elastically deformable section

[0942] 121 Incision

[0943] 122a-d side surface

[0944] 123a-d side surface

[0945] 124 Hard stop

[0946] 126 Hard stop

[0947] 128 Hard stop

[0948] 130 Opening

[0949] 132 Notch

[0950] 134 Ribs

[0951] 136 Protrusion

[0952] 136a Chamfered surface

[0953] 138 Ribs

[0954] 140 slots

[0955] 142 Axial fixing device

[0956] 144 Entrance

[0957] 146 Axial fixing device

[0958] 148 Rotating Fixture

[0959] 150 Rotating fixture

[0960] 152 Rotating fixture

[0961] 154 Rotating Fixture

[0962] 156 Ribs

[0963] 158a Incision

[0964] 158b Incision

[0965] 158c incision

[0966] 158d incision

[0967] 160 Nearside edge

[0968] 162 Distal edge

[0969] 164 Keep Protruding

[0970] 166 Window

[0971] 168a Tags

[0972] 168b Tags

[0973] 168c Tags

[0974] 168d Tags

[0975] 168e Tags

[0976] 169a Non-circular outer surface

[0977] 169b Non-circular inner surface

[0978] 170 External thread

[0979] 171 Fixed section

[0980] 172 Internal thread

[0981] 173 Surface

[0982] 174 End Stops

[0983] 176 End Stop

[0984] 177 Attachment

[0985] 178 Axial fixing device

[0986] 179 Attachment

[0987] 180 Axial fixing device

[0988] 182 Rotating Fixture

[0989] 184 Rotating Fixture

[0990] 186 Opening

[0991] 188 Section

[0992] 189 Threaded connection

[0993] 190 External thread

[0994] 192 Internal thread

[0995] 194 Pressing surface

[0996] 196 front surface

[0997] 198 Coupling device

[0998] 200 Coupling device

[0999] 202 First Chamber

[1000] 204 Second Chamber

[1001] 206 Bypass

[1002] 208 first sealing element

[1003] 210 Second sealing element / plunger

[1004] 212 Axial fixing device

[1005] 214 Axial fixing device

[1006] 216 Rotating Fixture

[1007] 218 Rotating Fixture

[1008] 220 Window

[1009] 221 Incision

[1010] 222 Window

[1011] 223 Notch

[1012] 224 Thread

[1013] 226 End surface

[1014] 228 Surface

[1015] 230 First thread

[1016] 232 Second thread

[1017] 234 snap-on components

[1018] 236 Opening

[1019] 238 Opening

[1020] 240 Opening

[1021] 242 Displacement Section

[1022] 244 Radial end stop

[1023] 246 External surface

[1024] 248 Interior Space

[1025] 249 Keeping section

[1026] 250 Bias element

[1027] 252 Opening

[1028] 254 Inner surface

[1029] 256 External surface

[1030] 258 Ring Space

[1031] 260 inner peripheral surface

[1032] 262 Peripheral surface

[1033] 264 Peripheral surface

[1034] 266 End face

[1035] 268 End face

[1036] 300 Drug Delivery Devices

[1037] 301 Cap

[1038] 305 Container Holder

[1039] 306-pin connector

[1040] 307 Connector

[1041] 318 Adjustment element

[1042] 323 quantitative supply component

[1043] 332 Shell

[1044] 333 Upper shell part

[1045] 334 quantitative supply element

[1046] 335 threaded connection

[1047] 336 Driver

[1048] 337 Another thread connection

[1049] 342 Piston rod guide

[1050] 343 Connector

[1051] 348 Drug Container

[1052] 349 Needle End

[1053] 354 Dose delivery mechanism

[1054] 500 Drug Delivery Devices

[1055] 501 Needle Assembly

[1056] 502 Casing

[1057] 503 Needle Cap

[1058] 504 Cap

[1059] 505 Container Holder

[1060] 506 Connector

[1061] 507 Clutch

[1062] 508 First Clutch Section

[1063] 509 Second clutch part

[1064] 513 Clutch Mechanism

[1065] 514 teeth

[1066] 515 teeth

[1067] 518 Adjustment element

[1068] 520 Coupling element

[1069] 523 quantitative supply component

[1070] 524 coupling member

[1071] 525 Extension

[1072] 527 Connector

[1073] 528 Sleeve

[1074] 528a External part

[1075] 529 Locking corresponding part

[1076] 530 Another locking corresponding part

[1077] 532 Housing

[1078] 533 Retaining lug

[1079] 534 Shell Window

[1080] 535 Opening

[1081] 543 Connector

[1082] 554 Dose delivery mechanism

[1083] 560 Rotatable Fixing

[1084] 561 Circular Edge

[1085] 562 Thread

[1086] 563 Rotating Fixing

[1087] 564 longitudinal ridge

[1088] 566 Lug

[1089] 567 Opening

[1090] 568 Radial stop

[1091] 569 Stop surface

[1092] 570 Rotatable Fixing

[1093] 571 Circular Edge

[1094] 573 Opening

[1095] 575 Ridge

[1096] 580 End Plate

[1097] 582 bars

[1098] 584 Axial fixing

[1099] 585 Rotating Fixing

[1100] 586 recess

[1101] 587 Paw

[1102] 590 recess ...

Claims

1. A dose delivery mechanism (54, 354, 554, 754) for a drug delivery device (10, 300, 500, 700), comprising: Housing (32, 332, 532); Piston rod (44); as well as Adjustment element (18, 318, 518), wherein the housing (32, 332, 532) is configured to be connected to a drug container (48, 348) sealed by a plunger (210), The dosage delivery mechanism (54, 354, 554, 754) has a pre-assembled state and an assembled state. wherein, in the assembled state, the dose delivery mechanism (54, 354, 554, 754) is configured to cause the piston rod (44) to move axially in a proximal direction (1) relative to the housing (32, 332, 532) during dose delivery, so that the piston rod (44) exerts an axial force in the proximal direction (1) on the plunger (210) of the drug container (48, 348) to discharge the drug from the drug container (48, 348), and wherein, in the pre-assembled state, the adjustment element (18, 318, 518) is configured to rotate relative to the housing (32, 332, 532), the rotation causing an axial movement of the piston rod (44) for adjusting the axial position of the piston rod (44) relative to the housing (32, 332, 532) before the dose delivery mechanism (54, 354, 554, 754) is transformed from the pre-assembled state to the assembled state, wherein the outer edge (19) of the adjustment element (18, 318, 518) is accessible to an assembler of the device in the pre-assembled state to achieve the rotation of the adjustment element (18, 318, 518) and the axial movement of the piston rod (44), wherein the adjustment element (18, 318, 518) is configured to perform the rotation at least when in a pre-assembled position relative to the housing (32, 332, 532), The pre-assembly position is the most distal position of the adjustment element (18, 318, 518) relative to the housing (32, 332, 532) in the pre-assembly state. wherein the dose delivery mechanism (54, 354, 554, 754) is configured to convert the rotation of the adjustment element (18, 318, 518) into the axial movement of the piston rod (44) in the pre-assembled state via a single threaded connection (189), The threaded connection (189) includes a first threaded element (44) threadably engaged with a second threaded element (38, 523).

2. The dosage delivery mechanism (354, 554, 754) according to claim 1, in, The dose delivery mechanism (354, 554, 754) includes a biasing element (250) which biases the adjustment element (318, 518) to the pre-assembled position relative to the housing (332, 532) in the pre-assembled state.

3. The dose delivery mechanism (54, 354, 554, 754) according to at least one of the preceding claims, in, In the assembled state, the first and second threaded elements (38, 44, 523) rotate relative to each other during one of dose setting and dose delivery, wherein, in the assembled state, the first and second threaded elements (38, 44, 523) do not rotate relative to each other during the other of dose setting and dose delivery.

4. The dosage delivery mechanism (554, 754) according to claim 3, in, During dose delivery in the assembled state, the first threaded element (44) is rotationally stationary relative to a third element (532) of the dose delivery mechanism (554, 754), and the second threaded element (523) is rotated relative to the third element (532), wherein, during adjustment of the piston rod (44) in the pre-assembled state, the first threaded element (44) rotates relative to the third element (532) of the dose delivery mechanism (554, 754), and the second threaded element (523) is rotationally stationary relative to the third element (532).

5. The dosage delivery mechanism (54, 354) according to claim 3, in, During dose setting in the assembled state, the first threaded element (44) is axially stationary relative to a third element (32, 332) of the dose delivery mechanism (54, 354), and the second threaded element (38) is axially movable relative to the third element (32, 332), wherein, during adjustment of the piston rod (44) in the pre-assembled state, the first threaded element (44) moves axially relative to the third element (32, 332) of the dose delivery mechanism (54, 354), and the second threaded element (38) remains axially stationary relative to the third element (32, 332).

6. The dosage delivery mechanism (54, 354) according to at least one of the preceding claims, in, The threaded connection (189) acts between the adjustment element (18, 318) and the piston rod (44).

7. The dose delivery mechanism (54, 354, 554, 754) according to at least one of the preceding claims, in, The dose delivery mechanism (54, 354, 554, 754) comprises another component (23, 323, 523), wherein, during adjustment of the piston rod (44) in the pre-assembled state, the adjustment element (18, 318, 518) is rotationally decoupled from the further component (23, 323, 523), wherein during dose setting in the assembled state, the adjustment element (18, 318, 518) is rotationally coupled to the further component (23, 323, 523), Therein, during dose delivery in the assembled state, the adjustment element (18, 318, 518) is rotationally decoupled from the further component (23, 323, 523).

8. The dosage delivery mechanism (54, 354, 554, 754) according to claim 7, in, The dosage delivery mechanism (54, 354, 554, 754) comprises a clutch mechanism (107, 507), The clutch mechanism (107, 507) comprises a first clutch member (22, 520) and a second clutch member (24, 524), wherein during dose setting in the assembled state, the first clutch member (22, 250) and the second clutch member (24, 524) engage with each other to rotationally couple the adjustment element (18, 318, 518) to the further member (23, 323, 523) in a closed state of the clutch mechanism (107, 507), wherein, during dose delivery in the assembled state, the first clutch member (22, 250) and the second clutch member (24, 524) are disengaged from each other to rotationally separate the adjustment element (18, 318, 518) from the further member (23, 323, 523) in the disconnected state of the clutch mechanism (107, 507).

9. The dosage delivery mechanism (54, 354) according to claim 8, in, The adjustment element (18) is rotationally decoupled from both the first clutch member (22) and the second clutch member (24) in the pre-assembled state.

10. The dosage delivery mechanism (554, 754) according to claim 8, in, The adjustment element (518) is rotationally fixed relative to one of the first clutch member (520) and the second clutch member (524) in the pre-assembled state, Wherein, during adjustment of the position of the piston rod (44) in the pre-assembled state, the clutch mechanism (107, 507) is in a disconnected state, and the first clutch member (520) and the second clutch member (524) are disengaged from each other, thereby allowing the adjustment element (18, 318, 518) to rotate relative to the other member (23, 323, 523).

11. The dosage delivery mechanism (554) according to claim 10, in, The clutch mechanism (507) comprises a first clutch part and a second clutch part, namely a first clutch part (508) and a second clutch part (509), wherein the first clutch part (508) and the second clutch part (509) engage with each other in a closed state of the clutch mechanism (507) and disengage from each other in an open state of the clutch mechanism (507), wherein, in the pre-assembled state of the dose delivery mechanism (554), the first clutch part (508) is located at a first axial side of the second clutch part (509) in the disconnected state of the clutch (507), wherein, in the assembled state of the dosage delivery mechanism (54), the first clutch part (508) is located at a second axial side of the second clutch part (509) in the disconnected state, The second axial side is opposite to the first axial side.

12. The dosage delivery mechanism (54, 354) according to at least one of the preceding claims, in, The adjustment element (18, 318) is rotatable relative to the counter element (22) in the pre-assembled state and is rotationally fixed, for example irreversibly rotationally fixed, to the counter element (22) in the assembled state.

13. The dosage delivery mechanism (54, 354) according to claim 12, in, The corresponding element (22) is a dose setting element (22) of the dose delivery mechanism (54, 354), The dose setting element (22) is configured to be grasped by a user of the dose delivery mechanism (54, 354) in the assembled state to set a dose to be delivered.

14. The dosage delivery mechanism (54, 354) according to at least one of claims 12 and 13, in, The adjustment element (18, 318) protrudes distally from the counterpart element (22) in the pre-assembled state.

15. The dosage delivery mechanism (54, 354) according to at least one of the preceding claims, in, The adjustment element (18, 318) is configured to rotate relative to the piston rod (44) when the adjustment element (18, 318) is rotated relative to the housing (32, 332) in the pre-assembled state.

16. The dose delivery mechanism (554, 754) according to at least one of claims 1 to 14, in, The adjusting element (518) is rotationally fixed relative to the piston rod (44) in the preassembled state.

17. Dose delivery mechanism (54, 354, 554, 754) according to at least one of the preceding claims, in, The adjustment element (18, 318, 518) is configured to be rotated in the assembled state to set a dose of drug to be delivered by the dose delivery mechanism (54, 354, 554, 754).

18. The dosage delivery mechanism (54, 354, 554, 754) according to claim 17, in, The dose delivery mechanism (54, 354, 554, 754) comprises a dose limiting mechanism (115) which limits a dose that can be set by a user in the assembled state, wherein the dose limiting mechanism (115) limits a rotational position of the adjustment element (18, 318, 518) relative to the housing (32, 332, 532), the rotational position corresponding to a dose that can be set by the user, Therein, the dose limiting mechanism (115) is inactive during rotation of the adjustment element (18, 318, 518) in the pre-assembled state.

19. A drug delivery device (10, 300, 500, 700) having a dose delivery mechanism (54, 354, 554, 754) according to any of the preceding claims, and a medicament container (48, 348) attached to the dose delivery mechanism (54, 354, 554, 754), the medicament container (48, 348) comprising a plunger (210), in, A bearing (46) located at the piston rod (44) is located at a predetermined distance relative to the plunger (210).

20. A method for adjusting the position of a piston rod (44) of a dose delivery mechanism (54, 354, 554, 754) of a drug delivery device (10, 300, 500, 700), The dosage delivery mechanism (54, 354, 554, 754) comprises: Housing (32, 332, 532); Piston rod (44); as well as Adjustment element (18, 318, 518), wherein the housing (32, 332, 532) is configured to be connected to a drug container (48, 348) sealed by a plunger (210), The method comprises: - providing a dose delivery mechanism (54, 354, 554, 754) in a pre-assembled state; wherein the outer edge (19) of the adjustment element (18, 318, 518) is accessible to an assembler of the device in the pre-assembled state so as to realize the rotation of the adjustment element (18, 318, 518) and the axial movement of the piston rod (44); - in the pre-assembled state, adjusting the axial position of the piston rod (44) relative to the housing (32, 332, 532) by rotating the adjustment element (18, 318, 518) in the pre-assembled state and thereby causing an axial movement of the piston rod (44) relative to the housing (32, 332, 532), wherein the rotation of the adjustment element (18, 318, 518) is converted into the axial movement of the piston rod (44) via a single threaded connection (189) of the dose delivery mechanism (54, 354, 554); and - transforming the dose delivery mechanism (54, 354, 554, 754) from the pre-assembled state into the assembled state, Wherein, in the assembled state, the dose delivery mechanism (54, 354, 554, 754) is configured to cause the piston rod (44) to move axially in a proximal direction (1) relative to the housing (32, 332, 532) during dose delivery, so that the piston rod (44) applies an axial force in the proximal direction (1) on the plunger (210) of the drug container (48, 348) to discharge the drug from the drug container (48, 348).

Images