Apparatus for drug delivery device and drug delivery device

Abstract

The present invention relates to an apparatus for a drug delivery device (1000), comprising: a housing element (4), a plunger rod (1) arranged axially movably relative to the housing element (4), a transmission member (2) arranged rotatably relative to the housing element (4), and an energy member (3) configured to provide energy for inducing a torque on the transmission member (2), where the transmission member (2) and the plunger rod (1) are operatively coupled such that a rotation of the transmission member (2) is translated into an axial movement of the plunger rod (1), the apparatus comprising a release state, in which: the energy member (3) induces a torque on the transmission member (2), the transmission member (2) rotates in a first rotational direction by the induced torque, thereby moving the plunger rod (1) axially in a distal direction (D), and the plunger rod (1) is fixed non-rotatably relative to the housing element (4). Furthermore, the present invention relates to a drug delivery device having such an apparatus.

Description

[Technical Field]

[0001] Apparatus for a drug delivery device is provided.Furthermore, a drug delivery device is provided. [Background technology]

[0002] Administering an injection is a process that poses multiple risks and challenges, both mental and physical, for users and healthcare professionals. Drug delivery devices can aim to make self-injection easier for patients. Traditional drug delivery devices can provide the force for administering the injection via a spring and can use a trigger button or another mechanism to activate the injection. Drug delivery devices can be single-use or reusable devices. Summary of the Invention [Problem to be solved by the invention]

[0003] There is a continuing need for improved drug delivery devices and apparatus for drug delivery devices. [Means for solving the problem]

[0004] One object to be achieved is to provide an arrangement for an improved drug delivery device. A further object to be achieved is to provide an improved drug delivery device. These objects are achieved inter alia by the subject matter of claims 1 and 15. Advantageous embodiments and further developments are subject to the dependent claims and are presented in the following description and figures.

[0005] First, an apparatus for the drug delivery device is specified. The apparatus can be a unit of the drug delivery device, for example a subassembly of the drug delivery device.

[0006] According to at least one embodiment, the device includes a housing element. The housing element can be hollow and / or elongated. The housing element can be a sleeve, for example, a cylindrical sleeve. In particular, the housing element can be a holder for an energy member, such as a drive spring, i.e., an element that can accommodate the energy member. The energy member can be secured to the housing element, for example, by securing one end of the drive spring to the housing element.

[0007] According to at least one embodiment, the device includes a plunger rod movably arranged in an axial direction relative to the housing element, i.e., in only one axial direction or in both axial directions. The plunger rod may be hollow or solid. The plunger rod may be cylindrical, for example, hollow cylindrical. If the plunger rod is hollow, it may receive an additional element or member, other than, for example, an energy member, for driving the plunger rod.

[0008] According to at least one embodiment, the device includes a transmission member. The transmission member can be rotatably disposed relative to the housing element. The transmission member can be hollow and / or elongated. The transmission member can be a sleeve. For example, the transmission member can be a rotation collar. The transmission member can be configured to be rotated in one or both rotational directions. The rotation axis of the transmission member can define a longitudinal axis of the device or drug delivery device or can be coincident with the longitudinal axis of the device or drug delivery device.

[0009] The housing element and / or plunger rod and / or transmission member can include or consist of plastic. Each of these can be integrally formed, i.e., of unitary construction, or can be integrally formed. Each of these can have a main direction of extension parallel to a longitudinal axis. The longitudinal axis can extend through, for example, through the center of, one or more or all of the aforementioned elements / members.

[0010] According to at least one embodiment, the device includes an energy member configured to provide energy for inducing a torque on the transmission member, preferably for driving the transmission member. In other words, the energy member can be configured to provide energy for rotating the transmission member relative to the housing element. The energy member can be a drive spring, such as a torsion drive spring, particularly a spiral torsion spring, a clock spring, or a power spring, or another component configured to induce torque, such as a gas cartridge or an electric motor. The drive spring can be formed from a metal, such as steel. The longitudinal axis can extend through the center of the drive spring.

[0011] The plunger rod can be received in the transmission member such that the transmission member circumferentially surrounds, e.g., completely circumferentially, at least a portion of the plunger rod. The transmission member can be received in the housing element and / or the energy member such that at least a portion of the transmission member is circumferentially surrounded, e.g., completely circumferentially, by the housing element and / or the energy member. The energy member can be received in the housing element such that at least a portion of the energy member is circumferentially surrounded, e.g., completely circumferentially, by the housing element.

[0012] According to at least one embodiment, the transmission member and plunger rod are operatively coupled such that rotation of the transmission member is or can be converted into axial movement of the plunger rod. The plunger rod and transmission member can be coupled by a gear, e.g., a screw interface, that converts rotational movement of the transmission member into axial movement of the plunger rod.

[0013] In this specification, unless otherwise stated, movement of a member or element or feature is to be understood as movement relative to a housing element.

[0014] According to at least one embodiment, the device includes a released state, in which the energy member induces a torque on the transmission member.

[0015] According to at least one embodiment, in the released state, the transmission member rotates in a first rotational direction due to the induced torque, thereby moving the plunger rod axially distally. The first rotational direction may be clockwise or counterclockwise when viewed in a plan view of the distal end of the device. In the released state, the transmission member can rotate by an angle greater than or equal to any one of the following values: 60°, 80°, 120°, 180°, 270°, or 360°. Preferably, in the released state, the transmission member rotates at least 360° or more. For example, the transmission member can rotate several times around its rotation axis. In the released state, the plunger rod can be driven by the transmission member to move distally at least 1 cm.

[0016] According to at least one embodiment, the plunger rod is non-rotatably fixed relative to the housing element, meaning that the plunger rod does not rotate or is prevented from rotating axially, e.g., distally, during movement.

[0017] In at least one embodiment, an apparatus for a drug delivery device includes a housing element, a plunger rod axially movable relative to the housing element, a transmission member rotatably disposed relative to the housing element, and an energy member configured to provide energy to induce torque on the transmission member. The transmission member and plunger rod are operably coupled such that rotation of the transmission member is converted into axial movement of the plunger rod. The apparatus includes a release state, in which the energy member induces torque on the transmission member, causing the transmission member to rotate in a first rotational direction due to the induced torque, thereby moving the plunger rod axially distally. The plunger rod is non-rotatably fixed relative to the housing element.

[0018] By non-rotatably fixing the plunger rod to the housing element, i.e., by preventing it from rotating distally during movement, the friction induced by the plunger rod when it strikes the stopper of the drug container / syringe is reduced, resulting in less heat being generated. In this way, it is possible to avoid providing a separate bearing element at the distal end of the plunger rod.

[0019] The drug delivery device and / or apparatus for the drug delivery device specified herein can be elongated and / or include a longitudinal axis, i.e., a main axis of elongation. In this specification, the direction parallel to the longitudinal axis is referred to as the axial direction. By way of example, the drug delivery device and / or apparatus can be cylindrical.

[0020] Furthermore, the drug delivery device and / or apparatus may include a longitudinal end, which may be oriented toward or pressed against a skin area of ​​the human body. This end is referred to herein as the distal end. A drug or agent may be delivered via the distal end. The opposite longitudinal end is referred to herein as the proximal end. The proximal end is positioned away from the skin area during use. The axial direction from the proximal end to the distal end is referred to herein as the distal direction. The axial direction from the distal end to the proximal end is referred to herein as the proximal direction. The distal end of a member or element of a drug delivery device and / or apparatus is herein understood to be the most distal end of the member / element. Accordingly, the proximal end of a member or element is herein understood to be the most proximal end of the element / member.

[0021] In other words, "distal" is used herein to designate a direction, end, or surface that is or will be positioned to point or face toward the dosing end of a drug delivery device or a component thereof, and / or points away from the proximal end, will be positioned to point away from the proximal end, or faces away from the proximal end. On the other hand, "proximal" is used herein to designate a direction, end, or surface that is or will be positioned to point or face away from the dosing end and / or distal end of a drug delivery device or a component thereof. The distal end can be the end closest to the dosing end and / or farthest from the proximal end, and the proximal end can be the end farthest from the dosing end. The proximal face can face away from the distal end and / or face toward the proximal end. The distal face can face toward the distal end and / or face away from the proximal end. The dispensing end may be, for example, the end of a needle to which the needle unit is or will be attached to the device.

[0022] As used herein, directions perpendicular to and / or intersecting the longitudinal axis are referred to as radial directions. Radially inward is a radial direction that points toward the longitudinal axis. Radially outward is a radial direction that points away from the longitudinal axis.

[0023] As used herein, the terms "angular," "azimuthal," or "rotational" are used synonymously. Such directions are perpendicular to the longitudinal axis and perpendicular to the radial direction.

[0024] An element or member or feature being non-rotatably, axially or radially fixed relative to another element or member or feature means that relative movement in the rotational, axial or radial direction between the two elements / members / features is not possible or is prevented.

[0025] In this specification, the terms "protrusion" and "boss" are used synonymously. The term "recess" can particularly refer to a depression or cutout or opening or hole.

[0026] According to at least one embodiment, the device includes at least one locked state, e.g., first and second locked states. The locked state can be a state of the device prior to the released state. In the locked state, the energy member can already induce a torque on the transmission member. For example, the drive spring can already be biased. However, in the locked state, rotation of the transmission member is prevented, for example, by a locking mechanism.

[0027] According to at least one embodiment, the plunger rod is non-rotatably fixed to the housing element via a spline interface. The spline interface can be formed directly between the plunger rod and the housing element. For example, the plunger rod can have spline elements, and the housing element can have spline elements that are complementary to and / or mate with the spline elements of the plunger rod. The spline elements of the plunger rod and the housing element can engage with each other, for example, with a form lock, thereby preventing rotation of the plunger rod relative to the housing element.

[0028] One of the spline elements of the housing element and the plunger rod can be a groove, and the other of the spline elements of the housing element and the plunger rod can be a protrusion. The protrusion can then engage or protrude into the groove, thereby preventing rotation of the plunger rod. The groove can extend parallel to the longitudinal axis. For example, the groove can be formed in the plunger rod, and the protrusion can be part of the housing element, for example, formed integrally with the housing element.

[0029] The housing element can include several spline elements, each of which engages with an assigned spline element of the plunger rod. For example, the plunger rod can include several grooves, such as at least two grooves, arranged rotationally symmetrically about the longitudinal axis. Correspondingly, the housing element can include several protrusions arranged rotationally symmetrically about the longitudinal axis.

[0030] According to at least one embodiment, in the released state, the transmission member rotates at least n times 360°, where n is an integer greater than or equal to 1. For example, n is one of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10.

[0031] According to at least one embodiment, the plunger rod and the transmission member are operably coupled via a threaded interface. The threaded interface can be formed directly between the plunger rod and the transmission member. The threaded interface can convert rotational movement of the transmission member into axial movement of the plunger rod. The plunger rod can include a thread that engages with a thread on the transmission member. The thread on the plunger rod can be an external thread and the thread on the transmission member can be an internal thread, or vice versa. The transmission member can be axially fixed to the housing element, for example, via an energy member. For example, one end of the drive spring that is not fixed to the housing element is fixed to the transmission member. For example, the transmission member can be fixed to the housing such that the force required to move the transmission member in one or both axial directions, particularly in the proximal direction, is greater than the force required to move the plunger rod axially.

[0032] Preferably, the spline interface is close to the threaded interface, for example by a distance of at most 1 cm, or at most 0.5 cm, or at most 0.2 cm, which is beneficial because torque on the plunger rod is resolved over a short distance, thereby reducing stress in the plunger rod.

[0033] According to at least one embodiment, the device has a first locked state in which a releasable first locking mechanism, also referred to as a first rotational locking mechanism, prevents or inhibits rotational movement of the transmission member. In the first locked state, the first locking mechanism can establish a rotational locking interface through which the transmission member and the housing element are coupled, thereby preventing rotational movement of the transmission member.

[0034] During intended use, the first locked state can be a state preceding the released state. The device can be switched from the first locked state to the released state by releasing the first locking mechanism. This can be done by a user, such as a patient using the device for self-administration of medication. In the first locked state, the energy member can already induce a force / torque on the transmission member. For example, the drive spring is already biased in the first locked state.

[0035] According to at least one embodiment, the first locking mechanism includes a first rotational locking element that is non-rotatable and / or axially fixed relative to the transmission member and a second rotational locking element that is non-rotatable and / or axially fixed relative to the housing element. The two rotational locking elements of the first locking mechanism can be configured to engage with each other. For example, in the first locked state, the two rotational locking elements of the first locking mechanism are engaged with each other. The first rotational locking element can be part of the transmission member. The second rotational locking element can be part of the housing element.

[0036] According to at least one embodiment, engagement of the rotational locking element of the first locking mechanism prevents rotational movement of the transmission member, particularly in a first rotational direction or both rotational directions.

[0037] According to at least one embodiment, at least one of the rotational locking elements of the first locking mechanism, e.g., the second rotational locking element, is displaceable. For example, the displaceable rotational locking element is displaceable in a second direction rather than the first rotational direction. The second direction can be perpendicular to the first rotational direction, e.g., radially, particularly radially outward. The other rotational locking element of the first locking mechanism can be fixed radially. In a first position of the displaceable rotational locking element, the rotational locking element of the first locking mechanism is engaged. In a second position of the displaceable rotational locking element, the two rotational locking elements of the first locking mechanism can be disengaged, e.g., to release the first locking mechanism and enable rotation of the transmission member. The second position can be downstream from the first position along the second direction.

[0038] According to at least one embodiment, the first locking mechanism is configured such that when the displaceable rotary locking element is in the first position, torque or energy induced by the energy member biases the displaceable rotary locking element in the second direction. In particular, when the displaceable rotary locking element is not held in the first position, i.e., not engaged with the other rotary locking element of the first locking mechanism, torque or energy transmitted from the energy member can automatically disengage the two rotary locking elements of the first locking mechanism. In other words, the rotary locking elements of the first locking mechanism can be configured such that torque or energy induced in the transmission member by the energy member is at least partially converted into a force biasing the displaceable rotary locking element in the second direction.

[0039] The first position can be the relaxed state of the displaceable rotary locking element, i.e., the position that the displaceable rotary locking element occupies when no external force is acting. Alternatively, in the second position, the displaceable rotary locking element can be in its relaxed state, and the first position can be a position in which the displaceable rotary locking element is biased toward the second position. A third position of the displaceable rotary locking element can also be located between the first and second positions along the second direction, with the displaceable rotary locking element in its relaxed state. In this case, the first and second positions can bias the displaceable rotary locking element in the second direction or against the second direction.

[0040] According to at least one embodiment, at least one of the rotary locking elements of the first locking mechanism includes a sliding feature that can abut against and / or along which the other rotary locking element of the first locking mechanism can slide. When the two rotary locking elements of the first locking mechanism are engaged, the first rotary locking element can induce a torque or force on the second rotary locking element as a result of a torque induced in the transmission member by the energy member. Preferably, the sliding feature is configured such that this torque or force is at least partially converted into a force in a second direction acting on the displaceable rotary locking element.

[0041] The sliding feature can be a ramp that is inclined relative to the second direction and the first rotational direction. For example, the angle between the ramp and the first rotational direction and / or the second direction is at least 10° and at most 80°. The ramp can be a surface against which the first and second rotational locking elements of the first locking mechanism abut, causing a torque to press the first rotational locking element against the second rotational locking element.

[0042] According to at least one embodiment, the displaceable rotary locking element of the first locking mechanism is oriented in the circumferential direction. This means that the main extension direction of the displaceable rotary locking element is along an angular direction. The displaceable rotary locking element can be elongated. For example, the displaceable element can be a flexible, particularly elastic, arm. One end of the displaceable rotary locking element can be radially, preferably also non-rotatably and / or axially fixed relative to the housing element. For example, when viewed along the extension and / or angularly of the displaceable element, the end of the displaceable rotary locking element away from the one end can be radially unfixed relative to the housing element, i.e., a free end, and thus radially displaceable. The free end can be oriented in the angular direction. In other words, the displaceable element can be pivotally connected to or integrated with the housing element, e.g., its body. The sliding feature can be located closer to the free end than to the end fixed relative to the housing element.

[0043] One of the first and second rotary locking elements of the first locking mechanism can include a protrusion, and the other can include a recess. The protrusion and the recess can also be referred to as a locking feature. The protrusion can be configured to engage or protrude into the recess. A sliding feature or a ramp can be part of the protrusion and / or the recess. The protrusion and / or the recess can be located closer to the free end than to the end fixed to the housing element. The protrusion can be oriented radially, for example, radially inward.

[0044] According to at least one embodiment, the first and second rotational locking elements of the first locking mechanism are configured to form an axial locking interface when engaged with one another. The axial locking interface prevents axial, e.g., proximal, movement of the transmission member. The axial locking interface can be unidirectional or bidirectional.

[0045] For example, the protrusion on one of the rotational locking elements of the first locking mechanism includes a surface that extends obliquely or perpendicularly to the longitudinal axis. The recess on the other of the rotational locking elements of the first locking mechanism can include or be defined by a surface that similarly extends obliquely or perpendicularly to the longitudinal axis. When engaged, the two surfaces abut against each other upon attempting to move the transmission member axially, e.g., in a proximal direction.

[0046] The protrusion and / or recess may include two sections defining a surface extending obliquely or perpendicularly to the longitudinal axis, and thus the protrusion may be a stepped protrusion and / or the recess may be a stepped recess.

[0047] According to at least one embodiment, the device has a second locked state, and in the second locked state, the releasable second locking mechanism prevents axial movement of the transmission member. This portion of the second locking mechanism that prevents axial movement is also referred to as the axial locking mechanism. Preferably, the second locking mechanism also prevents rotational movement of the transmission member. This portion of the second locking mechanism that prevents rotational movement is also referred to as the second rotational locking mechanism.

[0048] The second locked state can be the state of the device during assembly of the drug delivery device and before the first locked state. The second locked state can be the state in which the device is being transported. The device can be switched from the second locked state to the first locked state to prepare for the drug delivery process.

[0049] In the second locked state, the axial locking mechanism can establish an axial locking interface through which the transmission member and the housing element are coupled, thereby preventing axial movement of the transmission member, and the second rotational locking mechanism can establish a rotational locking interface through which the transmission member and the housing element are coupled, thereby preventing rotational movement of the transmission member.

[0050] According to at least one embodiment, the second locking mechanism or its axial locking mechanism each includes a first axial locking element that is non-rotatably and axially fixed relative to the transmission member and a second axial locking element that is non-rotatably and axially fixed relative to the housing element, and the two axial locking elements of the second locking mechanism can be configured to engage with each other.

[0051] According to at least one embodiment, engagement of the axial locking element of the second locking mechanism prevents axial movement of the transmission member, and preferably also rotational movement.

[0052] The first axial locking element of the second locking mechanism can be part of the transmission member. The second axial locking element of the second locking mechanism can be part of the housing element. One of the axial locking elements, e.g., the first axial locking element, can be a displaceable element, e.g., radially displaceable, and the other axial locking element can be radially fixed. The displaceable element can be axially oriented. The displaceable element can be a pivotable, flexible, or elastic arm. The other axial locking element, e.g., the second axial locking element, can include a recess. In the second locked state, the displaceable element can protrude into the recess, thereby preventing axial movement of the transmission member, e.g., to a position where the first locking mechanism is established.

[0053] According to at least one embodiment, the second locking mechanism or the second rotary locking mechanism, respectively, comprises a first rotary locking element that is non-rotatably and axially, preferably also radially, fixed relative to the transmission member and a second rotary locking element that is non-rotatably and axially, preferably also radially, fixed relative to the housing element, wherein the two rotary locking elements of the second locking mechanism can be configured to engage with each other.

[0054] According to at least one embodiment, engagement of the two rotational locking elements of the second locking mechanism prevents rotational movement of the transmission member.

[0055] The first rotary locking element of the second locking mechanism can be part of the transmission member. The first rotary locking element of the second locking mechanism can be the first rotary locking element of the first locking mechanism. The second rotary locking element of the second locking mechanism can be part of the housing element. One of the rotary locking elements of the second locking mechanism, e.g., the second rotary locking element, can include a locking feature in the form of a protrusion. The other rotary locking element of the second locking mechanism, e.g., the first rotary locking element, can include a locking feature in the form of a recess. In the second locked state, the protrusion can engage or protrude into the recess. The rotary locking element of the second locking mechanism can be configured not to prevent axial movement of the transmission member when engaged. Axial movement of the transmission member can disengage the two rotary locking elements of the second locking mechanism. Axial movement can be prevented by an axial locking interface.

[0056] According to at least one embodiment, the second rotational locking mechanism can be released by axial movement, particularly pure axial movement, of the transmission member. The axial movement to release the second rotational locking mechanism can be a proximal movement. The device can be configured such that to release the second rotational locking mechanism, the displaceable axial locking element must be displaced so that it is disengaged from the other axial locking element. This allows axial movement of the transmission member, which disengages the two rotational locking elements of the second locking mechanism.

[0057] Preferably, axial movement of the transmission member transfers the device from the second locked state to the first locked state. The two locking mechanisms can be configured such that rotational movement of the transmission member is prevented at all times during the transfer from the second locked state to the first locked state. For example, during axial movement, the rotational locking element of the first locking mechanism is engaged before the rotational locking element of the second locking mechanism is fully disengaged.

[0058] For example, the locking feature of the second rotary locking element of the first locking mechanism may be positioned immediately behind the locking feature of the second rotary locking element of the second locking mechanism, and may be angularly overlapping along the axial direction. In other words, the second rotary locking elements of the two locking mechanisms (or their respective locking features) may be angularly and / or radially aligned and / or axially offset from one another. At least a portion of the locking feature of the second rotary locking element of the first locking mechanism may have the same radial and / or angular extension as the locking feature of the second rotary locking element of the second locking mechanism, and / or may even be formed identically. The locking feature may also have free ends that are radially aligned. This facilitates engaging the same first rotary locking element with two different second rotary locking elements of both locking mechanisms.

[0059] According to at least one embodiment, in the second locked state, the transmission member is axially offset relative to the first locked state, e.g., in the second locked state, the transmission member is disposed downstream along the distal direction relative to the first locked state.

[0060] According to at least one embodiment, the transmission member includes a first portion, also referred to as an axial locking portion, and a second portion, also referred to as a rotational locking portion, which are axially offset. The first portion can have a larger diameter than the second portion. The first portion can be positioned proximally relative to the second portion. The first rotational locking element of the first and second locking mechanisms can be part of or formed by the second portion. The first axial locking element of the second locking mechanism can be part of or formed by the first portion. The first and / or second portions can be disc-shaped.

[0061] According to at least one embodiment, a third portion of the transmission member, also referred to as a connecting portion, is disposed between the first portion and the second portion. The third portion can have a smaller diameter than each of the first and second portions. For example, the third portion can be axial, e.g., cylindrical in shape. The first and / or second and / or third portions can be disposed within, i.e., circumferentially surrounded by, a housing element, at least in the first locked state. Furthermore, at least in the first locked state, the plunger rod can axially overlap one, some, or all of the first, second, and third portions of the transmission member.

[0062] According to at least one embodiment, the device is configured such that, in the released state, the transmission member moves axially relative to the housing element until it encounters an end stop, e.g., a proximal end stop, of the device. The end stop can be formed by the housing element or by another element or member axially fixed relative to the housing element. For example, the transmission member moves axially, e.g., proximally, and / or away from the second rotational locking element of the first and / or second locking mechanisms, by at least 1 mm or at least 5 mm. Preferably, the transmission member moves axially and / or rotatably during axial movement of the plunger rod.

[0063] According to at least one embodiment, in the released state, after hitting the end stop, the transmission member continues to rotate. Further axial movement can be prevented by the end stop. For example, after hitting the end stop, the transmission member continues to rotate at least 360°.

[0064] According to at least one embodiment, in the released state the transmission member moves in the proximal direction, in which case the end stop can be provided in the region of the proximal end of the device.

[0065] According to at least one embodiment, the end stop includes a friction reducing element. Additionally or alternatively, the proximal end of the transmission member may include a friction reducing element.

[0066] According to at least one embodiment, a low friction interface is formed between the friction reducing elements of the transmission member and the end stop.

[0067] According to at least one embodiment, at least one of the friction-reducing elements is a tapered protrusion. In particular, the protrusion tapers toward the respective other friction-reducing element. The protrusion may have a conical shape. For example, the friction-reducing element of the end stop is a tapered protrusion.

[0068] According to at least one embodiment, the other of the friction-reducing elements is a recess. The friction-reducing element is a protrusion that can protrude into the recess when the transmission member contacts the end stop. The recess can be formed by a concave surface located at the proximal end of the transmission member.

[0069] According to at least one embodiment, the recesses and / or protrusions are rotationally symmetric, preferably circularly symmetric, relative to the rotational and / or longitudinal axis of the transmission member.

[0070] According to at least one embodiment, the energy member is a drive spring, in particular a torsion drive spring, connected at a first connection point to the transmission member and at a second connection point to the housing element. The connection of the drive spring to the transmission member and / or the housing element is preferably non-releasable or permanent, i.e., the connection cannot be released without breaking the connection or is present in all states of the device.

[0071] According to at least one embodiment, during axial movement of the transmission member, the first and second connection points are moved axially relative to one another, in particular, the first connection point is moved proximally relative to the second connection point when the transmission member moves proximally, for example in a released state.

[0072] Next, a drug delivery device is specified. In particular, the drug delivery device includes a device according to any one of the described embodiments. Therefore, all features described in relation to the device are also disclosed for the drug delivery device, and vice versa. The drug delivery device can be an automatic injector.

[0073] According to at least one embodiment, the drug delivery device includes an apparatus according to any one of the above-described embodiments.

[0074] According to at least one embodiment, the drug delivery device includes a housing. The housing element can be fixed to the housing or can be integrated into the housing. The housing is preferably fixed axially and non-rotatably, preferably radially, relative to the housing element. The housing element can be part of the housing, e.g., integrally formed with the housing, or can be a separate element. The housing can comprise or consist of plastic and / or can be integrally formed. The housing can be hollow and / or elongated and / or hollow cylindrical. The housing can be a sleeve. The housing can be configured to hold or receive a drug container, e.g., a syringe. The housing can be configured to hold a drug container such that the drug container is fixed axially, non-rotatably, and / or radially relative to the housing. The housing element and / or the energy member and / or the plunger rod and / or the transmission member can be received in the housing, i.e., circumferentially surrounded by the housing.

[0075] According to at least one embodiment, the drug delivery device includes a medicament container. The medicament container can include a needle. The device and the medicament container can be received in a housing, i.e., can be circumferentially surrounded by the housing. The needle can form a distal end of the medicament container. The medicament container can be located distal to the transmission member and / or the plunger rod and / or the energy member, particularly in the first locked state. The medicament container can be arranged axially, non-rotatably, and / or radially fixed relative to the housing, i.e., cannot be moved relative to the housing during intended use of the drug delivery device. The medicament container can be a syringe, e.g., a pre-filled syringe. The end of the container opposite the needle can be sealed and closed by a movable member, e.g., a stopper or piston. The medicament container can contain a drug or agent, e.g., a liquid drug or agent. The drug delivery device can be configured to empty the medicament container when released. In other words, the medicament container can contain an amount of agent sufficient for exactly one drug delivery operation. The drug delivery operation can be performed when the drug delivery device or the device, respectively, is switched to the released state. The drug delivery device may be a single use and / or disposable device.

[0076] According to at least one embodiment, the drug delivery device includes a needle shroud telescopically coupled to the housing, the needle shroud axially movable relative to the housing between an extended position, e.g., a position where the needle is covered by the needle shroud, and a retracted position, e.g., a position where the needle is exposed. In the retracted position, the needle can penetrate body tissue. The needle shroud can be non-rotatably fixed to the housing.

[0077] For example, in the first locked state, the needle shroud is in its extended position. An element or region of the needle shroud, such as a sidewall of the needle shroud, can hold the displaceable rotational locking element of the first locking mechanism in its first position and prevent the displaceable rotational locking element from moving along the second direction from the first position. In this way, the first locking mechanism is maintained in a state established by the needle shroud.

[0078] For example, moving the needle shroud from its extended position to its retracted position moves the needle shroud in a proximal direction. Movement to the retracted position can release the first locking mechanism. By way of example, in the retracted position, the needle shroud no longer prevents the displaceable rotational locking element of the first locking mechanism from moving out of its first position in a second direction.

[0079] According to at least one embodiment, the drug delivery device includes a shroud spring. The shroud spring can be coupled to the needle shroud and the housing and / or housing element. The shroud spring can be configured to induce a restoring force acting distally on the needle shroud when the needle shroud is moved from the extended position toward the retracted position.

[0080] According to at least one embodiment, the drug container includes a stopper. The stopper can seal the drug container proximally. In a released state of the drug delivery device, the distal end of the plunger rod can abut against the stopper and can be driven by an energy member to urge the stopper distally. Distal movement of the stopper can result in the drug in the drug container being forced out of the drug delivery device through the needle.

[0081] According to at least one embodiment, in the first locked state, the plunger rod is axially spaced from the stopper. Thus, in the released state, the plunger rod first moves distally, then strikes the stopper, and then pushes the stopper distally. The axial movement of the transmission member preferably begins simultaneously with the axial movement of the plunger rod. Alternatively, the axial movement of the transmission member can begin only when or after the plunger rod strikes the stopper.

[0082] According to at least one embodiment, the movement of the stopper can begin with a delay relative to the initiation of movement of the transmission member and / or plunger rod, for example, the transmission member first moves a certain distance in a first rotational and / or axial direction before the stopper begins to move.

[0083] The drug delivery device can be used as follows: First, the drug delivery device or the apparatus, respectively, is in its first locked state. Then, the distal end of the drug delivery device is pressed against a skin area of ​​a body, for example, a human body. In this state, the distal end of the needle shroud can form the distal end of the drug delivery device. This moves the needle shroud from the extended position to the retracted position. This movement biases the shroud spring, which biases the needle shroud distally relative to the housing. In the retracted position, the first locking mechanism is released, and the drug delivery device switches from the first locked state to a released state. In the released state, the drug is delivered, for example, injected, into body tissue. Then, the distal end of the drug delivery device can be removed from the skin. The shroud spring moves the needle shroud distally, for example, back to the extended position.

[0084] The apparatus for a drug delivery device and the drug delivery device described herein will be described in more detail below based on exemplary embodiments with reference to the drawings. In the individual figures, the same reference numerals indicate the same elements. However, the size ratios involved are not necessarily to scale, and for better understanding, the individual elements may be shown with exaggerated size. [Brief explanation of the drawings]

[0085] [Figure 1] 1A-1C are different views of a first exemplary embodiment of a drug delivery device. [Figure 2] 1A-1C are different views of a first exemplary embodiment of a drug delivery device. [Figure 3] 1A-1C are different views of a first exemplary embodiment of a drug delivery device. [Figure 4] 1A-1C are different views of a first exemplary embodiment of a drug delivery device. [Figure 5] 1A-1C are different views of a first exemplary embodiment of a drug delivery device. [Figure 6] 1A-1C are different views of a first exemplary embodiment of a drug delivery device. [Figure 7] 1A-1C illustrate different positions during use of a drug delivery device according to a first exemplary embodiment. [Figure 8] 1A-1C illustrate different positions during use of a drug delivery device according to a first exemplary embodiment. [Figure 9] 1A-1C illustrate different positions during use of a drug delivery device according to a first exemplary embodiment. [Figure 10] 1A-1C illustrate different positions during use of a drug delivery device according to a first exemplary embodiment. [Figure 11] 1A-1C illustrate different positions during use of a drug delivery device according to a first exemplary embodiment. [Figure 12] 1A-1C illustrate different positions during use of a drug delivery device according to a first exemplary embodiment. [Figure 13]FIG. 1 is an exploded view illustrating a drug delivery device according to a first exemplary embodiment. [Figure 14] 2A-2C show subassemblies of the drug delivery device according to the first exemplary embodiment in more detail. [Figure 15] 2A-2C show subassemblies of the drug delivery device according to the first exemplary embodiment in more detail. [Figure 16] 2A-2C show subassemblies of the drug delivery device according to the first exemplary embodiment in more detail. [Figure 17] 3A-3C are different views of a second exemplary embodiment of a drug delivery device. [Figure 18] 3A-3C are different views of a second exemplary embodiment of a drug delivery device. [Figure 19] 3A-3C are different views of a second exemplary embodiment of a drug delivery device. [Figure 20] 3A-3C are different views of a second exemplary embodiment of a drug delivery device. [Figure 21] 3A-3C are different views of a second exemplary embodiment of a drug delivery device. [Figure 22] 3A-3C are different views of a second exemplary embodiment of a drug delivery device. [Figure 23] FIG. 10 is an exploded view showing a subassembly of a drug delivery device according to a second exemplary embodiment. [Figure 24] FIG. 10 is an exploded view showing a subassembly of a drug delivery device according to a second exemplary embodiment. [Figure 25] 1A-1C show members or apparatus of a drug delivery device according to a first and second exemplary embodiment in different positions in use to illustrate exemplary embodiments of a drive mechanism; [Figure 26] 1A-1C show members or apparatus of a drug delivery device according to a first and second exemplary embodiment in different positions in use to illustrate exemplary embodiments of a drive mechanism; [Figure 27] 1A-1C show members or apparatus of a drug delivery device according to a first and second exemplary embodiment in different positions in use to illustrate exemplary embodiments of a drive mechanism; [Figure 28] 1A-1C show a portion of a drug delivery device according to a first and second exemplary embodiment in different positions in use to illustrate exemplary embodiments of a first locking mechanism and release of the first locking mechanism. [Figure 29] 1A-1C show a portion of a drug delivery device according to a first and second exemplary embodiment in different positions in use to illustrate exemplary embodiments of a first locking mechanism and release of the first locking mechanism. [Figure 30] 1A-1C show a portion of a drug delivery device according to a first and second exemplary embodiment in different positions in use to illustrate exemplary embodiments of a first locking mechanism and release of the first locking mechanism. [Figure 31] 1A-1C show a portion of a drug delivery device according to a first and second exemplary embodiment in different positions in use to illustrate exemplary embodiments of a first locking mechanism and release of the first locking mechanism. [Figure 32] 1A-1C show a portion of a drug delivery device according to a first and second exemplary embodiment in different positions in use to illustrate exemplary embodiments of a first locking mechanism and release of the first locking mechanism. [Figure 33] 1A-1C show a portion of a drug delivery device according to a first and second exemplary embodiment in different positions in use to illustrate exemplary embodiments of a first locking mechanism and release of the first locking mechanism. [Figure 34] 10A-10C show portions of a drug delivery device according to the first and second exemplary embodiments in different positions in use to illustrate the first exemplary embodiment of a third locking mechanism. [Figure 35] 10A-10C show portions of a drug delivery device according to the first and second exemplary embodiments in different positions in use to illustrate the first exemplary embodiment of a third locking mechanism. [Figure 36]10A-10C show portions of a drug delivery device according to the first and second exemplary embodiments in different positions in use to illustrate the first exemplary embodiment of a third locking mechanism. [Figure 37] 10A-10C show portions of a drug delivery device according to the first and second exemplary embodiments in different positions in use to illustrate the first exemplary embodiment of a third locking mechanism. [Figure 38] 10A-10C show portions of a drug delivery device according to the first and second exemplary embodiments in different positions in use to illustrate the first exemplary embodiment of a third locking mechanism. [Figure 39] 10A-10D show a portion of a drug delivery device in different positions in use to illustrate a second exemplary embodiment of a third locking mechanism. [Figure 40] 10A-10D show a portion of a drug delivery device in different positions in use to illustrate a second exemplary embodiment of a third locking mechanism. [Figure 41] 1A-1C show portions of a drug delivery device according to a first and second exemplary embodiment in different positions in use to illustrate exemplary embodiments of a fall protection mechanism. [Figure 42] 1A-1C show portions of a drug delivery device according to a first and second exemplary embodiment in different positions in use to illustrate exemplary embodiments of a fall protection mechanism. [Figure 43] 1A-1D illustrate different subassemblies of a drug delivery device according to a first exemplary embodiment and steps during assembly of the drug delivery device. [Figure 44] FIG. 2 shows a portion of a front sub-assembly of a drug delivery device according to a first exemplary embodiment. [Figure 45] FIG. 2 shows a portion of a front sub-assembly of a drug delivery device according to a first exemplary embodiment. [Figure 46] FIG. 2 shows a portion of a front sub-assembly of a drug delivery device according to a first exemplary embodiment. [Figure 47]1A-1C illustrate different positions in an exemplary embodiment of a method for assembling a drug delivery device according to a first exemplary embodiment. [Figure 48] 1A-1C illustrate different positions in an exemplary embodiment of a method for assembling a drug delivery device according to a first exemplary embodiment. [Figure 49] 10A-10C show separate drive spring holders of drug delivery devices according to first and second exemplary embodiments; [Figure 50] 1A-1C illustrate different positions in an exemplary embodiment of a method for assembling a drug delivery device according to a first exemplary embodiment. [Figure 51] 1A-1C illustrate different positions in an exemplary embodiment of a method for assembling a drug delivery device according to a first exemplary embodiment. [Figure 52] 1A-1C illustrate different positions in an exemplary embodiment of a method for assembling a drug delivery device according to a first exemplary embodiment. [Figure 53] 1A-1C illustrate different positions in an exemplary embodiment of a method for assembling a drug delivery device according to a first exemplary embodiment. [Figure 54] 1A-1C show an exemplary embodiment of a feedback mechanism in different positions. [Figure 55] 1A-1C show an exemplary embodiment of a feedback mechanism in different positions. [Figure 56] 1A-1C show an exemplary embodiment of a feedback mechanism in different positions. [Figure 57] 10A-10C show different views of a third exemplary embodiment of a drug delivery device. [Figure 58] 10A-10C show different views of a third exemplary embodiment of a drug delivery device. [Figure 59] 10A-10C show different views of a third exemplary embodiment of a drug delivery device. [Figure 60] 10A-10C show different views of a third exemplary embodiment of a drug delivery device. [Figure 61] 10A-10C show different views of a third exemplary embodiment of a drug delivery device. [Figure 62] 10A-10C show different views of a third exemplary embodiment of a drug delivery device. [Figure 63] FIG. 10 shows a drug delivery device according to a third exemplary embodiment after use. [Figure 64] 10A-10C illustrate different subassemblies of a drug delivery device according to a third exemplary embodiment. [Figure 65] FIG. 10 is an exploded view showing a subassembly of a drug delivery device according to a third exemplary embodiment. [Figure 66] FIG. 10 is an exploded view showing a subassembly of a drug delivery device according to a third exemplary embodiment. [Figure 67] 10A-10D show a portion of a drug delivery device according to a third exemplary embodiment in different positions in use to illustrate the locking mechanism. [Figure 68] 10A-10D show a portion of a drug delivery device according to a third exemplary embodiment in different positions in use to illustrate the locking mechanism. [Figure 69] 10A-10D show a portion of a drug delivery device according to a third exemplary embodiment in different positions in use to illustrate the locking mechanism. [Figure 70] 10A-10D show a portion of a drug delivery device according to a third exemplary embodiment in different positions in use to illustrate the locking mechanism. [Figure 71] 10A-10D show different positions during assembly of a drug delivery device according to a third exemplary embodiment. [Figure 72] 10A-10D show different positions during assembly of a drug delivery device according to a third exemplary embodiment. [Figure 73] 10A-10D show different positions during assembly of a drug delivery device according to a third exemplary embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0086] 1. First Exemplary Embodiment of the Drug Delivery Device 1 and 2 show side views of a first exemplary embodiment of a drug delivery device 1000. Fig. 1 shows a first view of the drug delivery device 1000, and Fig. 2 shows a second view in which the device 1000 is rotated 90° about the longitudinal axis A compared to the first view.

[0087] 1 and 2 also show coordinate systems used herein to designate the positions of members or elements or features. The distal direction D and the proximal direction P extend parallel to the longitudinal axis A. The longitudinal axis A is the main axis of extension of the device 1000. The radial direction R is a direction perpendicular to and intersecting the longitudinal axis A. The azimuthal direction C, also called the angular or rotational direction, is a direction perpendicular to the radial direction R and the longitudinal axis A. To increase the clarity of the figures, not all of the following figures show the different directions and axes.

[0088] The drug delivery device 1000 according to the first exemplary embodiment is an auto-injector. The auto-injector 1000 includes a housing 100. At the distal end of the housing 100, a cap 110 is removably attached or coupled to the housing 100. The housing 100 can be formed as a single unit and can extend from the cap 110 to the proximal end of the auto-injector 1000. The housing 100 is a cylindrical sleeve.

[0089] 1 and 2, housing 100 includes a window 120 through which a medication container within housing 100 can be viewed. For example, through window 120, the fill level of a medication within the medication container or the advancement of a stopper within the medication container, or the clarity of the medication or degradation of the medication can be observed.

[0090] Figures 3 and 4 show the auto-injector 1000 in the same manner as Figures 1 and 2, but now the cap 110 and housing 100 are shown semi-transparent, thus allowing the visibility of further details of the auto-injector 1000 that are normally completely surrounded and hidden by the housing 100 and cap 110. It can be seen that the auto-injector 1000 further comprises a transmission member 2 in the form of a rotating collar 2, also referred to as the movable member 2 or drive member 2, respectively, an energy member 3 in the form of a torsion drive spring 3, in particular a spiral torsion drive spring (also commonly referred to as a clock spring or power spring), and a housing element 4 in the form of a drive spring holder 4.

[0091] The drive spring holder 4 is fixed to the housing 100, such that the drive spring holder 4 cannot rotate axially or move radially relative to the housing 100. For example, the drive spring holder 4 is fixed to the housing 100 with the aid of a clip (not shown). Alternatively, the drive spring holder 4 can be part of the housing 100, for example, integrally formed therewith. The drive spring holder 4 is received in the housing 100. The housing 100 completely surrounds the drive spring holder 4 in the circumferential direction.

[0092] The torsion drive spring 3 is connected to the drive spring holder 4 at a connection point. At a further connection point, the torsion drive spring 3 is connected to the rotating collar 2. The connection point is not visible in these views. The rotating collar 2 is arranged to be axially and rotatably movable relative to the drive spring holder 4. The torsion drive spring 3 circumferentially surrounds a portion of the rotating collar 2. When energized, the torsion drive spring 3 induces a torque on the rotating collar 2. This torque will cause the rotating collar 2 to rotate relative to the drive spring holder 4 if the rotation of the rotating collar 2 is not prevented by a locking mechanism (see further description below). The axis of rotation of the rotating collar 2 can define the longitudinal axis A or can be coincident with the longitudinal axis A.

[0093] The auto-injector 1000 further includes a release member 5 or protective member 5, respectively, in the form of a needle shroud 5, and a drug container holder 6 in the form of a syringe holder 6. The syringe holder 6 may be axially, and preferably non-rotatably, fixed relative to the housing 100. The syringe holder 6 is configured to hold a syringe. The syringe holder 6 includes a window 60 that overlaps / aligns with a window 120 in the housing 100. In this way, the syringe or drug container can be observed through the windows 60, 120.

[0094] The needle shroud 5 is arranged to be axially movably relative to the housing 100 or drive spring holder 4, respectively, and is matingly coupled to the housing 100 or drive spring holder 4, respectively. In particular, the needle shroud 5 is movable from an extended position, as shown in Figures 3 and 4, in the proximal direction P to a retracted position (see Figures 7 and 8), as will be described in further detail below.

[0095] The needle shroud 5 and the syringe holder 6 are movably coupled to one another via a shroud spring 7. One end of the shroud spring 7 is connected to the syringe holder 6, and the other end of the shroud spring 7 is connected to the needle shroud 5. This coupling is such that movement of the needle shroud 5 in a proximal direction P relative to the syringe holder 6 compresses the shroud spring 7, inducing a force in a distal direction D on the needle shroud 5.

[0096] 5 and 6 show two cross-sectional views of the auto-injector 1000, which are again rotated 90° relative to each other about the longitudinal axis. The cross-sectional plane includes the longitudinal axis A. In this view, it can be seen that the auto-injector 1000 further includes a plunger rod 1. The plunger rod 1 is primarily disposed within and circumferentially surrounded by the rotating collar 2. Only a small portion of the plunger rod 1 (less than 50% of its length) protrudes from the rotating collar 2 in the distal direction D. The rotating collar 2 is closed in the proximal direction P, and the plunger rod 1 does not protrude beyond the proximal end of the rotating collar 2. When measured along the longitudinal axis A, the plunger rod 1 is longer than the rotating collar 2.

[0097] The housing 100, housing element 4, plunger rod 1, rotation collar 2, needle shroud 5, syringe holder 6, and cap 110 can all include or consist of plastic. All of these components can each be integrally formed. The drive spring 3 and shroud spring 7 can include or consist of a metal, such as steel.

[0098] 5 and 6, a drug container 8, in this case a syringe 8, can be seen disposed within the syringe holder 6. The syringe 8 can be arranged axially and / or non-rotatably and / or radially fixed relative to the syringe holder 6 and / or the housing 100. The syringe 8 includes a drug-filled cartridge 81, a needle 80, and a stopper 82. The needle 80 is disposed at the distal end of the syringe 8. The stopper 82 seals the cartridge 81 in a proximal direction P. Moving the stopper 82 in a distal direction D forces the drug contained in the cartridge 81 out of the syringe 8 through the needle 80.

[0099] 5 and 6, it can be further seen that the needle 80 is covered by a needle shield 83, which encloses the needle 80 and protrudes in a distal direction D beyond the needle 80. The needle shield 83 may be formed from a rubber material. The cap 110 is connected to a gripping portion 111. The gripping portion 111 is held within the cap 110 by one or more bosses. The gripping portion 111 is coupled to the needle shield 83. The gripping portion 111 may be formed from a metal and may include barbs that engage the material of the needle shield 83.

[0100] When the cap 110 is removed from the housing 100, the gripping portion 111 pulls the needle shield 83 off the needle 80. The needle 80 is then circumferentially surrounded only by the retractable needle shroud 5.

[0101] 7 and 8 show two cross-sectional views of the auto-injector 1000 in use. Shown in a first position in use are the cap 110, grip 111, and needle shield 83 removed from the housing 100. The needle shroud 5 protrudes in a distal direction D from the housing 100.

[0102] 7 and 8, the distal end of the auto-injector 1000 formed by the needle shroud 5 can be pressed against a body, e.g., a human body. As a result, the needle shroud 5 moves from its extended position in a proximal direction P relative to the housing 100. This exposes the needle 80, which protrudes in a distal direction D beyond the needle shroud 5 and thus can now penetrate, or has already penetrated, body tissue.

[0103] 7 and 8, the auto-injector 1000 is still in a first locked state (as in the previous figures), also referred to as a pre-release or initial state, in which the torsion drive spring 3 is biased and induces a torque on the rotatable collar 2. However, a first locking mechanism (also referred to as a first rotational locking mechanism) prevents rotational movement of the rotatable collar 2. The first locking mechanism is described in further detail below.

[0104] In the first locked state, the proximal end of the rotating collar 2 is axially spaced from the proximal end stop of the housing 100. This allows axial movement of the rotating collar 2 in the proximal direction P. Furthermore, in the first locked state, the distal end of the plunger rod 1 is axially spaced from the stopper 82 of the syringe 8. Therefore, the plunger rod 1 can move axially in the distal direction D a predetermined distance until it hits the stopper 82.

[0105] 9 and 10 show two cross-sectional views of the auto-injector 1000 in a second position during use, where the auto-injector 1000 is in a released state. The needle shroud 5 has been moved further in the proximal direction P to a retracted position. This releases the first locking mechanism, thus unblocking rotation of the rotating collar 2. Torque induced by the torsion drive spring 3 on the rotating collar 2 causes it to rotate in a first rotational direction (clockwise or counterclockwise). A drive mechanism converts the rotation of the rotating collar 2 into axial movement of the plunger rod 1 in the distal direction D. The drive mechanism is described in further detail below. After moving a predetermined distance in the distal direction D, the plunger rod 1 can strike the stopper 82 of the syringe 8 and then push the stopper 82 in the distal direction D, thereby forcing the medication in the cartridge 81 through the needle 80 and into tissue.

[0106] As shown in FIGS. 9 and 10 , the rotatable collar 2 not only rotates but also moves in a proximal direction P until the proximal end of the rotatable collar 2 abuts against a proximal end stop of the housing 100. The end stop includes a protrusion 101 that tapers in a distal direction D. The protrusion 101 can be conical. The proximal end of the rotatable collar 2 includes a recess 200. For example, the surface of the proximal end of the rotatable collar 2 has a concave shape. The protrusion 101 can penetrate into the recess 200 when the proximal end of the rotatable collar 2 abuts against the end stop of the housing 100. The protrusion 101 and the recess 200 can each be designed to be rotationally symmetric or circularly symmetric with respect to the rotation axis of the rotatable collar 2. In this way, a low-friction interface is formed between the housing 100 and the rotatable collar 2, thereby enabling low-friction rotation of the rotatable collar 2 when the proximal end of the rotatable collar 2 abuts against the housing 100. In particular, the radius at which friction between the rotating collar 2 and the end stop acts approaches or becomes zero, and therefore the resulting torque resulting from friction also tends to zero, significantly reducing losses, allowing for reduced spring forces and / or improving injection performance.

[0107] 11 and 12 show two cross-sectional views of the auto-injector 1000 in a third position during use. The torsion drive spring 3 induces a further torque on the rotating collar 2, which, although abutting the end stop of the housing 100, rotates further, thereby moving the plunger rod 1 further in the distal direction D. The plunger rod 1 presses the stopper 82 further in the distal direction D, thereby delivering a predetermined dose of medication through the needle 80, e.g., into tissue. Between the described first and third positions, for example, the rotating collar 2 rotates several times about its axis of rotation.

[0108] 11 and 12, the auto-injector 1000 is in a third locked or post-release state in which the needle shroud 5 is again in its extended position, thus circumferentially surrounding the needle 80 so that the needle 80 does not protrude distally beyond the needle shroud 5. Movement of the needle shroud 5 in the extended position is automatic due to the force induced by the compressed shroud spring 7 when moving the needle shroud 5 from the extended position towards the retracted position.

[0109] In the third locked state of the auto-injector 1000 shown in Figures 11 and 12, the needle shroud 5 cannot return to the retracted position due to the third locking mechanism, which is described in further detail below.

[0110] 13 shows the auto-injector 1000 of the previous figures in an exploded view. The auto-injector 1000 includes a release subassembly FSA or front subassembly FSA, respectively, a drive subassembly RSA or rear subassembly RSA, respectively, and a syringe 8. To assemble the auto-injector 1000, the syringe 8 is inserted into the front subassembly FSA or rear subassembly RSA, and then the front subassembly FSA is inserted into the rear subassembly RSA. Assembly of the auto-injector 1000 is described in further detail below.

[0111] FIG. 14 shows a more detailed side view of the forward subassembly FSA. The syringe holder 6 includes two elongated arms 6b, which extend axially and are spaced apart from each other along an angular direction. The needle shroud 5 also includes two elongated arms 5b, which extend axially and are spaced apart from each other along an angular direction. The needle shroud 5 and syringe holder 6 are inserted into each other so that the arms 5b of the needle shroud 5 are positioned between the arms 6b of the syringe holder 6 along the angular direction. Furthermore, it can be seen that the arms 6b of the syringe holder 6 protrude in the proximal direction P beyond the arms 5b of the needle shroud 5.

[0112] The distal end of the syringe holder 6 is formed by a distal portion 6a in the form of a cylindrical portion 6a. This portion 6a is configured to hold a shroud spring 7. The cylindrical portion 6a is inserted into the shroud spring 7 so that an edge of the syringe holder 6 abuts the proximal end of the shroud spring 7. The shroud spring 7 circumferentially surrounds the cylindrical portion 6a of the syringe holder 6. The shroud spring 7 can be fixed to the cylindrical portion 6a, for example, by adhesive or by mechanical radial interference with the proximal coil of the shroud spring 7.

[0113] FIG. 15 shows the forward subassembly FSA in an exploded view. The forward subassembly FSA includes a cap 110, a gripper 111, a needle shroud 5, a shroud spring 7, and a syringe holder 6. The needle shroud 5 also includes a distal portion 5a in the form of a cylindrical portion 5a that forms the distal end of the needle shroud 5. The cylindrical portion 5a is configured to hold the shroud spring 7. The cylindrical portion 5a has the shape of a hollow cylinder, so that the shroud spring 7 can be inserted into this portion 5a, with the distal end of the shroud spring 7 abutting the bottom region of the cylindrical portion 5a. The shroud spring 7 can be fixed to the cylindrical portion 5a, for example, by adhesive or by mechanical radial interference with the distal coil of the shroud spring 7. In this manner, the needle shroud 5, shroud spring 7, and syringe holder 6 are coupled such that movement of the needle shroud 5 relative to the syringe holder 6 in the proximal direction P compresses the shroud spring 7. The shroud spring 7 may also be held in place by a coupling / snap between the needle shroud 5 and the syringe holder 6 in the most extended position, for example, by features 54 and 61, described further below.

[0114] 15, the syringe holder 6 includes a support portion 6c disposed proximally relative to the cylindrical portion 6a, and the support portion 6c is disposed between the arms 6b and the cylindrical portion 6a. After the syringe holder 6 is inserted into the needle shroud 5, the arms 5b of the needle shroud 5 cover the support portion 6c, i.e., are disposed radially outward relative to the support portion 6c.

[0115] 16 shows the rear subassembly RSA in an exploded view. The rear subassembly RSA includes a housing 100, a torsion drive spring 3, a rotating collar 2, a plunger rod 1, and a drive spring holder 4. The drive spring holder 4, the rotating collar 2, and the housing 100 each have the form of a sleeve. When assembling the rear subassembly RSA, the plunger rod 1 is inserted into the rotating collar 2, which is inserted into the torsion drive spring 3 and fixed to the torsion drive spring 3 at one connection point. The torsion drive spring 3 is inserted into the drive spring holder 4 and connected to the drive spring holder 4 at an additional connection point. The drive spring holder 4 is inserted into the housing 100.

[0116] 2. Second Exemplary Embodiment of the Drug Delivery Device 17 and 18 show a second exemplary embodiment of a drug delivery device 1000, which in this case is again an auto-injector 1000. Similar to FIGS. 1 and 2, FIGS. 17 and 18 show the auto-injector 1000 in two different views rotated 90° relative to each other about the longitudinal axis A.

[0117] 19 and 20 show the auto-injector 1000 of FIGS. 17 and 18 in the same rotated view, but with the housing 100 semi-transparent.

[0118] 21 and 22 show the auto-injector 1000 of FIGS. 17 and 18 in the same rotated view, but now in a cross-sectional view whose intersecting plane includes the longitudinal axis.

[0119] One difference between the auto-injector 1000 according to the second exemplary embodiment and the auto-injector according to the first exemplary embodiment is that in the second exemplary embodiment, the housing 100 includes two members instead of one member. The first member forms the distal member of the housing 100, and the second member forms the proximal member of the housing 100. The two members of the housing 100 are connected to each other, for example, with the aid of a clip (not shown). For example, the two members of the housing 100 are fixed to each other so that they cannot move axially, rotationally, or radially relative to each other.

[0120] FIG. 23 shows an exploded view of the front subassembly FSA of the automatic injector 1000 according to the second exemplary embodiment. The first member of the housing 100 is assigned to the front subassembly FSA. The needle shroud 5 can be inserted into this first member of the housing 100. The shroud spring 7 is connected to the needle shroud 5 and the first member of the housing 100, so that proximal movement of the needle shroud 5 relative to the first member of the housing 100 compresses the shroud spring 7. Unlike the first exemplary embodiment, the automatic injector according to the second exemplary embodiment does not include a syringe holder with two angularly spaced arms. Instead, the first member of the housing 100 is configured to hold a drug container, for example, in an axially and / or non-rotatably fixed manner. The first member of the housing 100 completely surrounds the needle shroud 5 in the circumferential direction.

[0121] An exploded view of the rear subassembly RSA of the auto-injector 1000 according to the second exemplary embodiment is shown in Figure 24. This rear subassembly is essentially identical to the rear subassembly RSA of the first exemplary embodiment. Only the second member of the housing 100 is assigned to the rear subassembly RSA, which can be shorter than the housing 100 of the first exemplary embodiment.

[0122] 3. Drive mechanism The conversion of rotational movement of the rotatable collar 2 induced by the torsion drive spring 3 into axial movement of the plunger rod 1 (drive mechanism) is described in more detail below in connection with Figures 25-27.

[0123] Figures 25 and 26 show the components or devices of the first and second exemplary embodiments of the auto-injector 1000 in different positions during use. The components shown include the rear subassembly (only the housing is not shown) and the syringe 8. In Figure 25 the auto-injector 1000 is in a first locked state, and in Figure 26 the auto-injector is in a released state.

[0124] As can be seen in Figures 25 and 26, the drive spring holder 4 includes two hollow sections 4a, 4b, both of which may be hollow cylindrical. The two sections 4a, 4b are arranged longitudinally of each other along the longitudinal axis. The first section 4a is located more proximally and has a larger inner diameter and a larger outer diameter than the second section 4b.

[0125] The rotating collar 2 is received in the drive spring holder 4. The proximal end of the rotating collar 2 protrudes from the drive spring holder 4 in the proximal direction P. The rotating collar 2 includes a shaft 20 and two portions 21, 22 having a diameter larger than the shaft 20. The two portions 21, 22 are axially spaced from each other and connected via the shaft 20. In this exemplary embodiment, the two portions 21, 22 are disk-shaped, although other shapes are possible. The first portion 21 has a diameter larger than the second portion 22. The first portion 21 is disposed within the first section 4a of the drive spring holder 4, and the second portion 22 is disposed within the second section 4b of the drive spring holder 4. The diameters of the portions 21, 22 are substantially the same as the inner diameters of the corresponding sections 4a, 4b, but are small enough to allow rotation of the rotating collar 2 relative to the drive spring holder 4. Furthermore, the diameter of the first portion 21 is larger than the inner diameter of the second section 4b, thereby limiting axial movement of the rotating collar 2 in the distal direction D.

[0126] 25, in the first locked state, the second portion 22 is offset in the proximal direction P from the second bottom ring 4d of the drive spring holder 4. Similarly, the first portion 21 is offset in the proximal direction P from the first bottom ring 4c of the drive spring holder 4.

[0127] The torsion drive spring 3 is received in the first section 4a and is fixed to the first section 4a at a connection point. The rotating collar 2 is received in the torsion drive spring 3, such that the torsion drive spring 3 circumferentially surrounds the axis 20 of the rotating collar 2 proximal to the first section 4a. The axis 20 of the rotating collar 2 is connected to the torsion drive spring 3 at a further connection point. The first portion 21 is offset in the distal direction D relative to the torsion drive spring 3. In the first locked state shown in FIG. 25 , the torsion drive spring 3 is biased and induces a torque on the rotating collar 2. Rotation of the rotating collar 2 is prevented with the aid of a first locking mechanism, which will be described further below.

[0128] The plunger rod 1 is received in the rotating collar 2. In a first locked state, a portion of the plunger rod 1 protrudes from the rotating collar 2 in a distal direction D. A stopper 82 of the syringe 8 is offset in the distal direction D from the distal end of the plunger rod 1.

[0129] FIG. 26 shows an auto-injector member or device in a released state. The first locking mechanism is released, thus no longer preventing rotation of the rotating collar 2. Due to torque induced by the drive spring 3, the rotating collar 2 rotates in a first rotational direction (clockwise or counterclockwise) within the drive spring holder 4. The rotating collar 2 and plunger rod 1 are operably coupled via a threaded interface. In this case, the plunger rod 1 includes an external thread 11, and the rotating collar 2 includes an internal thread (not visible) that engages with the external thread 11 of the plunger rod 1. The coupling via the threaded interface is such that rotation of the rotating collar 2 in the first rotational direction is translated into movement of the plunger rod 1 in the distal direction D.

[0130] During the axial movement of the plunger rod 1 induced by the rotation of the rotating collar 2, the plunger rod 1 itself does not rotate. This is achieved by the connection between the plunger rod 1 and the drive spring holder 4 via a spline interface. This is further illustrated in FIG. 27, which shows a three-dimensional view of the automatic injector member / device. The spline interface is achieved by the protrusions 40 of the drive spring holder 4 protruding from the second bottom ring 4d in the distal direction D. The protrusions 40 engage with or protrude into the grooves 10 of the plunger rod 1. The grooves 10 extend along the longitudinal axis A, i.e., essentially parallel to the longitudinal axis A. The grooves 10 are arranged opposite each other on the plunger rod 1. Instead of two grooves, one groove and one corresponding protrusion 40 would suffice, as shown in FIG. 27. However, three or more grooves 10 and associated protrusions 40 can also be used.

[0131] In exemplary embodiments, the spline interface is close to the thread interface, for example, by a distance of at most 1 cm or at most 0.5 cm. This is beneficial because the torque applied to the plunger rod 1 is resolved over a short distance, thereby reducing stress within the plunger rod 1. The plunger rod 1 is often a small member that is likely to deform.

[0132] As can be further seen in FIG. 26, the rotating collar 2 not only rotates as previously described, but also moves axially in the proximal direction P. The movement in the proximal direction P preferably begins as soon as rotation begins. In this way, the needle shroud 5 can re-extend if it is prematurely removed from the skin. The break-out force of the stopper 82 is typically 5 N or more. The ability of the torsion drive spring 3 to resolve axial loads can be less than this.

[0133] In the released state, the plunger rod 1 presses the stopper 82 in the distal direction D until the stopper 82 contacts the bottom region of the cartridge 81. At this time, further distal movement of the stopper 82 and the plunger rod 1 is prevented. After the movement of the plunger rod 1 and the rotating collar 2 is completed, a portion of the plunger rod 1 remains received in the rotating collar 2.

[0134] An example of the dimensions of the plunger rod 1 is as follows: The plunger rod 1 has a diameter of 8.0 mm and the pitch of the external thread is 3.17 mm. The coefficient of friction is 0.3. The average contact radius, i.e., the position of the thread flank from the central axis of the plunger rod 1, is 3.75 mm.

[0135] An example of a torsion drive spring 3 is as follows. The material is polished and blued SAE1095 steel. The height of the torsion drive spring is 12.0 mm, the material thickness is 0.168 mm, the length is 840.749 mm, the outer diameter is 20.0 mm, and the arbor diameter is 10.0 mm. The bending stress limit is 2000 N·mm -2 and Young's modulus is 20000 N·mm -2 and the number of rotations before energization is 3.

[0136] In general, the following conditions for the torsion drive spring have been found to be advantageous: The arbor diameter is between 12 and 25 times the thickness of the material. The length is between 5000 and 15000 times the thickness. The area of ​​the torsion drive spring 3 is half the area of ​​the drive spring holder 4 (e.g., in the first section 4a) ±10%. The bending stress of tempered, polished, and blued SAE 1095 steel should not exceed 2000 MPa.

[0137] An example of a syringe 8 used is as follows: The drug in the cartridge 81 has a volume of 2 ml. The viscosity of the material is 50 cP at room temperature. The diameter of the inner needle is 0.29 mm. The diameter of the inner cartridge is 8.65 mm. The friction of the stopper 82 is 10 N. The stopper gap, i.e. the initial gap between the proximal end of the stopper 82 and the distal end of the plunger rod 1, is 2 mm.

[0138] 4. First locking mechanism and release of first locking mechanism Each of the aforementioned first locking mechanisms or first rotary locking mechanisms and how they are released are described in further detail below in connection with Figures 28-33.

[0139] 28 shows a cross-sectional view of the automatic injector 1000 of the first and second exemplary embodiments, the cutting plane being perpendicular to the longitudinal axis A and passing through the second part 22 of the rotating collar 2. As can be seen, the drive spring holder 4 includes a displaceable element 41 in the form of a resilient arm (see also FIGS. 27 and 49). The resilient arm 41 can be formed integrally with the drive spring holder 4 and is arranged in the second section 4b of the drive spring holder 4. The resilient arm 41 is oriented in the circumferential direction, i.e. the main extension direction of the resilient arm 41 is along the angular direction C. One end of the resilient arm 41 is connected to the drive spring holder 4, the other end is free and movable in the radial direction R.

[0140] The resilient arm 41 includes a protrusion 410 that protrudes radially inward, i.e., toward the longitudinal axis A. The protrusion 410 tapers radially inward. The protrusion 410 includes a beveled surface 410a that extends essentially parallel to the longitudinal axis A and is inclined with respect to the radial direction R and the angular direction C. For example, the angle α between the beveled surface 410a and the radial direction R is at least 10° and at most 80°, preferably between 30° and 55°.

[0141] 28, the resilient arms 41 are in a first radial position, in which the projections 410 engage with or protrude into the recesses 220 of the second portion 22 of the rotatable collar 2, respectively. In this way, a rotation locking interface is formed, connecting the resilient arms 41 and the rotatable collar 2 and preventing the rotatable collar 2 from rotating.

[0142] The first radial position may be the relaxed position of the resilient arm 41 that it would occupy if no further radially inward and radially outward forces were acting on the resilient arm 41. Alternatively, the resilient arm 41 may be biased towards the first radial position, and thus the first radial position is the stressed position of the resilient arm 41.

[0143] As long as the resilient arm 41 is in the first radial position, with the projection 410 projecting into the recess 220, rotation of the rotatable collar 2 in the first rotational direction induced by the torsion drive spring 3 is prevented. However, torque acting on the rotatable collar 2 causes the surface of the second portion 22 that defines the recess 220 to press against the sloped surface 410a of the projection 410 of the resilient arm 41. This results in a force tending to move the resilient arm 41 radially outward from the first radial position to the second radial position. In other words, the torque induced by the torsion drive spring 3 biases the resilient arm 41 radially outward. If radial outward movement were possible, the first locking mechanism would automatically release and the automatic injector 1000 would enter a released state.

[0144] In the first locked state, the arms 5b of the needle shroud 5 are located at the height of the resilient arms 41, i.e., axially overlapping or aligned with the resilient arms 41, and prevent the resilient arms 41 from moving radially outwardly away from the first radial position. In effect, the resilient arms 41 abut radially outwardly against the needle shroud 5, and thus radially outward movement is prevented. The resilient arms 41 include further protrusions 411 that protrude radially outward and abut against the needle shroud 5. Radial outward movement of the needle shroud 5 is prevented, for example, by the housing 100 that circumferentially surrounds the needle shroud 5.

[0145] Figure 29 shows a portion of the auto-injector 1000 in the same state as in Figure 28, but now in a cross-sectional view with the longitudinal axis lying in the cutting plane. Here it can be seen that the arm 5b of the needle shroud 5 indeed comprises a first section 50a, i.e., a wall portion, and a second section 50b, i.e., a recess, e.g., a cutout. The recess 50b is offset in the distal direction D relative to the wall portion 50a. In the first, locked state, the needle shroud 5 is in its extended position, in which the wall portion 50a prevents the resilient arm 41 from moving radially outward.

[0146] 29 further illustrates that the needle shroud 5 can be moved from its extended position to its retracted position, which should result in axial and rotational overlap or alignment between the recesses 50b and the resilient arms 41. Movement of the needle shroud 5 in the proximal direction P requires a force, also referred to as an actuation force, which includes the force required to compress the shroud spring 7 and the frictional force resulting from the resilient arms 41 pressing against the needle shroud 5.

[0147] As a numerical example, assuming that the torque induced by the torsion drive spring 3 on the rotating collar 2 is 102 Nmm, the radius at which the rotating collar 2 abuts the protrusion 410 is 7.5 mm, and the angle α is 39°, the radial force on the elastic arm 41 should be approximately 10.57 N. Assuming that the friction coefficient is 0.3, the friction force should be approximately 3.17 N. Furthermore, assuming that the force compressing the shroud spring 7 is approximately 6 N, the starting force should be approximately 9 N.

[0148] 30 and 31 show portions of the auto-injector 1000 corresponding to those shown in FIGS. 28 and 29. The needle shroud 5 has now been moved to its retracted position (by overcoming the actuation force). This movement releases the first locking mechanism, thus switching the auto-injector 1000 from the first locked state to the released state. Because the recesses 50b of the needle shroud 5 are now at the level of the resilient arms 41, radial outward movement of the resilient arms 41 is no longer prevented. The resilient arms 41 are automatically biased out of their first radial position, induced by torque on the rotatable collar 2, to a second radial position, where the projections 410 no longer protrude into the recesses 220, thus dissolving the rotational locking interface and releasing the first locking mechanism. As a result, rotation of the rotatable collar 2 is no longer prevented. The rotating collar 2 begins to rotate due to the force induced by the drive spring 3 (see FIG. 30), thereby causing axial movement of the plunger rod 1 .

[0149] Figures 32 and 33 show portions of the auto-injector 1000 corresponding to those shown in Figures 28 and 29, where the auto-injector 1000 has been switched to a third locked or post-release state, e.g., the distal end of the auto-injector 1000 has been removed from the body, such that the needle shroud 5 automatically moves from the retracted position back to the extended position, induced by the shroud spring 7.

[0150] The protrusion 411 of the resilient arm 41 includes a sliding feature 411a in the form of a bevel 411a. The bevel 411a and the longitudinal axis may, for example, comprise an angle between 10° and 80°, inclusive. The edge of the needle shroud 5 that defines the recess 50b in the proximal direction P may contact this bevel 411a when the needle shroud 5 moves in the distal direction D. When the edge hits the protrusion 411, the bevel 411a presses the resilient arm 41 radially inward. In this way, the needle shroud 5 can return to the retracted position without getting stuck in the resilient arm 41. A sliding feature may additionally or alternatively be formed in the needle shroud 5 (see Figures 39 and 40).

[0151] If the resilient arms 41 do indeed abut the edges of the needle shroud 5 when the needle shroud 5 is moved in the distal direction D, the rotating collar 2, and in particular the second portion 22 of the rotating collar 2, has moved in the proximal direction P, allowing the resilient arms 41 to move radially inward. The second portion 22 is now therefore offset in the proximal direction P relative to the resilient arms 41. For this reason, it is particularly beneficial for the rotating collar 2 to move proximally as soon as the plunger rod 1 begins its distal movement, i.e., before the plunger rod 1 hits the stopper 82. If the user lifts the automatic injector 1000 from the skin prematurely, for example before the drug starts to be administered, the needle shroud 5 can still move back in the distal direction, activating the third locking mechanism described below.

[0152] 5.Third locking mechanism / post-release locking mechanism The third locking mechanism or post-release locking mechanism is described in further detail below in connection with Figures 34-40, respectively.

[0153] 34-38 illustrate a first exemplary embodiment of a third locking mechanism. This mechanism is configured to prevent the needle shroud 5 from being moved from the extended position to the retracted position after a drug has been delivered or the auto-injector has been actuated once, thereby reducing the risk of injury from an exposed needle. This third locking mechanism can be used in all exemplary embodiments of the auto-injector 1000 described herein.

[0154] Figure 34 again shows a cross-sectional view of a portion of the auto-injector 1000, the cutting plane including the longitudinal axis A. However, compared to that shown in, for example, Figure 33, the cutting plane has been rotated (see Figure 38 for a perspective view). It can be seen in Figure 34 that the arm 5b of the needle shroud 5 includes a first stop feature 51 in the form of a displaceable element 51 arranged at the proximal end of the arm 5b. The displaceable element 51 is a resilient arm 51 that may be integrally formed with the remainder of the needle shroud 5 and is thus axially and non-rotatably fixed to the remainder of the needle shroud 5. The resilient arm 51 therefore moves axially when the needle shroud 5 is moved axially.

[0155] As can be seen in FIG. 38, the resilient arm 51 is arranged at the same height as the wall portion 50a when viewed along the longitudinal axis A and is offset in an angular direction C from the wall portion 50a.

[0156] While extending in the proximal direction P, the resilient arms 51 also extend radially inward, i.e., the main extension direction of the resilient arms 51 has a component along the proximal direction P and a component along the radially inward direction. Thus, the proximal ends of the resilient arms 51 are located further radially inward than the distal ends of the resilient arms 51. The proximal ends of the resilient arms 51 are free and radially displaceable. The distal ends of the resilient arms 51 are connected to the remainder of the needle shroud 5. A twist is formed between the distal ends of the resilient arms 51 and the remainder of the needle shroud 5.

[0157] 34, the automatic injector 1000 is in a first locked state (also called the initial state or pre-release state), in which rotation of the rotatable collar 2 is prevented by the first locking mechanism, as described above. The resilient arms 51 are in a first radial position, which is their biased position. The resilient arms 51 are held in the first radial position and are prevented from moving radially inward by the second portion 22 of the rotatable collar 2. In this case, the drive spring holder 4 includes a recess 43, i.e., a cutout 43, into which the resilient arms 51 protrude. The resilient arms 51 abut radially inward against the second portion 22.

[0158] 35 shows a portion of the auto-injector 1000 in an in-use position, with the needle shroud 5 having been moved from its extended position to its retracted position, thereby switching the auto-injector 1000 to a released state. Together with the needle shroud 5, the resilient arms 51 move in the proximal direction P, such that the second portion 22 of the rotatable collar 2 no longer holds the resilient arms 51 in the first radial position, allowing the resilient arms 51 to move radially inward to the second radial position. In the released state, with the auto-injector 1000 and needle shroud 5 in the retracted position, the resilient arms 51 are offset in the proximal direction P relative to the second portion 22.

[0159] In the released state of the auto-injector 1000, the rotatable collar 2 moves in the proximal direction P from the unlocked position to the locked position, as shown in FIG.

[0160] FIG. 36 shows a portion of the automatic injector 1000 in a third locked state, also referred to as a post-release state, which is the state after use, i.e., after the medication has been dispensed. The third locked state is the state after the release state. In this third locked state, the required shroud 5 is still in its extended position. As can be seen in FIG. 36, the second portion 22 has moved in the proximal direction P so that the resilient arm 51 is displaced in the distal direction D relative to the second portion 22 and can no longer hold the resilient arm 51 in the first radial position. Thus, in the third locked state, the resilient arm 51 is in the second radial position. When an attempt is made to move the needle shroud 5 from the extended position toward the retracted position, the resilient arm 51 in the second radial position abuts against the second stop feature 22a, i.e., the surface of the second portion 22 that extends essentially perpendicular to the longitudinal axis and faces the distal direction D. This prevents further movement of the needle shroud 5 in the proximal direction P. For example, the auto-injector 1000 is configured such that in the third locked state, when the needle shroud 5 is moved in the proximal direction P before the needle is exposed, the resilient arm 51 abuts against the surface 22a of the second part 22.

[0161] When the resilient arm 51 contacts the surface 22a of the second portion 22, a locking interface is formed between the resilient arm 51 and the surface 22a. To this end, a recess 221 or notch 221 is formed in the surface 22a, which engages the proximal end of the resilient arm 51 when the resilient arm 51 contacts the surface 22a. The recess 221 is defined by a slope 221a that is inclined relative to the longitudinal axis A and the radial direction. For example, the angle between the slope 221a and the longitudinal axis and / or the radial direction is between 10° and 80°, inclusive. When the proximal end of the resilient arm 51 engages the recess 221, the resilient arm 51 contacts the slope 221a and slides along the slope 221a, thereby moving radially inward. Thus, the recess 221 with the slope 221a prevents the resilient arm 51 from sliding radially outward along the surface 22a.

[0162] The surface 22a of the second portion 22 can extend circumferentially for at least 270° around the longitudinal axis and / or axis of rotation of the rotatable collar 2 and can have a constant geometric configuration along its angular extension. In this way, the function of the third locking mechanism is substantially independent of how far the rotatable collar 2 rotates in the released state.

[0163] As can be further seen in FIGS. 34-36 , the resilient arm 51 includes a sliding feature 51 a in the form of a ramp 51 a. During movement of the needle shroud 5 from the retracted position to the extended position, the ramp 51 a abuts the proximal edge of the second portion 22. The ramp 51 a is designed to cause the resilient arm 51 to slide along the edge of the second portion 22, thus forcing the resilient arm 51 radially outward. This allows the resilient arm 51 to pass through the second portion 22 without getting stuck by the second portion 22. After passing the second portion 22 during movement toward the extended position, the resilient arm 51 bounces back to its second radial position.

[0164] 37 shows in cross section the auto-injector 1000 in the third, locked state. As can be seen, the needle shroud 5 cannot be moved in the proximal direction P far enough to expose the needle 80 because the resilient arm 51 first abuts against the surface 22a of the second part 22.

[0165] 39 and 40 show a second exemplary embodiment of the third locking mechanism, which can also be used in all exemplary embodiments of the auto-injector described herein.

[0166] The main difference with respect to the first exemplary embodiment is that in the third, locked state of the auto-injector 1000, when moving the needle shroud 5 towards the retracted position, the resilient arm 51 strikes against a stop feature 40a axially fixed on the drive spring holder 4 rather than a stop feature axially fixed on the rotation collar 2. The stop feature 40a is formed by an edge of the drive spring holder 4. The edge 40a defines a recess / cutout in the drive spring holder 4 in the proximal direction P.

[0167] A flap 46 is axially fixed to the drive spring holder 4 and may, for example, be formed integrally with the drive spring holder 4, and partially fills the recess. The distal end of the flap 46 is connected to the drive spring holder 4, while the proximal end of the flap 46 is free and radially displaceable. The proximal end of the flap 46 is spaced from the edge 40a by a small gap.

[0168] In the first locked state, when the needle shroud 5 is still in the extended position, the rotating collar 2, in particular the second portion 22 of the rotating collar 2, abuts radially outward against the flap 46 of the drive spring holder 4 and holds the flap 46 in a first radial position where the flap 46 ends radially outwardly substantially flush with the edge 40a. The second portion 22 prevents the flap 46 from being displaced radially inward. On the other hand, the flap 46 abuts against the resilient arm 51 of the needle shroud 5. In the first radial position of the flap 46, the flap 46 holds the resilient arm 51 in its first radial position.

[0169] Because the flap 46 ends flush with the edge 40a and is held in its first radial position by the second portion 22, subsequent movement of the needle shroud 5 in the proximal direction P allows the resilient arms 51 to pass over the edge 40a without getting stuck on the edge 40a. Further movement of the needle shroud 5 to its retracted position releases the first locking mechanism, switching the auto-injector 1000 from the first locked state to the released state and moving the rotatable collar 2 together with the second portion 22 in the proximal direction P to the locked position. The needle shroud 5 is shown in its retracted position in FIG. 39.

[0170] By again moving the needle shroud 5 from its retracted position to its extended position, the resilient arms 51 pass the edge 40a and come to a stop at the level of the flap 46. This position is shown in Figure 40. The automatic injector 1000 is now in a third locked state. The resilient arms 51, and optionally the flap 46, can be biased radially inwards. Thus, the resilient arms 51 and the flap 46 move radially inwards and each reach a second radial position. This is possible because the elements are no longer held in their respective first radial positions by the second part 22 of the rotating collar 2.

[0171] With the flap 46 in the second radial position, it does not end up flush with the edge 40a of the drive spring holder 4. Thus, when the needle shroud 5 is moved from the extended position towards the retracted position, the resilient arm 51 abuts the edge 40a, thereby preventing further movement of the needle shroud 5 in the proximal direction P.

[0172] 6.Fall protection mechanism Exemplary embodiments of the fall protection mechanism are described in further detail below in connection with Figures 41 and 42. The fall protection mechanism prevents the first locking mechanism from releasing when the auto-injector 1000 is unintentionally dropped. In fact, when the exemplary embodiments of the auto-injector 1000 described herein are in the first locked state, movement of the rotating collar 2 in the proximal direction P should release the first locking mechanism.

[0173] 41 shows a portion of the auto-injector 1000 of the first and second exemplary embodiments in a cross-sectional view showing the first element of the fall protection mechanism. In the first, locked state of the auto-injector 1000, when the needle shroud 5 is still in the extended (initial) position, the second part 22 and the resilient arm 41 engage with each other (the protrusion 410 projects into the recess 220), and this engagement is maintained by the needle shroud 5 holding the resilient arm 41 in its radial position, as described in connection with the first locking mechanism. However, this engagement also establishes an axial locking interface, thereby preventing axial movement of the rotation collar 2 in at least the proximal direction P.

[0174] For this purpose, the protrusion 410 of the resilient arm 41 is a stepped protrusion and has two sections 410b, 410c (see also FIG. 49). The recess 220 in the second part 22 of the rotatable collar 2 is a stepped recess and also has two sections 220b, 220c. The sections 410b, 410c are connected by a surface 410d extending essentially perpendicular to the longitudinal axis. The sections 220b, 220c are also connected by a surface 220d extending essentially perpendicular to the longitudinal axis. The surface 220d is located distal to the surface 410d. These surfaces 220d, 410d abut or strike against each other when the rotatable collar 2 is moved in the proximal direction P. In this way, the rotatable collar 2 is prevented from moving in the proximal direction P as long as the protrusion 410 protrudes into the recess 220.

[0175] However, the first part of the fall protection mechanism described in connection with FIG. 41 may also be released if the needle shroud 5 is unintentionally moved in the proximal direction P. Therefore, in one exemplary embodiment, the fall protection mechanism includes a second part shown in connection with FIG.

[0176] 42 shows a portion of the auto-injector in cross-section, with the cutting plane extending parallel to the longitudinal axis A. The distal end of the auto-injector is shown, with the cap 110 still connected to the housing 100. The cap 110 is in its most proximal position and cannot be moved further in the proximal direction P relative to the housing 100, as doing so would cause it to hit the housing 100. The cap 110 includes a radially displaceable cap locking element 110a, i.e., a resilient arm 110a, with a projection 110b projecting radially inward to engage a cap locking element 52, i.e., a recess 52, in particular a cutout 52, in the needle shroud 5.

[0177] 42 shows the auto-injector 1000 when it is dropped, causing proximal movement of the needle shroud 5. Due to its proximal movement, the needle shroud 5, and in particular the edge of the needle shroud 5 that defines the recess 52 in the distal direction D, hits the protrusion 110b. This prevents further movement of the needle shroud 5 in the proximal direction P as long as the cap 110 is connected to the housing 100. Therefore, the needle shroud 5 cannot reach a retracted position in which it would no longer hold the resilient arms 41 in their radial position.

[0178] In the position shown in FIG. 42, the housing 100 circumferentially surrounds the resilient arm 110a and abuts or nearly abuts the resilient arm 110a, thereby preventing radially outward movement of the resilient arm 110a, so that the resilient arm 110a cannot move radially outward or can only move slightly radially outward.

[0179] The protrusion 110b is located at the proximal end of the resilient arm 110a of the cap 110. Normally, when the drug delivery device is not dropped, the edge of the needle shroud 5 that defines the recess 52 in the distal direction D is located further distally than shown in FIG. 42 . When removing the cap 110, the cap 110 is moved in the distal direction D until the protrusion 110b hits the edge of the recess 52. Then, in this position of the cap 110, the housing 100 does not prevent the resilient arm 110a from being moved radially outward, so the resilient arm 110a can move radially outward. The resilient arm 110a can disengage from the recess 52, and the cap 110 can be completely removed. The protrusion 110b has a slope (sliding feature) that hits the edge of the recess 52 when the cap 110 is moved in the distal direction D, thereby deflecting the resilient arm 110a radially outward.

[0180] 7. Subassembly, Assembly, and Second Locking Mechanism Figure 43 shows in an exploded view the front subassembly FSA (also referred to as release subassembly FSA or container holder subassembly FSA) and the rear subassembly RSA (also referred to as drive subassembly RSA) of the automatic injector according to the first exemplary embodiment, as well as the position of the front subassembly FSA and the rear subassembly RSA when assembled into the automatic injector 1000. These figures correspond to Figures 13, 15 and 16. Therefore, reference is primarily made to the description associated with these figures.

[0181] 43 shows that the support portion 6c of the syringe holder 6 includes first rotation locking features 61 in the form of protrusions 61 or ribs 61 that project radially outward and have a primary direction of extension along the longitudinal axis. These ribs 61 are configured to engage with second rotation locking features 54 in the arms 5b of the needle shroud 5, in particular in the form of slots 54. The recesses 54 are also elongated, have a primary direction of extension along the longitudinal axis, and are longer than the ribs 61, so that when engaged, relative axial movement between the needle shroud 5 and the syringe holder 6 is possible.

[0182] Figure 44 shows a perspective view of the forward subassembly FSA. As previously described, the needle shroud 5 includes two arms 5b, which are angularly positioned between the two arms 6b of the syringe holder 6. The arms 6b of the syringe holder 6 protrude in the proximal direction P beyond the arms 5b of the needle shroud 5. The needle shroud 5 and the syringe holder 6 are connected by a shroud spring 7 and rotational locking features 61, 54, so that the needle shroud 5 can be moved axially but not rotationally relative to the syringe holder 6.

[0183] Figure 45 shows a portion of the front subassembly FSA of Figure 44. A window 60 is formed in arm 6b of syringe holder 6, through which a syringe or drug container placed in syringe holder 6 can be inspected. Window 60 is bounded by wall portion 60a of syringe holder 6. The diameter of window 60 decreases radially inward.

[0184] Syringe holder 6 further includes radially outwardly protruding snap features 62, or ribs, respectively, located at the distal and proximal ends of window 60. Snap features 62 are configured to engage housing 100 to secure syringe holder 6 thereto, thereby preventing axial and rotational movement of syringe holder 6 relative to housing 100.

[0185] 45, rib 61 protrudes into recess 54, thereby allowing axial movement of needle shroud 5 relative to syringe holder 6, but preventing rotational movement of needle shroud 5 relative to syringe holder 6. To that end, the width of recess 54 may be substantially the same as the width of rib 61.

[0186] 46 shows a detailed view of the distal end of the forward subassembly FSA, with the cap 110 attached to the needle shroud 5. The protrusions 110b of the resilient arms 110a protrude into the recesses 52 of the needle shroud 5, so that the cap 110 is loosely held in place against the needle shroud 5.

[0187] Figure 47 shows a portion of the posterior subassembly RSA in a perspective view. Figure 48 shows the posterior subassembly RSA in a cross-sectional view, with the longitudinal axis A extending in the cutting plane. Figure 50 shows the posterior subassembly RSA in a cross-sectional view, with the cutting plane extending perpendicular to the longitudinal axis A. An exemplary embodiment of the second locking mechanism is shown based on these figures.

[0188] As can be seen in FIG. 47 , a recess 44, specifically a cutout, is formed in the first section 4a of the syringe holder 4. The first portion 21 of the rotating collar 2 includes a displaceable axial locking element 210 in the form of a resilient arm 210 or clip 210. The resilient arm 210 is radially displaceable. The resilient arm 210 is configured to protrude into the recess 44 when in the first radial position, in which case the rear subassembly RSA is in a second locked state. Due to the engagement between the resilient arm 210 and the recess 44, when the rotating collar 2 is moved in the proximal direction P, the resilient arm 210 abuts against an edge of the drive spring holder 4 that defines the recess 44 in the proximal direction P, thereby establishing an axial locking interface and preventing proximal movement of the rotating collar 2 relative to the drive spring holder 4. This is one component of a second locking mechanism, also referred to as an axial locking mechanism.

[0189] 48, in the second locked state, the second portion 22 of the rotating collar 2 abuts against the second bottom ring 4d of the drive spring holder 4. The first portion 21 of the rotating collar 2 abuts against the first bottom ring 4c of the drive spring holder 4.

[0190] The second locking mechanism also includes a protrusion 45 (see also FIG. 49 ) that is part of the second portion 4 b of the drive spring holder 4 and that protrudes radially inward. The protrusion 45 cannot move in either direction relative to the remainder of the drive spring holder 4. The protrusion 45 can have the same form as the first section 410 b of the protrusion 410 of the resilient arm 41. The protrusion 45 is offset in the distal direction D relative to the resilient arm 41 or the protrusion 410, respectively. Furthermore, the second locking mechanism includes the second section 22 of the rotation collar 2, with the aforementioned recess 220 also forming part of the aforementioned first locking mechanism.

[0191] In the second locked state, the projection 45 projects into the recess 220 (see FIG. 50), thereby establishing a rotational locking interface. This engagement prevents rotation of the rotating collar 2 (the biased torsion drive spring 3 may already be in a state where it induces a torque on the rotating collar 2 in the second locked state). This is another member of the second locking mechanism, also referred to as the second rotational locking mechanism.

[0192] The second rotational locking mechanism does not require the needle shroud 5 to maintain the second locked state because the protrusions 45 are not radially displaceable. Therefore, rotation of the rotation collar 2 is not possible unless the rotation collar 2 is moved in the proximal direction P.

[0193] Figure 51 shows the auto-injector in an assembled position, with the rear and front subassemblies of the previous figures nested together. Figure 52 shows the same assembled position as Figure 51 in cross section.

[0194] As can be seen in FIG. 52 , the arms 6 b of the syringe holder 6 each include or form a pressing element 63 and a release element 64 at their proximal ends. The release element 64 protrudes beyond the pressing element 63 in the proximal direction P. Furthermore, the pressing element 63 is offset radially inward relative to the release element 64. When mated together, the release element 64 first abuts against the resilient arm 210, moving the resilient arm 210 radially inward, thus releasing the axial locking mechanism. This is achieved because the resilient arm 210 has a slope inclined with respect to the longitudinal axis, and a force acting on the slope in the proximal direction P presses the resilient arm 210 radially inward.

[0195] Simultaneously with or after mating of the rear subassembly with the front subassembly, the pressing element 63 abuts the first section 21 of the rotating collar 2 and presses the rotating collar 2 in the proximal direction P (see also FIG. 53 ). This releases the second rotational locking mechanism, transferring it from the second locked state to the first locked state. As the rotating collar 2 is pressed in the proximal direction P, the needle shroud 5 is moved to a position that holds the resilient arms 41 in their first radial positions, thereby occupying the first locked state. As a result of pressing the rotating collar 2 in the proximal direction P during assembly, the recesses 220 in the second part 22 disengage the protrusions 45 and then engage the protrusions 410 of the resilient arms 41 (see also FIG. 49 ).

[0196] 8. Feedback mechanism 54-56 show exemplary embodiments of feedback mechanisms that may be used in any of the exemplary embodiments of the drug delivery devices described herein.

[0197] Figure 54 shows a portion of an exemplary embodiment of a drug delivery device / auto-injector 1000 having such a feedback mechanism. In Figure 54, the auto-injector 1000 can be in a first locked state (initial state).

[0198] The feedback mechanism comprises a plunger rod 1 received in a rotating collar 2. The rotating collar 2 can be designed as described in connection with the previous figures. In particular, the rotating collar 2 is a sleeve. The plunger rod 1 is hollow, for example hollow cylindrical. A feedback energy member 14 in the form of a spring 14, for example a compression spring, is received in the plunger rod 1, i.e., in its cavity. Furthermore, a feedback element 12 in the form of a piston 12 is received in the plunger rod 1. The spring 14 is connected to the piston 12 and the plunger rod 1 and is compressed. The spring 14 induces a force in the proximal direction P on the piston 12, i.e. the piston 12 is biased in the proximal direction P relative to the plunger rod 1.

[0199] The plunger rod 1 includes axially oriented displaceable arms 13. The displaceable arms 13 may be resilient arms 13 and are disposed at the proximal end of the plunger rod 1. The displaceable arms 13 each include a stop feature 130 in the form of a protrusion 130 at the respective proximal end. Each of the displaceable arms 13, together with its protrusion 130, is radially displaceable. Each of the displaceable arms 13 is in a first radial position. The displaceable arms 13 can be biased radially outward. However, the displaceable arms 13 are held in the first radial position by the side walls of the rotating collar 2 circumferentially surrounding the plunger rod 1 at least at the height of the displaceable arms 13.

[0200] A protrusion 130 of the displaceable arm 13 projects into the cavity of the plunger rod 1. The proximal end of the piston 12 abuts against the protrusion 130, which prevents the piston 12 from moving in the proximal direction P beyond the protrusion 130 as driven by the spring 14.

[0201] 54, the piston 12 and the protrusion 130 each include a sliding feature in the form of a ramp that is inclined relative to the longitudinal axis and the radial direction. The piston 12 and the protrusion 130 abut each other at the ramp, thereby biasing the protrusion 130 or the displaceable arm 13, respectively, radially outward.

[0202] 55 shows the auto-injector 1000 in a released state. The torsion drive spring induces a torque on the rotating collar 2, which begins to rotate in a first rotational direction, thereby moving the plunger rod 1 in the distal direction D. The biased spring 14 and piston 12 move with the plunger rod 1 in the distal direction D. During this movement, the displaceable arm 13 of the plunger rod 1 is held in a first radial position by the side wall of the rotating collar 2 still circumferentially surrounding the resilient arm 13.

[0203] In the region of the distal end of the rotating collar 2, i.e., in the region between the first section 21 and the second section 22, the side wall of the rotating collar 2 is interrupted by a recess 23. When the plunger rod 1 reaches the feedback position, the displaceable arm 13 or the protrusion 130, respectively, overlaps this recess 23 axially and non-rotatably. The displaceable arm 13 is therefore no longer held in the first radial position. Due to the radial outward bias, the displaceable arm 13 leaves the first radial position and moves radially outward to a second radial position. In the second radial position, the piston 12, driven by the spring 14, is no longer prevented from moving past the protrusion 130 in the proximal direction P relative to the plunger rod 1. This is shown in FIG. 56.

[0204] 56, it can be seen that the piston 12 moves in the proximal direction P due to the force induced by the spring 14, thereby leaving the plunger rod 1 and eventually striking the proximal end 201 of the rotating collar 2, which forms the impact feature 201. This strike can trigger audible and / or tactile feedback to indicate to the user the end of the drug delivery process. For example, the auto-injector can be designed so that the piston 12 striking the impact feature 201 produces a noise of at least 20 dB.

[0205] 9. Third Exemplary Embodiment of the Drug Delivery Device Figures 57 and 58 show a third exemplary embodiment of a drug delivery device 1000. Figure 57 is a side view and Figure 58 is a side view rotated 90° about the longitudinal axis A relative to Figure 57. The drug delivery device 1000 is an auto-injector.

[0206] The auto-injector 1000 includes a housing 100 having a window 120. The window 120 can be used to inspect the fill level of a drug container or syringe, or the progression of a stopper within the housing 100, or the clarity of the drug, or drug degradation.

[0207] The auto-injector 1000 further includes a protective member 5 in the form of a needle shroud 5 that is telescopically coupled to the housing 100 and is axially movable relative to the housing 100 .

[0208] 59 and 60 show the same view of the auto-injector 1000 of FIGS. 57 and 58, but now with the housing 100 shown semi-transparent, allowing further members and elements of the auto-injector 1000 to be seen. It can be seen that the auto-injector 1000 further includes a rear cap 102 that closes the housing 100 at the proximal end. Furthermore, the auto-injector 1000 includes a drive spring holder 4, which is hollow, e.g., a sleeve. A torsion drive spring 3 is received in the drive spring holder 4. The torsion drive spring may be a spiral torsion spring. A rotation collar 2 is received in the torsion drive spring 3 and the drive spring holder 4. Furthermore, a movable member 9, also referred to as an actuation element 9, is provided in the form of an actuation collar 9. The actuation collar 9 is releasably axially coupled to the needle shroud 5, such that axial movement of the needle shroud 5 induces axial movement of the actuation collar 9. An actuation collar 9 is disposed downstream of the torsion drive spring 3 in the distal direction D and circumferentially surrounds a portion of the rotation collar 2 .

[0209] The auto-injector 1000 further includes a shroud spring 7 that couples the needle shroud 5 to the housing 100. The coupling via the shroud spring 7 is such that proximal movement of the needle shroud 5 relative to the housing 100 compresses the shroud spring 7. This compression urges the needle shroud 5 in the distal direction D relative to the housing 100.

[0210] 61 and 62 show the auto-injector 1000 of FIGS. 57 and 58 in the same view, but now in a cross-sectional view in which the cutting plane includes the longitudinal axis A. In this view, it can be seen that the auto-injector 1000 further includes a plunger rod 1. The plunger rod 1 is primarily received in and circumferentially surrounded by the rotating collar 2. Only a small portion of the plunger rod 1 (less than 50% of its length) protrudes from the rotating collar 2 in the distal direction D. The rotating collar 2 is closed in the proximal direction P, and the plunger rod 1 does not protrude beyond the proximal end of the rotating collar 2. Measured along the longitudinal axis, the plunger rod 1 is longer than the rotating collar 2.

[0211] The housing 100, housing element 4, plunger rod 1, rotating collar 2, needle shroud 5, and actuation element 9 can all comprise or consist of plastic. All of these components can each be integrally formed. The drive spring 3 and shroud spring 7 can comprise or consist of a metal, such as steel.

[0212] 61 and 62, it can be seen that a drug container 8, in this case a syringe 8, is disposed in a housing 100. The syringe 8 may be disposed axially and / or non-rotatably and / or radially fixed relative to the housing 100. The syringe 8 includes a drug-filled cartridge 81, a needle 80, and a stopper 82. The needle 80 is disposed at the distal end of the syringe 8. The stopper 82 seals the cartridge 81 in a proximal direction P. Moving the stopper 82 in a distal direction D forces the drug contained in the cartridge 81 out of the syringe 8 through the needle 80.

[0213] 61 and 62, it can be further seen that the needle 80 is covered by a needle shield 83, which encloses the needle 80 and protrudes beyond the needle 80 in a distal direction D. The needle shield 83 can be removed before using the auto-injector 1000.

[0214] To use the auto-injector 1000, the distal end of the auto-injector 1000, formed by the needle shroud 5, can be pressed against a body, e.g., a human body, causing the needle shroud 5 to move from its extended position in a proximal direction P relative to the housing 100. This exposes the needle 80, which protrudes in a distal direction D so that it can penetrate body tissue.

[0215] 61 and 62, the auto-injector 1000 is still in an initial state, hereinafter referred to as the locked state, in which the torsion drive spring 3 is biased and induces a torque on the rotatable collar 2. However, a locking mechanism prevents rotational movement of the rotatable collar 2. The locking mechanism is described in further detail below.

[0216] In this locked state, the proximal end of the rotating collar 2 can be axially spaced from the proximal end stop of the housing 100. This allows axial movement of the rotating collar 2 in the proximal direction P. Furthermore, in the locked state, the distal end of the plunger rod 1 is axially spaced from the stopper 82 of the syringe 8. Therefore, the plunger rod 1 can move axially in the distal direction D a predetermined distance until it hits the stopper 82.

[0217] The needle shroud 5 can be moved in the proximal direction P to a retracted position. This releases the locking mechanism, and therefore rotation of the rotating collar 2 is no longer prevented. The automatic injector switches from the locked state to the unlocked state. The torque induced by the torsion drive spring 3 on the rotating collar 2 causes the rotating collar 2 to rotate in a first rotational direction (clockwise or counterclockwise). For example, the rotating collar 2 rotates several times around its rotation axis. A drive mechanism, such as the drive mechanism described above, converts the rotation of the rotating collar 2 into axial movement of the plunger rod 1 in the distal direction D. After moving a predetermined distance in the distal direction D, the plunger rod 1 can strike the stopper 82 of the syringe 8 and then press the stopper 82 in the distal direction D, thereby forcing the drug in the cartridge 81 through the needle 80 and into the tissue.

[0218] The rotatable collar 2 can not only rotate but also move in the proximal direction P until the proximal end of the rotatable collar 2 abuts against a proximal end stop of the housing 100. The end stop includes a protrusion 101 that tapers in the distal direction D. The protrusion 101 can be conical. The proximal end of the rotatable collar 2 includes a recess 200. For example, the surface of the proximal end of the rotatable collar 2 has a concave shape. The protrusion 101 can penetrate into the recess 200 when the proximal end of the rotatable collar 2 abuts against the end stop of the housing 100. The protrusion 101 and the recess 200 can each be designed to be rotationally symmetric or circularly symmetric with respect to the rotation axis of the rotatable collar 2. In this way, a low-friction interface is formed between the housing 100 and the rotatable collar 2, thereby enabling low-friction rotation of the rotatable collar 2 when the proximal end of the rotatable collar 2 abuts against the housing 100. In particular, the radius at which friction between the rotating collar 2 and the end stop acts approaches or becomes zero, and therefore the resulting torque resulting from friction also tends to zero, significantly reducing losses, allowing for reduced spring forces and / or improving injection performance.

[0219] 63 shows in cross section the automatic injector 1000 according to the third exemplary embodiment after use. The plunger rod 1 abuts against the stopper 82, pushing it in the distal direction D. As a result, the drug in the cartridge 81 is forced out of the syringe 8 through the needle 80, e.g., whereby the drug is injected into body tissue.

[0220] 64 shows different subassemblies of an automatic injector 1000 according to a third exemplary embodiment. The automatic injector 1000 includes a forward subassembly FSA. The forward subassembly FSA includes a housing 100, a needle shroud 5, and a shroud spring 7 connecting the housing 100 and the needle shroud 5.

[0221] The auto-injector 1000 further includes a rear sub-assembly RSA, which has a plunger rod 1 , a rotation collar 2 , a torsion drive spring 3 , a drive spring holder 4 , and an activation collar 9 .

[0222] When assembling the front subassembly FSA and the rear subassembly RSA, the syringe 8 is first fitted into the housing 100 of the front subassembly FSA, and then the rear subassembly RSA is fitted into the housing 100. Finally, a rear cap 102 is attached to the proximal end of the housing 100 and can be fixed to the housing 100 via a clip.

[0223] 65 shows the forward subassembly FSA in an exploded view. The needle shroud 5 includes a hollow cylindrical distal portion 5a into which the shroud spring 7 can be fitted. Furthermore, the needle shroud 5 includes two arms 5b extending in the proximal direction P from the cylindrical portion 5a.

[0224] Figure 66 shows the rear subassembly RSA in an exploded view.

[0225] 9.1 Drive mechanism of the drug delivery device according to the third exemplary embodiment The drive mechanism of the auto-injector according to the third exemplary embodiment can be designed as the drive mechanism described above.

[0226] 9.2 Locking mechanism of a drug delivery device according to a third exemplary embodiment FIG. 67 shows a portion of the auto-injector 1000 according to the third exemplary embodiment in a locked state.

[0227] The upper part of Figure 67 above the horizontal dashed line shows a portion of the auto-injector 1000 in side view. The lower part of Figure 67 below the dashed line shows a portion of the auto-injector in a side view rotated 90° about the longitudinal axis A relative to the upper part.

[0228] FIG. 70, for example, shows the auto-injector 1000 in a cross-sectional view, also in the locked state, with the intersecting plane perpendicular to the longitudinal axis A.

[0229] Considering first FIG. 67, the needle shroud 5 includes a coupling feature 53 in the form of a resilient arm 53, which has a protrusion that projects radially inward. The actuation collar 9 has a coupling feature 92 in the form of a recess 92 or opening 92. The protrusion of the resilient arm 53 projects into the recess 92. In this manner, the needle shroud 5 and actuation collar 9 are axially coupled, such that axial movement of the needle shroud 5 induces axial movement of the actuation collar 9.

[0230] At the bottom of FIG. 67, it can be seen that the recess 92 is L-shaped and includes two sections angularly adjacent to one another. In the locked state shown in FIG. 67, the resilient arm 53 engages the first section of the recess 92. The first section of the recess 92 is bounded by edges of the activation collar 9 in the proximal direction P and the distal direction D. Thus, axial movement of the needle shroud 5 in the proximal direction P and the distal direction D causes the protrusion of the resilient arm 53 to abut one of these edges. As a result, when the needle shroud 5 is moved in the distal direction D, the activation collar 9 is moved in the distal direction D, and when the needle shroud 5 is moved in the proximal direction P, the activation collar 9 is moved in the proximal direction P. In other words, the needle shroud 5 is coupled to the activation collar 9 in the proximal direction P and the distal direction D.

[0231] On the other hand, the second section of the recess 92 is bounded only in the proximal direction P by an edge of the actuation collar 9. The second section of the recess 92 is open in the distal direction D and is not bounded by an edge of the actuation collar 9. Thus, if the protrusion of the resilient arm 53 engages the second section of the recess 92, moving the needle shroud 5 in the proximal direction P will cause the protrusion to hit the edge of the actuation collar 9, which will also move the actuation collar 9 in the proximal direction P. However, moving the needle shroud 5 in the distal direction D will cause the resilient arm 53 and the recess 92 to disengage.

[0232] Furthermore, it can be seen in FIG. 67 that the actuation collar 9 is connected to the drive spring holder 4 via a first rotation lock interface. The first rotation lock interface prevents rotation of the actuation collar 9 relative to the drive spring holder 4. On the other hand, as can be seen in FIG. 70, the rotation collar 2 and the actuation collar 9 are connected via a second rotation lock interface. The second rotation lock interface prevents rotation of the rotation collar 2 relative to the actuation collar 9. Therefore, in summary, rotation of the rotation collar 2 relative to the drive spring holder 4 is prevented by two rotation lock interfaces.

[0233] The first rotational locking interface is established by a slit 91a in the actuation collar 9 and a rib 47 of the drive spring holder 4 that engages with the slit 91. The rib 47 and the slit 91 are each elongated, with their primary extension along the longitudinal axis. As can be seen in FIG. 67, the slit 91a is a first section of a recess 91 in the actuation collar 9. The recess 91 also includes a second section 91b adjacent to the slit 91a in the distal direction D. Measured along the angular direction, the slit 91 has a smaller width than the second section 91b. The width of the second section 91b first increases away from the slit 91a and then becomes constant. Within this region of increasing width, the second section 91b is bounded by a slope 91c of the actuation collar 9 that is inclined relative to the longitudinal axis and the rotational direction. This slope 91c provides a sliding function. In the locked state shown in FIG. 67, the rib 47 engages with the slit 91a of the recess 91.

[0234] As can be seen in FIG. 70, the second rotational locking interface is achieved by the angular abutment of the protrusion 93 of the actuation collar 9 and the protrusion 24 of the rotatable collar 2. The protrusion 93 of the actuation collar 9 projects radially inward, and the protrusion 24 of the rotatable collar 2 projects radially outward. The protrusions 24, 93 abut against each other, such that the actuation collar 9 prevents or blocks rotation of the rotatable collar 2 relative to the actuation collar 9 induced by the biased torsional drive spring 3.

[0235] FIG. 68 shows the auto-injector 1000 with the needle shroud 5 moved proximally from its extended position toward its retracted position. The needle shroud 5 is now in an intermediate position between the extended and retracted positions. At this intermediate position, the rib 47 is transferred from the slit into the second section 91b. The force induced by the drive spring 3 presses the ramp 91c against the rib 47, causing the rib 47 to slide along the ramp 91c, thereby rotating the activation collar 9 through a predetermined angle in a first rotational direction relative to the drive spring holder 4 and the needle shroud 5. This rotation occurs automatically because the torque induced by the torsional drive spring 3 is transmitted to the activation collar 9 through the rotation collar 2 (via the second rotation lock interface). After the predetermined angle of rotation, the edge of the activation collar 9, which extends parallel to the longitudinal axis and defines the second section 91b of the recess 91 in the angular direction, abuts the rib 47. At this time, further rotation of the actuation collar 9 relative to the drive spring holder 4 in the first rotational direction is prevented.

[0236] However, as a result of the actuation collar 9 rotating a predetermined angle in the first rotational direction, the resilient arms 53 of the needle shroud 5 then engage with the second sections of the recesses 92 of the actuation collar 9, thereby decoupling the actuation collar 9 and the needle shroud 5 in the distal direction D. In other words, the coupling between the needle shroud 5 and the actuation collar 9 in the distal direction D is released.

[0237] 69 shows the automatic injector 1000 in a position where the needle shroud 5 has been further moved in the proximal direction P to a retracted position, and the activation collar 9 has also been further moved in the proximal direction P. In this retracted position of the needle shroud 5, the needle 80 of the automatic injector 1000 can be exposed, thereby allowing the needle 80 to be penetrated into body tissue. With the needle shroud 5 in the retracted position, the second rotation lock interface between the activation collar 9 and the rotation collar 2 is released, i.e., the protrusions 24 and 93 are now axially offset and no longer abut each other, thus placing the automatic injector 1000 in a released state, in which rotation of the rotation collar 2 relative to the activation collar 9 and drive spring holder 4 is enabled. The rotation collar 2 rotates in a first rotational direction, thereby driving the plunger rod 1 in the distal direction D, resulting in delivery of the drug through the needle 80 (see above).

[0238] Further movement of the actuation collar 9 in the proximal direction P results in a second interlocking feature 90, i.e., clip 90, of the actuation collar 9 engaging with the interlocking feature 48, i.e., recess 48, of the drive spring holder 4. The engagement between the clip 90 and the recess 48 is such that movement of the actuation collar 9 in the distal direction D is prevented. When the needle shroud 5 is moved from the retracted position back toward or into the extended position, the actuation collar 9 no longer complies and is no longer able to follow. As described above, the resilient arm 53 engages the second section of the recess 92, thereby enabling movement of the needle shroud 5 in the distal direction D relative to the actuation collar 9.

[0239] Figures 71 to 73 show different positions during assembly of the auto-injector 1000 according to the third exemplary embodiment: the rear sub-assembly is fitted into the front sub-assembly.

[0240] Figure 71 shows a first position in which the needle shroud 5 of the front sub-assembly and the activation collar 9 of the rear sub-assembly are not yet coupled to one another. Figure 71 is a side view of the auto-injector 1000 during assembly.

[0241] Figure 72 shows the position of Figure 71 in a cross-sectional view. It can be seen that the resilient arms 53 of the needle shroud 5 have a sliding feature in the form of a ramp. This ramp is designed so that, when it hits the distal end of the activation collar 9, a force is generated that presses the resilient arms 53 radially outward. The rear and front subassemblies can then be further fitted together, and the protrusions of the resilient arms 53 slide into the recesses 92 of the activation collar 9 as soon as they overlap axially and non-rotatably with this recess. In this way, a connection between the activation collar 9 and the needle shroud 5 is obtained.

[0242] FIG. 73 shows the auto-injector after connection of the needle shroud 5 and activation collar 9.

[0243] Further Explanations and Definitions The terms "drug" or "medicament" are used interchangeably herein to describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medications are used to treat, cure, prevent, or diagnose disease or otherwise improve physical or mental well-being. Drugs or medications can be used for a limited duration or periodically for chronic disorders.

[0244] As described below, drugs or pharmaceutical agents may contain at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules with a molecular weight of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids, such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0245] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two years. Storage can occur at room temperature (e.g., about 20°C) or refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components prior to and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to allow mixing of the two components by a user, if desired, prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0246] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary embolism. Further examples of disorders include acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in handbooks such as Rote Liste 2014 (e.g., but not limited to, Main Group 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index, 15th edition.

[0247] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative; glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, or an analog or derivative thereof; a dipeptidyl peptidase-4 (DPP4) inhibitor; or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or replaced amino acid residue can be either a codable amino acid residue, another naturally occurring residue, or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, for example, the molecular structure of human insulin in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-codable amino acids, or amino acids, including non-codable ones, are added to the naturally occurring peptide.

[0248] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0249] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0250] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flathead monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rexendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide). , HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexene, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP -DI-70, TT-401 (Pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0251] Examples of oligonucleotides are, for example, the cholesterol-lowering antisense therapeutic mipomersen sodium (Kynamro®) for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome.

[0252] Examples of DPP4 inhibitors are linagliptin, vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0253] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0254] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low-molecular-weight heparin or ultra-low-molecular-weight heparin or derivatives thereof, or sulfated polysaccharides, such as the polysulfated forms of the aforementioned polysaccharides, and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low-molecular-weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives include Hylan G-F20 (Synvisc®) and sodium hyaluronate.

[0255] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain antigen-binding ability. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single-chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, antibody fragment, or mutant that does not support Fc receptor binding, e.g., has a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins (CODVs) with a crossover binding region orientation.

[0256] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to antigen. Antibody fragments can include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, e.g., bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, e.g., bivalent, trivalent, tetravalent, and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0257] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences and that are primarily responsible for maintaining the proper orientation of the CDR sequences to enable antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDRs to interact with the antigen.

[0258] Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0259] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use as drugs or medicaments in drug delivery devices. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0260] Those skilled in the art will understand that modifications (additions and / or deletions) can be made to various components of the APIs, formulations, apparatus, methods, systems, and embodiments described herein without departing from the full scope and spirit of the present invention, and that the present invention encompasses such modifications and all equivalents thereof. Exemplary drug delivery devices can include needle-based injection systems as described in Table 1 of Chapter 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based injection systems can be broadly distinguished into multi-dose container systems and single-dose (partial or full expulsion) container systems. The containers can be interchangeable or integrated, non-interchangeable containers.

[0261] As further described in ISO 11608-1:2014(E), a multi-dose container system can include a needle-based injection device with replaceable containers. In such a system, each container holds multiple doses, and the dose size can be fixed or variable (pre-set by the user). Another multi-dose container system can include a needle-based injection device with an integrated, non-replaceable container. In such a system, each container holds multiple doses, and the dose size can be fixed or variable (pre-set by the user).

[0262] As further described in ISO11608-1:2014(E), a single-dose container system can include a needle-based injection device with replaceable containers. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable volume (full discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable volume (partial discharge). As also described in ISO11608-1:2014(E), a single-dose container system can include a needle-based injection device with an integrated, non-replaceable container. In one example of such a system, each container holds a single dose, thereby discharging the entire deliverable volume (full discharge). In a further example, each container holds a single dose, thereby discharging a portion of the deliverable volume (partial discharge).

[0263] The invention described herein is not limited by the description in connection with the exemplary embodiments. On the contrary, the invention includes any and all novel features and any and all combinations of features, and particularly any and all combinations of features in the claims, even if such features or such combinations themselves are not explicitly recited in the claims or exemplary embodiments. [Explanation of symbols]

[0264] 1 plunger rod 2 Rotating Colors 3 Torsion drive spring 4 Drive spring holder 4a First section of drive spring holder 4 4b second section of drive spring holder 4 4c First bottom ring of drive spring holder 4 4d Second bottom ring of drive spring holder 4 5 Needle Shroud 5a Cylindrical part 5b Arm 6 Drug container holder / syringe holder 6a Cylindrical part 6b Arm 6c Support part 7 Shroud spring 8. Drug containers / syringes 9 Startup Color 10 grooves 11 External Thread 12 pistons 13 Displaceable Arm 14 Feedback energy member / spring 20 axes 21 First Part 22 Second Part 22a surface 23 Recess 24 protrusions 40 protrusions 40a: Edge portion inside drive spring holder 4 41 Elastic Arm 43 Recess 44 recess 45 Protrusion 46 Flap 47 Ribs 48 recess 50a wall section 50b recess 51 Elastic Arm 51a ramp 52 recess 53 Elastic Arm 54 Recess 60 Windows 60a wall section 61 Ribs 62 Snap function 63 Pressing element 64 Release element 80 needles 81 Cartridge 82 Stopper 83 Needle Shield 90 clips 91 Recess 91a Slit / first section of recess 91 91b Second section of recess 91 91c slope 92 recess 93 Protrusion 100 Housing 101 Protrusion 102 Rear cap 110 Cap 110a Elastic Arm 110b protrusion 111 Gripping part 120 Windows 130 Protrusion 200 depressions 201 Impact Function 210 Elastic Arm / Clip 220 recess 220b First section of recess 220 220c second section of recess 220 220d Surface of recess 220 221 recess 221a Slope 410 Protrusion 410a Slope 410b First section of protrusion 410 410c second section of protrusion 410 410d Protrusion 410 surface 411 Protrusion 411a Slope 1000 Drug Delivery Devices / Auto-Injectors FSA forward subassembly RSA Rear Subassembly α angle D. Distal direction P proximal direction A Longitudinal / Axial Axis R Radial direction C. Orientation / Rotation / Angle Direction

Claims

1. An apparatus for a drug delivery device (1000): a housing element (4); a plunger rod (1) arranged axially movably relative to the housing element (4); a transmission member (2) rotatably arranged relative to a housing element (4); an energy member (3) configured to provide energy for inducing a torque on the transmission member (2); where: The transmission member (2) and the plunger rod (1) are operatively connected such that rotation of the transmission member (2) is translated into axial movement of the plunger rod (1); The device includes a release state, and in the release state: The transmission member (2) moves proximally relative to the housing element (4) until it hits an end stop; The energy member (3) induces a torque on the transmission member (2), the transmission member (2) is rotated in a first rotational direction by the induced torque, thereby moving the plunger rod (1) axially in a distal direction (D); The plunger rod (1) is fixed non-rotatably relative to the housing element (4); The device.

2. The plunger rod (1) is non-rotatably fixed to the housing element (4) via a spline interface; 10. The apparatus of claim 1.

3. In the released state, the transmission member (2) rotates at least n times 360°, where n is an integer greater than or equal to 1; and / or The plunger rod (1) and the transmission member (2) are operably coupled via a threaded interface; 3. The device according to claim 1 or 2.

4. the device has a first locked state, in which a releasable first locking mechanism prevents rotational movement of the transmission member (2); the first locking mechanism includes a first rotational locking element (22) non-rotatably and axially fixed relative to the transmission member (2) and a second rotational locking element (41) non-rotatably and axially fixed relative to the housing element (4), the rotational locking elements (22, 41) of the first locking mechanism being configured to engage with each other; Engagement of the rotational locking elements (22, 41) of the first locking mechanism prevents rotational movement of the transmission member (2); The device according to any one of claims 1 to 3.

5. The second rotational locking element (41) is a displaceable element, The displaceable rotary locking element (41) is radially displaceable, The displaceable rotary locking element (41) is oriented in the circumferential direction, 5. The apparatus of claim 4.

6. the device has a second locked state, in which a releasable second locking mechanism prevents axial and rotational movement of the transmission member (2); the second locking mechanism includes a first axial locking element (210) fixed axially and non-rotatably to the transmission member (2) and a second axial locking element (4a) fixed axially and non-rotatably to the housing element (4), the two axial locking elements (210, 4a) of the second locking mechanism being configured to engage with each other; Engagement of the axial locking element (210, 4a) of the second locking mechanism prevents axial movement of the transmission member (2); the second locking mechanism includes a first rotational locking element (22) non-rotatably and axially fixed relative to the transmission member (2) and a second rotational locking element (4b) non-rotatably and axially fixed relative to the housing element (4), the two rotational locking elements (22, 4b) of the second locking mechanism being configured to engage with each other; The engagement of the two rotational locking elements (22, 4b) of the second locking mechanism prevents rotational movement of the transmission member (2). The device according to any one of claims 1 to 5.

7. In the second locked state, the transmission member (2) is axially displaced relative to the first locked state.

7. The apparatus of claim 6.

8. In the released state, after hitting the end stop, the transmission member (2) continues to rotate, and / or The transmission member (2) moves in the proximal direction (P), The device according to any one of claims 1 to 7.

9. The end stop includes a friction reducing element (101), The proximal end of the transmission member (2) includes a friction reducing element (200); A low-friction interface is formed between the friction-reducing elements (101, 200); At least one of the friction-reducing elements (101, 200) is a tapered protrusion; The other of the friction-reducing elements (101, 200) is a recess.

9. The apparatus of claim 8.

10. the recesses and / or protrusions are rotationally symmetrical with respect to the rotation axis of the transmission member (2); 10. The apparatus of claim 9.

11. The energy member (3) is a drive spring and is connected to the transmission member (2) at a first connection point. 、 connected to the housing element (4) at a second connection point; During the axial movement of the transmission member (2), the first connection point and the second connection point are moved axially relative to each other. The device according to any one of claims 8 to 10.

12. A drug delivery device (1000) comprising: A device according to any one of claims 1 to 11; a housing (100) having a housing element (4) fixed to or integral with the housing (100); a drug container (8) having a needle (80); The drug delivery device includes a needle shroud (5) matingly connected to the housing (100), the needle shroud being axially movable relative to the housing (100) between an extended position in which the needle (80) is covered by the needle shroud (5) and a retracted position in which the needle (80) is exposed.

13. The drug delivery device of claim 12, wherein the drug delivery device (1000) is an auto-injector.

14. 14. A drug delivery device according to claim 12 or 13, wherein the drug reservoir (8) contains a drug.

Images