Drug delivery device and methods of assembling and use thereof

Abstract

A drug delivery device is provided. The drug delivery device comprises a drug subassembly and a drive subassembly, which is connectable to or releasably connected to the drug subassembly. The drug subassembly comprises a reservoir with a drug and a piercing element coupled to the reservoir and configured to be fluidly connectable to the reservoir, such that, when the piercing element is fluidly connected to the reservoir, an interior of the reservoir is in fluid communication with an exterior of the reservoir. The piercing element and the reservoir are movable relative to each other for fluidly connecting the piercing element to the reservoir. The drive subassembly comprises a carrier configured to receive the drug subassembly, a drive mechanism with a drive element configured to provide a force for delivering the drug from the reservoir, when the drive subassembly is triggered, a chassis, and an actuation element configured to trigger the drive subassembly, when being moved to a retracted position relative to the chassis.

Description

[0001] PAT24096-WO-PCT

[0002] Title

[0003] Drug delivery device and methods of assembling and use thereof

[0004] Background

[0005] Drug delivery devices provide a convenient option for injecting a drug to a subject, which can be a human or an animal. The drug may be injected by a user, e.g. via self-injection, if the subject itself performs the injection, or by another person, e.g. a healthcare professional. For example, drug delivery devices are safer against human error than conventional syringes. Due to increasing demand, hand-held drug delivery devices require mass production. Reducing manufacturing costs and increasing manufacturing speed is an ongoing challenge, in which user safety plays an important role.

[0006] Summary

[0007] The disclosure relates to a drug subassembly for a drug delivery device. Further, the disclosure relates to a drive subassembly for a drug delivery device. Further, the disclosure relates to a drug delivery device. Further the disclosure relates to a method of assembling a drug delivery device. Further, the disclosure relates to a method of using a drug delivery device.

[0008] It is an object of the disclosure to provide a drug subassembly and a drive subassembly for a drug delivery device as well as a drug delivery device, which improve assembly and functionality. For example, the subassemblies as well as the drug delivery device according to the disclosure should preferably be easily and / or comfortably usable and / or comprise as few parts as possible. Furthermore, it is an object of the disclosure to provide improved subassemblies and an improved drug delivery device. Furthermore, methods of assembling the drug subassembly, the drive subassembly and / or the drug delivery device shall be provided. The methods should preferably simplify the production / manufacturing of the subassemblies and the drug delivery device, making these processes more efficient and less prone to error. Furthermore, a method of using the drug delivery device shall be provided, which simplifies the use of the drug delivery device, making the use of the drug delivery device safer, more convenient for the subject and / or less prone to error. The objects are solved by the drug subassembly, the drive subassembly, the drug delivery device and / or the methods according to the appended independent claims. Further aspects are described in the dependent claims.

[0009] According to an embodiment of the disclosure, a drug subassembly for a drug delivery device is provided. For example, the drug delivery device may be an injection device such as an autoinjector and / or a pen-shaped injector and / or a flat injection device. The drug subassembly comprises a reservoir filled with a drug, e.g. a pre-filled cartridge.

[0010] The drug subassembly further comprises a piercing element, e.g. a needle, coupled to the reservoir and configured to be fluidly connectable to the reservoir, such that, when the piercing element is fluidly connected to the reservoir, an interior (inside) of the reservoir is in fluid communication with an exterior (outside) of the reservoir. In other words, drug from inside the reservoir may flow through the piercing element, i.e. from an inlet of the piercing element to an outlet of the piercing element, thereby exiting the reservoir. In other words, the outlet may be configured to deliver drug from the piercing element to an outside thereof, e.g. the drug from the reservoir which enters the piercing element via the inlet. For example, the outlet may be configured to deliver the drug into a body of the subject.

[0011] The inlet of the piercing element may be an inlet tip of a needle, an inlet needle, a spike or any other element suitable for connecting to the reservoir, e.g. by piercing the reservoir or a pierceable seal thereof. The outlet of the piercing element may be an outlet tip of a needle, an outlet needle or a separable injection needle, which can be connected to the drug subassembly, e.g. to a needle hub thereof. The outlet may be configured to pierce an injection site, e.g. a skin of the subject.

[0012] In one embodiment, the piercing element and the reservoir may be movable relative to each other for fluidly connecting the piercing element, e.g. the inlet thereof, to the reservoir. In one embodiment, the piercing element may be fluidly connected to the reservoir by being coupled to the reservoir such that the piercing element and the reservoir are not movable relative to each other.

[0013] In one embodiment, the reservoir may be a flexible reservoir, e.g. a deformable bag or pouch, which may be made of a deformable material such a plastic, silicone, rubber or the like. The flexible reservoir may be configured to be deformed in order to deliver drug from inside the reservoir. In one embodiment, the reservoir may be semi-rigid, e.g. a blow-fill-seal container, which may be deformed without breakage but which is not necessarily intended to be deformed. The semi-rigid reservoir may be made of plastic. In one embodiment, the reservoir may be non- deformable, e.g. a pre-filled cartridge. The cartridge may be made of a rigid material such as glass.

[0014] In one embodiment, the reservoir may comprise an opening forming an outlet for delivering the drug from the reservoir. The opening may be shaped as a flange. The reservoir may further comprise a pierceable seal for sealing the opening. The pierceable seal may be configured to be pierced by the piercing element, when the piercing element and the reservoir are moved towards each other. The pierceable seal may by a septum. The pierceable seal may be connected, e.g. fixedly attached, to the opening of the reservoir, such that the opening is sealed.

[0015] In one embodiment, the reservoir may be made of a pierceable material configured to be pierced by the piercing element, when the piercing element and the reservoir are moved towards each other. For example, if the reservoir is a blow-fill-seal container, the opening be an area of the container wall which has a thinner wall thickness than the remainder of the container, thereby facilitating the piercing the wall by the piercing element.

[0016] In one embodiment, the drug in the interior of the reservoir may be pressurized such that when the reservoir is fluidly connected to the piercing element, the drug is delivered from the reservoir due to a pressure difference between the interior and the exterior of the reservoir. In one embodiment, the reservoir may comprise a stopper movable within the reservoir to deliver the drug from the reservoir, e.g. through the opening.

[0017] In one embodiment, the drug subassembly may comprise a needle hub configured to hold at least a part of the piercing element, e.g. the inlet and / or the outlet. The needle hub and the reservoir may be movable relative to each other, e.g. towards each other. In one embodiment, the reservoir may be movable relative to the needle hub in a delivery direction, i.e. a direction in which the drug is delivered from the reservoir. Depending on the structure of the drug subassembly, the structure of a drive subassembly and / or the structure of a drug delivery device comprising at least one of these assemblies, the delivery direction may not always point in the same spatial direction along the whole delivery path (fluid path), i.e. from the reservoir to the outlet of the piercing element. For example, if the piercing element is a needle with a 90 degree bend, i.e. an inlet direction of the needle is perpendicular to an outlet direction thereof, the delivery direction bends likewise by 90 degrees between the inlet and the outlet. In other words, the spatial direction of the delivery direction may depend on a position within the delivery path. The drug subassembly may be configured such that the relative movement between the reservoir and the needle hub towards each other causes the piercing element to pierce the pierceable seal. For example, the reservoir may be moved towards the needle hub in order to make the piercing element pierce the pierceable seal. In other words, the reservoir may be moved relative to the needle hub in the delivery direction, which may be parallel to a longitudinal axis of the reservoir and / or the drug subassembly in this portion of the delivery path. For example, the delivery direction may point from the stopper towards the opening of the reservoir.

[0018] In one embodiment, the piercing element may comprise a user interface. The user interface may be configured to deliver drug from the reservoir to the subject. The outlet of the piercing element may comprise the user interface. For example, the user interface may be a distal portion of the outlet tip, the outlet needle or the injection needle, which enters the subject’s skin.

[0019] In one embodiment, the piercing element may be configured such that the inlet of the piercing element, which is configured to be connectable to the reservoir, points in a different direction than the outlet of the piercing element. For example, a longitudinal axis of the inlet may be perpendicular to a longitudinal axis of the outlet. Alternatively, the longitudinal axis of the inlet and the longitudinal axis of the outlet may form different angles, e.g. 10 degrees, 20 degrees, 45 degrees and so on, depending on the desired piercing angle, i.e. the angle formed between an injection surface, i.e. a surface of the subject comprising the injection site, e.g. the subject’s skin, and the outlet of the piercing element.

[0020] In one embodiment, the drug subassembly may comprise a releasable lock feature configured to prevent a fluidic connection between the piercing element and the reservoir, when the lock feature is in a locked state. For example, in the locked state, the lock feature may limit a relative movement of the piercing element and the reservoir towards each other so that the piercing element cannot pierce the pierceable seal. On the other hand, the lock feature may be configured to allow a fluidic connection between the piercing element and the reservoir in a released state. In one embodiment, the lock feature may be a deflectable arm, e.g. on the piercing element or on the needle hub, which may be releasably engage a corresponding protrusion, e.g. on the reservoir or on a needle shield, upon a user action, e.g. removal of the needle shield from the drug subassembly.

[0021] In one embodiment, the drug subassembly may comprise a coupling connectable to or connected to, e.g. releasably connected to, the reservoir, e.g. to the opening or the pierceable seal. The coupling may further be connectable to or connected to, e.g. releasably connected to, at least one of the needle hub and / or the piercing element. For example, the coupling may surround the needle hub, at least, partially. By way of example, the coupling may surround a needle hub extension of the needle hub. The coupling may be configured to align the piercing element and the reservoir, e.g. during assembly, storage, transportation and / or use. Further, during use, the coupling may guide the relative movement between the reservoir and the piercing element. For example, the coupling may align the reservoir and the piercing element during their relative movement towards each other such that the piercing element pierces a center, or a region close to the center, of the pierceable seal.

[0022] In one embodiment, the coupling may be connectable to the needle hub such that the coupling may align the piercing element, e.g. via the needle hub, and the reservoir, e.g. during the relative movement between the reservoir and the piercing element towards each other. When coupled to the needle hub, the coupling may be configured to protect an inlet of the piecing element, e.g. for avoiding mechanical damage and / or keeping it sterile.

[0023] In one embodiment, the coupling may comprise a main body with a connection feature. The main body may surround the inlet of the piercing element for protecting the inlet, as described before. The connection feature may be configured to connect, e.g. attach or couple, the coupling to the reservoir. For example, the connection feature may couple the coupling to the reservoir in a fixed or in a releasable manner.

[0024] In one embodiment, the connection feature may comprise at least one, e.g. at least two, snap arms with radial inward protrusions, extending towards the longitudinal axis. The snap arms may be spaced equidistantly in a circumferential direction of the connection feature. The snap arms may be deflectable in a radial outward direction, such that when the coupling is moved toward the reservoir, e.g. during assembly of the drug subassembly, the snap arms deflect radially outwardly when contacting the opening of the reservoir. This may tense the snap arms so that, when the radial inward protrusions align with an edge of the flange formed by the opening of the reservoir, the snap arms return to their non-deflected state so that the radial inward protrusions engage the flange, thereby fixing the coupling to the reservoir.

[0025] In one embodiment, the coupling may comprise at least one guide arm configured to interact with, e.g. engage, at least one corresponding recess in the needle hub for connecting the coupling to the needle hub. For example, there may be 2, 3, 4, 5, 6 or even more guide arms, which may be equidistantly arranged in the circumferential direction of the coupling. The guide arms may extend along a longitudinal direction of the coupling, which may be parallel to the delivery direction in this portion of the fluid path. As regards the function, the guide arm may defect and return to a non-deflected state in similar fashion as described before with regard to the snap arms of the connections feature for connecting the coupling to the reservoir. As such, the guide arm may be deflectable in a radial outward direction and may comprise a radial inward protrusion for engaging the corresponding recess of the needle hub, when connecting the coupling to the needle hub, similar to the snap arms of the connection feature. The interaction between the guide arms and the recesses may align the needle hub and the reservoir when moved towards each other.

[0026] In one embodiment, the guide arms may be pre-tensed toward the longitudinal axis of the coupling such that the guide arms are tensed, when being parallel to the longitudinal axis and even more tensed when deflecting outwardly. This may improve the engagement of the radial inward protrusions and the recesses and help keeping the engagement between the coupling and the needle hub.

[0027] In one embodiment, the coupling may comprise an insert. The insert may be configured to be attachable to an outer surface of the needle hub, e.g. the needle hub extension formed at an inlet end of the needle hub, and to at least one of the reservoir, e.g. the flange formed by the opening, and the pierceable seal. The attachment may be releasable. For example, the outer surface of the needle hub extension may slide along an inner surface of the insert, thereby aligning the needle hub and the reservoir and supporting, e.g. guiding, the relative movement between to piercing element and the reservoir. Further, the insert and the needle hub extension may be configured to be connected to each other such that the inlet of the piercing element may be kept clean and sterile. Hence, the coupling may ensure a clean fluid path from the reservoir to the injection site.

[0028] The insert may be made of a different material than the coupling. For example, the insert may be made of a flexible material like silicone or rubber or plastic. The insert may be configured to deform, preferably elastically, when an external force greater than a predetermined threshold force is applied thereto. For example, the insert may elastically deform during attachment of the insert to the reservoir and / or the pierceable seal and / or the needle hub. For example, the insert may be configured to stretch radially outwardly, when it is attached to the reservoir, such that the insert surrounds the opening of the reservoir. Likewise, the insert may be configured to deform, e.g. be compressed, when the insert is moved into the coupling.

[0029] In one embodiment, the insert may be configured to be imposed on the pierceable seal such that the insert, at least partially, surrounds the pierceable seal. The connection feature may be configured to maintain the insert on the pierceable seal by limiting a deformation of the portion of the insert which is imposed on the pierceable seal. The arms may be equidistantly distributed in a circumferential direction, such that an angular offset between all arms is the same. The arms may be deflectable, e.g. in a radial outward direction, and the inward protrusions may comprise an angled surface such that the insert can be easily connected to the connection feature, e.g. by pushing the insert into the connection feature which may cause the arms to radially outwards deflect until the protrusions are aligned with an end surface of the insert. If aligned, the arms may return to their non-deflected state and the protrusions engage the end surface.

[0030] In one embodiment, the drug subassembly may comprise a hub bracket configured to interact with a drive subassembly, when the drug subassembly is connected to, e.g. mounted to, the drive subassembly. The drive subassembly may be a drive subassembly of a drug delivery device, e.g. a drive subassembly as described herein. The hub bracket may comprise one or more mounting protrusions configured to interact with, e.g. engage, corresponding mounting guides of the drive subassembly, e.g. mounting guides of a chassis thereof, when the drug subassembly is connected to the drive subassembly. Due to the interaction, a movement of the hub bracket relative to the drive subassembly, e.g. to the chassis, may be limited. For example, a relative movement between the drug subassembly and the drive subassembly along the longitudinal axis of the reservoir may be limited. Likewise, a relative movement in a direction perpendicular to the delivery direction may be limited, such that the hub bracket may only be moved relative to the drive subassembly in one spatial direction.

[0031] In one embodiment, the hub bracket may have a rectangular or square cross-section, preferably with rounded corners, when looked at in the delivery direction. The mounting protrusions may comprise two arm-like extensions, extending outwardly from each of the four corners. The two arm-like extensions may be arranged and designed to form a mounting channel for accommodating the mounting guides of the drive subassembly, when the hub bracket is mounted to the drive subassembly. In other words, the mounting protrusions may slide along the mounting guides when the drug subassembly is connected to, e.g. mounted to, the drive subassembly. For example, the drug subassembly may be connected to the drive subassembly by moving the mounting protrusions relative to the mounting guides in the delivery direction.

[0032] In one embodiment, the hub bracket may have a cross-section with more or less than 4 corners, e.g. 3, 5, 6, or 8 corners. The number of mounting protrusions may correspond to the number of corners or may be chosen according to the desired limitation of the relative movement between the drug subassembly and the drive subassembly. In one embodiment, the hub bracket may be configured to secure engagement of the coupling and the needle hub. For example, the hub bracket may prevent a disengagement of the guide arms of the coupling from the recesses of the needle hub, by limiting a radial outward movement of the guide arms to keep them engaged in the recesses. The hub bracket may comprise a space for accommodating the needle hub, e.g. the needle hub extension, and / or the coupling, e.g. the guide arms thereof. The hub bracket may be configured to be imposed on the needle hub and / or the coupling, e.g. in the delivery direction, after the needle hub is connect to the coupling via the guide arms interacting with the recesses. For example, one side of the hub bracket may comprise an opening for allowing the hub bracket to be imposed on the coupling and the portion of the needle hub, e.g. the needle hub extension, where the coupling is connected to the needle hub.

[0033] In one embodiment, the piercing element may comprise at least one needle. The needle may comprise a bend, e.g. a 90 degree bend, such that an inlet end is perpendicular to an outlet end. The needle may be fixedly connected to the needle hub. The needle may comprise an outlet tip for piercing an injection site and an inlet tip for piercing the pierceable seal, when the reservoir and the piercing element are moved towards each other. The needle may be bent such that the outlet tip points in a different direction than the inlet tip. For example, the outlet tip may point in a direction perpendicular to the direction in which the inlet tip points. In other words, the outlet tip may point towards the injection surface while the inlet tip may point in a direction parallel to the injection surface, e.g. in a direction opposite to the delivery direction.

[0034] In one embodiment, a cross-section, e.g. a diameter, of the outlet of the piercing element may be smaller than a cross-section, e.g. a diameter, of the inlet of the piercing element. The following explanations exemplarily describe dimensional and / or geometric specifics of an outlet tip and an inlet tip of the piercing element, which are examples for the outlet and the inlet of the piercing element. If not indicated otherwise, these exemplary explanations apply other kinds of outlets and / or inlets of the piercing element, as described herein, likewise.

[0035] In one embodiment, a diameter of the outlet tip may be smaller than a diameter of the inlet tip. The diameter of the outlet tip and / or the diameter inlet tip may be designed to ensure that drug can flow through the needle from the inlet tip to the outlet tip. For reducing the pain for the subject, the diameter of the outlet tip may be minimized. This reduction may be limited by the desired minimum outflow rate. Alternatively or additionally, the diameter of the inlet tip may be maximized for improving the drug flow through the needle. The diameter may be a minimum diameter, a maximum diameter or an average diameter of the respective element. In one embodiment, a cross-section of the inlet tip may be larger than a cross-section of the outlet tip, e.g. at least 1.2 times larger, at least 1.5 times larger, at least 2 times larger, at least 3 times larger, at least 4 times larger, at least 5 times larger, at least 7 times larger, at least 10 times larger, at least 15 times larger, at least 20 times larger, at least 30 times larger, at least 40 times larger or at least 50 times larger.

[0036] The piercing element may comprise an intermediate section between the inlet and the outlet. For example, if the piercing element is a needle, the intermediate section may be formed between the inlet tip and the outlet tip. In one embodiment, the intermediate section may be tapered such that a cross-section, e.g. a diameter, thereof gradually decreases in the delivery direction, at least in a portion of the intermediate section, e.g. over the whole length of the intermediate section. Alternatively, the intermediate section may comprise one or more stepwise changes of the diameter.

[0037] In one embodiment, the piercing element may comprise two needles, an outlet needle and an inlet needle. The outlet needle may be fluidly connected to, i.e. in fluid communication with, the inlet needle. The inlet needle may be configured to connect to the reservoir, e.g. by piercing the pierceable seal, when the reservoir and the inlet needle are moved towards each other. The outlet needle may be configured to pierce the injection site. The inlet needle and / or the outlet needle may be fixedly connected to the needle hub.

[0038] In one embodiment, the inlet needle may be connected to the outlet needle by an internal fluid path. For example, the intermediate section may comprise the internal fluid path. Alternatively, the internal fluid path may be formed inside the needle hub. The internal fluid path may be bent, such that the outlet needle points in a different direction than the inlet needle. Depending on the desired piercing angle, i.e. the angle between the injection surface and the outlet needle, different curvatures of the internal fluid path may be realized, e.g. 10 degrees, 20 degrees, 45 degrees or 90 degrees. The internal fluid path may be a rigid fluid channel inside the needle hub or a separate fluid channel. The needle hub may comprise a channel space for accommodating the separate fluid channel. The separate fluid channel may be a flexible fluid channel, e.g. a flexible tube, which can be inserted into the channel space of the needle hub for connecting the inlet needle with the outlet needle.

[0039] The diameters and cross-sections of the inlet needle and the outlet needle may differ in the same way as the diameters and cross-sections of the inlet tip and the outlet tip, described in the foregoing. For example, the cross-section of the inlet needle may be larger than the crosssection of the outlet needle.

[0040] In one embodiment, the inlet of the piercing element may be a spike, e.g. a spike formed by the needle hub. For example, the needle hub extension may form the spike.

[0041] In one embodiment, the needle hub may comprise a needle receiving portion configured to receive an injection needle. The injection needle may be a needle which is not held in the needle hub but releasably attachable thereto. The needle receiving portion may be in fluid communication with the reservoir, e.g. via the internal fluid path and / or the inlet needle and / or the spike, as described in the foregoing. The needle receiving portion may be configured for threaded connection with the injection needle. The injection needle may be configured to pierce an injection site, similar to the outlet needle or the outlet tip, as described in the foregoing. The threaded connection may be a Luer-lock fitting.

[0042] In one embodiment, the drug subassembly may comprise a needle shield configured to cover the outlet of the piercing element, e.g. the outlet tip, the outlet needle or the separable injection needle, before use of the drug subassembly, e.g. before an injection performed with the drug subassembly. The needle shield may be configured to keep the outlet of the piercing element sterile and protect it against damage. The needle shield may be connectable to or releasably connected to the drug subassembly, e.g. to the piercing element and / or to the needle hub and / or to the separable injection needle and / or the hub bracket. The needle shield may be a rigid needle shield or a soft needle shield.

[0043] In one embodiment, the drug subassembly may comprise a safety cap connectable to or releasably connected to the needle shield, e.g. via a needle shield gripper. The safety cap may further be configured to be connectable or releasably connected to the needle hub and / or the hub bracket and / or the coupling.

[0044] According to an embodiment of the disclosure, a drive subassembly for a drug delivery device is provided. For example, the drug delivery device may be an injection device such as an autoinjector and / or a pen-shaped injector and / or a flat injection device. The drive subassembly is configured to provide a force for delivering a drug from a reservoir, e.g. from the reservoir of the drug subassembly as described above. The drive subassembly comprises a carrier configured to receive a reservoir with a drug or a drug subassembly. The drug subassembly may be a drug subassembly as described herein. The drive subassembly comprises a drive mechanism and a chassis for connecting the carrier and the drive mechanism. The drive mechanism comprises a drive element. The drive element may be configured to provide the force for delivering the drug from the reservoir. For example, the drive element may be a spring such as a compression spring or torsion spring.

[0045] The drive subassembly further comprises an actuation element movable relative to the chassis between an extended position and a retracted position. For example, the actuation element may be movable relative to the chassis in a direction perpendicular to a longitudinal axis of the chassis. In the extended position the actuation element extends beyond the chassis, e.g. beyond a bottom surface of the chassis, which may be a surface for contacting the subject’s skin. In the retracted position, the actuation element is, at least partially, telescoped into the chassis, such that it extends less beyond the chassis than in the extended position. The extended position may be a position of the actuation element relative to the chassis before the drive subassembly is triggered, i.e. a first extended position. Alternatively or additionally, the extended position may be a position of the actuation element relative to the chassis after the drive subassembly is triggered, i.e. a second extended position. The second extended position may also be referred to a safety position.

[0046] In one embodiment, the retracted position may be a position in which the actuation element extends less beyond the chassis than in any other position of the actuation element.

[0047] In one embodiment, the actuation element may be configured to trigger the drive subassembly. For example, drive subassembly may be triggered by moving the actuation element to its retracted position relative to the chassis, e.g. from the first extended position. The actuation element may be configured to interact with one or more of the carrier, the drive mechanism and the chassis, for limiting a relative movement between these components before the drive subassembly is triggered. The drive subassembly may further be configured such that when the actuation element is moved to its retracted position, the carrier and / or the drive mechanism may move relatively to the chassis, e.g. in the delivery direction. Further, triggering the drive mechanism may free the drive element, which may be primed, i.e. pre-tensed, when assembling the drive mechanism or the drive subassembly.

[0048] In one embodiment, the actuation element may be a needle shroud. The needle shroud may be configured to cover an outlet needle or the outlet tip of a piercing element, or the injection needle, when the needle shroud is in the extended position, e.g. before or after injection, when the drive subassembly is not pressed against an injection site. In one embodiment, the carrier may comprise a reception space configured to receive a reservoir therein, e.g. a reservoir of a drug subassembly as described herein. The reception space may comprise a flange support configured to support a flange of the reservoir, e.g. a flange formed by an opening of the reservoir, e.g. an outlet opening. For example, the flange support may be U-shaped such that it limits a movement of the reservoir in the delivery direction relative to the carrier, e.g. by providing a stop for a shoulder of the reservoir.

[0049] In one embodiment, the carrier may be movable relative to the chassis along its longitudinal axis, e.g. towards the actuation element, which may be in the delivery direction. A longitudinal axis of the carrier and / or the chassis and / or the drive mechanism and / or the drive subassembly may be parallel to the delivery direction.

[0050] In one embodiment, the drive subassembly may comprise a carrier spring, e.g. a compression spring, configured to provide a force for moving the carrier relative to the chassis, when the drive subassembly is triggered.

[0051] In one embodiment, the drive subassembly may comprise a carrier lock configured to limit a movement of the carrier relative to the chassis, when the actuation element is not in the retracted position, e.g. when the actuation element is in the extended position. For example, a movement of the carrier along relative to the chassis, e.g. along its longitudinal axis, may be limited. The carrier lock may comprise a carrier lock protrusion on the actuation element and a carrier lock recess in the carrier. The carrier lock protrusion and the carrier lock recess are configured to interact. For example, when the actuation element is not in the retracted position, the interaction may limit a relative movement between the carrier and the chassis, e.g. a movement of the carrier along its longitudinal axis. On the other hand, when the actuation element is in the retracted position, the interaction may be such that the carrier may move relative to the chassis, e.g. towards the actuation element.

[0052] Upon movement of the actuation element to the retracted position, the carrier lock protrusion may disengage, e.g. decouple from or move out of an engagement with, a first portion of the carrier lock recess, thereby releasing the carrier lock and allowing a relative movement between the carrier and the chassis, e.g. a movement of the carrier in the delivery direction. The carrier lock recess may be configured such that the movement of the carrier relative to the chassis is stopped by an interaction of the carrier lock protrusion with a second portion of the carrier lock recess. In other words, the drive subassembly may be triggered by moving the actuation element from the extended position to the retracted position. For example, the carrier lock recess may be shaped as a “II”, with arms / legs of the “II” pointing in a direction perpendicular to the longitudinal axis of the carrier, e.g. in the delivery direction. In the extended position of the actuation element, the carrier lock protrusion may interact with a first arm / leg of the U-shaped carrier lock recess. Upon movement of the actuation element to the retracted position, e.g. from the first extended position, the carrier lock protrusion may decouple the first arm / leg of the U-shaped carrier lock recess, thereby allowing a movement of the carrier relative to the chassis along the longitudinal axis of the chassis, e.g. substantially perpendicular to a main extension direction of the arm / leg. The movement of the carrier relative to the chassis results in a corresponding movement of the carrier relative to the actuation element, as a movement of the actuation element along the longitudinal axis of the chassis is limited. In other words, as the actuation element can only move along an axis perpendicular to the longitudinal axis of the chassis and / or carrier, the carrier lock protrusion and the carrier lock recess move relatively to each other, when the carrier moves relatively to the chassis.

[0053] Hence, when the actuation element is moved from the retracted position to the extended position, e.g. to the second extended position, the carrier lock protrusion interacts with a second arm / leg of the U-shaped carrier lock recess. Again, this interaction may limit a relative movement between the carrier and the chassis along the longitudinal axis of the chassis, e.g. a movement of the carrier away from the actuation element along its longitudinal axis.

[0054] The movement of the carrier relative to the chassis may be driven by a carrier spring force provided by the carrier spring.

[0055] When a drug subassembly, e.g. a drug subassembly as described herein, is connected to the drive subassembly, the relative movement between the carrier and the chassis may cause the reservoir of the drug subassembly to move towards the piercing element such that the piercing element is fluidly connected to the reservoir, e.g. by piercing the pierceable seal.

[0056] In one embodiment, the drive subassembly may comprise a drive bracket for connecting the drive mechanism to the chassis. The drive bracket may comprise at least one attachment feature, e.g. a radial protrusion, configured to interact with an attachment element of the chassis. The attachment element may comprise one or more grooves and / or protrusions, formed on inner side of the chassis. In one embodiment, the attachment element may be positioned at an end of the chassis which is opposite to an end of the chassis where a hub bracket, e.g. a hub bracket as described in the foregoing, may be connected to the chassis. In one embodiment, the drive bracket may comprise a flange forming a support for the carrier spring. For example, the flange may be a radial protrusion, which forms part of the attachment feature. In one embodiment, one end of the carrier spring may be fixedly connected to the flange of the drive bracket. In one embodiment, the carrier spring may be integrally formed with the drive bracket.

[0057] In one embodiment, the drive mechanism is configured to transfer a drive force of the drive element onto the reservoir such that drug is delivered from the reservoir, e.g. via a deformation of the reservoir. In one embodiment, the drive mechanism may comprise a plunger configured to transfer the drive force of the drive element onto a stopper movable within the reservoir, thereby causing a movement of the stopper within the reservoir in the delivery direction. The movement of the stopper within the reservoir may cause that drug is delivered from, e.g. pushed out of, the reservoir, e.g. through the opening.

[0058] In one embodiment, the plunger may comprise a push element for contacting the stopper and transferring the force of the drive element thereon. The push element may have a larger crosssection than the remainder of the plunger such that a contact interface between the push element and the stopper is maximized. This may improve the force transmission to the stopper because the force may be transmitted onto a larger area. Further, a large contact interface may be beneficial for a concentric force distribution. Further stress on the material of the plunger and / or the stopper may be reduced.

[0059] In one embodiment, the drive element may be configured to provide the drive force by gas being pressurized in a tank of the drive element.

[0060] In one embodiment, the plunger may be a lead screw. In one embodiment, the drive element may be a spring, e.g. a compression spring or a torsion spring. The drive element may be primed, e.g. pre-tensed. For example, the drive element may be tensed during assembly of the drive mechanism or during connection of the drive mechanism to the drive bracket. The pretensed drive element may be locked against a premature release, i.e. a release of the drive element before the drive subassembly is triggered. For example, the drive element may be secured against a premature release by an arbor break as described below.

[0061] In one embodiment, the drive mechanism may further comprise a drive housing configured to support the drive element, e.g. receive the drive element therein. The drive mechanism may further comprise an arbor and a drive nut. The arbor may be configured to be moved, e.g. rotated, relatively to the drive nut and / or the drive housing by the force of the drive element. The drive nut may be configured to transfer a movement of the arbor, e.g. a rotational movement caused by the drive element being a torsion spring, to the plunger, e.g. via a threaded engagement with the plunger.

[0062] In one embodiment, if the drive element is a torsion spring, the drive housing may further provide a rotational support for one end of the torsion spring. Hence, the drive housing may be secured in the drive subassembly against rotation with respect to the drive subassembly, e.g. the drive bracket, the carrier and / or the chassis.

[0063] In one embodiment, the drive housing may comprise a rotation stop feature configured to limit a rotation of the plunger relative to the carrier and / or the reservoir and / or the chassis and / or the drive housing and / or the arbor. Thus, the rotation stop feature may allow converting the rotational movement of the arbor into an axial movement of the plunger, e.g. in the delivery direction.

[0064] In other embodiments, the drive mechanism and its components, e.g. the drive element and / or the arbor and / or the drive nut and / or the plunger may be designed differently. The different design may lead to different relative movements between the components of the drive mechanism, e.g. it may cause the plunger to rotate during translation in the axial direction, such that the plunger performs a helical movement.

[0065] In one embodiment, the drive housing may comprise an outlet end wall. The outlet end wall may be configured to provide a support for an end of the carrier spring which does not contact the drive bracket. In other words, the carrier spring may extend between the drive bracket and the outlet end wall of the drive housing. The outlet end wall may further be configured to interact with an engagement feature of the carrier, e.g. an inward protrusion or a groove formed on an inner wall of the carrier. Hence, the outlet end wall of the drive housing may be axially fixed to the carrier, e.g. in or opposite to the delivery direction. Thus, a force of the carrier spring may be transferred via the outlet end wall of the drive housing to the carrier. This may cause an axial movement of the drive housing relative to the drive bracket and / or the chassis, e.g. along the longitudinal axis of the chassis in the delivery direction, when the carrier lock is released. Via the outlet end wall, this movement is transferred into a corresponding axial movement of the carrier relative to the chassis. In other words, the carrier may be moved towards the actuation element by the force of the carrier spring.

[0066] In one embodiment, the chassis may comprise an additional stop feature configured to interact with the carrier for stopping the carrier movement in the axial direction at a predetermined position, e.g. a position in which a piercing element is fluidly connected to an interior of a reservoir accommodated in the carrier. Alternatively, or additionally, the carrier lock recess may be configured to limit the movement of the carrier relative to the chassis, when the second arm / leg of the “II” interacts with the carrier lock protrusion on the actuation element.

[0067] In one embodiment, the drive mechanism may comprise a releasable arbor break configured to limit a movement, e.g. a rotation, of the arbor relative to the drive housing and / or the drive nut before the drive subassembly is triggered. The arbor break may comprise at least one deflectable arm. The at least one deflectable arm may be formed on the drive housing, e.g. a sidewall thereof. The deflectable arm may be configured to releasably engage an outer surface of the arbor. For example, the deflectable arm may comprise an inward protrusion configured to engage an arbor recess, e.g. a recess formed in an outer surface of the arbor. In one embodiment, the arbor recess may be formed between two teeth of a toothing formed on an outer surface of the arbor. The arbor break may further comprise an arbor break recess in the drive bracket configured such that the deflectable arm may deflect into the arbor break recess of the drive bracket, when the deflectable arm is aligned with the arbor break recess. For example, the deflectable arm may deflect in a radial outward direction into the arbor break recess of the drive bracket upon axial alignment. Due to the deflection, the inward protrusion of the deflectable arm may move out of the engagement with the arbor recess, thereby releasing the arbor break and allowing a rotation of the arbor relative to the drive housing and / or the drive nut.

[0068] In one embodiment, the inward protrusion and / or the teeth of the toothing on the outer surface of the arbor may be shaped to facilitate the outward deflection of the deflectable arm. For example, the inward protrusion and / or the teeth may be angled with respect to each other such that the inward protrusion may easily slide along the teeth, thereby causing the radial outward deflection of the deflectable arm, when the deflectable arm is aligned with the arbor break recess. The radial outward deflection may tense the arm such that, when the inward protrusion has passed one tooth and aligns with a next arbor recess, the deflectable arms returns to its relaxed state engaging the inward protrusion with the next arbor recess.

[0069] In one embodiment, the deflectable arm may be pre-tensed to facilitate its radial outward deflection into the arbor break recess of the drive bracket.

[0070] In one embodiment, the deflectable arm may align with the arbor break recess due to the movement of the carrier relative to the chassis in the delivery direction. In detail, the carrier spring may interact with the outlet end wall of the drive housing, e.g. push the outlet end wall of the drive housing in the delivery direction, thereby moving the drive housing relative to the drive bracket and / or the chassis in the delivery direction. The relative movement between the drive housing and the drive bracket may cause the deflectable arm to move relatively to the arbor break recess in the delivery direction. When reaching the arbor break recess, the deflectable arm is axially aligned with the arbor break recess, so that an inner surface of the drive bracket does not limit a radial outward movement of the deflectable arm and the deflectable arm can deflect into the arbor break recess.

[0071] In one embodiment, the arbor break may be designed to comprise more than one deflectable arm, e.g. 2, 3, 4, or even more deflectable arms.

[0072] In one embodiment, the drive subassembly may comprise a safety cap. The safety cap may be configured to be connectable to or releasably connected to the actuation element and / or the chassis. If the drive subassembly is connected to a drug subassembly, e.g. the drug subassembly described herein, the safety cap may further be connected to one or more of a needle shield, a needle hub, a coupling and a hub bracket of the drug subassembly. The safety cap may be configured to prevent a movement of the actuation element into the retracted position, when the safety cap is connected to the actuation element and / or the chassis. Further, the safety cap may be configured to limit a movement of the actuation element towards its retracted position, e.g. by surrounding a surface of the actuation element, which is configured to contact the subject, so that this surface cannot be operated and the actuation element cannot be moved towards its retracted position.

[0073] In one embodiment, the safety cap may comprise a needle shield gripper configured to interact with a needle shield for removing the needle shield from the piercing element, when the safety cap is removed from the actuation element and / or the chassis, and when a piercing element with a needle shield is present in the drive subassembly, e.g. when a drug subassembly as described in the foregoing is connected to the drive subassembly. The needle shield gripper may comprise one or more protrusions which are configured to engage one or more corresponding recesses in the needle shield.

[0074] In one embodiment, the drive subassembly may comprise a needle shroud spring configured to bias the actuation element towards its extended position. The needle shroud spring may extend between the actuation element, e.g. an inner surface thereof, and a flange formed on a needle hub or a hub bracket, when a needle hub and / or a hub bracket are connected to the drive subassembly. The needle hub and / or the hub bracket may be a needle hub or a hub bracket as described herein, e.g. in the context of the drug subassembly. The needle shroud spring may be a compression spring. The needle shroud spring may surround the needle shield. Where in contact with a flange of the needle hub, the needle shroud spring may be supported in a radial direction by a needle shroud spring support formed on the flange.

[0075] In one embodiment, the actuation element may comprise a lock-out feature (also referred to as safety lock-out mechanism) configured to interact with the carrier for locking the actuation element against a movement towards the retracted position, i.e. in a proximal direction, after the drive subassembly has been triggered. The lock-out feature may comprise one or more arms (lock-out arms) with clips configured to interact with the carrier, e.g. one or more lock-out recesses formed in a sidewall of the carrier. Upon movement of the actuation element towards the second extended position, e.g. due to the force of the needle shroud spring, the one or more arms may deflect inwardly as an angled distal surface of the clip slides along a protrusion of the sidewall of the carrier. When the actuation element reaches its second extended position the clip is aligned with the lock-out recess of the carrier. Thus, the one or more arms return to their non-deflected state and the clip engages the lock-out recess. This engagement limits a movement of the actuation element towards the retracted position, e.g. because a proximal surface of the clip is configured to be parallel to a distal surface of the lock-out recess, such than an interaction between these surfaces limits a movement of the actuation element towards the retracted position. In other words, the actuation element is locked in the safety position.

[0076] In the second extended position the actuation element may extend beyond the chassis by the same distance as it extended beyond the chassis in the first extended position, i.e. before the drive subassembly was triggered. Alternatively, in the second extended position, the actuation element may extend farther beyond the chassis as compared to the extension in the first extended position.

[0077] In one embodiment, the drive subassembly, e.g. the actuation element and the carrier, may be configured such that the actuation element may move towards the second extended position only after having been in the retracted position before. For example, the clips of the lock-out feature and the one or more lock-out recesses of the carrier may be positioned such that they cannot be brought in interaction before the drive subassembly has been triggered, e.g. before the carrier has moved relatively to the chassis towards the actuation element. Hence, it may be avoided that the actuation element is locked in the safety position before the drive subassembly has been triggered. In one embodiment, the lock-out feature and / or the lock-out recess may be arranged farther away from the reception space of the carrier than a first arm / leg of the U-shaped carrier lock recess and / or the carrier lock protrusion. For example, the lock-out feature and the lock-out recess may be arranged to be engaged when the carrier has moved to a final position relative to the chassis, e.g. after the drive subassembly has been triggered. In other words, the lock-out recess may be arranged between the legs of the U-shaped carrier lock recess.

[0078] In one embodiment, the drive subassembly, e.g. the chassis thereof, may comprise one or more mounting guides configured to interact with mounting protrusions of a drug subassembly, e.g. the mounting protrusions of the hub bracket as described in the foregoing, for connecting the drug subassembly to the drive subassembly, when the drug subassembly is mounted to the drive subassembly.

[0079] In one embodiment, the mounting guides may be configured to interact with the actuation element, e.g. with an actuation element guiding feature, for guiding the movement of the actuation element from the extended position to the retracted position, and vice versa. For example, the actuation element guiding feature may comprise one or more arms which slide along an inner surface of the mounting guides during movement of the actuation element relative to the chassis, thereby limiting a movement of the actuation element relative to the chassis in a plane perpendicular to the proximal-distal direction.

[0080] In one embodiment, the mounting guides may have a T-shaped cross-section and the mounting channels formed by the mounting protrusions may be configured to surround the T-shape, when the hub bracket is mounted to the chassis.

[0081] In one embodiment, the mounting guides may be bent at a bottom of the T-shaped crosssection for providing a support for a surrounding structure, e.g. a housing of a drug delivery device, if the drive subassembly is used in the drug delivery device.

[0082] In one embodiment, the carrier may comprise a viewing window, e.g. an opening in the sidewall of the carrier.

[0083] In one embodiment, the drive subassembly may be configured to provide a visual and / or audible (acoustic) and / or tactile (haptic) feedback regarding a status of the drive subassembly and / or the drug subassembly. For example, the drive subassembly may be configured to provide the feedback during use of the drive subassembly, e.g. during drug delivery. The feedback may inform the user about the progress of the drug delivery. In one embodiment, the drive subassembly is configured to provide the feedback several times during drug delivery. For example, the drive subassembly may be configured to provide the feedback during the whole drug delivery process until the drug delivery is completed. For example, the feedback may be provided depending on a speed of the drug delivery.

[0084] In one embodiment, the deflectable arm and / or the outer surface of the arbor, e.g. the toothing of the arbor, may be configured to provide the feedback. For example, the deflectable arm may be configured to provide a sound and / or a haptic feedback, each time the deflectable arm slides over one tooth and engages the next arbor recess of the toothing, when the arbor rotates relatively to the drive housing. Hence, the drive subassembly may be configured to provide a continuous feedback regarding the progress of the drug delivery process based on the rotation of the arbor. Alternatively, or additionally, the drive subassembly, e.g. the drive housing, may be designed such that the deflection of the deflectable arm and / or the rotation of the arbor may be visible from an outside.

[0085] In one embodiment, the distribution of teeth of the toothing may be designed according to the desired feedback. For example, if a continuous feedback during the whole drug delivery process shall be emitted, the teeth of the toothing may be equidistantly distributed around the outer surface of the arbor. Alternatively, the toothing may be designed to have teeth at certain angular positions for indicating only certain characteristic states of the delivery process. For example, the teeth may be distributed for indicating that a quarter of the dose, half the dose and / or the entire dose had been delivered.

[0086] By designing the arbor break differently, e.g. to comprise more than one deflectable arm, the feedback generation may be adjusted. Alternatively or additionally, the feedback generation may be adjusted by adjusting the material properties of the deflectable arm, e.g. its elasticity.

[0087] In one embodiment, the arbor may comprise at least one feedback generation arm for generating the acoustic and / or tactile feedback. The feedback generation arm may protrude from an outer surface of the arbor. For example, the feedback generation arm may protrude in a substantially radial direction, e.g. in the radial outward direction, toward the drive housing. The drive housing may comprise corresponding ridges for interacting with the feedback generation arm, when the arbor rotates with respect to the drive housing, thereby providing the acoustic and / or tactile feedback. The feedback generation arm and / or the ridges may be made of a material that is suitable for emitting the acoustic and / or tactile feedback, preferably a material with high sound conductivity. For example, the feedback generation arm and / or the ridges may be made of plastic. In one embodiment, the drive housing may be designed such that the deflection of the deflectable arm and / or the feedback generation arms can be viewed by the user, thereby providing a visual feedback about the progress of the drug delivery process.

[0088] According to an embodiment of the disclosure, a drug delivery device is provided. The drug delivery device comprises a reservoir and / or a drug subassembly, e.g. the drug subassembly according to one of foregoing embodiments, and a drive subassembly, e.g. the drive subassembly according to one of the foregoing embodiments. The drug subassembly may be releasably connected to the drive subassembly. For example, the drug subassembly may be connected to the drive subassembly by connecting a hub bracket of the drug subassembly to a chassis of the drive subassembly and / or by connecting a reservoir of the drug subassembly to a carrier and / or a drive mechanism of the drive subassembly. These connections may be releasable such that the drug subassembly may be disconnected from the drive subassembly without damaging or destroying the drug subassembly and / or the drive subassembly. In other words, one or both of the assemblies may be substituted with a new assembly of the same kind.

[0089] The drug delivery device may be configured to deliver drug from a reservoir to a subject, e.g. inject the drug percutaneously. For injecting the drug, the user may press the drug delivery device against a part of the subject’s body, e.g. against an arm, a leg, the abdomen, the glutes, the back or any other body part which is suitable for a percutaneous injection.

[0090] In one embodiment, the drug delivery device may comprise a housing configured to surround the drive subassembly and / or the drug subassembly at least partially. In one embodiment, the housing may be configured to receive the drug subassembly and the drive subassembly therein such that only the housing and safety cap are visible. After the safety cap is removed, the housing and the actuation element may be visible. When the drug delivery device is pressed against the injection site, the actuation element may move relatively to the housing, e.g. into the housing, and the piercing element may pierce the subject’s skin to inject drug into the subject. After the drug delivery device is removed from the injection site, the actuation element may move out of the housing such that the piercing element is covered by the actuation element and the housing are visible. Optionally, the safety cap may be re-connected to the drug delivery device, so that, if the safety cap is connected to the drug delivery device, only the housing and the safety cap are visible.

[0091] An outer surface of the housing may be configured to be held by the user when the drug delivery device is used. In one embodiment, the outer surface of the housing may comprise one or more ergonomic features configured to facilitate handling of the drug delivery device, e.g. steadying the drug delivery device on the injection surface during drug delivery. The ergonomic features may include at least one surface shaped according to the user’s anatomy, e.g. the anatomy of the user’s hand and / or arm. In other words, the ergonomic features may be configured to allow the user to securely handle the drug delivery device before, during and / or after injection. In one embodiment, the housing may be shaped and configured to be held by one hand or by both hands of the user.

[0092] The drug delivery device as mentioned in the foregoing may be an injection device, e.g. an autoinjector. The drug delivery device may have a flat shape or a pen-shape. The drug delivery device may be a variable dose device or a fixed dose device. The drug delivery device may be a single-use device, i.e. a device which is disposed after use. Alternatively, the drug delivery device may be a multiple-use device, which can be used more than once before disposal.

[0093] In one embodiment, the drug delivery device may be shaped to facilitate stably holding the drug delivery device against the injection site. For example, the drug delivery device may be shaped such that the user can steady the device on the injection site, e.g. by pressing the drug delivery device with a hand and / or an arm against the injection surface. For example, the drug delivery device may comprise an operation surface, e.g. a surface which substantially points away from the injection site, which may be configured for user interaction during drug delivery. In one embodiment, the operation surface may be ergonomically shaped according to the anatomy of the user’s arm and / or hand, thereby facilitating steadying the drug delivery device on the injection surface during injection.

[0094] In one embodiment, the drug delivery device may be configured such that a contact end of the device, i.e. an end which contacts the injection surface during injection, e.g. a surface of the chassis, is sized and / or shaped according to a shape of the injection surface. For example, the contact end may have a curvature which may correspond to the curvature of the injection surface.

[0095] In one embodiment, the drug delivery device may be a flat device with a low profile, i.e. a device which substantially extends in parallel to the injection surface. In other words, the extension of the drug delivery device in a direction perpendicular to the injection surface may be smaller than the extension in at least one direction parallel to the injection surface.

[0096] In one embodiment, the length of the drug delivery device may larger than the height of the drug delivery device and the height or the drug delivery device may be larger than the width of the drug delivery device. For example, the drug delivery device may have a height between 20mm and 80mm, e.g. between 30mm and 50mm, a width between 10mm and 100mm, e.g. between 20mm and 60mm, and / or a length between 50mm and 200mm, e.g. between 80mm and 150mm.

[0097] In one embodiment, the extension of the drug delivery device in a direction parallel to the injection surface may be at least 1.5 times, e.g. at least 2 times, the extension in a direction perpendicular to the injection surface. In one embodiment, the extension in parallel to the injection surface is at least 3 times the extension perpendicular to the injection surface, e.g. at least 3 times, at least 4 times, at least 5 times, at least 6 times, at least 7 times, at least 8 times, at least 9 times, at least 10 times, at least 15 times, at least 20 times, at least 25 times, at least 30 times, at least 40 times or at least 50 times. While these values are only exemplary, it should be noted that the extension of the drug delivery device in one direction perpendicular to the injection surface may be different than its extension in another direction perpendicular to the injection surface.

[0098] In one embodiment, the drug delivery device, e.g. the drive subassembly, may comprise a dose delivery limitation feature. The dose delivery limitation feature may be configured to limit an amount of drug that is delivered from the drug subassembly to less than the entire reservoir volume. Hence, the reservoir may be emptied in several delivery processes. For example, the dose delivery limitation feature may be a releasable mechanical stop in the drive subassembly which may limit the movement of the plunger relative to the reservoir to a desired delivery volume. Once the dose delivery limitation feature is released, the plunger may pass the mechanical stop and move further into the reservoir, thereby delivering the remaining amount of drug form the reservoir in a second delivery process. The drug delivery device may be configured such that the second delivery process is triggered by a movement of the actuation element relative to the chassis, similar to triggering the drive subassembly as described before.

[0099] In one embodiment, the drug delivery device may comprise at least one opening, e.g. an opening in the housing, for observing the movement of the arbor and / or the deflectable arm and / or the carrier and / or the stopper in the reservoir, in order to provide a visual feedback to the user regarding the status of the drug delivery device, e.g. the status or progress of the drug delivery.

[0100] According to an embodiment of the disclosure, a method of assembling a drug delivery device is provided. The drug delivery device may be a drug delivery device as described in the foregoing. The method may comprise the steps of assembling a drug subassembly, assembling a drive subassembly and assembling a drug delivery device, e.g. by connecting the drug subassembly and the drive subassembly. The drug subassembly may be the drug subassembly as described in the foregoing. The drive subassembly may be the drive subassembly as described in the foregoing.

[0101] The drug subassembly may be assembled by connecting, e.g. coupling or mounting or attaching or assembling, a reservoir filled with a drug to a piercing element. The connection between the reservoir and the piercing element is such that an interior of the reservoir is not fluidly connected to the piercing element in an initial reservoir position. For fluidly connecting the interior of the reservoir with the piercing element, the reservoir may be configured to be movable relative to the piercing element such that an inlet of the piercing element pierces the reservoir, e.g. a pierceable seal thereof. The reservoir may be pre-filled or may be filled in a reservoir-filling-step before the reservoir is connected to the piercing element.

[0102] The piercing element may be connected to a needle hub configured to hold at least a part of the piercing element. The needle hub may be connected to a coupling. One end of the coupling is configured to connect the piercing element, e.g. via the needle hub, to the reservoir, e.g. to an opening thereof forming a flange. Optionally, a hub bracket may be connected to another end of the coupling and / or the needle hub. For example, the hub bracket may be imposed on the needle hub and the coupling in a direction parallel to a longitudinal axis of the outlet of the piercing element until an inner upper end of the hub bracket contacts the guide arms of the coupling for keeping them engaged with the recesses in the needle hub.

[0103] In other words, the piercing element may be assembled, e.g. coupled, to the needle hub, the needle hub may be assembled to the coupling, the hub bracket may be assembled to the needle hub via the coupling, and the coupling may be assembled to the reservoir.

[0104] The drive subassembly may be assembled by connecting a drive mechanism to a drive bracket. This may include pre-tensing the drive element and securing the drive element against premature release. For example, if the drive mechanism includes a torsion spring and an arbor to be rotated by the torsion spring, the drive element may be tensed when connecting the drive mechanism to the drive bracket. The drive element may be secured against premature release by an arbor break which may limit the rotation of the arbor as long as the arbor break is not released, thereby preventing that the tensed torsion spring unwinds. Alternatively, drive mechanism may be pre-assembled, which may include pre-tensing a drive element and locking the drive element against premature release, e.g. within the drive mechanism.

[0105] Components of the drive mechanism are exemplarily described in the foregoing. Further, a carrier may be connected to a chassis. The chassis may comprise an actuation element, a needle shroud spring and / or a safety cap. Further, the drive bracket may be connected to the chassis. Further, the drive mechanism may be connected to the carrier. Connecting the carrier to the drive mechanism may compress a carrier spring between an outlet end wall of a drive housing of the drive mechanism and the drive bracket. Further, the safety cap may be connected to the actuation element and / or the chassis.

[0106] The method of assembling the drug delivery device comprises the step of connecting the drug subassembly and the drive subassembly. A hub bracket of the drug subassembly may be connected to the chassis of the drive subassembly, e.g. via mounting protrusions of the hub bracket and mounting guides of the chassis. This may compress the needle shroud spring between the needle hub and an inner surface of the actuation element, thereby biasing the actuation element towards its extended position. Further, by connecting the hub bracket to the chassis, the needle shield interacts with the needle shield gripper of the safety cap for engaging the needle shield and the needle shield gripper, e.g. for forming a non-releasable connection.

[0107] The reservoir of the drug subassembly may be inserted into the carrier of the drive subassembly, e.g. into the reception space. An opening of the reservoir may be supported, e.g. radially and / or axially, by the flange support of the carrier for limiting a movement of the reservoir relative to the carrier. In other words, the flange support may form an end of the reception space. An opposite end of the reservoir, i.e. an end of the reservoir opposite to the opening, may be connected to the drive mechanism, e.g. to the outlet end wall.

[0108] In one embodiment, the outlet end wall may comprise a protrusion, e.g. a protrusion forming a rim in the delivery direction, for supporting the opposite end of the reservoir. For example, the rim may have a diameter corresponding to a diameter of the opposite end, such that the opposite end may be supported by the rim. By way of example, an outer surface of the rim may have a diameter which corresponds to an inner diameter of the opposite end, so that the opposite end may be imposed on the rim. Alternatively, or additionally, an inner diameter of the rim may be larger than an outer diameter of the opposite end, so that the opposite end may be surrounded by the rim. In one embodiment, the outlet end wall may comprise more than one protrusion for forming a groove configured to receive the opposite end of the reservoir. According to an embodiment of the disclosure, a method of using a drug delivery device is provided. The drug delivery device may be a drug delivery device and / or the subassemblies referred to in this paragraph may be the drug delivery device and / or the subassemblies as described in the foregoing, as described in the foregoing.

[0109] The method comprises the step of removing a safety cap from a drive subassembly, e.g. by pulling it off the drive subassembly. The method further comprises the step of pressing the drug delivery device against an injection site, thereby moving an actuation element from an extended position into a retracted position to trigger the drive subassembly such that a piercing element of the drug subassembly is fluidly connected to a reservoir of the drug subassembly, and a drive mechanism of the drive subassembly interacts with the reservoir to deliver drug from the reservoir via the piercing element into a subject’s body. The method further comprises the step of removing the drug delivery device from the injection site. Removal of the drug delivery device from the injection site allows a movement of the actuation element to a second extended position, e.g. driven by a needle shroud spring. In the second extended position, the actuation element is configured to cover an outlet of the piercing element, e.g. an outlet tip, and outlet needle or a separable injection needle.

[0110] In one embodiment, the method comprises the step of re-connecting, e.g. re-attaching, the safety cap to the drug delivery device, e.g. to the drive subassembly. Re-attaching the safety cap covers a distal end of the actuation element. This may additionally improve the user’s safety as the outlet of the piercing element is fully covered.

[0111] In one embodiment, the method comprises the step of disposing the drug delivery device. When re-attached, the safety cap may be disposed with the drug delivery device. Alternatively, the safety cap me be disposed separately.

[0112] In one embodiment, the method comprises the step of re-using the drug delivery device, e.g. when the reservoir has been entirely emptied yet.

[0113] According to an embodiment of the disclosure, a method of delivering a drug from a drug delivery device is provided. The drug delivery device may be a drug delivery devices described in the foregoing. The method may comprise the step of using the drug delivery device, e.g. as described in the foregoing paragraphs relating to the method of using a drug delivery device according to embodiments of the disclosure. It should be noted that the order of the steps of the methods described herein is not limited to the order as exemplarily described. Instead, a skilled person will appreciate that one or more of the steps may be performed in a different order. Only if one step requires completion of another step, the described order of these two steps shall be considered mandatory.

[0114] The embodiments of the drug subassembly, the drive subassembly, the drug delivery device and the methods described in this disclosure simplify and / or replace the steps involved in administering a drug through a standard drug delivery device such as a syringe, in specific the steps of needle insertion, drug injection, needle removal and shielding.

[0115] The embodiments described in this disclosure enable administration of large volumes of drug as compared to conventional devices, e.g. autoinjectors and / or pen injectors. For example, the embodiments of the present disclosure may enable keeping the needle steady with respect to the injection site, thereby reducing pain to the user and facilitating a complete injection of the desired volume of the drug. By way of example, the embodiments of the present disclosure may enable user friendly and secure administration of volumes equal to or larger than 2ml, e.g. at least 2ml, at least 3ml, at least 4ml, at least 5ml, at least 6ml, at least 7ml, at least 8 ml or at least 9ml. However, by scaling the components of the subassemblies and / or the drug delivery device accordingly, even larger volumes, e.g. volumes equal to a larger than 10ml, may be administered. Further, some of the embodiments of the present disclosure enable an automatic drug delivery and injection by pressing the drug delivery device against the injection site with a sufficient force without requiring additional user interaction, e.g. operating an activation button.

[0116] The embodiments of the present disclosure are advantageous for users and / or subjects, when delivering larger volumes which require longer injection times, during which the user must stably hold the drug delivery device against the injection site. In conventional injection devices, e.g. pen injectors, this prolonged injection times can lead to discomfort for the subject, when the user performing the injection has limited dexterity, as the device may move relative to the injection surface. The profile and design of the subassemblies and the drug delivery device according to the present disclosure may enable parallel alignment of the majority of the subassemblies and / or the drug delivery device with the injection surface. This increases the contact surface between the drug delivery device and the injection surface such that relative movement between the drug delivery device and the injection surface may be reduced. This may facilitate stably holding the device in place for extended periods without causing discomfort to the subject. Further, the embodiments of the present disclosure enable a manual needle insertion by pressing the drug delivery device against the injection surface, thereby moving the activation element with respect to the chassis so the needle pierces the injection site. Hence, the user may determine the piercing speed with which the piercing element pierces the subject’s skin. Upon removal from the injection site, the safety lock-out mechanism may prevent access to the piercing element once the device is used, thereby reducing the risk of injuries due to accidental contact with the piercing element.

[0117] Further, the embodiments of the present disclosure may enable efficient drug delivery due to the design of the drive mechanism, e.g. due to the drive mechanism comprising the drive element coupled with the plunger, which may be a lead screw. The drive element may provide a nearly constant drive force during the whole drug delivery process, which may enable a constant flow rate of the drug. Further, the maximum force and / or pressure on the reservoir and components thereof, e.g. at the start of the dose delivery, may be reduced, thereby minimizing the potential for breakage of the reservoir or components thereof, e.g. breakage of the glass. Further, the reduction of drive force may result in lower stresses within the drive mechanism, so the components of the drive mechanism may be designed smaller. Hence, less material may be used for the drive subassembly, and the drug delivery device, which is beneficial for ecologic reasons.

[0118] Further, the embodiments of the present disclosure may enable the provision of a fluidly isolated reservoir until the piercing element is connected with the reservoir. Further, the drug subassembly may be self-contained, i.e. all components essential to the fluid path are integrated in the drug subassembly, which can be assembled separately from a drive subassembly. Hence, clean-room environments and / or aseptic environments are only necessary for assembling the drug subassembly. The connection of the drug subassembly and the drive subassembly for assembling the drug delivery device can be done in a standard assembly line. This may improve manufacturing efficiency and reduce manufacturing costs of the drug delivery device.

[0119] Further, the embodiments of the present disclosure, e.g. the design of the piercing element, may improve the user experience by enabling a smoother and more comfortable (less painful) injection. For example, by reducing the flow restriction in the piercing element, e.g. by an intermediate section with a gradually changing diameter, the flow rate may be high enough to avoid very long injection times, while piercing the injection site may not be too painful. Providing a continuous feedback during the whole delivery process may help the user understanding, when the drug is fully delivered. This may prevent movement of the drug delivery device during drug delivery or early interruption of the delivery process. This is of particular relevance the longer an injection takes, which usually correlates with the amount of drug to be injected.

[0120] The embodiments and features described in the foregoing may enhance the functionality, comfort, and / or safety of a drug delivery device and may enable a more effective drug delivery and improved user experience.

[0121] The making and using of the presently preferred embodiments are discussed in detail below. It should be appreciated, however, that the present disclosure provides many applicable concepts that can be embodied in a wide variety of specific contexts. The specific embodiments discussed are merely illustrative of specific ways to make and use the disclosed concepts, and do not limit the scope of the claims.

[0122] Moreover, same reference numerals refer to same technical features if not stated otherwise. As far as "may" is used in this application it means the possibility of doing so as well as the actual technical implementation. The present concepts of the present disclosure will be described with respect to preferred embodiments below in a more specific context namely drug delivery devices, especially drug delivery devices for humans or animals. The disclosed concepts may also be applied, however, to other situations and / or arrangements as well, e.g. for other injectors, spraying devices or inhalation devices.

[0123] The foregoing has outlined rather broadly the features and technical advantages of embodiments of the present disclosure. Additional features and advantages of embodiments of the present disclosure will be described hereinafter, e.g. of the subject-matter of dependent claims. It should be appreciated by those skilled in the art that the conception and specific embodiments disclosed may be readily utilized as a basis for modifying or designing other structures or processes for realizing concepts which have the same or similar purposes as the concepts specifically discussed herein. It should also be recognized by those skilled in the art that equivalent constructions do not depart from the spirit and scope of the disclosure, such as defined in the appended claims.

[0124] Brief description of the drawings For a more complete understanding of the presently disclosed concepts and the advantages thereof, reference is now made to the following description in conjunction with the accompanying figures. The figures are not drawn to scale. In the figures the following is illustrated in:

[0125] Figure 1A a perspective view of a drug subassembly according to an embodiment of the present disclosure,

[0126] Figure 1 B a perspective cross-sectional view of the drug subassembly of figure 1 A,

[0127] Figure 2A a perspective view of a drive subassembly according to an embodiment of the present disclosure,

[0128] Figure 2B a perspective cross-sectional view of the drive subassembly of figure 2A,

[0129] Figure 3 a perspective cross-sectional view of a drive mechanism of a drive subassembly according to an embodiment of the present disclosure,

[0130] Figures 4A to 4E different states of a drive subassembly, especially different states of a carrier lock and an actuation element lock-out, according to an embodiment of the present disclosure,

[0131] Figures 5A to 5C different states of an arbor break according to an embodiment of the present disclosure,

[0132] Figure 6 a perspective cross-sectional of a drug delivery device according to an embodiment of the present disclosure,

[0133] Figures 7A to 7F different states of a drug delivery device during use and steps of a method of using the drug delivery device according to an embodiment of the present disclosure,

[0134] Figures 8A to 8C different embodiments of a piercing element of a drug subassembly according to an embodiment of the present disclosure,

[0135] Figure 9 steps of a method of assembling a drug delivery device according to an embodiment of the present disclosure, and

[0136] Figure 10 sub-steps of a step of triggering a drive subassembly according to an embodiment of the present disclosure.

[0137] Description of exemplary embodiments

[0138] As a general note, “distal” is used herein to specify directions, ends or surfaces which are arranged or are to be arranged to face or point towards a dispensing end of the drug delivery device and / or point away from, are to be arranged to face away from or face away from the proximal end. On the other hand, “proximal” is used to specify directions, ends or surfaces which are arranged or are to be arranged to face away from or point away from the dispensing end and / or from the distal end of the drug delivery device or components thereof. The distal end may be the end closest to the dispensing end and / or furthest away from the proximal end and the proximal end may be the end furthest away from the dispensing end. A proximal surface may face away from the distal end and / or towards the proximal end. A distal surface may face towards the distal end and / or away from the proximal end. The dispensing end may be the needle end where a needle is arranged or a needle or needle unit is or is to be mounted to the device, for example. “Axial” may be used synonymously with “longitudinal”.

[0139] The distal end may be an end that is closer to a needle compared to a proximal end. Certain embodiments in this disclosure are illustrated with respect to a drug delivery device, e.g. an injection device, e.g. an autoinjector.

[0140] Figures 1A and 1B illustrate an embodiment of a drug subassembly 100 for a drug delivery device according to the present disclosure. The drug subassembly 100 comprises a reservoir 110 filled with a drug and a piercing element 120. The piercing element 120 and the reservoir 110 are movable relative to the each other to fluidly connect the piercing element 120 to the reservoir 110.

[0141] The illustrated reservoir 110 is a pre-filled cartridge with an opening 111 that is sealed by a pierceable seal 112. The opening 111 is formed as a flange to which the pierceable seal 112, e.g. a septum, is connected. The reservoir 110 further comprises a stopper 113 movable within the reservoir for delivering the drug through the opening 111 in a delivery direction DD .

[0142] The illustrated piercing element 120 is a needle comprising an inlet tip 121 , an intermediate section 122, which may be tapered (see figure 8A) and an outlet tip 123. The inlet tip 121 is configured to pierce the pierceable seal 112 when the reservoir 110 and the piercing element 120, are moved towards each other. For example, the reservoir 110 may be moved in the delivery direction DD relative to the piercing element 120 in order to cause the inlet tip 121 to pierce the seal 112. In the illustrated state of the drug subassembly 100, the reservoir 110 is spaced apart from the inlet tip 121.

[0143] The inlet tip 121 has a larger cross-section than the outlet tip 123. The piercing element 120 is bent by 90 degrees such that a longitudinal axis of the inlet tip 121 is perpendicular to a longitudinal axis of the outlet tip 123. The outlet tip 123 points in a distal direction D, i.e. towards an injection site. The piercing element 120 is held in place by a needle hub 130. The needle hub 130 and the reservoir 110 are movable towards each other for fluidly connecting the inlet tip 121 with the reservoir 110. The needle hub 130 comprises a needle hub extension 134 extending in a direction opposite to the delivery direction DD. The needle hub 130 further comprises a flange 131 formed at a distal end of the needle hub 130. The flange 131 comprises a needle shroud spring support 132 configured to radially support a needle shroud spring, e.g. a needle shroud spring 290 of a drive subassembly 200 as described below.

[0144] In the illustrated state, the outlet tip 123 is covered by a needle shield 128 detachably connected to the piercing element 120 and the needle hub 130. Upon removal of the needle shield 128, the outlet tip 123 is uncovered and may pierce into an injection site, e.g. a subject’s skin, when the outlet tip 123 is pressed against the injection site.

[0145] The needle hub 130 is coupled to the reservoir 110 via a coupling 140. The coupling 140 comprises guide arms 141 extending from a main body 142 of the coupling 140 in the delivery direction DD. Extending in a direction opposite to the delivery direction DD, the main body 142 comprises a connection feature 143 for connecting the coupling 140 to the reservoir 110. The connection feature 143 comprises deflectable arms equidistantly distributed around a circumference of the coupling 140.

[0146] The guide arms 141 are configured to interact with recesses formed in the needle hub 130 for aligning the needle hub 130 and the reservoir 110.

[0147] A hub bracket 150 is imposed on the needle hub 130 to prevent disengagement of the guide arms 141 from the recesses of the needle hub 130. Further, the hub bracket 150 comprises mounting protrusions 151 for mounting the drug subassembly 100 to a drive subassembly 200, as shown in figure 6. The coupling 140 comprises an insert 144 configured to interact with the needle hub extension 134 to align the inlet tip 121 with the opening 111 such that the inlet tip 121 pierces the pierceable seal 112 in a central position, when the reservoir 110 and the needle hub 130 are moved towards each other.

[0148] The insert 144 is further configured to be imposed on the pierceable seal 112 for connecting the coupling 140 to the opening 111. The arms of the connection feature 143 compress the part of the insert 144 which is imposed on the pierceable seal 112 such that the insert 144 does not detach from the pierceable seal 112. In one embodiment (not illustrated), the drug subassembly 100 may comprise a releasable lock feature configured to prevent a fluidic connection between the piercing element 120 and the reservoir 110, when the lock feature is in a locked state. For example, in the locked state, the lock feature may limit a relative movement of the piercing element 120 and the reservoir 110 towards each other. On the other hand, the lock feature may be configured to allow a fluidic connection between the piercing element 120 and the reservoir 110 in a released state.

[0149] Figures 2A and 2B illustrate an embodiment of a drive subassembly 200 for a drug delivery device according to the present disclosure. The illustrated drive subassembly 200 comprises a carrier 210 configured to receive a drug subassembly, e.g. the drug subassembly 100 as described in the foregoing. The carrier 210 comprises a reception space 211 in which a reservoir, e.g. the reservoir 110, is received. The drive subassembly 200 comprises a drive mechanism 250 and a chassis 230 for connecting the carrier 210 and the drive mechanism 250. The drive mechanism 250 comprises a drive element 251 (see figure 3). The drive element 251 is configured to provide a force for delivering the drug from the reservoir.

[0150] The drive subassembly further comprises an actuation element 270 movable relative to the chassis 230 between an extended position (see also figures 4A and 4E illustrating a first extended position and a second extended position, respectively) in which the actuation element 270 extends beyond the chassis 230 and a retracted position (see also figures 4B and 4C) in which the actuation element 270 is partially (see figure 4B) or fully (see figure 4C) telescoped into the chassis 230.

[0151] The illustrated actuation element 270 is a needle shroud configured to cover an outlet tip 123 of a piercing element 120, when the actuation element 270 is in the extended position. The drive subassembly 200 is configured such that moving the actuation element 270 to the retracted position triggers the drive subassembly 200.

[0152] The carrier 210 is movable relative to the chassis 230 in the delivery direction DD, when the actuation element 270 is in the retracted position and a carrier lock is released, as explained in detail below. The drive subassembly 200 comprises a carrier spring 258 configured to provide a force for moving the carrier 210 relative to the chassis 230.

[0153] The drive subassembly comprises a safety cap 295 configured to be releasably connected to the actuation element 270 and the chassis 230. The safety cap 295 is configured to prevent a movement of the actuation element 270 into the retracted position, when the safety cap 295 is connected to the drive subassembly 200, e.g. to the actuation element 270 and / or to the chassis 230. The safety cap 295 comprises a needle shield gripper 296 configured to interact with the needle shield 128 for removing the needle shield 128 from a piercing element 120, when the safety cap 295 is removed from the drive subassembly 200 and when a needle shield 128 is present in the drive subassembly 200, e.g. when a drug subassembly 100 is connected to the drive subassembly 200.

[0154] The drive subassembly 200 comprises a needle shroud spring 290 configured to bias the actuation element 270 towards its extended position. The needle shroud spring 290 is a compression spring, which extends between an inner surface 274 of the actuation element 270 and a flange formed on a needle hub, e.g. the flange 131 of the needle hub 130 of a drug subassembly 100 as described in the foregoing, when a needle hub is present in the drive subassembly, e.g. when a drug subassembly 100 is connected to the drive subassembly 200 (see figure 6).

[0155] The chassis 230 comprises four mounting guides 231 configured to interact with mounting protrusions of a hub bracket, e.g. the mounting protrusions 151 of the hub bracket 150 of the drug subassembly 100, when the drug subassembly 100 is connected to the drive subassembly 200 (see figure 6). The mounting guides 231 are further configured to interact with an actuation element guiding feature 271 for guiding the movement of the actuation element 270 from the extended to the retracted position, and vice versa. The chassis 230 further comprises an attachment element 232 configured to interact with a drive bracket 260 of the drive subassembly 200 for connecting the drive mechanism 250 to the chassis 230.

[0156] The drive bracket 260 comprises at least one attachment feature 261 , e.g. a radial protrusion, configured to interact with the attachment element 232 of the chassis 230. The drive bracket 260 further comprises a carrier spring support 263, e.g. formed as a flange, for supporting the carrier spring 258, thereby connecting one end of the carrier spring 258 to the chassis 230 via the drive bracket 260. As illustrated, the flange may be formed by a radial outward protrusion which may form part of the attachment feature 261 at the same time. The illustrated carrier spring 258 is a compression spring.

[0157] The illustrated carrier 210 further comprises a viewing window 219 formed in a sidewall of the carrier 210.

[0158] Figure 3 illustrates an embodiment of a drive mechanism 250 of a drive subassembly 200 according to the present disclosure. The drive mechanism 250 is configured to transfer a force of the drive element 251 onto the reservoir 110 such that drug is delivered from the reservoir 110. The illustrated drive mechanism 250 comprises a plunger 252 for transferring the force of the drive element 251 onto a stopper 113 of the reservoir 110, thereby causing a movement of the stopper 113 within the reservoir 110 so that drug is pushed out of the reservoir 110 in the delivery direction DD. For contacting the stopper 113, the plunger 252 comprises a push element 252b. The illustrated plunger 252 is a lead screw and the illustrated drive element 251 is a torsion spring

[0159] The drive mechanism 250 further comprises a drive housing 255 configured to support the drive element 251. The drive housing 255 comprises a rotation stop feature (not shown) configured to limit a rotation of the plunger 252 relative to the carrier 210 and / or the reservoir 110 and / or the chassis 230 and / or the drive housing 255 and / or an arbor 253 of the drive mechanism 250.

[0160] The drive housing 255 is further configured to support one end of the torsion spring 251. The other end of the torsion spring 251 is connected to the arbor 253. The arbor 253 is configured to be rotated by the force of the torsion spring 251.

[0161] The drive mechanism 250 further comprises a drive nut 254 configured to transfer the movement of the arbor 253 to the lead screw 252 via a threaded engagement with the lead screw 252. For example, an outer thread 252a of the lead screw 252 may interact with an inner thread 254a of the drive nut 254 for translating the rotational movement of the arbor 253 into an axial movement of the lead screw 252 since a rotation of the lead screw 252 is limited by the rotation stop feature.

[0162] The drive housing 255 comprises an outlet end wall 256 (see figure 2B) configured to provide a support for an end of the carrier spring 258 which does not contact the drive bracket 260 so that the carrier spring 258 extends between the drive bracket 260 and the outlet end wall 256. The outlet end wall 256 is further configured to interact with an engagement feature 213 of the carrier 210 (see figure 2B).

[0163] The engagement feature 213 comprises a groove formed on an inner wall of the carrier 210 into which edges of the outlet end wall 256 are inserted for axially fixing the drive housing 255 to the carrier 210. Due to the axial fixation, an axial movement of the outlet end wall 256 caused by the carrier spring 258 is transferred into an axial movement of the carrier 210 relative to the chassis 230, e.g. in the delivery direction DD. Figures 4A to 4E illustrate different states of a drive subassembly 200, especially a carrier lock and an actuation element lock-out thereof, according embodiments of the present disclosure.

[0164] The carrier lock is configured to limit a movement of the carrier 210 relative to the chassis 230, when the actuation element 270 is not in the retracted position. The carrier lock comprises a carrier lock protrusion 272 on the actuation element 270 and a carrier lock recess 214 in the carrier 210. As illustrated in the figures and described in the foregoing, the carrier lock recess 214 may be U-shaped so that its arms predominantly extend along a longitudinal axis of the actuation element 270. The carrier lock protrusion 272 and the carrier lock recess 214 are configured to interact, when the actuation element 270 is not in the retracted position (see figure 4A). The interaction limits a relative movement between the carrier 210 and the chassis 230, e.g. a movement of the carrier 210 in the delivery direction DD relative to the chassis 230.

[0165] When the actuation element 270 is in the retracted position, the interaction between the carrier protrusion 272 and the carrier lock recess 214 may allow a movement of the carrier 210 relative to the chassis 230 towards the actuation element 270. Hence, if a drug subassembly, e.g. the drug subassembly 100 as described herein, is connected to the drive subassembly 200, the movement of the actuation element 270 to the retracted position may trigger the drive subassembly 200 so that the carrier 210 may move relatively to the chassis 230 in the delivery direction DD. This may move the reservoir 110 towards the piercing element 120 such that the piercing element 120 pierces the pierceable seal 112 and establishes a fluid connection with the interior of the reservoir 110.

[0166] Upon movement of the actuation element 270 to the retracted position (see figures 4B to 4D), the carrier lock protrusion 272 moves out of a first portion of the carrier lock recess 214, thereby allowing a movement of the carrier 210 relative to the chassis 230 in the delivery direction DD (see figures 4B and 4C). In other words, the drive subassembly 200 is triggered by moving the actuation element 270 to the retracted position, thereby releasing the carrier lock. The movement of the carrier 210 relative to the chassis 230 is driven by a spring force provided by the carrier spring 258 (see figures 7D and 7E).

[0167] When a drug subassembly 100 is connected to the drive subassembly 200, the relative movement between the carrier 210 and the chassis 230 moves the reservoir 110 of the drug subassembly 100 in the delivery direction DD. Consequently, the reservoir 110 of the drug subassembly 100 is moved towards the piercing element 120, which is fixed in the axial direction by needle hub 130 and the hub bracket 150 interacting with the chassis 230 via the mounting protrusions 151 and the mounting guides 231. The movement of the reservoir 110 towards the piercing element 120 causes to piercing element 120 to pierce the pierceable seal 112, such that the piercing element 120 is fluidly connected to the reservoir 110.

[0168] Alternatively, or additionally, the piercing element 120 may be movable relative to the reservoir 110, e.g. towards the reservoir 110, such that due to the relative movement between the piercing element 120 and the reservoir 110, the piercing element 120 pierces the seal 112. For example, the needle hub 130 may be movably connected to the hub bracket 150 and / or the hub bracket 150 may be movably connected to the chassis 230 such that the piercing element 120 is movable relative to the reservoir 110.

[0169] The actuation element 270 further comprises a lock-out feature 273 configured to lock the actuation element 270 against a movement towards the retracted position after the drive subassembly 200 has been triggered. The lock-out feature 273 comprises an arm 273a with a clip 273b configured to interact with a lock-out recess 215 formed in a sidewall of the carrier 210 (see figure 4E). Upon movement of the actuation element 270 towards the second extended position, the arm 273a deflects inwardly as an angled distal surface of the clip 273b slides along a protrusion of the sidewall of the carrier 210 (see figures 4D and 4E). When the actuation element 270 reaches its second extended position (see figure 4E), the clip 273b is aligned with the lock-out recess 215. Thus, the arm 273a returns to a non-deflected state and the clip 273b engages the lock-out recess 215. The engagement limits a movement of the actuation element 270 towards the retracted position, e.g. because a proximal surface of the clip 273b is configured to be parallel to a distal surface of the lock-out recess 215, as illustrated in figure 4E.

[0170] The drive mechanism further comprises a releasable arbor break configured to limit a rotation of the arbor 253 before the drive subassembly 200 is triggered. Figures 5A to 5C illustrate different states of the arbor break according to an embodiment of the present disclosure.

[0171] The arbor break comprises a deflectable arm 257 formed on the drive housing 255, e.g. a sidewall thereof. The deflectable arm 257 comprises an inward protrusion 257a configured to engage an arbor recess 253a formed on an outer surface of the arbor 253. In the illustrated embodiment, the arbor recess 253a is formed between two teeth of a toothing formed on an outer surface of the arbor 253. The arbor break further comprises an arbor break recess 262 in the drive bracket 260 configured such that the deflectable arm 257 may deflect radially outwardly into the arbor break recess 262, when the deflectable arm 257 is aligned with the arbor break recess 262 (see figure 5C). The radial outward deflection may be caused by the inward protrusion 257a sliding along a tooth of the toothing, thereby disengaging the inward protrusion 257 from the arbor recess 253a. This releases the arbor break allowing a rotation of the arbor 253 relative to the drive housing 255 and the drive bracket 260. The rotation may by driven by a force provided by the drive element 251. The rotational movement of the arbor 253 is transferred into an axial movement of the plunger 252 to deliver the drug. The outward deflection may tense the deflectable arm 257, such that, when the inward protrusion 257a has passed the respective tooth of the toothing and aligns with a next arbor recess 253b - due to the rotation of the arbor 253 during drug delivery - the deflectable arm 257 returns radially inwardly to its non-deflected state, thereby engaging the inward protrusion 257 with the next arbor recess 253b. Upon engagement, a feedback may be emitted, which can be an audible feedback such as a clicking sound and / or a haptic feedback, indicating to the user the ongoing drug delivery process. Further, the deflection of the deflectable arm 257 into the arbor break recess may be visible for a user, thereby providing a visual feedback.

[0172] In one embodiment, if the toothing on the outer surface of the arbor 253 is continuous, as illustrated in figures 5A to 5C, the feedback is emitted continuously during the whole drug delivery process. Hence, the absence of the feedback may indicate to the user that the desired amount of drug has been completely delivered.

[0173] In one embodiment (not illustrated), the arbor 253 may comprise one or more feedback generation arms and the drive housing 255 may comprise corresponding ridges for interacting with the feedback generations arms, when the arbor 253 rotates with respect to the drive housing 255, thereby providing the audible and / or tactile feedback.

[0174] In one embodiment (not illustrated), the drive housing 255 may comprise a viewing portion, through which the deflection of the feedback generation arms may be viewed, so as to provide a visual feedback.

[0175] As illustrated in figures 5A to 5C, the deflectable arm 257 aligns with the arbor break recess 262 due to a movement of the drive housing 255 relative to the drive bracket 260 in the delivery direction DD. This movement is caused by the carrier spring 258 pushing the outlet end wall 256 of the drive housing 255 in the delivery direction DD, when the carrier lock is released.

[0176] Figure 6 illustrates an embodiment of a drug delivery device 300 according to the present disclosure. The drug delivery device 300 comprises a drug subassembly 100 and a drive subassembly 200 according to the foregoing embodiments. The drug delivery device 300 is configured to deliver drug from the reservoir 110 of the drug subassembly 100 to a subject via injection, as described in detail with respect to the other figures, e.g. figures 7A to 7F. The illustrated drug delivery device 300 is configured to facilitate stably holding the drug delivery device 300 against the injection site. For example, a distal surface of the chassis 230 may be shaped such that the user can steady the device 300 on the injection site by pressing the drug delivery device 300 with a hand and / or an arm against an injection surface, e.g. the subject’s skin.

[0177] By way of example, the drug delivery device 300 is illustrated as substantially extending in parallel to the injection surface. The extension of the drug delivery device 300 in the proximal- distal direction, perpendicular to the injection surface, may be smaller than the extension in at least one direction parallel to the injection surface, e.g. the delivery direction DD. For example, the extension in a direction parallel to the injection surface may be at least 1.5 times, e.g. 2 times, the extension in a direction perpendicular to the injection surface. Preferably, the extension in parallel to the injection surface is at least 5 times the extension perpendicular to the injection surface, e.g. 5 times, 7 times, 10 times, 15 times, 20 times, 25 times, 30 times, 40 times or 50 times.

[0178] The drug delivery device may further comprise a housing (not shown) configured to surround the drive subassembly 200 and the drug subassembly 100. The housing may be configured to be held by the user when the drug delivery device 300 is used. For example, the housing may comprise one or more ergonomic features configured to facilitate handling of the drug delivery device 300, e.g. steadying the drug delivery device 300 on the injection surface during drug delivery. The ergonomic features may include at least one surface shaped according to the user’s anatomy, e.g. the anatomy of the user’s hand and / or arm. In other words, the ergonomic features may be configured to allow the user to securely handle the drug delivery device before, during and / or after injection.

[0179] Figure 9 illustrates steps of a method of assembling the drug delivery device 300 according to an embodiment of the present disclosure. The method comprises the step S201 of assembling a drug subassembly 100 and the step S202 of assembling a drive subassembly 200. Further, the method comprises the step S203 of assembling a drug delivery device by connecting the drug subassembly 100 and the drive subassembly 200.

[0180] The drug subassembly 100 is assembled by connecting a reservoir 110 filled with a drug and a piercing element 120. The reservoir 110 may be pre-filled or may be filled in a reservoir-filling- step (not shown). In the first step S201a, the piercing element 120 is connected to a needle hub 130. In the second step S201b, the needle hub 130 is connected to a coupling 140. In the third step S201c, a coupling 140 is connected to the reservoir 110. In a fourth, optional, step S201d, a hub bracket 150 is connected to the needle hub 130 and to the coupling 140. A skilled person understands that the exemplary order of the steps described in this paragraph may be different and is not limited to the order illustrated in Figure 9. For example, the fourth step S201d may be performed after the first step S201a and before the second step S201b and / or the third step S201c.

[0181] In one embodiment, the piercing element 120 may be fixedly attached to the needle hub 130 to limit a relative movement between the piercing element 120 and the needle hub 130. The needle hub 130 may be connected to a hub bracket 150, e.g. such that a needle hub extension 134 extends beyond the hub bracket 150 in a direction opposite to the delivery direction DD.

[0182] Further, the needle hub 130 may be connected to the coupling 140 by moving the needle hub extension 134 towards guide arms 141 of the coupling 140 such that the guide arms 141 come into interaction with recesses of the needle hub 130, e.g. recesses in the needle hub extension 134. The hub bracket 150 may limit a reverse movement of the guide arms 141 for keeping the guide arms 141 connected to and engaged in the recesses of the needle hub 130.

[0183] The coupling 140 may be connected to the reservoir 110 via an insert 144 which can be imposed on a pierceable seal 112 of the reservoir 110. Further, a connection feature 143 of the coupling 143 may interact with the opening 111, which may form a flange, to limit a movement of the coupling 140 relative to the reservoir 110 in the delivery direction DD.

[0184] The drive subassembly 200 is assembled by a first step S202a of connecting a drive mechanism 250 to a drive bracket 260. This step may include pre-tensing the drive element 251 and securing the pre-tensed drive element 251 against a premature release as described herein, e.g. by means of an arbor break. In a second step S202b, a carrier 210 is connected to a chassis 230. In a third step S202c, the drive bracket 260 is connected to the chassis 230. In a fourth step S202d, the drive mechanism 250 is connected to the carrier 210. Connecting the drive mechanism 250 to the carrier 210 compresses a carrier spring 258 between an outlet end wall 256 of a drive housing 255 and the drive bracket 260. In a fifth step S202e, a safety cap 295 is connected to the drive subassembly 200, e.g. to the actuation element 270 and / or the chassis 230 thereof.

[0185] The drive mechanism 250 may be releasably attached to the drive bracket 260, so that it can be detached from the drive bracket 260, e.g. for substitution or repair. The connection between the carrier 210 and the chassis 230 may be such that the carrier 210 is movable relative to the chassis 230, e.g. in the delivery direction DD. The drive bracket 260 may be releasably attached to the chassis 230. The drive mechanism 250 may be releasably attached to the carrier 210, e.g. via the outlet end wall 256 being releasably attached to the connection feature 213 of the carrier 210. The safety cap 295 may be releasably connected to the actuation element 270 and the chassis 230 so that it can be pulled off the drive subassembly 200, e.g. by the user.

[0186] The method of assembling the drug delivery device 300 comprises the step S203 of connecting the drug subassembly 100 and the drive subassembly 200. In a first step S203a, the hub bracket 150 of the drug subassembly 100 is connected to the chassis 230 of the drive subassembly 200. For example, as illustrated in figure 6, the mounting protrusions 151 of the hub bracket 150 may be connected to the mounting guides 231 of the chassis 230. The connection may be realized by moving the hub bracket 150 relative to the chassis 230 along a longitudinal axis of the outlet of the piercing element 120 (i.e. in the distal direction D in figure 6). This compresses the needle shroud spring 290 between the needle hub 130 and the inner surface 274 of the actuation element 270, thereby biasing the actuation element 270 towards its extended position. Further, by connecting the hub bracket 150 to the chassis 230, the needle shield 128 interacts with the needle shield gripper 296 of the safety cap 295 for forming a non- releasable connection between the needle shield gripper 296 and the needle shield 128.

[0187] In a second step S203b, the reservoir 110 of the drug subassembly 100 is connected to the carrier 210, e.g. inserted into a reception space 211 such that an opening 111 is supported by a flange support 212. The flange support 212 is U-shaped for interacting with a shoulder of the reservoir 110. Further, the reservoir 110 is connected to the drive mechanism 250, e.g. such that an outlet end wall 256 of the drive housing 255 contacts the reservoir 110.

[0188] It should be noted that the order of the steps of the methods described above is not limited to the order as described. Instead, a skilled person will appreciate that one or more of the steps may be performed in a different order. Only if one step requires completion of another step, the described order of these two steps shall be considered mandatory.

[0189] Figures 7A to 7F illustrate different states of the drug delivery device 300 during use and the steps of a method of using the drug delivery device 300 according to an embodiment of the present disclosure.

[0190] In a first step S101 , the safety cap 295 is removed from the drug delivery device 300, e.g. from the drive subassembly 200, thereby removing the needle shield 128 from the piercing element (see figures 7A and 7B). As shown in figure 7B, the actuation element 270 is in the first extended position covering an outlet tip 123 or an outlet needle 123a or an injection needle 123b of the piercing element 120. In the following, it is assumed that the piercing element 120 comprises a needle with an inlet tip 121 and an outlet tip 123.

[0191] In a second step S102, the drug delivery device 300 is pressed against an injection site (not visible), thereby moving the actuation element 270 from the first extended position (see figures 7B and 7C) to the retracted position (see figure 7D). This causes actuation element 270 to move into the chassis 230 thereby uncovering the outlet tip 123 of the piercing element 120, so the outlet tip 123 pierces the injection site.

[0192] When the actuation element 270 is in its retracted position, the drive subassembly 200 is triggered, S103 (see also figure 10). The carrier lock protrusion 272 of the actuation element 270 moves out of a first leg of the carrier lock recess 214 of the carrier 210, so that the carrier 210 is not limited from moving and moves, S103a, in the delivery direction DD relatively to the chassis 230 due to a force provided by the carrier spring 258 (see figures 7D and 7E). Due to this movement, the reservoir 110 is moved towards the inlet tip 121 of the piercing element 120 such that the inlet tip 121 pierces the seal 112 (not visible). This fluidly connects, S103b, the piercing element 120 and the reservoir 110.

[0193] In order to move the carrier 210 in the delivery direction DD, the carrier spring 258 moves the outlet end wall 256 of the drive housing 255 in the delivery direction DD. This moves the drive housing 255 relatively to the drive bracket 260 in the delivery direction DD (see figures 7D and 7E), thereby releasing the arbor break (not visible) of the drive mechanism 250. This activates the drive mechanism 250 and the arbor 253 (not visible) rotates under the force of the drive element 251 (not visible). The rotation of the arbor 253 is translated into a movement of the plunger 252 (not visible) in the delivery direction DD. The movement of the plunger 252 is transferred to the stopper 113 within the reservoir 110 and drug is delivered, S103c, from the reservoir 110 through the piercing element 120 and injected to the subject via the outlet tip 123, which has pierced the subject’s skin.

[0194] At the end of the drug delivery process, the drug delivery device 300 is removed from the injection site, S104. Due to the force of the needle shroud spring 290 (not visible), the actuation element 270 moves to its second extended position in which it covers the outlet tip 123 of the piercing element 120 (see figures 7F and 4E). In the second extended position, the clip 273b of the lock-out feature 273 aligns with and engages the lock-out recess 215 in the carrier 210. This engagement limits a movement of the actuation element 270 towards its retracted position. Thus, even when pressing the drug delivery device 300 against the injection site again, the actuation element 270 cannot uncover the outlet tip 123 of the piercing element 120, so that the piercing element 120 cannot be touched by the user or the subject.

[0195] The method may further comprise the step S105 of re-connecting the safety cap 295 to the drug delivery device 300, e.g. to the drive subassembly 200.

[0196] Figures 8A to 8C illustrate different embodiments of a piercing element 120 and a needle hub 130 according to the present disclosure. In these embodiments, the needle hub 130 comprises a hub bracket attachment section 133 configured to interact with a hub bracket 150, when the hub bracket 150 is connected to the needle hub 130.

[0197] As illustrated in figure 8A, the piercing element 120 may comprise one needle. The needle may comprise an outlet tip 123 for piercing an injection site and an inlet tip 121 for piercing the pierceable seal 112 of a reservoir 110, when the reservoir 110 and the piercing element 120 are moved towards each other. The needle is bent such that the outlet tip 123 points in the distal direction D towards the injection surface. The inlet tip 121 points in a direction opposite to the delivery direction DD. Hence, a longitudinal axis of the inlet tip 121 is perpendicular to a longitudinal axis of the outlet tip 123.

[0198] The diameter of the inlet tip 121 is larger than the diameter of the outlet tip 123, e.g. twice as large. The diameter of the inlet tip 121 gradually decreases in a tapered intermediate section 122 of the piercing element 120 until reaching the diameter of the outlet tip 123.

[0199] In the embodiment illustrated in figure 8B, the piercing element 120 comprises two needles, an outlet needle 123a and an inlet needle 121a. The illustrated outlet needle 123a and the illustrated inlet needle 121a are fixedly connected to the needle hub 130. The outlet needle 123a is fluidly connected to the inlet needle 121a via an internal fluid path 136 of the needle hub 130. The outlet needle 123a is configured to pierce the injection site, similar to the outlet tip 123 described before. The inlet needle 121a is configured to connect to the reservoir 110, e.g. by piercing the pierceable seal 112, when the reservoir 110 and the inlet needle 121a are moved towards each other. In the embodiment shown in figure 8C, the needle hub 130 comprises a spike 121b for piercing the pierceable seal 112, instead of the inlet needle 121a or the inlet tip 121.

[0200] The internal fluid path 136 is a rigid channel inside the needle hub 130. The internal fluid path 136 is bent by 90 degrees, such that the outlet needle 123a points in the distal direction D, which is perpendicular to a direction in which the inlet needle 121a or the spike 121b point. In the embodiment illustrated in figure 8C, the needle hub 130 comprises a needle receiving portion 138 configured to receive an injection needle 123b. The injection needle may be releasably connected to the needle hub 130 via the needle receiving portion 138. The needle receiving portion 138 is fluidly connected to the reservoir 110 via the internal fluid path 136 and the spike 121b. Alternatively (not illustrated), the needle receiving portion 138 may be fluidly connected to the reservoir 110 via the inlet needle 121a as described in the foregoing. The needle receiving portion 138 is configured for threaded connection with the injection needle 123b, e.g. via the illustrated Luer-lock fitting.

[0201] Figure 10 illustrates some sub-steps S103a, S103b and S103c of triggering S103 a drug a drive subassembly 200 of a drug delivery device 300 according to an embodiment of the present disclosure. These sub-steps have been described in the foregoing.

[0202] The terms “drug” or “medicament” are used synonymously herein and 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 the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0203] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having 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; and nucleic acids, double 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 may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0204] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0205] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders.

[0206] Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are 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 as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0207] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue 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 “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0208] 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, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0209] 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-myristoyl LysB28ProB29 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-(w- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0210] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, 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.

[0211] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom. Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0212] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0213] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0214] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0215] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are 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 such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and immunoglobulin single variable domains. Additional examples of antigen-binding antibody fragments are known in the art.

[0216] The term “immunoglobulin single variable domain” (ISV), interchangeably used with “single variable domain”, defines immunoglobulin molecules wherein the antigen binding site is present on, and formed by, a single immunoglobulin domain. As such, immunoglobulin single variable domains are capable of specifically binding to an epitope of the antigen without pairing with an additional immunoglobulin variable domain. The binding site of an immunoglobulin single variable domain is formed by a single heavy chain variable domain (VH domain or VHH domain) or a single light chain variable domain (VL domain). Hence, the antigen binding site of an immunoglobulin single variable domain is formed by no more than three CDRs.

[0217] An immunoglobulin single variable domain (ISV) can be a heavy chain ISV, such as a VH (derived from a conventional four-chain antibody), or VHH (derived from a heavy-chain antibody), including a camelized VH or humanized VHH. For example, the immunoglobulin single variable domain may be a (single) domain antibody, a "dAb" or dAb or a Nanobody® ISV (such as a VHH, including a humanized VHH or camelized VH) or a suitable fragment thereof. [Note: Nanobody® is a registered trademark of Ablynx N.V.]; other single variable domains, or any suitable fragment of any one thereof.

[0218] “VHH domains”, also known as VHHs, VHH antibody fragments, and VHH antibodies, have originally been described as the antigen binding immunoglobulin variable domain of “heavy chain antibodies” (i.e. , of “antibodies devoid of light chains”; Hamers-Casterman et al. 1993 (Nature 363: 446-448). The term “VHH domain” has been chosen in order to distinguish these variable domains from the heavy chain variable domains that are present in conventional 4- chain antibodies (which are referred to herein as “VH domains”) and from the light chain variable domains that are present in conventional 4-chain antibodies (which are referred to herein as “VL domains”). For a further description of VHH’s, reference is made to the review article by Muyldermans 2001 (Reviews in Molecular Biotechnology 74: 277-302).

[0219] For the term “dAb’s” and “domain antibody”, reference is for example made to Ward et al. 1989 (Nature 341: 544), to Holt et al. 2003 (Trends Biotechnol. 21: 484); as well as to WO 2004 / 068820, WO 2006 / 030220, WO 2006 / 003388. It should also be noted that, although less preferred in the context of the present invention because they are not of mammalian origin, single variable domains can be derived from certain species of shark (for example, the so-called “IgNAR domains”, see for example WO 2005 / 18629).

[0220] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region 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 region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit 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 certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0221] 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).

[0222] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0223] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0224] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0225] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0226] Although embodiments of the present disclosure and their advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made therein without departing from the spirit and scope of the disclosure as defined by the appended claims. For example, it will be readily understood by those skilled in the art that many of the features, functions, processes and methods described herein may be varied while remaining within the scope of the present disclosure. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the subassemblies, drug delivery devices and methods or steps described in the present disclosure. As one of ordinary skill in the art will readily appreciate from the present disclosure subassemblies, devices, systems, processes, manufacture, methods or steps presently existing or to be developed later that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present disclosure. Accordingly, the appended claims are intended to include within their scope such subassemblies, devices, systems, processes, methods or steps. The embodiments mentioned in the first part of the description may be combined with each other. The embodiments of the description of figures may also be combined with each other. Further, it is possible to combine embodiments mentioned in the first part of the description with examples of the second part of the description which relates to Figures 1A to 10. List of reference numbers

[0227] DD delivery direction

[0228] D distal direction

[0229] P proximal direction

[0230] 100 drug subassembly

[0231] 110 reservoir

[0232] 111 opening

[0233] 112 pierceable seal

[0234] 113 stopper

[0235] 120 piercing element

[0236] 121 inlet tip

[0237] 121a inlet needle

[0238] 121b spike

[0239] 122 intermediate section

[0240] 123 outlet tip

[0241] 123a outlet needle

[0242] 123b injection needle

[0243] 128 needle shield

[0244] 130 needle hub

[0245] 131 flange

[0246] 132 needle shroud spring support

[0247] 133 hub bracket attachment section

[0248] 134 needle hub extension

[0249] 136 internal fluid path

[0250] 138 needle receiving portion

[0251] 140 coupling

[0252] 141 guide arms

[0253] 142 coupling main body

[0254] 143 connection feature

[0255] 144 insert

[0256] 150 hub bracket

[0257] 151 mounting protrusion

[0258] 200 drive subassembly

[0259] 210 carrier

[0260] 211 reception space 212 flange support

[0261] 213 engagement feature

[0262] 214 carrier lock recess

[0263] 215 lock-out recess

[0264] 219 viewing window

[0265] 230 chassis

[0266] 231 mounting guide

[0267] 232 attachment element

[0268] 250 drive mechanism

[0269] 251 drive element

[0270] 252 plunger

[0271] 252a outer thread

[0272] 252b plunger push element

[0273] 253 arbor

[0274] 253a arbor recess

[0275] 253b arbor recess

[0276] 254 drive nut

[0277] 254a inner thread

[0278] 255 drive housing

[0279] 256 outlet end wall

[0280] 257 deflectable arm

[0281] 257a inward protrusion

[0282] 258 carrier spring

[0283] 260 drive bracket

[0284] 261 attachment feature

[0285] 262 arbor break recess

[0286] 263 carrier spring support

[0287] 270 actuation element

[0288] 271 actuation element guiding feature

[0289] 272 carrier lock protrusion

[0290] 273 lock-out feature

[0291] 273a arm

[0292] 273b clip

[0293] 274 inner surface

[0294] 290 needle shroud spring

[0295] 295 safety cap

[0296] 296 needle shield gripper 300 drug delivery device

[0297] 5101 removing safety cap

[0298] 5102 pressing drug delivery device against injection site

[0299] 5103 triggering drive subassembly

[0300] S103a moving carrier in delivery direction

[0301] S103b fluidly connecting piercing element with reservoir

[0302] S103c delivering drug from reservoir

[0303] 5104 removing drug delivery device from injection site

[0304] 5201 assembling drug subassembly

[0305] S201a connecting piercing element to needle hub

[0306] S201b connecting needle hub to coupling

[0307] S201c connecting coupling to reservoir

[0308] S201d connecting hub bracket to needle hub and coupling

[0309] 5202 assembling drive subassembly

[0310] S202a connecting drive mechanism to drive bracket

[0311] S202b connecting carrier to chassis

[0312] S202c connecting drive bracket to chassis

[0313] S202d connecting drive mechanism to carrier

[0314] S202e connecting safety cap to drive subassembly

[0315] 5203 assembling drug delivery device

[0316] S203a connecting hub bracket to chassis

[0317] S203b connecting reservoir to carrier and drive mechanism

Claims

PAT24096-WO-PCTClaims1 . A drug delivery device (300), comprising: a drug subassembly (100); and a drive subassembly (200) releasably connected to the drug subassembly (100), wherein the drug subassembly (100) comprises: a reservoir (110) with a drug; and a piercing element (120) coupled to the reservoir (110) and configured to be fluidly connectable to the reservoir (110), such that, when the piercing element (120) is fluidly connected to the reservoir (110), an interior of the reservoir (110) is in fluid communication with an exterior of the reservoir (110), wherein the piercing element (120) and the reservoir (110) are movable relative to each other for fluidly connecting the piercing element (120) to the reservoir (110); and wherein the drive subassembly (200) comprises: a carrier (210) configured to receive the drug subassembly (100); a drive mechanism (250) with a drive element (251) configured to provide a force for delivering the drug from the reservoir (110), when the drive subassembly (200) is triggered; a chassis (230); and an actuation element (270) configured to trigger the drive subassembly (200), wherein the drive subassembly (200) is configured to be triggered by moving the actuation element (270) to a retracted position relative to the chassis (230).

2. The drug delivery device (300) of claim 1 , wherein the carrier (210) is connected to the chassis (230) such that the carrier (210) is movable relative to the chassis (230) towards the actuation element (270).

3. The drug delivery device (300) of claim 1 or 2, wherein the drug subassembly (100) comprises: a needle hub (130) configured to hold the piercing element (120); and a coupling (140) which surrounds the needle hub (130) at least partially, wherein the coupling (140) is configured to align the piercing element (120) and the reservoir (110).

4. The drug delivery device (300) of claim 3, wherein the coupling (140) comprises: a main body (142) with a connection feature (143); andat least one guide arm (141), wherein the connection feature (143) is configured to connect the coupling (140) to the reservoir (110); and wherein the at least one guide arm (141) is configured to engage a corresponding recess in the needle hub (130) for connecting the coupling (140) to the needle hub (130).

5. The drug delivery device (300) of claim 4, wherein the drug subassembly (100) comprises a hub bracket (150) configured to prevent a disengagement of the at least one guide arm (141) and the corresponding recess, when the hub bracket (150) is connected to the needle hub (130) and / or the coupling (140).

6. The drug delivery device (300) of any one of the preceding claims, wherein the chassis (230) comprises mounting guides (231) configured to interact with mounting protrusions (151) of the hub bracket (150), for limiting a relative movement between the drug subassembly (100) and the drive subassembly (200).

7. A method of assembling the drug delivery device (300) according to any one of the preceding claims, the method comprising the steps of: assembling (S201) the drug subassembly (100); assembling (S202) the drive subassembly (200); and assembling (S203) the drug delivery device (300) by connecting the drug subassembly (100) to the drive subassembly (200).

8. The method of claim 7, wherein assembling (S201) the drug subassembly (100) comprises the steps of: connecting the reservoir (110) to the piercing element (120), such that the piercing element (120) is movable relative to the reservoir (110) for fluidly connecting the interior of the reservoir (100) with the piercing element (120), wherein the piercing element (120) is connected to the reservoir (110) by: connecting (S201a) the piercing element (120) to the needle hub (130); connecting (S201b) the needle hub (130) to the coupling (140); connecting (S201c) the coupling (140) to the reservoir (110); and connecting (S201d) the hub bracket (150) to the needle hub (130) and / or the coupling (140).

9. The method of claim 7 or 8, wherein assembling (S202) the drive subassembly (200) comprises the steps of:connecting (S202a) the drive mechanism (250) to a drive bracket (260); connecting (S202b) the carrier (210) to the chassis (230); connecting (S202c) the drive bracket (260) to the chassis (230); connecting (S202d) the drive mechanism (250) to the carrier (210); and connecting (S202e) a safety cap (295) to the drive subassembly (200).

10. The method of claim 9, wherein connecting (S202a) the drive mechanism (250) to the drive bracket (260) comprises the step of pre-tensing the drive element (251) and securing the drive element (251) against a premature release before the drive subassembly (200) is triggered.

11. The method of claim 9 or 10, wherein, when the drive mechanism (250) is connected to the carrier (210), a carrier spring (258) is compressed between an outlet end wall (256) of a drive housing (255) of the drive mechanism (250) and the drive bracket (260).

12. The method of any one of claims 7 to 11 , wherein connecting the drug subassembly (100) to the drive subassembly (200) comprises: connecting (S203a) the hub bracket (150) to the chassis (230); connecting (S203b) one end of the reservoir (110) to the carrier (210), such that the reservoir (110) is received in a reception space (211) of the carrier (210) and an opening (111) of the reservoir (110) is supported by a flange support (212) of the carrier (210); and connecting (S203b) another end of the reservoir (110) to the outlet end wall (256).

13. The method of claim 12, wherein connecting (S203a) the hub bracket (150) to the chassis (230) comprises engaging mounting protrusions (151) of the hub bracket (150) with mounting guides (231) of the chassis (230).

14. The method of any one of claims 7 to 13, wherein connecting (S203a) the hub bracket (150) to the chassis (230) causes a compression of a needle shroud spring (290) configured to bias the actuation element (270) towards an extended position relative to the chassis (230), in which the actuation element (270) covers an outlet (121 , 121a, 121b) of the piercing element (120).

15. The method of claim 14, wherein connecting (S203a) the hub bracket (150) to the chassis (230) causes an engagement of a needle shield gripper (296) of the safety cap (295) with a needle shield (128) configured to cover an outlet (121, 121a, 121b) of the piercingelement (120), such that when the safety cap (295) is removed from the drive subassembly (200), the outlet (121 , 121a, 121b) of the piercing element (120) is exposed.

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