EP4661932A1

EP4661932A1 - Cartridge driver, medicament delivery device and method for operating a medicament delivery device

Info

Publication number: EP4661932A1
Application number: EP24703209.7A
Authority: EP
Inventors: Wen-Yen Lee; Meng-Jhen CHIOU
Original assignee: SHL Medical AG
Current assignee: SHL Medical AG
Priority date: 2023-02-09
Filing date: 2024-02-05
Publication date: 2025-12-17
Also published as: WO2024165491A1

Abstract

A cartridge driver (11) for a medicament delivery device (ioo), comprises a mechanical interface portion (in) contributing to a mechanical interface between the cartridge driver (n) and a plunger rod (13) of the medicament delivery device (100) for controlling an action of the plunger rod (13) on a stopper (102) of a cartridge (10) containing a medicament. The mechanical interface portion (111) is configured to support at least two stationary positions of the plunger rod (13) relative to the cartridge driver (11), the first of which positions represents a state of the plunger rod (13) before acting on the stopper, and a second of which positions represents a state after the plunger rod (13) having moved the stopper relative to the cartridge (10) for a distance sufficient to expel residual air from the cartridge (10) but insufficient to expel a majority of the medicament from the cartridge (10).

Description

CARTRIDGE DRIVER, MEDICAMENT DELIVERY DEVICE AND METHOD FOR OPERATING A MEDICAMENT DELIVERY DEVICE

TECHNICAL FIELD

The invention refers to a cartridge driver for a medicament delivery device, to a medicament delivery device, and to a method for operating a medicament delivery device.

BACKGROUND

Medicament delivery devices, in short, delivery devices, include pen-type manual injectors and auto-injectors. These delivery devices are generally known for the self-administration of medicament by patients without formal medical training. For example, patients suffering from diabetes may require repeated injections of insulin, or patients may require regular injections of other types of medicaments, such as growth hormones.

A medicament delivery device receives a medicament cartridge for storing the medicament. The cartridge comprises an outlet at its proximal end and a stopper slidable within the cartridge. The medicament is stored in the cartridge between the outlet and the stopper. In case a medicament delivery is desired, a plunger rod of the delivery device is activated and pushes the stopper further into the cartridge thereby expelling a dose of the medicament at the outlet of the cartridge.

The cartridge is provided by a medicament producer and/or a filling provider and is inserted into the delivery device. In one scenario, a syringe includes the cartridge and a needle representing the outlet of the cartridge. In such a scenario, the syringe is inserted into the delivery device. In a different scenario, the needle is part of and supported by the delivery device. A cartridge including the medicament is delivered to the delivery device manufacturer absent a needle. After inserting the cartridge into the delivery device, a seal of the cartridge is arranged distance from the needle. A mechanism is provided for effecting a penetration of the seal by the needle. In any of these scenarios, air may be contained in the cartridge. In the case of a sealed cartridge, air may be enclosed in the sealed cartridge, or air may pour through the needle into the cartridge after the needle has perforated the seal of the cartridge.

It is not desired to inject air into a patient’s body before the medicament. Accordingly, it is desired to remove air from the cartridge before dispensing the medicament into the patient’s body and to preferably remove the air automatically within the process of preparing the medicament delivery.

SUMMARY

Reference should now be made to the appended claims.

In the present disclosure, when the term “distal direction” is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term “distal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which during use of the medicament delivery device is/are located furthest away from the dose delivery site. Correspondingly, when the term “proximal direction” is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device. When the term “proximal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which during use of the medicament delivery device is/are located closest to the dose delivery site.

Further, the terms “longitudinal”, “longitudinally”, “axially” and “axial” refer to a direction extending from the proximal end to the distal end and along the device or components thereof, typically in the direction of the longest extension of the device and/or component.

Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction. Further, the terms “circumference”, “circumferential”, or “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a central axis extending in the direction of the longest extension of the device and/or component. Similarly, “radial” or “radially” refer to a direction extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis.

According to a first aspect of the present invention, a cartridge driver is provided for a medicament delivery device. The cartridge driver according to the present invention is inter alia configured to control actions of a plunger rod of the medicament delivery device on a stopper of a cartridge of the medicament delivery device containing a medicament. Accordingly, comprising: a proximal end, a distal end and a mechanical interface portion extending along a longitudinal axis between the proximal end and the distal end; wherein the proximal end of the cartridge driver is configured to be coupled to a cartridge, and the distal end of the cartridge driver is connected to a spring; a mechanical interface portion configured to interact with a plunger rod of the medicament delivery device for controlling an action of the plunger rod on a stopper of a cartridge containing a medicament; and wherein the mechanical interface portion comprises a stair structure comprising a first step and a second step at different longitudinal positions; wherein the first step and the second step are configured to releasably hold the plunger rod in two positions respectively relative to the cartridge driver. Therefore, the mechanical interface portion of the cartridge driver can support at least two stationary positions of the plunger rod relative to the cartridge driver. For example, a first of which positions represents a state of the plunger rod prior to acting on the stopper. A second of which positions represents a state after the plunger rod has moved the stopper relative to the cartridge for a distance sufficient to expel residual air from the cartridge but insufficient to expel a majority of the medicament from the cartridge.

The first position represents an initial state, i.e. prior to dispensing the medicament, and also prior to preparing the delivery device in a ready-to- dispense / activate state. Such initial state preferably is a state prior to any manipulation of the delivery device, i.e. preferably a state in which the delivery device is delivered by a manufacturer to distributors, pharmacies, doctors or patients. In this initial state, the plunger rod is preferably arranged distant from the stopper of the cartridge or maybe already arranged in touch with the stopper, however, absent a significant force acting on the stopper.

With help of the mechanical interface between the cartridge driver and the plunger rod, this initial state is locked until further action; i.e. the plunger rod is locked in the first position until further action.

The second position represents a prepared state of the delivery device in which the delivery device is prepared for delivery of the medicament. In the prepared state the plunger rod is in a second, more proximal position and has already pushed the stopper within the cartridge for a distance sufficient to expel residual air from the cartridge, i.e. air residual in the cartridge and/or needle. Accordingly, while the plunger rod transitions from its first to its second position the plunger rod act on the stopper and pushes the stopper further into the cartridge, thereby expelling air from the outlet of the cartridge and/or from the needle.

The first and second positions of the plunger rod are stop positions representing the initial and the prepared state. For this reason, the mechanical interface and in particular the mechanical interface portion of the cartridge driver is dimensioned subject to the geometry and the dimensions of components of the delivery device and/or subject to the dimensions and geometry of the cartridge to be received by the delivery device.

In a preferred example, the delivery device and its components such as the cartridge driver and the plunger rod extending along the longitudinal axis between a proximal end and a distal end. Preferably, the cartridge drive has a tubular structure including openings at its proximal and its distal end for receiving the plunger rod. In an assembled state, the plunger rod is arranged slidable and rotatable in the cartridge driver. The cartridge driver is configured to act on the cartridge holder arranged in the proximal direction of the cartridge driver. Preferably, an actuator such as a biased cartridge driver spring pushes the cartridge driver in the proximal direction. Accordingly, the cartridge driver is arranged slidable within the delivery device, in particular for driving a cartridge held by the cartridge holder towards a stationary needle hub supporting a needle to penetrate a seal of the cartridge by the needle in response to this relative movement. In a variant, the cartridge driver and cartridge holder may be an integral component.

It should be noted that the term 'cartridge' is referred to a medicament container, e.g., can be a syringe, e.g., a container barrel with an integral needle at its proximal end, or a vial that needs to be fluidly connected to a needle.

In a preferred example, the mechanical interface portion comprises a third step configured to support the plunger rod relative to the cartridge driver after the plunger rod has moved the stopper relative to the cartridge for a distance sufficient to expel a majority of the medicament from the cartridge.

Therefore, the mechanical interface portion of the cartridge driver can support a third stationary position of the plunger rod relative to the cartridge driver. The third position represents a state after delivery, i.e. after the plunger rod has moved the stopper within the cartridge for a distance sufficient to expel a majority of the medicament from the cartridge. Accordingly, the third position represents typically a state after the medicament is dispensed to the patient. Accordingly, when the plunger rod transitions from its second to its third position, the plunger rod is expected to act on the stopper and push the stopper into the cartridge, thereby causing the medicament to be expelled at the outlet of the cartridge and/or the needle.

The third position also acts as the stop position, and hence the mechanical interface and in particular, the dimensions of the mechanical interface portion of the cartridge driver are preferably calculated subject to the geometry and dimensions of components of the medicament delivery device, and in particular subject to the dimensions and geometry of the cartridge to be received by the delivery device.

In another preferred example, the mechanical interface is arranged in form of a stair-structured recess in a circumferential wall of the cartridge driver.

In another preferred example, the stair-structured recess is configured to interact with a protrusion of the plunger rod.

In another preferred example, a surface of the first step is inclined and facing in the distal direction; and a surface of the second step is inclined and facing in the distal direction.

The inclination of the surfaces provides an automatic transition of the plunger rod from one stop position to the next stop position under the impact of the biased plunger rod spring as will be explained later on in more detail.

The mechanical interface between the cartridge driver and the plunger rod preferably comprises the mechanical interface portion of the cartridge driver, an interface member of the plunger rod, and possibly further one or more interface members of different components interacting in combination with the plunger rod and the cartridge driver, and preferably dimensioned to block and/or release an axial movement of the plunger rod from one position to the next position.

Hence, the mechanical interface portion of the cartridge driver preferably is configured to also interact with an interface member of a rear enclosure of the delivery device, and with an interface member of a needle cover sleeve of the delivery device which interface members are preferably arranged and dimensioned for preventing a rotational movement of the plunger rod relative to the cartridge driver in the first and second positions. Accordingly, while the mechanical interface portion of the cartridge driver preferably assumes responsibility for guiding an interface member of the plunger rod and the plunger rod to the defined stop positions, the interface member of the rear enclosure and the interface member of the needle cover sleeve both preferably block the plunger rod at these stop positions. Preferably, the interface members of the rear enclosure and the needle cover sleeve both block the plunger rod interface member in the first position, while only the interface member of the needle cover sleeve blocks the plunger rod interface member in the second position.

In particular, in the case of the plunger rod being designated to travel within a hollow cartridge driver, the mechanical interface portion of the cartridge driver is embodied in its circumferential profile, preferably in form of one or more recesses configured to interact with a protrusion of the plunger rod, and preferably with a protrusion of the rear enclosure and a rib of the needle cover sleeve.

According to another aspect of the present invention, a medicament delivery device is provided, comprising a cartridge driver according to any of the preceding embodiments, as well as a plunger rod selectively engaged with the first step or the second step for controlling its action on a stopper of a cartridge to be received by the medicament delivery device and containing a medicament.

Preferably, the medicament delivery device comprises a plunger rod spring arranged for driving the plunger rod in the proximal direction relative to the cartridge driver. After the disengagement of a blocking interface member, the plunger rod spring is responsible for the movement of the plunger rod in the proximal direction.

Accordingly, it is preferred that the mechanical interface is configured to, in response to the disengagement of the further interface member/s from its/their blocking position/s cause an automatic transition of the plunger rod from the first to the second and preferably to any further position solely by a driving force exerted by the plunger rod spring. In a further embodiment, the medicament delivery device comprises a cartridge holder configured to receive a cartridge containing medicament, the cartridge holder being arranged at the proximal end of the cartridge driver. Preferably, an enclosure is provided enclosing i.e. the cartridge driver and cartridge holder. Preferably, a rear enclosure is attached to the distal end of the enclosures and covers a distal opening of the tubular enclosure. Preferably, the rear enclosure comprises an interface member such as a protrusion protruding in the proximal direction. The protrusion is radially and circumferentially arranged to interact e.g. with a recess of the cartridge driver.

Preferably, the delivery device further comprises a cartridge driver spring arranged for driving the cartridge driver and the cartridge holder in the proximal direction relative to the enclosure. Another mechanical interface is preferably provided between the cartridge holder and the enclosure for controlling a position of the cartridge holder relative to the enclosure along the longitudinal axis. This mechanical interface supports at least two stationary positions of the cartridge holder relative to the enclosure, i.e. a first position:

- in which the cartridge holder is retained in a first, distal position with respect to the enclosure against a force exerted by the biased cartridge driver spring;

- in which the plunger rod also takes its first, distal position with respect to the cartridge driver and in which the further interface member of the rear enclosure retains the plunger rod in the first position against a force exerted by the biased plunger rod spring.

Instead, in a second position, the cartridge holder is retained in a second, proximal position with respect to the enclosure.

A cap is preferably arranged at the proximal end of the enclosure - not necessarily attached to the enclosure but rather attached to the needle cover sleeve - and is rotationally coupled with the cartridge holder. A rotation of the cap, hence, evokes a rotation of the cartridge holder by way of which rotation of the mechanical interface between the cartridge holder and the enclosure releases the cartridge holder from its first position, such that the cartridge holder is pushed by means of the cartridge driver spring to its second, proximal position.

In a further embodiment, the delivery device comprises a needle, and a needle cover sleeve arranged in the enclosure. The needle cover sleeve is arranged to protect the needle in states other than during dispensing of the medicament. Preferably, the needle is provided in a needle hub, e.g. moulded into the needle hub or otherwise fixedly attached to the needle hub. The needle hub in turn is mounted to the enclosure at a defined longitudinal position relative to the enclosure. The needle hub additionally is rotationally coupled with the cartridge holder, e.g. by extending arms and/or snap fits, and is rotationally coupled with the cap, e.g. by a needle cap provided for protecting a proximal end of the needle. A manual rotation of the cap, e.g. between 20 and 90 angular degrees, rotates the needle hub relative to the enclosure, which rotating needle hub rotates the cartridge holder.

This rotation of the cap preferably releases the cartridge holder from its distal position relative to the enclosure such that the cartridge driver spring pushes the cartridge holder in the proximal direction, until a stop structure in the cartridge holder-enclosure interface stops further linear movement.

In the case of a cartridge holding the medicament being assembled into the cartridge holder, the cartridge is moved together with the cartridge holder towards the stationary needle hub and its needle, wherein a seal of the cartridge becomes penetrated by the needle.

Preferably, a septum is arranged on the needle hub and encloses a distal end of the needle. Hence, in response to the cartridge being pushed towards the needle hub in response to the rotation of the cap, the needle first perforates the septum and then the seal of the cartridge. The septum preferably has the form of a lid and is fixedly attached to a body of the needle hub. The septum preferably is made from a polymer, e.g., TPE, and is preferably elastic and compressible. In one embodiment, the septum is made from Si rubber and is made by injection moulding. Preferably, the choice of material for the septum includes a material withstanding sterilization given that the delivery device preferably is sterilized at the manufacturer. The septum remains compressed between the needle hub and the cartridge after the engagement of the needle with the cartridge. The septum not only protects the needle prior to the needle's engagement with the cartridge but also prevents the needle from contamination during the needle's engagement with the cartridge since the distal end of the needle is not exposed to the environment at any stage of the preparation of the delivery device. Additionally, in view of the elastic material of the septum, no residuals of the septum material are carried into the cartridge during the perforation process.

The cartridge holder-enclosure mechanical interface preferably is characterized by and dimensioned to: o in the first, distal position of the cartridge holder retain the seal of the cartridge distant from the needle; o in response to the rotation of the cap, transferring the cartridge holder including the cartridge to a second, proximal position whereby the needle preferably penetrates the septum first, and then the seal of the cartridge; o in the second, proximal position of the cartridge holder the cartridge driver-plunger rod interface assumes its second position with the interface member of the needle cover sleeve blocking the plunger rod in its second position.

Accordingly, at the end of the axial movement of the cartridge holder from its first position to its second position along the longitudinal axis, the interface member of the rear enclosure preferably disengages from the cartridge driver-plunger rod interface and allows the plunger rod to transition from its first position to its second position, thereby expelling air out of a cartridge in case of a cartridge being supported by the cartridge holder. Accordingly, after the needle is engaged with the cartridge, the cartridge is automatically primed.

Since preferably the cap is releasable mounted to the needle cover sleeve and the cartridge driver spring is arranged to co-drive the needle cover sleeve in the proximal direction relative to the enclosure in response to a rotation of the cap the needle cover sleeve also is axially moved from a first, distal position to a second, proximal position together with the cartridge holder in which second position the needle cover sleeve protrudes from the proximal end of the enclosure. Given that the cap is attached to the proximal end of the needle cover sleeve, preferably via a plug also referred to the septum that terminates the needle cover sleeve at its proximal end, and preferably holds the needle cap for protecting the needle, by removing the cap from the needle cover sleeve, the needle cap is removed from the needle and the delivery device is ready to be used, i.e. ready to be activated. In this state, the protruding needle cover sleeve protects the needle.

Hence, the needle cover sleeve arranged in its second, proximal position, is arranged axially back into the enclosure in the distal direction against the force of the cartridge driver spring. In case a user now holds the delivery device by its enclosure, puts the delivery device with the protruded proximal end of the needle cover sleeve on the dose delivery site and subsequently pushes the enclosure relative to the needle cover sleeve in the proximal direction, the needle cover sleeve retracts into the enclosure and the needle becomes exposed from the needle cover sleeve and is pushed into the skin of the user at the dose delivery site.

In a preferred embodiment, the needle cover sleeve also comprises an interface member contributing to the cartridge driver-plunger rod mechanical interface. The interface member, in the second position of the plunger rod, blocks a transition of the plunger rod to its third, most proximal position. However, in response to the above-illustrated retraction of the needle cover sleeve into and relative to the enclosure, the interface member of the needle cover sleeve is also relative to the enclosure and disengages from its blocking position in the cartridge driver- plunger rod interface. This disengagement unblocks the second position of the plunger rod and allows a subsequent linear movement of the plunger rod in the proximal direction from its second to its third position under the impact of the force of the plunger rod spring, thereby affecting expelling the medicament at the proximal end of the needle.

According to a further aspect of the present invention, a method is provided for operating a medicament delivery device according to claim 14. The medicament delivery device preferably is a medicament delivery device according to any of the above embodiments. It is presently abstained from redundantly introducing the components of the delivery device again. In the method, the medicament delivery device is provided in an initial state in which o the cartridge holder is held by a mechanical interface between the cartridge holder and the enclosure in a first, distal position against a force exerted by the biased cartridge driver spring; and o the plunger rod is held by a mechanical interface between the cartridge driver and the plunger rod in a first, distal position distant from the stopper against a force exerted by the biased plunger rod spring,

Then, the cap is rotated relative to the enclosure, e.g. manually by a user, thereby producing a rotation of the cartridge holder, the rotation of the cartridge holder releasing the cartridge holder from its first, distal position. The cartridge driver spring pushes the cartridge driver, the cartridge holder and the cartridge to a second proximal position relative to the enclosure during which transition the needle of the needle hub penetrates the seal of the cartridge. At or close to the cartridge holder reaching its second, proximal position, the interface member of the rear enclosure releases the plunger rod from its first position relative to the cartridge driver. The plunger rod spring pushes the plunger rod into a second, more proximal position relative to the cartridge driver, during which transition the plunger rod acts on the stopper of the cartridge and moves the stopper within the cartridge for a defined distance to expel air out of the cartridge.

In a preferred embodiment of the method the cartridge driver spring pushes the needle cover sleeve from a first, distal position into a second, proximal position, in which second position the needle cover sleeve protrudes from a proximal end of the enclosure. The cap is removed from the proximal end of the needle cover sleeve, thereby exposition the needle, and the needle cover sleeve is pushed back into the enclosure. During this transition of the needle cover sleeve, the interface member of the needle cover sleeve releases the plunger rod from its second position relative to the cartridge. The plunger rod spring pushes the plunger rod into a third, proximal position relative to the cartridge driver, thereby acting on the stopper within the cartridge and moving the stopper for a distance sufficient within the cartridge to expel a majority of the medicament from the cartridge.

Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to a/an/the element, apparatus, member, component, means, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, member component, means, etc., unless explicitly stated otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings, wherein

Figure 1 illustrates a partially transparent perspective view of a medicament delivery device in an initial state, according to an embodiment of the present invention;

Figure 2 illustrates an exploded view of a medicament delivery device according to an embodiment of the present invention; Figure 3 illustrates a partially transparent perspective view of a medicament delivery device in a cap-rotated state, according to an embodiment of the present invention;

Figure 4 illustrates a partially transparent perspective view of a medicament delivery device in a protruded state, according to an embodiment of the present invention;

Figure 5 illustrates a perspective view of the components of the medicament delivery device in the protruded state of Figure 4;

Figure 6 illustrates a perspective view of a cartridge driver according to an embodiment of the present invention;

Figure 7 illustrates a perspective view of a cartridge driver - plunger rod - rear enclosure combination of a medicament delivery device according to an embodiment of the present invention;

Figure 8 illustrates a perspective view of the components of the medicament delivery device in a state after priming, according to an embodiment of the present invention;

Figure 9 illustrates a partially transparent perspective view of a medicament delivery device in a protruded state after cap removal according to an embodiment of the present invention;

Figure 10 illustrates a partially transparent perspective view of a medicament delivery device in an activated state according to an embodiment of the present invention;

Figure 11 illustrates a perspective view of the components of the medicament delivery device of Figure 10;

Figure 12 illustrates a perspective view of the components of the medicament delivery device in the initial state according to an embodiment of the present invention; and Figure 13 illustrates a perspective view of the components of the medicament delivery device in the protruded state according to an embodiment of the present invention.

DETAILED DESCRIPTION

The same components and elements are referred to by the same reference signs across all Figures.

Figure 1 illustrates a partially transparent perspective view of a medicament delivery device 100 in an initial state, according to an embodiment of the present invention.

The delivery device 100 extends along a longitudinal axis illustrated by a dashed arrow between a proximal end P and a distal end D. The delivery device 100 presently takes an initial state, i.e. a state in which the delivery device may be distributed to recipients.

The delivery device 100 comprises a tubular-shaped enclosure 8 illustrated in a transparent manner and a cover-shaped rear enclosure 16 attached to a distal end of the tubular-shaped enclosure 8 so that a distal opening of the enclosure 8 is closed by the cover-shaped rear enclosure 16. Enclosure 8 encloses a needle cover sleeve comprising two tubular shaped portions 6 and 7, preferably of the same diameter and circumference, coupled to each other. A plug 5 is attached to the proximal end of the needle cover sleeve 6,7, and a cap 4 closes the delivery device 100 at its proximal end P.

A cartridge driver spring 12 is arranged between the needle cover sleeve 6,7 and the rear enclosure 16, and is biased in the initial state. Accordingly, given that the rear enclosure 16 is firmly attached to the enclosure 8, the cartridge driver spring 12 pushes the needle cover sleeve 6,7 in the proximal direction.

The needle cover sleeve 6,7 encloses, in its initial state, a combination of a cartridge 10 held by a cartridge holder 9 and a cartridge driver 11, the cartridge 10 and cartridge holder 9 being visible e.g. through an opening in the enclosure 8, and the cartridge driver 11 being visible through an opening of the needle cover sleeve portion 7. At the distal end D, a plunger rod 13 is visible. The plunger rod 13 is driven by a biased plunger rod spring 14. The plunger rod 13 reaches into and through the tubular-shaped cartridge driver 11.

A mechanical interface is provided between the cartridge holder 9 and the enclosure 8. In a preferred example, the mechanical interface presently encompasses a proximally directed surface 91 of the cartridge holder 9. In a preferred example, the cartridge holder 9 comprises a protrusion comprising the proximally directed surface. The mechanical interface further encompasses a distally directed surface of the enclosure member 8. In a preferred example, the enclosure comprises a protrusion from an inner surface of the tubular-shaped enclosure 8, the protrusion comprises the distally directed surface 81. In a preferred example, the protrusion is in form of a stair structure protruding from the inner surface of the tubular-shaped enclosure 8.

In the present initial state, the cartridge holder 9 is locked in a first position relative to the enclosure 8 where the proximally directed surface 91 is engaged with the distally directed surface 81 of the enclosure 8. , as shown in Figure 1. Thus, the cartridge holder 9 is prevented from being driven towards the proximal end under the impact of a force exerted by the biased cartridge driver spring 12 pushing on the cartridge driver 11, which cartridge driver 11 is coupled with the cartridge holder 9.

Figure 2 illustrates an exploded view of a medicament delivery device according to an embodiment of the present invention, preferably of the medicament delivery device of Figure 1. The components of the medicament delivery device are arranged in three rows I., II. and III. The components include the cap 4, a needle cap 3, a needle hub 20, a septum 2, the plug 5, the needle cover sleeve portion 6, the enclosure 8, the cartridge holder 9, a cartridge 10, the cartridge driver 11, the other needle cover sleeve portion 7, the cartridge driver spring 12, the plunger rod 13, the plunger rod spring 14, a lock bracket 15 and the rear enclosure 16. Figure 3 illustrates a partially transparent perspective view of a medicament delivery device 100, e.g. the medicament delivery device of Fig. 1 or Fig. 2, in a cap-rotated state, according to an embodiment of the present invention. In this Figure 3, the enclosure 8 is illustrated in a transparent manner, and the needle cover sleeve 6,7 is not shown for a better illustration of the other components. As can be derived from Figure 3, the needle cap 3 is attached to the needle hub 20 and protects a proximal portion of a needle 202. On the other hand, the needle cap 3 is mounted with and rotationally coupled to a cap 4. Accordingly, a rotation of the cap 4 relative to the enclosure 8 causes a rotation of the needle cap 3, and as a result a rotation of the needle hub 20.

Preferably, the needle hub 20 is mounted to the enclosure 8 by snap-fitting. For example, the needle hub 20 has the shape of arms 204 radially protruding from the needle hub body 201. Preferably, the arms snap fit to the enclosure 8. In the distal direction from the needle hub 20, the cartridge holder 9 is arranged with the cartridge 10 supported by the cartridge holder 9. An interface member 92 is provided at a proximal end of the cartridge holder 9. The interface member 92 is configured to be radially engaged with a cartridge holder interface member 203 of the needle hub 20 at least at in one direction so that the needle hub 20 the cartridge holder 9 can be rotated together at least in one rotational direction.

In a preferred example, the interface member 92 is in form of a recess. In a preferred example, the cartridge holder interface member 203 has the shape of arms protruding from the needle hub 20 in the distal direction. These arms preferably engage with the recess 92 in the cartridge holder 9. In the present state, these arms only partially reach into the recess, which, nevertheless, evokes a rotational coupling of the needle hub 20 and the cartridge holder 9. When the cap 4 is rotated, e.g. by a user of the delivery device 100, the cartridge holder 9 is rotated. As a result, the proximally directed surface 91 of the cartridge holder 9 is circumferentially offset from the distally directed surface 81 of the enclosure 8. Thus, the cartridge holder 9 is driven in the proximal direction by the cartridge driver spring 12. Accordingly, a transition of the delivery device 100 from an initial state to a subsequent state, preferably into a prepared state, i.e. a state after priming, is effected by rotating the cap 4. For example, as the cartridge 10 is held by the cartridge holder 9, the proximal movement of the cartridge holder 9 moves the cartridge 10 towards the needle 202, and thus, the fluid communication between the needle and the cartridge can be established. As a result, the cartridge 10 can be primed (the contained air can be expelled) via the needle 202.

As can be derived from Figure 3, in both the initial state as well as in the rotated cap state the needle 202 of the needle holder 20, at its distal end, is arranged distance from the cartridge 10, and in particular from a seal 101 arranged at the proximal end of the cartridge 10 and sealing the cartridge 10 from a leakage of the medicament.

Accordingly, the present delivery device 100 is of a kind in which the needle 202 is provided and assembled as part of the delivery device 100 rather than of the cartridge 10. The needle 202 which preferably reaches through the needle hub body 201 is arranged at a stationary position with respect to the enclosure 8. In order to prepare for a later injection, the cartridge 10 is to be moved towards the needle hub 20 in the proximal direction for the needle 202 to penetrate the seal 101 of the cartridge 10 as mentioned above.

Figure 4 illustrates a partially transparent perspective view of a medicament delivery device 100 in a protruded state, e.g. of the delivery device of Fig. 1 to 3, according to an embodiment of the present invention. Again, the enclosure 8 is depicted transparently. Now, needle cover sleeve 6,7 is shown again. In this state, the needle cover sleeve 6,7, together with the cap 4, protrudes from the proximal end of the enclosure 8 in a telescopic manner. The cap 4 is now rotated with respect to the cap shown in Figure 3, e.g. by the user of the delivery device 100. Such rotation disengages the cartridge holder 9 from the enclosure 8 as mentioned above, and allows the cartridge holder 9 to travel in the proximal direction. The biased cartridge driver spring 12 is, via the cartridge driver 11, responsible for such axial movement of the cartridge holder 9 from a first, distal position to a second, proximal position. As the cartridge driver spring 12 is also connected to the needle cover sleeve 6,7, the needle cover sleeve 6,7 is also biased in the proximal direction. In one example, the front part of the tubular needle cover sleeve 6 can be coated with a specific color, marks, texture... etc, to indicate to the user that the medicament delivery device 100 now is ready for carrying out an injection.

Figure 5 illustrates a perspective view of the components of the medicament delivery device 100 of Figure 4 in the protruded state. Enclosure 8, needle cover sleeve 6,7 and cartridge holder 9 are no longer shown in view of a better illustration of the inner components of the delivery device 100. As can best be seen in preceding Figure 5, the cartridge 10 preferably is a container, preferably tubular shaped, and holds the medicament. At its proximal end, the cartridge 10 is closed by the seal 101, while close to the distal end a stopper 102 is provided. The stopper 102 preferably is slidable and arranged in the cartridge 10. Pushing the stopper 102 in the proximal direction causes the medicament to expel through the needle 202 at its proximal end. The component to act on the stopper 102 is the plunger rod 13. However, the plunger rod 13 yet is arranged a distance from the stopper 102.

By the rotation of the cap (not shown) relative to the enclosure (not shown), the cartridge driver spring 12 (not shown) has pushed the cartridge driver 11, the cartridge holder (not shown) and the cartridge 10 in the proximal direction towards the stationary needle hub 20, thereby making a needle 202 of the needle hub 20 penetrate the seal 101 of the cartridge 10. The mechanical interface between the enclosure 8 and the cartridge holder 9 as shown in Figures 3 and 4 is dimensioned such that the cartridge 10 travels a sufficient distance in the proximal direction to safely meet the needle 202. And the driving force of the cartridge driver spring 12 is preferably dimensioned such that the needle 202 safely penetrates the seal 101 of the cartridge 10.

Figure 6 illustrates a perspective view of a cartridge driver 11 according to an embodiment of the present invention, and as preferably used in the delivery device of Figures 1 to 5. While the above-introduced cartridge holder - enclosure mechanical interface is configured to evoke a penetration of the seal of the cartridge by the needle, the cartridge driver n in combination with the plunger rod provides another mechanical interface controlling interaction between the plunger rod and a stopper in the cartridge.

The cartridge driver 11, and in particular a mechanical interface portion in of the cartridge driver 11 is responsible for controlling actions, i.e. stops or axial and/or rotational movements of the plunger rod. Presently, the cartridge driver 11 is tubular for guiding the plunger rod through. At the distal end D of the cartridge driver 11, the mechanical interface in is arranged in form of a defined shaped recess in a circumferential wall of the cartridge driver n. In a preferred example, the mechanical interface portion in comprises a stair- structured recess, including a first step nil, a second step 1112, and optionally a third step 1113 at different longitudinal positions. A surface of the first step 1111 is inclined and facing in the distal direction, and a surface of the second 1112 is inclined and facing in the distal direction. In a preferred example, a portion of the stair structured recess connecting between a second step 1112 and a third step is a slot snuggly fitted with the protrusion 131 of the plunger rod 13. The slot is configured to guide the plunger rod 13 to move straight in the proximal direction.

Figure 7 illustrates a perspective view of the cartridge driver - plunger rod - rear enclosure combination of a medicament delivery device according to an embodiment of the present invention. The plunger rod 13 reaches through the cartridge driver 11. A radial protrusion 131 of the distal end of the plunger rod 13 interacts with the mechanical interface portion 111 of the cartridge driver 11. Presently, the plunger rod 13 is held in the first position relative to the cartridge driver 11 by a combination of the first step 1111 and a proximally directed protrusion 161 of the rear enclosure 16. In a preferred example, the proximally directed protrusion 161 reaches into the recess in the cartridge driver 11. The proximally directed protrusion 161 extends from the rear enclosure 16 in the proximal direction and is arranged at a radial position that matches the radial position of the recess in the cartridge driver 11. In a preferred example as shown in Figure 7, the protrusion 161 is adjacent to the protrusion 131 of the plunger rod 13 when the plunger rod is spaced apart from the stopper 102. The proximally directed protrusion 161 and the cartridge driver 11 hence block the protrusion 131 of the plunger rod 13 from moving radially. As a result, the plunger rod 13 can only rest on the first step 1111 of the cartridge driver 11. Thus, before the cartridge driver 11 is moved in the proximal direction, the plunger rod 13 is held by the first step 1111 of the cartridge driver 11 against the plunger rod spring 14 from being moved in the proximal direction. Furthermore, in a preferred example, the distal needle cover sleeve 7 comprises an elongated rib extending from an inner surface of the distal needle cover sleeve. The elongated rib is positioned in the recess of the mechanical interface 111. In a preferred example, the protrusion 161 of the rear enclosure 16 is sandwiched between the protrusion 131 of the plunger rod 13 and the elongated rib of the needle cover sleeve 7 in a direction transverse to the longitudinal axis. In a preferred example, the elongated rib of the needle cover sleeve 7 is at least partially lined up with both the first step 1111 and the second step 1112. The function of the elongated rib of the needle cover sleeve 7 will be explained in detail later.

As is shown in Figures 4 and 5, in response to the cartridge holder 9 being released from its initial first, distal position in response to the rotation of the cap 4, the cartridge 10, the cartridge holder 9 and the cartridge driver 11 are pushed in the proximal direction by the cartridge driver spring 12, and so is the plunger rod 13. In response to the movement of these components relative to the enclosure 8 and the rear enclosure 16, the protrusion 161 of the rear enclosure 16 is spaced apart from the recess in the cartridge driver 11 (as the cartridge driver 11 is moved proximally relative to the rear enclosure 16). This state is shown in Figure 5. The protrusion 161 is about to leave its blocking position. This enables the protrusion 131 of the plunger rod 13, driven by the plunger rod spring (not shown), to slide along the inclined step 1111 which makes the plunger rod 13 rotate until the protrusion 131 of the plunger rod 13 leaves the inclined step 1111 and is free to move longitudinally towards the second step 1112, i.e. it's second, more proximal position. During the transition to the second step 1112, the plunger rod 13 engages with the stopper 102 and pushes the stopper 102 for a relatively small distance in the proximal direction. The distance is the distance between the first and second steps 1111, 1112 in the mechanical interface portion 111 of the cartridge driver 11. At the end of the transition of the plunger rod 13, the stopper 102 is moved within the cartridge 10 in the proximal direction sufficient to expel residual air from the proximal end of the cartridge 10 through the needle 202, but insufficient to expel the medicament from the needle, or only tiny amounts of the medicament. This state can be seen in Figure 8. In the meantime, the needle 202 is fluidly communicated with the cartridge 10 (as mentioned above); thus, the medicament delivery device 100 is primed.

Preferably, the delivery device is held upright by the user during this priming process, i.e. expelling the air out of the cartridge, since residual air then collects at the top of the cartridge 10. In other words, the user may be instructed to hold the medicament delivery device upright (pointing the proximal end of the medicament delivery device away from the ground) when the user plans to twist the cap 4.

Figure 9 illustrates a partially transparent perspective view of a medicament delivery device, such as the delivery device introduced in the previous Figures, in a protruded state after cap removal according to an embodiment of the present invention. Figure 9 preferably illustrates the state of the delivery device after priming, which is the state illustrated in Figure 8. In addition, the cap is removed from the needle cover sleeve 6,7. This afterpriming state represents the prepared state, in which the delivery device is ready to be used.

Figure 10 illustrates a partially transparent perspective view of a / the medicament delivery device in an activated state according to an embodiment of the present invention. In this state, the needle cover sleeve 6,7 is pushed back into the enclosure 8. This may represent the designated usage of the delivery device, i.e. putting the delivery device with its proximal end in the state of Figure 9 onto the dose delivery site, thereby holding the delivery device by its enclosure 8, and pushing the enclosure 8 in the proximal direction. Since the needle cover sleeve 6,7 is slidable arranged in the enclosure 8, the needle cover sleeve 6,7 moves back into the enclosure 8 against the force exerted by the cartridge driver spring 12. This makes the needle 202 penetrate the user’s skin.

In response to the needle cover sleeve 6,7 moving in the distal direction, the elongated rib extending of the needle cover sleeve portion 7 is retracted from the recess in the cartridge driver 11. This elongated rib is dimensioned to reach into the recess down to the third step 1113. This elongated rib blocks the protrusion 131 of the plunger rod 13 from leaving the second step 1112, and, hence, from leaving its second position relative to the cartridge driver 11.

Recapitulating that the plunger rod 13 in its second position represents the state after priming, a transition of the plunger rod 13 from its second to its third position causes the plunger rod 13 to push the stopper 102 further into the proximal direction into the cartridge 10 making the medicament expel from the needle 202 attached to the cartridge 10.

Figure 11 illustrates a perspective view of the components of the medicament delivery device of Figure 10 in the activated state. As can be seen, the protrusion 131 of the plunger rod 13 now is close to the third step 1113 in the stair structure of the cartridge driver 11. This represents a state after having expelled a majority of the medicament from the cartridge.

Figure 12 illustrates a perspective view of the components of the medicament delivery device in the initial state according to an embodiment of the present invention. Figure 12 focuses on the interface between the needle 202 of the needle hub 20 and the cartridge 10. In the initial state, as shown in Figure 12, a distal end of the needle 202 is protected by a septum 2 covering the needle 202 and resting on the needle hub body 201. In addition, the needle cap 3 protects a proximal end of the needle 202. The needle cap 3 preferably has a mechanical interface 31 for engaging with the cap 4. The needle cap 3 preferably is rotationally and axially fixed to the cap 4. For example, the mechanical interface 31 is a protrusion positioned within a recess of the cap

4-

Figure 13 illustrates a perspective view of the components of the medicament delivery device as shown in Figure 12, however, in the protruded state but before injection. The cartridge 10 was pushed with its seal 101 against the deformable septum 2, and then against the needle 202. Pushing the cartridge 10 on in the proximal direction causes the needle 202 to first penetrate the septum 2 and subsequently the seal 101 of the cartridge 10. In such a way, the needle 202 is not exposed to the environment at any time and will not be contaminated.

The drug delivery devices described herein can be used for the treatment and/or prophylaxis of one or more of many different types of disorders.

Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia and/or dyslipidemia, cardiovascular disease, diabetes (e.g. type 1 or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behget's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycaemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, Factor V Leiden), and cancer.

Exemplary types of drugs that could be included in the delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapies, radioisotopes and/or nuclear medicines, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogues, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies.

Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro- apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.

Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-i (GLP-i) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Ci esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin generelated peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor- associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-1/PD-L1) inhibitors/modulators, B-lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, Blymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulators, lymphocyte-activation gene 3 (LAG3; also known as cluster of differentiation 223 or CD223) antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation W137 (CDW137) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD159 or NKG2) modulators, glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig- like receptor (KIR) modulators, growth arrest-specific protein 6 (GAS6)/AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation W123 (CDwi23) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumorinfiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.

Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-ia, interferon beta-ib, peginterferon beta-ia, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins.

Exemplary drugs that could be included in the delivery devices described herein may also include, but are not limited to, oncology treatments such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, pertuzumab, transtuzumabpertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90- Yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab.

Exemplary drugs that could be included in the delivery devices described herein include “generic” or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the “innovator” or “branded” version of each, as in the non-limiting example of innovator medicament adalimumab and biosimilars such as adalimumab- afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.

Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g. diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer’s solution, Heparin Lock Flush solution, loo U/mL Heparin Lock Flush Solution, or 5000 U/mL Heparin Lock Flush Solution.

Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also include separately administered or co-formulated dispersion enhancers (e.g. an animal-derived, humanderived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.

Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mF0LF0X6, mFOLFOXy, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, MiniCHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, REPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE,

MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA/CO, EMA/EP, EP/EMA, TP/TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C- MOPP, GCD, GEMOX, CAV, DTPACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

Various modifications to the embodiments described are possible and will occur to those skilled in the art without departing from the invention which is defined by the following claims.

Claims

1. Cartridge driver (n) for a medicament delivery device (ioo), comprising:

- a proximal end, a distal end and a mechanical interface portion extending along a longitudinal axis between the proximal end and the distal end;

- wherein the proximal end of the cartridge driver (11) is configured to be coupled to a cartridge (io), and the distal end of the cartridge driver (11) is connected to a spring (12);

- a mechanical interface portion (111) configured to interact with a plunger rod (13) of the medicament delivery device (100) for controlling an action of the plunger rod (13) on a stopper (102) of a cartridge (10) containing a medicament; and wherein the mechanical interface portion (111) comprises a stair structure comprising a first step (1111) and a second step (1112) at different longitudinal positions; wherein the first step (1111) and the second step (1112) are configured to releasably hold the plunger rod (13) in two positions respectively relative to the cartridge driver (11).

2. Cartridge driver (11) according to claim 1, wherein the mechanical interface portion (111) comprises a third step (1113) configured to support the plunger rod (13) relative to the cartridge driver (11) after the plunger rod (13) having moved the stopper (102) relative to the cartridge (10) for a distance sufficient to expel a majority of the medicament from the cartridge (10).

3. Cartridge driver (11) according to claim 1 or claim 2, wherein the mechanical interface (111) is arranged in form of a defined shaped stair structured recess in a circumferential wall of the cartridge driver (11); wherein the stair structured recess is configured to interact with a protrusion (131) of the plunger rod (13).

4- Cartridge driver (11) according to any of the preceding claims, being of tubular shape and configured to receive the plunger rod (13).

5. Cartridge driver (11) according to any of the preceding claims, wherein a surface of the first step (1111) is inclined and facing in the distal direction; and a surface of the second step (1112) is inclined and facing in the distal direction.

6. Medicament delivery device (100) comprising: a cartridge driver (11) according to any of the preceding claims, a plunger rod (13) selectively engaged with the first step (1111) or the second step (1112).

7. Medicament delivery device (100) according to claim 6, comprising:

- a plunger rod spring (14) arranged for driving the plunger rod (13) in the proximal direction relative to the cartridge driver (11).

8. Medicament delivery device (100) according to claim 6 or 7 when dependent on claim 3, wherein the plunger rod comprises a protrusion (131).

9. Medicament delivery device (100) according to claim 8, when dependent on claim 5, comprising: an enclosure (8) and a rear enclosure (16) attached at the distal end of the enclosure (8); wherein the rear enclosure (16) comprises a protrusion (161) positioned within the stair-structured recess (111); and wherein the protrusion (161) is adjacent to the protrusion (131) of the plunger rod when the plunger rod (13) is spaced apart from the stopper (102).

10. Medicament delivery device (100) according to any of claims 6-9, comprising - a cartridge holder (9) configured to receive a cartridge (10) containing a medicament, the cartridge holder (9) is coupled to the proximal end of the cartridge driver (11) such that the cartridge holder (9) is axially fixed,

- a cartridge driver spring (12) connected to the cartridge driver for driving the cartridge driver (11) and the cartridge holder (9) in the proximal direction relative to the enclosure (8).

11. Medicament delivery device (100) according to claim 10, comprising

- a mechanical interface between the cartridge holder (9) and the enclosure (8) for releasably holding cartridge holder (9) relative to the enclosure (8) along the longitudinal axis against the cartridge driver spring (12), and

- a cap (4) arranged at the proximal end of the enclosure (8) and rotationally coupled with the cartridge holder (9) such that the cartridge holder (9) is rotated together with the cap relative to the enclosure (8) when the cap (4) is rotated relative to the enclosure (8).

12. Medicament delivery device (100) according to claim 11, wherein the cartridge holder (9) comprises a proximally directed surface (91) releasably engaged with a distally directed surface (81) of the enclosure (8).

13. Medicament delivery device (100) according to any of claims 10-12, comprising

- a needle (202), and

- a needle cover sleeve (6,7) arranged in the enclosure (8,16);

- wherein the cartridge driver spring (12) is arranged to also drive the needle cover sleeve (6,7) in the proximal direction relative to the enclosure (8), wherein the needle cover sleeve (6,7) is, in response to a rotation of the cap (4), axially moves from a first, distal position to a second, proximal position in which the needle cover sleeve (6,7) protrudes from the proximal end of the enclosure (8).

14. Medicament delivery device (100) according to claim 13, comprising

- a needle hub (20) mounted to the enclosure (8), rotationally coupled with the cartridge holder (9) and comprising the needle (202) extending along the longitudinal axis, and

- a cartridge (10) held by the cartridge holder (9) and containing a medicament, the cartridge (10) comprising a seal (101) at its proximal end and the stopper (102) at its distal end, wherein the cap (4) is rotationally coupled with the needle hub (1), wherein the cartridge holder (9) - enclosure (8) mechanical interface is dimensioned to: o in the first, distal position of the cartridge holder (9), retain the seal (102) of the cartridge (10) distant from the needle, o in response to the rotation of the cap (4), transferring the cartridge holder (9) including the cartridge (10) to the second, proximal position thereby making the needle (202) penetrate the seal (101), o in the second, proximal position of the cartridge holder (9) the cartridge driver (11) - plunger rod (13) mechanical interface assuming its second position with the interface member (71) of the needle cover sleeve (6,7) blocking the plunger rod (13) in its second position.

15. Medicament delivery device (100) according to claims 13 or 14, wherein the needle cover sleeve (6,7) is axially back into the enclosure (8,16) in the distal direction against the force of the cartridge driver spring (12), thereby disengaging the second further interface member of the needle cover sleeve (6,7) from its blocking position in the cartridge driver (11) - plunger rod (13) interface thereby allowing a subsequent linear movement of the plunger rod (13) in the proximal direction from its second to its third position thereby effecting expelling the medicament at the proximal end of the needle.