WO2025098848A1

WO2025098848A1 - Assembly for a medicament delivery device

Info

Publication number: WO2025098848A1
Application number: PCT/EP2024/080685
Authority: WO
Inventors: René ZANDER; Núria De Santiago Giner
Original assignee: SHL Medical AG
Current assignee: SHL Medical AG
Priority date: 2023-11-09
Filing date: 2024-10-30
Publication date: 2025-05-15
Anticipated expiration: 2026-05-09

Abstract

An assembly for a medicament delivery device (1), comprising: a plunger rod (19) having a longitudinal axis, the plunger rod (19) being axially biased in a first direction along the longitudinal axis, a delivery member cover (7) configured to move along the longitudinal axis, in the first direction from a first axial position to a second axial position, a shield link (17) axially biased in the first direction and engaging with the delivery member cover (7), such that axial movement of the delivery member cover (7) causes corresponding axial movement of the shield link (17), and a sleeve (15) arranged concentrically with and radially outside the plunger rod (19), wherein the plunger rod (19) and the sleeve (15) are engaged with a first snap connection when the delivery member cover (7) is in the first axial position, fixating the plunger rod (19) axially relative to the sleeve (15), wherein the shield link (17) has a radially inwards extending protrusion (17e) which cooperates with the first snap connection between the plunger rod (19) and the sleeve (15) when the delivery member cover (7) is moved from the first axial position to the second axial position, causing the plunger rod (19) to disengage from the sleeve (15) and to move a first distance in the first direction, and wherein the plunger rod (19) is configured to engage with the sleeve (15) with a second snap connection when the plunger rod (19) has moved the first distance.

Description

ASSEMBLY FOR A MEDICAMENT DELIVERY DEVICE

TECHNICAL FIELD

The present disclosure generally relates to medicament delivery devices.

BACKGROUND

Medicament delivery devices such as autoinjectors may have a plunger rod which is moved forward by a power source inside the medicament container during drug delivery. The plunger rod may be triggered by a rearward moving needle cover. The plunger rod may in this case be released from a forward- biased state by means of a rotator. The rotator is a component that is rotated from a first rotational position in which it holds plunger rod to a second rotational position in which the plunger rod is released, by cooperation with the rearward moving needle cover.

W02006057604 Ai discloses an example of an injection device with a tubular member that rotates to release the plunger.

SUMMARY

A general object of the present disclosure is to provide an assembly for a medicament delivery device which solves or at least mitigates the problems of the prior art.

There is hence according to a first aspect of the present disclosure provided an assembly for a medicament delivery device, comprising: a plunger rod having a longitudinal axis, the plunger rod being axially biased in a first direction along the longitudinal axis, a delivery member cover configured to move along the longitudinal axis, in the first direction from a first axial position to a second axial position, a shield link axially biased in the first direction and engaging with the delivery member cover, such that axial movement of the delivery member cover causes corresponding axial movement of the shield link, and a sleeve arranged concentrically with and radially outside the plunger rod, wherein the plunger rod and the sleeve are engaged with a first snap connection when the delivery member cover is in the first axial position, fixating the plunger rod axially relative to the sleeve, wherein the shield link has a radially inwards extending protrusion which cooperates with the first snap connection between the plunger rod and the sleeve when the delivery member cover is moved from the first axial position to the second axial position, causing the plunger rod to disengage from the sleeve and to move a first distance in the first direction, and wherein the plunger rod is configured to engage with the sleeve with a second snap connection when the plunger rod has moved the first distance.

The assembly thereby provides a priming feature, which is obtained by axial movement of all components involved for releasing the plunger rod. This is an alternative solution to releasing the plunger rod by a rotating component.

According to one embodiment the radially inwards extending protrusion is configured to engage with the sleeve with a third snap connection at the same location of the sleeve that engaged with the plunger rod with the first snap connection.

One embodiment comprises a release member comprising a radially inwards extending second protrusion, wherein when the delivery member cover is moved from the second position towards the first position, the radially inwards extending second protrusion cooperates with the third snap connection between the plunger rod and the sleeve, causing the plunger rod to disengage from the sleeve and to move axially a second distance in the first direction.

The release member thus sets the plunger rod free after priming by only axial movement of components, and the plunger rod can thus travel the second distance to its final axial position.

According to one embodiment the radially inwards extending second protrusion is configured to engage with the sleeve with a fourth snap connection at the same location of the sleeve that engaged with the plunger rod with the third snap connection. According to one embodiment the sleeve comprises a first and a second axially spaced apart radial through-opening, and the plunger rod comprises a set of at least one radially flexible arm, each arm being provided with a radially outwards extending protrusion, wherein one protrusion is configured to engage with the first radial through-opening to form the first snap connection and one protrusion is configured to engage with the second radial through-opening to form the second snap connection.

According to one embodiment the radially inwards extending protrusion of the shield link is configured to engage with the first radial through-opening to form the third snap connection.

According to one embodiment the radially inwards extending protrusion of the shield link is configured to push the arm radially inwards such that the arm disengages from the first radial through-opening.

According to one embodiment the radially inwards extending second protrusion is configured to engage with the second radial through-opening to form the fourth snap connection.

According to one embodiment the radially inwards extending second protrusion is configured to push the arm radially inwards such that the arm disengages from the second radial through-opening.

According to one embodiment the release member is configured to prevent the delivery member cover from moving from the second axial position to the first axial position radially inwards when the radially inwards extending second protrusion is engaged with the second radial through-opening.

The release member can thus provide an axial locking feature of the delivery member cover after the delivery member cover has reached the second axial position for the second time, i.e., after injection has been completed. The delivery member cover is thus prevented from exposing the delivery member after it has been axially locked. Alternatively, when the plunger rod has reached a final axial position, each arm of the plunger rod pushes the sleeve radially outwards such that a proximally facing surface of the sleeve bears against a distally facing surface of the release member, preventing the shield link to move back in the first direction.

One embodiment comprises an activator configured to move from a first position to a second position, wherein in the first position the activator engages with the plunger rod, preventing the plunger rod to move along the first direction, wherein the activator is configured to disengage from the plunger rod when the activator is moved to the second position, causing the plunger rod to move axially in the first direction and obtain the first snap connection with the sleeve.

The activator thus provides an initial activation of the assembly, releasing the plunger rod so that the plunger rod obtains the first snap connection with the sleeve.

According to one embodiment the activator is configured to move from the first position to the second position by rotation.

There is according to a second aspect of the present disclosure provided a medicament delivery device comprising an assembly of the first aspect.

One embodiment comprises a housing, wherein the sleeve is axially fixedly arranged relative to the housing.

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, component, means”, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, etc., unless explicitly stated otherwise. BRIEF DESCRIPTION OF THE DRAWINGS

The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:

Fig. i is a perspective view of an example of a medicament delivery device;

Fig. 2 is an exploded view of the medicament delivery device in Fig. 1;

Fig. 3 is an example of a plunger rod;

Fig. 4 shows a longitudinal section of an example of a sleeve;

Fig. 5 depicts a perspective view of a rear end member;

Fig. 6 is a perspective view of a shield link;

Figs 7A-7B show views of a release member;

Figs 8A-8B show longitudinal sections of the medicament delivery device in

Fig. 1 before activation,

Fig. 9 shows a side view of the medicament delivery device in Fig. 1 after activation;

Fig. 10 shows a longitudinal section of a rear portion of the medicament delivery device after activation;

Fig. 11 shows the medicament delivery device in Fig. 1 after priming;

Fig. 12 is a longitudinal section of a rear portion of the medicament delivery device after priming;

Fig. 13 is a perspective view of a rear portion of the medicament delivery device after priming;

Fig. 14 is a side view of the medicament delivery device when injection is being initiated; Fig. 15 shows internal components of the medicament delivery device when injection is being initiated; and

Fig. 16 depicts a longitudinal section of a rear portion of the medicament delivery device when the device has been locked out after use.

DETAILED DESCRIPTION

The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like numbers refer to like elements throughout the description.

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 under 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 under use of the medicament delivery device is/are located closest to the dose delivery site.

Further, the term “longitudinal”, “longitudinally”, “axially” or “axial” refer to a direction extending from the proximal end to the distal end, typically along the device or components thereof 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.

Fig. i is a perspective view of an example of a medicament delivery device i.

The medicament delivery device 1 is according to the example an autoinjector.

The medicament delivery device i described is disposable but could according to some variations be reusable.

The medicament delivery device 1 is an example of a device comprising an example of an assembly according to the present disclosure.

The medicament delivery device 1 comprises a housing 3.

The medicament delivery device 1 may comprise a removable cap 4.

The medicament delivery device 1 comprises an activator 5, or activation grip.

The cap 4 may be arranged around a needle shield protecting the needle of a syringe or medicament container arranged inside the housing 3.

The medicament delivery device 1 has a proximal end la and a distal end ib. The distal end ib is the rear end of the medicament delivery device 1. A rear end of the activator 5 defines the distal end ib. The opposite end of the medicament delivery device 1 is the proximal end la.

The activator 5 is configured to be moved between a first position and a second position. The movement is according to the present example rotation but could alternatively be e.g., linear motion. In Fig. 1 the activator 5 is in the first position, as indicated by a first visual mark 6a, e.g., a locked padlock, arranged on the outside of the housing 3, and which aligns with an indicator 6b on the activator 5. The housing 3 maybe provided with a second visual mark 6c, e.g., an open padlock. By turning the activator 5 from the first position to the second position, such that the indicator 6b aligns with the second visual mark 6c, the medicament delivery device 1 is activated and ready for use, as will be explained in more detail herein.

Fig. 2 is an exploded view of the medicament delivery device 1.

The medicament delivery device 1 comprises a delivery member cover 7, or needle shield. The delivery member cover 7 is at least partly received by the housing 3. The delivery member cover 7 is configured to move relative to the housing 3. The delivery member cover 7 is configured to move in the proximal direction and in the distal direction along the longitudinal axis of the medicament delivery device 1.

The delivery member cover 7 is configured to move between a plurality of axial positions. Before use, when the cap 4 is arranged around the rigid needle shield 9 or needle cap, as shown in Fig. 1, the delivery member cover 7 maybe arranged in an initial axial position relative to the housing 3. This corresponds to a maximally retracted position of the delivery member cover 7, relative to the housing 3. The activator 5 holds the delivery member cover 7 in the maximally retracted, or initial axial position before use when the activator 5 is in the first position.

The medicament delivery device 1 may comprise a front-end member 11, or needle shield front. The front-end member 11 maybe configured to be attached to a proximal end of the delivery member cover 7.

The medicament delivery device 1 comprises a medicament container assembly 13. The medicament container assembly 13 comprises a medicament container 13a, which holds a drug, arranged in the housing 3, and a delivery member 13b, e.g., a needle, assembled with the medicament container 13a. The medicament container assembly 13 also comprises the rigid needle shield 9 arranged around the delivery member 13b.

The medicament delivery device 1 comprises a sleeve or medicament container holder 15, or cartridge housing. The sleeve 15 is configured to hold the medicament container 13a. The sleeve 15 is arranged in the housing 3. The sleeve 15 is arranged to be axially fixed relative to the housing 3. The sleeve 15 may for example comprise sleeve protrusions 15a extending radially outwards, configured to be received by corresponding openings 3a in the housing 3 for engaging the sleeve 15 with the housing 3. The sleeve 15 maybe immovably arranged relative to the housing 3.

The delivery member cover 7 is arranged to receive a portion of the sleeve 15. The sleeve 15 may protrude in the distal direction from the delivery member cover 7. The delivery member cover 7 is axially movable relative to the sleeve 15.

The medicament delivery device 1 comprises a shield link 17. The shield link 17 may be generally tubular. The shield link 17 may be arranged around the sleeve 15. The shield link 17 engages with the delivery member cover 7. The shield link 17 is axially fixed relative to the delivery member cover 7. Axial movement of the delivery member cover 7 thus causes corresponding axial movement of the shield link 17. The shield link 17 may have proximally directed legs which extend radially underneath the delivery member cover 7 and connect with the delivery member cover 7. For example, the delivery member cover 7a, or delivery member cover may have one or more radial openings 7a and the shield link 17 may have a corresponding number of radially outwards extending protrusions 17a which are configured to snap into respective radial openings 7a.

The medicament delivery device 1 comprises a plunger rod 19. The plunger rod 19 is axially movable relative to the housing 3. The plunger rod 19 is configured to extend into the medicament container 13a to push a drug from the medicament container 13a through the delivery member 13b. The plunger rod 19 is arranged radially inwards of and concentrically with the sleeve 15. The plunger rod 19 is biased in a first direction, which is the proximal direction, i.e., towards the proximal end la of the medicament delivery device 1. The medicament delivery device 1 comprises a first resilient member 21, such as a spring, that biases the plunger rod 19 towards the proximal end la. The medicament delivery device 1 may further comprise a rod 23 around which first resilient member 21 is arranged, for stabilising the first resilient member 21.

The medicament delivery device 1 comprises a tubular rear end member 25, or activation knob. The tubular rear end member 25 is configured to engage with the activator 5. The tubular rear end member 25 is rotationally fixed relative to the activator 5. Thus, when the activator 5 is rotated from the first position to the second position, the tubular rear end member 25 is rotated concurrently with the activator 5.

The medicament delivery device 1 comprises a second resilient member 27. The second resilient member 27 may for example be a spring. The second resilient member 27 is configured to bias the shield link 17 in the proximal direction, i.e., towards the proximal end la. Since the shield link 17 is axially fixed relative to the delivery member cover 7, the second resilient member 27 also biases the delivery member cover 7 in the proximal direction towards a second axial position, which is a fully extended position of the delivery member cover 7 relative to the housing 3. The shield link 17 may have an outer skirt 17b against which a proximal end of the second resilient member 27 rests. A distal end of the second resilient member 27 may rest against a radial surface of the tubular rear end member 25.

Referring to Figures 7A and 7B, the medicament delivery device comprises release member 20. The release member 20 maybe tubular, cylindrical, or ring-shaped. The release member 20 is arranged to move axially relative to the sleeve 15. The release member 20 is configured to engage with the sleeve 15- Turning now to Fig. 3, a perspective view of the plunger rod 19 is shown. The plunger rod 19 is configured to engage with the sleeve 15 to control the axial position of the plunger rod 19 during various stages of operation of the medicament delivery device 1, as will be explained. The plunger rod 19 and the sleeve 15 are configured to engage with each other by means of snap connections.

The plunger rod 19 comprises a set of radially flexible arms 19a. In the present example, the set includes a plurality of radially flexible arms 19 a such as two radially flexible arms 19a. In the illustrated embodiment, the radially flexible arms 19a are arranged 180 degrees apart in the circumferential direction of the plunger rod 19. In other embodiments, different circumferential spacings and arrangements are employed. Each radially flexible arm 19 a is provided with a radially outwards extending protrusion 19b. The radially outwards extending protrusions 19b are in the present example in level with each other. The axial position of the radially outwards extending protrusions 19b is thus the same. Alternatively, their axial positions could be shifted.

The plunger rod 19 has a structure 19 c which extends radially outwards from the outer surface of the plunger rod 19.

Fig. 4 shows a longitudinal section of the sleeve 15. The sleeve 15 comprises a first radial through-opening 15b and a second radial through-opening 15c. The first and the second radial through-opening 15b and 15c are axially spaced apart. The first radial through-opening 15b and the second radial through-opening 15c have different axial positions on the outer surface of the sleeve 15. The first radial through-opening 15b is closer to a distal end 13d of the sleeve 15 than the second radial through-opening 15c is. In the example, the first and the second radial through-opening 15b and 15c are circumferentially spaced apart. The circumferential spacing is the same as for the radially flexible arms 19a, which in the example is 180 degrees. One, or a first, of the radially outwards extending protrusions 19b is configured to engage with the first radial through-opening 15b when the delivery member cover 7 is in a first axial position, obtained as a result of the activator 5 having been moved from the first position to the second position. The sleeve 15 and the plunger rod 19 thus engage with a first snap connection.

Another, or second, of the radially outwards extending protrusions 19b is configured to engage with the second radial through-opening 15c at a later stage of operation of the medicament delivery device 1, at which point the first radially outwards extending protrusion 19b has disengaged from the first radial through-opening 15b, as will be explained in more detail later.

Fig. 5 is a perspective view of the rear end member 25. The rear end member 25 has a proximal end 25a configured to receive a distal end portion of the plunger rod 19.

The rear end member 25 has an inner shelf 25b arranged proximally relative to a radial proximally directed surface igd of the structure 19c of the plunger rod 19 when the activator 5 is in the first position. The plunger rod 19 is thereby locked axially by the rear end member 25. When the activator 5 is moved to the second position, the rear end member 25 and thus the inner shelf 25b is shifted in the circumferential direction of the medicament delivery device 1, releasing the proximally biased plunger rod 19.

The rear end member 25 has a rib 25c extending circumferentially arranged on the outer surface of the rear end member 25.

Fig. 6 is a perspective view of the shield link 17. The shield link 17 has an inner surface provided with a protrusion 17c. The protrusion 17c is arranged axially aligned with and distally with respect to the rib 25c when the activator 5 is in the first position. The rib 25c is thus configured to prevent the proximally biased shield link 17 to move axially in the proximal direction. When the activator 5 is moved to the second position, the rear end member 25 and thus the rib 25c is shifted circumferentially, releasing the shield link 17 which together with the delivery member cover 7 to which it is coupled, is moved in the proximal direction.

The shield link 17 has a circumferentially extending heel 17b. The heel 17b is arranged to cooperate with the release member 20. The heel 17b is configured to axially move the release member 20 in the distal direction.

The shield link 17 has a radially inwards extending protrusion 17c. In the third axial position of the shield link, the radially inwards extending protrusion 17c is axially aligned with the one of the radially outwards extending protrusions 19b of the plunger rod 19. The radially inwards extending protrusion 17c is axially aligned with the first radial through- opening 15b.

Fig. 7A shows a perspective view of the release member 20. The release member 20 is arranged around the sleeve 15. The exemplified release member 20 has a rotation prevention feature 20a which mates with a corresponding feature of the sleeve 15. The rotation prevention feature 20a prevents relative rotation between the sleeve 15 and the release member 20.

The release member 20 comprises a radially inwards extending second protrusion 20b configured to be received by the second radial through- opening 15c. The radially inwards extending second protrusion 20b is provided on a radially flexible arm 20c.

Fig. 7B shows the release member 20 from another angle. The exemplified release member 20 has a release member protrusion 2od. The release member protrusion 2od maybe wedge-shaped, tapering in the distal direction. The release member protrusion 2od is provided on the outer surface of the release member 20.

The operation of the medicament delivery device 1 will now be described with reference to Figs 8A-16.

Fig. 8A shows a longitudinal section of the medicament delivery device 1 when the activator 5 is in the first position. Fig. 8B shows a close up of a rear portion of the medicament delivery device 1 in the state shown in Fig. 8A. The protrusion 17c of the shield link 17 bears against the rib 25c, which blocks the shield link 17 from moving forward in the proximal direction.

The radially outwards extending protrusions 19b are at this stage arranged distally with respect to the first and the second radial through-openings 15b and 15c. At this stage the radially outwards extending protrusions 19b are flexed radially inwards and do not engage with the sleeve 15.

Figs 9-10 illustrate the activator 5 in the second position. The activator 5 has thus been rotated from the first position to the second position. This causes the rear end member 25 to be rotated, whereby the shield link 17 and the plunger rod 19 are released. The cap 4 is still mounted to the medicament container assembly 13, limiting the proximal movement of the delivery member cover 7 and the shield link 17. The delivery member cover 7 attains its first axial position. The plunger rod 19 is also only allowed to move a limited distance in the proximal direction because it engages with the sleeve 15. One of the radially outwards extending protrusions 19b has been received into the first radial through-opening 15b. The first snap connection is thus formed between the plunger rod 19 and the sleeve 15 and the plunger rod 19 is once again axially locked.

Fig. 11 shows the medicament delivery device 1 when it has been primed. Priming is initiated by removing the cap 4. Removal of the cap 4 causes the delivery member cover 7 and the shield link 17 to move in the proximal direction. The delivery member cover 7 is moved from the first axial position to the second axial position, or fully extended position relative to the housing 3. The delivery member cover 7 fully covers the delivery member 13b.

In the process of priming, the shield link 17 is moved in the proximal direction. This causes the radially inwards extending protrusion lye to align with and bear against the radially flexible arm 19a engaged with the first radial through-opening 15b. Due to the radial inwards directed force applied by the radially inwards extending protrusion lye onto the radially flexible arm 19a, the radially flexible arm 19a flexes radially inwards. This causes the radially outwards extending protrusion 19b arranged in the first radial through-opening 15b to disengage from the first radial through-opening 15b. The radially inwards extending protrusion lye engages with the first radial through-opening 15b in another snap connection, herein termed a “third snap connection”, as shown in Fig. 12. The plunger rod 19 is thus allowed to move a second distance in the proximal direction. The second distance corresponds to the axial distance between the first radial through-opening 15b and the second radial through-opening 15c. When the plunger rod 19 has travelled the second distance, the other radially outwards extending protrusion 19b engages with the second radial through-opening 15c in a second snap connection between the plunger rod 19 and the sleeve 15.

Fig. 13 shows the medicament delivery device 1 with priming completed as in Fig. 12. The housing 3, the shield link 17, and the second resilient member 27 are hidden to expose underlying components, such as the release member 20. Moreover, the sleeve 15 is transparent. The release member 20 is arranged adjacent to and proximally of the second radial through-opening 15c.

Fig. 14 shows the medicament delivery device 1 when injection is about to commence. The delivery member cover 7 is moved into the housing 3 from the second position to a retraced position. This is normally done by placing and pressing the medicament delivery device 1 against the site of injection.

Fig. 15 shows internals of the medicament delivery device 1 when drug injection is about to commence, at the stage shown in Fig. 14. The delivery member cover 7 and the shield link 17 are moved in the distal direction. In a final stage of the distal movement of the shield link 17, the circumferentially extending heel 17b grabs a distally facing surface of the release member 20. This causes the release member 20 to be moved axially in the distal direction together with the shield link 17. The radially inwards extending second protrusion 20b thus moves onto the radially outwards extending protrusion 19b engaging with the second radial through-opening 15c. The radially flexible arm 19 a on which this radially outwards extending protrusion 19b is provided is thus flexed radially inwards. The radially outwards extending protrusion 19b thus disengages from the second radial through-opening 15b and the radially inwards extending second protrusion 20b engages with the second radial through-opening 15 to form a fourth snap connection. The plunger rod 19 is thereby disengaged from the sleeve 15, and the plunger rod 19 is released. The plunger rod 19 is as a result free to move inside the medicament container 13a to expel the drug and attain its final axial position inside the medicament container 13a.

When the injection has been completed, the medicament delivery device 1 is removed from the injection site. The proximally biased delivery member cover 7 is thus moved in the proximal direction to the fully extended position. According to some variations, in which the medicament delivery device 1 is a single-use or disposable device, the delivery member cover 7 is locked in the fully extended position at this stage.

Fig. 16 shows the medicament delivery device 1 when the delivery member cover 7 has been locked after the injection. The release member protrusion 2od of the release member 20 engages with a recess lyf on the inner surface of the shield link 17, preventing the shield link 17 to move in the distal direction. The delivery member cover 7 is thus locked in the fully extended position. As an alternative solution, each radially outwards extending protrusion of the plunger rod may push the sleeve radially outwards such that a proximally facing surface of the sleeve bears against a distally facing surface of the release member, preventing the shield link to move back in the distal direction.

The medicament 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, extmyasthenia gravis, Behqet'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 gene-related 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 (CD 19) inhibitors, B-lymphocyte 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 (CDW123) 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, transtuzumab-pertuzumab, 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, 100 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, human-derived, 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, Mini- CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, 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, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

The inventive concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.

Claims

1. An assembly for a medicament delivery device (1), comprising:

- a plunger rod (19) having a longitudinal axis, the plunger rod (19) being axially biased in a first direction along the longitudinal axis,

- a delivery member cover (7) configured to move along the longitudinal axis, in the first direction from a first axial position to a second axial position,

- a shield link (17) axially biased in the first direction and engaging with the delivery member cover (7), such that axial movement of the delivery member cover (7) causes corresponding axial movement of the shield link (17), and

- a sleeve (15) arranged concentrically with and radially outside the plunger rod (19), wherein the plunger rod (19) and the sleeve (15) are engaged with a first snap connection when the delivery member cover (7) is in the first axial position, fixating the plunger rod (19) axially relative to the sleeve (15), wherein the shield link (17) has a radially inwards extending protrusion (lye) which cooperates with the first snap connection between the plunger rod (19) and the sleeve (15) when the delivery member cover (7) is moved from the first axial position to the second axial position, causing the plunger rod (19) to disengage from the sleeve (15) and to move a first distance in the first direction, and wherein the plunger rod (19) is configured to engage with the sleeve (15) with a second snap connection when the plunger rod (19) has moved the first distance.

2. Assembly as claimed in claim 1, wherein the radially inwards extending protrusion (lye) is configured to engage with the sleeve (15) with a third snap connection at the same location of the sleeve (15) that engaged with the plunger rod (19) with the first snap connection.

3. Assembly as claimed in claim i or 2, comprising a release member (20) comprising a radially inwards extending second protrusion (20b), and wherein when the delivery member cover (7) is moved from the second position towards the first position, the radially inwards extending second protrusion (20b) cooperates with the third snap connection between the plunger rod (19) and the sleeve (15), causing the plunger rod (19) to disengage from the sleeve (15) and to move axially a second distance in the first direction.

4. Assembly as claimed in claim 3, wherein the radially inwards extending second protrusion (2oe) is configured to engage with the sleeve (15) with a fourth snap connection at the same location of the sleeve (15) that engaged with the plunger rod (19) with the third snap connection.

5. Assembly as claimed in any of the preceding claims, wherein the sleeve (15) comprises a first and a second axially spaced apart radial through- opening (15b, 15c), and the plunger rod (19) comprises a set of at least one radially flexible arm (19a), each arm (19a) being provided with a radially outwards extending protrusion (19b), wherein one radially outwards extending protrusion (19b) is configured to engage with the first radial through-opening (15b) to form the first snap connection and one radially outwards extending protrusion (19b) is configured to engage with the second radial through-opening (15c) to form the second snap connection.

6. Assembly as claimed in claim 5, wherein the radially inwards extending protrusion (lye) of the shield link (17) is configured to engage with the first radial through-opening (15b) to form the third snap connection.

7. Assembly as claimed in claim 5 or 6, wherein the radially inwards extending protrusion (lye) of the shield link (17) is configured to push the arm (19a) radially inwards such that the radially outwards extending protrusion (19b) disengages from the first radial through-opening (15b).

8. Assembly as claimed in any of claims 5-7 dependent of claim 4, wherein the radially inwards extending second protrusion (20b) is configured to engage with the second radial through-opening (15c) to form the fourth snap connection.

9. Assembly as claimed in any of claims 5-7 dependent of claim 3 or claim 8, wherein the radially inwards extending second protrusion (20b) is configured to push the arm (19a) radially inwards such that the radially outwards extending protrusion (19b) disengages from the second radial through-opening (15c).

10. Assembly as claimed in claim 8 or claim 9 when dependent on claim 8, wherein the release member (20) is configured engage with the shield link (17) when the radially inwards extending second protrusion (2oe) is engaged with the second radial through-opening (15c), preventing the delivery member cover (7) from moving from the second axial position to the first axial position.

11. Assembly as claimed in any of the preceding claims, comprising an activator (5) configured to move from a first position to a second position, wherein in the first position the activator (5) engages with the plunger rod (19), preventing the plunger rod (19) to move along the first direction, wherein the activator (5) is configured to disengage from the plunger rod (19) when the activator (5) is moved to the second position, causing the plunger rod (19) to move axially in the first direction and obtain the first snap connection with the sleeve (15).

12. Assembly as claimed in claim 11, wherein the activator (5) is configured to move from the first position to the second position by rotation.

13. Medicament delivery device (1) comprising an assembly as claimed in any of the preceding claims.

14. Medicament delivery device (1) as claimed in claim 13, comprising a housing (3), wherein the sleeve (15) is axially fixedly arranged relative to the housing (3).