Medicament delivery device and medicament delivery assembly

Abstract

The medicament delivery device (2) for accommodating a medicament container (3) comprises a container body (3d) containing a medicament and for expelling one or more doses of the medicament from the medicament container (3). The medicament delivery device (2) defines a device axis (A) and comprises - a needle assembly (5) comprising a needle device (5a) and a first assembly member (51); and - an attaching mechanism (15) for attaching the needle assembly (5) to a first part (16) of the medicament delivery device (2) in an attachment process in which the needle device (5a) moves distally and the first assembly member (51) carries out a first movement, the first movement comprising a distal movement, - a priming mechanism (18) configured to effect a conversion process in which a distal movement of the container body (3d) is derived from the first movement of the first assembly member (51).

Description

[0001] TITLE

[0002] Medicament Delivery Device and Medicament Delivery Assembly

[0003] TECHNICAL FIELD

[0004] The invention is in the field of medicament delivery devices. In particular, it relates to automatic medicament delivery devices. It relates especially to medicament delivery devices comprising an attachable needle assembly. The invention can more particularly relate to medicament delivery devices for delivering at least one dose which is different from the full contents of a medicament container assembled with the medicament delivery device, especially to medicament delivery devices for delivering multiple doses of a medicament from one medicament container.

[0005] BACKGROUND

[0006] Medicament delivery devices for automatic delivery of a medicament by selfadministration are well-known. Especially, they may be equipped to accommodate a medicament container, for example a medicament container with a septum (or another seal) to be perforated immediately prior to use, or a syringe. Often, the medicament delivery device and the medicament container are pre-assembled to constitute a medicament delivery assembly for self-administration.

[0007] Such medicament delivery devices and medicament delivery assemblies should generally be safe to use and easy to handle, and they should ensure delivery of the designated dose of the medicament with high accuracy.

[0008] Many such medicament delivery devices which are to deliver a single predetermined dose are "empty all", coming with a pre-filled syringe or vial as medicament container containing said pre-determined dose of the medicament. The dosing accuracy thus depends on the accuracy of the container filling equipment used for filling the container. Accordingly, the medicament delivery device in such cases is only required to empty all the medicine contained in the container.

[0009] However, in many applications, the medicament delivery device has to deliver at least one dose which is different from the full contents of a medicament container assembled with the medicament delivery device. E.g., pre-determined (preset) medicament doses have to be delivered repeatedly. In this case, e.g., multi-dose medicament delivery devices (also referred to as partial dose medicament delivery devices) can be used.

[0010] In view of environmental considerations, it is undesirable to use pre-filled single-dose medicament delivery devices and dispose one of those for each dose to be delivered (disposable auto-injectors). And even when using a medicament delivery device in which the medicament container can be replaced, it is still undesirable to dispose a (single-dose) medicament container for each medicament delivery.

[0011] One way of lowering the carbon footprint here is to reduce the amount of material involved, in particular plastics. This can be accomplished by enabling the medicament delivery device to deliver multiple doses instead of only a single one.

[0012] Multi-dose medicament delivery devices or further medicament delivery devices which deliver at least one dose, in particular a dose having a predetermined dosing amount which is different from the full contents of a medicament container assembled with the medicament delivery device, cannot depend on the filling equipment for dosing accuracy and instead have to rely on the device design. I.e., the medicament delivery device has to comply with corresponding regulations such as ISO requirements for dose accuracy. Thus, the medicament delivery device has to comprise a mechanism for ensuring a reliable delivery of accurate medicament doses. To fulfil such requirements, for each of the doses to be delivered, the dosing amount (dose volume) should be dependent on as few components as possible to minimize the risk of tolerance stack-up possibly causing an under- or overdose. Manufacturing tolerances need to be low, and long links of assembled parts should be avoided.

[0013] In addition, air present in the primary container can cause similar problems since it is typically impossible for the device to “know” whether it is air or medicament that is being expelled through the needle. And the dosing amount expelled usually is controlled by controlling the plunger stroke, i.e., by controlling the length of the axial (usually proximal) movement of the plunger rod device (or plunger rod), expecting that this corresponds to the length of the movement of the stopper device (or plunger). Therefore, for a plunger rod's stroke to accurately correlate to a dosing volume, the plunger rod needs to be in contact with the plunger during the whole stroke, also at the very beginning of the plunger rod movement. For most devices this means an additional user step (to be carried out by the patient) where he or she has to make an initial small medicament delivery into the air. This initial step (priming step) is to ensure contact between plunger rod and stopper. Sometimes it also ensures that any air inside the primary container is removed from the container before the first injection, i.e., before the delivery of the first dose.

[0014] SUMMARY

[0015] Therefore, one object of the invention is to create a new medicament delivery device for delivering one or more doses, in particular preset (pre-determined) doses, of a medicament from a medicament container with high accuracy.

[0016] Another object of the invention is to create a medicament delivery device for delivering multiple preset doses of a medicament from a medicament container with high accuracy.

[0017] Another object of the invention is to create a medicament delivery device which is particularly easy to use. Another object of the invention is to create a medicament delivery device which is particularly environment-friendly and / or has a small carbon footprint.

[0018] Furthermore, the medicament delivery device should be advantageous in terms of safety and reliability.

[0019] Further objects and various advantages emerge from the description and embodiments below.

[0020] These objects are at least partially achieved by devices and assemblies according to the patent claims.

[0021] The medicament delivery device is a medicament delivery device for accommodating a medicament container comprising a container body containing a medicament and for expelling one or more doses, in particular multiple doses, of the medicament from the medicament container. The medicament delivery device defines a device axis and comprises a needle assembly comprising a needle device, such as a needle embodied as a cannula, and a first assembly member; and an attaching mechanism for attaching the needle assembly to a first part of the medicament delivery device in an attachment process in which the needle device moves distally and the first assembly member carries out a first movement, in particular wherein the first movement comprises a distal movement.

[0022] Furthermore, the medicament delivery device comprises a priming mechanism configured to effect a conversion process in which a distal movement of the container body is derived from the first movement of the first assembly member.

[0023] The distal movement of the container body in particular can be a distal movement relative to the first part. Put slightly differently, one can say that in the conversion process, at least a part (or component) of the first movement of the first assembly member is converted into a distal movement of the container body.

[0024] By the provision of the priming mechanism, a user action which needs to be carried out anyway, namely the attaching of the needle assembly, can be made use of for accomplishing a priming step. The priming mechanism can effect a priming process, in particular a priming process taking place during the attachment process.

[0025] Thus, the user is relieved from taking an extra (additional) action for accomplishing the priming.

[0026] During the attachment process, the needle device can move distally relative to the first part.

[0027] In embodiments, the needle device pierces a seal of the medicament container, such as a septum, in particular wherein this piercing takes place, in the priming process, before said distal movement of the container body is derived from said first movement. This can in particular be the case in embodiments in which during the priming process, the needle device and the container body both move distally, more particularly the container body moving at least as fast distally as the needle device.

[0028] In embodiments, the medicament container comprises a stopper device, and the medicament delivery device comprises a plunger rod device comprising an abutting part; wherein the priming mechanism is configured to decrease an axial distance between the stopper device and the abutting part of the plunger rod device.

[0029] This way, an uncertainty in expelled dose volume can be reduced.

[0030] The abutting part can in particular be configured for abutting and proximally moving the stopper device during expelling the one or more doses. The decreasing said axial distance can in particular take place during the attachment process and / or by the conversion process.

[0031] In embodiments, the priming mechanism is configured to effect an abutting of the abutting part and the stopper device against one another. This can eliminate uncertainty in expelled dose volume related to an initial distance between abutting part and the stopper device.

[0032] Said abutting can in particular take place during the attachment process and / or by the conversion process.

[0033] In embodiments, the priming mechanism is configured to effect a proximal movement of the stopper device forced by the plunger rod device (due to the distal movement of the container body). This way, air can be expelled from the medicament container (if present therein) and / or a portion of the medicament can be expelled from the medicament container. This further increases dosing accuracy.

[0034] In embodiments, during the attachment process, the first part and the plunger rod device (more particularly the abutting part) have a constant axial distance to one another. Their relative axial position can be locked. E.g., both can have a fixed axial position relative to a housing part of the medicament delivery device.

[0035] In embodiments, the medicament delivery device comprises a biasing device configured to force the plunger rod device in a proximal direction.

[0036] In particular, the biasing device can comprise a spring device.

[0037] For example, the medicament delivery device comprises a release mechanism for selectively releasing the biasing device. In particular, when released, the biasing device forces the plunger rod device proximally, and when not released, the biasing device does not force the plunger rod device proximally, e.g., the biasing device can be blocked. The medicament delivery device can furthermore be configured such that during the attachment process the biasing device is not released.

[0038] In embodiments, the attaching mechanism comprises a screw coupling between the needle assembly and the first part. In particular, the first assembly member can comprise a thread, e.g., an inner thread, cooperating with a thread, e.g., an outer thread, of the first part. By screwing the first assembly member to the first part (during the attachment process), a distal movement of the first assembly member can take place (in addition to a rotational movement).

[0039] In embodiments, the attaching mechanism comprises a bayonet connection between the needle assembly and the first part. In particular, the first assembly member can comprise a protrusion such as a pin, cooperating with a suitable slit present in the first part. By connecting the first assembly member to the first part (during the attachment process) using the bayonet principle, a distal movement of the first assembly member can take place - in addition to a rotational movement.

[0040] In embodiments, the attaching mechanism comprises a ratch-type connection between the needle assembly and the first part. In particular, the needle assembly comprising an inner ratch cooperating with an outer ratch of the first part (or vice versa). By inserting the inner ratch into the outer ratch (during the attachment process), a distal movement of the first assembly member can take place.

[0041] In embodiments, the attaching mechanism comprises a snap-fit connection between the needle assembly and the first part. In particular, the first assembly member can comprise a protrusion on a lever cooperating with an opening present in the first part (or vice versa). By engaging the snap fit connection, a distal movement of the first assembly member can take place.

[0042] Other types of connections and movements are possible. In embodiments, the first movement comprises a distal movement, in particular wherein in the conversion process, the distal movement of the container body can be derived from the distal movement of the first assembly member. E.g., the distal movement of the first assembly member can be converted into a distal movement of the container body. This can be accomplished, e.g., in a simple process, directly converting the one distal movement into the other distal movement.

[0043] In embodiments, the priming mechanism comprises a spacer device configured to abut, in the conversion process, both, the first assembly member and the container body. E.g., the spacer device is arranged between the first assembly member and the container body. The spacer device, e.g., can be clamped between the first assembly member and the container body during the conversion process. During the conversion, the spacer device can be distally moved by the first arrangement member and can, itself, distally move the contained body.

[0044] In embodiments, during the conversion process, the spacer device abuts the first assembly member at one side, in particular proximally, and abuts the container body at another side, e.g., distally.

[0045] In embodiments, the first movement comprises a rotational movement, in particular wherein in the conversion process, the distal movement of the container body can be derived from the rotational movement of the first assembly member. E.g., the rotational movement of the first assembly member can be converted into a distal movement of the container body. This can be accomplished, e.g., in that the priming mechanism comprises one or more threaded parts cooperating with the needle assembly, more particularly cooperating with a rotatable part of the needle assembly (rotating during the attachment process). The threaded parts convert the rotational movement into a distal movement which can be converted into a distal movement of the container body by the threaded parts abutting the container body. In embodiments, the first part comprises a container compartment member configured to accommodate the medicament container. More particularly, the distal movement of the medicament container can be a distal movement of the medicament container relative to the container compartment member. During the conversion process, the medicament container can move distally relative to the container compartment member.

[0046] It is to be noted that in other priming processes which are known in the art, priming is accomplished by proximally moving the plunger rod (or plunger rod device), more particularly by proximally moving the plunger rod (or plunger rod device) relative to a container compartment member. And the container body either is unmoved relative to the container compartment member or (initially) moves proximally relative to the container compartment member.

[0047] In embodiments, the medicament container comprises a seal, e.g., a septum, and the medicament delivery device is configured to ensure that during the attachment process, the needle device pierces the seal prior to the priming mechanism deriving the distal movement of the container body.

[0048] In embodiments, the medicament delivery device comprises a dosing device for controlling a dosing amount for each of the one or more doses.

[0049] Various ways of embodying dosing devices are known, e.g., the dosing device can control the plunger rod stroke taking place for delivery of a dose, i.e., can control the distal movement carried out by the plunger rod device when a dose is expelled, by initially releasing and, at the end, blocking the biasing device.

[0050] The dosing device can, e.g., comprise the release mechanism mentioned above.

[0051] The medicament delivery assembly comprises the medicament delivery device as herein described and further comprises the medicament container assembled with the medicament delivery device. 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.

[0052] 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.

[0053] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0054] 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.

[0055] BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings.

[0057] Figure 1 a medicament delivery device assembly as delivered, shown without needle assembly, in a perspective view; Figure 2A a proximal portion of the medicament delivery device assembly of Fig. 1, in a perspective view;

[0058] Figure 2B the proximal portion of the medicament delivery device assembly of Fig. 2A, in a view onto a cross-section;

[0059] Figure 3A parts of the medicament delivery device of Figs. 2A, 2B, assembled, in a perspective view;

[0060] Figure 3B the parts of Fig. 3A, in a partially exploded view;

[0061] Figure 4 parts of the medicament delivery device assembly of Fig. 1, assembled, in a perspective view;

[0062] Figure 5 the container compartment member of the medicament delivery device of Figs. 2A, 2B, in a perspective view;

[0063] Figure 6 the first assembly member of the medicament delivery device of Figs. 2A, 2B, in a perspective view;

[0064] Figure 7A, 7B the spacer device of the medicament delivery device of Figs. 2A, 2B, in two different perspective views;

[0065] Figure 8A parts of the medicament delivery device assembly of Fig. 1 before attachment of the needle assembly, in a view onto a cross-section;

[0066] Figure 8B parts of the medicament delivery device assembly of Fig. 1 after attachment of the needle assembly, in a view onto a crosssection;

[0067] Figure 9A a detail of the parts of the medicament delivery device assembly of Fig. 8B, in a perspective partially transparent view;

[0068] Figure 9B a detail of the parts of the medicament delivery device assembly of Fig. 8B, in a perspective partially transparent view. DETAILED DESCRIPTION

[0069] Fig. i shows a medicament delivery device assembly 1 comprising a medicament delivery device 2 and a medicament container 3, wherein a needle assembly 5 of the medicament delivery device is not shown in Fig. 1.

[0070] Fig. 2A shows a proximal portion of the medicament delivery device assembly 1 of Fig. 1 in a perspective view, and Fig. 2B shows this proximal portion in a view onto a cross-section thereof. In Figs. 2A, 2B, needle assembly 5 is shown. Proximal housing part 4a is not shown in Fig. 2A.

[0071] Medicament delivery device 2 can be embodied as a partial dose medicament delivery device, in particular as a single-dose partial-dose medicament delivery device. But it can also be embodied as a multi-dose medicament delivery device, in particular as a multi-dose fixed-dose medicament delivery device. And it can be embodied as a variable-dose medicament delivery device, e.g., as a single-dose variable-dose medicament delivery device or as a multi-dose partial-dose medicament delivery device.

[0072] Medicament delivery device 2 defines a device axis A and comprises a housing 4 which can comprise, as illustrated, a proximal housing part 4a and a distal housing part 4b which, e.g., can be engaged to one another. And it can comprise an activation device 10, such as an activation button, for initiating a medicament delivery. However, other ways of initiating a medicament delivery can be implemented as well.

[0073] Medicament container 3 contains an amount of a medicament (not shown in the figures) and can be embodied as a cartridge. It comprises a container body 3d and a proximal seal 3a, such as a septum, to be pierced prior to use, and can comprise a crimp 3c fixing seal 3a to container body 3d.

[0074] Medicament container 3 further comprises a stopper 3b such as a plunger, proximally movable for forcing a medicament contained in the medicament container 3 through a needle 5a of needle assembly 5 having pierced seal 3a. Needle assembly 5 comprises a needle shield 5b (or needle cover) and an assembly member 51 (first assembly member) and is attachable to remaining parts of the medicament delivery device 2, e.g., in the illustrated embodiment, by an attaching mechanism 15 (cf. Fig. 8B) to a container compartment member 16 accommodating container 3.

[0075] Attaching mechanism 15 comprises a screw coupling established by an outer thread 156 of container compartment member 16 cooperating with an inner thread 155 of assembly member 51.

[0076] For proximally moving stopper 3b, medicament delivery device 2 can further comprise a plunger rod device 6 (only shown in Figs. 8A, 8B), such as a plunger rod, for cooperating with stopper 3b to move stopper 3b in proximal direction for expelling portions of the medicament from the medicament container 3 through attached needle 5a. In particular, plunger device 6 can comprise an abutting part 62 for cooperating with stopper 3b, in particular for abutting stopper 3b.

[0077] Medicament delivery device 2 can, for that purpose, comprises a biasing device, e.g., a spring 7, configured to force plunger rod device 6 proximally (cf. Figs. 8A, 8B). Other types of springs and other biasing devices could also be used.

[0078] Further, medicament delivery device 2 can comprise a dosing device, in particular for controlling a dosing amount for each of the doses of the medicament to be expelled (not shown). E.g., the dosing device can control an axial distance along which the plunger rod device moves proximally for the delivery of a dose.

[0079] Figs. 3A, 3B show parts of medicament delivery device 2 in a perspective view (in an assembled state, i.e., needle assembly 5 attached to container compartment member 16) and in a partially exploded view, respectively. Illustrated are container compartment member 16, a part of a priming mechanism 18 of medicament delivery device 2, namely a spacer device 181, and parts of needle assembly 5, namely needle 5a, assembly member 51 and further assembly members 52 and 53. Fig. 4 shows, in a perspective view, parts of medicament delivery device assembly 1 of Fig. i in an assembled state, namely medicament container 3 (container body 3d being illustrated as a transparent part), needle 5a and spacer device 181.

[0080] Fig. 5 shows, in a perspective view, container compartment member 16 which comprises outer thread 156 to cooperate with inner thread 155 during attachment of needle assembly 5 to container compartment member 16 and openings 150 cooperating with spacer device 181.

[0081] Fig. 6 shows, in a perspective view, (first) assembly member 51 which comprises inner thread 155 and an abutting surface 15a for abutting spacer device 181 or, more particularly, for abutting abutting surfaces 18a of contact members 183 of spacer device 181.

[0082] Figs. 7A, 7B show, in two different perspective views, spacer device 181 which comprises a ring member 182 and three contact members 183 protruding from ring member 182. Ring member 182 forms an abutting surface 18b to cooperate with (more particularly to abut) medicament container 3 or, more particularly, container body 3d. Abutting surface 18b is formed on a first side of ring member 182, whereas contact members 183 protrude from another side of ring member 182, e.g., on an approximately opposite side of ring member 182.

[0083] Each of the three contact members 183, more particularly each of the abutting surfaces 18a, cooperates with abutting surface 18b of ring member 182.

[0084] The provision of priming mechanism 18 ensures that upon attachment of needle assembly 5 (by means of attaching mechanism 15), a priming step is carried out “automatically”, thus relieving the user from having to take an additional action in order to achieve a priming of the medicament delivery device assembly. This can be explained with reference to Figs. 8A, 8B and Figs. 9A, 9B, with further reference to the other Figures.

[0085] Fig. 8A shows a view onto a cross-section of parts of the medicament delivery device assembly 1 of Fig. 1 before attachment of needle assembly 5 (pre-assembled state), whereas Fig. 8B shows, in the same way, parts of the medicament delivery device assembly 1 of Fig. 1 after attachment of needle assembly 5 (assembled state).

[0086] Fig. 9A shows a detail of the parts of the medicament delivery device assembly 1 of Fig. 8A (pre-assembled state), in a perspective view, wherein container compartment member 16 is shown in a transparent fashion, whereas Fig. 9B shows, in the same way, parts of the medicament delivery device assembly 1 of Fig. 1 after attachment of needle assembly 5 (assembled state).

[0087] In the pre-assembled state (Figs. 8A, 9A), medicament container 3 is accommodated in container compartment member 16 and it extends, in particular its container body 3d extends, at its distal end, slightly beyond compartment member 16.

[0088] Plunger rod device 6, more particularly abutting part 62, is slightly distant from stopper device 3b.

[0089] Contact member 183 of spacer device 181 extend far through openings 150 in container compartment member 16, extending out of container compartment member 16, while ring member 182 is located inside container compartment member 16, e.g., abutting container body 3d with its abutting surface 18b.

[0090] Spacer device 181 can be held in container compartment member 16, e.g., by means of a snap fit connection, cf. cooperating protrusions 150a in Fig. 5 and protrusions 183a (Figs. 7A, 7B), while being axially movable relative to container compartment member 16. Spacer device 181 can be movably attached to container compartment member. For a precise first dose - with a well-defined, easily predictable relation between plunger stroke (proximal travel of plunger rod device 6) and expelled dosing amount - the slight (but usually not very well-defined) distance between plunger rod device 6 (more particularly abutting part 62) and stopper device 3b is a problem. For precise dosing, plunger rod device 6 should be in contact with stopper device 3b already at the beginning of a dose delivery.

[0091] Attaching needle assembly 5 (using attaching mechanism 15) is anyway required in order to deliver a dose of medicine. Needle assembly 5 is attached using threads 155 and 156, i.e., first assembly part 51 is screwed onto container compartment member 16. This screwing movement comprises a distal movement of first assembly part 51 which therefore abuts (at its abutting surface 15a) contact members 183 of spacer device 181 or, more particularly, their respective abutting surfaces 18a.

[0092] This way, spacer device 181, with its contact members 183 extending through respective openings 150 in container compartment member 16, is distally moved and can distally move medicament container 3, in particular container body 3d, while abutting container body 3d with abutting surface 15a. Thus, by attaching (screwing on) needle assembly 5, container body 3d can be distally moved, until stopper devicesb (initially moving together with container body 6) abuts plunger rod device 6 (more particularly abutting part 62), and possibly even until a small portion of the medicament is expelled through needle 5a. The extent to which container body 3d is distally moved in reaction to the attachment process depends on the initial axial distance between plunger rod device 6 (more particularly abutting part 62) and stopper 3b and on the design of spacer device 181 and on its initial distance to container compartment member 16 (which can be zero, in which case spacer device 181 initially abuts container compartment member 16), and it depends on how far assembly member 51 (more particularly its abutting surface 15a) can distally move spacer device 181 which is, in the illustrated embodiment, limited by assembly member 51 abutting container compartment member 16 at the end of the attachment process. Other stops, in particular mechanical stops for limiting the distal movement of assembly member 51 during the attachment process are possible. This depends, too, on the type of attachment mechanism, as not only screw couplings are possible, but also others, such as bayonet connections, ratch-type connections, snap-fit connections.

[0093] Before spacer device 181 is moved by attaching needle assembly 5, needle 5a pierces seal 3a.

[0094] In the so-achieved assembled state (Figs. 8B, 9B), medicament container 3, in particular its container body 3d, extends at its distal end, a bit further beyond compartment member 16 than in the pre-assembled state

[0095] (Figs. 8A, 9A). And, importantly, plunger rod device 6 (more particularly abutting part 62) is in mechanical contact with stopper 3d in the assembled state.

[0096] Thus, attaching mechanism 15 in the illustrated embodiment comprises thread 155 of assembly member 51 and thread 156 of container compartment member 16. And priming mechanism 18 comprises spacer device 181.

[0097] Various other embodiments with different attaching mechanisms and / or other priming mechanisms are possible. E.g., a rotational movement of a first assembly member could be converted into a distal movement of container body 3d, e.g., using another threaded item.

[0098] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0099] 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.

[0100] 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.

[0101] 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 (CD19) 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 (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.

[0102] 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.

[0103] 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.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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, mFOLFOX6, 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. 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

CLAIMS1. A medicament delivery device (2) for accommodating a medicament container (3) comprising a container body (3d) containing a medicament and for expelling one or more doses of the medicament from the medicament container (3), the medicament delivery device (2) defining a device axis (A) and comprising a needle assembly (5) comprising a needle device (5a) and a first assembly member (51); an attaching mechanism (15) for attaching the needle assembly (5) to a first part (16) of the medicament delivery device (2) in an attachment process in which the needle device (5a) moves distally and the first assembly member (51) carries out a first movement, the first movement comprising a distal movement; a priming mechanism (18) configured to effect a conversion process in which a distal movement of the container body (3d) is derived from the first movement of the first assembly member (51).

2. The medicament delivery device (2) according to claim 1, the medicament container (3) comprising a stopper device (3b), the medicament delivery device (2) comprising a plunger rod device (6) comprising an abutting part (62); wherein the priming mechanism (18) is configured to decrease an axial distance between the stopper device (3b) and the abutting part of the plunger rod device (6).

3. The medicament delivery device (2) according to claim 2, the priming mechanism (18) being configured to effect an abutting of the abutting part (62) and the stopper device (3b) against one another4. The medicament delivery device (2) according to claim 2 or claim 3, the priming mechanism (18) being configured to effect a proximal movement of the stopper device (3b) forced by the plunger rod device (6).

5. The medicament delivery device (2) according to one of claims 2 to 4, being configured to ensure, during the attachment process, a constant axial distance between the first part (16) and the plunger rod device (6), more particularly between the first part (16) and the abutting part (62) of the plunger rod device (6).

6. The medicament delivery device (2) according to one of claims 2 to 5, comprising a biasing device (7) configured to bias the plunger rod device (6) in a proximal direction; wherein the biasing device (7) comprises a spring device.

7. The medicament delivery device (2) according to one of claims 1 to 6, the attaching mechanism (15) comprising at least one of a screw coupling between the needle assembly (5) and the first part (16); a bayonet connection between the needle assembly (5) and the first part (16); a ratch-type connection between the needle assembly (5) and the first part (16); a snap-fit connection between the needle assembly (5) and the first part (16).

8. The medicament delivery device (2) according to one of claims 1 to 7, the first movement comprising a distal movement, wherein the distal movement of the container body (3d) is derived from the distal movement of the first assembly member (51).

9. The medicament delivery device (2) according to claim 8, the priming mechanism (18) comprising a spacer device (181) configured to abut, in the conversion process, both, the first assembly member (51) and the container body (3d), wherein the spacer device (181) is arranged between the first assembly member (51) and the container body (3d).

10. The medicament delivery device (2) according to one of claims 1 to 9, the first movement comprising a rotational movement, wherein in the conversion process, the distal movement of the container body (3d) is derived from the rotational movement of the first assembly member (51).

11. The medicament delivery device (2) according to one of claims 1 to 10, wherein the first part (16) comprises a container compartment member configured to accommodate the medicament container (3).

12. The medicament delivery device (2) according to one of claims 1 to 11, the medicament container comprising a seal (3a), and the medicament delivery device (2) being configured to ensure that during the attachment process, the needle device (5a) pierces the seal (3a) prior to the priming mechanism (18) deriving the distal movement of the container body (3d).

13. The medicament delivery device (2) according to one of claims 1 to 12, comprising a dosing device for controlling a dosing amount for each of the one or more doses.

14. A medicament delivery assembly (1), comprising the medicament delivery device (2) according to one of claims 1 to 13, further comprising the medicament container (3) assembled with the medicament delivery device (2).

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