Medicament delivery device

Abstract

The invention provides a medicament delivery device (1) comprising a housing (10), a container carrier (20) being displaceable relative to the housing (10) and arranged to accommodate a container (30) having a needle (31) and a needle shield, and containing a medicament, a plunger rod (40) for expelling a medicament from the container (30), a manually operable activator (60) arranged to the housing (10) movable along the longitudinal axis with respect to the housing (10), wherein the manually operable activator (60) is connectable with the displaceable container carrier (20), wherein the longitudinal axis extends from the proximal to the distal end of the housing (10), a needle shield holder (70), the displaceable container carrier (20) being displaceable relative to the needle shield holder (70), wherein the manually operable activator (60) is movable between an initial state (A), one or more intermediate state(s) (B, C) and an end state (D), and reverse from the end state (D) to the initial state (A).

Description

[0001] Medicament delivery device

[0002] TECHNICAL FIELD

[0003] The present disclosure relates to a medicament delivery device for administering a medicament.

[0004] BACKGROUND

[0005] Reusable medicament delivery devices are known in the field, of a type having a housing for receiving a medicament container, such as a syringe with a needle, with a plunger rod that retracts after drug delivery and thus releases the force applied to a plunger in a drug container. The needle is commonly protected by a needle shield before use, and advantageously protected again after use. There is, thus, a need for a multi-use type medicament delivery member that provides an automatic de-capping of the needle shield from the needle of the drug container before medicament delivery. There is also a need for a multi-use type medicament delivery member that provides an automatic re-capping of the needle shield onto the needle of the drug container after medicament delivery, prior its disposal / replacement.

[0006] SUMMARY

[0007] The aim of the present invention is to remedy the drawbacks of the state of the art devices. This aim is obtained with a medicament delivery device according to the features of the independent claims. Preferable embodiments of the invention form the subject of the dependent claims.

[0008] According to first aspect, the invention provides a medicament delivery device comprising a housing, a container carrier being displaceable relative to the housing and arranged to accommodate a container having a needle and a needle shield, and containing a medicament, a plunger rod for expelling a medicament from the container when being accommodated in the container carrier, a manually operable activator arranged to the housing movable along the longitudinal axis with respect to the housing, wherein the manually operable activator is connectable with the displaceable container carrier, wherein the longitudinal axis extends from the proximal to the distal end of the housing, a needle shield holder arranged to receive and accommodate the needle shield, the displaceable container carrier being displaceable relative to the needle shield holder, wherein the manually operable activator is movable between an initial state, one or more intermediate state(s) and an end state, and reverse from the end state to the initial state, wherein in one of the intermediate states the manually operable activator is more distal than in the initial state and more distal than in the end state, wherein at the beginning or during movement of the manually operable activator from the initial state to the first intermediate state the manually operable activator connects to the container carrier such that the container carrier with the container is moved distally to thereby withdraw the needle from the needle shield, and wherein the medicament delivery device is configured to, during movement of the manually operable activator from the first intermediate state to the end state, move the container carrier with the container proximally and passing by the needle shield holder.

[0009] A reverse movement of the manually operable activator from the end state via an intermediate state to the initial state may cause the container carrier and the container to be displaced such that the needle is re-inserted into the needle shield.

[0010] The medicament delivery device may be configured to displace the container carrier in a direction normal to the longitudinal axis of the housing during movement of the manually operable activator (a) from the initial state to the intermediate states, (b) from the initial state to the end state, or (c) from the initial state to the intermediate states and from the intermediate states to the end state.

[0011] The housing may comprise a first groove pattern and a second groove pattern, the second groove pattern being opposite to the first groove pattern normal to the longitudinal axis, and wherein the container carrier comprises one or more first and second mating guide pins arranged in the corresponding first and second groove pattern. The container carrier may comprise a first groove pattern and a second groove pattern, the second groove pattern being opposite to the first groove pattern normal to the longitudinal axis, and wherein the housing comprises one or more first and second mating guide pins arranged in the corresponding first and second groove pattern.

[0012] The groove pattern may provide a one-way movement pattern for the container carrier between the initial state, one or more intermediate state(s), the end state, a third intermediate state and the initial state of the manually operable activator.

[0013] The manually operable activator may be arranged at a distal end of the housing.

[0014] The needle shield carrier may be axially fixed with respect to the housing.

[0015] According to a second aspect, the medicament delivery device comprising a housing, a container carrier arranged to accommodate a container having a needle and containing a medicament, a plunger rod for expelling a medicament from the container when being accommodated in the container carrier; a needle shield holder being displaceable relative to the housing and arranged to receive and accommodate a needle shield of the container; a manually operable activator arranged to the housing movable along the longitudinal axis with respect to the housing, wherein the manually operable activator is connectable with the displaceable needle shield holder, wherein the longitudinal axis extends from the proximal to the distal end of the housing, wherein the manually operable activator is movable between an initial state, an intermediate state and an end state, and reverse, wherein in the intermediate state the manually operable activator is more proximal than in the initial state and more proximal than in the end state, wherein at the beginning or during movement of the manually operable activator from the initial state to the intermediate state the manually operable activator connects to the needle shield holder such that the needle shield is moved proximally to withdraw the needle shield from the needle, and wherein the medicament delivery device is configured to, during movement of the manually operable activator from the intermediate state to the end state, move the needle shield holder with the needle shield distally and passing by the needle.

[0016] A reverse movement of the manually operable activator from the end state via the intermediate state to the initial state may cause the needle shield holder with the needle shield to be displaced such that the needle shield re-covers the needle.

[0017] The medicament delivery device may be configured to displace the needle shield holder with the needle shield in a direction normal to the longitudinal axis of the housing during movement of the manually operable activator (a) from the initial state to the intermediate state, (b) from the initial state to the end state, or (c) from the initial state to the intermediate state and from the intermediate state to the end state.

[0018] The manually operable activator may be arranged at a proximal part of the housing.

[0019] The housing may comprise a first groove pattern and a second groove pattern, the second groove pattern being opposite to the first groove pattern normal to the longitudinal axis, and wherein the needle shield holder comprises one or more first and second mating guide pins arranged in the corresponding first and second groove pattern.

[0020] The needle shield holder may comprise a first groove pattern and a second groove pattern, the second groove pattern being opposite to the first groove pattern normal to the longitudinal axis, and wherein the housing comprises one or more first and second mating guide pins arranged in the corresponding first and second groove pattern.

[0021] The groove pattern may provide a one-way movement pattern for the needle shield holder between the initial state, a first intermediate state, the end state, a second intermediate state and the initial state of the manually operable activator. The medicament delivery device may further comprise an actuator, wherein the actuator is moveable in a longitudinal direction with respect to the housing and the manually operable activator.

[0022] The actuator may be configured to withdraw the manually operable member distally from the housing.

[0023] The actuator may accommodate the plunger rod.

[0024] The medicament delivery device may be of the multi-use type.

[0025] The medicament delivery device may further comprise a cover connectable to the housing and comprising an opening so that a prefilled container with needle and needle shield can be inserted into the container carrier and needle shield holder and an emptied container with needle and needle shield can be removed from the container carrier and needle shield holder.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] As used herein, a mechanism or element "configured to" perform a specified function is indeed capable of performing the specified function without any alteration, rather than merely having potential to perform the specified function after further modification. In other words, the mechanism or element "configured to" perform a specified function is specifically selected, created, implemented, utilized, programmed, and / or designed for the purpose of performing the specified function. As used herein, "configured to" refers to existing characteristics of a mechanism or element which enable the mechanism or element to perform the specified function without further modification. For purposes of this disclosure, a mechanism or element described as being "configured to" perform a particular function can additionally or alternatively be described as being "adapted to" and / or as being "operative to" perform that function.

[0030] In the following, the term engagement encompasses any kind of interaction between the named features such as abutment, clamping, locking, biasing, flexing, etc.

[0031] BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:

[0033] Fig. 1 shows a perspective view of a medicament delivery device according to an embodiment of the present invention, in an injection state;

[0034] Fig. 2 shows a exploded perspective view of the components of the medicament delivery device according to an embodiment of the present invention; Fig. 3 shows a perspective top view of the medicament delivery device according to an embodiment of the present invention, with the cover omitted;

[0035] Fig. 4 shows a further exploded perspective view of the medicament delivery device according to an embodiment of the present invention;

[0036] Fig. 5 shows a cross-sectional view of the housing of the medicament delivery device .

[0037] DETAILED DESCRIPTION

[0038] 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.

[0039] Fig. 1 shows a perspective view of a first embodiment of the medicament delivery device 1 according to the present invention. The medicament delivery device is shown in the injection state. The medicament delivery device of this embodiment comprises a housing 10 that extends in proximal-distal direction and defines a longitudinal axis extending from the proximal to the distal end of the housing 10. Fig. 1 shows the housing 10 with the top wall or cover 18. Housing has opening 17 for a needle 31. When viewed from top like in Fig. 1, the housing 10 has - in this embodiment - a rectangular or substantially rectangular cross section. When viewed along the longitudinal axis, the housing 10 may have a rectangular or a squarelike cross section. However, the edges of the housing 10 and the cover 18 may be rounded, as shown in Fig. 1.

[0040] The medicament delivery device 1 of this embodiment further comprises a manually operable actuator 60 which is at least in part arranged within the housing 10. The manually operable actuator 60 is movable along the longitudinal axis with respect to the housing 10, as will be described in more detail below. In the shown embodiment, a part of the manually operable actuator 60 is arranged generally distal to the housing 10, i.e., it projects distally from the housing, or extends beyond the housing, respectively. Furthermore, in the shown embodiment, the manually operable activator 60 also accommodates an activator 50. Which such actuator 50, the user of the medicament delivery device 1 can move the manually operable activator 60 in distal direction. The actuator 50 further accommodates a plunger rod (not shown in Fig. 1) that acts on a plunger of the container or drug container, respectively, to expel the medicament from the medicament delivery device 1.

[0041] Fig. 1 also shows a release mechanism 80. Operation of the release mechanism 80 by the uses releases the plunger rod for administration of the medicament.

[0042] Fig. 2 shows the components of the medicament delivery device 1 in exploded perspective view. The housing 10 is in use covered by cover 18 that has an opening 19 through a medicament container can be inserted into the medicament delivery device 1 and removed therefrom after medicament injection.

[0043] Within the housing 10 a container carrier 20 is accommodated. The container carrier 20 is displaceable relative to the housing 10 in proximal and distal direction (and also in a direction perpendicular thereto) as will be described in more detail below. The container carrier 20 is arranged and shaped to accommodate a container 30, such as a syringe. The container 30 has a needle 31 which is covered by a needle shield (not shown in Fig. 2 but commonly known in the art), and contains a medicament. The medicament delivery device 1 of this embodiment is of the multi-use type so that the container 30 can be removed from the container carrier 20 after the medicament has been delivered, and a new container, i.e., a filled container 30 can be inserted into the displaceable container carrier 20 for a further delivery of a dose of medicament.

[0044] In the embodiment shown in Fig. 2 and 3, the displaceable container carrier 20 is arranged between the proximal and distal ends of the housing 10. Proximal to the container carrier 20 is a needle shield holder 70. The needle shield holder 70 is arranged to receive and accommodate the needle shield of the container 30 once the container 30 is accommodated in the container carrier 20. The needle shield holder 70 is arranged to the proximal part of the housing 10 in axially fixed way. For example, the needle shield holder 70 has two opposing protrusions or ribs 71 that are received in corresponding or mating grooves or recesses 16 at the proximal part of the housing 10.

[0045] The medicament delivery device 1 is configured to displace the container carrier 20 longitudinally and in a direction normal to the longitudinal axis of the housing 10. According to the preferred embodiment as shown in Figs. 1 to 5, such displacement of the container carrier 20 (and thus of the container 30 relative to the needle shield holder 70) is obtained by a groove-pin structure. Preferably, the housing 10 comprises a first groove pattern 11 and a second groove pattern 12. As can be seen in Fig 2, the second groove pattern 12 is opposite to the first groove pattern 11 normal to the longitudinal axis of the housing 10. Thus, the housing 10 has two wall sections extending in parallel. The first groove pattern 11 and the second groove pattern 12 mirror each other, i.e., are symmetrical to each other with regard to the longitudinal axis of the housing 10. Corresponding to the first groove pattern 11 and the second groove pattern 12, the container carrier 20 comprises one or more first and second mating guide pins 21, 22, 23, 24 arranged in the corresponding first and second groove patterns 11, 12. In fact, each of the first and second groove pattern 11 and 12 comprises two neighboring sub-pattern, each sub-pattern receiving on of the mating guide pins 21, 22, 23, 24.

[0046] Alternatively, the present invention also encompasses that the container carrier 20 comprises a first groove pattern and a second groove pattern (not shown), where the second groove pattern is opposite to the first groove pattern normal to the longitudinal axis of the container carrier 20. In this alternative, the housing 10 comprises one or more first and second mating guide pins arranged in the corresponding first and second groove pattern.

[0047] As explained above, the medicament delivery device 1 of this embodiment further comprises a manually operable actuator 60 which is arranged to the housing 10 and is movable along the longitudinal axis with respect to the housing 10.

[0048] The manually operable actuator 60 is releasably connectable with the displaceable container carrier 20. The manually operable activator 60 is movable between an initial state (in which the container is initially received in the container carrier 20), a first intermediate state (which is the most distal position of the manually operable activator 60), a second intermediate state (which is proximal to the first intermediate state), and an end state (as shown in Fig. 3). The end state is the most proximal position of the manually operable activator 60 in which the container assumes its position during the whole process. The manually operable activator 60 is furthermore moveable "in reverse", i.e. from the end state through the intermediate states, back to the initial state. During the reverse movement the manually operable activator may assume a third intermediate state being different from the first and second intermediate states. The states are provided by the shape of the first and second groove patterns 11, 12.

[0049] At the beginning or during movement (i.e., somewhat after the beginning of a movement) of the manually operable activator 60 from the initial state to the first intermediate state, the manually operable activator 60 connects to the container carrier 20 such that the container carrier 20 with the container 30 accommodated therein is moved distally. In this embodiment, the needle shield holder 70 does not move but is axially fixed in the housing 10, thus retaining the needle shield.

[0050] From Fig. 3, it can be seen that the manually operable activator 60 has been moved to the end state where the needle 31 extends beyond the housing 10. During this movement the container carrier 20 with the container 30 is moved proximally. However, the container 30 with the needle 31 passes by the needle shield holder 70 (and at the same time passes by the needle shield) so that the needle 31 can be exposed and extend proximally from the proximal end of the housing 10. In the embodiment shown in Fig. 3, movement of the manually operable activator 60 from the initial state via the first and second intermediate states to the end state causes the displaceable container carrier 20 to move downwards relative to the needle shield holder 70. In more general terms, the container carrier 20 is displaced to a different plane / level so that the longitudinal axis extending in proximal-distal direction through the container 30 is offset (for example parallel to the initial longitudinal axis defined in proximal-distal direction of the container 30 when the needle 31 of the container 30 is still covered by the needle shield). Instead of moving downwards, as shown in Fig. 3, and depending on the spatial configuration within the medicament delivery device 1, the displaceable container carrier 20 can be displaced in any direction (being upwards or sidewards or a combination thereof) as long as the container 30 is brought to a position offset from the initial position where the needle 31 is still covered by the needle shield.

[0051] Once the displaceable container carrier 20 has assumed its end state, the user can use the release mechanism 80 to move the plunger rod 40 and thus the plunger to expel the medicament from the container 30.

[0052] After the medicament has been delivered, the user of the medicament delivery device can perform a reverse movement of the manually operable activator 60 from the current end state via the intermediate state to the initial state. Such movement causes the container carrier 20 and the container 30 to be displaced such that the needle 31 is finally re-inserted into the needle shield. First, the container 30 and the needle 31 move distally until the longitudinal axis extending through the container 30 and the needle 31 again coincides with the initial longitudinal axis. In this position, the container 30 with the needle 31 is moved proximally towards the needle shield holder 70 and the needle shield, and the needle 31 is re-inserted into the needle shield.

[0053] The medicament delivery device may also have a needle sleeve that is released to project proximally from the housing to cover the needle 31 when the user removes the medicament delivery device 1 from the injection site before the container 30 is withdrawn and moved to its initial position.

[0054] In this position, the emptied container 30 can be removed from the medicament delivery device, and a new container 30 can be inserted.

[0055] The medicament delivery device of this embodiment further comprises a plunger rod 40 for expelling a medicament from the container 30 during use of the medicament delivery device 1, i.e., when the container 30 is accommodated in the container carrier 20. The actuator 50 may accommodate the plunger rod 40.

[0056] The actuator 50 is shown in Figs. 1 to 4 in the exemplary form of a "T" having a cross bar 55 extending normal to the longitudinal axis, i.e., normal to the extension of the main part of the actuator 50. Which such actuator 50, the user of the medicament delivery device 1 can easily move the manually operable activator 60 distally to withdraw the container from the injection site. The cross bar 55 is thus projecting through a longitudinally extending slit 68 (or better slits 68 at opposing sides) of the manually operable activator 60 (see Fig.3).

[0057] The plunger rod 40 is moveable towards a plunger of the container 30, and can thus displace the plunger within the container 20 to expel the medicament from the medicament delivery device 1. The plunger rod 40 displacement is triggered by the user operating the release mechanism 80, which is, for example, a spring loaded button acting through hole 69 in the manually operable activator 60.

[0058] The groove-pin structure provides for a defined movement of the displaceable container carrier 20 relative to the housing 10 due to a movement of the manually operable activator 60. In the embodiment shown in Figs. 1 to 4, the manually operable activator 60 comprises one or two engagement elements 61, 62. In the initial stage , these engagement elements 61 and 62 are still longitudinally offset, i.e. spaced from, the corresponding guide pins 22 and 24 of the container carrier 20. When the manually operable activator 60 is moved distally, at some point of the movement the engagement elements 61 and 62 contact and / or engage the guide pins 22 and 24, respectively so that further distal movement of the manually operable activator 60 causes distal displacement of the container carrier 20 to the first intermediate state. That is, the distally facing surfaces of the engagement elements 61 and 62 contact and / or engage the guide pins 22 and 24, respectively.

[0059] As soon as the direction of movement of the manually operable activator 60 is reversed, i.e. moved proximally, the guide pins 22 and 24 get in contact with second engagement elements 63 and 64 of the manually operable activator 60 which then push the container carrier 20 proximally. That is, the proximally facing surfaces of the engagement elements 63 and 64 contact and / or engage the guide pins 22 and 24, respectively.

[0060] The shape of the first groove pattern 11 and the second groove pattern 12 is such that the displacement of the container carrier 20 in a direction normal to the longitudinal axis of the housing 10 is achieved so that during proximal movement of the container carrier 20 the container carrier 20 can pass by the needle shield holder 70 to expose the needle 31 from the housing 10. The first groove pattern 11 and the second groove pattern 12 are respectively shaped and curved, and part of the curvature can be seen in Figs. 2 and 4.

[0061] An example of the first groove pattern 11 is illustrated in the cross-sectional view of Fig. 5. As mentioned above, the second groove pattern 12 mirrors the first groove pattern 11. In the preferred embodiment, each of the first groove pattern 11 and the second group pattern 12 comprises two groove structures or sub-patterns, respectively, arranged side by side to each other. In the preferred embodiment as shown in Fig. 5, a one-way movement pattern for the container carrier 20 is provided. Thus, the container carrier 20 is moveable between the initial state, a first intermediate state, a second intermediate state, the end state, a third intermediate state and back to the initial state of the manually operable activator 60.

[0062] In Fig. 5, reference numeral A points to the initial state of the first guide pin 21 and of the second guide pin 22 in the two neighboring sub-patterns. During movement of the container carrier 20 by the manually operable activator 60, these guide pins 21 and 22 move along the track provided by the groove patterns from this initial state A to a first intermediate state B. This first intermediate state B is the most distal location of the container carrier 20. As can be seen in Fig. 5, the movement from the initial state A to the first intermediate state B already causes the container carrier 20 to change its position relative to its initial position (in Fig. 5 the container carrier 20 moves downwards because the guide track is curved downwards). From the first intermediate state B, the container carrier 20 moves on to the second intermediate state, which is indicated by reference number C pointing to a state where the container is moved proximally but not yet so fat that the needle projects or the medicament can be delivered. A final proximally directed movement moves the container carrier 20 from the second intermediate state C to the end state D of the guide pins 21 and 22, respectively. From the end state D, the container carrier 20, i.e. the guide pins 21, 22 move on to a third intermediate state E, and from the third intermediate state E finally to the initial state A.

[0063] It can be seen in Fig. 5 that the first groove pattern 11 (and correspondingly the second groove pattern 12) comprises in each sub-pattern tongues 13 that are flexible. The flexible tongues 13 are deflectable and are deflected (in Fig. 5 upwards) when the guide pin 21 / 22 move from the first intermediate state B to the second intermediate state C. After having passed the tongues 13, the guide pins 21 / 22 move to the end state D which is the state where medicament delivery can be performed once triggered. The flexible tongues 13 then flex back and assume their initial state as shown in Fig. 5. This allows the guide pins 21 / 22 to then move along the upper surface of the flexible tongues 13 when transitioning from the end state D to the third intermediate state E. At the third intermediate state E, the groove pattern 11 comprises a second flexible tongue 14 that deflects upwards when being pushed by the guide pin 21 / 22 during its movement from the third intermediate state E to the initial state A. Once the guide pin 21 / 22 has passed the second flexible tongue 14, it flexes back into its initial position as shown in Fig. 5. This ensures that during the next drug delivery, i.e. during the next movement of the displaceable container carrier 20, the container carrier 20 follows the first and second groove pattern 11, 12, respectively, from the initial state A to the first intermediate state B, and so on, i.e., the guide pins 21, 22, slide above the flexible tongues 14.

[0064] Turning back to Fig. 3, in the embodiment of the medicament delivery device shown, the needle shield holder 70 is axially fixed with respect to the housing 10. This ensures that the needle shield is also axially fixed with respect to the housing 10 as soon as the container carrier 20 is moved distally to remove the needle 31 from the needle shield. Likewise, when the container carrier 20 is moved back to its initial position, the axial fixing of the needle shield holder 70 and thus of the needle shield allows for a re-capping of the needle 31 and the container 30.

[0065] As mentioned above, the manually operable activator 60 also accommodates the actuator 50 and the plunger rod 40. In the shown embodiment having a cross-bar type actuator 50, the actuator 50 is slidable within the manually operable activator 60.

[0066] Finally, the medicament delivery device 1 comprises element 90. Element 90 comprises, on its upper face, a knob that can be inserted into a slot in the inner face of cover 18, in order to hold it in place and avoid that the manually operable activator 60 opens.

[0067] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders. Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), hypercholesterolaemia and / or dyslipidemia, cardiovascular disease, diabetes (e.g. type 1 or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behcet'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.

[0068] 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.

[0069] 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.

[0070] 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-1 (GLP-1) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Cl 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 (TIG IT) 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 wl37 (CDwl37) 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 arrestspecific 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 wl23 (CDwl23) 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, tumor-infiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.

[0071] 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-la, interferon beta-lb, peginterferon beta-la, 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.

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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.

[0076] 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, mFOLFOX7, 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-1 E, ADOC, or PE.

[0077] The invention is further defined by the following items:

[0078] 1. Medicament delivery device (1) comprising a housing (10), a container carrier (20) being displaceable relative to the housing (10) and arranged to accommodate a container (30) having a needle (31) and a needle shield, and containing a medicament, a plunger rod (40) for expelling a medicament from the container (30) when being accommodated in the container carrier (20), a manually operable activator (60) arranged to the housing (10) movable along the longitudinal axis with respect to the housing (10), wherein the manually operable activator (60) is connectable with the displaceable container carrier (20), wherein the longitudinal axis extends from the proximal to the distal end of the housing (10), a needle shield holder (70) arranged to receive and accommodate the needle shield, the displaceable container carrier (20) being displaceable relative to the needle shield holder (70), wherein the manually operable activator (60) is movable between an initial state (A), one or more intermediate state(s) (B, C) and an end state (D), and reverse from the end state (D) to the initial state (A), wherein in one of the intermediate states (B) the manually operable activator (60) is more distal than in the initial state (A) and more distal than in the end state (D), wherein at the beginning or during movement of the manually operable activator (60) from the initial state (A) to the first intermediate state (B) the manually operable activator (60) connects to the container carrier (20) such that the container carrier (20) with the container (30) is moved distally to thereby withdraw the needle (31) from the needle shield, and wherein the medicament delivery device (1) is configured to, during movement of the manually operable activator (60) from the first intermediate state (B) to the end state (D), move the container carrier (20) with the container (30) proximally and passing by the needle shield holder (70).

[0079] 2. Medicament delivery device according to item 1, wherein reverse movement of the manually operable activator (60) from the end (B) state via an intermediate state (E) to the initial state (A) causes the container carrier (20) and the container (30) to be displaced such that the needle (31) is re-inserted into the needle shield.

[0080] 3. Medicament delivery device according to item 1, or 2, wherein the medicament delivery device (1) is configured to displace the container carrier (20) in a direction normal to the longitudinal axis of the housing (10) during movement of the manually operable activator (60) (a) from the initial state (A) to the intermediate states (B, C), (b) from the initial state (A) to the end state (D), or (c) from the initial state (A) to the intermediate states (B, C) and from the intermediate states (B, C) to the end state (D).

[0081] 4. Medicament delivery device according to any one of the preceding items, wherein the housing (10) comprises a first groove pattern (11) and a second groove pattern (12), the second groove pattern (12) being opposite to the first groove pattern (11) normal to the longitudinal axis, and wherein the container carrier (20) comprises one or more first and second mating guide pins (21, 22, 23, 24) arranged in the corresponding first and second groove pattern (11, 12).

[0082] 5. Medicament delivery device according to any one of items 1 to 3, wherein the container carrier (20) comprises a first groove pattern and a second groove pattern, the second groove pattern being opposite to the first groove pattern normal to the longitudinal axis, and wherein the housing comprises one or more first and second mating guide pins arranged in the corresponding first and second groove pattern.

[0083] 6. Medicament delivery device according to item 4 or 5, wherein the groove pattern provides a one-way movement pattern for the container carrier (20) between the initial state (A), one or more intermediate state(s) (B, C), the end state (D), a third intermediate state (E) and the initial state (A) of the manually operable activator (60).

[0084] 7. Medicament delivery device according to any one of the preceding items, wherein the manually operable activator (60) is arranged at a distal end of the housing.

[0085] 8. Medicament delivery device according to any one of the preceding items, wherein the needle shield carrier is axially fixed with respect to the housing (10).

[0086] 9. Medicament delivery device comprising a housing, a container carrier arranged to accommodate a container having a needle and containing a medicament, a plunger rod for expelling a medicament from the container when being accommodated in the container carrier; a needle shield holder being displaceable relative to the housing and arranged to receive and accommodate a needle shield of the container; a manually operable activator arranged to the housing movable along the longitudinal axis with respect to the housing, wherein the manually operable activator is connectable with the displaceable needle shield holder, wherein the longitudinal axis extends from the proximal to the distal end of the housing, wherein the manually operable activator is movable between an initial state, an intermediate state and an end state, and reverse, wherein in the intermediate state the manually operable activator is more proximal than in the initial state and more proximal than in the end state, wherein at the beginning or during movement of the manually operable activator from the initial state to the intermediate state the manually operable activator connects to the needle shield holder such that the needle shield is moved proximally to withdraw the needle shield from the needle, and wherein the medicament delivery device is configured to, during movement of the manually operable activator from the intermediate state to the end state, move the needle shield holder with the needle shield distally and passing by the needle.

[0087] 10. Medicament delivery device according to item 9, wherein reverse movement of the manually operable activator from the end state via the intermediate state to the initial state causes the needle shield holder with the needle shield to be displaced such that the needle shield re-covers the needle.

[0088] 11. Medicament delivery device according to item 9, or 10, wherein the medicament delivery device is configured to displace the needle shield holder with the needle shield in a direction normal to the longitudinal axis of the housing during movement of the manually operable activator (a) from the initial state to the intermediate state, (b) from the initial state to the end state, or (c) from the initial state to the intermediate state and from the intermediate state to the end state.

[0089] 12. Medicament delivery device according to any one of items 9 to 11, wherein the manually operable activator arranged at a proximal part of the housing.

[0090] 13. Medicament delivery device according to any one of items 9 to 12, wherein the housing comprises a first groove pattern and a second groove pattern, the second groove pattern being opposite to the first groove pattern normal to the longitudinal axis, and wherein the needle shield holder comprises one or more first and second mating guide pins arranged in the corresponding first and second groove pattern.

[0091] 14. Medicament delivery device according to any one of items 9 to 12, wherein the needle shield holder comprises a first groove pattern and a second groove pattern, the second groove pattern being opposite to the first groove pattern normal to the longitudinal axis, and wherein the housing comprises one or more first and second mating guide pins arranged in the corresponding first and second groove pattern.

[0092] 15. Medicament delivery device according to item 13 or 14, wherein the groove pattern provide a one-way movement pattern for the needle shield holder between the initial state, a first intermediate state, the end state, a second intermediate state and the initial state of the manually operable activator.

[0093] 16. Medicament delivery device according to any one of the preceding items, further comprising an actuator (50), wherein the actuator (50) is moveable in a longitudinal direction with respect to the housing (10) and the manually operable activator (60).

[0094] 17. Medicament delivery device according to item 16, wherein the actuator (50) is configured to withdraw the manually operable member (60) distally from the housing (10).

[0095] 18. Medicament delivery device according to item 16, or 17, wherein the actuator (50) accommodates the plunger rod (40).

[0096] 19. Medicament delivery device of any one of the preceding items, wherein the medicament delivery device (1) is of the multi-use type.

[0097] 20. Medicament delivery device of item 19, further comprising a cover (18) connectable to the housing (10) and comprising an opening (19) so that a prefilled container with needle and needle shield can be inserted into the container carrier and needle shield holder and an emptied container with needle and needle shield can be removed from the container carrier and needle shield holder.

Claims

CLAIMS1. Medicament delivery device (1) comprising a housing (10), a container carrier (20) being displaceable relative to the housing (10) and arranged to accommodate a container (30) having a needle (31) and a needle shield, and containing a medicament, a plunger rod (40) for expelling a medicament from the container (30) when being accommodated in the container carrier (20), a manually operable activator (60) arranged to the housing (10) movable along the longitudinal axis with respect to the housing (10), wherein the manually operable activator (60) is connectable with the displaceable container carrier (20), wherein the longitudinal axis extends from the proximal to the distal end of the housing (10), a needle shield holder (70) arranged to receive and accommodate the needle shield, the displaceable container carrier (20) being displaceable relative to the needle shield holder (70), wherein the manually operable activator (60) is movable between an initial state (A), one or more intermediate state(s) (B, C) and an end state (D), and reverse from the end state (D) to the initial state (A), wherein in one of the intermediate states (B) the manually operable activator (60) is more distal than in the initial state (A) and more distal than in the end state (D), wherein at the beginning or during movement of the manually operable activator (60) from the initial state (A) to the first intermediate state (B) the manually operable activator (60) connects to the container carrier (20) such that the container carrier (20) with the container (30) is moved distally to thereby withdraw the needle (31) from the needle shield, and wherein the medicament delivery device (1) is configured to, during movement of the manually operable activator (60) from the first intermediate state (B) to the end state (D), move the container carrier (20) with the container (30) proximally and passing by the needle shield holder (70).

2. Medicament delivery device according to claim 1, wherein reverse movement of the manually operable activator (60) from the end (B) state via an intermediate state (E) to the initial state (A) causes the container carrier (20) and the container (30) to be displaced such that the needle (31) is re-inserted into the needle shield.

3. Medicament delivery device according to claim 1, or 2, wherein the medicament delivery device (1) is configured to displace the container carrier (20) in a direction normal to the longitudinal axis of the housing (10) during movement of the manually operable activator (60) (a) from the initial state (A) to the intermediate states (B, C), (b) from the initial state (A) to the end state (D), or (c) from the initial state (A) to the intermediate states (B, C) and from the intermediate states (B, C) to the end state (D).

4. Medicament delivery device according to any one of the preceding claims, wherein the housing (10) comprises a first groove pattern (11) and a second groove pattern (12), the second groove pattern (12) being opposite to the first groove pattern (11) normal to the longitudinal axis, and wherein the container carrier (20) comprises one or more first and second mating guide pins (21, 22, 23, 24) arranged in the corresponding first and second groove pattern (11, 12).

5. Medicament delivery device according to any one of claims 1 to 3, wherein the container carrier (20) comprises a first groove pattern and a second groove pattern, the second groove pattern being opposite to the first groove pattern normal to the longitudinal axis, and wherein the housing comprises one or more first and second mating guide pins arranged in the corresponding first and second groove pattern.

6. Medicament delivery device according to claim 4 or 5, wherein the groove pattern provides a one-way movement pattern for the container carrier (20) between the initial state (A), one or more intermediate state(s) (B, C), the end state (D), a third intermediate state (E) and the initial state (A) of the manually operable activator (60).

7. Medicament delivery device according to any one of the preceding claims, wherein the manually operable activator (60) is arranged at a distal end of the housing.

8. Medicament delivery device according to any one of the preceding claims, wherein the needle shield carrier is axially fixed with respect to the housing (10).

9. Medicament delivery device comprising a housing, a container carrier arranged to accommodate a container having a needle and containing a medicament, a plunger rod for expelling a medicament from the container when being accommodated in the container carrier; a needle shield holder being displaceable relative to the housing and arranged to receive and accommodate a needle shield of the container; a manually operable activator arranged to the housing movable along the longitudinal axis with respect to the housing, wherein the manually operable activator is connectable with the displaceable needle shield holder, wherein the longitudinal axis extends from the proximal to the distal end of the housing, wherein the manually operable activator is movable between an initial state, an intermediate state and an end state, and reverse, wherein in the intermediate state the manually operable activator is more proximal than in the initial state and more proximal than in the end state, wherein at the beginning or during movement of the manually operable activator from the initial state to the intermediate state the manually operable activator connects to the needle shield holder such that the needle shield is moved proximally to withdraw the needle shield from the needle, and wherein the medicament delivery device is configured to, during movement of the manually operable activator from the intermediate state to the end state, move the needle shield holder with the needle shield distally and passing by the needle.

10. Medicament delivery device according to claim 9, wherein reverse movement of the manually operable activator from the end state via the intermediate state to the initial state causes the needle shield holder with the needle shield to be displaced such that the needle shield re-covers the needle.

111. Medicament delivery device according to claim 9, or 10, wherein the medicament delivery device is configured to displace the needle shield holder with the needle shield in a direction normal to the longitudinal axis of the housing during movement of the manually operable activator (a) from the initial state to the intermediate state, (b) from the initial state to the end state, or (c) from the initial state to the intermediate state and from the intermediate state to the end state.

12. Medicament delivery device according to any one of the preceding claims, further comprising an actuator (50), wherein the actuator (50) is moveable in a longitudinal direction with respect to the housing (10) and the manually operable activator (60).

13. Medicament delivery device according to claim 12, wherein in actuator (50) is configured to withdraw the manually operable member (60) distally from the housing (10).

14. Medicament delivery device according to claim 12, or 13, wherein the actuator (50) accommodates the plunger rod (40).

15. Medicament delivery device of any one of the preceding claims, further comprising a cover (18) connectable to the housing (10) and comprising an opening (19) so that a prefilled container with needle and needle shield can be inserted into the container carrier and needle shield holder and an emptied container with needle and needle shield can be removed from the container carrier and needle shield holder.

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