Medicament delivery device

Abstract

Medicament delivery device, the medicament delivery device having a proximal end pointing towards a dose delivery site during use of the medicament delivery device, and a distal end opposite the proximal end, the medicament delivery device comprising: a housing (3) comprising a longitudinal axis, a plunger rod (4) comprising a blocking protrusion, a medicament delivery member cover (1) coupled to the housing (3) and axially movable between an extended position and a retracted position with10 respect to the housing (3), wherein the housing (3) comprises a stop configured to engage with the blocking protrusion of the plunger rod (4), wherein the plunger rod (4) is axially blocked in a proximal direction with respect to the housing (3) in a first position of the blocking protrusion and axially moveable with respect to the housing (3) in a second position of the blocking protrusion, wherein the medicament delivery member cover (1) comprises an engagement surface configured to interact with the blocking protrusion, and wherein, when the medicament delivery member cover (1) is pushed in a distal direction into the retracted position, the engagement surface is configured to translate the blocking protrusion from the first position to the second position.

Description

[0001] Medicament delivery device

[0002] TECHNICAL FIELD

[0003] The present disclosure relates to a medicament delivery device and in particular to an activation mechanism of a medicament delivery device.

[0004] BACKGROUND

[0005] A medicament delivery device, in particular an autoinjector, according to the prior art comprises a housing comprising a front housing and a rear housing. The housing is adapted to hold a medicament container, such as a syringe. The syringe may be a pre-filled syringe and have a needle as a medicament delivery member arranged at a proximal end. When the autoinjector and / or the syringe are assembled, a protective needle sheath may be removably coupled to the needle. The protective needle sheath may be made of a flexible shell (for instance composed of rubber) and / or a rigid shell (for instance composed of plastic). A stopper, also called plunger, maybe arranged for sealing the syringe distally and for expelling a medicament contained in the syringe through the needle. In other exemplary embodiments, the medicament container may be a cartridge which includes the medicament and engages a removable needle (e.g., by threads, snaps, friction, etc.).

[0006] A cap may be removably disposed at a proximal end of the housing. The cap may include an element (e.g., a barb, a hook, a narrowed section, etc.) arranged to engage the protective needle sheath, the housing and / or a medicament delivery member cover, also referred to as needle cover, telescoped within the housing. The cap may comprise grip features for facilitating removal of the cap (e.g., by twisting and / or pulling the cap relative to the housing).

[0007] A medicament delivery member cover biasing member (for instance a coil spring) may be arranged to bias the medicament delivery member cover in a proximal direction relative to the housing, before injection, for safety reasons. The medicament delivery member cover biasing member needs to be compressed at the beginning of injection in order to retract the medicament delivery member cover inside the housing and uncover the medicament delivery member, thereby activating the device.

[0008] A pre-loaded drive biasing member, for instance a pre-compressed drive coil spring, may be arranged within the housing. A plunger rod may be used to forward force from the drive biasing member to the stopper. In an exemplary embodiment, the plunger rod is hollow and the drive biasing member is arranged within the plunger rod. In another exemplary embodiment, the plunger rod is solid and the drive biasing member engages a distal end of the plunger rod. When the pre-loaded drive biasing member is released, the drive biasing member biases the plunger rod in the proximal direction relative to the housing, releasing the plunger rod. Besides that, the plunger rod may itself comprise means for sealing the medicament container such that no stopper needs to be provided.

[0009] A plunger rod release mechanism may be arranged for preventing release of the plunger rod prior to retraction of the medicament delivery member cover relative to the housing and for releasing the plunger rod only once the medicament delivery member cover is sufficiently retracted.

[0010] A medicament delivery member cover lock mechanism (needle cover lock mechanism) may be arranged to prevent retraction of the medicament delivery member cover relative to the housing when the cap is in place, thereby avoiding unintentional activation of the autoinjector (e.g., if dropped, during shipping or packaging, etc.). Such mechanisms are known in the art and will not be described in detail.

[0011] However, there is a need to further improve the triggering mechanism of medicament delivery devices while effectively preventing inadvertent activation of the device.

[0012] This need is met by a device according to the present disclosure. SUMMARY

[0013] Reference should now be made to the appended claims.

[0014] The invention relates to a medicament delivery device, the medicament delivery device having a proximal end pointing towards a dose delivery site during use of the medicament delivery device, and a distal end opposite the proximal end, the medicament delivery device comprising: a housing comprising a longitudinal axis, a plunger rod comprising a blocking protrusion, a pre-loaded drive biasing member exerting a force on the plunger rod in the proximal direction, a medicament delivery member cover coupled to the housing and axially movable between an extended position and a retracted position with respect to the housing, wherein the housing comprises a stop configured to engage with the blocking protrusion of the plunger rod, wherein the plunger rod is axially blocked in a proximal direction with respect to the housing in a first position of the blocking protrusion and axially moveable with respect to the housing in a second position of the blocking protrusion, wherein the medicament delivery member cover comprises an engagement surface configured to interact with the blocking protrusion, and wherein, when the medicament delivery member cover is pushed in a distal direction into the retracted position, the engagement surface is configured to translate the blocking protrusion from the first position to the second position, wherein the plunger rod is rotationally provided with respect to the housing and the blocking protrusion is a blocking protrusion extending in a radial outward direction with respect to the longitudinal axis from a distal end of the plunger rod, the plunger rod further comprising a rotation protrusion extending in the radial outward direction proximal from the blocking protrusion, and the housing comprises a rear housing provided at the distal end of the medicament delivery device, and the stop comprises a rear housing blocking slot, and the blocking protrusion abuts a proximal surface of the blocking slot of the rear housing in the first position.

[0015] In a non-limiting embodiment, the medicament delivery member cover comprises two medicament delivery member cover arms extending in the distal direction, and the engagement surface of the medicament delivery member cover comprises at least one rotation slot provided at an inner circumferential surface of each of the arms.

[0016] In a non-limiting embodiment, the rotation slot, when the medicament delivery member cover is distally pushed in the retracted position, is configured to engage with the rotation protrusion of the plunger rod such that the rotation protrusion together with the blocking protrusion and the plunger rod are rotationally translated from the first position to the second position, and in the second position, the abutment of the blocking protrusion on the proximal surface of the rear housing blocking slot is released and the plunger rod is axially moveable in the proximal direction towards the medicament delivery site.

[0017] In a non-limiting embodiment, the rear housing blocking slot is substantially L-shaped or i-shaped.

[0018] In a non-limiting embodiment, in the first position, the blocking protrusion is axially fixed in the proximal direction in a circumferentially extending portion of the rear housing blocking slot, and in the second position, the blocking protrusion is axially moveable in the proximal direction in an axially extending portion of the rear housing blocking slot.

[0019] In a non-limiting embodiment, the rotation slot is substantially S-shaped, Z- shaped, or step-shaped.

[0020] In a non-limiting embodiment, the rotation slot comprises a distal longitudinal portion and a proximal longitudinal portion extending in the axial direction, and the distal longitudinal portion and the proximal longitudinal portion are offset from each other in the circumferential direction and the axial direction, and the distal longitudinal portion and the proximal longitudinal portion are connected by a lateral portion substantially extending in the circumferential direction.

[0021] In a non-limiting embodiment, in the first position, the rotation protrusion is axially moveable in the distal longitudinal portion of the rotation slot when the medicament delivery member cover is moved from the extended position to the retracted position, and the lateral portion of the rotation slot is configured to translate the rotation protrusion together with the plunger rod from the first position to the second position when the medicament delivery member cover is moved from the extended position to the retracted position, and in the second position, the rotation protrusion together with the plunger rod are axially moveable in the proximal longitudinal portion of the rotation slot when the medicament delivery member cover is moved from the extended position to the retracted position.

[0022] In a non-limiting embodiment, the medicament delivery member cover is rotationally fixed with respect to the rear housing.

[0023] The invention is specified by the independent claim. Preferred embodiments are defined in the dependent claims. In the following description, although numerous features may be designated as optional, it is nevertheless acknowledged that all features comprised in the independent claims are not to be read as optional.

[0024] 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.

[0025] 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.

[0026] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0027] Further, the terms “circumference”, “circumferential”, or “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a longitudinal 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.

[0028] When a component is said to move proximally, distally, axially in a proximal direction, axially in a distal direction or equivalent terms, the movement is relative to the housing of the injection device, unless mentioned otherwise.

[0029] 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.

[0030] BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings. Figure 1A shows a plunger rod according to an example of the present disclosure.

[0032] Figure 1B shows a distal end of a medicament delivery member cover according to an example of the present disclosure.

[0033] Figure 1C shows a housing according to an example of the present disclosure.

[0034] Figures 2A to 6D are depictions of an activation sequence of a medicament delivery device comprising the elements of Figures 1A to 1C.

[0035] Figure 7 is an exploded view of the device according to Figures 1A to 6D.

[0036] DETAILED DESCRIPTION

[0037] The activation mechanism according to the present invention can be employed for various medicament delivery devices. Thus, only the parts relevant for carrying out the disclosure will be described in detail.

[0038] In the figures, elements not essential for carrying out the invention have been omitted. In particular, not all figures show a complete outer housing, biasing members, a medicament container, cap, etc. in order not to render the depictions overly complicated and not to blur the scope of the disclosure.

[0039] In the following, the assembled state refers to a state in which the device is delivered to the patient, i.e., before activation and medicament delivery. In the assembled state, the plunger rod is in a locked position and not able to move in the proximal direction. In the activation state, the medicament delivery member cover is moved in the distal direction along the longitudinal axis from an extended position to a retracted position. In the activated state, the plunger rod is free to move in the proximal direction for medicament delivery. The plunger rod may thus be displaceable along the axial direction.

[0040] The medicament delivery member cover can be moved from the extended to the retracted position. Therefore, the medicament delivery member cover can be displaced in the axial direction. In the extended position, the medicament delivery member cover extends in a proximal direction from the housing. Thereby, a medicament delivery member, e.g., a needle, may be covered by the medicament delivery member cover. By pushing the medicament delivery member cover in the distal direction, e.g., by pushing the device onto a medicament delivery site, the medicament delivery member cover is moved to the retracted position for activating medicament delivery. After delivery, the medicament delivery member cover may be moved back to the extended position to cover the medicament delivery member. The medicament delivery member cover may also be locked in the extended position after medicament delivery to and prevent injuries of the patient.

[0041] In the following, the term engagement encompasses any kind of interaction between the named features such as abutment, clamping, locking, biasing, flexing, etc.

[0042] The present disclosure is directed towards a medicament delivery device, comprising a housing 2, 3 having a longitudinal axis, a plunger rod 4 comprising a blocking protrusion 41, 42, 43, 44 and a medicament delivery member cover 1 coupled to the housing 2, 3 and being axially movable between an extended position and a retracted position with respect to the housing 2, 3.

[0043] The housing 2, 3 comprises a stop 21, 31 configured to engage with the blocking protrusion 41, 42, 43, 44 of the plunger rod 4. The plunger rod 4 is axially fixed in a proximal direction towards a medicament delivery site with respect to the housing 2, 3 in a first position of the blocking protrusion 41, 42, 43, 44 and axially moveable with respect to the housing 2, 3 in a second position of the blocking protrusion 41, 42, 43, 44. The medicament delivery member cover 1 comprises an engagement surface 12, 13, 15 configured to interact with the blocking protrusion 41, 42, 43, 44. When the medicament delivery member cover 1 is pushed in a distal direction away from the medicament delivery site into the retracted position, the engagement surface 12, 13, 15 is configured to translate the blocking protrusion 41, 42, 43, 44 from the first position to the second position. In this embodiment, the plunger rod 4 is in a rotational configuration (rotational activation).

[0044] Fig. 1A shows a plunger rod 4 according to an embodiment. The plunger rod 4 comprises a longitudinally extending portion and a cylindrical part 45 provided distal of the longitudinally extending portion. The cylindrical part 45 may have a greater diameter than the longitudinally extending portion. The cylindrical part 45 may be hollow. The plunger rod 4 comprises a blocking protrusion 43 which may be provided on an outer circumferential surface of the cylindrical part 45. In particular, the blocking protrusion 43 may extend outward in a radial direction and may be provided at or towards a distal end of the plunger rod 4.

[0045] The plunger rod according to Fig. 1A further comprises a rotation protrusion 44. The rotation protrusion 44 may extend radially outward and may be provided at a middle section of the plunger rod 4. In particular, the rotation protrusion 44 may be provided at or below the proximal end of the cylindrical part 45.

[0046] The blocking protrusion 43 and the rotation protrusion 44 may be offset by 90 degrees with respect to each other in the circumferential direction as shown in the figures. Thus, the rear housing arms 23 comprising the blocking slot 21 and the medicament delivery member cover arms 11 comprising the rotation slot 15 (to be described below) may also be offset by 90 degrees in alternating order in the circumferential direction due to their engagement with the blocking protrusion 43 and the rotation protrusion 44, respectively.

[0047] However, the positions of the blocking protrusion 43 and the rotation protrusion 44 are not to be understood as limiting and their respective positions may be changed. Corresponding elements might have to be adapted accordingly.

[0048] The blocking protrusion 43 and the rotation protrusion 44 may together form the blocking protrusion as described above. Fig. 1B shows a distal end of a medicament delivery member cover 1 according to an embodiment. The medicament delivery member cover 1 may comprise at least one medicament delivery member cover arm n extending in the distal direction. Moreover, the medicament delivery member cover 1 may comprise a rotation slot 15 provided at an inner circumferential surface of each of the medicament delivery member cover arms 11.

[0049] The rotation slot 15 may be formed as a recess or as a cut-out. Moreover, as shown in Fig. 1B, material may be superimposed on the inner circumferential surface of the medicament delivery member cover arm 11 and the rotation slot 15 may be formed in the superimposed material.

[0050] The rotation slot 15 may substantially be formed in an S-shape, Z-shape, or step-shape. In particular, the rotation slot 15 may comprise a distal longitudinal portion and a proximal longitudinal portion which extend in the axial direction of the medicament delivery member cover 1 and are offset with respect to each other in the axial direction and the circumferential direction. The distal and proximal longitudinal portions may be connected by a middle portion (rotation slot lateral portion) substantially extending in the circumferential direction of the medicament delivery member cover 1. In particular, the middle portion may be slightly angled with respect to the circumferential direction as shown in Fig. 1B. The distal longitudinal portion and the proximal longitudinal portion may substantially have the same length.

[0051] By adjusting the angle of the middle portion, rotation of the plunger rod 4 via the rotation protrusion 44 may be controlled and facilitated.

[0052] Fig. 1C shows a rear housing 2 according to an embodiment. The rear housing 2 comprises a rear housing blocking slot 21 which may be provided in proximally extending arms 23 of the rear housing 2. The rear housing 2 may further comprise at least one snap fit 22 which may interact with a corresponding element on the housing 3 to couple the rear housing 2 to the housing 3. The blocking slot 21 maybe substantially L-shaped or i-shaped as shown in Fig. 1C. Hence, the blocking slot 21 may comprise a longitudinally extending / axially extending portion (longitudinal portion) which is open in the proximal direction and a lateral portion substantially extending in the circumferential direction of the rear housing 2. In the case of an L-shape, the lateral portion extends in the circumferential direction perpendicular to the longitudinal portion while in the case of a i-shape, the lateral portion extends in the circumferential and proximal direction. In other words, the lateral portion may be angled with respect to the circumferential direction. In the latter case, the blocking slot 21 may form a barbed hook for the blocking protrusion 43. The lateral portion and the longitudinal portion are connected to form the blocking slot 21.

[0053] In this embodiment, the medicament delivery member cover 1 is rotationally fixed with respect to the rear housing 2 (and the housing 3).

[0054] Figs. 2A to 5D show an activation sequence of a medicament delivery device comprising the plunger rod 4, the medicament delivery member cover 1 and the rear housing 2 of Figs. 1A to 1C.

[0055] Figs. 2A, 3A, 4A and 5A each show a partial view of the distal portion of the medicament delivery device from the same perspective and Figs. 2B, 3B, 4B and 5B each show a partial view of the distal portion of the medicament delivery device rotated 90 degrees around the longitudinal axis when compared to Figs. 2A, 3A, 4A and 5A.

[0056] In Figs. 2A, 3A, 4A and 5A, the medicament delivery member cover is transparently displayed.

[0057] In this embodiment, the plunger rod 4 is rotationally provided with respect to the rear housing 2 (and the housing 3, not shown) and the medicament delivery member cover 1.

[0058] The blocking protrusion is formed by the blocking protrusion 43 extending in a radial outward direction with respect to the longitudinal axis from the distal end of the plunger rod 4 and the rotation protrusion 44 extending in the radial outward direction proximal from the blocking protrusion 43 as described above and shown in Fig. 1A.

[0059] The rotation slot 15, in particular the lateral portion / middle portion thereof, forms the engagement surface.

[0060] In the first position, the blocking protrusion 43 abuts a proximal surface of the blocking slot 21 of the rear housing 2. In particular, the blocking protrusion 43 abuts a proximal surface of the lateral portion of the blocking slot 21. In case of an L-shaped blocking slot 21, the blocking protrusion 43 may have a regular rectangular shape when viewed from the side of the device as in the figures. In case of a i-shaped blocking slot 21, the blocking protrusion 43 may have a trapezoid shape corresponding to the shape of the lateral portion of the blocking slot 21 as shown, e.g., in Fig. 2B. In any case, the shape of the blocking protrusion 43 may correspond to the shape of the lateral portion of the blocking slot 21.

[0061] The angle of the lateral portion (i-shape) may serve as a barbed hook for securing the plunger rod 4 during transport and storage. Moreover, since the initial slope has to be overcome prior to medicament delivery, thus pushing the plunger rod 4 further in the distal direction, the energy accumulated in the drive biasing member may be increased and the medicament delivery might therefore be improved.

[0062] In Figs. 2A and 2B, the device is shown in the assembled state and the blocking protrusion 43, 44, i.e., the plunger rod, is in the first position.

[0063] In the first position, when the medicament delivery member cover 1 is distally pushed in the retracted position as indicated by the arrow in Fig. 2A, the rotation slot 15, i.e., the distal longitudinal portion of the rotation slot 15, moves along the rotation protrusion 44 until the rotation protrusion 44 reaches the middle portion of the rotation slot 15. This is shown in Fig. 3A. Figs. 3A and 3B show the device in the activation state, wherein the rotational position of the blocking protrusion 43, 44 is between the first and the second rotational position. By the abutment of the middle portion of the rotation slot 15 forming the engagement surface on the rotation protrusion 44, the rotation protrusion together with the plunger rod 4 and the blocking protrusion 43 are rotated from the first position towards the second position. As indicated by the arrows in Figs. 3A and 3B, due to the exemplarily shown i-shape of the blocking slot 21, the plunger rod 4 is rotated and forced in the distal direction as described above.

[0064] The angled middle portion of the rotation slot 15 as shown in the figures may aid the rotation. By varying the angle of the middle portion of the rotation slot 15 and the angle of the lateral portion of the blocking slot 21, a ratio of rotational movement to axial movement may be adapted and controlled. In that manner, handling of the medicament delivery device may be adjusted. The angles may be between 50 and 85 degrees with respect to the longitudinal axis.

[0065] For example, the angle of the middle portion of the rotation slot 15 maybe between 75 and 85 degrees, particularly 80 degrees with respect to the longitudinal axis and the angle of the lateral portion of the blocking slot may be between 50 and 70 degrees, particularly 60 degrees with respect to the longitudinal axis.

[0066] In Figs. 3A and 3B, the plunger rod 4 has been rotated via the engagement of the rotation slot 15 with the rotation protrusion 44 but is not yet free to move in the proximal direction. As can be seen in Fig. 3B, the blocking protrusion 43 has not passed the lateral portion of the blocking slot 21 and is therefore substantially locked in the proximal direction (except for a rotation back and proximal in the lateral portion).

[0067] Figs. 4A and 4B show the device in the activated state. The rotation protrusion 44 and thus the blocking protrusion 43 and the plunger rod 4 have been translated to the second position. In the second position, the abutment of the blocking protrusion 43 on the proximal surface of the rear housing blocking slot 21 is released. The plunger rod 4 is axially moveable in the proximal direction towards the medicament delivery site. In particular, the rotation protrusion 44 is axially moveable in the proximal longitudinal portion of the rotation slot 15 and the blocking protrusion 43 is axially moveable in the longitudinal portion of the blocking slot 21.

[0068] By the accumulated energy of the drive biasing member 6, the plunger rod 4 is pushed proximally to expel the medicament from the medicament container.

[0069] Fig. 5A and 5B show the device after medicament delivery. The plunger rod 4 is it its most proximal position.

[0070] Figs. 6A to 6D show the medicament delivery device during the abovedescribed activation sequence. The outer housing 3 and the cap have been omitted in this view.

[0071] As can be seen from Figs. 6A to 6D, the rear housing arms 23 and the medicament delivery member cover arms 11 maybe offset by 90 degrees in alternating order. Fig. 6A further shows the medicament delivery member cover biasing member 7 biasing the medicament delivery member cover 11 in the proximal direction and the syringe 5 on which the plunger rod 4 acts to expel a medicament dose.

[0072] The state of the device in Fig. 6A corresponds to Figs. 2A and 2B, Fig. 6B corresponds to Figs. 3A and 3B, Fig. 6C corresponds to Figs. 4A and 4B and Fig. 6D corresponds to Figs. 5A and 5B.

[0073] Fig. 7 shows an exploded view of the device according to Figs. 1A to 6D comprising a cap, a medicament delivery member cover biasing member 7, a needle sheath, a syringe 5, a medicament delivery member cover 1, a housing 3, a plunger rod 4, a drive biasing member 6 and a rear housing 2. The housing 3 may also comprise at least one medicament delivery member cover lock 33 which are biased towards the longitudinal axis and flex inwards after the medicament delivery member 1 is pushed into the extended position after medicament delivery by the medicament delivery member cover biasing member 7, thus blocking a distal movement of the medicament delivery member cover 1 and preventing the needle from getting exposed.

[0074] In the present disclosure, an improved mechanism for activation of a medicament delivery device and in particular for release of a plunger rod has been presented.

[0075] According to the present disclosure, handling of the medicament delivery device may be facilitated while preventing inadvertent activation of the device and injuries of a user.

[0076] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0077] 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, hi dradenitis 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, Behqet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycaemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, Factor V Leiden), and cancer.

[0078] 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.

[0079] 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.

[0080] 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 (CDW123) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumorinfiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer’s solution, Heparin Lock Flush solution, 100 U / mL Heparin Lock Flush Solution, or 5000 U / mL Heparin Lock Flush Solution. Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also include separately administered or co-formulated dispersion enhancers (e.g. an animal-derived, human-derived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.

[0085] 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.

[0086] 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. Medicament delivery device, the medicament delivery device having a proximal end pointing towards a dose delivery site during use of the medicament delivery device, and a distal end opposite the proximal end, the medicament delivery device comprising: a housing (2, 3) comprising a longitudinal axis, a plunger rod (4) comprising a blocking protrusion (41, 42, 43, 44), a pre-loaded drive biasing member (6) exerting a force on the plunger rod (4) in the proximal direction, a medicament delivery member cover (1) coupled to the housing (2, 3) and axially movable between an extended position and a retracted position with respect to the housing (2, 3), wherein the housing (2, 3) comprises a stop (21, 31) configured to engage with the blocking protrusion (41, 42, 43, 44) of the plunger rod (4), wherein the plunger rod (4) is axially blocked in a proximal direction with respect to the housing (2, 3) in a first position of the blocking protrusion (41, 42, 43, 44) and axially moveable with respect to the housing (2, 3) in a second position of the blocking protrusion (41, 42, 43, 44), wherein the medicament delivery member cover (1) comprises an engagement surface (12, 13, 15) configured to interact with the blocking protrusion (41, 42, 43, 44), wherein, when the medicament delivery member cover (1) is pushed in a distal direction into the retracted position, the engagement surface (12, 13, 15) is configured to translate the blocking protrusion (41, 42, 43, 44) from the first position to the second position, wherein the plunger rod (4) is rotationally provided with respect to the housing (2, 3) and the blocking protrusion is a blocking protrusion (43) extending in a radial outward direction with respect to the longitudinal axis from a distal end of the plunger rod (4), the plunger rod (4) further comprising a rotation protrusion (44) extending in the radial outward direction proximal from the blocking protrusion (43),wherein the housing comprises a rear housing (2) provided at the distal end of the medicament delivery device, wherein the stop comprises a rear housing blocking slot (21), and wherein the blocking protrusion (43) abuts a proximal surface of the blocking slot (21) of the rear housing (2) in the first position.

2. Medicament delivery device according to claim 1, wherein the medicament delivery member cover (1) comprises two medicament delivery member cover arms (11) extending in the distal direction, wherein the engagement surface of the medicament delivery member cover (1) comprises at least one rotation slot (15) provided at an inner circumferential surface of each of the arms (11).

3. Medicament delivery device according to claim 2, wherein the rotation slot (15), when the medicament delivery member cover (1) is distally pushed in the retracted position, is configured to engage with the rotation protrusion (44) of the plunger rod (4) such that the rotation protrusion (44) together with the blocking protrusion (43) and the plunger rod (4) are rotationally translated from the first position to the second position, wherein in the second position, the abutment of the blocking protrusion (43) on the proximal surface of the rear housing blocking slot (21) is released and the plunger rod (4) is axially moveable in the proximal direction towards the medicament delivery site.

4. Medicament delivery device according to any one of claims 1 to 3, wherein the rear housing blocking slot (2) is substantially L-shaped or 1- shaped.

5. Medicament delivery device according to any one of claims 1 to 4, wherein in the first position, the blocking protrusion (43) is axially fixed in the proximal direction in a circumferentially extending portion of the rear housing blocking slot (21), andwherein in the second position, the blocking protrusion (43) is axially moveable in the proximal direction in an axially extending portion of the rear housing blocking slot (21).

6. Medicament delivery device according to any one of claims 2 to 5, wherein the rotation slot (15) is substantially S-shaped, Z-shaped, or stepshaped.

7. Medicament delivery device according to any one of claims 2 to 6, wherein the rotation slot (15) comprises a distal longitudinal portion and a proximal longitudinal portion extending in the axial direction, wherein the distal longitudinal portion and the proximal longitudinal portion are offset from each other in the circumferential direction and the axial direction, and wherein the distal longitudinal portion and the proximal longitudinal portion are connected by a lateral portion substantially extending in the circumferential direction.

8. Medicament delivery device according to any one of claims 2 to 7, wherein in the first position, the rotation protrusion (44) is axially moveable in the distal longitudinal portion of the rotation slot (15) when the medicament delivery member cover (1) is moved from the extended position to the retracted position, wherein the lateral portion of the rotation slot (15) is configured to translate the rotation protrusion (44) together with the plunger rod (4) from the first position to the second position when the medicament delivery member cover (1) is moved from the extended position to the retracted position, and wherein in the second position, the rotation protrusion (44) together with the plunger rod (4) are axially moveable in the proximal longitudinal portion of the rotation slot (15) when the medicament delivery member cover (1) is moved from the extended position to the retracted position.

9. Medicament delivery device according to any one of claims 1 to 8, wherein the medicament delivery member cover (1) is rotationally fixed with respect to a rear housing (2).

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