Medicament delivery device

Abstract

[Medicament delivery device] The present disclosure relates to a medicament delivery device (1) extending generally along a longitudinal axis (L), and having a proximal end configured to point towards a dose delivery site and a distal end configured to point away from the dose delivery site, the medicament delivery device (1) comprising: - a cassette (10) comprising a syringe holder (13) for holding a syringe (14) - a power pack (20) comprising  a drive spring (25)  a plunger rod (24) to expel medicament from the syringe (24) when driven proximally by the drive spring (25) - a distal button (22) wherein the syringe holder (13) comprises a least a leg (133) extending distally and having, at its distal end, a seat (133a) for a proximal part (242a) of a lever (242) of the plunger rod (24) such that when the proximal part (242a) is received in the seat (133a), the plunger rod (24) cannot move proximally relative to the syringe holder (13), wherein the button (22) comprises at least an arm (222) extending proximally and having, at its proximal end, a knob (222a) configured such that a proximal movement of the button (22) brings the knob (222a) into contact with a bottom surface (242b) of the lever (242), thereby lifting the proximal part (242a) of the lever (242) out of the seat (133a).

Description

[0001] MEDICAMENT DELIVERY DEVICE

[0002] TECHNICAL FIELD

[0003] The present invention relates to a button-activatable medicament delivery device with a replaceable syringe.

[0004] BACKGROUND

[0005] Medicament delivery devices such as injectors are nowadays often handled by the end user during medicament delivery.

[0006] Some medicament delivery devices contain a syringe. Syringes are used for a single medicament delivery operation.

[0007] In some cases, the entire medicament delivery device may be disposable so that a user only has to be concerned about the medicament delivery operation and the disposal of the medicament delivery device.

[0008] In other cases, the medicament delivery device may be configured to be used multiple times. This requires changing of the syringe. Such a medicament delivery device generally comprises a cassette and a power pack. The cassette can be connected to the power pack before use, and disconnected from the power pack after use. The cassette comprises a syringe, and the syringe can be changed when the cassette has been disassembled from the power pack. The power pack generally comprises a plunger rod and a drive spring biased against a plunger rod surface. Before use, the drive spring is pre-tensioned and the plunger rod cannot move proximally, that is to say towards the proximal end of the medicament delivery device, the proximal end being the end configured to point towards a dose delivery site. Upon activation of the medicament delivery device, the plunger rod is released and the drive spring drives the plunger rod proximally. The plunger rod thereby displaces a plunger of the syringe, resulting in expelling said medicine from said syringe. Such an activation may result from the user pressing a button of the medicament delivery device. SUMMARY

[0009] An object of the present disclosure is to provide a button-activatable and reusable medicament delivery device, having a low number of components and easy to operate.

[0010] There is hence provided a medicament delivery device extending generally along a longitudinal axis, and having a proximal end configured to point towards a dose delivery site and a distal end configured to point away from the dose delivery site, the medicament delivery device comprising:

[0011] - a cassette comprising a syringe holder configured for holding a syringe

[0012] - a power pack comprising:

[0013] • a drive spring

[0014] • a plunger rod to expel medicament from the syringe when driven proximally by the drive spring

[0015] - a distal button wherein the syringe holder comprises a least a leg extending distally and having, at its distal end, a seat for a proximal part of a lever of the plunger rod such that when the proximal part is received in the seat, the plunger rod cannot move proximally relative to the syringe holder, wherein the button comprises at least an arm extending proximally and having, at its proximal end, a knob configured such that a proximal movement of the button brings the knob into contact with a bottom surface of the lever, thereby lifting the proximal part of the lever out of the seat.

[0016] Before activation, when the cassette is mounted to the power pack, the proximal part of the lever of the plunger rod is located in the seat of the syringe holder, preventing a proximal movement of the plunger rod. Pressing the button releases the plunger rod, enabling the drive spring to move the plunger rod proximally. Various embodiments may preferably implement the following features.

[0017] In a non-limiting embodiment, the lever is configured to rotate around its distal end.

[0018] In a non-limiting embodiment, the drive spring extends partially inside the plunger rod, a proximal end of the drive spring being configured to bear against a distally-facing support surface of the plunger rod, wherein when the cassette is being mounted to the power pack, the seat of the leg reaches the proximal part of the lever of the plunger rod, which biases the plunger rod distally, thereby loading the drive spring.

[0019] In a non-limiting embodiment, the power pack comprises a guide rod comprising a flange at its distal end, a distal end of the drive spring being configured to bear against the flange.

[0020] In a non-limiting embodiment, the plunger rod comprises a radial protrusion, wherein the power pack comprises a top housing part having a support rib configured to stop a proximal course of the plunger rod.

[0021] In a non-limiting embodiment, the cassette comprises a needle cover configured to be arranged concentrically with and radially outside of the syringe and held by the syringe holder, wherein the needle cover comprises at least a hook at its distal end, the hook being configured for engaging a shoulder of a case of the syringe holder.

[0022] In a non-limiting embodiment, the needle cover comprises or cooperates with a resilient element configured to be compressed when the needle cover is pressed against the injection site, and released when the pressure stops.

[0023] In a non-limiting embodiment, the needle cover comprises a flange at its proximal end. In a non-limiting embodiment, the cassette comprises a proximal cap, wherein in a first position of the proximal cap, the proximal cap is attached to the case of the syringe holder and the case is attached to a housing of the power pack.

[0024] In a non-limiting embodiment, in a second position of the proximal cap, the proximal cap is attached to the case of the syringe holder and the case is detached from the housing of the power pack.

[0025] In a non-limiting embodiment, the proximal cap comprises at least a wing having a through-opening, wherein the case of the syringe holder comprises at least a flexible member having a reattachment hook, wherein in the second position, the reattachment hook is locked into the through-opening, thereby securing the proximal cap to the syringe holder.

[0026] In a non-limiting embodiment, the housing of the power pack comprises at least a through-hole, wherein the flexible member has an attachment hook, wherein in the first position, the attachment hook is locked into the through- hole, thereby securing the case to the housing, and wherein in the second position, the wing biases the flexible member radially, thereby detaching the case from the housing.

[0027] In a non-limiting embodiment, in the second position, the proximal cap has been rotated of 90° around the longitudinal axis.

[0028] In a non-limiting embodiment, the power pack comprises a button spring arranged at least partly within a shell of the button, the button spring biasing distally the button.

[0029] In a non-limiting embodiment, the syringe holder comprises an inner support flange configured to mate a flange of the syringe. 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.

[0030] 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.

[0031] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings.

[0037] Fig. 1 shows a perspective view of a medicament delivery device according to an example, said device comprising a cassette and a power pack.

[0038] Fig. 2A to 2C show different views of the cassette, respectively a perspective view in a pre-assembled configuration, that is to say before assembly of the cassette and the power pack, the same perspective view with a proximal cap of the cassette represented transparent, and an exploded perspective view.

[0039] Fig. 3A to 3D show different views of the power pack, respectively a perspective view in the pre-assembled configuration, the same perspective view with a top housing part lifted and represented transparent, an exploded perspective view, and a longitudinal cross-section view.

[0040] Fig. 4 shows a longitudinal cross-section view of a proximal portion of the medicament delivery device in a final configuration, post injection and when a proximal cap of the cassette has been reattached.

[0041] Fig. 5A shows a perspective view of a distal portion of the medicament delivery device in an assembled configuration, after the cassette and the power pack have been assembled.

[0042] Fig. 5B shows a perspective view of the distal portion of the medicament delivery device in an activation configuration, after a button of the power pack has been pressed.

[0043] Fig. 6 shows the medicament delivery device in a subsequent configuration where the injection has ended, in a longitudinal cross-sectional view. DETAILED DESCRIPTION

[0044] 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.

[0045] Fig. 1 shows a perspective view of a medicament delivery device 1 according to an example, said device comprising a cassette io and a power pack 20 removably attached to each other, prior to an injection. The exemplified medicament delivery device 1 is an injector. The injector in the present example is an autoinjector.

[0046] The medicament delivery device 1 extends along a longitudinal axis L between a proximal end, where the drug is ejected, and a distal end. The proximal end is configured to point towards a dose delivery site (i.e., the patient’s skin) during use of the medicament delivery device 1, and the distal end is configured to point away from the dose delivery site. The power pack 20 is reusable, but the cassette 10 is single use and must be disposed after an injection.

[0047] Fig. 2A to 2C show different views of the cassette 10. The cassette 10 comprises a proximal cap 12, a syringe holder 13, a syringe 14 and a needle cover 15. Fig. 2A shows a perspective view in a pre-assembled configuration, that is to say before assembly of the cassette 10 to the power pack 20; Fig. 2B shows same perspective view with the proximal cap 12 represented transparent; Fig. 2C shows an exploded perspective view.

[0048] With reference to Fig. 2C, the syringe 14 comprises a cylindrical barrel 141 containing a set dosage of a medicament, a needle 142 attached at the proximal end of the barrel (visible on Fig. 6), a plunger (or stopper) 143 axially moveable inside the barrel 141 to expel the medicament from the barrel 141 through the needle 142, and a flange 144 at the distal end of the barrel 141.

[0049] The needle cover 15, mainly cylindrical, is configured to be arranged concentrically with and radially outside of the barrel 141. A distal portion of the needle cover 15 comprises a resilient element 151. In the example, the resilient element 151 is integral with the needle cover 15. The resilient element 151 is in this case made of perforations on the circumference of the distal portion of the needle cover 15. Alternatively, the resilient element may be made of a polymer material. Alternatively, the cassette 10 could comprise a resilient element which is a separate component placed at the distal end of the needle cover 15. In this case, the resilient element could for example be a metal spring.

[0050] In addition, the distal portion of the needle cover 15 comprises two hooks 152 at their distal end. Finally, the needle cover 15 comprises a flange 154 at its proximal end, configured to be pressed against the patient’s skin during injection.

[0051] The syringe 14 and the needle cover 15 are held by the syringe holder 13. The syringe holder 13 comprises a case 132. The case 132 is non-cylindrical. In the present example, a transversal cross-section of the proximal cap 12 has a general square shape. The flange 144 of the syringe 14 is configured to mate with an inner support flange 132b of the case 132. The hooks 152a of the needle cover 15 are configured for engaging a shoulder 132c of the case 132 of the syringe holder 13, as illustrated on Fig. 4, thereby attaching the needle cover 15 to the syringe holder 13.

[0052] The syringe holder 13 comprises a cylindrical proximal portion 131 configured to be arranged concentrically with and radially outside of the needle cover 15. Before injection, the needle cover 15 extends proximally outside of the proximal portion 131 of the syringe holder 13, covering the needle 142. During the injection, when the flange 154 of the needle cover 15 is pressed against the patient’s skin, the resilient element 151 is compressed which retracts the needle cover 15 inside the proximal portion 131 of the syringe holder 13, thereby uncovering the needle 142. After injection, when the flange 154 of the needle cover 15 is removed from the patient’s skin, the needle cover 15 extends proximally again from the proximal portion 131 of the syringe holder 13, recovering the needle 142. This is due to the force of the resilient element 151.

[0053] In the present non-limiting example, the proximal cap 12 is non-cylindrical. In the present example, a transversal cross-section of the proximal cap 12 has a general square shape. The proximal cap 12 comprises two wings 121 extending distally, whose usage will be described later.

[0054] Finally, the syringe holder 13 comprises two legs 133 extending distally from the case 132, parallel to each other. Each leg 133 comprises, at its distal end, a seat 133a whose usage will be described later.

[0055] Fig. 3A to 3D show different views of the power pack 20. The power pack 20 comprises a distal button 22, a rear resilient member that is in this example an helical button spring 23, a plunger rod 24, an helical drive spring 25, a guide rod 26, a top housing part 27 and a bottom housing part 28. Fig. 3A shows a perspective view in the pre-assembled configuration; Fig. 3B shows the same perspective view with the top housing part 27 lifted and represented transparent; Fig. 3C shows an exploded perspective view; and Fig. 3D shows a longitudinal cross-section view.

[0056] The top housing part 27 and the bottom housing part 28 are attached to each other to form a housing 27, 28 enclosing at least partially the rest of the elements of the power pack 20. The housing 27, 28 is non-cylindrical. In the present example, a transversal cross-section of the housing 27, 28 has a general square shape. The top housing part 27 comprises a through-hole 270, the bottom housing part 28 comprises a through-hole as well (not visible on the figures). The usage of said through-holes 270 is explained hereafter. The proximal cap 12 is configured to be attached to the syringe holder 13 in two different positions. In the present embodiment, the non-cylindrical shapes of the proximal cap 12 and the case 132 of the syringe holder 13 help the user to identify the possible orientations of the proximal cap 12. However, a cylindrical version of the proximal cap 12 and the case 132 of the syringe holder 13 would be possible, with the help of visual marks or labels to identify the possible orientations. In the assembled configuration of the medicament delivery device 10, the proximal cap 12 is attached to the syringe holder 13 according to the first position. Fig. 2A and 2B show the proximal cap 12 in said first position. In the first position, the wings 121 of the proximal cap 12 are fitted into recesses 132a (only one being visible on the figures) of the case 132 of the syringe holder 13. Besides that, in the first position of the proximal cap 12, attachment hooks 135b on distally-extending and radially-flexible members 135 of the case 132 of the syringe holder 13 are received and locked into the through-holes 270 (cf. Fig 3A for instance) of the top and bottom housing parts 27, 28. This secures the syringe holder 13 to the housing 27,28, thereby securing the cassette 10 to the power pack 20.

[0057] To enable the injection, the proximal cap 12 needs to be removed by the patient from the rest of the cassette 10. Then, after the injection, the proximal cap 12 needs to be reattached by the patient to the rest of the cassette 10, before removal of the cassette 10 from the power pack 20. When reattached, the proximal cap 12 needs to be placed in the second position. In this example, the second position is rotated 90 degrees about the longitudinal axis. In the second position of the proximal cap 12, illustrated on Fig. 4, the wings 121 of the proximal cap 12 push the flexible members 135 of the case 132 of the syringe holder 13 towards the centre of the housing 27, 28, which unlocks the attachment hooks 135b. Besides that, in the second position of the proximal cap 12, reattachment hooks 135a on the flexible members 135 of the case 132 of the syringe holder 13 are received and locked into through- openings 121a on the wings 121 of the proximal cap 12, thereby securing the proximal cap 12 to the syringe holder 13. As visible on Fig. 3D, the plunger rod 24 is mainly cylindrical and hollow and extends axially partly inside the housing 27, 28. The drive spring 25 and the guide rod 26 are arranged at least partly within the plunger rod 24. The drive spring 25 is configured to be arranged concentrically with and radially outside of the guide rod 26. The guide rod 26 is used to guide the drive spring 25. The proximal end of the drive spring 25 is configured to bear against a distally-facing support surface 241 at the proximal end of the plunger rod 24. The distal end of the drive spring 25 is configured to bear against a flange 261 at the distal end of the guide rod 26. The plunger rod 24 is thereby biased proximally in the syringe holder 13 by the drive spring 25.

[0058] The button 22 comprises a shell 221 that is hollow. The button spring 23 is arranged at least partly within the shell 221 of the button 22. The distal end of the button spring 23 is configured to bear against a proximally-facing support surface 221a at the distal end of the shell 221 of the button 22. The proximal end of the button spring 23 is configured to bear against a distally- facing surfaces 271, 281 of the top and bottom housing parts 27, 28. The button 22 is thereby biased distally by the button spring 23. When a proximal force is applied by the patient on the button 22, that is to say when the button 22 is pressed, the button spring 23 is compressed. When the force is released, the button spring 23 unloads and the button 22 moves back into the distal direction.

[0059] The plunger rod 24 is used to forward force from the drive spring 25 to the plunger 143 when the drive spring 25 releases its energy.

[0060] First, the drive spring 25 needs to be compressed (that is to say, loaded). The compression of the drive spring 25 is performed during attachment of the cassette 10 to the power pack 20. To this end, the plunger rod 24 comprises two levers 242 on each side of the outer cylindrical surface of the plunger rod 24. As visible on Fig. 5A and 5B, the distal end 242c of each lever 242 is fixedly attached to the outer cylindrical surface of the plunger rod 24, and the lever 242 can rotate around its distal end 242c. Initially, before attachment of the cassette 10 to the power pack 20, the levers 242 extend with an angle 0 compared to the longitudinal axis L (cf. Fig. 3B). Each lever 242 is configured to cooperate with a seat 133a of a leg 133 of the syringe holder 13. More precisely, the seat 133a is configured to form a receiving and supporting area for a proximal part 242a of the lever 242, as illustrated on Fig. 5A. When the levers 242 of the plunger rod 24 are in the seats, a movement of the plunger rod 24 in the proximal direction is impossible. When the cassette 10 is assembled to the power pack 20, the legs 133 of the syringe holder 13 are inserted in the housing 27, 28. At some point the proximal parts 242a come into contact with the seats 133a. The distally-directed forces applied on the proximal parts 242a of the levers 242 by the seats 133a displace the plunger rod 24 axially in the distal direction, which loads (at least partially) the drive spring 25.

[0061] In a non-limiting embodiment, the loading of the drive spring 25 is divided into two steps.

[0062] In a first step, the plunger rod 24 is moves distally to a specific axial position by mounting the cassette 10 to the power pack 20 and said position does not allow to load entirely the drive spring 25.

[0063] In a second step, during activation of the medicament delivery device 1, pressing the needle cover 15 against the skin of the patient creates another distal movement of the plunger rod 24 that finishes to load the drive spring 25. The second step requires for the needle cover 15 to have legs extending distally, able to contact the plunger rod levers 242 and push them distally further. The needle cover legs run parallel to the legs 133 of the syringe holder 13, used to perform the first step. Furthermore, the legs of the needle cover need to keep the levers of the plunger rod in the activated position during the first millimetres of proximal movement of the plunger rod of the drug delivery, thereby preventing the legs of the needle cover from catching on the seats 133a. Alternatively, the needle cover pushes directly the syringe holder 13 to force it distally deeper into the housing 27, 28. At the end of the second step, the button 22 can be used. This advantageous feature decreases the risk of an activation of the medicament delivery device in case of a drop. Then, to allow the medicament to be expelled, the drive spring 25 needs to unload. Indeed, while the energy of the drive spring is released, the drive spring 25 acts on the plunger rod 22 and moves the plunger rod 22 in the proximal direction relative to the housing 27, 28. To this end, the button 22 further comprises two arms 222 extending proximally from the shell 221, parallel to each other. Each arm 222 comprises, at its proximal end, a knob 222a. Each knob 222a is configured to cooperate with one of the levers 242 of the plunger rod 24. More precisely, the knob 222a is configured to contact a bottom surface 242b of the lever 242, as illustrated on Fig. 5A. When the button 22 is pressed, the arms 222 of the button 22 move proximally. Consequently, the knobs 222a slide proximally along the bottom surfaces 242b of the levers 242, which rotates the levers 242 around their distal ends 242c and lifts the levers 242 out of their seats 133a, as illustrated on Fig. 5B. Once the levers 242 are out of their seats 133a, the plunger rod 24 is free to move proximally.

[0064] The proximal course of the plunger rod 24 is stopped when a proximally facing surface of a radial protrusion 243 on the plunger rod 24 contacts a distally-facing surface of a support rib 272 extending radially inwards from an inner surface of the top housing part 27. This situation is represented on Fig. 6.

[0065] The medicament delivery device 1 described hereabove is loadable with a cassette 10 containing a syringe 14, the used cassette is removeable after injection, and the syringe in the cassette is replaceable in a simple manner. More particularly, after the cassette 10 is removed from the power pack 20, the proximal cap 12 can be separated from the rest of the cassette 10 to replace the syringe. For that purpose, in the second position of the proximal cap 12, the reattachment hooks 135a on the flexible members 135 of the case 132 of the syringe holder 13 are lightly connected and easy to disassemble from the through-openings 121a on the wings 121 of the proximal cap 12. Then, after new syringe is added, the proximal cap 12 is rotated back 90 degrees into the first position and remounted. The medicament delivery device 1 is thereby reusable. The inventive concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.

[0066] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0067] 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.

[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-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. 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.

[0071] 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.

[0072] 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. Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mF0LF0X6, mFOLFOXy, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini- CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC- EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP,

[0076] 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.

Claims

CLAIMS1. Medicament delivery device (1) extending generally along a longitudinal axis (L), and having a proximal end configured to point towards a dose delivery site and a distal end configured to point away from the dose delivery site, the medicament delivery device (1) comprising:- a cassette (io) comprising a syringe holder (13) for holding a syringe (14)- a power pack (20) comprising• a drive spring (25)• a plunger rod (24) to expel medicament from the syringe (24) when driven proximally by the drive spring (25)- a distal button (22) wherein the syringe holder (13) comprises a least a leg (133) extending distally and having, at its distal end, a seat (133a) for a proximal part (242a) of a lever (242) of the plunger rod (24) such that when the proximal part (242a) is received in the seat (133a), the plunger rod (24) cannot move proximally relative to the syringe holder (13), wherein the button (22) comprises at least an arm (222) extending proximally and having, at its proximal end, a knob (222a) configured such that a proximal movement of the button (22) brings the knob (222a) into contact with a bottom surface (242b) of the lever (242), thereby lifting the proximal part (242a) of the lever (242) out of the seat (133a).

2. Medicament delivery device (1) according to claim 1, wherein the lever (242) is configured to rotate around its distal end (242c).

3. Medicament delivery device (1) according to any of the previous claims, wherein the drive spring (25) extends partially inside the plunger rod (24), a proximal end of the drive spring (25) beingconfigured to bear against a distally-facing support surface (241) of the plunger rod (24), wherein when the cassette (10) is being mounted to the power pack (20), the seat (133a) of the leg (133) reaches the proximal part (242a) of the lever (242) of the plunger rod (24), which biases the plunger rod (24) distally, thereby loading the drive spring (25).

4. Medicament delivery device (1) according to the previous claim, wherein the power pack (20) comprises a guide rod (26) comprising a flange (261) at its distal end, a distal end of the drive spring (25) being configured to bear against the flange (261).

5. Medicament delivery device (1) according to any of the previous claims, wherein the plunger rod (24) comprises a radial protrusion (243), wherein the power pack (20) comprises a top housing part (27) having a support rib (272) configured to stop a proximal course of the plunger rod (24).

6. Medicament delivery device (1) according to any of the previous claims, wherein the cassette (10) comprises a needle cover (15) configured to be arranged concentrically with and radially outside of the syringe (14) and held by the syringe holder (13), wherein the needle cover comprises at least a hook (152a) at its distal end, the hook (152a) being configured for engaging a shoulder (132c) of a case (132) of the syringe holder (13).

7. Medicament delivery device (1) according to the previous claim, wherein the needle cover (15) comprises or cooperates with a resilient element (151) configured to be compressed when the needle cover (15) is pressed against the injection site, and released when the pressure stops.

8. Medicament delivery device (1) according to claim 6 or claim 7, wherein the needle cover (15) comprises a flange at its proximal end.

9. Medicament delivery device (1) according to any of the claims 6 to 8, wherein the cassette (10) comprises a proximal cap (12), wherein in a first position of the proximal cap (12), the proximal cap (12) is attached to the case (132) of the syringe holder (13) and the case (132) is attached to a housing (27, 28) of the power pack (20).

10. Medicament delivery device (1) according to the previous claim, wherein in a second position of the proximal cap (12), the proximal cap (12) is attached to the case (132) of the syringe holder (13) and the case (132) is detached from the housing (27, 28) of the power pack (20).

11. Medicament delivery device (1) according to the previous claim, wherein the proximal cap (12) comprises at least a wing (121) having a through-opening (121a), wherein the case (132) of the syringe holder (13) comprises at least a flexible member (135) having a reattachment hook (135a), wherein in the second position, the reattachment hook (135a) is locked into the through-opening (121a), thereby securing the proximal cap (12) to the syringe holder (13).

12. Medicament delivery device (1) according to the previous claim, wherein the housing (27, 28) of the power pack (20) comprises at least a through-hole (270), wherein the flexible member (135) has an attachment hook (135b), wherein in the first position, the attachment hook (135b) is locked into the through-hole (270), thereby securing the case (132) to the housing (27, 28), and wherein in the second position, the wing (121) biases the flexible member (135) radially, thereby detaching the case (132) from the housing (27, 28).13- Medicament delivery device (1) according to any of claims 10 to 12, wherein in the second position, the proximal cap (12) has been rotated of 90° around the longitudinal axis (L).

14. Medicament delivery device (1) according to any of the previous claims, wherein the power pack (20) comprises a button spring (23) arranged at least partly within a shell (221) of the button (22), the button spring (23) biasing distally the button (23).

15. Medicament delivery device (1) according to any of the previous claims, wherein the syringe holder (13) comprises an inner support flange (132b) configured to mate a flange (144) of the syringe (14).

Images