Auto injector

Abstract

The invention provides an auto injector, comprising a power unit (2) having a plunger rod (13); a drug cassette (3) for accommodating a medicament container (10); a mechanical connection mechanism (20, 60) for releasable connection of the drug cassette (3) with the power unit (2); a locking mechanism (22, 30, 40) for locking the connection of the drug cassette (3) with the power unit (2); and an activating mechanism capable of releasing the locking mechanism (22, 30, 40) when plunger rod retraction is completed.

Description

[0001] Auto injector

[0002] TECHNICAL FIELD

[0003] The present disclosure relates to an auto injector, in particular to an auto injector for administering a medicament.

[0004] BACKGROUND

[0005] Reusable auto injectors are known in the field, of a type having a plunger rod that retracts after drug delivery and thus releases the force applied to a piston in a drug container, and having a drug cassette containing the drug container removably attached to a power unit in which the plunger rod is mounted. The user interface of the auto injector can be programmed to instruct the user to lift the auto injector from the injection site when the plunger rod reaches an end dose position. However, the plunger rod still needs time to return to its initial position, and if the user removes the drug cassette from the power unit before plunger rod retraction is complete, the (still) exposed plunger rod might be damaged. This may affect the functionality of a motor of the power unit.

[0006] SUMMARY

[0007] Thus, an object underlying the present invention is to provide an auto injector that may prevent separation of the drug cassette and the power unit of the auto injector prior to complete plunger rod retraction, and reduce the likelihood of damage to the plunger rod. This object is achieved with an auto injector according to independent claim 1. Preferred aspects are defined in the dependent claims.

[0008] The invention provided an auto injector, comprising a power unit having a plunger rod; a drug cassette for accommodating a medicament container for containing a medicament, from which medicament container the medicament is deliverable under a force applied by the plunger rod; a mechanical connection mechanism for releasable connection of the drug cassette with the power unit; a locking mechanism for locking the connection of the drug cassette with the power unit; and an activating mechanism capable of releasing the locking mechanism when plunger rod retraction is completed. The locking mechanism may comprise a latch member.

[0009] The power unit may comprise a power unit proximal plate having a proximal plate recess.

[0010] The proximal plate recess is sized and shaped to moveably accommodate therein the latch member.

[0011] The drug cassette may have a rear cap, and the rear cap may comprise a rear cap distal plate. The rear cap distal plate may comprise a rear cap recess to axially moveably accommodate therein the latch member. The latch member and the rear cap recess may provide a key lock mechanism.

[0012] The latch member may be biased into the rear cap recess by a latch spring.

[0013] The latch member may be operatively engageable by the plunger rod.

[0014] The latch member may comprise an axial through hole accommodating the plunger rod therein.

[0015] The latch member and the plunger rod may comprise corresponding engaging elements. The corresponding engaging elements may provide for an engagement during plunger rod retraction. The engagement is configured to displace the latch member against the bias force of the latch spring and out of engagement with the rear cap recess.

[0016] The latch member may comprise an inner flange provided in or at the through hole.

[0017] The plunger rod may have a stepped structure providing a radial step. The activating mechanism may be provided by the stepped structure of the plunger rod and the inner flange.

[0018] The plunger rod may comprise a plunger rod adapter providing the stepped structure and being located proximally relative to the inner flange. The mechanical connection mechanism may be formed by a drug cassette connection part and a mating connection part at the power unit. The mechanical connection mechanism may be a bayonet-type connection mechanism.

[0019] The latch member may have a main body and at least one rib extending radially and axially therefrom. A groove may be formed between the latch member main body and each of the at least one rib. The groove may be configured to accommodate therein the proximal end of the latch spring.

[0020] The latch member may comprise an outer flange. The outer flange may abut against the rear cap distal plate when plunger rod retraction is complete.

[0021] The axial ribs may be radially spaced from the latch member main body so that a respective groove is formed between the outer surface of the latch member main body and the radially inner surface of the axial ribs. These grooves may be provided to accommodate the latch spring between the axial ribs and the latch member main body. The proximal side of the latch spring may abut against the distal surface of the outer flange.

[0022] In order to prevent that the user releases the drug cassette from the power unit before the plunger rod is fully retracted, the locking mechanism may be provided for locking the connection of the drug cassette with the power unit. The locking mechanism may be formed by the rear cap recess, the latch member, and the latch spring.

[0023] The latch member may be accommodated in the proximal plate recess of the power unit. Due to the latch spring, the latch member may be biased in proximal direction, and may specifically be biased into the rear cap recess of the rear cap distal plate.

[0024] The latch member may be sized and shaped such that it is accommodated in the proximal plate recess and at the same time (in its locking state) accommodated in the rear cap recess. The axial rib / axial ribs is / are sized and shaped that in the locking state of the latch member the axial rib(s) may engage(s) at the same time the proximal plate recess and the rear cap recess so that a rotation of the drug cassette relative to the power unit is prevented.

[0025] In the present disclosure, when the term "distal direction" is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term "distal part / end" is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which under use of the medicament delivery device is / are located furthest away from the dose delivery site. Correspondingly, when the term "proximal direction" is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device. When the term "proximal part / end" is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which under use of the medicament delivery device is / are located closest to the dose delivery site.

[0026] Further, the term "longitudinal", "longitudinally", "axially" or "axial" refer to a direction extending from the proximal end to the distal end, typically along the device or components thereof in the direction of the longest extension of the device and / or component.

[0027] Similarly, the terms "transverse", "transversal" and "transversally" refer to a direction generally perpendicular to the longitudinal direction.

[0028] Further, the terms "circumference", "circumferential", or "circumferentially" refer to a circumference or a circumferential direction relative to an axis, typically a central axis extending in the direction of the longest extension of the device and / or component. Similarly, "radial" or "radially" refer to a direction extending radially relative to the axis, and "rotation", "rotational" and "rotationally" refer to rotation relative to the axis.

[0029] BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which: Fig. 1 shows a perspective view of an autoinjector according to an embodiment of the present invention;

[0031] Fig. 2 shows a perspective view of a part of the internal structure of the autoinjector according to an embodiment of the present invention with some components omitted;

[0032] Fig. 3 shows a perspective view of the interface components of the power unit and the drug cassette of the autoinjector according to an embodiment of the present invention;

[0033] Fig. 4 shows a detailed perspective view of the interface components of the power unit and the drug cassette of the autoinjector according to an embodiment of the present invention;

[0034] Fig. 5 shows components of the power unit and the drug cassette of the autoinjector being separated from each other;

[0035] Fig. 6 shows a perspective view of a distal part of the drug cassette of the autoinjector according to an embodiment of the present invention;

[0036] Fig. 7 shows an exploded perspective view of a locking mechanism for locking the connection of the drug cassette with the power unit of the autoinjector according to an embodiment of the present invention;

[0037] Fig. 8 shows a perspective view of part of the plunger rod and the locking mechanism;

[0038] Fig. 9 shows a perspective view of a latch member of the autoinjector according to an embodiment of the present invention;

[0039] Fig. 10 shows an exploded perspective view of the mechanical connection mechanism and the locking mechanism of the autoinjector according to an embodiment of the present invention; and

[0040] Fig. 11 shows an exploded perspective view of components of the autoinjector according to an embodiment of the present invention.

[0041] DETAILED DESCRIPTION

[0042] 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.

[0043] Fig. 1 shows a perspective view of an autoinjector 1 according to an embodiment of the present invention. The autoinjector comprises a power unit 2 at the distal part thereof, and a drug cassette 3 at the proximal part thereof. The drug cassette 3 can be separated from the power unit 2 and replaced with a new drug cassette.

[0044] Fig. 2 shows a perspective view of the autoinjector 1 of Fig. 1 with some elements of the housing of the power unit 2 omitted so that the internal structure of the power unit 2 and the interface between the power unit 2 and the drug cassette 3 are visible. Fig. 2 shows a bayonet coupling feature 60 of the drug cassette 3 that is releasably couplable with a corresponding, mating, structure of the power unit 2. The invention encompasses other coupling mechanisms known to the person skilled in the art and is not limited to a bayonet coupling.

[0045] The interface between the power unit 2 and the drug cassette 3 is shown in more detail in Fig. 3, where even more components of the autoinjector 1 are omitted. Fig. 3 shows that the drug cassette 3 has a drug container 10 with an optional needle 11 attached to it. Fig. 3 also shows a rear cap 20 of the drug cassette 3. Furthermore, Fig. 3 shows the distal part of the plunger rod 13.

[0046] In Fig. 4, the container 10 with its optional needle 11 is also omitted so that a plunger rod proximal part 15 of the plunger rod 13 is visible. The plunger rod proximal part 15 acts on the piston of the container 10 when the medicament is administered. As can be seen in Fig. 4, the plunger rod 13 extends in a distal-proximal direction through the interface between the power unit 2 and the drug cassette 3, i.e., through the respective components of the power unit 2 and the drug cassette 3, and specifically extends through the rear cap 20 of the drug cassette 3 into the drug cassette 3. As shown in Figs. 5 and 6, the rear cap 20 has a rear cap distal plate 21, and a through hole 24 for the plunger rod is provided in the rear cap distal plate 21. Furthermore, the rear cap distal plate 21 comprises a rear cap recess 22, or indentation, which will be described in more detail below.

[0047] Fig. 5 also shows that the power unit 2 has a power unit proximal plate 51. The power unit proximal plate 51 faces the rear cap distal plate 21 when the drug cassette 3 is coupled to the power unit 2. However, an axial gap may be provided between the power unit proximal plate 51 and the rear cap distal plate 21, as can be seen, for example, in Fig. 4.

[0048] Fig. 5 also shows a latch member 30 that is displaceably mounted to the power unit proximal plate 51, as will be described in more detail below.

[0049] Fig. 7 shows that the power unit proximal plate 51 has a proximal plate recess 52. Fig. 7 also shows latch member 30. As can be seen in Fig. 7, the proximal plate recess 52 is sized and shaped corresponding to the size and shape of the latch member 30 so that the latch member 30 can be accommodated in the proximal plate recess 52 to assume a configuration as shown in Fig. 5. Fig. 7 also shows a plunger rod adapter 14, which will be described in more detail below. Fig. 7 also shows that latch member 30 has a through hole 33.

[0050] Fig. 8 illustrates how the plunger rod proximal part 15 is located proximally to the latch member 30. Fig. 8 also shows a latch spring 40.

[0051] Details of the latch member 30 can be seen in Fig. 9. Latch member 30 has at least one rib 31. In the embodiment shown in Fig. 9, two ribs 31 are shown which are arranged opposite to each other with respect to the longitudinal axis of the auto injector, e.g. on either side of the axis or spaced 180° from one another circumferentially. In another embodiment, there may be just one rib and in yet another embodiment there may be two or more ribs. In this latter case, the ribs may be spaced equidistantly around the axis. The at least one rib 31 extends radially from the latch member main body 36, and the rib 31 also extends axially parallel to the longitudinal axis of the auto injector 1. The latch member 30 has a through hole 33, and in Fig. 9 an inner flange 34 can be seen which is arranged in the through hole 33. The inner flange 34 can be a circumferential flange, i.e. in annular form. However, the invention also encompasses that the through hole 33 of the latch member 30 has one or more protrusions extending radially inwards. The flange 34 or one or more protrusions provide an abutment surface for the plunger rod adapter 14, as will be described in more detail below. Furthermore, Fig. 9 shows that the latch member main body 36 comprises an outer flange 35 that is, preferably, also of annular shape.

[0052] Fig. 10 shows the plunger rod proximal part 15, the latch member 30 with its two axial ribs

[0053] 31 and the latch spring 40 in relation to the rear cap 20. When the drug cassette 3 is mounted to the power unit 2, the drug cassette 3 and the power unit 2 are moved by the user towards each other, and during this movement the plunger rod proximal part 15 is moved through the through hole 24 of the rear cap 20.

[0054] Fig. 11 is an exploded view showing the plunger rod proximal part 15, the plunger rod adapter 14, the latch member 30 and the latch spring 40. As can be seen in Fig. 11, the axial ribs 31 are radially spaced from the latch member main body 36 so that a respective groove

[0055] 32 is formed between the outer surface of the latch member main body 36 and the radially inner surface of the axial ribs 31. These grooves 32 are provided to accommodate the latch spring 40 between the axial ribs 31 and the latch member main body 36. The proximal side of the latch spring 40 abuts against the distal surface of the outer flange 35 (see Fig. 10).

[0056] As described above, the drug cassette and the power unit can be releasably connected to each other by means of a bayonet connection, for example. The bayonet connection can be released by the user in order to remove the drug cassette 3 from the power unit 2, and in order to connect a fresh drug cassette 3 to the power unit 2 for the next use of the autoinjector. In order to prevent the user from releasing the drug cassette 3 from the power unit 2 before the plunger rod 13 is fully retracted, a locking mechanism is provided for locking the connection of the drug cassette 3 with the power unit 2. The locking mechanism is formed by the rear cap recess 22, the latch member 30, and the latch spring 40. As has been explained above, the latch member 30 is accommodated in the proximal plate recess 52 of the power unit. However, due to the latch spring 40, the latch member 30 is biased in proximal direction, and is specifically biased into the rear cap recess 22 of the rear cap distal plate 21. The latch member 30 is sized and shaped such that it is accommodated in the proximal plate recess 52 and at the same time (in its locking state) accommodated in the rear cap recess 22. The axial rib(s) 31 is / are sized and shaped such that in the locking state of the latch member 30 the axial rib(s) 31 engage(s) at the same time the proximal plate recess 52 and the rear cap recess 22 so that a rotation of the drug cassette 3 relative to the power unit 2 is prevented. Thus, the latch member 30 and the rear cap recess 22 provide a key lock mechanism.

[0057] The latch member 30 is operatively engageable by the plunger rod 13. As has been described above, the latch member 30 comprises an axial through hole 33 accommodating the plunger rod 13 therein, in particular the plunger rod adapter 14. The plunger rod 13 with its plunger rod adapter 14 and the inner flange 34 of the latch member 30 provide an activating mechanism that is capable of releasing the locking mechanism when the plunger rod retraction is completed, or at the time the drug cassette 3 is coupled to the power unit 2. In particular, the plunger rod adapter 14 and the inner flange 34 (or one or more protrusions, as described above) form corresponding engaging elements that provide for an engagement of the plunger rod 13 with the latch member 30 during plunger rod retraction. This engagement is configured to displace the latch member 30 against the bias force of the latch spring 40 and out of engagement with the rear cap recess 22. In other words, during plunger rod retraction, the plunger rod draws the latch member 30 back into the proximal plate recess 52. In comprising the plunger rod adapter 14, the plunger rod 13 has a stepped structure providing a radial step. Due to this stepped structure of the plunger rod 13, the plunger rod adapter 14 - during plunger rod retraction - contacts or abuts at the inner flange 34. Thus, plunger rod retraction causes the latch member 30 to withdraw from the engagement with the rear cap recess 22 and to be displaced or moved into the proximal plate recess 52 to assume a state that is shown in Fig. 5.

[0058] Thus, according to the present invention, the latch member 30 and thus the power unit 2 are always in engagement with the drug cassette 3, i.e. the rear cap distal plate 21, during administration of the medicament and until plunger rod retraction is complete. Thus, inadvertent release of the drug cassette 3 from the power unit 2 is prevented. This engagement between the latch member 30 and the rear cap 20 is controlled by the position of the plunger rod 13. When the plunger rod 13 is at its initial retracted position, or when the plunger rod 13 is in its retracted position after injection, the plunger rod 13 holds or pulls the latch member 30 back into the power unit 2 so that it is no longer in engagement with the rear cap 20 of the drug cassette 3. On the other hand, during the injection process, the plunger rod 13 is moved forward (and the plunger rod proximal part 15 pushes on the piston of the container 10). Due to the bias force provided by the latch spring 40, the latch member 30 is moved from its initial position in proximal direction so that it engages with the rear cap recess 22 of the rear cap 20. The axial ribs 31 of the latch member 30 constrain rotational motion of the drug cassette 3 relative to the power unit 2 should the user make an attempt to decouple the drug cassette 3 from the power unit 2.

[0059] The on-body injection devices / medicament delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders. Exemplary disorders include, but are not limited rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), hypercholesterolaemia and / or dyslipidemia, cardiovascular disease, diabetes (e.g. type 1 or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behcet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycaemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, Factor V Leiden), and cancer. 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.

[0060] 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.

[0061] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-1 (GLP-1) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Cl esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene- related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor-associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-1 / PD-L1) inhibitors / modulators, B-lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, B-lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (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 wl37 (CDwl37) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD159 or NKG2) modulators, glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig- like receptor (KIR) modulators, growth 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 wl23 (CDwl23) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumor-infiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.

[0062] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-la, interferon beta-lb, peginterferon beta-la, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins.

[0063] 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.

[0064] 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.

[0065] Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine. Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer's solution, Heparin Lock Flush solution, 100 U / mL Heparin Lock Flush Solution, or 5000 U / mL Heparin Lock Flush Solution.

[0066] 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 coformulated dispersion enhancers (e.g. an animal-derived, human-derived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.

[0067] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C- MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE. The invention is further defined by the following clauses:

[0068] 1. An auto injector, comprising a power unit having a plunger rod; a drug cassette for accommodating a medicament container for containing a medicament, from which medicament container the medicament is deliverable under a force applied by the plunger rod; a mechanical connection mechanism for releasable connection of the drug cassette with the power unit; a locking mechanism for locking the connection of the drug cassette with the power unit; and an activating mechanism capable of releasing the locking mechanism when plunger rod retraction is completed.

[0069] 2. The auto injector of clause 1, wherein locking mechanism comprises a latch member.

[0070] 3. The auto injector of clause 2, wherein the power unit comprises a power unit proximal plate having a proximal plate recess.

[0071] 4. The auto injector of clause 3, wherein the proximal plate recess is sized and shaped to moveably accommodate therein the latch member.

[0072] 5. The auto injector of and one of clauses 2 to 4, wherein the drug cassette has a rear cap, and the rear cap comprises a rear cap distal plate.

[0073] 6. The auto injector of clause 5, wherein the rear cap distal plate comprises a rear cap recess to axially moveably accommodate therein the latch member.

[0074] 7. The auto injector of clause 6, wherein the latch member and the rear cap recess provide a key lock mechanism.

[0075] 8. The auto injector of any one of clauses 2 to 7, wherein the latch member is biased into the rear cap recess by a latch spring. 9. The auto injector of any one of clauses 2 to 8, wherein the latch member operatively engageable by the plunger rod.

[0076] 10. The auto injector of clause 9, wherein the latch member comprises an axial through hole accommodating the plunger rod therein.

[0077] 11. The auto injector of clause 10, wherein the latch member and the plunger rod comprise corresponding engaging elements.

[0078] 12. The auto injector of clause 11, wherein the corresponding engaging elements provide for an engagement during plunger rod retraction.

[0079] 13. The auto injector of clause 12, wherein the engagement is configured to displace the latch member against the bias force of the latch spring and out of engagement with the rear cap recess.

[0080] 14. The auto injector of clause any one of clauses 10 to 13, wherein the latch member comprises an inner flange provided in or at the through hole.

[0081] 15. The auto injector of clause 14, wherein the plunger rod has a stepped structure providing a radial step.

[0082] 16. The auto injector of clause 15, wherein the activating mechanism is provided by the stepped structure of the plunger rod and the inner flange.

[0083] 17. The auto injector of clause 16, wherein the plunger rod comprises a plunger rod adapter providing the stepped structure and being located proximally relative to the inner flange.

[0084] 18. The auto injector of any one of clauses 1 to 17, wherein the mechanical connection mechanism is formed by a drug cassette connection part and a mating connection part at the power unit. 19. The auto injector of clause 18, wherein the mechanical connection mechanism is a bayonet-type connection mechanism.

[0085] 20. The auto injector of any one of clauses 8 to 19, wherein the latch member has a main body and at least one rib extending radially and axially therefrom.

[0086] 21. The auto injector of clause 20, wherein a groove is formed between the latch member main body and each of the at least one rib. 22. The auto injector of clause 21, wherein the groove is configured to accommodate therein the proximal end of the latch spring.

[0087] 23. The auto injector of any one of clauses 5 to 22, wherein the latch member comprises an outer flange.

[0088] 24. The auto injector of clause 23, wherein the outer flange abuts against the rear cap distal plate when plunger rod retraction is complete.

Claims

Claims1. An auto injector, comprising a power unit (2) having a plunger rod (13); a drug cassette (3) for accommodating a medicament container (10) for containing a medicament, from which medicament container (10) the medicament is deliverable under a force applied by the plunger rod (13); a mechanical connection mechanism (20, 60) for releasable connection of the drug cassette (3) with the power unit (2); a locking mechanism for locking the connection of the drug cassette (3) with the power unit (2); and an activating mechanism capable of releasing the locking mechanism when plunger rod retraction is completed.

2. The auto injector of claim 1, wherein locking mechanism comprises a latch member (30).

3. The auto injector of claim 2, wherein the power unit (2) comprises a power unit proximal plate (51) having a proximal plate recess (52).

4. The auto injector of claim 3, wherein the proximal plate recess (52) is sized and shaped to moveably accommodate therein the latch member (30).

5. The auto injector of and one of claims 2 to 4, wherein the drug cassette (3) has a rear cap (20), and the rear cap (20) comprises a rear cap distal plate (21).

6. The auto injector of claim 5, wherein the rear cap distal plate (21) comprises a rear cap recess (22) to axially moveably accommodate therein the latch member (30).

7. The auto injector of claim 6, wherein the latch member (30) and the rear cap recess (22) provide a key lock mechanism.

8. The auto injector of claims 6 or 7, wherein the latch member (30) is biased into the rear cap recess (22) by a latch spring (40).

9. The auto injector of any one of claims 6 to 8, wherein the latch member (30) operatively engageable by the plunger rod (13).

10. The auto injector of claim 9, wherein the latch member (30) comprises an axial through hole (33) accommodating the plunger rod (13) therein.

11. The auto injector of claim 10, wherein the latch member (30) and the plunger rod (13) comprise corresponding engaging elements.

12. The auto injector of claim 11, wherein the corresponding engaging elements provide for an engagement during plunger rod retraction.

13. The auto injector of claim 12, wherein the engagement is configured to displace the latch member (30) against the bias force of the latch spring (40) and out of engagement with the rear cap recess (22).

14. The auto injector of claim any one of claims 10 to 13, wherein the latch member (30) comprises an inner flange (34) provided in or at the through hole (33).

15. The auto injector of any one of claims 1 to 14, wherein the mechanical connection mechanism (60) is formed by a drug cassette connection part (60) and a mating connection part at the power unit (2).

Images