WO2026008320A1 - Drive assembly for a medicament delivery device - Google Patents

Abstract

Drive assembly comprising a body (10); a button (20); a plunger rod (30); a driver (40) capable of driving the plunger rod (30); a drive spring (50) for driving the driver (40); and a spring locking element (60); wherein the driver (40) comprises a first locking structure (42) capable of locking said driver (40) to the button (20) in an actuated state; wherein the button (20) comprises a second locking structure (21) for releasably locking said first locking structure (42), and an activating structure (23) capable of releasing the first locking structure (42) of the driver (40) from the second locking structure (21) for driving the driver (40) and the plunger rod (30); wherein the body (10) comprises a first engagement structure (13) and the button (20) comprises a second engagement structure (22) being engageable with the first engagement structure (13) such that a manual rotational operation of the button (20) results in a displacement of the button (20) and re-engagement of first locking structure (42) and of the second locking structure (21).

Description

Drive assembly for a medicament delivery device

TECHNICAL FIELD

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

BACKGROUND

US 8 376 993 B2 discloses a multiple dosage injector. Some known medicament delivery devices have a medicament container, and a drive assembly having a power reservoir for expelling the medicament from the medicament container. The power reservoir may also be used to drive components of the medicament delivery device during medicament delivery. Typically, such drive assembly is connected to the housing. It would be desirable to have a drive assembly that can be disengaged from the housing after medicament delivery and attached to another container housing for administering another dose of medicament.

SUMMARY

The aim of the present invention is to remedy the drawbacks of the state of the art devices.

According to a first aspect, the invention provides a drive assembly for a medicament delivery device, the drive assembly comprising: a body having a proximal end and a distal end; a button; a plunger rod defining a longitudinal axis of the drive assembly; a driver capable of, upon activation, driving the plunger rod in proximal direction; a drive spring for driving the driver; and a spring locking element; wherein the driver comprises a first locking structure capable of locking said driver to the button in an actuated state; wherein the button comprises a second locking structure for releasably locking said first locking structure, and an activating structure capable of, upon manual proximally directed operation, releasing the first locking structure of the driver from the second locking structure for driving the driver and the plunger rod; wherein the body comprises a first engagement structure and the button comprises a second engagement structure being engageable with the first engagement structure such that a manual rotational operation of the button results in a distally directed displacement of the button and re-engagement of first locking structure of the driver and of the second locking structure of the button.

The first engagement structure may be at the distal end of the body.

The second engagement structure may be at the proximal end of a distal crown of the button.

At least one of the first engagement structure and the second engagement structure may be of wave of cam shape.

The rotational operation of the button may cause re-charging of the drive assembly.

Re-charging of the drive assembly may be by the re-engagement of first locking structure of the driver and of the second locking structure of the button.

Upon manual proximally directed operation of the button the first engagement structure and the second engagement structure may be brought into engagement.

The activating structure may be disposed distal to the second engagement structure.

The first engagement structure and the second engagement structure may provide a cog interface rotationally locking the driver to the button.

The first engagement structure may have a polygonal cross section transverse to the longitudinal axis.

The second engagement structure may have a mating a polygonal cross section transverse to the longitudinal axis. The manual rotational operation of the button may be a clockwise operation.

The plunger rod may be rotationally locked by the body.

The body may comprise an inner locking structure.

The inner locking structure may be adapted to rotationally lock the plunger rod.

The inner locking structure may be formed by at least one rib or wall.

The at least one rib or wall may extend transverse to the longitudinal axis of the plunger rod.

The plunger rod may comprise a groove section.

The groove section may extend along the longitudinal axis of the plunger rod.

The groove section may be in engagement with the inner locking structure.

The inner locking structure may extend radially.

The plunger rod may be arranged coaxially within the driver.

The driver may be axially fixed.

The driver with its proximal end may abut against a distal end of the inner locking structure.

The plunger rod may comprise an external thread structure.

The driver may comprise a rib or protrusion.

The rib or protrusion may engage the external thread of the plunger rod. The external thread structure may be formed as a helical groove.

The helical groove may have a constant pitch. The helical groove may have a non-constant pitch. The pitch may be gradually increasing in proximal-distal direction of the plunger rod.

The driver may comprise a connection structure for connecting the proximal end of the drive spring to the driver.

The spring locking element may comprise a connection structure for connecting the distal end of the drive spring to the spring locking element.

The spring locking element may be rotatably fixed in the body.

The spring locking element may be axially fixed in the body.

The drive spring may be a torsion spring.

Preferably, the drive assembly further comprise a brake assembly. More preferably, the brake assembly is for preventing counter-clockwise operation of the button.

The brake assembly may comprise a ratchet member.

The ratchet member may be provided at the button.

A plurality of external teeth may be provided at the body engaging said ratchet member.

The external teeth may extend axially.

The ratchet member may extend axially. Stopping surfaces of the external teeth of the body may engage stopping surfaces of teeth of the ratchet member to prevent the button from rotating with respect to the body in counter-clockwise direction.

The body may comprise a releasable locking structure at its proximal end for engagement with a medicament container of a medicament delivery device.

In the present disclosure, when the term "distal direction" is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term "distal part/end" is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which 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.

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

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

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.

BRIEF DESCRIPTION OF THE DRAWINGS 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 the drive assembly for a medicament delivery device according to the present invention;

Fig. 2 shows an exploded perspective view of the drive assembly for a medicament delivery device according to the present invention;

Fig. 3 shows a different exploded perspective view of the drive assembly for a medicament delivery device according to the present invention;

Fig. 4 shows a perspective view of the body of the drive assembly for a medicament delivery device according to the present invention;

Fig. 5 shows a partly broken-away perspective view of the drive assembly for a medicament delivery device according to the present invention prior to use;

Fig. 6 shows a partly broken-away perspective view of the drive assembly for a medicament delivery device according to the present invention in a delivery state;

Fig. 7 shows a partly broken-away perspective view of the drive assembly for a medicament delivery device according to the present invention in a re-charging state;

Fig. 8 shows a partly broken-away perspective view of a part of the drive assembly for a medicament delivery device according to the present invention;

Fig. 9 shows a further partly broken-away perspective view of a part of the drive assembly for a medicament delivery device according to the present invention; and

Fig. 10 shows a partly broken-away perspective view of the brake assembly of the drive assembly for a medicament delivery device according to the present invention.

DETAILED DESCRIPTION

Fig. 1 shows a perspective view of the drive assembly for a medicament delivery device according to the first embodiment of the present invention. The drive assembly comprises a body 10 that has a proximal end 11 and a distal end 12. The drive assembly also comprises a button 20. The body 10 comprises a first engagement structure 13 at the distal end of the body 10. Furthermore, the button 20 has a second engagement structure 22 at the proximal end of a distal crown of the button 20. The first engagement structure 13 and the second engagement structure 22 are engageable with each other. It is illustrated in Fig. 1 that the button 20 is rotatable. Such manual rotational operation of the button results - in addition to the rotation - in a distally directed displacement of the button 20. At least one of the first engagement structure 13 and the second engagement structure 22 is of a wave or a cam shape, which is also illustrated in Fig. 1. In Fig. 1, the first engagement structure 13 and the second engagement structure 22 are not yet engaged. Rather, the proximal edge of the crown is spaced from a distally directed edge of the body 10 by a gap 18. The button 20 is axially movable in proximal direction towards the body 10, which closes the gap 18 and brings the first engagement structure 13 and the second engagement structure 22 into engagement.

At or adjacent the proximal end 11 of the body 10, the body 10 comprises an engagement structure 14 for engaging the body 10 of the drive assembly with a medicament container or medicament cassette of a medicament delivery device. It is preferred that this engagement structure is a releasable locking structure 14 for engagement with the medicament container. Thus, the drive assembly can be releasably connected with and disconnected from the medicament container of a medicament delivery device.

Fig. 2 shows a perspective exploded view of the components of the drive assembly of this embodiment of the present invention. In addition to the body 10 and the button 20, Fig. 2 shows a plunger rod 30 that also defines a longitudinal axis of the drive assembly. Fig. 2 also shows a driver 40 that is capable of, upon activation, driving the plunger rod 30 in proximal direction. The driver 40 is drivable by a drive spring 50. Furthermore, Fig. 2 shows a spring locking element 60.

It can be seen in Fig. 2 and Fig. 3 that the driver 40 comprises a first locking structure 42 that is capable of locking the driver 40 to the button 20 in a compressed or actuated state of the drive assembly. In turn, the button 20 comprises a second locking structure 21 for releasably locking the first locking structure 42 of the driver 40 to the button 20. The button 20 also comprises an activating structure 23 (not shown in Fig. 2 but in Fig. 7) that is capable of, upon manually proximally directed operation of the button 20, releasing the first locking structure 42 of the driver 40 from the second locking structure 21 so that the driver 40 can rotate by means of the drive spring 50. Once the first locking structure 42 of the driver 40 is released from the second locking structure 21 of the button 20, the driver 40 and thus the plunger rod 30 are driven. The activating structure 23 is disposed distal to the second locking structure 21 of the button 20. The activating structure is, for example, an area having a cross section or diameter larger than that of the second locking structure 21 so that the first locking structure 42 is no longer locked but the driver 40 can freely rotate. Fig. 6 shows the driver 40 in this position.

The first locking structure 42 and the second locking structure 21 provide a cog interface rotationally locking the driver 40 to the button 20. The first locking structure 42 may have a polygonal cross-section transverse to the longitudinal axis. Furthermore, the second locking structure 21 may have a mating polygonal cross-section transverse to the longitudinal axis. It can be seen in Fig. 2 that the polygonal cross-sectional shape of the first locking structure 42 of the driver 40 has a proximally directed curvature 44 or somewhat rounded shape, which facilitates re-insertion of the first locking structure 42 into the second locking structure 21 of the button 20 when the button 20 moves distally to the driver 40.

The plunger rod 30 of the drive assembly of this embodiment is rotationally locked by the body 10 (this is shown in Fig. 9). Therefore, the body 10 comprises an inner locking structure 16 that is adapted to rotationally lock the plunger rod 30. The inner locking structure 16 is, e.g., formed by at least one rib or wall extending transverse to the longitudinal axis of the plunger rod 30. This can also be seen in Fig 5. The plunger rod 30 comprises a groove section 31 (also shown in Fig.3) that extends along the longitudinal axis of the plunger rod 30. This groove section 31 is in engagement with the inner locking structure 16 of the body 10. A protrusion 17 of the inner locking structure 16 extends radially inwards in order to engage into the groove section 31 of the plunger rod 30. This can be seen in detail in Fig. 9.

The plunger rod 30 is arranged coaxially within the driver 40. The driver 40 is axially fixed relative to the body. Rotation of the driver 40 results in an axial movement of the plunger rod 30. The transmission of the rotational movement of the driver 40 into an axial movement of the plunger rod 30 is caused by an engagement of an external thread structure 32 of the plunger rod 30 and a rib or protrusion 45 (see Fig. 8) of the driver 40 engaging the external thread structure 32 of the plunger rod 30. Furthermore, the driver 40 with its proximal end 43 abuts against a distal end of the inner locking structure 16 of the body 10. This can also be seen in Fig. 5. The external thread structure 32 of the plunger rod 30 may be formed as a helical groove. The helical groove may have a constant pitch, as shown in Fig. 2, for example. However, the helical groove may also have, in an alternative embodiment, a non-constant pitch. The non-constant pitch may be gradually increasing in proximal-distal direction of the plunger rod 30.

In order to be driven by the drive spring 50, the driver 40 comprises a connection structure 41 (see Fig. 3) for connecting the proximal end 51 of the drive spring 50 to the driver 40. Furthermore, the spring locking element 60 comprises a connection structure 61 for connecting the distal end 52 of the drive spring 50 to the spring locking element 60. The connection structure 61 may be an axially extending groove for receiving the distal end 52 of the drive spring 50.

The spring locking element 60 is rotatably fixed to the body 10. This is achieved with slots 62 (see Fig. 3) engaging corresponding protrusions (not shown) in the body 10. Furthermore, the spring locking element 60 is axially fixed to the body 10.

In the illustrated example, the drive spring 50 is a torsion spring.

The drive assembly according to the illustrated embodiment also comprises a brake assembly for preventing, e.g., counter-clockwise operation of the button 20 (assuming that the manual rotation operation of the button 20 is a clockwise operation. (Needless to say that these two rotational directions may be reversed). The brake assembly comprises a ratchet member 24 (see Fig. 10) that is provided at the button 20. Furthermore, the brake assembly comprises a plurality of external teeth 15 that are provided at the body 10 (see Fig. 4). The external teeth 15 engage the ratchet member 24 of the button 20. As can be seen in, e.g., Fig. 4, the external teeth 15 of the body 10 extend axially at the inside of the body 10. Furthermore, the ratchet member 24 of the button 20 extends axially, as can be seen in Fig. 10. It can also be seen in Fig. 10 that stopping surfaces 15s of the external teeth 15 of the body 10 engage stopping surfaces 25s of the teeth 25 of the ratchet member 24. This prevents the button 20 from rotating with respect to the body 10 in counter-clockwise direction. Thus, operation of the drive assembly of this embodiment is as follows. In order to initiate delivery of a medicament from a medicament container of a medicament delivery device attached to the drive assembly, the user moves or pushes the button 20 from its initial position as shown in Fig. 5 proximally, i.e., towards the delivery site. At the external surface of the drive assembly, the previously mentioned gap 18 between the button 20 and the body 10 is closed (see in Fig. 6) so that the first engagement structure 13 and the second engagement structure 22 enter into engagement with each other. At the same time, the second locking structure 21 of the button 20 is moved axially in proximal direction relative to the first locking structure 42 of the driver 40. Thus, the button 20 is moved out of engagement with the driver 40. This results in a rotation of the driver 40 caused by the drive spring 50. The driver 40 is now free to rotate because its first locking structure 42 is now in radial alignment with the activating structure 23 of the button 20. Rotation of the driver 40 causes axial movement of the plunger rod 30, as discussed above.

Upon completion of the medicament delivery, the user manually rotates the button 20, for example in clockwise direction (as indicated by the arrow in the figures). This rotation of the button 20 causes a distally directed axial displacement of the button 20 due to the engagement of the respective first and second engagement structures 13, 22. This axial movement of the button 20 brings its second locking structure 21 into re-engagement with the first locking structure 42 of the driver 40. Thus, the rotation of button 20 results in a rotation of the driver 40 in a direction opposite to the driving direction for advancing the plunger rod 30. Movement of the driver 40 in this opposite direction causes retraction of the plunger rod 30 into the drive assembly. At the same time, the drive spring 50 is again loaded. The brake assembly between the body 10 and the button 20 prevents an inadvertent rotational movement of the button 20 in counter-clockwise direction because the brake assembly, i.e. the engagement of the teeth 15 of the body 10 and the ratchet member 24 of the button 20, allows only a uni-directional movement of the button 20 relative to the body 10. Once the plunger rod 30 is fully retracted and the spring 50 fully loaded, the drive assembly can be removed from the medicament delivery device and can be attached to another medicament delivery device for further medicament delivery. The drive assembly can be disengaged from the housing after medicament delivery and attached to another container housing for administering another dose of medicament. The drive assembly described herein can be used for medicament delivery devices for the treatment and/or prophylaxis of one or more of many different types of disorders.

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

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. Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.

Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-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 arrestspecific protein 6 (GAS6)/AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation wl23 (CDwl23) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumor-infiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.

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.

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.

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. 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, 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 specified by the following items:

1. Drive assembly for a medicament delivery device, the drive assembly comprising: a body (10) having a proximal end (11) and a distal end (12); a button (20); a plunger rod (30) defining a longitudinal axis of the drive assembly; a driver (40) capable of, upon activation, driving the plunger rod (30) in proximal direction; a drive spring (50) for driving the driver (40); and a spring locking element (60); wherein the driver (40) comprises a first locking structure (42) capable of locking said driver (40) to the button (20) in a pressurised state; wherein the button (20) comprises a second locking structure (21) for releasably locking said first locking structure (42), and an activating structure (23) capable of, upon manual proximally directed operation, releasing the first locking structure (42) of the driver (40) from the second locking structure (21) for driving the driver (40) and the plunger rod (30); wherein the body (10) comprises a first engagement structure (13) and the button (20) comprises a second engagement structure (22) being engageable with the first engagement structure (13) such that a manual rotational operation of the button (20) results in a distally directed displacement of the button (20) and re-engagement of first locking structure (42) of the driver (40) and of the second locking structure (21) of the button (20).

2. The drive assembly of item 1, wherein the first engagement structure (13) is at the distal end of the body (10).

3. The drive assembly of any one of the preceding items, wherein the second engagement structure (22) is at the proximal end of a distal crown of the button (20).

4. The drive assembly of any one of the preceding items, wherein at least one of the first engagement structure (13) and the second engagement structure (22) is of wave of cam shape.

5. The drive assembly of any one of the preceding items, wherein rotational operation of the button (20) causes re-charging of the drive assembly by the re-engagement of first locking structure (42) of the driver (40) and of the second locking structure (21) of the button (20).

6. The drive assembly of any one of the preceding items, wherein upon manual proximally directed operation of the button (20) the first engagement structure (13) and the second engagement structure (22) are brought into engagement. 7. The drive assembly of any one of the preceding items, wherein the activating structure (23) is disposed distal to the second engagement structure (22).

8. The drive assembly of any one of the preceding items, wherein the first engagement structure (13) and the second engagement structure (22) provide a cog interface rotationally locking the driver (40) to the button (20).

9. The drive assembly of any one of the preceding items, wherein the first engagement structure (13) has a polygonal cross section transverse to the longitudinal axis.

10. The drive assembly of item 9, wherein the second engagement structure has a mating a polygonal cross section transverse to the longitudinal axis.

11. The drive assembly of any one of items 5 to 10, wherein the manual rotational operation of the button (20) is a clockwise operation.

12. The drive assembly of any one of the preceding items, wherein the plunger rod (30) is rotationally locked by the body (10).

13. The drive assembly of item 12, wherein the body (10) comprises an inner locking structure (16) adapted to rotationally lock the plunger rod (30).

14. The drive assembly of item 13, wherein the inner locking structure (16) is formed by at least one rib or wall extending transverse to the longitudinal axis of the plunger rod (30).

15. The drive assembly of any one of items 13 or 14, wherein the plunger rod (30) comprises a groove section (31) extending along the longitudinal axis of the plunger rod (30).

16. The drive assembly of item 15, wherein the groove section (31) is in engagement with the inner locking structure (16).

17. The drive assembly of any one of the items 13 to 16, wherein the inner locking structure (16) extends radially. 18. The drive assembly of any one of the preceding items, wherein the plunger rod (30) is arranged coaxially within the driver (40).

19. The drive assembly of any one of the preceding items, wherein the driver (40) is axially fixed.

20. The drive assembly of any one of the preceding items, insofar as dependent on item 13, wherein the driver (40) with its proximal end (43) abuts against a distal end of the inner locking structure (16).

21. The drive assembly of any one of the preceding items, wherein the plunger rod (30) comprises an external thread structure (32).

22. The drive assembly of item 21, wherein the driver (40) comprises a rib or protrusion (41) engaging the external thread structure (32) of the plunger rod (30).

23. The drive assembly of item 21 or 22, wherein the external thread structure (32) is formed as a helical groove.

24. The drive assembly of item 23, wherein the helical groove has a constant pitch.

25. The drive assembly of item 23, wherein the helical groove has a non-constant pitch.

26. The drive assembly of item 25, wherein the pitch is gradually increasing in proximal- distal direction of the plunger rod (30).

27. The drive assembly of any one of the preceding items, wherein the driver (40) comprises a connection structure (41) for connecting the proximal end (51) of the drive spring (50) to the driver (40).

28. The drive assembly of any one of the preceding items, wherein the spring locking element (60) comprises a connection structure (61) for connecting the distal end (52) of the drive spring (50) to the spring locking element (60). 29. The drive assembly of any one of the preceding items, wherein the spring locking element (60) is rotatably fixed in the body (10).

30. The drive assembly of any one of the preceding items, wherein the spring locking element (60) is axially fixed in the body (10).

31. The drive assembly of any one of the preceding items, wherein the drive spring (50) is a torsion spring.

32. The drive assembly of any one of the preceding items, further comprising a brake assembly for preventing counter-clockwise operation of the button (20).

33. The drive assembly of item 32, wherein the brake assembly comprises a ratchet member (24) provided at the button (20) and a plurality of external teeth (15) provided at the body (10) engaging said ratchet member (24).

34. The drive assembly of item 33, wherein the external teeth (15) extend axially and the ratchet member (24) extends axially.

35. The drive assembly of item 33 or 34, wherein stopping surfaces of the external teeth (15) of the body (10) engage stopping surfaces of teeth (25) of the ratchet member (24) to prevent the button (20) from rotating with respect to the body (10) in counterclockwise direction.

36. The drive assembly of any one of the preceding items, wherein the body (10) comprises a releasable locking structure (14) at its proximal end (11) for engagement with a medicament container of a medicament delivery device.

Claims

1. Drive assembly for a medicament delivery device, the drive assembly comprising: a body (10) having a proximal end (11) and a distal end (12); a button (20); a plunger rod (30) defining a longitudinal axis of the drive assembly; a driver (40) capable of, upon activation, driving the plunger rod (30) in proximal direction; a drive spring (50) for driving the driver (40); and a spring locking element (60); wherein the driver (40) comprises a first locking structure (42) capable of locking said driver (40) to the button (20) in an actuated state; wherein the button (20) comprises a second locking structure (21) for releasably locking said first locking structure (42), and an activating structure (23) capable of, upon manual proximally directed operation, releasing the first locking structure (42) of the driver (40) from the second locking structure (21) for driving the driver (40) and the plunger rod (30); wherein the body (10) comprises a first engagement structure (13) and the button (20) comprises a second engagement structure (22) being engageable with the first engagement structure (13) such that a manual rotational operation of the button (20) results in a distally directed displacement of the button (20) and re-engagement of first locking structure (42) of the driver (40) and of the second locking structure (21) of the button (20).

2. The drive assembly of claim 1, wherein the first engagement structure (13) is at the distal end of the body (10).

3. The drive assembly of any one of the preceding claims, wherein the second engagement structure (22) is at the proximal end of a distal crown of the button (20).

4. The drive assembly of any one of the preceding claims, wherein rotational operation of the button (20) causes re-charging of the drive assembly by the re-engagement of first locking structure (42) of the driver (40) and of the second locking structure (21) of the button (20).

5. The drive assembly of any one of the preceding claims, wherein upon manual proximally directed operation of the button (20) the first engagement structure (13) and the second engagement structure (22) are brought into engagement.

6. The drive assembly of any one of the preceding claims, wherein the activating structure (23) is disposed distal to the second engagement structure (22).

7. The drive assembly of any one of the preceding claims, wherein the first engagement structure (13) and the second engagement structure (22) provide a cog interface rotationally locking the driver (40) to the button (20).

8. The drive assembly of any one of the preceding claims, wherein the plunger rod (30) is rotationally locked by the body (10).

9. The drive assembly of any one of the preceding claims, wherein the plunger rod (30) is arranged coaxially within the driver (40).

10. The drive assembly of any one of the preceding claims, wherein the driver (40) is axially fixed.

11. The drive assembly of any one of the preceding claims, wherein the plunger rod (30) comprises an external thread structure (32).

12. The drive assembly of claim 11, wherein the driver (40) comprises a rib or protrusion (41) engaging the external thread structure (32) of the plunger rod (30).

13. The drive assembly of any one of the preceding claims, wherein the driver (40) comprises a connection structure (41) for connecting the proximal end (51) of the drive spring (50) to the driver (40).

14. The drive assembly of any one of the preceding claims, wherein the spring locking element (60) comprises a connection structure (61) for connecting the distal end (52) of the drive spring (50) to the spring locking element (60).

15. The drive assembly of any one of the preceding claims, further comprising a brake assembly for preventing counter-clockwise operation of the button (20).