Medicament delivery device

Abstract

Medicament Delivery Device A medicament delivery device (100) has a sub-assembly (214) comprising a drive member (302) that is a helical compression spring, a plunger rod (300), a holder (304) and a guide rod (308) The guide rod (308) supports the drive member (302) along its length and the guide rod (308) and drive member (302) are at least partially received within a bore (303) of the plunger rod (300). The guide rod (308) is secured to the holder (304) to retain the drive member (302) in the bore (303) between a distally facing surface (309) of the plunger rod (300) and a proximally facing surface (311) of the guide rod (308).

Description

[0001] Medicament Delivery Device

[0002] Field of the Disclosure

[0003] The present disclosure relates to a medicament delivery device. It is particularly but not exclusively applicable to a sub-assembly for a medicament delivery device, such as a power-pack sub-assembly, and to a method of assembling the sub-assembly and / or the medicament delivery device.

[0004] Background

[0005] A medicament delivery device may house a medicament container that contains a medicament for delivery to a user, e.g. by injection. A plunger rod biased by a drive member may be arranged to transfer force provided by a drive member to a plunger of the medicament container to expel the medicament from the medicament container. In one example, the plunger rod may be a hollow cylinder and the drive member may be a helical compression spring mounted inside the plunger rod.

[0006] Summary of the Disclosure

[0007] Aspects of the disclosure are defined in the accompanying claims.

[0008] According to one aspect of the disclosure, there is provided a sub-assembly for a medicament delivery device, the sub-assembly comprising: a drive member that is a helical compression spring; a plunger rod moveable in use in a proximal direction to transfer force from the drive member to a plunger of a medicament container housed in the medicament delivery device to expel a medicament from the medicament container, which plunger rod has a bore within which the drive member is received and a distally facing surface abutted by a proximal end of the drive member; a holder moveable between a first position in which it prevents the movement of the plunger rod and a second position in which the holder releases the plunger rod for the movement; and a guide rod that supports the drive member along its length and has a proximally facing surface abutted by a distal end of the drive member, the guide rod being at least partially receivable within the bore of the plunger rod, wherein one of the holder and the guide rod has one or more recesses and the other of the holder and the guide rod has one or more protrusions, the recess(es) and the protrusion(s) cooperating with one another to secure the guide rod to the holder so as to retain the drive member in the bore of the plunger rod between the distally facing surface of the plunger rod and the proximally facing surface of the guide rod. Optionally, the protrusion(s) snap-fit(s) into the recess(es) upon movement of the guide rod in a proximal direction relative to the holder.

[0009] Optionally, there are two or more recesses and two or more protrusions, the recesses and protrusions being equally spaced from one another circumferentially.

[0010] Optionally, the protrusions are moveable within the recesses such that the guide rod is moveable in a proximal direction relative to the holder against the force of the drive member.

[0011] Optionally, the guide rod has a length that extends a majority of a length of the drive member when the drive member is in a compressed state.

[0012] According to another aspect of the disclosure, there is provided a medicament delivery device comprising the sub-assembly described above; a body for accommodating the sub-assembly; and an end cap mountable to a distal end of the body, wherein the end cap urges the guide rod in a proximal direction against the force of the drive member when the end cap is mounted to the body.

[0013] Optionally, a proximally facing surface of the holder is arranged to abut a distally facing surface of the medicament container when the holder is in the first position.

[0014] According to another aspect of the disclosure, there is provided a method of assembling a medicament delivery device, the method comprising: mounting a drive member, which is a helical compression spring, on a guide rod such that the guide rod supports the drive member along its length and a distal end of the drive member abuts a proximally facing surface of the guide rod; inserting the drive member and guide rod into a bore of a plunger rod, which plunger rod is moveable in use in a proximal direction to transfer force from the drive member to a plunger of a medicament container housed in the medicament delivery device to expel a medicament from the medicament container, such that a proximal end of the drive member abuts a distally facing surface of the plunger rod; and mounting the drive member, guide rod and plunger rod to a holder moveable between a first position in which it prevents the movement of the plunger rod and a second position in which the holder releases the plunger rod for the movement, wherein one of the holder and the guide rod has one or more recesses and the other of the holder and the guide rod has one or more protrusions, the recess(es) and the protrusion(s) cooperating with one another to secure the guide rod to the holder so as to retain the drive member in the bore of the plunger rod between the distally facing surface of the plunger rod and the proximally facing surface of the guide rod. Brief Description of the Drawings

[0015] Embodiments of the disclosure are now be described, by way of example only, with reference to the accompanying drawings, in which:

[0016] Fig. 1 is a schematic perspective view of a medicament delivery device according to a first embodiment;

[0017] Fig. 2 is a schematic exploded perspective view of some of the components of the medicament delivery device shown in Fig. 1;

[0018] Fig. 3 is a schematic cross-sectional view from one side of some components of a powerpack of the medicament delivery device shown in Fig. 1, including a guide rod;

[0019] Figs. 4A and 4B are schematic cross-sectional views from one side of some components of the powerpack of the medicament delivery device shown in Fig. 1 at two different stages of assembly; and

[0020] Figs. 5A and 5B are schematic cross-sectional views from one side of some of the components of the medicament delivery device shown in Fig. 1, housing medicament containers of slightly differing dimensions respectively.

[0021] Detailed Description of the Preferred Embodiments

[0022] In the present disclosure, when the terms "distal direction" or "distally" are used, they refer to a direction pointing away from a medicament delivery site during use of the medicament delivery device. When the term "distal" is used, it refers to a location away from the medicament delivery site in use. For example, a "distal" part or end of the medicament delivery device, or a "distal" part or end of a component of the medicament delivery device, is a part or end that is located furthest away from the medicament delivery site in use. Correspondingly, when the terms "proximal direction" or "proximally" are used, they refer to a direction pointing towards the medicament delivery site during use of the medicament delivery device. When the term "proximal" is used it refers to a location closest to the medicament delivery site in use. For example, a "proximal" part or end of the medicament delivery device, or a "proximal" part or end of a component of the medicament delivery device, is a part or end that is located closest to the medicament delivery site in use. The terms "longitudinal", "axial", "longitudinally" and "axially" refer to a direction extending from a proximal end to a distal end, typically along the device or a component thereof in the direction of the longest extension of the device and / or component.

[0023] The terms "transverse", "transversal" and "transversally" refer to a direction generally perpendicular to the longitudinal direction.

[0024] 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. The terms "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.

[0025] Referring to Fig. 1, a medicament delivery device 100 comprises a body 102. A removable cap 104 is provided at proximal end of the body 102, which removeable cap 104 is removable by a user to allow access between a medicament container (not shown) housed in the medicament delivery device 100 and a medicament delivery site, e.g. on a user's body. An end cap 106 or "rear cap" is provided at the distal end of the body 102. The end cap 106 closes an opening at the distal end of the body 102 through which some components of the medicament delivery device 100 are inserted during assembly of the medicament delivery device 100.

[0026] Referring to Fig. 2, the removeable cap 104 has a cap body 200 that accommodates a delivery member shield remover 202. The cap body 200 is generally a hollow tube in which the delivery member shield remover 202 is at least partially located. The delivery member shield remover 202 is mounted to the cap body 200 to be moveable to a limited extent relative to the cap body 200 in an axial direction. The delivery member shield remover 202 has a flange 204 at a proximal end and arms 206 extending in a distal direction, which flange 204 and arms 206 engage with the cap body 200 to secure the delivery member shield remover 202 in the cap body 200 whilst allowing the limited axial movement.

[0027] A distal end surface 201 of the cap body 200 is curved such that the distal end surface 201 extends further in the distal direction at some points around the circumference of the cap body 200 than at others. A corresponding proximally facing surface 203 is provided on the body 102 of medicament delivery device 100. The distal end surface 201 of the cap body 200 cooperates with the proximally facing surface 203 of the body 102 of the medicament delivery device 100 such that rotating the cap 104 relative to the body 102 of the medicament delivery device 100 causes the surfaces 201, 203 to urge the cap 104 away from the body 102 in a proximal direction, e.g. to assist with removal of the cap 104.

[0028] The body 102 of the medicament delivery device 100 houses a medicament container 208. The medicament container 208 has a medicament delivery member 210 for delivering a medicament contained in the medicament container 208 to the user and a plunger 212 for expelling the medicament from the medicament container 208. In the illustrated embodiment the medicament container 208 is a syringe and the medicament delivery member 210 is a needle.

[0029] The medicament container 208 has a delivery member shield 209 for covering the delivery member 210 prior to use. The delivery member shield 209 has a rigid outer part and a flexible inner part, which may respectively be referred to as a rigid needle shield and a flexible needle shield. The delivery member shield remover 202 of the removeable cap 104 is arranged to grip the delivery member shield 209 such that the delivery member shield 209 is removed from the medicament container 208 as the removeable cap 104 is removed from the body 102 of the medicament delivery device 100.

[0030] The body 102 of the medicament delivery device 100 houses a sub-assembly 214. The sub-assembly 214 is arranged to cause the medicament to be expelled from the medicament container 218 by urging the plunger 212 in a proximal direction. As such, the sub-assembly 214 may be referred to as a power-pack sub-assembly. It is described in more detail below.

[0031] The medicament delivery device 100 has a delivery member guard 216 moveable in an axial direction between a first position in which it covers the delivery member 210 and a second position in which it exposes the delivery member 210. The delivery member guard 216 extends from the vicinity of the delivery member 210, e.g. the proximal end of the medicament delivery device 100, to the sub-assembly 214. A proximal end of the delivery member guard 216 generally surrounds the delivery member 210 except to allow for movement to the second position to expose the delivery member 210. In the illustrated embodiment the proximal end of the delivery member guard 214 is generally tubular with an end surface that is closed except for an aperture through which the delivery member 210 may extend when the delivery member guard 216 is in the second position. The delivery member guard 216 has arms 218 that extend in the distal direction for engaging with the sub-assembly 214. A biasing member 220 is provided for biasing the delivery member guard 216 towards the first position. In the illustrated embodiment, the biasing member 220 is a helical compression spring mounted on the sub-assembly 214. The end cap 106 is arranged to be at least partially received within the body 102, e.g. it has at least a portion that is a cylinder of slightly smaller diameter than an internal diameter of the body 102. The end cap 106 has a recess 222 that cooperates with a protrusion 224 on the body 102 to secure the end cap 106 to the body 106. When the end cap 106 is secured to the body 106, the end cap 106 closes the distal end of the body 106. In the illustrated embodiment, there are two such recesses 222 and two such protrusions 224, but other numbers of recesses 222 and protrusions 224 may be provided in other embodiments. The recesses 222 and protrusions 224 are typically equally spaced from one another circumferentially, so arranged at 180° from one another in the illustrated embodiment. In other embodiments the recess 222 may be provided on the body 102 and the protrusion 224 may be provided on the end cap 106, or other mechanisms for attaching the end cap 106 to the body 102 may be provided.

[0032] Referring to Figure 3, the sub-assembly 214 comprises a plunger rod 300, a drive member 302 and a holder 304. The plunger rod 300 is moveable in use in a proximal direction to transfer force from the drive member 302 to the plunger 212 of the medicament container 208 to expel the medicament from the medicament container 208. The holder 304 is moveable between a first position in which it prevents the movement of the plunger rod 300 and a second position in which it releases the plunger rod 300 for the movement. More specifically, in the first position arms 305 of the holder 304 interact with recesses 307 of the plunger rod 300 to prevent movement of the plunger rod 300, whereas in the second position the arms 305 of the holder 304 can flex radially outwards so that they no longer interact with the recesses 307 of the plunger rod 300 and the plunger rod is released for movement. An actuator 306 is provided that cooperates with the arms 218 of the delivery member guard 216 and the holder 304 such that movement of the delivery member guard 216 to the second position allows the holder 304 to release the plunger rod 300.

[0033] The plunger rod 300 is generally hollow. More specifically, the plunger rod 300 has a bore 303 extending along it's length. The bore 303 houses the drive member 302, which in the illustrated embodiment is a helical compression spring. The drive member 302 is mounted on a guide rod 308, which is also accommodated in the bore 303. The guide rod 308 supports the drive member 302 along its length. In some embodiments, the guide rod 308 is made of plastics. The guide rod 308 may be at least partially in an inner space defined by the drive member 302. In the illustrated embodiment, this inner space the interior of the helical compression spring, that is the volume defined by the helix.

[0034] The plunger rod 300 has a distally facing surface 309 abutted by a proximal end of the drive member

[0035] 302, and the guide rod 308 has a proximally facing surface 311 abutted by a distal end of the drive member 302. Whilst some of the drawings show slight gaps between the drive member 302 and the surfaces 309, 311, these gaps are not present in the assembled device.

[0036] The holder 304 has a recess 310 and the guide rod 308 has a protrusion 312. The recess 310 and the protrusion 312 cooperate with one another to secure the guide rod 308 to the holder 304 so as to retain the drive member 300 in the bore 303 of the plunger rod 300 between the distally facing surface 309 of the plunger rod 302 and the proximally facing surface 311 of the guide rod 306. When the guide rod 308 is inserted into the bore 303 and secured by the protrusions 312 and recesses 310, and the actuator 306 is positioned to prevent the holder 304 from releasing the plunger rod 300, the drive member 302 is fully biased, e.g. the helical compression spring is in a (maximally or fully) compressed state.

[0037] In the illustrated embodiment there are two recesses 310 and two protrusions 312, but any number of pairs of recesses 310 and protrusions 312 may be provided, or even some other mechanism for securing the guide rod 308 to the holder 304. The recesses 310 are typically spaced equidistantly in a circumferential direction, as are the protrusions 312. In the illustrated embodiment, the two recesses 310 are spaced by 180°, as are the protrusions 312. The protrusion(s) 312 is / are arranged to snap-fit into the recess(es) 310 from a distal position, e.g. as the guide rod 308 is inserted into the bore 303 in a proximal direction. The protrusions 312 each have a sloped surface proximally located to facilitate the snap-fitting.

[0038] It can be seen from the drawings that the recesses 310 are longer in a longitudinal direction that the recesses 312. This means that once the guide rod 308 is secured in the bore 303 by the protrusions 312 being in the recesses 310, the guide rod 308 remains free to move longitudinally within the bore 303 to a limited extent. Effectively, the recesses 310 are slots in which the protrusions 312 may slide.

[0039] It can also be seen from the drawings that the protrusions 312 have a proximally facing surface that is sloped inwardly towards the proximal direction and a distally facing surface that is perpendicular to the longitudinal direction. This makes it easier to insert the guide rod 308 into the bore 303 than to remove the guide rod 308 from the bore (once the protrusions 312 are located in the recesses 310). For example, a portion of the holder 304 distal of the recesses 310 may flex radially outwardly to allow the protrusions 312 to pass into the recesses 310. In one embodiment, the guide rod 308 is therefore secured to the holder 304 by a snap-fit arrangement. In other embodiments, the guide rod 308 may be secured to the holder 304, and e.g. inside the bore 303, by other types of fixings.

[0040] Referring to Figs. 4A and 4B, with the drive member 302 and guide rod 308 secured in the bore 303 of the plunger rod 300, the sub-assembly 214 can be inserted into the body 102 of the medicament delivery device 100. The biasing member 220 is mounted to the outside of the holder 304 so as to extend between a distally facing surface of the actuator 304 and a proximally facing surface of the end cap 106. Urging the end cap 106 towards the body 102 compresses the biasing member 220. Eventually the end cap 106 is received into the body and the protrusion(s) 224 of the body 102 cooperate with recess(es) 222 of the end cap 106 to secure the end cap 106 to the body 102, and thereby retain the biasing member 220 in a compressed state between the distally facing surface of the actuator 304 and the proximally facing surface of the end cap and also retain the sub-assembly 214 in the body 102. Because the guide rod 308 secures the drive member 302 in the bore 303 of the plunger rod 300 prior to these components being installed in the body 102 of the medicament delivery device 100, assembly is simplified in comparison to a situation in which both the drive member 302 and the biasing member 220 must be compressed simultaneously.

[0041] Referring to Figures 5A and 5B, with the sub-assembly 214 mounted in the body 102 of the medicament delivery device 100, a proximally facing surface of the holder 304 abuts a distally facing surface of the medicament container 208. In other words, the holder 304 rests against a flange of the medicament container 208. The medicament container 208 mounted in the medicament delivery device 100 may vary in size, and particularly in length. To illustrate this, the medicament container 208 shown in Figure 5A extends slightly further in distal direction that the medicament container 208 shown in Figure 5B. The result of this is that the holder 304 is displaced distally by the medicament container 208 shown in Figure 5A to a slightly greater extent than by the medicament container 208 shown in Figure 5B, and the end cap 106 protrudes slightly from the open end of the body 102 of the medicament delivery device 100 when the medicament container 208 shown in Figure 5A is present, but is flush to the open end of the body when the medicament container 208 shown in Figure 5B is present. Moreover, the holder 308 is located slightly more distally with respect to the guide rod 308 when the medicament container 208 shown in Figure 5B is present then when the medicament container shown in Figure 5A is present. In this way, different sizes and shapes of medicament containers, along with other manufacturing tolerances, can be accommodated.

[0042] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0043] 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, Behget'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.

[0044] 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.

[0045] 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-cel I receptors, or costimulatory proteins.

[0046] 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 (H ER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-1 (GLP-1) modulators, glucosedependent 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 (TN F RS F4 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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, M EC, 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.

Claims

Claims1. A sub-assembly (214) for a medicament delivery device (100), the sub-assembly (214) comprising: a drive member (302) that is a helical compression spring; a plunger rod (300) moveable in use in a proximal direction to transfer force from the drive member (302) to a plunger (212) of a medicament container (208) housed in the medicament delivery device (100) to expel a medicament from the medicament container (208), which plunger rod (300) has a bore (303) within which the drive member (302) is received and a distally facing surface (309) abutted by a proximal end of the drive member (302); a holder (304) moveable between a first position in which it prevents the movement of the plunger rod (300) and a second position in which the holder (304) releases the plunger rod (300) for the movement; and a guide rod (308) that supports the drive member (300) along its length and has a proximally facing surface (311) abutted by a distal end of the drive member (300), the guide rod (308) being at least partially receivable within the bore (303) of the plunger rod (302), wherein one of the holder (304) and the guide rod (308) has one or more recesses (310) and the other of the holder (304) and the guide rod (308) has one or more protrusions (312), the recess(es) (310) and the protrusion(s) (312) cooperating with one another to secure the guide rod (308) to the holder (304) so as to retain the drive member (302) in the bore (303) of the plunger rod (300) between the distally facing surface (309) of the plunger rod (300) and the proximally facing surface (311) of the guide rod (308).

2. The sub-assembly (214) of claim 1, wherein the protrusion(s) (312) snap-fit(s) into the recess(es) (310) upon movement of the guide rod (308) in a proximal direction relative to the holder (304).

3. The sub-assembly (214) of claim 1 or claim 2, wherein there are two or more recesses (310) and two or more protrusions (312), the recesses (310) and protrusions (312) being equally spaced from one another circumferentially.

4. The sub-assembly (214) of any one of the preceding claims, wherein the protrusions (312) are moveable within the recesses (310) such that the guide rod (308) is moveable in a proximal direction relative to the holder (304) against the force of the drive member (302).

5. The sub-assembly (214) of any one of the preceding claims, wherein the guide rod (308) has a length that extends a majority of a length of the drive member (302) when the drive member (302) is in a compressed state.

6. The medicament delivery device (100) comprising: the sub-assembly (214) of any one of the preceding claims; a body (102) for accommodating the sub-assembly (214); and an end cap (106) mountable to a distal end of the body (102), wherein the end cap (106) urges the guide rod (308) in a proximal direction against the force of the drive member (302) when the end cap (106) is mounted to the body (102).

7. The medicament delivery device (100) of claim 6, wherein a proximally facing surface of the holder (304) is arranged to abut a distally facing surface of the medicament container (208) when the holder (304) is in the first position.

8. A method of assembling a medicament delivery device (100), the method comprising: mounting a drive member (302), which is a helical compression spring, on a guide rod (308) such that the guide rod (308) supports the drive member (302) along its length and a distal end of the drive member (302) abuts a proximally facing surface (311) of the guide rod (308); inserting the drive member (302) and guide rod (308) into a bore (303) of a plunger rod (300), which plunger rod (300) is moveable in use in a proximal direction to transfer force from the drive member (302) to a plunger (212) of a medicament container (208) housed in the medicament delivery device (100) to expel a medicament from the medicament container (208), such that a proximal end of the drive member (302) abuts a distally facing surface (309) of the plunger rod (300); and mounting the drive member (302), guide rod (308) and plunger rod (300) to a holder (304) moveable between a first position in which it prevents the movement of the plunger rod (300) and a second position in which the holder (304) releases the plunger rod (300) for the movement, wherein one of the holder (304) and the guide rod (308) has one or more recesses (310) and the other of the holder (304) and the guide rod (308) has one or more protrusions (312), the recess(es) (310) and the protrusion(s) (312) cooperating with one another to secure the guide rod (308) to the holder (304) so as to retain the drive member (302) in the bore (303) of the plunger rod(300) between the distally facing surface (309) of the plunger rod (300) and the proximally facing surface (311) of the guide rod (308).

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