Medicament delivery device
Patent Information
- Application Number
- EP2023837222
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-01-04
- Filing Date
- 2023-12-20
- Publication Date
- 2025-11-12
AI Technical Summary
Current medicament delivery devices lack simplicity and effective mechanisms to prevent inadvertent activation, which can lead to accidental medicament release.
A medicament delivery device featuring a rotatable plunger rod and activation ring with sloped surfaces and recesses, along with a stop rib mechanism, which ensures the plunger rod is locked in place until the device is properly activated, preventing accidental release.
The solution provides a safe and simple mechanism for plunger rod release, enhancing manufacturing and assembly efficiency while preventing unintended activation and increasing the force for medicament delivery.
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Figure 1.1
Abstract
Description
[0001] Medicament delivery device
[0002] TECHNICAL FIELD
[0003] The present disclosure relates to a medicament delivery device and in particular to a medicament delivery device comprising a rotatable plunger rod.
[0004] BACKGROUND
[0005] A medicament delivery device, in particular an autoinjector, according to the prior art comprises a housing comprising a front housing and a rear housing. The housing is adapted to hold a medicament container, such as a syringe. The syringe may be a pre-filled syringe and have a needle as a medicament delivery member arranged at a proximal end. When the autoinjector and / or the syringe are assembled, a protective needle sheath may be removably coupled to the needle. The protective needle sheath may be made of a flexible shell (for instance composed of rubber) and / or a rigid shell (for instance composed of plastic). A stopper, also called plunger, may be arranged for sealing the syringe distally and for expelling a medicament contained in the syringe through the needle. In other exemplary embodiments, the medicament container may be a cartridge which includes the medicament and engages a removable needle (e.g., by threads, snaps, friction, etc.).
[0006] A cap may be removably disposed at a proximal end of the housing. The cap may include an element (e.g., a barb, a hook, a narrowed section, etc.) arranged to engage the protective needle sheath, the housing and / or a medicament delivery member cover, also referred to as needle cover, telescoped within the housing. The cap may comprise grip features for facilitating removal of the cap (e.g., by twisting and / or pulling the cap relative to the housing). A medicament delivery member cover biasing member may be arranged to bias the medicament delivery member cover in a proximal direction relative to the housing, before injection, for safety reasons. The medicament delivery member cover biasing member needs to be compressed at the beginning of injection in order to retract the medicament delivery member cover inside the housing and uncover the medicament delivery member, thereby activating the device.
[0007] A pre-loaded drive biasing member, for instance a pre-compressed drive spring, may be arranged within the housing. A plunger rod may be used to forward force from the drive biasing member to the stopper. In an exemplary embodiment, the plunger rod is hollow and the drive biasing member is arranged within the plunger. In another exemplary embodiment, the plunger rod is solid and the drive biasing member engages a distal end of the plunger rod. When the pre-loaded drive biasing member is released, the drive biasing member biases the plunger rod in the proximal direction relative to the housing, releasing the plunger rod. Besides that, the plunger rod may itself comprise means for sealing the medicament container such that no stopper needs to be provided.
[0008] A plunger rod release mechanism may be arranged for preventing release of the plunger rod prior to retraction of the medicament delivery member cover relative to the housing and for releasing the plunger rod only once the medicament delivery member cover is sufficiently retracted.
[0009] A medicament delivery member cover lock mechanism (needle cover lock mechanism) may be arranged to prevent retraction of the medicament delivery member cover relative to the housing when the cap is in place, thereby avoiding unintentional activation of the autoinjector (e.g., if dropped, during shipping or packaging, etc.). Such mechanisms are known in the art and will not be described in detail. However, there is a need to further simplify the structure of medicament delivery devices while effectively preventing inadvertent activation of the device.
[0010] This need is met by a device according to the present disclosure.
[0011] SUMMARY
[0012] Reference should now be made to the appended claims.
[0013] The invention relates to a medicament delivery device, comprising: a rear housing provided at a distal end of the medicament delivery device, wherein the distal end is pointing away from a medicament delivery site during use of the medicament delivery device, a medicament delivery member cover, a rotatable activation ring, and a rotatable plunger rod, wherein the medicament delivery member cover comprises at least one sloped surface configured to interact with at least one corresponding sloped protrusion provided on the rotatable activation ring, wherein the activation ring comprises at least one recess configured to interact with at least one corresponding boss provided on the rotatable plunger rod, wherein the boss abuts a stop rib provided at the rear housing, wherein the stop rib extends in a circumferential direction with respect to a longitudinal axis of the medicament delivery device and is configured to block, in an assembled state and activation state of the medicament delivery device, a movement of the plunger rod in a proximal direction towards the medicament delivery site, wherein the at least one sloped surface is configured to, when the medicament delivery member cover is pushed in the distal direction, rotate the rotatable activation ring via the at least one sloped protrusion, and the at least one recess is configured to rotate the rotatable plunger rod via the at least one boss together with the rotatable activation ring, and wherein the plunger rod, in an activated state of the medicament delivery device, is released in the proximal direction after the boss has passed a circumferential end of the stop rib in a rotating direction of the plunger rod.
[0014] In a non-limiting embodiment, the stop rib comprises a stop notch provided at the circumferential end in the rotating direction of the plunger rod, and the stop notch extends in a distal direction.
[0015] In a non-limiting embodiment, the medicament delivery device further comprises a drive biasing member configured to provide a force to the plunger rod able to bias the plunger rod in the proximal direction.
[0016] In a non-limiting embodiment, the medicament delivery member comprises two arms extending in a distal direction, and the sloped surfaces are located at respective distal ends of the arms.
[0017] In a non-limiting embodiment, the plunger rod is provided inside the activation ring in a radial direction with respect to the longitudinal axis and the activation ring is provided inside the rear housing and the medicament delivery member cover, respectively, in the radial direction.
[0018] In a non-limiting embodiment, the rear housing comprises two housing arms extending in a proximal direction, and the stop rib is provided on each of the two housing arms, and preferably, the stop rib protrudes radially inwards.
[0019] In a non-limiting embodiment, the boss protrudes radially outwards.
[0020] In a non-limiting embodiment, the sloped protrusion protrudes radially outwards.
[0021] In a non-limiting embodiment, the housing arms and the medicament delivery member cover arms are offset by 90 degrees, in alternating order. The invention is specified by the independent claim. Preferred embodiments are defined in the dependent claims. In the following description, although numerous features may be designated as optional, it is nevertheless acknowledged that all features comprised in the independent claims are not to be read as optional.
[0022] In the present disclosure, when the term “distal direction” is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term “distal part / end” is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which during use of the medicament delivery device is / are located furthest away from the dose delivery site. Correspondingly, when the term “proximal direction” is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device. When the term “proximal part / end” is used, this refers to the part / end of the delivery device, or the parts / ends of the members thereof, which during use of the medicament delivery device is / are located closest to the dose delivery site.
[0023] Further, the terms “longitudinal”, “longitudinally”, “axially” and “axial” refer to a direction extending from the proximal end to the distal end and along the device or components thereof, typically in the direction of the longest extension of the device and / or component.
[0024] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.
[0025] Further, the terms “circumference”, “circumferential”, or “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a longitudinal axis extending in the direction of the longest extension of the device and / or component. Similarly, “radial” or “radially” refer to a direction extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis. When a component is said to move proximally, distally, axially in a proximal direction, axially in a distal direction or equivalent terms, the movement is relative to the housing of the injection device, unless mentioned otherwise.
[0026] Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to a / an / the element, apparatus, member, component, means, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, member component, means, etc., unless explicitly stated otherwise.
[0027] BRIEF DESCRIPTION OF THE DRAWINGS
[0028] Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings.
[0029] Figure 1 shows a partial view of a medicament delivery device according to a non-limiting embodiment of the invention, in an assembled state.
[0030] Figure 2 shows an exploded view of a medicament delivery device according to a non-limiting embodiment of the invention.
[0031] Figure 3 shows the medicament delivery device of Figure 1 in an activation state.
[0032] Figure 4A shows a partial view of Figure 1 and Figure 4B shows a partial view of Figure s.
[0033] Figure 5 shows a rear housing of a medicament delivery device according to a non-limiting embodiment of the invention.
[0034] Figure 6A shows a partial view of Figure 1 and Figure 6B shows a partial view of Figure s. DETAILED DESCRIPTION
[0035] The (rotating) plunger rod activation mechanism as described herein can be applied to a number of medicament delivery devices. Hence, only the elements which are important for releasing a rotating plunger rod are further described.
[0036] In the figures, elements not essential for carrying out the invention have been omitted. In particular, the figures do not show a complete outer housing, biasing members, a medicament container, cap, etc. in order not to render the depictions overly complicated and not to blur the scope of the disclosure.
[0037] Fig. 1 shows a partial view of an exemplary medicament delivery device in an assembled state. The assembled state herein refers to a state in which the device is delivered to the patient, i.e., before activation and medicament delivery. The medicament delivery device extends generally along a longitudinal axis and comprises a plunger rod 4 extending along the longitudinal axis too.
[0038] In an assembled state, the plunger rod 4 is in a locked position. In an activation state, the plunger rod is rotated, but still locked in the axial direction. In an activated state, the plunger rod is free to move in the proximal direction for medicament delivery. The plunger rod 4 may thus be displaceable along the longitudinal axis.
[0039] Fig. 2 shows an exploded view of Fig. 1.
[0040] According to the present disclosure, the medicament delivery device comprises a medicament delivery member cover 1, the plunger rod 4, and an activation ring 3 radially positioned between the medicament delivery member cover 1 and the plunger rod 4. The plunger rod 4 and the activation ring 3 are both rotationally movable around the longitudinal axis.
[0041] Moreover, the medicament delivery device has a housing preferably comprising a front (proximal) housing (not shown) and a rear (distal) housing 2. The rear housing 2 may also be referred to as rear cap. The front and rear housing may also be integrally provided according to a non-limiting embodiment.
[0042] The medicament delivery member cover 1 may be biased in a proximal direction by a spring or another energy accumulating member (not shown), to protect a medicament delivery member before activation. Besides that, a drive biasing member (not shown), for instance a coil spring, may be provided to push the plunger rod 4 in a proximal direction after activation, i.e., release of the plunger rod 4.
[0043] The plunger rod 4 comprises a boss 41. The boss 41 may be provided at a distal end of the plunger rod 4. In Fig. 2, the boss 41 is at the very distal end of the plunger rod 4, i.e., directly adjacent to a distally facing surface of the plunger rod 4. Alternatively, the boss 41 maybe located at some distance from the distally facing surface, i.e., with an offset towards the proximal end of the plunger rod 4.
[0044] The activation ring 3 comprises a recess 32 corresponding to and configured to interact with the boss 41. The recess 32 may be a groove or, as shown in the figures, a cut-out. The length in axial direction of the recess 32 is adapted to accommodate the boss 41 to such extent that the plunger rod 4 is prevented from rotating by the lateral edges of the recess 32. In case the boss 41 is offset towards the proximal end, as mentioned above, the length of the groove or recess hat to be correspondingly larger or the axial overlap of the activation ring 3 over the distal end of the plunger rod 4 has to be larger to compensate for the offset.
[0045] The activation ring 3 further comprises a sloped protrusion 31. The protrusion 31 protrudes radially from the outer circumferential surface of the activation ring 31.
[0046] The sloped protrusion 31 is depicted as an essentially right-angled triangle (in cross-section when viewed in radial direction). One edge of the right angle extends parallel to the longitudinal axis, the other edge of the right angle extends parallel to a distal surface of the rear housing, and the slope is the edge opposite the right angle. However, other geometries are possible, for instance the edge opposite the right-angle could be curved, or the sloped protrusion may have another shape such as a round boss or a polygon which may alternatively be used to provide the intended functionality.
[0047] The medicament delivery member cover 1 comprises a corresponding sloped surface 12 at a distal end thereof configured to interact with the sloped protrusion 31. The medicament delivery member cover 1 may comprise two arms 11 extending parallel to the longitudinal axis in a distal direction, wherein a sloped surface 12 is provided on both distal ends of the arms 11, respectively. Accordingly, the activation ring 3 may comprise two protrusions 31 for interaction with a corresponding arm 12. The sloped protrusion 31 (or each protrusion 31) may be provided at a proximal end of the activation ring 3. This is shown in Fig.2, for example. Alternatively, the protrusion 31 (or each protrusion 31) may be located at some distance from the proximal end of the activation ring 3, i.e., with an offset towards the distal end of the activation ring 3.
[0048] The activation ring 3 may be axially fixed relative to the housing. For example, the activation ring 3 may abut the distal end of the device, i.e., the rear housing 2, and the sloped surface 12 and may therefore be axially fixed between the rear housing 2 and the medicament delivery member cover 1.
[0049] The inner surface of the rear housing 2 comprises a stop rib 21 configured to block a movement of the plunger rod 4 in the proximal direction. The plunger rod 4 is thus in a locked state in an axial direction but free to rotate.
[0050] The rear housing 2 may comprise two arms 23 extending in a proximal direction. The rear housing arms 23 and the arms 11 of the medicament delivery member cover may be offset by 90 degrees as shown in the figures. The stop rib 21 may be provided on a radially inner side of the housing arms 23 with respect to the longitudinal axis of the device. The stop rib 21 may form a circular segment in a circumferential direction with respect to the longitudinal axis. In other words, the stop rib 21 may have an arc shape. Optionally, a stop notch 22 may be provided at a circumferential end of the stop rib 21 in a rotation direction of the activation ring 3 and the plunger rod 4. The stop notch 22 will be further described later.
[0051] The medicament delivery member cover 1 and the rear housing 2 may both be provided in a non-rotatable configuration. The medicament delivery member cover 1 can be displaced in the axial direction.
[0052] The plunger rod 4 may be a substantially cylindrical element extending along the longitudinal axis of the device. The plunger rod 4 may be provided inside the activation ring 3 in a radial direction with respect to the longitudinal axis and the activation ring 3 may be provided inside the rear housing 2 and the medicament delivery member cover 1, respectively, in the radial direction. The activation ring 3 may substantially be a hollow cylinder. In other words, the activation ring 3 may partially receive the distal end of the plunger rod 4.
[0053] Fig. 3 shows the device of Figs. 1 and 2 in an activation state, meaning the medicament delivery member cover 1 has been pushed in a distal direction, e.g. by pushing the medicament delivery device on an injection / medicament delivery site, thereby rotating the activation ring 3 and the plunger rod 4.
[0054] The activation will be further described with reference to Figs. 4A and 4B, wherein Fig. 4A shows the dashed section of Fig. 1 (assembled state) and Fig. 4B shows the dashed section of Fig. 3 (activation state).
[0055] In particular, when the medicament delivery member cover 1 is pushed in the distal direction as indicated by the arrow, the sloped surface 12 abuts the sloped protrusion 31. Since the medicament delivery member cover 1 is non- rotatable relative to the housing, the abutment forces the rotatable activation ring 3 to rotate (to the left in the figures). Due to the engagement of the recess 32 with the boss 41, the rotatable plunger rod 4 rotates together with the activation ring 3. Due to the abutment of the boss 41 on the stop rib 21, the plunger rod 4 cannot move in the proximal direction but rotates along the stop rib 21 without axial displacement. After a certain amount of rotation, the boss 41 reaches the circumferential end of the stop rib 21 as shown in Fig. 4B. In Fig. 4B, the plunger rod 4 is still axially locked and not able to move in the proximal direction due to the still abutment on the stop rib 21.
[0056] As soon as the boss 41 passes the circumferential end of the stop rib 21, the plunger rod 4 is free to move in the proximal direction by the force of the drive biasing member to expel the medicament.
[0057] Fig. 5 shows a perspective view of the rear housing 2 according to an example. The stop rib 21 may comprise a stop notch 22 provided at the circumferential end in the rotating direction of the plunger rod 4. The stop notch 22 may extend from the stop rib 21 in a distal direction. The stop notch 22 may have a sloped surface.
[0058] By said stop notch 22, an inadvertent activation of the medicament delivery device may by prevented since it provides an additional resistance which may not be overcome by accidental operation of the medicament delivery member cover 1. Moreover, the stop notch 22 during the activation state further urges the plunger rod 4 in the distal direction via the boss 41 overcoming the stop notch 22, thus further compressing the drive biasing member and providing a higher activation force when the device transitions from the activation state to the activated state.
[0059] Fig. 6A shows the dashed section of Fig. 1, i.e., the medicament delivery device in the assembled state, wherein the rear / distal housing 2 is transparently displayed. The boss 41 is received in the cut-out 32, rests on and abuts the stop rib 21 and the optionally provided stop notch 22 and is thus prevented from moving in the proximal and radial direction.
[0060] Fig. 6B shows the device in the activated state. Again, the rear housing 2 is transparently displayed. Due to the interaction of the sloped surface 12 with the sloped protrusion 31 and in turn the interaction of the recess 32 with the boss 41, both the activation ring 3 and the plunger rod 4 have been rotated such that the boss 41 has passed the circumferential end of the stop rib 21 and the stop notch 22, respectively. As indicated by the arrow, the plunger rod 4 is now free to be moved in the proximal direction by the force of the drive biasing member to expel a medicament.
[0061] The boss 41 may have an irregular shape as shown in the figures, and best seen in Fig. 6B. By providing an essentially right-angled side of the boss 41 (when viewed in radial direction), a more distinct activation point may be achieved. However, the boss may also have a round, rectangular or polygonal shape.
[0062] In addition or as an alternative to the stop notch 22 on the stop rib 21, a stop notch (not shown) may be provided on the distal disk shaped end of the rear housing 2. The activation ring 3 may comprise a corresponding protrusion (not shown). When the medicament delivery member cover 1 is pushed onto the medicament delivery site and in turn, the activation ring 3 is rotated, the protrusion on the activation ring 3 first has to overcome the stop notch before the activation ring 3 can be rotated far enough to release the plunger rod.
[0063] By providing a medicament delivery device as presented above, a simple and safe plunger rod release mechanism may be provided. In particular, the structure having a rotatable activation ring and a rotatable plunger rod require a slimmer distal end of the plunger rod and thus facilitate manufacturing and assembly. The stop notch provides a further safety mechanism preventing inadvertent activation of the device. Moreover, the drive biasing member force on the plunger rod may be increased and the medicament delivery may thus be improved.
[0064] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.
[0065] 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.
[0066] 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.
[0067] 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.
[0068] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-i (GLP-i) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Ci esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor- associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-1 / PD-L1) inhibitors / modulators, B-lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, B-lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulators, lymphocyte-activation gene 3 (LAG3; also known as cluster of differentiation 223 or CD223) antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation W137 (CDW137) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD159 or NKG2) modulators, glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig- like receptor (KIR) modulators, growth arrest-specific protein 6 (GAS6) / AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation W123 (CDwi23) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumorinfiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.
[0069] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-ia, interferon beta-ib, peginterferon beta-ia, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins. 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.
[0070] 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.
[0071] 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.
[0072] 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.
[0073] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOXy, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini- CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC- EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C- MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.
[0074] Various modifications to the embodiments described are possible and will occur to those skilled in the art without departing from the invention which is defined by the following claims.
[0075] Reference Signs
Claims
CLAIMS1. Medicament delivery device, comprising: a rear housing (2) provided at a distal end of the medicament delivery device, wherein the distal end is pointing away from a medicament delivery site during use of the medicament delivery device, a medicament delivery member cover (1), a rotatable activation ring (3), and a rotatable plunger rod (4), wherein the medicament delivery member cover (1) comprises at least one sloped surface (12) configured to interact with at least one corresponding sloped protrusion (31) provided on the rotatable activation ring (3), wherein the activation ring (3) comprises at least one recess (32) configured to interact with at least one corresponding boss (41) provided on the rotatable plunger rod (4), wherein the boss (41) abuts a stop rib (21) provided at the rear housing (2), wherein the stop rib (21) extends in a circumferential direction with respect to a longitudinal axis of the medicament delivery device and is configured to block, in an assembled state and activation state of the medicament delivery device, a movement of the plunger rod (4) in a proximal direction towards the medicament delivery site, wherein the at least one sloped surface (12) is configured to, when the medicament delivery member cover (1) is pushed in the distal direction, rotate the rotatable activation ring (3) via the at least one sloped protrusion (31), and the at least one recess (32) is configured to rotate the rotatable plunger rod (4) via the at least one boss (41) together with the rotatable activation ring (3), and wherein the plunger rod (4), in an activated state of the medicament delivery device, is released in the proximal direction after the boss (41) has passed a circumferential end of the stop rib (21) in a rotating direction of the plunger rod (4).
2. Medicament delivery device according to claim 1, wherein the stop rib (21) comprises a stop notch (22) provided at the circumferential end in the rotating direction of the plunger rod (4), wherein the stop notch (22) extends in a distal direction.
3. Medicament delivery device according to any one of the preceding claims, further comprising a drive biasing member configured to provide a force to the plunger rod (4) able to bias the plunger rod (4) in the proximal direction.
4. Medicament delivery device according to any one of the preceding claims, wherein the medicament delivery member comprises two arms (11) extending in a distal direction, wherein the sloped surfaces (12) are located at respective distal ends of the arms (11).
5. Medicament delivery device according to any one of the preceding claims, wherein the plunger rod (4) is provided inside the activation ring (3) in a radial direction with respect to the longitudinal axis and the activation ring (3) is provided inside the rear housing (2) and the medicament delivery member cover (1), respectively, in the radial direction.
6. Medicament delivery device according to any one of claims 4 or 5, wherein the rear housing (2) comprises two housing arms (23) extending in a proximal direction, wherein the stop rib (21) is provided on each of the two housing arms (23), wherein preferably, the stop rib (21) protrudes radially inwards.
7. Medicament delivery device according to any one of the preceding claims, wherein the boss (41) protrudes radially outwards.
8. Medicament delivery device according to any one of the preceding claims, wherein the sloped protrusion (31) protrudes radially outwards.
9. Medicament delivery device according to any one of claims 4 to 8, wherein the housing arms (23) and the medicament delivery member cover arms (11) are offset by 90 degrees, in alternating order.