Cap assembly for a medicament delivery device

Abstract

A cap assembly (4) for a medicament delivery device including a delivery member shield, the cap assembly (4) comprising: a hollow outer cap body having a proximal end, and an open distal end, wherein the cap body has radially flexible tongues (4a-3) extending towards the distal end inside the cap body, the flexible tongues (4a-3) being configured to receive a delivery member shield between them, a delivery member shield remover (4b) arranged to releasably engage with the cap body, the delivery member shield remover (4b) being arranged coaxially with and radially outside the tongues (4a-3), wherein the delivery member shield remover (4b) has radially inward extending structures arranged to engage with a delivery member shield, and wherein when a delivery member shield has been received between, and bears against the tongues (4a-3), the tongues (4a-3) are forced to flex radially outwards and press against an inner surface of the delivery member shield remover (4b).

Description

[0001] CAP ASSEMBLY FOR A MEDICAMENT DELIVERY DEVICE

[0002] TECHNICAL FIELD

[0003] The present disclosure generally relates to medicament delivery devices.

[0004] BACKGROUND

[0005] Medicament delivery devices such as autoinjectors may have a detachable cap which protects the delivery member, e.g., the needle, and the medicament container, from mechanical impact.

[0006] Medicament delivery devices may also comprise a needle shield arranged around the needle. The needle shield prevents accidental needle sticks and keeps the medicament container sterile.

[0007] The cap may comprise a cap body and a gripper which is attached to the cap body during the assembly process. The function of the gripper is to grab into the needle shield such that the needle shield is removed from the needle when the cap is pulled off from the main body of the medicament delivery device.

[0008] In the eventuality that a medicament delivery device accidentally is dropped, it may, depending on the orientation and the weight of the device, happen that the impact force causes the needle shield remover to detach from the cap body. This may result in that the needle shield is not removed from the medicament container when the cap is pulled from the main body of the medicament delivery device.

[0009] SUMMARY

[0010] In view of the above, a general object of the present disclosure is to provide a cap assembly for a medicament delivery device which solves or at least mitigates the problems of the prior art.

[0011] There is hence according to a first aspect provided a cap assembly for a medicament delivery device including a delivery member shield, the cap assembly comprising: a hollow outer cap body having a proximal end, and an open distal end, wherein the cap body has radially flexible tongues extending towards the distal end inside the cap body, the flexible tongues being configured to receive a delivery member shield between them, a delivery member shield remover arranged to releasably engage with the cap body, the delivery member shield remover being arranged coaxially with and radially outside the tongues, wherein the delivery member shield remover has radially inward extending structures arranged to engage with a delivery member shield, and wherein when a delivery member shield has been received between, and bears against the tongues, the tongues are forced to flex radially outwards and press against an inner surface of the delivery member shield remover.

[0012] The tongues are thus wedged between the delivery member shield and the delivery member shield remover. Therefore, in case a medicament delivery device comprising the cap assembly is dropped, the risk that the delivery member shield remover disengages from the cap body upon impact is reduced.

[0013] According to one embodiment the cap body comprises a tubular portion arranged radially outside a proximal end portion of the delivery member shield remover, wherein an outer surface of the delivery member shield remover is configured to engage with an inner surface of the tubular portion.

[0014] The delivery member shield remover is thus pressed in a direction generally towards the tubular portion, i.e., radially outwards, when a delivery member shield has been received between, and bears against the tongues. The delivery member shield remover is thus pushed against the inner surface of the tubular portion, with which the outer surface of the delivery member shield engages. The engagement between the delivery member shield remover and the cap body is thus increased by the presence of the delivery member shield. The risk of disengagement of the delivery member shield remover from the cap body is thus reduced. According to one embodiment one of the outer surface of the delivery member shield remover and the inner surface of the tubular portion has a rib and the other one of the outer surface of the delivery member shield remover and the inner surface of the tubular portion has a groove configured to receive the rib for releasably engaging the delivery member shield remover with the cap body. The rib and groove configuration fixates the delivery member shield remover axially relative to the tubular portion of the cap body.

[0015] According to one embodiment the rib extends along the entire circumference of the outer surface of the delivery member shield remover or the inner surface of the tubular portion.

[0016] According to one embodiment the groove extends along the entire circumference of the other one of the outer surface of the delivery member shield remover or the inner surface of the tubular portion.

[0017] According to one embodiment at least some of the tongues have an outer surface provided with a wavelike pattern in the circumferential direction of the cap body. The wavelike pattern may facilitate creating local contact between the delivery member shield remover and the tongues.

[0018] According to one example, all the tongues have an outer surface provided with a wavelike pattern in the circumferential direction of the cap body.

[0019] According to one embodiment the tongues have bevelled distal ends. This facilitates radial deflection of the tongues when the delivery member shield is being inserted between the tongues during assembly.

[0020] According to one embodiment the bevelled distal ends are bevelled in a direction radially inwards.

[0021] According to one embodiment the cap body comprises a polymer material.

[0022] According to one embodiment the delivery member shield remover comprises metal. According to one embodiment the structures are radially inward extending tabs.

[0023] According to one embodiment the delivery member shield remover extends beyond the distal end of the cap body in a direction towards the distal end.

[0024] There is according to a second aspect provided a medicament delivery device comprising a cap assembly of the first aspect.

[0025] One embodiment comprises a syringe having a delivery member, and a delivery member shield arranged around the delivery member, wherein the delivery member shield is arranged between the tongues which are flexed radially outwards and bear against an inner surface of the delivery member shield remover, wedging the tongues between the delivery member shield and the delivery member shield remover.

[0026] There is according to a third aspect provided an assembly for a medicament delivery device including a delivery member shield, the cap assembly comprising: a delivery member shield, a hollow outer cap body having a proximal end, and an open distal end, wherein the cap body has radially flexible tongues extending towards the distal end inside the outer body, and wherein the flexible tongues are configured to receive the delivery member shield between them, a delivery member shield remover arranged to releasably engage with the cap body, the delivery member shield remover being arranged coaxially with and radially outside the tongues, wherein the delivery member shield remover has radially inward extending structures arranged to engage with the delivery member shield, and wherein when the delivery member shield has been received between, and bears against the tongues, the tongues are forced to flex radially outwards and press against an inner surface of the delivery member shield remover, wedging the tongues between the delivery member shield and the delivery member shield remover.

[0027] 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, component, means”, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, etc., unless explicitly stated otherwise.

[0028] BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:

[0030] Fig. i is a perspective view of an example of a medicament delivery device;

[0031] Fig. 2 is an exploded view of the medicament delivery device in Fig. 1;

[0032] Fig. 3 shows a perspective view of a cap assembly;

[0033] Fig. 4 is a perspective view of a delivery member shield remover of the cap assembly;

[0034] Fig. 5 is a sectional view of a cap body of the cap assembly;

[0035] Fig. 6 is a sectional view of the cap assembly, including the delivery member shield remover;

[0036] Fig. 7 is a perspective view of a syringe;

[0037] Fig. 8 is a longitudinal section of a proximal portion of the medicament delivery device in Fig. 1; and

[0038] Fig. 9 is a perspective view of another example of a cap body.

[0039] DETAILED DESCRIPTION

[0040] The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like numbers refer to like elements throughout the description.

[0041] 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.

[0042] 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.

[0043] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

[0044] 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.

[0045] Fig. i is a perspective view of an example of a medicament delivery device i.

[0046] The medicament delivery device 1 is according to the example an autoinjector. The medicament delivery device 1 comprises a housing 3.

[0047] The medicament delivery device 1 comprises a removable cap assembly 4.

[0048] The exemplified medicament delivery device 1 is merely one example of a device comprising a cap assembly according to the present disclosure.

[0049] The cap assembly 4 may be arranged around a delivery member shield protecting the delivery member of a medicament container arranged inside the housing 3.

[0050] The medicament delivery device 1 has a proximal end la and a distal end ib. The distal end ib is the rear end of the medicament delivery device 1. The opposite end of the medicament delivery device 1 is the proximal end la.

[0051] Fig. 2 is an exploded view of the medicament delivery device 1.

[0052] The medicament delivery device 1 comprises a delivery member cover 5. The delivery member cover 5 is at least partly received by the housing 3.

[0053] The delivery member cover 5 is configured to move axially relative to the housing 3. The delivery member cover 5 is configured to move along the longitudinal axis of the housing 3, between an extended position relative to the housing 3 and a retracted position relative to the housing 3.

[0054] The medicament delivery device 1 comprises a medicament container assembly. The medicament container assembly comprises a medicament container 9a, which holds a drug, arranged in the housing 3, and a delivery member 9b, e.g., a needle, assembled with the medicament container 9a. The medicament container assembly also comprises a delivery member shield, in the form of a rigid needle shield 9c and / or a flexible needle shield 9d arranged around the delivery member 9b. The delivery member shield 9c, 9d is configured to be arranged around the delivery member 9b to protect the delivery member 9b mechanically as well as for sterility. The medicament container assembly maybe a syringe. The cap assembly 4 comprises a cap body 4a and a delivery member shield remover 4b configured to be attached to the cap body 4a.

[0055] The delivery member shield remover 4b is arranged to engage with, or grip into the delivery member shield 9c, 9d.

[0056] Before use, the cap assembly 4 is attached to the delivery member shield 9c, 9d, in a state of the medicament delivery device 1 shown in Fig. 1.

[0057] When the cap assembly 4 is removed, the delivery member shield, i.e., the rigid needle shield 9c and / or the flexible needle shield 9d, is removed from the delivery member 9b together with the cap assembly 4.

[0058] The medicament delivery device 1 comprises a medicament container holder 11. The medicament container holder 11 is configured to hold the medicament container 9a. The medicament container holder 11 is arranged in the housing 3. The medicament container holder 11 may be arranged to be axially fixed relative to the housing 3. The medicament container holder 11 may for example comprise radial protrusions extending radially outwards, configured to be received by corresponding openings in the housing 3 for engaging the medicament container holder 11 with the housing 3. The medicament container holder 11 may be immovably arranged relative to the housing 3.

[0059] The medicament delivery device 1 comprises a first resilient member 7 arranged to bias the delivery member cover 5 in the proximal direction, i.e., towards the extended position. The first resilient member 7 may be a spring, e.g., a compression spring. The first resilient member 7 may for example be arranged around, and bear against the medicament container holder 11.

[0060] The medicament delivery device 1 comprises a plunger rod 13. The plunger rod 13 is axially movable relative to the housing 3. The plunger rod 13 is configured to extend into the medicament container 9a to push the drug from the medicament container 9a through the delivery member 9b.

[0061] The plunger rod 13 is biased in a first direction, which is the proximal direction, i.e., towards the proximal end la of the medicament delivery device 1. The medicament delivery device 1 comprises a second resilient member 15, such as a spring, e.g., a compression spring, that biases the plunger rod 13 in the proximal direction.

[0062] The medicament delivery device 1 may further comprise a rod 17 around which the second resilient member 15 is arranged, for stabilising the second resilient member 15.

[0063] The plunger rod 13 is configured to move in the proximal direction inside the housing 3, from an initial axial position to a final position.

[0064] The plunger rod 13 may comprise radial recesses 13a.

[0065] The medicament delivery device 1 may comprise a U-shaped bracket 19. The U-shaped bracket 19 is arranged with its bottom of the U-shape facing towards the distal end ib of the medicament delivery device 1. The second resilient member 15 is configured to bias the U-shaped bracket 19 in the distal direction.

[0066] The medicament delivery device 1 comprises a rotator 21 and a rear cap structure 23.

[0067] The rear cap structure 23 is configured to engage with the plunger rod 13 to maintain the plunger rod 13 in its initial axial position. The rear cap structure 23 has a tubular proximal portion provided with radially flexible arms 23a. Each flexible arm 23a is configured to engage with a respective radial recess 13a of the plunger rod 13 before the medicament delivery device 1 has been activated or triggered to perform medicament delivery.

[0068] The rotator 21 is arranged radially outside of and around the tubular proximal portion. The rotator 21 is configured to rotate relative to the tubular proximal portion from a first rotational position, which it holds prior to activation of the medicament delivery device 1, to a second rotational position. The rotator 21 has an inner surface which when the rotator 21 is in the first rotational position bears against the flexile arms 23a, preventing the flexible arms 23a to disengage from a respective one of the radial recesses 13a.

[0069] The rotator 21 has an inner surface provided with inner recesses or windows which are arranged circumferentially offset from the flexible arms 23a when the rotator 21 is in the first rotational position.

[0070] The rotator 21 is configured to cooperate with the delivery member cover 5 when the delivery member cover 5 is moved linearly from the extended position towards the retracted position. The rotator 21 is configured to translate linear movement of the delivery member cover 5 to rotation. The rotator 21 has a guide structure 21a configured to cooperate with radially inwards extending pins of distally extending legs 5a of the delivery member cover 5 such that when the delivery member cover 5 is moved towards the retracted position the pins cooperate with cam surfaces of the guide structure 21a. This causes rotation of the rotator 21 from the first rotational position to the second rotational position. When the delivery member cover 5 reaches the retracted position, the inner recesses, or windows, of the inner surface of the rotator 21 align with the flexible arms 23a of the rear cap structure 23.

[0071] The flexible arms 23a are thereby able to flex radially outwards and disengage from the radial recesses 13a of the plunger rod 13 and the plunger rod 13 is thus released to move axially from the initial axial position towards the final position.

[0072] When the plunger rod 13 is released and reaches its final position, the U- shaped bracket 19 which previously was in engagement with the rear cap structure 23 is released and impacts with a radial surface, e.g., inside the rear cap structure 23. This causes an audible click, indicating that the medicament delivery operation has been finalised.

[0073] Fig. 3 is a perspective view of an example of the cap assembly 4. The cap body 4a is hollow. The cap body 4a has a proximal end 4a-i and a distal end 4a-2, which is an open end. The proximal end 4a-i maybe a closed end. The cap body 4a may comprise a polymer material. The cap body 4a may for example be made of plastics.

[0074] The delivery member shield remover 4b may be tubular. The delivery member shield remover 4b is configured to be attached to the cap body 4a. The delivery member shield remover 4b is releasably attachable to the cap body 4a. The delivery member shield remover 4b is arranged coaxially with the cap body 4a inside the cap body 4a.

[0075] The delivery member shield remover 4b has radially inwards extending structures 4b-i. The radially inwards extending structures 4b-i are arranged to engage with the delivery member shield 9c, 9d. The radially inwards extending structures 4b-i are distributed along the circumferential direction of the delivery member shield remover 4b. The radially inwards extending structures 4b-i maybe axially aligned, i.e., they maybe arranged in the same transverse plane. The radially inwards extending structures 4b-i are radially flexible. The radially inwards extending structures 4b-i maybe provided in a distal end portion of the delivery member shield remover 4b. The radially inwards extending structures 4b-i may be radially inward extending tabs.

[0076] The distal end portion of the delivery member shield remover 4b may extend axially beyond the distal end 4a-2 of the cap body 4a. The delivery member shield remover 4b may thus protrude from the cap body 4a. The radially inwards extending structures 4b-i may thus be arranged outside the cap body 4a.

[0077] The delivery member shield remover 4b may be made of metal.

[0078] Fig. 4 is a perspective view of the delivery member shield remover 4b. According to the example, the delivery member shield remover 4b has a rib 4b-2. The rib 4b-2 is provided on the outer surface of the delivery member shield remover 4b. The rib 4b-2 may extend circumferentially. The rib 4b-2 may extend along the entire circumference of the delivery member shield remover 4b. The rib 4b-2 maybe arranged along a proximal end portion of the delivery member shield remover 4b. Fig. 5 depicts a longitudinal section of the cap body 4a. The cap body 4a has a plurality of radially flexible tongues 43-3 extending towards the distal end 4a- 2 inside the outer body 4a. The tongues 43-3 are configured to receive the delivery member shield 9c, 9d between them. The tongues 43-3 are designed to receive the delivery member shield 9c, 9d with a tight fit.

[0079] The tongues 4a-3 may extend from a proximal wall 4a-4 of the cap body 4a in a direction towards the distal end 4a-2.

[0080] The tongues 4a-3 may oppose one another in a radial direction. In the illustrated embodiment, there are two tongues 4a-3. The tongues 43-3 are spaced equally in a circumferential direction, so in the illustrated embodiment by 180 degrees. In other embodiments, different numbers of tongues 4a-3, e.g. two or more tongues 4a-3, may be provided.

[0081] The delivery member shield remover 4b is arranged radially outside the tongues 43-3.

[0082] The cap body 4a has a tubular portion 43-5. The tubular portion 43-5 may extend from the proximal wall 4a-4 in a direction towards the distal end 4a-2 of the cap body 4a. The tubular portion 4a-b may have a shorter axial extension than the axial length of the tongues 4a-3.

[0083] According to the example, the tubular portion 43-5 has a groove 4a-6 provided in its inner surface. The groove 4a-6 may extend circumferentially. The groove 4a-6 may extend along the entire circumference of the tubular portion 43-5.

[0084] The groove 4a-6 is configured to receive the rib 4b-2 of the delivery member shield remover 4b. The delivery member shield remover 4b is thereby engaged with the cap body 4a. The delivery member shield remover 4b is thus prevented from moving axially relative to the cap body 4a.

[0085] As an alternative to the above, the rib maybe provided on the inner surface of the tubular portion and the delivery member shield remover may be provided with the groove, or with a slot, arranged to engage with the rib. According to one example, the tongues 4a-3 have bevelled distal ends 4a-y. The bevelled distal ends 4a-7 maybe bevelled in a direction radially inwards. The radial thickness of the tongues 4a-3 may thus increase gradually in a direction towards the proximal end 4a-i of the cap body 4a. Alternatively, the distal ends of the tongues may not be bevelled. The distal ends may for example present an outer surface that is perpendicular or essentially perpendicular to the inner surface of the respective tongue.

[0086] As shown in Fig. 6, in an assembled state of the cap assembly 4, prior to receiving a delivery member shield 9c, 9d, a proximal end portion of the delivery member shield remover 4b is arranged radially in between the tubular portion 43-5 and the tongues 4a-3. The rib 4b-2 engages with the groove 4a-6. The outer surface of each tongue 43-3 is radially spaced apart from the inner surface of the delivery member shield remover 4b.

[0087] Fig. 7 shows the medicament container assembly 9 in an assembled state, with the delivery member shield 9c, 9d arranged around the delivery member 9b.

[0088] Turning now to Fig. 8, a longitudinal section of a proximal portion of the medicament delivery device 1 in the state depicted in Fig. 1 is shown. The cap assembly 4 is thus fitted to the delivery member shield 9c, 9d, and according to the example, attached to the housing 3. The tongues 43-3 are flexed radially outwards by the delivery member shield 9c, 9d, which is arranged between the tongues 4a-3, and which has a radial dimension that is larger than the radial distance between the tongues 4a-3. The tongues 43-3 flex out such that they bear against the inner surface of the delivery member shield remover 4b. The tongues 43-3 are thus wedged between the inner surface of the delivery member shield remover 4b and the outer surface of the delivery member shield 9c, 9d. As a result, in case the medicament delivery device 1 is accidentally dropped, the risk that the delivery member shield remover 4b disengages from the cap body 4a is reduced. Fig. 9 shows a second example of a cap assembly 4’. The delivery member shield remover, which is identical to the delivery member shield remover 4b described above, is not shown. Some, or all the tongues 4a’-3 of the cap body 4a’ have an outer surface provided with a wavelike pattern 5 in the circumferential direction of the cap body 4a’-3. The outside surface of the tongues 4a’-3 is thus undulating in the circumferential direction. The wave crests of the wavelike pattern may be pointy, or sharp, or smooth. The cap assembly 4’ is otherwise identical to the cap assembly 4.

[0089] The medicament delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0090] 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, extmyasthenia gravis, Behqet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycaemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE) -mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, Factor V Leiden), and cancer. 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.

[0091] 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.

[0092] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-i (GLP-i) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Ci esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor- associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-1 / PD-L1) inhibitors / modulators, B-lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, B-lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulators, lymphocyte-activation gene 3 (LAG3; also known as cluster of differentiation 223 or CD223) antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation W137 (CDW137) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD159 or NKG2) modulators, glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig- like receptor (KIR) modulators, growth arrest-specific protein 6 (GAS6) / AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation W123 (CDW123) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumorinfiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies.

[0093] 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.

[0094] 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.

[0095] 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.

[0096] 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.

[0097] 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.

[0098] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mF0LF0X6, mFOLFOXy, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini- CHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC- EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, 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.

[0099] The inventive concept has mainly been described above with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.

Claims

CLAIMS1. Cap assembly (4; 4’) for a medicament delivery device (1) including a delivery member shield (9c, 9d), the cap assembly (4; 4’) comprising:- a hollow outer cap body (4a; 4a’) having a proximal end (4a-i), and an open distal end (4b-2), wherein the cap body (4a) has radially flexible tongues (4a-3; 4a’- 3) extending towards the distal end (4b-2) inside the cap body (4a; 4a’), the flexible tongues (4a-3; 4a’-3) being configured to receive a delivery member shield (9c, 9d) between them,- a delivery member shield remover (4b) arranged to releasably engage with the cap body (4a; 4a’), the delivery member shield remover (4b) being arranged coaxially with and radially outside the tongues (4a-3;4a’-3), wherein the delivery member shield remover (4b) has radially inward extending structures (4b-i) arranged to engage with a delivery member shield (9c, 9d), and wherein when a delivery member shield (9c, 9d) has been received between, and bears against the tongues (4a-3; 4a’-3), the tongues (4a-3; 4a’- 3) are forced to flex radially outwards and press against an inner surface of the delivery member shield remover (4b).

2. Cap assembly (4; 4’) as claimed in claim 1, wherein the cap body (4a; 4a’) comprises a tubular portion (43-5) arranged radially outside a proximal end portion of the delivery member shield remover (4b), wherein an outer surface of the delivery member shield remover (4b) is configured to engage with an inner surface of the tubular portion (43-5).

3. Cap assembly (4; 4’) as claimed in claim 2, wherein one of the outer surface of the delivery member shield remover (4b) and the inner surface of the tubular portion (43-5) has a rib (4b-2) and the other one of the outersurface of the delivery member shield remover (4b) and the inner surface of the tubular portion (43-5) has a groove (4a-6) configured to receive the rib (4b-2) for releasably engaging the delivery member shield remover (4b) with the cap body (4a; 4a’).

4. Cap assembly (4; 4’) as claimed in claim 3, wherein the rib (4b-2) extends along the entire circumference of the outer surface of the delivery member shield remover (4b) or the inner surface of the tubular portion (4a- 5)-5. Cap assembly (4; 4’) as claimed in claim 4, wherein the groove (4b-2) extends along the entire circumference of the other one of the outer surface of the delivery member shield remover (4b) or the inner surface of the tubular portion (43-5).

6. Cap assembly (4’) as claimed in any of the preceding claims, wherein at least some of the tongues (4a’-3) have an outer surface provided with a wavelike pattern (5) in the circumferential direction of the cap body (4a’).

7. Cap assembly (4; 4’) as claimed in any of the preceding claims, wherein the tongues (4a-3; 4a’-3) have bevelled distal ends (43-7).

8. Cap assembly (4’) as claimed in claim 7, wherein the bevelled distal ends (43-7) are bevelled in a direction radially inwards.

9. Cap assembly (4; 4’) as claimed in any of the preceding claims, wherein the cap body (4a; 4a’) comprises a polymer material.

10. Cap assembly (4; 4’) as claimed in any of the preceding claims, wherein the delivery member shield remover (4b) comprises metal. ii. Cap assembly (4; 4’) as claimed in any of the preceding claims, wherein the structures (4b-i) are radially inward extending tabs.

12. Cap assembly (4; 4’) as claimed in any of the preceding claims, wherein the delivery member shield remover (4b) extends beyond the distal end (4a- 2) of the cap body (4a; 4a’) in a direction towards the distal end (4a-2).

13. Medicament delivery device (1) comprising a cap assembly (4; 4’) as claimed in any of the preceding claims.

14. Medicament delivery device (1) as claimed in claim 13, comprising a syringe having a delivery member (9b), and a delivery member shield (9c, 9d) arranged around the delivery member (9b), wherein the delivery member shield (9c, 9d) is arranged between the tongues (4a-3; 4a’-3) which are flexed radially outwards and bear against an inner surface of the delivery member shield remover (4b), wedging the tongues (4a-3; 4a’-3) between the delivery member shield (9c, 9d) and the delivery member shield remover (4b).

15. Cap assembly (4; 4’) for a medicament delivery device (1) including a delivery member shield (9c, 9d), the cap assembly (4; 4’) comprising:- a delivery member shield (9c, 9d),- a hollow outer cap body (4a; 4a’) having a proximal end (4a-i), and an open distal end (4a-2), wherein the cap body (4a; 4a’) has radially flexible tongues (4a-3; 4a’-3) extending towards the distal end (4a-2) inside the cap body (4a; 4a’), and wherein the flexible tongues (4a-3; 4a’-3) are configured to receive the delivery member shield (9c, 9d) between them,- a delivery member shield remover (9b) arranged to releasably engage with the cap body (4a; 4a’), the delivery member shield remover (4b) being arranged coaxially with and radially outside the tongues (4a-3;4a’-3), wherein the delivery member shield remover (4b) has radially inward extending structures (4b-i) arranged to engage with the delivery member shield (9c, 9d), andwherein when the delivery member shield (9c, 9d) has been received between, and bears against the tongues (4a-3; 4a’-3), the tongues (4a-3; 4a’- 3) are forced to flex radially outwards and press against an inner surface of the delivery member shield remover (4b), wedging the tongues (4a-3; 4a’-3) between the delivery member shield (9c, 9d) and the delivery member shield remover (4b).

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