Filling tool

Abstract

The present disclosure relates to a filling tool (adapter) for a medicament container comprising a casing having an entry port and a filling port in fluid combination with the entry port, wherein the filling port is configured to be connected to the medicament container, an actuator, a flexible element having a first end fixedly attached to the casing and a second end removably attached to the casing, wherein the flexible element extends over the actuator and a safety element releasably engaged with the actuator, wherein the safety element is configured to block movement of the actuator when engaged with the actuator. The safety element is tethered to the flexible element. The safety element is disengaged from the actuator when the second end of the flexible element is removed from the casing, thus allowing movement of the actuator.

Description

[0001] FILLING TOOL

[0002] TECHNICAL FIELD

[0003] The present disclosure relates to a filling tool or an adapter for a medicament delivery device as well as a corresponding medicament delivery system.

[0004] BACKGROUND

[0005] Depending on the type of medicament delivery device, a medicament container is pre-filled in a pharmacy, a hospital or by the patients themselves.

[0006] Medications may be compounded - prepared in an aseptic manner - by a pharmacy from vials or other bulk storage containers. These medications can vary and comprise fixed dosing, weight -based dosing, or body surface area dosing using syringes, needles, and vial spikes. Additionally, medications maybe compounded even if the dose is not variable (i.e., “fixed” or “flat” dosing”) or if a filled vial is the only available form (i.e., a prefilled reservoir, such as a flexible bag, is not available). This is in the case for, e.g., some biologic medications and investigational medications used in clinical trials.

[0007] According to current workflows, a pharmacist or pharmacy technician prepares a given medicament compound (e.g., 50mL of an oncology medication) and places it in a final container, such as a syringe, IV bag, or medication cassette. As each component of medication is added to the final container, the patient dose is thereby compounded.

[0008] In pharmacy / compounding settings, better solutions are needed to improve the usability, intuitiveness, and ensure that the mental model for use is apparent to a user with clinical training, such as a pharmacist or pharmacy technician but also to patients having no technical or medicinal knowledge but being required to prepare a medication themselves. Additionally, better solutions are needed to improve compatibility of such a device with protocols commonly used in pharmacy compounding environments to prepare sterile parenteral medications. Further, in order to ensure correct medicament delivery and dosage, it is important that the medicament container is correctly filled and sealed since improper or premature sealing may adversely affect the medicament delivery or lead to an undesired spillage.

[0009] It is therefore an object of the present disclosure to provide a filling tool facilitating filling of a drug into a medicament container. Moreover, it is an object of the present disclosure to ensure correct use of the filling tool and thus prevent erroneous, insufficient or premature sealing of the container. It is also an object of the present disclosure to provide guidance to a user to ensure correct use of the filling tool.

[0010] These objects are met by the present disclosure.

[0011] SUMMARY

[0012] The invention is specified by the independent claims. 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.

[0013] The present disclosure relates to a filling tool (adapter) for a medicament container comprising a casing having an entry port and a filling port in fluid combination with the entry port, wherein the filling port is configured to be connected to the medicament container, an actuator, a flexible element having a first end fixedly attached to the casing and a second end removably attached to the casing, wherein the flexible element extends over the actuator and a safety element releasably engaged with the actuator, wherein the safety element is configured to block movement of the actuator when engaged with the actuator. The safety element is tethered to the flexible element. The safety element is disengaged from the actuator when the second end of the flexible element is removed from the casing, thus allowing movement of the actuator.

[0014] Various embodiments may preferably implement the following features. Preferably, the safety element is a cap partially extending over the actuator.

[0015] Preferably, the flexible element extends over the cap.

[0016] Preferably, the safety element is or comprises a protrusion or a pin.

[0017] Preferably, the safety element at least partially extends through the actuator.

[0018] Preferably, the entry port is configured for attaching a medicament reservoir and filling, through the filling port, a medicament into the medicament container.

[0019] Preferably, the flexible element is a peel-off label.

[0020] Preferably, the filling tool further comprises a closure assembly, wherein the closure assembly is actuated by moving the actuator and configured for sealing the medicament container.

[0021] Preferably, the actuator is a push button or a lever.

[0022] The present disclosure further relates to a system comprising a medicament container and the filling tool as outlined above. The filling tool is releasably connected to the medicament container.

[0023] Various embodiments may preferably implement the following features.

[0024] Preferably, the medicament container is a flexible bag.

[0025] Preferably, the system further comprises a cassette configured to receive the medicament container.

[0026] Preferably, the cassette is configured to be pressurised.

[0027] Preferably, the closure assembly comprises a sealing element and the actuator is configured, when actuated, to press the sealing element on the medicament container, thus sealing the medicament container.

[0028] Preferably, the filling tool is releasably attached to the cassette. Preferably, the filling tool comprises a release button configured to release attachment of the filling tool to the cassette when actuated.

[0029] In the present disclosure, the terms “longitudinal”, “longitudinally”, “axially” and “axial” refer to a direction extending from along the device or components thereof in the direction of the longest extension of the device and / or component (z-axis).

[0030] Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction (x- / y-axis).

[0031] 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.

[0032] 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.

[0033] BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings. In the figures, the same reference numerals denote the same or similar elements.

[0035] FIG. 1 shows a perspective view of a medicament delivery device with a filling tool according to an embodiment of the present disclosure. FIG. 2 shows a perspective view of a medicament delivery device with a filling tool during a filling process according to an embodiment of the present disclosure.

[0036] FIG. 3 shows a partially exploded view of a medicament delivery device with a filling tool according to an embodiment of the present disclosure.

[0037] FIG. 4A shows a partial view of a filling tool after a filling process according to an embodiment of the present disclosure.

[0038] FIG. 4B shows a safety element according to the embodiment of FIG. 4A.

[0039] FIG. 5 shows a perspective view of a medicament delivery device with a removed filling tool according to an embodiment of the present disclosure.

[0040] FIG. 6 shows a perspective view of a filling tool according to an embodiment of the present disclosure.

[0041] FIGS. 7A to 7C show flexible elements according to embodiments of the present disclosure.

[0042] FIGS. 8A and 8B show states of a medicament delivery device with a filling tool during a filling process according to an embodiment of the present disclosure.

[0043] FIGS. 9A and 9B show states of a medicament delivery device with a filling tool during a filling process according to an embodiment of the present disclosure.

[0044] FIG. 10 shows a cross-sectional view of a filling tool according to an embodiment of the present disclosure.

[0045] DETAILED DESCRIPTION

[0046] The terms filling tool and adapter maybe used synonymously in this disclosure. Moreover, some elements and functions which are known in the field of medicament delivery devices will not be described in detail for the sake of brevity.

[0047] The present disclosure relates to a filling tool or adapter for use with a medicament delivery device and, as shown in FIG. 1, to a system comprising a medicament delivery device and the filling tool.

[0048] In the following, reference will be made to a medicament delivery device having a cassette 5 which can be pressurised (pneumatic drive). This exemplary cassette is hermetically sealed and provided with a medicament container 3 (e.g., a flexible bag, not shown) which, as pressure is applied, pushes out the drug contained therein for medicament delivery. In this example, the port for pressurising is provided on a bottom end (negative z- axis) of the cassette 5 and has the form of a shroud 7. The delivery port through which the drug is dispensed is provided on an opposite end of the cassette 5 (in this view covered by the filling tool). However, the filling tool presented herein can also be used for different kinds of medicament delivery devices and the present disclosure is not limited to the shown configuration.

[0049] The filling tool comprises a casing 1 having an entry port 14 and a filling port 13 (not shown) in fluid combination with the entry port 14. The filling port 13 is configured to be connected to the medicament container 3 (not shown, in FIG. 1 within the cassette 5). The casing 1 has an actuator 11, and a flexible element 2. A first end of the flexible element 2 is substantially fixedly attached to the casing 1 (e.g., with a strong adhesive, wedged between the casing 1 and a cassette 5, or tucked under the casing 1) and a second end of the flexible element 2 is removably (e.g., with a weaker adhesive than the one used for the first end) attached to the casing 1. The flexible element 2 extends over the actuator 11 and a safety element 12 which is releasably engaged with the actuator 11. The safety element 12 is configured to block movement of the actuator 11 when engaged with the actuator 11. Further, the safety element 12 is tethered to the flexible element 2. Thus, the safety element 12 is disengaged from the actuator 11 when the second end of the flexible element 2 is removed from the casing 1 to allow movement of the actuator 11. The flexible element 2 extending over the actuator n encompasses a complete or partial extension over the actuator n. Moreover, as will also be evident from the following figures, the flexible element 2 may extend over the actuator n in a vertical direction (e.g., FIG. 1) or in a circumferential direction (e.g., FIG. 8A).

[0050] The actuator n maybe provided as part of a sealing assembly configured to seal the medicament container 3 after the filling process is completed. In particular, by moving the actuator 11, typically by pressing it downwards (negative z-axis), a sealing member is pushed onto the medicament container 3 at the filling port 13 to seal the drug within the container and allow storage, shipment or medicament delivery. A more detailed description of the sealing process via a filling tool is for example described in the document WO 2025 / 111000 Al.

[0051] FIG. 2 shows the filling tool of FIG. 1 during a filling process, i.e., attached to a cassette 5 and with a syringe 4 connected to the entry port 14. The entry port 14 may be a Luer port. The entry port 14 may be covered by a lid, a label, or a dust cap to prevent contamination. When the syringe 4 is attached, the medicament is pushed / pumped from the syringe 4, or another medicament container, via the entry port 14 and the filling port 13 (not shown) into the medicament container 3 housed within the cassette 5.

[0052] The flexible element 2 may comprise an opening or a cut-out for the entry port 14 to allow access to the entry port 14. In the figures, the flexible element 2 is shown to extend only on one lateral side of the entry port 14. However, the flexible element 2 may also be formed as a tongue extending on both lateral sides of the entry port 14 and having an (e.g., central) opening for allowing access to the entry port 14. With this configuration, the flexible element 2 may not be removed during the filling process with a syringe 4 attached since the removal would be blocked by the connection between the syringe 4 and the entry port 14. FIG. 3 shows the filling tool and cassette 5 of FIG. 1 in a partially exploded view in which the flexible element 2 and the safety element 12 have been removed from the casing 1 (see dashed lines).

[0053] In order to facilitate removal of the flexible element 2, it may comprise at least one-fold 21 (break, tear line, in the present configuration two folds 21 are shown) at which the flexible element 2 is allowed to bend. The flexible element 2 does therefore not need to be fully flexible, but it is sufficient that it maybe folded during removal. The flexible element 2 maybe made from, for example, paper, cardboard, plastics, a plastic foil, or a mixture thereof. The safety element 12 may be tethered / attached (e.g., glued, wedged, heat staking, co-moulding, etc.) to an inside of the flexible element 2. In that manner, when the flexible element 2 is (partially) removed or folded away from the casing 1, the safety element 12 is removed together with the flexible element 2.

[0054] The flexible element 2 may also be provided as a plurality of sub-elements. For example, two sub-elements 2 maybe wedged into two opposing sides of the safety element 12 such that the safety element 12 is removed together with the flexible element 2. Also, the flexible element 2 may comprise a subelement covering the entry port 14 to prevent contamination.

[0055] FIG. 4A is a partial enlarged view of the filling tool with the flexible element 2 folded away and the safety element 12 removed, and FIG. 4B shows a rear view of the removed safety element 12. As can be seen, the safety element 12 comprises at least one protrusion 120, in this case two, and the actuator 11 comprises at least one corresponding opening or recess no, in this case also two. As long as the protrusions 120 are received in the recesses no, i.e., as long as the safety element 12 is attached, the actuator 11 cannot be pressed downwards due to the protrusions 120 abutting an upper end of the casing 1. When the safety element 12 is removed together with the flexible element 2, the actuator 11 can be pressed for sealing the medicament container 3 as indicated by the arrow in FIG. 4A. After the medicament container 3 has been sealed, the filling tool may be removed from the cassette 5 by pressing at least one release button 15. In the figures, two lateral release buttons 15 are shown but the release button 15 may also be provided in a different form. Moreover, the filling tool may have a further internal safety mechanism preventing actuation of the release button 15 prior to actuation of the actuator 11.

[0056] FIG. 5 is a perspective view of the filling tool (flexible element 2 omitted) and the cassette 5 after filling and sealing the medicament container 3 by actuation of the actuator 11 and releasing the filling tool from the cassette 5 by pushing the release button 15. The cassette 5 may comprise a tubing set 6 on its upper end through which the drug contained in the medicament container 3 is delivered to a patient.

[0057] According to the embodiment shown in FIG. 6, the safety element 12 is a cap partially extending over the actuator 11. The cap 12 may cover the actuator on at least two sides and maybe open on one side. For example, the cap 12 may extend over the top, the front side and both lateral sides of the actuator 11 and be supported on the casing 1. Thus, the actuator 11 cannot be pressed down since the cap 12 covers the actuator 11 and sits on the top of the casing 1.

[0058] A rear side of the cap 12 maybe open to allow a swivel or swing movement for removal from the actuator 11. Note that the filling tool / casing 1 is turned by 180° compared to FIGS. 1 to 5 such that Fig. 6 shows a rear view of the casing 1 and the safety element 12. The swivel movement maybe in the x-y-plane, i.e., around the z-axis (longitudinal / vertical axis, lateral removal) or around the x-axis (horizontal axis, vertical removal). The working principle is the same as described above and the cap 12 may be tethered to the flexible element 2 for removal after the filling process.

[0059] The flexible element 2 may extend over the cap 12. As noted above, extension may encompass a variety of configurations partially or fully covering the cap 12 in a lateral and / or vertical direction. FIG. 7A shows an exemplary configuration of the flexible element 2 for lateral removal, wherein the flexible element 2 is shown in a flat, extended state. The slim part on the right-hand side is attached to the rear side of the casing, and on the left-hand side of the flexible element 2, the cap 12 is attached.

[0060] FIG. 7B shows a further exemplary configuration of the flexible element 2 for horizontal removal, wherein the flexible element 2 is shown in a flat extended state. The folds 21 are not indicated in FIG. 7B. The upper part of the flexible element 2 is attached to the back side of the casing 1, the middle part is folded over the actuator 11 and the front part is removably attached to the casing 1. An opening over the entry port 14 (see step number 1) is provided for allowing attachment of the syringe 4 or the like. A flap (see step number 2) is provided to facilitate gripping and removal. The flexible element 2 of FIG. 7C corresponds to the one of FIG. 7B but has a gripping ring or loop, i.e., a flap with a gripping hole.

[0061] As depicted in FIGS. 7 A to 7C and the following figures, the flexible element 2 maybe a label comprising information for a user, e.g., step-by-step instructions for use of the filling tool.

[0062] When folded over (or around) the casing, the configuration as shown in FIGS. 8A and 8B is achieved. FIG. 8A is a front view of the filling tool attached to the cassette 5, wherein the cassette 5 is transparently displayed and houses the medicament container 3. Step 1 comprises attaching the syringe 4 and filling, via the entry port 14, the medicament container 3. After removal of the syringe 4, the flexible element 2 may be detached from the front surface of the casing in step 2, taking the safety element 12 (in this case, the cap 12) with it. During the removal, the flexible element 2 may swivel around the fold 21. Hence, the actuator 11 is unlocked and ready to be operated in step 3 for sealing the medicament container 3. Finally, in step 4, the release button 15 is actuated for removing the filling tool from the cassette 5.

[0063] FIGS. 9A and 9B show an embodiment similar to the one of FIGS. 8A and 8B, wherein the flexible element 2 comprises a tear line and is partially removed from the filling tool. For example, the tear line maybe provided horizontally such that a lower part of the flexible element remains on the casing i and an upper part is folded away to remove the safety element 12 and expose the actuator 11.

[0064] The flexible element 2 may comprise a loop, ring, or flap (as shown in FIGS. 8 and 9) for facilitating gripping the flexible element 2.

[0065] The safety element 12 comprise a protrusion 120 as shown in FIG. 4B or may be formed as a pin. The safety element 12 may at least partially extend through the actuator 11.

[0066] In an embodiment, the entry port 14 is configured for attaching a medicament reservoir 4 (e.g., a syringe) and filling, through the filling port 13, a medicament into the medicament container 3.

[0067] The flexible element 2 maybe a peel-off label. The flexible element 2 may comprise instructions for using the filling tool.

[0068] The flexible element 2 may also cover and / or obstruct access to the release button 15 such that an inadvertent premature release is prevented.

[0069] Referring to FIG. 10, the filling tool may further comprise a closure assembly. As noted above, the closure assembly will be only briefly described herein and is laid out in more detail in, e.g., WO 2024 / 110558 Al, which is incorporated herein by reference.

[0070] The closure assembly is actuated by moving the actuator 11 and configured for sealing the medicament container 3. For that purpose, the closure assembly comprises a plunger 82, which is connected to and moved together with the actuator 11, and a gasket seal 81 provided on the plunger 82. The gasket seal 81 is provided on a side of the plunger 82 opposite to the actuator 11. After the medicament is filled in the medicament container 3 via the filling port 13, the actuator 11 is actuated. This pushes the gasket seal 81, via the plunger 82, onto the medicament container port 31 for sealing. The medicament can subsequently be delivered from the medicament container 3 via the tubing 6.

[0071] The actuator 11 maybe a push button or a lever.

[0072] The present disclosure further relates to a system comprising a medicament container 3 and the filling tool as outlined above. The filling tool is releasably connected to the medicament container 3.

[0073] The medicament container 3 maybe is a (flexible) bag. Further, the system may comprise a cassette 5 configured to receive the medicament container 3. The filling tool may be attached to the cassette 5 as outlined above. The cassette 5 maybe configured to be pressurised, e.g., via the pressure port 7.

[0074] The closure assembly may comprise a sealing element (e.g., gasket 81) and the actuator 11 may be configured, when actuated, to press the sealing element 81 on the medicament container 3 (e.g., a medicament container port 31), thus sealing the medicament container 3.

[0075] The filling tool may be releasably attached to the cassette 5. It may for example be released by actuating a release button 15. As shown in FIG. 10, hooks may be provided which, as the release button 15 is actuated, are disengaged from the cassette 5 to allow removal of the filling tool / casing 1.

[0076] According to the present disclosure, an improved and failure safe filling tool is presented ensuring correct medication and use of the filling tool itself. The flexible element ensures locking of the actuator during the filling process to prevent premature sealing and prevents inadvertent release of the filling tool prior to finishing the filling and sealing process.

[0077] The present disclosure facilitates the user-performed container closure, a critical step for pharmacy-filled cassettes, in a way that is ergonomic, reliable, and consistent with sterile compounding requirements and best practice. It also reduces the risk for errors during the filling and medicament delivery process. The present disclosure is also applicable for closed system transfer devices (CSTD). The CSTDs maybe used on the Luer port, but the present disclosure also encompasses CSTDs or other devices that are not removable from the Luer port after attachment, i.e., are disposed of together with the filling tool.

[0078] The possibility of providing user instructions on the flexible element / label additionally provides for a selective reveal design enforcing proper use steps and presenting only information required at each use step to an end user of the device.

[0079] Further, the flexible element allows incorporation of instructional content directly on the device, for situations where instructional materials cannot be introduced into use environment (e.g., paper IFU in a pharmacy cleanroom).

[0080] This may also encourage desired user actions and discourage undesired user actions by varying icon readability in different orientations (e.g., use steps are left-to-right reading only when cassette and filling tool are positioned as intended).

[0081] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0082] 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, Behqef 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.

[0083] 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.

[0084] 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.

[0085] 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 (CD 19) 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer’s solution, Heparin Lock Flush solution, 100 U / mL Heparin Lock Flush Solution, or 5000 U / mL Heparin Lock Flush Solution. Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or maybe 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.

[0091] 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.

[0092] 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.

Claims

CLAIMS1. Filling tool for a medicament container (3) comprising: a casing (1) having an entry port (14) and a filling port (13) in fluid combination with the entry port (14), wherein the filling port (13) is configured to be connected to the medicament container (3); an actuator (11); a flexible element (2) having a first end fixedly attached to the casing (1) and a second end removably attached to the casing (1), wherein the flexible element (2) extends over the actuator (11); a safety element (12) releasably engaged with the actuator (11), wherein the safety element (12) is configured to block movement of the actuator (11) when engaged with the actuator (11); wherein the safety element (12) is tethered to the flexible element (2); and wherein the safety element (12) is disengaged from the actuator (11) when the second end of the flexible element (2) is removed from the casing (1), thus allowing movement of the actuator (11).

2. Filling tool according to claim 1, wherein the safety element (12) is a cap partially extending over the actuator (11); and wherein the flexible element (2) extends over the cap.

3. Filling tool according to claim 1, wherein the safety element (12) is or comprises a protrusion or a pin.

4. Filling tool according to claim 1 or 3, wherein the safety element (12) at least partially extends through the actuator (11).

5. Filling to according to any one of claims 1 to 4, wherein the entry port (14) is configured for attaching a medicament reservoir and filling, through the filling port (13), a medicament into the medicament container (3).

6. Filling tool according to any one of claims 1 to 5, wherein the flexible element (2) is a peel-off label.

7. Filling tool according to any one of claims 1 to 6, further comprising a closure assembly, wherein the closure assembly is actuated by moving the actuator (11) and configured for sealing the medicament container (3).

8. Filling tool according to any one of claims 1 to 7, wherein the actuator (11) is a push button or a lever.

9. System comprising a medicament container (3) and the filling tool according to any one of claims 1 to 8, wherein the filling tool is releasably connected to the medicament container (3).

10. System according to claim 9, wherein the medicament container (3) is a flexible bag.

11. System according to claim 9 or 8, further comprising a cassette (5) configured to receive the medicament container (3).

12. System according to claim 11, wherein the cassette (5) is configured to be pressurised.

13. System according to any one of claims 9 to 12, wherein the closure assembly comprises a sealing element and the actuator (11) is configured, when actuated, to press the sealing element on the medicament container (3), thus sealing the medicament container (3).

14. System according to any one of claims 11 to 13, wherein the filling tool is releasably attached to the cassette (5);wherein the filling tool comprises a release button (15) configured to release attachment of the filling tool to the cassette (5) when actuated.

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