Cassette for medicament delivery device

Abstract

The present disclosure relates to a cassette for a medicament delivery device, comprising a shell, a medicament bag configured to receive a fluid medicament, wherein the medicament bag comprises a port in fluid connection with an interior of the medicament bag. The medicament bag is enclosed by the shell. A gap is formed inside the shell configured to receive a peripheral part of the medicament bag and configured to allow the peripheral part of the medicament bag to move along the gap.

Description

[0001] CASSETTE FOR MEDICAMENT DELIVERY DEVICE

[0002] TECHNICAL FIELD

[0003] The present disclosure relates to a cassette for a medicament delivery device. In particular, the disclosure relates to a cassette containing a medicament bag which may be pressurised for medicament delivery.

[0004] BACKGROUND

[0005] Flexible medicament bags containing a liquid drug are used in various manually or automatically operated medicament delivery devices. However, the flexible nature of the medicament bag may in some cases lead to a collapse or deformation of the medicament bag during filling or during medicament delivery and thus hinder completely filling or emptying the medicament bag. This is of particular importance for higher volume bags.

[0006] With higher volumes, bending and kinking during or after the filling procedure starts with lower pressure inside the bag. Bending and kinking not only affect the filling and emptying completeness, but also might hinder the film barrier property, the seal seam integrity or might by identified as a quality issue. One way is to increase the footprint to remain the internal pressure low which is not beneficial for the overall device size.

[0007] Other cassettes according to the prior art hold the medicament bag at the seam in order to provide tension to the bag and avoid deformation to improve filling and emptying of the bag.

[0008] However, the solutions according to the prior art may not fully account for various bag shapes as well as the shape change during the filling and medicament delivery process. The present invention has thus been made to remedy the above shortcomings. In particular, the present invention may allow for a certain guided movement of the medicament bag within the cassette, therefore facilitating filling and ensuring a complete discharging of the drug.

[0009] SUMMARY

[0010] 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.

[0011] The present disclosure relates to a cassette for a medicament delivery device, comprising a shell, a medicament bag configured to receive a fluid medicament, wherein the medicament bag comprises a port in fluid connection with an interior of the medicament bag. The medicament bag is enclosed by the shell. A gap is formed inside the shell configured to receive a peripheral part of the medicament bag and configured to allow the peripheral part of the medicament bag to move along the gap.

[0012] Various embodiments may preferably implement the following features.

[0013] Preferably, a height of the gap is greater than a height (thickness) of the peripheral part of the medicament bag.

[0014] Preferably, the gap is formed at least laterally on two opposing sides of the shell, respectively. Preferably, the gap is formed at least on two lateral opposing sides of the shell.

[0015] Preferably, the shell comprises an upper shell and a lower shell.

[0016] Preferably, the lower shell comprises a tongue and the upper shell comprises a corresponding groove configured to receive the tongue. Preferably, the groove and the tongue substantially extend around the periphery of the upper shell and the lower shell, respectively.

[0017] Preferably, the port is fixed to the shell.

[0018] Preferably, the medicament bag is only fixed to the shell via the port.

[0019] Preferably, the medicament bag is fixed to the shell via the port by ultrasonic welding.

[0020] Preferably, the upper shell and the lower shell are connected by ultrasonic welding, and the port is connected to the upper shell and the lower shell by ultrasonic welding.

[0021] Preferably, the upper shell and the lower shell are assembled to each other in an air-tight manner.

[0022] Preferably, the cassette further comprises an air inlet port configured for connecting a pump for pressurising an internal space of the shell.

[0023] Preferably, the cassette further comprises a shroud removably or fixedly attached to the shell, wherein the air inlet port is provided in the shroud.

[0024] Preferably, the gap is configured to allow the peripheral part to move in a first axis direction and / or second axis direction while substantially blocking movement in a third axis direction.

[0025] Preferably, movement of the peripheral part is dependent on a filling state of the medicament bag.

[0026] 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 (x-axis direction, first axis direction, length). Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction (y-axis direction, second axis direction, width).

[0027] A height direction (z-axis direction, third axis direction, height) as used herein is a direction perpendicular to the x-y-plane.

[0028] 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.

[0029] 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.

[0030] BRIEF DESCRIPTION OF THE DRAWINGS

[0031] 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.

[0032] FIG. i shows an exploded view of a cassette according to an embodiment of the present disclosure.

[0033] FIGS. 2A to 2E show different stages of the assembly of a cassette according to an embodiment of the present disclosure.

[0034] FIG. 3A shows a side view of a cassette according to an embodiment of the present disclosure. FIG. 3B shows a partial sectional view along the line E-E of FIG. 3A.

[0035] DETAILED DESCRIPTION

[0036] The present disclosure relates to a cassette or a bag assembly for a medicament delivery device.

[0037] The cassette comprises a shell 31, 32 and a medicament bag 1 configured to receive a fluid medicament. The medicament bag 1 comprises a port 2 in fluid connection with an interior of the medicament bag 1. The medicament bag 1 is enclosed by the shell 31, 32. That is, the medicament bag 1 may be located in an internal space or volume of the shell 31, 32.

[0038] A gap 33 is formed inside the shell 31, 32 configured to receive a peripheral part 11 of the medicament bag 1 and configured to allow the peripheral part 11 of the medicament bag 1 to move or slide along the gap 33.

[0039] The gap 33 maybe provided on lateral sides si, S2 inside the shell 31, 32. The lateral sides si, S2 may refer to opposing sides. The lateral sides si, S2 may refer to opposing sides extending along the longitudinal direction of the device (x-axis). The lateral sides si, S2 may extend parallel to a filling direction of the medicament bag 11 via the port 2. In a substantially rectangular medicament bag 1 (such as also the wavy bag shown in FIG. 1), the lateral sides si, S2 may refer to the sides not comprising the port 2 and not opposing the port 2.

[0040] The peripheral part 11 may refer to at least a part of the circumference of the medicament bag 1. In particular, the peripheral part 11 may relate to the maximum extension of the medicament bag 1 in the lateral direction (positive / negative y-axis direction) and / or in the longitudinal direction (positive-negative x-axis direction).

[0041] Typically, a medicament bag 1 comprises a circumferential (welded) seam connecting and sealing two plastic sheets to another such that an internal volume for receiving a medicament is formed. The seam may constitute the peripheral part n. The port 2 may also be welded into the medicament bag’s i seam.

[0042] Movement of the medicament bag i, in particular the peripheral part n, is possible along a longitudinal extension of the gap 33. That is, the peripheral part 11 may be able to move in the positive and negative x-axis direction indicated in the figures, depending on a filling state of the medicament bag 1.

[0043] For example, when the medicament bag 1 is filled, the peripheral part 11 may move inside the gap 33 towards the port 2 (in the positive x-axis direction) and / or towards a centre line of the shell 31, 32 (y-axis direction). In the figures, the centre line may extend through the port 2 and an air inlet port 4 to be described later, but the port 2 and air inlet port 4 may also be provided on different positions than the ones depicted in the figures.

[0044] The medicament bag 1 depicted in the figures is a wavy or zig-zag shaped medicament bag 1 but the disclosure is not limited thereto. Such a wavy bag may improve exploitation of the internal volume of the medicament bag 1 by reducing or eliminating dead space (i.e., may ensure and facilitate proper filling of the bag 1) and may also ensure completely emptying the medicament bag 1 during medicament delivery. Moreover, bending or kinking of the medicament bag 1 may be avoided.

[0045] Such wavy shape may comprise one or more bumps that may be uniformly or irregularly distributed along a circumference of the medicament bag 1. The wave may be a substantially sinusoidal wave, triangular wave or asymmetrical wave. Alternatively, the medicament bag 1 may have a round shape, a rectangular shape or a substantially rectangular shape with at least one curved side (tapered).

[0046] The present disclosure can be applied irrespective of an outer shape of the medicament bag 1. Depending on the shape, more or less parts / area of the medicament bag’s circumference forms the peripheral part 11 received in the gap 33. As noted above, the peripheral part 11 may refer to the maximum lateral / longitudinal extension of the medicament bag i (such as the three tips per side of the medicament bag’s i waves shown in FIGS, i and 2B).

[0047] FIGS. 1 and 2B also show an optional channel 12 provided in the medicament bag i. Said channel 12 may extend along a centre line of the medicament bag 1 (which may correspond to the centre line of the shell 31, 32). The channel 12 maybe pre-formed and extend in the height direction (z-axis). The channel may be symmetrical with respect to the x-y plane or provided only in the positive or negative z-axis direction.

[0048] During emptying of the medicament bag 1, said channel may avoid that the two films of the medicament bag 1 contact each other (at least in the area of the channel 12) and block further removal of the fluid from the medicament bag 1. By providing the channel 12, the medicament can be fully extracted from the medicament bag 1 since the film layers to cannot adhere to one another over the complete area of the bag 1. Once most of the fluid has been removed and there is only fluid remaining in the channel 12, the channel 12 may collapse by pressure, thus completely pushing out the remaining fluid.

[0049] The channel 12 may substantially extend from the port 2 to the end of the bag 1 opposite the port 2 (in the longitudinal direction, x-axis). However, shape, diameter, cross-section and longitudinal extension may vary depending on the concrete requirements.

[0050] Instead of a one-part shell 31, 32, the cassette according to an embodiment may comprise an upper shell 31 and a lower shell 32 as exemplarily shown in the exploded view of FIG. 1. A medicament bag 1 is configured to receive a fluid medicament. The medicament bag 1 comprises a port 2 in fluid connection with an interior of the medicament bag 1. The medicament bag 1 is enclosed by the upper shell 31 and the lower shell 32. A gap 33 (slot) is formed between the upper shell 31 and the lower shell 32. Said gap 33 is configured to receive a peripheral part 11 of the medicament bag 1 and is configured to allow the peripheral part 11 of the medicament bag 1 to move along the gap 33. In particular, the gap 33 may allow the peripheral part 11 to move in a longitudinal direction with respect to the port 2.

[0051] As used herein, the terms upper shell 31 and lower shell 32 are not to be understood as limiting or requiring a certain orientation of the shells / shell parts or the cassette and can thus be used interchangeably. The shell parts may also be referred to as a first shell 31 and a second shell 32. The shell parts 31, 32 may substantially be mirror symmetric or, as noted above, identical / the same part. That is, the shell parts 31, 32 maybe integrally formed or formed as a monolithic element and the cassette may thus comprise a single shell part configured to receive the medicament bag 1. The detailed description exemplarily refers to an upper shell 31 and lower shell 32 but the present disclosure is not limited thereto.

[0052] The upper shell 31 and the lower shell 32 may form an outer appearance of the cassette.

[0053] As noted above, according to an embodiment, the gap 33 is dimensioned such that the peripheral part 11 of the medicament bag 1, e.g., a seam or part of a seam of the medicament bag 1, is received therein but able to move. That is, the medicament bag is not being held but rather guided in the gap 33. This maybe advantageous during filling and / or emptying of the medicament bag 1 since the peripheral shape or dimensions of the medicament bag 1 may change according to a filling state of the medicament bag 1.

[0054] Hence, a height g of the gap may be greater than a height b (thickness) of the peripheral part 11 of the medicament bag 1 (see FIG. 3B). The height g may herein refer to a distance between upper and lower shell 31, 32 in the gap region, i.e., the z-direction in the figures.

[0055] The gap height g may also substantially correspond to the peripheral part height b as long as it allows relative movement of the peripheral part 11 in the gap 33- The gap 33 may be formed laterally. Said gap 33 may be formed on two lateral opposing sides si, S2 (opposing in the y-axis direction), or on at least three sides between the upper shell 31 and the lower shell 32.

[0056] In FIG. 1, the gap 33 is shown as substantially extending around an inner circumference of the upper shell 31 and the lower shell 32. However, the gap 33 may also be provided in segments corresponding to an outer shape of a medicament bag 1 placed inside the cassette.

[0057] The cassette may also comprise an air inlet port 4 formed between the upper shell 31 and the lower shell 32. The air inlet port 4 may be used to pressurise an interior of the cassette, i.e., the space between the upper shell 31 and the lower shell 32, e.g., by attaching a driving system comprising an air pump (not shown). Thereby, a fluid (e.g., a medicament) contained in the medicament bag 1 may be emptied through the port.

[0058] Although the air intake port 4 is shown on a side opposing the port 2, the present disclosure is not limited thereto and the port 4 may be provided on any side of the cassette.

[0059] The assembled state as used herein may refer to the cassette after manufacture, as shipped to a pharmacist (e.g., empty, filled) or as handed out to a patient (e.g., filled). Assembly of the cassette will be further described below. In the assembled state of the cassette, the port 2 may be fixed to the upper shell 31 and the lower shell 32. In particular, the medicament bag 1 may be only fixed via the port 2 (or at the port region) to the upper shell 31 and the lower shell 32.

[0060] Further, in the assembled state, the cassette maybe hermetically sealed, i.e., in an air-tight manner.

[0061] A shape of the upper shell 31 and / or the lower shell 32 may substantially follow a contour of a medicament bag 1 in a filled state, i.e., in its maximum height extension (z-axis). Alternatively, the upper shell 31 and / or the lower shell 32 may have an internal cavity for receiving the medicament bag 1 therein and a regular outer appearance or a combination of the above.

[0062] FIG. 2A shows a first assembly step of a cassette according to an embodiment in which the lower shell 32 is provided. With respect to FIG. 1, the lower shell 32 is turned by 180°.

[0063] Then, the medicament bag 1 is placed in the lower shell 32 as shown in FIG. 2B and the upper shell 31 is placed on the lower shell (FIG. 2C).

[0064] The upper shell 31 and the lower shell 32 are subsequently connected. In particular, as noted above, the upper shell 31 and lower shell 32 maybe connected to form an air-tight inner chamber.

[0065] Said connection may particularly be achieved by ultrasonic welding, but may also be achieved by gluing, snap-fit or any other suitable method. Subsequently, the port 2 is connected to the upper shell 31 and the lower shell 32. This may be done by ultrasonic welding or any other of the above- mentioned methods.

[0066] Thereby, the upper shell 31 and the lower shell 32 are assembled to each other in an air-tight manner. This also includes the port 2 assembled to the upper shell 31 and the lower shell 32.

[0067] FIG. 2D shows an assembled and sealed cassette according to an embodiment, wherein the view is rotated by 180° with respect to FIG. 2C.

[0068] As noted above, the cassette may further comprise an air inlet port 4 configured for connecting an air pump for pressurising the space between the upper shell 31 and the lower shell 32. The air inlet port 4 may, e.g., comprise a one-way valve sealing an interior of the cassette or may be open but seal the interior once a driving system is connected to the cassette. That is, depending on the driving system to be attached, the cassette may be fully sealed or sealed on all sides apart from the air inlet port 4. In an embodiment, the cassette further comprises a shroud 5 (removably or fixedly) connected to the upper shell 31 and the lower shell 32. The shroud 5 is also connected in an air-tight manner to the upper shell 31 and the lower shell 32. The air inlet port 4 may be provided in the shroud 5. In case a driving system is not to be attached directly to the cassette, the shroud 5 may allow attachment of a driving system to the cassette for pressurising the interior of the cassette and for allowing medicament delivery. As noted above, the shroud 5 is shown opposite the port 2 but the present disclosure is not limited to this configuration and the shroud 5 (and / or the air intake port 2) may be provided on any side of the cassette. However, the shroud function can also be integrated in any one of the shell parts 31, 32 or the port 2.

[0069] Although an assembling / welding sequence has been described in which the medicament bag 1 is placed in the lower shell 32 and subsequently, the upper shell 31 is attached to the lower shell 32 and the port is attached to the upper and lower shell 31, 32, the present disclosure is also applicable to other assembling sequences.

[0070] For example, the port may first be welded to one shell (preferably from the inside) and the second shell may then be welded on top to seal the cassette. Also, the shell parts may be welded to each other or manufactured as a single part having a slot or gap allowing insertion of the bag. The port is subsequently welded to the pre-assembled shells with a wide collar to seal the slot or gap. Further alternatively, the port may comprise a seal, such as an O- ring or the like, which, when placed between the shell parts seals the shell parts welded to one another.

[0071] FIG. 3A is a lateral view of a cassette according to an embodiment in the assembled state and also showing the optional shroud 5 attached.

[0072] As can be seen in this view, the shape of the cassette, i.e., the upper shell 31 and the lower shell 32, may substantially follow a contour of the medicament bag 1 but other shapes may also be possible. FIG. 3B is a partial sectional view along the line E-E of FIG. 3A showing the gap 33 formed between the upper shell 31 and the lower shell 32. As noted above, the height g of the gap 33 maybe larger than the height / thickness b of the peripheral part / seam 11 of the medicament bag 1.

[0073] According to an embodiment, the upper shell 31 comprises a groove 35 and the lower shell 32 comprises a corresponding tongue 34 configured to be received in the groove 35, or vice versa. In an embodiment, the groove 35 and the tongue 34 substantially extend around the periphery of the upper shell 31 and the lower shell 32, respectively (apart from the port 2 region and air inlet port 4 region). However, the contact surfaces between the upper shell 31 and the lower shell 32 may also have another engaging shape or be flat.

[0074] As shown in the cross section of FIG. 3B, the periphery or parts of the periphery of the medicament bag 1 may be guided in the gap 33 without being held. That is, the gap 33 may allow movement of the medicament bag 1, in particular its peripheral region, in the longitudinal and the lateral direction (x-axis / y-axis). The term periphery / peripheral region may refer to a seam or sealing region of the medicament bag 1, generally extending around the medicament bag 1 except for the port 2 region.

[0075] The gap 33 may be particularly useful for filling and emptying of the medicament bag 1. When a medicament bag 1 is filled, its height extension (z- axis direction) changes, thus also affecting the outer shape, i.e., the peripheral region / peripheral part 11 of the medicament bag 1. In other words, when the medicament bag 1 expands, the sides of the bag 1 may contract to compensate for the change of internal volume. That is, during filling, the medicament bag 11 may contract in the x-axis direction and / or y-axis direction. Consequently, the medicament bag 1 may expand in the x-axis direction and / or y-axis direction when the medicament bag 1 is emptied. This contraction or expansion may then lead to a (sliding) movement of the peripheral part 11 in the gap 33. Hence, by fixing the medicament bag 1 only in the port 2 region to the cassette and allowing it and the peripheral part n, respectively, to be guided in the gap 33, the medicament bag 1 may be able to move while still being guided, thus allowing complete filling of the medicament bag 1 and thus using its full capacity. This may particularly apply to the longitudinal direction. The same applies to the emptying process in which the medicament bag 1 may also change its outer shape in the reverse direction.

[0076] The gap 33 can be easily adjusted to the needs (dimension, surface, parallelism), e.g., by using an injection moulding process. The medicament bag 1 may be positioned and supported by the cassette / vessel but is not fixed in the longitudinal direction with respect to the port 2.

[0077] In the figures, a medicament bag 1 having a zig-zag shape or wave shape is shown as an example. This shows that the present disclosure is also applicable to irregularly shaped medicament bags 1 where only parts of the periphery are guided in the gap 33. However, the present disclosure may in principle be applied to any sort and shape of medicament bag 1 and cassette.

[0078] The delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders.

[0079] 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, hi dradenitis 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, 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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, loo U / mL Heparin Lock Flush Solution, or 5000 U / mL Heparin Lock Flush Solution.

[0088] 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.

[0089] 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. 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. Cassette for a medicament delivery device, comprising:- a shell (31, 32);- a medicament bag (1) configured to receive a fluid medicament, wherein the medicament bag (1) comprises a port (2) in fluid connection with an interior of the medicament bag (1); wherein the medicament bag (1) is enclosed by the shell (31, 32); wherein a gap (33) is formed inside the shell (31, 32) configured to receive a peripheral part (11) of the medicament bag (1) and configured to allow the peripheral part (11) of the medicament bag (1) to move along the gap (33).

2. Cassette according to claim 1, wherein a height (g) of the gap (33) is greater than a height (b) of the peripheral part (11) of the medicament bag (1).

3. Cassette according to claim 1 or 2, wherein the gap (33) is formed laterally on two opposing sides (si, S2) of the shell (31, 32), respectively.

4. Cassette according to any one of claims 1 to 3, wherein the shell comprises an upper shell (31) and a lower shell (32).

5. Cassette according to any one of claims 1 to 4, wherein the lower shell (32) comprises a tongue (34) and the upper shell (31) comprises a corresponding groove (35) configured to receive the tongue (34).

6. Cassette according to claim 5, wherein the groove (35) and the tongue (34) substantially extend around the periphery of the upper shell (31) and the lower shell (32), respectively.

7. Cassette according to any one of claims 1 to 6, wherein the port (2) is fixed to the shell (31, 32).

8. Cassette according to any one of claims 1 to 7, wherein the medicament bag (1) is only fixed to the shell (31, 32) via the port (2), preferably by ultrasonic welding.

9. Cassette according to any one of claims 4 to 8, wherein the upper shell (31) and the lower shell (32) are connected by ultrasonic welding, and the port (2) is connected to the upper shell (31) and the lower shell (32) by ultrasonic welding.

10. Cassette according to any one of claims 4 to 9, wherein the upper shell (31) and the lower shell (32) are assembled to each other in an air-tight manner.

11. Cassette according to any one of claims 1 to 10, wherein the cassette further comprises an air inlet port (4) configured for connecting a pump for pressurising an internal space of the shell (31, 32).

12. Cassette according to claim n, wherein the cassette further comprises a shroud (5) removably or fixedly attached to the shell (31, 32), wherein the air inlet port (4) is provided in the shroud (5).

13. Cassette according to any one of claims 1 to 12, wherein the gap (33) is configured to allow the peripheral part (11) to move in a first axis direction (x) and / or second axis direction (y) while substantially blocking movement in a third axis direction (z).

14. Cassette according to any one of claims 1 to 13, wherein movement of the peripheral part (11) is dependent on a filling state of the medicament bag (1).

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