Film bag

Abstract

The present disclosure relates to a film bag comprising a port, two film layers welded to each other, enclosing the port and configured to form an internal volume for receiving a fluid. The film layers extend in a first axis direction and a second axis direction. A welding seam of the two film layers has a wave shape in a plane spanned by the first axis and second axis. The disclosure also relates to a corresponding enclosure.

Description

TECHNICAL FIELD The present disclosure relates to a film bag, and more particularly to a medicament bag. BACKGROUND Film bags, in particular film bags for storing medicaments, have been widely used and are known from the prior art. Such film bags exhibit excellent barrier properties and allow long storage, similar to glass vials. Such a film bag may consist of three main parts: a multilayer film, which is welded to a bag together with the port, which contains the interfaces and is the access to the drug content and lastly the closure to close the whole system. Such bags are often designed for a small form factor and fixed fill volumes, known in advance during consultations with a partner. Thus, the bag filling and dispense behaviours can be known in advance and design modifications maybe made during customisation for a specific content such as a medication. Typical volume values are 2-25 ml. However, depending on the use, e.g., the type of medicament or a prescription regimen, the design should be adapted for larger volume use. In that case, complete filling and emptying as well as safe storage independent of the volume to be filled must be ensured. An object of the present disclosure is thus to provide a film bag having a higher volume, e.g., 50 ml, 100 ml, or higher. Another object of the present disclosure is ensuring reliable filling and emptying of the film bag, even if the fill volume is not known in advance. Another object of the present disclosure is to provide a film bag suitable for use in both pharma fill (prefill) and pharmacy fill scenarios to simplify clinical trials with new molecules and commercialisation of approved molecules. In other words, it is an object of the present disclosure to meet the requirement of reliable filling and dispensing independent of the filled volume or the filling setting. Another object of the present disclosure is to protect a film bag, in particular a filled medicament bag, from damage and to facilitate handling of a film bag. These objects are met with the features of the present disclosure. SUMMARY 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. The present disclosure relates to a film bag comprising a port, two film layers welded to each other, enclosing the port and configured to form an internal volume for receiving a fluid. The film layers extend in a first axis direction and a second axis direction. A welding seam of the two film layers has a wave shape in a plane spanned by the first axis and second axis. Various embodiments may preferably implement the following features. Preferably, the wave shape comprises at least two waves of similar shapes and amplitudes. Preferably, the wave shape comprises waves with a sine, curve, zig zag or sawtooth shape. In one embodiment, the wave shape is made of two parts that are symmetrical with respect to the first axis direction. Preferably, the two parts of the wave shape extend along the full length of the film bag with respect to the second axis. In another embodiment, the wave shape extends along the full length of the welding seam. Preferably, the film bag has a generally round shape. Preferably, when the internal volume is filled with the fluid, the film layers are configured to bend in a third axis direction perpendicular to the plane. Preferably, a curvature of the wave shape is configured to minimise dead areas of the internal volume when the internal volume is filled with the fluid. Preferably, the fluid is a medicament. The present disclosure further relates to a system for enclosing a film bag comprising an enclosure and a film bag. In an embodiment, the film bag is a film bag as described above. The enclosure comprises a first enclosure part and a second enclosure part configured to be releasably connected to each other to enclose the film bag. The first enclosure part and the second enclosure part comprise complementary attachment means. The attachment means are configured to fixate the film bag when the first enclosure part and the second enclosure part are connected to each other. Various embodiments may preferably implement the following features. Preferably, the film bag comprises two film layers welded to each other, wherein the film layers substantially follow the form of the enclosure. Preferably, the attachment means are configured to clamp the film layers. Preferably, the attachment means are positioned towards a perimeter of the enclosure. Preferably, the film layers comprise at least one fixating member configured to engage with the attachment means. Preferably, the fixating member is a hole. Preferably, the attachment means of the first enclosure part is a pin or post and the attachment means of the second enclosure part is a hole or recess configured to receive the pin. Preferably, the first enclosure part and the second enclosure part are connected by a snap fit, clamps, screw, slide-in, or hinge, preferably by a living hinge. Preferably, the attachment means are configured to connect and hold the first enclosure part and the second enclosure part. Preferably, the first enclosure part and the second enclosure part substantially follow a shape of a filled film bag in a cross-section. Preferably, the first enclosure part and / or the second enclosure part are transparent. Preferably, the first enclosure part and / or the second enclosure part comprise(s) a reception space for receiving a label. In the present disclosure, the terms “vertical”, “vertically”, “longitudinal”, “longitudinally”, “axially” and “axial” refer to a second axis direction (y-axis) typically extending in the direction of the longest extension of the device and / or component. Similarly, the terms “horizontal”, “horizontally”, “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction (first axis direction, x-axis). The first and second axes span a first plane (x-y-plane). A third axis direction (z-axis) is perpendicular to the first plane (x-y-plane). 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. 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. BRIEF DESCRIPTION OF THE DRAWINGS Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings. Therein, same reference numerals denote the same or similar elements. Fig. 1A to 3 show film bags according to various embodiments. Fig. 4 shows a cross-sectional view of a film bag according to an embodiment. Fig. 8 shows a film bag according to an embodiment, equipped to collaborate with an enclosure. Fig. 9 shows an enclosure according to an embodiment. Fig. io shows the film bag of Fig. 8 inserted into the enclosure of Fig. 9. Fig. 11 shows a cross-sectional view of Fig. 10. DETAILED DESCRIPTION When filling film bags, one challenging aspect is bending and kinking during or after the filling procedure starting with lower pressure inside the bag. This behaviour should be prevented as it might have an impact to the film barrier property, the seal seam integrity or might by identified as a quality issue. The above-mentioned behaviour may be dependent on fill volume, geometry of the bag, filling rate and filling device used, and other factors. These factors can vary widely based on the use case for the film bag. Thus, improved solutions are needed to optimise the size and shape of the film bag to guarantee proper bag performance (i.e., consistent filling, reduction of trapped air during filling, and full dispense of the content) up to 100 ml or more. This might be relevant for delivery of larger volume subcutaneous biologies, such as oncology medications and treatments for chronic disease. Figure 1A shows a film bag i according to an embodiment. The film bag i comprises a port 2 and two film layers n, 12 (see Fig. 4) welded to each other, enclosing the port 2 and configured to form an internal volume for receiving a fluid. The film layers 11,12 extend in a first axis direction (x-axis direction) and a second axis direction (y-axis direction). A welding seam 3 of the two film layers 11,12 has a wave shape in a plane spanned by the first axis and second axis (x-y-plane). In Fig. 1A, three waves or bumps are provided on each lateral side of the film bag 1. The film bag 1 is generally rectangular in shape. As outlined below, the film bag 1 may generally also have a square shape, a circular shape or an irregular shape. The port 2 may also be provided at a different location, i.e., on a top or bottom surface of the film bag 1 rather than being enclosed by the welding seam 3. The figures of this disclosure all use the example of a welding seam 3 enclosing a port 2 but the disclosure is not limited thereto. The number of waves or bumps may be dependent on the internal volume of the film bag 1. In particular, the higher the internal volume, the larger the number of waves may be. In general, the number of waves may be equal to or larger than two. Preferably, the number of waves may be three or four. The waves may particularly be provided symmetrically to a centre axis extending through the port 2, i.e., symmetrical with respect to the second axis direction. The waves / bumps may have the same shape each or may be provided in different curvature radii. Embodiments with different numbers of waves are illustrated on Fig. 1B to 1D. Fig. 1B - resp. 1C, 1D - shows a film bag with two waves. This configurations is well suited for bags of 25mL - resp. 50mL, 100mL. In those embodiments, the wave shape comprises waves of similar shapes and amplitudes, that have a sine or curved shape. The wave shape is made of two parts that are symmetrical with respect to the first axis direction, and the two parts of the wave shape extend along the full length of the film bag with respect to the second axis y. Fig. 1B to 1D also show an optional channel 12 provided in the film bag 1. Said channel 12 may extend along a centre line of the bag 1, from the port 2 and along the second axis y. The channel 12 may be symmetrical with respect to the x-y plane or provided only in the positive or negative z-axis direction. During emptying of the medicament bag 1, said channel may avoid that the two films of the bag 1 contact each other (at least in the area of the channel 12) and block further removal of the fluid from the bag 1. By providing the channel 12, the medicament can be fully extracted from the 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. The channel 12 may substantially extend from the port 2 to the end of the bag 1 opposite the port 2. However, shape, diameter, cross-section and longitudinal extension may vary depending on the concrete requirements. As shown in Fig. 2, the film bag 1 may also exhibit a substantially rectangular shape having, e.g., three waves or bumps. Fig. 3 is a further example of a rectangular film bag 1 having four waves or bumps. When the internal volume of the film bag 1 is filled with the fluid, the film layers 11,12 may be configured to bend in a third axis direction (z-axis direction) perpendicular to the plane and the welding seam 3 is configured to substantially extend in the plane. That is the film layers 11,12 bend outwardly (positive / negative z-axis direction) while at least a part of the welding seam 3 substantially remains flat such that no bending or kinking movement of the film bag 1 occurs. In particular, the top part of the film bag 1, i.e., the port 2 area, and the bottom part of the film bag 1 opposite the port 2 may not be provided with waves and may not deform. The wave area at the lateral sides of the film bag 1 may, depending on the filling volume, the size of the bag 1, etc., slightly deform but, due to the wave shape, in a controlled manner. The welding seam 3 may extend outwardly in the circumferential direction to provide structural rigidity. That is, the welding seam 3 may exhibit a certain width sufficient to reduce the risk of bending. The width of the seam 3 maybe uniform around the perimeter of the film bag 1. Alternatively, the width of the seam 3 may vary in order to reinforce rigidity of certain areas of the film bag 1. Fig. 4 shows a cross-section of a filled film bag 1 through the x-z-plane. The wave shape maybe uniformly distributed, e.g., at the lateral sides of the film bag 1. Alternatively, the wave shapes may also be symmetrical with respect to a horizontal axis (parallel to the x-axis) passing substantially through the centre of the film bag 1. As mentioned above, the symmetry may help to provide consistency and predictability of the film bag’s 1 behaviour but the film bag 1 may also be provided in an irregular shape. Accordingly, a length L of the waves, as a fraction of the total length B of the film bag 1 (for B=i), maybe L < -, wherein N is the number of waves. The length L may indicate a longitudinal extension (y-axis) of the wave. In particular, L may indicate the length of a full wave. It may be measured starting at the lowest point of the wave as indicated in the figures, i.e., the point closest to the central longitudinal axis (parallel to the second axis / y-axis), in a direction perpendicular to the first axis (x-axis). The wave may be a sinusoidal wave or an asymmetrical wave. The shape may depend on the location on the film bag 1, i.e., in the middle or towards the ends. The lower waves, that is, the waves distant from the port 2, maybe formed as half waves. The length L is thus measured from the end of the film bag i to the beginning of the next wave. Moreover, for a height H of the waves, the following may apply: 0.2 < - < 0.8, preferably 0.25 < - < 0.4. The height H may indicate a full amplitude of the wave, i.e., the maximum distance in the first axis direction (x-axis). For the length of the waves, the following may apply: 20 mm < L < 80 mm. Preferably, the length is 30 mm < L < 50 mm. In a preferred embodiment, the length L is not smaller than 20mm and not bigger than 80mm. Preferably, the length L is between 30mm and 50mm. The total length B of the film bag may be 60 mm < B <150 mm. The height H and length L may be different for each wave / bump.Fig. 5 shows an outline of a film bag 1 according to an embodiment. The film bag 1 is symmetrical with respect to the second axis direction and comprises three irregular waves on each side with heights Hi, H2 and lengths Li, L2, respectively. The overall shape of the film bag 1 of Fig. 9 is substantially oval or circular. Fig. 6 shows a (filled) film bag 1 according to an embodiment having a substantially circular shape. The waves maybe uniformly distributed around a perimeter of the film bag 1 apart from an area where the port 2 is provided. In other words, the wave shape extends along the full length of the welding seam. Fig. 7 shows an outline of a film bag 1 according to an embodiment. The film bag 1 is symmetrical with respect to the second axis direction and comprises three regular waves on each side. The overall shape of the film bag i is rectangular. In an embodiment, an angle 0 between the inside and outside radius (as shown in Fig. 5 and Fig. 6) maybe between 8o° and 1500. In some embodiments, an angle between 100 and 1100 maybe preferred. In the embodiments of Fig. 1B to 1D, the angle 0 between two waves is 1100. In the embodiment of Fig. 5, the angle is given as ca. 1040 and in the embodiment Fig. 6, the angle is given as ca. 1080, but these are only to be understood as examples and are not intended to limit the scope of the present disclosure. This angle 0 is defined by a line or the tangent transition line of two radius / splines touching each other. The wave shape may also be a zig zag or sawtooth shape. The overall shape of the film bag 1 may also be oval, trapezoid, or round. The shape and position of the waves may thus be adapted accordingly. A curvature of the wave shape maybe configured to minimise dead areas of the internal volume when the internal volume is filled with the fluid. Herein, dead areas denote areas in which air bubbles remain after filling of the film bag 1 or which cannot be filled in conventional bags due to deformation of the bag. In other words, when dead areas are present, the internal volume of the film bag 1 cannot be fully used. The wave shape maybe provided at all sides of the film bag 1 apart from where the port 2 is located. The fluid maybe a medicament as further outlined below. Fig. 8 shows a film bag 1 according to an embodiment. This shows a substantially rectangular film bag 1 but the present disclosure is not limited thereto. As described above, the film bag 1 may comprise a first and second film layer 11,12 welded together to form an internal volume. The welding seam 3 may not be provided at the circumference of the film bag 1 but rather offset to the inside. That is, the film bag i (the film layers 11, 12) may extend further from a periphery of the welding seam 3. The welding seam 3 may have substantially the same shape as the outer circumference of the film bag 1, only offset to the inside, or, as shown in Fig. 8, have a different shape, e.g., a wave shape. In other words, the edge or circumference of the film bag 1 may not necessarily correspond to the welding seam 3. The film bag 1 may thus include additional film material extending beyond the perimeter seal 3, e.g., with mounting hole features (fixating members 13) at the outer edges. Fig. 9 shows an enclosure 4 according to an embodiment which may be used with a film bag 1 as disclosed with reference to Fig. 8. The enclosure 4 comprises a first enclosure part 41 and a second enclosure part 42 configured to be releasably connected to each other to enclose the film bag 1. The first enclosure part 41 and the second enclosure part 42 comprise complementary attachment means 5. Said attachment means 5 are configured to fixate the film bag 1 when the first enclosure part 41 and the second enclosure part 42 are connected to each other. The film bag 1 may comprise two film layers 11,12 welded to each other and the film layers 11,12 may substantially follow the form of the enclosure 4. That is, in the shown example of Figs. 5 and 6, both the enclosure 4 and the film bag 1 have a substantially rectangular shape. The attachment means 5 maybe configured to clamp the film layers 11,12. Thus, the attachment means 5 may be provided as a ridge (not shown) on the first enclosure part 41 or the second enclosure part 42 such that the film bag 1 is clamped between the ridge and the opposed enclosure part 41, 42. Alternatively, a ridge and a corresponding groove may be provided on the first enclosure part 41 and the second enclosure part 42, respectively such that the film bag 1 is clamped between the ridge and the groove. 11 The ridge and, if present, the groove, may be elongated members. They may substantially extend along the lateral sides over the complete or almost complete length (y-axis direction) of the enclosure 4. Alternatively, an intermittent ridge / groove, i.e., a plurality of shorter ridges / grooves maybe provided to secure the film bag 1. Also, clamps or snaps may be provided on the first enclosure part 41 or the second enclosure part 42 into which the film bag 1 is inserted prior to closing the enclosure 4. The attachment means 5 maybe positioned towards a perimeter of the enclosure 4. The film bag 1 (the film layers 11,12) may comprise at least one fixating member 13 configured to engage with the attachment means 5. For example, the fixating member 13 maybe a hole. Thus, the attachment means 5 of the first enclosure part 41 may be a pin or post and the attachment means 5 of the second enclosure part 42 maybe a hole or recess configured to receive the pin (or vice versa). The pin 5 is thus configured to receive the hole 13 such that the film bag 1 is fixed when the enclosure 4 is closed and the pin of the first enclosure part 41 is received by the hole of the second enclosure part 42. A fit between the holes (fixating members 13) and posts (attachment means 5) may be provided to be intentionally loose fit, allowing some movement of the film bag 1 during filling. The attachment means 5 maybe positioned symmetrically with respect to a centre axis of the enclosure 4. For example, at least two attachment means 5 maybe provided on either side of the enclosure. The enclosure 4 may comprise reinforcement ribs or additional bars to strengthen its rigidity and provide further protection to the film bag 1. Fig. 10 shows an enclosure 4 having a film bag 1 placed and secured therein. The first enclosure part 41 and second enclosure part 42 may be integrally formed or formed as two separate parts. That is, the first enclosure part 41 and second enclosure part 42 maybe formed as two separate half shells. The outer appearance of the half shells may be the same or similar and they may in particular be symmetrical. The first enclosure part 41 and the second enclosure part 42 may be connected by a snap fit, clamps, screw or slide-in. Also, they maybe connected by a hinge, preferably by a living hinge. In an embodiment, the attachment means 5 may be configured to connect and hold the first enclosure part 41 and the second enclosure part 42. In that case, no additional fixation is necessary. The first enclosure part 41 and the second enclosure part 42 may substantially follow a shape of a filled film bag 1 in a cross-section (x-z-plane). This is depicted in Fig. 11, wherein the film bag 1 is indicated by the dotted line. That is, the shape of the enclosure 4 may essentially pick up the shape of a filled film bag 1. The enclosure 4 may also have a different shape in the cross-section adapted for receiving the volume of a filled film bag 1. The first enclosure part 41 and / or the second enclosure part 42 maybe transparent. In that manner, a label placed on the film bag 1 for indicating its content may be easily read even when the film bag 1 is placed in the closed enclosure 4. Also, the first enclosure part 41 and / or the second enclosure part 42 may comprise a reception space for receiving a label. The reception space may be flat. As indicated above, the film bag 1 may be a film bag 1 as described above. The film bag 1 disclosed herein may be formed of a cyclic olefin copolymer (COC) and Polychlorotrifluoroethylene (PCTFE / Aclar) composite and may further comprise an interposing tie layer. Unless indicated otherwise, all figures and embodiments disclosed herein are compatible with each other. In the present disclosure, an improved film bag and enclosure to protect said film bag has been described. In particular, to avoid kinking or bending and to avoid “dead areas”, which are not filled with liquid, a “follow the water” bag has been described. Several geometries have been assessed and liquid inside created kinks or did not cover all the footprint of the bag. Both effects can be overcome by an optimal distribution of tension inside of the film bag, provided by the new geometry comprising a wave shaped welding seam. The film bag geometry is designed to follow the liquid spreading behavior. In particular, the wave / zig-zag geometry provides vertical flexibility allowing the film bag to adapt to the liquid behaviour while it is being filled or emptied as well as in the filled state. The Wave / zig-zag geometry is pronounced enough to avoid kinking while being straight enough to allow proper filling. The designed film bag presents a wavy / zigzag geometry, with multiple bumps on each side. Moreover, the described enclosure offers, by fully surrounding the film bag, protection from external forces that might compress or puncture or otherwise damage the film bag. By offering a more rigid surrounding component that is a standard size for the filled film bag, any interfaces between bag and subsequent system components (injection set, packaging, drive unit, etc.) can be standardised more easily due to its known geometry. Through the flat label space on the enclosure, labels can be applied without contacting the bag material. This has advantages for film bag integrity and drug stability (no adhesives on bag material surfaces) as well as general handling (difficulty with applying label to soft or contoured surfaces). In case of a medical application, with a rigid component surrounding the film bag, the patient and pharmacist end-users are able to hold and handle the film bag and connect it to a medicament delivery system with less risk of damaging to the film bag, and with more mechanical affordances in the system components like guiding features, lead-ins, connection points that are able to offer assistance for those connection actions. The film bags described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders. 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. 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. 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. 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 i and programmed death-ligand 1 (PD-i / PD-Li) 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. Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-ia, interferon beta-ib, peginterferon beta-ia, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins. Exemplary drugs that could be included in the delivery devices described herein may also include, but are not limited to, oncology treatments such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab. 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. 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. 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, 5 FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, MiniCHOP, 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 10  +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, 15 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

1. Film bag (1), comprising:a port (2);two film layers (11,12) welded to each other, enclosing the port (2) and configured to form an internal volume for receiving a fluid;wherein the film layers (11,12) extend in a first axis (x) direction and a second axis (y) direction, andwherein a welding seam (3) of the two film layers (11,12) has a wave shape in a plane spanned by the first axis (x) and second axis (y).

2. Film bag (1) according to the previous claim, wherein the wave shape comprises at least two waves of similar shapes and amplitudes.

3. Film bag (1) according to the previous claim, wherein the wave shape comprises waves with a sine, curve, zig zag or sawtooth shape.

4. Film bag (1) according to any of the previous claims, wherein, when the internal volume is filled with the fluid, the film layers (11,12) are configured to bend in a third axis (z) direction perpendicular to the plane.

5. Film bag (1) according to any of the previous claims, wherein the wave shape is made of two parts that are symmetrical with respect to the second axis (y) direction.

6. Film bag (1) according to the previous claim, wherein the two parts of the wave shape extend along the full length of the film bag (1) with respect to the second axis (y).

7. Film bag (1) according to any of claims 1 to 4, wherein the wave shape extends along the full length of the welding seam (3).

8. Film bag (1) according to the previous claim, wherein the film bag (1) has a generally round shape.

9. Film bag (1) according to any of the previous claims, wherein a curvature of the wave shape is configured to minimise dead areas of the internal volume when the internal volume is filled with the fluid.

10. Film bag (1) according to any of the previous claims, wherein the fluid is a medicament.

11. System for enclosing a film bag, comprising:an enclosure (4); anda film bag (1) according to any of the previous claims;wherein the enclosure (4) comprises a first enclosure part (41) and a second enclosure part (42) configured to be releasably connected to each other to enclose the film bag,wherein the first enclosure part (41) and the second enclosure part (42) comprise complementary attachment means (5), andwherein the attachment means (5) are configured to fixate the film bag when the first enclosure part (41) and the second enclosure part (42) are connected to each other.

12. System according to the previous claim, wherein the two film layers (11, 12) of the film bag (1) substantially follow the form of the enclosure (4).

13. System according to claim 11 or claim 12, wherein the attachment means (5) are configured to clamp the film layers (11,12) of the film bag (1).

14. System according to any one of claims 11 to 13, wherein the attachment means (5) are positioned towards a perimeter of the enclosure (4).

15. System according to any one of claims 11 to 14, wherein the film layers (11,12) comprise at least one fixating member (13) configured to engage with the attachment means (5).

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