Film back

Abstract

The present invention relates to a film bag comprising a port and two film layers welded together to surround the port and form an internal volume for receiving fluid. The film layers extend in a first axial direction and a second axial direction. The weld seam of the two film layers has a wave shape in a plane formed by the first axis and the second axis. The present invention also relates to a corresponding enclosure.

Description

Technology Field

[0001] The present invention relates to a film bag, and more specifically to a medicament bag. Background Technology

[0002] Film bags, particularly those for storing pharmaceuticals, have been widely used and are known from the prior art. These film bags exhibit excellent barrier properties similar to glass vials and enable long-term storage. Such film bags can consist of three main parts: a multilayer film welded to form the bag, a port containing an interface that provides access to the drug contents, and finally, a closure to seal the entire system.

[0003] Such bags are often designed with a small form factor and a fixed filling volume that are known in advance during consultation with a partner. Therefore, the bag filling and dispensing behavior can be known in advance, and design modifications can be made during customization for specific contents, such as pharmaceuticals. Typical volume values ​​are 2 to 25 ml.

[0004] However, depending on the intended use, for example, the type of medicine or prescription plan, the design must be adjusted for the use of a larger volume. In such cases, regardless of the filling volume, complete filling and emptying, as well as safe storage, must be ensured.

[0005] Accordingly, the object of the present invention is to provide a film bag having a higher volume, e.g., 50 ml, 100 ml, or more. Another object of the present invention is to ensure reliable filling and emptying of the film bag even if the filling volume is not known in advance. Another object of the present invention is to provide a film bag suitable for use in both pharmaceutical company filling (pre-filling) and pharmacy filling scenarios to simplify clinical trials using novel molecules and commercialization of approved molecules. In other words, the object of the present invention is to meet the requirements for reliable filling and emptying regardless of the filling volume or filling setting. Another object of the present invention is to protect the film bag, in particular the filled medicine bag, from damage and to facilitate the handling of the film bag.

[0006] These objectives are satisfied by the features of the present invention.

[0007] The present invention is defined by the independent claim. Preferred embodiments are defined in the dependent claim. In the following description, a number of features may be designated as optional, but it is acknowledged that none of the features included in the independent claim are to be understood as optional.

[0008] The present invention relates to a film bag comprising a port and two film layers welded together to surround the port and formed an internal volume for receiving fluid. The film layers extend in a first axial direction and a second axial direction. The weld seam of the two film layers has a wave shape in a plane formed by the first axis and the second axis.

[0009] Various embodiments can preferably implement the following features.

[0010] Preferably, the wave shape includes at least two waves of similar shape and amplitude.

[0011] Preferably, the wave shape includes a sine wave, a curve, a zigzag, or a sawtooth shape.

[0012] In one embodiment, the wave shape is made of two parts that are symmetric with respect to the first axis direction.

[0013] Preferably, two parts of the wave shape extend along the entire length of the film bag with respect to the second axis.

[0014] In another embodiment, the wave shape extends along the entire length of the weld seam.

[0015] Preferably, the film bag generally has a circular shape.

[0016] Preferably, when the internal volume is filled with fluid, the film layer is configured to bend in a third axial direction perpendicular to the plane.

[0017] Preferably, the wave-shaped curvature is configured to minimize the dead area of ​​the internal volume when the internal volume is filled with fluid.

[0018] Preferably, the fluid is medicine.

[0019] The present invention also relates to a system for enclosing a film bag, comprising an enclosure and a film bag. In one embodiment, the film bag is a film bag as described above. The enclosure comprises a first enclosure portion and a second enclosure portion configured to be releaseably connected to each other to enclose the film bag. The first enclosure portion and the second enclosure portion comprise complementary attachment means. The attachment means are configured to secure the film bag when the first enclosure portion and the second enclosure portion are connected to each other.

[0020] Various embodiments can preferably implement the following features.

[0021] Preferably, the film bag comprises two film layers welded together, and the film layers substantially follow the shape of the enclosure.

[0022] Preferably, the attachment means is configured to clamp the film layer.

[0023] Preferably, the attachment means is positioned toward the perimeter of the enclosure.

[0024] Preferably, the film layer includes at least one fixing member configured to engage with an attachment means.

[0025] Preferably, the fixing member is a hole.

[0026] Preferably, the attachment means of the first enclosure portion is a pin or a post, and the attachment means of the second enclosure portion is a hole or recess configured to receive a pin.

[0027] Preferably, the first enclosure portion and the second enclosure portion are connected by a snap fit, clamp, screw, slide-in, or hinge, preferably a living hinge.

[0028] Preferably, the attachment means is configured to connect and maintain the first enclosure portion and the second enclosure portion.

[0029] Preferably, the first enclosure portion and the second enclosure portion substantially follow the shape of the film bag filled in cross-section.

[0030] Preferably, the first enclosure portion and / or the second enclosure portion is transparent.

[0031] Preferably, the first enclosure portion and / or the second enclosure portion includes a receiving space for receiving a label.

[0032] In this disclosure, the terms “vertical,” “vertically,” “longitudinal,” “longitudinal,” “axial,” and “axial” typically refer to a second axial direction (y-axis) extending in the longest extension direction of the device and / or component.

[0033] Similarly, the terms "horizontal," "horizontally," "transverse," "transverse," and "transversely" refer to a direction generally perpendicular to the longitudinal direction (the first axis direction, the x-axis).

[0034] The first and second axes form the first plane (xy plane). The third axis direction (z-axis) is perpendicular to the first plane (xy plane).

[0035] Additionally, the terms “circumference,” “circumferential,” or “circumferentially” refer to the circumference or circumferential direction relative to an axis, typically in the direction of the longest extension of a device and / or component. Similarly, “radial,” or “radially” refers to a direction extending radially relative to an axis, and “rotation,” “rotational,” and “rotationally” refer to rotation relative to an axis.

[0036] Generally, all terms used in the claims shall be interpreted according to their common meaning in the art unless otherwise expressly defined in this specification. All references to elements, devices, parts, components, means, etc., shall be openly interpreted as referring to at least one instance of elements, devices, parts, components, means, etc., unless otherwise expressly stated. Brief explanation of the drawing

[0037] Embodiments of the present invention will now be described merely as examples and with reference to the following accompanying drawings. Herein, the same reference numerals indicate the same or similar elements. FIGS. 1a to 3 illustrate film bags according to various embodiments. FIG. 4 illustrates a cross-sectional view of a film bag according to one embodiment. FIG. 8 illustrates a film bag according to one embodiment, configured to cooperate with an enclosure. FIG. 9 illustrates an enclosure according to one embodiment. FIG. 10 shows the film bag of FIG. 8 inserted into the enclosure of FIG. 9. Figure 11 illustrates a cross-sectional view of Figure 10. Specific details for implementing the invention

[0038] When filling film bags, one problematic aspect is bending or kinking during or after the filling procedure, starting from the lower pressure inside the bag. This behavior must be prevented because it can affect film barrier properties and seal integrity, or be identified as a quality issue. The aforementioned behavior may vary depending on the filling volume, bag geometry, filling speed, the filling device used, and other factors. These factors can vary widely based on the use case for the film bag.

[0039] Therefore, an improved solution is needed to optimize the size and shape of film bags to ensure adequate bag performance (i.e., consistent filling, reduced air trapped during filling, and complete discharge of contents) up to 100 ml or more. This may be relevant to the delivery of larger volume subcutaneous biologics, such as oncology drugs and treatments for chronic diseases.

[0040] FIG. 1a illustrates a film bag (1) according to one embodiment. The film bag (1) comprises a port (2) and two film layers (11, 12) (see FIG. 4) welded together to surround the port (2) and form an internal volume for receiving fluid. The film layers (11, 12) extend in a first axial direction (x-axis direction) and a second axial direction (y-axis direction). The weld seam (3) of the two film layers (11, 12) has a wave shape in a plane (xy plane) formed by the first axis and the second axis. In FIG. 1a, three waves or bumps may be provided on each lateral surface of the film bag (1). The film bag (1) is generally rectangular in shape. As outlined below, the film bag (1) may also generally have a square shape, a circular shape, or an irregular shape.

[0041] The port (2) may also be provided at a different location, i.e., on the upper or lower surface of the film bag (1), rather than being surrounded by a weld seam (3). All drawings of the present disclosure use examples of a weld seam (3) surrounding the port (2), but the present disclosure is not limited thereto.

[0042] The number of waves or bumps may be determined by the internal volume of the film bag (1). In particular, the larger the internal volume, the more waves may be.

[0043] Generally, the number of waves may be two or more. Preferably, the number of waves may be three or four. The waves may be provided symmetrically with respect to a central axis extending particularly through the port (2), that is, symmetrically with respect to the second axis direction. Each wave / bump may have the same shape or may be provided with different radii of curvature.

[0044] Embodiments having different numbers of waves are illustrated in FIGS. 1b through 1d. FIG. 1b—and FIG. 1c and FIG. 1d, respectively—show a film bag having two waves. This configuration is very suitable for bags of 25 mL—and 50 mL and 100 mL, respectively. In such embodiments, the wave shape comprises waves of similar shape and amplitude having a sinusoidal or curved shape. The wave shape consists of two parts symmetrical with respect to a first axis direction, and the two parts of the wave shape extend along the entire length of the film bag with respect to a second axis (y).

[0045] FIGS. 1b through 1d also illustrate an optional channel (12) provided within the film bag (1). The channel (12) may extend from the port (2) along the centerline of the bag (1) and along a second axis (y). The channel (12) may be symmetric with respect to the xy plane or may be provided only in the direction of the positive or negative z-axis.

[0046] While emptying the medicine bag (1), the channel can prevent the two films of the bag (1) from coming into contact with each other (at least in the area of ​​the channel (12)) and blocking further removal of fluid from the bag (1). By providing the channel (12), the medicine can be completely removed from the bag (1) because the film layers cannot adhere to each other across the entire area of ​​the bag (1). Once most of the fluid has been removed and fluid remains only within the channel (12), the channel (12) can collapse under pressure, thereby completely pushing out the remaining fluid.

[0047] The channel (12) may substantially extend from the port (2) to the end of the bag (1) opposite the port (2). However, the shape, diameter, cross-section, and longitudinal extension may vary depending on specific requirements.

[0048] As illustrated in FIG. 2, the film back (1) may also have a substantially rectangular shape, for example, having three waves or bumps. FIG. 3 is an additional example of a rectangular film back (1) having four waves or bumps.

[0049] When the internal volume of the film bag (1) is filled with fluid, the film layers (11, 12) may be configured to bend in a third axial direction (z-axis direction) perpendicular to the plane, and the weld seam (3) is configured to extend substantially within the plane. That is, the film layers (11, 12) bend outward (positive / negative z-axis direction), while at least a portion of the weld seam (3) is kept substantially flat so that no bending or kinking movement of the film bag (1) occurs. In particular, the upper part of the film bag (1), i.e., the port (2) area, and the lower part of the film bag (1) opposite the port (2) may not be provided with waves and may not be deformed. The wave area on the lateral side of the film bag (1) may be slightly deformed depending on the filling volume, the size of the bag (1), etc., but may be deformed in a controlled manner due to the wave shape.

[0050] The weld seam (3) may extend outwardly in a circumferential direction to provide structural rigidity. That is, the weld seam (3) may have a certain width sufficient to reduce the risk of bending. The width of the seam (3) may be uniform along the circumference of the film bag (1). Alternatively, the width of the seam (3) may vary to reinforce the rigidity of a certain area of ​​the film bag (1).

[0051] FIG. 4 shows a cross-section of a filled film bag (1) through the xz plane.

[0052] The wave shape may be uniformly distributed, for example, on the lateral surface of the film bag (1). Alternatively, the wave shape may also be symmetric with respect to a horizontal axis (parallel to the x-axis) that substantially passes through the center of the film bag (1). As described above, while symmetry may help provide consistency and predictability of the behavior of the film bag (1), the film bag (1) may also be provided with an irregular shape.

[0053] Therefore, as a fraction of the total length (B) of the film back (1) (for B=1), the length of the wave (L) is It can be, where N is the number of waves. Length (L) may represent the longitudinal extension (y-axis) of the wave. In particular, L may represent the total length of the wave. This can be measured starting from the lowest point of the wave, 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), as shown in the drawing.

[0054] The wave may be a sinusoidal wave or an asymmetric wave. The shape may depend on the position on the film bag (1), that is, whether it is in the middle or towards the end. The lower wave, that is, the wave far from the port (2), may be formed as a half wave. Thus, the length (L) is measured from the end of the film bag (1) to the beginning of the next wave.

[0055] Furthermore, regarding the wave height (H), the following may apply: , preferably Height (H) can represent the total amplitude of the wave, that is, the maximum distance in the first axis direction (x-axis).

[0056] Regarding the wave length, the following may apply: 20 .

[0057] Preferably, the length is 30 am.

[0058] In a preferred embodiment, the length (L) is 20 mm or more and 80 mm or less. Preferably, the length (L) is 30 mm to 50 mm.

[0059] The total length of the film back (B) is It could be.

[0060] The height (H) and length (L) may differ for each wave / bump. FIG. 5 illustrates the contour of a film bag (1) according to one embodiment. The film bag (1) is symmetric with respect to a second axis direction and contains three irregular waves on each face, each having a height (H1, H2) and lengths (L1, L2). The overall shape of the film bag (1) in FIG. 9 is substantially elliptical or circular.

[0061] FIG. 6 illustrates a (filled) film bag (1) according to one embodiment having a substantially circular shape. The waves can be uniformly distributed around the perimeter of the film bag (1), excluding the area where the port (2) is provided. In other words, the wave shape extends along the entire length of the weld seam.

[0062] FIG. 7 illustrates the outline of a film bag (1) according to one embodiment. The film bag (1) is symmetric with respect to the second axis direction and includes three regular waves on each side. The overall shape of the film bag (1) is rectangular.

[0063] In one embodiment, the angle (θ) between the inner radius and the outer radius (as illustrated in FIGS. 5 and 6) may be 80° to 150°. In some embodiments, an angle of 100° to 110° may be preferred. In the embodiments of FIGS. 1b through 1d, the angle (θ) between two waves is 110°. In the embodiment of FIG. 5, the angle is given as approximately 104°, and in the embodiment of FIG. 6, the angle is given as approximately 108°, but these should be understood merely as examples and are not intended to limit the scope of the invention.

[0064] This angle (θ) is defined by two lines of radius / spline or tangent transition lines that are tangent to each other.

[0065] The wave shape can also be a zigzag or sawtooth shape.

[0066] The overall shape of the film bag (1) can also be elliptical, trapezoidal, or circular. Accordingly, the shape and position of the wave can be adjusted accordingly.

[0067] The wave-shaped curvature can be configured to minimize the dead area of ​​the internal volume when the internal volume is filled with fluid. Here, the dead area refers to an area where bubbles remain after filling the film bag (1) or an area that cannot be filled due to deformation of the bag in a conventional bag. In other words, if a dead area exists, the internal volume of the film bag (1) cannot be fully utilized.

[0068] Wave shapes can be provided on all sides of the film bag (1) except where the port (2) is located.

[0069] The fluid may be a medicine as additionally described below.

[0070] FIG. 8 illustrates a film bag (1) according to one embodiment. While it illustrates a film bag (1) that is substantially rectangular, the invention is not limited thereto. As described above, the film bag (1) may include a first film layer and a second film layer (11, 12) that are welded together to form an internal volume. The weld seam (3) may not be provided around the perimeter of the film bag (1) but may be offset inward. That is, the film bag (1) (film layers (11, 12)) may extend further from the periphery of the weld seam (3). The weld seam (3) may have substantially the same shape as the outer perimeter of the film bag (1), may be merely offset inward, or may have a different shape, for example, a wave shape, as illustrated in FIG. 8.

[0071] In other words, the edge or perimeter of the film bag (1) may not necessarily correspond to the weld seam (3). Accordingly, the film bag (1) may include additional film material extending beyond the perimeter seal (3), and, for example, there is a mounting hole feature (fixing member (13)) on the outer edge.

[0072] FIG. 9 illustrates an enclosure (4) according to one embodiment that can be used with a film bag (1) as disclosed with reference to FIG. 8.

[0073] The enclosure (4) includes a first enclosure portion (41) and a second enclosure portion (42) configured to be releaseably connected to each other to surround the film bag (1). The first enclosure portion (41) and the second enclosure portion (42) include complementary attachment means (5). The attachment means (5) is configured to secure the film bag (1) when the first enclosure portion (41) and the second enclosure portion (42) are connected to each other.

[0074] The film bag (1) may include two film layers (11, 12) welded together, and the film layers (11, 12) may substantially follow the shape of the enclosure (4). That is, in the example illustrated in FIGS. 5 and 6, both the enclosure (4) and the film bag (1) have a substantially rectangular shape.

[0075] The attachment means (5) may be configured to clamp the film layers (11, 12). Accordingly, the attachment means (5) may be provided as a ridge (not shown) on the first enclosure portion (41) or the second enclosure portion (42) so that the film bag (1) can be clamped between the ridge and the opposite enclosure portion (41, 42). Alternatively, a ridge and a corresponding groove may be provided on the first enclosure portion (41) and the second enclosure portion (42), respectively, so that the film bag (1) can be clamped between the ridge and the groove.

[0076] The ridges and, if present, the grooves may be elongated members. They may extend along the lateral surface along substantially the full or nearly full length (in the y-axis direction) of the enclosure (4). Alternatively, discontinuous ridges / grooves, i.e., multiple shorter ridges / grooves, may be provided to secure the film bag (1).

[0077] Additionally, a clamp or snap may be provided on the first enclosure portion (41) or the second enclosure portion (42) into which the film bag (1) is inserted before closing the enclosure (4).

[0078] The attachment means (5) can be positioned toward the perimeter of the enclosure (4).

[0079] The film bag (1) (film layers (11, 12)) may include at least one fixing member (13) configured to engage with an attachment means (5).

[0080] For example, the fixing member (13) may be a hole. Thus, the attachment means (5) of the first enclosure portion (41) may be a pin or a post, and the attachment means (5) of the second enclosure portion (42) may be a hole or a recess configured to receive a pin (or vice versa). Thus, the pin (5) is configured to receive the hole (13), so that the film bag (1) is fixed when the enclosure (4) is closed and the pin of the first enclosure portion (41) is received by the hole of the second enclosure portion (42).

[0081] The fit between the hole (fixing member (13)) and the post (attachment means (5)) can be intentionally provided to be loosely fitted so as to allow some movement of the film bag (1) during filling.

[0082] The attachment means (5) may be positioned symmetrically with respect to the central axis of the enclosure (4). For example, at least two attachment means (5) may be provided on both sides of the enclosure.

[0083] The enclosure (4) may include reinforcing ribs or additional bars to enhance its rigidity and provide additional protection for the film bag (1).

[0084] FIG. 10 illustrates an enclosure (4) in which a film bag (1) is placed and fixed inside.

[0085] The first enclosure portion (41) and the second enclosure portion (42) may be formed integrally or as two separate portions. That is, the first enclosure portion (41) and the second enclosure portion (42) may be formed as two separate half shells. The appearance of the half shells may be identical or similar, and in particular, symmetrical.

[0086] The first enclosure portion (41) and the second enclosure portion (42) may be connected by a snap fit, clamp, screw, or slide-in. Additionally, they may be connected by a hinge, preferably by a living hinge.

[0087] In one embodiment, the attachment means (5) may be configured to connect and hold the first enclosure portion (41) and the second enclosure portion (42). In such a case, additional fixing is not required.

[0088] The first enclosure portion (41) and the second enclosure portion (42) may substantially follow the shape of the filled film bag (1) in the cross-section (xz plane). This is as illustrated in FIG. 11, where the film bag (1) is indicated by a dotted line. That is, the shape of the enclosure (4) may essentially take the shape of the filled film bag (1). The enclosure (4) may also have different cross-sectional shapes configured to accommodate the volume of the filled film bag (1).

[0089] The first enclosure portion (41) and / or the second enclosure portion (42) may be transparent. In this way, even when the film bag (1) is placed inside a closed enclosure (4), a label placed on the film bag (1) to indicate its contents can be easily read.

[0090] Additionally, the first enclosure portion (41) and / or the second enclosure portion (42) may include a receiving space for receiving a label. The receiving space may be flat.

[0091] As shown above, the film bag (1) may be the film bag (1) as described above.

[0092] The film bag (1) disclosed in this specification may be formed from a cyclic olefin copolymer (COC) and a polychlorotrifluoroethylene (PCTFE / Aclar) composite and may further include an interposed tie layer.

[0093] Unless otherwise indicated, all drawings and embodiments disclosed in this specification are compatible with one another.

[0094] In the present disclosure, an improved film bag and an enclosure for protecting said film bag are described.

[0095] In particular, to avoid kinking or bending and to avoid "dead zones" that are not filled with liquid, a "follow the water" bag was described. Several geometric structures were evaluated, and the internal liquid did not create kinking or cover the entire footprint of the bag. Both effects can be overcome by the optimal tension distribution inside the film bag, provided by a new geometric structure that includes a wave-shaped weld seam.

[0096] The film bag geometry is designed to follow liquid diffusion behavior. In particular, the wave / zigzag geometry provides vertical flexibility, allowing the film bag to adapt to liquid behavior not only while being filled or emptied but also when filled. The wave / zigzag geometry is straight enough to allow for proper filling and distinct enough to avoid bending.

[0097] The designed film back exhibits a wave / zigzag geometric structure having multiple bumps on each side.

[0098] Furthermore, the described enclosure provides protection from external forces that could compress, puncture, or otherwise damage the film bag by completely enclosing the film bag.

[0099] By providing a more rigid peripheral component of standard size to the filled film bag, any interface between the bag and subsequent system components (injection set, packaging, drive unit, etc.) can be more easily standardized due to its known geometry.

[0100] Through the flat label space on the enclosure, the label can be applied without contacting the bag material. This offers advantages regarding film bag integrity and drug stability (no adhesive on the bag material surface) as well as general handling (difficulty in applying labels to soft or contoured surfaces).

[0101] In the case of medical applications, by using rigid components surrounding the film bag, patient and pharmacist end users can grasp and handle the film bag and connect it to a drug delivery system, while reducing the risk of damage to the film bag and providing more mechanical affordance in system components such as guiding features, lead-ins, and connection points to support such connection actions.

[0102] The film bag described in this specification may be used for the treatment and / or prevention of one or more of a number of different types of disorders.

[0103] Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), hypercholesterolemia and / or dyslipidemia, cardiovascular disease, diabetes mellitus (e.g., type 1 or type 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjögren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behcet's disease, hemorrhagic lymphohistiocytosis, atopic dermatitis, retinal disease (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious disease, bone disease (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, Transplantation, acute hypoglycemia, obesity, anaphylaxis, allergy, sickle cell disease, Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies, systemic infusion reaction, immunoglobulin E (IgE)-mediated hypersensitivity, cytokine release syndrome, immunodeficiency (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiency (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiency, hormone deficiency, coagulation disorders (e.g., hemophilia, von Willebrand disease, factor V Leiden), and cancer.

[0104] Exemplary types of drugs that may be included in the delivery device 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 therapy, radioisotopes and / or nuclear medicine, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodiases, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogs, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapy, cell or gene therapy, oncolytic viruses, or immunotherapy.

[0105] Exemplary drugs that may be included in the delivery device described herein include, but are not limited to: immuno-oncology or in vivo oncology agents, e.g., immune checkpoints, cytokines, chemokines, differentiation clusters, 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 co-stimulatory proteins.

[0106] Exemplary drugs that may be included in the delivery device described herein include, but are not limited to: drugs exhibiting the proposed mechanism of action, e.g., human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-1 (GLP-1) modulators, glucose-dependent insulin-stimulating polypeptide (GIP) modulators, differentiation cluster 38 (CD38) modulators, differentiation cluster 22 (CD22) modulators, C1 esterase modulators, bradykinin modulators, CC 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, differentiation cluster 79B (CD79B) regulators, tumor-associated calcium signaling factor 2 (Trop-2) regulators, differentiation cluster 52 (CD52) regulators, B cell maturation antigen (BCMA) regulators, enzyme regulators, platelet-derived growth factor receptor A (PDGFRA) regulators, differentiation cluster 319 (CD319 or SLAMF7) regulators, programmed cell death protein 1 and programmed cell death ligand 1 (PD-1 / PD-L1) inhibitors / regulators, B-lymphocyte antigen differentiation cluster 19 (CD19) inhibitors, B-lymphocyte antigen differentiation cluster 20 (CD20) regulators, differentiation cluster 3 (CD3) regulators, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing 3 (TIM-3) regulators, T-cell immune receptor (TIGIT) regulators having Ig and ITIM domains, T cells V-domain Ig inhibitors of VISTA activation modifiers, indoleamine 2,3-deoxygenase (IDO or INDO) modifiers, poliovirus receptor-associated immunoglobulin domain-containing protein (PVRIG) modifiers, lymphocyte-activated gene 3 (LAG3;Differentiation cluster 223 (also known as CD223) antagonist, differentiation cluster 276 (CD276 or B7-H3) antigen modulator, differentiation cluster 47 (CD47) antagonist, differentiation cluster 30 (CD30) modulator, differentiation cluster 73 (CD73) modulator, differentiation cluster 66 (CD66) modulator, differentiation cluster w137 (CDw137) agonist, differentiation cluster 158 (CD158) modulator, differentiation cluster 27 (CD27) modulator, differentiation cluster 58 (CD58) modulator, differentiation cluster 80 (CD80) modulator, differentiation cluster 33 (CD33) modulator, differentiation cluster 159 (CD159 or NKG2) modulator, glucocorticoid-induced TNFR-associated (GITR) protein modulator, killer Ig-like receptor (KIR) modulator, growth arrest-specific protein 6 (GAS6) / AXL pathway modulators, proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, differentiation cluster w123 (CDw123) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cell receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or OX40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, differentiation cluster 40 (CD40) modulators, tumor-infiltrating lymphocyte (TIL) therapy, or T-cell receptor (TCR) therapy.;

[0107] Exemplary drugs that may be included in the delivery device described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (ametopterin), tocilizumab, interferon beta-1a, interferon beta-1b, pegylated interferon beta-1a, sumatriptan, darbepoetin alpha, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-TMCA, sertolizumab pegol, satralizumab, Denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab and immunoglobulin.

[0108] Exemplary drugs that may be included within the delivery device described herein may also include, but are not limited to: oncological treatments, e.g., ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiflimab, 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 tiuxetane, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, Ofatumumab, Olaratumab, Panitumumab, Polatuzumab Vedotin, Ramucirumab, Sacituzumab Gobitecan, Tafacitamab, or Margetuximab.

[0109] Exemplary drugs that may be included in the delivery device described herein include "generic" or biosimilar equivalents of any of the foregoing ones, and the foregoing molecular name should not be interpreted as being limited to the respective "innovator" or "brand" versions, as in non-limiting examples of the innovator drug adalimumab and biosimilars, e.g., adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

[0110] Exemplary drugs that may be included in the delivery device described herein also include, but are not limited to: drugs used in adjuvant chemotherapy or neoadjuvant chemotherapy, e.g., alkylating agents, plant alkaloids, antitumor antibiotics, antimetabolites, or topoisomerase inhibitors, enzymes, retinoids, or corticosteroids. Exemplary chemotherapy drugs include, but are not limited to, 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, valubicin, vincristine, vinblastine, or vinorelbine.

[0111] Exemplary drugs that may be included in the delivery device 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]), antithrombotic agents, 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 Rock flush solution, or 5000 U / mL heparin rock flush solution.

[0112] Pharmaceutical formulations comprising, but not limited to, any of the drugs described herein are also considered for use in the delivery devices described herein, for example, pharmaceutical formulations comprising a drug (or a pharmaceutically acceptable salt of such drug) and a pharmaceutically acceptable carrier as listed herein are considered. 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 a dispersion enhancer (e.g., animal-derived, human-derived, or recombinant hyaluronidase enzyme), concentration modifier or enhancer, stabilizer, buffer, or other excipients that are separately administered or co-formulated.

[0113] Exemplary drugs that may be included in the delivery device described herein are multi-drug therapy regimens, e.g., AC, dose-intensive AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, dose-intensive CHOP, EPOCH, dose-controlled 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, VeIP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE, but It is not limited.

[0114] Various modifications to the described embodiments are possible and will occur to those skilled in the art without departing from the invention as defined by the following claims.

Claims

Claim 1 A film bag (1), comprising a port (2); and two film layers (11, 12) welded together to surround the port (2) and formed to form an internal volume for receiving fluid; wherein the film layers (11, 12) extend in a first axis (x) direction and a second axis (y) direction, and the weld seam (3) of the two film layers (11, 12) has a wave shape in a plane formed by the first axis (x) and the second axis (y). Claim 2 In claim 1, the film bag (1) comprises at least two waves of similar shape and amplitude. Claim 3 In paragraph 2, the film bag (1) comprises a wave shape having a sine wave, a curve, a zigzag, or a sawtooth shape. Claim 4 A film bag (1) according to any one of claims 1 to 3, 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. Claim 5 A film bag (1) according to any one of claims 1 to 4, wherein the wave shape is formed from two parts symmetric with respect to the second axis (y) direction. Claim 6 In claim 5, the two parts of the wave shape extend along the entire length of the film bag (1) with respect to the second axis (y). Claim 7 In any one of claims 1 to 4, the wave shape is a film bag (1) that extends along the entire length of the weld seam (3). Claim 8 In claim 7, the film bag (1) generally has a circular shape. Claim 9 A film bag (1), wherein, in any one of claims 1 to 8, the wave-shaped curvature is configured to minimize the dead area of ​​the internal volume when the internal volume is filled with the fluid. Claim 10 A film bag (1) according to any one of claims 1 to 9, wherein the fluid is a medicine. Claim 11 A system for enclosing a film bag, comprising: an enclosure (4); and a film bag (1) according to any one of claims 1 to 10; wherein the enclosure (4) comprises a first enclosure portion (41) and a second enclosure portion (42) configured to be releaseably connected to each other to enclose the film bag, and the first enclosure portion (41) and the second enclosure portion (42) each comprise a complementary attachment means (5), and the attachment means (5) is configured to secure the film bag when the first enclosure portion (41) and the second enclosure portion (42) are connected to each other. Claim 12 In claim 11, the two film layers (11, 12) of the film bag (1) substantially follow the shape of the enclosure (4), in a system. Claim 13 A system according to claim 11 or 12, wherein the attachment means (5) is configured to clamp the film layers (11, 12) of the film bag (1). Claim 14 A system according to any one of claims 11 to 13, wherein the attachment means (5) is positioned toward the perimeter of the enclosure (4). Claim 15 A system according to any one of claims 11 to 14, wherein the film layers (11, 12) comprise at least one fixing member (13) configured to engage with the attachment means (5).

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