Medication bag

Abstract

The present disclosure relates to a medicament pouch comprising: a port having a seal configured to close an interior volume of the medicament pouch; and a flap configured to cover the port. The flap comprises a port element releasably connected to the port.

Description

Technical Field

[0001] This disclosure relates to a pharmaceutical bag, and more particularly to a pharmaceutical bag including a wing connected to a port of the pharmaceutical bag. Background Technology

[0002] Medications manufactured and dispensed through pharmacies are required to have physical labels that include patient and medication information to prevent dosing errors. The label and its contents must be visible or accessible. Pharmacists prefer to place their labels on hard, flat, and smooth surfaces to keep them as flat as possible, thus ensuring label consistency, legibility, and safety.

[0003] Typically, the label is placed directly on the infusion bag. This label may contain information about the specific patient, drug name and dosage, expiration date, or administration information. The label varies depending on the pharmacy, region, type of therapy, and administration device used, and is a primary medication safety strategy.

[0004] Label sizes are not standardized across pharmacies and vary considerably. Even within a single pharmacy setting, multiple label sizes may exist in use. This variation in label sizes hinders the option of designing devices to accommodate a single label size. Designing devices to accommodate the largest label size is also impractical.

[0005] When shape, size, or features prevent labeling in the preferred manner, pharmacists will try alternative methods, including “marking,” or wrapping the label around the object and affixing it so that it protrudes from the object. Marking is a very common practice, often used when labeling small boxes, vials, inhalers, and syringes. While common, this method is not preferred because exposed labels protrude and are easily torn off. Examples of devices with significant limitations include elastic pumps, which have prompted changes in labeling practices. Elastic pumps undergo drastic shape changes, which prevent pharmacists from labeling the medicine container directly, leading them to label it on the tubing instead. The combination of exposed and bent tubing carries the risk of label damage and detachment.

[0006] For IV therapy, flexible containers (such as DEHP or EVA) are typically used. However, in some devices, a more rigid membrane layer on the drug bag may be required to maintain long-term drug stability, as the drug can be pre-filled (unlike adding it before administration in an IV setting) and because pressure may be applied to the bag itself for dispensing.

[0007] Furthermore, when medicine bags are filled to different volumes, the thickness and shape of the bags may change, thus hindering simple, repeatable label placement.

[0008] Even if the label is successfully (or can) placed on the filled bag, there are potential undesirable effects on system function. Pharmacy labels may interfere with the features and interface of the medication cartridge, potentially hindering proper device operation and, if improperly placed, preventing drug delivery.

[0009] The applied label may selectively harden different parts of the bag by adding extra thickness or tension between different parts of the bag surface, thus causing undesirable or unpredictable changes to drug delivery or the emptying of the entire bag.

[0010] Furthermore, because labels are typically created in pharmacies, they are not standardized in terms of size, placement, or, importantly, adhesives. Since current pharmacy labeling is done shortly before dispensing to patients, long-term stability of the medication in the bag is not required. However, for longer storage periods, it is desirable to avoid labeling directly onto the bag material to prevent adverse effects on the barrier properties of the medication or on other leachates (e.g., adhesive residues or components), as substances from the adhesive can migrate through the bag material.

[0011] Labeling is mandatory, but it needs to be placed in a location that does not interfere with the functionality of the medicine bag or delivery device. Complicating matters is that the choice of label placement is often determined by pharmacists or pharmacy technicians who may not typically handle products with label placement restrictions, or who generally only deal with products with clearly defined restrictions.

[0012] Existing or "standard" IV bags have two ports. The first port is used to fill the bag with medication, typically using a needle; this port is made of a self-sealing, elastic material. Once filled by a pharmacist or pharmacy technician, this port is no longer needed and is no longer used. The relatively large, non-self-sealing second port remains closed during filling and only opens during medication administration when an IV puncture device / kit is inserted.

[0013] To prevent contamination or puncture of the incorrect port during administration, pharmacists typically place a port seal on the first port after filling and validating the formulation. Port seals are usually made of plastic or foil material with an adhesive backing and optionally have tamper-evident features to prevent removal. Many different port seal designs are available and are not standardized because they do not affect product functionality in an IV setting.

[0014] This increases the risk to the main container, as described above via the label. More specifically, if pharmacists “transfer” their IV mental model to the port located on the Keystone flexible container, the device may become unusable, or adhesive residue or portions of the port seal may remain on the sealing surface if the port seal is removed before use, adversely affecting product functionality. Therefore, an improved solution is needed to allow pharmacists to maintain their mental model while protecting proper product functionality.

[0015] Therefore, improved solutions are needed to address these considerations in order to maintain drug safety while accelerating drug development and commercialization by reducing the required analytical / mechanical characterization work.

[0016] These objectives are achieved through the features of this disclosure. Summary of the Invention

[0017] The invention is defined by the independent claims. Preferred embodiments are defined in the dependent claims. In the following description, although many features may be specified as optional, it is acknowledged that all features included in the independent claims should not be construed as optional.

[0018] This disclosure relates to a pharmaceutical bag comprising: a port having a seal configured to close the internal volume of the pharmaceutical bag; and a flap configured to cover the port. The flap includes a port element releasably connected to the port.

[0019] Various implementation schemes can preferably achieve the following features.

[0020] Preferably, the port element is a snap-fit ​​member configured to engage the port so that the flap can be releasably connected to the port.

[0021] Preferably, the snap-fit ​​component is configured to engage the lateral side of the port or is mounted on the port's access channel or seal.

[0022] Preferably, the port element is capable of releasing geothermal heat to be soldered to the port.

[0023] Preferably, the winglets are formed in a generally U-shape around the port.

[0024] Preferably, the wing substantially covers at least the first side of the medicine bag.

[0025] Preferably, the wing at least partially covers the second side of the medicine bag opposite to the first side.

[0026] Preferably, the wing can be releasably connected to the second side.

[0027] Preferably, the wing is integrally formed with the medicine bag.

[0028] Preferably, the fixed end of the wing is attached to or integrally formed with the medicine bag on the side opposite to the port.

[0029] Preferably, the free end of the blade is located at the port, and preferably, the port element is located at or toward the free end.

[0030] Preferably, the free end of the wing is located on the second side of the medicine bag.

[0031] Preferably, the port element includes a stop that is configured to contact the seal of the port.

[0032] Preferably, the wing includes perforations configured to allow removal of the wing from the medicine bag.

[0033] Preferably, the wing is welded to the seam of the medicine bag.

[0034] Preferably, the wing is formed from the membrane layer of the medicine bag.

[0035] Preferably, the winglets are at least partially formed of an elastic material.

[0036] Preferably, the port element is configured to be removed from the port by the elastic deformation of the wing.

[0037] Preferably, the winglet includes at least two elastic portions. Preferably, the at least partially elastic winglet includes at least one opening and / or at least two legs.

[0038] Preferably, the flap is at least partially transparent. Preferably, a portion of the flap is at least partially opaque and is provided with one or more contrasting colors, which are configured to allow inspection of the contents of the internal volume of the medicine bag. Preferably, one or more of the colors are black, white, or grayscale.

[0039] Preferably, the winglet contains a tag and / or sequence information. Preferably, the tag and / or sequence information is placed on the non-elastic portion of the winglet.

[0040] In this disclosure, the terms “vertical,” “vertically,” “longitudinal,” “longitudinal,” “axial,” and “axial” refer to the direction extending from the proximal end to the distal end and along the device or its components, typically along the longest extending direction of the device and / or components (second axis, y-axis).

[0041] Similarly, the terms “horizontal,” “horizontally,” “lateral,” “transverse,” and “laterally” refer to a direction that is approximately perpendicular to the longitudinal direction (the first axis, the x-axis).

[0042] The height direction can refer to the direction of the third axis (z-axis) perpendicular to the xy plane.

[0043] Furthermore, the terms "circumferential," "circumferential," or "circumferentially" refer to a circumferential or circumferential direction relative to an axis, which is typically a central axis extending in the longest direction of extension of the device and / or component. Similarly, "radial" or "radiallyly" refers to a direction extending radially relative to an axis, and "rotational," "rotational," and "rotationally" refer to rotation relative to an axis.

[0044] Generally, unless otherwise expressly defined herein, all terms used in the claims shall be interpreted according to their ordinary meaning in the technical field. Unless otherwise expressly stated, all references to one / the element, device, component, part, apparatus, etc. shall be openly interpreted as referring to at least one instance of the element, device, component, part, apparatus, etc. Attached Figure Description

[0045] Embodiments of this disclosure will now be described by way of example only and with reference to the following figures. In the figures, the same reference numerals denote the same or similar elements.

[0046] Figures 1A and 1B show a winged medicine bag according to an embodiment of the present disclosure.

[0047] Figure 2A and Figure 2B A pharmacy bag having flaps in an engaged state is shown according to an embodiment of the present disclosure.

[0048] Figure 2C A cross-sectional view of the engagement of the wing and port according to an embodiment of the present disclosure is shown.

[0049] Figures 3A to 3C The attachment of a port element to a port of a medicine bag according to an embodiment of the present disclosure is shown.

[0050] Figures 4A and 4B show the wing according to an embodiment of the present disclosure.

[0051] Figure 5 A winged medicine bag according to an embodiment of the present disclosure is shown. Detailed Implementation

[0052] This disclosure relates to a pharmaceutical bag 1 as shown in Figures 1A and 1B, which includes a port 2 allowing fluid to enter and exit an internal volume of the pharmaceutical bag 1. The port 2 may include a seal configured to close the internal volume of the pharmaceutical bag 1. A flap 3 is configured to cover the port 2. The flap 3 includes a port element 32 releasably connected to the port 2.

[0053] Figures 1A and 1B schematically illustrate the medicine bag 1 and its components, wherein, for clarity, port element 32 and port 2 are depicted as separate from each other. This can be referred to as the pre-engaged position.

[0054] The flap 3 and port element 32 are not configured to close port 2, as outlined above, which is closed by a seal. Instead, the flap 3 and port element 32 are configured to protect the port and indicate whether the medicine bag 1 has been used or tampered with. Furthermore, the flap 3 provides an attachment surface for labeling the medicine bag 1.

[0055] The flap 3 can be formed of the same material as the medicine bag 1. It can be integrally formed with the medicine bag 1, for example, by providing a large lower film layer, which is folded during welding to form the flap 3. Alternatively, the flap 3 can be attached to the medicine bag 1, for example, by gluing or welding to it. Specifically, the flap 3 can be attached to the medicine bag 1 at its lower end (i.e., the end away from port 2).

[0056] The flap 3 can be formed in a specific shape, specifically a U-shape, that follows the shape of the medication bag 1 in the region of port 2 (see Figures 1A and 1B). In this way, the flap 3 can maintain its position above port 2. Furthermore, as shown in Figure 1B, the flap 3 can extend further downward and can be attached to the medication bag 1 via a removal member 5 (see dashed line). The removal member 5 can be attached to the medication bag 1 via a ring 51 or via a releasable adhesive fastener. The ring 51 can also serve as a pull ring 51, for example, for allowing a detector to enter and facilitate the removal of the flap 3. A tag or sequence information 41 can be provided on the removal member 5. This information 41 can provide further guidance to the patient, for example, in cases involving protocols that require delivery of multiple medications in a specific order.

[0057] Tag 4 can be attached to wing 3, as shown in Figures 1A and 1B.

[0058] Although in Figure 1A, the flap 3 substantially covers the first side of the medicine bag 1, in Figure 1B the flap extends to at least partially cover the second side of the medicine bag 1. The width of the flap 3 (lateral direction, x-axis) can be equal to or less than the width of the medicine bag 1. The flap 3 can be arranged centered / symmetrically with respect to the central axis of the medicine bag 1.

[0059] Although port element 32 is depicted as being located on the side of the port in Figures 1A and 1B, this disclosure is not limited thereto, and port element 32 may also be configured to be mounted on port 2.

[0060] Port element 32 may be a snap-fit ​​member configured to engage port 2 so that the flap 3 can be releasably connected to port 2. The snap-fit ​​member may be configured to engage the lateral side of port 2 or fitted onto the inlet channel or seal of port 2.

[0061] Port element 32 can also be heat-welded to port 2. Heat welding can be performed laterally or at the top. For example, at least one pin, bridging element, etc., can be provided to allow port element 32 to be heat-welded to port 2.

[0062] As outlined above, the flap 3 can be formed in a generally U-shape around the port. In one embodiment, the flap 3 substantially covers at least a first side of the medicine bag 1. In another embodiment, the flap 3 at least partially covers a second side of the medicine bag 1 opposite to the first side. In one embodiment, the flap 3 is releasably attached to the second side, for example, by removing the member 5.

[0063] In one embodiment, the flap 3 is integrally formed with the medicine bag 1. In another embodiment, the fixed end of the flap 3 is attached to or integrally formed with the medicine bag 1 on the side opposite to the port 2.

[0064] In one embodiment, the free end of the flap 3 is located at the port 2. The port element 32 may be located at or toward the free end. Furthermore, the free end of the flap 3 may be located on the second side of the medicine bag 1. The free end may include a removal member 5.

[0065] In one embodiment, port element 32 includes a stop (not shown) configured to contact the seal of port 2. Port element 32 may not be configured to close or seal the medicine bag 1, but rather to protect port 2 before use.

[0066] In one embodiment, the flap 3 includes a perforation configured to allow removal of the flap 3 from the medicine bag 1. That is, the perforation forms a break point and allows the flap 3 to be removed during use after the contents have been verified.

[0067] In one embodiment, the flap 3 is welded to the seam of the medicine bag 1. The flap 3 may be formed from the membrane layer of the medicine bag 1.

[0068] Figure 2A A side view of the medicine bag 1 as described above is shown, wherein the port element 32 is attached to or snapped onto the port 2 (engaged position). Figure 2B A configuration is shown in which port element 32 can be releasably connected, specifically thermally soldered, to port 2. In this embodiment, two solder bridges are shown as an example, but this disclosure is not limited thereto.

[0069] Figure 2C This is a schematic cross-sectional view showing the port element 32 snapped onto port 2. This view corresponds to... Figure 2A The top view of the engagement configuration is shown. The port element 32 can be flexible to the extent that it can be attached to and removed from the port 2. Specifically, the port element 32 can be configured to allow and facilitate removal by a person with impaired dexterity or finger strength without the risk of damaging the port element 32 or the port 2.

[0070] exist Figures 3A to 3C In the illustrated embodiment, the wing 3 is formed of an elastic material. The accompanying drawings show the attachment of port element 32 to port 2, wherein the removal process includes equivalent steps in reverse order.

[0071] exist Figure 3A In this configuration, wing 3 is free and does not provide protection for port 2. (As...) Figure 3B As indicated by the arrow, the wing 3 can be elastically stretched in the longitudinal direction (upward). In this way, the port element 32 can be placed, for example, on the port 2 to protect the port. Figure 3C Due to the elasticity of the winglet 3, the port element 32 is firmly held on the port 2. Therefore, the port element 32 is configured to be removed from the port 2 by the elastic deformation of the winglet 3, i.e., in the reverse order.

[0072] Therefore, the process can be as follows. In the initial state, the flap 3 is in a compressed / shortened state. The lower part of the flap is fixed to the medicine bag 1 by adhesive, thermal welding, mechanical connection, or integrally formed with the medicine bag 1 (see also above). The port element 32 can have a snap-fit ​​connection, or it can have an inverted shape of port 2, sized to fit onto port 2. The user can hold the medicine bag at the lower part of the medicine bag 1 and pull the flap 3 upward. The flap 3 extends elastically from a first length to a second length. After the port element 32 is placed on port 2, the user releases the flap 3, thereby "snap-fitting" the port element 32 into the appropriate position on port 2 or the port seal.

[0073] As described above, the wing 3 may be provided with a perforated portion that is strong enough to withstand the tensile force during the elastic deformation of the wing 3, but is configured to allow the wing 3 to be removed when needed. This allows the wing 3, with attached tags, etc., to be separated from the medicine bag 1 and facilitates the recycling of the corresponding components.

[0074] Figures 4A and 4B illustrate embodiments of the resilient flap 3. In one embodiment, to prevent accidental removal of the label 4 during elastic deformation, the flap 3 may include at least one resilient portion 31 and at least one non-resilient portion to which the label 4 is attached. In Figure 4A, the non-resilient portion is indicated by a dashed line, wherein the flap includes resilient portions 31 disposed above and below, respectively. For example, the label 4 may be attached within the non-resilient portion of Figure 4A, as indicated by the dashed line, thereby preventing deformation or damage (e.g., tearing) during the extension of the resilient flap 3. The dotted area 4 may represent the label 4 itself or a label attachment surface that may be smaller than the label 4.

[0075] The wing 3 may also include at least one opening and / or a leg to improve elastic behavior. In Figure 4B, the wing 3 includes an elastic leg 31 formed by an opening in the wing 3 and another opening to improve elastic behavior. Furthermore, the entire wing 3 may be made of an elastic material, i.e., comprising a single elastic portion 31, with the tag 4 attached between the dashed lines. Due to the opening / leg, the relatively thin element can deform more than the central portion, allowing the attached tag 4 to remain in place.

[0076] If the wing 3 is made entirely of an elastic material, and the label 4 is attached to the elastic wing 3, for example by adhesive, the adhesive surface can have a sufficient reinforcing effect on that particular area (even though the underlying substrate itself is elastic), thus forming the non-elastic portion of the wing 3.

[0077] As described above, port element 32 is attached to port 2 and port element is removed from the port.

[0078] As outlined above, this disclosure is not limited to the embodiments shown, and the wing 3 may be made fully elastic or include one or more elastic portions 31 and one or more inelastic portions.

[0079] The wing 3 can be manufactured as a two-piece structure. As outlined above, the label 4 attachment surface can be attached to the resilient wing 3 only at the center, allowing the relatively thin leg to extend preferentially over the center portion where the label 4 is attached. Alternatively, in this configuration, the label attachment surface can be inelastic, while the wing 3 and therefore the port element 32 can retain their elastic function. As shown, the resilient leg (unlike a fully elastic element) can be configured to control the ease and extension of the extension of the port 2 relative to the bottom and top of the medicine bag 1.

[0080] Alternatively, the wing 3 can be made from a single component, with only a portion (e.g., the bottom or top portion) provided with the elastic element. Thus, flexible and non-flexible regions are combined. This can be achieved, for example, by secondary injection molding or overmolding with an elastic material.

[0081] In one embodiment, the flap 3 is at least partially transparent, thereby allowing visual inspection of the medicine bag 1. Therefore, the contents of the internal volume of the medicine bag 1, such as medication, can be inspected.

[0082] A portion of the wing 3 may be at least partially opaque. This portion may be provided with one or more contrasting colors configured to allow inspection of the contents of the internal volume of the medicine bag (1). One or more of the colors may be black, white, or grayscale.

[0083] As outlined above, the wing 3 may contain tag 4 and / or sequence information. Such information may also be set on the removal component 5.

[0084] Figure 5 A medicine bag 1 with a flap 3 is shown, the flap having space for applying a label 4 as described above. The figure shows the medicine bag 1 in a filled state, delivered to a patient with the port element 32 attached to the port 2. The flap 3 is attached to the lower part of the medicine bag 1.

[0085] When the medicine bag 1 is inserted into a medicine delivery device (e.g., a medicine delivery device case), the protective flap 3 conforms the label 4 to the surface of the case, thereby reducing the likelihood of accidental removal from the device if the label gets stuck on something. Furthermore, the flap 3 protects the port 2 from damage, fits the existing pharmacy mindset, and is intentionally designed to prevent accidental removal, thus avoiding accidental removal. It also maintains the position of the label 4 during transport and handling, enhancing readability and medication safety.

[0086] Furthermore, since the protective flap 3 is movable, the medicine can be inspected during manufacturing or by the pharmacist during filling. Alternatively, the back side (facing the bag surface) can be colored, such as having a black, gray, or white surface (or a combination thereof), thus allowing a predictable, consistent background for detailed inspection, such as of particulate matter.

[0087] This type of inspection is common for manual visual inspection of parenteral products manufactured in large-volume pharmaceutical manufacturing facilities. However, it is generally not available in pharmacy settings and cannot be used as a "built-in" option for empty parenteral containers, especially in pharmacies. In any case, the surface will be visible through the side of the medication bag 1 opposite the protective flap 3 and will still allow external labeling of the filled bag 1 without interfering with the inspection. It is worth noting that this feature can be used during dispensing and before administration. The feature can also be colored (e.g., with black and white portions or other sufficiently contrasting portions), thus allowing for labeling according to pharmacopoeia (e.g., USP). <1> EMA Appendix 1, USP <790> (e.g., EP 2.9.20, EP5.17.12 or JP 6.06) or other requirements to perform effective particle and / or foreign matter inspection.

[0088] As outlined above, the flap 3 can extend to cover both sides of the bag 1. The first side can be provided with a label space as previously described. The other side can also include information such as scheme sequence or contents information and / or attachment / removal components 5.

[0089] Advantageously, this allows labeling to fit pharmacy workflows, but the information can be placed “label-down” in the packaging, thus exposing the top surface with the removal indicator and serial number to the patient, thereby improving intuitiveness and avoiding removal of the port element / port protector 32 until the correct dosing time is reached.

[0090] Unlike labeling, marking is designed to track the master container during manufacturing, assembly, and inspection. It can also provide valuable information should any inconsistencies occur on-site, and if the legitimate manufacturer can identify the released sample. This information may include, for example, batch information, a Universal Device Identifier (UDI), expiration information, or other markings required to track the drug bag / device during manufacturing or post-market surveillance activities.

[0091] As described above, any handling of the membrane (i.e., the drug pouch 1 in direct contact with the drug) carries risks. Here, "markers" (wings 3) are presented on either side or both sides of the flexible drug pouch 1. Flexibility is provided by design in the direction of the ports 2. The top and bottom sides of the pouch 1 are designed to be more rigid, thus exhibiting less deformation. Since the top region contains the port 2 connection for dispensing the drug from the main container (drug pouch 1), the bottom portion provides a preferred area for attaching the wings 3.

[0092] The markings on the flap 3 can be made by any method, such as laser (to remove dark imprinted areas to create "reverse" printing, or by marking dark areas on a light background), printing, embossing, etc. Since this area of ​​the membrane does not come into direct contact with the drug, the barrier properties are not adversely affected.

[0093] The medicine pouches described in this article can be used to treat and / or prevent one or more of many different types of diseases.

[0094] Exemplary diseases 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 (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 disorders, anemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behçet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetes mellitus). Diseases that may cause macular edema, uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplantation, acute hypoglycemia, obesity, allergic reactions, allergies, sickle cell disease, Alzheimer's disease, Parkinson's disease, Lewy body dementia, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndromes, immunodeficiency (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, Leiden factor V), and cancer.

[0095] Exemplary drug types that may 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 therapy, radioisotopes and / or nuclear drugs, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptides, 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.

[0096] Exemplary drugs that may be included in the delivery device described herein include, but are not limited to: immuno-oncology or biological oncology agents, such as immune checkpoints, cytokines, chemokines, differentiation clusters, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or co-stimulatory proteins.

[0097] Exemplary drugs that may be included in the delivery device described herein include, but are not limited to, those exhibiting the proposed mechanisms 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-1 (GLP-1) modulators, glucose-dependent insulinotropic peptide (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 activator (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) modulators, tumor-associated calcium signaling transduction protein 2 (Trop-2) modulators, differentiation cluster 52 (CD38) modulators, and differentiation cluster 22 (CD38) modulators. 52) Modulators, B cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, differentiation cluster 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death ligand 1 (PD-1 / PD-L1) inhibitors / modulators, B lymphocyte antigen differentiation cluster 19 (CD19) inhibitors, B lymphocyte antigen differentiation cluster 20 (CD20) modulators, differentiation cluster 3 (CD3) modulators , cytotoxic T lymphocyte-associated protein 4 (CTLA-4) inhibitors, T cell immunoglobulin mucin domain 3 (TIM-3) modulators, T cell immune receptor Ig and ITIM domain-containing modulators (TIGIT) modulators, V domain T cell activation inhibitor (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-associated immunoglobulin domain protein (PVRIG) modulators, lymphocyte activation gene 3 (LAG3);Also known as differentiation cluster 223 (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-related (GITR) protein modulator, cytotoxic cell immunoglobulin-like receptor (KIR) modulator, growth arrest-specific protein 6 (G Modulators of the AS6 / AXL pathway, 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, endothelial glycoprotein 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-stimulatory molecule (ICOS) modulators, differentiation cluster 40 (CD40) modulators, tumor-infiltrating lymphocyte (TIL) therapy, or T cell receptor (TCR) therapy.

[0098] Exemplary drugs that may be included in the delivery device described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, errinumab, gakanezumab, remimab-vfrm, alicicumab, methotrexate, tocilizumab, interferon β-1a, interferon β-1b, pegylated interferon β-1a, sumatriptan, dapoxetine α, belimumab, sarerucumab, semaglutide, and others. Dupilumab, relizumab, omalizumab, glucagon, adrenaline, naloxone, insulin, amylin, vedolizumab, eculizumab, lavuzizumab, kelzanilizumab-tmca, cytokine, saturizumab (pegylated), saturizumab, denosumab, romozumab, benazeprizumab, emizumab, teirazumab, olizumab, ocrezumab, ocfatumab, natezumab, mepolizumab, resazazumab-rzaaa, ichezumab, and immunoglobulins.

[0099] Exemplary drugs that may be included in the delivery device described herein may also include, but are not limited to, oncology treatments such as: ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, acitumab, ceprimab, rituximab, trastuzumab, trastuzumab emtansine, detrastuzumab, pertuzumab, trastuzumab-pertuzumab, alemtuzumab, mabetoumab- blmf, bevacizumab, berintouzumab, vebutusumab, cetuximab, daratouzumab, ilotusumab, gemutuzumab, yttrium-90 teimozumab, esatatouzumab, moglizazumab, parcitouzumab, octatouzumab, octatouzumab, olazumab, panitumumab, polotouzumab, ramoxituzumab, gosatutuzumab, tancitouzumab, or magitouzumab.

[0100] Exemplary drugs that may be included in the delivery devices described herein include any of the foregoing “generic” or biosimilar equivalents, and the foregoing molecular names should not be construed as limited to “innovator” or “branded” versions of each, as in the non-limiting examples of the innovator drug adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

[0101] Exemplary drugs that may be included in the delivery device described herein also include, but are not limited to, those used as adjuvants or neoadjuvant chemotherapy, such as alkylating agents, plant alkaloids, antitumor antibiotics, antimetabolites or topoisomerase inhibitors, enzymes, retinoids or corticosteroids. Exemplary chemotherapy drugs include, for example but 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, dazometazidine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, phenylalanine mustard, methotrexate, pemetrexed, mitomycin, mitoxantrone, tesiromoxim, topotecan, pentorubicin, vincristine, vinblastine, or vinorelbine.

[0102] 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, preservatives, anticoagulants, fibrinolytic agents (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytic agents, or diluents such as sterile water for injection (SWFI), 0.9% sodium chloride injection, 0.45% sodium chloride injection, 5% glucose injection, a mixture of 5% glucose and 0.45% sodium chloride, sodium lactate Ringer's injection, heparin Loebrion flushing solution, 100 U / mL heparin Loebrion flushing solution, or 5000 U / mL heparin Loebrion flushing solution.

[0103] Pharmaceutical formulations, including but not limited to any of the drugs described herein, are also considered for use in the delivery devices described herein, such as pharmaceutical formulations comprising the drugs listed herein (or pharmaceutically acceptable salts of drugs) and a pharmaceutically acceptable carrier. Such formulations may contain 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 contain dispersants (e.g., animal-derived, human-derived, or recombinant hyaluronidase), concentration modifiers or enhancers, stabilizers, buffers, or other excipients, administered alone or co-formulated.

[0104] Exemplary medications that may be included in the delivery devices described herein include, but are not limited to, multi-drug therapy regimens such as AC, dose-dense 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-dense CHOP, EPOCH, dose-dense 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, VeIP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC or PE.

[0105] Various modifications to the described embodiments are possible and will be apparent to those skilled in the art without departing from the invention as defined by the appended claims.

Claims

1. A medicine bag (1), the medicine bag comprising: Port (2), the port having a seal configured to close the internal volume of the medicine bag (1); A winglet (3) is configured to cover the port (2); The winglet (3) includes a port element (32) that can be releasably connected to the port (2).

2. The medicine bag (1) according to claim 1, wherein the port element (32) is a snap-fit ​​member configured to engage the port (2) to releasably connect the flap (3) to the port (2).

3. The medicine bag (1) according to claim 2, wherein the snap-fit ​​member is configured to engage the lateral side of the port (2) or be fitted into the inlet channel of the port (2) or the seal.

4. The medicine bag (1) according to claim 1, wherein the port element (32) is capable of releasing geothermal welding to the port (2).

5. The medicine bag (1) according to any one of claims 1 to 4, wherein the wing (3) is formed in a generally U-shape around the port (2).

6. The medicine bag (1) according to any one of claims 1 to 5, wherein the wing (3) substantially covers at least a first side of the medicine bag (1), and Preferably, the wing (3) at least partially covers the second side of the medicine bag (1) opposite to the first side. Preferably, the wing (3) is releasably connected to the second side.

7. The medicine bag (1) according to any one of claims 1 to 6, wherein the wing (3) is integrally formed with the medicine bag (1).

8. The medicine bag (1) according to any one of claims 1 to 8, wherein the fixed end of the wing (3) is attached to the medicine bag (1) or integrally formed with the medicine bag (1) on the side opposite to the port (2), and / or The free end of the blade (3) is disposed at the port (2), wherein preferably, the port element (32) is disposed at or toward the free end.

9. The medicine bag (1) according to any one of claims 6 to 8, wherein the free end of the wing (3) is disposed on the second side of the medicine bag (1).

10. The medicine bag (1) according to any one of claims 1 to 9, wherein the port element (32) includes a stop configured to contact the seal of the port (2).

11. The medicine bag (1) according to any one of claims 1 to 10, wherein the flap (3) includes a perforation configured to allow removal of the flap (3) from the medicine bag (1), and / or The wing (3) is welded to the seam of the medicine bag (1), or The wing (3) is formed from the membrane layer of the medicine bag (1).

12. The medicine bag (1) according to any one of claims 1 to 11, wherein the wing (3) is at least partially formed of an elastic material (31), Preferably, the port element (32) is configured to be removed from the port (2) by elastic deformation of the winglet (3).

13. The medicine bag (1) according to claim 12, wherein the wing (3) comprises at least two elastic portions (31), and / or The at least partially elastic winglet (3) includes at least one opening and / or at least two legs.

14. The medicine bag (1) according to any one of claims 1 to 13, wherein the wing (3) is at least partially transparent, and / or A portion of the wing (3) is at least partially opaque and is provided with one or more contrasting colors, which are configured to allow inspection of the contents of the internal volume of the medicine bag (1). Preferably, one or more of the colors are black, white, or grayscale.

15. The medicine bag (1) according to any one of claims 1 to 14, wherein the flap (3) comprises a label (4, 41) and / or sequence information (4, 41). Preferably, the tag (4, 41) and / or the sequence information (4, 41) are placed on the inelastic portion of the wing (3).

Images