Drug delivery system and method thereof

Abstract

The present invention A cassette (1) equipped with a drug bag (12), a connector (32), and a pump unit (2) that can be connected to the cassette (1) via the connector (32) and is configured to introduce air around the drug bag (12) inside the cassette (1), comprising a pump (3), an air inlet (35), an air valve (31), and a pressure sensor (6), The present invention relates to a drug delivery system comprising: an air inlet path between an air inlet (35) and a connector (32), the air inlet path comprising a pump (3), an air return path between the connector (32) and the air valve (31) when the air valve (31) is open, and a pump unit (2) defining the air inlet path and a pressure sensor (6) configured to measure the pressure in a cassette (1).

Description

Technical Field

[0001] The present disclosure relates to the field of drug delivery systems.

Background Art

[0002] Some drugs need to be stored in a refrigerator for reasons of shelf life and so that the drug does not lose its properties. However, generally, and also in the case of automatic and semi-automatic delivery systems, injection of cold substances can sometimes be painful, so the drug should reach ambient temperature to make delivery more comfortable. Furthermore, temperature also affects the viscosity of some drugs.

[0003] In an autoinjector, the patient should typically warm the drug at room temperature for about 30 minutes. However, depending on the amount and packaging of the drug, this step can take longer than expected or desired.

[0004] When delivering a large amount of drug contained within a bag in a cassette, an air pocket between the bag and the atmosphere can insulate the drug and it may warm more slowly than when the drug is contained within a glass vial, which can be problematic.

[0005] One conventional way to measure the temperature to know when the drug is ready for injection is to place some type of electronic device within or near the drug, or to place some type of temperature-sensitive label on the drug container. However, these solutions add cost and complexity and can also have an adverse impact on sustainability.

[0006] Thus, an object of the present disclosure is to improve the drawbacks of the prior art.

Summary of the Invention

[0007] According to an aspect, a (partially) reusable drug delivery device / system is provided.

[0008] Depending on the embodiment, the time required for the drug to rise in temperature can be reduced.

[0009] Depending on the method, drug delivery may be more comfortable for the patient.

[0010] Furthermore, the methods and systems described herein are provided not only for measuring the temperature of a drug and indicating when it is ready for injection, but also for accelerating the raising of the drug's temperature.

[0011] The present invention is specified in the independent claims. Preferred embodiments are defined in the dependent claims. In the following description, many features may be specified as optional, but it should not be understood that not all features included in the independent claims are optional.

[0012] According to a first aspect, the present invention relates to a drug delivery system, A cassette equipped with a medication bag, Connector and A pump unit that can be connected to a cassette via a connector and is configured to introduce air into the cassette around the drug bag, the pump unit comprising a pump, an air inlet, an air valve, and a pressure sensor, An air inlet path between an air inlet and a connector, wherein the air inlet path includes a pump, The system includes a pump unit that defines an air return path between the connector and the air valve when the air valve is open, The pressure sensor relates to a drug delivery system configured to measure the pressure within a cassette.

[0013] Accordingly, this disclosure encompasses a drug delivery system having a pneumatic circuit with separate inlet and return paths, the inlet and outlet of the pump unit converging at a cassette connection, i.e., a connector. Through these separate inlet and outlet paths, a continuous airflow can be provided to warm the inside of the cassette and, therefore, the drug contained in the drug bag. Alternatively, by closing the air valve, the cassette can be pressurized and the drug can be discharged from the cassette.

[0014] In a non-limiting embodiment, the cassette comprises at least one baffle plate inside, the baffle plate configured to distribute and / or guide air introduced into the cassette from an air inlet path to an air return path.

[0015] In a non-limiting embodiment, the baffle plate comprises at least one ridge inside the cassette.

[0016] In a non-limiting embodiment, the pump unit includes a processing unit configured to control the pump and air valve according to the measured pressure.

[0017] In a non-limiting embodiment, the pressure sensor is located between the pump and the connector.

[0018] In a non-limiting embodiment, the pressure sensor is located between the air valve and the connector.

[0019] In a non-limiting embodiment, the processing unit is configured to determine the change in temperature inside the cassette based on the measured pressure.

[0020] According to a second aspect, the present invention is a method for warming a drug bag in a drug delivery system according to a first aspect of the present invention, The pump provides a continuous airflow from the air inlet path to the air return path inside the cassette, wherein the air valve is open and the temperature of the airflow is higher than the temperature of the air inside the cassette (1). A method comprising measuring the pressure within a cassette by means of a pressure sensor.

[0021] In a non-limiting embodiment, the method further comprises stopping a continuous airflow and closing an air valve when the pressure is constant.

[0022] In a non-limiting embodiment, the method further comprises determining a change in temperature inside the cassette based on the measured pressure.

[0023] In a non-limiting embodiment, the temperature change is determined based on the ideal gas law, preferably in accordance with Gay-Lussac's law.

[0024] In the present disclosure, when the term "distal direction" is used, this refers to the direction away from the dose delivery site during use of the drug delivery device. When the term "distal part / end" is used, this refers to the part / end of the delivery device, or the part / end of its member, that is located furthest away from the dose delivery site during use of the drug delivery device. Correspondingly, when the term "proximal direction" is used, this refers to the direction towards the dose delivery site during use of the drug delivery device. When the term "proximal part / end" is used, this refers to the part / end of the delivery device, or the part / end of its member, that is located closest to the dose delivery site during use of the drug delivery device.

[0025] Furthermore, the terms "longitudinal", "longitudinally", "axially", and "axial" refer to the direction of the longitudinal extension of the device extending along the x-axis in the figure.

[0026] Similarly, the terms "lateral", "laterally", "transverse", "transversal", and "transversally" refer to a direction generally perpendicular to the longitudinal direction (x-axis), shown as the y-axis in the figures.

[0027] The terms "vertical" and "vertically" refer to a direction perpendicular to the plane (x-y plane) extending in the longitudinal and lateral directions, shown as the z-axis in the figures.

[0028] Furthermore, the terms "circumference", "circumferential", or "circumferentially" refer to the circumference or circumferential direction with respect to an axis. Similarly, "radial" or "radially" refers to a direction extending radially with respect to an axis, and "rotation", "rotational", and "rotationally" refer to rotation with respect to an axis.

[0029] The term "separable" according to the present invention means that the pump unit can be physically separated from the cassette. The separable pump unit can also be carried on or attached to the cassette.

[0030] In certain embodiments of the present invention, the term "independent" means that the pump unit is functionally independent from the cassette and drug bag. The pump unit according to the present invention can thus work with multiple different cassettes as desired by the user, and the cassettes are adapted to communicate with the pump unit. This provides the user with several options regarding the use of the pump unit. However, if desired, the independence of the pump unit can be deactivated, disabled, or at least limited so that a given pump unit can operate with only one or a limited number of cassettes.

[0031] In general, all terms used in the claims should be interpreted according to their common meanings in the art unless otherwise expressly defined herein. All references to elements, devices, members, components, means, etc., should be openly interpreted as referring to at least one instance of such elements, devices, members, components, means, etc., unless otherwise expressly stated. [Brief explanation of the drawing]

[0032] Herein, embodiments of the present disclosure will be described with reference to the following accompanying drawings, merely as examples.

[0033] [Figure 1A] An embodiment of the drug delivery system according to this disclosure is shown in its pre-assembly state. [Figure 1B] Figure 1A shows the drug delivery system in its assembled state. [Figure 1C] Figure 1A or Figure 1B shows the drug delivery system in its assembled state. [Figure 2A] A cross-sectional view of a cassette according to an embodiment of this disclosure is shown. [Figure 2B] Figure 2A shows another cross-sectional view of the cassette. [Figure 3A] This shows a perspective view of the inside of a pump unit according to an embodiment of the present disclosure. [Figure 3B] This shows a perspective view of the inside of a pump unit according to an embodiment of the present disclosure. [Figure 3C] This shows a perspective view of the inside of a pump unit according to an embodiment of the present disclosure. [Figure 4] A cross-sectional view illustrating a schematic example of an airflow channel according to an embodiment of this disclosure is shown. [Figure 5] A schematic diagram of the airflow channel according to the embodiment of this disclosure is shown. [Figure 6] An illustrative graph of the temperature rise stages of the cassette according to the embodiments of this disclosure is shown. [Figure 7] An exemplary graph of the pressure change during the heating phase of the cassette according to an embodiment of this disclosure is shown. [Modes for carrying out the invention]

[0034] All elements and embodiments described below with reference to the drawings can be combined unless otherwise indicated.

[0035] Figure 1A shows an overview of a drug delivery system according to an embodiment of the present disclosure. The system comprises a pump unit 2 and a cassette 1. The cassette 2 may be connectable to an infusion set 5. For example, a standard Luer connector may be used. However, other types of infusion sets and connectors may be used with the present disclosure. The cassette 1 and the pump unit 2 may be provided separately and may be connectable to each other.

[0036] Figure 1B shows the pump unit 2 and cassette 1 (to which the injection set 5 is attached) between the assembly or connection of both parts. The pump unit 2 slides on or off the cassette 1. Although Figure 1B shows the sliding engagement between the pump unit 2 and the cassette 1, this is merely an embodiment and should not be understood as limiting the present disclosure.

[0037] Figure 1C shows the assembled drug delivery system. The pump unit 2 is attached to the cassette 1, and both parts are locked to each other. This prepares the device for drug delivery. After drug delivery, the pump unit 2 can be removed or detached from the cassette by pressing the release button 22 on the pump unit 2.

[0038] The pump unit 2 may thus be separable from the cassette 1. Specifically, the pump unit 2 may be functionally independent from the cassette 1 and the drug bag 12. The pump unit 2 according to the present invention can thus work with multiple different cassettes 1 as desired by the user, and the cassettes 1 are adapted to communicate with the pump unit 2. The pump unit 2 may also be configured to connect to only one (one type) cassette 1.

[0039] In the top view, both the pump unit 2 and the cassette 1 may have an elliptical shape. Specifically, the pump unit 2 and the cassette 1 may have similar or identical shapes in the xy-plane. In the assembled state, the circumferences of the pump unit 2 and the cassette 1 may be coplanar with respect to each other. The vertical extension of the pump unit 2 and the cassette 1 may vary depending on the type and volume of electronic equipment and components provided in the pump unit 2, and the drug (i.e., drug bag 12) provided in the cassette 1.

[0040] Here, we will explain various parts of the system in more detail.

[0041] Figure 2A shows a cross-sectional view of a cassette 1 according to an embodiment, along the longitudinal direction (xz plane). Cassette 1 comprises an outer shell 11, which may be formed as a single rigid shell or as a plurality of shell parts assembled together. The outer shell 11 or shell parts may be closed by a cassette lid 17. Inside the outer shell 11 is a drug bag 12 containing a drug (medicine). The drug may be a liquid at the time of administration. The drug bag 12 may be a flexible (foldable) drug bag 12. The volume of the drug bag may be, for example, 10 ml to 250 ml, preferably 50 ml to 100 ml. The drug bag 12 has an outlet port 13, which may also be used to fill the drug bag 12 during manufacturing. The outlet port 13 may be accessible through each opening in the outer shell 11. The outlet port 13 may be provided with a valve, such as a pinch valve, to allow the drug to flow out only when the valve is open, for example by attaching an injection set 5. Cassette 1 may further include an inlet passage 14 that allows a fluid, specifically air, to enter the cassette 1.

[0042] Cassette 1 and drug bag 12 may be disposable units or may be refillable.

[0043] A cassette locking mechanism 15 may be provided for attaching and securing the pump unit 2 to the cassette 1. The locking mechanism 15 may be provided on the cassette lid 17. In the figure, a guide rail 15 of the slide-on mechanism is shown. However, the pump unit 2 and the cassette 1 may also be connected by snap fasteners, clamps, screws or any other suitable means of connection. The locking mechanism 15 may also include a locking notch 16, which will be described later.

[0044] Cassette 1 is provided in an airtight manner, except for the inlet passage 14. That is, the outer shell 11 or outer shell portion and the cassette lid 17 are connected in such a way that the inside of cassette 1 is sealed. Therefore, the opening through which the outlet port 13 passes is also sealed so that air cannot pass through.

[0045] Figure 2B is a further cross-sectional view of the cassette according to Figure 2A, along the transverse direction (yz plane). As can be seen from the figure, a space is provided between the outer shell 11, the cassette lid 17, i.e., the interior of the cassette 1, and the drug bag 12. For drug delivery, the interior of the cassette 1 is pressurized by introducing a fluid, specifically air, into the space through the inlet passage 14. This pressure acts on the foldable drug bag 12, pushing the drug out through the outlet port 13 for drug delivery. This process will be described in more detail below.

[0046] Figure 3A is a perspective view of a pump unit 2 according to an embodiment. In the embodiment shown in the figure, the pump unit 2 comprises two shell sections 25, but may consist of one single shell section 25 or three or more shell sections 25. In Figures 3A to 3C, the shell section 25 facing the viewer is omitted to allow for internal inspection.

[0047] The drug delivery system includes a connector 32 between the pump unit 2 and the cassette 1. The connector 32 functions as an air inlet / outlet for pressurizing / depressurizing the cassette 1. The connector 32 may be provided with a sealing member 33. The sealing member 33 may be an O-ring fitted into a recess of the connector 32, as shown in Figure 3A. This allows the sealing member 33 to be compressed radially when the cassette 1 is attached to the pump unit 2 in order to seal the connection between the connector 32 and the inlet passage 14, as will be further described below.

[0048] The pump unit 2 comprises a pump 3, in particular an air pump 3. The pump unit 2 further comprises an air valve 31. The air valve 31 and connector 32 may be connected by piping 34.

[0049] The pump unit 2 further comprises electronic equipment such as a processing unit 4 for controlling the drug delivery device. The processing unit 4 may also be referred to as a control unit. The processing unit 4 may comprise at least one processor, memory, at least one power supply 45, and a communication interface 46. The communication interface 46 may be used to charge the power supply 45 and to connect the pump unit 2 to a computer or server. In addition to the power supply 45, or instead of the power supply 45, the pump unit 2 may comprise a disposable battery. In addition, a wireless communication module may be provided.

[0050] The pump unit 2 may also include an identification unit (not shown) configured to identify the type of cassette 1 to be attached to the pump unit 2, i.e., drug parameters or prescription details such as type, volume, temperature for delivery, delivery rate, and delivery time. Thus, the cassette 1 may have an identification tag that enables the pump unit 2 to identify the cassette 1. This can be achieved, for example, via RFID, NFC, etc. The identification tag on the cassette 1 may preferably be a passive component.

[0051] The processing unit 4 can control the operation of the pump 3 and the air valve 31. Furthermore, the processing unit 4 may be connected to a power switch 41 for initiating drug delivery or switching the device on or off, an indicator 42 for indicating various states of the device, and a connection switch 43 for detecting whether the cassette 1 is attached to the pump unit 2. The indicator 42 may comprise at least one lighting means such as an LED and / or a sound generator i.e., a speaker. The indicator 42 may provide visual and / or auditory feedback of the device's status, which may include at least one of the following: the active state of the processing unit 4, the mounting status of the cassette 1, the operating state, the battery status, the drug temperature, the pressure state, the error state, the type of drug, whether the device is ready for injection, or whether the injection was successful. The pump unit 2 may further comprise at least one pressure sensor and / or at least one temperature sensor (not shown). The pressure sensor may be provided at a suitable location in the air passage, e.g., the connector 32, the pump 3, the air valve 31, or the piping 34. The temperature can be measured, for example, at the air inlet 35, connector 32, pump 3 or air valve 31, or between them in the piping 34. Specifically, the temperature of the incoming air and / or the temperature of the air flowing out of cassette 1 can be measured to obtain data on the drug temperature inside cassette 1. The drug temperature can also be measured directly.

[0052] Figure 3B is a perspective view of the pump unit 2 from the other side of the device, i.e., rotated 180° around the vertical z-axis. In this case as well, the shell portion 25 facing the viewer is omitted from the figure.

[0053] The pump unit 2 further comprises an air inlet which may include an air inlet 35. The air inlet 35 is also connected to the pump 3 via piping.

[0054] Figure 3C, which shows the same perspective view as Figure 3B, omits most of the features other than the airflow path. For drug delivery, ambient air is drawn in by the pump 3 through the air inlet 35 and supplied to the cassette 1, which is attached via the connector 32. During this process, the air valve 31 is closed to pressurize the cassette 1. When the pressure inside the cassette 1 should be released, the air valve 31 opens, and air flows out to the outside through the piping 34 and the air valve 31. Note that the air inlet 35 and air outlet (i.e., air valve 31) may be provided within the pump unit 2, which cannot be hermetically sealed. Alternatively, an opening may be provided in the shell portion 25 to allow air to pass through, or the air inlet 35 and air outlet (i.e., air valve 31) may be connected to the outside.

[0055] Figure 4 shows the airflow inside the device according to an embodiment. Here, solid lines represent incoming air and dashed lines represent outgoing air. For drug delivery, the air valve 31 is closed and ambient air is drawn in by the pump 3 through the air inlet 35 and piping 34 and then supplied to the cassette 1 via piping 34, connector 32, and inlet passage 14. By pressurizing the air into the cassette 1, the inside of the cassette 1 is pressurized, and the pressure acts on the drug bag 12 to push the drug into the infusion set. In other words, the pressure inside the cassette 1 applies a force to the drug bag 12, specifically to the outer surface of the drug bag 12. Thereafter, the drug is pushed out of the drug bag 12 through the outlet port 13.

[0056] When air should be released from cassette 1, the air valve 31 is opened, and the inside of cassette 1 can be depressurized through the inlet passage 14, connector 32, piping 34, and air valve 31.

[0057] Figure 5 is a further schematic diagram of the air passages (inlet and return passages) between the drug delivery system and the method for warming the drug in the cassette 1 of the drug delivery system according to an embodiment of the present invention. As described above, the pump unit 2 comprises a pump 3 and an air inlet 35 connected to the pump 3. The pump unit 2 also comprises an air valve 31, also referred to as a blow-off valve. The pump unit 2 may also comprise a controller or processing unit 4 configured to control the pump 3 and the air valve 31. The pump unit 2 comprises at least one pressure sensor 6. The pressure sensor 6 can measure the pressure of the fluid inside the cassette 1. The fluid may be air. At least one pressure sensor 6 is connected to the processing unit 4 (controller) and can be controlled by the processing unit 4. A temperature sensor (not shown) may also be provided. The pressure sensor 6 may be located behind the pump 3 in the direction of airflow, i.e., between the connector 32 and the pump 3. Alternatively, the pressure sensor 6 may be located between the connector 32 and the air valve 31.

[0058] The pump unit 2 may be connected to the cassette 1 via the connector 32 and the inlet passage 14, as described above. The cassette 1 may include a flow path setting baffle plate 18 for guiding or directing the airflow inside the cassette 1. The injection set 5 may be connected to the cassette 1 via, for example, a check valve having a crack pressure 19.

[0059] The connection between the connector 32 and the inlet passage 14 can be designed to provide separate air inlets and return paths. For example, the connector 32 may be divided by a separator. The path from the pump 3 (inlet path) and the path to the air valve 31 (outlet path) may be separated by a separator.

[0060] As described above, in cassette 1, at least one flow path setting baffle plate 18 may be provided to direct the airflow coming from pump 3 through connector 32 and inlet passage 14 so that effective air distribution is achieved inside cassette 1. This is schematically shown in Figure 5 (but omitted in previous figures). The baffle plate 18 may be formed by a ridge or similar structure inside cassette 1. The baffle plate 18 may extend laterally, i.e., in the y-direction from one inner wall of cassette 1 to the other inner wall.

[0061] As described above, during drug delivery, cassette 1 is pressurized by pump 3, which sends air into the cassette, and depressurized by opening the (blow-off) air valve 31.

[0062] In embodiments of the (accelerated) warming method for drugs according to the present invention, forced convection can be used at a constant flow rate before drug delivery.

[0063] Accordingly, this disclosure encompasses a drug delivery system having a pneumatic circuit with separate inlet and return paths, where the inlet and outlet of the pump unit 2 (drive assembly) converge at the connection point of the cassette 1, i.e., the connector 32 of the pump unit 2 and the inlet passage 14 of the cassette 1. This is shown in Figure 5, where the connection between the pump unit 2 and the cassette 1 is represented by a male radial sealing interface.

[0064] The air valve 31 is normally closed and preferably latched during drug delivery, but is open in the convection-based drug warming method according to the present invention. Using separate inlet and return paths, warm air is pumped into the cassette 1 and exits through the air valve 31 and the return path. The cassette 1 may include a baffle or duct mechanism 18 that pushes incoming air over most of the drug container (drug bag 12) to maximize heat transfer, as outlined above.

[0065] Through these separate inlet and outlet pathways, a continuous airflow can be provided, if desired, to warm the inside of the cassette 1 and, consequently, the drug contained in the drug bag 12. Alternatively, the cassette can be pressurized by closing the air valve 31.

[0066] The internal temperature of cassette 1 can be determined as follows:

[0067] When removed from the refrigerator, both the formulation in the drug container 12 and the air in the cassette 1 first reach refrigeration temperature. Once the cassette 1's casing warms to room temperature, the air inside the cassette 1 acts as an insulator between the cassette 1's shell 11 (cassette casing) and the surface of the drug container 12. Because air has a low thermal mass, it can reach a steady state between the two surfaces relatively quickly. Since the cassette casing 11 is in contact with the ambient air, it can warm up more rapidly than the formulation in the container 12. However, over time, the enclosed formulation will equilibrium too quickly at room temperature, regardless of whether the “accelerated” heat transfer and heating method described herein is implemented. This behavior is shown in Figure 6, where the cassette warms up first, followed by the internal air, and finally the formulation.

[0068] Specifically, in Figure 6, the dashed line represents room temperature, the leftmost thick line represents the temperature of cassette 1, the middle line represents the average air temperature of cassette 1, and the rightmost line represents the drug temperature inside drug container 12 over time. As can be seen from the graph, cassette 1 reaches room temperature the fastest, and then the internal temperature of cassette 1 and drug container 12, i.e., the drug, reaches room temperature.

[0069] As described above, the drug delivery system can be equipped with a pressure sensor 6 in an appropriate location. Therefore, since the system is equipped with a pressure sensor 6 (preferably located in the pump unit 2 as described above) connected to the air volume of the cassette 1, it is possible to detect the presence of a temperature change in the net temperature of the air in the cassette 1 by measuring the air pressure in the cassette 1 using the law of ideal gases, or more specifically, Gay-Lussac's law. Determination or monitoring of the pressure or pressure change inside the cassette 1 can be performed by at least one pressure sensor 6 or a processing unit 4 which may be connected to at least one pressure sensor 6. Since a fluid path check valve can prevent the outflow of fluid from the drug container 12, the internal volume of the cassette 1 is considered to be constant at a sufficiently low pressure. When the formulation temperature (i.e., the temperature of the drug bag 12) reaches a steady state, the pressure measurement in the cassette 1 becomes constant. Conversely, before the drug reaches a steady state, the drug temperature, and therefore the bulk air temperature, both change and equilibrium with the ambient temperature, and as a result, the pressure signal from the constant volume system changes. Figure 7 shows an experimentally measured example of the heating phase that occurs in a functionally equivalent pneumatic system. Here, the pressure of cassette 1 over time is shown.

[0070] In Figure 7, the upper graph shows the pressure change inside cassette 1 after it has been removed from the freezer. As can be seen from the figure, the pressure change shows the steepest slope due to the large temperature difference between the ambient air and the drug container 12. As a result, the middle graph, which shows the pressure change over time in cassette 1 after it has been removed from the refrigerator, is gentler, and the slope of the lower graph, which shows the pressure change in cassette 1 after it has been slightly cooled, is even smoother.

[0071] This method makes it possible to detect thermal equilibrium within the drug cassette 1 without requiring direct local temperature measurement. Once appropriate equilibrium is detected, the controller 4 can initiate drug delivery. The air valve 31 is then closed.

[0072] The figures in this disclosure refer to a slide-on mechanism between a pump unit 2 and a cassette 1. Such a slide-on mechanism may facilitate sealing of both units relative to each other by engagement of a connector 32 with an inlet passage 14. However, other mechanisms such as snap-fits or screw-in connections may be provided, as long as an airtight connection is ensured that the pump 3 can pressurize the cassette 1.

[0073] Furthermore, an air inlet and outlet may be provided separately within the cassette 1.

[0074] The method described above can be carried out using the previously described drug delivery system.

[0075] This disclosure may also include a pump unit 2 and / or cassette 1 for use with the described system and / or method. Specifically, this disclosure includes a pump unit 2 independent of cassette 1.

[0076] The delivery devices described herein can be used for the treatment and / or prevention of one or more of many different types of disorders.

[0077] Exemplary disorders include rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), hypercholesterolemia and / or lipid metabolism disorders, cardiovascular disease, diabetes (e.g., type 1 or type 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, sweat gland abscess, Sjögren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anemia, hereditary angioedema, systemic lupus erythematosus, and lupus kidney. This includes, but is not limited to, inflammation, myasthenia gravis, Behçet's disease, hemophagocytic syndrome, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infections, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplantation, acute hypoglycemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer's disease, Parkinson's disease, Lewy body dementia, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndrome, 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, factor V-Leiden disease), and cancer.

[0078] Examples of drug types that may be contained 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, antagonists, radioligand therapies, radioisotopes and / or nuclear agents, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptide bodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogs, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T-cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies.

[0079] Exemplary drugs that may be included in the delivery devices described herein include, but are not limited to, immunotumor agents or biotumor agents such as 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 costimulatory proteins.

[0080] Exemplary drugs that may be included in the delivery devices described herein include 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 polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, C1 esterase modulators, bradykinin modulators, CC chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, and B-cell activating factors. Factor (BAFF), P-selectin modulator, neonatal Fc receptor (FcRn) modulator, calcitonin gene-related peptide (CGRP) modulator, epidermal growth factor receptor (EGFR) modulator, differentiation cluster 79B (CD79B) modulator, tumor-associated calcium signaling transducer 2 (Trop-2) modulator, differentiation cluster 52 (CD52) modulator, B-cell maturation antigen (BCMA) modulator, enzyme modulator, platelet-derived growth factor receptor A modulatorA (PDGFRA) modulator, differentiation cluster 319 (CD319 or SLAMF7) modulator, programmed cell death protein 1 and programmed death-ligand 1 (PD-1 / PD-L1) inhibitor / modulator, B lymphocyte antigen differentiation cluster 19 (CD19) inhibitor, B lymphocyte antigen differentiation cluster 20 (CD20) modulator, differentiation cluster 3 (CD3) modulator, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulator, T cell immunoreceptor with Ig and ITIM domain (TIGIT) modulator, V-domain Ig suppressor of T cell Activation (VISTA) modulator, indoleamine 2,3-dioxygenase (IDO or INDO) modulator, poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulator, lymphocyte-activation gene 3 (LAG3; also known as differentiation cluster 223 or CD223) antagonist, differentiation cluster 276 (CD276 or B7-H3) antigen modulator, differentiation cluster 47 (cluster of differentiation 47, CD47) antagonist, differentiation cluster 30 (cluster of differentiation 30, CD30) modulator, differentiation cluster 73 (cluster of differentiation 73, CD73) modulator, differentiation cluster 66 (cluster(CD66) modulator, (CDw137) agonist, (CD158) modulator, (CD27) modulator, (CD58) modulator, (CD80) modulator, (CD33) modulator, (CD159 or NKG2) modulator, (GITR) protein modulator, (KIR) modulator, (CD159) modulator. 6. GAS6) / AXL pathway modulator, A proliferation-inducing ligand (APRIL) receptor modulator, human leukocyte antigen (HLA) modulator, epidermal growth factor receptor (EGFR) modulator, B lymphocyte cell adhesion molecule modulator, cluster of differentiation w123 (CDw123) modulator, Erbb2 tyrosine kinase receptor modulator, endoglin modulator, mucin modulator, mesothelin modulator, hepatitis A virus cellular receptor 2 (HAVCR2) antagonist, cancer-testis antigen (cancer-testisDrugs exhibiting the following mechanisms of action include, but are not limited to, antigen (CTA) modulators, tumor necrosis factor receptor superfamily member 4 (TNFRSF4 or OX40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumor-infiltrating lymphocyte (TIL) therapy, or T-cell receptor (TCR) therapy.

[0081] Illustrative drugs that may be included in the delivery devices described herein include etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (ametopterin), tocilizumab, interferon β-1a, interferon β-1b, pegylated interferon β-1a, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, and Examples include, but are not limited to, supilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, chrysanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immunoglobulins.

[0082] Examples of drugs that may be included in the delivery devices described herein include ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, semiprimab, rituximab, trastuzumab, ad-trastuzumab emtansine, fam-trastuzumab deruxtecan-NXKI, pertuzumab, transtuzumab pertuzumab, alemtuzumab, verantamab mahodotin-blmf, bevacizumab, blinatumomab, and ble Other tumor treatments that may be mentioned include, but are not limited to, ntuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasdotox, obinutuzumab, ofatumumab, olaratumumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafacitamab, or margetuximab.

[0083] Examples of drugs that may be included in the delivery devices described herein include any of the aforementioned "generic" or biosimilar equivalents, and the aforementioned molecular names should not be construed as being limited to their respective "original" or "branded" versions, such as the original drug adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz, but not limited to these examples.

[0084] Exemplary drugs that may be included in the delivery devices described herein include, but are not limited to, alkylating agents, plant alkaloids, antitumor antibiotics, antimetabolites, or topoisomerase inhibitors, enzymes, retinoids, or corticosteroids used in adjuvant or neoadjuvant chemotherapy. Examples of 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, barrubicin, vincristine, vinblastine, or vinorelbine.

[0085] Examples of drugs that may be included in the delivery devices described herein 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% saline, 0.45% saline, 5% dextrose in water, 5% dextrose in 0.45% saline, lactated Ringer's solution, heparin lock flush solution, 100 U / mL heparin lock flush solution, or 5000 U / mL heparin lock flush solution.

[0086] Pharmaceutical formulations, including but not limited to any drugs described herein, such as pharmaceutical formulations comprising drugs (or pharmaceutically acceptable salts thereof) and pharmaceutically acceptable carriers listed herein, are also intended for use in delivery devices described herein. 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 sole active ingredient, and may also contain dispersion enhancers (e.g., animal-derived, human-derived, or recombinant hyaluronidase enzymes), concentration modifiers or enhancers, stabilizers, buffers, or other excipients, which may be administered separately or formulated together.

[0087] Exemplary drugs that may be included in the delivery devices described herein include AC, high-dose 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, concentrated 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, and CALGB. Examples of multidrug therapy regimens include, but are not limited to, 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.

[0088] Various modifications to the embodiments described are possible and will be conceived by those skilled in the art without departing from the present invention as defined by the following claims.

Claims

1. A drug delivery system, A cassette (1) equipped with a drug bag (12), Connector (32) and A pump unit (2) is connectable to the cassette (1) via the connector (32) and configured to introduce air into the cassette (1) around the drug bag (12), the pump unit (2) comprising a pump (3), an air inlet (35), an air valve (31), and a pressure sensor (6), An air inlet path between the air inlet (35) and the connector (32), wherein the air inlet path includes a pump (3), The system includes a pump unit (2) that defines an air return path between the connector (32) and the air valve (31) when the air valve (31) is open, The drug delivery system is configured such that the pressure sensor (6) measures the pressure inside the cassette (1).

2. The drug delivery system according to claim 1, wherein the cassette (1) includes inside it at least one baffle plate (18) configured to distribute and / or guide air introduced into the cassette (1) from the air inlet path to the air return path.

3. The drug delivery system according to claim 2, wherein the baffle plate (18) comprises at least one ridge inside the cassette (1).

4. The drug delivery system according to any one of claims 1 to 3, wherein the pump unit (2) includes a processing unit (4) configured to control the pump (3) and the air valve (31) according to the measured pressure.

5. The drug delivery system according to any one of claims 1 to 4, wherein the pressure sensor (6) is located between the pump (3) and the connector (32).

6. The drug delivery system according to any one of claims 1 to 5, wherein the pressure sensor (6) is located between the air valve (31) and the connector (32).

7. The drug delivery system according to any one of claims 1 to 6, wherein the processing unit (4) is configured to determine the change in temperature inside the cassette (1) based on the measured pressure.

8. The drug delivery system according to any one of claims 1 to 7, wherein the temperature change is determined based on the law of ideal gases, preferably in accordance with Gay-Lussac's law.

9. A method for warming a drug bag (12) of a drug delivery system according to any one of claims 1 to 8, The pump (6) provides a continuous airflow into the cassette (1) from the air inlet path to the air return path, wherein the air valve (31) is open and the temperature of the airflow is higher than the temperature of the air inside the cassette (1), A method comprising measuring the pressure inside the cassette (1) using the pressure sensor (6).

10. The method according to any one of claims 1 to 9, further comprising stopping the continuous airflow and closing the air valve (31) when the pressure is constant.

11. The method according to claim 9 or 10, further comprising determining a change in the temperature inside the cassette based on the measured pressure.

12. The drug delivery system according to any one of claims 1 to 11, wherein the temperature change is determined based on the law of ideal gases, preferably in accordance with Gay-Lussac's law.

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