Drug delivery system and method therefor

Abstract

The present disclosure relates to a medication delivery system comprising a cassette with a medication bag therein and a pump unit separable from the cassette, wherein an air flow connection is provided between the pump unit and an interior of the cassette. The pump unit comprises a pump and an air valve. The pump is configured to pressurize the interior of the cassette to apply pressure to the medication bag. The air valve is configured to depressurize the cassette by releasing pressure from the interior of the cassette.

Description

[Technical Field]

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

[0002] Some medications need to be stored in a refrigerator for shelf life reasons and / or to prevent the medication from losing its properties. However, in general, and even in the case of automated and semi-automated delivery systems, the medication should typically reach ambient temperature to make delivery more comfortable, since injection of a cold substance can be painful. Furthermore, temperature also affects the viscosity of some medications.

[0003] In drug delivery systems, patients typically allow the drug to warm at room temperature for about 30 minutes, however, depending on the amount and packaging of the drug, this step may take longer than expected or desired.

[0004] One conventional way to measure the temperature to know when a medication is ready for injection is to place some type of electronic device in or near the medication, or some type of temperature-sensitive label on the medication container, however, these solutions add cost and complexity and also have negative impacts on sustainability.

[0005] It is therefore an object of the present disclosure to remedy at least some of the shortcomings of the prior art. Summary of the Invention

[0006] According to an embodiment, a (partially) reusable drug delivery device / system is provided.

[0007] According to an embodiment, the time required for heating the drug may be reduced.

[0008] According to aspects, drug delivery may be more comfortable for the patient.

[0009] According to aspects, incorrect or inaccurate drug delivery may be prevented.

[0010] According to aspects, dosing, including sequential dosing of multiple drugs, can be facilitated.

[0011] Additionally, methods and systems according to the present disclosure are provided for accelerating the heating of the medication as well as measuring the temperature of the medication and indicating when it is ready for injection.

[0012] The present invention is specified in the independent claims. Preferred embodiments are defined in the dependent claims. In the following description, a number of features may be specified as optional, but it is recognized that not all features contained in the independent claims should nevertheless be read as optional.

[0013] The present disclosure relates to a medication delivery system comprising: a cassette with a medication bag therein; and a pump unit separable from the cassette, wherein an air flow connection is provided between the pump unit and an interior of the cassette. The pump unit comprises a pump and an air valve, wherein the pump is configured to pressurize the interior of the cassette to apply pressure to the medication bag, and the air valve is configured to depressurize the cassette by releasing pressure from the interior of the cassette. Additionally, the pump unit comprises a processing unit configured to control the pump and the air valve to cyclically pressurize and depressurize the interior of the cassette. Additionally, the processing unit is configured to perform the cyclic pressurization and depressurization based on a difference between an ambient air temperature and a temperature inside the cassette.

[0014] Various embodiments may preferably implement the following features.

[0015] Preferably, the pump unit is separate from the cassette.

[0016] Preferably, the cassette comprises an inlet passage configured to communicate with a connector of the pump unit.

[0017] Preferably, the pump is configured to pressurize the cassette via the connector and the inlet passage.

[0018] Preferably, the connector comprises a sealing member configured to hermetically seal the connection between the connector and the inlet passage.

[0019] Preferably, the cassette comprises at least one outer shell and a lid, the inlet passage preferably being provided in the lid.

[0020] Preferably, the medication bag is provided inside at least one outer shell and a lid.

[0021] Preferably, the medication bag is a flexible medication bag.

[0022] Preferably, the cassette and the pump unit are connectable to one another via a slide-on connection.

[0023] Preferably, the cassette includes a cassette locking mechanism and the pump unit includes a corresponding pump unit locking mechanism configured to secure the cassette and pump unit relative to one another.

[0024] Preferably, one of the cassette locking mechanism and the pump unit locking mechanism includes a guide rail, and the other of the cassette locking mechanism and the pump unit locking mechanism includes a corresponding guide groove.

[0025] Preferably, the guide rail has a substantially T-shaped cross section.

[0026] Preferably, the pump unit comprises at least one temperature sensor and / or at least one pressure sensor, which are preferably provided in the air flow path at the pump and / or at the air valve.

[0027] Preferably, the at least one temperature sensor is configured to measure at least one of the ambient air temperature and the temperature inside the cassette.

[0028] Preferably, the at least one pressure sensor is configured to measure the pressure inside the cassette.

[0029] Preferably, the pump unit comprises a processing unit.

[0030] Preferably, the processing unit comprises a processor, a memory and a communication interface.

[0031] Preferably, the processing unit is configured to control at least one of a pump, an air valve, an indicator, or a communication interface.

[0032] Preferably, the pump unit comprises a connection switch configured to switch on the processing unit when the cassette is attached to the pump unit.

[0033] Preferably, the pump unit comprises a power switch configured to activate the pump.

[0034] Preferably, the pump unit comprises an air filter and the pump is arranged to draw air through the air filter.

[0035] Preferably, a temperature sensor is provided in the air filter.

[0036] Preferably, the pump unit is reusable.

[0037] Preferably, the cassette is hermetically sealed away from the inlet passage.

[0038] Preferably, the pump unit comprises a release button configured to release the detachable pump unit from the cassette.

[0039] The present disclosure further relates to a pump unit comprising a pump and an air valve, the pump unit being configured for a system as described above.

[0040] Various embodiments may preferably implement the following features.

[0041] Preferably, the pump unit comprises a connector for fluid connection with the pump.

[0042] Preferably, the connector comprises a sealing member.

[0043] Preferably, the pump unit includes a pump unit locking mechanism.

[0044] Preferably, the pump unit locking mechanism comprises a guide rail or a guide groove.

[0045] Preferably, the guide rail has a substantially T-shaped cross section.

[0046] Preferably, the pump unit comprises at least one temperature sensor and / or at least one pressure sensor, which are preferably provided in the air flow path at the pump and / or at the air valve.

[0047] Preferably, the at least one temperature sensor is configured to measure at least one of the ambient air temperature and the temperature inside the cassette.

[0048] Preferably, the pump unit comprises a processing unit.

[0049] Preferably, the processing unit comprises a processor, a memory and a communication interface.

[0050] Preferably, the processing unit is configured to control at least one of a pump, an air valve, an indicator, or a communication interface.

[0051] Preferably, the pump unit comprises a connection switch configured to switch on the processing unit when the cassette is attached to the pump unit.

[0052] Preferably, the pump unit comprises a power switch configured to activate the pump.

[0053] Preferably, the pump unit comprises an air filter and the pump is arranged to draw air through the air filter.

[0054] Preferably, a temperature sensor is provided in the air filter.

[0055] Preferably, the pump unit is reusable.

[0056] Preferably, the pump unit comprises a release button.

[0057] The present disclosure further encompasses a cassette with a medication bag therein, the cassette being configured for a medication delivery system as described above.

[0058] Various embodiments may preferably implement the following features.

[0059] Preferably, the cassette includes an inlet passageway in fluid communication with the interior of the cassette.

[0060] Preferably, the cassette further comprises at least one outer shell and a lid, the inlet passage preferably being provided in the lid.

[0061] Preferably, the medication bag is provided inside at least one outer shell and a lid.

[0062] Preferably, the medication bag is a flexible medication bag.

[0063] Preferably, the cassette includes a cassette locking mechanism.

[0064] Preferably, the cassette locking mechanism comprises a guide rail or a guide groove.

[0065] Preferably, the guide rail has a substantially T-shaped cross section.

[0066] Preferably, the cassette is hermetically sealed away from the inlet passage.

[0067] The present disclosure further provides a method for controlling the temperature of a drug in a drug delivery system according to the present invention, the method comprising: measuring the outlet temperature of the released air; Measuring an inlet temperature; calculating a temperature difference between the inlet temperature and the outlet temperature; The method comprises: pressurizing a cassette containing a medication bag; Releasing the pressurized air from the cassette after a predetermined time; repeating the applying and releasing steps in response to the measured temperature difference.

[0068] In the present disclosure, when the term "distal direction" is used, it 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, it refers to the part / end of the delivery device, or part / end of a member thereof, that is located furthest from the dose delivery site during use of the drug delivery device. Correspondingly, when the term "proximal direction" is used, it refers to the direction towards the dose delivery site during use of the drug delivery device. When the term "proximal part / end" is used, it refers to the part / end of the delivery device, or part / end of a member thereof, that is located nearest to the dose delivery site during use of the drug delivery device.

[0069] Additionally, the terms "longitudinal," "longitudinal," "axially," and "axial" refer to the direction of longitudinal extension of the device, which extends along the x-axis in the figures.

[0070] Similarly, the terms "lateral," "laterally," "transverse," "transversal," and "transversally" refer to a direction generally perpendicular to the longitudinal direction (x-axis), which is shown as the y-axis in the figures.

[0071] The terms "vertical" and "vertically" refer to a direction perpendicular to the plane spanned by the lengthwise and widthwise directions (the xy plane), which is shown in the figures as the z-axis.

[0072] Additionally, the terms "circumference," "circumferential," or "circumferentially" refer to the circumference or direction of a circle relative to an axis. 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.

[0073] The term "separable" according to the present invention means that the pump unit can be physically separated from the cassette. A separable pump unit can also be carried on or attached to the cassette.

[0074] The term "independent" according to certain embodiments of the present invention means that the pump unit is functionally independent from the cassette and medication bag. A pump unit according to the present invention can thereby cooperate with a number of different cassettes, as desired by the user, with the cassettes 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 such that a given pump unit can be deactivated, disabled, or at least limited so that it can operate with only one or a limited number of cassettes.

[0075] In general, all terms used in the claims should be interpreted according to their ordinary meaning in the art unless expressly defined otherwise herein. All references to elements, devices, members, components, means, etc. should be openly interpreted as referring to at least one instance of the element, device, member, component, means, etc. unless expressly stated otherwise. [Brief explanation of the drawings]

[0076] Embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings in which: [Figure 1A] 1 illustrates an embodiment of a drug delivery system according to the present disclosure in an unassembled state. [Figure 1B] 1B shows the drug delivery system according to FIG. 1A in an assembled state. [Figure 1C] 1A or 1B in an assembled state. [Figure 2A] 1 illustrates a cross-sectional view of a cassette according to an embodiment of the present disclosure. [Figure 2B] 2B shows another cross-sectional view of the cassette according to FIG. 2A. [Figure 3A] 1 shows a perspective view of the interior of a pump unit according to an embodiment of the present disclosure. [Figure 3B] 1 shows a perspective view of the interior of a pump unit according to an embodiment of the present disclosure. [Figure 3C] 1 shows a perspective view of the interior of a pump unit according to an embodiment of the present disclosure. [Figure 4A] 1 shows a detailed partial view of a locking mechanism according to an embodiment of the present disclosure. [Figure 4B] 1 shows a detailed partial view of a locking mechanism according to an embodiment of the present disclosure. [Figure 5] FIG. 10 is a perspective view of a locking mechanism according to an embodiment of the present disclosure. [Figure 6A] 1 illustrates a partial view of a connection switch according to an embodiment of the present disclosure. [Figure 6B] 1 illustrates a partial view of a connection switch according to an embodiment of the present disclosure. [Figure 7] 10A and 10B illustrate cross-sectional views of a connection between a cassette and a pump unit according to an embodiment of the present disclosure. [Figure 8] 1 shows a cross-sectional view that schematically illustrates an air flow path according to an embodiment of the present disclosure. [Figure 9] 1 shows a flowchart of an embodiment of the present disclosure. [Figure 10] 1 shows a flowchart of an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0077] All elements and embodiments described below with reference to the drawings may be combined unless otherwise indicated.

[0078] 1A shows an overview of a drug delivery device according to an embodiment of the present disclosure. The system includes a pump unit 2 and a cassette 1. Cassette 2 may be connectable to a tubing set 5. For example, a standard Luer connection may be used. However, other types of tubing sets and connections may be used with the present disclosure. Cassette 1 and pump unit 2 may be provided separately and connectable to each other.

[0079] 1B shows the pump unit 2 and cassette 1 (with tubing set 5 attached) during assembly or connection of both parts. The pump unit 2 is slid onto the cassette 1 or vice versa. While FIG. 1B shows a sliding engagement between the pump unit 2 and cassette 1, this is merely an example and should not be understood as limiting the present disclosure.

[0080] 1C shows the drug delivery system in an assembled state. The pump unit 2 is attached to the cassette 1 and both parts are locked together. The device is now ready for drug delivery. After drug delivery, the pump unit 2 can be removed or separated from the cassette by pressing the release button 22 on the pump unit 2.

[0081] The pump unit 2 may thereby be separable from the cassette 1. Specifically, the pump unit 2 may be functionally independent from the cassette 1 and the medication bag 12. The pump unit 2 according to the present invention may thereby cooperate with a plurality of different cassettes 1, as desired by a user, the cassettes 1 being adapted to communicate with the pump unit 2. The pump unit 2 may also be configured to be connectable to only one (one type of) cassette 1.

[0082] In a 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 an assembled state, the circumferences of the pump unit 2 and the cassette 1 may be flush with each other. The vertical extension of the pump unit 2 and the cassette 1 may vary depending on the electronics and components provided in the pump unit 2 and the type and volume of the medication (i.e., medication bag 12) provided in the cassette 1.

[0083] The various parts of the system will now be described in more detail.

[0084] FIG. 2A shows a cross-sectional view of a cassette 1 according to an embodiment taken along the longitudinal direction (x-axis). The cassette 1 includes an outer shell 11, which may be formed as a single rigid shell or as multiple shell sections assembled together. The outer shell 11 or shell sections may be closed by a cassette lid 17. A drug bag 12 containing a drug (medicine) is provided inside the outer shell 11. The drug may be liquid at the time of administration. The drug bag 12 may be flexible (foldable). 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 reached through a respective 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, e.g., by attaching a tubing set 5. The cassette 1 may further comprise an inlet passage 14 that allows fluid, in particular air, to enter the cassette 1 .

[0085] The cassette 1 and medication bag 12 may be disposable units or may be refillable.

[0086] 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 figures, guide rails 15 of a slide-on mechanism are shown. However, the pump unit 2 and cassette 1 may also be connectable by snap-fit, clamps, screws or any other suitable connecting means. The locking mechanism 15 may also comprise locking notches 16, which will be described later.

[0087] The cassette 1 is provided airtight 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 interior of the cassette 1 is sealed. Therefore, the opening through which the outlet port 13 passes is also sealed so that air cannot pass through.

[0088] Figure 2B is a further cross-sectional view of the cassette according to Figure 2A along the transverse direction (y-axis). As can be seen, a space is provided between the outer shell 11 and the cassette lid 17, i.e., the interior of the cassette 1, and the medication bag 12. For medication 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 then acts on the collapsible medication bag 12, forcing the medication out through the outlet port 13 for medication delivery. This process is described in more detail below.

[0089] 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 parts 25, but may consist of one single shell part 25 or three or more shell parts 25. In FIGS. 3A-3C, the shell part 25 facing the viewer has been omitted to allow for inspection of the interior.

[0090] The pump unit 2 comprises a pump 3, in particular an air pump 3, an air or pressure valve 31, and a connector 32 serving as an air outlet for pressurizing the cassette 1. The connector 32 may be provided with a sealing member 33, which may be an O-ring fitted into a recess in the connector 32, as shown in FIG. 3A, so that the sealing member 33 can be radially compressed when the cassette 1 is attached to the pump unit 2 to seal the connection between the connector 32 and the inlet passage 14, as will be explained further below. The pump 3, the air valve 31, and the connector 32 may be connected by tubing 34.

[0091] The pump unit 2 further comprises electronics such as a processing unit 4 for controlling the medication 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, a 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. The pump unit 2 may comprise a disposable battery in addition to or instead of the power supply 45. Additionally, a wireless communication module may be provided.

[0092] The pump unit 2 may also comprise an identification unit (not shown) configured to identify the type of cassette 1 attached to the pump unit 2, i.e., drug parameters or prescription details such as type, volume, temperature for delivery, rate of delivery, time of delivery, etc. Thus, the cassette 1 may be provided with an identification tag that enables the pump unit 2 to identify the cassette 1. This may be achieved, for example, via RFID, NFC, etc. The identification tag of the cassette 1 may preferably be a passive component.

[0093] The processing unit 4 may 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, and / or an indicator 42 for indicating various device states 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 illumination means, such as an LED, and / or a sound generator or speaker. The indicator 42 may provide visual and / or audible feedback of the device's status, which may include at least one of the following: an active state of the processing unit 4, an attached state of the cassette 1, an operating state, a battery state, a drug temperature, a pressure state, an error state, a drug type, 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 point in the air flow path, for example, in the connector 32, the pump 3, the air valve 31, or the tubing 34. The temperature may be measured, for example, at the air filter 35, the connector 32, the pump 3, or the air valve 31, or between them in the piping 34. Specifically, the temperature of the incoming air and / or the temperature of the air exiting the cassette 1 may be measured to obtain data on the drug temperature within the cassette 1. Alternatively, the drug temperature may be measured directly.

[0094] 3B is a perspective view of the pump unit 2 from the other side of the device, i.e., rotated 180° about the vertical z-axis. Again, the shell part 25 facing the viewer has been omitted from the illustration.

[0095] The pump unit 2 further comprises an air inlet which may be equipped with an air filter 35. The air inlet / air filter 35 is also connected to the pump 3 via piping 34.

[0096] The distribution unit may connect the pump 3, the air filter 34, the connector 32, and the air valve 31 to and through the piping 34. The distribution unit may be a connector or an air switch. The distribution unit may also include a valve. In an embodiment, at least one of the air filter 34, the connector 32, or the air valve 31 may be connected directly to the pump 3.

[0097] 3C, which shows the same perspective view as FIG. 3B, omits most of the features other than the air flow path. Specifically, ambient air is drawn in by pump 3 through air filter 35 and piping 34 and provided to attached cassette 1 via connector 32. During this process, air valve 31 is closed to pressurize cassette 1. When the pressure in cassette 1 needs to be released, air valve 31 opens, allowing air to flow out through piping 34 and air valve 31. Note that air inlet 35 and air outlet (i.e., air valve 31) may be provided within pump unit 2 that cannot be hermetically sealed. Alternatively, openings may be provided in shell portion 25 to allow air to pass through or to connect air inlet 31 and air outlet 35 to the outside.

[0098] 4A, 4B, and 5, an exemplary locking mechanism between cassette 1 and pump unit 2 according to an embodiment will be described. As already described above, cassette 1 may include cassette locking mechanism 15, and pump unit 2 may include a corresponding pump unit locking mechanism 21. Specifically, cassette unit locking mechanism 15 may be a guide rail, and pump unit locking mechanism 21 may be a guide groove. In an embodiment, guide rail 15 may be a T-shaped rail, and guide groove 21 may be recessed to receive guide rail 15. The engagement between guide rail 15 and guide groove 21 can be seen in FIG. 5, which shows a cross-sectional view along the y-axis of cassette 1 and pump unit 2 in an attached state.

[0099] The locking mechanism between the pump unit 2 and the cassette 1 may be provided in the opposite way, i.e. with a pump unit locking mechanism 21 with a guide rail and a cassette unit locking mechanism 21 with a corresponding guide groove.

[0100] Herein, the longitudinal direction of insertion (negative x-direction) may be referred to as the insertion direction, while the opposite longitudinal direction (positive x-direction) may be referred to as the release direction.

[0101] Referring to FIG. 4A, the guide rail 15 may include a locking notch 16 that engages with the pump unit locking portion 23. Other parts of the pump unit 2 are omitted from this view to more clearly show the locking mechanism. The pump unit locking portion 23 may be provided in the locking portion guide groove 24 or the shell portion 25 of the pump unit 2 (see FIG. 3C), respectively. The locking portion 23 is connected to the release button 22 and is movable laterally (in the y-axis) in the locking portion guide groove 24 by actuation of the release button 22. The release button 22 may be provided with a spring that acts laterally on the locking portion 23 and the release button 22. As can be seen in FIG. 4B, the locking portion 23 may include a region that protrudes in the negative z-direction (downward in the view) and is configured to engage with the locking notch 16. The protruding region may be inclined, i.e., curved, toward the insertion direction (negative x-direction).

[0102] The installation process may be as follows: The pump unit 2 slides on the cassette 1 in the longitudinal direction (negative x-direction, insertion direction) as shown in FIG. 1B via the engagement between the guide rail 15 and the guide groove 21 (see FIG. 5 ). At the start of the sliding movement, the inclined region of the locking portion 23 abuts against the guide rail 15, thereby pushing the locking portion 23 laterally. The release button 22 may also move laterally together with the locking portion 23. The pump unit 2 and the cassette 1 are thereby guided relative to each other via the above engagement until they reach the assembled state. In the assembled state, the locking portion 23 has completely passed the start of the locking notch 16, allowing it to move freely laterally (y-direction) into the locking notch 16 due to the force of the spring. The longitudinal end surfaces of the locking portions 23 abut against abutment surfaces 18 at the longitudinal ends of the locking notches 16 in the release direction, thereby preventing movement of the pump unit 2 relative to the cassette 1 in that release direction. Furthermore, in the assembled state, the connector 32 engages with the inlet passage 14, thereby preventing further movement in the insertion direction (negative x-direction), as will be explained further below. Reaching the assembled state may be indicated to the patient or user by auditory and / or tactile feedback, such as a click or vibration, caused by the interaction of the locking portions 23 and the locking notches 16.

[0103] Additionally, the pump unit 2, specifically the processing unit 4, can be activated and switched from a sleep state to an active state by a connection switch 43. Therefore, the connection switch 43 can detect whether the cassette 1 is attached. The connection switch 43 can be provided at a longitudinal end of the pump unit 2 in a release direction toward the lower end of the pump unit 2 (negative z-direction), i.e., toward the cassette 1. While a mechanical connection switch 43 with a switch portion 44 is shown in the figure, the connection switch 43 can also be an optical sensor, an inductive sensor, or another electronic detection device. In FIG. 6A , the pump unit 2 is not attached or not fully attached to the cassette 1. The switch portion 44 faces the negative z-direction (downward in the figure). When the pump unit 2 is fully slid onto the cassette 1, parts of the cassette 1, in this case the lid 17 and the guide rail 15, lift the switch portion 44, thereby informing the processing unit 4 via the switch portion 44 that the cassette 1 is fully attached and the drug delivery device is thereby assembled for drug delivery.

[0104] FIG. 7 shows the airflow connection between the pump unit 2 and the cassette 1. The inlet passage 14 may protrude vertically (z-direction) from the cassette 1 and the lid 17, respectively. The pump unit 2 or the shell part 25 may have a respective receiving area recessed or cut out from the shell part 25 to receive the connector 32. Specifically, the connector 32 may be provided as a protruding rod protruding longitudinally (insertion direction) and slid into the inlet passage 14. As indicated above, the connection should be airtight to allow the interior of the cassette 1 to be pressurized via the connector 32 using air provided by the pump 3. Therefore, a sealing member 33 may be provided to seal the connection between the connector 32 and the inlet passage 14. The sealing member 33 may be an O-ring or other suitable means to prevent air leakage. In the case of the O-ring shown in FIG. 7, a radial recess may be provided in the connector 32 into which the O-ring fits. When the cassette 1 is attached to the pump unit 2, the connector 32 is slid into the inlet passage 14 and the sealing member 33 is compressed radially, thereby sealing the connection between the cassette 1 and the pump unit 2.

[0105] FIG. 8 illustrates airflow within a device according to an embodiment. Here, solid lines indicate incoming air and dashed lines indicate outgoing air. For drug delivery, ambient air is drawn by pump 3 through air filter 35 and tubing 34 and then provided to cassette 1 via tubing 34, connector 32, and inlet passage 14. By pumping air into cassette 1, the interior of cassette 1 is pressurized, and pressure acts on drug bag 12 to force the drug into the tubing set. In other words, the pressure within cassette 1 applies a force to drug bag 12, specifically against the outer surface of drug bag 12. This forces the drug out of drug bag 12 through outlet port 13.

[0106] When air is to be released from the cassette 1 , the air valve 31 is opened and the interior of the cassette 1 can be depressurized through the inlet passage 14 , the connector 32 , the tubing 34 and the air valve 31 .

[0107] The figures of this disclosure refer to a slide-on mechanism between the pump unit 2 and the cassette 1. Such a slide-on mechanism may facilitate sealing both units relative to one another by engagement of the connector 32 with the inlet passage 14. However, other mechanisms, such as a snap fit, threaded fastening, etc., may be provided, so long as an airtight connection is ensured that allows the pump 3 to pressurize the cassette 1.

[0108] Also, separate air inlet and outlet ports may be provided in the cassette 1 .

[0109] The operation of the drug delivery system according to this embodiment will now be described, and an exemplary flow chart of the method is depicted in FIG.

[0110] The pharmacy may be instructed to prepare S1 a cassette 1 with medication bag 12 according to the patient's prescription. Depending on the medication, cassette 1 may be stored in a cool, dark place, such as a refrigerator. This allows the patient to retrieve cassette 1 from the refrigerator and let it sit at room temperature for a period of time (e.g., 30 minutes) before delivery for acclimatization.

[0111] The patient then assembles the device S2 by connecting the pump unit 2 to the cassette 1 as described above. The cassette 1 activates the connection switch 43 S3, which activates the processing unit 4 and signals that the cassette 1 is attached S4. The patient may now attach the tubing set 5 to the cassette 1 S5.

[0112] Processing unit 4 may operate indicators 42 S6 to inform the patient of the current status of the device S7. Specifically, indicators 42 may provide visual and / or audible feedback of the device status, which may include at least one of the active status of processing unit 4, the attachment status of cassette 1, the operating status, the battery status, the drug temperature, the pressure status, the error status, the type of drug, whether the device is ready for injection, or whether the injection was successful.

[0113] When the indicator 42 shows that the device is ready for injection, the patient activates the power switch 41 S8, sending a start signal to the processing unit 4 to start or pause the injection S9.

[0114] The processing unit 4 activates the air pump 3 to pressurize the cassette 1 and begin the injection S10. When the patient pauses or stops the injection via the power switch 41, the air valve 31 (pressure valve) can be operated to release the pressure in the cassette 1 and stop the drug flow.

[0115] When an injection is initiated, the pump 3 aspirates ambient air S11 and pressurizes the cassette 1 with the ambient air S12, as described above. A pressure sensor measures or senses the pressure within the cassette 1 S13 and transmits the data to the processing unit 4 S14. The patient is then injected S15 via the tubing set 5. The pump 3 increases the pressure within the cassette 1. The maximum pressure may be limited by the pressure sensor, which notifies the processing unit 4. The pressure acts on the collapsible medication bag 12, which contains the medication. The pressurized medication is forced through the needle, through the tubing set 5, and into the patient's tissue. The amount of the delivered dose may be controlled by time and cassette pressure.

[0116] Depending on the delivery status, the processing unit 4 may operate the air valve 31 S16, thereby depressurizing the cassette 1 S17. Once the dose has been given, the processing unit 4 may operate the pressure valve 31, which releases pressure from the cassette 1. An indicator 42 on the pump unit 2 may notify the patient that the injection is complete. The tubing set 5 may be removed from the body and discarded together with the cassette 1 in a medical waste container. The pump unit 2 is reusable and can be stored until the next scheduled injection.

[0117] The processing unit 4 may further transmit S18 the injection parameters to the cloud, a mobile device, a computer, a server, etc.

[0118] The methods described above can be carried out using the drug delivery systems previously described.

[0119] As mentioned above, some medications need to be stored in a refrigerator. However, in general, because injection of cold substances can be painful, medications should reach ambient temperature to make delivery more comfortable. Furthermore, temperature also affects the viscosity of some medications.

[0120] In an embodiment, to shorten the time to reach the correct temperature, air is circulated within cassette 1 by applying overpressure and then releasing the overpressure to atmosphere by opening pressure valve 31. This can be repeated several times to exchange the cooled air with warmer ambient air from around pump unit 2 (by exchanging heat with the cold medication). A temperature sensor in the air circuit (in pump unit 2) can measure the temperature of the air entering the system via air filter 35. Air can be provided by pump 3 to cassette 1 as described above via tubing 34, connector 32, and inlet passage 14. Pressurized air can be stored within cassette 1 for a set time to warm the medication. After the set time, the pressurized air can be released to atmosphere via tubing 34 by opening air valve 31. The temperature of the outlet air stream can be measured and used as an indicator of the temperature of the medication within medication bag 12 within cassette 1. Specifically, a calculation can be used to determine when the medication is ready for injection, using the difference between the inlet and outlet air temperatures. The patient may then be notified via indicator 42 that the injection can begin.

[0121] The shortening of the heating time is facilitated in three ways. First, air exchange after a certain time, and the intake of new (warm) air from the surroundings and the expulsion of cooler air, will accelerate the heating. Second, convection, i.e., the movement / circulation of air within the cassette 1, accelerates the procedure of heating the drug bag 12. This occurs with each air exchange, but can also be done more frequently by blowing or releasing air for a short period of time. Third, the air within the cassette 1 can be heated by the increased pressure from the pump 3. That is, heat transfer can be more efficient due to the higher air pressure against the drug-holding drug bag 12.

[0122] The process for the assembled device as described above may be performed as follows, with reference to FIG. 10 : The processing unit 4 drives the air pump 3 to draw in ambient air at T1, draw in ambient air at T2, and pressurize the interior of the cassette 1 at T3. After a predetermined time, the processing unit 4 operates the air valve 31 to depressurize the cassette 1 at T4 and release the air at T5. Due to heat exchange with the cold drug, the released air will likely be cooler than the ambient air. A temperature sensor measures the temperature of the released air during depressurization T5 and sends the data to the processing unit 4 at T6. Depending on the measured temperature, the processes T1-T6 may be repeated until a preset temperature is reached or until the temperature difference between the ambient air (incoming air) and the exchanged air (outgoing air) falls below a certain threshold.

[0123] The methods described above can be performed using the drug delivery systems previously described and are compatible with the methods previously described.

[0124] The present disclosure may also encompass a pump unit 2 and / or cassette 1 for use with the described systems and / or methods. Specifically, the present disclosure encompasses a pump unit 2 that is separate from the cassette 1.

[0125] The invention is further defined by the following clauses. 1. A drug delivery system comprising: a cassette 1 having a drug bag 12 therein; a pump unit 2 separable from the cassette 1, an air flow connection being provided between the pump unit 2 and the interior of the cassette 1; The pump unit 2 includes a pump 3 and an air valve 31. The pump 3 is configured to pressurize the interior of the cassette 1 to apply pressure to the drug bag 12; The air valve 31 is configured to depressurize the cassette 1 by releasing pressure from inside the cassette 1, a drug delivery system. 2. A drug delivery system as described in clause 1, wherein the pump unit 2 is independent of the cassette 1. 3. The cassette 1 comprises an inlet passage 14 configured to communicate with the connector 32 of the pump unit 2; 3. A drug delivery system according to clause 1 or 2, wherein the pump 3 is configured to pressurise the cassette 1 via the connector 32 and the inlet passage 14. 4. A drug delivery system as described in item 3, wherein the connector 32 comprises a sealing member 33 configured to hermetically seal the connection between the connector 32 and the inlet passage 14. 5. A drug delivery system described in any one of clauses 1 to 4, wherein the cassette 1 comprises at least one outer shell 11 and a lid 17, and the inlet passage 14 is preferably provided in the lid 17. 6. A medication delivery system as described in clause 5, wherein the medication bag 12 is provided inside at least one outer shell 11 and a lid 17. 7. A drug delivery system described in any one of clauses 1 to 6, wherein the drug bag 12 is a flexible drug bag 12. 8. A drug delivery system according to any one of clauses 1 to 7, wherein the cassette 1 and the pump unit 2 are connectable to each other via a slide-on connection. 9. A drug delivery system described in any one of clauses 1 to 8, wherein the cassette 1 is provided with a cassette locking mechanism 15 and the pump unit 2 is provided with a corresponding pump unit locking mechanism 21 configured to secure the cassette 1 and the pump unit 2 relative to each other. 10. A drug delivery system as described in clause 9, wherein one of the cassette locking mechanism 15 and the pump unit locking mechanism 21 has a guide rail, and the other of the cassette locking mechanism 15 and the pump unit locking mechanism 21 has a corresponding guide groove. 11. The medication delivery system of clause 10, wherein the guide rail has a substantially T-shaped cross section. 12. A drug delivery system described in any one of clauses 1 to 11, wherein the pump unit 2 is provided with at least one temperature sensor and / or at least one pressure sensor, and the at least one temperature sensor and / or at least one pressure sensor are preferably provided in the air flow path of the pump 3 and / or the air valve 31. 13. A drug delivery system as described in clause 12, wherein at least one temperature sensor is configured to measure at least one of the ambient air temperature and the temperature inside the cassette 1. 14. A drug delivery system as described in clause 12 or 13, wherein at least one pressure sensor is configured to measure the pressure inside the cassette 1. 15. A drug delivery system according to any one of clauses 1 to 14, wherein the pump unit 2 comprises a processing unit 4. 16. A drug delivery system as described in clause 15, wherein the processing unit 4 comprises a processor, a memory, and a communication interface. 17. A drug delivery system as described in clause 15 or 16, wherein the processing unit 4 is configured to control at least one of the pump 3, the air valve 31, the indicator 42, or the communication interface 46. 18. A drug delivery system described in any one of clauses 15 to 17, wherein the pump unit 2 is provided with a connection switch 43 configured to switch on the processing unit 4 when the cassette 1 is attached to the pump unit 2. 19. A drug delivery system as described in any one of clauses 15 to 18, wherein the pump unit 2 is provided with a power switch 41 configured to activate the pump 3. 20. A drug delivery system described in any one of clauses 15 to 19, wherein the processing unit 4 is configured to control the pump 3 based on the ambient air temperature, or the temperature inside the cassette 1, or the difference between the ambient air temperature and the temperature inside the cassette 1. 21. A drug delivery system described in any one of clauses 15 to 20, wherein the processing unit 4 is configured to control the pump 3 and the air valve 3 to cyclically pressurize and depressurize the interior of the cassette 1. 22. A drug delivery system as described in clause 21, wherein the processing unit 4 is configured to perform periodic pressurization and depressurization based on the ambient air temperature, or the temperature inside the cassette 1, or the difference between the ambient air temperature and the temperature inside the cassette 1. 23. A drug delivery system as described in any one of clauses 1 to 22, wherein the pump unit 2 is provided with an air filter 35 and the pump 3 is configured to draw air through the air filter 35. 24. The drug delivery system of clause 23, wherein the temperature sensor is provided in the air filter 35. 25. A drug delivery system as described in any one of clauses 1 to 24, wherein the pump unit 2 is reusable. 26. A drug delivery system as described in any one of clauses 1 to 25, wherein the cassette 1 is hermetically sealed away from the inlet passage 14. 27. A drug delivery system described in any one of clauses 1 to 26, wherein the pump unit 2 is provided with a release button 22 configured to release the detachable pump unit 2 from the cassette 1. 28. A pump unit 2 comprising a pump 3 and an air valve 31, the pump unit 2 being configured for a system described in any one of clauses 1 to 27. 29. The pump unit 2 according to clause 28, wherein the pump unit 2 comprises a connector 32 for fluid connection with the pump 3. 30. The pump unit 2 according to clause 29, wherein the connector 32 comprises a sealing member 33. 31. A pump unit 2 as described in any one of clauses 28 to 30, wherein the pump unit 2 is provided with a pump unit locking mechanism 21. 32. The pump unit 2 according to clause 31, wherein the pump unit locking mechanism 21 comprises a guide rail or a guide groove. 33. The pump unit 2 according to clause 32, wherein the guide rail has a substantially T-shaped cross section. 34. A pump unit 2 as described in any one of clauses 28 to 33, wherein the pump unit 2 is provided with at least one temperature sensor and / or at least one pressure sensor, which are preferably provided in the air flow path of the pump 3 and / or the air valve 31. 35. The pump unit 2 according to clause 34, wherein the at least one temperature sensor is configured to measure at least one of the ambient air temperature and the temperature inside the cassette 1. 36. A pump unit 2 according to any one of clauses 28 to 35, wherein the pump unit 2 comprises a processing unit 4. 37. The pump unit 2 according to clause 36, wherein the processing unit 4 comprises a processor, a memory and a communication interface. 38. A pump unit 2 according to clause 36 or 37, wherein the processing unit 4 is configured to control at least one of the pump 3, the air valve 31, the indicator 42 or the communication interface 46. 39. A pump unit 2 as described in any one of clauses 36 to 38, wherein the pump unit 2 is provided with a connection switch 43 configured to switch on the processing unit 4 when the cassette 1 is attached to the pump unit 2. 40. A pump unit 2 as described in any one of clauses 36 to 39, wherein the pump unit 2 comprises a power switch 41 configured to activate the pump 3. 41. A pump unit 2 described in any one of clauses 36 to 40, wherein the processing unit 4 is configured to control the pump 3 based on the ambient air temperature, or another measured temperature, or the difference between the ambient air temperature and the other measured temperature. 42. A pump unit 2 according to any one of clauses 36 to 41, wherein the processing unit 4 is configured to control the pump 3 and the air valve 3 to operate periodically. 43. The pump unit 2 according to clause 42, wherein the processing unit 4 is configured to perform periodic activation based on the ambient air temperature, or another measured temperature, or the difference between the ambient air temperature and another measured temperature. 44. A pump unit 2 as described in any one of clauses 28 to 43, wherein the pump unit 2 is provided with an air filter 35 and the pump 3 is configured to draw air through the air filter 35. 45. The pump unit 2 according to clause 44, wherein a temperature sensor is provided in the air filter 35. 46. ​​A pump unit 2 as described in any one of clauses 28 to 45, wherein the pump unit 2 is reusable. 47. A pump unit 2 as described in any one of clauses 28 to 46, wherein the pump unit 2 is provided with a release button 22. 48. A cassette 1 having a drug bag 12 therein, the cassette 1 being configured for a drug delivery system as described in any one of clauses 1 to 27. 49. The cassette 1 according to clause 48, wherein the cassette 1 comprises an inlet passage 14 in fluid communication with the interior of the cassette 1. 50. A cassette (1) according to clause (49), further comprising at least one outer shell (11) and a lid (17), the inlet passage (14) being preferably provided in the lid (17). 51. A cassette 1 according to clause 50, wherein the drug bag 12 is provided inside at least one outer shell 11 and a lid 17. 52. A cassette 1 described in any one of clauses 48 to 51, wherein the drug bag 12 is a flexible drug bag 12. 53. A cassette 1 according to any one of clauses 48 to 52, wherein the cassette 1 comprises a cassette locking mechanism 15. 54. The cassette 1 according to clause 53, wherein the cassette locking mechanism 15 comprises a guide rail or a guide groove. 55. A cassette 1 according to clause 54, wherein the guide rail has a substantially T-shaped cross section. 56. A cassette 1 according to any one of clauses 48 to 55, wherein the cassette 1 is hermetically sealed away from the inlet passage 14. 57. A method for controlling a drug delivery system according to any one of clauses 1 to 27, the system comprising a cassette 1 comprising a drug bag 12 and a pump unit 2 detachably provided on the cassette 1; The method comprises: pressurizing the cassette 1 to apply pressure to the medication bag 12 (S12); releasing the contents of the drug bag 12 by pressurizing step S12 (S15); S17 depressurizing cassette 1. 58. A method for controlling the temperature of a drug in a drug delivery system, the method comprising: Pressurizing the cassette 1 containing the drug bag 12 (T3); and releasing T4 the pressurized air from the cassette 1 after a predetermined time. 59. The method of clause 58, further comprising measuring T5 the outlet temperature of the released air. 60. The method of clause 59, further comprising repeating the T3 step of pressurizing and the T4 step of releasing in response to the measured outlet temperature. 61. The method of clause 59 or 60, further comprising measuring the inlet temperature and calculating the temperature difference between the inlet temperature and the outlet temperature. 62. The method of clause 61, further comprising repeating the T3 step of applying pressure and the T4 step of releasing pressure depending on the measured temperature difference.

[0126] The delivery devices described herein can be used for the treatment and / or prevention of one or more of many different types of disorders.

[0127] Exemplary disorders include rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), hypercholesterolemia and / or dyslipidemia, cardiovascular disease, diabetes (e.g., type 1 diabetes or type 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjogren'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, and the like. These conditions include, but are 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, infection, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycemia, obesity, anaphylaxis, allergy, sickle cell disease, Alzheimer's disease, Parkinson's disease, Lewy body dementia, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immune deficiencies, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, factor V Leiden), and cancer.

[0128] Exemplary types of drugs 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, antagonists, radioligand therapy, radioisotopes and / or nuclear agents, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, 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.

[0129] Exemplary drugs that may be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology agents such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, clotting factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T cell receptors, B cell receptors, or costimulatory proteins.

[0130] Exemplary drugs that can be included in the delivery devices described herein include modulators of the human epidermal growth factor receptor 2 (HER-2) receptor, 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, B-cell activating factor (B-CFR) modulators, and the like. Modulators of BAFF (Basal-Associated Fc Factor), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor-associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PGF) modulators, and other modulators of EGFR.modulators of cluster of differentiation 19 (CD19), inhibitors of cluster of differentiation 20 (CD20), modulators of cluster of differentiation 3 (CD3), inhibitors of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), modulators of T-cell immunoglobulin and mucin-domain containing-3 (TIM-3), and inhibitors of T cell immunoreceptor with Ig and ITIM domains. domain (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulators, lymphocyte-activation gene 3 (LAG3) modulators; also known as cluster of differentiation 223 or CD223 antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (clusterCluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation w137 (CDw137) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster 80 (CD80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD159 or NKG2) modulators, glucocorticoid-induced TNFR-related TNFR-related (GITR) protein modulators, killer Ig-like receptor (KIR) modulators, growth arrest-specific protein 6 (GAS6) / AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B lymphocyte cell adhesion molecule modulators, cluster of differentiation w123 (CDw123) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HCV 2) modulators, and2, 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, cluster of differentiation 40 (CD40) modulators, tumor-infiltrating lymphocyte (TIL) therapy, or T-cell receptor (TCR) therapy, but are not limited to these.

[0131] Exemplary drugs that may be included in the delivery devices described herein include etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-1a, interferon beta-1b, pegylated interferon beta-1a, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dextromethorphan, thiazolinone, thiazolinone, thiazolinone, thiazolinone-1, thiazolinone-2, thiazolinone-3, thiazolinone-4, thiazolinone-5, thiazolinone-6, thiazolinone-7, thiazolinone-8, thiazolinone-9, thiazolinone-10, thiazolinone-11, thiazolinone-12, thiazolinone-13, thiazolinone-14, thiazolinone-15, thiazolinone-16, thiazolinone-17, thiazolinone-18, thiazolinone-19, thiazolinone-20, thiazolinone-21, thiazolinone-22, thiazolinone-23, thiazolinone-24, thiazolinone-25, thiazolinone-26, thiazolinone-27, thiazolinone-28, thiazolinone-29, thiazolinone-30, thiazolinone-31, thiazolinone-32, thiazolinone-33, thiazo These include, but are not limited to, tupiliumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulin.

[0132] Exemplary drugs that may be included in the delivery devices described herein include ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecanqui, pertuzumab, transtuzumab pertuzumab, alemtuzumab, belantamab mafodotin blmf, bevacizumab, blinatumomab, brentuximab, and rituximab. Oncology treatments such as ximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab may also be mentioned, but are not limited to these.

[0133] Exemplary drugs that may be included in the delivery devices described herein include "generic" or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as being limited to each "originator" or "brand" version, such as, by way of non-limiting example, the originator drug adalimumab, and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

[0134] Exemplary drugs that may be included in the delivery devices described herein also include, but are not limited to, those used in post- or pre-operative chemotherapy, such as alkylating agents, plant alkaloids, antitumor antibiotics, antimetabolites, or topoisomerase inhibitors, enzymes, retinoids, or corticosteroids. Exemplary chemotherapy drugs include, by way of example only, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.

[0135] Exemplary drugs that may be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g., hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator (r-TPA)), antithrombolytic agents, 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.

[0136] Pharmaceutical formulations, including, but not limited to, any of the drugs described herein, such as those containing a drug listed herein (or a pharmaceutically acceptable salt thereof) and a pharmaceutically acceptable carrier, are also contemplated for use in the delivery devices described herein. Such formulations may contain one or more other active ingredients (e.g., in combination with one or more active drugs) or may be the only active ingredient, and may also include dispersion enhancers (e.g., animal-derived, human-derived, or recombinant hyaluronidase enzymes), concentration modifiers or enhancers, stabilizers, buffers, or other excipients, administered separately or co-formulated.

[0137] 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, high-dose CHOP, EPOCH, dose-adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB These include, but are not limited to, multidrug treatment regimens such as 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.

[0138] 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 claims that follow.

Claims

1. 1. A drug delivery system comprising: a cassette (1) having a drug bag (12) therein; a pump unit (2) separable from the cassette (1), an air flow connection being provided between the pump unit (2) and the interior of the cassette (1), The pump unit (2) includes a pump (3) and an air valve (31). the pump (3) is configured to pressurize the interior of the cassette (1) to apply pressure to the drug bag (12); The air valve (31) is configured to release the pressure from the interior of the cassette (1), thereby depressurizing the cassette (1).

2. 2. The drug delivery system of claim 1, wherein the pump unit (2) comprises at least one temperature sensor and / or at least one pressure sensor, preferably provided in an air flow path of the pump (3) and / or the air valve (31) and / or an air filter (35) connected to the pump (3).

3. 3. The medication delivery system of claim 2, wherein the at least one temperature sensor is configured to measure at least one of the ambient air temperature and the temperature inside the cassette (1).

4. 4. A drug delivery system according to claim 2 or 3, wherein the at least one pressure sensor is configured to measure the pressure inside the cassette (1).

5. 5. The drug delivery system of claim 1, wherein the pump unit (2) comprises a processing unit (4), the processing unit (4) being configured to control the pump (3) based on the ambient air temperature, or the temperature inside the cassette (1), or the difference between the ambient air temperature and the temperature inside the cassette (1).

6. the pump unit (2) comprises a processing unit (4), the processing unit (4) being configured to control the pump (3) and the air valve (3) to cyclically pressurize and depressurize the interior of the cassette (1); The drug delivery system of any one of claims 1 to 5, wherein the processing unit (4) is preferably configured to perform the cyclic pressurization and depressurization based on the ambient air temperature, or the temperature inside the cassette (1), or the difference between the ambient air temperature and the temperature inside the cassette (1).

7. A drug delivery system according to any one of claims 1 to 6, wherein the pump unit (2) is independent of the cassette (1).

8. The cassette (1) comprises an inlet passage (14) configured to communicate with a connector (32) of the pump unit (2); The drug delivery system of any one of claims 1 to 7, wherein the pump (3) is configured to pressurize the cassette (1) via the connector (32) and the inlet passage (14).

9. the cassette (1) comprises at least one outer shell (11) and a lid (17), the inlet passage (14) being preferably provided in the lid (17); A drug delivery system according to any one of claims 1 to 8, wherein the drug bag (12) is preferably provided inside the at least one outer shell (11) and the lid (17).

10. The drug delivery system according to any one of claims 1 to 9, wherein the drug bag (12) is a flexible drug bag (12).

11. A method for controlling the temperature of a drug in a drug delivery system, preferably according to any one of claims 1 to 10, said method comprising: Pressurizing (T3) the cassette (1) containing the drug bag (12); and releasing (T4) said pressurized air from said cassette (1) after a predetermined time.

12. 12. The method of claim 11, further comprising measuring the outlet temperature of the released air (T5).

13. 13. The method of claim 12, further comprising repeating the pressurizing (T3) and releasing (T4) steps in response to the measured outlet temperature.

14. 14. The method of claim 12 or 13, further comprising measuring an inlet temperature and calculating a temperature difference between the inlet temperature and the outlet temperature.

15. 15. The method of claim 14, further comprising repeating the applying (T3) and releasing (T4) steps depending on the measured temperature difference.

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