Medicament delivery systems and methods thereof

Abstract

The present disclosure relates to a medicament delivery system comprising: a cartridge comprising a medicament pouch in the interior thereof; the pump unit can be separated from the box, and an air flow connecting part is arranged between the pump unit and the inner part of the box. The pump unit includes a pump and an air valve. The pump is configured to pressurize the interior of the cartridge to apply pressure to the medicament bag. The air valve is configured to depressurize the cartridge by releasing the pressure from the interior of the cartridge.

Description

Technical Field

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

[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 with automated and semi-automated delivery systems, medications should typically be brought to ambient temperature to make delivery more comfortable, as injecting cold substances can be painful. Furthermore, temperature also affects the viscosity of some medications.

[0003] In a drug delivery system, the patient should typically allow the drug to warm at room temperature for about 30 minutes. However, depending on the volume and packaging of the drug, this step may take longer than expected or desired.

[0004] One conventional way to measure temperature to know when a medication is ready for injection is to place some type of electronics in or near the medication, or to place some type of temperature-sensitive label on the medication container. However, these solutions add cost and complexity, and can also negatively impact sustainability.

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

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

[0007] According to one aspect, the warming time of a drug can be reduced.

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

[0009] According to one aspect, erroneous or incorrect medicament delivery can be prevented.

[0010] According to one aspect, a medication regimen comprising sequential dispensing of multiple medications can be facilitated.

[0011] Additionally, methods and systems according to the present disclosure are provided to accelerate the warming of a medication as well as to measure the temperature of the medication and indicate when it is ready for injection.

[0012] The invention is defined by the independent claims. Preferred embodiments are defined in the independent claims. In the following description, although many features may be designated as optional, it is acknowledged that all features included in the independent claims should not be understood as optional.

[0013] The present disclosure relates to a drug delivery system comprising: a box including a drug bag in its interior; a pump unit that is separable from the box, wherein an air flow connection is provided between the pump unit and the interior of the box, wherein the pump unit comprises a pump and an air valve, wherein the pump is configured to pressurize the interior of the box to apply pressure to the drug bag, and wherein the air valve is configured to depressurize the box by releasing the pressure from the interior of the box.

[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 channel 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 access channel.

[0018] Preferably, the connector comprises a sealing member configured to seal the connection between the connector and the access channel in an airtight manner.

[0019] Preferably, the cartridge comprises at least an outer shell and a cover, wherein the access channel is preferably provided in the cover.

[0020] Preferably, the medicament pouch is provided inside the at least one outer shell and the lid.

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

[0022] Preferably, the cassette and the pump unit are connectable to each other via a sliding connection.

[0023] Preferably, the cassette comprises a cassette locking mechanism and the pump unit comprises a corresponding pump unit locking mechanism configured to secure the cassette and the pump unit relative to each other.

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

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

[0026] Preferably, the pump unit comprises at least one temperature sensor and / or at least one pressure sensor, wherein the at least one temperature sensor and / or the at least one pressure sensor are preferably arranged in the air flow path at the pump and / or 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 of the interior of the box.

[0028] Preferably, the at least one pressure sensor is configured to measure the pressure in the interior of the cartridge.

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

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

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

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

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

[0034] Preferably, the processing unit is configured to control the pump based on the ambient air temperature or the temperature of the interior of the cassette or a difference between the ambient air temperature and the temperature of the interior of the cassette.

[0035] Preferably, the processing unit is configured to control the pump and the air valve to periodically pressurize and depressurize the interior of the cartridge.

[0036] Preferably, the processing unit is configured to perform the periodic pressurization and depressurization based on the ambient air temperature or the temperature of the interior of the box or the difference between the ambient air temperature and the temperature of the interior of the box.

[0037] Preferably, the pump unit comprises an air filter, wherein the pump is configured to draw air through said air filter.

[0038] Preferably, a temperature sensor is provided at the air filter.

[0039] Preferably, the pump unit is reusable.

[0040] Preferably, the box is sealed in an airtight manner except for the access channel.

[0041] Preferably, the pump unit comprises a release button configured to release the detachable pump unit from the cassette.

[0042] The present disclosure further relates to a pump unit comprising a pump and an air valve, wherein the pump unit is configured for use in a system as described above.

[0043] Various embodiments may preferably implement the following features.

[0044] Preferably, the pump unit comprises a connector in fluid connection with the pump.

[0045] Preferably, the connector comprises a sealing member.

[0046] Preferably, the pump unit comprises a pump unit locking mechanism.

[0047] Preferably, the pump unit locking mechanism comprises a guide rail or a guide groove.

[0048] Preferably, the guide rail has a generally T-shaped cross-section.

[0049] Preferably, the pump unit comprises at least one temperature sensor and / or at least one pressure sensor, wherein the at least one temperature sensor and / or the at least one pressure sensor are preferably arranged in the air flow path at the pump and / or the air valve.

[0050] Preferably, the at least one temperature sensor is configured to measure at least one of the ambient air temperature and the temperature of the interior of the box.

[0051] Preferably, the pump unit comprises a processing unit.

[0052] Preferably, the processing unit includes a processor, a memory and a communication interface.

[0053] Preferably, the processing unit is configured to control at least one of the pump, the air valve, the indicator or the communication interface.

[0054] Preferably, the pump unit comprises a connection switch configured to switch on the processing unit if a cassette is attached to the pump unit.

[0055] Preferably, the pump unit comprises a power switch configured to activate the pump.

[0056] Preferably, the processing unit is configured to control the pump based on the ambient air temperature or another measured temperature or a difference between the ambient air temperature and the another measured temperature.

[0057] Preferably, the processing unit is configured to control the pump and the air valve to be driven periodically.

[0058] Preferably, the processing unit is configured to perform the periodic driving based on the ambient air temperature or another measured temperature or a difference between the ambient air temperature and the another measured temperature.

[0059] Preferably, the pump unit comprises an air filter, wherein the pump is configured to draw air through said air filter.

[0060] Preferably, a temperature sensor is provided at the air filter.

[0061] Preferably, the pump unit is reusable.

[0062] Preferably, the pump unit comprises a release button.

[0063] The present disclosure also includes a box including a drug bag inside thereof, wherein the box is configured for use with the drug delivery system as described above.

[0064] Various embodiments may preferably implement the following features.

[0065] Preferably, the cartridge comprises an access channel in fluid connection with the interior of the cartridge.

[0066] Preferably, the cartridge further comprises at least one outer shell and a cover, wherein the access channel is preferably provided in the cover.

[0067] Preferably, the medicament pouch is provided inside the at least one outer shell and the lid.

[0068] Preferably, the medicine bag is a flexible medicine bag.

[0069] Preferably, the cassette includes a cassette locking mechanism.

[0070] Preferably, the cartridge locking mechanism comprises a guide rail or a guide groove.

[0071] Preferably, the guide rail has a generally T-shaped cross-section.

[0072] Preferably, the box is sealed in an airtight manner except for the access channel.

[0073] The present disclosure further relates to a method for controlling a drug delivery system as described above, the system comprising a cartridge comprising a drug bag and a pump unit detachably disposed at the cartridge, the method comprising pressurizing the cartridge to apply pressure to the drug bag, releasing the contents of the drug bag through the pressurizing step, and depressurizing the cartridge.

[0074] The present disclosure further relates to a method for controlling the temperature of a medicament in a medicament delivery system, wherein the method includes pressurizing a cartridge containing bags of medicament and releasing the pressurized air from the cartridge after a predetermined period of time.

[0075] Various embodiments may preferably implement the following features.

[0076] Preferably, the method further comprises measuring the outflow temperature of the released air.

[0077] Preferably, the method further comprises repeating the pressurizing step and the releasing step according to the measured outflow temperature.

[0078] Preferably, the method further comprises measuring an inflow temperature and calculating a temperature difference between the inflow temperature and the outflow temperature.

[0079] Preferably, the method further comprises repeating the pressurizing step and the releasing step according to the measured temperature difference.

[0080] In the present disclosure, when the term "distal direction" is used, this refers to a direction pointing away from the dose delivery site during use of the drug delivery device. When the term "distal portion / distal end" is used, this refers to the portion / end of the delivery device or the portion / end of a component of the delivery device that is positioned furthest from the dose delivery site during use of the drug delivery device. Correspondingly, when the term "proximal direction" is used, this refers to a direction pointing towards the dose delivery site during use of the drug delivery device. When the term "proximal portion / proximal end" is used, this refers to the portion / end of the delivery device or the portion / end of a component of the delivery device that is positioned closest to the dose delivery site during use of the drug delivery device.

[0081] Furthermore, the terms "longitudinal," "longitudinally," "axially," and "axially" refer to the direction of the longitudinal extension of the device, which in the figures extends along the x-axis.

[0082] Similarly, the terms "lateral," "laterally," "transverse," and "transversely" refer to a direction generally perpendicular to the longitudinal direction (x-axis), which is labeled the y-axis in the drawings.

[0083] The terms "vertical" and "vertically" refer to a direction perpendicular to a plane spanned by the longitudinal and lateral directions (the xy plane), which is labeled the z-axis in the drawings.

[0084] Furthermore, the terms "circumferential," "circumferential," or "circumferentially" refer to a circumferential or circumferential direction relative to an axis. Similarly, "radial" or "radially" refer to directions extending radially relative to an axis, and "rotational," "rotational," and "rotationally" refer to rotation relative to an axis.

[0085] According to the present invention, the term "detachable" means that the pump unit can be physically separated from the cassette. A detachable pump unit can also be carried on or attached to the cassette.

[0086] According to certain embodiments of the present invention, the term "stand-alone" means that the pump unit is functionally independent of the cassette and the medication bag. Thus, a pump unit according to the present invention can be used with a plurality of different cassettes, which are adapted to communicate with the pump unit, depending on the needs of the user. Thus, the user is provided with several options regarding the use of the pump unit. However, if desired, the independence of the pump unit can be deactivated or disabled, or at least limited, so that a given pump unit can be operated with only one or a limited number of cassettes.

[0087] Generally speaking, unless otherwise expressly defined herein, all terms used in the claims should be interpreted according to their ordinary meaning in the technical field. Unless otherwise expressly stated, all references to an element, device, component, part, device, etc. should be interpreted openly as referring to at least one instance of an element, device, component, part, device, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0088] Embodiments of the present disclosure will now be described, by way of example only, with reference to the following drawings.

[0089] Figure 1A An embodiment of a drug delivery system according to the present disclosure is shown in a pre-assembled state.

[0090] Figure 1B Shown in assembled state according to Figure 1A drug delivery system.

[0091] Figure 1C Shown in assembled state according to Figure 1A or Figure 1B drug delivery system.

[0092] Figure 2A A cross-sectional view of a cartridge according to an embodiment of the present disclosure is shown.

[0093] Figure 2B Shown according to Figure 2A Another cross-sectional view of the box.

[0094] Figure 3A 、 Figure 3B and Figure 3C A perspective view illustrating the interior of a pump unit according to an embodiment of the present disclosure is shown.

[0095] Figure 4A and Figure 4B A detailed partial view of a locking mechanism according to an embodiment of the present disclosure is shown.

[0096] Figure 5 A cross-sectional view of a locking mechanism according to an embodiment of the present disclosure is shown.

[0097] Figure 6A and Figure 6B A partial view of a connection switch according to an embodiment of the present disclosure is shown.

[0098] Figure 7 A cross-sectional view illustrating the connection between a cassette and a pump unit according to an embodiment of the present disclosure.

[0099] Figure 8A cross-sectional view schematically illustrating an air flow path according to an embodiment of the present disclosure is shown.

[0100] Figure 9 A flow chart illustrating an embodiment of the present disclosure is shown.

[0101] Figure 10 A flow chart illustrating an embodiment of the present disclosure is shown. DETAILED DESCRIPTION

[0102] Unless otherwise stated, all elements and embodiments described below with reference to the figures may be combined.

[0103] Figure 1A An overview of a drug delivery system according to an embodiment of the present disclosure is shown. The system includes a pump unit 2 and a cassette 1. The cassette 2 can be connected to a tubing set 5. For example, a standard Luer connector can be used. However, other types of tubing sets and connectors can be used with the present disclosure. The cassette 1 and pump unit 2 can be provided separately and can be connected to each other.

[0104] Figure 1B The two parts are shown during assembly or connection of the pump unit 2 and the cassette 1 (with the tubing set 5 attached). The pump unit 2 is slid onto the cassette 1 and vice versa. Figure 1B In FIG, a sliding engagement between the pump unit 2 and the cassette 1 is shown, but this is merely an example and should not be construed as limiting the present disclosure.

[0105] Figure 1C The drug delivery system is shown in an assembled state. The pump unit 2 has been attached to the cartridge 1, and the two parts are locked relative to each other. The device is thus ready for drug delivery. After drug delivery, the pump unit 2 can be removed or separated from the cartridge by pushing the release button 22 on the pump unit 2.

[0106] The pump unit 2 can thus be separated from the cartridge 1. In particular, the pump unit 2 can be functionally independent of the cartridge 1 and the medication bag 12. Thus, the pump unit 2 according to the present invention can be used with a plurality of different cartridges 1, which are adapted to communicate with the pump unit 2, depending on the needs of the user. The pump unit 2 can also be configured to be connectable to only one (type) of cartridges 1.

[0107] In top view, both the pump unit 2 and the cartridge 1 may have an oval shape. In particular, the pump unit 2 and the cartridge 1 may have similar or identical shapes in the xy plane. In the assembled state, the circumferences of the pump unit 2 and the cartridge 1 may be flush with each other. The vertical extensions of the pump unit 2 and the cartridge 1 may vary depending on the type and volume of the electronics and components disposed in the pump unit 2 and the medication (i.e., the medication bag 12) disposed in the cartridge 1.

[0108] The various parts of the system will now be described in more detail.

[0109] Figure 2A Shown is a cross-sectional view of the box 1 according to the embodiment along the longitudinal direction (x axis).Box 1 includes an outer shell 11, which can be formed as a single hard shell or a plurality of shell parts assembled together.Outer shell 11 or shell parts can be closed by lid 17.Inside outer shell 11, a medicine bag 12 containing medicament (drug) is provided.Medicament can be a liquid, particularly when distributing.Medicine bag 12 can be a flexible (collapsible) medicine bag 12.The volume of medicine bag can be, for example, between 10ml and 250ml, preferably between 50ml and 100ml.Medicine bag 12 has an outlet port 13, which can also be used for filling medicine bag 12 during production.Outlet port 13 can pass through the corresponding opening in outer shell 11.Outlet port 13 can be provided with a valve (such as a pinch valve) to allow medicament to flow out only when the valve is opened (for example, by attaching pipeline group 5). The cartridge 1 may also comprise an access channel 14 allowing fluid, in particular air, to enter the interior of the cartridge 1 .

[0110] The cartridge 1 and medicament pouch 12 may be single use units or may be refillable.

[0111] In order to attach and secure the pump unit 2 to the cassette 1, a cassette locking mechanism 15 may be provided. The locking mechanism 15 may be provided on the cassette cover 17. In the accompanying drawings, guide rails 15 of a sliding mechanism are shown. However, the pump unit 2 and the cassette 1 may also be connected by snap-fitting, clamping, threading, or any other suitable connection method. The locking mechanism 15 may further include a locking notch 16, which will be described later.

[0112] The box 1 is provided in an airtight manner except for the inlet channel 14. That is, the outer shell 11 or the outer shell part and the box cover 17 are connected so that the interior of the box 1 is sealed. Therefore, the opening through which the outlet port 13 passes is also sealed so as not to allow air to pass through.

[0113] Figure 2B is based on Figure 2A 1 and 2. The box of claim 1 is another cross-sectional view along the lateral direction (y-axis). As can be seen from the accompanying drawings, a space is provided between the outer shell 11, the lid 17 (i.e., the inside of the box 1) and the medicine bag 12. For drug delivery, the inside of the box 1 is pressurized by introducing a fluid (particularly air) into the space through the inlet passage 14. Thus, pressure acts on the collapsible medicine bag 12 and forces the medicine to pass through the outlet port 13 to deliver the medicine. This process will be described in more detail below.

[0114] Figure 3Ais a perspective view of a pump unit 2 according to an embodiment. In the embodiment shown in the figures, the pump unit 2 comprises two housing parts 25, but it may also comprise a single housing part 25 or more than two housing parts 25. Figures 3A to 3C In FIG. 2 , the housing part 25 facing the viewer has been omitted to allow inspection of the interior.

[0115] The pump unit 2 comprises a pump 3 (particularly an air pump 3), an air valve or pressure valve 31 and a connector 32 which serves as an air outlet for pressurizing the cartridge 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 in the connector 32, such as Figure 3A Thus, when the cassette 1 is attached to the pump unit 2, the sealing member 33 can be radially compressed to seal the connection between the connector 32 and the inlet channel 14, as will be described further below. The pump 3, air valve 31 and connector 32 can be connected by a conduit 34.

[0116] The pump unit 2 also includes electronic components (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 include 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. In addition to or in place of the power supply 45, the pump unit 2 may also include a disposable battery. In addition, a wireless communication module may be provided.

[0117] The pump unit 2 may further include an identification unit (not shown) configured to identify the type of cartridge 1 attached to the pump unit 2, i.e., the parameters or prescription details of the medication, such as type, volume, delivery temperature, delivery rate, delivery time, etc. Thus, the cartridge 1 may include an identification tag that allows the pump unit 2 to identify the cartridge 1. This may be achieved, for example, via RFID, NFC, etc. It may be preferred that the identification tag at the cartridge 1 is a passive component.

[0118] The processing unit 4 can control the operation of the pump 3 and the air valve 31. Furthermore, the processing unit 4 can be connected to a power switch 41 for initiating drug delivery or turning the device on or off, and / or an indicator 42 for indicating various states of the device, as well as a connection switch 43 for detecting whether the cartridge 1 is attached to the pump unit 2. The indicator 42 can include at least one lighting device, such as an LED, and / or a sound generator or speaker. The indicator 42 can provide visual and / or auditory feedback of the device's status, which can include at least one of the active state of the processing unit 4, the attachment state of the cartridge 1, the operational state, the battery state, the drug temperature, the pressure state, an error state, the drug type, whether the device is ready for injection, or whether the injection was successful. The pump unit 2 can also include at least one pressure sensor and / or at least one temperature sensor (not shown). The pressure sensor can be positioned at a suitable point in the air flow path, for example, at the connector 32, the pump 3, the air valve 31, or the conduit 34. The temperature can be measured, for example, at the air filter 35, the connector 32, the pump 3, the air valve 31, or between the conduits 34. In particular, the temperature of the incoming air and / or the temperature of the air flowing out of the cartridge 1 may be measured in order to obtain data on the temperature of the medicament inside the cartridge 1. Furthermore, the medicament temperature may be measured directly.

[0119] Figure 3B is a perspective view of the pump unit 2 from the other side of the device (ie rotated 180° about the vertical z-axis). Furthermore, the housing part 25 facing the viewer has been omitted in the figure.

[0120] The pump unit 2 further comprises an air inlet which may comprise an air filter 35. The air inlet / air filter 35 is also connected to the pump 3 via a conduit 34.

[0121] The dispensing unit can connect the pump 3, air filter 34, connector 32 and air valve 31 to the pipeline 34 and be connected via the pipeline. The dispensing unit can be a connector or an air switch. The dispensing unit can also include a valve. In one embodiment, at least one of the air filter 34, connector 32 or air valve 31 can be directly connected to the pump 3.

[0122] In showing Figure 3B The same perspective Figure 3C, most of the features except the air flow path have been omitted. In particular, ambient air is sucked in by the pump 3 via an air filter 35 and a pipe 34 and provided to the attached box 1 via a connector 32. During this process, the air valve 31 is closed so that the box 1 is pressurized. When the pressure inside the box 1 is to be released, the air valve 31 is opened, and air flows to the outside via the pipe 34 and the air valve 31. The air inlet 35 and the air outlet (i.e., the air valve 31) can be arranged inside the pump unit 2, and the pump unit may not be airtightly sealed. Alternatively, an opening can be provided in the housing part 25, which allows air to pass through or connects the air inlet 31 and the air outlet 35 to the outside.

[0123] refer to Figure 4A 、 Figure 4B and Figure 5 , describes an exemplary locking mechanism between the cassette 1 and the pump unit 2 according to an embodiment. As already described above, the cassette 1 may include a cassette locking mechanism 15, and the pump unit 2 may include a corresponding pump unit locking mechanism 21. In particular, the cassette unit locking mechanism 15 may be a guide rail, and the pump unit locking mechanism 21 may be a guide groove. In one embodiment, the guide rail 15 may be a T-shaped rail, and the guide groove 21 may be recessed to receive the guide rail 15, respectively. The engagement of the guide rail 15 and the guide groove 21 may be from Figure 5 It is seen that the figure shows a cross-sectional view along the y-axis of the cassette 1 and the pump unit 2 in an attached state.

[0124] The locking mechanism between the pump unit 2 and the cassette 1 may also be arranged in reverse, ie, the pump unit locking mechanism 21 comprises guide rails, and the cassette unit locking mechanism 21 comprises corresponding guide grooves.

[0125] 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.

[0126] refer to Figure 4A , the guide rail 15 may include a locking notch 16 that engages a pump unit locking feature 23. Other parts of the pump unit 2 have been omitted in this view to more clearly illustrate the locking mechanism. The pump unit locking feature 23 may be disposed in a locking feature guide groove 24 or housing feature 25 of the pump unit 2, respectively (see FIG. Figure 3C ). The locking part 23 may be connected to the release button 22 and may be moved in the lateral / transverse direction (y-axis) in the locking part guide groove 24 by actuation of the release button 22. The release button 22 may be provided with a spring acting on the locking part 23 and the release button 22 in the lateral direction. Figure 4B As can be seen, the locking feature 23 may include a portion that protrudes in the negative z-direction (downward in the drawings) and is configured to engage the locking notch 16. The protruding portion may be inclined or skewed toward the insertion direction (negative x-direction).

[0127] The attachment process can be as follows. The pump unit 2 is connected via the guide rail 15 and the guide groove 21 (see Figure 5 ) Figure 1B 16, thereby preventing the pump unit 2 from moving relative to the cassette 1 in the longitudinal direction (negative x-direction, insertion direction) shown. At the beginning of the sliding movement, the inclined portion of the locking element 23 abuts the guide rail 15, thereby pushing the locking element 23 in the lateral direction. The release button 22 can also move laterally together with the locking element 23. Thus, the pump unit 2 and the cassette 1 are guided relative to each other via the above-mentioned engagement until they reach the assembled state. In the assembled state, the locking element 23 has completely passed the beginning of the locking notch 16 and is therefore free to move into the locking notch 16 in the lateral direction (y-direction) due to the force of the spring. The longitudinal end surface of the locking element 23 abuts the abutment surface 18 at the longitudinal end of the locking notch 16 in the release direction, thereby preventing the pump unit 2 from moving relative to the cassette 1 in the release direction. In addition, in the assembled state, the connector 32 engages with the access channel 14, thereby preventing further movement in the insertion direction (negative x-direction). This will be described further below. The patient or user may be informed that the assembled state is achieved by audible and / or tactile feedback, such as a click or vibration produced by the interaction of the locking feature 23 and the locking notch 16 .

[0128] In addition, the pump unit 2 (especially the processing unit 4) can be started by the connection switch 43 and switched from a sleep state to an active state. Therefore, the connection switch 43 can detect whether the box 1 is attached. The connection switch 43 can be set at the longitudinal end of the pump unit 2 in the release direction and toward the lower end of the pump unit 2 (negative z direction), that is, toward the box 1. In the accompanying drawings, a mechanical connection switch 43 including a switch part 44 is shown, but the connection switch 43 can also be an optical sensor, an inductive sensor or another electronic detection device. Figure 6A , the pump unit 2 is not attached or not fully attached to the cassette 1. The switch part 44 points in the negative z-direction (downward in the drawing). When the pump unit 2 is completely slid onto the cassette 1, parts of the cassette 1 (in this case, the cover 17 and the guide rail 15) lift the switch part 44, thereby notifying the processing unit 4 via the switch part 44 that the cassette 1 is fully attached and the drug delivery device is thus assembled for drug delivery.

[0129] exist Figure 7, the air flow connection between the pump unit 2 and the box 1 is shown. The inlet channel 14 may protrude in the vertical direction (z direction) from the box 1 and the cover 17, respectively. The pump unit 2 or the housing part 25 may include a corresponding receiving portion that is recessed or cut out from the housing part 25 for receiving the connector 32. In particular, the connector 32 may be provided as a protruding rod that protrudes in the longitudinal direction (insertion direction) and may be slid into the inlet channel 14. As noted above, the connection should be airtight so as to allow the interior of the box 1 to be pressurized via the connector 32 using the air provided by the pump 3. Therefore, a sealing member 33 may be provided, which seals the connection between the connector 32 and the inlet channel 14. The sealing member 33 may be an O-ring or other suitable device to prevent air leakage. In the example Figure 7 In the case of an O-ring as shown, 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 radially compressed, thereby sealing the connection between the cassette 1 and the pump unit 2.

[0130] Figure 8 Shown is the air flow inside the device according to the embodiment.Wherein, solid line indicates inflow of air, and dotted line indicates outflow of air.For medicament delivery, ambient air is sucked by pump 3 through air filter 35 and pipeline 34, is then provided to box 1 via pipeline 34, connector 32 and inlet channel 14.By pumping air into box 1, the inside of box 1 is pressurized, and wherein pressure acts on medicine bag 12 to force medicine into pipeline group.In other words, the pressure in the inside of box 1 applies force to medicine bag 12 (particularly to the outer surface of medicine bag 12).Thus, medicament is pushed out of medicine bag 12 by outlet port 13.

[0131] In a case where air is to be released from the cartridge 1 , the air valve 31 is opened, and the interior of the cartridge 1 can be depressurized through the inlet passage 14 , the connector 32 , the pipe 34 , and the air valve 31 .

[0132] The figures of this disclosure relate to a sliding mechanism between the pump unit 2 and the cartridge 1. This sliding mechanism facilitates sealing the two units relative to each other due to the engagement of the connector 32 with the access channel 14. However, other mechanisms, such as snap-fits, threaded connections, etc., may also be provided, as long as a gas-tight connection is ensured that allows the pump 3 to pressurize the cartridge 1.

[0133] Furthermore, the air inlet and the air outlet may be provided separately in the box 1 .

[0134] The operation of the drug delivery system according to the embodiment will now be described. Figure 9 An exemplary flow chart of the method is depicted.

[0135] The pharmacy can be instructed to prepare S1 a box 1 with a medicine bag 12 according to the patient's prescription. Depending on the medicine, the box 1 can be stored in a cool and dark place such as a refrigerator. Therefore, the patient can take the box 1 from the refrigerator for conditioning before delivery and let it stand at room temperature for a period of time (e.g., 30 minutes).

[0136] The patient then assembles S2 the device by connecting the pump unit 2 to the cassette 1 as described above. The cassette 1 operates S3 the connection switch 43, thereby activating S4 the processing unit 4 and notifying the cassette 1 that it has been attached. The patient can now attach S5 the tubing set 5 to the cassette 1.

[0137] The processing unit 4 may operate S6 an indicator 42 to inform S7 the patient of the current status of the device. In particular, the indicator 42 may provide visual and / or audible feedback of the device status, which may include at least one of an activity status of the processing unit 4, an attachment status of the cartridge 1, an operational status, a battery status, a medication temperature, a pressure status, an error status, a medication type, whether the device is ready for injection, or whether the injection has been successful.

[0138] When the indicator 42 indicates that the device is ready for injection, the patient may operate S8 the power switch 41 which sends S9 a start signal telling the processing unit 4 to start or pause the injection.

[0139] The processing unit 4 drives S10 the air pump 3 for pressurizing the cartridge 1 and starting the injection. In case 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 inside the cartridge 1 and stop the drug flow.

[0140] When the injection begins, the pump 3 draws in ambient air (S11) and pressurizes the cartridge 1 with it (S12) as described above. A pressure sensor can measure (S13) or sense the pressure inside the cartridge 1 and transmit the data (S14) to the processing unit 4. Consequently, the patient is injected (S15) via the tubing set 5. The pump 3 increases the pressure inside the cartridge 1. The maximum pressure can be limited by the pressure sensor, which informs the processing unit 4. The pressure acts on the collapsible medication bag 12 containing the medication. The pressurized medication is forced through the tubing set 5 and into the patient's tissue via the needle. The amount of the delivered dose can be controlled by time and cartridge pressure.

[0141] Depending on the delivery status, the processing unit 4 may operate S16 the air valve 31, thereby depressurizing the cartridge 1 S17. When the dose is administered, the processing unit 4 may operate the pressure valve 31, which releases pressure from the cartridge 1. An indicator 42 on the pump unit 2 may inform the patient that the injection is complete. The tubing set 5 may be removed from the main body and disposed of in a medical waste container along with the cartridge 1. The pump unit 2 is reusable and can be stored until the next scheduled injection.

[0142] The processing unit 4 may further send S18 the injection parameters to a cloud, a mobile device, a computer, a server or the like.

[0143] The methods described above may be performed using an agent delivery system as previously described.

[0144] As mentioned above, some medications need to be stored in a refrigerator. However, in general, medications should be brought to ambient temperature to make delivery more comfortable, as injecting cold substances can be painful. In addition, temperature also affects the viscosity of some medications.

[0145] In one embodiment, to shorten the time it takes to reach the correct temperature, air is circulated in the cartridge 1 by increasing overpressure and then releasing it to the atmosphere by opening the pressure valve 31. This can be repeated several times to exchange the cooled air (through heat exchange with the cold medication) with the warmer ambient air from around the pump unit 2. A temperature sensor in the air circuit (inside the pump unit 2) can measure the temperature of the air flowing into the system via the air filter 35. As described above, air can be supplied to the cartridge 1 by the pump 3 via the pipe 34, the connector 32, and the inlet channel 14. The pressurized air can be contained within the cartridge 1 for a set period of time to warm the medication. After the set period, the pressurized air can be released to the atmosphere via the pipe 34 by opening the air valve 31. The temperature of the outlet airflow can be measured. This temperature can be used as an indicator of the temperature of the medication within the medication bag 12 in the cartridge 1. In particular, a calculation using the difference between the air inflow temperature and the air outflow temperature can be used to determine when the medication is ready for injection. The patient can then be notified via the indicator 42 that the injection can begin.

[0146] This shortening of warming is facilitated in three ways. First, air exchange over time, drawing in new (warm) air from the surrounding environment and expelling cooler air, will accelerate warming. Second, convection (i.e., the movement / circulation of air within the box 1) will accelerate the process of warming the medication bag 12. This occurs with each air exchange, but can also be done more frequently by briefly blowing in or releasing air. Third, the air inside the box 1 can be warmed by the increased pressure from the pump 3. In other words, due to the higher air pressure acting on the medication bag 12, heat transfer may be more efficient.

[0147] You can refer to the following Figure 10The process for assembling the device as described above is performed. The processing unit 4 can drive T1 the air pump 3 to draw in T2 ambient air and pressurize T3 the interior of the box 1. The processing unit 4 can operate T4 the air valve 31 to decompress T5 the box 1 and release the air after a predetermined period of time. Due to the heat exchange with the cold medicine, the released air will likely be colder than the ambient air. The temperature sensor measures the temperature of the released air during decompression T5 and sends the data to the processing unit 4 T6. Based on the measured temperature, the process T1 to T6 can be repeated until a preset temperature is reached, or until the temperature difference between the ambient air (inflowing air) and the exchange air (outflowing air) is below a certain threshold.

[0148] The methods described above can be performed with, and are also compatible with, the drug delivery systems as previously described.

[0149] The present disclosure may also include a pump unit 2 and / or cassette 1 for use with the described systems and / or methods. In particular, the present disclosure includes a pump unit 2 separate from the cassette 1 .

[0150] The present disclosure is further defined by the following items.

[0151] 1. A drug delivery system, comprising:

[0152] A box 1 comprising a medicine bag 12 inside it,

[0153] a pump unit 2 , which is separable from the cartridge 1 , wherein an air flow connection is provided between the pump unit 2 and the interior of the cartridge 1 ,

[0154] The pump unit 2 includes a pump 3 and an air valve 31.

[0155] wherein the pump 3 is configured to pressurize the interior of the cartridge 1 to apply pressure to the medicine bag 12, and

[0156] The air valve 31 is configured to decompress the cartridge 1 by releasing the pressure from the interior of the cartridge 1 .

[0157] 2. The drug delivery system according to item 1, wherein the pump unit 2 is independent of the cassette 1.

[0158] 3. A drug delivery system according to item 1 or 2, wherein the box 1 includes an inlet channel 14, which is configured to communicate with the connector 32 of the pump unit 2, and wherein the pump 3 is configured to pressurize the box 1 via the connector 32 and the inlet channel 14.

[0159] 4. A drug delivery system according to item 3, wherein the connector 32 includes a sealing member 33, which is configured to seal the connection between the connector 32 and the access channel 14 in an airtight manner.

[0160] 5. The drug delivery system according to any one of items 1 to 4, wherein the cartridge 1 comprises at least one outer shell 11 and a cover 17 , wherein the access channel 14 is preferably provided in the cover 17 .

[0161] 6. The drug delivery system according to item 5, wherein the drug bag 12 is provided inside the at least one outer shell 11 and the cover 17.

[0162] 7. The drug delivery system according to any one of items 1 to 6, wherein the drug bag 12

[0163] It is a flexible medicine bag 12.

[0164] 8. The drug delivery system according to any one of items 1 to 7, wherein the cassette 1 and the pump unit 2 are connectable to each other via a sliding connection.

[0165] 9. A drug delivery system according to any one of items 1 to 8, wherein the box 1 includes a box locking mechanism 15, and the pump unit 2 includes a corresponding pump unit locking mechanism 21, which is configured to fix the box 1 and the pump unit 2 relative to each other.

[0166] 10. The drug delivery system according to item 9, wherein one of the cartridge locking mechanism 15 and the pump unit locking mechanism 21 comprises a guide rail, and wherein the other of the cartridge locking mechanism 15 and the pump unit locking mechanism 21 comprises a corresponding guide groove.

[0167] 11. A drug delivery system according to claim 10, wherein the guide rail has a generally T-shaped cross-section.

[0168] 12. The drug delivery system according to any one of items 1 to 11, wherein the pump unit 2

[0169] At least one temperature sensor and / or at least one pressure sensor are included, wherein the at least one temperature sensor and / or the at least one pressure sensor are preferably arranged in the air flow path at the pump 3 and / or the air valve 31 .

[0170] 13. A drug delivery system according to item 12, wherein the at least one temperature sensor is configured to measure at least one of the ambient air temperature and the temperature of the interior of the cartridge 1 .

[0171] 14. The drug delivery system according to item 12 or 13, wherein the at least one pressure sensor is configured to measure the pressure of the interior of the cartridge 1 .

[0172] 15. The drug delivery system according to any one of items 1 to 14, wherein the pump unit 2

[0173] A processing unit 4 is included.

[0174] 16. The drug delivery system according to item 15, wherein the processing unit 4 comprises a processor, a memory and a communication interface.

[0175] 17. The drug delivery system according to item 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.

[0176] 18. The drug delivery system according to any one of items 15 to 17, wherein the pump unit 2

[0177] A connection switch 43 is included, which is configured to switch on the processing unit 4 if the cassette 1 is attached to the pump unit 2 .

[0178] 19. The drug delivery system according to any one of items 15 to 18, wherein the pump unit 2

[0179] A power switch 41 is included which is configured to activate the pump 3 .

[0180] 20. A drug delivery system according to any one of items 15 to 19, wherein the processing unit 4 is configured to control the pump 3 based on the ambient air temperature or the temperature of the interior of the box 1 or the difference between the ambient air temperature and the temperature of the interior of the box 1.

[0181] 21. The drug delivery system according to any one of items 15 to 20, wherein the processing unit 4 is configured to control the pump 3 and the air valve 3 to periodically pressurize and depressurize the interior of the cartridge 1 .

[0182] 22. The drug delivery system according to item 21, wherein the processing unit 4 is configured to determine the drug delivery status based on the ambient air temperature or the temperature of the interior of the cartridge 1 or the ambient air temperature.

[0183] Periodic pressurization and decompression are performed according to the temperature difference of the interior of the cartridge 1 .

[0184] 23. The drug delivery system according to any one of items 1 to 22, wherein the pump unit 2

[0185] An air filter 35 is included, wherein the pump 3 is configured to draw air through the air filter 35 .

[0186] 24. A drug delivery system according to item 23, wherein a temperature sensor is provided at the air filter 35.

[0187] 25. The drug delivery system according to any one of items 1 to 24, wherein the pump unit 2

[0188] Is reusable.

[0189] 26. A drug delivery system according to any one of items 1 to 25, wherein the cartridge 1 is sealed in an airtight manner except for the access channel 14.

[0190] 27. The drug delivery system according to any one of items 1 to 26, wherein the pump unit 2

[0191] A release button 22 is included, which is configured to release the detachable pump unit 2 from the cassette 1 .

[0192] 28. A pump unit 2 comprising a pump 3 and an air valve 31, wherein the pump unit 2 is configured for use in a system according to any one of items 1 to 27.

[0193] 29. Pump unit 2 according to item 28, wherein the pump unit 2 comprises a connector 32 in fluid connection with the pump 3.

[0194] 30. Pump unit 2 according to item 29, wherein the connector 32 comprises a sealing member 33.

[0195] 31. The pump unit 2 according to any of items 28 to 30, wherein the pump unit 2 comprises a pump unit locking mechanism 21 .

[0196] 32. Pump unit 2 according to item 31, wherein the pump unit locking mechanism 21 comprises a guide rail or a guide groove.

[0197] 33. Pump unit 2 according to item 32, wherein the guide rail has a substantially T-shaped cross section.

[0198] 34. The pump unit 2 according to any one of items 28 to 33, wherein the pump unit 2 comprises at least one temperature sensor and / or at least one pressure sensor, wherein the at least one temperature sensor and / or the at least one pressure sensor are preferably arranged in the pump unit 2.

[0199] 3 and / or in the air flow path at the air valve 31.

[0200] 35. Pump unit 2 according to item 34, wherein the at least one temperature sensor is configured

[0201] At least one of the ambient air temperature and the temperature of the interior of the box 1 is measured.

[0202] 36. Pump unit 2 according to any of items 28 to 35, wherein the pump unit 2 comprises a processing unit 4.

[0203] 37. Pump unit 2 according to item 36, wherein the processing unit 4 comprises a processor, a memory and a communication interface.

[0204] 38. The pump unit 2 according to item 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.

[0205] 39. The pump unit 2 according to any of items 36 to 38, wherein the pump unit 2 comprises a connection switch 43 configured to switch on the processing unit 4 if the cassette 1 is attached to the pump unit 2.

[0206] 40. The pump unit 2 according to any of items 36 to 39, wherein the pump unit 2 comprises a power switch 41 configured to activate the pump 3.

[0207] 41. Pump unit 2 according to any of items 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 a difference between the ambient air temperature and the another measured temperature.

[0208] 42. The pump unit 2 according to any one of items 36 to 41, wherein the processing unit 4

[0209] It is configured to control the pump 3 and the air valve 3 to be driven periodically.

[0210] 43. Pump unit 2 according to item 42, wherein the processing unit 4 is configured to perform a periodic driving based on the ambient air temperature or another measured temperature or a difference between the ambient air temperature and the another measured temperature.

[0211] 44. The pump unit 2 according to any one of items 28 to 43, wherein the pump unit 2 comprises an air filter 35, wherein the pump 3 is configured to draw air through the air filter 35.

[0212] 45. Pump unit 2 according to item 44, wherein a temperature sensor is provided at the air filter 35.

[0213] 46. ​​The pump unit 2 according to any one of items 28 to 45, wherein the pump unit 2 is reusable.

[0214] 47. The pump unit 2 according to any of items 28 to 46, wherein the pump unit 2 comprises a release button 22.

[0215] 48. A cartridge 1 comprising a medication bag 12 in its interior, wherein the cartridge 1 is configured for use with the medication delivery system according to any one of items 1 to 27.

[0216] 49. Cassette 1 according to item 48, wherein the cartridge 1 comprises an access channel 14 connected to the interior fluid of the cartridge 1.

[0217] 50. Cassette 1 according to item 49, further comprising at least one outer shell 11 and a cover 17, wherein the access channel 14 is preferably provided in the cover 17.

[0218] 51. Cassette 1 according to item 50, wherein said medication bag 12 is arranged inside said at least one outer shell 11 and said cover 17.

[0219] 52. The cartridge 1 according to any one of items 48 to 51, wherein the medicament pouch 12 is a flexible medicament pouch 12.

[0220] 53. The cartridge 1 according to any one of items 48 to 52, wherein the cartridge 1 comprises a cartridge locking mechanism 15.

[0221] 54. The cartridge 1 according to item 53, wherein the cartridge locking mechanism 15 comprises a guide rail or a guide groove.

[0222] 55. Cassette 1 according to item 54, wherein the guide rail has a generally T-shaped cross-section.

[0223] 56. The cartridge 1 according to any one of items 48 to 55, wherein, except for the access channel 14, the cartridge 1 is sealed in an airtight manner.

[0224] 57. A method for controlling a drug delivery system according to any one of items 1 to 27, the system comprising a cartridge 1 comprising a drug bag 12, and a pump unit 2, the pump unit being detachably arranged at the cartridge 1,

[0225] The method comprises:

[0226] The box 1 is pressurized S12 to apply pressure to the medicine bag 12,

[0227] The contents of the medicine bag 12 are released S15 through the pressurization step S12, and the box 1 is depressurized S17.

[0228] 58. A method for controlling the temperature of a drug in a drug delivery system, wherein the method comprises:

[0229] The box 1 containing the medicine bag 12 is pressurized T3.

[0230] After a predetermined period of time, the pressurized air is released T4 from the cartridge 1 .

[0231] 59. The method of item 58, further comprising measuring the outflow temperature of the air released by T5.

[0232] 60. The method according to item 59 further comprises repeating the pressurizing step T3 and the releasing step T4 according to the measured outflow temperature.

[0233] 61. The method of item 59 or 60, further comprising measuring an inflow temperature and calculating a temperature difference between the inflow temperature and the outflow temperature.

[0234] 62. The method according to item 61 further comprises repeating the pressurizing step T3 and the releasing step T4 according to the measured temperature difference.

[0235] The delivery devices described herein can be used to treat and / or prevent one or more of many different types of diseases.

[0236] Exemplary diseases include, but are not limited to, rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), hypercholesterolemia and / or dyslipidemia, cardiovascular disease, diabetes (e.g., type 1 or type 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjögren's syndrome, migraines, cluster headaches, multiple sclerosis, neuromyelitis optica spectrum disorders, anemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behçet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetes mellitus), glaucoma, leukemia, leukemia, scleroderma, leukemia, necrosis factor-α, leukemia, scleroderma ... diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplants, acute hypoglycemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer's disease, Parkinson's disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndrome, 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), and cancer.

[0237] 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, reversal agents, radioligand therapy, radioisotopes and / or nuclear medicines, 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.

[0238] 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, coagulation factors, enzymes, enzyme inhibitors, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T cell receptors, B cell receptors, or co-stimulatory proteins.

[0239] Exemplary drugs that can be included in the delivery devices described herein include, but are not limited to, those that exhibit the proposed mechanism of action, such as: human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-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 (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin gene-related peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor-associated calcium signaling protein 2 (Trop-2) modulators, cluster of differentiation 52 (CD 52) regulators, B cell maturation antigen (BCMA) regulators, enzyme regulators, platelet-derived growth factor receptor A (PDGFRA) regulators, cluster of differentiation 319 (CD319 or SLAMF7) regulators, programmed cell death protein 1 and programmed death ligand 1 (PD-1 / PD-L1) inhibitors / regulators, B lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, B lymphocyte antigen cluster of differentiation 20 (CD20) regulators, cluster of differentiation 3 (CD3) regulators , cytotoxic T lymphocyte-associated protein 4 (CTLA-4) inhibitors, T cell immunoglobulin mucin domain 3 (TIM-3) modulators, T cell immunoreceptor containing Ig and ITIM domains (TIGIT) modulators, V domain inhibitory factor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-associated immunoglobulin domain protein (PVRIG) modulators, lymphocyte activation gene 3 (LAG3;Cluster of differentiation 223 (CD223) antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation w137 (CDw137) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD159 or NKG2) modulators, glucocorticoid-induced TNFR-related (GITR) protein modulators, killer cell immunoglobulin-like receptor (KIR) modulators, growth arrest-specific protein 6 (G AS6) / AXL pathway modulators, proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B lymphocyte cell adhesion molecule modulators, cluster of differentiation w123 (CDw123) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cell receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily member 4 (TNFRSF4 or OX40) modulators, adenosine receptor modulators, inducible T cell costimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumor-infiltrating lymphocyte (TIL) therapy, or T cell receptor (TCR) therapy.

[0240] Exemplary drugs that can be included in the delivery devices described herein include, but are not limited to, etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erezumab, gadolinium-vfrm, alirocumab, methotrexate (methotrexate), tocilizumab, interferon beta-1a, interferon beta-1b, peginterferon beta-1a, sumatriptan, darbepoetin alfa, belimumab, sarrelumab, semaglutide, Dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, lavuzumab, crizenzaluzumab-tmca, certolizumab pegol, satrelizumab, denosumab, romotuzumab, benralizumab, emicizumab, tirazumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins.

[0241] Exemplary drugs that can be included in the delivery devices described herein can also include, but are not limited to, tumor therapies such as: ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, seplizumab, rituximab, trastuzumab, emtansine, detrastuzumab, pertuzumab, trastuzumab-pertuzumab, alemtuzumab, mabetuzumab- blmf, bevacizumab, belintuzumab, vebruximab, cetuximab, daratumumab, elotuzumab, gemtuzumab, ibritumomab tiuxetan yttrium-90, isatuzumab, moglizumab, pasituximab, obinutuzumab ofatumumab, olaratumumab, panitumumab, pollotuzumab, ramucirumab, gosartumumab, tancitumomab, or makituximab.

[0242] Exemplary drugs that may be included in the delivery devices described herein include any of the aforementioned "generic" or biosimilar equivalents, and the aforementioned molecule names should not be construed as limited to the "innovator" or "brand" versions of each, as in the non-limiting example of the innovator agent adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

[0243] Exemplary drugs that may be included in the delivery devices described herein also include, but are not limited to, those used in adjuvant or neoadjuvant chemotherapy, such as alkylating agents, plant alkaloids, antitumor antibiotics, antimetabolites or topoisomerase inhibitors, enzymes, retinoids, or corticosteroids. Exemplary chemotherapeutic drugs include, for example, 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, valrubicin, vincristine, vinblastine, or vinorelbine.

[0244] 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, preservatives, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% sodium chloride injection, 0.45% sodium chloride injection, 5% dextrose injection, a mixture of 5% dextrose and 0.45% sodium chloride, sodium lactate Ringer's injection, heparin Rockwell's solution, 100 U / mL heparin Rockwell's solution, or 5000 U / mL heparin Rockwell's solution.

[0245] Pharmaceutical formulations including but not limited to any of the drugs described herein are also contemplated for use in the delivery devices described herein, such as pharmaceutical formulations comprising the drugs listed herein (or pharmaceutically acceptable salts of the drugs) and pharmaceutically acceptable carriers. Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also include dispersion enhancers (e.g., animal-derived, human-derived, or recombinant hyaluronidase), concentration regulators or enhancers, stabilizers, buffers, or other excipients, administered alone or formulated together.

[0246] Exemplary drugs that can be included in the delivery devices described herein include, but are not limited to, multi-drug regimens such as AC, dose-dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, dose-dense CHOP, EPOCH, dose-dense adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7+3, 5+2, 7+4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCE OP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, E MA / 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.

[0247] Various modifications to the described embodiments are possible and will occur to those skilled in the art without departing from the invention as defined by the following claims.

Claims

1. A drug delivery system, comprising: a box (1) comprising a medicine bag (12) inside the box, a pump unit (2) which is separable from the cassette (1), wherein an air flow connection is provided between the pump unit (2) and the interior of the cassette (1), The pump unit (2) comprises a pump (3) and an air valve (31), wherein the pump (3) is configured to pressurize the interior of the box (1) to apply pressure to the medicine bag (12), and The air valve (31) is configured to depressurize the cartridge (1) by releasing the pressure from the interior of the cartridge (1).

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

3. The drug delivery system according to claim 2, wherein the at least one temperature sensor is configured to measure at least one of the ambient air temperature and the temperature of the interior of the box (1).

4. The drug delivery system according to claim 2 or 3, wherein the at least one pressure sensor is configured to measure the pressure of the interior of the cartridge (1).

5. A drug delivery system according to any one of claims 1 to 4, wherein the pump unit (2) comprises a processing unit (4), and wherein the processing unit (4) is configured to control the pump (3) based on the ambient air temperature or the temperature of the interior of the box (1) or the difference between the ambient air temperature and the temperature of the interior of the box (1).

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

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

9. The drug delivery system according to any one of claims 1 to 8, wherein the cartridge (1) comprises at least one outer shell (11) and a cover (17), wherein the access channel (14) is preferably provided in the cover (17), and The medicine bag (12) is preferably arranged inside the at least one outer shell (11) and the cover (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 medicament in a medicament delivery system, preferably according to any one of claims 1 to 10, wherein the method comprises: The box (1) containing the medicine bag (12) is pressurized (T3), After a predetermined period of time, the pressurized air is released (T4) from the cartridge (1).

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

13. The method according to claim 12, further comprising repeating the pressurizing (T3) step and the releasing (T4) step according to the measured outflow temperature.

14. The method according to claim 12 or 13, further comprising measuring an inflow temperature and calculating a temperature difference between the inflow temperature and the outflow temperature.

15. The method according to claim 14, further comprising repeating the pressurizing (T3) step and the releasing (T4) step according to the measured temperature difference.

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