Cassette of a drug delivery device and a drug delivery device

Abstract

A cassette (1; 1'; 1'') of a drug delivery device (2; 2'; 2''), the drug delivery device comprising a fluid pressure power source (21), the cassette (1; 1'; 1'') comprising a container carrier (10; 10', 10', 10', 10a'', 10b'', 10c'', 10d'') and a drug container (M; Ma, Mb, Mc, Md; Ma', Mb', Mc', Md'), the drug container having a body (M0; M0'; M0''; M0a, M0b; M0a, M0a', M0a'', M0b, M0b'; M0b'') and a fluid outlet (M1; M1'), the body (M0; M0'; M0''; M0a, M0b; M0a, M0a', M0a'', M0b, M0b'; M0b'') including a flexible portion; the drug container (M; Ma, Mb, Mc, Md; Ma', Mb', Mc', Md') being at least partially disposed within the container carrier (10; 10'; 10''; 10'''; 10a'', 10b'', 10c'', 10d''); the container carrier (10; 10'; 10''; 10'''; 10a'', 10b'', 10c'', 10d'') comprising a fluid seal chamber (11; 11'; 11''; 11a''', 11b''', 11c'''; 11a'''', 11b'''', 11c'''', 11d''''' ; 11'''''、11'''''、11a'''''、11b'''''、11c'''''、11d''''' ; 11a'''''、11b'''''、11c'''''、11d''''' ; 11a'''''、10e''''' ; 11a'''''、11b''''''); the fluid seal chamber (11; 11'; 11''; 11a''', 11b''', 11c'''; 11a'''''、11b'''''、11c'''''、11d''''' ; 11'''''、11'''''、11a'''''、11b'''''、11c'''''、11d''''' ; 11a'''''、11b'''''、11c'''''、11d''''' ; 11a'''''、10e''''' ; 11a'''''、11b'''''') including an inlet (110; 110'; 110''; 110'''; 110''''' ; 110a), the inlet (110, 110';110’’; 110’’’; 110’’’’; 110a) are configured to be fluidly connected to the outlet of a fluid pressure power source of a reusable body of a drug delivery device.;

Description

Technical Field

[0001] The present disclosure generally relates to cassettes of drug delivery devices, and more particularly to cassettes having a drug container with a flexible portion, wherein the flexible portion is connected to a fluid-tight chamber.

Background Art

[0002] Drug delivery devices such as pen-type manual syringes or auto-injectors are generally known for self-administration of drugs by patients who have not received formal medical training. Motor-driven drug delivery devices are desirable for delivering high-volume and / or high-viscosity drugs, or multiple different drugs.

[0003] Many motor-driven systems exist for delivering drugs, such as in the case of parenteral delivery. For example, peristaltic drives or piston pumps are common in the art. However, motor-driven drug delivery systems have drawbacks in some applications. These drawbacks become prominent when considering devices that can deliver multiple drugs, such as devices configured to administer sequential dosing regimens without intervention by a healthcare professional (HCP) during the course of treatment. Additionally, in-line pump elements often contain silicone oil as a lubricating means, which, although mostly inert, can introduce potential concerns regarding drug stability, especially when particularly sensitive drugs are delivered through the in-line pump element.

[0004] It is difficult to accommodate multiple drugs without increasing the size of the drive unit. If the device requires a separate motor for each additional drug, the power requirements, size, complexity, and cost of the device in each application can potentially become unmanageable, especially during the final configuration and assembly (i.e., dosing) of the device by the pharmacist. The administration of multiple drugs requires that the motor be driven for a certain duration, e.g., 1 to 6 hours. The motors required can consume large amounts of power and may require a larger battery or permanent power source, which can increase weight or reduce the mobility of the patient using the device. Further, a powerful motor or large gear train may be required to provide the required torque or motive power, which can increase weight and noise and may confuse the patient. In addition, such components can add manufacturing complexity and associated costs that are undesirable in a device used in the home. Accordingly, there is a need for a lightweight delivery device having a lightweight, quiet, and powerful drive, preferably located external to the drug flow path and preferably independent of the number of drugs delivered or the duration of delivery.

[0005] In some cases, multiple drugs must remain fluidly separated to prevent mixing of drugs that can cause unintended or undesirable effects (e.g., loss of potency, efficacy, or aggregation) and to prevent potential compatibility issues between the drugs and / or drug formulation components (i.e., excipients). While this may not be relevant for a single dosing device, it is no longer true if the drug delivery device is intended to deliver two or more drug products.

[0006] The different agents used with the system can each have different volumes and / or viscosities. For example, some agents may be at a fixed dose, while other agents may be at a variable dose specific to each patient. The power requirements of the motor-driven pump can vary based on the desired flow rate and volume delivered for each agent. This can require a novel approach for programming the pump for each agent. This complicates dosing. Accordingly, there is a need for an improved system and device for administration that can use separate disposable fluid paths (e.g., reservoirs and tubing sets) to deliver a volume of an agent at a given viscosity that is not known a priori. Further, there is a need for an improved system and device for administering multiple agents while using a single pump mechanism that can be flexibly configured to deliver one or more agents in the desired order governed by a prescribed dosing regimen without the need for prior knowledge of the number, volume, or viscosity of the agents.

SUMMARY OF THE INVENTION

[0007] The present invention is defined by the appended claims and reference is made thereto.

[0008] Accordingly, a cassette for a drug delivery device is provided, the drug delivery device comprising a reusable body having a fluid pressure power source. The cassette comprises a container carrier and a drug container having a body and a fluid outlet. The body includes a flexible portion. The drug container is at least partially disposed within the container carrier. The container carrier comprises a fluid-sealed chamber. The fluid-sealed chamber comprises an inlet. The inlet is configured to be fluidly connected to an outlet of the fluid pressure power source of the reusable body of the drug delivery device. The fluid-sealed chamber is connected to the flexible portion of the body of the drug container such that when the inlet receives output fluid from the fluid pressure power source, the output fluid flows into the fluid-sealed chamber and the drug contained within the drug container is pushed out under the pressure of the output fluid. The fluid outlet is configured to be connected to a drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device.

[0009] The cassette is configured to be used with a drug delivery device.

[0010] Preferably, according to another embodiment, the cassette is configured to be used with a portable drug delivery device.

[0011] Preferably, according to another embodiment, the body of the drug container includes a flexible bag and / or a flexible tube.

[0012] Preferably, according to another embodiment, the body of the drug container is a flexible bag received within a fluid-tight chamber.

[0013] Preferably, according to another embodiment, the fluid pressure power source is a pneumatic power source or a hydraulic power source. The pneumatic power source is configured to output gas to the cassette and release the drug contained within the cassette by increasing the gas pressure around the fluid-tight chamber. The hydraulic power source is configured to output liquid to the cassette and discharge the drug contained within the cassette by increasing the hydraulic pressure around the fluid-tight chamber. When the fluid pressure power source is a pneumatic power source, the fluid-tight chamber is airtight. When the fluid pressure power source is a hydraulic power source, the fluid-tight chamber can be either airtight or liquid-tight.

[0014] Accordingly, a drug delivery device comprising a cassette as disclosed in the present disclosure can provide a drive system for a pneumatically or hydraulically driven drug delivery device that can deliver one or more drugs in a desired order and at a desired drug delivery flow rate respectively. The system does not require prior knowledge of the volume and / or viscosity of each drug. Accordingly, the reusable body of the drug delivery device can be used for different drugs contained in different disposable cassettes. The drug container can be filled with the drug, and the filling can be performed by a pharmacy ("filling at the time of use"), for example, in a compounding room of a hospital or an infusion center, or by a drug manufacturer ("pre-filling"). During use, a fluid, such as a gas or a liquid, can be added into the cassette at a known mass flow rate to fold the flexible container in the cassette and deliver its contents to the patient at a known controllable volume flow rate.

[0015] Preferably, according to another embodiment, the cassette is configured to be attached to the reusable body of the drug delivery device.

[0016] Preferably, according to another embodiment, the cassette comprises a cassette housing.

[0017] Preferably, according to another embodiment, the cassette housing is configured to be attached to the reusable body of the drug delivery device.

[0018] Preferably, according to another embodiment, the container carrier is disposed within the cassette housing.

[0019] Alternatively, the container carrier is configured to be operably attached to the reusable body of the drug delivery device. In this example, the cassette does not require a cassette housing.

[0020] Preferably, according to another embodiment, the cassette is configured to be removably attached to the reusable body of the drug delivery device.

[0021] Preferably, according to another embodiment, the fluid sealing chamber is a secondary flexible bag that completely encloses the drug container. This can be achieved by a multi-layer bag assembly in which one port is the fluid outlet of the fluid sealing chamber and the other port is the inlet of the fluid sealing chamber.

[0022] Preferably, according to another embodiment, the body of the drug container includes a delivery tube.

[0023] Preferably, according to another embodiment, the delivery tube is a flexible tube of the body of the drug container.

[0024] Preferably, according to another embodiment, the flexible portion of the body is at least partially received within the fluid sealing chamber.

[0025] Preferably, according to another embodiment, the fluid sealing chamber includes a tube inlet and a tube outlet. The flexible delivery tube is configured to be positioned between the tube inlet and the tube outlet.

[0026] Preferably, according to another embodiment, the flexible delivery tube includes two tube valves. The fluid sealing chamber is configured to surround a portion of the flexible delivery tube that is between the two tube valves.

[0027] Preferably, according to another embodiment, the fluid sealing chamber includes an outlet configured to be connected to a vacuum device, whereby when the pressure within the fluid sealing chamber is reduced, the drug contained within the drug container is drawn into the flexible delivery tube.

[0028] Preferably, according to another embodiment, the inlet of the fluid sealing chamber is the outlet of the fluid sealing chamber.

[0029] Alternatively, according to another embodiment, the drug container is configured to be attached to a tube set including a delivery tube.

[0030] Preferably, according to another embodiment, the fluid outlet of the drug container is configured to be connected to a drug delivery member via a delivery tube. In this example, the fluid outlet of the drug container is configured to be attached to one end of the delivery tube, and the drug delivery member is configured to be attached to the other end of the delivery tube.

[0031] Preferably, according to another embodiment, the tube set includes a piercing member configured to establish fluid communication between the delivery tube and the drug container by piercing through the fluid outlet of the drug container.

[0032] Preferably, according to another embodiment, the piercing member is a needle cannula.

[0033] Preferably, according to another embodiment, the delivery tube includes a tube valve.

[0034] Preferably, according to another embodiment, the tube valve is an in-line valve included in the delivery tube.

[0035] Preferably, according to another embodiment, the tube valve of the delivery tube is a one-way valve such that fluid cannot flow through the delivery tube towards the drug container.

[0036] Preferably, according to another embodiment, the tube valve of the delivery tube is an umbrella valve, a disk spring valve, a ball valve, or a pinch valve.

[0037] Preferably, according to another embodiment, the drug delivery device includes a delivery flow sensor.

[0038] Preferably, according to another embodiment, the delivery flow sensor is attached to the fluid outlet of the drug container and / or the delivery tube of the tubing set.

[0039] Preferably, according to another embodiment, the container carrier comprises a container chamber configured to at least partially receive the drug container.

[0040] Preferably, according to another embodiment, the fluid seal chamber is expandable. The fluid seal chamber is adjacent to the flexible portion of the body, and the output fluid from the fluid pressure power source flows into the fluid seal chamber and is configured to expand the fluid seal chamber to press the drug container.

[0041] Preferably, according to another embodiment, the inlet of the fluid seal chamber comprises a valve.

[0042] Preferably, according to another embodiment, the valve at the inlet of the fluid seal chamber is a one-way valve, and the fluid can only pass through the one-way valve to enter the fluid seal chamber.

[0043] Preferably, according to another embodiment, the cassette includes at least two drug containers.

[0044] Preferably, according to another embodiment, the cassette comprises at least two container carriers.

[0045] Preferably, according to another embodiment, at least two containers each accommodate one of at least two drug containers.

[0046] Preferably, according to another embodiment, the drug delivery device comprises a multi-way valve connected to a fluid pressure power source, such as a 2 / 2-way valve, a 3 / 2-way valve, a 5 / 2-way valve. One port of the multi-way valve is configured to be attached to a fluid-tight chamber in one of at least two container carriers, and another port of the multi-way valve is configured to be attached to a fluid-tight chamber in another one of at least two container carriers.

[0047] Preferably, according to another embodiment, the cassette comprises one container carrier, and the container carrier comprises at least two fluid-tight chambers.

[0048] Preferably, according to another embodiment, the at least two fluid-tight chamber container carriers each contain at least two drug containers, one by one.

[0049] Preferably, according to another embodiment, each drug container is provided with a fluidically separated connection to the patient so that the separate drugs do not mix during administration unless desired on the patient side.

[0050] Preferably, according to another embodiment, a one-way valve is disposed between at least two fluid-tight chambers.

[0051] Preferably, according to another embodiment, the one-way valve disposed between at least two fluid-tight chambers is a disposable valve, such as a fragile valve.

[0052] Preferably, according to another embodiment, only one fluid-tight chamber of one of the at least two container carriers comprises an inlet configured to be fluidly connected to a fluid pressure power source.

[0053] Preferably, according to another embodiment, the one-way valve between two fluid-sealed chambers is configured to open when a first fluid pressure threshold is reached. The valve at the inlet of the fluid-sealed chamber configured to be fluid-connected to the fluid pressure power source is configured to open when a second fluid pressure threshold is reached. The first fluid pressure threshold is equal to or greater than the second fluid pressure threshold.

[0054] Preferably, according to another embodiment, the valve at the inlet of the fluid-sealed chamber configured to be fluid-connected to the fluid pressure power source is configured to open when a second fluid pressure threshold is reached. The predetermined threshold is greater than the second fluid pressure threshold.

[0055] Preferably, according to another embodiment, the predetermined threshold is greater than the first fluid pressure threshold.

[0056] Preferably, according to another embodiment, the fluid-sealed chamber includes a discharge valve configured to discharge the fluid flowing in the fluid-sealed chamber to the outside of the fluid-sealed chamber.

[0057] Preferably, according to another embodiment, when the fluid pressure reaches a predetermined threshold, the discharge valve is configured to discharge the fluid flowing from the fluid pressure power source and accumulating in the fluid-sealed chamber to the outside of the fluid-sealed chamber and around the cassette or the receiving container included in the cassette.

[0058] Preferably, according to another embodiment, the discharge valve is connected to an emergency button. When the emergency button is activated, the discharge valve is configured to discharge the fluid flowing in the fluid-sealed chamber to the outside of the fluid-sealed chamber and around the cassette or the receiving container included in the cassette, thus stopping the force that causes the movement of the drug contained in the container.

[0059] Preferably, according to another embodiment, the emergency button can be pushed, pulled, slid, or twisted with respect to the reusable body of the container carrier or the drug delivery device to activate the emergency button.

[0060] Alternatively, according to another embodiment, the release valve is configured to decelerate the drug delivery rate.

[0061] Alternatively, according to another embodiment, the release valve is connected to a rotatable orifice.

[0062] Preferably, according to another embodiment, the fluid-sealed chamber of the container carrier is made of at least partially rigid material.

[0063] Preferably, according to another embodiment, the fluid-sealed chamber of the container carrier is formed by a container frame configured to be attached to the drug container and an internal chamber of the container carrier. The container frame is configured to surround the drug container.

[0064] Alternatively or additionally, according to another embodiment, the fluid-sealed chamber of the container carrier is formed by a container frame configured to be attached to the drug container and a cap configured to be attached to the container frame. The container frame is configured to surround the drug container.

[0065] Preferably, according to another embodiment, the cap includes a tubing set.

[0066] Preferably, according to another embodiment, when the cap is attached to the container frame, the delivery tube is in fluid connection with the drug container surrounded by the container frame.

[0067] Preferably, according to another embodiment, when the cap is attached to the container frame, the piercing member is configured to pierce the fluid outlet of the drug container.

[0068] Alternatively, according to another embodiment, when the cap is attached to the container frame, the piercing member is configured to pierce the fluid outlet of the drug container when the piercing trigger is actuated.

[0069] Preferably, according to another embodiment, the fluid sealing chamber comprises a pressure sensor.

[0070] Preferably, according to another embodiment, the fluid sealing chamber is connected to a fluid sealing measurement chamber. The fluid sealing measurement chamber is configured to be connected to a fluid pressure power source and is configured to have the same fluid pressure level as the fluid sealing chamber. The fluid sealing measurement chamber comprises a piston. The piston is configured to be operably connected to a position sensor configured to sense the position of the piston within the fluid sealing measurement chamber.

[0071] Preferably, according to another embodiment, the piston position sensor is configured to monitor the pressure level within the fluid sealing chamber by monitoring the position of the piston.

[0072] Preferably, according to another embodiment, the container carrier comprises a position sensor configured to detect the position of the drug container.

[0073] Preferably, according to another embodiment, the drug container position sensor is configured to monitor the pressure level within the fluid sealing chamber by monitoring the position of the drug container.

[0074] Another aspect of the present invention provides a drug delivery device comprising a cassette.

[0075] Preferably, according to another embodiment, the drug delivery device is portable.

[0076] Preferably, according to another embodiment, the drug delivery device is worn on the body under or over clothing.

[0077] Preferably, according to another embodiment, the drug delivery device is an injection device, for example, an infusion device or an on-body syringe.

[0078] Preferably, according to another embodiment, the drug delivery member is a hypodermic needle or an insertion needle having a flexible cannula.

[0079] Preferably, according to another embodiment, the drug delivery device comprises a reusable body and a replaceable drug delivery member.

[0080] Preferably, according to another embodiment, the reusable body of the drug delivery device comprises a fluid pressure power source connected to an inlet of a fluid-sealed chamber of a container carrier. The fluid outlet is operably connected to the drug delivery member.

[0081] Preferably, according to another embodiment, the drug delivery device comprises a processor electrically connected to the fluid pressure power source and a power source connected to the processor. The processor and the power source are housed within the reusable body.

[0082] Preferably, according to another embodiment, the fluid-sealed chamber is adjacent to the fluid pressure power source. The fluid pressure power source is directly fluid-connected to the inlet of the fluid-sealed chamber.

[0083] Preferably, according to another embodiment, the transfer tube is disposed between the fluid pressure power source and the inlet of the fluid-sealed chamber. The fluid pressure power source is fluid-connected to the inlet of the fluid-sealed chamber via the transfer tube.

[0084] Preferably, according to another embodiment, the transfer tube is attached to the container frame.

[0085] Preferably, according to another embodiment, the drug delivery device is configured to be attached to two or more cassettes.

[0086] Preferably, according to another embodiment, two or more cassettes are stacked on top of each other.

[0087] Preferably, according to another embodiment, the drug delivery device is configured to be attached to a cassette comprising a plurality of drug containers.

[0088] Preferably, according to another embodiment, the drug delivery device comprises a user interface attached to a reusable body.

[0089] Preferably, according to another embodiment, the user interface is electrically connected to a processor.

[0090] Preferably, according to another embodiment, the user interface is a button protruding from the outer surface of the reusable body.

[0091] Preferably, according to another embodiment, the user interface is a screen or touch panel disposed on the outer surface of the reusable body.

[0092] Preferably, according to another embodiment, the drug delivery device comprises a display.

[0093] Preferably, according to another embodiment, the drug delivery device comprises an orientation sensor such that a display, screen, or touch panel can always be presented to the user in a right-facing graphic display.

[0094] Preferably, according to another embodiment, the drug delivery device comprises a wireless communication receiver connected to a processor. The wireless communication receiver can be based on, as non-limiting examples, radio frequency identification (RFID), near-field communication (NFC), Bluetooth® (registered trademark), Bluetooth low energy (BLE), ultra-wide band (UWB), wireless fidelity (Wi-Fi), cellular communication, and infrared (IR) technologies.

[0095] Preferably, according to another embodiment, the drug delivery device comprises a wireless communication transmitter connected to a processor. The wireless communication transmitter can be based on, as non-limiting examples, RFID, NFC, Bluetooth® (registered trademark), BLE, UWB, Wi-Fi, cellular communication, and IR technologies.

[0096] Preferably, according to another embodiment, the wireless communication receiver is configured to receive a wireless signal from a remote device or an information tag.

[0097] Preferably, according to another embodiment, the wireless communication transmitter is configured to transmit a wireless signal to a remote device or an information tag.

[0098] Preferably, according to another embodiment, the pressure sensor and / or position sensor of the piston of the fluid-sealed measurement chamber, and / or the position sensor of the container carrier, are electrically connected to the processor.

[0099] Preferably, according to another embodiment, the processor is configured to control a fluid pressure power source according to signals from the pressure sensor and / or position sensor of the piston of the fluid-sealed measurement chamber, and / or the position sensor of the container carrier, to output fluid into the fluid-sealed chamber.

[0100] Accordingly, the drug delivery device provides real-time control of drug delivery operations to the drug delivery system. The system can have two control modes for drug dispensing (pressure control and flow rate control). In a pressure-controlled embodiment, a set pressure is maintained within the fluid-sealed chamber to throttle drug outflow, possibly due to the pressure at the drug delivery site, e.g., the subcutaneous back pressure of the patient, and / or the liquid pressure resistance of the drug decreasing as the drug warms due to drug, environmental, or system parameters, e.g., environmental conditions, such as temperature-dependent viscosity.

[0101] Alternatively, when the fluid pressure power source is a pneumatic power source, the flow rate may be controlled in a closed-loop manner using the ideal gas law and / or its simplifications, namely Boyle's law and Charles's law. The system can be configured to calculate (i.e., estimate) the remaining drug. The system can be configured to calculate (i.e., estimate) the residual dose volume by measuring the pressure of the fixed internal space within the fluid-sealed chamber and thus calculating the void volume within the fluid-sealed chamber based on the mass of fluid that has flowed into the fluid-sealed chamber. This is accomplished by continuously or periodically monitoring the dosing of each drug by means of a processor and at least one of a pressure sensor(s), a position sensor(s) of the piston of the fluid-sealed measurement chamber, and a position sensor(s) of the container carrier. Note in this example that the flow rate means the flow rate out of the drug container. The flow rate is not necessarily equal to the delivery rate of the drug contained within the drug container, i.e., the rate at which the user receives the drug from the drug delivery device (drug delivery rate). For example, if other rate control mechanisms are used, such as a pinch valve attached to a flexible tube, the delivery rate of the contained drug can be different from the flow rate. Alternatively, if no other rate control is employed, such as when a flexible bag is attached to the drug delivery member, e.g., a needle in this example, the flow rate is substantially equal to the delivery rate of the drug contained within the drug container.

[0102] Furthermore, in the example where the fluid pressure power source is a pneumatic power source, the volume of the drug in the drug container can be determined using the ideal gas law and its simplifications, such as Boyle's law and Charles's law. The application of the ideal gas law is important for the operation of the volume measurement system (flow rate control, drug volume sensing). This is because the volume of an abstract geometric shape cannot be directly investigated by known cost-effective detection methods. However, for commercially providing this device, it is unlikely that this system uses a pure ideal gas, and the use of ambient air is very advantageous. Therefore, although the ideal gas law PV = nRT is directly applicable to an ideal gas, it does not fully represent ambient air. By introducing the compressibility factor z into the ideal gas law, a general application to ambient air PV = znRT becomes possible. At predictable system temperatures and pressures (280 - 310 K, 1 - 10 bar), 0.9992 < z < 1.0004, and thus air can be approximated as an ideal gas. Alternatively, to compensate for the inherent sensitivity to environmental variables and improve pump performance in the presence of environmental uncertainties, the drug delivery device may optionally include an atmospheric pressure sensor and / or an ambient temperature sensor, a "compensation block", so that the calculation can be calibrated based on the detection from the compensation block.

[0103] To further simplify the equation, since the predictable values are in a narrow range of 280 - 310K, it is clear that the temperature term T has little effect. Even if the air volume starts at 280K and rises to 310K over the course of the volume sensing operation, the temperature term alone cannot cause a reduction in volume evaluation accuracy exceeding ±5%. This is a very conservative case since the controlled air temperature is likely to be dominated by the drug container enclosure temperature and indirectly by the ambient room temperature. Further, since the container carrier can be vented to the ambient air (e.g., by a release valve), the air within the container carrier is approximately equal to the room temperature and this will not introduce any temperature-based inaccuracies. Enabling a measurement sensitivity of ±5% at this step is highly likely to be clinically acceptable and is far more sensitive than current pharmacy practice volume verification methods that do not include the ability for empirical evaluation. However, the introduction of a system air temperature sensor or a local container carrier air temperature sensor will remove the uncertainty due to the temperature difference between the room temperature air and the internal air of the cassette. Obviously, injections and infusions are used herein, but the accuracy of the system can be determined on a case-by-case basis if the physiological route of administration and appropriate clinical parameters therefor are provided.

[0104] In a preferred system control model, the converted ideal gas law is as follows. Since PV ∝ nR and nR represents the number or mass m of molecules in the system, thus the reduction is PV ∝ m; V ∝ m / iP. To determine the interstitial volume of the system at any given time, the system must track the mass transferred to the control volume, for example, through a known relationship between the drive parameter and the injected mass or through a known volume comparison proxy control region such as a conventional accumulator model where air is distributed. In the volume evaluation step, it is important that the unfilled volume of the drug cassette and the internal air volume of the device are known. This is because the volume evaluation device evaluates the air volume of the system and the filled volume of the drug is equal to the difference between the air volume of the unfilled system and the air volume of the filled system.

[0105] The ability to determine the volume of the drug within the drug container is particularly advantageous because the system can determine it based solely on the change in mass without reacting to the initial filling and without knowing the initial filling volume (i.e., no programming step is required). Thus, by directly calculating the volume of the drug within the drug container, there is a unique advantage that a third party can verify the drug contained within the drug container in a blind manner before use. This enables determination of the initial state of the drug container.

[0106] Furthermore, in another example, the flow rate is not directly sensed. Rather, the system repeatedly calculates the interstitial volume of the system. If the only way the interstitial volume can change is due to liquid exiting the drug container, then the rate of change of the interstitial volume is equal to the liquid flow rate.

[0107] To avoid the noise observed in liquid flow rate calculations when adjacent interstitial volume measurements are used, it is possible to filter the measurements to obtain a cleaner signal. One such approach involves a buffer and linear regression. In each controller evaluation, the initial conditions of the container carrier (calculated by the ideal gas law and its simplification) are added to the buffer, and linear regression is performed on that buffer. The slope of the regression line is the flow rate.

[0108] The system enables continuous control of the flow rate, and thereby: performs continuous fluid delivery into the fluid-sealed chamber while monitoring the pressure, removes the fluid flowing in from the fluid pressure power source from the fluid-sealed chamber while monitoring the pressure, determines the target flow rate, and / or delivers the accumulated pressure or vents the fluid-sealed chamber to reduce the pressure around the cassette or the receiving container contained within the cassette and remove the cause of all forward fluid movement, thereby suddenly stopping the flow (e.g., during an emergency or a systemic infusion reaction). For example, the system can control the release valve to release fluid around the cassette or the receiving container contained within the cassette based on detections from one or more connected sensors. The system enables changes in the flow rate during the drug delivery operation, as may be required during common rate adjustment regimens in oncology, and enables each cassette to have a desired flow rate that can be configured independently. Different drug cassettes or container carriers may be combined in a desired order, and each cassette may have any desired fluid volume and may be delivered at a desired flow rate independent of parameters such as viscosity, volume, or other drug, patient, or system configuration (e.g., cannula gauge).

[0109] Further, in another example, the system can include a target maintenance mechanism. In this example, since ideally there is a linear relationship between pressure and liquid flow rate, the target maintenance period simply adjusts the system's pressure target in proportion to the measured flow rate error. The flow rate error is interpreted as the ratio between the target liquid flow rate and the measured liquid flow rate, rather than the difference. The pressure target adjustment method can take many forms, but all essentially supply the flow rate error as an input for response adjustment. Some controllers such as a Proportional Integral (PI) controller, a Proportional-Integral-Derivative (PID) controller, or a bang-bang controller can be used.

[0110] Furthermore, when the drug delivery member is an insertion needle having an injection needle or a soft cannula, the system can also detect needle withdrawal when a pressure drop in the fluid seal chamber is detected.

[0111] Preferably, according to another embodiment, the intentional break point can be located near the needle tip. For example, when the delivery tube is pulled in a manner that would normally remove the needle from the patient's skin, the tube instead breaks at this junction, separating the delivery tube from the needle tip.

[0112] This break has the effect of removing the pressure drop associated with the needle and subcutaneous tissue backpressure. Thus, for a drug delivered at a controlled flow rate, the upstream driving pressure decreases.

[0113] In a drive system that can continuously monitor the pressure and / or flow rate of the drug exiting the drug container, these sudden flow changes are detectable, indicating separation of the delivery tube from the terminal needle and presenting an error condition to stop the injection.

[0114] Preferably, according to another embodiment, the fluid pressure power source is connected to the fluid seal chambers of two container carriers, and the processor is configured to control the fluid pressure power source to selectively output fluid to at least one of the fluid seal chambers.

[0115] Preferably, according to another embodiment, the processor is configured to control the fluid pressure power source to selectively output fluid into at least one of the fluid seal chambers according to signals from a pressure sensor and / or a position sensor of the piston in the fluid seal measurement chamber and / or a position sensor of the container carrier.

[0116] Preferably, according to another embodiment, the processor is configured to control a fluid pressure power source to output a certain amount of fluid. That certain amount is either predetermined or depends on signals from a pressure sensor and / or a position sensor of the piston of the fluid-sealed measurement chamber and / or a position sensor of the container carrier. Thereby, only that certain amount of drug contained within the drug container can be pushed out from the fluid outlet.

[0117] Preferably, according to another embodiment, the fluid pressure power source comprises a piezoelectric pump configured to output fluid from the fluid pressure power source. Also, it is preferable to use a piezoelectric pump as the pneumatic power source. Using a piezoelectric pump can be advantageous as it can provide a quiet or silent operation and can provide a lower power operation compared to motor-driven solutions.

[0118] Preferably, according to another embodiment, the fluid pressure power source comprises a motor-based fluid pump configured to output fluid from the fluid pressure power source.

[0119] Preferably, according to another embodiment, when lower cost or complexity is desired, the fluid pressure power source comprises a piston pump.

[0120] Preferably, according to another embodiment, when the fluid pressure power source is a pneumatic power source, the pneumatic power source is a diaphragm pump that is sufficiently controlled when lower cost or complexity is desired.

[0121] Preferably, according to another embodiment, when the fluid pressure power source is a pneumatic power source, the pneumatic power source includes an electronic engine, for example, a MEMS engine, and a liquid substance. In this example, the engine is configured to cause an electrochemical reaction of the liquid substance to generate a propulsive gas.

[0122] Preferably, according to another embodiment, the fluid pressure power source is a fluid pump having an inlet fluidly connected to the environment and an inlet filter connected to the inlet of the fluid pump, and is provided with an inlet filter connected to the fluid pump so as to prevent contamination from the environment, such as dust, from entering the fluid pump.

[0123] Preferably, according to another embodiment, the fluid pressure power source comprises a pump outlet check valve, a downstream controllable discharge valve (venting to the atmosphere) following it, a flow sensor, a pressure sensor, and an outlet filter connected to the fluid sealing chamber.

[0124] Preferably, according to another embodiment, the fluid pressure power source comprises a pressurized fluid canister configured to output fluid from the fluid pressure power source.

[0125] Preferably, according to another embodiment, when the fluid pressure power source is a pneumatic power source, the pneumatic power source includes a pressurized gas canister.

[0126] According to another embodiment, the drug delivery device is preferably an infusion device.

[0127] Preferably, according to another embodiment, the fluid pressure power source is a pneumatic power source. In this embodiment, the fluid output from the fluid pressure power source is a gas, such as air or nitrogen.

[0128] Preferably, according to another embodiment, the fluid pressure power source is a hydraulic power source. In this embodiment, the fluid output from the fluid pressure power source is a liquid, such as water or oil.

[0129] Furthermore, another aspect of the present invention provides a method for controlling a drug delivery device. The drug delivery device includes a fluid pressure power source, which is a pneumatic power source as described in any of the above embodiments. The drug delivery device includes a fluid-sealed chamber as described in any of the above embodiments, and the fluid-sealed chamber houses a drug container. The drug container is a flexible bag having a fluid outlet. The flexible bag contains a drug. The method includes the following steps in the following order: Receiving at least one of a measured pressure level of the fluid pressure in the fluid-sealed chamber and a measured flow rate of the drug exiting the fluid outlet of the flexible bag; Obtaining information from a database using the received measurement; and Providing a signal based on the obtained information to cause one or more electronic components of the drug delivery device to perform an operation or to stop a currently executing operation of one or more electronic components of the drug delivery device.

[0130] The method is configured to monitor the state of the fluid-sealed chamber by monitoring the pressure level in the fluid-sealed chamber and / or the velocity of the drug exiting the fluid outlet of the flexible bag, and accordingly adjust the drug delivery operation. As a result, for example, an overshoot situation of the pneumatic power source and / or the entire drug delivery system can be avoided, so that the pneumatic power source and the drug delivery device are protected. Furthermore, user actions, such as premature removal of the drug delivery member, can be tracked.

[0131] This method can also be used to calculate the actual delivered drug and / or the residual drug in the drug container by inspecting the drug actually filled in the drug container and comparing the initial inspected volume of the drug with the inspected volume of the drug after use. Note that the calculation of the filled volume of the drug is performed based on the measurement of the pressure level of the fluid pressure in the fluid-sealed chamber. Therefore, the measured value can be obtained either by directly measuring the pressure level in the fluid-sealed chamber or by calculating using the velocity of the drug (measurement value of the flow rate) exiting from the fluid outlet of the flexible bag. Further, for calculating the filled volume of the drug, the measured value of the pressure level of the fluid pressure in the fluid-sealed chamber can be a positive pressure level or a negative pressure level. For example, a pneumatic fluid power source can be controlled to input a certain amount of fluid, such as gas, air, into the fluid-sealed chamber for measuring the drug filling volume (a certain amount of fluid will be discharged from the discharge valve after the calculation of the filled volume of the drug and before the drug delivery operation). Alternatively, when controlling the pneumatic fluid power source such that the drug filling volume calculation is performed based on the information of the magnitude of the vacuum, the fluid, such as gas, air, between the fluid-sealed chamber and the flexible bag can be drawn out.

[0132] Preferably, according to another embodiment, the step of receiving at least one of the measured value of the pressure level of the fluid pressure in the fluid-sealed chamber and the measured value of the flow rate of the drug exiting from the fluid outlet of the flexible bag includes the step of receiving the measured value of the pressure level of the fluid pressure in the fluid-sealed chamber and the measured value of the flow rate of the drug exiting from the fluid outlet of the flexible bag.

[0133] Preferably, according to another embodiment, the step of obtaining information from the database using the received measured value includes the following steps in the following order: calculating a value using the ideal gas law and its simplification based on the received measured value; comparing the calculated value with a predetermined value; and generating a result of the comparison.

[0134] Preferably, according to another embodiment, the step of generating a comparison result and the step of obtaining information from a database using the received measurement values further include the step of providing the compared result with the information obtained by collating it with the information from the database.

[0135] Preferably, according to another embodiment, after the step of generating a comparison result, the step of obtaining information from a database using the received measurement values further includes the step of providing the information obtained by providing the comparison result.

[0136] Preferably, according to another embodiment, the information obtained relates to at least one of the actually filled volume of the drug in the drug container, the volume of the drug remaining in the drug container after use, the air in the delivery tube, the delivery member being away from the delivery site, and the delivery occlusion.

[0137] Preferably, according to another embodiment, the predetermined value relates to at least one of the volume of the drug container, the volume of the drug contained in the drug container, the target flow rate of the drug exiting the fluid outlet of the flexible bag, the target pressure level of the fluid pressure in the fluid sealing chamber, the previously received flow rate of the drug exiting the fluid outlet of the flexible bag, the previously received pressure level of the fluid pressure in the fluid sealing chamber, and the previously calculated volume of the drug contained in the drug container.

[0138] Preferably, according to another embodiment, the predetermined value is received from an information tag on the drug container.

[0139] Preferably, according to another embodiment, the operation of one or more electronic components of the drug delivery device is configured by the provided signal to perform or stop at least one of providing an instruction to the user of the drug delivery device, performing a drug delivery operation, transmitting data to a remote server, adjusting the pressure level of the fluid pressure in the fluid sealing chamber, and adjusting the drug release rate from the fluid outlet of the flexible bag.

[0140] Preferably, according to another embodiment, the processor of the drug delivery device described in any one of the above embodiments is configured to execute the method according to any one of the above embodiments.

[0141] Preferably, according to another embodiment, the fluid-sealed chamber of the cassette is operably connected to a pressure sensor configured to measure a pressure level measurement of the fluid pressure within the fluid-sealed chamber and / or a flow sensor configured to measure the velocity of the drug exiting the fluid outlet of the flexible bag.

[0142] Preferably, according to another embodiment, the cassette is operably connected to the pressure sensor and the flow sensor.

[0143] Preferably, according to another embodiment, the cassette comprises a pressure sensor and a flow sensor.

[0144] Preferably, according to another embodiment, the reusable body of the drug delivery device comprises a processor.

[0145] Preferably, according to another embodiment, the processor is electrically connected to a fluid pressure power source.

[0146] Preferably, according to another embodiment, the processor is electrically connected to the pressure sensor and the flow sensor when the cassette is attached to the reusable body of the drug delivery device.

[0147] Preferably, according to another embodiment, the reusable body of the drug delivery device comprises a communication unit configured to read an information tag on the drug cassette when the cassette is attached to the reusable body of the drug delivery device.

[0148] Preferably, according to another embodiment, the communication unit is electrically connected to the processor.

[0149] Preferably, according to another embodiment, the communication unit is an RFID / NFC reader and / or an RFID / NFC writer.

[0150] The drug delivery devices described herein can be used for the treatment and / or prevention of one or more of many different types of disorders. Exemplary disorders include, but are not limited to, rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), hypercholesterolemia, diabetes (e.g., type 2 diabetes), psoriasis, migraine, multiple sclerosis, anemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycemia, obesity, anaphylaxis, and allergies. Exemplary types of drugs that can be included in the drug delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, antibodies, antibody-drug conjugates, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogs, protein variants, protein precursors, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies and / or protein derivatives.Exemplary drugs that may be included in the drug delivery devices described herein include, but are not limited to (non-limiting examples of related disorders are shown in parentheses): etanercept (rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)), evolocumab (hypercholesterolemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraine), alirocumab (rheumatoid arthritis), methotrexate or amethopterin (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-1a (multiple sclerosis), sumatriptan (migraine), adalimumab (rheumatoid arthritis), darbepoetin alfa (anemia), belimumab (lupus), peginterferon beta-1a' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatitis, asthma, nasal polyps, allergy), glucagon (acute hypoglycemia), epinephrine (anaphylaxis), insulin (diabetes), atropine and vedolizumab (inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)), ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiprimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, pertuzumab, trastuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab. Pharmaceutical formulations containing any drug described herein, including but not limited to, pharmaceutical formulations containing the drugs (or pharmaceutically acceptable salts of the drugs) listed herein and pharmaceutically acceptable carriers are also contemplated for use in the drug delivery devices described herein.A pharmaceutical preparation containing a drug (or a pharmaceutically acceptable salt of the drug) listed in this specification may contain one or more other active ingredients or may be the only active ingredient present.

[0151] Exemplary drugs that may be included in the drug delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology agents such as immune checkpoint, cytokine, chemokine, cluster of differentiation, interleukin, integrin, growth factor, enzyme, signaling protein, apoptosis-promoting protein, anti-apoptosis protein, T cell receptor, B cell receptor, or costimulatory protein.

[0152] Exemplary drugs that may be included in the drug delivery devices described herein include, but are not limited to, HER-2 receptor modulators, interleukin modulators, interferon modulators, CD38 modulators, CD22 modulators, CCR4 modulators, VEGF modulators, EGFR modulators, CD79b modulators, Trop-2 modulators, CD52 modulators, BCMA modulators, PDGFRA modulators, SLAMF7 modulators, PD-1 / PD-L1 inhibitors / modulators, B lymphocyte antigen CD19 inhibitors, B lymphocyte antigen CD20 modulators, CD3 modulators, CTLA-4 modulators, TIM-3 modulators, VISTA modulators, INDO inhibitors, LAG3 (CD223) antagonists, CD276 antigen modulators, CD47 antagonists, CD30 modulators, CD73 modulators, CD66 modulators, CDw137 agonists, CD158 modulators, CD27 modulators, CD58 modulators, CD80 modulators, CD33 modulators, APRIL receptor modulators, HLA antigen modulators, EGFR modulators, B lymphocyte cell adhesion molecule modulators, CDw123 modulators, Erbb2 tyrosine kinase receptor modulators, mesothelin modulators, HAVCR2 antagonists, NY-ESO-1 OX40 receptor agonist modulators, adenosine A2 receptors, ICOS modulators, CD40 modulators, those showing proposed mechanisms of action such as TIL therapy or TCR therapy, and the like.

[0153] Exemplary drugs that may be included in the drug delivery device described herein include AC, high-dose AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapiOx, 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 8811, HIDAC, X, CALGB, 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, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE, and the like multi-drug treatment regimens.

[0154] Exemplary drugs that may be included in the drug delivery device described herein include, but are not limited to, those used in chemotherapy such as alkylating agents, plant alkaloids, antitumor antibiotics, antimetabolites, or topoisomerase inhibitors, enzymes, retinoids, or corticosteroids. Exemplary chemotherapeutic agents include, by way of example and not limitation, 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.

[0155] Furthermore, all terms used in the claims should be construed according to their ordinary meanings in the art, unless otherwise explicitly defined herein. All references to "a / an," "the," "element," "device," "member," "component," "means," etc. should be construed broadly as referring to at least one example of the element, device, member, component, means, etc., unless otherwise explicitly stated.

Brief Description of the Drawings

[0156] Hereinafter, embodiments of the concepts of the present invention will be described by way of example only with reference to the accompanying drawings.

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Figure 37B

Embodiments for Carrying Out the Invention

[0157] Figures 1 to 37B show some exemplary cassettes 1; 1’’; 1’’’ of the drug delivery device 2; 2; 2’’. The drug delivery device 2; 2; 2’’ comprises a reusable body 20; 20’; 20’’; 20’’’ having a fluid pressure power source 21. The fluid pressure power source can be a pneumatic power source or a hydraulic power source. The pneumatic power source is configured to output gas to the cassette to discharge the contained drug by increasing the fluid pressure of the gas, and the hydraulic power source is configured to output liquid to the cassette to discharge the contained drug by increasing the fluid pressure of the liquid. In a preferred example, the drug delivery device 2 is a portable device. The cassettes 1; 1’’; 1’’’ comprise a container carrier 10 and drug containers M; Ma, Mb, Mc, Md; Ma’, Mb’, Mc’, Md’.

[0158] The drug containers M; Ma, Mb, Mc, Md; Ma’, Mb’, Mc’, Md’ are configured to be at least partially received within the container carriers 10; 10’; 10’’; 10’’’; 10a’’, 10b’’, 10c’’, 10d’’. The drug containers M; Ma, Mb, Mc, Md; Ma’, Mb’, Mc’, Md’ include a body M0; M0’; M0’’; M0a, M0b; M0a, M0a’, M0a’’, M0b, M0b’; M0b’’ and a fluid outlet M1; M1’; Ma1, Mb1, Mc1. The body M0; M0’; M0’’; M0a, M0b; M0a, M0a’, M0a’’, M0b, M0b’; M0b’’ is configured to contain the drug. The drug contained within the body M0; M0’; M0’’; M0a, M0b; M0a, M0a’, M0a’’, M0b, M0b’; M0b’’ is configured to move out of the body M0; M0’; M0’’; M0a, M0b; M0a, M0a’, M0a’’, M0b, M0b’; M0b’’ through the fluid outlet M1; M1’; M1’’; Ma1, Mb1, Mc1.

[0159] First, each component of the cassette, including optional components, will be described in detail. Examples of cassettes including different combinations of the described components will be described in detail later.

[0160] The bodies M0; M0'; M0''; M0a, M0b; M0a, M0a', M0a'', M0b, M0b'; M0b'' include a flexible portion. In a preferred example, the bodies M0; M0'; M0''; M0a, M0b; M0a, M0a', M0a'', M0b, M0b'; M0b'' include a flexible bag and / or a flexible tube. In some of the following examples, when it is mentioned that the delivery tube is flexible, it should be noted that the term "delivery tube" and the term "flexible tube" are used interchangeably. In other words, when the delivery tube is flexible, the delivery tube can be the flexible tube of the body of the drug container. In one example, the body M0 includes a flexible bag M0a configured to contain a drug, as shown in FIGS. 2A-2B. In this example, the flexible portion of the body M0 is defined by the flexible bag. In this example, the fluid outlet M1 can be directly connected to the drug delivery member 23 of the drug delivery device, such as a steel injection needle, or the fluid outlet M1 is configured to be operably connected to the drug delivery member 23. For example, as shown in FIGS. 32-34C, the fluid outlet M1 is operably connected to one end of a delivery tube 31, and the other end of the delivery tube 31 is connected to the drug delivery member 23, or the body includes a rigid delivery tube connected to the body M0. The rigid delivery tube defines the fluid outlet M1. Alternatively, the body M0' includes a delivery tube M0b, and in this example, the delivery tube M0b is flexible. In this example, the flexible portion of the body M0' is defined by a part of the delivery tube M0b. In this example, the body M0' can be partially made from a rigid material, such as a glass ampoule, and can be assembled / integrated with the delivery tube M1'. In this example, the delivery tube M1' defines the fluid outlet M1, which means that the flexible delivery tube M1' can be connected to the drug delivery member 23.

[0161] In a preferred example, the body of the drug container includes a flexible bag received within a fluid-tight chamber.

[0162] In a preferred example, the main body of the drug container comprises a flexible bag and a flexible tube; or the main body of the drug container comprises a flexible bag configured to be operably connected to a flexible tube 31 (not part of the main body). In this example, regardless of whether the flexible part of the main body configured to be pressed by the fluid from the fluid pressure power source is part of the flexible bag or part of the flexible tube (when the main body includes the flexible tube), the delivery rate of the drug contained in the drug container can be controlled by operating the flexible tube. For example, a pinch valve can be attached to the flexible tube, and the delivery rate (drug delivery rate) of the drug contained in the drug container can be adjusted via the pinch valve. Preferably, in this example, a flow meter can be connected to the flexible tube to measure the delivery rate of the drug contained in the drug container. The flow meter can be a pinwheel sensor, an ultrasonic sensor, and / or a calorimetric sensor. It should be noted that the drug delivery rate may be such that the speed control configuration may be arranged outside the drug container. For example, since the pinch valve is attached to a flexible tube that is not part of the main body of the drug container, the flow rate (flow rate) of the drug exiting the drug container may not be equal.

[0163] In one example where the body includes a delivery tube or the body of the drug container includes a flexible bag configured to be operably connected to a flexible tube 31 (not part of the body), the delivery tube optionally includes a tube valve M2. Additionally, in a preferred example, the tube valve is a one-way valve M2, and the drug flowing in the delivery tube cannot flow back towards the body of the drug container M. Instead, the drug flowing in the delivery tube can only flow towards the fluid outlets M1; M1’; Ma1, Mb1, Mc1. Additionally, in a preferred example, the tube valve M2 of the delivery tube is an umbrella valve, a spring-based valve, or a ball valve. It should be noted that the tube valve is a useful safety device. However, it is not necessarily an essential component for the cassette of the present disclosure. For example, when the drug container is configured to stand upright with respect to the ground, i.e., when the fluid outlet is directed towards the ground, during the use of the drug delivery device comprising the cassette of the present disclosure, the gravity of the drug in the body can prevent the drug from flowing back towards the body. Alternatively, when the drug container is configured to receive a pressure high enough to discharge the drug from the fluid outlet, this pressure can also prevent the drug from flowing back towards the body.

[0164] In one example, the container carriers 10; 10'; 10''; 10'''; 10a'', 10b'', 10c'', 10d'' include fluid-sealed chambers 11; 11'; 11''; 11a''', 11b''', 11c'''; 11a'''', 11b'''', 11c'''', 11d''''' ; 11''''' ', 11''''' ', 11a''''' ', 11b''''' ', 11c''''' ', 11d''''' '; 11a''''' ', 11b''''' ', 11c''''' ', 11d''''' '. In this example, since most of the connections between components are pre-assembled, the drug delivery device can be easily used by the end user, and the end user only needs to attach the cassette to the power source 21 and connect the delivery member 23 to the cassette. In one example, the fluid-sealed chambers 11a''''' ', 10e''' of the container carrier formed by the container frame 11a''''' '; 11a''''' ', 11b''''' 'are configured to be attached to the drug container M as shown in FIGS. 32 and 34A-34C. In one example, as shown in FIG. 32, the fluid-sealed chambers 11a''''' ', 11b''''' 'of the container carrier are formed by the container frame 11a''''' 'and the internal chamber 10e''' of the container carrier 10''''' '. Alternatively, or additionally, the fluid-sealed chambers 11a''''' ', 11b''''' 'of the container carrier are formed by the container frame 11a''''' 'and a cap 11b''''' 'configured to be attached to the container frame 11a''''' '.

[0165] Container frame 11a; 11a is configured to surround the drug container M. In one example, as shown in FIG. 32, the container frame 11a is configured to surround the outer contour of the drug container M. This example is suitable when the drug container is a flexible bag. Since the container frame supports the outer contour of the drug container, the risk of kinking during drug filling can be reduced. In this example, the container frame 11a can be formed in a shape that conforms to the outer contour of the flexible bag. For example, when the flexible bag is substantially rectangular, the container frame can be a substantially rectangular ring configured to closely surround the outer contour of the flexible bag.

[0166] Alternatively or additionally, as shown in FIGS. 34A - 34C, the container frame 11a is configured to receive a part of the drug container M. In this example, the container frame includes a cavity for at least partially receiving the flexible bag. In this example, compared to the previous example, more outer surface area of the flexible bag is surrounded by the container frame.

[0167] Preferably, the cap includes a tube set 3 (to be described in detail later). In a preferred example, the drug container M includes a fixture M4 configured to engage with one or more corresponding fixtures 30a, 30b of the cap. For example, the fixture M4 is a flange and the corresponding fixtures 30a, 30b are protrusions. In an example as shown in FIGS. 34A - 34C, the cap includes a first set of corresponding fixtures 30a positioned closer to the piercing member 32 (to be described in detail later), and a second set of corresponding fixtures 30b. In this example, the drug container M is attached to the corresponding fixtures 30b of the second set as shown in FIG. 34B and is configured to be pushed before use to engage with the corresponding fixtures 30a of the first set as shown in FIG. 34C. As a result, a fluid connection between the delivery tube 31 and the drug container M is established. For example, the drug container M may be pre - attached to the corresponding fixtures 30b of the second set as shown in FIG. 34B, whereby the user can simply push the drug container before use to engage with the corresponding fixtures 30a of the first set.

[0168] In one example, as shown in FIGS. 34A - 34C, the cap 11b’’’’’’’’’’ and the container frame 11a’’’’’’’’’’’’ form a fluid - sealed chamber. Alternatively, the cap 11b’’’’’’’’’’, the container frame 11a’’’’’’’’, and the internal chamber 10e’’’’’ of the container carrier 10’’’’’ form a fluid - sealed chamber as shown in FIG. 33. Alternatively, as shown in FIG. 32, the container frame 11a’’’’ and the internal chamber 10e’’’’’ of the container carrier 10’’’’’ form a fluid - sealed chamber.

[0169] Pre - attachment can be done by the care provider or on the production line. The cap is configured to seal the container frame to form a fluid - tight chamber. In a preferred example, the cap is attached to the container frame via screw engagement, snap - fit engagement, or is clamped. In a preferred example, a rubber ring 4 is disposed between the cap 11b’’’’’’’’’’ and the container frame 11a’’’’’’’’’ to enhance the fluid seal depending on the level of fluid seal required for the design. The cap can be dome - shaped with a delivery tube extending through the center of the dome - shaped cap, or the cap can be any suitable shape depending on the design of the container frame and / or container carrier.

[0170] In another example, the container carriers 10; 10'; 10''; 10'''; 10a'', 10b'', 10c'', 10d' do not fully enclose the fluid-tight chambers 11; 11'; 11''; 11a''', 11b''', 11c'''; 11a'''', 11b'''', 11c'''', 11d'''; 11'''''、11''''''、11a'''''''、11b'''''''、11c'''''''、11d'''''''; 11a''''''''、11b''''''''、11c''''''''、11d''''''''. Instead, the fluid-tight chambers 11; 11'; 11''; 11a''', 11b''', 11c'''; 11a'''', 11b'''', 11c'''', 11d'''; 11'''''、11''''''、11a'''''''、11b'''''''、11c'''''''、11d'''''''; 11a''''''''、11b''''''''、11c''''''''、11d'''''''' are formed by a combination of the container carriers 10; 10'; 10'' 10''', 10a'', 10b'', 10c'', 10d' and a part of the drug delivery device 2 including the cassette. That is, the container carrier of the cassette partially constitutes the fluid-tight chambers 11; 11'; 11''; 11a''', 11b''', 11c'''; 11a'''', 11b'''', 11c'''', 11d'''; 11'''''、11''''''、11a'''''''、11b'''''''、11c'''''''、11d'''''''; 11a''''''''、11b''''''''、11c''''''''、11d'''''''' and the drug delivery device also partially comprises the fluid-tight chambers 11; 11'; 11''; 11a''', 11b''', 11c'''; 11a'''', 11b'''', 11c'''', 11d'''; 11'''''、11''''''、11a'''''''、11b'''''''、11c'''''''、11d'''''''; 11a''''''''、11b''''''''、11c''''''''、11d''''''''.In other words, the fluid-sealed chambers 11; 11'; 11''; 11a''', 11b''', 11c'''; 11a'''', 11b'''', 11c'''', 11d''''' ; 11''''' , 11''''' , 11a''''' , 11b''''' , 11c''''' , 11d''''' ; 11a''''' , 11b''''' , 11c''''' , 11d''''' are formed only when the cassette is attached to a part of the drug delivery device, as shown, for example, in FIG. 16. In this example, the container carriers 10; 10'; 10''; 10'''; 10a'', 10b'', 10c'', 10d' can be chambers or frames (to be described in detail later). In this example, the drug delivery device can be made compact and the material cost can be reduced. Further, the cassette includes the container carriers 10; 10'; 10''; 10'''; 10a'', 10b'', 10c'', 10d', and a plurality of connection ports such as connection ports to a plurality of delivery members and / or connection ports to the power source 21 can be provided by the container carriers. Thus, the end user can easily connect the power source and / or the delivery member to the drug container.

[0171] The fluid-sealed chambers 11; 11'; 11''; 11a''', 11b''', 11c'''; 11a'''', 11b'''', 11c'''', 11d''''' ; 11''''' , 11''''' , 11a''''' , 11b''''' , 11c''''' , 11d''''' ; 11a''''' , 11b''''' , 11c''''' , 11d''''' include inlets 110; 110'; 110''; 110'''; 110''''' ; 110a. The inlets 110; 110'; 110''; 110'''; 110''''' ; 110a are configured to be fluid-connected to the outlet 210 of the fluid pressure power source 21 of the reusable body of the drug delivery device 2. Note that when the fluid pressure power source is a pneumatic power source, the fluid-sealed chamber is airtight, and when the fluid pressure power source is a hydraulic power source, the fluid-sealed chamber is airtight or liquid-tight.

[0172] Fluid sealing chambers 11; 11’; 11’’; 11a’’’, 11b’’’, 11c’’’; 11a’’’’, 11b’’’’, 11c’’’’, 11d’’’’; 11’’’’’, 11’’’’’’, 11a’’’’’’’, 11b’’’’’’’, 11c’’’’’’’, 11d’’’’’’’; 11a’’’’’’’’, 11b’’’’’’’’, 11c’’’’’’’’, 11d’’’’’’’’ are connected to the flexible portions of the main bodies M0; M0’; M0’’; M0a, M0b; M0a, M0a’, M0a’’, M0b, M0b’; M0b’’ of the drug containers M, M’. Thus, when the inlets 110; 110’ receive the output fluid from the fluid pressure power source 21, the output fluid flows into the fluid sealing chambers 11 11’; 11’’; 11’’’, and the drugs contained in the drug containers M; Ma, Mb, Mc, Md; Ma’, Mb’, Mc’, Md’ are extruded under the pressure of the output fluid M1; M1’.

[0173] In one example, the body M0; M0'; M0a, M0b; M0a, M0a', M0a'', M0b, M0b'; M0b'' is at least partially received within the fluid-sealed chamber 1111'; 11''; 11a''', 11b''', 11c'''; 11a'''', 11b'''', 11c'''', 11d''''' 11''''' 11''''' 11a''''' 11b''''' 11c''''' 11d''''' 11a''''' 11b''''' 11c''''' 11d''''' In one example, as shown in FIGS. 8 and 32, the entire body M0 can be disposed within the fluid-sealed chamber 11''''' In one example, the fluid outlet M1 extends outside the fluid-sealed chamber 11''''' Alternatively, the fluid outlet M1''' is fluidly connected to the delivery tube 31'' as shown in FIG. 34C. In these two examples, the body M0 includes a flexible bag. In one example, as shown in FIG. 2A, when the body includes a delivery tube M0b' and the delivery tube M0b' is flexible, the fluid-sealed chamber 11' includes a tube inlet 111' and a tube outlet 112'. In this example, the delivery tube is configured to be positioned between the tube inlet 111' and the tube outlet 112'. In a preferred example, the delivery tube M0b includes two tube valves M2, M2'. In a preferred example, the fluid-sealed chamber 11' is configured to surround a portion of the delivery tube between the two tube valves M2, M2' as shown in FIGS. 3A-3B.

[0174] Alternatively, as shown in FIG. 4, the fluid-sealing chamber is expandable 11''. The fluid-sealing chamber 11'' is adjacent to the flexible portion of the body M0, and the output fluid from the fluid pressure power source flows into the fluid-sealing chamber 11'', and is configured to expand the fluid-sealing chamber 11'' to press the drug container M. In an example shown in FIG. 4, the body M0'' includes a flexible bag, and the fluid-sealing chamber 11'' is configured to expand when the output fluid from the fluid pressure power source flows into the fluid-sealing chamber 11'', thereby pressing the flexible bag, and thus, the drug contained in the flexible bag can be discharged. In this example, the flexible bag can be directly connected to the drug delivery member, or the flexible bag can include a flexible tube extending from the fluid-sealing chamber 11'' and / or the container carrier. Alternatively, when the body includes a flexible tube, the fluid-sealing chamber 11'' is configured to expand when the output fluid from the fluid pressure power source flows into the fluid-sealing chamber 11'', thereby pressing the flexible tube. In a preferred example, the fluid-sealing chamber is also a tube. In this example, the fluid-sealing chamber is attached to one or more flexible tubes of the body of the drug container. In this example, the multi-lumen drug delivery tube is formed by at least one fluid-sealing chamber tube and at least one flexible tube of the body of the drug container. In this example, one lumen of the multi-lumen drug delivery tube is connected to the fluid pressure power source, and the other one lumen of the multi-lumen is connected to the drug container.

[0175] In this example, the container carrier includes a rigid container chamber, and the flexible portion of the drug container and the fluid-sealing chamber are at least partially disposed within the rigid container chamber of the container carrier.

[0176] The inlets 110; 110’; 110’’; 110’’’; 110’’’’; 110a of the fluid sealing chamber are configured to be connected to the fluid pressure power source 21. For example, the outlet 210 of the fluid pressure power source 21 can be directly connected to the inlets 110; 110’ of the fluid sealing chamber, or the outlet of the fluid pressure power source 21 can be connected to the inlet of the fluid sealing chamber via a transfer tube 22. In one example, the inlet 110’’’ of the fluid sealing chamber comprises valves 114; 114’. Alternatively, if the outlet of the fluid pressure power source 21 comprises a valve, the inlet of the fluid sealing chamber may not comprise a valve. The valve can be a multi-directional valve 114’ (described in detail later). Alternatively, the valve 114 can be a one-way valve, such that the fluid output from the fluid pressure power source 21 can only flow towards the fluid sealing chamber. In one example, the fluid sealing chamber is made of at least partially rigid material. In one example where the fluid sealing chamber is made of at least partially rigid material, the fluid sealing chamber is made of a plastic material that is structurally reinforced to form the walls of the fluid sealing chamber, such as a honeycomb matrix. In other words, the walls of the fluid sealing chamber are not flat, but instead, a honeycomb matrix or a plurality of rib protrusions are provided. When the fluid sealing chamber is made of rigid plastic, the rigid plastic walls can be brittle. For example, rigid plastic can easily crack when a cassette or a drug delivery device containing the cassette drops and hits a hard surface, such as a flat hard floor. Structural reinforcement such as a honeycomb matrix can make the plastic walls more flexible and thus more robust. Alternatively, the fluid sealing chamber can be a secondary flexible bag 11’’’’ that completely encloses the drug container, as shown in FIG. 12. This can be achieved by a multi-layer bag assembly where one port is the fluid outlet of the fluid sealing chamber and the other port is the inlet of the fluid sealing chamber. Alternatively or additionally, the fluid sealing chamber can be cylindrical, and due to the self-reinforcing property of the cylinder under internal pressure, the cylindrical fluid sealing chamber can achieve a high degree of structural stability under pressure without excessive use of plastic.

[0177] In another example, as shown in FIG. 1, the fluid sealing chamber 11 includes a discharge valve 115 configured to discharge the fluid flowing into the fluid sealing chamber 11 from the fluid sealing chamber 11. The discharge valve is an optional safety design configured to immediately stop the drug delivery operation. For example, the discharge valve 115 can be connected to a user-accessible emergency button and can be either part of the cassette or part of the reusable body 20; 20'; 20''; 20''' of the drug delivery device. Thus, when the user needs to stop the drug delivery operation, for example, due to a harmful drug reaction, the user can open the discharge valve 115 by activating, for example, pressing / pulling the emergency button. Thus, the flow of fluid in the fluid sealing chamber can be immediately released, thereby stopping the drug delivery operation. In addition, the discharge valve 115 can also be designed to discharge the fluid flowing into the fluid sealing chamber from the fluid sealing chamber when the fluid pressure reaches a predetermined threshold value. Thus, the pressure in the fluid sealing chamber can be controlled to be below a safe pressure value, for example, a pressure value that does not damage the drug delivery device and / or the drug container.

[0178] Furthermore, the discharge valve can be configured to slow down the drug delivery rate. In this example, a partial cassette decompression mechanism can be provided. This effect is intentional and controlled and has the effect of reducing or (by closing the valve) increasing again the flow rate of the drug exiting the drug container. In a preferred example, the discharge valve is connected to a rotatable orifice.

[0179] Furthermore, in an example where the main bodies M0a, M0b include flexible tubes, the fluid-sealed chamber 11’ includes an outlet 113’ configured to be connected to a vacuum device. As shown in FIGS. 2B and 3B, when the pressure in the fluid-sealed chamber decreases, the drug contained in the drug container is sucked into the flexible tube. In this example, the administered dose delivered can be more accurate. In this example, as shown in FIGS. 2B and 3B, when the pressure of the fluid-sealed chamber 11’ decreases, a specific amount of the drug is configured to be sucked into the flexible tube. Then, this fixed amount of the drug is configured to be discharged out of the fluid outlet when the fluid flows into the fluid-sealed chamber 11’, as shown in FIGS. 2A and 3A. Preferably, in this example, the flexible tube includes two tube valves M2, M3 disposed between the tube inlet of the fluid-sealed chamber 11’ and the tube outlet of the fluid-sealed chamber 11’. Therefore, any potential leakage of the drug in the fluid-sealed chamber 11’, which may affect the accuracy of the dose, can be avoided. In an example, as shown in FIGS. 2A-3B, the fluid-sealed chamber 11’ includes an opening as the inlet 110 and another opening as the outlet 113’. Alternatively, the inlet of the fluid-sealed chamber is the outlet of the fluid-sealed chamber. In this example, the drug delivery device includes a “Y”-shaped tube having a main tube portion connected to the fluid-sealed chamber and two split tube portions. One of the split tube portions is connected to a vacuum device and the other is connected to a pneumatic fluid source. The two valves can be respectively disposed in the two split tube portions. Note that the vacuum device and the fluid pressure power source can be two separable devices, for example, two independent pumps, or one pump and one ventilator. Alternatively, the vacuum device may be part of the fluid pressure power source. For example, the fluid pressure power source may be a reversible pump.

[0180] In another example, the fluid seal chamber 11 includes a pressure sensor 116 as shown in FIG. 1. Alternatively, the fluid seal chamber 11'''''' is connected to a fluid seal measurement chamber 13 as shown in FIG. 8. In this example, the container carrier 10''' includes the fluid seal measurement chamber 13 and the fluid seal chamber 11. The fluid seal measurement chamber 13 is configured to be connected to a fluid pressure power source 21 and to have the same fluid pressure level as the fluid seal chamber 11''''''. The fluid seal measurement chamber includes a piston 130. The piston 130 is configured to be operably connected to a position sensor configured to sense the position of the piston 130 within the fluid seal measurement chamber 13. In this example, the position sensor can be either part of the cassette or part of the drug delivery device. In this example, the pressure within the fluid seal chamber can be measured based on the sensed position of the piston 130 in the fluid seal measurement chamber 13. Alternatively, the container carrier includes a position sensor configured to detect the position of the drug container. In this example, the pressure within the fluid seal chamber can be measured based on the sensed position of the drug container. For example, the position sensor is configured to continuously capture an image of the drug container. Thus, the pressure level within the fluid seal chamber can be calculated based on, for example, image recognition techniques using images of the drug container showing different levels of deformation. Further, the drug cassette optionally includes a flow sensor.

[0181] Cassette 1; 1’’; 1’’’ is configured to be attached to the reusable body 20; 20’; 20’’; 20’’’ of the drug delivery device 2. Preferably, cassette 1; 1’; 1’’ is configured to be releasably attached to the reusable body of the drug delivery device 2. In this example, the user can replace the cassette with a new one and return the used cassette after use. This example is suitable for users who need to obtain regular drug delivery. Alternatively, the cassette can be attached to the reusable body of the drug delivery device in such a way that it cannot be removed (by the user of the drug delivery device). In this example, the user can return the entire drug delivery device after use. This example is suitable for users who need to receive highly regulated drugs, such as toxic or poisonous drugs. In one example, the cassette can be locked to the reusable body via a magnetic lock that can only be released by a tool, such as a predetermined magnet array.

[0182] Cassette 1; 1’; 1’’ is attached to the drug delivery device 2, and the fluid outlets M1; M1’; Ma1, Mb1, Mc1 are configured to be connected to the drug delivery member 23 of the drug delivery device 2.

[0183] In one example, the cassette includes a cassette housing. In this example, the container carrier is disposed within the cassette housing. Alternatively, the container carrier is configured to be operably attached to the reusable body of the drug delivery device. In this example, the cassette does not require a cassette housing. These two examples are suitable for a container carrier having a flexible portion. For example, when the fluid-sealed chamber is made from a secondary flexible bag.

[0184] In another example, the cassette comprises two drug containers. In one example, the cassette comprises two container carriers 10a'', 10b'' as shown in FIGS. 5-6 and 31. The two container carriers 10a'', 10b'' each contain two drug containers. The two container carriers 10a'', 10b'' each comprise at least two fluid-sealed chambers 11a''', 11b''', 11c'''. FIGS. 5 and 31 show an example in which the drug containers comprise flexible bags Ma, Mb, Mc disposed within the fluid-sealed chambers 11a'''; 11b'''; 11c'''. In a preferred example, as shown in FIG. 31, the two container carriers are stacked on top of each other. In an example without a cassette housing, a plurality of cassettes are stacked on top of each other. Alternatively or additionally, the cassette comprises a cassette housing and the two container carriers are stacked on top of each other within the cassette housing. FIG. 6 is a diagram showing an example in which the main bodies M0a, M0b of the drug containers comprise a flexible tube M0b disposed within the fluid-sealed chambers 11a'''', 11b'''', 11c'''', or the container carriers 10a''; 10'''''' comprise at least two fluid-sealed chambers 11a''', 11b'''; 11a''''''''', 10e''''''. In this example, the at least two fluid-sealed chambers 11a''', 11b''' are configured to respectively receive two flexible portions of at least two main bodies of the two drug containers Ma, Mb. In one example, as shown in FIG. 32, the two fluid-sealed chambers 11a''''''''', 10e'''''' can be formed by a container frame 11a''''''''', and an internal chamber 10e'''''' of the container 10''''''.

[0185] In one example, each drug container is provided with a fluidically separate connection to the patient so that the different drugs do not mix during administration unless desired on the patient side. For example, each drug container is connected to its own drug delivery member 23a', 23b', 23c', 23d'.

[0186] In a preferred example, the cassette includes three or more drug containers as shown in FIGS. 5-6, FIGS. 13-14, FIG. 22, FIG. 24, and FIG. 32. In a preferred example, the plurality of drug containers are accommodated in a cassette having a combination of a plurality of container carriers and a plurality of fluid-sealed chambers. For example, the cassette includes three drug containers and two container carriers. In this example, one container carrier is configured to include two fluid-sealed chambers and accommodate two drug containers respectively; the other of the container carriers includes one fluid-sealed chamber configured to accommodate the third drug container.

[0187] In a preferred example, the one-way valve 101 is disposed between two fluid-sealed chambers 11a'' and 11b''. The two fluid-sealed chambers 11a'' and 11b'' may be part of one single container carrier, or may be included in two container carriers respectively as shown in FIGS. 5 and 14.

[0188] In another preferred example, only one of the two fluid-sealed chambers 11a'' and 11b'', i.e., the fluid-sealed chamber 11a'', is provided with an inlet 110 configured to be fluid-connected to the fluid pressure power source 21. In this example, the drugs in the two drug containers can be sequentially delivered to the patient. For example, the two drug containers are configured to contain two different drugs, and only the first predetermined drug is completely delivered to the patient, and the second predetermined drug can be delivered to the patient.

[0189] For example, the one-way valve 101 between two fluid-sealed chambers 11a’’ and 11b’’ is configured to open when a first fluid pressure threshold is reached. The valve 114 at the inlet 110’’’ of the fluid-sealed chamber configured to be fluid-connected to the fluid pressure power source 21 is configured to open when a second fluid pressure threshold is reached. The first fluid pressure threshold is equal to or higher than the second fluid pressure threshold. Alternatively, the first fluid pressure threshold may be lower than the second fluid pressure threshold, but may also be higher than the resistive pressure from the tissue where the drug delivery member is disposed. In this example, the drug delivery member is an injection needle or a soft cannula. The specific value of the resistive pressure depends on the target tissue, for example, muscle or subcutaneous tissue.

[0190] In an example where the fluid-sealed chamber includes a release valve 115, the predetermined threshold is greater than the second fluid pressure threshold. In another preferred example, the predetermined threshold is greater than the first fluid pressure threshold.

[0191] In an example where the fluid-sealed chamber includes an inlet 110’ and an outlet 113’, two one-way valves are disposed between the two fluid-sealed chambers and are configured to open in opposite directions. Alternatively, one multi-way valve can be disposed between the two fluid-sealed chambers. The multi-way valve can be configured to open in different directions based on different pressure thresholds. The above multi-way valve can be, for example, a 2 / 2-way valve, a 3 / 2-way valve, a 5 / 2-way valve, etc.

[0192] Some examples of different cassettes will be described in detail below.

[0193] In the first example, the cassette comprises a container carrier 10 having a single fluid-sealed chamber 11. More specifically, in this example, the container carrier 10 is the fluid-sealed chamber 11 as shown in FIG. 1. In this example, the fluid-sealed chamber 11 is made of a rigid material. In the first example, the body M0 of the drug container M is a flexible bag. The flexible bag is partially or fully accommodated within the fluid-sealed chamber 11, and when fluid flows into the fluid-sealed chamber 11, the fluid presses against the flexible bag, thereby causing at least a portion of the contained drug to be discharged from the fluid outlet M1 of the drug container M. In this example, the fluid outlet M1 of the drug container M is a part of the flexible bag, as shown in FIG. 8, and the fluid outlet M1 is configured to connect to the drug delivery member of the drug delivery devices 2, 2, 2'' when the cassette is attached to the drug delivery devices 2, 2, 2''. More specifically, the fluid outlet M1 of the drug container M is connected to an injection needle or a soft cannula configured to be placed under the patient's skin. Additionally, the fluid-sealed chamber 11 optionally comprises a release valve 115, as shown in FIG. 1. Further, in a preferred example, the inlet 110 of the fluid-sealed chamber 11 comprises a one-way valve 114, such as an umbrella valve, a disc spring valve, or a ball valve. Alternatively, the inlet 110 of the fluid-sealed chamber 11 comprises a multi-way valve. Alternatively, in another example, the fluid-sealed chamber 11 is made of a flexible material, such as a secondary flexible bag 11'''' as shown in FIG. 12.

[0194] In the second example, the cassette comprises a container carrier 10 having one fluid-sealed chamber. More specifically, in this example, the container carrier 10 is the fluid-sealed chamber. In this example, the fluid-sealed chamber is made of a rigid material. In the second example, the main bodies M0a, M0b of the drug container M are a combination of a flexible bag M0a and a flexible tube M0b extending from the flexible bag M0a to the delivery tube outlet, as shown in FIGS. 2A-2B. In this example, the delivery tube M0b is flexible. In this example, the fluid outlet M1' is the delivery tube outlet. The flexible bag M0a is partially or completely housed within the fluid-sealed chamber, and when fluid flows into the fluid-sealed chamber, the fluid presses against the flexible bag, thereby discharging at least a portion of the contained drug from the fluid outlet M1' of the drug container M. In this example, the fluid outlet M1' of the drug container M is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet M1' of the drug container M is connected to an injection needle or a soft cannula configured to be placed under the patient's skin. Additionally, the fluid-sealed chamber optionally comprises a release valve 115, as shown in FIG. 1. Additionally, the inlet of the fluid-sealed chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. Additionally, the delivery tube M0b optionally comprises a tube valve, the tube valve being a one-way valve, such as an umbrella valve, a disc spring valve, or a ball valve, and the tube valve is configured to prevent any fluid from flowing back through the delivery tube M0b into the flexible bag M0a of the main bodies M0a, M0b of the drug container M. Alternatively, the inlet of the fluid-sealed chamber comprises a multi-way valve. Alternatively, in another example, the fluid-sealed chamber is made of a flexible material, such as a secondary flexible bag M0a11'''', as shown in FIG. 12.

[0195] In the third example, the cassette comprises a container carrier having one fluid-sealed chamber. More specifically, in this example, the container carrier is the fluid-sealed chamber. In this example, the fluid-sealed chamber is made of a rigid material. In the third example, the body of the drug container is a combination of a glass cartridge and a delivery tube extending from the glass cartridge to the delivery tube outlet. In this example, the delivery tube is flexible. Alternatively, the cartridge can be made of a rigid plastic material. In this example, the fluid outlet is the delivery tube outlet. In the third example, the delivery tube is partially housed within the fluid-sealed chamber. In this example, the fluid-sealed chamber comprises a tube inlet and a tube outlet. The delivery tube is configured to be positioned between the tube inlet and the tube outlet. Thus, when fluid flows into the fluid-sealed chamber, the fluid presses against the delivery tube, thereby discharging at least a portion of the contained drug from the fluid outlet of the drug container. Note that the delivery tube can be fully housed within the fluid-sealed chamber. In the third example, the fluid outlet of the drug container is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of the drug container is connected to a hypodermic needle or a soft cannula configured to be placed under the patient's skin. Additionally, the fluid-sealed chamber optionally comprises a release valve 115. Additionally, the inlet of the fluid-sealed chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disk spring valve, or a ball valve. Additionally, the delivery tube optionally comprises a tube valve. The tube valve is a one-way valve, such as an umbrella valve, a disk spring valve, or a ball valve, and the tube valve is configured to prevent any fluid from flowing back through the delivery tube into the glass cartridge of the body of the drug container. Alternatively, the inlet of the fluid-sealed chamber comprises a multi-way valve. Alternatively, in another example, the fluid-sealed chamber is made of a flexible material, such as a secondary flexible bag 11''''.

[0196] In the fourth example, the cassette comprises a container carrier having one fluid-sealed chamber. More specifically, in this example, the container carrier is the fluid-sealed chamber. In this example, the fluid-sealed chamber is made of a rigid material. In this example, the body of the drug container is a combination of a glass cartridge and a delivery tube extending from the glass cartridge to the delivery tube outlet. In this example, the delivery tube is flexible. Alternatively, the cartridge can be made of a rigid plastic material. In this example, the fluid outlet is the delivery tube outlet. In this example, the delivery tube is partially housed within the fluid-sealed chamber. In this example, the fluid-sealed chamber comprises a tube inlet and a tube outlet. The delivery tube is configured to be positioned between the tube inlet and the tube outlet. In the fourth example, the delivery tube comprises two tube valves. The tube valves are one-way valves, such as umbrella valves, disc spring valves, or ball valves, and the tube valves are configured to prevent any fluid from flowing back through the delivery tube into the flexible bag of the body of the drug container. More specifically, one of the two tube valves is close to the tube inlet of the fluid-sealed chamber and the other of the two tube valves is close to the tube outlet of the fluid-sealed chamber. Thus, when fluid flows into the fluid-sealed chamber, the fluid presses against the delivery tube, thereby discharging at least a portion of the contained drug from the fluid outlet of the drug container. Note that the delivery tube can be fully housed within the fluid-sealed chamber. In this example, the fluid outlet of the drug container is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of the drug container is connected to a hypodermic needle or a soft cannula configured to be placed under the patient's skin. Additionally, the fluid-sealed chamber optionally comprises a release valve 115. Additionally, the inlet of the fluid-sealed chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. Alternatively, the inlet of the fluid-sealed chamber comprises a multi-way valve.Alternatively, in another example, the fluid seal chamber is made from a flexible material, such as a secondary flexible bag 11''''.

[0197] In the fifth example, the cassette comprises a container carrier having one fluid-sealed chamber. More specifically, in this example, the container carrier is the fluid-sealed chamber. In this example, the fluid-sealed chamber is made of a rigid material. In the fifth example, the fluid-sealed chamber 11’ comprises an inlet 110’ and an outlet 113’ as shown in FIGS. 2A-2B. The inlet 110’ of the fluid-sealed chamber 11’ is configured to be fluidly connected to a fluid pressure power source. The outlet 113’ of the fluid-sealed chamber 11’ is configured to be connected to a vacuum device. In this example, the body of the drug container is a combination of a glass cartridge and a delivery tube extending from the glass cartridge to the delivery tube outlet. In this example, the delivery tube is flexible. Alternatively, the cartridge can be made of a rigid plastic material. In this example, the fluid outlet is the delivery tube outlet. In this example, the delivery tube is partially housed within the fluid-sealed chamber. In this example, the fluid-sealed chamber 11’ comprises a tube inlet 111’ and a tube outlet 112’ as shown in FIGS. 2A-2B. The delivery tube is configured to be positioned between the tube inlet 111’ and the tube outlet 112’. In the fifth example, the inlet 110’ of the fluid-sealed chamber 11’ and the outlet 113’ of the fluid-sealed chamber 11’ are positioned between the tube inlet 111’ of the fluid-sealed chamber 11’ and the tube outlet 113’ of the fluid-sealed chamber 11’. Thus, when the pressure within the fluid-sealed chamber decreases, a certain amount of the drug within the glass cartridge is drawn into a portion of the delivery tube housed within the fluid-sealed chamber. Thereafter, when fluid from the fluid pressure power source flows into the fluid-sealed chamber, the fluid presses against the delivery tube, thereby discharging at least a portion of a certain amount of the drug within the delivery tube from the fluid outlet of the drug container. Note that the delivery tube can be fully housed within the fluid-sealed chamber. In this example, the fluid outlet of the drug container is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of the drug container is connected to a hypodermic needle or a soft cannula configured to be placed under the patient's skin.In addition, the fluid sealing chamber optionally comprises a release valve 115. Additionally, the inlet of the fluid sealing chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. Additionally, the delivery tube optionally comprises a tube valve. The tube valve is a one-way valve, such as an umbrella valve, a disc spring valve, or a ball valve, and the tube valve is configured to prevent any fluid from flowing back through the delivery tube into the glass cartridge of the body of the drug container. Alternatively, the inlet of the fluid sealing chamber comprises a multi-way valve. Alternatively, in another example, the fluid sealing chamber is made of a flexible material, such as a secondary flexible bag 11'''' as shown in FIG. 12.

[0198] In the sixth example, the cassette comprises a container carrier having one fluid-sealed chamber. More specifically, in this example, the container carrier is the fluid-sealed chamber. In this example, the fluid-sealed chamber is made of a rigid material. In the sixth example, the fluid-sealed chamber comprises an inlet and an outlet. In the sixth example, the inlet of the fluid-sealed chamber and the inlet of the fluid-sealed chamber are the same orifices 110'', 113'' of the fluid-sealed chamber, as shown in FIGS. 3A - 3B. In the sixth example, the orifices 110'', 113'' of the fluid-sealed chamber are connected to a device capable of providing both vacuum and output fluid. In this example, the body of the drug container is a combination of a glass cartridge and a delivery tube extending from the glass cartridge to the delivery tube outlet. In this example, the delivery tube is flexible. Alternatively, the cartridge can be made of a rigid plastic material. In this example, the fluid outlet is the delivery tube outlet. In the sixth example, the delivery tube is partially housed within the fluid-sealed chamber. In this example, the fluid-sealed chamber comprises a tube inlet and a tube outlet. The delivery tube is configured to be positioned between the tube inlet and the tube outlet. In this example, the orifices 110'', 113'' of the fluid-sealed chamber are positioned between the tube inlet of the fluid-sealed chamber and the tube outlet of the fluid-sealed chamber. Thus, when the pressure within the fluid-sealed chamber decreases, a certain amount of the drug within the glass cartridge is drawn into a portion of the delivery tube housed within the fluid-sealed chamber. Subsequently, when the output fluid flows into the fluid-sealed chamber, the fluid presses against the delivery tube, thereby discharging at least a portion of a certain amount of the drug within the delivery tube from the fluid outlet of the drug container. Note that the delivery tube can be fully housed within the fluid-sealed chamber. In the sixth example, the fluid outlet of the drug container is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of the drug container is connected to a hypodermic needle or a soft cannula configured to be placed under the patient's skin.In addition, as shown in FIG. 1, the fluid-sealed chamber optionally comprises a discharge valve 115. In addition, the inlet of the fluid-sealed chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. In addition, the delivery tube optionally comprises a tube valve. The tube valve is a one-way valve, such as an umbrella valve, a disc spring valve, or a ball valve, and the tube valve is configured to prevent any fluid from flowing back through the delivery tube into the glass cartridge of the body of the medicament container. Alternatively, the inlet of the fluid-sealed chamber comprises a multi-way valve. Alternatively, in another example, the fluid-sealed chamber is made of a flexible material, such as a secondary flexible bag 11'''' as shown in FIG. 12.

[0199] In the seventh example, the cassette comprises a container carrier having one fluid-sealed chamber. More specifically, in this example, the container carrier is the fluid-sealed chamber. In this example, the fluid-sealed chamber is made of a rigid material. In the seventh example, the fluid-sealed chamber comprises an inlet and an outlet. The inlet of the fluid-sealed chamber is configured to be fluidly connected to a fluid pressure power source. The outlet of the fluid-sealed chamber is configured to be connected to a vacuum device. In this example, the body of the drug container is a combination of a glass cartridge and a delivery tube extending from the glass cartridge to the delivery tube outlet. In this example, the delivery tube is flexible. Alternatively, the cartridge can be made of a rigid plastic material. In this example, the fluid outlet is the delivery tube outlet. In this example, the delivery tube is partially housed within the fluid-sealed chamber. In this example, the fluid-sealed chamber comprises a tube inlet and a tube outlet. The delivery tube is configured to be positioned between the tube inlet and the tube outlet. In the seventh example, the delivery tube comprises two tube valves. The tube valves are one-way valves, such as umbrella valves, disc spring valves, or ball valves, and the tube valves are configured to prevent any fluid from flowing back through the delivery tube into the flexible bag of the body of the drug container. More specifically, one of the two tube valves is close to the tube inlet of the fluid-sealed chamber, and the other of the two tube valves is close to the tube outlet of the fluid-sealed chamber. In the seventh example, the inlet of the fluid-sealed chamber and the outlet of the fluid-sealed chamber are positioned between the tube inlet of the fluid-sealed chamber and the tube outlet of the fluid-sealed chamber. Thus, when the pressure within the fluid-sealed chamber decreases, a certain amount of the drug within the glass cartridge is drawn into a portion of the delivery tube housed within the fluid-sealed chamber. Thereafter, when fluid from the fluid pressure power source flows into the fluid-sealed chamber, the fluid presses against the delivery tube, thereby discharging at least a portion of a certain amount of the drug within the delivery tube from the fluid outlet of the drug container. Note that the delivery tube can be completely housed within the fluid-sealed chamber.In this example, the fluid outlet of the drug container is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of the drug container is connected to an injection needle or a soft cannula configured to be placed under the patient's skin. Additionally, the fluid-sealed chamber optionally comprises a release valve 115 as shown in FIG. 1. Additionally, the inlet of the fluid-sealed chamber optionally comprises a one-way tube valve, for example, an umbrella valve, a disc spring valve, or a ball valve. Alternatively, the inlet of the fluid-sealed chamber comprises a multi-directional valve. Alternatively, in another example, the fluid-sealed chamber is made of a flexible material, for example, a secondary flexible bag 11'''' as shown in FIG. 12.

[0200] In the eighth example, the cassette comprises a container carrier having one fluid-sealed chamber. More specifically, in this example, the container carrier is the fluid-sealed chamber. In this example, the fluid-sealed chamber is made of a rigid material. In the eighth example, the fluid-sealed chamber comprises an inlet and an outlet. In this example, the inlet of the fluid-sealed chamber and the inlet of the fluid-sealed chamber are the same orifices 110'', 113'' of the fluid-sealed chamber as shown in FIGS. 3A - 3B. In this example, the orifices 110'', 113'' of the fluid-sealed chamber are connected to a device capable of providing both vacuum and output fluid. In this example, the body of the drug container is a combination of a glass cartridge and a delivery tube extending from the glass cartridge to the delivery tube outlet. In this example, the delivery tube is flexible. Alternatively, the cartridge can be made of a rigid plastic material. In this example, the fluid outlet is the delivery tube outlet. In this example, the delivery tube is partially housed within the fluid-sealed chamber. In this example, the fluid-sealed chamber comprises a tube inlet and a tube outlet. The delivery tube is configured to be positioned between the tube inlet and the tube outlet. In this example, the orifices 110'', 113'' of the fluid-sealed chamber are positioned between the tube inlet of the fluid-sealed chamber and the tube outlet of the fluid-sealed chamber. In the eighth example, the delivery tube comprises two tube valves. The tube valves are one-way valves, such as umbrella valves, disc spring valves, or ball valves, and the tube valves are configured to prevent any fluid from flowing back through the delivery tube into the flexible bag of the body of the drug container. More specifically, one of the two tube valves is close to the tube inlet of the fluid-sealed chamber, and the other of the two tube valves is close to the tube outlet of the fluid-sealed chamber. In this example, the inlet of the fluid-sealed chamber and the outlet of the fluid-sealed chamber are positioned between the tube inlet of the fluid-sealed chamber and the tube outlet of the fluid-sealed chamber. Thus, when the pressure within the fluid-sealed chamber decreases, a specific amount of the drug within the glass cartridge is drawn into a portion of the delivery tube housed within the fluid-sealed chamber.Thereafter, when the output fluid flows into the fluid-sealed chamber, the fluid presses against the delivery tube, thereby discharging at least a portion of a specific amount of the drug within the delivery tube from the fluid outlet of the drug container. Note that the delivery tube can be fully contained within the fluid-sealed chamber. In this example, the fluid outlet of the drug container is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of the drug container is connected to an injection needle or a soft cannula configured to be disposed under the patient's skin. Additionally, the fluid-sealed chamber optionally includes a release valve 115, as shown in FIG. 1. Additionally, the inlet of the fluid-sealed chamber optionally includes a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. Alternatively, the inlet of the fluid-sealed chamber includes a multi-way valve. Alternatively, in another example, the fluid-sealed chamber is made of a flexible material, such as a secondary flexible bag 11''''', as shown in FIG. 12.

[0201] In the ninth example, the cassette comprises a container carrier having one fluid-sealed chamber 11'. More specifically, in this example, the container carrier is the fluid-sealed chamber 11'. In this example, the fluid-sealed chamber 11' is made of a rigid material. In the ninth example, the main bodies M0a, M0b of the drug container are a combination of a flexible bag M0a and a delivery tube M0b extending from the flexible bag M0a to the delivery tube outlet, as shown in FIGS. 2A-2B. In this example, the delivery tube M0b is flexible. In this example, the fluid outlet M1' is the delivery tube outlet. In the ninth example, the delivery tube M0b is partially accommodated within the fluid-sealed chamber 11'. In this example, the fluid-sealed chamber 11' comprises a tube inlet and a tube outlet. The delivery tube is configured to be positioned between the tube inlet 111' and the tube outlet 112'. Thus, when fluid flows into the fluid-sealed chamber, the fluid presses against the delivery tube, thereby discharging at least a portion of the contained drug from the fluid outlet of the drug container. Note that the delivery tube may be fully accommodated within the fluid-sealed chamber. In the ninth example, the fluid outlet of the drug container is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of the drug container is connected to an injection needle or a soft cannula configured to be placed under the patient's skin. Additionally, the fluid-sealed chamber optionally comprises a release valve 115, as shown in FIG. 1. Additionally, the inlet of the fluid-sealed chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. Additionally, the delivery tube optionally comprises a tube valve. The tube valve is a one-way valve, such as an umbrella valve, a disc spring valve, or a ball valve, and is configured to prevent any fluid from flowing back through the delivery tube into the flexible bag of the main body of the drug container. Alternatively, the inlet of the fluid-sealed chamber comprises a multi-way valve. Alternatively, in another example, the fluid-sealed chamber is made of a flexible material, such as a secondary flexible bag 11'''', as shown in FIG. 12.

[0202] In the 10th example, the cassette comprises a container carrier having one fluid-sealed chamber 11'. More specifically, in this example, the container carrier is the fluid-sealed chamber 11'. In this example, the fluid-sealed chamber is made of a rigid material. In this example, the main bodies M0a, M0b of the drug container are a combination of a flexible bag M0a and a delivery tube M0b extending from the flexible bag M0a to the delivery tube outlet, as shown in FIGS. 2A-2B. In this example, the delivery tube is flexible. In this example, the fluid outlet M1' is the delivery tube outlet. In this example, the delivery tube is partially housed within the fluid-sealed chamber. In this example, the fluid-sealed chamber comprises a tube inlet 111' and a tube outlet 112'. The delivery tube is configured to be positioned between the tube inlet and the tube outlet. In the 10th example, the delivery tube comprises two tube valves M2, M2'. The tube valves M2, M2' are one-way valves, for example, umbrella valves, disc spring valves, or ball valves, and the tube valves M2, M2' are configured to prevent any fluid from flowing back through the delivery tube into the flexible bag of the main body of the drug container. More specifically, one of the two tube valves M2, M2' is close to the tube inlet 111' of the fluid-sealed chamber 11', and the other of the two tube valves M2, M2' is close to the tube outlet 112' of the fluid-sealed chamber 11'. Thus, when fluid flows into the fluid-sealed chamber, the fluid presses against the delivery tube, thereby discharging at least a portion of the contained drug from the fluid outlet of the drug container. Note that the delivery tube can be completely housed within the fluid-sealed chamber. In this example, the fluid outlet of the drug container is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of the drug container is connected to a hypodermic needle or a soft cannula configured to be placed under the patient's skin. Additionally, the fluid-sealed chamber optionally comprises a release valve 115, as shown in FIG. 1.In addition, the inlet of the fluid sealing chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. Alternatively, the inlet of the fluid sealing chamber comprises a multi-way valve. Alternatively, in another example, the fluid sealing chamber is made of a flexible material, such as a secondary flexible bag 11'''' as shown in FIG. 12.

[0203] In the 11th example, the cassette comprises a container carrier having one fluid-sealed chamber. More specifically, in this example, the container carrier is the fluid-sealed chamber. In this example, the fluid-sealed chamber is made of a rigid material. In the 11th example, as shown in FIGS. 2A to 2B, the fluid-sealed chamber comprises an inlet 111’ and an outlet 113’. The inlet 110’ of the fluid-sealed chamber 11’ is configured to be fluid-connected to a fluid pressure power source. The outlet 113’ of the fluid-sealed chamber 11’ is configured to be connected to a vacuum device. In this example, the main bodies M0a, M0b of the drug containers are a combination of a flexible bag M0a and a delivery tube M0b extending from the flexible bag to the delivery tube outlet. In this example, the delivery tube is flexible. In this example, the fluid outlet M1’ is the delivery tube outlet. In this example, the delivery tube is partially housed within the fluid-sealed chamber. In this example, the fluid-sealed chamber 11’ comprises a tube inlet 111’ and a tube outlet 112’. The delivery tube M0b is configured to be positioned between the tube inlet 111’ and the tube outlet 112’. In the 11th example, the inlet 110’ of the fluid-sealed chamber 11’ and the outlet 113’ of the fluid-sealed chamber 11’ are positioned between the tube inlet 111’ of the fluid-sealed chamber 11’ and the tube outlet 112’ of the fluid-sealed chamber 11’. Thus, when the pressure within the fluid-sealed chamber 11’ decreases, a certain amount of the drug within the flexible bag M0a is drawn into a portion of the delivery tube M0b housed within the fluid-sealed chamber 11’. Thereafter, when fluid from the fluid pressure power source flows into the fluid-sealed chamber 11’, the fluid presses against the delivery tube M0b, thereby discharging at least a portion of a certain amount of the drug within the delivery tube M0b from the fluid outlet of the drug container. Note that the delivery tube may be fully housed within the fluid-sealed chamber. In this example, the fluid outlet of the drug container is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of the drug container is connected to a hypodermic needle or a soft cannula configured to be placed under the patient's skin.In addition, as shown in FIG. 1, the fluid-sealed chamber optionally comprises a discharge valve 115. In addition, the inlet of the fluid-sealed chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. In addition, the delivery tube optionally comprises a tube valve. The tube valve is a one-way valve, such as an umbrella valve, a disc spring valve, or a ball valve, and the tube valve is configured to prevent any fluid from flowing back through the delivery tube into the flexible bag of the body of the drug container. Alternatively, the inlet of the fluid-sealed chamber comprises a multi-way valve. Alternatively, in another example, as shown in FIG. 12, the fluid-sealed chamber is made of a flexible material, such as a secondary flexible bag 11''''.

[0204] In the 12th example, the cassette comprises a container carrier having one fluid-sealed chamber 11'. More specifically, in this example, the container carrier is the fluid-sealed chamber 11'. In this example, the fluid-sealed chamber 11' is made of a rigid material. In the 12th example, as shown in FIGS. 3A - 3B, the fluid-sealed chamber 11' has an inlet and an outlet. In the 12th example, the inlet 110'' of the fluid-sealed chamber 11' and the outlet 113'' of the fluid-sealed chamber 11' are the same orifice of the fluid-sealed chamber 11'. In the 12th example, the orifices 110'', 113'' of the fluid-sealed chamber 11' are connected to a device that can provide both vacuum and output fluid. In this example, the body of the drug container is a combination of a flexible bag and a delivery tube extending from the flexible bag to the delivery tube outlet. In this example, the delivery tube is flexible. In this example, the fluid outlet is the delivery tube outlet. In the 12th example, the delivery tube is partially housed within the fluid-sealed chamber 11'. In this example, the fluid-sealed chamber 11' has a tube inlet and a tube outlet. The delivery tube is configured to be positioned between the tube inlet and the tube outlet. In this example, the orifices 110'', 113'' of the fluid-sealed chamber 11' are disposed between the tube inlet 110'' of the fluid-sealed chamber 11' and the tube outlet of the fluid-sealed chamber 11'. Thus, when the pressure within the fluid-sealed chamber 11' decreases, a certain amount of the drug within the flexible bag is drawn into a portion of the delivery tube housed within the fluid-sealed chamber 11'. Subsequently, when the output fluid flows into the fluid-sealed chamber 11', the fluid presses against the delivery tube, thereby discharging at least a portion of a certain amount of the drug within the delivery tube from the fluid outlet of the drug container. Note that the delivery tube can be completely housed within the fluid-sealed chamber 11'. In the 12th example, the fluid outlet of the drug container is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of the drug container is connected to an injection needle or a soft cannula configured to be disposed under the patient's skin.In addition, as shown in FIG. 1, the fluid-sealed chamber 11 optionally includes a discharge valve 115. In addition, the inlet 110'' of the fluid-sealed chamber 11' optionally includes a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. In addition, the delivery tube optionally includes a tube valve. The tube valve is a one-way valve, such as an umbrella valve, a disc spring valve, or a ball valve, and is configured to prevent any fluid from flowing back through the delivery tube into the flexible bag of the body of the drug container. Alternatively, the inlet 110'' of the fluid-sealed chamber 11' includes a multi-way valve. Alternatively, in another example, as shown in FIG. 12, the fluid-sealed chamber 11 is made of a flexible material, such as a secondary flexible bag 11''''.

[0205] In Example 13, the cassette comprises a container carrier having one fluid-sealed chamber. More specifically, in this example, the container carrier is the fluid-sealed chamber. In this example, the fluid-sealed chamber is made of a rigid material. In Example 13, the fluid-sealed chamber comprises an inlet and an outlet. The inlet of the fluid-sealed chamber is configured to be fluidly connected to a fluid pressure power source. The outlet of the fluid-sealed chamber is configured to be connected to a vacuum device. In this example, the body of the drug container is a combination of a flexible bag and a delivery tube extending from the flexible bag to the delivery tube outlet. In this example, the delivery tube is flexible. In this example, the fluid outlet is the delivery tube outlet. In this example, the delivery tube is partially housed within the fluid-sealed chamber. In this example, the fluid-sealed chamber comprises a tube inlet and a tube outlet. The delivery tube is configured to be positioned between the tube inlet and the tube outlet. In Example 13, the delivery tube comprises two tube valves. The tube valves are one-way valves, such as umbrella valves, disc spring valves, or ball valves, and are configured to prevent any fluid from flowing back through the delivery tube into the flexible bag of the body of the drug container. More specifically, one of the two tube valves is close to the tube inlet of the fluid-sealed chamber, and the other of the two tube valves is close to the tube outlet of the fluid-sealed chamber. In Example 13, the inlet of the fluid-sealed chamber and the outlet of the fluid-sealed chamber are positioned between the tube inlet of the fluid-sealed chamber and the tube outlet of the fluid-sealed chamber. Thus, when the pressure within the fluid-sealed chamber decreases, a certain amount of the drug within the flexible bag is drawn into a portion of the delivery tube housed within the fluid-sealed chamber. Thereafter, when fluid from the fluid pressure power source flows into the fluid-sealed chamber, the fluid presses against the delivery tube, thereby discharging at least a portion of a certain amount of the drug within the delivery tube from the fluid outlet of the drug container. Note that the delivery tube can be completely housed within the fluid-sealed chamber.In this example, the fluid outlet of the drug container is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of the drug container is connected to a hypodermic needle or a soft cannula configured to be placed under the patient's skin. Additionally, the fluid seal chamber optionally comprises a release valve 115. Additionally, the inlet of the fluid seal chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. Alternatively, the inlet of the fluid seal chamber comprises a multi-directional valve. Alternatively, in another example, the fluid seal chamber is made of a flexible material, such as a secondary flexible bag 11''''.

[0206] In the 14th example, the cassette comprises a container carrier having one fluid-sealed chamber. More specifically, in this example, the container carrier is the fluid-sealed chamber. In this example, the fluid-sealed chamber is made of a rigid material. In the 14th example, the fluid-sealed chamber comprises an inlet and an outlet. In this example, the inlet of the fluid-sealed chamber and the outlet of the fluid-sealed chamber are the same orifices 110'', 113'' of the fluid-sealed chamber as shown in FIGS. 3A - 3B. In this example, the orifices 110'', 113'' of the fluid-sealed chamber are connected to a device that can provide both vacuum and output fluid. In this example, the body of the drug container is a combination of a flexible bag and a delivery tube extending from the flexible bag to the delivery tube outlet. In this example, the delivery tube is flexible. In this example, the fluid outlet is the delivery tube outlet. In this example, the delivery tube is partially housed within the fluid-sealed chamber. In this example, the fluid-sealed chamber comprises a tube inlet and a tube outlet. The delivery tube is configured to be positioned between the tube inlet and the tube outlet. In this example, the orifices 110'', 113'' of the fluid-sealed chamber are positioned between the tube inlet of the fluid-sealed chamber and the tube outlet of the fluid-sealed chamber. In the 14th example, the delivery tube comprises two tube valves. The tube valves are one-way valves, such as umbrella valves, disc spring valves, or ball valves, and the tube valves are configured to prevent any fluid from flowing back through the delivery tube into the flexible bag of the body of the drug container. More specifically, one of the two tube valves is close to the tube inlet of the fluid-sealed chamber, and the other of the two tube valves is close to the tube outlet of the fluid-sealed chamber. In this example, the inlet of the fluid-sealed chamber and the outlet of the fluid-sealed chamber are positioned between the tube inlet of the fluid-sealed chamber and the tube outlet of the fluid-sealed chamber. Thus, when the pressure within the fluid-sealed chamber decreases, a certain amount of drug within the flexible bag is drawn into a portion of the delivery tube housed within the fluid-sealed chamber.Thereafter, when the output fluid flows into the fluid-sealed chamber, the fluid presses against the delivery tube, thereby discharging at least a portion of a certain amount of the agent within the delivery tube from the fluid outlet of the agent container. Note that the delivery tube can be completely housed within the fluid-sealed chamber. In this example, the fluid outlet of the agent container is configured to connect to the agent delivery member of the agent delivery device when the cassette is attached to the agent delivery device. More specifically, the fluid outlet of the agent container is connected to a hypodermic needle or a soft cannula configured to be placed under the patient's skin. Additionally, the fluid-sealed chamber optionally comprises a release valve 115. Additionally, the inlet of the fluid-sealed chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. Alternatively, the inlet of the fluid-sealed chamber comprises a multi-way valve. Alternatively, in another example, the fluid-sealed chamber is made of a flexible material, such as a secondary flexible bag 11''''.

[0207] In the 15th example, the cassette comprises a container carrier having a plurality of fluid-sealed chambers. In this example, each fluid-sealed chamber is made of a rigid material. In the 15th example, the container carrier is configured to accommodate a plurality of drug containers, respectively, within the plurality of fluid-sealed chambers. In this example, each of the plurality of drug containers is identical. Alternatively, each of the plurality of drug containers has the same shape as each other but different sizes from each other. Alternatively, at least two of the plurality of drug containers are geometrically different from each other. In the 15th example, each body of each of the plurality of drug containers is a flexible bag. Each flexible bag is partially or completely accommodated within one of the plurality of fluid-sealed chambers, and when fluid flows into the fluid-sealed chamber, the fluid presses against the flexible bag, thereby discharging at least a portion of the contained drug from the fluid outlet of the drug container. In this example, the fluid outlet of at least one of the plurality of drug containers is part of the flexible bag, and at least one fluid outlet of the plurality of drug containers is configured to connect to a drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of at least one of the plurality of drug containers is connected to a hypodermic needle or a soft cannula configured to be placed under the patient's skin. Alternatively, the fluid outlet of each of the plurality of drug containers is part of each flexible bag, and the fluid outlet of each of the plurality of drug containers is configured to connect to one independent drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of each of the plurality of drug containers is connected to one hypodermic needle and / or one soft cannula configured to be placed under the patient's skin. In addition, at least one of the plurality of fluid-sealed chambers, in this example, comprises a release valve. Further, in a preferred example, at least one inlet of the plurality of fluid-sealed chambers comprises a one-way valve, such as an umbrella valve, a disc spring valve, or a ball valve. Alternatively, at least one inlet of the plurality of fluid-sealed chambers comprises a multi-way valve.Alternatively, in another example, at least one of the plurality of fluid-sealed chambers is made of a flexible material, such as a secondary flexible bag 11''''. Additionally, at least one of the plurality of fluid-sealed chambers optionally comprises a discharge valve 115.

[0208] In the 16th example, the cassette comprises a container carrier having a plurality of fluid-sealed chambers. In this example, each fluid-sealed chamber is made of a rigid material. In the 16th example, the container carrier is configured to accommodate a plurality of drug containers, respectively, within the plurality of fluid-sealed chambers. In this example, each of the plurality of drug containers is identical. Alternatively, each of the plurality of drug containers has the same shape as each other, but different sizes from each other. Alternatively, at least two of the plurality of drug containers are geometrically different from each other. In the 16th example, each main body of each of the plurality of drug containers is a flexible bag. Each flexible bag is partially or completely accommodated within one of the plurality of fluid-sealed chambers. In this example, only one of the plurality of fluid-sealed chambers is provided with an inlet configured to be fluidly connected to a fluid pressure power source. In this example, a one-way valve is disposed between each two of the plurality of fluid-sealed chambers. Thus, the fluid first flows into the fluid-sealed chamber having the inlet, and then sequentially flows into each of the remaining plurality of fluid-sealed chambers through each one-way valve between each two of the plurality of fluid-sealed chambers. Thus, the fluid sequentially presses each of the flexible bags within the different plurality of fluid-sealed chambers, thereby sequentially discharging at least a portion of the contained drug from the fluid outlet of each drug container. In this example, the fluid outlet of at least one of the plurality of drug containers is part of the flexible bag, and the fluid outlet of at least one of the plurality of drug containers is configured to be connected to a drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of at least one of the plurality of drug containers is connected to an injection needle or a soft cannula configured to be disposed under the skin of the patient. Alternatively, the fluid outlet of each of the plurality of drug containers is part of each flexible bag, and the fluid outlet of each of the plurality of drug containers is configured to be connected to one independent drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of each of the plurality of drug containers is connected to one injection needle and / or one soft cannula configured to be disposed under the skin of the patient.In addition, at least one of the plurality of fluid-sealed chambers, in this example, comprises a discharge valve. Further, in a preferred example, the only inlet of the plurality of fluid-sealed chambers comprises a one-way valve, such as an umbrella valve, a disc spring valve, or a ball valve. Alternatively, only one inlet of the plurality of fluid-sealed chambers comprises a multi-way valve. Alternatively, in another example, at least one of the plurality of fluid-sealed chambers is made of a flexible material, such as a secondary flexible bag 11''''. In addition, at least one of the plurality of fluid-sealed chambers optionally comprises a discharge valve 115.

[0209] In the 17th example, the cassette comprises a container carrier having a plurality of fluid-sealed chambers. In this example, each fluid-sealed chamber is made of a rigid material. In the 17th example, the container carrier is configured to accommodate a plurality of drug containers respectively within the plurality of fluid-sealed chambers. In this example, each of the plurality of drug containers is identical. Alternatively, each of the plurality of drug containers has the same shape as each other but different sizes from each other. Alternatively, at least two of the plurality of drug containers are geometrically different from each other. In the 17th example, each body of each of the plurality of drug containers is a combination of a flexible bag and a flexible tube extending from the flexible bag to the delivery tube outlet. In this example, the delivery tube is flexible. In this example, the fluid outlet is the delivery tube outlet. Each flexible tube is partially or completely accommodated within one of the plurality of fluid-sealed chambers, and when fluid flows into the fluid-sealed chamber, the fluid presses against the flexible tube, thereby discharging at least a portion of the contained drug from the fluid outlet of the drug container. In this example, the fluid outlet of at least one of the plurality of drug containers is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of at least one of the plurality of drug containers is connected to a hypodermic needle or a soft cannula configured to be placed under the patient's skin. Alternatively, the fluid outlet of each of the plurality of drug containers is part of each flexible bag, and the fluid outlet of each of the plurality of drug containers is configured to connect to one independent drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of each of the plurality of drug containers is connected to one hypodermic needle and / or one soft cannula configured to be placed under the patient's skin. In addition, at least one of the plurality of fluid-sealed chambers comprises a release valve in this example. Further, in a preferred example, the inlet of at least one of the plurality of fluid-sealed chambers comprises a one-way valve, such as an umbrella valve, a disc spring valve, or a ball valve.In addition, the delivery tube optionally comprises a tube valve, the tube valve being a one-way valve, such as an umbrella valve, a disc spring valve, or a ball valve, the tube valve being configured to prevent any fluid from flowing back through the delivery tube into the flexible bag of the body of the drug container. Alternatively, at least one inlet of the plurality of fluid-sealed chambers comprises a multi-way valve. Alternatively, in another example, at least one of the plurality of fluid-sealed chambers is made of a flexible material, such as a secondary flexible bag 11''''. In addition, at least one of the plurality of fluid-sealed chambers optionally comprises a discharge valve 115.

[0210] In the 18th example, the cassette comprises a container carrier having a plurality of fluid-sealed chambers. In this example, each fluid-sealed chamber is made of a rigid material. In the 18th example, the container carrier is configured to accommodate a plurality of drug containers, respectively, within the plurality of fluid-sealed chambers. In this example, each of the plurality of drug containers is identical. Alternatively, each of the plurality of drug containers has the same shape as each other but different sizes from each other. Alternatively, at least two of the plurality of drug containers are geometrically different from each other. In the 18th example, each body of each of the plurality of drug containers is a combination of a cartridge and a flexible tube extending from the cartridge to the delivery tube outlet. The cartridge is made of glass or plastic. In this example, the delivery tube is flexible. In this example, the fluid outlet is the delivery tube outlet. Each flexible tube is partially or completely accommodated within one of the plurality of fluid-sealed chambers, and when fluid flows into the fluid-sealed chamber, the fluid presses against the flexible tube, thereby discharging at least a portion of the contained drug from the fluid outlet of the drug container. In this example, the fluid outlet of at least one of the plurality of drug containers is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of at least one of the plurality of drug containers is connected to a hypodermic needle or a soft cannula configured to be placed under the patient's skin. Alternatively, the fluid outlet of each of the plurality of drug containers is part of each flexible bag, and the fluid outlet of each of the plurality of drug containers is configured to connect to one independent drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of each of the plurality of drug containers is connected to one hypodermic needle and / or one soft cannula configured to be placed under the patient's skin. In addition, at least one of the plurality of fluid-sealed chambers comprises a release valve in this example. Further, in a preferred example, the inlet of at least one of the plurality of fluid-sealed chambers comprises a one-way valve, such as an umbrella valve, a disc spring valve, or a ball valve.In addition, the delivery tube optionally comprises a tube valve, which is a one-way valve, such as an umbrella valve, a disc spring valve, or a ball valve, and the tube valve is configured to prevent any fluid from flowing back through the delivery tube into the cartridge of the body of the drug container. Alternatively, at least one inlet of the plurality of fluid-sealed chambers comprises a multi-way valve. Alternatively, in another example, at least one of the plurality of fluid-sealed chambers is made of a flexible material, such as a secondary flexible bag 11''''. In addition, at least one of the plurality of fluid-sealed chambers optionally comprises a discharge valve 115.

[0211] In a 19th example, the cassette comprises a container carrier having one fluid-sealed chamber. More specifically, in this example, the fluid-sealed chamber is expandable. In this example, the container carrier is made of a rigid material. In this example, the body of the drug container is a flexible bag. In this example, both the flexible bag and the fluid-sealed chamber are housed within the container carrier. The flexible bag is adjacent to the fluid-sealed chamber, and when fluid flows into the fluid-sealed chamber, the fluid-sealed chamber expands, thereby pressing against the flexible bag and causing at least a portion of the contained drug to be discharged from the fluid outlet of the drug container. In this example, the fluid outlet of the drug container is part of the flexible bag and is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of the drug container is connected to a hypodermic needle or a soft cannula configured to be placed under the patient's skin. In addition, the fluid-sealed chamber optionally comprises a discharge valve 115. Further, in a preferred example, the inlet of the fluid-sealed chamber comprises a one-way valve, such as an umbrella valve, a disc spring valve, or a ball valve. Alternatively, the inlet of the fluid-sealed chamber comprises a multi-way valve.

[0212] In the 20th example, the cassette comprises a container carrier 10' having one fluid-sealed chamber 11''. More specifically, in this example, the fluid-sealed chamber 11'' is expandable. In this example, the container carrier 10' is made of a rigid material. In this example, the body of the drug container is a combination of a flexible bag and a delivery tube extending from the flexible bag to the delivery tube outlet. In this example, both the flexible bag and the fluid-sealed chamber 11'' are housed within the container carrier 10'. The flexible bag is adjacent to the fluid-sealed chamber 11'', and when fluid flows into the fluid-sealed chamber 11'', the fluid-sealed chamber 11'' expands, thereby pressing against the flexible bag and causing at least a portion of the contained drug to be discharged from the fluid outlet of the drug container, as shown in FIG. 4. In this example, the fluid outlet of the drug container is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of the drug container is connected to an injection needle or a soft cannula configured to be placed under the patient's skin. Additionally, the fluid-sealed chamber 11'' optionally comprises a release valve 115. Additionally, the inlet of the fluid-sealed chamber 11'' optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. Additionally, the delivery tube optionally comprises a tube valve, which is a one-way valve, such as an umbrella valve, a disc spring valve, or a ball valve, and the tube valve is configured to prevent any fluid from flowing back through the delivery tube into the flexible bag of the body of the drug container. Alternatively, the inlet of the fluid-sealed chamber 11'' comprises a multi-way valve.

[0213] In the 21st example, the cassette comprises a container carrier having one fluid-sealed chamber. More specifically, in this example, the fluid-sealed chamber is expandable. In this example, the container carrier is made of a rigid material. In the 21st example, the body of the drug container is a combination of a glass cartridge and a delivery tube extending from the glass cartridge to the delivery tube outlet. In this example, the delivery tube is flexible. Alternatively, the cartridge can be made of a rigid plastic material. In this example, the fluid outlet is the delivery tube outlet. In this example, both the flexible tube and the fluid-sealed chamber are at least partially housed within the container carrier. The flexible tube is adjacent to the fluid-sealed chamber, and when fluid flows into the fluid-sealed chamber, the fluid-sealed chamber expands, thus pressing the flexible tube and thereby discharging at least a portion of the contained drug from the fluid outlet of the drug container. In the 21st example, the fluid outlet of the drug container is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of the drug container is connected to an injection needle or a soft cannula configured to be placed under the patient's skin. Additionally, the fluid-sealed chamber optionally comprises a release valve 115. Additionally, the inlet of the fluid-sealed chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. Additionally, the delivery tube optionally comprises a tube valve. The tube valve is a one-way valve, such as an umbrella valve, a disc spring valve, or a ball valve, and the tube valve is configured to prevent any fluid from flowing back through the delivery tube into the glass cartridge of the body of the drug container. Alternatively, the inlet of the fluid-sealed chamber comprises a multi-way valve.

[0214] In the 22nd example, the cassette comprises a container carrier having one fluid-sealed chamber. More specifically, in this example, the fluid-sealed chamber is expandable. In this example, the container carrier is made of a rigid material. In the 22nd example, the body of the drug container is a combination of a flexible bag and a delivery tube extending from the flexible bag to the delivery tube outlet. In this example, the delivery tube is flexible. In this example, the fluid outlet is the delivery tube outlet. In this example, both the flexible tube and the fluid-sealed chamber are at least partially housed within the container carrier. The flexible tube is adjacent to the fluid-sealed chamber, and when fluid flows into the fluid-sealed chamber, the fluid-sealed chamber expands, thereby pressing against the flexible tube and causing at least a portion of the contained drug to be discharged from the fluid outlet of the drug container. In the 22nd example, the fluid outlet of the drug container is configured to connect to the drug delivery member of the drug delivery device when the cassette is attached to the drug delivery device. More specifically, the fluid outlet of the drug container is connected to a hypodermic needle or a soft cannula configured to be placed under the patient's skin. Additionally, the fluid-sealed chamber optionally comprises a release valve 115. Additionally, the inlet of the fluid-sealed chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. Additionally, the delivery tube optionally comprises a tube valve. The tube valve is a one-way valve, such as an umbrella valve, a disc spring valve, or a ball valve, and is configured to prevent any fluid from flowing back through the delivery tube into the flexible bag of the body of the drug container. Alternatively, the inlet of the fluid-sealed chamber comprises a multi-way valve.

[0215] In the 23rd example, the cassette comprises a container carrier 10'''' having one fluid-sealed chamber. In this example, the fluid-sealed chamber 11 is made of a rigid material. In this example, the fluid-sealed chamber 11 is configured to be disposed within the container carrier 10. In this example, the container carrier 10'''' comprises a connection port 17 configured to be releasably attached to either an outlet of a fluid pressure power source of a reusable body of a drug delivery device or another connection port of another container carrier 10''''. In this example, each container carrier 10'''' is configured to be stacked on top of one another as shown in FIG. 31. In a preferred example, the body of the drug container is a flexible bag. In a preferred example, the fluid outlet of the drug container M is configured to be fluidly connected to the tubing set 3. Preferably, the drug container is configured to be attached to the tubing set 3. The tubing set 3 comprises a delivery tube 31. Preferably, the fluid outlet of the drug container is configured to be connected to a drug delivery member via the delivery tube. In this example, the fluid outlet of the drug container is configured to be attached to one end of the delivery tube, and the drug delivery member is configured to be attached to the other end of the delivery tube. Preferably, the tubing set comprises a piercing member 32 configured to establish fluid communication between the delivery tube 31 and the drug container M by piercing through the fluid outlet of the drug container M as shown in FIG. 34C. In this example, the drug container can be completely sealed before use. Additionally, the fluid-sealed chamber optionally comprises a release valve 115. Additionally, the inlet of the fluid-sealed chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. Alternatively, the inlet of the fluid-sealed chamber comprises a multi-way valve.

[0216] In the 24th embodiment, the cassette comprises a container carrier 10'''' having at least two fluid-sealed chambers. In this example, the fluid-sealed chambers 11a''''''''''', 10e'''''' of the container carrier are formed by the container frame 11a'''''''''' and the internal chamber 10e'''''' of the container carrier 10''''. In this example, the container frame 11a'''''''''' can be made of a rigid material or a flexible material. Preferably, the interface formed between the container frame 11a'''''''''' and the internal chamber 10e'''''' of the container carrier 10'''' is airtight. In a preferred example, the body of the drug container is a flexible bag. In a preferred example, the fluid outlet of the drug container M is configured to be fluidly connected to the tube set 3. Preferably, the drug container is configured to be attached to the tube set 3. The tube set 3 comprises a delivery tube 31. Preferably, the fluid outlet of the drug container is configured to be connected to a drug delivery member via the delivery tube. In this example, the fluid outlet of the drug container is configured to be attached to one end of the delivery tube, and the drug delivery member is configured to be attached to the other end of the delivery tube. Preferably, the tube set comprises a piercing member 32 configured to establish fluid communication between the delivery tube 31 and the drug container M through the fluid outlet of the drug container M, as shown in FIG. 34C. Additionally, the fluid-sealed chamber optionally comprises a release valve 115. Additionally, the inlet of the fluid-sealed chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. Alternatively, the inlet of the fluid-sealed chamber comprises a multi-way valve. Preferably, as shown in FIG. 32, container frames 11a'''''''''' of the same size can be provided for different amounts of drug respectively.

[0217] In the 25th example, the cassette comprises a container carrier 10’’’’’ having one fluid-sealed chamber. In this example, the fluid-sealed chambers 11a’’’’’’’’’’, 11b’’’’’’’’’’ of the container carrier are formed by a container frame 11a’’’’’’’’’’ and a cap 11b’’’’’’’’’’ configured to be attached to the container frame 11a’’’’’’’’’’. In this example, the container frame 11a’’’’’’’’’ can be made of a rigid material or a flexible material. In a preferred example, the body of the drug container is a flexible bag. In a preferred example, the fluid outlet of the drug container M is configured to be fluidly connected to the tube set 3. Preferably, the drug container is configured to be attached to the tube set 3. The tube set 3 comprises a delivery tube 31. Preferably, the tube set 3 is part of the cap 11b’’’’’’’’’’. Preferably, the fluid outlet of the drug container is configured to be connected to a drug delivery member via the delivery tube. In this example, the fluid outlet of the drug container is configured to be attached to one end of the delivery tube, and the drug delivery member is configured to be attached to the other end of the delivery tube. Preferably, the tube set 3 comprises a piercing member 32 configured to establish fluid communication between the delivery tube 31 and the drug container M through the fluid outlet of the drug container M as shown in FIG. 34C. Preferably, the piercing member 32 is configured to pierce the fluid outlet M1’’’ of the drug container M when the cap 11b’’’’’’’’’ is attached to the container frame 11a’’’’’’’’’. In addition, the fluid-sealed chamber optionally comprises a release valve 115. In addition, the inlet of the fluid-sealed chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. Alternatively, the inlet of the fluid-sealed chamber comprises a multi-way valve. In this example, the container carrier partially receives the drug container and the fluid-sealed chamber as shown in FIG. 33. In a preferred example, different sizes of container carriers can be provided for different amounts of drug as shown in FIG. 33.

[0218] In the 26th example, the cassette comprises a container carrier 10’’’’’ having one fluid-sealed chamber. In this example, the fluid-sealed chambers 11a’’’’’’’’’’ and 11b’’’’’’’’’’ of the container carrier are formed by a container frame 11a’’’’’’’’’ and a cap 11b’’’’’’’’’’ configured to be attached to the container frame 11a’’’’’’’’’. In this example, the container frame 11a’’’’’’’’’ can be made of a rigid material or a flexible material. In a preferred example, the body of the drug container is a flexible bag. In a preferred example, the fluid outlet of the drug container M is configured to be fluidly connected to the tube set 3. Preferably, the drug container is configured to be attached to the tube set 3. The tube set 3 comprises a delivery tube 31. Preferably, the tube set 3 is part of the cap 11b’’’’’’’’’ . Preferably, the fluid outlet of the drug container is configured to be connected to a drug delivery member via the delivery tube. In this example, the fluid outlet of the drug container is configured to be attached to one end of the delivery tube, and the drug delivery member is configured to be attached to the other end of the delivery tube. Preferably, the tube set 3 comprises a piercing member 32 configured to establish fluid communication between the delivery tube 31 and the drug container M through the fluid outlet of the drug container M as shown in FIG. 34C. Preferably, the piercing member 32 is configured to pierce the fluid outlet M1’’ of the drug container M when the cap 11b’’’’’’’’’ is attached to the container frame 11a’’’’’’’’’ and the piercing trigger is actuated. In one example, the piercing trigger can be a push button connected to the piercing member 32, and the piercing member 32 can be configured to pierce the fluid outlet M1’’’ of the drug container M when the push button is pushed towards the drug container M. Alternatively, the piercing member is connected to a biasing member and biased towards the drug container M; a latch is configured to hold the piercing member against the biasing member. In this example, the latch is moved away from the piercing member when the piercing trigger is actuated, for example, by a mechanical or electrical method. For example, the latch can be a solenoid latch.In addition, the fluid-sealed chamber optionally comprises a discharge valve 115. In addition, the inlet of the fluid-sealed chamber optionally comprises a one-way tube valve, for example, an umbrella valve, a disc spring valve, or a ball valve. Alternatively, the inlet of the fluid-sealed chamber comprises a multi-directional valve. In this example, the container carrier partially receives the drug container and the fluid-sealed chamber as shown in FIG. 33. In a preferred example, as shown in FIG. 33, container carriers of different sizes can be provided respectively for different amounts of drug.

[0219] In the 27th example, the cassette comprises a container carrier having a plurality of fluid-sealed chambers. In this example, each fluid-sealed chamber is made of a rigid material. In the 27th example, the container carrier is configured to accommodate a plurality of drug containers, respectively, within the plurality of fluid-sealed chambers. In this example, each of the plurality of drug containers is identical. Alternatively, each of the plurality of drug containers has the same shape as each other but different sizes from each other. Alternatively, at least two of the plurality of drug containers are geometrically different from each other. In the 27th example, each body of each of the plurality of drug containers is a flexible bag. Each flexible bag is partially or completely accommodated within one of the plurality of fluid-sealed chambers, and when fluid flows into the fluid-sealed chamber, the fluid presses against the flexible bag, thereby discharging at least a portion of the contained drug from the fluid outlet of the drug container. In this example, the container carrier comprises a connection port configured to be releasably attached to either the outlet of the fluid pressure power source of the reusable body of the drug delivery device or another connection port of another container carrier. In this example, each container carrier is configured to be stacked on top of each other as shown in FIG. 31. In a preferred example, the body of the drug container is a flexible bag. In a preferred example, the fluid outlet of the drug container M is configured to be fluidly connected to the tube set 3. Preferably, the drug container is configured to be attached to the tube set 3. The tube set 3 comprises a delivery tube 31. Preferably, the fluid outlet of the drug container is configured to be connected to the drug delivery member via the delivery tube. In this example, the fluid outlet of the drug container is configured to be attached to one end of the delivery tube, and the drug delivery member is configured to be attached to the other end of the delivery tube. Preferably, the tube set comprises a piercing member 32 configured to establish fluid communication between the delivery tube 31 and the drug container M through the fluid outlet of the drug container M as shown in FIG. 34C. In this example, the drug container can be completely sealed before use. Additionally, the fluid-sealed chamber optionally comprises a release valve 115.In addition, the inlet of the fluid sealing chamber optionally comprises a one-way tube valve, for example, an umbrella valve, a disc spring valve, or a ball valve. Alternatively, the inlet of the fluid sealing chamber comprises a multi-way valve.

[0220] In the 28th example, the cassette comprises a container carrier having a plurality of fluid-sealed chambers. In this example, each fluid-sealed chamber is made of a rigid material. In the 28th example, the container carrier is configured to accommodate a plurality of drug containers in the plurality of fluid-sealed chambers respectively. In this example, each of the plurality of drug containers is identical. Alternatively, each of the plurality of drug containers has the same shape as each other but different sizes from each other. Alternatively, at least two of the plurality of drug containers are geometrically different from each other. In the 28th example, each body of each of the plurality of drug containers is a flexible bag. Each flexible bag is partially or completely accommodated in one of the plurality of fluid-sealed chambers. When fluid flows into the fluid-sealed chamber, the fluid presses the flexible bag, thereby discharging at least a part of the contained drug from the fluid outlet of the drug container. In this example, the fluid-sealed chamber of the container carrier is formed by the container frame and the internal chamber of the container carrier. In this example, the container frame can be made of a rigid material or a flexible material. Preferably, the interface formed between the container frame 11a’’’’’’’’’ and the internal chamber of the container carrier is airtight. In a preferred example, the body of the drug container is a flexible bag. In a preferred example, the fluid outlet of the drug container M is configured to be fluidly connected to the tube set 3. Preferably, the drug container is configured to be attached to the tube set 3. The tube set 3 comprises a delivery tube 31. Preferably, the fluid outlet of the drug container is configured to be connected to a drug delivery member via the delivery tube. In this example, the fluid outlet of the drug container is configured to be attached to one end of the delivery tube, and the drug delivery member is configured to be attached to the other end of the delivery tube. Preferably, the tube set comprises a perforating member 32 configured to establish fluid communication between the delivery tube 31 and the drug container M through the fluid outlet of the drug container M as shown in FIG. 34C. In addition, each fluid-sealed chamber optionally comprises a release valve 115. In addition, the inlet of the fluid-sealed chamber optionally comprises a one-way tube valve, for example, an umbrella valve, a disc spring valve, or a ball valve.Alternatively, the inlet of the fluid sealing chamber is provided with a multi-directional valve. Preferably, as shown in FIG. 32, container frames of the same size can be provided for different amounts of the drug, respectively.

[0221] In the 29th example, the cassette comprises a container carrier having a plurality of fluid-sealed chambers. In this example, each fluid-sealed chamber is made of a rigid material. In the 15th example, the container carrier is configured to accommodate a plurality of drug containers, respectively, within the plurality of fluid-sealed chambers. In this example, each of the plurality of drug containers is identical. Alternatively, each of the plurality of drug containers has the same shape as each other but different sizes from each other. Alternatively, at least two of the plurality of drug containers are geometrically different from each other. In the 15th example, each body of each of the plurality of drug containers is a flexible bag. Each flexible bag is partially or completely accommodated within one of the plurality of fluid-sealed chambers, and when fluid flows into the fluid-sealed chamber, the fluid presses against the flexible bag, thereby discharging at least a portion of the contained drug from the fluid outlet of the drug container. In this example, each fluid-sealed chamber of the container carrier is formed by a container frame and a cap configured to be attached to the container frame. In this example, the container frame can be made of a rigid material or a flexible material. In a preferred example, the body of the drug container is a flexible bag. In a preferred example, the fluid outlet of the drug container M is configured to be fluidly connected to the tube set 3. Preferably, the drug container is configured to be attached to the tube set 3. The tube set 3 comprises a delivery tube 31. Preferably, the tube set 3 is part of the cap. Preferably, the fluid outlet of the drug container is configured to be connected to a drug delivery member via the delivery tube. In this example, the fluid outlet of the drug container is configured to be attached to one end of the delivery tube, and the drug delivery member is configured to be attached to the other end of the delivery tube. Preferably, the tube set 3 comprises a perforating member 32 configured to establish fluid communication between the delivery tube 31 and the drug container M through the fluid outlet of the drug container M as shown in FIG. 34C. Preferably, the perforating member 32 is configured to perforate the fluid outlet M1''' of the drug container M when the cap is attached to the container frame. In addition, each fluid-sealed chamber optionally comprises a release valve 115.In addition, the inlet of the fluid sealing chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. Alternatively, the inlet of the fluid sealing chamber comprises a multi-way valve. In this example, the container carrier partially receives the drug container and the fluid sealing chamber, as shown in FIG. 33. In a preferred example, as shown in FIG. 33, container carriers of different sizes can be provided respectively for different amounts of drugs.

[0222] In the 30th example, the cassette comprises a container carrier having a plurality of fluid-sealed chambers. In this example, each fluid-sealed chamber is made of a rigid material. In the 15th example, the container carrier is configured to accommodate a plurality of drug containers respectively within the plurality of fluid-sealed chambers. In this example, each of the plurality of drug containers is identical. Alternatively, each of the plurality of drug containers has the same shape as each other but different sizes from each other. Alternatively, at least two of the plurality of drug containers are geometrically different from each other. In the 15th example, each main body of each of the plurality of drug containers is a flexible bag. Each flexible bag is partially or completely accommodated within one of the plurality of fluid-sealed chambers, and when fluid flows into the fluid-sealed chamber, the fluid presses the flexible bag, thereby discharging at least a portion of the contained drug from the fluid outlet of the drug container. In this example, each fluid-sealed chamber of the container carrier is formed by a container frame and a cap configured to be attached to the container frame. In this example, the container frame can be made of a rigid material or a flexible material. In a preferred example, the main body of the drug container is a flexible bag. In a preferred example, the fluid outlet of the drug container M is configured to be fluidly connected to the tube set 3. Preferably, the drug container is configured to be attached to the tube set 3. The tube set 3 comprises a delivery tube 31. Preferably, the tube set 3 is part of the cap. Preferably, the fluid outlet of the drug container is configured to be connected to a drug delivery member via the delivery tube. In this example, the fluid outlet of the drug container is configured to be attached to one end of the delivery tube, and the drug delivery member is configured to be attached to the other end of the delivery tube. Preferably, the tube set 3 comprises a piercing member 32 configured to establish fluid communication between the delivery tube 31 and the drug container M through the fluid outlet of the drug container M as shown in FIG. 34C. Preferably, the piercing member 32 is configured to pierce the fluid outlet M1''' of the drug container M when the cap is attached to the container frame and the piercing trigger is actuated.In one example, the piercing trigger can be a push button connected to the piercing member 32, and the piercing member 32 can be configured to pierce the fluid outlet M1'' of the drug container M when the push button is pushed towards the drug container M. Alternatively, the piercing member is connected to a biasing member and biased towards the drug container M; in this example where the latch is configured to hold the piercing member against the biasing member, the latch is moved away from the piercing member when the piercing trigger is actuated, for example, by mechanical or electrical means. For example, the latch can be a solenoid latch. Additionally, each fluid sealing chamber optionally includes a discharge valve 115. Additionally, the inlet of the fluid sealing chamber optionally includes a one-way tube valve, for example, an umbrella valve, a disc spring valve, or a ball valve. Alternatively, the inlet of the fluid sealing chamber includes a multi-way valve. In this example, the container carrier partially receives the drug container and the fluid sealing chamber, as shown in FIG. 33. In a preferred example, as shown in FIG. 33, different sized container carriers can be provided for different amounts of drug, respectively.

[0223] In the 31st example, the cassette comprises a cassette housing configured to be releasably attached to a reusable body of the drug delivery device. The cassette comprises a plurality of container carriers each having one or more fluid-sealed chambers. In this example, each fluid-sealed chamber is made of a rigid material. In the 31st example, the container carriers are configured to receive a plurality of drug containers, respectively, within the plurality of fluid-sealed chambers. In this example, each of the plurality of drug containers is identical. Alternatively, each of the plurality of drug containers has the same shape as each other but different sizes from each other. Alternatively, at least two of the plurality of drug containers are geometrically different from each other. In the 27th example, each body of each of the plurality of drug containers is a flexible bag. Each flexible bag is partially or fully received within one of the fluid-sealed chambers, and when fluid flows into the fluid-sealed chamber, the fluid presses against the flexible bag, thereby discharging at least a portion of the contained drug from the fluid outlet of the drug container. In this example, the container carrier comprises a connection port configured to be releasably attached to either the outlet of the fluid pressure power source of the reusable body of the drug delivery device or another connection port of another container carrier. In this example, each container carrier is configured to be stacked on top of each other within the cassette housing as shown in FIG. 31. In a preferred example, the body of the drug container is a flexible bag. In a preferred example, the fluid outlet of the drug container M is configured to be fluidly connected to the tubing set 3. Preferably, the drug container is configured to be attached to the tubing set 3. The tubing set 3 comprises a delivery tube 31. Preferably, the fluid outlet of the drug container is configured to be connected to the drug delivery member via the delivery tube. In this example, the fluid outlet of the drug container is configured to be attached to one end of the delivery tube, and the drug delivery member is configured to be attached to the other end of the delivery tube. Preferably, the tubing set comprises a piercing member 32 configured to establish fluid communication between the delivery tube 31 and the drug container M through the fluid outlet of the drug container M as shown in FIG. 34C. In this example, the drug container can be completely sealed before use.In addition, the fluid-sealed chamber optionally comprises a discharge valve 115. Additionally, the inlet of the fluid-sealed chamber optionally comprises a one-way tube valve, such as an umbrella valve, a disc spring valve, or a ball valve. Alternatively, the inlet of the fluid-sealed chamber comprises a multi-way valve.

[0224] It should be noted that the container carrier can be reusable or disposable as in the above examples. In one example where the container carrier is reusable, the container carrier comprises a body and a cover for sealing the body. The cover can be completely removed from the body. Alternatively, instead of a cover, the body comprises a hinged door that movably seals the body. In this example, the user can return the used cassette to a recycling point or pharmacy. The used drug container can be removed from the container carrier. The container carrier is now ready to be used for another new drug container. In one example where the container carrier is disposable, the container carrier is configured to seal the drug container once the drug container is assembled to the container carrier.

[0225] As noted above, if the cassette is configured to be connected to a vacuum device, the vacuum device can discharge the fluid in the fluid-sealed chamber as a discharge valve, so it should be noted that the cassette does not need to have a discharge valve 115.

[0226] Another aspect of the present invention provides a drug delivery device 2; 2; 2'' comprising a cassette as described above. The drug delivery device comprises a reusable body 20; 20'; 20''; 20''' and a replaceable drug delivery member 23; 23'a, 23bd, 23c', 23d'. The reusable body 20; 20'; 20''; 20''' of the drug delivery device 2; 2; 2'' comprises a fluid pressure power source 21 connected to an inlet 110; 110'; 110''; 110''; 110'''; 110a of a fluid seal chamber 11; 11'; 11''; 11a''', 11b''', 11c'''; 11a'''', 11b'''', 11c'''', 11d'''''11'''''',''11'''''''', 11a''''''', 11b''''''', 11c''''''', 11d''''''', 11a''''''''', 11b''''''''', 11c''''''''', 11d'''''''''. In a preferred example, the fluid pressure power source is a pneumatic power source, and as a result, the pneumatic power source can output a gas, such as air or nitrogen, into the fluid seal chamber. Alternatively, the fluid pressure power source is a hydraulic power source, and the hydraulic power source can output a liquid, such as water or oil, into the fluid seal chamber.

[0227] In one example, as shown in FIG. 27, the fluid pressure power source 21″; 21″′ includes a fluid pump 21a″ having an inlet fluidly connected to the environment, and an inlet filter 21b″ connected to the inlet of the fluid pump 21a″ that can prevent contaminants from the environment, such as dust, from entering the fluid pump 21a″. Thus, the ingress protection of the fluid pressure power source can be at the IP56 level. In a preferred example, the fluid pressure power source 21″; 21″′ includes a pump outlet check valve 21g″, a downstream controllable discharge valve 21d″ (venting to the atmosphere) following it, a flow rate sensor 21f″, a pressure sensor 21e″, and an outlet filter 21c″ configured to be connected to a fluid sealing chamber. The fluid pressure power source 21″; 21″′ is optionally connected to a compensation block 21h″ and a controller 21i″. The controller 21i″ can be a processor within a reusable body of a drug delivery device connected to the fluid pressure power source. Alternatively, the controller 21i″ may be incorporated into the fluid pressure power source. Details of the compensation block 21h″ will be described later. The flow rate sensor and the pressure sensor are optional with respect to the fluid pressure power source 21″; 21″. For example, the examples shown in FIGS. 29 - 30 do not have a flow rate sensor. Note that the flow rate sensor within the fluid pressure power source is configured to measure the fluid flow rate of the fluid pressure power source.

[0228] In another example, as shown in FIG. 28, the fluid pressure power source 21″′ further includes one or more multi - way valves 21j″′, such as 2 / 2 - way valves, 3 / 2 - way valves, 5 / 2 - way valves. The outlet port of each multi - way valve defines the outlet 210 of the fluid pressure power source 21″′. In this example, the fluid pressure power source 21″′ can be connected to a plurality of cassettes and / or a plurality of fluid sealing chambers within one cassette.

[0229] Alternatively or additionally, the drug delivery device 2’’ comprises a multi-directional valve 29 connected to a fluid pressure power source 21’’. In this example, as shown in FIGS. 29-30, the outlet 210 of the fluid pressure power source 21’’ is configured to connect to a port of the multi-directional valve 29, and the other port 29a of the multi-directional valve 28 is configured to be attached to a fluid sealed chamber. In this example, the inlet of the fluid sealed chamber is fluidly connected to the outlet 210 of the fluid pressure power source via the multi-directional valve 29. As a result, one fluid pressure power source 21’’ can be connected to a plurality of fluid sealed chambers, and thus can be connected to a plurality of drug containers.

[0230] Further, the fluid pump 21a’’ can be a piezoelectric pump, a motor-based fluid pump, a piston pump, or a diaphragm pump.

[0231] The drug delivery device comprises replaceable drug delivery members 2323’a, 23bd, 23c’, 23d’ configured to connect to the fluid outlets M1; M1’; Ma1, Mb1, Mc1 of the drug containers M; Ma, Mb, Mc, Md; Ma’, Mb’, Mc’, Md’. In a preferred example, the drug delivery device 2 is configured to deliver a plurality of drugs and / or a large amount of drugs to a patient.

[0232] In one example, the drug delivery device includes a tubing set 3. As described above, the tubing set 3 comprises a delivery tube 31. The fluid outlet M1’’’ of the drug container M is configured to be attached to one end of the delivery tube 31, and the drug delivery member 23 is configured to be attached to the other end of the delivery tube 31. In this example, both the drug delivery member 23 and the tubing set 3 are replaceable. In a preferred example, the tubing set 3 comprises a piercing member 32 configured to establish a fluid connection between the delivery tube 3 and the drug container M as described above.

[0233] The drug delivery device 2;2;2’’ is configured to deliver a plurality of drugs and / or a large amount of drugs to a patient, and the drug delivery time is long, for example, it can be 2 or 3 hours. Therefore, in a preferred example, the drug delivery device is portable. Thus, the user can easily carry the drug delivery device 2 for movement and travel, and the patient can also easily carry the drug delivery device 2 during the drug delivery operation. In a preferred example, the drug delivery device comprises a user-wearable functional part 25;25’;25’’ connected to a reusable body. Skin contact with the adhesive material can easily cause skin reactivity such as infection, heat, allergy, and / or rash. Therefore, the user-wearable functional part is preferably configured not to adhere to and attach to the patient's skin, for example, not to be attached to the user via an adhesive material. In a preferred example, as shown in FIGS. 9-10, FIGS. 17-19, and FIGS. 20-21, the user-wearable functional part is a belt, shoulder strap, neck strap, vest, harness, belt clip, parts thereof, or combinations thereof.

[0234] Therefore, the user can easily carry the drug delivery device 2;2;2’’. Further, the patient can easily carry the drug delivery device 2;2;2’’ during the drug delivery operation. Thus, the patient's mobility is hardly restricted during the drug delivery operation. In a preferred example, the user-wearable functional part is provided with one or more of a sustained antibacterial agent, an antifungal agent, or an antiviral agent. In a preferred example, the user-wearable functional part comprises a coating containing fibers (e.g., silver fibers) woven into a fabric material and is provided through a secondary coating, spraying, or dipping operation, or by selecting an outer fabric layer characterized by sustained antibacterial, antifungal, or antiviral properties.

[0235] In a preferred example, the drug delivery device is an injection device, for example, an infusion device or an on-body syringe. In this example, the drug delivery member is an injection needle or an insertion needle having a flexible cannula.

[0236] The fluid pressure power source 21 is configured to generate / discharge a pressurized fluid, for example, a liquid or a gas, and deliver the pressurized fluid into the fluid-sealed chamber. In a preferred example, the fluid pressure power source 21 is configured to generate / discharge a pressurized gas. In one example, the fluid pressure power source can be a pressurized gas canister. In a preferred example, the fluid pressure power source includes a piezoelectric pump. Alternatively, the fluid pressure power source comprises a motor-based fluid pump, for example, a diaphragm pump or a piston pump, as described above.

[0237] In one example, the fluid sealing chamber is adjacent to the fluid pressure power source. Therefore, the fluid pressure power source is fluidly connected directly to the inlet of the fluid sealing chamber. Alternatively, as shown in FIG. 7, a transfer tube 22 is disposed between the fluid pressure power source 21 and the inlet of the fluid sealing chamber 11. In this example, the fluid pressure power source is fluidly connected to the inlet of the fluid sealing chamber via the transfer tube 22. In one example, the drug delivery device is configured to be attached to at least two drug containers Ma, Mb, Mc, Md, as shown in FIG. 11. In this example, the fluid pressure power source 21 is connected to one fluid sealing chamber via the transfer tube 22a', and indirectly connected to other fluid sealing chambers via other transfer tubes 22b', 22c', 22d'. The transfer tubes 22a', 22b', 22c', 22d' are configured to direct the output fluid from the fluid pressure power source towards the respective fluid sealing chambers. In one example where the fluid pressure power source of the drug delivery device is connected to more than two cassettes, the connection disclosed in the embodiment shown in FIG. 11 is also applicable. In the example shown in FIG. 11, the plurality of cassettes are configured to be connected to the fluid pressure power source 21 via the plurality of transfer tubes 22a', 22b', 22c', 22d'. In this example, the reusable body 20' is configured to house the fluid pressure power source 21 and, optionally, one or more electronic components, such as a piezoelectric pump, processor(s), wireless communication unit(s), touch screen(s), display(s), microphone(s), LED light(s), speaker(s), vibration motor(s), accelerometer(s), gyro sensor(s), memory, temperature sensor(s), temperature regulation unit(s), battery, etc. In a preferred example, the reusable body 20 is compact and easy to carry.

[0238] In one example, each delivery tube extends between two opposing ends. Each delivery tube includes two screw connection heads respectively attached to the two opposing ends of the delivery tube. In this example, the fluid pressure power source 21' of the drug delivery device includes a corresponding screw head, and the user can screw one delivery tube 22a' to the fluid pressure power source 21' of the cassette and the drug delivery device, whereby the fluid pressure power source 21' of the drug delivery device is fluidly connected to the delivery tube. The user can screw the remaining portion of the delivery tube between the two cassettes. In this example, since all the delivery tubes can be identical in this embodiment, the manufacturing cost can be reduced and it is also easy for the user to use. In one example where the cassette includes a cassette housing, two corresponding screw heads are disposed on the wall of the cassette housing. Alternatively, two corresponding screw heads are disposed on the wall of the fluid sealing chamber. Instead of a screw connection, a luer connection or a bayonet connection can be used between the delivery tube, the cassette, and the fluid pressure power source. Thus, the cassette can be releasably attached to the drug delivery device.

[0239] Alternatively, as shown in FIGS. 21-23, the reusable body 20'''' includes a base 20''''. The base 20'''' is configured to house a fluid pressure power source 21. In the preferred example shown in FIGS. 21-23, the user-wearable functional part 25' of the reusable body 20'''' includes a neck strap. In this example, the base 20'''' includes a front portion configured to be disposed adjacent to the patient's chest and a rear portion configured to be disposed adjacent to the patient's back. In this example, the cassette includes a plurality of fluid-sealed chambers 11a''''''''''', 11b'''''''', 11c'''''''', 11d'''''''', as shown in FIGS. 13, 14, and 22. As described above, each fluid-sealed chamber includes one of a plurality of drug containers Ma, Mb, Mc, Md, as shown in FIGS. 21 and 23. In this example, the cassette is configured to be removably attached to the base 20'''' by, for example, snap fitting or a groove-ridge connection. In a preferred example, at least two of the plurality of drug containers include fluid outlets Ma1, Mb1, Mc1 that are fluidly separated from the fluid outlet of any other one of the plurality of drug containers. Thus, at least two drug containers are provided with fluidly separated connections to the patient so that the different drugs do not mix during administration unless desired on the patient side. Note that the connection between the fluid-sealed chambers as shown in FIG. 22 can also be used as a connection for connecting a plurality of different cassettes or a plurality of different container carriers. Also, as shown in FIG. 21, the transfer tube 22 extends from the rear portion of the base 20'''' to the front portion of the base 20'''' so as to be able to transfer the output fluid from the fluid pressure power source 21 to the fluid-sealed chamber of the cassette.

[0240] The over-the-shoulder design, i.e., the design as shown in FIGS. 10 and 20-23, disperses the weight of the device across the patient's back, chest, and shoulders as seen in FIG. 10. When worn above or below the clothing, it provides a short path to the abdominal area. As shown in FIG. 20, the fluid pressure power source 21 is disposed at the rear of the base and is a reusable component. The fluid pressure power source 21 accommodates both a pneumatic drive system and a mechanical drive system for flexibility. In one preferred embodiment, the fluid pressure power source 21 also has a battery that can be recharged between uses of the device. In an alternative embodiment, the fluid pressure power source 21 does not have a battery, and the battery is provided as a removable component (i.e., the module described later) on the front or back. The shoulder straps are designed to be comfortable even when the reusable body contains the maximum drug volume. They are used to conceal one or more tubes and / or wires that make electrical, optical, pneumatic, or other connections from the front to the back. As seen in FIG. 21, the cassette(s) is a disposable component located at the front of the base and can be arranged according to the desired dosing sequence or regimen. The cassette may be pre-filled by a pharmacy, a pharmaceutical manufacturer, or both. The cassettes may be attached in sequence, or alternatively, if low weight is desired, the cassettes may be connected one at a time by the patient, although this is not expected to be a preferred commercial embodiment.

[0241] As seen in FIG. 22, the large volume concept and the small volume concept can also be stacked in various configurations for more complex regimens and automated delivery. The cassette includes a flexible bag (although in a preferred embodiment, a syringe, cartridge, or other container is also possible) and an outer rigid cassette sized to fit the volume they contain. When multiple cassettes are used, they may be provided with their own individual feedback indicators, e.g., of the light / LED type, during the process or at the end of administration, or the feedback may be provided into the upper unit (or both the upper unit and the cassette) using a wired connection.

[0242] The cassette is filled by a pharmacist or selected from pre-filled options, then assembled securely in turn (slide, click, etc.), capped, and the preparation step is completed. Other cassettes may be inserted in between. This forms a single unit that is transported to the patient using common cold chain transportation such as that used for self-injectors. The patient receives the assembled cartridges and attaches them to the umbilical of the drive unit as shown in Figure 21. Although Figure 21 shows two lines, the desired number of lines may be connected, or each attachment point may make more than two connections as in the case of multiple lumens or multiple conductor sets. One line can optionally be dedicated to emergency drug delivery if required by the patient's regimen. The luer fittings of Figure 22, and the removable connection assemblies of the luer tubes and release mechanisms of Figure 21, may ideally be replaced by any suitable connector designed for secure attachment, easy intentional removal, and difficult unintentional removal, and for general design principles to accommodate a wide variety of user populations. Figure 21 also shows an optional power button and status lights on each lit module. As shown in Figure 23, the end cap that completes the sequence also incorporates a Tyvek-type clip 25’’ for securing the reusable body for active users. This clip 25’’ may be placed on the center seam of the shirt, or if there is no seam, a magnetic closure may be provided on the other side of the shirt. Figure 21 or other similar features may optionally be included to prevent unwanted drooping of the reusable body during infusion, especially when the user wearing the device leans forward. Here, in Figure 23, a side view of the module can also be seen, showing the interlock mechanism. Figure 23 also shows the optional release of tube strain, and other tube management functions may be available based on tube length and diameter, number of tubes, and intended injection site(s).

[0243] Alternatively, FIGS. 21-23 can also schematically show that the drug delivery device comprises a reusable body having a plurality of sections for receiving a plurality of cassettes. In this example, each of the plurality of fluid-sealed chambers 11a''''''''', 11b'''''','' 11c'''''','' 11d'''''','' in FIG. 22 is received within a different section of the reusable body, respectively.

[0244] Further, alternatively, instead of the cascade connection between the reusable body 20'''' of the drug delivery device 2' and one or more cassettes as shown in FIGS. 21-23, the reusable body 20; 20'; 20'' of the drug delivery device 2' is configured to accommodate one or more cassettes as shown in FIGS. 9-10 and FIGS. 17-19. In this example, the reusable body comprises an inner section for accommodating one or more cassettes. The cassette can be attached to the inner section of the reusable body via a magnetic connection, a releasable snap-fit connection, a threaded connection, and / or a bayonet connection. Thus, the cassette can be releasably attached to the drug delivery device.

[0245] In one example, the fluid pressure power source 21 is attached to the inner section of the reusable body 20'', as shown in FIGS. 15 and 17. In another example, as shown in FIGS. 16 and 18, the fluid pressure power source 21 is attached to a cassette, and the cassette is attached to the inner section of the reusable body 20''. In one example, the reusable body 20'' comprises two covers connected to each other via hinges, as shown in FIGS. 15 and 17. Alternatively, the reusable body 20''' has a wall around the inner section, in other words, the inner section of the reusable body 20''' is a space having a boundary provided by the wall, as shown in FIGS. 16 and 18. In this example, the wall around the opening is configured such that the cassette is arranged within the inner section through the opening. For example, the user inserts the cassette into the inner section of the reusable body 20''' through the opening. In this example, the cassette can be attached to the inner section of the reusable body 20'' via the connection of a groove and a ridge.

[0246] In the examples shown in FIGS. 16 and 18, instead of being attached to the cassette, the fluid pressure power source can be detachably attached independently to the inner section of the reusable body. For example, after inserting the fluid pressure power source into the inner section of the reusable body, the cassette can be inserted into the inner section. In this example, the fluid pressure power source can be reusable or disposable. Further, in an example where the drug container is a combination of a flexible bag M0a and a delivery tube M0b extending from the flexible bag, as shown in FIG. 16, the flexible bag M0 of the drug container M is disposed within the fluid-tight chamber 11 of the cassette. The delivery tube M0b is wound around the frame 15 of the cassette. In this example, the cassette is configured to be partially disposed within the inner section of the reusable body 20''' as shown in FIG. 18. When the cassette is disposed within the reusable body, the frame 15 and the delivery tube M0b are disposed outside the inner section of the reusable body 20'''. Further, in another example, the cassette provides a filter 28 connected to the delivery tube M0b. In a preferred example, the filter 28 is configured to expel air bubbles contained in the contained drug so that the air bubbles are not delivered into the user's body.

[0247] Furthermore, instead of having the fluid sealing chamber 11 as part of the cassette as described above, the fluid sealing chamber 11 can be used as a cassette and a reusable body. For example, as shown in FIG. 16, the cassette includes a drug container frame 16 configured to surround the drug container M. In this example, the drug container M is attached to the drug container frame 16 and configured to be inserted into the inner section of the reusable body. When the drug container frame 16 is disposed in the inner section of the reusable body, the inner section of the reusable body, together with the drug container frame 16, forms a fluid sealing chamber. In this example, the cassette can be made of less plastic material, and thus the cost of the cassette can be reduced. In another example, the drug container frame 16 includes a connector to the fluid pressure power source 21, such as a valve; thus, the fluid pressure power source can be operated only to release fluid into the fluid sealing chamber when the drug container frame 16 is inserted into the inner section of the reusable body. Furthermore, the reusable body 20''' includes a connection track 26. In an example shown in FIG. 16, the connection track 26 is formed by two ribs. The connection track 26 enables a plurality of reusable bodies 20''' to be attached together. For example, the reusable body includes a connection track 26 on one side and a connection protrusion on the other side opposite to the connection track 26. The connection protrusion is configured to be attached to the connection track 26 by sliding along the connection track 26. In this example, the reusable body includes a communication spot 27 configured to connect to a corresponding communication unit of another reusable body. For example, as shown in FIG. 16, the communication spot 27 is disposed within the connection track 26, and the corresponding communication unit is disposed within the connection protrusion. The communication spot can be a conductive spot configured to be in electrical contact and connected to the corresponding communication unit. Alternatively, the communication spot 27 can be an RFID / NFC circuit configured to be connected to the corresponding communication unit via a non-contact connection.In this example, the user interface 24 comprises a corresponding communication unit configured to be connected to the communication spot 27. In a preferred example, the user interface 24 comprises a corresponding communication unit and can be attached to a reusable body by attaching it to the connection track 26 so that the user interface 24 can be attached to the reusable body. In the example shown in FIG. 26, two reusable bodies 20''' each with two cassettes inserted are attached to each other. The user interface 24 is attached to one of the two reusable bodies 20'''. In this example, the user interface 24 is configured to detect how many cassettes are connected via the connection between the communication spot and the corresponding communication unit, and then to control the drugs in the different cassettes to be delivered.

[0248] In a preferred example where the reusable body is configured to accommodate the cassette, as shown in FIG. 19, the user-wearable function unit 25'' is a belt clip.

[0249] In another example, as shown in FIGS. 9, 24-25, and 31, the reusable body 20 of the drug delivery device 2 is configured to accommodate a plurality of cassettes 1a, 1b. In this example, the reusable body 20 includes an inner section for accommodating more cassettes 1a, 1b. In this example, the reusable body 20 includes a body 20a that includes the inner section, optionally, a frame 20b configured to have more cassettes 1a, 1b attached thereto, and a lid 20c configured to seal the body 20a. Similar to the previous example, the cassettes 1a, 1b can be attached to the inner section of the reusable body via a magnetic connection, a releasable snap-fit connection, a threaded connection, and / or a bayonet connection. In a preferred example, the cassettes 1a, 1b can be attached to the frame 20b of the reusable body 20 via a magnetic connection, a releasable snap-fit connection, a threaded connection, and / or a bayonet connection. Thus, when the frame is removably attached to the body 20a, the cassette can be removably attached to the drug delivery device. In this example, the reusable body 20 includes one or more drug containers (flexible bags) and a filling port for use in a pharmacy clean room or a pharmaceutical filling room. In one example, the frame 20b includes one or more tube openings 20bb for being respectively connected to one or more tubes and / or drug delivery members. In a preferred example, the frame 20b has an integrated tube set and a delivery member (e.g., a needle). The tube set and the needle are collected in a tube management sleeve (at the bottom of the reusable body) that enables compact transportation and avoids entanglement before use and during needle application. Alternatively, the tubes may optionally be terminated within modular connectors, and the tube set and the needle(s) may be separately attached as part of the use process. The reusable body includes a battery, a fluid pressure power source, and a drug container interface, e.g., via the lid 20c. This design is intentionally made to be unaffected by orientation or gravity. The form factor has a simple set of use steps that can be performed multiple times.In this example, the user inserts the cassette into the drug delivery device as seen in FIGS. 25A - 25B, attaches the needle to the injection site, and simply presses the start button to administer the complete treatment regimen. For a regimen of multiple drugs, the device may send a reminder to the user of when to proceed or reject a drug loaded out of sequence. In one example, the fluid - sealed chamber 11 is formed by a reusable body 20 and a frame 20b. In this example, the inlet 110 of the fluid - sealed chamber 11 is disposed within the reusable body 20 as shown in FIG. 25C. Additionally, as shown in FIG. 25C, a plurality of inlets 110 of the fluid - sealed chamber 11 can be provided.

[0250] Alternatively, FIGS. 9, 24 - 25, and 32 can also schematically show that the drug delivery device comprises one cassette having a plurality of drug containers. In this example, the drug delivery, as well as the body 20 and the frame 20b described as part of the reusable body of the drug delivery device, should be regarded as part of the cassette in this example. In other words, in this example, the reusable body of the drug delivery device only comprises a fluid pressure power source 21, and further a user interface 24 and a user-wearable functional part 25. In this example, the body (reference numeral 20 in FIGS. 24 - 25B) and the frame (reference numeral 20b in FIGS. 24 - 25B) are the container carriers of the cassette. In this example, the container carriers of the cassette are reusable. As described above, the frame is configured to be attached to more drug containers (reference numeral 1a in FIGS. 24 - 25B), and the lid (reference numeral 20c in FIGS. 24 - 25B) is configured to seal the body of the cassette (reference numeral 20a in FIGS. 24 - 25B). Similar to the previous example, the drug containers can be attached to the inner section of the reusable body via magnetic connection, releasable snap-fit connection, threaded connection, and / or bayonet connection. In a preferred example, the drug containers can be attached to the frame of the reusable body via magnetic connection, releasable snap-fit connection, threaded connection, and / or bayonet connection. Thus, when the frame is detachably attached to the body, the drug containers can be detachably attached to the cassette. Similarly, in this example, the frame comprises one or more tube openings (having reference numeral 20bb in FIGS. 24 - 25B) for being respectively connected to one or more tubes and / or drug delivery members. In a preferred example, the frame has an integrated tube set and a needle. The tube set and the needle are collected in a tube management sleeve (at the bottom of the reusable body) that enables transportation in a compact state and avoids entanglement before use and during needle application. Alternatively, the tubes may optionally be terminated within modular connectors, and the tube set and the needle(s) may be separately attached as part of the use process.In this example, the body and the lid form a fluid-sealed chamber. Thus, when fluid flows into the body, the fluid can push out the drug contained in the drug container and deliver the drug to the patient via the drug delivery member. In this example, the patient connects the cassette to the fluid pressure power source 21 as seen in FIGS. 25A-25B, attaches the needle to the injection site, and simply presses the start button to administer the complete treatment regimen.

[0251] In another example, the drug delivery device 2; 2'; 2'' comprises a processor electrically connected to the fluid pressure power source 21 and a power source connected to the processor, such as a battery. The processor and the power source are housed within a reusable body 20; 20'; 20''; 20'''. In this example, the above-described controller 21i'' can be the processor of the drug delivery device or is electrically connected to such a processor.

[0252] In another example, the drug delivery device 2; 2'; 2'' comprises a user interface 24 attached to the reusable body 20; 20'; 20''; 20''', as shown in FIGS. 9 and 18. The user interface 24 is electrically connected to the processor. In one example, the user interface is a button protruding from the outer surface of the reusable body. In another example, the user interface is a touch panel disposed on the outer surface of the reusable body. Further, in another example, the drug delivery device comprises an orientation sensor, such as a gyro sensor, so that a display, screen, or touch panel can always be presented to the user in a right-facing graphic display, as shown in FIGS. 37A-37B.

[0253] In another example, the drug delivery device comprises a wireless communication receiver and / or transmitter connected to a processor. The wireless communication receiver and / or transmitter can be of any suitable long-range or short-range wireless communication technology, such as RF, Bluetooth®, Zigbee®, 3G, 4G, 5G. The wireless communication receiver is configured to receive wireless signals from a remote device and / or information tags to the processor. The wireless communication transmitter is configured to transmit a wireless signal from the processor to a remote device or write information to an information tag. In this example, instead of a user interface, the user can use a remote device, such as a smartphone, to control and / or monitor the drug delivery operation. Further, in another example, the communication transmitter is configured to write the information used to an information tag of the cassette. The information can be the residual drug in the cassette.

[0254] In another example, a pressure sensor and / or a position sensor of the piston of the fluid seal measurement chamber, and / or a position sensor and / or a flow rate sensor of the container carrier, and / or a sensor for evaluating the mass flow rate into the fluid seal chamber(s) are electrically connected to the processor. Optionally, a temperature sensor is electrically connected to the processor. In this example, the temperature sensor is configured to monitor the temperature of the fluid seal chamber. In this example, the processor is configured to control the fluid pressure power source according to signals from the pressure sensor and / or the position sensor of the piston of the fluid seal measurement chamber, and / or the position sensor of the container carrier to output fluid into the fluid seal chamber. In one example, when the fluid pressure power source is a pneumatic power source, the processor controls the pneumatic power source 21 to output fluid at a constant pressure level greater than the resistance pressure value of the target tissue until the drug container is empty or a predetermined amount of the contained drug is delivered. Since the volume of the fluid seal chamber is known, the residual drug in the drug containers M;M' can be calculated by monitoring the pressure level in the fluid seal chamber based on the application of the ideal gas law. Similarly, in another example, the processor is configured to control so that the drug contained in the drug container is delivered at a constant delivery rate by maintaining a constant pressure level in the fluid seal chamber during the drug delivery operation. In a preferred example, no other flow rate control configurations are used. Therefore, the flow rate is substantially equal to the delivery rate of the drug contained in the drug container. In this example, when the detected pressure level drops, the processor controls the fluid pressure power source to deliver more fluid, and when the detected pressure level rises, the processor stops the fluid pressure power source or starts a vacuum device.

[0255] Furthermore, in an example where the body of the drug container includes a flexible bag and a flexible tube, instead of using the pressure level to control the delivery rate of the drug contained in the drug container as described above, the delivery rate of the drug contained in the drug container of the drug delivery device can be controlled by compressing the flexible tube. For example, another fluid-sealed tube connected to a fluid pressure power source can be attached to the flexible tube. In this example, when the fluid from the fluid pressure power source flows into the fluid-sealed tube, the fluid-sealed tube can press the flexible tube of the drug container, thereby controlling the delivery rate of the drug contained in the drug container of the drug delivery device. Alternatively, as described above, the delivery rate of the drug contained in the drug container can be adjusted by manipulating the flexible tube (e.g., by a pinch valve).

[0256] In an example where the cassette includes a drug container, the drug container includes a temperature sensor and / or a timer. The temperature sensor is configured to monitor the temperature of the contained drug, and the timer is configured to record the storage period of the container drug. In this example, when the cassette is attached to the reusable body, the processor is configured to be electrically connected to the temperature sensor and / or the timer, and the state of the contained drug can be verified by the processor. For example, if the contained drug has been stored for too long, or if it has been exposed to a high temperature that may affect the efficiency of the contained drug, the processor can generate a warning display to the user and / or send a warning signal to a remote device.

[0257] In another example, the fluid pressure power source 21 is connected to at least two fluid-sealed chambers 11a''', 11b''', 11c'''; 11a''''''', 11b''''''', 11c''''''', 11d'''''''; 11a''''''''', 11b''''''''', 11c''''''''', 11d''''''''', as shown in FIGS. 5, 13, and 14. For example, the fluid pressure power source 21 is connected to at least two fluid-sealed chambers 11a''', 11b''', 11c'''; 11a''''''', 11b''''''', 11c''''''', 11d''''''', via at least two separate fluid paths, such as two independent fluid transfer tubes or dual lumen tubes, as shown in FIGS. 5 and 13. Alternatively, the fluid pressure power source 21 is connected to at least two fluid-sealed chambers 11a''''''''', 11b''''''''', 11c''''''''', 11d''''''''', via a main flow path having a split sub-flow path divided into two and a control valve, as shown in FIG. 14. In this example, the processor is configured to control the fluid pressure power source to selectively output fluid into at least one of the fluid-sealed chambers 11a''', 11b''', 11c'''; 11a''''''', 11b''''''', 11c''''''', 11d'''''''; 11a''''''''', 11b''''''''', 11c''''''''', 11d'''''''''.

[0258] In an example where a pressure sensor and / or a position sensor of the fluid-sealed measurement chamber, and / or a position sensor of the container carrier are electrically connected to the processor, the processor is configured to control the fluid pressure power source to selectively output fluid into at least one fluid-sealed chamber according to signals from a pressure sensor and / or a position sensor of the fluid-sealed measurement chamber, a position sensor of the container carrier, and / or a sensor for evaluating the mass flow rate into the fluid-sealed chamber.

[0259] Furthermore, in another example, the processor is configured to control a fluid pressure power source to output a certain amount of fluid. In this example, the certain amount is either pre-determined or depends on signals from a pressure sensor and / or a position sensor of the fluid-tight measurement chamber, and / or a position sensor of the container carrier. Thereby, only a certain amount of the drug contained in the drug container can be pushed out from the fluid outlet.

[0260] In an example where the drug delivery device 2 includes a wireless communication receiver connected to the processor and is configured to be attached to a cassette containing a plurality of drug containers, the wireless communication receiver is an RFID reader configured to read an RFID tag on the cassette. In this example, the RFID tag contains information regarding the flow rate for each individual drug, the delivery order between different drugs, the dosage, emergency stop information, etc.

[0261] In one example, the fluid-sealed chamber comprises a pressure sensor and a flow sensor. In a preferred example, the drug container is a flexible bag completely received within the fluid-sealed chamber. In this example, when the user attaches cassette 1 to the reusable body 20 of the drug delivery device, the fluid-sealed chamber is connected to the fluid pressure power source 21. Before the delivery tube is fluid-connected to the drug container, the processor can control the fluid pressure power source that pressurizes the fluid-sealed chamber, and thus, by the ideal gas law and / or its simplification as described above, measure the initial state of the drug container, e.g., the actual filling volume of the drug. The processor is configured to continuously monitor the pressure and flow rate of the fluid-sealed chamber via the pressure sensor and the flow sensor during the drug delivery operation. As a result, as shown in FIG. 36, compared to the relationship between the flow rate and the pressure in the normal delivery operation 300, when the drug delivery member is removed prematurely 302, and / or when the delivery tube contains air 301 (the flow rate increases but the pressure does not increase), and / or when a delivery blockage occurs 303 (the pressure increases but the flow rate does not increase), the event(s) can be detected by monitoring the pressure level and the flow rate, and thus, the processor can control the fluid pressure power source 21 to stop or decelerate. The processor can also control the release valve to open, and the processor can provide feedback to the user. In a preferred example, one or more processors of the drug delivery device can be programmed with a machine learning module, and thus, the relationship between the flow rate and the pressure in the normal delivery operation 300 and / or the determination of the changes 301, 302, 303 made by one or more processors can be self-adjusted during use to increase the accuracy of event detection.

[0262] In one example, as shown in FIG. 13, the fluid pressure power source 21 is connected to the cassette 1 via a dual lumen tube. In this example, one inner tube of the dual lumen tube includes a first valve 26a and the other inner tube of the dual lumen tube includes a second valve 26b. In this example, the fluid pressure power source 21 is connected to a first set of drug containers Ma, Mb, Mc via the first valve 26a. In this example, each drug container is housed within one of the separate fluid-sealed chambers 11a''''''''', 11b''''''''', 11c''''''''', 11d'''''''''. Each fluid-sealed chamber includes an inlet and valves 114a'', 114b'', 114c'' at the inlet. Also, the fluid pressure power source 21 is connected to a second drug container Md via the second valve 26b. The second drug container Md is housed within another fluid-sealed chamber 11d'''''''' having an inlet and a valve 114d'' at the inlet. In this example, the patient is to receive drugs sequentially from each of the drug containers Ma, Mb, Mc and the patient is to receive drugs from the second drug container M0d only in the event of an emergency, e.g., when an adverse drug reaction appears. In this example, the processor controls the first valve 26a to open and close the second valve 26b. The valves 114a'', 114b'', 114c'' for each fluid-sealed chamber can be designed to have different resistances such that they open only when the previous drug container is empty or when controlled by the processor. In the event of an emergency (either detected by another sensor or the user activates the emergency button as described above), the processor can close the first valve 26a and open the second valve 26d, whereby the output fluid from the fluid pressure power source can flow into the fluid-sealed chamber having the second drug container Md.

[0263] In another example, as shown in FIG. 14, instead of the first valve and the second valve, a single multi-way valve 114''' can be used to connect the first set of drug containers Ma, Mb, Mc and the second drug container Md (emergency drug) to the fluid pressure power source 21. In this example, the processor controls the multi-way valve 114''' to close, open towards the first set of drug containers Ma, Mb, Mc, or open towards the second drug container M0d' (emergency drug). In this example, each of the first set of drug containers Ma, Mb, Mc is housed within separate fluid-tight chambers 11a''''''''', 11b''''''''', 11c'''''''''. In this example, only one of the fluid-tight chambers 11a'''''''''' has an inlet connected to the fluid pressure power source 21. A one-way valve 101 is disposed between the two fluid-tight chambers 11a''''''''', 11b''''''''', 11c'''''''''. Thus, only when the previous drug container is empty can the pressure in the previous fluid-tight chamber be accumulated to open the one-way valve 101, allowing fluid from the fluid pressure power source 21 to flow into the next fluid-tight chamber.

[0264] In one example, each of the first set of drug containers Ma, Mb, Mc used in a design as shown in FIG. 14 includes a flexible bag. Additionally, each of the first set of drug containers Ma, Mb, Mc used in a design as shown in FIG. 14 includes a flexible tube as described above. In this example, the second drug container Md includes a flexible bag. Additionally, the second set of drug containers Md used in a design as shown in FIG. 14 includes a flexible tube as described above.

[0265] Alternatively, in another example, each of the first set of drug containers Ma, Mb, Mc used in the design shown in FIG. 14 includes a flexible bag. Additionally, each of the first set of drug containers Ma, Mb, Mc used in a design as shown in FIG. 14 includes a flexible tube as described above. In this example, the second drug container Md includes a cartridge made of a rigid material, such as glass or rigid plastic. Additionally, the second set of drug containers Md used in a design as shown in FIG. 14 includes a flexible tube as described above.

[0266] Furthermore, the examples shown in FIGS. 13 - 14 only schematically show a plurality of fluid - sealed chambers. In one example, each of the plurality of fluid - sealed chambers is housed in one independent cassette. Alternatively, all of the plurality of fluid - sealed chambers are housed in one cassette. Alternatively, at least one of the plurality of fluid - sealed chambers is housed in one cassette and the remainder of the plurality of fluid - sealed chambers is housed in another cassette.

[0267] Furthermore, the drug delivery members 23; 23a, 23b, 23c, 23d are injection needles or insertion needles having soft cannulas, and the processor can also detect the removal of the drug delivery members 23, 23a, 23b, 23c, 23d when a predetermined pressure drop is detected, because when the drug delivery members 23; 23a, 23b, 23c, 23d are removed from the target tissue, the resistance pressure of the target tissue becomes less significant.

[0268] Furthermore, intentional break points can be arranged near the drug delivery members 23; 23a, 23b, 23c, 23d. For example, when the delivery tube of the main body of the drug container is normally pulled to move the drug delivery members 23; 23a, 23b, 23c, 23d away from the patient, the delivery tube of the main body of the drug container instead breaks at this joint to separate the delivery tube of the main body of the drug container from the drug delivery members 23; 23a, 23b, 23c, 23d, avoiding the possibility of damage by the drug delivery members 23, 23a, 23b, 23c, 23d.

[0269] This break also has the effect of removing the pressure drop associated with the needle and subcutaneous tissue back pressure. Thus, for a drug delivered at a controlled flow rate, the upstream driving pressure is reduced.

[0270] Thus, when the removal of the drug delivery member is detected, the processor can generate a display on the user interface and / or transmit a warning signal to a remote device. The processor can also stop the fluid pressure power source 21 and open the release valve 115 to stop the drug delivery operation.

[0271] As shown in FIG. 36, other events, such as the delivery tube containing air or the occurrence of an occlusion, can be detected using any of the pressure sensors and / or the aforementioned flow sensors.

[0272] As described above, the term "flow rate" referred to in the following examples is the flow rate of the drug exiting the drug container.

[0273] Furthermore, in an example where the fluid pressure power source 21’’; 21’’’ is a pneumatic power source, the volume of the drug in the drug container can be determined using the ideal gas law and its simplifications, such as Boyle's law and Charles's law, as described in the summary section of this specification. However, as noted above, it is unlikely that the system will use a pure ideal gas for commercial provision of this device, and the use of ambient air is highly advantageous. To compensate for the inherent sensitivity to environmental variables and improve pump performance in the presence of environmental uncertainty, the compensation block 21h’’ described above can be used. The compensation block 21h’’ includes an atmospheric pressure sensor and / or an ambient temperature sensor so that calculations can be calibrated based on detections from the compensation block 21h’’. Optionally, the compensation block can include a humidity sensor to compensate for changes in air density. In a preferred example, the flow sensor can be an integrated temperature sensor. Note that the compensation block can be a unit having one or more sensors as described above. Alternatively, the compensation block can be a control structure programmed into one or more processors of the drug delivery device, and in this example, all sensors are located in the cassette, the fluid-sealed chamber, and / or the pneumatic fluid pressure power source. In this example, all sensors are connected to one or more processors of the drug delivery device.

[0274] Furthermore, in another example, the flow rate is not directly sensed. Instead, the system repeatedly calculates the dead volume of the system. If the only way the dead volume can change is due to liquid exiting the drug container, then the rate of change of the dead volume is equal to the flow rate.

[0275] To avoid the noise observed in liquid flow rate calculations when adjacent dead volume measurements are used, it is possible to filter the measurements to obtain a cleaner signal. One such approach involves a buffer and linear regression. In each controller evaluation, the initial conditions of the container carrier (calculated by the ideal gas law and its simplifications) are added to the buffer, and linear regression is performed on that buffer. The slope of the regression line is the flow rate.

[0276] The system enables continuous control of the flow rate. In one example, the target flow rate is achieved by continuously delivering fluid into the fluid-sealed chamber while monitoring the pressure, by removing the fluid flowing from the fluid pressure power source from the fluid-sealed chamber while monitoring the pressure, and / or by delivering the accumulated pressure or exhausting the fluid-sealed chamber, stopping the flow suddenly (e.g., during an emergency or a systemic infusion reaction), and reducing the pressure to the environment around the cassette. For example, the system can control the release valve to release fluid to the environment around the cassette based on detections from one or more connected sensors. The system allows for changes in the flow rate during drug delivery operations, as may be required in common rate adjustment regimens in oncology, and enables each cassette to have a desired flow rate that can be configured independently. Different drug cassettes or container carriers may be combined in a desired order, each cassette may have any desired fluid volume, and may be delivered at a desired flow rate regardless of parameters such as viscosity, volume, or other drug, patient, or system configuration (e.g., cannula gauge).

[0277] Furthermore, in an example where the fluid pressure power source is a pneumatic fluid pressure power source, the system can be controlled using a target maintenance mechanism as shown in FIG. 35, and the system (the operation of the fluid pressure power source when connected to the fluid - sealed chamber of the cassette) can be configured using the target maintenance mechanism 200. In this example, information regarding the initial state of the cassette is measured by measurement modules 207, 208, 209. The measurement modules include a flow - rate calculation module 209 that calculates the flow rate of the drug exiting the fluid outlet of the flexible bag, an air - quantity calculation module 208 that calculates the amount of air in the fluid - sealed chamber, and an initial information input 207. The flow - rate information is input into a flow - rate error detection module 201 and can adjust the pressure target via an adjustment module 203. The adjusted target pressure can be used by an air - mass module 205 together with a sensor module 206 to adjust the air mass in the fluid - sealed chamber in order to adjust the pressure level in the fluid - sealed chamber. In this example, since ideally there is a linear relationship between pressure and liquid flow rate, the target maintenance period simply adjusts the pressure target of the system in proportion to the measured flow - rate error. The flow - rate error is interpreted as the ratio between the target liquid flow rate and the measured liquid flow rate, rather than the difference. The pressure - target adjustment method can take many forms, but all essentially supply the flow - rate error as an input for response adjustment. Several controllers such as a Proportional Integral (PI) controller, a Proportional - Integral - Derivative (PID) controller, or a bang - bang controller can be used. In one example, the target maintenance mechanism can be designed such that the current system pressure and the pressure target are evaluated by a PID function, and the output of the PID function (in the form of a fluid - pressure - power - source command) is compared with fluid - pressure - power - source activity limitations such as a limited - power operation window and an on - time duration rule to ensure air - flow sensing accuracy. If permitted, the fluid pressure power source operates for the calculated amount of time.In a preferred example, an intermittent high air flow rate is easier to accurately sense with a thermal mass flow sensor than a continuous low air flow rate, so a time-based (rather than intensity-based) is used for the target maintenance mechanism. Between each pressure control loop, the PID output is converted to a fluid pressure power source on-time (percentage of the control cycle). In an example where the fluid sealing chamber includes a release valve, a release control mechanism can be used. The release control mechanism can be designed to compare the pressure target with the current system pressure. If the difference between these pressures is greater than a threshold and is negative, the release control mechanism is activated. In a preferred example, the processor of the drug delivery device is configured to temporarily stop the drug delivery operation when the release control mechanism is activated. In one example, the drug delivery operation can be temporarily stopped by clamping the delivery tube. In this example, the drug delivery device includes a clamp electrically connected to the processor. For example, the clamp is connected to a solenoid wire. Once the release control mechanism is activated, it starts venting (opens the release valve), and the system records the current void air volume and the injected fluid mass, such as air mass, gas mass. Once the pressure drops below the target, the release control mechanism closes the release valve, and the system performs a new calculation of the injected fluid mass, such as air mass, gas mass, and then provides a signal to the processor to continue the drug delivery operation.

[0278] In a preferred example, a drug delivery device can be controlled by the following method. The drug delivery device includes a fluid pressure power source that is a pneumatic power source as described in any of the above examples. The drug delivery device includes a fluid sealing chamber as described in any of the above examples, and the fluid sealing chamber houses a drug container. The drug container is a flexible bag having a fluid outlet. The flexible bag contains the drug. The method includes the following steps in the following order: · Receiving at least one of a measured pressure level of the fluid pressure in the fluid sealing chamber and a measured flow rate of the drug exiting the fluid outlet of the flexible bag; · A step of obtaining information from a database using the received measurement values; and · A step of providing a signal based on the obtained information to cause one or more electronic components of the drug delivery device to perform an operation or to stop a currently executing operation of one or more electronic components of the drug delivery device.

[0279] Preferably, both a pressure level measurement of the fluid pressure within the fluid-sealed chamber and a flow rate measurement of the drug exiting the fluid outlet of the flexible bag are received. In a preferred example, the method is executed by a processor of the drug delivery device. In a preferred example, the fluid-sealed chamber comprises a pressure sensor and a flow rate sensor. In a preferred example, the step of obtaining information from the database using the received measurement values includes the following steps in the following order: · A step of calculating a value based on the received measurement values using the ideal gas law and its simplifications; · A step of comparing the calculated value with a predetermined value; and · A step of generating a result of the comparison.

[0280] In a preferred example, the calculation is executed by a processor. Alternatively or additionally, the communication unit of the drug delivery device can transmit the received measurement values to a remote server and / or a personal computing device for which it is to be calculated. In this example, the processor is configured to receive the calculated value and / or the result of the comparison (in the example where the comparison is also executed in the remote server and / or the personal computing device).

[0281] Note that the predetermined value is received from the information tag on the drug container. Alternatively or additionally, the predetermined value is input from the user interface. Alternatively or additionally, the predetermined value is downloaded from a remote server. Alternatively or additionally, the predetermined value is stored in the processor and / or memory of the drug delivery device. Further, the predetermined value relates to at least one of the volume of the drug container, the volume of the drug contained in the drug container, the target flow rate of the drug exiting the fluid outlet of the flexible bag, the target pressure level of the fluid pressure in the fluid seal chamber, the previously received flow rate of the drug exiting the fluid outlet of the flexible bag, the previously received pressure level of the fluid pressure in the fluid seal chamber, and the previously calculated volume of the drug contained in the drug container.

[0282] Further, in a preferred example, after the step of generating the comparison result, the step of obtaining information from the database using the received measurement value further includes the step of providing the information obtained by collating the comparison result with the information from the database. Alternatively or additionally, after the step of generating the comparison result, the step of obtaining information from the database using the received measurement value further includes the step of providing the information obtained by providing the comparison result.

[0283] The information obtained relates to at least one of the actually filled volume of the drug in the drug container, the volume of the drug remaining in the drug container after use, the air in the delivery tube, the delivery member being away from the delivery site, and the delivery occlusion (which can be determined as an "end of administration" event).

[0284] Further, the operation of one or more electronic components of the drug delivery device is configured by the provided signal to perform or stop at least one of providing an instruction to the user of the drug delivery device, performing a drug delivery operation, transmitting data to a remote server, adjusting the pressure level of the fluid pressure in the fluid seal chamber, and adjusting the drug release rate from the fluid outlet of the flexible bag.

[0285] Furthermore, the reusable body of the drug delivery device, and / or the cassette housing of the cassette, and / or the container carrier of the cassette, and / or the fluid-sealed chamber of the cassette may comprise a compound characterized by sustained antibacterial, antifungal, and / or antiviral properties (i.e., may be formed within or with such compounds).

[0286] Alternatively, a compound characterized by sustained antibacterial, antifungal, and / or antiviral properties can be applied to the formed (i.e., finished) components by a secondary process (e.g., chemical vapor deposition), spraying, or dipping process.

[0287] In a preferred example, a multi-way valve, such as a 2 / 2-way valve, 3 / 2-way valve, 5 / 2-way valve, can be a solenoid valve as described above.

[0288] Primarily, the concepts of the present invention have been described with reference to several examples. However, as will be readily understood by those skilled in the art, other embodiments other than those disclosed above are equally possible within the scope of the concepts of the present invention as defined by the appended claims.

[0289] Some other aspects of the present invention are disclosed in the following clauses. Clause 1 A cassette (1; 1'; 1'') of a drug delivery device (2; 2'; 2''), the drug delivery device comprising a reusable body (20; 20') having a fluid pressure power source (21; 21'), the cassette (1; 1'; 1'') comprising: a container carrier (10; 10'; 10''; 10'''; 10a'', 10b'', 10c'', 10d''); and A drug container (M; Ma, Mb, Mc, Md; Ma’, Mb’, Mc’, Md’) comprising a body (M0; M0’; M0’’; M0a, M0b; M0a, M0a’, M0a’’, M0b, M0b’; M0b’’) and a fluid outlet (M1; M1’), the body (M0; M0’; M0’’; M0a, M0b; M0a, M0a’, M0a’’, M0b, M0b’; M0b’’) including a flexible portion; the drug container (M; Ma, Mb, Mc, Md; Ma’, Mb’, Mc’, Md’) being at least partially disposed within a container carrier (10; 10’; 10’’; 10’’’; 10a’’, 10b’’, 10c’’, 10d’’); The container carrier (10; 10’; 10’’; 10’’’; 10a’’, 10b’’, 10c’’, 10d’’) comprising a fluid seal chamber (11; 11’; 11’’; 11a’’’, 11b’’’, 11c’’’; 11a’’’’, 11b’’’’, 11c’’’’, 11d’’’’; 11’’’’’, 11’’’’’’, 11a’’’’’’, 11b’’’’’’, 11c’’’’’’, 11d’’’’’; 11a’’’’’’, 11b’’’’’’, 11c’’’’’’, 11d’’’’’; 11a’’’’’’’, 10e’’’’’; 11a’’’’’’’’, 11b’’’’’’’); the fluid seal chamber (11; 11’; 11’’; 11a’’’, 11b’’’, 11c’’’; 11a’’’’, 11b’’’’, 11c’’’’, 11d’’’’; 11’’’’’, 11’’’’’’, 11a’’’’’’, 11b’’’’’’, 11c’’’’’’, 11d’’’’’; 11a’’’’’’, 11b’’’’’’, 11c’’’’’’, 11d’’’’’; 11a’’’’’’’, 10e’’’’’; 11a’’’’’’’’, 11b’’’’’’’) comprising an inlet (110; 110’; 110’’; 110’’’; 110’’’’; 110a); the inlet (110, 110’; 110’’; 110’’’; 110’’’’; 110a) being configured to be fluidly connected to an outlet of a fluid pressure power source of a reusable body of a drug delivery device; The fluid sealing chamber (11; 11’; 11’’; 11a’’’, 11b’’’, 11c’’’; 11a’’’’, 11b’’’’, 11c’’’’, 11d’’’’; 11’’’’’, 11’’’’’’, 11a’’’’’’’, 11b’’’’’’’, 11c’’’’’’’, 11d’’’’’’’; 11a’’’’’’’’, 10e’’’’’; 11a’’’’’’’’, 11b’’’’’’’’) is connected to the flexible portion of the main body (M0; M0’; M0’’; M0a, 0b; M0a, M0a’, M0a’’, M0b, M0b’; M0b’’) of the drug container (M; Ma, Mb, Mc, Md; Ma’, Mb’, Mc’, Md’), whereby the inlet (110; 110’; 110’’; 110’’’; 110’’’’; 110a) receives the output fluid from the fluid pressure power source (21; 21’), and the output fluid flows into the fluid sealing chamber (11; 11’; 11’’; 11a’’’, 11b’’’, 11c’’’; 11a’’’’, 11b’’’’, 11c’’’’, 11d’’’’; 11’’’’’, 11’’’’’’, 11a’’’’’’’, 11b’’’’’’’, 11c’’’’’’’, 11d’’’’’’’; 11a’’’’’’’’, 10e’’’’’; 11a’’’’’’’’, 11b’’’’’’’’); at least a part of the drug contained in the drug container (M; Ma, Mb, Mc, Md; Ma’, Mb’, Mc’, Md’) is extruded under the pressure of the output fluid; And the fluid outlet (M1; M1’) is configured to be connected to the drug delivery member (23; 23a’, 23b’, 23c’, 23d’) of the drug delivery device (2; 2’; 2’’) when the cassette (1; 1’; 1’’) is attached to the drug delivery device (2; 2’; 2’’).

[0290] Clause 2. The cassette according to Clause 1, comprising a cassette housing, wherein the container carrier is disposed within the cassette housing.

[0291] Clause 3 The cassette according to clause 1 or 2, wherein the cassette is configured to be releasably attached to a reusable body of the drug delivery device.

[0292] Clause 4 The cassette according to any one of clauses 1 to 3, wherein the body of the drug container comprises a flexible bag and / or a flexible tube.

[0293] Clause 5 The cassette according to any one of clauses 1 to 4, wherein the body comprises a delivery tube.

[0294] Clause 6 The cassette according to the combination of clause 4 and clause 5, wherein the body of the drug container comprises a flexible tube, and the delivery tube is the flexible tube of the body.

[0295] Clause 7 The cassette according to any one of clauses 1 to 6, wherein the flexible portion of the body is at least partially received within a fluid-sealed chamber.

[0296] Clause 8 The cassette according to the combination of clause 6 and clause 7, wherein the fluid-sealed chamber comprises a tube inlet and a tube outlet, and the delivery tube is configured to be positioned between the tube inlet and the tube outlet.

[0297] Clause 9 The cassette according to clause 7 or 8, wherein the fluid-sealed chamber comprises an outlet configured to be connected to a vacuum device, whereby when the pressure within the fluid-sealed chamber decreases, the drug contained within the drug container is drawn into the delivery tube.

[0298] Clause 10 The cassette according to clause 9, wherein the inlet of the fluid-sealed chamber is the outlet of the fluid-sealed chamber.

[0299] Clause 11. The cassette according to any one of Clauses 1 to 6, wherein the container carrier includes a container chamber configured to at least partially receive a drug container, the fluid-sealed chamber is inflatable, the fluid-sealed chamber is adjacent to a flexible portion of the body, whereby the output fluid from the fluid pressure power source flows into the fluid-sealed chamber and is configured to inflate the fluid-sealed chamber to press the drug container.

[0300] Clause 12. The cassette according to any one of Clauses 1 to 4, wherein the cassette includes a container carrier having one fluid-sealed chamber therein, the container carrier includes a connection port configured to be releasably attached to either an outlet of a fluid pressure power source of a reusable body of a drug delivery device or another connection port of another container carrier, and the container carriers are configured to be stacked on top of each other.

[0301] Clause 13. The cassette according to Clause 12, comprising one container carrier, wherein the container carrier includes a connection port configured to be releasably attached to either an outlet of a fluid pressure power source of a reusable body of a drug delivery device or another connection port of another container carrier of another cassette, and a plurality of cassettes are configured to be stacked on top of each other.

[0302] Clause 14. The cassette according to Clause 12 dependent on Clause 2, or the cassette according to Clauses 3 to 4 dependent on Clause 2, wherein the cassette includes a plurality of container carriers stacked on top of each other within a cassette housing.

[0303] Clause 15. The cassette according to any one of Clauses 1 to 4 or Clauses 12 to 13, wherein the fluid-sealed chamber is configured to receive a drug container.

[0304] Clause 16. The cassette according to Clause 14, wherein the fluid-sealed chamber is formed by a container frame.

[0305] Clause 17. The cassette according to clause 15, wherein the fluid-sealed chamber is formed by an inner chamber of a container frame and a container carrier.

[0306] Clause 18. The cassette according to clause 15, wherein the fluid-sealed chamber is formed by a container frame and a cap configured to be attached to the container frame.

[0307] Clause 19. The cassette according to clause 17, wherein the cap comprises a tube set including a delivery tube operably connected to a fluid outlet of a drug container in the fluid-sealed chamber.

[0308] Clause 20. The cassette according to clause 18, wherein the tube set comprises a perforated member configured to establish fluid communication between the delivery tube and the drug container through a fluid outlet of the drug container.

[0309] Clause 21. The cassette according to any one of clauses 1 to 20, wherein an inlet of the fluid-sealed chamber comprises a valve.

[0310] Clause 22. The cassette according to clause 21, wherein the valve at the inlet of the fluid-sealed chamber is a one-way valve.

[0311] Clause 23. The cassette according to any one of clauses 1 to 22, wherein the cassette comprises at least two fluid-sealed chambers, and each of the two fluid-sealed chambers houses at least two drug containers.

[0312] Clause 24. The cassette according to clause 23, wherein a one-way valve is disposed between the two fluid-sealed chambers.

[0313] Clause 25. The cassette according to clause 24, wherein only one of the at least two fluid-sealed chambers has an inlet configured to be fluid-connected to a fluid pressure power source.

[0314] Clause 26 The one-way valve between two fluid-sealed chambers is configured to open when a first fluid pressure threshold is reached, and the valve at the inlet of the fluid-sealed chamber configured to be fluid-connected to a fluid pressure power source is configured to open when a second fluid pressure threshold is reached. The first fluid pressure threshold is greater than or equal to the second fluid pressure threshold. When dependent on Clause 21 or Clause 22, the cassette according to Clause 25.

[0315] Clause 27 The fluid-sealed chamber includes a discharge valve configured to discharge the fluid flowing into the fluid-sealed chamber, and the fluid can flow out of the fluid-sealed chamber through the discharge valve. The cassette according to any one of Clauses 1 to 26.

[0316] Clause 28 The valve at the inlet of the fluid-sealed chamber configured to be fluid-connected to a fluid pressure power source is configured to open when the second fluid pressure threshold is reached, and the discharge valve is configured to discharge the fluid flowing into the fluid-sealed chamber out of the fluid-sealed chamber when the fluid pressure reaches a predetermined threshold. The predetermined threshold is greater than the second fluid pressure threshold. The cassette according to Clause 18 when dependent on Clause 21 or 22.

[0317] Clause 29 The predetermined threshold is greater than the first fluid pressure threshold. The cassette according to Clause 28 when dependent on Clause 26.

[0318] Clause 30 The fluid-sealed chamber of the container carrier is at least partially made of a rigid material. The cassette according to any one of Clauses 1 to 29.

[0319] Clause 31: The fluid sealing chamber is provided with a pressure sensor, and / or the fluid sealing chamber is connected to a fluid sealing measurement chamber, which is configured to be connected to a fluid pressure power source and to have the same fluid pressure level as the fluid sealing chamber. The fluid sealing measurement chamber is provided with a piston, and the piston is operably connected to a position sensor configured to sense the position of the piston within the fluid sealing measurement chamber, and / or the container carrier is provided with a position sensor configured to detect the position of the drug container. The cassette according to any one of Clauses 1 to 30.

[0320] Clause 32: The container carrier partially includes a fluid sealing chamber configured to be formed by a combination of the container carrier and the reusable body of the drug delivery device when the cassette is attached to the reusable body of the drug delivery device. The cassette according to any one of Clauses 1 to 31.

[0321] Clause 33: A drug delivery device comprising the cassette according to any one of Clauses 1 to 32, comprising a reusable body and a replaceable drug delivery member. The reusable body of the drug delivery device includes a fluid pressure power source connected to the inlet of the fluid sealing chamber of the container carrier, and the fluid outlet is operably connected to the drug delivery member.

[0322] Clause 34: The fluid sealing chamber is formed by the container carrier of the cassette and the reusable body when the cassette is attached to the reusable body. The drug delivery device according to Clause 33.

[0323] Clause 35: The drug delivery device includes a processor electrically connected to the fluid pressure power source and a power source connected to the processor. The processor and the power source are housed within the reusable body. The drug delivery device according to Clause 33 or 34.

[0324] Clause 36. The drug delivery device according to clause 35, wherein the delivery tube is disposed between the fluid pressure power source and the inlet of the fluid sealing chamber, and the fluid pressure power source is fluid-connected to the inlet of the fluid sealing chamber via the delivery tube.

[0325] Clause 37. The drug delivery device according to clause 35, wherein the fluid sealing chamber is adjacent to the fluid pressure power source, and the fluid pressure power source is directly fluid-connected to the inlet of the fluid sealing chamber.

[0326] Clause 38. The drug delivery device according to any one of clauses 35 to 37, comprising a user interface attached to a reusable body, the user interface being electrically connected to a processor, the user interface being a button protruding from the outer surface of the reusable body, and the user interface being a touch panel disposed on the outer surface of the reusable body.

[0327] Clause 39. The drug delivery device according to any one of clauses 35 to 38, when dependent on clause 31, wherein the pressure sensor and / or position sensor of the fluid sealing measurement chamber, and / or the position sensor of the container carrier are electrically connected to the processor.

[0328] Clause 40. The drug delivery device according to clause 39, wherein the processor is configured to control the fluid pressure power source to output fluid into the fluid sealing chamber according to signals from the pressure sensor and / or position sensor of the fluid sealing measurement chamber, and / or the position sensor of the container carrier.

[0329] Clause 41. The drug delivery device according to any one of clauses 35 to 40, when dependent on clause 14, wherein the fluid pressure power source is connected to at least two fluid sealing chambers, and the processor is configured to control the fluid pressure power source to selectively output fluid to at least one fluid sealing chamber.

[0330] Clause 42: When dependent on Clause 39, the drug delivery device according to Clause 41, wherein the processor is configured to control a fluid pressure power source to selectively output fluid into at least one fluid-tight chamber according to signals from a pressure sensor and / or a position sensor of the fluid-tight measurement chamber and / or a position sensor of the container carrier.

[0331] Clause 43: The processor is configured to control a fluid pressure power source to output a specific amount of fluid, where the specific amount is predetermined or depends on signals from a pressure sensor and / or a position sensor of the fluid-tight measurement chamber and / or a position sensor of the container carrier, so that only that specific amount of drug contained in the drug container can be extruded from the fluid outlet, for the drug delivery device according to Clause 39 or 38.

[0332] Clause 44: The drug delivery device according to any one of Clauses 33 to 43, wherein the fluid pressure power source is a pneumatic power source.

[0333] Clause 45: The drug delivery device according to Clause 44, wherein the pneumatic power source includes a piezoelectric pump configured to output fluid from the pneumatic power source.

[0334] Clause 46: The drug delivery device according to Clause 44 or 45, wherein the fluid output from the pneumatic power source is a gas.

[0335] Clause 47: The drug delivery device according to any one of Clauses 33 to 34, wherein the drug delivery device is an infusion device.

[0336] Clause 48: The drug delivery device according to any one of Clauses 33 to 47, wherein the fluid pressure power source includes a fluid pump having an inlet fluid-connected to the environment, and the inlet filter connected to the inlet of the fluid pump includes an inlet filter connected to the fluid pump.

[0337] Clause 49: The fluid pressure power source includes a multi-directional valve, and the outlet port of each multi-directional valve is the drug delivery device according to any one of Clauses 33 to 48 that defines the outlet of the fluid pressure power source.

[0338] Clause 50: The drug delivery device according to any one of Clauses 33 to 49, comprising a multi-directional valve connected to the outlet of the fluid pressure power source.

[0339] Clause 51: The drug delivery device according to any one of Clauses 33 to 50, comprising a tube set having a delivery tube and a piercing member, the piercing member being configured to establish a fluid connection between the delivery tube and the drug container.

[0340] Clause 52: A method for controlling a drug delivery device having a fluid pressure power source that is a pneumatic power source and a fluid-sealed chamber including a drug container, wherein: the inlet of the fluid-sealed chamber is connected to the outlet of the fluid pressure power source, the drug container is a flexible bag having a fluid outlet, the flexible bag contains the drug, and the method, in the following order: Receiving at least one of a pressure level measurement of the fluid pressure in the fluid-sealed chamber and a flow rate measurement of the speed of the drug exiting the fluid outlet of the flexible bag; Obtaining information from a database using the received measurement; and Providing a signal based on the obtained information to cause one or more electronic components of the drug delivery device to perform an operation or to stop a currently executing operation of one or more electronic components of the drug delivery device. A method including the above steps.

[0341] Clause 53: The step of receiving at least one of a pressure level measurement of the fluid pressure in the fluid-sealed chamber and a flow rate measurement of the speed of the drug exiting the fluid outlet of the flexible bag Includes the step of receiving a pressure level measurement of the fluid pressure in the fluid-sealed chamber and a flow rate measurement of the speed of the drug exiting the fluid outlet of the flexible bag, and is the method according to Clause 52.

[0342] The step of obtaining information from a database using the received measurement values in accordance with clause 54 is the following steps in the following order: Calculating a value based on the received measurement values using the ideal gas law and its simplifications; Comparing the calculated value with a predetermined value; and Generating a result of the comparison The method according to clause 52 or 53, including:

[0343] After the step of generating the result of the comparison, the step of obtaining information from a database using the received measurement values in accordance with clause 55 The method according to clause 54, further including the step of providing the obtained information by collating the result of the comparison with the information from the database.

[0344] After the step of generating the result of the comparison, the step of obtaining information from a database using the received measurement values in accordance with clause 56 The method according to clause 54 or 55, further including the step of providing the obtained information by providing the result of the comparison.

[0345] The obtained information relates to at least one of the actually filled volume of the drug in the drug container, the volume of the drug remaining in the drug container after use, the air in the delivery tube, the delivery member being away from the delivery site, and the delivery occlusion, according to the method of clause 56 or 57.

[0346] The predetermined value relates to at least one of the volume of the drug container, the volume of the drug contained in the drug container, the target flow rate of the drug exiting the fluid outlet of the flexible bag, the target pressure level of the fluid pressure in the fluid seal chamber, the previously received flow rate of the drug exiting the fluid outlet of the flexible bag, the previously received pressure level of the fluid pressure in the fluid seal chamber, and the previously calculated volume of the drug contained in the drug container, according to any one of clauses 54 to 57.

[0347] The value specified in clause 59 is the method described in clause 58 received from the information tag on the drug container.

[0348] Clause 60 The operation of one or more electronic components of the drug delivery device is configured to be executed or stopped by a provided signal, and provides an instruction to the user of the drug delivery device, a drug delivery operation, transmits data to a remote server, adjusts the pressure level of the fluid pressure in the fluid seal chamber, and adjusts the drug release rate from the fluid outlet of the flexible bag. The method according to any one of clauses 52 to 59, which is at least one of them.

[0349] Clause 61 The processor is configured to execute the method according to any one of clauses 48 to 56, the drug delivery device according to clause 35, or, when dependent on clause 35, according to any one of clauses 36 to 51.

[0350] Clause 62 A drug delivery device comprising a cassette according to any one of clauses 1 to 32, comprising a reusable body and a replaceable drug delivery member, wherein the reusable body of the drug delivery device comprises a fluid pressure power source connected to the inlet of the fluid seal chamber of the container carrier, the fluid outlet is operably connected to the drug delivery member, and the drug delivery device comprises a processor configured to execute the method according to any one of clauses 48 to 56. A drug delivery system.

[0351] Clause 63 The fluid seal chamber of the cassette is operably connected to a pressure sensor configured to measure the pressure level measurement value of the fluid pressure in the fluid seal chamber and / or a flow sensor configured to measure the speed of the drug exiting the fluid outlet of the flexible bag. The drug delivery system according to clause 62.

[0352] Clause 64 The cassette is the drug delivery device according to clause 63, which is operably connected to a pressure sensor and a flow sensor.

[0353] Clause 65 The cassette is the drug delivery device according to clause 64, which comprises a pressure sensor and a flow sensor.

[0354] Clause 66. A reusable body of a drug delivery device, which is a drug delivery device according to any one of Clauses 62 to 65 and includes a processor.

[0355] Clause 67. A drug delivery device according to Clause 66, wherein the processor is electrically connected to a fluid pressure power source.

[0356] Clause 68. A drug delivery device according to a combination of Clause 67 and any one of Clauses 66 to 67, wherein the processor is electrically connected to a pressure sensor and a flow rate sensor when a cassette is attached to the reusable body of the drug delivery device.

[0357] Clause 69. A drug delivery device according to any one of Clauses 62 to 68, wherein the reusable body of the drug delivery device includes a communication unit configured to read an information tag on a drug cassette when the cassette is attached to the reusable body of the drug delivery device.

[0358] Clause 70. A drug delivery device according to a combination of Clauses 68 and 69, wherein the communication unit is electrically connected to the processor.

[0359] Clause 71. A drug delivery device according to any one of Clauses 69 or 70, wherein the communication unit is an RFID / NFC reader and / or an RFID / NFC writer.

[0360] Clause 72. A drug delivery device according to any one of Clauses 62 to 71, wherein the pneumatic power source includes a piezoelectric pump configured to output a fluid from the pneumatic power source.

[0361] Clause 73. A drug delivery device according to Clause 72, wherein the fluid output from the pneumatic power source is a gas.

[0362] Clause 74. A drug delivery device according to any one of Clauses 62 to 73, wherein the drug delivery device is an infusion device.

[0363] Clause 75. The drug delivery device according to any one of Clauses 62 to 74, wherein the fluid pressure power source includes a fluid pump having an inlet fluidly connected to the environment, and an inlet filter connected to the inlet of the fluid pump includes an inlet filter connected to the fluid pump.

[0364] Clause 76. The drug delivery device according to any one of Clauses 62 to 75, wherein the fluid pressure power source includes a multi-way valve, and an outlet port of each multi-way valve defines an outlet of the fluid pressure power source.

[0365] Clause 77. The drug delivery device according to any one of Clauses 62 to 76, comprising a multi-way valve connected to an outlet of the fluid pressure power source.

[0366] Clause 78. The drug delivery device according to any one of Clauses 62 to 77, comprising a tube set having a delivery tube and a piercing member, the piercing member being configured to establish a fluid connection between the delivery tube and the drug container.

Claims

Claim 1 A cassette (1; 1''; 1''') configured for use with a drug delivery device (2; 2'; 2''), said drug delivery device comprising a reusable body (20; 20') having a fluid pressure power source (21; 21'), said cassette (1; 1'; 1'') comprising a container carrier (10; 10'; 10''; 10'''; 10a'', 10b'', 10c'', 10d''); a drug container (M; Ma, Mb, Mc, Md; Ma', Mb', Mc', Md') comprising a body (M0; M0'; M0''; M0a, M0b; M0a, M0a', M0a'', M0b, M0b'; M0b'') and a fluid outlet (M1; M1'), said body (M0; M0'; M0''; M0a, M0b; M0a, M0a', M0a'', M0b, M0b'; M0b'') including a flexible portion, said drug container (M; Ma, Mb, Mc, Md; Ma', Mb', Mc', Md') being at least partially disposed within said container carrier (10; 10'; 10''; 10'''; 10a'', 10b'', 10c'', 10d''); The container carrier (10; 10'; 10''; 10'''; 10a'', 10b'', 10c'', 10d'') comprises a fluid-tight chamber (11; 11'; 11''; 11a''', 11b''', 11c'''; 11a'''', 11b'''', 11c'''', 11d'''', 11'''''、11'''''、11a'''''、11b'''''、11c'''''、11d''''';11a'''''、11b'''''、11c'''''、11d''''';11a'''''、10e''''';11a'''''、11b'''''), and the fluid-tight chamber (11; 11'; 11''; 11a''', 11b''', 11c'''; 11a'''', 11b'''', 11c'''', 11d''''';11'''''、11'''''、11a'''''、11b'''''、11c'''''、11d''''';11a'''''、11b'''''、11c'''''、11d''''';11a'''''、10e''''';11a'''''、11b''''')comprises an inlet (110, 110', 110'', 110'''', 110a''); the inlet (110, 110'; 110''; 110'''; 110'''; 110a) is configured to be fluidly connected to an outlet (210) of the fluid pressure power source of the reusable body of the drug delivery device; The fluid-sealing chamber (11; 11'; 11''; 11a''', 11b''', 11c'''; 11a'''', 11b'''', 11c'''', 11d'''', 11'''''、11''''''、11a'''''''、11b'''''''、11c'''''''、11d'''''''、11a''''''''、11b''''''''、11c''''''''、11d''''''''、11a'''''''''、10e''''''、11a''''''''''、11b''''''''''), is connected to the flexible portion of the main body (M0; M0'; M0''; M0a, M0b; M0a, M0a', M0a'', M0b, M0b'; M0b'') of the drug container (M; Ma, Mb, Mc, Md; Ma', Mb', Mc', Md'); as a result, the inlet (110; 110'; 110''; 110'''; 110''''; 110a) receives the output fluid from the fluid pressure power source (21; 21'), and the output fluid flows into the fluid-sealing chamber (11; 11'; 11''; 11a''', 11b''', 11c'''; 11a'''', 11b'''', 11c'''', 11d'''', 11'''''、11''''''、11a'''''''、11b'''''''、11c'''''''、11d'''''''、11a''''''''、11b''''''''、11c''''''''、11d''''''''、11a'''''''''、10e''''''、11a''''''''''、11b''''''''''), and at least a part of the drug contained in the drug container (M; Ma, Mb, Mc, Md; Ma', Mb', Mc', Md') is pushed out under the pressure of the output fluid; And the fluid outlet (M1; M1') is configured to be connected to the drug delivery member (23; 23a', 23b', 23c', 23d') of the drug delivery device (2; 2'; 2'') when the cassette (1; 1'; 1'') is attached to the drug delivery device (2; 2'; 2''). **Claim 2** The cassette according to claim 1, wherein the main body of the drug container includes a flexible bag received in the fluid-sealing chamber. **Claim 3** The cassette includes the container carrier having one fluid-sealing chamber in the container carrier. The container carrier is configured with a connection port that is releasably attachable to either the outlet of the fluid pressure power source of the reusable body of the drug delivery device or another connection port of another container carrier, and the container carriers are configured to be stacked on top of each other. The cassette according to claim 1 or 2.

4. The cassette is one container carrier, and is configured with the connection port that is releasably attachable to either the outlet of the fluid pressure power source of the reusable body of the drug delivery device or another connection port of another container carrier of another cassette, and the plurality of cassettes are configured to be stacked on top of each other. The cassette according to claim 3, comprising one container carrier.

5. The cassette is configured with a cassette housing that is releasably attachable to the reusable body of the drug delivery device, and the cassette comprises a plurality of container carriers stacked on top of each other within the cassette housing. The cassette according to claim 3.

6. The cassette according to any one of claims 1 to 5, wherein the fluid sealing chamber is formed by a container frame.

7. The cassette according to claim 6, wherein the fluid sealing chamber is formed by the container frame and an internal chamber of the container carrier.

8. The cassette according to claim 6, wherein the fluid sealing chamber is formed by the container frame and a cap configured to be attached to the container frame.

9. The cassette according to claim 8, wherein the cap comprises a tube set operably connected to the fluid outlet of the drug container within the fluid sealing chamber.

10. The cassette according to claim 9, wherein the tube set comprises a perforated member configured to establish fluid communication between the delivery tube and the drug container through the fluid outlet of the drug container.

11. The cassette according to any one of claims 1 to 10, wherein the fluid sealing chamber is provided with a discharge valve configured to discharge the fluid flowing into the fluid sealing chamber, and the fluid can flow out of the fluid sealing chamber through the discharge valve.

12. A drug delivery device comprising the cassette according to any one of claims 1 to 11, wherein the drug delivery device comprises a reusable body and a replaceable drug delivery member, and the reusable body of the drug delivery device comprises the fluid pressure power source connected to the inlet of the fluid sealing chamber of the container carrier, and the fluid outlet is operably connected to the drug delivery member.

13. The drug delivery device according to claim 12, wherein the fluid pressure power source comprises a multi-directional valve, and the outlet port of each multi-directional valve defines the outlet of the fluid pressure power source.

14. The drug delivery device according to claim 12, comprising a multi-directional valve connected to the outlet of the fluid pressure power source.

15. The drug delivery device according to any one of claims 12 to 14, wherein the fluid pump is a piezoelectric pump.

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